Apparatus and method for cooling and / or heating an organ

Abstract

A thermal therapy system, device, and method of using the same are disclosed. A local hypothermia treatment of the pancreas using delivery and placement procedures in a patient's stomach, including a cooling balloon system, is disclosed. This can be used for the treatment of pancreatitis in a patient. The cooling balloon system may have a mechanism for acting on pancreatitis without systemically affecting or inducing hypothermia in the patient. The local hypothermia system may have a simplified delivery system and can be aimed at reducing the patient's pain while reducing the metabolic activity of the inflamed pancreatitis in the patient.

Description

Technical Field

[0001] (Cross - Reference to Related Applications)

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 363,926, filed on April 29, 2022, U.S. Provisional Patent Application No. 63 / 381,520, filed on October 28, 2022, and U.S. Provisional Patent Application No. 63 / 492,189, filed on March 24, 2023. Each of these is hereby incorporated by reference in its entirety for all purposes.

Background Art

[0002]

[0002] Systems capable of performing local hypothermia treatment for pancreatic inflammation and / or pancreatitis, and using such systems for obesity, the treatment of pancreatic cancer, hypothermia for other body structures and organs, and general thermoregulation, are disclosed. The disclosed methods and devices can be used for both hypothermia and hyperthermia treatments, or for combining both heat applications during medical procedures.

[0003]

[0003] Pancreatitis can be classified as acute and / or chronic. Pancreatitis has many etiologies including, but not limited to, alcoholic, gallbladder and / or gallstone - related, and / or other causes / idiopathic. In any case, inflammation can occur in the pancreas that can affect the patient's endocrine and exocrine functions. Severe pancreatitis can occur in one out of four patients, and the associated mortality rate is 5%.

[0004]

[0004] A system that can reduce pancreatic inflammation while decreasing metabolic activity can provide benefits to patients, physicians, and / or healthcare systems that require ICU admission for patients with pancreatitis.

[0005]

[0005] Disclosed is local hypothermia that can be performed by internal and external heat exchangers and heating and / or cooling devices that raise and / or lower body temperature.

[0006]

[0006] A system for local hypothermia is particularly useful for treating certain physical disabilities or inflammations. General forms of local hypothermia have been demonstrated by applying an ice pack to an ankle sprain or circulating a cooling pad after orthopedic procedures.

Summary of the Invention

[0007]

[0007] A thermotherapy system, device, and method are disclosed.

[0008]

[0008] Disclosed herein is a system for inducing local hypothermia. The pancreas can be heated / cooled directly and / or indirectly. For example, the pancreas can be directly cooled by inserting a needle into the pancreas. The needle and / or catheter can be inserted transabdominally and / or laparoscopically. The needle can directly remove heat from the pancreas. The pancreas can be indirectly cooled by cooling an organ, fluid (liquid or gas), and / or tissue adjacent to the pancreas. For example, the gastric wall, dermis, and / or duodenum adjacent to the pancreas can be cooled, thereby cooling the pancreas.

[0009]

[0009] The heat exchange process can occur outside and / or inside the patient. The methods of heat exchange can include thermoelectric cooling, vapor compression refrigeration, phase change, Carnot cycle refrigeration, reverse Rankine refrigeration, evaporative cooling, heat tunnel cooling, magnetic refrigeration, circulating refrigeration, non-circulating refrigeration, adsorption cycle, elastocaloric refrigeration, fridgigate, vortex tube, pulse tube refrigeration, and / or thermoacoustics.

[0010]

[0010] The catheter can be introduced orally and / or nasally. The catheter can extend into the stomach, duodenum, intestine, jejunum, and / or the interior of the Vater ampulla. The catheter can transport cold fluid to cool the stomach, duodenum, intestine, jejunum, and / or the Vater ampulla, thereby indirectly cooling the pancreas. The catheter can have one and / or more lumens. The catheter can circulate fluid. For example, the catheter can have an inflow and / or outflow lumen, and the inflow lumen can transport colder fluid than the outflow lumen. The catheter can have one lumen for transporting cooling fluid into and / or out of the patient. For example, cold fluid can be introduced into the patient, remain within the patient for a period of time, and then be removed after warming.

[0011]

[0011] The heat transfer fluid can come into direct contact with the patient's organs, tissues, and / or fluids. The heat transfer fluid can come into indirect contact with the patient's organs, tissues, and / or fluids, for example, when it is within a catheter, one balloon, and / or multiple balloons.

[0012]

[0012] The catheter and / or balloon can be positioned using a magnet. To visualize the position of the catheter and / or balloon, various imaging methods can be used, including but not limited to X-ray, CT, MRI, and ultrasound. The catheter can include multiple lumens. The catheter can include one or more lumens for aspiration, delivering additional tools, delivering additional sensors, delivering drugs, and / or delivering nutrients.

[0013]

[0013] One or more external cooling pads can be placed on the outer surface of the patient's stomach, in extremely close proximity to the patient's pancreas, to provide cooling energy that can function with an internal cooling system for hypothermia methods. These pads can be connected to the same cooling box that drives the internal catheter system and / or to a separate component from the cooling box.

[0014]

[0014] The external cooling pad may have a magnetic source that can assist in juxtaposing a catheter and / or balloon against the portion of the stomach immediately adjacent to the pancreas. The external cooling pad may have a magnetic source that facilitates articulation of the distal end of the catheter system to position an additional balloon within the patient's duodenum.

[0015]

[0015] The external cooling pad can provide electromagnetic energy to drive or rotate a rod within the balloon system to promote circulation of the cooling medium within the balloon. The electromagnetic energy can be used to open or close valves to circulate the cooling medium between various sections or chambers of one or more balloons or within the catheter system. The electromagnetic energy can be used to open or close valves to administer nutrients to the patient. The electromagnetic energy can be used to expand a structure or stent within the catheter system to open a lumen or deflect the catheter to articulate it.

[0016]

[0016] A mechanical structure can be deployed to assist in positioning the catheter and / or balloon. Components within the catheter can assist the physician or operator in juxtaposing the balloon against the inner wall of the stomach to more efficiently transport cooling energy to the pancreas. Mechanisms for improving the deployment and positioning of the catheter system and balloon include applying torque to elements within the catheter or articulating elements within the catheter to enable the operator to manipulate the distal end of the catheter system.

[0017]

[0017] The catheter system may have inflatable or deployable protrusions that can press the hypothermia balloon portion of the system against the inner wall of the stomach closest to the pancreas. These protrusions can be inflatable balloon extensions for pressing the balloon against the pancreas. Other protrusions can be mechanically deployed by a tension wire or coil that can protrude when rotated by the operator.

[0018]

[0018] The catheter system and balloon can be designed to reduce the amount of expansion or mass within the stomach while increasing the surface area in contact with the inner wall of the stomach.

[0019]

[0019] A plurality of sensors can be used to monitor the patient and / or the cooling system. Contact and / or non-contact temperature probes can be used to monitor various tissues, organs, and / or fluids of the patient. Contact and / or non-contact temperature probes can be used to monitor the temperature of the heat transfer fluid at one and / or more locations. A PH sensor can be used to monitor the acidity of gastric juice. Sensors can be used to monitor the position of the patient, catheter, and / or one or more balloons. An internal pressure sensor within the catheter system can provide signals to the operator and physician indicating that the patient is experiencing backflow, muscle spasms, or integrity failure within the catheter system.

[0020]

[0020] The distal end of the catheter system may have an endoscope for visualizing the gastric wall. The distal ends of the catheter and balloon may have an endoscope for visualizing the gastric wall. The visualization source can assist the operator in placing an additional balloon within the duodenum.

[0021]

[0021] The catheter can be isolated. The isolated catheter can be highly efficient in transporting cold fluid into the patient. The isolated catheter can reduce unintended cooling to other organs including, but not limited to, the esophagus. The catheter may include a material with low thermal conductivity. The catheter can be configured such that cold fluid is positioned at the center of the catheter. Air can be circulated outside the central lumen of the catheter to maintain an isolation air layer between the cooling medium and the body area left untreated.

[0022]

[0022] The outer surface of the catheter can be isolated and covered with an expandable membrane that can be filled with air or a warming medium. The expandable membrane can expand to a diameter larger than that of the catheter during insertion. This dimension can be 1 mm, 5 mm, or 10 mm in diameter. The insertion diameter of the catheter system can be reduced to improve patient comfort. The isolation membrane can be expanded in the section of the catheter that can be isolated once it is placed inside the body. For example, the isolation membrane can be expanded by air or a warming medium in the esophagus or nasopharyngeal region.

[0023]

[0023] Once a cooling medium is introduced into the balloon, the air or warming medium circulating for active isolation can isolate the non-balloon part of the system so as to apply a higher temperature to the intended treatment area of the body. In this regard, the air or warming medium for isolation can be dynamic.

[0024]

[0024] Isolation can be achieved by isolating the cooling medium in the hypothermia balloon from the rest of the catheter system. The isolation process can be carried out using a catheter with a valve. Once the cooling medium is injected, air can be introduced into the system.

[0025]

[0025] The catheter can have a communication port that can provide the operator with a mechanism for administering an analgesic that soothes or paralyzes body openings, the esophagus, and the stomach. The analgesic can be administered to reduce tissue irritation during the treatment period.

[0026]

[0026] Applying a hydrophilic coating to the outer surface of the catheter system can reduce the friction during instrument insertion and reduce the effect of friction over time while the catheter system is positioned inside the body.

[0027]

[0027] The communication port for the outer surface of the balloon can improve the contact of the balloon with the inner wall of the stomach. The communication port can deliver a limited amount of cooled medium directly to the stomach wall.

[0028]

[0028] The catheter system can be designed to enter the duodenum through the pylorus and to further perform cooling within the large intestine, anatomically very close to the head of the pancreas.

[0029]

[0029] The distal end of the catheter system may have a helical configuration to facilitate entry into the duodenum.

[0030]

[0030] The distal end of the catheter system can have a helical configuration and can be designed to rotate about the central axis of the catheter independently of the proximal portion of the catheter system. This configuration can stabilize the catheter system at the nasopharyngeal section of the patient, while the distal end rotates independently to facilitate entry into the duodenum.

[0031]

[0031] The catheter system has an expandable lumen and can reduce the outer shape of the system for entry.

[0032]

[0032] The catheter system has an expandable lumen at the distal portion of the catheter and can facilitate heat transfer at a desired section for cooling the patient's anatomical structure.

[0033]

[0033] Regarding the local hypothermia treatment itself, the following steps describe the key points of the method and variations for performing the treatment on the patient. Once diagnosed with pancreatitis, the patient can be placed in an appropriate position for the treatment with the catheter supplies and cooling box prepared for use.

[0034]

[0034] System Preparation: The cryotherapy catheter system package can be prepared for use as per the instructions. This preparation can include pre-filling the internal lumens of the system, flowing a medium through the through-lumen, testing the integrity of the balloon, and coating the outside of the catheter system with an analgesic before insertion into the patient. The cooling box can be prepared using a medium such as saline and placed in a cooling cycle or mode. The catheter system can be system-checked by integrity sensors, flow sensors, and other sensors and then coupled to the cooling box.

[0035]

[0035] Method of Pancreatic Local Hypothermia

[0036]

[0036] Connection to the Cooling Box: The connection to the cooling box can be programmed by an identifier or EEPROM to ensure single-patient use. The cooling box can have an on-screen display showing system preparation procedures, sensor status, and other real-time temperatures, fluid pressures, medium flow rates, and other values. The cooling box can have software / firmware for generating various cooling regimens or programs using general or specific hypothermia parameters. The cooling box can be mounted on a bedside IV pole or stand or be a freestanding type on the floor or table. The cooling box can be made portable by being a wearable box, miniaturized, battery-powered, and adapted to be worn by the patient. The patient can be easily transported from the bedside or be able to move independently during treatment. The cooling box can be configured to communicate via Bluetooth or Wi-Fi for remote control by medical professionals.

[0037]

[0037] Insertion of the Catheter System into the Patient: The catheter system can be placed via the nasal, oral, or transgastric route. The catheter system can be delivered in a thin state with a balloon inserted, housed, and / or encapsulated within the distal portion of the catheter system.

[0038]

[0038] Placement of the catheter in the stomach: The catheter system may be flexible for delivery to the stomach. Within the catheter, the tension wire can be bent like a joint to deflect the distal end of the catheter. Within the lumen of the catheter, a braid material or mandrel can provide rigidity for torque to selectively rotate the curved section of the catheter. The mandrel within the catheter can be removed by the operator once placed in the stomach to provide further flexibility or to provide a lumen for fluid, media, aspiration, or infusion of nutrients to the patient. The distal end of the catheter may have an echo source chip or ultrasonic sensor that facilitates identification of the distal tip of the catheter by external ultrasonic or acoustic devices.

[0039]

[0039] Deployment of the balloon in the stomach: The balloon at the distal end of the catheter can be expanded or ejected by separating, pulling, or rotating a part of the catheter to expose the balloon. The internal stent within the balloon facilitates the deployment of the balloon and can easily achieve a predetermined shape of the balloon.

[0040]

[0040] Filling of the balloon with a medium: The catheter system can be coupled to a cooling box to fill the balloon with a cooling medium. As a prior step, the balloon can be filled with air to fully deploy the balloon before filling with the medium or to check and confirm the position of the balloon. The cooling box can deliver filtered air, CO2, or other gases and then deliver the cooling medium. After delivering the cooling medium, air can be delivered to supply isolation means to the esophagus and upper nasal cavity and oral cavity.

[0041]

[0041] Balloon juxtaposition against the gastric wall: The balloon can be placed in the lower stomach by the effect of gravity. Further, by applying torque to the distal end of the catheter system within the stomach and bending it like a joint, juxtaposition near the area of the pancreas can be achieved. By actuating one or more tension wires within the catheter system, the distal end of the catheter system can be bent like a joint within a curved shape, thereby allowing the balloon to be placed closer to the inner wall of the stomach. The catheter system may have protrusions that can provide a counterforce to position the balloon closer to the pancreas relative to the inner wall of the stomach. These protrusions can be deployed similar to stents, baskets, or deflecting ribs. The protrusions can be inflatable bumps, cones, or balloons that can push the distal end of the catheter closer to the inner wall of the stomach. The distal end of the catheter system may have a ferromagnetic substance that can be interlocked with an external magnetic force that allows the balloon to approach the pancreas.

[0042]

[0042] Balloon inflation: At the distal end of the catheter, the balloon can be filled using air, liquid, gas, media, and combinations thereof. The inflation of the balloon can be monitored and measured by the pressure and total volume of the delivered air, liquid, gas, or media. An opening or port within the catheter that can be in fluid communication with an internal lumen or multiple lumens can supply the inflation medium into the balloon.

[0043]

[0043] Inflation method for reducing the pressure in the stomach: The balloon can be supplied with a cooling medium and monitored so as to reduce the total pressure in the stomach and minimize the patient's pain. A pressure sensor within the cooling balloon can record the response contraction in the stomach acting on the balloon and the catheter system. In response to an increase in pressure due to the force acting on the catheter system from the stomach, the inflation medium, the pressure of the inflation medium, and / or the volume within the balloon can be reduced or increased according to the force monitored and recorded in the stomach.

[0044]

[0044] Monitoring Hypothermia Therapy: When hypothermia therapy is being performed, the thermocouple on the catheter system can provide feedback on the temperatures of the expansion medium, the catheter, the outer surfaces of the balloon, and the multiple outer surfaces of the balloon that are in contact with the gastric wall near the pancreas and areas remote from the pancreatic area. Hypothermia therapy can be monitored over time and checked against the patient's body temperature. A wearable thermometer can be coupled to the cooling chamber to provide feedback against excessive hypothermia or to add additional cooling medium as appropriate.

[0045]

[0045] Simultaneous Procedures including Endoscopy, Diagnostic Fluid or Content Sampling, Ultrasound and Fluoroscopy, and Drug Delivery during Hypothermia Therapy: The catheter system can be configured to allow insertion of an endoscope for internal visualization or to use an integrated endoscope. The catheter system can have ports that allow sampling of fluids or substances within the stomach for diagnostic purposes. The catheter system can be configured using an echo source or a radiopaque substance or member that facilitates detection by ultrasound or fluoroscopy. Doppler ultrasound can be used to record the flow of the expansion medium in the catheter system, the gastric vasculature, and areas near the pancreas. The catheter system can be configured using ports that allow delivery of drugs to the patient. Ports can be placed at specific locations on the catheter system to provide drugs or analgesics to the nasal, oral, and esophageal passages, and the stomach. Ports can be placed on the outer portion of the balloon to directly deliver drugs and analgesics to the inner gastric wall near the pancreas.

[0046]

[0046] Nutritional intake of patients during treatment: The catheter system may have a lumen for supplying nutrients such as nutritional media to the patient. Nutrient delivery can be performed using an external pressure or mechanical force directly supplied by a medical expert or a cooling box. The catheter system has an expandable lumen that expands in response to the mechanical force of the supplied nutrients, thereby delivering the nutrients to the patient's digestive tract. The expandable lumen that can expand when used with the patient's nutritional intake makes it possible to minimize the insertion and wearing profile of the catheter system.

[0047]

[0047] Confirmation of hypothermia treatment: During treatment, the overall enzymatic activity of the pancreas can be monitored to demonstrate and monitor the effectiveness of the treatment. The metabolic activity of the pancreas can be monitored by a PET scan. Temperature measurements at the gastric wall and other locations inside and outside the catheter system within the patient can provide a determination of the hypothermia treatment dose.

[0048]

[0048] Continuation or protocol of treatment: The duration of hypothermia treatment can be in an on-off cycle or continuous during the treatment. Hypothermia treatment can start at a certain cooling temperature and then be lowered in a stepwise manner. The stepwise manner can be to change to another temperature setting after proceeding at a certain low temperature setting for a specific duration, or to return to a lower temperature setting after returning to a reference. The treatment protocol can be programmed in the cooling box or can respond to feedback from a temperature sensor within the catheter system or the patient's body temperature measurement.

[0049]

[0049] Completion of treatment: Hypothermia treatment can be stopped by the completion of a known cooling protocol or by the patient's body temperature measurement reaching a specific predetermined stop point. The treatment can be stopped when the patient achieves a specific level of improvement in symptoms, enzymatic measurements, or metabolic activity.

[0050]

[0050] Removal of the device from the patient: Once the treatment is complete, all balloons and external projections can be deflated to remove the inflation medium and gas, minimizing bending or rigidity, such as at the joints of the distal end of the catheter, to reduce the stiffness of the system for removal from the patient.

[0051]

[0051] Regional pancreatic hypothermia without systemic hypothermia has been shown to reduce the severity of acute pancreatitis induced by different methods in rats.

Brief Description of the Drawings

[0052]

[0052] The drawings shown and described are exemplary variations and are non-limiting. Throughout the drawings, like reference numerals indicate the same features or features that are functionally equivalent.

[0053]

Figure 1

[0053] Schematic of a thermotherapy system deployed in a patient's digestive system.

Figure 2a

[0054] Cross-section of the catheter is shown.

Figure 2b

[0054] Cross-section of the catheter is shown.

Figure 2c

[0054] Cross-section of the catheter is shown.

Figure 2d

[0054] Cross-section of the catheter is shown.

Figure 3

[0055] Schematic of another embodiment of a thermotherapy system deployed in a patient's digestive system is shown.

Figure 4a

[0056] Cross-section of the distal end of the cooling device with a partially inflated balloon is shown.

Figure 4b

[0056] Cross-section of the distal end of the cooling device with a partially inflated balloon is shown.

Figure 5a

[0057] Cross-section of the distal end of an additional embodiment of the cooling device with a partially inflated balloon is shown.

Figure 5b

[0057] Shows a cross-section of the distal end of an additional embodiment of the cooling device with a partially inflated balloon.

Figure 6

[0058] Shows data from a simulated local cooling system.

Figure 7

[0059] Shows a schematic of another embodiment of a thermotherapy system deployed in a patient's digestive system.

Figure 8

[0060]

[0057] Shows a cross-section of the distal end of an additional embodiment of the cooling device with a partially inflated balloon.

Figure 9

[0061] Shows a schematic of another embodiment of a thermotherapy system deployed transabdominally.

Figure 10

[0062] Shows a mechanical structure that can position and / or fix a cooling balloon on the gastric wall adjacent to the pancreas.

Figure 11

[0063] Shows a pyloric plug in a suitable position to prevent the outflow of cooling fluid into the duodenum, and also shows a permeable and / or semi-permeable membrane and / or coating disposed on the gastric wall that can prevent and / or slow down fluid absorption into the gastric wall.

Figure 12

[0064] Shows that the target temperature of the pancreas can be achieved in an artificial pancreas (using bovine tissue) using cooled fluid circulating through a cooling balloon placed in an artificial stomach (using bovine gastric tissue) in a water bath at body temperature (37 °C).

Figure 13a

[0065] Shows the stomach and pancreas in one of two different isometric views.

Figure 13b

[0065] Shows the stomach and pancreas in one of two different isometric views.

Figure 14a

[0066] Shows an isometric view of the stomach and pancreas with the front half removed, and shows a catheter disposed in the stomach with an elastic balloon in a contracted configuration.

Figure 14b

[0066] Shows an isometric view of the stomach and pancreas with the front half removed, and shows a catheter disposed in the stomach with an elastic balloon in an inflated configuration.

Figure 15a

[0067] An isometric view of the stomach and pancreas with the anterior half removed, showing a catheter disposed within the stomach and duodenum together with a non-elastic stomach balloon in a constricted configuration and a duodenal balloon in a constricted configuration.

Figure 15b

[0067] An isometric view of the stomach and pancreas with the anterior half removed, showing a catheter disposed within the stomach and duodenum together with an elastic balloon in an inflated configuration and a duodenal balloon in a constricted configuration.

Figure 15c

[0067] An isometric view of the stomach and pancreas with the anterior half removed, showing a catheter disposed within the stomach and duodenum together with an elastic balloon in an inflated configuration and a duodenal balloon in an inflated configuration.

Figure 16a

[0068] An isometric view of the stomach and pancreas with the anterior half removed, showing a catheter disposed within the stomach together with three inflatable balloons.

Figure 16b

[0068] An isometric view of the stomach and pancreas with the anterior half removed, showing a catheter disposed within the stomach together with six inflatable balloons.

Figure 16c

[0068] An isometric view of the stomach and pancreas with the anterior half removed, showing a catheter disposed within the stomach together with a plurality of inflatable balloons on the front side and the rear side.

Figure 17

[0069] An isometric view of the stomach and pancreas with the anterior half removed, showing a catheter extending through the stomach to the duodenum in an unconstrained configuration. The catheter includes a catheter lock portion and a duodenal device.

Figure 18

[0070] An isometric view of the stomach and pancreas with the anterior half removed, showing a catheter disposed within the stomach in a helical configuration.

Figure 19

[0071] An isometric view of the stomach and pancreas with the anterior half removed, showing a catheter extending through the stomach via a percutaneous port and / or a port in the gastric wall.

Figure 20

[0072] An isometric view of the stomach and pancreas with the anterior half removed, showing a catheter including a coil within the stomach and duodenum.

Figure 21

[0073] The stomach and pancreas with the anterior half removed are shown in an isometric view, showing a catheter extending from an introducer.

Figure 22

[0074] The stomach and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the stomach together with a plurality of inflatable balloons.

Figure 23

[0075] The stomach and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the stomach together with a plurality of inflatable lumens and / or balloons.

Figure 24

[0076] The stomach and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the stomach and an intestinal plug within the duodenum.

Figure 25

[0077] The stomach and pancreas with the anterior half removed are shown in an isometric view, showing a catheter extending into the pancreatic duct through the stomach and a pyloric plug.

Figure 26

[0078] The stomach and pancreas are shown in an isometric view, showing a cooling device disposed on the surface of the pancreas.

Figure 27a

[0079] A cross-section of the catheter is shown.

Figure 27b

[0079] A cross-section of the catheter is shown.

Figure 27c

[0079] A cross-section of the catheter is shown.

Figure 27d

[0079] A cross-section of the catheter is shown.

Figure 27e

[0079] A cross-section of the catheter is shown.

Figure 27f

[0079] A cross-section of the catheter is shown.

Figure 28a

[0080] A cross-section of the catheter and a balloon in a contracted configuration is shown.

Figure 28b

[0080] A cross-section of the catheter and a balloon in an inflated configuration is shown.

Figure 28c

[0080] A cross-section of the catheter and a balloon in an inflated configuration is shown.

Figure 28d

[0080] A cross-section of the catheter and a balloon in an inflated configuration is shown.

Figure 28e

[0080] Shows a cross-section of a catheter and an inflated balloon.

Figure 28f

[0080] Shows a cross-section of a catheter and an inflated balloon.

Figure 29

[0081] Shows a side view of the catheter together with a plurality of broken lines.

Figure 30

[0082] Is a schematic diagram of a system capable of providing heat transfer to the stomach.

Figure 31

[0082] Is a schematic diagram of a system capable of providing heat transfer to the stomach.

Figure 32

[0083] Shows an exemplary view of the duodenum and pancreas together with a catheter passing through an artery.

Figure 33

[0084] Shows data from a simulated local cooling system.

Figure 34

[0085] Shows an isometric view of the stomach and pancreas with the front half removed, showing a catheter including a distal end formed into a tapered coil.

Figure 35a

[0086] Shows an isometric view of the stomach, pancreas, and catheter with the front half removed, showing the catheter together with an inversion membrane connecting the inner and outer catheters, showing the catheter proximal to the pylorus.

Figure 35b

[0086] Shows an isometric view of the stomach, pancreas, and catheter with the front half removed, showing the catheter together with an inversion membrane connecting the inner and outer catheters, showing a detailed view of the tip of the catheter shown in FIG. 35a.

Figure 35c

[0086] Shows an isometric view of the stomach, pancreas, and catheter with the front half removed, showing the catheter together with an inversion membrane connecting the inner and outer catheters, showing the catheter entering the pylorus.

Figure 35d

[0086] Shows an isometric view of the stomach, pancreas, and catheter with the front half removed, showing the catheter together with an inversion membrane connecting the inner and outer catheters, showing a detailed view of the tip of the catheter shown in FIG. 35c.

Figure 36

[0087] The stomach and pancreas with the front half removed are shown in an isometric view, showing a coiled catheter positioned within the esophagus.

Figure 37a

[0088] A modified example of the catheter within the stomach is shown.

Figure 37b

[0089] A modified example of the catheter within the stomach is shown.

Figure 38

[0090] A modified example of the catheter along with a remote sensor is shown.

Figure 39a

[0091] The tip of a device with a proboscis is shown, and a side view of the tip of the proboscis is shown.

Figure 39b

[0091] The tip of a device with a proboscis is shown, and a side cross-section of the tip of the proboscis is shown.

Figure 40

[0092] A cross-section of the catheter is shown.

Figure 41

[0093] A modified example of a catheter inserted on a guide wire together with an esophageal valve is shown.

Figure 42

[0094] Shows how the core body temperature can be affected using a thermotherapy system.

Figure 43

[0095] A heat-insulating pad on the patient's face is shown.

Figure 44

[0096] A heat-insulating mechanism on the posterior part of the throat is shown.

Figure 45a

[0097] A modified example of a catheter within the stomach with an expandable catheter array is shown.

Figure 45b

[0097] A modified example of a catheter within the stomach with an expandable catheter array is shown.

Figure 46a

[0098] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter introduced into the stomach.

Figure 46b

[0098] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, shown in a front view of the stomach with the front half made transparent, showing a catheter introduced into the stomach.

Figure 46c

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach.

Figure 46d

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach.

Figure 46e

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach.

Figure 46f

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach.

Figure 46g

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach.

Figure 46h

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach.

Figure 46i

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach.

Figure 46j

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach.

Figure 46k

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach.

Figure 46l

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach.

Figure 46m

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach.

Figure 46n

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach.

Figure 46o

[0098] A view of the stomach with the anterior half of the stomach shown transparently, as seen from the front, showing the catheter introduced into the stomach and the catheter removed from the stomach.

Figure 46p

[0098] A view of the stomach with the anterior half shown transparently, seen from the front, showing the catheter removed from the stomach.

Figure 46q

[0098] A view of the stomach with the anterior half shown transparently, seen from the front, showing the catheter removed from the stomach.

Figure 46r

[0098] A view of the stomach with the anterior half shown transparently, seen from the front, showing the catheter removed from the stomach.

Figure 46s

[0098] A view of the stomach with the anterior half shown transparently, seen from the front, showing the catheter removed from the stomach.

Figure 46t

[0098] A view of the stomach with the anterior half shown transparently, seen from the front, showing the catheter removed from the stomach.

Figure 46u

[0098] A view of the stomach with the anterior half shown transparently, seen from the front, showing the catheter removed from the stomach.

Figure 46v

[0098] A view of the stomach with the anterior half shown transparently, seen from the front, showing the catheter removed from the stomach.

Figure 46w

[0098] A view of the stomach with the anterior half shown transparently, seen from the front, showing the catheter removed from the stomach.

Figure 46x

[0098] A view of the stomach with the anterior half shown transparently, seen from the front, showing the catheter removed from the stomach.

Figure 46y

[0098] A view of the stomach with the anterior half shown transparently, seen from the front, showing the catheter removed from the stomach.

Figure 46z

[0098] A view of the stomach with the anterior half shown transparently, seen from the front, showing the catheter removed from the stomach.

Figure 46z1

[0098] A view of the stomach with the anterior half shown transparently, seen from the front, showing the catheter removed from the stomach.

Figure 46z2

[0098] An isometric view of the stomach, duodenum, and pancreas with the anterior half removed, showing the catheter removed from the stomach.

Figure 46z3

[0098] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter removed from the stomach.

Figure 47a

[0099] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter introduced into the stomach.

Figure 47b

[0099] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter introduced into the stomach.

Figure 47c

[0099] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter introduced into the stomach.

Figure 47d

[0099] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter introduced into the stomach.

Figure 47e

[0099] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter introduced into the stomach and the catheter removed from the stomach.

Figure 47f

[0099] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter removed from the stomach.

Figure 47g

[0099] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter removed from the stomach.

Figure 47h

[0099] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter removed from the stomach.

Figure 47i

[0099] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter removed from the stomach.

Figure 48a

[0100] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter introduced into the stomach.

Figure 48b

[0100] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter introduced into the stomach.

Figure 48c

[0100] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter introduced into the stomach.

Figure 48d

[0100] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter introduced into the stomach.

Figure 48e

[0100] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter introduced into the stomach and the catheter removed from the stomach.

Figure 48f

[0100] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter removed from the stomach.

Figure 48g

[0100] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter removed from the stomach.

Figure 48h

[0100] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter removed from the stomach.

Figure 48i

[0100] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter removed from the stomach.

Figure 49a

[0101] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter in the body.

Figure 49b

[0101] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter in the body.

Figure 49c

[0101] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter in the body.

Figure 49d

[0101] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter in the body.

Figure 49e

[0101] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter in the body.

Figure 49f

[0101] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing the catheter in the body.

Figure 49g

[0101] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 49h

[0101] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 49i

[0101] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 50a

[0102] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 50b

[0102] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 50c

[0102] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 50d

[0102] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 50e

[0102] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 50f

[0102] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 50g

[0102] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 50h

[0102] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 50i

[0102] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 51a

[0103] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 51b

[0103] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter within the body.

Figure 51c

[0103] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 51d

[0103] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 51e1

[0103] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 51e2

[0103] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 51e3

[0103] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 51e4

[0103] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 51e5

[0103] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 51e6

[0103] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 52a

[0104] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 52b

[0104] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 52c

[0104] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 52d

[0104] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 53a

[0105] The stomach, duodenum, and pancreas with the anterior half removed are shown in an isometric view, showing a catheter within the body.

Figure 53b

[0105] The stomach, duodenum, and pancreas with the front half removed are shown in an isometric view, showing a catheter inside the body.

Figure 54a

[0106] Examples of deformation of the catheter during bending and extension are shown.

Figure 54b

[0106] Examples of deformation of the catheter during bending and extension are shown.

Figure 54c

[0106] Examples of deformation of the catheter during bending and extension are shown.

Figure 54d

[0106] Examples of deformation of the catheter during bending and extension are shown.

Figure 55a

[0107] Examples of deformation of the catheter are shown.

Figure 55b

[0108] Examples of deformation of the catheter are shown.

Figure 55c

[0109] Examples of cross-sectional views passing through line 55c - 55c of the catheter in FIG. 55a are shown.

Figure 55d

[0110] Examples of cross-sectional views passing through line 55d - 55d of the catheter in FIG. 46g are shown.

Figure 56

[0111] It is a schematic diagram of a system capable of performing heat transfer therapy.

Figure 57a

[0112] It is a front x-ray photograph of a catheter introduced into the stomach.

Figure 57b

[0112] It is a front x-ray photograph of a catheter introduced into the stomach.

Figure 57c

[0112] It is a front x-ray photograph of a catheter introduced into the stomach.

Figure 57d

[0112] It is a front x-ray photograph of a catheter introduced into the stomach.

Figure 58a

[0113] It is a front x-ray photograph of a catheter introduced into the stomach.

Figure 58b

[0113] It is a front x-ray photograph of a catheter introduced into the stomach.

Mode for Carrying Out the Invention

[0054]

[0114] Figure 1 shows a modified example of the thermotherapy system 33. The thermotherapy system 33 can be, for example, a local thermotherapy system. The thermotherapy system 33 can be, for example, a heat transfer therapy system. For example, the thermotherapy system 33 can be a heating therapy system and / or a cooling therapy system. For example, the thermotherapy system 33 can deliver thermotherapy (e.g., heating therapy and / or cooling therapy) to the heat transfer target 146. The thermotherapy system 33 can transfer heat to and / or from the heat transfer target 146. Transferring heat to the heat transfer target 146 can include, for example, raising the temperature of the heat transfer target 146 and / or heating the heat transfer target 146. Transferring heat from the heat transfer target 146 can include, for example, lowering the temperature of the heat transfer target 146 and / or cooling the heat transfer target 146. The heat transfer target 146 can include, for example, one or more organs. The one or more organs can include one or more organs of the digestive tract 110, one or more organs adjacent to the digestive tract 110, or any combination thereof. For example, the heat transfer target 146 can include the esophagus 5, the stomach 2, the pancreas 1, the pylorus 65, the duodenum 37, the jejunum 10, any portion along the digestive tract 110 behind the jejunum 10, or any combination thereof.

[0055]

[0115] Figure 1 shows that the thermotherapy system 33 can include the heat transfer device 4 and / or the heat exchange system 13. Figure 1 shows that the heat transfer device 4 can be connected (e.g., detachably connected) to the heat exchange system 13. The heat exchange system 13 can be, for example, an external heat exchange system. The heat transfer device 4 can transfer heat to and / or from the heat transfer target 146. The heat transfer device 4 can raise and / or lower the temperature of the heat transfer target 146, for example. The heat transfer device 4 can heat and / or cool the heat transfer target 146, for example.

[0056]

[0116] Figure 1 shows that the heat transfer device 4 can have and / or be, for example, a catheter 9, a balloon 3, or any combination thereof. For example, the heat transfer device 4 includes the catheter 9 but does not include the balloon 3. As another example, the transducer 4 may include the balloon 3 but not the catheter 9. As yet another example, the heat transfer device 4 can include the catheter 9 and the balloon 3. As yet another example, the heat transfer device 4 can be the catheter 9. As yet another example, the heat transfer device 4 can be the balloon 3. As yet another example, the heat transfer device 4 can be the catheter 9 and the balloon 3. Figure 1 shows that the catheter 9 and / or the balloon 3 can transfer heat to and / or from the heat transfer target 146. Figure 1 shows that the catheter 9 and / or the balloon 3 can increase and / or decrease the temperature of the heat transfer target 146. Figure 1 shows that the catheter 9 and / or the balloon 3 can heat and / or cool the heat transfer target 146. For example, the balloon 3 can be a heating and / or cooling balloon, and / or the catheter 9 can be a heating and / or cooling catheter. For example, Figure 1 shows that the thermotherapy system 33 can be a heat exchange catheter system and / or a heat exchange balloon system. For example, the catheter 9 can be a heat exchange catheter, and the balloon 3 can be a heat exchange balloon.

[0057]

[0117] Figure 1 shows that the heat transfer device 4 (e.g., catheter 9 and / or balloon 3) can be inserted into and / or removed from the target site 147. For example, Figure 1 shows that the catheter 9 and / or balloon 3 can be inserted into the target site 147 as indicated by arrow 112, and / or that the catheter 9 and / or balloon 3 can be removed from the target site 147 as indicated by arrow 114. The target site 147 can be, for example, one or more organs within the body 152. The target site 147 can be, for example, the space and / or body cavity within one or more organs within the body 152. For example, the target site 147 can include the esophagus 5, stomach 2, pylorus 65, duodenum 37, jejunum 10, any portion along the digestive tract 110 behind the jejunum 10, or any combination thereof. The target site 147 can be, for example, the position (e.g., the desired position) of the catheter 9 and / or balloon 3 within the body 152 during heat transfer to and / or from the heat transfer target 146 via the catheter 9 and / or balloon 3. The heat transfer target 146 can be, for example, the target heat transfer position. For example, the heat transfer target 146 can be the stomach 2, pylorus 65, duodenum 37, and / or pancreas 1, and the target site 147 can be the stomach 2, pylorus 65, duodenum 37, and / or jejunum 10.

[0058]

[0118] Figure 1 shows that the balloon 3 can be, for example, a gastric balloon. Figure 1 shows that the balloon 3 can be, for example, a lower gastric balloon. Figure 1 shows that the balloon 3 can be positioned within the stomach 2, inflated within the stomach 2, deflated within the stomach 2, or any combination thereof. The balloon 3 can be fixed to the catheter 9. The balloon 3 can be fixed to the catheter 9, for example, releasably and / or permanently.

[0059]

[0119] The heat exchanger 4, catheter 9, and / or balloon 3 can be delivered orally and / or nasally, for example, via the nose 11 and / or mouth 12. For example, FIG. 1 shows that the heat exchanger 4, catheter 9, and / or balloon 3 can be delivered nasally via the nose 11. The heat exchanger 4, catheter 9, and / or balloon 3 can pass through the patient's esophagus 5.

[0060]

[0120] FIG. 1 shows that the thermotherapy system 33 can include a pump 148, a fluid 6, and / or a fluid container 150. FIG. 1 shows that the heat exchange system 13 can include a pump 148, a fluid 6, and / or a fluid container 150. The pump 148 can be, for example, a recirculation pump. The fluid 6 can be, for example, a heat transfer fluid. The fluid container 150 holds a certain volume of the fluid 6. The fluid 6 can be injected into and / or discharged from the catheter 9 and / or balloon 3 by the pump 148. The fluid 6 can be injected into the catheter 9 and / or balloon 3 by the pump 148. For example, FIG. 1 shows that the fluid 6 can be circulated and / or recirculated through the catheter 9 and / or balloon 3 by the pump 148. FIG. 1 shows that, for example, the pump 148 can inject the fluid 6 from the fluid container 150 into the catheter 9 and / or balloon 3, and / or the pump 148 can inject the fluid 6 from the catheter 9 and / or balloon 3 into the fluid container 150. FIG. 1 shows that, for example, the thermotherapy system 33 can be a closed-loop heat exchange system. For example, the balloon 3 can be inflated by filling it with the fluid 6. FIG. 1 shows the balloon 3 in an inflated configuration with a portion of the fluid 6 inside the balloon 3. For example, the balloon 3 can be deflated by removing the fluid 6 from the balloon 3.

