Device and method for cooling and / or heating organ
Through the local cryogenic treatment system, the cooling medium is delivered to the vicinity of the pancreas by using catheters and balloons, solving the problem that the prior art is difficult to effectively alleviate pancreatic inflammation, and achieving effective reduction of pancreatic inflammation and reducing metabolic activity.
Patent Information
- Application Number
- CN202380051133.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-03-24
- Filing Date
- 2023-05-01
- Publication Date
- 2025-04-11
AI Technical Summary
The prior art is difficult to effectively alleviate pancreatic inflammation and reduce metabolic activity, especially in the case of acute pancreatitis, where there is a certain risk of death.
The temperature of the pancreas is directly or indirectly adjusted through internal and external heat exchangers and heating or cooling devices. The system includes a catheter and a balloon through which cooling media is delivered to organs, fluids and tissues near the pancreas, cooling the pancreas.
Through local hypothermia treatment, pancreatic inflammation can be effectively reduced, metabolic activity, and the patient's pain can be reduced, and the severity of acute pancreatitis can be reduced without systemic hypothermia.
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Figure CN119816273A_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims priority to U.S. Provisional Application No. 63 / 363,926, filed on April 29, 2022, U.S. Provisional Application No. 63 / 381,520, filed on October 28, 2022, and U.S. Provisional Application No. 63 / 492,189, filed on March 24, 2023, all of which are incorporated herein by reference in their entirety for all purposes. Technical Field
[0003] The present application discloses a system capable of providing local hypothermia treatment for inflammation of the pancreas and / or pancreatitis, as well as the use of the system for treating obesity, pancreatic cancer, hypothermia of other body structures and organs, and general body temperature regulation. The disclosed methods and apparatus can be used for both hypothermia and hyperthermia, or a combination of both heat applications, during medical procedures. Background Art
[0004] Pancreatitis can be acute and / or chronic. Pancreatitis has a variety of causes, including but not limited to alcohol-induced, gallbladder and / or gallstone-related, and / or other causes / idiopathic. In each case, the pancreas becomes inflamed, affecting the patient's endocrine and exocrine function. Severe pancreatitis occurs in one in four patients and is associated with a 5% mortality rate.
[0005] A system that can alleviate pancreatic inflammation and reduce metabolic activity could benefit patients, physicians, and / or healthcare systems that require hospitalization of pancreatitis patients in the ICU.
[0006] The present application discloses localized hypothermia, which is provided by internal and external heat exchangers and heating and / or cooling devices for increasing and / or decreasing body temperature.
[0007] Systems for localized hypothermia are particularly useful for treating specific bodily injuries or inflammations. A common form of localized hypothermia is placing an ice pack on a sprained ankle or using a circulating cooling pad after orthopedic surgery. Summary of the Invention
[0008] The present application discloses thermal therapy systems, devices, and methods.
[0009] This article describes a system for inducing localized hypothermia. The pancreas can be heated and / or 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 through the abdomen and / or through a laparoscope. The needle can directly remove heat from the pancreas. The pancreas can be indirectly cooled by cooling organs, liquids (liquid or gas) and / or tissues near the pancreas. For example, the stomach wall, dermis and / or duodenum adjacent to the pancreas can be cooled to cool the pancreas.
[0010] The heat exchange process can occur outside the patient's body and / or inside the patient's body. Heat exchange methods can include thermoelectric cooling, vapor compression refrigeration, phase change, Carnot cycle refrigeration, reverse Rankine refrigeration, evaporative cooling, thermotunnel cooling, magnetic refrigeration, cyclic refrigeration, non-cyclic refrigeration, sortpion cycle, elastocaloric refrigeration, refrigerator gate, vortex tube, pulse tube refrigeration, and / or thermoacoustics.
[0011] The catheter can be introduced orally and / or nasally. The catheter can extend to the stomach, duodenum, intestine, jejunum, and / or ampulla of Vater. The catheter can deliver a cold fluid to cool the stomach, duodenum, intestine, jejunum, and / or ampulla of Vater; 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 lumen and / or an outflow lumen; the inflow lumen can deliver a cooler fluid than the outflow lumen. The catheter can have a lumen for delivering a cooling fluid into and / or out of the patient; for example, a cold fluid can be introduced, retained within the patient for a period of time, and then removed after the fluid has warmed.
[0012] The heat transfer fluid may be in contact with the patient's organs, tissues and / or bodily fluids; the heat transfer fluid may be in indirect contact with the patient's organs, tissues and / or fluids; for example, the heat transfer fluid may be in a catheter, a balloon and / or multiple balloons.
[0013] A magnet can be used to position the catheter and / or balloon. Various imaging modalities can be used to visualize the position of the catheter and / or balloon, 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, delivery of additional tools, delivery of additional sensors, delivery of medications, and / or delivery of nutrients.
[0014] One or more external cooling pads can be placed on the outside of the patient's stomach near the patient's pancreas to provide cooling energy that can work in conjunction with the internal cooling system for hypothermia. These cooling pads can be connected to the same cooling box that drives the internal catheter system and / or a separate component of the cooling box.
[0015] The external cooling pad may have a magnetic source that can facilitate conformation of the catheter and / or balloon to the portion of the stomach proximal to the pancreas. The external cooling pad may have a magnetic source that facilitates articulation of the distal end of the catheter system for placement of an additional balloon within the patient's duodenum.
[0016] External cooling pads can provide electromagnetic energy to drive or rotate rods within the balloon system to facilitate circulation of a cooling medium within the balloon. Electromagnetic energy can be used to open or close valves to circulate a cooling medium between different sections or chambers of one or more balloons, or to circulate a cooling medium within a catheter system. Electromagnetic energy can be used to open or close valves to provide nutrition to a patient. Electromagnetic energy can be used to expand structures or stents within a catheter system to open a lumen or to deflect and flex a catheter.
[0017] Mechanical structures can be deployed to help position the catheter and / or balloon. Components within the catheter can help the physician or operator better conform the balloon to the stomach lining to more effectively deliver cooling energy to the pancreas. Mechanisms used to improve the deployment and positioning of the catheter system and balloon include torquing or articulating elements within the catheter, allowing the operator to manipulate the distal end of the catheter system.
[0018] The catheter system can have inflatable or deployable protrusions that can force the cryoballoon portion of the system against the stomach lining closest to the pancreas. These protrusions can be extensions of the inflatable balloon to push the balloon toward the pancreas. Other protrusions can be mechanically deployed using pull wires or coils that can be rotated by the operator.
[0019] The catheter system and balloon can be designed to reduce the amount of distension or mass in the stomach while providing a greater surface area in contact with the stomach lining.
[0020] Multiple sensors can be used to monitor the patient and / or the cooling system. Contact temperature probes and / or non-contact temperature probes can be used to monitor various tissues, organs, and / or fluids of the patient. Contact temperature probes and / or non-contact temperature probes can be used to monitor the temperature of the heat transfer fluid at one or more locations. A pH sensor can be used to monitor the acidity of gastric fluid. Sensors can be used to monitor the position of the patient, catheter, and / or balloon. Internal pressure sensors within the catheter system can provide signals to the operator and physician indicating that the patient is experiencing reflux, spasm, or integrity failure within the catheter system.
[0021] The distal end of the catheter system can have an endoscope to provide visualization of the stomach wall. The distal end of the catheter and balloon can be equipped with an endoscope to provide visualization of the stomach wall. A visualization source can help the operator place additional balloons in the duodenum.
[0022] The catheter can be insulated. An insulated catheter can more efficiently deliver the cooling fluid to the patient. An insulated catheter can reduce any unintended cooling of other organs, including but not limited to the esophagus. The catheter can include a material with low thermal conductivity. The catheter can be configured so that the cooling fluid can be located in the center of the catheter. Air can be circulated outside the central lumen of the catheter to maintain an insulating layer of air between the cooling medium and the body part not being treated.
[0023] The outer surface of the catheter can be insulated and covered with an expandable membrane that can be filled with air or a heating medium. The expandable membrane can expand to a diameter larger than the catheter during insertion. This diameter can be 1 mm, 5 mm, or 10 mm. The insertion diameter of the catheter system can be reduced to improve patient comfort. Once placed in the body, the insulating membrane can be expanded in a portion of the catheter that can be insulated. For example, the insulating membrane can be expanded with air or a heating medium in the esophageal or nasopharyngeal region.
[0024] The air or heating medium used for insulation can be dynamic in that once the cooling medium is introduced to the balloon, the non-balloon portion of the system can be insulated with circulating air or heating medium for active insulation to provide a higher temperature to the intended treatment area of the body.
[0025] Thermal insulation can be provided by isolating the cooling medium in the cryoballoon from the rest of the catheter system. This isolation can be achieved using a valved catheter. Once the cooling medium is injected, air can be introduced into the system.
[0026] The catheter may have a communication port that provides a mechanism for the operator to administer analgesics to soothe or numb the bodily orifices, esophagus, and stomach. Analgesics may be administered to reduce tissue irritation during treatment.
[0027] The outer surface of the catheter system may be coated with a hydrophilic coating to reduce friction during instrument insertion and the effects of friction over time while the catheter system is positioned within the body.
[0028] The communication port leading to the outer surface of the balloon can improve the contact between the balloon and the inner wall of the stomach. The communication port can deliver a limited amount of cooling medium directly to the stomach wall.
[0029] The catheter system can be designed to enter the duodenum through the pylorus to provide further cooling within the large intestine and in closer anatomical proximity to the head of the pancreas.
[0030] The distal end of the catheter system may have a spiral configuration to facilitate entry into the duodenum.
[0031] 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 in the patient's nasopharynx while the distal end can rotate independently to facilitate access to the duodenum.
[0032] The catheter system may have an expandable lumen to reduce the profile of the system during access.
[0033] The catheter system may have an expandable lumen at the distal portion of the catheter to facilitate heat transfer at a desired location for cooling the patient's anatomy.
[0034] For the localized hypothermia procedure itself, the following steps outline the methods and variations for treating a patient.Once pancreatitis is diagnosed, the patient is positioned for the procedure with catheter supplies and a cooling box.
[0035] System Preparation: The cryogenic catheter system package can be prepared for use according to the instructions for use, which may include pre-filling the system's internal lumen, flushing any through-lumens with a medium, testing the integrity of the balloon, and coating the exterior of the catheter system with an analgesic prior to insertion into the patient. The cooling box can be prepared with a medium such as saline and placed in a cooling cycle or cooling mode. The catheter system can be connected to the cooling box and sensors can be used to check the integrity of the system, flow rate, and other sensors.
[0036] Methods of Localized Hypothermia of the Pancreas
[0037] Connecting to a cooling box: The connection to the cooling box can be programmed with an identifier or EEPROM to ensure single patient use. The cooling box can have a screen display showing the system preparation process, sensor status and other real-time temperatures, fluid pressures, media flow rates and other values. The cooling box can have software / firmware for generating various cooling schemes or programs with general low-temperature parameters or specific low-temperature parameters. The cooling box can be mounted on a bedside infusion (IV) pole, on a stand or independently mounted on the floor or table. The cooling box can be a wearable box that can be miniaturized, battery-powered and suitable for wearing on the patient for easy portability. During treatment, the patient can be easily transferred from the bedside or move on their own. The cooling box can be configured to communicate via Bluetooth or Wi-Fi for remote control by a medical professional.
[0038] Inserting the catheter system into the patient: The catheter system can be placed through the nose, mouth, or gastric route. The catheter system can be delivered in a low profile state in which the balloon can be sheathed, housed, and / or contained within the distal portion of the catheter system.
[0039] Placing the catheter in the stomach: The catheter system can be delivered into the stomach in a flexible manner. Within the catheter, a pull wire can flexibly bend the distal end of the catheter for deflection. Within the lumen of the catheter, a braided material or mandrel can provide stiffness for torque to selectively rotate the curved section of the catheter. Once the catheter is placed in the stomach, the operator can remove the mandrel within the catheter to provide further flexibility or to provide a lumen for fluids, media, suction, or injection of nutrients into the patient. The distal end of the catheter can have an echogenic tip or ultrasound sensor, which helps to identify the distal tip of the catheter with an external ultrasound or audio device.
[0040] Deployment of the Balloon in the Stomach: The balloon at the distal end of the catheter can be unrolled or unsheathed by separating, pulling, or rotating a portion of the catheter to reveal the balloon. Deployment of the balloon can be facilitated by an internal stent within the balloon, which helps the balloon assume its desired shape.
[0041] Filling the balloon with a cooling medium: The catheter system can be connected to a cooling box to fill the balloon with a cooling medium. As a preliminary step, the balloon can be filled with air to allow for full deployment before filling with the cooling medium, or to allow for inspection and verification of the balloon's position. The cooling box can deliver filtered air, carbon dioxide, or other gases, followed by the cooling medium. Air can be delivered after the cooling medium to provide thermal insulation for the esophagus and upper nasal and oral passages.
[0042] Apposition of the Balloon to the Stomach Wall: The balloon can be positioned in the lower part of the stomach by gravity. Further adhesion near the pancreatic area can be achieved by twisting and flexibly bending the distal end of the catheter system in the stomach. Actuating a pull wire or multiple pull wires within the catheter system can flexibly bend the distal end of the catheter system into a curved shape that forces the balloon closer to the inner stomach wall. The catheter system can have protrusions that can provide a reaction force to position the balloon close to the inner stomach wall closer to the pancreas. These protrusions can be deployed like stents, baskets, or deflecting ribs. The protrusions can be inflatable nubs, 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 can have a ferromagnetic material that can interact with external magnetic forces to bring the balloon closer to the pancreas.
[0043] Balloon Distension: Air, liquid, gas, media, or combinations thereof can be used to fill the balloon at the distal end of the catheter. The balloon's expansion can be monitored and measured by the pressure and total volume of air, liquid, gas, or media delivered. The distension media can be supplied to the balloon through an opening or port within the catheter, which can be in fluid communication with one or more internal lumens.
[0044] Inflation Methods to Reduce Gastric Pressure: A cooling medium can be supplied to the balloon and monitored to reduce overall gastric pressure, minimizing patient discomfort. A pressure sensor within the cooling balloon can register reactive contractions within the stomach that act on the balloon and catheter system. In response to increased pressure caused by the stomach exerting forces on the catheter system, the inflation medium within the balloon, as well as the pressure and / or volume of the inflation medium, can be reduced or increased in response to the forces monitored and recorded within the stomach.
[0045] Monitoring Hypothermia Treatment: During hypothermia treatment, thermocouples on the catheter system provide feedback on the temperature of the inflation medium, the catheter, the balloon's outer surface, and multiple balloon outer surfaces in contact with the stomach wall closer to the pancreas and areas farther from the pancreas. Hypothermia treatment can be monitored over time and checked by the patient's body temperature. A wearable thermometer can be connected to the cooling box to provide feedback on excessive hypothermia or to add additional cooling medium as needed.
[0046] Concurrent Procedures include endoscopy, sampling of diagnostic fluids or contents, ultrasound and fluoroscopy, and drug delivery during cryotherapy: The catheter system can allow insertion of an endoscope for internal visualization, or the catheter system can be constructed with an integrated endoscope. The catheter system can have a port that enables sampling of fluids or substances in the stomach for diagnostic purposes. The catheter system can be constructed with echogenic or radiopaque materials or components to facilitate ultrasound or fluoroscopic detection. Doppler ultrasound can be used to record the flow of the inflation medium in the catheter system and the vasculature of the area near the stomach and pancreas. The catheter system can be constructed with a port that can deliver drugs to the patient. The port can be located at a specific location on the catheter system to apply drugs or analgesics to the nose, mouth, and esophageal passages as well as the stomach. The port can be located on the outside of the balloon to deliver drugs and analgesics directly to the inner stomach wall near the pancreas.
[0047] Patient nutrition during treatment: The catheter system can have a lumen for supplying nutrition, such as a nutrient medium, to the patient. Nutritional delivery can be provided by external pressure or mechanical force directly provided by the healthcare provider or a cooling box. The catheter system can have an expandable lumen that responds to the mechanical force of the supplied nutrition and expands, allowing the nutrition to reach the patient's gastrointestinal tract. The expandable lumen allows for minimizing the insertion and wearing profile of the catheter system, which can be expanded for use with patient nutrition.
[0048] Confirmation of hypothermia therapy: Overall pancreatic enzyme activity can be monitored during treatment to confirm and monitor the effectiveness of the procedure. PET scans can be used to monitor pancreatic metabolic activity. Temperature measurements of the patient's stomach wall and other locations within and outside the ductal system can determine the amount of hypothermia treatment.
[0049] Continuation or Protocols of Treatment: The duration of hypothermia therapy can be cycled in an on-off fashion or can be continuous during treatment. Hypothermia therapy can start at one cooling temperature and then decrease the temperature in steps. Stepwise cooling can be performed by maintaining a lower temperature setting for a period of time before decreasing to another lower temperature, or by returning to baseline and then decreasing back to a lower temperature setting. Therapy protocols can be pre-programmed within the cooling box or can respond to feedback from a temperature sensor in the catheter system or to patient temperature measurements.
[0050] Treatment completion: Hypothermia therapy can be discontinued upon completion of a known cooling regimen or when the patient's temperature measurements reach a predetermined stopping point. Treatment can be discontinued when the patient's symptoms, enzymatic measurements, or metabolic activity have improved to a certain degree.
[0051] Removal of the device from the patient: Once treatment is complete, all balloons and external projections can be free of inflation media and gas, and articulations or stiffeners at the distal end of the catheter can be minimized to reduce system stiffness during removal from the patient.
[0052] Without the need for systemic hypothermia, studies have shown that local pancreatic hypothermia can reduce the severity of acute pancreatitis induced by different methods in rats. BRIEF DESCRIPTION OF THE DRAWINGS
[0053] The figures shown and described are of illustrative variants and not restrictive. The same reference numerals indicate the same features or functionally equivalent features throughout.
[0054] Figure 1 Schematic diagram showing a hyperthermia system deployed in a patient's digestive system.
[0055] Figures 2a to 2d Different cross sections of the catheter are shown.
[0056] Figure 3 A schematic diagram showing another embodiment of a thermal therapy system deployed in a patient's digestive system.
[0057] Figure 4a and Figure 4b Cross-section of the distal end of the cooling device showing the balloon partially inflated.
[0058] Figure 5a and Figure 5b A cross-section of the distal end of an additional embodiment of a cooling device is shown with the balloon partially inflated.
[0059] Figure 6 Data from a simulated local cooling system are shown.
[0060] Figure 7 A schematic diagram showing another embodiment of a thermal therapy system deployed in a patient's digestive system.
[0061] Figure 8 A cross-section of the distal end of an additional embodiment of a cooling device is shown with the balloon partially inflated.
[0062] Figure 9 A schematic diagram illustrating another embodiment of a transabdominally deployed thermal therapy system.
[0063] Figure 10 A mechanical structure is shown that can position and / or secure a cooling balloon to the stomach wall adjacent to the pancreas.
[0064] Figure 11 Shown is a pyloric plug in place to prevent cooling fluid from flowing into the duodenum, and shown are impermeable and / or semipermeable membranes and / or coatings deposited on the stomach wall that can prevent and / or slow absorption of fluid into the stomach wall.
[0065] Figure 12 It was shown that target temperature of the pancreas could be achieved in a simulated pancreas (using bovine tissue) in a body temperature (37°C) water bath using chilled fluid circulating in a cooling balloon placed in a simulated stomach (using bovine stomach tissue).
[0066] Figure 13a and Figure 13b The stomach and pancreas are shown in two different isometric views.
[0067] Figure 14a and Figure 14b Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 14a The catheter is shown in the stomach with the elastic balloon in a deflated configuration. Figure 14b The catheter is shown in the stomach with its elastic balloon in an inflated configuration.
[0068] Figures 15a to 15c Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 15a The catheters are shown in the stomach and duodenum with the non-elastic gastric balloon in a deflated configuration and the duodenal balloon in a deflated configuration. Figure 15b The catheter is shown in the stomach and duodenum with the elastic balloon in an inflated configuration and the duodenal balloon in a deflated configuration. Figure 15c The catheter is shown in the stomach and duodenum with the elastic balloon in an inflated configuration and the duodenal balloon in an inflated configuration.
[0069] Figures 16a to 16c Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 16a A catheter with three inflatable balloons is shown positioned in the stomach. Figure 16b A catheter with six inflatable balloons is shown positioned in the stomach. Figure 16c A catheter with multiple inflatable balloons on the anterior and posterior sides is shown positioned in the stomach.
[0070] Figure 17 Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 17 The catheter is shown extending through the stomach to the duodenum in an unconstrained configuration.The catheter comprises a catheter barb and a duodenal device.
[0071] Figure 18 Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 18 The catheter is shown in a helical configuration positioned in the stomach.
[0072] Figure 19 Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 19 A catheter is shown extending through the stomach through a percutaneous port and / or a port in the stomach wall.
[0073] Figure 20 Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 20Shown are catheters with coils in the stomach and duodenum.
[0074] Figure 21 Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 21 A catheter is shown extending from an introducer.
[0075] Figure 22 Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 22 A catheter with multiple inflatable balloons is shown in the stomach.
[0076] Figure 23 Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 23 A catheter with multiple inflatable lumens and / or balloon is shown in the stomach.
[0077] Figure 24 Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 24 Shown is a catheter in the stomach and an intestinal plug in the duodenum.
[0078] Figure 25 Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 25 The duct extending through the stomach, pyloric plug and into the pancreatic duct is shown.
[0079] Figure 26 The stomach and pancreas are shown in an isometric view. Figure 26 Shown is a cooling device placed on the surface of the pancreas.
[0080] Figures 27a to 27f Various cross sections of the conduit are shown.
[0081] Figure 28a Figures 28f to 28f show cross-sections of the catheter and balloon in the inflated and deflated configurations.
[0082] Figure 29 Shown is a side view of a catheter with multiple broken wires.
[0083] Figure 30 and Figure 31 Schematic diagram showing a system that can provide heat transfer to the stomach.
[0084] Figure 32 An exemplary view of the duodenum and pancreas is shown with a catheter passed through an artery.
[0085] Figure 33 Data from a simulated local cooling system are shown.
[0086] Figure 34 Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 34 The catheter is shown with the distal end forming a tapered coil.
[0087] Figures 35a to 35d Shown in an isometric view is the stomach, pancreas, and duct with the anterior half removed. Figures 35a to 35d A catheter is shown with an inverted membrane connecting the inner and outer catheters. Figure 35a The catheter is shown proximal to the pylorus; Figure 35b Show Figure 35a Detailed view of the catheter tip. Figure 35c The catheter entering the pylorus is shown; Figure 35d Show Figure 35c Detailed view of the catheter tip.
[0088] Figure 36 Shown in an isometric view is the stomach and pancreas with the front half removed. Figure 36 The coiled catheter is shown positioned in the esophagus.
[0089] Figure 37a A variation of the catheter in the stomach is shown.
[0090] Figure 37b A variation of the catheter in the stomach is shown.
[0091] Figure 38 A variation of a catheter with a remote sensor is shown.
[0092] Figures 39a to 39b The tip of the device with the proboscis is shown. Figure 39a Side view showing the tip of the beak tube, Figure 39b A cross-sectional side view showing the tip of the beak tube.
[0093] Figure 40 A cross section of a catheter is shown.
[0094] Figure 41 A variation of a catheter with an esophageal valve is shown inserted over a guidewire.
[0095] Figure 42 Shows how using a hyperthermia system affects core body temperature.
[0096] Figure 43 Shown is a thermal pad on the patient's face.
[0097] Figure 44 Showing the insulation mechanism at the back of the throat.
[0098] Figure 45a and Figure 45b A variation of a catheter with an expandable catheter array is shown in the stomach.
[0099] Figure 46a 、 Figure 46b 、 Figure 46z2 and Figure 46z3 Shown in an isometric view are the stomach, duodenum, and pancreas with the anterior half removed. Figure 46b to Figure 46z1 Shown is a front view of the stomach with the front half of the stomach shown transparent. Figures 46a to 46o The introduction of the catheter into the stomach is shown. Figure 46o to Figure 46z3 Removal of the catheter from the stomach is shown.
[0100] Figures 47a to 47i Shown in an isometric view are the stomach, duodenum, and pancreas with the anterior half removed. Figures 47a to 47e The introduction of the catheter into the stomach is shown. Figures 47e to 47i Removal of the catheter from the stomach is shown.
[0101] Figures 48a to 48i Shown in an isometric view are the stomach, duodenum, and pancreas with the anterior half removed. Figures 48a to 48e The introduction of the catheter into the stomach is shown. Figures 48e to 48i Removal of the catheter from the stomach is shown.
[0102] Figures 49a to 49i Shown in an isometric view are the stomach, duodenum, and pancreas with the anterior half removed. Figures 49a to 49i A catheter is shown inside the body.
[0103] Figures 50a to 50i Shown in an isometric view are the stomach, duodenum, and pancreas with the anterior half removed. Figures 50a to 50i A catheter is shown inside the body.
[0104] Figures 51a to 51e6 Shown in an isometric view are the stomach, duodenum, and pancreas with the anterior half removed. Figures 51a to 51e6 A catheter is shown inside the body.
[0105] Figures 52a to 52d Shown in an isometric view are the stomach, duodenum, and pancreas with the anterior half removed. Figures 52a to 52d A catheter is shown inside the body.
[0106] Figures 53a to 53b Shown in an isometric view are the stomach, duodenum, and pancreas with the anterior half removed. Figures 53a to 53b A catheter is shown inside the body.
[0107] Figures 54a to 54d Variations in catheter bending and unbending are shown.
[0108] Figure 55a One variation of a catheter is shown.
[0109] Figure 55bOne variation of a catheter is shown.
[0110] Figure 55c Show Figure 55a A variation of a cross-sectional view of the catheter along line 55c-55c.
[0111] Figure 55d Show Figure 46g Variation of the cross-sectional view of the middle conduit along line 55d-55d.
[0112] Figure 56 is a schematic diagram of a system that can provide heat transfer therapy.
[0113] Figures 57a to 57d This is a frontal x-ray of the stomach after the catheter is inserted.
[0114] Figures 58a to 58b This is a frontal x-ray of the stomach after the catheter is inserted. DETAILED DESCRIPTION
[0115] Figure 1 A variation of a thermal therapy system 33 is shown. The thermal therapy system 33 can be, for example, a local thermal therapy system. The thermal therapy system 33 can be, for example, a heat transfer therapy system. For example, the thermal therapy system 33 can be a heating therapy system and / or a cooling therapy system. For example, the thermal therapy system 33 can deliver thermal therapy (e.g., heating therapy and / or cooling therapy) to a heat transfer target 146. The thermal therapy system 33 can, for example, transfer heat to and / or from the heat transfer target 146. Transferring heat to the heat transfer target 146 can include, for example, increasing 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, decreasing 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 gastrointestinal tract 110, one or more organs adjacent to the gastrointestinal 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 gastrointestinal tract 110 caudal to the jejunum 10, or any combination thereof.
[0116] Figure 1 It is shown that the thermal therapy system 33 may include a heat transfer device 4 and / or a heat exchange system 13 . Figure 1The heat exchanger 4 is shown as being connectable (e.g., removably connectable) to the heat exchange system 13. The heat exchange system 13 may be, for example, an external heat exchange system. The heat exchanger 4 may transfer heat to and / or from a heat transfer target 146. The heat exchanger 4 may, for example, increase and / or decrease the temperature of the target 146. The heat exchanger 4 may, for example, heat and / or cool the heat transfer target 146.
[0117] Figure 1 The heat exchanger 4 is shown to include and / or may be, for example, a catheter 9, a balloon 3, or any combination thereof. For example, the heat exchanger 4 includes the catheter 9 but does not include the balloon 3. As another example, the heat exchanger 4 may include the balloon 3 but does not include the catheter 9. As yet another example, the heat exchanger 4 may include both the catheter 9 and the balloon 3. As yet another example, the heat exchanger 4 may be the catheter 9. As yet another example, the heat exchanger 4 may be the balloon 3. As yet another example, the heat exchanger 4 may be both the catheter 9 and the balloon 3. Figure 1 It is shown that the catheter 9 and / or balloon 3 can transfer heat to and / or from the heat transfer target 146. Figure 1 It is shown that the catheter 9 and / or balloon 3 can increase and / or decrease the temperature of the heat transfer target 146. Figure 1 It is shown that the catheter 9 and / or balloon 3 can heat and / or cool the target 146. For example, the balloon 3 can be a heating balloon and / or a cooling balloon and / or the catheter 9 can be a heating catheter and / or a cooling catheter. For example, Figure 1 The thermal therapy system 33 shown 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 / or the balloon 3 can be a heat exchange balloon.
[0118] Figure 1 It is shown that the heat transmitter 4 (e.g., catheter 9 and / or balloon 3) can be inserted into and / or withdrawn from the target site 147. For example, Figure 1It is shown that the catheter 9 and / or balloon 3 can be inserted into the target site 147 as shown by arrow 112 and / or the catheter 9 and / or balloon 3 can be withdrawn from the target site 147 as shown by arrow 114. The target site 147 can be, for example, one or more organs in the body 152. The target site 147 can be, for example, a space and / or cavity within one or more organs in the body 152. For example, the target site 147 can include the esophagus 5, the stomach 2, the pylorus 65, the duodenum 37, the jejunum 10, any portion of the tail of the jejunum 10 along the gastrointestinal tract 110, or any combination thereof. The target site 147 can be, for example, a location (e.g., a desired location) of the catheter 9 and / or balloon 3 in the body 152 during the process of transferring heat to and / or from the heat transfer target 146. The heat transfer target 146 can be, for example, a target heat transfer location. For example, the heat transfer target 146 may be the stomach 2 , the pylorus 65 , the duodenum 37 and / or the pancreas 1 , and the target site 147 may be the stomach 2 , the pylorus 65 , the duodenum 37 and / or the jejunum 10 .
[0119] Figure 1 The balloon 3 shown may be, for example, a gastric balloon. Figure 1 The balloon 3 shown may be, for example, a subgastric balloon. Figure 1 The balloon 3 is shown to be positioned in the stomach 2, inflated in the stomach 2, deflated in the stomach 2, or any combination thereof. The balloon 3 can be secured to the catheter 9. The balloon 3 can be, for example, releasably and / or permanently secured to the catheter 9.
[0120] The heat transmitter 4, catheter 9 and / or balloon 3 may be delivered orally and / or nasally, for example through the nose 11 and / or mouth 12. For example, Figure 1 It is shown that the heat transmitter 4, catheter 9 and / or balloon 3 can be delivered transnasally through the nose 11. The heat transmitter 4, catheter 9 and / or balloon 3 can be passed through the esophagus 5 of the patient.
[0121] Figure 1 The thermal therapy system 33 is shown to include a pump 148 , fluid 6 , and / or reservoir 150 . Figure 1 The heat exchange system 13 is shown to include a pump 148, a fluid 6, and / or a reservoir 150. The pump 148 can be, for example, a circulation pump. The fluid 6 can be, for example, a heat transfer fluid. The reservoir 150 holds a certain volume of the fluid 6. The fluid 6 can be pumped into and / or out of the catheter 9 and / or the balloon 3 by the pump 148. The fluid 6 can be pumped through the catheter 9 and / or the balloon 3 by the pump 148. For example, Figure 1 It is shown that fluid 6 can be circulated and / or recirculated through catheter 9 and / or balloon 3 by pump 148. Figure 1It is shown that, for example, pump 148 can pump fluid 6 from reservoir 150 into catheter 9 and / or balloon 3, and / or pump 148 can pump fluid 6 from catheter 9 and / or balloon 3 into reservoir 150. For example, Figure 1 The thermal therapy system 33 shown may be a closed loop heat exchange system. For example, the balloon 3 may be inflated by filling the balloon 3 with a fluid 6. Figure 1 The balloon 3 is shown in an inflated configuration, with a portion of fluid 6 located in the balloon 3. The balloon 3 can be deflated, for example, by removing the fluid 6 from the balloon 3.
[0122] Figure 1 The balloon 3 is shown to be conformable to the wall 108 (also referred to as the stomach wall 108) of the stomach 2. For example, the balloon 3 can have a large surface area contact with the wall of the stomach 2.
[0123] Figure 1 The catheter 9 is shown to have a catheter tip 7. The catheter tip 7 can be, for example, the distal tip of the catheter 9 and / or the heat spreader 4. The catheter tip 7 can be connected to the catheter 9 and / or integrated with the catheter 9. For example, Figure 1 The catheter tip 7 is shown as being integrated with the catheter 9. The heat transmitter 4, catheter 9, catheter tip 7, and / or balloon 3 can be positioned adjacent to and / or near the pancreas 1. The balloon 3 can be positioned adjacent to a gastric pancreas wall 8. The gastric pancreas wall 8 can be, for example, a portion of a stomach wall 108 adjacent to, opposite to, and / or near the pancreas 1. The fluid 6 can increase and / or decrease the temperature of the gastric pancreas wall 8 and / or pancreas 1. The fluid 6 can transfer heat to and / or extract heat from the pancreas 1 and / or the gastric pancreas wall 8.
[0124] 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, salt water, oil, fat, synthetic and / or organic.
[0125] The heat spreader 4, fluid 6, balloon 3 and / or catheter 9 can be sterile, clean, unclean and / or non-sterile. The heat spreader 4, catheter 9 and / or balloon 3 can be disposable, reusable, cleanable, re-cleanable, sterilizable and / or re-sterilizable.
[0126] Nutrients, medications, sensors, devices, and / or tools can be delivered through the heat transmitter 4, catheter 9, and / or balloon 3. For example, the nutrients, medications, sensors, devices, and / or tools can be expelled from the catheter tip 7. The catheter tip 7 can apply suction to the stomach 2. The nutrients, medications, sensors, devices, and / or tools can be delivered to the duodenum 37 and / or the jejunum 10. Figure 1It is shown that the catheter 9, balloon 3 and / or heat transmitter 4 can be passed through the nose 11. The catheter 9, balloon 3 and / or heat transmitter 4 can be passed through the mouth 12. The catheter 9, balloon 3 and / or heat transmitter 4 can be connected to (e.g., removably connected to) a 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 system and / or a cooling system. The heat exchange system 13 can cool the fluid 6 and / or remove heat from the fluid 6, the heat exchange system 13 can heat the fluid 6 and / or transfer heat to the fluid 6, and / or the heat exchange system 13 can cool the fluid 6 and / or remove heat from the fluid 6 and can heat the fluid 6 and / or transfer heat to the fluid 6. The catheter 9, balloon 3 and / or heat transmitter 4 can be connected to (e.g., removably connected to) the cooling system 13 at the connector 14. For example, Figure 1 The proximal end of the catheter 9 is shown to be detachably connected to a connector 14. The connector 14 may provide fluid, optical, and / or electrical coupling between the cooling system 13 and the heat spreader 4, catheter 9, and / or balloon 3.