[0061]

[0121] FIG. 1 shows that the balloon 3 can conform to the wall 108 of the stomach 2 (also referred to as the gastric wall 108). For example, the balloon 3 can have a large surface area in contact with the wall of the stomach 2.

[0062]

[0122] Figure 1 shows that the catheter 9 can have a catheter tip 7. The catheter tip 7 can be, for example, the distal tip of the catheter 9 and / or the heat transfer device 4. The catheter tip 7 can be attached to the catheter 9 and / or integrated with the catheter 9. For example, Figure 1 shows that the catheter tip 7 can be integrated with the catheter 9. The heat transfer device 4, the catheter 9, the catheter tip 7, and / or the balloon 3 can be positioned adjacent to and / or near the pancreas 1. The balloon 3 can be positioned near the gastropancreatic wall 8. The gastropancreatic wall 8 can be, for example, a portion of the gastric wall 108 adjacent to, opposite to, and / or proximate to the pancreas 1. The fluid 6 can increase and / or decrease the temperature of the gastropancreatic wall 8 and / or the pancreas 1. The fluid 6 can transfer heat to and / or remove heat from the pancreas 1 and / or the gastropancreatic wall 8.

[0063]

[0123] The fluid 6 can be, for example, a liquid, a gas, a plasma, and / or a solid. The fluid 6 can be, for example, water, saline, oil, fat, synthetic products, and / or organic substances.

[0064]

[0124] The heat transfer device 4, the fluid 6, the balloon 3, and / or the catheter 9 can be in a sterilized, clean, dirty, and / or unsterilized state. The heat transfer device 4, the catheter 9, and / or the balloon 3 can be disposable, reusable, washable, rewashable, sterilizable, and / or resterilizable.

[0065]

[0125] Nutrients, drugs, sensors, devices, and / or tools can be delivered via the heat exchanger 4, catheter 9, and / or balloon 3. For example, the nutrients, drugs, sensors, devices, and / or tools can exit from the catheter tip 7. The catheter tip 7 can aspirate the stomach 2. Nutrients, drugs, sensors, devices, and / or tools can be delivered to the duodenum 37 and / or jejunum 10. FIG. 1 shows that the catheter 9, balloon 3, and / or heat exchanger 4 can pass through the nose 11. The catheter 9, balloon 3, and / or heat exchanger 4 can pass through the mouth 12. The catheter 9, balloon 3, and / or heat exchanger 4 can be connected (e.g., detachably connected) to the heat exchange system 13. The heat exchange system 13 can include, for example, a computer, a user interface, a controller, a control system, a pump 148, and / or a heating and / or cooling system. The heat exchange system 13 can cool and / or remove heat from the fluid 6, the heat exchange system 13 can heat and / or transfer heat to the fluid 6, and / or the heat exchange system 13 can both cool and / or remove heat from the fluid 6 and heat and / or transfer heat to the fluid 6. The catheter 9, balloon 3, and / or heat exchanger 4 can be connected (e.g., detachably connected) to the cooling system 13 with a connector 14. For example, FIG. 1 shows that the proximal end of the catheter 9 can be detachably connected to the connector 14. The connector 14 can provide a fluidic coupling, an optical coupling, and / or an electrical coupling between the cooling system 13 and the heat exchanger 4, catheter 9, and / or balloon 3.

[0066]

[0126] The catheter 9 can be, for example, a tube having zero, one, or a plurality of lumens. For example, the catheter 9 can have from 0 to 10 or more lumens, and the number of lumens can increase by one within this range (for example, 0 lumens, 1 lumen, 2 lumens, 3 lumens, 4 lumens, 5 lumens, 10 lumens). FIGS. 2a to 2d show that the catheter 9 can have various cross-sections. The cross-section of the catheter 9 can be constant and / or vary along the length of the catheter 9. FIGS. 2a to 2d show that the lumens can have various cross-sections. The cross-section of the lumen can be constant and / or vary along the length of the catheter 9. FIGS. 2a to 2d show that the catheter 9 and / or the heat transfer device 4 can have the lumen 15, the lumen 16, the lumen 17, and / or the lumen 18 (also referred to as the first lumen 15, the second lumen 16, the third lumen 17, and / or the fourth lumen 18, respectively). FIGS. 2a to 2d show that the catheter 9 and / or the heat transfer device 4 can have any combination of the first lumen 15, the second lumen 16, the third lumen 17, and / or the fourth lumen 18. The lumens 15, 16, 17, and / or 18 can be heat transfer lumens and / or auxiliary lumens. For example, the lumens 15 and 16 can be heat transfer lumens, and the lumens 17 and 18 can be auxiliary lumens. For example, the lumen 15 can be the first heat transfer lumen, the lumen 16 can be the second heat transfer lumen, the lumen 17 can be the first auxiliary lumen, and the lumen 18 can be the second auxiliary lumen. For example, the lumen 15 can be an inflow lumen, and the lumen 16 can be an outflow lumen.

[0067]

[0127] The first lumen 15 and / or the second lumen 16 can transport fluid 6. For example, fluid 6 can be transported between the balloon 3 and the heat exchange system 13 via the first lumen 15 and the second lumen 16 within the catheter 9. The fluid 6 can be circulated in a certain direction via the catheter 9 and / or the heat transfer device 4. For example, the fluid 6 can flow distally through the first lumen 15 and proximally through the second lumen 16, and vice versa. The fluid 6 can be at different temperatures within the first lumen 15 and / or the second heat transfer lumen 16. For example, FIGS. 2a to 2c show that the fluid 6 moving from the heat exchange system 13 (e.g., from the fluid container 150) to the balloon 3 can move within the first lumen 15 and return within the second lumen 16, thereby reducing heat transfer from other parts of the body such as the esophagus 5. The fluid 6 can flow in both proximal and distal directions through the first lumen 15 and / or the second lumen 16. For example, the fluid 6 can flow distally through the first lumen 15 to inflate the balloon 3, stay within the balloon 3 for a certain time period, and then flow proximally through the first lumen 15. The third lumen 17 and / or the fourth lumen 18 can transport, for example, nutrients, drugs, sensors, devices, and / or tools. The third lumen 17 and / or the fourth lumen 18 can aspirate the stomach 2, duodenum 37, and / or jejunum 10. The thickness 20 of the catheter wall 154 can vary at various cross-sections of the catheter 9 and / or within the same cross-section of the catheter 9. The catheter 9 can have an outer diameter 19 of the catheter. The outer diameter 19 of the catheter can be constant and / or vary along the length of the catheter 9. The cross-section of the catheter 9 can be, for example, circular, square, elliptical, triangular, and / or other geometric shapes. The outer diameter 19 of the catheter can be continuous and / or discontinuous. The outer diameter 19 of the catheter can have protrusions, depressions, grooves, keyways, and / or ridges.

[0068]

[0128] Figure 3 shows that the heat exchanger 4, the catheter 9, and / or the plug 28 can be delivered orally through the mouth 12. Figure 3 shows that the fluid 6 can come into direct contact with the wall of the stomach 2 and / or the gastropancreatic wall 8. For example, the fluid 6 can be transported to the stomach 2 through the first lumen 15 and / or the second lumen 16. Depending on the patient's orientation, the fluid 6 can be adjacent to the gastropancreatic wall 8 by gravity alone. The fluid 6 can be a naturally occurring fluid present in the stomach 2. For example, the fluid 6 can be gastric acid, gastric juice, stomach acid, blood, and / or ascites. The fluid 6 can be, for example, a compressed gas and / or a phase change material. For example, the fluid 6 can be delivered through the catheter 9 in a liquid state and then change to a gas when it exits the catheter tip 7. When the fluid 6 changes from a liquid to a gas, it can absorb energy (e.g., a significant amount of energy), thereby reducing the temperature of the stomach 2, the gastropancreatic wall 8, the pancreas 1, the duodenum 37, and / or the jejunum 10. The catheter tip 7 can be located within the stomach 2, the duodenum 37, the jejunum 10, and / or the pancreas 1. The fluid 6 can be, for example, alcohol, nitrogen, carbon dioxide, a coolant (e.g., Freon, CFC, HFC, R22, R-290, R-600a, R-717, R-1234, R-744, R-32, R-134a, and / or R-410a, etc.). The fluid 6 can be stored at a pressure higher than the ambient pressure and / or transported within the catheter 9. The catheter 9 can transfer heat to and / or from the stomach 2, the gastropancreatic wall 8, the pancreas 1, the duodenum 37, and / or the jejunum 10 by a thermoelectric process. For example, the heat exchange methods can include thermoelectric cooling, vapor compression refrigeration, phase change, Carnot cycle refrigeration, reverse Rankine refrigeration, evaporative cooling, heat tunnel cooling, magnetic refrigeration, cyclic refrigeration, non-cyclic refrigeration, adsorption cycle, elastocaloric refrigeration, fridge gate, vortex tube, pulse tube refrigeration, thermoacoustics, and / or any combination thereof. Figure 3 shows that the intestinal plug 28 can be deployed at the target site 147. The intestinal plug 28 can be fixed to the distal end or near the distal end of the catheter 9 and / or removed from the catheter 9. The intestinal plug 28 can be delivered through the catheter 9.For example, the intestinal plug 28 can be delivered via the third lumen 17 and / or the fourth lumen 18. The intestinal plug 28 can form an outflow obstruction at the stomach 2, duodenum 37, jejunum 10, pyloric sphincter 66, and / or the intestinal interface. The intestinal plug 28 can obstruct the movement of fluid out of the stomach 2. The intestinal plug 28 can be bioabsorbable. A coating can be delivered to the stomach 2 to change the absorption rate and / or fluid absorption through the gastric wall 108 and / or the gastropancreatic wall 8. The coating can be absorbed and / or decomposed at a predetermined rate.

[0069]

[0129] The heat transfer device 4, catheter 9, balloon 3, catheter tip 7, and / or any component passing through the catheter 9 can include zero, one, or a plurality of sensors 21 (also referred to as one sensor 21 or a plurality of sensors 21), for example, from 0 to 10 or more sensors 21, and the number of sensors can increase by one within this range (for example, 0 sensors, 1 sensor, 2 sensors, 3 sensors, 10 sensors). The sensor 21 can monitor, for example, temperature, energy, PH, pressure, movement, gravity, orientation, position, electromagnetic waves, magnetism, light, contact, and / or flow rate. The sensor 21 can monitor, for example, substantially all heat transfer and / or heat transfer rate from the patient (e.g., body 152) to the heat transfer device 4, catheter 9, and / or balloon 3. For example, one or more sensors 21 can monitor the temperature of the fluid 6 entering and exiting the catheter 9, heat transfer device 4, heat exchange system 13, and / or balloon 3. The sensor 21 can be connected to the heat exchange system 13. For example, the sensor 21 can be placed in the patient's bladder, mouth, nose, skin, dermis, pancreas, jejunum, esophagus, stomach, and / or any other organ, tissue, and / or the patient's body fluid. The sensor 21 can monitor the patient's local and / or systemic hypothermia and / or normothermia. The sensor 21 can monitor gastric juice content including, but not limited to, the acidity of gastric juice.

[0070]

[0130] Sensor 21 can provide an alarm to the patient, physician, nurse, and / or other staff. Sensor 21 can determine the orientation of the patient, fluid 6, balloon 3, catheter 9, heat transfer device 4, and / or catheter tip 7. Sensor 21 can determine whether the patient is in an ideal position or a non-ideal position for an efficient local hypothermia method of the pancreas 1. For example, sensor 21 can determine whether balloon 3, fluid 6, and / or catheter tip 7 are adjacent to the gastropancreatic wall 8. The patient can move or be moved to improve the patient's comfort and / or prevent pain (e.g., bedsores). The patient can move and / or be moved at regular intervals. The heat exchange system 13 can provide manual and / or automatic feedback based on sensor 21. For example, if the pressure is out of range and / or the patient is not in an ideal treatment position, balloon 3 can be automatically deflated.

[0071]

[0131] Balloon 3 can be adjusted, moved, inflated, and / or deflated periodically. For example, to help prevent bedsores, balloon 3 can be deflated every 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, and / or 120 minutes. The frequency and duration of inflation / deflation of balloon 3 can be controlled manually and / or automatically by the heat exchange system 13.

[0072]

[0132] Figure 4a shows that balloon 3 can be in fluid communication with the first lumen 15 via balloon port 22. Heat transfer device 4 and / or catheter 9 can have a plurality of balloon ports 22. The plurality of balloon ports 22 allows for an improvement in the flow of fluid 6. For example, the plurality of balloon ports 22 can provide redundancy in case one of the balloon ports 22 is blocked. For example, the plurality of balloon ports 22 can provide redundancy in case one of the balloon ports 22 is obstructed.

[0073]

[0133] Figure 4b shows that balloon 3 can be in fluid communication with the first lumen 15 and / or the second lumen 16 via balloon port 22. For example, fluid 6 can flow distally from the heat exchange system 13 in the lumen flow direction 24a, exit the first lumen 15 in the balloon port flow direction 23a via balloon port 22a, circulate within balloon 3, enter the second lumen 16 in the balloon port flow direction 23b via balloon port 22b, and proceed proximally in the lumen flow direction 24b towards the heat exchange system 13. Fluid 6 can be heated and / or cooled within the heat exchange system 13 and then proceed distally towards balloon 3.

[0074]

[0134] Balloon 3 can have one or more fluids. For example, FIGS. 5a - 5b show that balloon 3 can be filled with fluid 6 (e.g., a heat transfer fluid) and / or isolation fluid 25. Isolation fluid 25 can have a lower thermal conductivity than fluid 6. Isolation fluid 25 can be, for example, a gas such as air, oxygen, and / or nitrogen. Fluid 6 and / or isolation fluid 25 can proceed through the first lumen 15 and / or the second lumen 16. The density of fluid 6 can be higher than, lower than, and / or equal to the density of isolation fluid 25. For example, fluid 6 may remain at the bottom of balloon 3 due to gravity. The bottom of balloon 3 can be adjacent to the gastropancreatic wall 8. The volume of balloon 3 can be equal to the volume of isolation fluid 25 and / or fluid 6 contained within balloon 3. Heat transfer through balloon 3 can occur mainly at the surface in contact with fluid 6. The configuration shown in FIGS. 5a - 5b allows adjustment of the volume and / or position of the balloon independent of the heat transfer characteristics and / or heat transfer surface of balloon 3. For example, balloon 3 can be safely positioned within the stomach 2 and / or contact multiple surfaces of the stomach 2 while performing local heating and / or cooling of a small portion of the stomach 2.

[0075]

[0135] FIG. 5a shows that the balloon 3 can have a fluidly separated compartment or volume (e.g., the first compartment can receive the isolation fluid 25 and the second compartment can receive the fluid 6), and / or the heat exchanger 4 (e.g., the catheter 9) can have one or more balloons 3 (e.g., capable of receiving the fluid 6 and / or the isolation fluid 25) and one or more isolation balloons adjacent to the balloon 3 (e.g., capable of receiving the isolation fluid).

[0076]

[0136] FIG. 5b shows that an isolated gastric balloon 26 can be present inside and / or outside the balloon 3. The isolated balloon 26 can be in fluid communication with the first lumen 15 via the balloon port 22a. The balloon 3 can be in fluid communication with the second lumen 16 via the balloon port 22b. The isolated balloon 26 can be filled with the isolation fluid 25.

[0077]

[0137] The heat transfer rate of the heat exchanger 4, the catheter 9, and / or the balloon 3 can be controlled, for example, using various methods. The thermal conductivity of the fluid 6 can be adjusted. The volume of the fluid 6, the volume of the balloon 3, and / or the portion of the balloon 3 in contact with the gastropancreatic wall 8 can be adjusted. The temperature of the fluid 6 exiting the heat exchange system 13 can be adjusted. The flow rate of the fluid 6 passing through the catheter 9, the heat exchanger 4, and / or the balloon 3 can be adjusted.

[0078]

[0138] FIG. 6 shows that the pancreatic temperature can be reduced by periodically pulsing the fluid 6 proximally and distally through the catheter 9. The fluid 6 can be heated and / or cooled by the heat exchange system 13. The cold fluid 6 can pass through the catheter 9 and / or inflate the balloon 3. The cold fluid 6 can increase in temperature when removing energy from the gastropancreatic wall 8 and / or the pancreas 1. The fluid 6 can be periodically removed from the balloon 3 and / or the stomach 2. The frequency of the cycle of the fluid 6 can be based on time, temperature, and / or other parameters. Over the entire cycle, the temperature of the pancreas 1 can decrease until it reaches an equilibrium steady state.

[0079]

[0139] Figure 7 shows that the catheter 9 and / or the heat transfer device 4 may have or may be attached to the gastric positioning mechanism 27. The gastric positioning mechanism 27 can be a mechanical structure. The gastric positioning mechanism 27 can be deployed near the cooling film and / or the balloon 3. The gastric positioning mechanism 27 can ensure that the catheter 9, the catheter tip 7, and / or the balloon 3 are properly positioned relative to the gastropancreatic wall 8. The gastric positioning mechanism 27 can be a soft stent, a helical object, a balloon, and / or a mesh. The positioning mechanism 27 can be expanded after being delivered with a small outer diameter and then placed in the stomach 2. The gastric positioning mechanism 27 can be a bioabsorbable and / or biodegradable material. The gastric positioning mechanism 27 can support the cardiac, fundus, body, pyloric antrum, pyloric canal, or any combination thereof of the stomach. The catheter 9, the heat transfer device 4, the catheter tip 7, the balloon 3, and / or the isolated gastric balloon 26 may include one marker 29 and / or a plurality of markers 29. The marker 29 can assist visualization by ultrasound, CT, X-ray, MRI, and / or other imaging methods. The marker 29 can be magnetic. For example, the sensor 21 can determine the absolute and / or relative position of the marker 29. With the marker 29, the operator can adjust the position of the catheter 9, the heat transfer device 4, the catheter tip 7, the balloon 3, and / or the isolated gastric balloon 26 via an external magnet and / or magnetic field. The heat exchange system 13, the catheter 9, the heat transfer device 4, the catheter tip 7, the balloon 3, and / or the isolated gastric balloon 26 may have a safety valve 30. The safety valve 30 can provide a pressure relief mechanism for the first lumen 15 and / or the second lumen 16. When the pressure in the balloon 3 exceeds the threshold, the excess fluid can exit through the safety valve 30. For example, when the stomach 2 contacts and compresses the balloon 3, the fluid 6 can exit through the safety valve 30 (for example, this can suppress and / or prevent damage to the heat transfer device 4, the catheter 9, and / or the patient). The set point of the safety valve 30 can be fixed and / or adjustable. The safety valve 30 can be controlled by the heat exchange system 13.

[0080]

[0140] Figure 8 shows that the heat transfer device 4 and / or the catheter 9 may have one or more isolation ports 31. The isolation ports 31 allow the isolation fluid 25 to travel along the outside of the catheter 9. The isolation fluid 25 can be warm and / or at room temperature. The isolation fluid 25 may be in contact with the stomach 2, esophagus 5, mouth 12, nose 11, and / or other patient tissues. The isolation ports 31 can be at various positions along the catheter 9. Having the isolation fluid 25 allows positioning of a balloon on the catheter 9. The outer diameter 19 of the heat transfer device 4 and / or the catheter 9 may have an isolation material including, but not limited to, aerogel, air, foam, rubber, gas, vacuum, wood, and / or polymer. The isolation fluid 25 and the fluid 6 can travel through the first lumen 15 and / or the second lumen 16. For example, the fluid 6 (e.g., warm and / or cold fluid 6) can be delivered distally through the first lumen 15 to fill the balloon 3, and then the isolation fluid 25 can be delivered through the first lumen 15 to remove the cold fluid 6 from other sections of the catheter 9 (e.g., thereby reducing heat transfer to other organs such as the esophagus 5). An external or internal warming system (e.g., external pad 32) can be applied to the patient. For example, a blanket can be placed on top of another blanket to prevent systemic hypothermia.

[0081]

[0141] Figure 9 shows that the heat transfer device 4 and / or the catheter 9 can be delivered transabdominally and / or laparoscopically. The catheter tip 7 can be inserted directly into the pancreas 1. The fluid 6 can be delivered directly into the pancreas 1, the abdominal cavity, and / or other tissues. Compressed gas can be delivered to the pancreas 1 and can cool the pancreas 1 when it evaporates. Figure 9 shows that the thermotherapy system 33 may include an external pad 32. Figure 9 shows that the external pad 32 can be positioned on the patient. One or more external pads 32 can be positioned on the patient. The external pad 32 may include a sensor 21. The external pad 32 can heat and / or cool the patient. The external pad 32 may include a magnet and / or imaging to assist in positioning the heat transfer device 4.

[0082]

[0142] Figure 10 shows that the stomach positioning mechanism can be or can have a fixing mechanism 34 that can position and / or fix the heat transfer device 4 and / or the catheter 9 within the stomach 2. The fixing mechanism 34 can be a mechanical structure such as an elastic coil. The fixing mechanism 34 can position and / or fix the balloon 3 to the gastropancreatic wall 8. The fixing mechanism 34 can support the cardia, fundus, body, pyloric antrum, pyloric canal, or any combination thereof.

[0083]

[0143] Figure 11 shows that an impermeable membrane 35 can be deployed within the stomach 2. The impermeable membrane 35 can be a permeable, semi-permeable, and / or impermeable membrane and / or coating. The impermeable membrane 35 can be soluble and / or resorbable. A pyloric plug 36 can be disposed within the stomach 2. The pyloric plug 36 can be positioned to prevent the cooling fluid from flowing out into the duodenum and / or jejunum 10. The impermeable membrane 35 can prevent and / or slow down fluid absorption into the wall of the stomach 2.

[0084]

[0144] Figure 12 shows that within a water tank at body temperature (37 °C), the target temperature of the pancreas can be achieved within an artificial pancreas (using bovine tissue) using cooled fluid circulating through a cooling balloon disposed within an artificial stomach (using bovine stomach tissue).

[0085]

[0145] Figures 13a and 13b show that the esophagus 5 can extend to the stomach 2 and then to the pylorus 65 and duodenum 37. The pancreas 1 can be in direct and / or indirect contact with the stomach 2 and / or duodenum 37. The pancreas 1 can be divided into various regions including, but not limited to, the pancreatic head 38, pancreatic body 64, and / or pancreatic tail 39. The pancreatic tail 39 can be in direct and / or indirect contact with the stomach 2. The pancreatic head 38 can be in direct and / or indirect contact with the stomach 2, pylorus 65, and / or duodenum 37.

[0086]

[0146] Figures 14a and 14b show that balloon 3 can be elastic. Balloon 3 can be connected to catheter 9. Balloon 3 can be an extruded tube made of polymer, elastomer, and / or rubber. For example, balloon 3 can be a thin-walled extruded silicone tube. Balloon 3 can have approximately the same outer diameter as catheter 9 in the contracted configuration shown in Figure 14a. Balloon 3 can be inflated by fluid 6. Balloon 3 can be inflated to a low pressure that can conform to and / or match stomach 2. Due to the peristaltic movement and / or motility of stomach 2, balloon 3 can be manipulated and / or moved. For example, the contraction of the stomach can cause balloon 3 to be directed and / or pushed towards pylorus 65. Catheter tip 7 can remain within stomach 2, esophagus 5, pylorus 65, and / or duodenum 37. Catheter tip 7 can have ports for suction, decompression, replenishment, and / or insertion instruments. Catheter tip 7 can be introduced and / or positioned over a guidewire. Balloon 3 can be fixed to catheter 9 by adhesive, ultrasonic welding, heat shrink tubing, metal band, and / or reflow melting. Balloon 3 can be inserted into and / or removed from esophagus 5 and / or stomach 2 in the contracted configuration shown in Figure 14a. Balloon 3 can be inflated to the inflated configuration shown in Figure 14b. Catheter shaft 86 can be parallel to and / or concentric with catheter 9. Sagittal axis 87 (also known as the anteroposterior axis) can extend through the body center from front to back. For example, when a person rolls over, they rotate about sagittal axis 87. Frontal axis 88 can extend through the body center from left to right. For example, when a person somersaults, they rotate about frontal axis 88. The dimensions of balloon 3 can be shorter and / or longer along these various axes. For example, balloon 3 can be longer in the direction along frontal axis 88 than along sagittal axis 87.

[0087]

[0147] Figures 15a through 15c show that balloon 3 can be inelastic. For example, balloon 3 can be made from a polymer that is flexible but not designed to stretch. For example, balloon 3 can be made from PET, LDPE, HDPE, Mylar, and / or nylon. Balloon 3 can be filled to a volume smaller than its maximum capacity. Duodenal device 40 can be an elastic and / or inelastic balloon fixed to catheter 9. Duodenal device 40 can act as a container for balloon 3. For example, when external pressure compresses balloon 3 (e.g., peristalsis, movement, vomiting, etc.), fluid 6 can move from balloon 3 to duodenal device 40. Duodenal device 40 can function as a buffer to assist in adjusting, maintaining, and / or controlling the volume and / or pressure of balloon 3. Duodenal device 40 can cycle between the contracted configuration shown in FIG. 15b and the expanded configuration shown in FIG. 15c. Duodenal device 40 can help cool and / or warm pancreas 1, pylorus 65, and / or duodenum 37. Duodenal device 40 can help cool and / or warm pancreatic head 38. Balloon 3 can help cool and / or warm stomach 2 and / or pancreas 1. Catheter 9, balloon 3, and / or duodenal device 40 can help cool and / or warm core body temperature and / or specific organs within the body.

[0088]

[0148] Figures 16a, 16b, and 16c show that the balloon 3 can be an inelastic structure that expands. The balloon 3 is divided into lobes 89 and can have a joining zone where the polymer sheets are joined thermally, chemically (e.g., ultrasonic welding, ultrasonic welding, thermal bonding), or mechanically with threads or staple joining to form the lobes. The lobes are fluidly connected to the catheter to allow for fluid circulation. The joining zone can form a flow path that allows flexibility in one or more directions. Figure 16c shows that the joining zone surrounds lobe 89a, allowing flexibility in all directions. The spacing between the joining sections can determine the height of lobe expansion and can limit the height or thickness of the balloon's limit expansion or the pressure on the stomach in the anterior-posterior direction.

[0089]

[0149] Figures 16b and 16c show a two-layer lobe or inflation zone. The front layer 43 can be inflated with gas or a fluid at a lower temperature compared to the layer 44 closest to the posterior wall of the stomach. This low-temperature zone helps isolate the cooling of the anterior wall of the stomach adjacent to the pancreas and isolate the posterior wall of the stomach. The outer edge of the balloon can be provided with a radiopaque or echo-source marker to indicate complete inflation or full deployment of the balloon. The catheter tip 7 can remain within the stomach 2, esophagus 5, pylorus 65, and / or duodenum 37. The catheter tip 7 can have ports for suction, decompression, replenishment, and / or insertion instruments. The catheter tip 7 can be introduced and / or positioned over a guidewire.

[0090]

[0150] The balloon curvature radius 85 can be the same and / or vary along the length of the balloon 3 and / or the catheter 9. The balloon curvature radius 85 can be inverted. The balloon curvature radius 85 can be greater than about 0.5 inches (1.3 cm), more precisely greater than about 1 inch (2.5 cm), more precisely greater than about 2 inches (5.1 cm), more precisely greater than about 3 inches (7.6 cm), more precisely greater than about 5 inches (12.7 cm), more precisely greater than about 7 inches (17.8 cm), more precisely greater than about 10 inches (25.4 cm), more precisely greater than about 15 inches (38.1 cm), and / or more precisely greater than about 20 inches (50.8 cm). The balloon curvature radius 85 can be less than about 20 inches (50.8 cm), more precisely less than about 15 inches (38.1 cm), more precisely less than about 10 inches (25.4 cm), more precisely less than about 7 inches (17.8 cm), more precisely less than about 5 inches (12.7 cm), more precisely less than about 3 inches (7.6 cm), more precisely less than about 2 inches (5.1 cm), more precisely less than about 1 inch (2.5 cm), more precisely less than about 0.5 inches (1.3 cm).

[0091]

[0151] Figure 17 shows that the catheter 9 can function as a heat transfer device. The catheter 9 can have a surface area suitable for performing heat transfer between the stomach 2 and the fluid 6. A physician can insert a predetermined length of the catheter 9 into the stomach 2. The physician can adjust the length of the catheter 9 disposed within the stomach 2 to adjust the surface area of the catheter 9 disposed within the stomach 2, thereby controlling the heat transfer between the heat exchanger 4 and the stomach 2. The catheter 9 can be fixed to and / or move relative to the stomach 2. For example, the catheter 9 can be moved by peristalsis and / or movement. The catheter 9 can directly and / or indirectly cool the wall of the stomach 2. For example, the catheter 9, the balloon 3, and / or the heat exchanger 4 can cool the gastric juice and / or fluid located within the stomach 2. The catheter 9 can include a catheter lock portion 45. The catheter 9 can include a plurality of catheter lock portions 45. The catheter lock portion 45 can be a brush-like flap on the catheter 9. The catheter lock portion 45 can be integral with the catheter 9 and / or a separate component from the catheter 9. The catheter lock portion 45 can help guide the catheter 9 into the duodenum 37 and / or the pylorus 65. The catheter lock portion 45 can help hold the catheter 9 within the duodenum 37 and / or the pylorus 65. A given cross-section of the catheter 9 can include zero, 1, and / or a plurality of catheter lock portions 45. The catheter lock portion 45 can provide greater axial friction and / or resistance in one direction. For example, the force for pushing and / or pulling the catheter 9 and / or the catheter lock portion 45 distally can be made less than the force for pushing and / or pulling the catheter 9 and / or the catheter lock portion 45 proximally. The catheter lock portion 45 can cause the catheter 9 to self-advance into the duodenum 37. The duodenum device 40 can be a weight. For example, an additional weight at and / or near the catheter tip 7 can help guide and / or direct the catheter 9 into the duodenum 37 and / or the pylorus 65. For example, an additional weight at and / or near the catheter tip 7 can help hold and / or maintain the catheter 9 within the duodenum 37 and / or the pylorus 65.The duodenal device 40 can be useful for guiding and / or directing the catheter 9 into and / or towards the duodenum 37 and / or the pylorus 65. The duodenal device 40 can be useful for holding and / or maintaining the catheter 9 within the duodenum 37 and / or the pylorus 65. The duodenal device 40 can be a balloon. The duodenal device 40 can be inflated to increase the friction between the heat transfer device 4 and an organ (such as the duodenum 37). The duodenal device 40 can be inflated after passing through the pyloric sphincter 66 and / or the pylorus 65. For example, if the duodenal device 40 expands after passing through the pyloric sphincter 66 and / or the pylorus 65, this can be useful for holding the catheter tip 7 within the duodenum 37. The duodenal device 40 can be a braided cord and / or a flexible material whose diameter can be adjusted based on its length. For example, reducing the axial length of the duodenal device 40 can increase the radial diameter. The catheter lock 45 can be retractable and / or expandable.

[0092]

[0152] Figure 18 shows that the catheter 9 can have a helical shape and / or a helical outer profile. For example, the section of the catheter 9 can be heat-set and / or formed into a helical shape. Additional materials and / or components can be used to generate and / or adjust the shape of the catheter 9. For example, the catheter 9 can be manufactured from two materials having different coefficients of thermal expansion, such that the shape and / or outer profile can change when the catheter 9 is exposed to body temperature and / or the temperature from the fluid 6. A wire (e.g., made of metal and / or plastic) can be inserted into the lumen of the catheter 9 to generate a helical shape and / or to straighten the catheter 9. For example, during insertion and / or removal, it may be desirable for the catheter 9 to be substantially straight. The wire can be formed into a helix and held within the catheter 9 to assist in maintaining the helical shape. The wire can be fixed to the catheter tip 7 and then pulled, torqued, twisted, and / or pushed against the catheter 9 to adjust the shape of the catheter 9. For example, if the wire is off-axis and taut, this can cause the catheter 9 to be curled into a helical shape. The wire can be made from a shape memory alloy (e.g., nitinol) that can adjust its shape based on temperature. To form a helical shape in the catheter, the lumen of the catheter 9 can be placed under high or low pressure. The catheter 9 can include one and / or more sensors 21. The sensor 21a can be different from the sensor 21b. The sensors 21 can measure temperature, pressure, flow, pH, sound, enzymes, proteins, biological activity, and / or motion. The sensors 21 can extend outside the body of the catheter 9 by a sensor length 103. The sensors 21 can extend at various angles away from the catheter 9, and thus the sensor length 103 can be less than, equal to, and / or greater than the sensor radial length 104. The sensor radial length 104 can be the minimum distance from the sensor 21 to the body of the catheter 9. The sensor radial length 104 and / or the sensor length 103 can be changed and / or adjusted. For example, the sensors 21 can be adhered to the body of the catheter 9 by a dissolvable and / or releasable adhesive, heat shrink, glue, and / or mechanism.For example, when the temperature, acidity, and / or pressure change, the tip of the sensor 21 can be released from the body of the catheter 9.

[0093]

[0153] FIG. 19 shows that the catheter 9 can be introduced into the stomach 2 through the wall of the stomach 2. For example, the catheter 9 can be introduced through the percutaneous port 46. The catheter 9 can be introduced through the front and / or rear portions of the stomach 2. The catheter 9 can be introduced into the cardiac orifice, fundus, body, pylorus 65, duodenum 37, and / or pyloric sphincter 66 of the stomach.

[0094]

[0154] Figure 20 shows that the catheter 9 can have one and / or more coils and / or spirals. For example, a section of the catheter 9 can be heat-set and / or formed into a spiral shape. Additional materials and / or components can be used to generate and / or adjust the shape of the catheter 9. For example, the catheter 9 can be manufactured from two materials having different coefficients of thermal expansion, such that the shape and / or outer profile can change when the catheter 9 is exposed to body temperature and / or the temperature from the fluid 6. A wire (e.g., made of metal and / or plastic) can be inserted into the lumen of the catheter 9 to generate a spiral shape and / or to straighten the catheter 9. For example, during insertion and / or removal, it may be desirable for the catheter 9 to be substantially straight. The wire can be coiled and held within the catheter 9 to assist in maintaining the spiral shape. The wire can be fixed to the catheter tip 7 and then pulled, torqued, twisted, and / or pushed against the catheter 9 to adjust the shape of the catheter 9. For example, if the wire is off-axis and taut, this can cause the catheter 9 to be coiled into a spiral shape. The wire can be made from a shape memory alloy (e.g., nitinol) that can adjust its shape based on temperature. To form a spiral shape in the catheter, the lumen of the catheter 9 can be placed under high or low pressure. The catheter 9 can have a gastric coil 47 and / or an engagement device 48. The gastric coil 47 can extend into the duodenum 37. The engagement device 48 can extend into the stomach 2. The gastric coil 47 can provide additional surface area and / or flexibility. The gastric coil 47 and / or the helical shape can help prevent the catheter 9 from becoming entangled and / or forming knots. The engagement device 48 can help hold the catheter tip 7 within the duodenum 37. The engagement device 48 and / or the gastric coil 47 can help increase thermal contact with the fluid and / or tissue. For example, the engagement device 48 can increase thermal contact with the duodenum 37. The engagement device 48 and / or the gastric coil 47 can provide some tension relief to counteract and / or resist peristalsis, movement, and / or other external forces. The engagement device 48 can be, for example, a duodenal coil.A tether 73 can be fixed to a fixation point 74 on the catheter 9. The tether 73 can extend alongside the catheter 9 and / or enter the catheter 9 at a fixation port 75. The tether 73 can inhibit or prevent a portion of the catheter 9 from passing through the duodenum 37. The tether 73 can ensure that a portion of the catheter 9 does not pass through the duodenum 37. For example, the tether 73 can limit the distal movement of a section of the catheter 9 proximate to the fixation point 74 into the pylorus 65 and / or the duodenum 37. The maximum distance between the fixation point 74 and the fixation port 75 can be adjusted by pulling the tether 73 taut against the catheter 9. For example, the distance between the fixation point 74 and the fixation port 75 may be large during insertion, use, and / or removal. For example, the distance between the fixation point 74 and the fixation port 75 can be greater during insertion and / or removal than when the catheter 9 is positioned in an appropriate location within the stomach. The tether 73 can pass through the interior of the first lumen 15, the second lumen 16, the third lumen 17, and / or the fourth lumen 18. The tether 73 can be fixed to the catheter 9, the nose 11, and / or the heat transfer device 4. For example, the tether 73 can be fixed to the proximal portion of the catheter 9 outside the body after being pulled taut. For example, during removal, the tether 73 can be released from the proximal portion of the catheter 9 outside the body to facilitate removal of the catheter 9 from the patient. The tether 73 can be made from natural and / or synthetic polymers. The tether 73 can be made from metal, plastic, and / or ceramic. The proximal portion of the tether 73, the catheter 9, and / or the heat transfer device 4 can be fixed to the patient (e.g., the nose 11, the mouth 12, and / or other locations on the patient). An actuator can generate the translation of the tether and can have an automatic locking portion such as a ratchet. Alternatively, the actuator can be manually locked in place. Deployment of this actuator can ensure and / or enable consistent tension by maintaining a constant force (via a spring) or adjusting the distance. The actuator can be, for example, a lever, a motor, and / or a wheel. The actuator can have a visual indicator for feedback regarding the travel distance or locked state. The tether 73 can be pulled taut.The tether 73 can be pulled, for example, so that the fixed point 74 is near and / or adjacent to the fixed port 75. By maintaining the fixed point 74 near and / or adjacent to the fixed port 75, the risk of knot formation in the catheter 9 and / or the migration of the catheter 9 can be reduced. The distance between the fixed point 74 and the fixed port 75 can be approximately equal to the length of the tether 73 between the fixed point 74 and the fixed port 75. The total length of the catheter 9 between the fixed point 74 and the fixed port 75 can be greater than the length of the tether 73 between the fixed point 74 and the fixed port 75. The tether 73 can be, for example, a string. The tether 73 can be, for example, a fixed string.

[0095]

[0155] Figure 21 shows that the introducer 49 can be inserted into the esophagus 5 and / or the stomach 2. The introducer 49 allows for an easier placement and / or a more controlled placement of the heat transfer device 4. The catheter 9 and / or the inner catheter 51 can be introduced through the introducer 49. The introducer 49 can be more rigid than the catheter 9 and / or the inner catheter 51. The introducer 49 can include various features including a bend-and-stay, deformable, deflectable guide catheter, sensors, etc. The inner catheter 51 can be a flexible single-lumen tube. The inner catheter 51 can provide a high surface area to volume ratio. The fluid 6 can pass through the inner catheter 51. The inner catheter 51 can be the catheter 9. The introducer 49 can provide isolation between the catheter 9 and the tissue and / or organs. For example, the introducer 49 can provide thermal insulation between the catheter 9 and the esophagus 5, the nose 11, the mouth 12, and / or the stomach 2. For example, the introducer 49 can provide thermal insulation between the heat transfer device 4 and the esophagus 5, the nose 11, the mouth 12, and / or the stomach 2.