[0127] The catheter 9 can be, for example, a tube having zero, one, or more lumens. For example, the catheter 9 can have from zero to more than ten lumens, including every lumen increment within this range (e.g., 0 lumen, 1 lumen, 2 lumens, 3 lumens, 4 lumens, 5 lumens, 10 lumens). Figures 2a to 2d The conduit 9 is shown to have various cross-sections. The cross-section of the conduit 9 may be constant and / or may vary along the length of the conduit 9. Figures 2a to 2d The lumen shown can have various cross-sections. The cross-section of the lumen can be constant and / or can vary along the length of the catheter 9. Figures 2a to 2d It is shown that the catheter 9 and / or heat exchanger 9 can have a lumen 15, a lumen 16, a lumen 17 and / or a lumen 18 (also referred to as a first lumen 15, a second lumen 16, a third lumen 17 and / or a fourth lumen 18, respectively). Figures 2a to 2d It is shown that the catheter 9 and / or the heat transfer device 4 can have any combination of a first lumen 15, a second lumen 16, a third lumen 17 and / or a fourth lumen 18. Lumen 15, lumen 16, lumen 17 and / or lumen 18 can be heat transfer lumens and / or accessory lumens. For example, lumen 15 and lumen 16 can be heat transfer lumens, and lumen 17 and lumen 18 can be accessory lumens. For example, lumen 15 can be a first heat transfer lumen, lumen 16 can be a second heat transfer lumen, lumen 17 can be a first accessory lumen, and lumen 18 can be a second accessory lumen. For example, lumen 15 can be an inflow lumen, and lumen 16 can be an outflow lumen.
[0128] 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 through the first lumen 15 and the second lumen 16 in the catheter 9. The fluid 6 can circulate through the catheter 9 and / or the heat exchanger 4 in a constant direction; for example, the fluid 6 can flow distally through the first lumen 15 and proximally through the second lumen 16, or vice versa. The fluid 6 can be at different temperatures in the first lumen 15 and / or the second heat transfer lumen 16. For example, Figures 2a to 2c Fluid 6 traveling from heat exchange system 13 (e.g., from reservoir 150) to balloon 3 is shown to travel in first lumen 15 and return in second lumen 16, thereby reducing heat transfer from other parts of the body (e.g., esophagus 5). Fluid 6 can flow proximally and distally through first lumen 15 and / or second lumen 16. For example, fluid 6 can flow distally through first lumen 15 to inflate balloon 3, reside within balloon 3 for a period of time, and then flow proximally through first lumen 15. Third lumen 17 and / or fourth lumen 18 can, for example, deliver nutrients, medications, sensors, devices, and / or tools. Third lumen 17 and / or fourth lumen 18 can provide suction to stomach 2, duodenum 37, and / or jejunum 10. The thickness 20 of catheter wall 154 can vary at different cross-sections of catheter 9 and / or within the same cross-section of catheter 9. Catheter 9 can have an outer diameter 19. The outer diameter 19 of the conduit can be constant and / or vary along the length of the conduit 9. The cross-section of the conduit 9 can be, for example, circular, square, oval, triangular, and / or other geometric shapes. The outer diameter 19 of the conduit can be continuous and / or discontinuous. The outer diameter 19 of the conduit can have bumps, divots, grooves, splines, and / or ridges.
[0129] Figure 3 The heat transmitter 4 , catheter 9 , and / or plug 28 are shown as being orally deliverable through the mouth 12 . Figure 3It is shown that fluid 6 can be in direct contact with the stomach wall 2 and / or the gastro-pancreatic wall 8. For example, fluid 6 can be delivered to the stomach 2 through the first lumen 15 and / or the second lumen 16. Depending on the patient's position (orientation), gravity alone can force the liquid 6 to be adjacent to the gastro-pancreatic wall 8. Fluid 6 can be a fluid naturally present in the stomach 2. For example, fluid 6 can be gastric acid, gastric juice, stomach acid (stomachacid), blood and / or abdominal fluid. Fluid 6 can be, for example, compressed gas and / or phase change material. For example, fluid 6 can be delivered through catheter 9 in liquid form and then converted into gas when leaving catheter tip 7. When fluid 6 is converted from liquid to gas, fluid 6 can absorb energy (for example, a large amount of energy), thereby reducing the temperature of the stomach 2, gastro-pancreatic wall 8, pancreas 1, duodenum 37 and / or jejunum 10. Catheter tip 7 can be located at stomach 2, duodenum 37, jejunum 10 and / or pancreas 1. Fluid 6 can be, for example, alcohol, nitrogen, carbon dioxide, or a refrigerant (e.g., Freon, CFC, HFC, R22, R-290, R-600a, R-717, R-1234, R-744, R-32, R-134a, and / or R-410a). Fluid 6 can be stored and / or transported in conduit 9 at a pressure greater than ambient pressure. Conduit 9 can transfer heat to or from the stomach 2, gastro-pancreatic wall 8, pancreas 1, duodenum 37, and / or jejunum 10 via a thermoelectric process. For example, heat exchange methods can include thermoelectric cooling, vapor compression cooling, phase change cooling, Carnot cycle cooling, reverse Rankine cooling, evaporative cooling, heat tunnel cooling, magnetic cooling, cyclic cooling, non-cyclic cooling, sortpion cycle, elastocaloric cooling, refrigerator door, vortex tube, pulse tube cooling, thermoacoustic cooling, or any combination thereof. Figure 3 It is shown that the plug 28 can be deployed at the target site 147. The plug 28 can be fixed at the distal end of the catheter 9 or near the distal end of the catheter 9, and / or can be detached from the catheter 9. The plug 28 can be delivered through the catheter 9. For example, the plug 28 can be delivered through the third lumen 17 and / or the fourth lumen 18. The plug 28 can form an outflow obstruction at the interface of the stomach 2, the duodenum 37, the jejunum 10, the pyloric sphincter 66 and / or the intestine. The plug 28 can block the flow of liquid from the stomach 2. The plug 28 can be bioabsorbable. A coating can be delivered to the stomach 2 to change the absorption rate and / or adsorption rate of the fluid through the stomach wall 108 and / or the gastro-pancreatic wall 8. The coating can be absorbed and / or degraded at a predetermined rate.
[0130] The heat transmitter 4, catheter 9, balloon 3, catheter tip 7 and / or any component passing through the catheter 9 may include zero, one or more sensors 21 (also referred to as sensors 21, for example, from 0 to more than 10 sensors 21, including every sensor increment within this range (for example, 0 sensors, 1 sensor, 2 sensors, 3 sensors, 10 sensors). The sensors 21 can monitor, for example, temperature, energy, pH, pressure, motion, gravity, direction, position, electromagnetic waves, magnetism, light, contact and / or flow rate. The sensors 21 can monitor, for example, the approximate total heat transfer and / or heat transfer from the patient (e.g., body 152) to the heat transmitter 4, catheter 9 and / or balloon 3. For example, one or more sensors 21 can monitor the temperature of the fluid 6 entering and leaving the catheter 9, the heat transmitter 4, the heat exchange system 13, and / or the 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 patient fluid. The sensor 21 can monitor the patient's local hypothermia and / or systemic hypothermia and / or normal body temperature. The sensor 21 can monitor gastric contents, including but not limited to gastric acidity.
[0131] The sensor 21 can provide an alarm to the patient, doctor, nurse and / or other staff. The sensor 21 can determine the orientation of the patient, fluid 6, balloon 3, catheter 9, heat transmitter 4 and / or catheter tip 7. The sensor 21 can determine whether the patient is in an ideal position or non-ideal position for effective local hypothermia of the pancreas 1. For example, the sensor 21 can determine whether the balloon 3, fluid 6 and / or catheter tip 7 are adjacent to the gastric and pancreatic wall 8. The patient can move or be moved to improve the patient's comfort and / or prevent ulcers (such as pressure sores). The patient can move and / or be moved at fixed intervals. The heat exchange system 13 can provide manual feedback and / or automatic feedback based on the sensor 21. For example, if the pressure is out of range and / or the patient is not in the ideal treatment position, the balloon 3 can be automatically deflated.
[0132] The balloon 3 can be periodically adjusted, moved, inflated, and / or deflated. For example, to help prevent pressure sores, the 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 the inflation / deflation of the balloon 3 can be manually and / or automatically controlled by the heat exchange system 13.
[0133] Figure 4aThe balloon 3 is shown to be in fluid communication with the first lumen 15 via a balloon port 22. The heat spreader 4 and / or the catheter 9 can have multiple balloon ports 22. Multiple balloon ports 22 can improve the flow of the fluid 6. For example, multiple balloon ports 22 can provide redundancy in case one of the balloon ports 22 becomes blocked. For example, multiple balloon ports 22 can provide redundancy in the event that one of the balloon ports 22 becomes blocked.
[0134] Figure 4b The balloon 3 is shown to be in fluid communication with the first lumen 15 and / or the second lumen 16 via the balloon port 22. For example, fluid 6 can travel distally from the heat exchange system 13 along lumen flow direction 24a, fluid 6 can exit the first lumen 15 through balloon port 22a along balloon port flow direction 23a, fluid 6 can circulate within the balloon 3, fluid 6 can enter the second lumen 16 through balloon port 22b along balloon port flow direction 23b, and fluid 6 can travel proximally toward the heat exchange system 13 along lumen flow direction 24b. The fluid 6 can be heated and / or cooled in the heat exchange system 13 before traveling distally toward the balloon 3.
[0135] The balloon 3 may contain one or more fluids. For example, Figure 5a to Figure 5b The balloon 3 is shown as being filled with a fluid 6 (e.g., a heat transfer fluid) and / or an insulating fluid 25. The insulating fluid 25 can have a lower thermal conductivity than the fluid 6. The insulating fluid 25 can be, for example, a gas, such as air, oxygen, and / or nitrogen. The fluid 6 and / or the insulating fluid 25 can travel through the first lumen 15 and / or the second lumen 16. The density of the fluid 6 can be greater than, less than, and / or equal to the density of the insulating fluid 25. For example, the fluid 6 can reside at the bottom of the balloon 3 due to gravity. The bottom of the balloon 3 can be adjacent to the gastric and pancreatic wall 8. The volume of the balloon 3 can be equal to the volume of the insulating fluid 25 and / or the volume of the fluid 6 contained within the balloon 3. Heat transfer through the balloon 3 occurs primarily at surfaces in contact with the fluid 6. Figure 5a to Figure 5b The configuration shown in can allow the volume and / or position of the balloon to be adjusted independently of the heat transfer properties and / or heat transfer surface of the balloon 3. For example, the balloon 3 can be securely positioned in the stomach 2 and / or can contact multiple surfaces of the stomach 2 while providing localized heating and / or localized cooling to a small portion of the stomach 2.
[0136] Figure 5a It is shown that the balloon 3 can have fluidly separated compartments or volumes (e.g., a first compartment can receive an insulating fluid 25 and a second compartment can receive a fluid 6), and / or the heat transfer device 4 (e.g., a catheter 9) can have one or more balloons 3 (e.g., which can receive a fluid 6 and / or an insulating fluid 25) and one or more insulating balloons adjacent to the balloon 3 (e.g., which can receive an insulating fluid).
[0137] Figure 5b The insulating gastric balloon 26 is shown as being located inside and / or outside of the balloon 3. The insulating gastric balloon 26 can be in fluid communication with the first lumen 15 via balloon port 22a. The balloon 3 can be in fluid communication with the second lumen 16 via balloon port 22b. The insulating gastric balloon 26 can be filled with an insulating fluid 25.
[0138] For example, various methods can be used to control the heat transfer rate of the heat exchanger 4, the catheter 9, and / or the balloon 3. 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 gastro-pancreatic 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 traveling through the catheter 9, the heat exchanger 4, and / or the balloon 3 can be adjusted.
[0139] Figure 6 The pancreas is shown to be cooled by periodically pulsing fluid 6 proximally and distally through catheter 9. Fluid 6 can be heated and / or cooled by heat exchange system 13. Cool fluid 6 can travel through catheter 9 and / or inflate balloon 3. As cool fluid 6 removes energy from the gastropancreatic wall 8 and / or pancreas 1, the temperature of cool fluid 6 can increase. Fluid 6 can be periodically removed from balloon 3 and / or stomach 2. The frequency of circulation of fluid 6 can be based on time, temperature, and / or other parameters. With each cycle, the temperature of pancreas 1 decreases until a steady-state equilibrium is reached.
[0140] Figure 7The catheter 9 and / or heat transmitter 4 are shown as having or being connected to a stomach positioning mechanism 27. The stomach positioning mechanism 27 can be a mechanical structure. The stomach positioning mechanism 27 can be deployed together with the cooling membrane and / or balloon 3. The stomach positioning mechanism 27 can ensure that the catheter 9, the catheter tip 7, and / or the balloon 3 are correctly positioned relative to the stomach and pancreatic wall 8. The stomach positioning mechanism 27 can be a soft stent, a spiral, a balloon, and / or a mesh. The stomach positioning mechanism 27 can be delivered with a small outer diameter and then expanded in the stomach 2. The stomach positioning mechanism 27 can be made of a bioabsorbable and / or biodegradable material. The stomach positioning mechanism 27 can brace against the cardia, the gastric fundus, the gastric body, the pyloric atrium, the pyloric canal, or any combination thereof. The catheter 9, the heat transmitter 4, the catheter tip 7, the balloon 3, and / or the insulated gastric balloon 26 can include a marker 29 and / or multiple markers 29. The marker 29 can aid visualization using ultrasound, CT, X-ray, MRI, and / or other imaging modalities. Marker 29 can be magnetic. For example, sensor 21 can determine the absolute and / or relative position of marker 29. Marker 29 can allow the operator to adjust the position of catheter 9, heat exchanger 4, catheter tip 7, balloon 3, and / or insulated gastric balloon 26 using external magnets and / or magnetic fields. Heat exchange system 13, catheter 9, heat exchanger 4, catheter tip 7, balloon 3, and / or insulated gastric balloon 26 can include a relief valve 30. Relief valve 30 provides a pressure relief mechanism for first lumen 15 and / or second lumen 16. If the pressure in balloon 3 exceeds a threshold, excess fluid can flow out of relief valve 30. For example, if stomach 2 contracts and compresses balloon 3, fluid 6 can flow out of relief valve 30 (e.g., to inhibit and / or prevent damage to heat exchanger 4, catheter 9, and / or the patient). The set point for relief valve 30 can be fixed and / or adjustable. Relief valve 30 can be controlled by heat exchange system 13.
[0141] Figure 8The heat transmitter 4 and / or the catheter 9 are shown to have one or more insulating ports 31. The insulating ports 31 can allow an insulating fluid 25 to pass along the outside of the catheter 9. The insulating fluid 25 can be warm and / or at room temperature. The insulating fluid 25 can come into contact with the stomach 2, esophagus 5, mouth 12, nose 11, and / or other patient tissues. The insulating ports 31 can be located at different locations along the catheter 9. A balloon can be positioned above the catheter 9 to have the insulating fluid 25. The outer diameter 19 of the heat transmitter 4 and / or the catheter 9 can have an insulating material including, but not limited to, aerogel, air, foam, rubber, gas, vacuum, wood, and / or polymer. The insulating fluid 25 and the fluid 6 can travel through the first lumen 15 and / or the second lumen 16. For example, fluid 6 (e.g., hot and / or cold fluid 6) can be delivered distally through first lumen 15 to fill balloon 3, and then insulating fluid 25 can be delivered through first lumen 15 to remove cold fluid 6 from other portions of catheter 9 (e.g., thereby reducing heat transfer to other organs such as esophagus 5). An external heating system or an internal heating system (e.g., external pad 32) can be applied to the patient. For example, a blanket can be placed on top of a blanket to prevent systemic hypothermia.
[0142] Figure 9 The heat transmitter 4 and / or 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 to the pancreas 1, the peritoneal cavity, and / or other tissues. Compressed gas can be delivered to the pancreas 1 and can cool the pancreas 1 upon evaporation. Figure 9 The thermal therapy system 33 is shown to include an external pad 32 . Figure 9 An external pad 32 is shown positioned on the patient. One or more external pads 32 can be placed on the patient. The external pad 32 can include a sensor 21. The external pad 32 can provide heating and / or cooling to the patient. The external pad 32 can have magnets and / or imaging to help position the heat transmitter 4.
[0143] Figure 10 The stomach positioning mechanism shown may be a fixation mechanism 34 or may include a fixation mechanism 34 that can position and / or secure the heat transmitter 4 and / or catheter 9 in the stomach 2. The fixation mechanism 34 may be a mechanical structure, such as an elastic coil. The fixation mechanism 34 can position and / or secure the balloon 3 to the stomach and pancreas wall 8. The fixation mechanism 34 may abut the cardia, gastric fundus, gastric body, pyloric atrium, pyloric canal, or any combination thereof.
[0144] Figure 11An impermeable membrane 35 is shown that can be deployed in the stomach 2. The impermeable membrane 35 can be a permeable membrane, a semipermeable membrane, and / or an impermeable membrane and / or a coating. The impermeable membrane 35 can be dissolvable and / or absorbable. A pyloric plug 36 can be deposited in the stomach 2. The pyloric plug 36 can be positioned to prevent the cooling fluid from draining into the duodenum and / or jejunum 10. The impermeable membrane 35 can prevent and / or slow the absorption of fluid into the wall of the stomach 2.
[0145] Figure 12 It was shown that target temperature of the pancreas could be achieved in a simulated pancreas (using bovine tissue) in a body temperature (37°C) water bath using cooling fluid circulating in a cooling balloon placed in a simulated stomach (using bovine stomach tissue).