[0096]

[0156] Figure 22 shows that the catheter 9 can have a balloon, such as a plurality of radially expanding balloons. Figure 22 shows that the balloon can be fluidly coupled to the catheter. The balloon can be elastic, inelastic, or a combination of elastic and inelastic. A plurality of balloons arranged in sequence can increase the flexibility along the axis of the catheter while increasing the surface area for temperature exchange compared to a single balloon. The inelastic balloon can be produced such that the diameter of the balloon is limited and the volume of the balloon is limited regardless of pressure. Similarly, the self-limiting diameter of the inelastic balloon limits the radially outward pressure on the gastric wall. There can be a combination of elastic and inelastic balloons. The low-pressure inelastic balloon can expand to conform to the gastric folds or curvature and have a wall thin enough to allow closer contact and greater heat transfer. The same catheter with an inelastic balloon can have an elastic region or bellows that can expand for internal pressure relief. To maintain the integrity of the inelastic balloon material, there is an internal or external pressure on the inelastic balloon. Any of the cooling balloons can be an extruded tube made of polymer, elastomer, and / or rubber. For example, the balloon 3 can be a thin-walled extruded silicone tube. The balloon 3 can have approximately the same outer diameter as the catheter 9 in the contracted configuration shown in Figure 22. The balloon 3 can be inflated by the fluid 6. The balloon 3 can be inflated to a low pressure that conforms to and / or matches the stomach 2. The peristaltic movement and / or motility of the stomach 2 can operate and / or move the most distal balloon 3. For example, the contraction of the stomach can direct and / or push the balloon 3 towards the pylorus 65. The catheter tip 7 can remain within the stomach 2, esophagus 5, pylorus 65, and / or duodenum 37. The catheter tip 7 can have ports for suction, decompression, replenishment, and / or insertion instruments. The catheter tip 7 can be introduced and / or positioned on a guidewire. The plurality of cooling balloons 3 can be fixed to the catheter 9 by adhesive, ultrasonic welding, heat shrink tubing, metal bands, and / or reflow melting.A plurality of balloons 3 can be inserted into and / or removed from the esophagus 5 and / or the stomach 2 in the contracted configuration shown in FIG. 22. The cooling balloon material 3 can be made of PET, LDPE, HDPE, Mylar, and / or nylon, or an elastic material such as silicone or urethane. A series of the most distal balloons 3 can have a size such that they can be placed in the duodenum by a peristaltic movement or an imaging-guided placement. Such a balloon in the duodenum can function both to fix the position and to perform cooling in the duodenum to cool the pancreatic head adjacent to the duodenum. The duodenal device 40 can be an elastic and / or non-elastic balloon fixed to the catheter 9. The duodenal device 40 can act as a container for the balloons 3.

[0097]

[0157] FIG. 23 shows that the lumen of the catheter 9 can expand. For example, the entire catheter wall 20 and / or a section of the catheter wall 20 can expand under pressure. The expandable catheter wall can be a balloon 3. The expandable catheter wall allows for an increase in the surface area of the catheter 9 during use. The expandable catheter wall can be in a non-expanded configuration during insertion and / or removal. The expandable catheter wall can include an expandable tube and / or balloon fixed concentrically around the catheter 9. The catheter 9 can include a catheter port 52 at the catheter tip 7 and / or along the circumference of the catheter 9. The catheter 9 can include a plurality of catheter ports 52. The catheter ports 52 can provide distributed access for decompression, replenishment, tools, and / or sensors. The catheter ports 52 can be connected to the first lumen 15, the second lumen 16, the third lumen 17, and / or the fourth lumen 18. The size and / or diameter of the catheter ports 52 can be the same and / or different from each other.

[0098]

[0158] FIG. 24 shows the intestinal valve 90 at the level of the intestine past the farthest dilated portion 41. The intestinal valve 90 can be placed by an endoscope and can be fixed by expanding radially or having a clamp-like holding mechanism. The intestinal valve 90 may have a clamp-like holding mechanism. The intestinal valve 90 can be fixed in place by expanding the intestinal valve 90 radially and / or engaging the clamp-like holding mechanism with the tissue. The intestinal valve 90 can be activated remotely by a signal via an attached wire or wirelessly by remote control or magnetic activation. When the valve is in the closed position, cold or warm fluid can be introduced into the stomach and the duodenal region with a proximal plug and circulated within this region to cool the sections of the stomach and duodenum adjacent to the pancreas. The cold or warm fluid can proceed into the pancreatic duct through the farthest dilated portion 41. The intestinal valve 90 can be programmed to open at set intervals or set temperatures via a built-in sensor, enabling the discharge of the fluid after the cooling fluid has been warmed by the surrounding structure. The intestinal valve 90 can be opened manually or automatically by remote control. By opening the intestinal valve 90, endogenous fluids such as secretions or ingested food or liquid can be passed through.

[0099]

[0159] Figure 25 shows the pyloric valve 91 at the level of the pylorus. The pyloric valve 91 can be placed by an endoscope and can be fixed by expanding radially, or having a key-like retaining mechanism, or having a geometric shape that engages the pylorus to seal the stomach 2. The pyloric valve 91 can have a key-like retaining mechanism. The pyloric valve 91 can be fixed in place by expanding the pyloric valve 91 radially and / or engaging the key-like retaining mechanism with the tissue. The pyloric valve 91 can be activated remotely by a signal via an attached wire, or wirelessly by remote control or magnetic activation. When the pyloric valve 91 is in the closed position, cold or warm fluid can be introduced into the stomach region and circulated within this region to cool the section of the stomach 2 adjacent to the pancreas 1. By closing the pyloric valve 91, the amount of fluid that can be absorbed is controlled by restricting or preventing the fluid from entering the intestine. Once the cold fluid has been transferred from the stomach 2 and surrounding organs and the fluid has been warmed, the fluid can be automatically cycled out by suction and replaced with cold fluid. Since the lumen of the catheter 9 having the catheter tip 7 continues beyond the pyloric valve 91, direct replenishment can be performed into the intestine, avoiding irritation of the stomach 2. The pyloric valve 91 can be programmed to open at set intervals or set temperatures via a built-in sensor, enabling the discharge of fluid after the cooling fluid has been warmed by the surrounding structure. The pyloric valve 91 can be opened manually or automatically by remote control. By opening the pyloric valve 91, endogenous fluids such as secretions or ingested food or liquid can be passed through.

[0100]

[0160] Figure 26 shows the peritoneal cooling device 53 applied to the outer surface of the pancreas 1. The peritoneal cooling device 53 can be a balloon and / or a catheter. With the peritoneal cooling device 53, fluid can be circulated via the peritoneal cooling device catheter 54. The peritoneal cooling device 53 can be placed laparoscopically or by direct transabdominal placement.

[0101]

[0161] Figures 27a through 27f show that the catheter 9 can include various cross-sectional shapes. The cross-section of the catheter 9 can be the same and / or different along its length. Figure 27a shows that the catheter 9 can have a circular and / or substantially circular lumen. The diameters and / or areas of the first lumen 15, the second lumen 16, the third lumen 17, and / or the fourth lumen 18 can be the same and / or different. Figure 27b shows that the cross-sections of the first lumen 15 and / or the second lumen 16 can be non-circular. The circular cross-sectional shape of the third lumen 17 and / or the fourth lumen 18 may be desirable to improve the passage of tools, sensors, food, tissue, and / or other substances. The circular cross-sectional shape of the first lumen 15 and / or the second lumen 16 can enable an increase in flow and / or a reduction in pressure drop. The non-circular cross-sectional shape of the first lumen 15 and / or the second lumen 16 can enable an increase in the hydraulic diameter. The non-circular cross-sectional shape of the first lumen 15 and / or the second lumen 16 can increase heat transfer through the wall of the catheter 9 by increasing the surface area in contact with the fluid 6. Figure 27c shows that the cross-sectional shape of the catheter 9 can be non-circular. Figure 27c shows that the wall thickness of the catheter 9 can vary differently at a given cross-section. Making the catheter wall 20 thinner can enable an increase in heat transfer through the catheter wall 20. The lumen of the catheter 9 can expand and / or contract under various pressures. For example, under high pressure, the cross-section of the catheter 9 can change from that shown in Figure 27b to that shown in Figure 27c. The catheter 9 of Figure 23 can have the cross-sections of Figures 27b and 27c. The catheter wall 20 can be elastic and / or inelastic. Figures 27d and 27e show that heat transfer through the catheter outer diameter 19 can be maximized by the cross-sectional shape of the catheter 9. For example, the non-circular shape of the first lumen 15 and / or the second lumen 16 can increase heat transfer through the catheter wall 20 by maximizing contact with the outer wall of the catheter 9. Figure 27f shows that the diameter and / or area of the third lumen 17 can be different from the diameter and / or area of the fourth lumen 18. The third lumen 17 may be beneficial with a larger diameter when used for suction, decompression, replenishment, and / or the passage of tools.The fourth lumen 18 may be useful for ventilation, replenishment, sensing, and / or for the passage / installation of small tools / sensors. The first lumen 15, the second lumen 16, the third lumen 17, and / or the fourth lumen 18 can be helical about and / or through the catheter 9. The first lumen 15, the second lumen 16, the third lumen 17, and / or the fourth lumen 18 can be helical with respect to each other and / or more aligned with each other.

[0102]

[0162] FIGS. 28a and 28b show that a tube and / or balloon can be fixed concentrically on the catheter 9. The balloon 3 can be fixed concentrically on the catheter 9. The catheter 9 of FIG. 23 may have the cross-sections of FIGS. 28a and 28b. The balloon 3 can be fixed to the catheter 9 in one and / or a plurality of balloon seal regions 55. The balloon seal regions 55a and / or 55b can prevent the fluid 6 from moving between the first lumen 15 and the second lumen 16. The fluid 6 can move from the first lumen 15 through the catheter holes 65 into the balloon 3. The catheter holes 65 can be punched, skived, melted, cut, laser cut, drilled, machined, and / or formed in the catheter wall 20. The catheter 9 may have a plurality of catheter holes 65. For example, the fluid 6 can exit from one of the catheter holes 65 into the balloon 3 and then enter back into the catheter 9 through a second one of the catheter holes 65. The first lumen 15 and / or the second lumen 16 can be blocked in a specific region to push the fluid 6 into the balloon 3. The balloon seal region 55 can fix the balloon 3 to the catheter 9 by adhesive, brazing, heat shrink tube, spring, melting, and / or ultrasonic welding.

[0103]

[0163] Figure 29 shows that the catheter outer diameter 19 can vary over the length of the catheter 9. For example, the catheter outer diameter 19 can be made smaller at the nose portion to minimize discomfort and / or heat transfer to the nasal cavity. The catheter outer diameter 19 may be small in areas where heat transfer is undesirable. For example, the catheter outer diameter 19 may be small at the nose 11, mouth 12, head, and / or esophagus 5. Making the catheter outer diameter 19 smaller can reduce the risk of knots and / or tangles and / or improve passage, insertion, removal, and / or bending. Making the catheter outer diameter 19 larger can improve heat transfer, increase the heat transfer surface area, and reduce the risk of knots and / or tangles. The distal portion of the catheter 9 may not include the third lumen 17 and / or the fourth lumen 18. When the distal portion of the catheter 9 does not include the third lumen 17 and / or the fourth lumen 18, the distal portion of the catheter 9 may have a smaller catheter outer diameter 19. For example, the distal portion of the catheter 9 may have only the first lumen 15 and / or the second lumen 16. As another example, the distal thermal portion of the catheter 9 may have the first lumen 15 and / or the second lumen 16, but may not include the third lumen 17 and / or the fourth lumen 18).

[0104]

[0164] Figure 30 shows that a portion of the fluid 6 can proceed directly from the output port of the heat exchange system 13 to the return port of the heat exchange system 13 through the bypass lumen 63 without passing through the heat exchanger 4 and / or entering the stomach 2. For example, the minimum flow rate that the heat exchange system 13 has (e.g., requires) may be greater than what can pass through the catheter 9. By passing a portion of the fluid 6 through the catheter 9 and the remainder through the bypass lumen 63, the bypass lumen 63 enables the heat exchange system 13 to maintain a sufficiently large flow rate. The bypass lumen 63, the heat exchange system 13, the catheter 9, and / or other components may have sensors, pressure relief valves, and / or switches for controlling the flow through the bypass lumen 63. For example, the user can adjust the flow of the fluid 6 through the catheter 9 without adjusting the heat exchange system 13. For example, during startup, all of the fluid 6 may pass through the bypass lumen 63 until it reaches an appropriate temperature. After the fluid 6 reaches an appropriate temperature, it can be switched to flow entirely and / or partially through the catheter 9. In an emergency, all of the fluid 6 can pass through the bypass lumen 63 without turning off and / or adjusting the heat exchange system 13. The bypass lumen 63 can provide some attenuation and / or pressure relief to the catheter 9. The IV pouch 62 can be fixed to the IV pole 57. The IV pouch 62 can contain saline, nutrients, food, water, drugs, and / or other materials. The contents of the IV pouch 62 can be connected to the catheter 9 via the external auxiliary lumen 61. The external auxiliary lumen 61 can be connected to the third lumen 17 and / or the fourth lumen 18. The flow rate of the contents of the IV pouch 62 can be controlled by adjusting the height of the IV pouch 62 relative to the patient. The IV pouch 62 and / or the contents of the IV pouch 62 can be heated and / or cooled before and / or during the procedure. The contents of the IV pouch 62 can provide additional heating and / or cooling to the stomach 2, the pancreas 1, the duodenum 37, and / or other organs of the patient. The flow rate of the contents of the IV pouch 62 can be controlled using metering devices such as peristaltic pumps, drip chambers, and / or valves. The flow of the fluid 6 returning from the catheter 9 can return to the heat exchange system 13 after passing through the return pouch 60.For example, fluid 6 can move from catheter 9 to catheter-pouch return lumen 58, to return pouch 60, and then to pouch-cooler return lumen 59. The height of return pouch 60 relative to the patient and / or heat exchange system 13 can be adjusted. The height of return pouch 60 relative to stomach 2 can affect the pressure of fluid 6 within balloon 3 and / or other elements of heat transfer device 4.

[0105]

[0165] FIG. 31 shows that an external auxiliary lumen can be connected to vacuum 67. Vacuum 67 can provide suction and / or decompression. Vacuum 67 can provide intermittent vacuum and / or pressure. External auxiliary lumen 61 can be connected to vacuum 67, IV pouch 62, and / or other components / sensors. Heat exchange system 13 can move fluid 6 in a certain direction and / or circuit. Heat exchange system 13 can inject and / or remove fluid 6. For example, heat exchange system 13 can inject and / or remove fluid 6 using a peristaltic pump and / or a syringe pump. Heat exchange system 13 can heat and / or cool fluid 6. Heat transfer device 4 can heat and / or cool tissue and / or organs. Heat transfer device 4, catheter 9, and / or balloon 3 can heat and / or cool stomach 2, pancreas 1, and / or duodenum 37.

[0106]

[0166] FIG. 32 shows that catheter 9 and / or heat transfer device 4 can access pancreas 1 via an artery. For example, catheter 9 can pass through aorta 72, celiac artery 68, splenic artery 69, pancreatic artery 70, and / or gastroduodenal artery 71. When catheter 9 is disposed inside an artery, it can perform more efficient and / or localized heat transfer. For example, by disposing catheter 9 inside pancreatic artery 70, it can perform more efficient and / or direct heat transfer to pancreas 1. Catheter 9 can pass through the venous system.

[0107]

[0167] Figure 33 shows that the heat transfer device 4 can cool the physical simulation of the stomach 2 and / or the pancreas 1. The model used to obtain the data shown in Figure 33 included a flexible silicone stomach 2 and pancreas 1 placed in a water bath at 37°C. Thermocouples were placed at various locations within the pancreas 1. Approximately 90 cm of the catheter 9 was placed inside the simulated stomach 2 in a configuration similar to that shown in Figure 18. To simulate gastric juice, approximately 10 mL of fluid was placed inside the stomach 2. The catheter 9 was connected to an external recirculating cooling system, and fluid at 5 - 15°C was flowed through the catheter 9 at approximately 100 mL / min. After approximately 30 minutes, the mechanism gently manipulated the stomach 2 to simulate gentle peristalsis and / or movement of the stomach. Figure 33 shows that the thermotherapy system 33 can cool the physically simulated pancreas 1. Figure 33 shows that the gentle peristalsis and / or movement of the stomach 2 can help to equalize the temperature of the pancreas 1 (for example, the latter half of the graph has a narrower maximum / minimum temperature band than the first half). The heat transfer device 4 used to obtain the data in Figure 33 was removing approximately 20 - 30 watts in the steady state.

[0108]

[0168] Figure 34 shows a catheter that is rotatable for placement and advancement into the pylorus 65 and duodenum 37 by the catheter tip 7. The catheter 9 can have a tapered coil distal diameter 79 that may be smaller than the tapered coil maximum diameter 78. The coil diameter of the tapered coil proximal diameter 77 may be smaller than the tapered coil maximum diameter 78 as it transitions into the helical section of the catheter 9. In the nose, or the narrowest section of the passage from the nose to the stomach, when a forward rotational force is applied to the helical section of the catheter as it passes through the pylorus into the intestine, the introducer 49 or the open-ended catheter can provide a support surface for the main cooling catheter 9. The introducer can prevent the sensitive portion of the nasal passage from receiving the torque applied to the main heat transfer catheter.

[0109]

[0169] FIGS. 35a through 35d show a linear inversion catheter comprising a first catheter 80 that can be connected to a membrane 82 at the distal end. The membrane 82 can be connected to a second catheter 81, can comprise a seal or connection port, and can have an annular portion that responds to a hydraulic pressure applied by a fluid, medium, or gas. The hydraulic pressure can invert the membrane 82 without friction. A third catheter can be delivered within the first catheter 80 and the second catheter 81. The third catheter can include a lumen for the inflow and outflow of a cooling (or heating) medium supplied by an external controller and a lumen for the aspiration or delivery of nutrients for a patient.

[0110]

[0170] The linear inversion catheter can deliver the catheter system through the nasopharynx and into the esophagus 5. Position the distal end of the first catheter 80 at the patient's nostril, and hydraulic pressurization can be performed by a fluid, medium, or gas from an external source. Once pressurized, the second catheter 81 can be advanced to advance the membrane 82 through the nasopharynx and into the esophagus 5. Once the membrane 82 and the second catheter are fully expanded, the third catheter can be delivered within the lumen of the second catheter 81 to supply the catheter cooling system described herein. A passive or active isolation source for protecting the patient's nasopharynx from the thermal cooling energy from the third catheter can be supplied by a hydraulic fluid, medium, or gas. As an active isolation source, a heated fluid, medium, or gas can be introduced into the annular portion of the membrane to provide isolation from the cooling energy supplied by the internal third catheter. As a passive isolation source, the annular portion of the linear inversion catheter can be filled with air or gas to provide an insulator.

[0111]

[0171] Figure 35b shows that a linear inversion catheter can be configured at the distal end of the catheter system after delivery into the patient's stomach. The distal end 7 of the first catheter 80 can be positioned near the patient's pylorus. Connecting the first catheter 80 to a membrane 82 that can be connected to a second catheter and pressurizing it with a fluid, medium, or gas allows the second catheter 81 to advance and invert the membrane towards the pylorus. The operation of expanding the membrane 82 is self-seeking and can be adapted to intubate the pylorus 65 and also to advance through the duodenum 37. A lumen for a third catheter through which thermal cooling energy can be delivered to this anatomical location may be present within the second catheter 81.

[0112]

[0172] The entire catheter system can be configured using both a linear inversion delivery system for providing access via the patient's nasopharynx and a second linear inversion delivery system for sending cooling energy into the patient's duodenum 37.

[0113]

[0173] Figure 35d shows that to deliver fluid 6 to the duodenum 37, the membrane 82 can be inverted to form two layers. These two layers can always be connected at the distal end of the first catheter tip 7 where the inner layer of the first catheter 80 begins to invert onto the outer layer of the second catheter 81. The proximal ends of these layers are temporarily locked together by an annular clamp during the initial insertion of the catheter into the desired area. Upon reaching the stomach, the annular clamp is unlocked at the proximal end and the second catheter 81 can slide proximally relative to the first layer 81. The distal movement of the second catheter 81 along the axis on the first catheter 80 allows the distal end of the catheter to advance into the stomach, further past the pylorus 65 and into the duodenum 37. The heat transfer fluid introduced at the proximal end can travel between the first catheter 80 and the second catheter 81 and reach the intestine and the stomach. The heat transfer fluid can be circulated for a certain heat exchange with the tissue surrounding the catheter. The center of the lumen of the first catheter 80 can function as a suction or supply tube.

[0114]

[0174] Figure 35d shows a linear inversion catheter with a single-layer catheter that can be inverted to form two layers. These two layers can always be connected at the catheter tip where the layer of the first catheter 80 begins to invert onto the outer layer of the second catheter 81. Figure 35d shows that a heat transfer catheter having a fluid 6 or one or more lumens for replenishment and aspiration can be connected to the center of the inner layer of the first catheter 80 of the linear inversion catheter. The proximal ends of these layers are temporarily locked together by an annular clamp during the initial insertion of the catheter 9 into the desired area. Upon reaching the stomach, the annular clamp is unlocked at the proximal end and the outer layer can slide proximally relative to each layer. By the distal movement of the outer layer along the axis on the inner layer, the distal end of the catheter can advance into the stomach and further into the duodenum 37 past the pylorus 65. After delivering the heat transfer catheter 9 to the desired position, the first catheter 80 and the second catheter 81 at the proximal end can be locked by annular compression to stabilize the position and prevent relative movement.

[0115]

[0175] Figure 36 shows that the catheter 9 can be disposed within the stomach 2 and / or the esophagus 5. The catheter 9 can be coiled, for example, to maximize contact with adjacent organs including, but not limited to, the esophagus 5. For example, the catheter 9 can be coiled to ensure contact with the esophagus 5 while maintaining radial and / or longitudinal flexibility. The coiled section of the catheter 9 can expand, contract, and / or deform to ensure contact with the esophagus 5. The cross-section of the coil can be circular (e.g., which may appear like a standard compression and / or tension spring), or another shape (e.g., elliptical, square, triangular, etc.). The coiled catheter 9 can maximize thermal contact and / or heat transfer with the esophagus 5. The fluid 6 can circulate within the catheter 9. The first lumen 15 is positioned on the outer circumference of the coil and the second lumen 16 is positioned on the inner circumference of the coil to maximize heat transfer to the esophagus 5.

[0116]

[0176] Figures 37a and 37b show that when the catheter 9 is in the deployed configuration, the catheter 9 can have a lattice shape 103. Figures 37a and 37b show that when the tether 73 is actuated (e.g., withdrawn, pulled), the lattice shape 103 can change, for example, from the lattice first shape 103a to the lattice second shape 103b. Figure 37a shows that the catheter 9 can have the lattice first shape 103a before the tether 73 is actuated, for example, when the tether 73 is in the non-actuated position. Figure 37b shows that the catheter 9 can have the lattice second shape 103b after the tether 73 is actuated, for example, when the tether 73 is in the actuated position. The catheter 9 can be deployed with or without using the tether 73. The catheter 9 can be deployed with or without actuating the tether 73. For example, the deployed configuration of the catheter 9 in Figure 37a can be a partially deployed configuration of the catheter 9, and the deployed configuration of the catheter 9 in Figure 37b can be a fully deployed configuration of the catheter 9. As another example, the deployed configuration of the catheter 9 in Figure 37a can be a fully deployed configuration of the catheter 9. The catheter 9 may not include a tether (tether 73). In such a case, the deployed configuration of the catheter 9 in Figure 37a can be a fully deployed configuration.

[0117]

[0177] Figure 38 shows that the catheter 9 may have a remote sensor 93. The remote sensor 93 may be integral with and / or separate from the catheter 9. For example, the remote sensor 93 can be inserted and / or ingested separately from the catheter 9. For example, the remote sensor 93 can be adhered and / or fixed to the catheter 9 during insertion and then separated and / or partially removed from the catheter 9 once the device is placed in the stomach 2. The remote sensor 93 can be connected to the catheter 9 using a remote sensor tether 94. The remote sensor 93 can communicate wirelessly and / or without wires. The remote sensor 93 may have a battery source and / or a power generation source (e.g., thermoelectric). The remote sensor 93 can be charged and / or powered wirelessly (e.g., inductive charging). The remote sensor tether 94 can be transmitted optically and / or electrically to the catheter 9. For example, the remote sensor tether 94 can include an electrical wire and / or an optical fiber cable. The remote sensor 93 can monitor temperature, pH, gastric motility, and / or other important metrics. The remote sensor 93 may include a camera. The remote sensor 93 can monitor various wavelengths (e.g., light, infrared, and / or ultraviolet). The remote sensor 93 can measure the temperature of the stomach and / or the gastropancreatic wall 8. The remote sensor 93 can detect whether the surrounding medium is solid, liquid, and / or gas (e.g., by measuring the electrical resistance and / or conductivity between two points).

[0118]

[0178] Figures 39a and 39b show that the tip of catheter 9 may include an elongate portion 97. The diameter 95 of the elongate portion may be smaller than, larger than, and / or equal to the catheter OD19. The stiffness of the elongate portion 97 may be the same as and / or different from the remainder of catheter 9. For example, the elongate portion 97 may facilitate insertion of catheter 9 into the nose 11 and / or other organs. The elongate portion 97 may provide a soft tip to prevent catheter 9 from irritating the walls of the stomach 2 and / or other organs. The elongate portion 97 may prevent catheter 9 from tunneling into tissue. The elongate portion 97 may have a different radiopacity and / or echo brightness than the remainder of catheter 9. For example, the elongate portion 97 may include a metal marker band. The elongate portion 97 may be denser than the remainder of catheter 9. Catheter 9, elongate portion 97, and / or any part of the thermotherapy system 33 may be barium sulfate (i.e., BaSO 4) may include radiopaque additives such as. The length 96 of the elongated portion may be about 1 cm. The elongated portion 97 may have an elongated tip 100 that does not cause trauma. The elongated tip may be rounded and / or dome-shaped. The sensor 21 can be embedded and / or fixed in the elongated portion 97. For example, the sensor 21 may be a thermistor, a thermocouple, an RTD, and / or another temperature sensor. The sensor 21 can be a pH measurement and / or a camera. The remote sensor 93 may be the sensor 21. The first lumen 15, the second lumen 16, the third lumen 17, and / or the fourth lumen 18 may or may not extend into the elongated portion 97. For example, the elongated portion 97 may be insulated from the rest of the catheter 9 to more accurately measure the temperature of the stomach 2. The sensor 21 may be connected to an external console, a DAQ, a data acquisition device, a heat exchange system 13, a computer, and / or other systems by a sensor cable 107. The sensor cable 107 may be a remote sensor tether 94. The sensor cable 107 may be a wire, a cable, an optical fiber tube, and / or a conduit capable of transmitting information. The sensor cable 107 may pass outside the catheter 9 and / or through one of the catheter lumens. The catheter 9 may include a confluence zone 105. The confluence zone 105 allows the first lumen 15 to be in fluid communication with the second lumen 16. The length 106 of the sensor elongated portion may be shorter than, equal to, and / or longer than the length 96 of the elongated portion. The length of the sensor elongated portion may be large enough to minimize heat transfer between the catheter 9 and the sensor 21. For example, the region of the catheter 9 proximal to the confluence zone 105 may be warmer and / or colder than the region distal to the confluence zone 105. The sensor 21 may be an infrared temperature sensor.

[0119]

[0179] Figure 40 shows that the diameters of the first lumen 15, the second lumen 16, and / or the third lumen 17 may be the same and / or different. The pressure at the distal tip of the catheter 9 and / or at the balloon 3 can be determined by the ratio of the hydraulic diameter of the first lumen 15 to the hydraulic diameter of the second lumen 16. For example, the ratio of the hydraulic diameters of the first lumen 15 and the second lumen 16 may be directly proportional to the pressure drop through the length of the lumen (and thus the pressure at the balloon 3). It may be desirable to reduce the pressure of the balloon 3 for improved compliance and / or flexibility.

[0120]

[0180] Figure 41 shows that the catheter 9 can be introduced over the guide wire 99. The guide wire 99 may pass through the third lumen 17 and / or the fourth lumen 18. The guide wire 99 may be coated with a hydrophilic and / or hydrophobic material. The guide wire 99 may be separate from the catheter 9 and / or may be integral with the catheter 9. The thermal therapy system 33 may include an esophageal valve 92. The esophageal valve 92 can control the amount and / or velocity of fluid traveling from the esophagus 5 to the stomach 2 and / or vice versa. The catheter 9 may pass through the esophageal valve 92. The catheter 9 can be permanently fixed to the esophageal valve 92 and / or can be removable from the esophageal valve 92. The esophageal valve 92 may be a backflow prevention valve. The guide wire 99 can guide the catheter 9 to a specific region (e.g., the pylorus and / or the antrum of the stomach 2).

[0121]

[0181] Figure 42 shows that the thermal therapy system 33 can actively control the core body temperature of a patient. In this study, approximately 75 cm of the catheter 9 having a cross-section similar to that shown in FIG. 27b was randomly positioned in the stomach (similar to FIG. 18). The core body temperature of a human patient decreased during the active cooling period 98 and increased when cooling ended. The core body temperature was monitored using a zero heat flux thermometer (3M Bair Hugger (trademark)).

[0122]

[0182] Figure 43 shows that an isolation pad 101 can be arranged between the catheter 9 and the patient to prevent discomfort. The isolation pad 101 may be made of a soft foam. The isolation pad 101 can be permanently fixed to the catheter 9 and / or be detachable. The isolation pad 101 may have an adhesive on one surface to adhere the catheter 9 and / or the isolation pad 101 to the patient.

[0123]

[0183] Figure 44 shows that the catheter 9 can have an isolation coil 102. The isolation coil 102 may have a preformed shape of the catheter 9. The isolation coil 102 can minimize the contact between the catheter 9 and the posterior part of the throat and / or other organs. The guide wire 99 can keep the isolation coil 102 straight during insertion into the nose 11. The isolation coil 102 may have a foam heat insulator to minimize the heat transfer between the catheter 9 and the patient.

[0124]

[0184] Figures 45a and 45b show a modified example of the catheter 9 in the stomach 2 with an expandable catheter array.

[0125]

[0185] Figures 46a to 46z3 show that the catheter 9 can be inserted into the body and / or removed from the body. For example, Figures 46a to 46z3 show that the catheter 9 can be inserted into the digestive tract 110 and / or removed from the digestive tract 110. For example, Figures 46a to 46o show that the catheter 9 can be inserted into the stomach 2 as indicated by the arrow 112, and Figures 46o to 46z3 show that the catheter 9 can be removed from the stomach 2 as indicated by the arrow 114. The insertion direction as shown by the arrow 112 can be, for example, opposite to the removal direction as shown by the arrow 114. Figures 46a to 46z3 show that the catheter 9 can be inserted into the stomach 2 through, for example, the esophagus 5 and / or removed from the stomach 2. Figures 46a to 46z3 show that the target site 147 can be, for example, the stomach 2.

[0126]

[0186] The catheter 9 can have one or more configurations 116 within the body, for example, within the digestive tract 110. The catheter 9 can be formed into the configuration 116, for example, during insertion of the catheter 9 into the body and / or during removal of the catheter 9 from the body. The catheter 9 can be formed into the configuration 116, for example, by inserting the catheter 9 into the body and / or removing the catheter 9 from the body. Each of the configurations 116 can include, for example, the placement of the catheter 9 inside the body (e.g., inside the digestive tract 110). For example, FIGS. 46a through 46z3 show 29 configurations 116 that the catheter 9 can have within the body during insertion into and / or removal from the digestive tract 110. These can include, for example, configurations 116a through 116z3 or any combination thereof. For example, FIGS. 46a and 46z3 show that configurations 116a and 116z3 correspond to placements that the catheter 9 can have within the esophagus 5, and FIGS. 46b through 46z2 show that configurations 116b through 116z2 correspond to placements that the catheter 9 can have within the stomach 2. Configurations 116a through 116z3 can be, for example, the first of 29 configurations 116a through 116z3 that the catheter 9 can form during insertion of the catheter 9 into the body and / or during removal of the catheter 9 from the body.

[0127]

[0187] For example, when the catheter 9 is in the body, including the case where the catheter 9 is any one of the configurations 116 (for example, the configurations 116a to 116z3 from FIG. 46a to FIG. 46z3), the catheter 9 can transfer heat to and / or from the body (for example, to and / or from the heat transfer target 146). Any one of the configurations 116 can be, for example, the operating state (also referred to as the operating configuration) of the catheter 9. When the catheter 9 is in the operating configuration (for example, one or any combination of the configurations 116), the catheter 9 can transfer heat to and / or from the body, for example, by injecting a fluid through the lumen of the catheter 9. The fluid is, for example, the fluid 6, and the lumen can be, for example, the lumen 15 and / or the lumen 16. For example, FIGS. 46a to 46z3 show that the catheter 9 can have the lumen 15 and the lumen 16, where the lumen 15 can be the inflow lumen and the lumen 16 can be the outflow lumen. FIGS. 46a to 46z3 show, for example, that each of the configurations 116a to 116z3 can be the operating configuration of the catheter 9.

[0128]

[0188] Each configuration 116 of the catheter 9 can be a partially deployed configuration and / or a fully deployed configuration of the catheter 9. For example, FIGS. 46a through 46z3 show that configurations 116a - 116n and 116p - 116z3 can be partially deployed configurations of the catheter 9, and configuration 116o can be a fully deployed configuration of the catheter 9. As another example, any of the configurations 116 (e.g., configurations 116a - 116z3) can be a fully deployed configuration. For example, if configuration 116f is a fully deployed configuration, the catheter 9 can be inserted into the body to form configuration 116f and then removed from the body without forming configurations 116g - 116o. When the catheter 9 is in a partially deployed configuration (e.g., configurations 116a - 116z3), the catheter 9 can transfer heat to and / or from the body, for example, by injecting fluid 6 through lumens 15 and 16. When the catheter 9 is in a fully deployed configuration (e.g., configurations 116a - 116z3), the catheter 9 can transfer heat to and / or from the body, for example, by injecting fluid 6 through lumen 15 and / or lumen 16.

[0129]

[0189] The configuration 116 formed by the catheter 9 during removal of the catheter 9 from the body may be the same as or different from the configuration 116 formed by the catheter 9 during insertion of the catheter 9 into the body. FIGS. 46a through 46z3 show, for example, that the configuration 116 (e.g., configurations 116o - 116z3) formed by the catheter 9 during removal can be the same as the configuration 116 (e.g., configurations 116a - 116o) formed by the catheter 9 during insertion. For example, FIGS. 46a through 46z3 show that configurations 116p - 116z3 can be the same as configurations 116n - 116a respectively (e.g., the 16th configuration 116p can be the same as the 14th configuration 116n, and the 27th configuration 116z1 can be the same as the 3rd configuration 116c). As another example, the configuration 116 formed by the catheter 9 during removal of the catheter 9 from the body may be different from the configuration 116 formed by the catheter 9 during insertion of the catheter 9 into the body.

[0130]

[0190] The catheter 9 can be formed into one or more of the configurations 116 at the target site 147, for example, during, and / or after, flowing (e.g., injecting) fluid into the lumen of the catheter 9. The catheter 9 can be formed into the configuration 116 at the target site 147, for example, during, and / or after, flowing (e.g., injecting) fluid into the first lumen 15 and / or the second lumen 16 of the catheter 9. For example, FIGS. 46a through 46o show that the catheter 9 can be formed into the configurations 116a through 116o before flowing fluid 6 into the first lumen 15 and / or the second lumen 16, and FIGS. 46p through 46z3 show that the catheter 9 can be formed into the configurations 116p through 116z3 after flowing (e.g., injecting) fluid 6 into the first lumen 15 and / or the second lumen 16.

[0131]

[0191] When fluid is flowed through the catheter 9, the configuration 116 of the catheter 9 may or may not change. For example, FIGS. 46a through 46z3 show that the configuration 116 of the catheter 9 may not change when fluid is flowed through the catheter 9 (e.g., into the inflow lumen and / or the outflow lumen of the catheter 9). The configuration 116 can maintain a constant state before, during, or after flowing (e.g., injecting) fluid through the catheter 9. For example, FIGS. 46a through 46z3 show that the configuration 116 (e.g., the configurations 116a through 116z3) can maintain a constant state before, during, or after flowing (e.g., injecting) fluid through the catheter 9.

[0132]

[0192] The catheter 9 can be formed into one or more of the configurations 116 in the digestive tract 110, for example, by inserting the catheter 9 into the digestive tract 110 and / or removing the catheter 9 from the digestive tract 110. For example, by inserting the catheter 9 into the stomach 2 and / or a portion of the digestive tract 110 behind the stomach 2 (e.g., into the duodenum 27), and / or by removing the catheter 9 from the stomach 2 and / or a portion of the digestive tract 110 behind the stomach 2 (e.g., from the duodenum 37), the catheter 9 can be formed into one or more of the configurations 116 in the digestive tract 110.

[0133]

[0193] The catheter 9 can form one or more shapes 117 (also referred to as catheter shapes 117) within the body, for example, when inserting the catheter 9 into the body and / or when removing the catheter 9 from the body. Each shape 117 can be, for example, the arrangement of the catheter 9 inside the body. Each shape 117 can be defined by, for example, the path that the catheter 9 has within the body. For example, each shape 117 can include the path that the catheter 9 passes through within the body, such as the path passing through the digestive tract 110 (for example, passing through the stomach 2, the pylorus 65, and / or the duodenum 37). Each component 116 of the catheter 9 can include a catheter shape 117. Each shape 117 can correspond to a component 116 of the catheter 9. For example, FIGS. 46a to 46z3 show that the components 116a to 116z3 each include and / or correspond to the shapes 117a to 117z3, and when the catheter 9 is in the components 116a to 116z3, the shapes 117a to 117z3 can be the arrangement of the catheter 9. For example, FIGS. 46a to 46z3 show that the catheter 9 can have 29 shapes 117 that it can have within the body, for example, during insertion into the digestive tract 110 and / or during removal from the digestive tract 110. These can include, for example, the shapes 117a to 117z3 or any combination thereof. For example, FIGS. 46a and 46z3 show that the shapes 117a and 117z3 can be the shapes (for example, paths) that the catheter 9 can have within the esophagus 5, and FIGS. 46b to 46z2 show that the shapes 117b to 117z2 can be the shapes (for example, paths) that the catheter 9 can have within the stomach 2. The shapes 117a to 117z3 can be, for example, the first of the 29 shapes 117a to 117z3 that the catheter 9 can have during insertion of the catheter 9 into the body and / or during removal of the catheter 9 from the body.

[0134]

[0194] The catheter shape 117 of each component 116 may depend on, for example, the length of the catheter 9 within the digestive tract 110 (e.g., within the stomach 2, within the pylorus 65, and / or within the duodenum 37), the entry angle of the catheter 9 into the stomach 2 (e.g., from the esophagus 5), the entry angle of the catheter 9 into the duodenum 37 (e.g., from the stomach 2), the rigidity of the catheter 9, the diameter of the catheter 9, the size of the stomach 2, the size of the duodenum 37, the size of the organ adjacent to the stomach 2 (e.g., the pancreas), the size of the organ adjacent to the duodenum 37 (e.g., the pancreas), or any combination thereof. For example, based on these factors, a given length of the catheter 9 inserted into the stomach 2 (e.g., 100 cm of the catheter 9, 150 cm of the catheter 9, 200 cm of the catheter 9) can form various components 116 having various shapes 117 within the stomach 2. For example, FIGS. 46a through 46z3 show that the catheter 9 can have shapes 117a through 117z3 within the stomach 2 when the catheter 9 is inserted 30 cm to 300 cm, and more precisely when inserted 30 cm to 150 cm. The inserted length can increase by 1 cm within these ranges. As another example, due to these factors, inserting the same length (e.g., 100 cm, 150 cm, 200 cm) of the same catheter 9 (e.g., literally the same catheter 9, or two different catheters 9 with the same manufacturer and model) into the same stomach 2 twice can result in forming the catheter 9 into two different components 116 and / or forming the catheter 9 into two identical components 116. The catheter 9 can have, for example, a minimum bending radius of 1.0 cm to 3.0 cm, and the minimum bending radius can increase by 0.1 cm within this range (e.g., 1.0 cm, 1.5 cm, 1.6 cm, 2.5 cm). The rigidity of the catheter 9 can be quantified, for example, as the force required to bend the catheter 9. The axial force for bending the catheter 9 can be, for example, greater than 2.0 Newtons to greater than 6.0 Newtons, and can increase by 0.1 Newton within this range (e.g., greater than 2.0 N, greater than 3.0 N, greater than 4.0 N, greater than 4.5 N, greater than 4.8 N, greater than 5.0 N, greater than 6.0 N).The axial force for bending the catheter 9 can be, for example, from 2.0 N to 6.0 N, and can increase by 0.1 N within this range (for example, over 2.0 N, over 3.0 N, over 4.0 N, over 4.5 N, over 4.8 N, over 5.0 N, over 6.0 N).