[0146] Figure 13a and Figure 13b The esophagus 5 is shown to extend to the stomach 2, followed by the pylorus 65, and then the duodenum 37. The pancreas 1 can be in direct and / or indirect contact with the stomach 2 and / or the duodenum 37. The pancreas 1 can be divided into different regions, including but not limited to the head 38, the body 64, and / or the tail 39. The tail 39 can be in direct and / or indirect contact with the stomach 2. The head 38 can be in direct and / or indirect contact with the stomach 2, the pylorus 65, and / or the duodenum 37.
[0147] Figure 14a and Figure 14b The balloon 3 shown can be elastic. The balloon 3 can be connected to the catheter 9. The balloon 3 can be an extruded tube made of a polymer, elastomer and / or rubber. For example, the balloon 3 can be a thin-walled extruded silicone tube. Figure 14a Shown in the deflated configuration, the balloon 3 can have an outer diameter that is approximately the same as the catheter 9. The balloon 3 can be inflated with a fluid 6. The balloon 3 can be inflated to a low pressure that can adapt and / or conform to the stomach 2. The peristaltic motion and / or motility of the stomach 2 can manipulate and / or move the balloon 3. For example, gastric contractions can prompt and / or force the balloon 3 toward the pylorus 65. The catheter tip 7 can remain in the stomach 2, esophagus 5, pylorus 65 and / or duodenum 37. The catheter tip 7 can have ports for suction, decompression, feeding and / or insertion of instruments. The catheter tip 7 can be introduced and / or positioned over a guidewire. The balloon 3 can be secured to the catheter 9 with adhesives, ultrasonic welding, heat shrink tubing, metal tape and / or reflux melting. Figure 14a The deflated configuration shown is for inserting the balloon 3 into the esophagus 5 and / or stomach 2 and / or removing it from the esophagus 5 and / or stomach 2. The balloon 3 can be inflated to Figure 14b8. The inflated configuration shown. The catheter axis 86 can be parallel to and / or concentric with the catheter 9. The sagittal axis 87 (also known as the anterior-posterior axis) can pass through the center of the body from front to back. For example, when a person does a cartwheel, they rotate about the sagittal axis 87. The frontal axis 88 can pass through the center of the body from left to right. For example, when a person does a somersault, they rotate about the frontal axis 88. The dimensions of the balloon 3 in these different axes can be shorter and / or longer. For example, the length of the balloon 3 along the frontal axis 88 can be longer than the length along the sagittal axis 87.
[0148] Figures 15a to 15c The balloon 3 shown can be non-elastic. For example, the balloon 3 can be made of a polymer that is flexible but not designed to stretch. For example, the balloon 3 can be made of PET, LDPE, HDPE, mylar and / or nylon. The balloon 3 can be filled to a volume less than its maximum capacity. The duodenal device 40 can be an elastic balloon and / or a non-elastic balloon fixed to the catheter 9. The duodenal device 40 can be used as a reservoir for the balloon 3. For example, if external pressure (such as peristalsis, movement, vomiting, etc.) compresses the balloon 3, the fluid 6 can move from the balloon 3 to the duodenal device 40. The duodenal device 40 can be used as a damper to help regulate, maintain and / or control the volume and / or pressure of the balloon 3. The duodenal device 40 can be used in Figure 15b The deflation structure shown and Figure 15c Duodenal device 40 can help cool and / or warm the pancreas 1, pylorus 65, and / or duodenum 37. Duodenal device 40 can help cool and / or warm the pancreatic head 38. Balloon 3 can help cool and / or warm the stomach 2 and / or pancreas 1. Catheter 9, balloon 3, and / or duodenal device 40 can help cool and / or warm the core body temperature and / or specific organs in the body.
[0149] Figure 16a 、 Figure 16b and Figure 16c The balloon 3 is shown as an inflatable, non-elastic structure. The balloon 3 can be divided into lobes 89 having bonded zones, which can be formed by thermal bonding, chemical bonding (e.g., ultrasonic welding, ultrasonic welding, thermal bonding), mechanical bonding (thread, staples) between polymer sheets to form lobes. The lobes are fluidically connected to the conduit to allow liquid to circulate. The bonded zones can form channels that can be flexible in more than one direction. Figure 16c The adhesive area shown can surround the leaf 89a, allowing flexibility in all directions. The spacing between the adhesive portions can determine the height of the leaf expansion, limit the height or thickness of the balloon, and limit expansion or pressure on the stomach in the anterior-posterior direction.
[0150] Figure 16b and Figure 16c Two lobes or inflated areas are shown. The front layer 43 can be filled with gas or a cooler fluid than the layer 44 closest to the posterior stomach wall. This cooler temperature zone helps isolate the cooling of the anterior stomach wall adjacent to the pancreas and insulates the posterior stomach wall. The outer edge of the balloon can be marked with a radiopaque marker or an echogenic marker to indicate complete inflation or full deployment of the balloon. The catheter tip 7 can remain in the stomach 2, esophagus 5, pylorus 65 and / or duodenum 37. The catheter tip 7 can have ports for suction, decompression, delivery and / or insertion of instruments. The catheter tip 7 can be introduced and / or positioned over a guidewire.
[0151] The balloon radius of curvature 85 can be constant and / or vary along the length of the balloon 3 and / or catheter 9. The balloon radius of curvature 85 can be inverted. The balloon radius of curvature 85 can be greater than approximately 0.5 inches (1.3 cm), more narrowly greater than approximately 1 inch (2.5 cm), still more narrowly greater than approximately 2 inches (5.1 cm), yet more narrowly greater than approximately 3 inches (7.6 cm), yet more narrowly greater than approximately 5 inches (12.7 cm), yet more narrowly greater than approximately 7 inches (17.8 cm), yet more narrowly greater than approximately 10 inches (25.4 cm), yet more narrowly greater than approximately 15 inches (38.1 cm), and / or yet more narrowly greater than approximately 20 inches (50.8 cm). The balloon radius of curvature 85 can be less than about 20 inches (50.8 cm), even more narrowly less than about 15 inches (38.1 cm), even more narrowly less than about 10 inches (25.4 cm), even more narrowly less than about 7 inches (17.8 cm), even more narrowly less than about 5 inches (12.7 cm), even more narrowly less than about 3 inches (7.6 cm), even more narrowly less than about 2 inches (5.1 cm), even more narrowly less than about 1 inch (2.5 cm), even more narrowly less than about 0.5 inches (1.3 cm).
[0152] Figure 17The catheter 9 shown can function as a heat transfer device. The catheter 9 can have a sufficient surface area to provide heat transfer between the stomach 2 and the fluid 6. A physician can insert a predetermined length of catheter 9 into the stomach 2. By adjusting the length of catheter 9 within the stomach 2, the physician can adjust the surface area of catheter 9 within the stomach 2, thereby controlling the heat transfer between the heat exchanger 4 and the stomach 2. The catheter 9 can be fixed and / or moved relative to the stomach 2. For example, peristalsis and / or movement can cause the catheter 9 to move. The catheter 9 can directly and / or indirectly cool the walls of the stomach 2. For example, the catheter 9, balloon 3, and / or heat exchanger 4 can cool gastric fluid and / or fluid within the stomach 2. The catheter 9 can include catheter barbs 45. The catheter 9 can include multiple catheter barbs 45. The catheter barbs 45 can be cilia-like flaps on the catheter 9. The catheter barbs 45 can be an integral part of the catheter 9 and / or a separate component from the catheter 9. The catheter barbs 45 can help guide the catheter 9 to the duodenum 37 and / or pylorus 65. The catheter barbs 45 can help to retain the catheter 9 in the duodenum 37 and / or pylorus 65. A given cross-section of the catheter 9 can include zero, one, or more catheter barbs 45. The catheter barbs 45 can provide greater axial friction and / or resistance in one direction. For example, the force that propels and / or pulls the catheter 9 and / or the catheter barbs 45 toward the distal end can be less than the force that propels and / or pulls the catheter 9 and / or the catheter barbs 45 toward the proximal end. The catheter barbs 45 can enable the catheter 9 to self-advance to the duodenum 37. The duodenal device 40 can be a weight. For example, the extra weight at and / or near the catheter tip 7 can help to guide and / or promote the catheter 9 to enter the duodenum 37 and / or pylorus 65. For example, the extra weight at and / or near the catheter tip 7 can help to retain and / or maintain the catheter 9 in the duodenum 37 and / or pylorus 65. The duodenal device 40 can help guide and / or facilitate the entry of the catheter 9 into the duodenum 37 and / or pylorus 65. The duodenal device 40 can help retain and / or maintain the catheter 9 in the duodenum 37 and / or pylorus 65. The duodenal device 40 can be a balloon. The duodenal device 40 can be inflated to increase friction between the heat transmitter 4 and the organ (e.g., the duodenum 37). The duodenal device 40 can be inflated after it passes through the pyloric sphincter 66 and / or pylorus 65. For example, if the duodenal device 40 is expanded after it passes through the pyloric sphincter 66 and / or pylorus 65, it can then help retain the catheter tip 7 in the duodenum 37. The duodenal device 40 can be a braided and / or flexible material whose diameter can be adjusted based on its length. For example, contracting the axial length of the duodenal device 40 can increase its radial diameter.The catheter barbs 45 may be retractable and / or extendable.
[0153] Figure 18 The catheter 9 is shown as having a helical shape and / or profile. For example, a portion of the catheter 9 can be heat-set and / or formed into a helical shape. Additional materials and / or components can be used to create and / or adjust the shape of the catheter 9. For example, the catheter 9 can be made of two materials with different coefficients of thermal expansion; for example, when the catheter 9 is exposed to body temperature and / or temperature from the fluid 6, it can change its shape and / or profile. A wire (e.g., metal and / or plastic) can be inserted into the lumen of the catheter 9 to form the helical shape and / or straighten the catheter 9. For example, during insertion and / or removal, it is desirable for the catheter 9 to remain generally straight. The wire can be formed into a helical shape and retained in the catheter 9 to help maintain the helical shape. The wire can be secured to the catheter tip 7 and then pulled, twisted, twisted, and / or advanced relative to the catheter 9 to adjust the shape of the catheter 9. For example, if the wire is offset from the axis and tightened, it can curl the catheter 9 into a helical shape. The wire can be made of a shape-memory alloy (e.g., nitinol) that can adjust its shape based on temperature. The lumen of catheter 9 can be placed under high or low pressure to force the catheter into a spiral shape. Catheter 9 can include one or more sensors 21. Sensor 21a can be different from sensor 21b. Sensor 21 can measure temperature, pressure, flow, pH, sound, enzymes, proteins, biological activity, and / or motion. Sensor 21 can extend a sensor length 103 outside the body of catheter 9. Sensor 21 can extend away from catheter 9 at various angles, so that sensor length 103 can be less than, equal to, and / or greater than sensor radial length 104. Sensor radial length 104 can be the minimum distance from sensor 21 to the body of catheter 9. Sensor radial length 104 and / or sensor length 103 can be changed and / or adjusted. For example, sensor 21 can be adhered to the body of catheter 9 using a dissolvable and / or releasable adhesive, heat shrink tubing, glue, and / or a mechanism. For example, changes in temperature, acidity, and / or pressure can cause the tip of sensor 21 to release from the body of catheter 9.
[0154] Figure 19 It is shown that a 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 a percutaneous port 46. The catheter 9 can be introduced through the anterior portion and / or the posterior portion of the stomach 2. The catheter 9 can be introduced into the gastric cardia, gastric fundus, gastric body, pylorus 65, duodenum 37, and / or pyloric sphincter 66.
[0155] Figure 20The catheter 9 is shown as having one or more coils and / or spirals. For example, a portion of the catheter 9 can be heat-set and / or formed into a spiral shape. Additional materials and / or components can be used to create and / or adjust the shape of the catheter 9. For example, the catheter 9 can be made of two materials with different coefficients of thermal expansion; for example, when the catheter 9 is exposed to body temperature and / or temperature from the fluid 6, it can change its shape and / or contour. A wire (e.g., metal and / or plastic) can be inserted into the lumen of the catheter 9 to form the spiral shape and / or straighten the catheter 9. For example, during insertion and / or removal, it is desirable for the catheter 9 to remain generally straight. The wire can be formed into a spiral and retained in the catheter 9 to help maintain the spiral shape. The wire can be fixed to the catheter tip 7 and then pulled, twisted, twisted, and / or advanced relative to the catheter 9 to adjust the shape of the catheter 9. For example, if the wire is offset from the axis and tightened, it can curl the catheter 9 into a spiral shape. The wire can be made of a shape memory alloy (e.g., Nitinol) that can adjust its shape based on temperature. The lumen of catheter 9 can be placed under high or low pressure to force the catheter into a spiral shape. Catheter 9 can have a gastric coil 47 and / or an engager 48. Gastric coil 47 can extend into the duodenum 37. Engager 48 can extend into the stomach 2. Gastric coil 47 can provide additional surface area and / or flexibility. Gastric coil 47 and / or the spiral shape can help prevent catheter 9 from kinking and / or forming knots. Engager 48 can help retain catheter tip 7 in the duodenum 37. Engager 48 and / or gastric coil 47 can help increase thermal contact with fluid and / or tissue. For example, engager 48 can increase thermal contact with the duodenum 37. Engager 48 and / or gastric coil 47 can provide strain relief to offset and / or resist peristalsis, movement, and / or other external forces. Engager 48 can be, for example, a duodenal coil. A tether 73 can be secured to an anchor point 74 on the catheter 9. The tether 73 can extend along the catheter 9 and / or can enter the catheter 9 at an anchor 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 restrict a portion of the catheter 9 proximal to the anchor point 74 from traveling distally to the pylorus 65 and / or the duodenum 37. The tether 73 can be tightened relative to the catheter 9 to adjust the maximum distance between the anchor point 74 and the anchor port 75. For example, the distance between the anchor point 74 and the anchor port 75 can be greater during insertion, use, and / or removal. For example, the distance between the anchor point 74 and the anchor port 75 can be greater during insertion / removal than once positioned in 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 secured to the catheter 9, the nose 11, and / or the heat transmitter 4. For example, once the tether 73 is tightened, it can be secured to the proximal portion of the catheter 9 outside the body. For example, during removal, the tether 73 can be released from the proximal portion of the catheter 9 outside the body to more easily remove the catheter 9 from the patient's body. The tether 73 can be made of natural polymers and / or synthetic polymers. The tether 73 can be made of metal, plastic, and / or ceramic. The proximal portion of the tether 73, the catheter 9, and / or the heat transmitter 4 can be secured to the patient (e.g., the nose 11, the mouth 12, and / or other points on the patient's body). The proximal end of the tether can be connected to an actuator. The actuator can translate the tether and can have an automatic locking portion like a ratchet. Alternatively, the actuator can be manually locked into place. The deployment of the actuator can ensure and / or achieve consistent tension by maintaining a constant force (via a spring) or distance adjustment. The actuator can be, for example, a lever, a motor, or a transmission wheel. The actuator can have a visual indicator for feedback of travel distance or lock status. The tether 73 can be tightened. For example, the tether 73 can pull the anchor point 74 to the vicinity of and / or adjacent to the anchor port 75. Keeping the anchor point 74 near and / or adjacent to the anchor port 75 can reduce the risk of the catheter 9 becoming tangled and / or dislodged. The distance between the anchor point 74 and the anchor port 75 can be approximately equal to the length of the tether 73 between the anchor point 74 and the anchor port 75. The total length of the catheter 9 between the anchor point 74 and the anchor port 75 can be greater than the length of the tether 73 between the anchor point 74 and the anchor port 75. The tether 73 can be, for example, a string. The tether 73 can be, for example, an anchor string.
[0156] Figure 21It is shown that an introducer 49 can be inserted into the esophagus 5 and / or stomach 2. The introducer 49 can make the placement of the heat transmitter 4 easier and / or more controlled. The catheter 9 and / or the inner catheter 51 can be introduced through the introducer 49. The introducer 49 can be stiffer than the catheter 9 and / or the inner catheter 51. The introducer 49 can include various features, including bend-and-stay, deformability, a deflectable guide catheter, sensors, etc. The inner catheter 51 can be a compliant 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 thermal insulation between the catheter 9 and the tissue and / or organ. For example, the introducer 49 can provide thermal insulation between the catheter 9 and the esophagus 5, nose 11, mouth 12 and / or stomach 2. For example, the introducer 49 may provide thermal insulation between the heat transmitter 4 and the esophagus 5 , nose 11 , mouth 12 and / or stomach 2 .
[0157] Figure 22 The catheter 9 shown may have a balloon, such as a plurality of radially expandable balloons. Figure 22 The balloon is shown as being fluidically connected to a catheter. The balloon can be elastic, inelastic, or a combination of elastic and inelastic. Compared to a single balloon, multiple balloons arranged in sequence can provide greater flexibility along the catheter's axis while creating a larger surface area for temperature exchange. Inelastic balloons can be manufactured so that their diameter is limited regardless of pressure, limiting their volume. Similarly, the self-limiting diameter of an inelastic balloon limits the radially outward pressure acting on the stomach wall. Combinations of elastic and inelastic balloons are possible. Inelastic balloons under low pressure have sufficiently thin walls so that they can expand and conform to the rugae or curvature of the stomach, allowing for closer contact and greater heat transfer. The same catheter with an inelastic balloon can have an elastic region or bellows that can expand to reduce pressure when there is internal or external pressure on the inelastic balloon to maintain the integrity of the inelastic balloon material. Any cooling balloon can be an extruded tube made of a polymer, elastomer, and / or rubber. For example, the balloon 3 may be a thin-walled extruded silicone tube. Figure 22In the deflated configuration shown, the balloon 3 can have an outer diameter that is approximately the same as the catheter 9. The balloon 3 can be inflated with a fluid 6. The balloon 3 can be inflated to a low pressure that can adapt to and / or match the stomach 2. The peristaltic motion and / or motility of the stomach 2 can manipulate and / or move the balloon 3. For example, gastric contractions can prompt and / or force the balloon 3 toward the pylorus 65. The catheter tip 7 can remain in the stomach 2, esophagus 5, pylorus 65 and / or duodenum 37. The catheter tip 7 can have ports for suction, decompression, delivery and / or insertion of instruments. The catheter tip 7 can be introduced and / or positioned over a guidewire. Multiple cooling balloons 3 can be secured to the catheter 9 using adhesives, ultrasonic welding, heat shrink tubing, metal tape and / or reflux melting. Figure 22 The deflated structure shown is inserted into and / or removed from the esophagus 5 and / or stomach 2 by multiple balloons 3. The cooling balloon material 3 can be made of PET, LDPE, HDPE, mylar and / or nylon or an elastic material such as silicone gum or urethane. The distal end balloon of the series connection can be sized so that peristaltic motion or placement guided by imaging can be placed in the duodenum. This balloon in the duodenum can be used for anchoring position or cooling is provided for the duodenum, with the object of cooling the pancreatic head adjacent to the duodenum. The duodenal device 40 can be an elastic balloon and / or a non-elastic balloon fixed to a conduit 9. The duodenal device 40 can be used as a reservoir for balloon 3.
[0158] Figure 23 The lumen of the catheter 9 is shown to be expandable. For example, the entire catheter wall 20 and / or a portion of the catheter wall 20 can expand under pressure. The expandable catheter wall can be a balloon 3. The expandable catheter wall can increase the surface area of the catheter 9 during use. The expandable catheter wall can be in an unexpanded configuration during insertion and / or removal. The expandable catheter wall can include an expandable tube and / or an expandable balloon concentrically fixed around the catheter 9. The catheter 9 can include a catheter port 52 located at the catheter tip 7 and / or along the circumference of the catheter 9. The catheter 9 can include multiple catheter ports 52. The catheter port 52 can provide distributed access for decompression, delivery, tools and / or sensors. The catheter port 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 port 52 can be the same and / or different.
[0159] Figure 24An intestinal valve 90 is shown located at the level of the intestine behind the ampulla of Vater 41. The intestinal valve 90 can be placed endoscopically and anchored by radial expansion or having barb-like retention features. The intestinal valve 90 can have barb-like retention features. The intestinal valve 90 can be anchored in place by radial expansion of the intestinal valve 90 and / or engaging the barb-like retention features with tissue. The intestinal valve 90 can be remotely activated by remote control or magnet activation via a connected wired signal or wireless signal. When the valve is in the closed position, a cold or hot fluid can be introduced and circulated in the stomach and proximal obstructed duodenal region to cool a portion of the stomach and the duodenum adjacent to the pancreas. The cold or hot fluid can enter the pancreatic duct through the ampulla of Vater 41. The intestinal valve 90 can be programmed to open at set intervals or set temperatures via onboard sensors so that the cooling fluid is discharged after the fluid is warmed by the surrounding structures. The intestinal valve 90 can be opened manually or automatically by remote control. Opening of the intestinal valve 90 allows resident fluids such as secretions or ingested food or liquids to pass through.
[0160] Figure 25 The pyloric valve 91 is shown located at the level of the pylorus. The pyloric valve 91 can be placed endoscopically and anchored by radial expansion or by having a barbed retention feature or a geometry that allows it to be stuck in the pylorus to seal the stomach 2. The pyloric valve 91 can have a barbed retention feature. The pyloric valve 91 can be anchored in place by radial expansion of the pyloric valve 91 and / or by engaging the barbed retention feature with tissue. The pyloric valve 91 can be remotely activated by remote control or magnet activation via a connected wired or wireless signal. When the pyloric valve 91 is in the closed position, cold or hot fluid can be introduced and circulated in the stomach area to cool the portion of the stomach 2 adjacent to the pancreas 1. The closure of the pyloric valve 91 controls how much fluid can be absorbed by limiting or preventing fluid from entering the intestine. Once the cold fluid is diverted from the stomach 2 and surrounding organs, causing the fluid to warm, it can be emptied by suction and replaced with cold fluid in an automated cycle. The lumen of catheter 9 with catheter tip 7 continuously passes through pyloric valve 91, allowing direct infusion into the intestine and bypassing any irritation to stomach 2. Pyloric valve 91 can be programmed to open at set intervals or at a set temperature via onboard sensors, allowing the cooling fluid to be discharged after being warmed by the surrounding structures. Pyloric valve 91 can be opened manually or automatically via remote control. Opening pyloric valve 91 allows the passage of retained fluid, such as secretions or ingested food or liquids.
[0161] Figure 26A peritoneal cooling device 53 is shown applied to the outer surface of the pancreas 1. The peritoneal cooling device 53 can be a balloon and / or a catheter. Fluid can be circulated with the peritoneal cooling device 53 through the peritoneal cooling device catheter 54. The peritoneal cooling device 53 can be placed laparoscopically or directly through the abdomen.
[0162] Figures 27a to 27f The catheter 9 is shown to comprise various cross-sectional profiles. The cross-section of the catheter 9 may be the same and / or different along its length. Figure 27a The catheter 9 is shown to have a circular and / or approximately 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 may be the same and / or different. Figure 27b The cross-section of the first lumen 15 and / or the second lumen 16 can be non-circular. A circular cross-sectional profile of the third lumen 17 and / or the fourth lumen 18 can be desirable for improving the passage of tools, sensors, food, tissue, and / or other substances. The circular cross-sectional profile of the first lumen 15 and / or the second lumen 16 can allow for a higher flow rate and / or a lower pressure drop. The non-circular cross-sectional profile of the first lumen 15 and / or the second lumen 16 can allow for a larger hydraulic diameter. The non-circular cross-sectional profile of the first lumen 15 and / or the second lumen 16 can increase heat transfer through the wall of the catheter 9 by providing a larger surface area in contact with the fluid 6. Figure 27c It is shown that the cross-sectional profile of the conduit 9 may be non-circular. Figure 27c The wall thickness of the conduit 9 can be varied at a given cross section. A thinner conduit wall 20 can allow for increased heat transfer through the conduit wall 20. The lumen of the conduit 9 can expand and / or contract at different pressures. For example, at high pressures, the cross section of the conduit 9 can be varied from Figure 27b The cross section shown transforms into Figure 27c Cross section shown. Figure 23 The catheter 9 in the Figure 27b and Figure 27c The conduit wall 20 may be elastic and / or inelastic. Figure 27d and Figure 27e The cross-sectional profile of the catheter 9 is shown to maximize heat transfer through the catheter outer diameter 19. For example, the non-circular profile of the first lumen 15 and / or the second lumen 16 can maximize contact with the outer wall of the catheter 9, thereby increasing heat transfer through the catheter wall 20. Figure 27fThe diameter and / or area of the third lumen 17 shown can be different from the diameter and / or area of the fourth lumen 18. If the third lumen 17 is used for suction, decompression, delivery and / or passage of tools, it can benefit from a larger diameter. The fourth lumen 18 is conducive to venting, delivery, sensing and / or 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 spiral around and / or pass through the catheter 9. The first lumen 15, the second lumen 16, the third lumen 17 and / or the fourth lumen 18 can spiral around and / or twist around each other.
[0163] Figure 28a and Figure 28b It is shown that the tube and / or balloon can be fixed concentrically on the catheter 9. The balloon 3 can be fixed concentrically on the catheter 9. Figure 23 The catheter 9 in the Figure 28a and Figure 28b The balloon 3 can be secured to the catheter 9 at one or more balloon sealing regions 55. The balloon sealing regions 55a and / or the balloon sealing regions 55b can prevent the fluid 6 from passing between the first lumen 15 and the second lumen 16. The fluid 6 can pass from the first lumen 15 to the balloon 3 through the catheter hole 65. The catheter hole 65 can be punched, skived, melted, cut, laser cut, drilled, machined, and / or formed into the catheter wall 20. The catheter 9 can have multiple catheter holes 65. For example, the fluid 6 can flow out of one of the catheter holes 65 into the balloon 3 and then back into the catheter 9 through a second catheter hole 65. The first lumen 15 and / or the second lumen 16 can be blocked in certain areas to force the fluid 6 into the balloon 3. The balloon sealing regions 55 can secure the balloon 3 to the catheter 9 by adhesive, brazing, heat shrink tubing, springs, melting, and / or ultrasonic welding.
[0164] Figure 29The catheter outer diameter 19 is shown as varying along the length of the catheter 9. For example, the catheter outer diameter 19 may be smaller in the nasal region to minimize discomfort and / or heat transfer to the nasal cavity. The catheter outer diameter 19 may be smaller in areas where heat transfer is not desired. For example, the catheter outer diameter 19 may be smaller in the nose 11, mouth 12, head, and / or esophagus 5. A smaller catheter outer diameter 19 may reduce the risk of knots and / or kinks and / or enable improved navigation, insertion, removal, and / or bending. A larger catheter outer diameter 19 may improve heat transfer, increase the heat transfer surface area, and reduce the risk of knots and / or kinks. The distal portion of the catheter 9 may not have the third lumen 17 and / or the fourth lumen 18. If the distal portion of the catheter 9 does not have 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 portion of the thermal catheter 9 may have the first lumen 15 and / or the second lumen 16 , but may not have the third lumen 17 and / or the fourth lumen 18 .
[0165] Figure 30A bypass lumen 63 is shown to allow some fluid 6 to flow directly from the output port of heat exchange system 13 to the return port of heat exchange system 13, without passing through heat exchanger 4 and / or entering stomach 2. For example, heat exchange system 13 may have (e.g., require) a minimum flow rate that is greater than the flow rate that can flow through catheter 9. Bypass lumen 63 can maintain a sufficiently high flow rate for heat exchange system 13 by directing some fluid 6 through catheter 9 and the remainder through bypass lumen 63. Bypass lumen 63, heat exchange system 13, catheter 9, and / or other components can have sensors, pressure relief valves, and / or switches to control the flow through bypass lumen 63. For example, a user can adjust the flow of fluid 6 through catheter 9 without adjusting heat exchange system 13. For example, during startup, all fluid 6 can pass through bypass lumen 6 until it reaches the appropriate temperature. Once the fluid 6 reaches the appropriate temperature, it can be switched to flow fully or partially through catheter 9. In an emergency, all fluids 6 can flow through the bypass lumen 63 without shutting down and / or adjusting the heat exchange system 13. The bypass lumen 63 can provide some damping and / or decompression for the catheter 9. The infusion bag (IV bag) 62 can be fixed to the infusion pole (IV pole) 57. The IV bag 62 can contain saline, nutrients, food, water, medicine and / or other substances. The contents of the IV bag 62 can be connected to the catheter 9 through 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 bag 62 can be controlled by adjusting the height of the IV bag 62 relative to the patient. The IV bag 62 and / or the contents of the IV bag 62 can be heated and / or cooled before and / or during surgery. The contents of the IV bag 62 can provide additional heating and / or cooling for the patient's stomach 2, pancreas 1, duodenum 37 and / or other organs. A metering device (e.g., a peristaltic pump, a drip chamber, and / or a valve) can be used to control the flow rate of the contents of IV bag 62. Fluid 6 from catheter 9 can be returned through return pouch 60 before returning to heat exchange system 13. For example, fluid 6 can be transferred from catheter 9 to catheter-pouch return lumen 58, then 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 in balloon 3 and / or other components of heat exchanger 4.
[0166] Figure 31It is shown that the external auxiliary lumen can be connected to a vacuum 67. The vacuum 67 can provide suction and / or pressure reduction. The vacuum 67 can provide intermittent vacuum and / or intermittent pressure. The external auxiliary lumen 61 can be connected to the vacuum 67, the IV bag 62 and / or other components / sensors. The heat exchange system 13 can transfer fluid 6 in a constant direction and / or loop. The heat exchange system 13 can inject and / or extract fluid 6. For example, the heat exchange system 13 can use a peristaltic pump and / or a syringe pump to inject and / or extract fluid 6. The heat exchange system 13 can heat and / or cool the fluid 6. The heat transmitter 4 can heat and / or cool tissue and / or organs. The heat transmitter 4, catheter 9 and / or balloon 3 can heat and / or cool the stomach 2, pancreas 1 and / or duodenum 37.
[0167] Figure 32 The catheter 9 and / or heat transfer device 4 can be introduced into the pancreas 1 through an artery. For example, the catheter 9 can be passed through the aorta 72, the celiac artery 68, the splenic artery 69, the pancreatic artery 70, and / or the gastroduodenal artery 71. If the catheter 9 is located within an artery, it can provide more efficient and / or localized heat transfer. For example, by being located within the pancreatic artery 70, the catheter 9 can provide more efficient and / or direct heat transfer to the pancreas 1. The catheter 9 can also be passed through the venous system.
[0168] Figure 33 The heat exchanger 4 is shown to cool the physical simulation of the stomach 2 and / or pancreas 1. Figure 33 The model of the data shown consists of a soft silicone stomach 2 and pancreas 1 placed in a 37 degree Celsius water bath. Thermocouples were placed at different locations in the pancreas 1. A catheter 9 of approximately 90 cm in length was placed in a chamber similar to Figure 18 A simulated stomach 2 is constructed as shown. Approximately 10 mL of fluid is placed inside the stomach 2 to simulate gastric fluid. A catheter 9 is connected to an external circulating cooling system, and fluid at 5 to 15 degrees Celsius flows through the catheter 9 at a rate of approximately 100 mL / minute. After approximately 30 minutes, the stomach 2 is gently manipulated using a mechanism to simulate gentle peristalsis and / or movement of the stomach 2. Figure 33 It is shown that the thermal therapy system 33 can cool the physically simulated pancreas 1 . Figure 33 This shows that gentle peristalsis and / or movement of the stomach 2 may help average the temperature of the pancreas 1 (eg the maximum / minimum temperature fluctuation band in the second half of the graph is narrower than in the first half). Figure 33 The heat spreader 4 in the data removes about 20 watts to 30 watts of heat in a steady state.
[0169] Figure 34A rotatable catheter is shown that can be positioned and advanced through the catheter tip 7 into the pylorus 65 and duodenum 37. The catheter 9 can have a tapered coil distal diameter 79 that can be smaller than the tapered coil maximum diameter 78. As the tapered coil proximal diameter 77 transitions into the helical portion of the catheter 9, the coil diameter at the tapered coil proximal diameter 77 can be smaller than the tapered coil maximum diameter 78. As the tapered coil proximal diameter 77 gradually transitions into the helical portion of the catheter 9, the coil diameter at the tapered coil proximal diameter 77 can be smaller than the tapered coil maximum diameter 78. In the narrowest portion of the nasal or naso-gastric passage, an introducer 49 or open catheter can be located to provide a bearing surface for the main cooling catheter 9 as forward and rotational forces are applied to the helical portion of the catheter through the pylorus and into the intestine. The introducer can prevent the more sensitive portions of the nasal passage from feeling the torque applied to the main heat transfer catheter.
[0170] Figures 35a to 35d A linear everting catheter is shown with a first catheter 80 that can be connected to a membrane 82 at its distal end. The membrane 82 can be connected to a second catheter 81 having a sealing port or a connection port, and the membrane 82 can have an annulus that responds to hydraulic pressure supplied by a fluid, medium, or gas. The hydraulic pressure causes the membrane 82 to evert or roll insideout in a frictionless manner. Within the first catheter 80 and the second catheter 81, a third catheter can be delivered. The third catheter can have an inflow lumen and an outflow lumen for a cooling (or heating) medium supplied by an external controller, as well as a lumen for suctioning or delivering nutrients to the patient.
[0171] The linear eversion catheter can be delivered through the nasopharynx and into the esophagus 5. The distal end of the first catheter 80 can be positioned at the patient's nostril and can be hydraulically pressurized by a fluid, medium or gas provided by an external source. Once pressurized, the second catheter 81 can be advanced to roll the membrane 82 through the nasopharynx and into the esophagus 5. Once the membrane 82 and the second catheter are fully extended, a third catheter can be delivered within the lumen of the second catheter 81 to supply the catheter cooling system described herein. The hydraulic oil, medium or gas can provide a passive or active source of insulation to protect the patient's nasopharynx from the thermal cooling energy from the third catheter. As an active source of insulation, a heated fluid, medium or gas can be introduced within the ring of the membrane to provide insulation from the cooling energy supplied by the internal third catheter. As a passive source of insulation, the ring of the linear eversion catheter can be filled with air or gas to supply an insulator.
[0172] Figure 35bOnce the linear eversion catheter is delivered into the patient's stomach, it can be deployed at the distal end of the catheter system. The distal end 7 of the first catheter 80 can be positioned toward the patient's pylorus. The first catheter 80 can be connected to a membrane 82, which can be connected to a second catheter. When pressurized by a fluid, medium, or gas, the second catheter 81 can be advanced to evert the membrane toward the pylorus. The unrolling action of the membrane 82 can be autonomous and suitable for cannulating the pylorus 65 and advancing into and through the duodenum 37. Within the second catheter 81 can be a lumen for a third catheter that can deliver thermal cooling energy to this anatomical location.
[0173] The entire catheter system can be configured with a linear everting delivery system to enter through the patient's nasopharynx and a second linear everting delivery system to bring cooling energy into the patient's duodenum 37 .