[0135]

[0195] During removal of the catheter 9 from the body, the shape 117 formed by the catheter 9 may be the same as or different from the shape 117 formed by the catheter 9 during insertion of the catheter 9 into the body. FIGS. 46a to 46z3 show, for example, that the shape 117 (for example, shapes 117o to 117z3) formed by the catheter 9 during removal may be the same as the shape 117 (117a to 117o) formed by the catheter 9 during insertion. For example, FIGS. 46a to 46z3 show that the shapes 117p to 117z3 may be the same as the shapes 117n to 117a, respectively (for example, the 16th shape 117p may be the same as the 14th shape 117n, and the 27th shape 117z1 may be the same as the 3rd shape 117c). As another example, the shape 117 formed by the catheter 9 during removal of the catheter 9 from the body may be different from the shape 117 formed by the catheter 9 during insertion of the catheter 9 into the body.

[0136]

[0196] The shape 117 of the catheter 9 in each configuration 116 may include, for example, one or more straight sections of the catheter 9 and / or one or more curved sections of the catheter 9.

[0137]

[0197] The catheter shape 117 of the deployed configuration (e.g., configuration 116) may include, for example, one or more loops 118 formed by the catheter 9. The catheter 9 can have, for example, 1 to 30 or more loops 118 in the deployed configuration (e.g., configuration 116), and the number of loops can increase by one within this range (e.g., 1 loop, 2 loops, 3 loops, 4 loops, 5 loops, 10 loops, 40 loops). One or more straight sections of the catheter 9 and / or one or more curved sections of the catheter 9 can define one or more loops 118. For example, FIGS. 46a through 46z3 show that the catheter 9 can have 1 to 4 or more loops 118 in the deployed configuration (e.g., configuration 116), including, for example, loop 118a, loop 118b, loop 118c, loop 118d, or any combination thereof. Loops 118a through 118d can be, for example, the first loop through the fourth loop (e.g., the first loop 118a, the second loop 118b, the third loop 118c, the fourth loop 118d).

[0138]

[0198] Each of the loops 118 can have a loop first end 118-1, a loop second end 118-2, and a loop head 118-3.

[0139]

[0199] FIGS. 46a through 46z3 show that, for example, loop 118a can have a loop first end 118a-1, a loop second end 118a-2, and a loop head 118a-3. The loop first end 118a-1, the loop second end 118a-2, and the loop head 118a-3 can be, for example, the first loop first end 118a-1, the first loop second end 118a-2, and the first loop head 118a-3, respectively.

[0140]

[0200] Figures 46a through 46z3 show that, for example, loop 118b can have a loop first end 118b-1, a loop second end 118b-2, and a loop head 118b-3. The loop first end 118b-1, the loop second end 118b-2, and the loop head 118b-3 can be, for example, a second loop first end 118b-1, a second loop second end 118b-2, and a second loop head 118b-3, respectively.

[0141]

[0201] Figures 46a through 46z3 show that, for example, loop 118c can have a loop first end 118c-1, a loop second end 118c-2, and a loop head 118c-3. The loop first end 118c-1, the loop second end 118c-2, and the loop head 118c-3 can be, for example, a third loop first end 118c-1, a third loop second end 118c-2, and a third loop head 118c-3, respectively.

[0142]

[0202] Figures 46a through 46z3 show that, for example, loop 118d can have a loop first end 118d-1, a loop second end 118d-2, and a loop head 118d-3. The loop first end 118d-1, the loop second end 118d-2, and the loop head 118d-3 can be, for example, a fourth loop first end 118d-1, a fourth loop second end 118d-2, and a fourth loop head 118d-3, respectively.

[0143]

[0203] The first loop end 118-1 can be, for example, the first longitudinal end of the loop 118 along the catheter 9 (e.g., along the central longitudinal axis of the catheter 9). The second loop end 118-2 can be, for example, the second longitudinal end of the loop 118 along the catheter 9 (e.g., along the central longitudinal axis of the catheter 9). The first loop end 118-1 and / or the second loop end 118-2 can form the base of the loop 118 (also referred to as the loop base). The loop base can be, for example, the base of the first loop end 118-1, the base of the second loop end 118-2, a straight axis connecting the bases of the first loop end 118-1 and the second loop end 118-2, the position where the first loop end 118-1 and the second loop end 118-2 intersect each other, or any combination thereof. The loop head 118-3 can be between the first loop end 118-1 and the second loop end 118-2. For example, the loop head 118-3 can be at the central part of the loop 118 between the first loop end 118-1 and the second loop end 118-2 (e.g., along the catheter 9). As another example, the loop head 118-3 can include a part of the first loop end 118-1 and a part of the second loop end 118-2. The loop head 118-3 can be on the opposite side (e.g., the diametrically opposite side) of the base of the loop 118. The loop head 118-3 can have a loop apex. As another example, the loop head 118-3 can be the loop apex. The loop apex can be the midpoint along the catheter 9 between the first loop end 118-1 and the second loop end 118-2, and / or the loop apex can be the farthest point along the loop 118 measured along the straight line from the loop base to the loop apex. The loop apex can, for example, divide the loop 118 into a first half part and a second half part (e.g., into two equal or unequal half parts). The first half part of the loop 118 can include, for example, a part (e.g., half) of the first loop end 118-1 and / or the loop head 118-3. The second half part of the loop 118 can include, for example, a part (e.g., half) of the second loop end 118-2 and / or the loop head 118-3. The loop head 118-3 can connect the first loop end 118-1 and the second loop end 118-2 to each other.As another example, if the loop head 118-3 is considered to be (e.g., different from another section of the catheter 9) the loop apex, the loop first end 118-1 and the loop second end 118-2 can be in contact at the loop head 118-3 (e.g., at the loop apex). The loop 118 can be symmetric or asymmetric with respect to a straight axis that intersects the loop base and the loop head 118-3 (e.g., the loop apex). The loop first end 118-1 can be shorter than, longer than, or the same length as the loop second end 118-2. The loop second end 118-2 can be shorter than, longer than, or the same length as the loop first end 118-1.

[0144]

[0204] The loop first end 118-2, the loop second end 118-2, and the loop head 118-3 of each loop 118 can be, for example, different sections of the catheter 9 along the length of the catheter 9. Different loops 118 can include the same and / or different sections of the catheter 9. The loop 118 can include the same and / or different sections of the catheter 9 as another loop 118. For example, a first loop (e.g., loop 118a) can include the same and / or different sections of the catheter as a second loop (e.g., loops 118b, 118c, and / or 118d). As another example, a first loop (e.g., loop 118b) can include the same and / or different sections of the catheter as a second loop (e.g., loops 118a, 118c, or 118d). The loop first end 118-1, the loop second end 118-2, and the loop head 118-3 can have relative positions with respect to each other along the length of the catheter 9. For example, FIGS. 46a through 46z3 show that the loop first end 118-1 can be proximal to the loop second end 118-2 and the loop head 118-3 along the length of the catheter 9, that the loop second end 118-2 can be distal to the loop first end 118-1 and the loop head 118-3 along the length of the catheter 9, and that the loop head 118-3 can be distal to the loop first end 118-1 and proximal to the loop second end 118-2 along the length of the catheter 9.

[0145]

[0205] Each loop 118 can be, for example, a closed loop or an open loop (e.g., one or more of the loops 118 can be open loops and one or more of the loops 118 can be closed loops). An open loop can be, for example, a loop 118 having a loop first end 118-1 separated from a loop second end 118-2 by a gap. A closed loop can be, for example, a loop 118 in which the loop first end 118-1 crosses the loop second end 118-2 or vice versa. The loop first end 118-1 and the loop second end 118-2 of the closed loop may or may not be in contact with each other.

[0146]

[0206] The catheter shape 117 of the deployed configuration (e.g., configuration 116) can include, for example, one or more cells 122. The catheter 9 can have, for example, 1 to 30 or more cells 122 in the deployed configuration (e.g., configuration 116), and the number of cells can increase by one within this range (e.g., 1 cell, 2 cells, 3 cells, 4 cells, 5 cells, 10 cells, 30 cells). One or more straight sections of the catheter 9 and / or one or more curved sections of the catheter 9 can define one or more cells 122. For example, the loop 118 can define a cell 122. The cell 122 can be defined by the outer surface of the catheter 9. The boundary of the cell 122 can be the catheter 9, such as the outer surface of the catheter 9. The cell 122 can be, for example, a space, an opening, a hole, and / or a through-hole between sections of the catheter 9 when the catheter is in the deployed configuration (e.g., configuration 116). For example, FIGS. 46a through 46z3 show that the catheter 9 can have 1 to 4 or more cells 122, including, for example, cell 122a, cell 122b, cell 122c, cell 122d, or any combination thereof, in the deployed configuration (e.g., configuration 116). The cells 122a through 122d can be, for example, the first cell through the fourth cell (e.g., the first cell 122a, the second cell 122b, the third cell 122c, the fourth cell 122d). Each cell 122 can be, for example, a closed cell or an open cell. An open cell can be, for example, a cell 122 of an open loop. A closed cell can be, for example, a cell 122 of a closed loop.

[0147]

[0207] The catheter 9 can be formed into the catheter shape 117, for example, into a loop 118, within the digestive tract 110 by, for example, inserting the catheter 9 into the digestive tract 110 and / or by removing the catheter 9 from the digestive tract 110. For example, the catheter 9 can be formed into one or more shapes 117, for example, into one or more loops 118, within the digestive tract 110 by inserting the catheter 9 into the stomach 2 and / or into a portion of the digestive tract 110 behind the stomach 2 (e.g., into the pylorus 65 and / or the duodenum 37), and / or by removing the catheter 9 from the stomach 2 and / or from a portion of the digestive tract 110 behind the stomach 2 (e.g., from the pylorus 65 and / or the duodenum 37), or by any combination thereof.

[0148]

[0208] When the catheter 9 is inserted into the digestive tract 110, the catheter 9 engages with the wall of the digestive tract 110, is pushed against the wall of the digestive tract 110, and / or is constrained by the wall of the digestive tract 110, whereby, for example, the catheter 9 can form a configuration 116 having a shape 117 by forming a bend, forming a loop (e.g., loop 118), overlapping, intersecting, contacting itself, or any combination thereof. The wall of the digestive tract 110 can include, for example, one or more walls of the stomach 2, one or more walls of the pylorus 65, one or more walls of the duodenum 37, one or more walls of the digestive tract 110 behind the duodenum 37, or any combination thereof. FIGS. 46a through 46o show, for example, that as the catheter 9 is gradually inserted into the stomach 2 (e.g., via the esophagus 5), the catheter 9 can gradually form a more complex configuration 116 having a more complex shape 117. FIGS. 46a through 46o show, for example, that a loop 118 can be gradually formed by a more proximal portion of the catheter.

[0149]

[0209] As the catheter 9 is withdrawn from the digestive tract 110, the catheter 9 becomes straight and / or its curvature becomes less, such that, for example, the catheter 9 can unravel, unwind, uncoil, uncurl, unfold, and / or unbend to form a configuration 116 having a shape 117. As the catheter 9 is withdrawn from the digestive tract 110, the loop 118 may collapse (e.g., unravel, unwind, uncoil, uncurl, unfold, and / or unbend). FIGS. 46o through 46z3 show, for example, that as the catheter 9 is gradually withdrawn from the stomach 2 (e.g., via the esophagus 5), the catheter 9 can gradually form an uncomplicated configuration 116 having an uncomplicated shape 117.

[0150]

[0210] By inserting the catheter 9 into the target site 147 (e.g., the stomach 2, the pylorus 65, the duodenum 37, and / or the portion of the digestive tract 110 behind the duodenum 37) and / or withdrawing the catheter 9 from the target site 147, the loop 118 and the cell 122 can be formed.

[0151]

[0211] The loop 118 can change in size and / or shape at the target site 147. For example, as the catheter 9 is inserted into the target site 147, the size of the loop 118 (e.g., outer circumference, length, width, and / or height) can increase and / or decrease.

[0152]

[0212] Loop 118 may have an outer circumference (also referred to as the loop outer circumference). The loop outer circumference can be measured, for example, along the central longitudinal axis of the catheter 9 from the loop first end 118-1 to the loop second end 118-2. The loop outer circumference can be, for example, from 5.0 cm to 80.0 cm and can increase by 0.5 cm within this range (e.g., 5.0 cm, 9.5 cm, 15.0 cm, 30.0 cm, 50.0 cm, 80.0 cm). The loop outer circumference can be, for example, greater than 9.0 cm to greater than 70.0 cm and can increase by 0.5 cm within this range (e.g., greater than 5.0 cm, greater than 9.5 cm, greater than 15.0 cm, greater than 30.0 cm, greater than 50.0 cm, greater than 80.0 cm). The loop outer circumference can be, for example, less than 80.0 m. The loop outer circumference may be, for example, larger than the lesser curvature of the stomach 2 and / or larger than the greater curvature of the stomach 2. FIGS. 46a through 46z3 show that the size (e.g., outer circumference) of the loop 118 can increase and decrease at the target site 147. FIGS. 46a through 46z3 show, for example, that at least one of the loops 118 (e.g., loop 118a) can have an outer circumference greater than 9.5 cm. FIGS. 46a through 46z3 show, for example, that as the catheter 9 is inserted into and / or removed from the target site 147, the shape of the loop 118 can change as the section forming the loop 118 (e.g., the loop first end 118-1, the loop second end 118-2, and / or the loop head 118-3) becomes straight and / or forms a bend and / or curves.

[0153]

[0213] Loop 118 may have a length, width, and height (also referred to as loop length, loop width, and loop height).

[0154]

[0214] The length of each loop 118 can be measured along a straight axis (also referred to as a straight line) from the base of the loop 118 to the loop head 118-3 of the loop 118 (e.g., to the apex of the loop 118). The loop length can be, for example, 3.0 cm to 40.0 cm, and can increase by 0.5 cm within this range (e.g., 3.0 cm, 9.0 cm, 15.0 cm, 30.0 cm, 40.0 cm). The loop length can be, for example, greater than 3.0 cm to greater than 30.0 cm, and can increase by 0.5 cm within this range (e.g., greater than 3.0 cm, greater than 9.0 cm, greater than 15.0 cm, greater than 30.0 cm). The loop length may be, for example, greater than the lesser curvature of the stomach 2, greater than the greater curvature of the stomach 2, and / or greater than the length of the duodenum 37. For example, the loop length can be greater than 25% to greater than 100% of the length of the duodenum 37. For example, when the loop 118 is inside both the stomach 2 and the duodenum 37, the loop length may be greater than the greater curvature of the stomach 2. The loop length can be greater than 3 cm. The loop length can be, for example, less than 20.0 cm to less than 40.0 cm, and can increase by 0.5 cm within this range (e.g., less than 20.0 cm, less than 30.0 cm, less than 40.0 cm). The loop length may be, for example, less than the width of the widest section of the stomach 2 and / or less than the greater curvature of the stomach 2.

[0155]

[0215] The width of each loop 118 can be measured along a straight axis (also referred to as a straight line) from a point on the first loop end 118-1 of the loop 118 to a point on the second loop end 118-2 of the loop 118. The loop width can be, for example, from 3.0 cm to 40.0 cm, and can increase by 0.5 cm within this range (e.g., 3.0 cm, 9.0 cm, 15.0 cm, 30.0 cm, 40.0 cm). The loop width can be, for example, greater than 3.0 cm to greater than 30.0 cm, and can increase by 0.5 cm within this range (e.g., greater than 3.0 cm, greater than 9.0 cm, greater than 15.0 cm, greater than 30.0 cm). The loop width may be, for example, greater than the lesser curvature of the stomach 2, greater than the greater curvature of the stomach 2, and / or greater than the width of the duodenum 37. For example, the loop width can be greater than 25% to greater than 100% of the width of the duodenum 37. The loop width can be greater than 3 cm. The loop width can be, for example, less than 20.0 cm to less than 40.0 cm, and can increase by 0.5 cm within this range (e.g., less than 20.0 cm, less than 30.0 cm, less than 40.0 cm). The loop width may be, for example, less than the width of the widest section of the stomach 2 and / or less than the greater curvature of the stomach 2. The loop width may be the same as or different from the loop length.

[0156]

[0216] The height of each loop 118 can be 1.0 to 7.0 times or more the diameter of the catheter 9. The height of each loop 118 can be, for example, the height in a flat surface where the loop extends through the first loop end 118-1, the second loop end 118-2, and the loop head 118-3.

[0157]

[0217] Figures 46a through 46z3 show that the loop 118 can have various sizes, shapes, and relative positions. Figures 46a through 46z3 show that some of the loops 118 can be smaller than some of the other loops 118. Figures 46a through 46z3 show that some of the loops 118 can be larger than some of the other loops 118.

[0158]

[0218] Loop 118 may have one or more straight sections and / or curved sections of catheter 9. The curved section of loop 118 may have a constant or variable radius. Each loop 118 may have the same radius and / or a different radius from another loop.

[0159]

[0219] For example, when advancing catheter 9 into target site 147 and / or when withdrawing catheter 9 from target site 147, loop 118 may change from an open loop to a closed loop inside target site 147 (e.g., inside stomach 2, pylorus 65, and / or duodenum 37), and / or may change from a closed loop to an open loop inside target site 147 (e.g., inside stomach 2, pylorus 65, and / or duodenum 37). Loop 118 may have a closed section and an open section.

[0160]

[0220] Each loop 118 may have the same size or a different size from another of loop 118. A first loop (e.g., one of loop 118) may have the same size or a different size from a second loop (e.g., another one of loop 118).

[0161]

[0221] Each loop 118 may have the same shape or a different shape from another of loop 118. A first loop (e.g., one of loop 118) may have the same shape or a different shape from a second loop (e.g., another one of loop 118). Loop 118 may have, for example, a spherical shape, an elliptical shape, a teardrop shape, an irregular shape, or any combination thereof.

[0162]

[0222] For example, by inserting the catheter 9 into the target site 147 and / or removing it from the target site 147, the catheter 9 can be moved relative to the loop 118 within the target site 147. For example, FIGS. 46a through 46z3 show that the catheter 9 within the target site 147 can be moved relative to the loop 118 (e.g., pushed and / or pulled), whereby it is possible to form and / or loosen, for example, one or more loops 118. The catheter 9 can be moved within the target site 147 so as to contact and / or not contact the loop 118. The catheter 9 can be moved (e.g., slid) relative to one or more of the loops 118 within the target site 147. By pushing and / or pulling the catheter 9 into the loop 118, the loop 118 may move and / or change shape within the target site 147. The catheter 9 can be moved above and / or below one or more of the loops 118 within the target site 147.

[0163]

[0223] For example, by inserting the catheter 9 into the target site 147 and / or removing it from the target site 147, the loops 118 can be moved relative to each other within the target site 147. For example, FIGS. 46a through 46z3 show that the loops 118a through 118d within the target site 147 can be moved relative to each other. The loops 118 can be moved within the target site 147 so as to contact and / or not contact each other. The loops 118 can be moved (e.g., slid) relative to each other within the target site 147. The loops 118 can be moved within the target site 147 so as to approach and / or separate from each other. The loops 118 can be moved above and / or below each other within the target site 147.

[0164]

[0224] Cell 122 may change in size and / or shape at the target site 147. For example, as the catheter 9 is inserted into the target site 147 (e.g., the stomach 2 and / or the duodenum 37), the size (e.g., area, length, and / or height) of the cell 122 may increase and / or decrease.

[0165]

[0225] Cell 122 may have an area (also referred to as cell area). The cell area may have a shape defined (e.g., enclosed) by the loop 118. For example, the cell area of the cell 122a may be the area of the space enclosed by the loop 118a. The loop area can be, for example, 7 cm 2 ~300 cm 2 and can increase by 1 cm 2 at a time within this range (e.g., 7 cm 2 , 50 cm 2 , 100 cm 2 , 300 cm 2 ). The loop area can be, for example, greater than 7 cm 2 to greater than 300 cm 2 and can increase by 1 cm 2 at a time within this range (e.g., greater than 7 cm 2 , greater than 50 cm 2 , greater than 100 cm 2 , greater than 300 cm 2 ). Figures 46a through 46z3 show, for example, that as the size of the loop 118 expands and / or contracts within the target site 147, the size of the cell 122 can expand and / or contract within the target site 147. Figures 46a through 46z3 show, for example, that as the shape of the loop 118 changes, the shape of the cell 122 can change.

[0166]

[0226] Cell 122 may have a length, width, and height (also referred to as cell length, cell width, and cell height).

[0167]

[0227] The cell length can be measured along the same axis along which the loop length can be measured. For example, the cell length can be measured along a straight axis from the base of loop 118 to the loop head 118-3 of loop 118. The cell length may be the same as or different from the loop length. For example, if the loop length is measured from the base of loop 118 to the outer surface of loop head 118-3, the cell length may be the same length as the loop length. As another example, if the loop length is measured from the base of loop 118 to the central longitudinal axis of catheter 9 of loop head 118-3, the cell length may be, for example, the loop length minus the radius or diameter of catheter 9.

[0168]

[0228] The cell width can be measured along the same axis along which the loop width can be measured. For example, the cell width can be measured along a straight axis from a point on loop first end 118-1 of loop 118 to a point on loop second end 118-2 of loop 118. The cell width may be the same as or different from the loop width. For example, if the points on loop first end 118-1 and loop second end 118-2 are on the outer surface (e.g., the radially inner surface of loop 118), the cell width may be the same length as the loop width. As another example, if the points on loop first end 118-1 and loop second end 118-2 are on the central longitudinal axis of catheter 9, the cell width may be, for example, the loop width minus the diameter of catheter 9.

[0169]

[0229] The cell height can be, for example, the same as the loop height.

[0170]

[0230] Figures 46a through 46z3 show that cell 122 can have various sizes, shapes, and relative positions. Figures 46a through 46z3 show that some of cells 122 can be smaller than some of the others of cell 122. Figures 46a through 46z3 show that some of cells 122 can be larger than some of the others of cell 122.

[0171]

[0231] For example, when advancing the catheter 9 to the target site 147 and / or when removing the catheter 9 from the target site 147, the cell 122 may change from an open cell to a closed cell inside the target site 147 (e.g., inside the stomach 2, the pylorus 65, and / or the duodenum 37), and / or may change from a closed cell to an open cell inside the target site 147 (e.g., inside the stomach 2, the pylorus 65, and / or the duodenum 37). The loop 118 may define the open and / or closed cells 122. For example, the open loop 118 may define the open cell 122, and the closed loop 118 may define the open cell 122. As another example, a loop 118 in which the loop first end 118-1 and the loop second end 118-2 cross each other may define one or more open cells 122 and one or more closed cells 122 (e.g., the tip of the loop 118 may define the closed cell 122, and the base of the loop 118 may define the open cell 122).

[0172]

[0232] Each cell 122 may have the same size or a different size from another one of the cells 122. A first cell (e.g., one of the cells 122) may have the same size or a different size from a second cell (e.g., another one of the cells 122).

[0173]

[0233] Each cell 122 may have the same shape or a different shape from another one of the cells 122. A first cell (e.g., one of the cells 122) may have the same shape or a different shape from a second cell (e.g., another one of the cells 122). The cell 122 may have, for example, a spherical shape, an elliptical shape, a teardrop shape, an irregular shape, or any combination thereof.

[0174]

[0234] The cells 122 can be aligned with each other, shifted relative to each other, overlapped with each other, or any combination thereof. For example, FIGS. 46a to 46z3 show that the cells 122 can be shifted relative to each other and / or overlapped with each other. Each of the cells 122 can have a cell central axis extending through the central cell 122. When two cells 122 are aligned with each other, the central axes of the two cells 122 can be aligned with each other (e.g., made to coincide) so that the catheter 9 can have a spiral shape. When two cells 122 are shifted relative to each other, the central axes of the two cells 122 can be shifted relative to each other. For example, when two cells 122 are shifted relative to each other, the central axes of the two cells 122 can be separated by a certain gap (also referred to as a cell axis gap). The cell central axis can extend through the cell 122 at an angle perpendicular to the cell surface. The cell axis gap between the cell central axis of a first cell (e.g., one of the cells 122) and the cell central axis of a second cell (e.g., another one of the cells 122) can be, for example, 1 cm to 40 cm or more, and can increase by 1 cm within this range (e.g., 1 cm, 5 cm, 10 cm, 20 cm, 40 cm). The cell axis gap can be, for example, more than 1 cm to more than 40 cm, and can increase by 1 cm within this range (e.g., more than 1 cm, more than 3 cm, more than 4 cm, more than 5 cm, more than 40 cm). The cell axis gap may be larger than the lesser curvature of the stomach 2 and / or larger than the greater curvature of the stomach 2. One or more of the cell central axes can be parallel to another cell central axis. One or more of the cell central axes can be at an angle (e.g., less than 180 degrees) relative to another cell central axis. The cells 122 can be separated from each other only by the gap between the loops, and / or the cells 122 can overlap with each other.

[0175]

[0235] For example, by inserting the catheter 9 into and / or removing it from the target site 147, the cells 122 can be moved relative to each other within the target site 147 (e.g., above and / or below each other). The cells 122 can be moved so as to be aligned with each other and / or not aligned within the target site 147. The cells 122 can be moved from a first misaligned position to a second misaligned position. The cells 122 may or may not be moved so as to be aligned with each other.

[0176]

[0236] The catheter 9 (e.g., a part of one of the loops 118) can be moved across one or more of the cells 122. The portion of the catheter 9 extending across the cell 122 may partially occlude (also referred to as partially obstruct) the cell 122. By moving the catheter 9 on the cell 122 and / or moving the catheter 9 away from the cell 122, the cell 122 may or may not be occluded. When the catheter 9 is moved across the cell 122, for example, the cell 122 can be divided into two or more sub-cells.

[0177]

[0237] FIGS. 46a through 46z3 show that the catheter 9 (e.g., loop 118) and / or the cell 122 can have various arrangements and orientations within the target site 147, e.g., with respect to a flow path through the target site 147 and / or one or more walls of the target site 147. For example, a flow path through the stomach 2 may follow a path having a curvature axis that does not contact the gastric wall 108 from the gastroesophageal junction 120 of the gastrointestinal tract 110 through the stomach 2 to the pylorus 65. FIGS. 46a through 46z3 show that when the catheter 9 is in a deployed configuration (e.g., configuration 116), the catheter 9 may block the center of a flow path through the target site 147 (e.g., a flow path extending through the stomach 2, the pylorus 65, and / or the duodenum 37). FIGS. 46a through 46z3 show that when the catheter 9 is in a deployed configuration (e.g., configuration 116), the catheter 9 may extend across the center of a flow path through the target site 147 (e.g., a flow path extending through the stomach 2, the pylorus 65, and / or the duodenum 37). When the catheter 9 is in a deployed configuration, the catheter 9 (e.g., loop 118) may contact the anterior wall of the stomach 2, the posterior wall of the stomach 2, the superior wall of the stomach 2, the inferior wall of the stomach 2, the lateral wall of the stomach 2, the proximal wall of the stomach 2, the distal wall of the stomach 2, or any combination thereof. When the catheter 9 is in a deployed configuration, the cell 122 may face the anterior wall of the stomach 2, the posterior wall of the stomach 2, the superior wall of the stomach 2, the inferior wall of the stomach 2, the lateral wall of the stomach 2, the proximal wall of the stomach 2, the distal wall of the stomach 2, or any combination thereof. For example, FIGS. 46a through 46z3 show that the cell 122 may face the anterior wall and the posterior wall of the stomach 2. The cell central axis of the cell 122 can be at an angle of 70 degrees to 110 degrees with respect to the longitudinal axis of the flow path through the target site 147 (e.g., with respect to a flow path having a curvature axis from the gastroesophageal junction 120 of the gastrointestinal tract 110 to the pylorus 65), and the angle can increase by one degree within this range (e.g., 70 degrees, 90 degrees, 110 degrees). For example, the cell 122 can be perpendicular to the flow path through the target site 147.

[0178]

[0238] Loop 118 and / or cell 122 can be formed and / or collapsed within target site 147 in any order. For example, FIGS. 46a through 46o show that loop 118 (e.g., 118a, 118b, 118c, and / or 118d) can be formed in the illustrated order, and FIGS. 46o through 46z3 show that loop 118 (e.g., 118a, 118b, 118c, and / or 118d) can be collapsed in the illustrated order. For example, when the size (e.g., outer perimeter) of loop 118 shrinks, when the loop length of loop 118 shrinks, when the loop width of loop 118 shrinks, when the loop height 118 of loop 118 shrinks, or in any combination thereof, loop 118 can be considered to have collapsed. For example, loop 118 can be collapsed by removing catheter 9 from target site 147. Loop 118 and / or cell 122 can be formed and / or collapsed in any order at target site 147, e.g., sequentially and / or simultaneously. For example, FIGS. 46a through 46c show that loop 118a can be formed before loop 118b during the first stage of loop formation, and FIGS. 46d through 46f show that loop 118a and loop 118b can be formed simultaneously during the second stage of loop formation. As another example, FIGS. 46x through 46z show that loop 118a and loop 118b can collapse simultaneously during the first stage of loop collapse, and FIGS. 46d through 46f show that loop 118a can collapse after loop 118b has collapsed during the second stage of loop collapse.

[0179]

[0239] FIGS. 46a through 46z3 show that the catheter 9 can be inserted into and / or withdrawn from the target site 147 such that the catheter 9 intersects the target site 147 crosswise in multiple directions and / or extends across the target site 147. FIGS. 46a through 46z3 show that the target site 147 can be the stomach 2. By inserting the catheter 9 into the target site 147, the catheter 9 can be placed within the target site 147. By removing the catheter 9 from the target site 147, the catheter 9 can be withdrawn from the target site 147.

[0180]

[0240] FIGS. 46a through 46z3 show that when the catheter 9 is in a deployed configuration (e.g., configuration 116), the catheter 9 can define a mesh having cells (e.g., cell 122), a lattice structure having cells (e.g., cell 122), a mat having cells (e.g., cell 122), a path (e.g., a meandering path) defining cells (e.g., cell 122) and nodes (e.g., the nodes can be where the catheters 9 intersect each other. The catheters 9 may or may not contact each other at the nodes), a winding path defining cells (e.g., cell 122), a serpentine path defining cells (e.g., cell 122), a scaffold having cells (e.g., cell 122), a 3D structure having cells (e.g., cell 122), an amorphous 3D structure having cells (e.g., cell 122), an arrangement having cells (e.g., cell 122), a web having cells (e.g., cell 122), a network having cells (e.g., cell 122), a maze having cells (e.g., cell 122), a patchwork of sections of catheters 9 intersecting each other crosswise, an entangled structure, a coil, a coiled structure, or any combination thereof. For example, FIGS. 46a through 46z3 show that the catheter 9 can form a coil 138 inside the target site 147 such that the catheter 9 bends in multiple directions (e.g., vertically and / or horizontally) within the target site 147. FIGS. 46a through 46z3 show, for example, that the catheter 9 can extend in multiple directions within the target site 147 and / or can proceed in a zigzag manner within the target site 147.

[0181]

[0241] The catheter 9 may have an overall length of 124 (also referred to as the overall length of the entire catheter 124). The overall length 124 of the catheter can be, for example, 100 cm to 900 cm or more, and can increase by 1 cm within this range (for example, 100 cm, 200 cm, 300 cm, 500 cm, 900 cm). The overall length 124 can be, for example, the overall length of the catheter 9 from the proximal end of the catheter 9 to the distal end of the catheter 9. The overall length 124 can be, for example, the overall length of the catheter 9 from the proximal end of the catheter 9 to the catheter tip 7. The overall length 124 can be, for example, the overall length of the catheter 9 from the proximal terminal of the catheter 9 to the distal terminal of the catheter 9 (for example, the distal terminal of the catheter tip 7). For example, the overall length 124 can be the overall length of the catheter 9 from the connector 14 to the distal terminal of the catheter 9. As another example, the overall length 124 can be, for example, the overall length of the catheter 9 from the handle of the catheter 9 to the distal terminal of the catheter 9 (for example, the distal terminal of the catheter tip 7).

[0182]

[0242] The length 126 of the catheter 9 (also referred to as the catheter length 126) can be inserted into and / or removed from the target site 147. The length 126 of the catheter 9 can be a part of the total length 124 of the catheter. The catheter length 126 can be, for example, 20 cm to 600 cm, 20 cm to 300 cm, 30 cm to 300 cm, 50 cm to 300 cm, 70 cm to 300 cm, or 110 cm to 300 cm, and can increase by 1 cm within these ranges (e.g., 20 cm, 30 cm, 40 cm, 50 cm, 60 cm, 100 cm, 110 cm, 150 cm, 300 cm, 600 cm). The length 126 can be, for example, 5% to 90% of the total length 124, and can increase by 1% within this range (e.g., 5%, 10%, 50%, 90%). The length 126 can be, for example, 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, and / or 70% or more of the total length 124. The length 126 of the catheter 9 within the target site 147 can include the distal portion of the catheter 9. For example, 50% or less of the total length 124 can be within the target site 147. As another example, the length 126 of the catheter 9 within the target site 147 can include the proximal portion and the distal portion of the catheter 9. For example, more than 50% of the total length 124 can be within the target site 147. For example, the catheter 9 can have a midpoint between the proximal end and the distal end of the catheter 9. The proximal portion of the catheter 9 can be the portion of the catheter 9 proximal to the midpoint and the distal portion of the catheter 9 can be the portion of the catheter 9 distal to the midpoint such that the proximal portion and the distal portion of the catheter 9 can have the same length (e.g., 50% of the total length 124).

[0183]

[0243] The various lengths of the catheter 9 (e.g., any length 126) can be introduced into and / or removed from the target site 147. The length 126 of the catheter 9 within the target site 147 can be expanded and / or contracted. For example, depending on the size of the target site 147 (e.g., the stomach 2 and / or the duodenum 37) and / or other organs (e.g., the duodenum 37 and / or the pancreas 1), longer and / or shorter portions of the catheter 9 can be introduced and / or removed. The length 126 of the catheter 9 within the target site 147 can be adjusted, for example, before, during, and / or after heat transfer to and / or from the catheter 9 (e.g., before, after, or during flowing the fluid 6 through the catheter 9). For example, the length of the catheter 126 within the target site 147 can be expanded and / or contracted. Adjusting the length of the catheter 9 within the target site 147 can, for example, affect the surface area of the catheter 9 in contact with the stomach 2 and / or can affect the overall heat transfer to and / or from the stomach 2 and / or other organs. FIGS. 46a through 46o show, for example, that when the length 126 of the catheter 9 within the target site 147 is expanded, the surface area of the catheter 9 within the target site 147 can increase, and the overall heat transfer to and / or from the stomach 2 and / or other organs can increase. FIGS. 46o through 46z3 show, for example, that when the length 126 of the catheter 9 within the stomach 2 is contracted, the surface area of the catheter 9 within the stomach 2 can decrease, and the overall heat transfer to and / or from the stomach 2 and / or other organs can be reduced. By expanding and / or contracting, for example, the length 126 of the catheter 9 within the target site 147, the configuration 116 and shape 117 of the catheter 9 can be changed. For example, by expanding and / or contracting the length 126 of the catheter 9 within the target site 147, the configuration 116 and shape 117 of the catheter 9 can be changed from a first configuration and a first shape (e.g., any configuration 116 and shape 117) to a second configuration and a second shape (e.g., any configuration 116 and shape 117).For example, any of the configurations 116 and shapes 117 from FIGS. 46a to 46z3 can be the first configuration and the first shape, respectively, and any of the configurations 116 and shapes 117 from FIGS. 46a to 46z3 can be the second configuration and the second shape, respectively. For example, FIGS. 46a to 46z3 show that the arrangement and / or path (e.g., shape 117) that the catheter 9 can have within the target site 147 can depend on the length of the catheter 9 within the target site 147. FIGS. 46a to 46z3 show that, for example, as the catheter 9 is inserted into and / or removed from the target site 147, the arrangement and / or path (e.g., shape 117) of the catheter 9 can change. FIGS. 46a to 46z3 show that, for example, by expanding and / or contracting the length 126 of the catheter 9 within the target site 147, the arrangement and / or path (e.g., shape 117) of the catheter 9 can be changed.

[0184]

[0244] The catheter 9 can have one or more heat transfer regions 128, such as heat transfer regions 128 from 1 to 30, for example, and the number of heat transfer regions can increase by one within this range (e.g., one heat transfer region, two heat transfer regions, 30 heat transfer regions). One or more portions of the catheter 9 can be the heat transfer region 128. One or more portions of the catheter 9 can have the heat transfer region 128. The heat transfer region 128 can have a certain length (e.g., a certain section) of the catheter 9. The heat transfer region 128 can be a continuous length of the catheter 9. For example, the heat transfer region 128 can be the length of the catheter 9 such as length 126 and / or total length 124. For example, the portion of the catheter 9 within the target site 147 can be the heat transfer region 128, and / or the entire length of the catheter 9 can be the heat transfer region 128. As another example, the heat transfer region 128 can be 50% to 100% of the length of the catheter 9 (e.g., catheter length 126) that can be positioned within the target site 147. As another example, when the catheter 9 is in the deployed configuration (e.g., configuration 116), the heat transfer region 128 can be 50% to 100% of the length of the catheter 9 (e.g., catheter length 126) within the target site 147 (e.g., within the stomach 2 and / or duodenum 37). As another example, when the catheter 9 is in the deployed configuration (e.g., configuration 116), the heat transfer region 128 can be 50% to 100% of the length of the catheter 9 (e.g., catheter length 126) inside the body (e.g., inside the mouth, nasal cavity, nasal passages, esophagus 5, stomach 2, pylorus 65, duodenum 37, jejunum 10, or any combination thereof). FIGS. 46a through 46z3 show, for example, that the heat transfer region 128 can extend continuously along the length of the catheter 9 (e.g., length 126). FIGS. 46a through 46z3 show that the heat transfer region 128 is the catheter 9 and can be, for example, a certain length of the catheter 9 (e.g., the length 126 of the catheter 9). The heat transfer region 128 can be, for example, one or more lengths (e.g., one or more sections) of the catheter 9. The heat transfer regions 128 can be integrated with and / or attached to each other. The heat transfer region 128 can be, for example, the loop 118. Each loop 118 of the configuration 116 can be a different heat transfer region 128 or different portions of the same heat transfer region 128.For example, FIGS. 46a through 46z3 show that each loop 118 of configuration 116 can be a different part of the same heat transfer region 128.