[0174] Figure 35d To deliver fluid 6 to the duodenum 37, membrane 82 can be everted to form two layers, which can be permanently connected to the distal end of the first catheter tip 7, with the inner first catheter 80 layer initially everted to the outer second catheter 81 layer. During initial insertion of the catheters into the desired area, the proximal ends of the layers are temporarily locked together by an annular clamp. Upon reaching the stomach, the annular clamp can be unlocked proximally, and the second catheter 81 can be slid proximally relative to the first layer 81. The second catheter 81 is moved distally along the axis of the first catheter 80, advancing the distal end of the catheter into the stomach, past the pylorus 65, and into the duodenum 37. A heat transfer fluid is introduced proximally and can travel between the first and second catheters 80, 81 to reach the intestine and stomach. The heat transfer fluid can be circulated for constant heat exchange with the tissue surrounding the catheters. The center of the lumen of the first catheter 80 can serve as a suction or delivery tube.
[0175] Figure 35d A linear everting catheter is shown having a single layer of catheter that can be everted to form two layers that can be connected all the way to the catheter tip, with the first catheter 80 layer beginning to evert over the second catheter 81 layer. Figure 35dA heat transfer catheter is shown having one or more lumens for fluid 6 or for delivery and aspiration that can be connected to the center of the inner layer of the first catheter 80 of the linear eversion catheter. During the initial insertion of the catheter 9 into the desired area, the proximal ends of the layers are temporarily locked together by an annular clamp. Upon reaching the stomach, the annular clamp can be unlocked proximally and the outer layer can be slid proximally relative to the layers. Distal movement of the outer layer along the axis of the inner layer causes the distal end of the catheter to be pushed forward into the stomach, through the pylorus 65 and into the duodenum 37. Once the heat transfer catheter 9 is delivered to the desired location, the first and second catheters 80, 81 can be locked at their proximal ends by annular compression to stabilize the position and prevent relative movement.
[0176] Figure 36 The catheter 9 is shown as being positioned in the stomach 2 and / or esophagus 5. The catheter 9 can be coiled 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 flexibility and / or longitudinal flexibility. The coiled portion 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., it can look like a standard compression spring and / or extension spring) or can be another shape (e.g., oval, square, triangular, etc.). The coiled catheter 9 can maximize thermal contact and / or heat transfer with the esophagus 5. A fluid 6 can circulate within the catheter 9. The first lumen 15 can be positioned on the outer periphery of the coil, and the second lumen 16 can be positioned on the inner periphery of the coil to maximize heat transfer with the esophagus 5.
[0177] Figure 37a and Figure 37b It is shown that the catheter 9 may have a lattice shape 103 when the catheter 9 is in the expanded configuration. Figure 37a and Figure 37b It is shown that actuating (eg, withdrawing, pulling) the tether 73 can change the mesh shape 103 , for example, from a mesh first shape 103 a to a mesh second shape 103 b . Figure 37a The catheter 9 is shown as having a mesh first shape 103a prior to actuation of the tether 73 (eg, when the tether 73 is in an inactive position). Figure 37b It is shown that after actuation of the tether 73, for example when the tether 73 is in the actuated position, the catheter 9 can have a mesh second shape 103b. The catheter 9 can be deployed with or without the tether 73. The catheter 9 can be deployed with or without actuation of the tether 73. For example, Figure 37a The expanded configuration of the catheter 9 may be a partially expanded configuration of the catheter 9, Figure 37b The expanded configuration of the catheter 9 in can be the fully expanded configuration of the catheter 9. As another example, Figure 37a The expanded configuration of the catheter 9 in the embodiment may be the fully expanded configuration of the catheter 9. The catheter 9 may not have a tether (e.g., tether 73). In this case, Figure 37a The expanded configuration of the catheter 9 in may be a fully expanded configuration.
[0178] Figure 38 The catheter 9 is shown as having a remote sensor 93. The remote sensor 93 can be integrated with the catheter 9 and / or detachable from the catheter 9. For example, the remote sensor 93 can be inserted and / or swallowed 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 detached and / or partially detached from the catheter 9 when the device is positioned in the stomach 2. The remote sensor 93 can be tethered to the catheter 9 using a remote sensor tether 94. The remote sensor 93 can communicate wirelessly and / or by wire. The remote sensor 93 can have a battery source and / or a power source (e.g., thermoelectric). The remote sensor 93 can be recharged and / or recharged wirelessly (e.g., inductively). The remote sensor tether 94 can be optically and / or electrically connected to the catheter 9. For example, the remote sensor tether 94 can include an electrical wire and / or a fiber optic cable. The remote sensor 93 can monitor temperature, pH, gastric motility, and / or other key indicators. The remote sensor 93 can include a camera. The remote sensor 93 can monitor different wavelengths (e.g., optical, infrared, and / or ultraviolet). Remote sensor 93 can measure the temperature of stomach 2 and / or the temperature of gastro-pancreatic wall 8. Remote sensor 93 can detect whether the surrounding medium is solid, fluid and / or gas (eg, by measuring resistance and / or conductivity between two points).
[0179] Figure 39a and Figure 39bThe tip of the catheter 9 is shown to have a beak tube 97. The beak tube diameter 95 can be less than, greater than, and / or equal to the catheter outer diameter (OD) 19. The hardness of the beak tube 97 can be the same as or different from that of the rest of the catheter 9. For example, the beak tube 97 can make it easier to insert the catheter 9 into the nose 11 and / or other organs. The beak tube 97 can provide a soft tip to prevent the catheter 9 from irritating the wall of the stomach 2 and / or other organs. The beak tube 97 can prevent the catheter 9 from tunneling into tissue. The beak tube 97 can have a different radiopacity and / or echogenicity than the rest of the catheter 9. For example, the beak tube 97 can include a metal marker band. The beak tube 97 can be denser than the rest of the catheter 9. Any portion of the catheter 9, the beak tube 97, and / or the thermal therapy system 33 can include a radiopaque additive, such as barium sulfate (i.e., BaSO4). The beak tube length 96 is approximately 1 cm. The beak tube 97 can have an atraumatic beak tube tip 100. The beak tube tip can be rounded and / or dome-shaped. Sensor 21 can be embedded in and / or secured to beak tube 97. For example, sensor 21 can be a thermistor, thermocouple, RTD, and / or other temperature sensor. Sensor 21 can measure pH and / or can be a camera. Remote sensor 93 can be sensor 21. First lumen 15, second lumen 16, third lumen 17, and / or fourth lumen 18 can extend into beak tube 97 and / or not. For example, beak tube 97 can be thermally isolated from the rest of catheter 9, enabling more accurate measurement of stomach 2 temperature. Sensor cable 107 can connect sensor 21 to an external console, DAQ, data acquisition device, heat exchange system 13, computer, and / or other system. Sensor cable 107 can be remote sensor tether 94. Sensor cable 107 can be a wire, cable, fiber optic tube, and / or conduit capable of transmitting information. Sensor cable 107 can pass through the exterior of catheter 9 and / or through one of the catheter lumens. Catheter 9 can include a merge zone 105. Merging region 105 enables fluid communication between first lumen 15 and second lumen 16. Sensor beak tube length 106 can be less than, equal to, and / or greater than beak tube length 96. Sensor beak tube length can be sufficiently large to minimize heat transfer between catheter 9 and sensor 21. For example, areas of catheter 9 near merging region 105 can be warmer and / or cooler than areas farther from merging region 105. Sensor 21 can be an infrared temperature sensor.
[0180] Figure 40The diameters of the first lumen 15, the second lumen 16, and / or the third lumen 17 can be the same and / or different. The pressure at the distal tip of the catheter 9 and / or balloon 3 can be determined by the ratio of the hydraulic diameters of the first lumen 15 to the hydraulic diameters of the second lumen 16. For example, the ratio of the hydraulic diameters of the first lumen 15 to the second lumen 16 can be proportional to the pressure drop across the lumen length (and therefore the pressure at the balloon 3). To increase compliance and / or flexibility, it may be desirable to reduce the pressure of the balloon 3.
[0181] Figure 41 It is shown that the catheter 9 can be introduced through a guide wire 99. The guide wire 99 can pass through the third lumen 17 and / or the fourth lumen 18. The guide wire 99 can be coated with a hydrophilic material and / or a hydrophobic material. The guide wire 99 can be separated from and / or integrated 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 rate of fluid flowing from the esophagus 5 to the stomach 2 and / or the amount and / or rate of fluid flowing from the stomach 2 to the esophagus 5. The catheter 9 can pass through the esophageal valve 92. The catheter 9 can be permanently fixed to the esophageal valve 92 and / or the catheter 9 can be removed from the esophageal valve 92. The esophageal valve 92 can be an anti-reflux valve. The guide wire 99 can guide the catheter 9 to certain areas (e.g., the pylorus and / or antrum of the stomach 2).
[0182] Figure 42 The thermal therapy system 33 can actively control the core body temperature of the patient. In this study, a catheter 9 of approximately 75 cm was randomly placed in the stomach (similar to Figure 18 ), whose cross section is similar to Figure 27b Cross-section shown. Core body temperature of a human patient decreased during the active cooling period 98 and increased at the end of cooling. A zero heat flux thermometer (3M BairHugger TM )Monitor core body temperature.
[0183] Figure 43 A thermal pad 101 is shown as being placed between the catheter 9 and the patient to prevent any discomfort. The thermal pad 101 may be a soft foam. The thermal pad 101 may be permanently affixed to the catheter 9 and / or may be removable. The thermal pad 101 may have an adhesive on one surface to adhere the catheter 9 and / or the thermal pad 101 to the patient.
[0184] Figure 44The catheter 9 is shown as having an insulation coil 102. The insulation coil 102 may be a preformed shape of the catheter 9. The insulation coil 102 may minimize contact between the catheter 9 and the back of the throat and / or other organs. The guidewire 99 may keep the insulation coil 102 straight during insertion into the nose 11. The insulation coil 102 may have foam insulation to minimize heat transfer between the catheter 9 and the patient.
[0185] Figure 45a and Figure 45b A variation of the catheter 9 in the stomach 2 is shown, having an array of inflatable catheters.
[0186] Figures 46a to 46z3 It is shown that the catheter 9 can be inserted into the body and / or withdrawn from the body. For example, Figures 46a to 46z3 It is shown that the catheter 9 can be inserted into and / or withdrawn from the gastrointestinal tract 110. For example, Figures 46a to 46o It is shown that the catheter 9 can be inserted into the stomach 2 as shown by arrow 112, Figure 46o to Figure 46z3 It is shown that the catheter 9 can be removed from the stomach 2 as shown by arrow 114. For example, the insertion direction as shown by arrow 112 can be opposite to the withdrawal direction as shown by arrow 114. Figures 46a to 46z3 It is shown that a catheter 9 can be introduced into the stomach 2 and / or removed from the stomach 2 , for example, through the esophagus 5 . Figures 46a to 46z3 The target site 147 is shown to be, for example, the stomach 2 .
[0187] The catheter 9 can have one or more configurations 116 in the body (e.g., in the gastrointestinal tract 110). The catheter 9 can be formed into the configuration 116, for example, during the process of inserting the catheter 9 into the body and / or during the process of withdrawing 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 by withdrawing the catheter 9 from the body. Each configuration 116 can include, for example, the arrangement of the catheter 9 in the body (e.g., in the gastrointestinal tract 110). For example, Figures 46a to 46z3 116 , including, for example, configurations 116a to 116z3 or any combination thereof, that the catheter 9 may have in the body during insertion and / or withdrawal from the gastrointestinal tract 110 . Figure 46a and Figure 46z3 Configurations 116a and 116z3 are shown to correspond to arrangements that the catheter 9 may have in the esophagus 5. Figures 46b to 46z2 Configurations 116b to 116z2 shown may correspond to arrangements that catheter 9 may have in stomach 2. Configurations 116a to 116z3 may, for example, be first to twenty-ninth configurations, 116a to 116z3, respectively, that may be formed during insertion and / or withdrawal of catheter 9 into the body.
[0188] When the catheter 9 is located within the body, including, for example, when the catheter 9 is in any configuration 116 (e.g. Figures 46a to 46z3 16a through 116z3), the catheter 9 can transfer heat to and / or from the body (e.g., to and / or from the heat transfer target 146). Any configuration 116 can be, for example, an operating state (also referred to as an operating configuration) of the catheter 9. When the catheter 9 is in an operating configuration (e.g., in one of the configurations 116 or any combination thereof), the catheter 9 can transfer heat to and / or from the body, for example, by pumping a fluid through a lumen in the catheter 9. The fluid can be, for example, fluid 6, and the lumen can be, for example, lumen 15 and / or lumen 16. For example, Figures 46a to 46z3 The catheter 9 shown may have a lumen 15 and a lumen 16 , where lumen 15 may be an inflow lumen and lumen 16 may be an outflow lumen. Figures 46a to 46z3 It is shown that, for example, configurations 116a through 116z3 may each be an operational configuration of the catheter 9 .
[0189] 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, Figures 46a to 46z3 Configurations 116a through 116n and 116p through 116z3 are shown as partially deployed configurations of catheter 9, while configuration 116o is the fully deployed configuration of catheter 9. As another example, any configuration 116 (e.g., configurations 116a through 116z3) can be the fully deployed configuration. For example, when configuration 116f is the fully deployed configuration, catheter 9 can be inserted into the body to form configuration 116f and then removed from the body without forming configurations 116g through 116o. When catheter 9 is in the partially deployed configuration (e.g., configurations 116a through 116z3), catheter 9 can transfer heat to and / or from the body, for example, by pumping fluid 6 through lumen 15 and lumen 16. When catheter 9 is in the fully deployed configuration (e.g., configurations 116a through 116z3), catheter 9 can transfer heat to and / or from the body, for example, by pumping fluid 6 through lumen 15 and / or lumen 16.
[0190] The configuration 116 formed by the catheter 9 during withdrawal 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. Figures 46a to 46z3 It is shown that, for example, the configurations 116 (e.g., configurations 116o to 116z3) formed by the catheter 9 during withdrawal can be the same as the configurations 116 (e.g., configurations 116a to 116o) formed by the catheter 9 during insertion. Figures 46a to 46z3It is shown that configurations 116p through 116z3 can be the same as configurations 116n through 116a, respectively (e.g., the sixteenth configuration 116p can be the same as the fourteenth configuration 116n, and the twenty-seventh configuration 116z1 can be the same as the third configuration 116c). As another example, the configuration 116 formed by the catheter 9 during withdrawal from the body can be different from the configuration 116 formed by the catheter 9 during insertion into the body.
[0191] The catheter 9 can be formed into one or more configurations 116 in the target site 147, for example, before, during, and / or after fluid is passed through (e.g., pumped) the lumen in the catheter 9. The catheter 9 can be formed into the configuration 116 in the target site 147, for example, before, during, and / or after fluid is passed through (e.g., pumped) the first lumen 15 and / or the second lumen 16 in the catheter 9. For example, Figures 46a to 46o The catheter 9 is shown as being formed into configurations 116a to 116o before the fluid 6 passes through the first lumen 15 and / or the second lumen 16. Figure 46p to Figure 46z3 The catheter 9 is shown as being formed into configurations 116 p through 116 z 3 after fluid 6 has been passed (eg, pumped) through the first lumen 15 and / or the second lumen 16 .
[0192] Passing the fluid through the conduit 9 may or may not change the configuration 116 of the conduit 9. For example, Figures 46a to 46z3 It is shown that passing fluid through the catheter 9 (e.g., through an inflow lumen and / or an outflow lumen in the catheter 9) may not change the configuration 116 of the catheter 9. The configuration 116 may remain unchanged before, during, and / or after the fluid is passed (e.g., pumped) through the catheter 9. For example, Figure 46a to Figure 46z3 It is shown that the configurations 116 (eg, configurations 116a through 116z3) may remain unchanged before, during, and after fluid is passed through (eg, pumped through) the conduit 9.
[0193] The catheter 9 can be formed into one or more configurations 116 in the gastrointestinal tract 110, for example, by inserting the catheter 9 into the gastrointestinal tract 110 and / or by withdrawing the catheter 9 from the gastrointestinal tract 110. For example, the catheter 9 can be formed into one or more configurations 116 in the gastrointestinal tract 110 by inserting the catheter 9 into the stomach 2 and / or a portion of the gastrointestinal tract 110 caudal to the stomach 2 (e.g., into the duodenum 27) and / or by withdrawing the catheter 9 from the stomach 2 and / or a portion of the gastrointestinal tract 110 caudal to the stomach 2 (e.g., from the duodenum 37), or any combination thereof.
[0194] The catheter 9 can be formed into one or more shapes 117 (also referred to as catheter shapes 117) in the body, for example, as the catheter 9 is inserted into the body and / or as the catheter 9 is withdrawn from the body. Each shape 117 can be, for example, a placement of the catheter 9 in the body. Each shape 117 can be defined, for example, by the path that the catheter 9 takes in the body. For example, each shape 117 can include the path that the catheter 9 takes through the body, such as through the gastrointestinal tract 110 (e.g., through the stomach 2, pylorus 65, and / or duodenum 37). Each configuration 116 of the catheter 9 can include a catheter shape 117. Each shape 117 can correspond to a configuration 116 of the catheter 9. For example, Figure 46a to Figure 46z3 Configurations 116a through 116z3 are shown to include and / or correspond to shapes 117a through 117z3, respectively, such that shapes 117a through 117z3 may be arrangements of the conduit 9 when the conduit 9 is in configurations 116a through 116z3, respectively. Figures 46a to 46z3 It is shown that the catheter 9 can have twenty-nine shapes 117, which can be taken in vivo during, for example, insertion into and / or withdrawal from the gastrointestinal tract 110, including, for example, shapes 117a to 117z3 or any combination thereof. Figure 46a and Figure 46z3 The shapes 117a and 117z3 shown may be shapes (eg, paths) that the catheter 9 may have in the esophagus 5. Figures 46b to 46z2 Shapes 117b to 117z2 may be shapes (e.g., paths) that the catheter 9 may have in the stomach 2. Shapes 117a to 117z3 may be, for example, first to twenty-ninth shapes 117a to 117z3 that the catheter 9 may have during insertion and / or extraction of the catheter 9 from the body, respectively.
[0195] The catheter shape 117 in each configuration 116 can depend on, for example, the length of the catheter 9 in the gastrointestinal tract 110 (e.g., in the stomach 2, in the pylorus 65, and / or in the duodenum 37), the angle of entry of the catheter 9 into the stomach 2 (e.g., from the esophagus 5), the angle of entry of the catheter 9 into the duodenum 37 (e.g., from the stomach 2), the stiffness 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 organs adjacent to the stomach 2 (e.g., the pancreas), the size of organs adjacent to the duodenum 37 (e.g., the pancreas), or any combination thereof. For example, based on these factors, inserting a catheter 9 of a given length into the stomach 2 (e.g., a 100 cm catheter 9, a 150 cm catheter 9, a 200 cm catheter) can form various configurations 116 having various shapes 117 in the stomach 2. For example, Figures 46a to 46z3As shown, catheter 9 can have shapes 117a through 117z3 within stomach 2 as it is inserted from 30 cm to 300 cm, or more narrowly, as it is inserted from 30 cm to 150 cm (including every 1 cm increment within this range). As another example, due to these factors, inserting the same catheter 9 (e.g., a substantially identical catheter 9 of the same make and model or two different catheters 9) of the same length (e.g., 100 cm, 150 cm, 200 cm) into the same stomach 2 on two different occasions can result in catheter 9 forming into two different configurations 116 and / or can result in catheter 9 forming into two identical configurations 116. Catheter 9 can have a minimum bend radius of, for example, 1.0 cm to 3.0 cm, including every 0.1 cm increment within this range (e.g., 1.0 cm, 1.5 cm, 1.6 cm, 2.5 cm). The stiffness of catheter 9 can be quantified, for example, as the force required to bend catheter 9. The axial force of the curved conduit 9 can be, for example, greater than 2.0 Newtons to 6.0 Newtons, including every 0.1 Newton increment within this range (e.g., greater than 2.0N, greater than 3.0N, greater than 4.0N, greater than 4.5N, greater than 4.8N, greater than 5.0N, greater than 6.0N). The axial force of the curved conduit 9 can be, for example, 2.0 Newtons to 6.0 Newtons, including every 0.1 Newton increment within this range (e.g., 2.0N, 3.0N, 4.0N, 4.5N, 4.8N, 5.0N, 6.0N).
[0196] The shape 117 formed by the catheter 9 during withdrawal of the catheter 9 from the body 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. Figures 46a to 46z3 It is shown that, for example, the shape 117 (e.g., shape 117o to shape 117z3) formed by the catheter 9 during withdrawal can be the same as the shape 117 (e.g., shape 117a to shape 117o) formed by the catheter 9 during insertion. Figures 46a to 46z3 It is shown that shapes 117p to 117z3 can be the same as shapes 117n to 117a, respectively (e.g., shape 117p can be the same as shape 117n, and shape 117z1 can be the same as shape 117c). As another example, shape 117 formed by catheter 9 during withdrawal from the body can be different from shape 117 formed by catheter 9 during insertion into the body.
[0197] The shape 117 of the conduit 9 in each configuration 116 may include, for example, one or more straight sections of the conduit 9 and / or one or more curved sections of the conduit 9 .
[0198] The catheter shape 117 in the expanded configuration (e.g., configuration 116) can include, for example, one or more loops 118 formed by the catheter 9. The catheter 9 in the expanded configuration can have, for example, from 1 to more than 30 loops 118 (e.g., configuration 116), including every loop increment 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, Figures 46a to 46z3 The catheter 9 shown in the expanded configuration (e.g., configuration 116) can have one to four or more loops 118, including, for example, loop 118a, loop 118b, loop 118c, loop 118d, or any combination thereof. Loops 118a to 118d can be, for example, first to fourth loops (e.g., first loop 118a, second loop 118b, third loop 118c, fourth loop 118d).
[0199] Each loop 118 may have a first loop end 118 - 1 , a second loop end 118 - 2 , and a loop head 118 - 3 .
[0200] Figures 46a to 46z3 Shown for example loop 118a can have loop first end 118a-1, loop second end 118a-2 and loop head 118a-3. Loop first end 118a-1, loop second end 118a-2 and loop head 118a-3 can be, for example, first loop first end 118a-1, first loop second end 118a-2 and first loop head 118a-3 respectively.
[0201] Figures 46a to 46z3 For example, loop 118b is shown to have a loop first end 118b-1, a loop second end 118b-2, and a loop head 118b-3. Loop first end 118b-1, loop second end 118b-2, and 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.
[0202] Figures 46a to 46z3 For example, loop 118c is shown to have a loop first end 118c-1, a loop second end 118c-2, and a loop head 118c-3. Loop first end 118c-1, loop second end 118c-2, and 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.
[0203] Figures 46a to 46z3For example, loop 118d is shown to have a loop first end 118d-1, a loop second end 118d-2, and a loop head 118d-3. Loop first end 118d-1, loop second end 118d-2, and loop head 118d-3 can, for example, be a fourth loop first end 118d-1, a fourth loop second end 118d-2, and a fourth loop head 118d-3, respectively.
[0204] The loop first end 118-1 can be for example first longitudinal end of the loop 118 along conduit 9 (for example along the central longitudinal axis of conduit 9).The loop second end 118-2 can be for example second longitudinal end of the loop 118 along conduit 9 (for example along the central longitudinal axis of conduit 9).The loop first end 118-1 and / or the loop second end 118-2 can form the bottom (base) (also referred to as the loop bottom) of loop 118.The loop bottom can be for example the bottom of the loop first end 118-1, the bottom of the loop second end 118-2, the straight axis of the bottom that connects the bottom of the loop first end 118-1 and the loop second end 118-2, the position that wherein the loop first end 118-1 and the loop second end 118-2 cross each other, or their arbitrary combination.The loop head 118-3 can be between the loop first end 118-1 and the loop second end 118-2. In another embodiment, the loop head 118-3 can be the middle portion of the loop 118 (for example conduit 9) between the loop first end 118-1 and the loop second end 118-2. As another example, the loop head 118-3 can include a part for the loop first end 118-1 and a part for the loop second end 118-2. The loop head 118-3 can be relative to the bottom of the loop 118 (for example diameter relative (diametrically opposite)). The loop head 118-3 can have a loop vertex. As another example, the loop head 118-3 can be a loop vertex. The loop vertex can be the midpoint along conduit 9 between the loop first end 118-1 and the loop second end 118-2, and / or the loop vertex can be the farthest point measured along the straight line of the loop 118 from the loop bottom to the loop vertex. The loop vertex can for example be divided into first half and second half (for example be divided into two equal or unequal parts (halves)) with the loop 118. The first half of the ring 118 can comprise a part (for example half) of the ring first end 118-1 and / or the ring head 118-3. The second half of the ring 118 can comprise a part (for example half) of the ring second end 118-2 and / or the ring head 118-3. The ring first end 118-1 and the ring second end 118-2 can be connected to each other by the ring head 118-3. As another example, when the ring head 118-3 is regarded as the ring vertex (for example relative to another part of conduit 9 (opposed to another section of the of thecatheter 9))), the ring first end 118-1 and the ring second end 118-2 can meet (for example at the ring vertex) at the ring head 118-3 place. The ring 118 can be symmetrical or asymmetric with respect to the straight axis that intersects with the ring bottom and the ring head 118-3 (for example the ring vertex). The loop first end 118 - 1 may be shorter, longer, or the same length as the loop second end 118 - 2 .The loop second end 118 - 2 may be shorter, longer, or the same length as the loop first end 118 - 1 .
[0205] For each loop 118, the loop first end 118-1, the loop second end 118-2, and the loop head 118-3 can be, for example, different portions of the conduit 9 along the length of the conduit 9. Different loops 118 can include the same and / or different portions of the conduit 9. The loops 118 can include the same and / or different portions of the conduit 9 as another loop 118. For example, a first loop (e.g., loop 118a) can include the same and / or different portions of the conduit 9 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 portions of the conduit as a second loop (e.g., loop 118a, loop 118c, or loop 118d). The loop first end 118-1, the loop second end 118-2, and the loop head 118-3 can have relative positions to each other along the length of the conduit 9. For example, Figures 46a to 46z3 It is shown that the first end 118-1 of the loop can be located proximal to the second end 118-2 of the loop and the loop head 118-3 along the length of the catheter 9, the second end 118-2 of the loop can be located distal to the first end 118-1 of the loop and the loop head 118-3 along the length of the catheter 9, and the loop head 118-3 can be located distal to the first end 118-1 of the loop and proximal to the second end 118-2 of the loop along the length of the catheter 9.
[0206] Each loop 118 can be for example a closed loop (closed loop) or an open loop (open loop) (for example one or more loops 118 can be an open loop, and one or more loops 118 can be a closed loop). The open loop can be for example a loop 118 with a loop first end 118-1, and the loop first end 118-1 and the loop second end 118-2 are separated by a gap. The closed loop can be for example a loop 118 with a loop first end 118-1 that intersects with 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 can contact each other or not contact each other.
[0207] The catheter shape 117 in the expanded configuration (e.g., configuration 116) can include, for example, one or more cells 122. The catheter 9 in the expanded configuration (e.g., configuration 116) can have, for example, from 1 to more than 30 cells 122, including every cell increment 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 the one or more cells 122. For example, the loop 118 can define the cells 122. The cells 122 can be defined by the outer surface of the catheter 9. The boundary of the cells 122 can be the catheter 9, for example, the outer surface of the catheter 9. For example, when the catheter is in the expanded configuration (e.g., configuration 116), the cells 122 can be, for example, spaces, openings, holes and / or through-holes between portions of the catheter 9. For example, Figures 46a to 46z3 The catheter 9 shown in the expanded configuration (e.g., configuration 116) can have one to four or more chambers 122, including, for example, chamber 122a, chamber 122b, chamber 122c, chamber 122d, or any combination thereof. Chambers 122a to 122d can be, for example, the first to fourth chambers (e.g., the first chamber 122a, the second chamber 122b, the third chamber 122c, and the fourth chamber 122d). Each chamber 122 can be, for example, a closed chamber or an open chamber. An open chamber can be, for example, an open-loop chamber 122. A closed chamber can be, for example, a closed-loop chamber 122.
[0208] The catheter 9 can be formed into a catheter shape 117, for example, into a loop 118, in the gastrointestinal tract 110, for example, by inserting the catheter 9 into the gastrointestinal tract 110 and / or by withdrawing the catheter 9 from the gastrointestinal tract 110. For example, the catheter 9 can be formed into one or more shapes 117, for example, into one or more loops 118, in the gastrointestinal tract 110 by inserting the catheter 9 into the stomach 2 and / or a portion of the gastrointestinal tract 110 caudal to the stomach 2 (for example, into the pylorus 65 and / or the duodenum 27) and / or by withdrawing the catheter 9 from the stomach 2 and / or a portion of the gastrointestinal tract 110 caudal to the stomach 2 (for example, from the pylorus 65 and / or the duodenum 37), or any combination thereof.
[0209] As the catheter 9 is inserted into the gastrointestinal tract 110, the catheter 9 can engage with, be advanced against, and / or be constrained by the wall of the gastrointestinal tract 110, which can, for example, cause the catheter 9 to form a bend, form a loop (e.g., loop 118), fold over itself, cross itself, contact itself, or any combination thereof to form a configuration 116 having a shape 117. The wall of the gastrointestinal 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 gastrointestinal tract 110 caudal to the duodenum 37, or any combination thereof. Figures 46a to 46o It is shown that, for example, as the catheter 9 is progressively inserted into the stomach 2 (eg, through the esophagus 5), the catheter 9 can be progressively formed into a more complex configuration 116 having a more complex shape 117. For example, Figures 46a to 46o It is shown that the loop 118 can be formed stepwise from a more proximal portion of the catheter.
[0210] As the catheter 9 is withdrawn from the gastrointestinal tract 110, the catheter 9 may straighten and / or become less curved, which may, for example, cause the catheter 9 to untwist, unfold, loosen, straighten, open, and / or straighten to form a configuration 116 having a shape 117. As the catheter 9 is withdrawn from the gastrointestinal tract 110, the loop 118 may collapse (e.g., untwist, unfold, loosen, straighten, open, and / or straighten). Figure 46o to Figure 46z3 It is shown that, for example, the catheter 9 may be gradually formed into a less complex configuration 116 having a less complex shape 117 as the catheter 9 is gradually withdrawn from the stomach 2 (eg, through the esophagus 5).
[0211] Loop 118 and chamber 122 may be formed by inserting and / or withdrawing catheter 9 into a target site 147 (eg, stomach 2 , pylorus 65 , duodenum 37 , and / or a portion of gastrointestinal tract 110 caudal to duodenum 37 ).
[0212] The loop 118 may change size and / or shape within the target site 147. For example, as the catheter 9 is inserted into the target site 147, the size (eg, circumference, length, width, and / or height) of the loop 118 may increase and / or decrease.
[0213] The loop 118 can have a girth (also referred to as the loop girth). For example, the loop girth can be measured along the central longitudinal axis of conduit 9 from the loop first end 118-1 to the loop second end 118-2. The loop girth can be, for example, 5.0cm to 80.0cm, including every 0.5cm increment (for example, 5.0cm, 9.5cm, 15.0cm, 30.0cm, 50.0cm, 80.0cm) within this scope. The loop girth can, for example, be greater than 9.0cm to 70.0cm, including every 0.5cm increment (for example, greater than 5.0cm, 9.5cm, 15.0cm, 30.0cm, 50.0cm, 80.0cm) within this scope. The loop girth can, for example, be less than 80.0cm. The loop girth can, for example, be greater than the lesser curvature of stomach 2 and / or greater than the greater curvature of stomach 2. Figures 46a to 46z3 It is shown that the size (eg, circumference) of the loop 118 can increase and decrease within the target site 147 . Figures 46a to 46z3 It is shown, for example, that the circumference of at least one loop 118 (eg, loop 118a) may be greater than 9.5 cm. Figures 46a to 46z3 It is shown that, for example, as the catheter 9 is inserted into and / or withdrawn from the target site 147, the shape of the loop 118 can change when the portion forming the loop 118 (e.g., the portion forming 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 curve and / or bends.
[0214] The loop 118 may have a length, a width, and a height (also referred to as loop length, loop width, and loop height).
[0215] The length of each loop 118 can be measured along straight axis (also referred to as straight line) from the bottom of loop 118 to the loop head 118-3 of loop 118 (for example, to the apex of loop 118). Loop length can be for example 3.0cm to 40.0cm, includes every 0.5cm increment (for example 3.0cm, 9.0cm, 15.0cm, 30.0cm, 40.0cm) within this scope. Loop length can for example be greater than 3.0cm to 30.0cm, includes every 0.5cm increment (for example greater than 3.0cm, 9.0cm, 15.0cm, 30.0cm) within this scope. Loop length can for example be greater than the lesser curvature of stomach 2, greater than the greater curvature of stomach 2 and / or greater than the length of duodenum 37. For example, loop length can be greater than 25% to 100% of the length of duodenum 37. For example, when loop 118 was positioned at stomach 2 and duodenum, loop length can be greater than the greater curvature of stomach 2. The loop length can be greater than 3 cm. The loop length can be, for example, less than 20.0 cm to 40.0 cm, including every 0.5 cm increment within this range (e.g., less than 20.0 cm, 30.0 cm, 40.0 cm). The loop length can be, for example, less than the width of the widest part of the stomach 2 and / or less than the greater curvature of the stomach 2.
[0216] 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 loop first end 118-1 of the loop 118 to a point on the loop second end 118-2 of the loop 118. The loop width can be, for example, 3.0 cm to 40.0 cm, including every 0.5 cm increment 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 30.0 cm, including every 0.5 cm increment within this range (e.g., greater than 3.0 cm, 9.0 cm, 15.0 cm, 30.0 cm). The loop width can 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 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 40.0 cm, including every 0.5 cm increment therein (e.g., less than 20.0 cm, 30.0 cm, 40.0 cm). The loop width can be, for example, less than the width of the widest portion of the stomach 2 and / or less than the greater curvature of the stomach 2. The loop width can be the same as or different from the loop length.
[0217] The height of each loop 118 may be 1.0 to 7.0 times or more the diameter of the conduit 9. The height of each loop 118 may be, for example, the height of a plane extending through the loop first end 118-1, the loop second end 118-2, and the loop head 118-3.
[0218] Figures 46a to 46z3 The loops 118 shown can have various sizes, shapes, and relative positions. Figures 46a to 46z3 It is shown that some loops 118 may be smaller than another loop 118 . Figures 46a to 46z3 It is shown that some loops 118 may be larger than another loop 118 .
[0219] The loops 118 may have one or more straight and / or curved sections of the conduit 9. The curved sections of the loops 118 may have a constant radius or a variable radius. Each loop 118 may have the same radius and / or a different radius than another loop.