[0185]

[0245] The heat transfer region 128 can have a length 130 (also referred to as the heat transfer region length 130). The length 130 can be, for example, 10% or more, 20% or more, 30% or more, 40% or more, 50% or more, 60% or more, and / or 70% or more of the length 126 and / or the overall length 124. The length 130 may be the same as or different from the catheter length 126 and / or the overall length 124. For example, a portion of catheter 9 having a length 126 can be the heat transfer region 128 (e.g., a continuous heat transfer region), and the configuration 116 and shape 117 of catheter 9 can be made to be the configuration and shape of the heat transfer region 128. For example, the heat transfer region 128 can be formed in the configuration 116 having the shape 117. Each loop 118 of the shape 117 can be a different heat transfer region 128 (e.g., the outer perimeter of each loop 118 can be the length of each heat transfer region 128), and / or can be a different part of the same heat transfer region 128 (e.g., a portion of the catheter having a length 126 can be the heat transfer region 126). The ratio of the length 130 to the length of the target site 147 can be, for example, 1.5 to 20.0.

[0186]

[0246] The path (e.g., shape 117) of the heat transfer region 128 within the target site 147 can vary. For example, FIGS. 46a through 46z3 show that the path (e.g., shape 117) that the heat transfer region 128 can have within the target site 147 can depend on the length 130 of the heat transfer region 128 within the target site 147. FIGS. 46a through 46z3 show, for example, that the path (e.g., shape 117) of the heat transfer region 128 can change as catheter 9 is inserted into and / or removed from the target site 147. FIGS. 46a through 46z3 show, for example, that the path (e.g., shape 117) can be changed by expanding and / or contracting the length 126 of catheter 9 within the target site 147.

[0187]

[0247] When the catheter 9 is in the deployed configuration (e.g., configuration 116), the heat transfer region 128 can be proximal and / or distal to the catheter tip 7. For example, FIGS. 46a through 46z3 show that the heat transfer region 128 can be proximal to the catheter tip 7. When the catheter 9 is in the deployed configuration, the heat transfer region 128 can be proximal and / or distal to the distal end of the catheter 9. For example, FIGS. 46a through 46z3 show that the heat transfer region 128 can be proximal to the distal end of the catheter 9. FIGS. 46a through 46z3 show that the heat transfer region 128 can extend proximally away from the catheter tip 7. As another example, the heat transfer region 128 can extend proximally away from the catheter tip 7 and / or distally away from the catheter tip 7. The heat transfer region 128 can be between the distal end and the proximal end of the catheter 9 along the length of the catheter 9. The heat transfer region 128 can be between the distal terminal and the proximal terminal of the catheter 9 along the length of the catheter 9.

[0188]

[0248] The heat transfer region 128 can be any portion of the catheter 9 having a lumen (e.g., lumen 15 and / or lumen 16), for example. For example, the heat transfer region 128 can be any portion of a catheter having an inflow lumen and / or an outflow lumen (e.g., lumen 15 and / or lumen 16). The distal terminal of the heat transfer region 128 can be, for example, the confluence zone 105 of the inflow lumen and the outflow lumen. The confluence zone 105 is inside the catheter 9 and can be, for example, inside the distal end of the catheter 9. The confluence zone 105 is inside the distal end of the catheter (e.g., inside the catheter tip 7), for example, 0.10 cm to 10.00 cm proximal to the distal terminal of the catheter 9, and this value can increase by 0.10 cm within the range (e.g., 0.10 cm, 1.00 cm, 2.00 cm, 5.00 cm, 10.00 cm). The heat transfer region 128 can terminate at any location along the length of the catheter 9. For example, the heat transfer region 128 can terminate at the location where the inflow lumen and the outflow lumen merge (e.g., the confluence zone 105).

[0189]

[0249] When a fluid (e.g., fluid 6) is present within the catheter 9 (e.g., the heat transfer region 128), the catheter 9 can transfer heat. For example, when the fluid is injected through the lumen of the catheter 9 (e.g., the heat transfer region 128), such as through the inflow lumen and the outflow lumen (e.g., lumen 15 and lumen 16), the catheter 9 can transfer heat to and / or from the body. For example, when the fluid is present within the catheter 9 (e.g., within the heat transfer region 128) and has a temperature higher or lower than the surrounding tissue, heat can be transferred from the fluid through the catheter wall to the surrounding tissue and / or from the surrounding tissue through the catheter wall to the fluid. When the fluid is present within the catheter 9 (e.g., within the heat transfer region 128) and has a temperature higher or lower than the surrounding tissue, the fluid can release and / or absorb heat, for example, through the wall of the catheter 9. The catheter 9 can release and / or absorb heat.

[0190]

[0250] The catheter 9 may have one or more heat transfer zones 132 (also referred to as heating zones 132). The heat transfer zone 132 may extend from one or more heat transfer regions 128. The heat transfer zone 132 can be, for example, a space adjacent to the catheter 9. The heat transfer zone 132 can extend away from the catheter 9 (e.g., radially). For example, the heat transfer zone 132 can have a cylindrical shape (e.g., a hollow cylindrical shape) that extends along the length of the catheter 9 (e.g., the overall length 124, the length 126, and / or the length of the heat transfer region 128). The catheter 9 can extend through the heat transfer zone 132. For example, the catheter 9 can extend through the longitudinal center of the heat transfer zone 132. The heat transfer zone 132 can extend, for example, a distance 132d (e.g., a radius) of 1 cm to 10 cm or more away from the catheter 9 (e.g., radially) when measured from the central longitudinal axis Ac of the catheter 9 or from the outer surface of the catheter 9. This distance can increase by 1 cm within this range (e.g., 1 cm, 2 cm, 5 cm, 10 cm).

[0191]

[0251] The heat transfer zones 132 of the various lengths (also referred to as sections) of the catheter 9 can overlap with each other. For example, when the catheter 9 is in configuration 116, the first heating zone of the first length of the heat transfer region 128 can overlap with the second heating zone of the second length of the heat transfer region 128. The first heating zone is any heating zone 132 of the first length of the catheter 9, and the second heating zone can be any heating zone 132 of the second length of the catheter 9. For example, the first heating zone can be a heating zone 132 that extends from the loop first end 118-1 to the loop second end 118-2 of one of the loops 118 (e.g., loop 118a), and the second heating zone can be a heating zone 132 that extends from the loop first end 118-1 to the loop second end 118-2 of another one of the loops 118 (e.g., loop 118b, 118c, or 118d). As another example, the first heating zone can be a heating zone 132 that extends from one of the loops 118 (e.g., loop 118a), and the second heating zone can be a heating zone 132 that extends from another one of the loops 118 (e.g., loop 118b, 118c, or 118d). As yet another example, the first heating zone can be a heating zone 132 that extends from the loop first end 118-1 to the loop second end 118-2 of one of the loops 118 (e.g., loop 118a), and the second heating zone can be a heating zone 132 that extends from the loop second end 118-2 of the same or a different loop 118 (e.g., loop 118a, loop 118b, 118c, or 118d).

[0192]

[0252] Catheter 9 may have various configurations 116 and / or shapes 117 within the target site 147. For example, catheter 9 may have the configurations 116 and shapes 117 shown in FIGS. 46a through 58b. Catheter 9 may have various positions relative to itself, the target site 147, and the surrounding organs. For example, catheter 9 may have various positions relative to itself, the target site 147, and the surrounding organs as shown in FIGS. 46a through 58b. Loops 118 may have various relative positions with respect to each other. For example, loops 118 may have the relative positions with respect to each other shown in FIGS. 46a through 58b. Loops 118 may have various sizes and / or shapes. For example, loops 118 may have the sizes and / or shapes shown in FIGS. 46a through 58b. Cells 122 may have various sizes, shapes, and / or relative positions. For example, cells 122 may have the sizes, shapes, and / or relative positions shown in FIGS. 46a through 58b.

[0193]

[0253] In FIGS. 46b through 46z2, reference points B1 - B2, C1 - C2, D1 - D4, E1 - E3, F1 - F3, G1 - G3, H1 - H4, I1 - I5, J1 - J5, K1 - K5, L1 - L5, M1 - M5, N1 - N5, O1 - O5 are provided to assist in the identification of various sections of catheter 9 and also to assist in the description of the shapes 117 (e.g., shapes 117a - 117z3) and / or loops 118 that catheter 9 may have. The reference points are used, for example, to represent various sections of catheter 9. The various sections are integral with each other and / or can be attached to each other. For example, the various sections of catheter 9 can be multiple sections of a single length of catheter 9 (e.g., multiple sections of the entire length 124 of catheter 9). Reference points B1, C1, D1, E1, D1, E1, F1, G1, H1, I1, J1, K1, L1, M1, N1, and O1 can indicate, for example, the distal end of catheter 9 and / or the distal end of the heat transfer region 128. Reference points B2, C2, D3, E3, F3, G3, H4, I5, J5, K5, L5, M5, N5, and O5 can indicate, for example, the position where catheter 9 enters the target site 147.

[0194]

[0254] FIGS. 46a through 46o show that when the catheter 9 is in the 1st through 15th configurations 116a - 116o, the catheter 9 can have the 1st through 15th shapes 117a - 117o respectively. FIGS. 46a through 46o show that by inserting the catheter 9 into the target site 147, the catheter 9 can change into the 1st through 15th configurations 116a - 116o. FIGS. 46o through 46z3 show that when the catheter 9 is in the 15th through 29th configurations 116o - 116z3, the catheter 9 can have the 15th through 29th shapes 117o - 117z3 respectively. FIGS. 46a through 46z3 show that by removing the catheter 9 from the target site 147, the catheter 9 can change into the 15th through 29th configurations 116o - 116z3.

[0195]

[0255] FIG. 46a shows that when the catheter tip 7 is in the esophagus 5, the catheter 9 may not include the loop 118. As another example, when the catheter tip 7 is in the esophagus 5, the catheter 9 may have a loop that can expand when entering the target site 147 and / or when the loop is inflated.

[0196]

[0256] FIG. 46b shows that the first loop 118a can be formed by sections B1 - B2 of the catheter 9. The length of sections B1 - B2 of the catheter 9 can be, for example, length 126.

[0197]

[0257] Figure 46c shows that the first loop 118a can be formed by sections C1 - C2 of the catheter 9. The length of sections C1 - C2 of the catheter 9 can be, for example, a length of 126. Figure 46c shows that the size (e.g., outer circumference) of the first loop 118a may be larger when the catheter 9 is in the third configuration 116c than when the catheter 9 is in the second configuration 116b. Figure 46c shows that the gap between the first loop first end 118a - 1 and the first loop second end 118a - 2 may be smaller when the catheter 9 is in the third configuration 116c than when the catheter 9 is in the second configuration 116b. Figure 46c shows that the catheter tip 7 can be in a different position within the target site 147 when the catheter 9 is in the third configuration 116c compared to when the catheter 9 is in the second configuration 116b. For example, Figure 46c shows that the catheter tip 7 may be closer to the upper part of the stomach 2 and / or the gastroesophageal junction 120 when the catheter 9 is in the third configuration 116c than when the catheter 9 is in the second configuration 116b.

[0198]

[0258] FIG. 46d shows that a first loop 118a can be formed by sections D1 - D3 of the catheter 9, and that a second loop 118b can be formed by sections D2 - D4 of the catheter 9. The length of sections D1 - D3 of the catheter 9 can be, for example, a length of 126. The length of sections D2 - D4 can be, for example, less than the length of sections D1 - D3. FIG. 46d shows that section D3 - D4 of the second loop 118b can be within the esophagus 5 and section D2 - D3 of the second loop 118b can be within the target site 147. FIG. 46d shows that the same section of the catheter 9 can define multiple loops 118. For example, FIG. 46d shows that section D2 - D3 of the catheter 9 can be a section of the first loop 118a and a section of the second loop 118b. FIG. 46d shows, for example, that the second loop 118b can be formed from a section (e.g., section D2 - D3) of the first loop 118a. FIG. 46d shows that the size (e.g., outer perimeter) of the first loop 118a can be larger when the catheter 9 is in the fourth configuration 116d than when the catheter 9 is in the third configuration 116c. FIG. 46d shows that the gap between the first loop first end 118a - 1 and the first loop second end 118a - 2 can be smaller when the catheter 9 is in the fourth configuration 116d than when the catheter 9 is in the third configuration 116b. FIG. 46d shows that when the catheter 9 is in the fourth configuration 116d, the distal end 7 of the catheter within the target site 147 can be in the same position as when the catheter 9 is in the third configuration 116c.

[0199]

[0259] Figure 46e shows that the first loop 118a can be formed by sections E1 - E3 of the catheter 9, and that the second loop 118b can be formed by sections E2 - E3 of the catheter 9. The length of sections E1 - E3 of the catheter 9 can be, for example, a length of 126. The length of sections E2 - E3 can be, for example, less than the length of sections E1 - E3. Figure 46e shows that the size (e.g., outer circumference) of the first loop 118a and / or the second loop 118b may be larger when the catheter 9 is in the fifth configuration 116e than when the catheter 9 is in the fourth configuration 116d. Figure 46e shows that the second loop 118b may be closer to the catheter tip 7 when the catheter 9 is in the fifth configuration 116e than when the catheter 9 is in the fourth configuration 116d. Figure 46e shows that the second loop 118b (e.g., the second loop head 118b - 3) may be closer to the first loop 118a (e.g., the first loop first end 118a - 1 and / or the first loop head 118a - 3) when the catheter 9 is in the fifth configuration 116e than when the catheter 9 is in the fourth configuration 116d. Figure 46d shows that when the catheter 9 is in the fifth configuration 116e, the catheter tip 7 within the target site 147 can be in the same position as when the catheter 9 is in the fourth configuration 116d. Figure 46e shows that the gap between the first loop first end 118a - 1 and the first loop second end 118a - 2 may be smaller when the catheter 9 is in the fifth configuration 116e (e.g., the gap between reference points E1 and E3) than when the catheter 9 is in the fourth configuration 116d (e.g., the gap between reference points D1 and D3).

[0200]

[0260] FIG. 46f shows that a first loop 118a can be formed by sections F1 - F3 of the catheter 9, and that a second loop 118b can be formed by sections F2 - F3 of the catheter 9. The length of sections F1 - F3 of the catheter 9 can be, for example, a length of 126. The length of sections F2 - F3 can be, for example, less than the length of sections F1 - F3. FIG. 46f shows that when the catheter 9 is in the sixth configuration 116f rather than in the fifth configuration 116e, the size (e.g., outer circumference) of the first loop 118a and / or the second loop 118b may be larger. FIG. 46f shows that when the catheter 9 is in the sixth configuration 116f rather than in the fifth configuration 116e, the second loop 118b (e.g., the second loop head 118b - 3) may be closer to the first loop 118a (e.g., the first loop first end 118a - 1 and / or the first loop head 118a - 3).

[0201]

[0261] Figure 46g shows that the first loop 118a can be formed by sections G1 - G3 of the catheter 9, and that the second loop 118b can be formed by sections G2 - G3 of the catheter 9. The length of sections G1 - G3 of the catheter 9 can be, for example, length 126. The length of sections G2 - G3 can be, for example, less than the length of sections G1 - G3. Figure 46g shows that the size (e.g., outer perimeter) of the first loop 118a and / or the second loop 118b may be larger when the catheter 9 is in the seventh configuration 116g than when the catheter 9 is in the sixth configuration 116f. Figure 46g shows that the second loop 118b (e.g., the second loop head 118b - 3) may be closer to the first loop 118a (e.g., the first loop first end 118a - 1 and / or the first loop head 118a - 3) when the catheter 9 is in the seventh configuration 116g than when the catheter 9 is in the sixth configuration 116f. Figures 46d through 46g show that as the length of the catheter 9 within the target site 147 (e.g., the stomach 2) increases, the second loop 118b can move towards the first loop 118a. Figures 46f through 46g show that as the length of the catheter 9 within the target site 147 (e.g., the stomach 2) increases, the second loop 118b can move across the first loop 118a (e.g., above or below the first loop 118a). Figures 46f through 46g show that as the length of the catheter 9 within the target site 147 increases, the first loop 118a can be closed by being pinched, dividing the first cell 122a into a plurality of sub - cells, for example, into a first sub - cell 122a1 and a second sub - cell 122a2. Figure 46g shows that the first sub - cell 122a1 can be an open cell and the second sub - cell 122a2 can be a closed cell. Figure 46g shows, for example, that a second cell 122b can exist between the first sub - cell 122a1 and the second sub - cell 122a2. Figures 46d through 46f show that as the length of the catheter 9 within the target site 147 (e.g., the stomach 2) increases, the second loop 118b (e.g., the second loop first end 118b - 1) can move towards the catheter tip 7.Figures 46f through 46g show that as the length of the catheter 9 within the target site 147 (e.g., the stomach 2) increases, the second loop 118b (e.g., the first end 118b-1 of the second loop) can move away from the catheter tip 7.

[0202]

[0262] Figure 46h shows that the first loop 118a can be formed by sections H1 - H4 of the catheter 9, the second loop 118b can be formed by sections H2 - H4 of the catheter 9, and the third loop 118c can be formed by sections H3 - H4 of the catheter 9. The length of sections H1 - H4 of the catheter 9 can be, for example, length 126. The lengths of sections H2 - H3 and H3 - H4 can be, for example, less than the length of sections H1 - H4. Figure 46h shows that the size (e.g., outer perimeter) of the third loop 118c may be larger when the catheter 9 is in the eighth configuration 116h than when the catheter 9 is in the seventh configuration 116g. Figure 46h shows that the third loop 118c can be farther from the gastroesophageal junction 120 when the catheter 9 is in the eighth configuration 116h than when the catheter 9 is in the seventh configuration 116g. Figure 46h shows that the same section of the catheter 9 can define multiple loops 118. For example, Figure 46h shows that sections H3 - H4 of the catheter 9 can be sections of the second loop 118b and the third loop 118c. Figure 46h shows that the first loop 118 can extend in and out within the target site 147. For example, Figure 46h shows that the first end 118a - 1 of the first loop can extend in and out within the target site 147. Figure 46h shows that a part of the first loop 118a can extend across (e.g., above or below) the second cell 122b. Figure 46h shows that a part of the first loop 118a extending across the second cell 122b may partially block the second cell 122b. Figure 46h shows that by the second loop 118b extending across (e.g., above or below) the first loop 118a, a cell 134 can be generated between the first loop 118a and the second loop 118b. Figure 46h shows that the first section of the catheter 9 (e.g., the second loop head 118b - 3) can extend across the second section of the catheter 9 (e.g., the second end 118a - 2 of the first loop and / or the first loop head 118 - 3) at two positions such as both ends of the cell 134.FIG. 46h shows that, for example, a cell 134 can be generated between the radially outer surface of the first loop 118a and the radially inner surface of the second loop 118b.

[0203]

[0263] FIG. 46i shows that the first loop 118a can be formed by sections I1 - I5 of the catheter 9, the second loop 118b can be formed by sections I2 - I4 of the catheter 9, and the third loop 118c can be formed by sections I3 - I5 of the catheter 9. The length of sections I1 - I5 of the catheter 9 can be, for example, length 126. The lengths of sections I2 - I4 and I3 - I5 can be, for example, less than the length of sections I1 - I5. FIG. 46i shows that the size (e.g., outer circumference) of the third loop 118c may be larger when the catheter 9 is in the ninth configuration 116i than when the catheter 9 is in the eighth configuration 116h. FIGS. 46h - 46i show that as the length of the catheter 9 within the target site 147 increases, the second loop 118b is closed by being pinched, which may divide the second cell 122b into a plurality of sub - cells, for example, into a first sub - cell 122b1 and a second sub - cell 122b2. FIG. 46i shows that the first sub - cell 122b1 can be an open cell and the second sub - cell 122b2 can be a closed cell. FIG. 46i shows that, for example, the first section of the catheter 9 (e.g., the first end 118b - 1 of the second loop and / or the head 118c - 3 of the third loop) may be adjacent to and / or in contact with the second section of the catheter 9 (e.g., the second end 118b - 2 of the second loop) at position Z1. FIGS. 46h - 46i show that, for example, as the length of the catheter 9 within the target site 147 increases, the first section of the catheter 9 (e.g., the first end 118b - 1 of the second loop and / or the head 118c - 3 of the third loop) may be adjacent to and / or in contact with the second section of the catheter 9 (e.g., the second end 118b - 2 of the second loop) at the first position Z1.

[0204]

[0264] Figure 46j shows that the first loop 118a can be formed by sections J1 - J5 of the catheter 9, the second loop 118b can be formed by sections J2 - J4 of the catheter 9, and the third loop 118c can be formed by sections J3 - J5 of the catheter 9. The length of sections J1 - J5 of the catheter 9 can be, for example, length 126. The lengths of sections J2 - J4 and J3 - J5 can be, for example, less than the length of sections J1 - J5. Figure 46j shows that the size (e.g., outer circumference) of the third loop 118c may be larger when the catheter 9 is in the tenth configuration 116j than when the catheter 9 is in the ninth configuration 116i. From Figure 46i to Figure 46j, as the length of the catheter 9 within the target site 147 increases, the first section of the catheter 9 (e.g., the first end 118b - 1 of the second loop and / or the head 118c - 3 of the third loop) may move (e.g., push) the second section of the catheter 9 (e.g., the second end 118b - 2 of the second loop) from the first position Z1 to the second position Z2. Figure 46j shows that the position Z2 can be located a distance Z3 away from the esophagus 5 and / or near the pylorus 65. The distance Z3 can be, for example, 1 cm to 5 cm or more, and can increase by 1 cm within this range (e.g., 1 cm, 2 cm, 3 cm, 5 cm). From Figure 46i to Figure 46j, for example, as the catheter 9 is inserted into the target site 147, the first section of the catheter 9 (e.g., the first end 118b - 1 of the second loop and / or the head 118c - 3 of the third loop) can move into the second section of the catheter 9 (e.g., the second end 118b - 2 of the second loop), indicating that the first section can deform the second section. From Figure 46i to Figure 46j, for example, when the catheter 9 is inserted into the target site 147, the second section of the catheter 9 (e.g., the second end 118b - 2 of the second loop) can resist the movement of the first section of the catheter 9 (e.g., the first end 118b - 1 of the second loop and / or the head 118c - 3 of the third loop) into the target site 147.

[0205]

[0265] FIG. 46k shows that a first loop 118a can be formed by sections K1-K5 of the catheter 9, a second loop 118b can be formed by sections K2-K4 of the catheter 9, and a third loop 118c can be formed by sections K3-K5 of the catheter 9. The length of sections K1-K5 of the catheter 9 can be, for example, length 126. The lengths of sections K2-K4 and K3-K5 can be, for example, less than the length of sections K1-K5. FIG. 46k shows that the size (e.g., outer circumference) of the third loop 118c may be larger when the catheter 9 is in the 11th configuration 116k than when the catheter 9 is in the 10th configuration 116j. FIG. 46k shows that a part of the second loop 118b (e.g., the second end 118b-2 of the second loop) can extend across the third cell 122c. FIG. 46k shows that a part of the second loop 118b extending across the third cell 122c may partially block the third cell 122c. FIG. 46k shows that a first section of the catheter 9 (e.g., the first end 118b-1 of the second loop and / or the head 118c-3 of the third loop) can extend across a second section of the catheter 9 (e.g., the second end 118b-2 of the second loop) at two positions (e.g., above or below the second section). FIG. 46k shows that the third cell 122c can overlap with the first cell 122a (e.g., with the second sub-cell 122a2).

[0206]

[0266] FIG. 46l shows that a first loop 118a can be formed by sections L1 - L5 of the catheter 9, a second loop 118b can be formed by sections L2 - L4 of the catheter 9, and a third loop 118c can be formed by sections L3 - L5 of the catheter 9. The length of sections L1 - L5 of the catheter 9 can be, for example, length 126. The lengths of sections L2 - L4 and L3 - L5 can be, for example, less than the length of sections L1 - L5. FIG. 46l shows that when the catheter 9 is in the 12th configuration 116l rather than the 11th configuration 116k, many portions of the third cell 122c can overlap with the first cell 122a (e.g., with the second sub - cell 122a2). FIG. 46l shows that a first section of the catheter 9 (e.g., the first end 118b - 1 of the second loop and / or the head 118c - 3 of the third loop) can be adjacent to and / or in contact with a second section of the catheter 9 (e.g., the head 118a - 3 of the first loop). FIGS. 46k through 46l show that, for example, as the length of the catheter 9 within the target site 147 increases, a first section of the catheter 9 (e.g., the first end 118b - 1 of the second loop and / or the head 118c - 3 of the third loop) can move so as to be adjacent to and / or in contact with a second section of the catheter 9 (e.g., the head 118a - 3 of the first loop). FIGS. 46h through 46l show that as the length of the catheter 9 within the target site 147 (e.g., the stomach 2) increases, the third loop 118c can move towards the boundary of the shape 117.

[0207]

[0267] FIG. 46m shows that a first loop 118a can be formed by sections M1 - M5 of the catheter 9, a second loop 118b can be formed by sections M2 - M4 of the catheter 9, a third loop 118c can be formed by sections M3 - M5 of the catheter 9, and a fourth loop 118d can be formed by sections M4 - M5 of the catheter 9. The length of sections M1 - M5 of the catheter 9 can be, for example, 126 in length. The lengths of sections M2 - M4, M3 - M5, and M4 - M5 can be, for example, less than the length of sections M1 - M5. FIG. 46m shows that when the catheter 9 is in the 13th configuration 116m rather than in the 12th configuration 116l, many portions of the third cell 122c can overlap with the first cell 122a (e.g., with the second sub - cell 122a2). FIG. 46m shows that the second loop 118b and the third loop 118c can define an infinite shape. For example, FIG. 46m shows that sections M2 - M4 of the catheter 9 can include an infinite shape.

[0208]

[0268] FIG. 46n shows that a first loop 118a can be formed by sections N1 to N5 of the catheter 9, a second loop 118b can be formed by sections N2 to N4 of the catheter 9, a third loop 118c can be formed by sections N3 to N5 of the catheter 9, and a fourth loop 118d can be formed by sections N4 to N5 of the catheter 9. The length of sections N1 to N5 of the catheter 9 can be, for example, a length of 126. The lengths of sections N2 to N4, N3 to N5, and N4 to N5 can be, for example, less than the length of sections N1 to N5. FIG. 46n shows that the size (e.g., outer circumference) of the fourth loop 118d may be larger when the catheter 9 is in the 14th configuration 116n than when the catheter 9 is in the 13th configuration 116m. FIGS. 46m to 46n show that as the length of the catheter 9 within the target site 147 increases, the third loop 118c is closed by being pinched, for example, dividing the third cell 122c into a plurality of sub-cells, such as a first sub-cell 122c1 and a second sub-cell 122c2. FIG. 46n shows that the first sub-cell 122c1 can be an open cell and the second sub-cell 122c2 can be a closed cell. FIG. 46n shows, for example, that a first section (e.g., the first end 118c-1 of the third loop and / or the head 118d-3 of the fourth loop) of the catheter 9 can be adjacent to and / or in contact with a second section (e.g., the second end 118c-2 of the third loop) of the catheter 9. FIGS. 46m to 46n show, for example, that as the length of the catheter 9 within the target site 147 increases, a first section (e.g., the first end 118c-1 of the third loop and / or the head 118d-3 of the fourth loop) of the catheter 9 can move to be adjacent to and / or in contact with a second section (e.g., the second end 118c-2 of the third loop) of the catheter 9.

[0209]

[0269] Figure 46o shows that a first loop 118a can be formed by sections O1 - O5 of the catheter 9, a second loop 118b can be formed by sections O2 - O4 of the catheter 9, a third loop 118c can be formed by sections O3 - O5 of the catheter 9, and a fourth loop 118d can be formed by sections O4 - O5 of the catheter 9. The length of sections O1 - O5 of the catheter 9 can be, for example, a length of 126. Figure 46o shows that, for example, the length 126 can be 110 cm. The lengths of sections O2 - O4, O3 - O5, and O4 - O5 can be, for example, less than the length of sections O1 - O5. Figure 46o shows that the size (e.g., outer circumference) of the fourth loop 118d may be larger when the catheter 9 is in the 15th configuration 116o than when the catheter 9 is in the 14th configuration 116n. Figure 46o shows that a first section of the catheter (e.g., the first end 118c - 1 of the third loop and / or the head end 118d - 3 of the fourth loop) of the catheter 9 can extend across the second cell 122b. Figure 46o shows that a part of the catheter extending across the second cell 122b may partially block the second cell 122b. Figure 46o shows that a first section of the catheter 9 (e.g., the first end 118c - 1 of the third loop and / or the head end 118d - 3 of the fourth loop) of the catheter 9 can extend across a second section of the catheter 9 (e.g., the second end 118c - 2 of the third loop) at two positions (e.g., above or below the second section). Figure 46o shows that the fourth cell 122d can overlap with the second cell 122b (e.g., with the second sub - cell 122b2). Figures 46a through 46o show that the first loop 118a can include the second loop 118b, the third loop 118c, and the fourth loop 118d.

[0210]

[0270] Loop 118 can be formed proximal and / or distal to the catheter tip 7 within the target site 147. For example, FIGS. 46a through 46z3 show that loop 118 can be formed distal to the catheter tip 7 within the target site 147. For example, FIGS. 46a through 46z3 show that loop 118 (e.g., second loop 118b, third loop 118c, and fourth loop 118d) can be formed between the catheter tip 7 and the pylorus 65.

[0211]

[0271] FIGS. 46o through 46z3 show that the catheter 9 can be removed from the target site 147. FIGS. 46o through 46z3 show that loop 118 can be collapsed within the target site 147 and / or removed from the target site 147. FIGS. 46o through 46z3 show that collapsing loop 118 can include straightening loop 118, loosening the curvature of the loop, reducing the outer perimeter of loop 118, reducing the loop length of loop 118, reducing the width of loop 118, reducing the height of loop 118, or any combination thereof. FIGS. 46a through 46z3 show that loop 118 can be collapsed within the target site 147 by removing the catheter 9 from the target site 147.

[0212]

[0272] FIGS. 46a through 46o show that the catheter 9 can form a coil (e.g., coil 138) within the target site 147, for example, by inserting the catheter 9 into the target site 147. FIGS. 46a through 46o show that, for example, as the catheter 9 is inserted into the target site 147, the coil 138 (e.g., the length 126 of the catheter 9 within the target site 147) becomes entangled, increases in size, increases the number of extensions within the target site 147, and / or increases in density (e.g., per 1 cm of the target site 147) 3It shows that there may be an increase in the amount of catheter 9 per unit volume of the target site 147, such as an increase in the amount of the catheter hit. Figures 46a to 46z3 show that the catheter 9 may form a coil 138 (for example, gradually form). Figures 46o to 46z3 show that, for example, as the catheter 9 is removed from the target site 147, the coil 138 may become unentangled, smaller in size, decrease in the number of extensions at the target site 147, and / or decrease in density at the target site 147. Figures 46o to 46z3 show that as the catheter 9 is removed from the target site 147, the coil shape of the catheter 9 may stretch (for example, gradually stretch). Figures 46o to 46z3 show that, for example, as the catheter 9 is removed from the target site 147, the coil 138 may stretch (for example, gradually stretch) within the target site 147.

[0213]

[0273] Figures 46a to 46z3 show that when the catheter 9 is in the deployed configuration (for example, configuration 116), the heat transfer region 128 may be within the stomach 2 and the esophagus 5.

[0214]

[0274] Figures 47a to 47i show that the catheter 9 can be inserted into and / or removed from the stomach 2. Figures 47a to 47i show that various lengths of the catheter 9 (for example, the lengths 126 shown in Figures 47b to 47h) can be introduced into and / or removed from the stomach 2. Figures 47a to 47i show various configurations 116 and shapes 117 that the catheter 9 may have. The configurations 116 and shapes 117 in Figures 47a to 47i may be different from the configurations 116 and shapes 117 in Figures 46a to 46z3, for example. Figures 47a to 47i show that, for example, when the catheter 9 has the first to ninth configurations 116a - 116i, the catheter 9 may have the first to ninth shapes 117a - 117i, respectively. As another example, the catheter 9 within the target site 147 may have any combination of the loops 118 and / or cells 122 shown in Figures 46b to 46z2 and Figures 47b to 47i.

[0215]

[0275] Figures 47a through 47e show that the catheter 9 can be inserted into the target site 147 as indicated by the arrow 112.

[0216]

[0276] Figure 47a shows that when the catheter tip 7 is within the esophagus 5, the catheter 9 may not include the loop 118.

[0217]

[0277] Figure 47b shows that the first loop 118a can be an open loop. Figure 47b shows that in the illustrated configuration 116, the length 126 can be, for example, 15 cm to 40 cm (e.g., 25 cm).

[0218]

[0278] Figure 47c shows that the first loop 118a can be a closed loop. Figures 47b through 47c show that, for example, by inserting the catheter 9 into the target site 147, the first loop 118 can change from an open loop to a closed loop. Figures 47b through 47c show that the size (e.g., outer circumference) of the first loop 118a may be larger when the catheter 9 is in the third configuration 116c than when the catheter 9 is in the second configuration 116b. Figure 47c shows that in the illustrated configuration 116, the length 126 can be, for example, 20 cm to 90 cm (e.g., 50 cm).

[0219]

[0279] Figure 47d shows that the first loop 118a and the second loop 118b can be closed loops, and that the third loop 118c can be an open loop. Figure 47d shows that the first loop 118a can overlap with the second loop 118b. Figure 47d shows that the second loop 118b can overlap with the first loop 118a. Figure 47d shows that a part of the second loop 118b can be behind the first loop 118a. Figure 47d shows that the first cell 122a and the second cell 122b can overlap with each other and can be offset from each other. For example, Figure 47d shows that the lower part of the first cell 122a can overlap (e.g., be aligned) with the upper part of the second cell 122b. Figure 47d shows that in the illustrated configuration 116, the length 126 can be, for example, 70 cm to 200 cm (e.g., 80 cm).

[0220]

[0280] Figure 47e shows that the first loop 118a, the second loop 118b, and the third loop 118c can be closed loops. Figures 47d to 47e show that, for example, by inserting the catheter 9 into the target site 147, the third loop 118 can change from an open loop to a closed loop. Figures 47d to 47e show that the size (e.g., outer circumference) of the third loop 118c can be larger when the catheter 9 is in the fifth configuration 116e than when the catheter 9 is in the fourth configuration 116d. Figures 47d to 47e show that the size (e.g., outer circumference) of the third loop 118c can expand and / or contract independently of the size of the first loop 118 and / or the second loop 118b. Figure 47e shows that in the illustrated configuration 116, the length 126 can be, for example, 80 cm to 180 cm (e.g., 90 cm).

[0221]

[0281] FIGS. 47d through 47e show that after a proximal loop (e.g., the first loop 118a) is formed within the target site 147, a distal loop (e.g., the second loop 118b and / or the third loop 118c) can be formed within the target site 147. FIG. 47e shows that after a proximal cell (e.g., the first cell 122a) is formed within the target site 147, a distal cell (e.g., the second cell 122b and / or the third cell 122c) can be formed within the target site 147.

[0222]

[0282] FIGS. 47a through 47e show that by inserting the catheter 9 into the target site 147, the loops 118 and the cells 122 can be formed. The loops 118 can be formed within the target site 147 in any order, e.g., sequentially and / or simultaneously. For example, FIGS. 47a through 47e show that the first loop 118a, the second loop 118b, and the third loop 118c can be formed sequentially. For example, FIGS. 47a through 47e show that the first loop 118a can be formed within the target site 147, then the second loop 118b can be formed within the target site 147, and then the third loop 118c can be formed within the target site 147. For example, FIGS. 47a through 47e show that the second loop 118b can be formed after the first loop 118a is formed, and that the third loop 118c can be formed after the first loop 118a and / or the second loop 118b are formed.

[0223]

[0283] Figures 47a through 47e show, for example, that loop 118a can be formed during a first stage of loop formation, loop 118b can be formed during a second stage of loop formation, and loop 118c can be formed during a third stage of loop formation. The first stage of loop formation can be before the second stage of loop formation. The second stage of loop formation can be after the first stage of loop formation. The third stage of loop formation can be after the second stage of loop formation. While the second loop 118b is being formed (e.g., during the second stage of loop formation), the first loop 118a can have a constant size and / or shape. As another example, while the second loop 118b is being formed (e.g., during the second stage of loop formation), the size (e.g., outer perimeter) of the first loop 118a can increase and / or decrease, the shape of the first loop 118a can change, or any combination thereof. While the third loop 118c is being formed (e.g., during the third stage of loop formation), the first loop 118a and / or the second loop 118b can have a constant size and / or shape. As another example, while the third loop 118c is being formed (e.g., during the third stage of loop formation), the size (e.g., outer perimeter) of the first loop 118a and / or the second loop 118b can increase and / or decrease, the shape of the first loop 118a and / or the second loop 118b can change, or any combination thereof.

[0224]

[0284] FIGS. 47a through 47e show that different sections of catheter 9 can form different loops 118 at different times and / or at different stages of loop formation. For example, FIGS. 47a through 47e show that when catheter 9 is in the third configuration 116c, the first section of catheter 9 can form a first loop 118a, and that when catheter 9 is in the fourth configuration 116d, the first section of catheter 9 can form a third loop 118c and the second section of catheter 9 can form a first loop 118a. As another example, FIGS. 47a through 47e show that when catheter 9 is in the third configuration 116c, the first section of catheter 9 can form a first loop 118a, and that when catheter 9 is in the fifth configuration 116e, the first section of catheter 9 can form a third loop 118c and the second section of catheter 9 can form a first loop 118a. When catheter 9 is in the third configuration 116c, the fourth configuration 116d, and the fifth configuration 116e, the first section of catheter 9 can have the same length. FIGS. 47a through 47e show that the first section of catheter 9 can be distal to the second section of the catheter along the length of catheter 9. FIGS. 47a through 47e show, for example, that the first section of catheter 9 can be the distal end of catheter 9. FIGS. 47a through 47e show, for example, that the first section of catheter 9 can have catheter tip 7. As yet another example, during a first stage of loop formation, the first section of catheter 9 forms a first loop 118a, during a second stage of loop formation, the first section of catheter 9 forms a second loop 118b and the second section of catheter 9 forms a first loop 118a, and during a third stage of loop formation, the first section of catheter 9 forms a third loop 118c, the second section of catheter 9 forms a second loop 118b, and the third section of catheter 9 can form a first loop 118a. FIGS. 47a through 47e show, for example, that when catheter 9 is inserted into target site 147, catheter tip 7 can follow the path of catheter 9 within target site 147.Figures 47a through 47e illustrate, for example, that when advancing catheter 9 into target site 147, one or more sections of catheter 9 proximal to catheter tip 7 may follow the path of the distal section (e.g., distal tip 7) passing through target site 147 (e.g., when catheter 9 is inserted into target site 147, the proximal section of catheter 9 may follow the path of the distal section of catheter 9 within target site 147). For example, Figures 47a through 47e show that a second loop 118b may be formed distal to a first loop 118a, and that a third loop 118c may be formed distal to the first loop 118a and the second loop 118b. Figures 47a through 47e illustrate, for example, that when catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the third loop 118c is the most distal loop along the length of catheter 9 within target site 147, and the first loop 118a may be the most proximal loop along the length of catheter 9 within target site 147. Figures 47d and 47e illustrate, for example, that when catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first loop 118a is proximal to the second loop 118b and the third loop 118c within target site 147, and the second loop 118b may be proximal to the third loop 118c within target site 147.

[0225]

[0285] Figures 47e through 47i show that the catheter 9 can be removed from the target site 147 as indicated by arrow 114. Figures 47e through 47i show that the loop 118 can be collapsed within the target site 147 and / or removed from the target site 147. Figures 47e through 47i show that collapsing the loop 118 can include straightening the loop 118, loosening the curvature of the loop, reducing the outer perimeter of the loop 118, reducing the loop length of the loop 118, reducing the width of the loop 118, reducing the height of the loop 118, or any combination thereof. Figures 47e through 47i show that the loop 118 can be collapsed within the target site 147 by removing the catheter 9 from the target site 147 as indicated by arrow 114. Figures 47e through 47i show, for example, that as the catheter 9 is removed (e.g., pulled) from the target site 147 into the esophagus 5, the catheter 9 may straighten and / or the curvature may loosen within the target site 147.

[0226]

[0286] Loop 118 can be collapsed and / or removed from the target site 147 in any order, for example sequentially and / or simultaneously. For example, FIGS. 47e to 47i show that the first loop 118a, the second loop 118b, and the third loop 118c can be collapsed within the target site 147 sequentially and / or removed from the target site 147. FIGS. 47e to 47i show, for example, that when the first loop 118a, the second loop 118b, and the third loop 118c are collapsed (for example, when they are smaller in size), they can be removed from the target site 147. For example, FIGS. 47e to 47i show that the first loop 118a can be collapsed and removed from the target site 147, then the second loop 118b can be collapsed and removed from the target site 147, and then the third loop 118c can be collapsed and removed from the target site 147. For example, FIGS. 47e to 47i show that the second loop 118b can be collapsed and removed from the target site 147 after the first loop 118a has been collapsed and removed from the target site 147, and that the third loop 118c can be collapsed and removed from the target site 147 after the first loop 118a and the second loop 118b have been collapsed and removed from the target site 147. FIGS. 47e to 47i show that when removing the catheter 9 from the target site 147, starting from the most proximal loop (for example, loop 118a) and ending with the most distal loop (for example, loop 118c), loop 118 can be collapsed independently of each other. FIGS. 47e to 47i show that when the first loop 118a is being collapsed and removed from the target site 147, the second loop 118b and the third loop 118c can move (for example, be pulled) towards the gastroesophageal junction 120. FIGS. 47e to 47i show that when the second loop 118b is being collapsed and removed from the target site 147, the third loop 118c can move (for example, be pulled) towards the gastroesophageal junction 120.

[0227]

[0287] FIGS. 47e through 47i show, for example, that during a first stage of catheter removal, a section of catheter 9 defining a first loop 118a can be removed from target site 147, that during a second stage of catheter removal, a section of catheter 9 defining a second loop 118b can be removed from target site 147, and that during a third stage of catheter removal, a section of catheter 9 defining a third loop 118c can be removed from target site 147. During the first stage of catheter removal, the first loop 118a can collapse within the target site 147. During the second stage of catheter removal, the second loop 118b can collapse within the target site 147. During the third stage of catheter removal, the third loop 118c can collapse within the target site 147. As another example, for instance, if the size of the first loop 118a, the second loop 118b, and / or the third loop 118c is smaller than the passage of the esophagus 5, the first loop 118a, the second loop 118b, and / or the third loop 118c can be removed from the target site 147 without collapsing. The first stage of catheter removal can be before the second stage of catheter removal. The second stage of catheter removal can be after the first stage of catheter removal. The third stage of catheter removal can be after the second stage of catheter removal. While the first loop 118a is being removed (e.g., during the first stage of catheter removal), the second loop 118b and / or the third loop 118c can have a constant size and / or shape. As another example, while the first loop 118a is being removed (e.g., during the first stage of catheter removal), the size (e.g., outer perimeter) of the second loop 118b and / or the third loop 118c can increase and / or decrease, the shape of the second loop 118b and / or the third loop 118c can change, or any combination thereof can occur. While the second loop 118b is being removed (e.g., during the second stage of catheter removal), the third loop 118c can have a constant size and / or shape.As another example, while the second loop 118b is removed (e.g., during the second stage of loop formation), the size (e.g., outer perimeter) of the third loop 118c can expand and / or contract, the shape of the third loop 118c can change, or any combination thereof. FIGS. 47e through 47i show, for example, that as the catheter 9 is withdrawn from the target site 147, one or more distal sections of the catheter 9 may follow the path of the proximal section within the target site 147 (e.g., as the catheter 9 is inserted into the target site 147, a distal section of the catheter 9 may follow the path of the proximal section of the catheter 9 within the target site 147).

[0228]

[0288] FIGS. 47a through 47e show, for example, that the catheter 9 can form a coil (e.g., coil 138) within the target site 147 by inserting the catheter 9 into the target site 147. FIGS. 47e through 47i show that as the catheter 9 is withdrawn from the target site 147, the coil 138 may extend (e.g., gradually extend) within the target site 147.

[0229]

[0289] FIGS. 47a through 47i show, for example, that the configuration 116 formed by the catheter 9 during withdrawal can be the same as the configuration 116 formed by the catheter 9 during insertion. As another example, the configuration 116 formed by the catheter 9 during withdrawal of the catheter 9 from the body may be different from the configuration 116 formed by the catheter 9 during insertion of the catheter 9 into the body.

[0230]

[0290] FIGS. 48a through 48i show that the catheter 9 can be inserted into and / or removed from the stomach 2. FIGS. 48a through 48i show that various lengths of the catheter 9 (e.g., the length 126 shown in FIGS. 48b through 48h) can be introduced into and / or removed from the stomach 2. FIGS. 48a through 48i show the various configurations 116 and shapes 117 that the catheter 9 can have. The configurations 116 and shapes 117 of FIGS. 48a through 48i may be different from, for example, the configurations 116 and shapes 117 of FIGS. 46a through 46z3. FIGS. 48a through 48i show, for example, that when the catheter 9 has the first through ninth configurations 116a - 116i, the catheter 9 can have the first through ninth shapes 117a - 117i, respectively.

[0231]

[0291] Figures 48a through 48i show the same configuration 116 and shape 117 as Figures 47a through 47i, but indicate that the loop 118 can be formed differently and / or can collapse and / or be removed in a different order. For example, Figures 48a through 48e show that the coil 138 can have a preset shape. For example, Figures 48a through 48i show that the catheter 9 and / or the guide wire 99 can have a preset shape in the shape of the coil 138. Figures 48a through 48i show that the coil 138 can be, for example, a loose coil (e.g., a coil in which the loops 118 and / or the cells 122 are offset from each other). Figures 48a through 48i show various shapes 117 of the coil 138. When the catheter 9 is inserted into the target site 147, the catheter 9 is biased to form a preset shape (e.g., of the coil 138), so that it can automatically form the preset shape after being released from restraint by the esophagus 5 and inserted into the target site 147. As another example, when removing the guide wire 99 from the catheter 9 as indicated by the arrow 111, the catheter 9 is biased to form a preset shape, so that it can automatically form the preset shape (e.g., the shape of the coil 138) after the guide wire 99 is removed from the catheter 9 within the target site 147. The catheter 9 can form the loops 118 and the cells 122 by forming a preset shape within the target site 147. The preset shape can have the loops 118 and the cells 122. The preset shape can be, for example, the shape of Figures 48b through 48h. For example, when the catheter 9 enters the target site 147 and / or when the guide wire 99 is removed from the catheter 9 within the target site 147, the catheter 9 can form a preset shape within the target site 147. By removing and / or introducing the guide wire 99 to / from the catheter 9, the shape of the catheter 9 within the target site 147 can be adjusted.

[0232]

[0292] FIGS. 48a through 48e show that a section of the catheter 9 distal to the section of the catheter 9 forming the second loop 118b and the third loop 118c can form the first loop 118a. FIGS. 48a through 48e show that a section of the catheter 9 distal to the section of the catheter 9 forming the third loop 118c can form the second loop 118b. FIGS. 48d and 48e show, for example, that when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first loop 118a can be distal to the second loop 118b and the third loop 118c along the length 126 of the catheter 9, and that the second loop 118b can be distal to the third loop 118c along the length 126 of the catheter 9. FIGS. 48a through 48e show, for example, that when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first loop 118a can be the most distal loop along the catheter 9 within the target site 147, and that the third loop 118c can be the most proximal loop along the catheter 9 within the target site 147. FIGS. 48d and 48e show, for example, that when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first loop 118a can be distal to the second loop 118b and the third loop 118c within the target site 147, and that the second loop 118b can be distal to the third loop 118c within the target site 147.

[0233]

[0293] Figures 48a through 48e show that loop 118 and cell 122 can be formed by inserting catheter 9 into target site 147 and / or by removing guidewire 99 from catheter 9. Loop 118 can be formed within target site 147 in any order, for example sequentially and / or simultaneously. For example, Figures 48a through 48e show that a first loop 118a, a second loop 118b, and a third loop 118c can be formed sequentially. For example, Figures 48a through 48e show that a first loop 118a can be formed within target site 147, then a second loop 118b can be formed within target site 147, and then a third loop 118c can be formed within target site 147. For example, Figures 48a through 48e show that a second loop 118b can be formed after a first loop 118a is formed, and that a third loop 118c can be formed after a first loop 118a and / or a second loop 118b are formed.

[0234]

[0294] Figures 48a through 48e show, for example, that loop 118a can be formed during a first stage of loop formation, loop 118b can be formed during a second stage of loop formation, and loop 118c can be formed during a third stage of loop formation. The first stage of loop formation can be before the second stage of loop formation. The second stage of loop formation can be after the first stage of loop formation. The third stage of loop formation can be after the second stage of loop formation. While the second loop 118b is being formed (e.g., during the second stage of loop formation), the first loop 118a can have a constant size and / or shape. As another example, while the second loop 118b is being formed (e.g., during the second stage of loop formation), the size (e.g., outer perimeter) of the first loop 118a can increase and / or decrease, the shape of the first loop 118a can change, or any combination thereof. While the third loop 118c is being formed (e.g., during the third stage of loop formation), the first loop 118a and / or the second loop 118b can have a constant size and / or shape. As another example, while the third loop 118c is being formed (e.g., during the third stage of loop formation), the size (e.g., outer perimeter) of the first loop 118a and / or the second loop 118b can increase and / or decrease, the shape of the first loop 118a and / or the second loop 118b can change, or any combination thereof.

[0235]

[0295] Figures 48a through 48e show that different sections of catheter 9 can form different loops 118 at different times and / or at different stages of loop formation. For example, Figures 48a through 48e show that when catheter 9 is in the third configuration 116c, the first section of catheter 9 can form the first loop 118a, and when catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first section of catheter 9 can form the first loop 118a, the second section of catheter 9 can form the second loop 118b, and further the third section of catheter 9 can form the third loop 118c.

[0236]

[0296] FIGS. 48e through 48i show that the catheter 9 can be removed from the target site 147. FIGS. 48e through 48i show that the loop 118 can be collapsed within the target site 147 and / or removed from the target site 147. FIGS. 48e through 48i show that collapsing the loop 118 can include straightening the loop 118, loosening the curvature of the loop, reducing the outer perimeter of the loop 118, reducing the loop length of the loop 118, reducing the width of the loop 118, reducing the height of the loop 118, or any combination thereof. FIGS. 48e through 48i show that the loop 118 can be collapsed within the target site 147 by removing the catheter 9 from the target site 147, inserting the guide wire 99 into the esophagus 5 and / or into the target site 147 through the catheter 9 and removing the catheter 9 from the target site 147 over the guide wire 99, or any combination thereof. As the catheter 9 is removed (e.g., pulled) into the esophagus 5 as indicated by the arrow 114, as the guide wire 99 is inserted into the catheter 9 as indicated by the arrow 113, and as the catheter 9 is removed (e.g., pulled) over the guide wire 99 as indicated by the arrow 114, the catheter 9 may straighten and / or the curvature may loosen within the target site 147.

[0237]

[0297] Loop 118 can be collapsed and / or removed from the target site 147 in any order, for example sequentially and / or simultaneously. For example, FIGS. 48e to 48i show that the third loop 118c, the second loop 118b, and the first loop 118a can be sequentially collapsed within the target site 147 and / or removed from the target site 147. FIGS. 48e to 48i show, for example, that when the third loop 118c, the second loop 118b, and the first loop 118a are collapsed (e.g., when they are smaller in size), they can be removed from the target site 147. For example, FIGS. 48e to 48i show that the third loop 118c can be collapsed and removed from the target site 147, then the second loop 118b can be collapsed and removed from the target site 147, and then the first loop 118a can be collapsed and removed from the target site 147. For example, FIGS. 48e to 48i show that after the third loop 118c is collapsed and removed from the target site 147, the second loop 118b can be collapsed and removed from the target site 147, and that after the second loop 118b and the third loop 118c are collapsed and removed from the target site 147, the first loop 118a can be collapsed and removed from the target site 147. FIGS. 48e to 48i show that when removing the catheter 9 from the target site 147, starting from the most proximal loop (e.g., loop 118c) and ending with the most distal loop (e.g., loop 118a), the loops 118 can be collapsed independently of each other. FIGS. 48e to 48i show that when the third loop 118c is being collapsed and removed from the target site 147, the second loop 118b and the first loop 118a can move (e.g., be pulled) towards the gastroesophageal junction 120. FIGS. 48e to 48i show that when the second loop 118b is being collapsed and removed from the target site 147, the first loop 118a can move (e.g., be pulled) towards the gastroesophageal junction 120.

[0238]

[0298] FIGS. 48e through 48i illustrate, for example, that during a first stage of catheter removal, a section of catheter 9 defining third loop 118c can be removed from target site 147, that during a second stage of catheter removal, a section of catheter 9 defining second loop 118b can be removed from target site 147, and that during a third stage of catheter removal, a section of catheter 9 defining first loop 118a can be removed from target site 147. During the first stage of catheter removal, third loop 118c can collapse within target site 147. During the second stage of catheter removal, second loop 118b can collapse within target site 147. During the third stage of catheter removal, first loop 118a can collapse within target site 147. As another example, third loop 118c, second loop 118b, and / or first loop 118c can be removed from target site 147 without collapsing. The first stage of catheter removal can be before the second stage of catheter removal. The second stage of catheter removal can be after the first stage of catheter removal. The third stage of catheter removal can be after the second stage of catheter removal. While third loop 118c is being removed (e.g., during the first stage of catheter removal), second loop 118b and / or first loop 118a can have a constant size and / or shape. As another example, while third loop 118c is being removed (e.g., during the first stage of catheter removal), the size (e.g., outer perimeter) of second loop 118b and / or first loop 118a can increase and / or decrease, the shape of second loop 118b and / or third loop 118c can change, or any combination thereof can occur. While second loop 118b is being removed (e.g., during the second stage of catheter removal), first loop 118a can have a constant size and / or shape. As another example, while second loop 118b is being removed (e.g., during the second stage of loop formation), the size (e.g., outer perimeter) of first loop 118a can increase and / or decrease, the shape of third loop 118c can change, or any combination thereof can occur.

[0239]

[0299] Figures 48a through 48i show, for example, that configuration 116 formed by catheter 9 during removal can be the same as configuration 116 formed by catheter 9 during insertion. As another example, configuration 116 formed by catheter 9 during removal of catheter 9 from the body may be different from configuration 116 formed by catheter 9 during insertion of catheter 9 into the body.

[0240]

[0300] Figures 49a through 49i show that catheter 9 can be inserted into stomach 2 and / or duodenum 37 and / or removed from stomach 2 and / or duodenum 37. Figures 49a through 49i show, for example, that target site 147 can be stomach 2 and / or duodenum 37. Figures 49a through 49i show that various lengths of catheter 9 (e.g., length 126 shown in Figures 49b through 49h) can be introduced into stomach 2 and / or duodenum 37 and / or removed from stomach 2 and / or duodenum 37. Figures 49a through 49i show various configurations 116 and shapes 117 that catheter 9 can have. Figures 49a through 49i show, for example, that when catheter 9 has configurations 116a through 116i from the first to the ninth, catheter 9 can have shapes 117a through 117i from the first to the ninth, respectively.

[0241]

[0301] The catheter tip 7 and / or the elongate portion 97 can be moved so as to contact and / or not contact the stomach 2, duodenum 37, and / or other organs. For example, FIGS. 49a through 49i show that the elongate portion 97 can be moved so as to contact and not contact the stomach 2. For example, FIGS. 49a through 49b show that the elongate portion 97 can be moved so as to contact the stomach 2 during insertion, and FIGS. 49h through 49i show that the elongate portion 97 can be moved so as not to contact the stomach 2 during removal. FIGS. 49a through 49b show, for example, that the elongate portion 97 can be moved so as to contact the stomach 2 by advancing the catheter 9 into the stomach 2 as indicated by arrow 112, and FIGS. 49h through 49i show, for example, that the elongate portion 97 can be moved so as not to contact the stomach 2 by removing the catheter 9 from the stomach 2 as indicated by arrow 114. When the catheter 9 is in the deployed configuration (e.g., configuration 116), the elongate portion 97 may or may not contact the wall of the stomach 2. For example, FIGS. 49b through 49h show that the elongate portion 97 can contact the stomach wall 108 when the catheter 9 is in the deployed configuration (e.g., configurations 116b through 116h).

[0242]

[0302] The catheter tip 7 and / or the elongate portion 97 can be permanently and / or temporarily engaged with the wall of the stomach 2, the duodenum 37, and / or another organ. The stomach wall 108 can include a natural-occurring structure within the stomach 2, such as, for example, one gastric mucosal fold, a plurality of gastric mucosal folds, an ulcer, or any combination thereof. FIGS. 49b through 49h illustrate that the elongate portion 97 can be permanently and / or temporarily engaged with the stomach wall 108, such as, for example, one gastric mucosal fold, a plurality of gastric mucosal folds, an ulcer, or any combination thereof. When the catheter 9 is within the stomach 2, the elongate portion 97 can, for example, releasably secure and / or releasably engage the distal end of the catheter 9 (e.g., the catheter tip 7) to the stomach wall 108. The catheter 9 can, for example, releasably secure and / or releasably engage to the stomach wall 108 via the elongate portion 97 by friction between the elongate portion 97 and the stomach wall 108, by inserting the elongate portion 97 between two gastric mucosal folds (e.g., between two adjacent gastric mucosal folds), or any combination thereof. For example, by removing the catheter 9 from the stomach 2 as indicated by arrow 114, the catheter 9 can be disengaged and / or disassociated from the stomach wall 108 by moving (e.g., pulling) the elongate portion 97 away from the stomach wall 108.

[0243]

[0303] FIGS. 49a through 49b show that when the catheter 9 is inserted into the stomach 2, the elongate portion 97 can engage with the gastric wall 108 (e.g., can be moved to contact the gastric wall 108). Once the elongate portion 97 engages with the gastric wall 108, while the catheter 9 is advancing into the stomach 2, while the catheter 9 is being withdrawn from the stomach 2, and / or while the catheter 9 is migrating within the stomach 2 and / or the duodenum 37, the elongate portion 97 can maintain its engagement with the gastric wall 108 (e.g., can maintain contact with the gastric wall 108), can be disengaged from the gastric wall 108 (e.g., can be moved to no longer contact the gastric wall 108), can re-engage with the gastric wall 108, or can be any combination thereof. FIGS. 49d through 49e show that the catheter 9 can migrate within the stomach 2 and / or the duodenum 37 due to natural gastric motility and / or peristalsis of the stomach 2. FIGS. 49a through 49e show that the movement and / or deployment of the catheter 9 can include the insertion of the catheter 9 into the stomach 2 and / or the duodenum 37, the migration of the catheter 9 within the stomach 2 and / or the duodenum 37, the withdrawal of the catheter 9 from the stomach 2 and / or the duodenum 37, or any combination thereof. For example, during insertion, withdrawal, and / or migration of the catheter 9, when the catheter 9 moves within the stomach 2 and / or the duodenum 37, the elongate portion 97 may move relative to the gastric wall 108 and / or remain in a fixed position. While advancing the catheter 9 into the stomach 2, while pushing and / or migrating the catheter 9 into the duodenum 37, while withdrawing the catheter 9 from the stomach 2, while withdrawing the catheter 9 from the duodenum 37, or during any combination thereof, the elongate portion 97 may, for example, move relative to the gastric wall 108 and / or remain in a fixed position. For example, FIGS. 49b through 49h show that while advancing the catheter 9 into the stomach 2, while the catheter 9 migrates into the duodenum 37, while withdrawing the catheter 9 from the stomach 2, and while withdrawing the catheter 9 from the duodenum 37, the elongate portion 97 may remain in a fixed position relative to the gastric wall 108.

[0244]

[0304] While advancing the catheter 9 into the stomach 2, while pushing and / or shifting the catheter 9 into the duodenum 37, while removing the catheter 9 from the stomach 2, while removing the catheter 9 from the duodenum 37, or during any combination thereof, the elongate portion 97 can move away from the engagement position (e.g., the engagement position shown in FIG. 49b) by 0.00 to 5.0 cm or more in any direction along the stomach wall 108, in any direction away from the stomach wall 108 (e.g., in a direction away perpendicularly), in any direction approaching the stomach wall 108 (e.g., in a direction approaching perpendicularly), or any combination thereof. This value can increase by 0.1 cm within this range (e.g., 0.0 cm, 0.1 cm, 1.0 cm, 2.0 cm, 3.0 cm, 5.0 cm). A 0.0 cm movement of the elongate portion 97 can correspond to the elongate portion 97 remaining stationary relative to the stomach wall 108. For example, FIGS. 49b through 49h show that the elongate portion 97 can remain stationary relative to the stomach wall 108 (e.g., a 0.00 cm movement) while advancing the catheter 9 into the stomach 2, while pushing and / or shifting the catheter 9 into the duodenum 37, while removing the catheter 9 from the stomach 2, while removing the catheter 9 from the duodenum 37, or during any combination thereof. FIGS. 49h through 49i show that the catheter 9 can be disengaged from the stomach wall 108 (e.g., can be moved so as not to contact the stomach wall 108). FIGS. 49h through 49i show, for example, that the elongate portion 97 can be disengaged from the stomach wall 108 by removing the catheter 9 from the stomach 2. Removing the catheter 9 from the stomach 2 can include, for example, pulling the elongate portion 97 toward the gastroesophageal junction 120 from the stomach wall 108.

[0245]

[0305] Once the elongate portion 97 and / or the catheter tip 7 contacts the stomach wall 108, the elongate portion 97 and / or the catheter tip 7 may or may not pivot on the stomach wall 108. For example, FIGS. 49b through 49h show that when the elongate portion 97 is in contact with the stomach wall 108, the elongate portion 97 and the catheter tip 7 may not pivot on the stomach wall 108. As another example, when the elongate portion 97 is in contact with the stomach wall 108, the catheter tip 7 can pivot on the stomach wall 108.

[0246]

[0306] During the insertion of the catheter 9 into the stomach 2, the elongated portion 97 may or may not be pressed (e.g., pressed) against the stomach wall 108. For example, FIGS. 49a to 49b show that the elongated portion 97 may be pressed against the stomach wall 108 during the insertion of the catheter 9 into the stomach 2. When the elongated portion 97 is pressed against the stomach wall 108 during the insertion of the catheter 9 into the stomach 2, the elongated portion 97 can, for example, suppress and / or prevent the catheter tip 7 from digging a hole into and / or through the stomach wall 108 by, for example, deflecting. For example, FIGS. 49b to 49c show that the elongated portion 97 can be flexible and / or can be a flexible tip that can deform (e.g., bend) when pressed against the stomach wall 108.

[0247]

[0307] FIGS. 49d to 49e show that the catheter 9 can enter into the duodenum 37. The insertion of the catheter 9 into the stomach 2 can cause the catheter 9 to enter into the duodenum 37, and the natural gastric movement and / or peristalsis can urge and / or cause the catheter 9 to enter into the duodenum 37 and / or into the intestine behind the duodenum 37, or any combination thereof may be possible. The catheter 9 can, for example, migrate from the stomach 2 through the pylorus 65 into the duodenum 37 due to the natural movement and / or peristalsis of the stomach 2. For example, FIGS. 49d to 49e show that the insertion of the catheter 9 into the stomach 2 can cause the catheter 9 to enter into the duodenum 37. As another example, FIGS. 49d to 49e show that the natural gastric movement and / or peristalsis can urge and / or cause the catheter 9 to enter into the duodenum 37. As yet another example, FIGS. 49d to 49e show that the insertion of the catheter 9 into the stomach 2 can cause the catheter 9 to enter into the duodenum 37, and that the natural gastric movement and / or peristalsis can urge and / or cause the catheter 9 to enter into the duodenum 37.

[0248]

[0308] Before, during, and / or after flowing (e.g., injecting) a fluid (e.g., fluid 6) through the lumen of the catheter 9, the catheter 9 and / or the catheter tip 7 can enter the duodenum. For example, FIGS. 49d through 49e show that the catheter tip 7 can migrate into the duodenum 37 while injecting (e.g., recirculating) the fluid 6 through the inflow and outflow lumens of the catheter 9.

[0249]

[0309] Before, during, and / or after the catheter tip 7 enters the stomach 2, the catheter 9 can enter the duodenum 37. FIGS. 49a to 49e show that the catheter 9 can enter the duodenum 37 after the catheter tip 7 enters the stomach 2. When the catheter tip 7 is in the stomach 2, esophagus 5, pylorus 65, duodenum 37, and / or outside the body, the catheter 9 can enter the duodenum 37. For example, FIGS. 49a to 49e show that the catheter 9 can enter the duodenum 37 when the catheter tip 7 is in the stomach 2. Before, during, and / or after the elongate portion 97 enters the stomach 2, the catheter 9 can enter the duodenum 37. For example, FIGS. 49a to 49e show that the catheter 9 can enter the duodenum 37 after the elongate portion 97 enters the stomach 2. When the elongate portion 97 is in the stomach 2, esophagus 5, pylorus 65, duodenum 37, and / or outside the body, the catheter 9 can enter the duodenum 37. For example, FIGS. 49a to 49e show that the catheter 9 can enter the duodenum 37 when the elongate portion 97 is in the stomach 2. Before, during, and / or after the catheter tip 7 and / or the elongate portion 97 engages the gastric wall 108, the catheter 9 can enter the duodenum 37. For example, FIGS. 49a to 49e show that the catheter 9 can enter the duodenum 37 after the elongate portion 97 is pushed to engage (e.g., contact) the gastric wall 108. While the catheter tip 7 and / or the elongate portion 97 is engaged with the gastric wall 108 (e.g., when the catheter tip 7 and / or the elongate portion 97 is in contact with the gastric wall 108), and / or while the catheter tip 7 and / or the elongate portion 97 is disengaged from the gastric wall 108 (e.g., when the catheter tip 7 and / or the elongate portion 97 is not in contact with the gastric wall 108), the catheter 9 can enter the duodenum 37. For example, FIGS. 49a to 49e show that the catheter 9 can enter the duodenum 37 while the elongate portion 97 is engaged with (e.g., in contact with) the gastric wall 108. During the insertion and / or migration of the catheter 9, the catheter tip 7 may or may not remain in the stomach 2. For example, FIGS. 49a to 49e show that the catheter tip 7 may remain in the stomach 2 during the insertion and / or migration of the catheter 9.

[0250]

[0310] When at least 10 cm to 150 cm or more of the catheter 9 is in the stomach 2, the catheter 9 can enter into the duodenum 37. This value can increase by 1 cm within this range (for example, at least 10 cm, at least 30 cm, at least 40 cm, at least 70 cm, at least 100 cm). For example, FIGS. 49a to 49e show that the catheter 9 can enter into the duodenum 37 when at least 30 cm of the catheter 9 is in the stomach 2.

[0251]

[0311] FIGS. 49e to 49f show that the catheter 9 can be removed from the duodenum 37, for example, by removing (for example, pulling) the catheter 9 from the stomach 2 as indicated by the arrow 114.

[0252]

[0312] Before, during, and / or after removing the catheter tip 7 from the stomach 2, the catheter 9 can be removed from the duodenum 37. For example, FIGS. 49e through 49i show that the catheter 9 can be removed from the duodenum 37 before removing the catheter tip 7 from the stomach 2. When the catheter tip 7 is within the stomach 2, within the esophagus 5, within the pylorus 65, within the duodenum 37, and / or outside the body, the catheter 9 can be removed from the duodenum 37. For example, FIGS. 49e through 49i show that the catheter 9 can be removed from the duodenum 37 when the catheter tip 7 is within the stomach 2. Before, during, and / or after removing the elongate portion 97 from the stomach 2, the catheter 9 can be removed from the duodenum 37. For example, FIGS. 49e through 49i show that the catheter 9 can be removed from the duodenum 37 before removing the elongate portion 97 from the stomach 2. When the elongate portion 97 is within the stomach 2, within the esophagus 5, within the pylorus 65, within the duodenum 37, and / or outside the body, the catheter 9 can be removed from the duodenum 37. For example, FIGS. 49e through 49i show that the catheter 9 can be removed from the duodenum 37 when the elongate portion 97 is within the stomach 2. Before, during, and / or after the elongate portion 97 engages the gastric wall 108, the catheter 9 can be removed from the duodenum 37. For example, FIGS. 49e through 49i show that the catheter 9 can be removed from the duodenum 37 after the elongate portion 97 has been pushed (e.g., contacted) into engagement with the gastric wall 108. During the time when the catheter tip 7 and / or the elongate portion 97 is engaged with the gastric wall 108 (e.g., when the catheter tip 7 and / or the elongate portion 97 is in contact with the gastric wall 108), and / or during the time when the catheter tip 7 and / or the elongate portion 97 is disengaged from the gastric wall 108 (e.g., when the catheter tip 7 and / or the elongate portion 97 is not in contact with the gastric wall 108), the catheter 9 can be removed from the duodenum 37. For example, FIGS. 49e through 49i show that the catheter 9 can be removed from the duodenum 37 while the elongate portion 97 is engaged with (e.g., in contact with) the gastric wall 108.

[0253]

[0313] When at least 10 cm to 150 cm or more of the catheter 9 is within the stomach 2, the catheter 9 can be removed from the duodenum 37. This value can increase by 1 cm within this range (for example, at least 10 cm, at least 30 cm, at least 40 cm, at least 70 cm, at least 100 cm). For example, FIGS. 49e to 49i show that the catheter 9 can be removed from the duodenum 37 when at least 30 cm of the catheter 9 is within the stomach 2.

[0254]

[0314] When the catheter 9 is within the duodenum 37, the catheter tip 7 can be within the stomach 2 and / or the duodenum 37. For example, FIG. 49e shows that when the catheter 9 is within the duodenum 37, the catheter tip 7 can be within the stomach 2.

[0255]

[0315] When the catheter 9 is within the duodenum 37, the elongated portion 97 can be within the stomach 2 and / or the duodenum 37. For example, FIG. 49e shows that when the catheter 9 is within the duodenum 37, the elongated portion 97 can be within the stomach 2.

[0256]

[0316] When the catheter 9 is in the deployed configuration, the catheter 9 may or may not be within the stomach 2 and / or the duodenum 37. For example, FIGS. 49b to 49d and FIGS. 49f to 49h show that the catheter 9 can be within the stomach 2 in the deployed configuration (for example, configurations 116b to 116d and 116f to 116h), and FIG. 49e shows that the catheter 9 can be within the stomach 2 and the duodenum 37 when the catheter is in the deployed configuration (for example, configuration 116e).

[0257]

[0317] FIGS. 49b to 49h show that the catheter 9 can form a deployed configuration by inserting the catheter 9 into the stomach 2, by inserting the catheter 9 into the duodenum 37, by the natural gastric motility and / or peristalsis causing the catheter 9 to migrate from the stomach 2 through the pylorus 65 into the duodenum 37, by removing the catheter 9 from the stomach 2, by removing the catheter 9 from the duodenum 37, or by any combination thereof.

[0258]

[0318] When the catheter 9 is in the deployed configuration (e.g., configuration 116), zero, one, or more sections of the catheter 9 can be within the stomach 2 and zero, one, or more sections of the catheter 9 can be within the duodenum 37. For example, FIG. 49e shows that when the catheter 9 is in the deployed configuration (e.g., configuration 116e), the first section of the catheter 9 (e.g., sections e1 - e2) is within the stomach 2, the second section of the catheter 9 (e.g., sections e2 - e3) is within the duodenum 37, and the third section of the catheter 9 (e.g., sections e3 - e4) can be within the stomach 2. By advancing the second section of the catheter 9 into the duodenum 37 (e.g., by inserting the catheter 9 into the stomach 2), by promoting and / or advancing the second section of the catheter 9 into the duodenum 37 by natural stomach movement and / or peristalsis, or by any combination thereof, the second section of the catheter 9 can enter the duodenum 37. For example, FIGS. 49d to 49e show that by promoting and / or advancing the second section of the catheter 9 into the duodenum 37 through the pylorus 65 by natural stomach movement and / or peristalsis, the second section of the catheter 9 can enter the duodenum 37. FIG. 49e shows that the second section of the catheter 9 can be between the first and second sections of the catheter 9 along the length of the catheter 9. FIG. 49e shows, for example, that when the catheter 9 is in a straight configuration, the first section of the catheter 9 can be distal to the second and third sections of the catheter 9, and the second section of the catheter 9 can be distal to the first section of the catheter 9. FIG. 49e shows that when the catheter 9 is in configuration 116e, the first section of the catheter 9 is closer to the pancreas 1 than the third section of the catheter 9, the third section of the catheter 9 is closer to the gastroesophageal junction 120 than the first section of the catheter 9, and vice versa can also be true.

[0259]

[0319] FIG. 49e shows that a loop 118 (e.g., the first loop 118a) can be formed by sections e1 to e4 of the catheter 9. FIG. 49e shows, for example, that the first loop 118a can be in the stomach 2 and the duodenum 37. For example, FIG. 49e shows that the loop head can be in the duodenum 37 and the loop base can be in the stomach 2. FIG. 49e shows that the cell 122 (e.g., the first cell 122a) can be in the stomach 2 and the duodenum 37. The lengths of sections e1 to e4 of the catheter 9 can be, for example, the length 126. FIG. 49e shows that the length 126 can be, for example, 50 cm to 120 cm (e.g., 80 cm). FIGS. 49d to 49e show that the size (e.g., outer circumference) of the first loop 118a is likely to be larger when the catheter 9 is in the fifth configuration 116e than when the catheter 9 is in the fourth configuration 116d. FIG. 49e shows that there can be a first gap between sections e1 to e2 and sections e3 to e4 in the stomach 2, a second gap between the first end (e.g., the end near point e2) and the second end (e.g., the end near point e3) of the second section e2 to e3 in the duodenum 37, and that the second gap can be less than the first gap. The second gap can be, for example, at least 1 cm to 10 cm smaller than the first gap, and this value can increase by 1 cm within this range (e.g., at least 1 cm, at least 5 cm, at least 10 cm). For example, FIG. 49e shows that the second gap can be at least 4 cm smaller than the first gap. FIGS. 49d to 49e show that the central portion of the catheter 9 between points e1 and e4 can enter the duodenum 37 while the catheter tip 7 and / or the elongate portion 97 are in the stomach 2.

[0260]

[0320] In FIG. 49e, reference points e1 to e4 are provided to assist in identifying the first, second, and third sections of the catheter 9. The first, second, and third sections of the catheter 9 (e.g., sections e1 to e2, e2 to e3, and e3 to e4) may be integral with each other and / or attached to each other. For example, FIG. 49e shows that section e1 to e2 may be integral with section e2 to e3, section e2 to e3 may be integral with section e3 to e4, and section e3 to e4 may be integral with the portion of the catheter 9 within the esophagus 5. For example, FIG. 49e shows that the first, second, and third sections of the catheter 9 may be a single length section of the catheter 9 (e.g., a section of the entire length 124 of the catheter 9). The reference point e1 may indicate, for example, the distal end of the catheter 9, the distal end of the elongate portion 97, the distal end of the heat transfer region 128, or any combination thereof. The reference point e2 may indicate, for example, the first position where the catheter 9 passes through the pylorus 65. The reference point e3 may indicate, for example, the second position where the catheter 9 passes through the pylorus 65. The reference point e4 may indicate, for example, the position where the catheter 9 enters the target site 147 (e.g., the stomach 2).

[0261]

[0321] The catheter 9 can pass through the pylorus 65, for example, 0 to 10 times or more, and this number can increase by 1 within this range (e.g., 0 times, 1 time, 2 times, 3 times, 4 times, 10 times). For example, FIGS. 49b to 49d and FIGS. 49f to 49h show that when the catheter 9 is within the stomach 2, the catheter 9 can pass through the pylorus 65 zero times. As another example, FIG. 49e shows that when the catheter 9 is within the stomach 2, the catheter 9 can pass through the pylorus 65 twice (e.g., at the first and second positions respectively indicated by the reference points e2 and e3). For example, FIG. 49e shows that two different sections of the catheter 9 can pass through the pylorus 65 simultaneously.

[0262]

[0322] When the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the stomach 2 can be, for example, at least 20 cm to 300 cm, and this value can increase by 1 cm within this range (for example, at least 30 cm, at least 40 cm, at least 50 cm, at least 60 cm, at least 70 cm, at least 80 cm, at least 90 cm, at least 100 cm). For example, Fig. 49e shows that when the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the stomach 2 can be at least 50 cm. When the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the stomach 2 can be, for example, 20 cm to 300 cm or more, and this value can increase by 1 cm within this range (for example, 20 cm, 50 cm, 100 cm, 150 cm, 300 cm). For example, Fig. 49e shows that when the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the stomach 2 can be 55 cm. Fig. 49e shows that the length 126 of the catheter 9 in the stomach 2 can be, for example, the lengths of sections e1 - e2 and e3 - e4.

[0263]

[0323] When the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the duodenum 37 can be, for example, at least 1 cm to 80 cm, and this value can increase by 1 cm within this range (for example, at least 1 cm, at least 5 cm, at least 10 cm, at least 20 cm, at least 30 cm, at least 40 cm, at least 60 cm, at least 80 cm). For example, Fig. 49e shows that when the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the duodenum 37 can be at least 20 cm. When the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the duodenum 37 is, for example, 1 cm to 80 cm or more, and this value can increase by 1 cm within this range (for example, 1 cm, 10 cm, 30 cm, 50 cm, 80 cm). For example, Fig. 49e shows that when the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the duodenum 37 can be 25 cm. Fig. 49e shows that the length 126 of the catheter 9 in the duodenum 37 can be, for example, the length of section e2 - e3.

[0264]

[0324] When the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the stomach 2 can be, for example, 40 cm to 300 cm longer than the length 126 of the catheter 9 in the duodenum 37. This value can increase by 1 cm within this range (for example, 40 cm, 50 cm, 60 cm, 100 cm, 200 cm, 300 cm).

[0265]

[0325] FIGS. 49a to 49i show that the catheter 9 can extend multiple times within the target site 147. For example, the first time it extends from the stomach to the duodenum 37 from proximal to distal, and the second time it extends from the duodenum 37 to the stomach 2 from distal to proximal.

[0266]

[0326] FIG. 49e shows that when the catheter 9 is in the deployed configuration, the catheter 9 can have undulations along its length. FIG. 49e shows that the undulations can be, for example, bends of the catheter 9. The undulations can have, for example, a sine wave pattern, a meandering pattern, a zigzag pattern, or any combination thereof. FIGS. 49e to 49f show that when the catheter 9 is removed from the body, the undulations can become straight.

[0267]

[0327] FIGS. 49e to 49f show that when the total length of the catheter 9 in the duodenum 37 decreases, the total length of the catheter 9 in the stomach 2 can simultaneously decrease.

[0268]

[0328] FIGS. 49a to 49e show, for example, that the target site 147 can be the stomach 2 and that the catheter 9 can enter the duodenum 37. As another example, FIGS. 49a to 49e show, for example, that the target site 147 can be the stomach 2 and the duodenum 37.

[0269]

[0329] When the catheter 9 is within the stomach 2, within the duodenum 37, and / or within the intestine behind the duodenum 37, the catheter 9 can transfer heat to and / or from the surrounding tissue. For example, FIGS. 49b through 49d and FIGS. 49f through 49h show that the catheter 9 can transfer heat to and / or from the stomach 2, and FIG. 49e shows that the catheter 9 can transfer heat to and / or from the stomach 2 and / or the duodenum 37.

[0270]

[0330] FIGS. 49a through 49i show that the catheter 9 can have an elongate portion 97. The elongate portion 97 can be attached to and / or integrated with the catheter tip 7. For example, FIGS. 49a through 49i show that the elongate portion 97 can be the distal end of the catheter tip 7.

[0271]

[0331] FIGS. 49a through 49i show, for example, that the configuration 116 formed by the catheter 9 during removal can be the same as the configuration 116 formed by the catheter 9 during insertion. As another example, the configuration 116 formed by the catheter 9 during removal of the catheter 9 from the body can be different from the configuration 116 formed by the catheter 9 during insertion of the catheter 9 into the body.

[0272]

[0332] Figures 50a through 50i show that the catheter 9 can be inserted into the stomach 2 and / or the duodenum 37 and / or removed from the stomach 2 and / or the duodenum 37. Figures 50a through 50i show, for example, that the target site 147 can be the stomach 2 and the duodenum 37. Figures 50a through 50i show that various lengths of the catheter 9 (such as the length 126 shown in Figures 50b through 50h) can be introduced into the stomach 2 and / or the duodenum 37 and / or removed from the stomach 2 and / or the duodenum 37. Figures 50a through 50i show the various configurations 116 and shapes 117 that the catheter 9 can have. Figures 50a through 50i show, for example, that when the catheter 9 has the first through ninth configurations 116a - 116i, the catheter 9 can have the first through ninth shapes 117a - 117i, respectively.

[0273]

[0333] Figures 50a through 50i show that the catheter tip 7 can be moved so as to contact and not contact the duodenum 37. For example, Figures 50a through 50b show that the catheter tip 7 can be moved so as to contact the duodenum 37 during insertion, and Figures 50h through 50i show that the catheter tip 7 can be moved so as not to contact the duodenum 37 during removal. Figures 50a through 50b show, for example, that the catheter tip 7 can be moved so as to contact the duodenum 37 by advancing the catheter 9 within the stomach 2 as indicated by the arrow 112, and Figures 50h through 50i show, for example, that the catheter tip 7 can be moved so as not to contact the duodenum 37 by removing the catheter 9 from the stomach 2 as indicated by the arrow 114. When the catheter 9 is in the deployed configuration (such as configuration 116), the catheter tip 7 may or may not contact the wall 136 of the duodenum 37 (also referred to as the duodenal wall 136). For example, Figures 50b through 50h show that when the catheter 9 is in the deployed configuration (such as configurations 116b - 116h), the elongate portion 97 can contact the duodenal wall 136.

[0274]

[0334] The duodenal wall 136 may include a natural occurring mechanism within the duodenum 37 that includes, for example, one duodenal fold (also referred to as a Kerkring fold). FIGS. 50b through 50h show that the catheter tip 7 may be permanently and / or temporarily engaged with the duodenal wall 136, such as a duodenal fold. When the catheter 9 is within the duodenum 37, the catheter tip 7 can, for example, releasably fix and / or releasably engage the distal end of the catheter 9 to the duodenal wall 136. The catheter 9 can, for example, releasably fix and / or releasably engage to the duodenal wall 136 through the catheter tip 7 by friction between the catheter tip 7 and the duodenal wall 136, the catheter tip 7 being sandwiched between two duodenal folds (e.g., between two adjacent duodenal folds), or any combination thereof. For example, by removing the catheter 9 from the duodenum 37 as indicated by the arrow 114, and moving (e.g., pulling) the catheter tip 7 away from the duodenal wall 136, the catheter 9 can be unfixed and / or disengaged from the duodenal wall 136.

[0275]

[0335] FIGS. 50a through 50b show that when the catheter 9 is inserted into the duodenum 37, the catheter tip 7 can be engaged with the duodenal wall 136 (e.g., can be moved to contact the duodenal wall 136). Once the catheter tip 7 is engaged with the duodenal wall 136, while the catheter 9 is advancing into the stomach 2, while the catheter 9 is being removed from the stomach 2, while the catheter 9 is being inserted into the duodenum 37, while the catheter 9 is being removed from the duodenum 37, while the catheter 9 is migrating within the stomach 2 and / or the duodenum 37, or during any combination thereof, the catheter tip 7 can maintain the engaged state with the duodenal wall 136 (e.g., can maintain the contact state with the duodenal wall 136), can be disengaged from the duodenal wall 136 (e.g., can be moved to no longer contact the duodenal wall 136), can re-engage with the duodenal wall 136, or can be any combination thereof. For example, during insertion, removal, and / or migration of the catheter 9, when the catheter 9 moves within the stomach 2 and / or the duodenum 37, the catheter tip 7 may move relative to the duodenal wall 136 and / or remain in a fixed position. While advancing the catheter 9 into the stomach 2, while pushing and / or migrating the catheter 9 into the duodenum 37, while removing the catheter 9 from the stomach 2, while removing the catheter 9 from the duodenum 37, or during any combination thereof, the catheter tip 7 may, for example, move relative to the duodenal wall 136 and / or remain in a fixed position. For example, FIGS. 50b through 50h show that while advancing the catheter 9 into the stomach 2, while inserting the catheter 9 into the duodenum 37, while removing the catheter 9 from the stomach 2, and while removing the catheter 9 from the duodenum 37, the catheter tip 7 may remain in a fixed position relative to the duodenal wall 136.

[0276]

[0336] While advancing the catheter 9 into the stomach 2, while pushing and / or migrating the catheter 9 into the duodenum 37, while removing the catheter 9 from the stomach 2, while removing the catheter 9 from the duodenum 37, or during any combination thereof, the catheter tip 7 can move away from 0.00 to 5.0 cm or more from an engagement position (e.g., the engagement position shown in FIG. 50b) in any direction along the duodenal wall 136, in any direction away from the duodenal wall 136 (e.g., in a direction away vertically), in any direction approaching the duodenal wall 136 (e.g., in a direction approaching vertically), or in any combination thereof. This value can increase by 0.1 cm within this range (e.g., 0.0 cm, 0.1 cm, 1.0 cm, 2.0 cm, 3.0 cm, 5.0 cm). A 0.0 cm movement of the catheter tip 7 can correspond to the catheter tip 7 remaining stationary relative to the duodenal wall 136. For example, FIGS. 50b to 50h show that the catheter tip 7 can maintain the same position relative to the duodenal wall 136 (e.g., a 0.0 cm movement) while advancing the catheter 9 into the stomach 2, while pushing and / or migrating the catheter 9 into the duodenum 37, while removing the catheter 9 from the stomach 2, while removing the catheter 9 from the duodenum 37, or during any combination thereof. FIGS. 50h to 50i show that the catheter 9 can be disengaged from the duodenal wall 136 (e.g., can be moved so as not to contact the duodenal wall 136). FIGS. 50h to 50i show, for example, that the catheter tip 7 can be disengaged from the duodenal wall 136 by removing the catheter 9 from the stomach 2. Removing the catheter 9 from the stomach 2 can include, for example, pulling the catheter tip 7 from the duodenal wall 136 towards the gastroesophageal junction 120.

[0277]

[0337] Once the elongated portion 97 and / or the catheter tip 7 contacts the duodenal wall 136, the elongated portion 97 and / or the catheter tip 7 may or may not pivot on the duodenal wall 136. For example, FIGS. 50b to 50c show that when the catheter tip 7 contacts the duodenal wall 136 during insertion, the catheter tip 7 can pivot on the duodenal wall 136, and FIGS. 50g to 50h show that when the catheter tip 7 contacts the duodenal wall 136 during removal, the catheter tip 7 can pivot on the duodenal wall 136.

[0278]

[0338] During the insertion of the catheter 9 into the stomach 2, the catheter tip 7 may or may not be pressed (e.g., pushed) against the duodenal wall 136. For example, FIGS. 50a to 50b show that the catheter tip 7 may be pressed into the duodenal wall 136 during the insertion of the catheter 9 into the stomach 2. When the catheter tip 7 is pressed against the duodenal wall 136 during the insertion into the stomach 2, as shown in FIGS. 50b to 50c, for example, by the catheter 9 bending and / or the catheter tip 7 pivoting on the duodenal wall 136, it is possible to suppress and / or prevent the catheter tip 7 from digging a hole into and / or through the duodenal wall 136. For example, FIGS. 50b to 50c show that the catheter tip 7 can be flexible and / or can be a flexible tip that can deform (e.g., bend) when pressed against the duodenal wall 136.

[0279]

[0339] FIGS. 50a to 50e show that the catheter tip 7 and the catheter 9 can be inserted into the duodenum 37. For example, FIGS. 50a to 50e show that when the catheter tip 7 and the catheter 9 are inserted into the stomach 2 as indicated by the arrow 112, it is possible to insert the catheter tip 7 and the catheter 9 into the duodenum 37.

[0280]

[0340] Before, during, and / or after the catheter tip 7 and / or the elongate portion 97 enters the duodenum 37, the catheter 9 can enter the duodenum 37. For example, FIGS. 50a to 50b show that the catheter tip 7 can enter the duodenum 37 before the body of the catheter 9 (e.g., the body of the catheter 9 can be the portion of the catheter 9 proximal to the catheter tip 7). FIGS. 50a to 50e show, for example, that the catheter 9 can enter the duodenum 37 after the catheter tip 7 has entered the duodenum 37. FIGS. 50a to 50e show, for example, that the catheter 9 can enter the duodenum 37 when the catheter tip 7 is within the duodenum 37. Before, during, and / or after the catheter tip 7 and / or the elongate portion 97 engages the duodenal wall 136, the catheter 9 can enter the duodenum 37. For example, FIGS. 50a to 50e show that the catheter 9 can enter the duodenum 37 before pushing the catheter tip 7 against (e.g., into contact with) the duodenal wall 136. During the engagement of the catheter tip 7 and / or the elongate portion 97 with the duodenal wall 136 (e.g., when the catheter tip 7 and / or the elongate portion 97 is in contact with the gastric wall 108), and / or during the disengagement of the catheter tip 7 and / or the elongate portion 97 from the gastric wall 108 (e.g., when the catheter tip 7 and / or the elongate portion 97 is not in contact with the gastric wall 108), the catheter 9 can enter the duodenum 37. For example, FIGS. 50a to 50e show that the catheter 9 can enter the duodenum 37 while the catheter tip 7 is engaged with (e.g., in contact with) the duodenal wall 136. During the insertion and / or translocation of the catheter 9, the catheter tip 7 may or may not remain within the duodenum 37. For example, FIGS. 50a to 50e show that the catheter tip 7 may remain within the duodenum 37 during the insertion and / or translocation of the catheter 9.

[0281]

[0341] When any length of the catheter 9 is within the stomach 2, the catheter tip 7 and / or the elongate portion 97 can enter into the duodenum 37. For example, when at least 10 cm to 150 cm or more of the catheter 9 is within the stomach 2, the catheter tip 7 and / or the elongate portion 97 can enter into the duodenum 37. This value can be increased by 1 cm within this range (e.g., at least 10 cm, at least 30 cm, at least 40 cm, at least 70 cm, at least 100 cm).

[0282]

[0342] Figures 50e to 50i show that, for example, the catheter 9 can be removed from the duodenum 37 by removing (e.g., pulling) the catheter 9 from the stomach 2 as indicated by the arrow 114.

[0283]

[0343] Before, during, and / or after removing the catheter tip 7 and / or the elongate portion 97 from the duodenum 2, the catheter 9 can be removed from the duodenum 37. For example, Figures 50e to 50i show that the catheter 9 can be removed from the duodenum 37 before removing the catheter tip 7 from the stomach 2. Figures 49e to 49i show, for example, that the catheter 9 can be removed from the duodenum 37 when the catheter tip 7 is within the duodenum 37.

[0284]

[0344] Before, during, and / or after the catheter tip 7 and / or the elongate portion 97 engages the duodenal wall 136, the catheter 9 can be removed from the duodenum 37. For example, FIGS. 50e through 50i show that after the catheter tip 7 is pushed (e.g., contacted) to engage the duodenal wall 136, the catheter 9 can be removed from the duodenum 37. While the catheter tip 7 and / or the elongate portion 97 is engaged with the duodenal wall 136 (e.g., while the catheter tip 7 and / or the elongate portion 97 is in contact with the duodenal wall 136), and / or while the catheter tip 7 and / or the elongate portion 97 is disengaged from the duodenal wall 136 (e.g., when the catheter tip 7 and / or the elongate portion 97 is not in contact with the duodenal wall 136), the catheter 9 can be removed from the duodenum 37. For example, FIGS. 50e through 50i show that the catheter 9 can be removed from the duodenum 37 while the catheter tip 7 is engaged with (e.g., in contact with) the duodenal wall 136.

[0285]

[0345] When at least 10 cm to 150 cm or more of the catheter 9 is within the stomach 2, the catheter tip 7 and / or the catheter 9 can be removed from the duodenum 37. This value can increase by 1 cm within this range (e.g., at least 10 cm, at least 30 cm, at least 40 cm, at least 70 cm, at least 100 cm). For example, FIGS. 50e through 50i show that when at least 20 cm of the catheter 9 is within the stomach 2, the catheter tip and / or the catheter 9 can be removed from the duodenum 37.

[0286]

[0346] FIGS. 50b through 50h show that when the catheter 9 is within the duodenum 37, the catheter tip 7 can be within the duodenum 37.

[0287]

[0347] FIGS. 50b through 50h show that when the catheter is in the deployed configuration (e.g., configurations 116b - 116h), the catheter 9 can be within the stomach 2 and the duodenum 37.

[0288]

[0348] FIGS. 50b through 50h show that the catheter 9 can form a deployed configuration by inserting the catheter 9 into the stomach 2, by inserting the catheter 9 into the duodenum 37, by removing the catheter 9 from the stomach 2, by removing the catheter 9 from the duodenum 37, or by any combination thereof.

[0289]

[0349] FIGS. 50b through 50h show that when the catheter 9 is in the stomach 2, the catheter 9 can pass through the pylorus 65 once (e.g., at the reference point x in FIG. 50e).

[0290]

[0350] FIGS. 50b through 50h show that when the catheter 9 is in a deployed configuration (e.g., configurations 116b - 116h), the first section of the catheter 9 (e.g., the portion of the catheter 9 distal to the pylorus 65) can be in the duodenum 37 and the second section of the catheter 9 (e.g., the portion of the catheter proximal to the pylorus 65) can be in the stomach 2. The portion of the catheter 9 distal to the pylorus 65 can be pushed and / or migrated into the duodenum 37. For example, FIGS. 50a through 50e show that by inserting the catheter 9 into the stomach 2, the portion of the catheter 9 distal to the pylorus 65 can be pushed into the duodenum 37.

[0291]

[0351] FIGS. 50a through 50i show that the catheter 9 can form the loops 118 and the cells 122 as shown when inserting and / or removing the catheter 9 into / from the target site 147, for example. FIGS. 50b through 50h show that the loop 118 can be an open loop. FIGS. 50a through 50i show that the target site 147 can be, for example, the stomach 2 and the duodenum 37.

[0292]

[0352] FIGS. 50a through 50b show that the catheter tip 7 can enter the duodenum before the body of the catheter.

[0293]

[0353] FIGS. 50a through 50b show that when the catheter 9 is inserted into the stomach 2 and the duodenum 37, the catheter 9 can form a first loop 118a and a second loop 118b. FIGS. 50a through 50b show that the first loop 118a can be formed within the stomach 2 and the second loop 118b can be formed within the stomach 2 and the duodenum 37. For example, FIG. 50b shows that a first end and a second end of the first loop can be formed within the stomach 2, a first end of the second loop can be formed within the stomach 2, and a second end of the second loop can be formed within the duodenum 37. FIG. 50b shows that the lesser curvature of the stomach 2 can be within the first cell 122a and the pancreatic head 38 and the pylorus 65 can be within the second cell 122b.

[0294]

[0354] Figure 50c shows that a loop 118 (e.g., a third loop 118c) may be present within the duodenum 37. Figures 50b through 50c show that when inserting the catheter 9 into the stomach 2 and the duodenum 37, the catheter 9 may form the third loop 118c. Figures 50b through 50c show that the third loop 118c may be formed within the duodenum 37. Figures 50b through 50c show that when the catheter tip 7 is within the duodenum 37, for example, as indicated by arrow 112, advancing the catheter 9 into the duodenum 37 may form the third loop 118c within the duodenum 37. Figure 50c shows that the first end of the third loop, the second end of the third loop, and the head of the third loop may be within the duodenum 37. Figures 50b through 50c show that when the catheter tip 7 is engaged with the duodenal wall 136 (e.g., Kerkring fold), and the catheter 9 continues to be inserted into the stomach 2 as indicated by arrow 112, for example, when the catheter tip 7 pivots relative to the duodenal wall 136, a section of the catheter 9 proximal to the catheter tip 7 may advance beyond (e.g., distally, backward) the catheter tip 7. Figure 50c shows that the section of the catheter 9 that has advanced beyond the catheter tip 7 may be the third loop 118c. Figure 50c shows that when the catheter 9 is in a deployed configuration (e.g., when the catheter 9 is in the third configuration 116c), the third loop 118c may be distal to the catheter tip 7. Figure 50b shows that before the third loop 118c is formed, the portion of the catheter 9 that defines the third loop 118c of Figure 50c may be proximal to the catheter tip 7. As another example, when the catheter 9 is in a straight configuration, Figure 50c shows that the portion of the catheter 9 that defines the third loop 118c may be proximal to the catheter tip 7. Figure 50c shows that the lesser curvature of the stomach 2 may be within the first cell 122a, and the pancreatic head 38, the Vater ampulla 41, and the pylorus 65 may be within the second cell 122b.

[0295]

[0355] When inserting the catheter 9 into the target site 147, the outer circumference of the loop 118 c...

Claims

1. A device for changing the temperature of an organ, comprising: a tube having a lumen, a first tube portion, and a second tube portion, wherein fluid can flow through the lumen; a tether capable of maintaining the distance between the first tube portion and the second tube portion via the tether; A device comprising the above.

2. A device for changing the temperature of an organ, comprising: a tube having a lumen, a first tube portion, and a second tube portion, wherein fluid can flow through the lumen; a tether; wherein the tube has a first configuration and a second configuration, and the tether is under greater tension when the tube is in the second configuration than when the tube is in the first configuration.

3. A device for changing the temperature of an organ, comprising: a tube having a lumen, a first tube portion, and a second tube portion, wherein fluid can flow through the lumen; a tether capable of changing the distance between the first tube portion and the second tube portion via the tether; A device comprising the above.

4. A device for changing the temperature of an organ, comprising: a tube having a lumen, a first tube portion, and a second tube portion, wherein fluid can flow through the lumen; a tether capable of restricting the movement of the second tube portion away from the first tube portion via the tether; A device comprising the above.

5. A device for changing the temperature of a first organ, comprising: a tube having a lumen, a first tube portion, and a second tube portion, wherein fluid can flow through the lumen, and wherein 50 cm to 150 cm of the tube can be positioned within a second organ adjacent to the first organ.

6. A device for changing the temperature of an organ, comprising: a tube having a lumen, a first tube portion, and a second tube portion, wherein fluid can flow through the lumen, and wherein the tube can be formed in a grid shape.

7. A method for changing the temperature of a first organ, comprising: positioning a tube having a lumen, a first tube portion, and a second tube portion within a second organ; Positioning a tether within the second organ; Maintaining a distance between the first tube portion and the second tube portion via the tether; A method comprising the steps of. **Claim 8** A method for changing the temperature of a first organ, comprising: Positioning a tube having a lumen, a first tube portion, and a second tube portion within a second organ; Positioning a tether within the second organ; Changing the tube from a first configuration to a second configuration or enabling the tube to change from the first configuration to the second configuration, Wherein the tether is under greater tension when the tube is in the second configuration than when the tube is in the first configuration. **Claim 9** A method for changing the temperature of a first organ, comprising: Positioning a tube having a lumen, a first tube portion, and a second tube portion within a second organ; Positioning a tether within the second organ; Changing the distance between the first tube portion and the second tube portion via the tether; A method comprising the steps of. **Claim 10** A method for changing the temperature of a first organ, comprising: Positioning a tube having a lumen, a first tube portion, and a second tube portion within a second organ; Positioning a tether within the second organ; Restricting movement of the second tube portion away from the first tube portion via the tether; A method comprising the steps of. **Claim 11** A method for changing the temperature of a first organ, comprising: Positioning 50 cm to 150 cm of a tube having a lumen, a first tube portion, and a second tube portion within a second organ adjacent to the first organ. **Claim 12** A method for changing the temperature of a first organ, comprising: Positioning a tube having a lumen, a first tube portion, and a second tube portion within a second organ; Forming the tube in a grid pattern within the second organ; A method comprising the steps of. **Claim 13** The device or method according to any one of claims 1 to 12, wherein the tube can be formed in a grid pattern. **Claim 14** The device or method according to any one of claims 1 to 13, wherein when the tether is under tension, the distance between the first tube portion and the second tube portion can be maintained via the tether. **Claim 15** The device or method according to any one of claims 1 to 14, wherein when the tether is in a tensioned state, movement of the second tube portion away from the first tube portion via the tether can be restricted.

16. The device or method according to any one of claims 1 to 15, wherein the tube has a tube distal end, the tether has a tether distal end, and when the tether is in the tensioned state, the tube distal end can move away from the tether distal end by a threshold distance.

17. The device or method according to any one of claims 1 to 16, wherein the tube has a tube distal end, the tether has a tether distal end, and when the tether is in the tensioned state, the distal end of the tube can move away from the tether distal end by a threshold distance.

18. The device or method according to any one of claims 1 to 17, wherein the second tube portion has a proximal end of the second tube portion and a distal end of the second tube portion, the distance between the first tube portion and the second tube portion includes the distance between the first tube portion and the proximal end of the second tube portion, when the tether is in the tensioned state, the distance between the first tube portion and the second tube portion can be maintained via the tether, and when the tether is in the tensioned state, the distal end of the second tube portion can move away from the first tube portion by a threshold distance.

19. The device or method according to any one of claims 1 to 18, wherein the threshold distance is from 1 cm to 50 cm.

20. The device or method according to any one of claims 1 to 19, wherein the threshold distance is from 1 cm to 25 cm.

21. The device or method according to any one of claims 1 to 20, wherein the threshold distance is from 1 cm to 10 cm.

22. The device or method according to any one of claims 1 to 21, wherein the threshold distance is from 1 cm to 5 cm.

23. The device or method according to any one of claims 1 to 22, wherein the threshold distance is measured along the central longitudinal axis of the tube between the tether distal end and the tube distal end.

24. The threshold distance is measured along a straight line between the distal end of the tether and the distal end of the tube, the device or method according to any one of claims 1 to 23.

25. When the distal end of the tube is less than the threshold distance from the distal end of the tube tether, movement of the distal end of the tube away from the distal end of the tether can be allowed, and when the distal end of the tube is at the threshold distance from the distal end of the tether, movement of the distal end of the tube away from the distal end of the tether can be prevented by the tether and / or by the tension of the tube, the device or method according to any one of claims 1 to 24.

26. The tube has a first configuration and a second configuration, and the distal end of the tether is closer to the first part of the tube when the tube is in the second configuration than when the tube is in the first configuration, the device or method according to any one of claims 1 to 25.

27. The second part of the tube is closer to the first part of the tube when the tube is in the second configuration than when the tube is in the first configuration, the device or method according to any one of claims 1 to 26.

28. The tube can move from the first configuration to the second configuration via the tether, the device or method according to any one of claims 1 to 27.

29. When the tube is in the first configuration, the second part of the tube is at a first distance from the first part of the tube, and when the tube is in the second configuration, the second part of the tube is at a second distance from the first part of the tube, and the second distance is shorter than the first distance, the device or method according to any one of claims 1 to 28.

30. The second distance includes the distance between the first part of the tube and the second part of the tube, the device or method according to any one of claims 1 to 29.

31. The tether is subjected to greater tension when the tube is in the second configuration than when the tube is in the first configuration, the device or method according to any one of claims 1 to 30.

32. When the tube is in the second configuration, the tether is in a state of being under tension, the device or method according to any one of claims 1 to 31.

33. The device or method according to any one of claims 1 to 32, wherein when the tube is in the first configuration, the tether is in a non-tensioned state.

34. The device or method according to any one of claims 1 to 33, wherein the tube has a third configuration, the tube is movable from the second configuration to the third configuration, and when the tube is in the third configuration, the distal end of the tube is at the threshold distance from the distal end of the tether.

35. The device or method according to any one of claims 1 to 34, wherein the second portion of the tube includes the distal end of the tube.

36. The device or method according to any one of claims 1 to 35, wherein when the tube is in the first configuration, the second portion of the tube is distal to the first portion of the tube, and when the tube is in the second configuration, the second portion of the tube is distal to the first portion of the tube.

37. The device or method according to any one of claims 1 to 36, wherein the first portion of the tube includes a first port and the second portion of the tube includes a second port.

38. The device or method according to any one of claims 1 to 37, wherein the second port is closer to the first port when the tube is in the second configuration than when the tube is in the first configuration.

39. The device or method according to any one of claims 1 to 38, wherein the second port is farther from the first port when the tube is in the third configuration than when the tube is in the second configuration.

40. The device or method according to any one of claims 1 to 39, wherein the tether is attached to the tube between the first port and the second port.

41. The device or method according to any one of claims 1 to 40, wherein the tether is attached to the second portion of the tube between the first port and the second port.

42. The device or method according to any one of claims 1 to 41, wherein the tether is movable through the first port.

43. The device or method according to any one of claims 1 to 42, wherein when the tube is in the first configuration, the tether is within the first port, and when the tube is in the second configuration, the tether is within the first port.

44. The device or method according to any one of claims 1 to 43, wherein when the tube is in the third configuration, the tether is within the first port.

45. The device or method according to any one of claims 1 to 44, wherein the second port is at the distal end or the distal termination of the tube.

46. The device or method according to any one of claims 1 to 45, wherein a tool can be delivered through the second port.

47. The device or method according to any one of claims 1 to 46, wherein a nutrient can be delivered through the second port.

48. The device or method according to any one of claims 1 to 47, wherein when the tube is in the first configuration, the tether is loose, and when the tube is in the second configuration, the tether is taut.

49. The device or method according to any one of claims 1 to 48, wherein when the tube is in the first configuration, the section of the tether has a bend, and when the tube is in the second configuration, the section of the tether is straight.

50. The device or method according to any one of claims 1 to 49, wherein when the tube is in the first configuration, the tether is under zero tension.

51. The device or method according to any one of claims 1 to 50, wherein when the tube is in the first configuration, the tether has a first tension, and when the tube is in the second configuration, the tether has a second tension, and the second tension is greater than the first tension.

52. The device or method according to any one of claims 1 to 51, wherein the first tension is zero tension.

53. The device or method according to any one of claims 1 to 52, wherein when the tube is in the first configuration, the tether is in a non-tensioned state, and when the tube is in the second configuration, the tether is in a tensioned state.

54. The device or method according to any one of claims 1 to 53, wherein when the tether is in the tensioned state, the movement of the second part of the tube away from the first part of the tube can be prevented by the tether.

55. The device or method according to any one of claims 1 to 54, wherein when the tether is in the tensioned state, the second tube portion can move toward the first tube portion via the tether.

56. The device or method according to any one of claims 1 to 55, wherein when the tether is in the tensioned state, the second tube portion can be pulled toward the first tube portion via the tether.

57. The tube has a port, the tether has a tether distal end, and the tether distal end is farther from the port when the tube is in the second configuration than when the tube is in the first configuration, the device or method according to any one of claims 1 to 56.

58. The device or method according to any one of claims 1 to 57, wherein the port is proximal to the tether distal end when the tube is in the first configuration and when the tube is in the second configuration.

59. The device or method according to any one of claims 1 to 58, wherein the tether is within the port when the tube is in the first configuration and when the tube is in the second configuration.

60. The device or method according to any one of claims 1 to 59, wherein the tether can move from a non-operating position to an operating position.

61. The device or method according to any one of claims 1 to 60, wherein the tether can move from the non-operating position to the operating position via control of a handle of the device.

62. The device or method according to any one of claims 1 to 61, wherein when the tether is in the non-operating position, the distance between the first tube portion and the second tube portion can be reduced by applying tension to the tether.

63. The device or method according to any one of claims 1 to 62, wherein the non-operating position is a non-retracted position of the tether.

64. The device or method according to any one of claims 1 to 63, wherein when the tether is in the operating position, the distance between the first tube portion and the second tube portion can be increased by relaxing the tension of the tether.

65. The device or method according to any one of claims 1 to 64, wherein the operating position is a retracted position of the tether.

66. The tether has a distal end, and the distal end of the tether is closer to the first portion of the tube when the tether is in the actuated position than when the tether is in the non-actuated position, the device or method according to any one of claims 1 to 65.

67. The second portion of the tube is closer to the first portion of the tube when the tether is in the actuated position than when the tether is in the non-actuated position, the device or method according to any one of claims 1 to 66.

68. The tether is under greater tension when the tether is in the actuated position than when the tether is in the non-actuated position, the device or method according to any one of claims 1 to 67.

69. When the tether is in the actuated position, the distance between the first portion of the tube and the second portion of the tube can be maintained via the tether, the device or method according to any one of claims 1 to 68.

70. The tube includes a heat transfer region, the device or method according to any one of claims 1 to 69.

71. A portion of the tube includes a heat transfer region, the device or method according to any one of claims 1 to 70.

72. The heat transfer region has a heat transfer region length, and the ratio of the heat transfer region length to the length of the organ, the first organ, or the second organ includes 1.5 to 20.0, the device or method according to any one of claims 1 to 71.

73. The heat transfer region includes 80% to 100% of the length of the tube that can be positioned adjacent to the organ or the first organ, the device or method according to any one of claims 1 to 72.

74. The heat transfer region has a heat transfer region length including 20 cm to 200 cm of the tube, the device or method according to any one of claims 1 to 73.

75. The heat transfer region has a heat transfer region length of 20 cm to 150 cm, the device or method according to any one of claims 1 to 74.

76. The heat transfer region has a heat transfer region length of 75 cm to 150 cm, the device or method according to any one of claims 1 to 75.

77. The heat transfer region has a heat transfer region length of 50 cm to 150 cm, the device or method according to any one of claims 1 to 76.

78. The device or method according to any one of claims 1 to 77, wherein the heat transfer region has a heat transfer region length of 50 cm to 100 cm.

79. The device or method according to any one of claims 1 to 78, wherein the heat transfer region includes a certain length of the tube.

80. The device or method according to any one of claims 1 to 79, wherein the heat transfer region includes a certain continuous length of the tube.

81. The device or method according to any one of claims 1 to 80, wherein the heat transfer region includes the first part of the tube and the second part of the tube.

82. The device or method according to any one of claims 1 to 81, wherein the heat transfer region includes the second part of the tube.

83. The device or method according to any one of claims 1 to 82, wherein the heat transfer region is distal to the first part of the tube.

84. The device or method according to any one of claims 1 to 83, wherein the tube has a distal end of the tube, and the heat transfer region includes the distal end of the tube.

85. The device or method according to any one of claims 1 to 84, wherein when the tube is in a deployed configuration, the heat transfer region intersects 0 to 15 times.

86. The device or method according to any one of claims 1 to 85, wherein when the tube is in a deployed configuration, the heat transfer region intersects 0 to 10 times.

87. The device or method according to any one of claims 1 to 86, wherein when the tube is in a deployed configuration, the heat transfer region intersects 0 to 5 times.

88. The device or method according to any one of claims 1 to 87, wherein when the tube is in a deployed configuration, a first outer portion of the heat transfer region contacts a second outer portion of the heat transfer region.

89. The device or method according to any one of claims 1 to 88, wherein the first outer portion of the heat transfer region includes a first portion of the outer surface of the tube, and the second outer portion of the heat transfer region includes a second portion of the outer surface of the tube.

90. The device or method according to any one of claims 1 to 89, wherein the first outer portion of the heat transfer region and the second outer portion of the heat transfer region are separated by a distance measured along the length of the tube.

91. The device or method according to any one of claims 1 to 90, wherein when the tube is in a deployed configuration, the heat transfer region has 0 to 15 bends.

92. The device or method according to any one of claims 1 to 91, wherein when the tube is in the deployed configuration, the heat transfer region has from 0 to 10 bends.

93. The device or method according to any one of claims 1 to 92, wherein when the tube is in the deployed configuration, the heat transfer region has from 0 to 5 bends.

94. The device or method according to any one of claims 1 to 93, wherein the heat transfer region has more bends when the tube is in the deployed configuration than when the tube is in the undeployed configuration.

95. The device or method according to any one of claims 1 to 94, wherein the tube can be deployed from a first deployed configuration to a second deployed configuration, and the tube has more bends when it is in the second deployed configuration than when it is in the first deployed configuration.

96. The device or method according to any one of claims 1 to 95, wherein the tube can be deployed from the second deployed configuration to a third deployed configuration, and the tube has more bends when it is in the third deployed configuration than when it is in the second deployed configuration.

97. The device or method according to any one of claims 1 to 96, wherein when the tube is in the first deployed configuration, the tube has 1 bend, when the tube is in the second deployed configuration, the tube has 2 bends, and when the tube is in the third deployed configuration, the tube has 3 bends.

98. The device or method according to any one of claims 1 to 97, wherein when the tube is in the first deployed configuration, the tube has from 1 to 2 bends, when the tube is in the second deployed configuration, the tube has from 3 to 4 bends, and when the tube is in the third deployed configuration, the tube has from 5 to 10 bends.

99. The device or method according to any one of claims 1 to 98, wherein when the tube is in the deployed configuration, the heat transfer region has from 0 to 15 loops.

100. The device or method according to any one of claims 1 to 99, wherein when the tube is in the deployed configuration, the heat transfer region has from 0 to 10 loops.

101. The device or method according to any one of claims 1 to 100, wherein when the tube is in the deployed configuration, the heat transfer region has loops from 0 to 5.

102. The device or method according to any one of claims 1 to 101, wherein the heat transfer region has more loops when the tube is in the deployed configuration than when the tube is in the non-deployed configuration.

103. The device or method according to any one of claims 1 to 102, wherein when the tube is in the deployed configuration, the tube defines a mesh having cells.

104. The device or method according to any one of claims 1 to 103, wherein a mesh having cells can be formed by the tube.

105. The device or method according to any one of claims 1 to 104, wherein when the tube is in the deployed configuration, the tube defines a lattice structure having cells.

106. The device or method according to any one of claims 1 to 105, wherein a lattice structure having cells can be formed by the tube.

107. The device or method according to any one of claims 1 to 106, wherein the tube can be deployed from a first deployed configuration to a second deployed configuration, and the tube has more loops when it is in the second deployed configuration than when it is in the first deployed configuration.

108. The device or method according to any one of claims 1 to 107, wherein the tube can be deployed from the second deployed configuration to a third deployed configuration, and the tube has more loops when it is in the third deployed configuration than when it is in the second deployed configuration.

109. The device or method according to any one of claims 1 to 108, wherein when the tube is in the first deployed configuration, the tube includes 0 loops, when the tube is in the second deployed configuration, the tube includes 1 loop, and when the tube is in the third deployed configuration, the tube includes 2 loops.

110. When the tube is in the deployed first configuration, the tube includes from 0 to 2 loops, when the tube is in the deployed second configuration, the tube includes from 3 to 4 loops, and when the tube is in the deployed third configuration, the tube includes from 5 to 10 loops, the device or method according to any one of claims 1 to 109.

111. The deployed configuration is the second configuration, the device or method according to any one of claims 1 to 110.

112. When the tube is in the undeployed configuration, the heat transfer region is straight, the device or method according to any one of claims 1 to 111.

113. The tether can move along the outside of the tube and along the tube, the device or method according to any one of claims 1 to 112.

114. The tether can move into the tube, the device or method according to any one of claims 1 to 113.

115. The tether is flexible or rigid, the device or method according to any one of claims 1 to 114.

116. The tube can move via the tether, the device or method according to any one of claims 1 to 115.

117. When the tether is in the non-operating position, the first part of the tube and the second part of the tube are separated by a first distance, and when the tether is in the operating position, the first part of the tube and the second part of the tube are at a second distance portion, and the second distance is shorter than the first distance, the device or method according to any one of claims 1 to 116.

118. The first part of the tube can move closer to the second part of the tube via the tether, the device or method according to any one of claims 1 to 117.

119. The first part of the tube can move to contact the second part of the tube via the tether, the device or method according to any one of claims 1 to 118.

120. The tube can change from a first shape to a second shape via the tether, the device or method according to any one of claims 1 to 119.

121. A bend can be formed in the tube via the tether, the device or method according to any one of claims 1 to 120.

122. The device or method according to any one of claims 1 to 121, wherein the tether is attached to the tube. **Claim 123** The device or method according to any one of claims 1 to 122, wherein the tether has a non-operating state and an operating state, and more of the distal end of the tether is outside the tube when the tether is in the non-operating state than when the tether is in the operating state. **Claim 124** The device or method according to any one of claims 1 to 123, wherein the tether has a non-operating state and an operating state, and more of the distal end of the tether is inside the tube when the tether is in the operating state than when the tether is in the non-operating state. **Claim 125** The device or method according to any one of claims 1 to 124, wherein the tether can be retracted through the tube. **Claim 126** The device or method according to any one of claims 1 to 125, wherein the tether has a distal end of the tether, the distal end of the tether is attached to the tube, and the distal end of the tether is closer to the port of the tube when the tether is in the operating state than when the tether is in the non-operating state. **Claim 127** The device or method according to any one of claims 1 to 126, wherein the tether is configured to prevent the formation of knots in the tube. **Claim 128** The device or method according to any one of claims 1 to 127, wherein the tether is configured to limit or prevent the movement of the tube. **Claim 129** The device or method according to any one of claims 1 to 128, wherein the tether is configured to limit or prevent the movement of the tube distal to the distal end of the tether. **Claim 130** The device or method according to any one of claims 1 to 129, wherein the tether is configured to limit or prevent the movement of the portion of the tube distal to the distal end of the tether away from the portion of the tube proximal to the distal end of the tether. **Claim 131** The device or method according to any one of claims 1 to 130, wherein when the tube and the tether are in a first body space, the tether is configured to inhibit or prevent the movement of the tube from the first body space to a second body space. **Claim 132** The device or method according to any one of claims 1 to 131, wherein when the tube and the tether are within a first body space, the tether is configured to restrict movement of the tube from the first body space to a second body space.

133. The device or method according to any one of claims 1 to 132, further comprising an engagement device, the engagement device having the lumen.

134. The device or method according to any one of claims 1 to 133, wherein the engagement device includes a distal end of the tube.

135. The device or method according to any one of claims 1 to 134, wherein the engagement device includes a distal coil within the tube having 1 to 5 turns.

136. The device or method according to any one of claims 1 to 135, wherein the distal coil has a spiral outer shape.

137. The device or method according to any one of claims 1 to 136, wherein the distal coil has a helical outer shape.

138. The device or method according to any one of claims 1 to 137, wherein the engagement device is configured to hold the distal end of the catheter within the duodenum.

139. The device or method according to any one of claims 1 to 138, wherein the tube is insertable into a patient, and when the engagement device is within the patient's duodenum, the tether is within the patient's stomach.

140. The device or method according to any one of claims 1 to 139, wherein the engagement device includes the heat transfer region.

141. The device or method according to any one of claims 1 to 140, wherein the engagement device includes a distal end of the heat transfer region.

142. The device or method according to any one of claims 1 to 141, wherein the engagement device has an engagement length of 2 cm to 10 cm.

143. The device or method according to any one of claims 1 to 142, wherein the engagement device has an engagement length of 2 to 20 cm.

144. The device or method according to any one of claims 1 to 143, wherein the engagement device has an engagement length of 2 cm to 40 cm.

145. The lumen includes a first lumen, the tube has a second lumen, the fluid can flow through the first lumen towards the distal end of the tube, and the fluid can flow through the second lumen towards the proximal end of the tube. The device or method according to any one of claims 1 to 144.

146. The tube includes a catheter. The device or method according to any one of claims 1 to 145.

147. The tether includes a wire or a string. The device or method according to any one of claims 1 to 146.

148. The fluid includes a liquid or a gas. The device or method according to any one of claims 1 to 147.

149. The fluid can flow through the lumen at a temperature higher than 37°C. The device or method according to any one of claims 1 to 148.

150. The fluid can flow through the lumen at a temperature between 37°C and 50°C. The device or method according to any one of claims 1 to 149.

151. The fluid can flow through the lumen at a temperature between 37°C and 45°C. The device or method according to any one of claims 1 to 150.

152. The fluid can flow through the lumen at a temperature between 37°C and 40°C. The device or method according to any one of claims 1 to 151.

153. The fluid can flow through the lumen at a temperature between 37.1°C and 45.0°C. The device or method according to any one of claims 1 to 152.

154. The fluid can flow through the lumen at a temperature lower than 37°C. The device or method according to any one of claims 1 to 153.

155. The fluid can flow through the lumen at a temperature between 2°C and 20°C. The device or method according to any one of claims 1 to 154.

156. The fluid can flow through the lumen at a temperature between 4°C and 20°C. The device or method according to any one of claims 1 to 155.

157. The fluid can flow through the lumen at a temperature between 5°C and 15°C. The device or method according to any one of claims 1 to 156.

158. The fluid can flow through the lumen at a temperature between 5°C and 8°C. The device or method according to any one of claims 1 to 157.

159. The device or method according to any one of claims 1 to 158, wherein the fluid can flow through the lumen at a temperature of 10°C.

160. The device or method according to any one of claims 1 to 159, wherein the fluid can flow through the first lumen at a temperature of 5°C to 8°C, and the fluid can flow through the second lumen at a temperature of 11°C to 13°C.

161. The device or method according to any one of claims 1 to 160, wherein the tube is configured to maintain flexibility under pressure.

162. The device or method according to any one of claims 1 to 161, wherein the tube is configured to limit the maximum volume.

163. The device or method according to any one of claims 1 to 162, wherein the tube is configured to limit the maximum volume.

164. The device or method according to any one of claims 1 to 163, further comprising a balloon.

165. The device or method according to any one of claims 1 to 164, wherein the balloon is elastic or inelastic.

166. The device or method according to any one of claims 1 to 165, wherein the balloon can be inflated by the fluid.

167. The device or method according to any one of claims 1 to 166, wherein the balloon includes bubbles, ridges, ribs, or dots.

168. The device or method according to any one of claims 1 to 167, wherein the balloon includes a first chamber and a second chamber.

169. The device or method according to any one of claims 1 to 168, wherein 50 cm to 150 cm of the tube can be inserted into the stomach.

170. The device or method according to any one of claims 1 to 169, wherein the lumen can expand.

171. The device or method according to any one of claims 1 to 170, further comprising a temperature sensor, a pressure sensor, an enzyme sensor, and / or a motion sensor.

172. The device or method according to any one of claims 1 to 171, further comprising a visualization aid.

173. The device or method according to any one of claims 1 to 172, wherein the visualization aid includes a magnet, a radiopaque marker, and / or an echo source marker.

174. The device or method according to any one of claims 1 to 173, further comprising a bypass lumen to enable precooling of the fluid, to enable the cooler to continue operating without flow through the tube, and / or to avoid low flow alarms.

175. The device or method according to any one of claims 1 to 174, wherein the return height of the fluid can be adjusted to improve the pressure control of the device.

176. The tube has a first section with a first diameter and a second section with a second diameter, the first diameter being smaller than the second diameter to improve comfort when inserted into the nose or mouth, and the second diameter being larger than the first diameter for improved flow or surface area within the organ. The device or method according to any one of claims 1 to 175.

177. The device or method according to any one of claims 1 to 176, wherein the tube is configured to change the temperature of the organ from the stomach and / or duodenum.

178. The device or method according to any one of claims 1 to 177, wherein the first organ includes the pancreas.

179. The lumen includes a first lumen, the tube further includes a second lumen and a third lumen, the first lumen includes an inflow lumen for the fluid, and the second lumen includes an outflow lumen for the fluid. The device or method according to any one of claims 1 to 178.

180. The device or method according to any one of claims 1 to 179, wherein the third lumen includes a working channel.

181. The device or method according to any one of claims 1 to 180, wherein the third lumen includes a suction lumen.

182. The device or method according to any one of claims 1 to 181, wherein a tool can be delivered through the third lumen.

183. The device or method according to any one of claims 1 to 182, wherein a nutrient can be delivered through the third lumen.

184. The device or method according to any one of claims 1 to 183, wherein the first lumen has a smaller diameter than the second lumen.

185. The device or method according to any one of claims 1 to 184, wherein the first lumen and the second lumen have the same diameter.

186. The tube includes a rod-shaped portion, a weighted tip, and / or a coiled tip, and the device or method according to any one of claims 1 to 185.

187. 1 cm to 30 cm of the tube is positioned within a third organ, and the third organ is adjacent to the first organ, and the device or method according to any one of claims 1 to 186.

188. The 1 cm to 30 cm of the tube that can be positioned within the third organ is distal to the 50 cm to 150 cm of the tube that can be positioned within the second organ, and the device or method according to any one of claims 1 to 187.

189. The second organ includes the stomach, and the device or method according to any one of claims 1 to 188.

190. The third organ includes the duodenum, and the device or method according to any one of claims 1 to 189.

191. The first organ includes the pancreas, and the device or method according to any one of claims 1 to 190.

192. The lattice shape includes struts and cells, and the device or method according to any one of claims 1 to 191.

193. The cells include the holes of the lattice shape, and the device or method according to any one of claims 1 to 192.

194. The first part of the tube or the second part of the tube includes the struts, and the device or method according to any one of claims 1 to 193.

195. The section of the tube includes the struts, and the device or method according to any one of claims 1 to 194.

196. The lattice shape includes a first strut and a second strut, and the device or method according to any one of claims 1 to 195.

197. The lattice shape includes a first cell and a second cell, and the device or method according to any one of claims 1 to 196.

198. The first cell includes a first hole of the lattice shape, and the second cell includes a second hole of the lattice shape, and the device or method according to any one of claims 1 to 197.

199. The first part of the tube includes the first strut, and the second part of the tube includes the second strut, and the device or method according to any one of claims 1 to 198.

200. The first part of the tube includes the first strut and the second strut, and the device or method according to any one of claims 1 to 199.

201. The second part of the tube includes the first support and the second support, the device or method according to any one of claims 1 to 200.

202. The first section of the tube includes the first support, the device or method according to any one of claims 1 to 201.

203. The second section of the tube includes the second support, the device or method according to any one of claims 1 to 202.

204. The lattice shape includes a junction, the device or method according to any one of claims 1 to 203.

205. The junction includes the part of the lattice shape where the first support and the second support intersect each other, the device or method according to any one of claims 1 to 204.

206. The junction includes the part of the lattice shape where the first support intersects below or above the second support, the device or method according to any one of claims 1 to 205.

207. The junction includes the part of the lattice shape where the first support contacts the second support, the device or method according to any one of claims 1 to 206.

208. The junction includes a friction point configured to resist the movement of the second support away from the first support, the device or method according to any one of claims 1 to 207.

209. The junction includes a friction point configured to resist the transition of the tube, the device or method according to any one of claims 1 to 208.

210. The first support and the second support are continuous with each other, the device or method according to any one of claims 1 to 209.

211. There is a third support between the first support and the second support, the device or method according to any one of claims 1 to 210.

212. The support includes the length of the tube between two junctions, the device or method according to any one of claims 1 to 211.

213. The first support includes the length of the tube between two junctions, the device or method according to any one of claims 1 to 212.

214. The second support includes the length of the tube between two junctions, the device or method according to any one of claims 1 to 213.

215. The support is straight or has a bend, the device or method according to any one of claims 1 to 214.

216. The device or method according to any one of claims 1 to 215, wherein the first strut is straight or has a bend.

217. The device or method according to any one of claims 1 to 216, wherein the second strut is straight or has a bend.

218. The device or method according to any one of claims 1 to 217, wherein the cell includes an open cell or a closed cell.

219. The device or method according to any one of claims 1 to 218, wherein the first cell includes an open cell or a closed cell.

220. The device or method according to any one of claims 1 to 219, wherein the second cell includes an open cell or a closed cell.

221. The device or method according to any one of claims 1 to 220, wherein the tube has a non-lattice shape and the lattice shape.

222. The device or method according to any one of claims 1 to 221, wherein the tube can be formed from the non-lattice shape to the lattice shape.

223. The device or method according to any one of claims 1 to 222, wherein the tube can change from the non-lattice shape to the lattice shape.

224. The device or method according to any one of claims 1 to 223, wherein the tube can change from the lattice shape to the non-lattice shape.

225. The tube has a tube distal end, and when the tube has the non-lattice shape, the portion of the tube that defines the first strut when the tube has the lattice shape is farther from the tube distal end than the portion of the tube that defines the second strut when the tube has the lattice shape. The device or method according to any one of claims 1 to 224.

226. The device or method according to any one of claims 1 to 225, wherein when the tube has the lattice shape, the first strut is farther from the tube distal end than the second strut.

227. The device or method according to any one of claims 1 to 226, wherein when the tube has the lattice shape, the first strut is closer to the tube distal end than the second strut.

228. The device or method according to any one of claims 1 to 227, wherein when the tube has the lattice shape, the distance between the first support and the second support can be increased or decreased.

229. The device or method according to any one of claims 1 to 228, wherein when the tube has the lattice shape, the first support can move towards and away from the second support.

230. The device or method according to any one of claims 1 to 229, wherein the lattice shape can be formed by 20 cm to 200 cm of the tube.

231. The device or method according to any one of claims 1 to 230, wherein the organ includes a first organ, and the lattice shape can be formed within a second organ.

232. The device or method according to any one of claims 1 to 231, wherein the second organ is the stomach.

233. The device or method according to any one of claims 1 to 232, wherein the non-lattice shape includes a straight configuration or a linear configuration of the tube.

234. The device or method according to any one of claims 1 to 233, wherein the joint portion includes the lattice-shaped portion where the first part of the tube and the second part of the tube intersect each other.

235. The device or method according to any one of claims 1 to 234, wherein the lattice shape can be formed by the tube within the second organ.

236. The device or method according to any one of claims 1 to 235, wherein the lattice shape can be formed by the tube through the tube bending while advancing into the second organ.

237. The device or method according to any one of claims 1 to 236, wherein when the tube has the lattice shape, the tube includes 1 to 50 bends.

238. The device or method according to any one of claims 1 to 237, wherein when the tube has the lattice shape, the tube includes 1 to 30 bends.

239. The device or method according to any one of claims 1 to 238, wherein when the tube has the lattice shape, the tube includes 10 to 50 bends.

240. The device or method according to any one of claims 1 to 239, further comprising a tether, wherein the size of the cell, the first cell, or the second cell can be changed via the tether.

241. The device or method according to any one of claims 1 to 240, further comprising a tether, wherein the shape of the cell, the first cell, or the second cell can be changed via the tether.

242. The device or method according to any one of claims 1 to 241, wherein another fluid can flow through the cell, the first cell, or the second cell.

243. The device or method according to any one of claims 1 to 242, wherein a nutrient can flow through the cell, the first cell, or the second cell.

244. The device or method according to any one of claims 1 to 243, wherein the cell, the first cell, or the second cell is configured to provide a space through which a nutrient passes.

245. The device or method according to any one of claims 1 to 244, wherein when the tube is in the first configuration, the tube has the lattice shape.

246. The device or method according to any one of claims 1 to 245, wherein when the tube is in the second configuration, the tube has the lattice shape.

247. The device or method according to any one of claims 1 to 246, wherein when the tube is in the third configuration, the tube has the lattice shape.

248. The device or method according to any one of claims 1 to 247, wherein when the tube has the lattice shape, the lattice shape includes from 20 cm to 200 cm of the tube.

249. The device or method according to any one of claims 1 to 248, wherein when the tube is in the deployed configuration, the tube has the lattice shape, and the lattice shape is defined by from 20 cm to 200 cm of the tube.

250. The device or method according to any one of claims 1 to 249, wherein the lattice shape includes the heat transfer region.

251. The device or method according to any one of claims 1 to 250, wherein when the tube has the lattice shape, the fluid can flow through the lumen.

252. The device or method according to any one of claims 1 to 251, wherein when the tube is in a fully deployed configuration, the tube has the lattice shape.

253. The device or method according to any one of claims 1 to 252, wherein when the tube is in a fully deployed configuration, the tether is in the operating position and the tube has the lattice shape.

254. The method according to any one of claims 1 to 253, wherein forming the tube in the lattice shape within the second organ includes advancing the tube into the second organ.

255. The method according to any one of claims 1 to 254, wherein forming the tube in the lattice shape within the second organ includes gradually advancing the tube into the second organ.

256. The method according to any one of claims 1 to 255, wherein forming the tube in the lattice shape within the second organ includes bending the tube within the second organ.

257. The method according to any one of claims 1 to 256, further including changing the tube from the lattice shape to a non-lattice shape by retracting the tube from the second organ.

258. The method according to any one of claims 1 to 257, further including changing the tube from the lattice shape to a non-lattice shape by gradually retracting the tube from the second organ.

259. The method according to any one of claims 1 to 258, further including changing the tube from the lattice shape to a non-lattice shape by stretching the tube within the second organ.

260. The method according to any one of claims 1 to 259, further including changing the temperature of the first organ by flowing the fluid through the lumen within the second organ.

261. The method according to any one of claims 1 to 260, further including changing the temperature of the first organ by flowing the fluid through the heat transfer region within the second organ.

262. The method according to any one of claims 1 to 261, further including changing the temperature of the first organ by flowing the fluid through the lumen within the third organ.

263. The method according to any one of claims 1 to 262, further comprising preventing the formation of knots in the tube via the tether.

264. The method according to any one of claims 1 to 263, further comprising preventing the entanglement of the tube via the tether.

265. The method according to any one of claims 1 to 264, further comprising restricting or preventing the migration of the tube from the second organ to the third organ via the tether.

266. Positioning the tube within the second organ according to any one of claims 1 to 265 includes positioning 50 cm to 150 cm of the tube within the second organ.

267. The method according to any one of claims 1 to 265, further comprising positioning the tube within a third organ.

268. The method according to any one of claims 1 to 267, wherein the first organ is the pancreas, the second organ includes the stomach, and the third organ includes the duodenum.

269. Positioning the tube within the third organ according to any one of claims 1 to 268 includes positioning 1 cm to 40 cm of the tube within the third organ.

270. The method according to any one of claims 1 to 269, further comprising adding or removing the tube from the second organ to adjust the cooling power of the tube.

271. The device or method according to any one of claims 1 to 270, wherein 50 cm to 150 cm of the heat transfer region can be positioned within the second organ.

272. The device or method according to any one of claims 1 to 271, wherein 1 cm to 40 cm of the heat transfer region can be positioned within the third organ.

273. The device or method according to any one of claims 1 to 272, wherein the tube has an overall length of 30 cm to 250 cm.

274. The device or method according to any one of claims 1 to 273, wherein when the tube is in a fully deployed configuration, 50 cm to 150 cm of the tube is within the second organ.

275. The device or method according to any one of claims 1 to 274, wherein when the tube is in the fully deployed configuration, 0 cm to 40 cm of the tube is within the third organ.

276. The device or method according to any one of claims 1 to 275, wherein when the tube is in the fully deployed configuration, 50 cm to 150 cm of the heat transfer region is within the second organ.

277. The device or method according to any one of claims 1 to 276, wherein when the tube is in the fully deployed configuration, 0 cm to 40 cm of the heat transfer region is within the third organ.

278. Any combination of claims 1 to 277.

279. Any combination of the features disclosed herein.

280. A system or device having any combination of features in any one or any combination of the drawings.

281. A method having any combination of the steps disclosed herein.

282. A device, product, process, system, kit, component, or use, characterized by comprising one or more of the features disclosed herein.

283. A method of changing the temperature of the digestive tract behind the gastroesophageal junction of the digestive tract via a catheter, comprising: inserting 50 cm to 300 cm of the catheter into the stomach of the digestive tract; adding or removing fluid from the catheter through an inflow port and an outflow port using a cooling or heating power of 10 watts to 100 watts.

284. The method according to claim 283, further comprising changing the temperature of the digestive tract behind the gastroesophageal junction of the digestive tract via the 50 cm to 300 cm of the catheter inserted into the stomach.

285. The method according to claim 283, further comprising circulating the fluid through an inflow lumen and an outflow lumen extending through the 50 cm to 300 cm of the catheter inserted into the stomach.

286. The method according to claim 285, wherein the fluid has a temperature higher than 37°C or the fluid has a temperature lower than 37°C.

287. The method according to claim 286, further comprising raising and / or lowering the temperature of the digestive tract behind the gastroesophageal junction of the digestive tract by 1°C to 20°C.

288. The method according to claim 286, further comprising raising and / or lowering the temperature of the wall of the digestive tract behind the gastroesophageal junction of the digestive tract by 1°C to 20°C.

289. The method according to claim 288, wherein the wall of the digestive tract behind the gastroesophageal junction of the digestive tract is adjacent to the pancreas.

290. A method of changing the temperature of the digestive tract behind the gastroesophageal junction of the digestive tract, comprising: positioning a first section of a catheter within the stomach of the digestive tract; transferring heat to or from the digestive tract, including recirculating a fluid through an inflow lumen and an outflow lumen within the first section of the catheter; The method, wherein the length of the first section of the catheter is greater than the length of the greater curvature of the stomach.

291. The method according to claim 290, wherein transferring heat to or from the digestive tract includes transferring heat to or from the digestive tract via the first section of the catheter within the stomach.

292. The method according to claim 290, wherein the length of the first section of the catheter is greater than the greater curvature of the stomach while transferring heat to or from the digestive tract.

293. The method according to claim 290, wherein the length of the first section of the catheter is 10 cm to 300 cm greater than the greater curvature of the stomach.

294. The method according to claim 290, wherein the length (Lc) of the first section of the catheter within the stomach is N times the length (Ls) of the greater curvature of the stomach, represented by the equation Lc = N Ls, and N is a positive real number including 1.00 to 20.

00.

295. The method according to claim 290, wherein the distal end of the catheter includes the first section of the catheter, and the proximal end of the catheter includes the first section of the catheter.

296. The method according to claim 290, wherein the fluid has a temperature higher than 37°C or the fluid has a temperature lower than 37°C.

297. A method of changing the temperature of the digestive tract behind the gastroesophageal junction of the digestive tract, comprising: positioning a lumen of a certain length within the stomach of the digestive tract; flowing a fluid through the length of the lumen at a certain flow rate over a treatment period; The method, wherein the flow rate is at least 20 mL / min and the treatment period is at least 2 hours. A method, wherein the length of the lumen in the stomach is from 30 cm to 150 cm.

298. The method according to claim 297, wherein the volume of the length of the lumen in the digestive tract is from 2.0 mL to 50.0 mL.

299. The method according to claim 297, wherein the flow rate is less than 200 mL / min and / or the treatment period includes from 2 hours to 31 days.

300. The method according to claim 297, further comprising flowing from 4 L to 9,000 L of the fluid through the length of the lumen.

301. The method according to claim 297, further comprising flowing the fluid through the length of the lumen in the stomach at a flow rate including from 20 mL / min to 200 mL / min.

302. The lumen includes a first lumen, and the method further comprises: positioning a second lumen of a certain length in the stomach; flowing the fluid through the length of the second lumen at the flow rate over the treatment period; wherein the length of the second lumen in the stomach is from 30 cm to 150 cm; the first lumen includes an inflow lumen, and the second lumen includes an outflow lumen; the first lumen and the second lumen merge with each other at a confluence point, and the confluence point is inside the catheter. The method according to claim 297.

303. A device comprising a catheter including a heat transfer region, wherein a heating zone extends radially from the heat transfer region; the heat transfer region includes a length from 50 cm to 300 cm; when the catheter is in a deployed configuration, a first heating zone of a first length of the heat transfer region overlaps a second heating zone of a second length of the heat transfer region.

304. The device according to claim 303, further comprising a recirculation pump.

305. The device according to claim 303, further comprising an inflow port and an outflow port at a proximal end of the catheter.

306. The device according to claim 303, wherein the heat transfer regions intersect when the catheter is in the deployed configuration.

307. The device according to claim 303, wherein a first outer portion of the heat transfer region contacts a second outer portion of the heat transfer region when the catheter is in the deployed configuration.

308. The device according to claim 303, wherein when the catheter is in a straight configuration, the first length of the heat transfer region and the second length of the heat transfer region are separated by at least 10 cm.

309. When the catheter is in a straight configuration, the first length of the heat transfer region is proximal to the second length of the heat transfer region, The device according to claim 303, wherein when the catheter is in the deployed configuration, the first length of the heat transfer region is distal to the second length of the heat transfer region.

310. A recirculation pump, A catheter having a lumen, wherein a first end of the lumen includes an inflow port and a second end of the lumen includes an outflow port, and when the recirculation pump is recirculating fluid, the inflow port and the outflow port are in fluid communication with the recirculation pump, When the catheter is in the deployed configuration, an adherer is attached to the catheter, When the catheter is in the deployed configuration, the volume of the lumen distal to the inflow port and the outflow port is less than 50 mL, The device, wherein when the catheter is in the deployed configuration, the length of the catheter between the adherer and the distal tip of the catheter is at least 80 cm.

311. The device according to claim 310, wherein when the catheter is in the deployed configuration, the volume of the lumen distal to the inflow port and the outflow port is less than 20 mL or 10 mL.

312. The device according to claim 310, wherein when the catheter is in the deployed configuration, the length of the catheter between the adherer and the distal tip of the catheter is shorter than 175 cm or 300 cm.

313. The device according to claim 310, wherein when the catheter is in the deployed configuration, the internal volume of the device distal to the inflow port and the outflow port is less than 100 cm, 50 cm, or 20 cm.

314. The device according to claim 313, wherein the internal volume of the device distal to the inflow port and the outflow port includes the volume of the lumen.

315. The device according to claim 310, wherein the adherer includes an adhesive.

316. The device according to claim 310, wherein the adherer includes a tape.

317. A recirculation pump, A catheter having a lumen, wherein a first end of the lumen includes an inflow port, a second end of the lumen includes an outflow port, the inflow port and the outflow port are at a first end of the catheter, and when the recirculation pump is recirculating fluid, the inflow port and the outflow port are in fluid communication with the recirculation pump. When the catheter is in a deployed configuration, an applicator is attached to the catheter. When the catheter is in the deployed configuration, the length of the catheter between the applicator and the distal end of the catheter is greater than 90 cm from the applicator. A device, wherein when the catheter is in the deployed configuration, the distance measured along a straight line from the applicator to the distal end of the catheter is shorter than 60 cm.

318. The device according to claim 317, wherein when the catheter is in the deployed configuration, the length of the catheter between the applicator and the distal end of the catheter is shorter than 175 cm or 300 cm.

319. The device according to claim 317, wherein the deployed configuration includes a first deployed configuration, the straight line includes a first straight line, and when the catheter is in a second deployed configuration, the distance measured along a second straight line from the applicator to the distal end of the catheter is longer than 60 cm.

320. The device according to claim 319, wherein the distance measured along the second straight line from the applicator to the distal end of the catheter is 1 cm to 15 cm longer than the distance measured along the first straight line from the applicator to the distal end of the catheter.

321. The device according to claim 317, wherein when the catheter is in the deployed configuration, the length of the catheter between the applicator and the distal end of the catheter intersects 1 to 5 times.

322. The device according to claim 317, wherein the applicator includes an adhesive and / or a single tape.

323. A method of changing the temperature of the digestive tract behind the gastroesophageal junction of the digestive tract, forming a first length of the catheter into a first loop inside the stomach of the digestive tract, the first loop including a first loop first end that intersects a first loop second end, and the width of the first loop being greater than 3 cm, forming the first length of the catheter into the first loop. A method of transferring heat to and / or from the digestive tract, including recirculating a fluid through an inflow lumen and an outflow lumen within the catheter, wherein the inflow lumen and the outflow lumen extend through the first length of the catheter.

324. The method of claim 323, wherein forming the first length of the catheter into the first loop includes advancing the catheter into the stomach.

325. The method of claim 323, wherein forming the first length of the catheter into the first loop includes gradually forming the first length of the catheter into the first loop within the stomach as the catheter is advanced into the stomach.

326. The method of claim 323, wherein the first end of the first loop contacts the second end of the first loop.

327. The method of claim 323, wherein the first end of the first loop and the second end of the first loop are movable to contact and / or not contact each other via peristaltic movement of the stomach.

328. The method of claim 323, wherein forming the first length of the catheter into the first loop includes crossing the catheter within the stomach, folding the catheter within the stomach, and / or forming a bend in the catheter within the stomach.

329. The method of claim 323, further including forming a second length of the catheter into a second loop within the stomach after forming the first loop within the stomach.

330. A method of changing the temperature of the digestive tract behind the gastroesophageal junction of the digestive tract, comprising: forming, within the stomach, a first section of the catheter into a first loop defining a first cell by advancing the catheter into the stomach; transferring heat to and / or from the digestive tract, including recirculating a fluid through an inflow lumen and an outflow lumen within the catheter when the first cell is distal to the distal end of the catheter; A method as described above.

331. The method of claim 330, wherein forming the catheter into the first loop within the stomach includes crossing the catheter within the stomach and / or forming a bend in the catheter within the stomach.

332. The method according to claim 330, wherein forming the catheter into the first loop that defines the first cell in the stomach by advancing the catheter into the stomach of the digestive tract includes pressing the catheter against the wall of the stomach.

333. The method according to claim 330, wherein the inflow lumen and the outflow lumen are within the first section of the catheter.

334. The method according to claim 330, wherein when the catheter is in a straight configuration, the first section of the catheter is straight.

335. The method according to claim 330, further comprising forming a second section of the catheter into a second loop that defines a second cell in the stomach by advancing the catheter into the stomach.

336. The method according to claim 335, further comprising moving the first loop relative to the second loop and / or moving the second loop relative to the first loop.

337. A method of changing the temperature of the digestive tract behind the gastroesophageal junction of the digestive tract, comprising: forming a first section of a catheter into a first loop in the stomach of the digestive tract; forming or moving a second loop at the distal side of the first loop, which is forming a second section of the catheter into the second loop in the stomach, wherein when the catheter is in a straight configuration, the first section of the catheter is distal to the second section of the catheter; transferring heat to and / or from the digestive tract through the catheter; and the method includes these steps.

338. The method according to claim 337, further comprising forming the first section of the catheter into the first loop in the stomach by advancing the first section of the catheter into the stomach.

339. The method according to claim 338, wherein forming the catheter into the first loop in the stomach by advancing the catheter into the stomach includes pressing the catheter against the wall of the stomach.

340. The method of claim 337, further comprising forming the second section of the catheter into the second loop within the stomach by advancing the second section of the catheter into the stomach.

341. The method of claim 340, wherein forming the catheter into the second loop within the stomach by advancing the catheter into the stomach includes pushing the catheter against the wall of the stomach.

342. The method of claim 337, wherein forming the second section of the catheter into the second loop includes moving the second section of the catheter relative to the first section of the catheter and / or moving the second section of the catheter above or below the first section of the catheter.

343. A device comprising a catheter having a first section, the first section having a first section first configuration and a first section second configuration, wherein when the first section is in the first section first configuration, the first section is straight, wherein when the first section is in the first section second configuration, the first section includes a first loop having a first loop first end that intersects a first loop second end at a first position along the catheter, and the width of the first loop is greater than 3 cm when measured from an axis perpendicular to the central longitudinal axis of the catheter.

344. The device of claim 343, further comprising a recirculation pump, the catheter including an inflow lumen and an outflow lumen, the inflow lumen and the outflow lumen being in fluid communication with the recirculation pump when the recirculation pump is recirculating fluid.

345. The device of claim 343, the catheter including an inflow lumen and an outflow lumen, through which fluid can flow.

346. The device of claim 345, wherein when the fluid is within the inflow lumen and the outflow lumen, the fluid can absorb or release heat.

347. The device of claim 343, wherein the first loop first end contacts the first loop second end at the first position.

348. The device according to claim 343, wherein the first end and the second end of the first loop are separated by a first loop gap at the first position.

349. The device according to claim 343, wherein the length of the first loop measured along a straight line from the base of the first loop to the head of the first loop is greater than 3 cm.

350. The device according to claim 343, wherein the outer circumference of the first loop measured along the central longitudinal axis of the catheter from the first end of the first loop to the second end of the first loop is greater than 9.5 cm.

351. The device according to claim 343, wherein the catheter further includes a second section having a first configuration and a second configuration of the second section. When the second section is in the first configuration of the second section, the second section is straight. When the second section is in the second configuration of the second section, the second section includes a second loop having a first end and a second end of the second loop.

352. The device according to claim 351, wherein when the second section is in the second configuration of the second section, the first end of the second loop intersects the second end of the second loop at a second position along the catheter.

353. Comprising a catheter having a first section and a second section, The catheter has a first configuration and a second configuration, When the catheter is in the first configuration, the first section and the second section are less curved than when the catheter is in the second configuration, and the first section is distal to the second section. When the catheter is in the second configuration, the first section includes a first loop, the second section includes a second loop, and the second section is distal to the first section such that the second loop is distal to the first loop. Device.

354. The device according to claim 353, wherein when the catheter is in the first configuration, the first section and the second section are straight.

355. The device according to claim 353, wherein when the catheter is in the second configuration, the first loop includes an open loop or a closed loop, and the second loop includes an open loop or a closed loop.

356. The device according to claim 353, further comprising a recirculation pump, wherein the catheter includes an inflow lumen and an outflow lumen, and when the recirculation pump is recirculating fluid, the inflow lumen and the outflow lumen are in fluid communication with the recirculation pump.

357. The device according to claim 353, wherein the outer perimeter of the first loop measured along the central longitudinal axis of the catheter is smaller or larger when the catheter is in the second configuration than when the catheter is in the first configuration.

358. The device according to claim 353, wherein the first loop defines a first cell having a first cell central axis, the second loop defines a second cell having a second cell central axis, and the first cell central axis is offset from the second cell central axis.

359. The device according to claim 353, wherein the first loop is closer to or farther from the second loop when the catheter is in the second configuration than when the catheter is in the third configuration, and the first configuration, the second configuration, and the third configuration are deployed configurations.

360. The device according to claim 353, wherein the outer perimeter of the second loop measured along the central longitudinal axis of the catheter is smaller or larger when the catheter is in the second configuration than when the catheter is in the third configuration, and the first configuration, the second configuration, and the third configuration are deployed configurations.

361. The device according to claim 353, wherein when the catheter is in the second configuration, the first loop includes an open loop, and when the catheter is in the third configuration, the first loop includes a closed loop, and the first configuration, the second configuration, and the third configuration are deployed configurations.

362. The device according to claim 353, wherein when the catheter is in the second configuration, the second loop includes a closed loop, and when the catheter is in the third configuration, the first loop includes an open loop, and the first configuration, the second configuration, and the third configuration are deployed configurations.

363. A method of changing the temperature of the stomach via a catheter, the catheter including an inflow channel, an outflow channel, a first temperature sensor, a second temperature sensor, and an elongate portion, the elongate portion including the first temperature sensor, wherein when the catheter is in a straight configuration, the elongate portion and the first temperature sensor are distal to the inflow channel, the outflow channel, and the second temperature sensor, the method comprising: positioning the catheter within the stomach, including positioning the first temperature sensor and the elongate portion closer to the pylorus than the second temperature sensor; transferring heat to and / or from the stomach via the catheter positioned within the stomach; A method comprising the above steps.

364. The method according to claim 363, wherein when the catheter is in the straight configuration, the first temperature sensor and the second temperature sensor are separated by a first distance, and when the catheter is in a deployed configuration, the first temperature sensor and the second temperature sensor are separated by a second distance, and the first distance is longer than the second distance.

365. The method according to claim 364, wherein the first distance is from 50 cm to 300 cm and the second distance is from 5 cm to 40 cm.

366. The method according to claim 363, wherein positioning the catheter within the stomach includes positioning the first temperature sensor and the elongate portion from 1 to 20 cm from the pylorus.

367. The method according to claim 363, wherein positioning the catheter within the stomach includes positioning the second temperature sensor closer to the lower gastroesophageal sphincter than the first temperature sensor and the elongate portion.

368. The method according to claim 367, wherein positioning the catheter within the stomach includes positioning the second temperature sensor from 1 cm to 20 cm from the lower gastroesophageal sphincter.

369. The method according to claim 363, wherein when the catheter is in the straight configuration, the second temperature sensor is 50 cm to 300 cm proximal to the first temperature sensor.

370. Further comprising measuring the temperature of the stomach by the first temperature sensor and / or measuring the temperature of the stomach by the second temperature sensor, wherein the first temperature sensor is embedded in the elongated portion, and transferring heat to and / or from the stomach through the catheter positioned in the stomach includes flowing a fluid through the inflow channel and the outflow channel, the method according to claim 363.

371. A method of changing the temperature of the stomach via a catheter, the catheter including an inflow channel, an outflow channel, a first temperature sensor, a second temperature sensor, and an elongated portion, the elongated portion including the first temperature sensor, and when the catheter is in a straight configuration, the elongated portion and the first temperature sensor are distal to the inflow channel, the outflow channel, and the second temperature sensor, the method comprising: Positioning the catheter in the stomach, including positioning the first temperature sensor and the elongated portion further from the pylorus than the second temperature sensor; Transferring heat to and / or from the stomach through the catheter positioned in the stomach; A method comprising.

372. When the catheter is in the straight configuration, the first temperature sensor and the second temperature sensor are separated by a first distance, and when the catheter is in a deployed configuration, the first temperature sensor and the second temperature sensor are separated by a second distance, the first distance being longer than the second distance, the method according to claim 371.

373. Positioning the catheter in the stomach includes positioning the second temperature sensor from 1 cm to 20 cm from the pylorus, the method according to claim 371.

374. Positioning the catheter in the stomach includes positioning the second temperature sensor further from the lower gastroesophageal sphincter than the first temperature sensor and the elongated portion, the method according to claim 371.

375. Positioning the catheter in the stomach includes positioning the first temperature sensor and the elongated portion from 1 cm to 20 cm from the lower gastroesophageal sphincter, the method according to claim 374.

376. The method according to claim 371, wherein when the catheter is in the straight configuration, the second temperature sensor is 50 cm to 300 cm proximal to the first temperature sensor.

377. The method according to claim 371, further comprising measuring the temperature of the stomach by the first temperature sensor and / or measuring the temperature of the stomach by the second temperature sensor, wherein the first temperature sensor is embedded in the elongate portion and transfers heat to and / or from the stomach via the catheter positioned in the stomach, and wherein transferring heat to and / or from the stomach includes flowing fluid through the inflow channel and the outflow channel.

378. A method of changing the temperature of the stomach via a catheter, the catheter including an inflow channel, an outflow channel, a first temperature sensor, a second temperature sensor, and an elongate portion, the elongate portion including the first temperature sensor, the method comprising: positioning the catheter in the stomach in a first operating configuration, wherein when the catheter is in the first operating configuration, the first temperature sensor and the second temperature sensor are in the stomach, and the catheter moves from the first operating configuration to a second operating configuration, and wherein when the catheter is in the second operating configuration, the first temperature sensor is in the pylorus or duodenum and the second temperature sensor is in the stomach.

379. The method according to claim 378, wherein the catheter moves from the first operating configuration to the second operating configuration and includes the portion of the catheter that migrates from the stomach through the pylorus into the duodenum.

380. The method according to claim 378, wherein the catheter moves from the first operating configuration to the second operating configuration and includes the portion of the catheter that passively moves from the stomach through the pylorus into the duodenum.

381. transferring heat to and / or from the stomach when the catheter is in the first operating configuration; and transferring heat to and / or from the stomach, the pylorus, and the duodenum when the catheter is in the second operating configuration. further comprising, when the catheter is in the first operating configuration, transferring heat to and / or from the stomach, which includes flowing a fluid through an inflow lumen and an outflow lumen within the catheter when the catheter is in the first operating configuration, when the catheter is in the second operating configuration, transferring heat to and / or from the stomach, the pylorus, and the duodenum, which includes flowing the fluid through the inflow lumen and the outflow lumen within the catheter when the catheter is in the second operating configuration, and / or the method according to claim 378. **Claim 382** further comprising transferring heat to and / or from the stomach when the catheter moves from the first operating configuration to the second operating configuration, which includes flowing the fluid through the inflow lumen and the outflow lumen within the catheter when the catheter moves from the first operating configuration to the second operating configuration, the method according to claim 381. **Claim 383** A catheter comprising an inflow channel, an outflow channel, a first temperature sensor, a second temperature sensor, and an elongate portion, the elongate portion including the first temperature sensor, when the catheter is in a straight configuration, the elongate portion and the first temperature sensor are distal to the inflow channel, the outflow channel, and the second temperature sensor, when the catheter is in the straight configuration, the first temperature sensor and the second temperature sensor are separated by a first distance, when the catheter is in a first operating configuration, the first temperature sensor and the second temperature sensor are separated by a second distance, the first distance being longer than the second distance, a device. **Claim 384** The device according to claim 383, wherein the first distance is from 50 cm to 300 cm and the second distance is from 5 cm to 40 cm. **Claim 385** The device according to claim 384, wherein when the catheter is in a second operating configuration, the first temperature sensor and the second temperature sensor are separated by a third distance, the third distance being longer than the second distance. **Claim 386** The device according to claim 385, wherein the third distance is 5 cm to 30 cm longer than the second distance.

387. The device according to claim 384, wherein when the catheter is in the straight configuration, the second temperature sensor is 50 cm to 300 cm proximal to the first temperature sensor.

388. The device according to claim 383, wherein the first temperature sensor is embedded in the elongate portion.

389. The device according to claim 383, wherein the first temperature sensor includes a first thermocouple and the second temperature sensor includes a second thermocouple.

390. The device according to claim 383, through which fluid can flow through the inflow lumen and the outflow lumen.

391. The method according to claim 390, wherein when the fluid flows through the inflow lumen and the outflow lumen, heat can be absorbed or released by the catheter.

392. Any combination of claims 1 to 391.

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