[0220] For example, as the catheter 9 is advanced into the target site 147 and / or withdrawn from the target site 147, the loop 118 may change from an open loop to a closed loop within the target site 147 (e.g., within the stomach 2, pylorus 65, and / or duodenum 37), and / or may change from a closed loop to an open loop within the target site 147 (e.g., within the stomach 2, pylorus 65, and / or duodenum 37). The loop 118 may have a closed section and an open section.
[0221] Each loop 118 can have the same size or a different size than another loop 118. A first loop (eg, one of the loops 118) can have the same size or a different size than a second loop (eg, the other loop 118).
[0222] Each loop 118 can have the same shape or a different shape than another loop 118. A first loop (e.g., one of the loops 118) can have the same shape or a different shape than a second loop (e.g., the other loop 118). The loops 118 can have, for example, a bulbous shape, an oval shape, a teardrop shape, an irregular shape, or any combination thereof.
[0223] The catheter 9 can be moved relative to the loop 118 in the target site 147, for example, by inserting the catheter 9 into the target site 147 and / or withdrawing the catheter 9 from the target site 147. For example, Figures 46a to 46z3 The catheter 9 within the target site 147 is shown as being movable (e.g., pushed and / or pulled) relative to the loops 118, which can cause, for example, one or more loops 118 to form and / or untwist. The catheter 9 can be moved into and / or out of contact with the loops 118 in the target site 147. The catheter 9 can be moved (e.g., slid) against one or more loops 118 in the target site 147. The catheter 9 can be pushed and / or pulled into the loops 118, which can cause the loops 118 to move and / or change shape in the target site 147. The catheter 9 can be moved over and / or under one or more loops 118 in the target site 147.
[0224] The loops 118 can be moved relative to each other in the target site 147, for example, by inserting the catheter 9 into the target site 147 and / or withdrawing it from the target site 147. For example, Figures 46a to 46z3 Loops 118a-118d are shown as being movable relative to one another in target site 147. Loops 118 can be moved into and out of contact with one another in target site 147. Loops 118 can be moved (e.g., slid) against one another in target site 147. Loops 118 can be moved toward and / or away from one another in target site 147. Loops 118 can be moved over and / or under one another in target site 147.
[0225] The chamber 122 may change 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 duodenum 37), the size (e.g., area, length, and / or height) of the chamber 122 may increase and / or decrease.
[0226] The cell 122 may have an area (also referred to as a cell area). The cell area may be the space defined (e.g., surrounded) by the ring 118. For example, the cell area of the cell 122a may be the area of the space surrounded by the ring 118a. The ring area may be, for example, 7 cm 2 Up to 300cm 2 , including every 1cm within this range 2 Increment (e.g. 7cm 2 , 50cm 2 , 100cm 2 , 300cm 2 The loop area can be, for example, larger than 7 cm 2 Up to 300cm 2 , including every 1cm within this range 2 Increment (e.g. greater than 7cm 2 , 50cm 2 , 100cm 2 , 300cm 2 ). Figures 46a to 46z3 It is shown that the size of the chamber 122 can increase and / or decrease within the target site 147, for example, as the size of the loop 118 increases and / or decreases, respectively, within the target site 147. Figures 46a to 46z3 The shape of the cell 122 is shown to be changeable, for example, as the shape of the ring 118 changes.
[0227] The cell 122 may have a length, a width, and a height (also referred to as a cell length, a cell width, and a cell height).
[0228] Can measure cell length along the axle identical with measuring loop length.For example, can measure cell length along the straight axis from the bottom of loop 118 to the loop head 118-3 of loop 118.Cell length can be identical or different with loop length.For example, when measuring loop length from the bottom of loop 118 to the outer surface of loop head 118-3, cell length can be identical with loop length.As another example, when measuring loop length from the bottom of loop 118 to the central longitudinal axis of the conduit 9 in the loop head 118-3, cell length can be that for example loop length deducts radius or the diameter of conduit 9.
[0229] In some embodiments, the cell width can be measured along the same axis with measuring the ring width.For example, the cell width can be measured along the straight axis from the point on the ring first end 118-1 of the ring 118 to the point on the ring second end 118-2 of the ring 118. The cell width can be identical or different with the ring width.For example, when the point on the ring first end 118-1 and the point on the ring second end 118-2 were positioned on the outer surface (for example the radially inner surface of the ring 118), the cell width can be identical with the ring width. As another example, when the point on the ring first end 118-1 and the point on the ring second end 118-2 were positioned on the central longitudinal axis of conduit 9, the cell width can be that the ring width for example deducts the diameter of conduit 9.
[0230] The cell height may, for example, be the same as the ring height.
[0231] Figures 46a to 46z3 The cells 122 shown can have various sizes, shapes, and relative positions. Figures 46a to 46z3 It is shown that some cells 122 may be smaller than another cell 122 . Figures 46a to 46z3 It is shown that some cells 122 may be larger than another cell 122 .
[0232] For example, as the catheter 9 is advanced into the target site 147 and / or as the catheter 9 is withdrawn from the target site 147, the chamber 122 can change from an open chamber to a closed chamber within the target site 147 (e.g., within the stomach 2, pylorus 65, and / or duodenum 37) and / or can change from a closed chamber to an open chamber within the target site 147 (e.g., within the stomach 2, pylorus 65, and / or duodenum 37). The loop 118 can define the open chamber 122 and / or the closed chamber 122. For example, the open loop 118 can define the open chamber 122, and the closed loop 122 can define the open chamber 122. As another example, the loop 118 in which the loop first end 118-1 and the loop second end 118-2 cross each other can define one or more open chambers 122 and one or more closed chambers 122 (e.g., the tip of the loop 118 can define the closed chamber 122, and the bottom of the loop 118 can define the open chamber 122).
[0233] Each chamber 122 can have the same or different dimensions as another chamber 122. A first chamber (eg, one of the chambers 122) can have the same or different dimensions as a second chamber (eg, another of the chambers 122).
[0234] Each cell 122 can have the same shape as or a different shape than another cell 122. A first cell (e.g., one of the cells 122) can have the same shape as or a different shape than a second cell (e.g., another of the cells 122). The cells 122 can have, for example, a bulbous shape, an elliptical shape, a teardrop shape, an irregular shape, or any combination thereof.
[0235] The cells 122 can be aligned with each other, can be offset from each other, can overlap each other, or any combination thereof. Figures 46a to 46z3 The cells 122 are shown to be offset from each other and / or to overlap each other. Each cell 122 can have a cell center axis extending through the central cell 122. When two cells 122 are aligned with each other, the center axes of the two cells 122 can be aligned with each other (e.g., overlap) so that the conduit 9 can have a spiral shape. When the two cells 122 are offset from each other, the center axes of the two cells 122 can be offset from each other. For example, when the two cells 122 are offset from each other, the center axes of the two cells 122 can be separated by a gap (also referred to as a cell axis gap). The center axes of the cells 122 can extend through the cells 122 at an angle perpendicular to the cell surface. The cell axis gap between the cell center axis of a first cell (e.g., one of the cells 122) and the cell center axis of a second cell (e.g., another cell 122) can be, for example, 1 cm to 40 cm or more, including every 1 cm increment within this range (e.g., 1 cm, 5 cm, 10 cm, 20 cm, 40 cm). The cell axis spacing can be, for example, greater than 1 cm to 40 cm, including every 1 cm increment within this range (e.g., greater than 1 cm, 3 cm, 4 cm, 5 cm, 40 cm). The cell axis spacing can be greater than the lesser curvature of the stomach 2 and / or greater than the greater curvature of the stomach 2. One or more cell central axes can be parallel to another cell central axis. One or more 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 by gaps between the loops and / or the cells 122 can overlap each other.
[0236] The chambers 122 can be moved relative to each other (e.g., above and / or below each other) in the target site 147, for example, by inserting and / or withdrawing the catheter 9 from the target site 147. The chambers 122 can be moved into alignment and / or out of alignment with each other in the target site 147. The chambers 122 can be moved from a first offset position to a second offset position. The chambers 122 can be moved into alignment and / or out of alignment with each other, or they may not be moved into alignment and / or out of alignment with each other.
[0237] The conduit 9 (e.g., a portion of one of the loops 118) can be moved through one or more cells 122. The portion of the conduit 9 extending through a cell 122 can partially block (also referred to as partially obstruct) the cell 122. The cell 122 can be blocked and / or unblocked by moving the conduit 9 over the cell 122 and / or by moving the conduit 9 away from the cell 122, respectively. Moving the conduit 9 over a cell 122 can, for example, divide the cell 122 into two or more subcells.
[0238] Figures 46a to 46z3 The conduit 9 (e.g., loop 118) and / or chamber 122 are shown to have various arrangements and orientations within the target site 147, e.g., relative to a flow path through the target site 147 and / or one or more walls of the target site 147. For example, the flow path through the stomach 2 can be a path that does not contact the stomach wall 108 along a curved axis from the gastroesophageal junction 120 of the gastrointestinal tract 110 through the stomach 2 to the pylorus 65. Figures 46a to 46z3 The catheter 9 is shown to occlude the center of a flow path through a target site 147 (eg, a flow path extending through the stomach 2 , pylorus 65 , and / or duodenum 37 ) when the catheter 9 is in an expanded configuration (eg, configuration 116 ). Figures 46a to 46z3 It is shown that when the catheter 9 is in the expanded configuration (e.g., configuration 116), the catheter 9 can extend through the center of the flow path of the target site 147 (e.g., a flow path extending through the stomach 2, pylorus 65, and / or duodenum 37). When the catheter 9 is in the expanded configuration, the catheter 9 (e.g., loop 118) can 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 the expanded configuration, the chamber 122 can 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, Figures 46a to 46z3The chamber 122 is shown to face the anterior wall of the stomach 2 and the posterior wall of the stomach 2. The central axis of the chamber 122 can be angled from 70 degrees to 110 degrees relative to the longitudinal axis of the flow path through the target site 147 (e.g., relative to the flow path from the gastroesophageal junction 120 of the gastrointestinal tract 110 to the pylorus 65 having a curved axis), including every 1 degree increment therebetween (e.g., 70 degrees, 90 degrees, 110 degrees). For example, the chamber 122 can be perpendicular to the flow path through the target site 147.
[0239] The loops 118 and / or cells 122 may be formed and / or collapsed in any order within the target site 147. For example, Figures 46a to 46o It is shown that the loops 118 (e.g., 118a, 118b, 118c, and / or 118d) can be formed in the order shown, Figure 46o to Figure 46z3 The loops 118 (e.g., 118a, 118b, 118c, and / or 118d) are shown as collapsing in the order shown. For example, the loops 118 are considered collapsed when a size (e.g., circumference) of the loops 118 decreases, a loop length of the loops 118 decreases, a loop width of the loops 118 decreases, a loop height of the loops 118 decreases, or any combination thereof. The loops 118 can be collapsed, for example, by withdrawing the catheter 9 from the target site 147. The loops 118 and / or chambers 122 can be formed and / or collapsed in the target site 147 in any order, for example, sequentially and / or simultaneously. For example, Figures 46a to 46c It is shown that during the first stage of loop formation, loop 118a may be formed before loop 118b. Figures 46d to 46f It is shown that during the second stage of loop formation, loop 118a and loop 118b can be formed simultaneously. As another example, Figures 46x to 46z It is shown that during the first stage of loop collapse, loops 118a and 118b may be collapsed simultaneously. Figures 46d to 46f It is shown that during the second stage of loop collapse, loop 118a may be collapsed after loop 118 has collapsed.
[0240] Figures 46a to 46z3 It is shown that the catheter 9 can be packed and / or unpacked from a target site 147 within the body such that the catheter 9 crosses and / or extends through the target site 147 in multiple directions. Figures 46a to 46z3 The target site 147 shown may be the stomach 2. The catheter 9 may be inserted into the target site 147 by inserting the catheter 9 into the target site 147. The catheter 9 may be released from the target site 147 by withdrawing the catheter 9 from the target site 147.
[0241] Figures 46a to 46z3The catheter 9 is shown to define, when in an expanded configuration (e.g., configuration 116), a mesh having cells (e.g., cell 122), a lattice structure having cells (e.g., cell 122), a matting having cells (e.g., cell 122), a path (e.g., a tortuous path) defining cells (e.g., cell 122) and nodes (e.g., a node can be where the catheter 9 crosses itself—the catheter 9 may or may not be in contact with itself at a node), a meandering path defining cells (e.g., cell 122), a serpentine path defining cells (e.g., cell 122), or a serpentine path defining cells (e.g., cell 122). The invention can include a path, a stent with cells (e.g., cells 122), a 3D structure with cells (e.g., cells 122), an amorphous 3D structure with cells (e.g., cells 122), an arrangement with cells (e.g., cells 122), a web with cells (e.g., cells 122), a network with cells (e.g., cells 122), a maze with cells (e.g., cells 122), a patchwork of portions of conduit 9 that can crisscross each other, a tangle, a coil, a coiled structure, or any combination thereof. For example, Figures 46a to 46z3 The catheter 9 is shown as being able to form a coil 138 inside the target site 147 such that the catheter 9 is wound back and forth in multiple directions on the target site 147 (eg, longitudinally and / or laterally). Figure 46a to Figure 46z3 It is shown that, for example, the catheter 9 can extend through the target site 147 in multiple directions and / or in a zigzag pattern.
[0242] The catheter 9 can have a total length 124 (also referred to as total catheter length 124). The total catheter length 124 can be, for example, 100 cm to 900 cm or longer, including every 1 cm increment within this range (e.g., 100 cm, 200 cm, 300 cm, 500 cm, 900 cm). The total length 124 can be, for example, the total length of the catheter 9 from the proximal end of the catheter 9 to the distal end of the catheter 9. The total length 124 can be, for example, the total length of the catheter 9 from the proximal end of the catheter 9 to the catheter tip 7. The total length 124 can be, for example, the total length of the catheter 9 from the proximal end of the catheter 9 to the distal end of the catheter 9 (e.g., to the distal end of the catheter tip 7). For example, the total length 124 can be, for example, the total length of the catheter 9 from the connector 14 to the distal end of the catheter 9. As another example, the total length 124 can be, for example, the total length of the catheter 9 from the handle of the catheter 9 to the distal end of the catheter 9 (e.g., to the distal end of the catheter tip 7).
[0243] A 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 portion 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, including every 1 cm increment within this range (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, including every 1% increment within this range (e.g., 5%, 10%, 50%, 90%). The length 126 can be, for example, more than 10%, more than 20%, more than 30%, more than 40%, more than 50%, more than 60%, and / or more than 70% 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, less than 50% of the total length 124 can be located 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 of the catheter 9 and the distal portion of the catheter 9. For example, more than 50% of the total length 124 can be located within the target site 147. For example, the catheter 9 can have a midpoint between the proximal end of the catheter 9 and the distal end of the catheter 9. The proximal portion of the catheter 9 can be the portion of the catheter 9 that is closer to the midpoint, and the distal portion of the catheter 9 can be the portion of the catheter 9 that is farther from the midpoint, such that the proximal portion of the catheter 9 and the distal portion of the catheter 9 can have the same length (e.g., 50% of the total length 124).
[0244] Catheters 9 of varying lengths (e.g., any length 126) can be introduced into and / or removed from a target site 147. The length 126 of the catheter 9 within the target site 147 can be increased and / or decreased. For example, catheters 9 of longer and / or shorter lengths can be introduced and / or removed 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). The length 126 of the catheter 9 within the target site 147 can be adjusted, for example, before, during, and / or after heat is transferred to and / or from the catheter 9 (e.g., before, after, and / or while passing fluid 6 through the catheter 9). For example, the length 126 of the catheter 9 within the target site 147 can be increased and / or decreased. 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 affect the overall heat transferred to the stomach 2 and / or other organs. Figures 46a to 46oIt is shown that, for example, increasing the length 126 of the catheter 9 in the target site 147 can increase the surface area of the catheter 9 within the target site 147, which can increase the total heat transferred to and / or from the stomach 2 and / or other organs. Figure 46o to Figure 46z3 It is shown that, for example, reducing the length 126 of the catheter 9 in the stomach 2 can reduce the surface area of the catheter 9 within the stomach 2, which can reduce the total amount of heat transferred to and / or from the stomach 2 and / or other organs. The configuration 116 and shape 117 of the catheter 9 can be changed, for example, by increasing and / or decreasing the length 126 of the catheter 9 in the target site 147. For example, 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, by increasing and / or decreasing the length 126 of the catheter 9 in the target site 147. For example, Figures 46a to 46z3 Any configuration 116 and shape 117 in may be a first configuration and a first shape, respectively, Figures 46a to 46z3 Any configuration 116 and shape 117 in can be a second configuration and a second shape, respectively. For example, Figures 46a to 46z3 It is shown that the arrangement and / or path (eg, shape 117 ) that catheter 9 may have within target site 147 may depend on the length of catheter 9 within target site 147 . Figures 46a to 46z3 It is shown that, for example, as the catheter 9 is inserted into and / or withdrawn from the target site 147 , the alignment and / or path of the catheter 9 (eg, shape 117 ) may change. Figures 46a to 46z3 It is shown that the alignment and / or path (eg, shape 117 ) of the catheter 9 may be altered, for example, by increasing and / or decreasing the length 126 of the catheter 9 within the target site 147 .
[0245] The conduit 9 can have one or more heat transfer regions 128, e.g., from 1 to 30 or more heat transfer regions 128, including every increment of 1 heat transfer region within this range (e.g., 1 heat transfer region, 2 heat transfer regions, 30 heat transfer regions). One or more portions of the conduit 9 can be a heat transfer region 128. One or more portions of the conduit 9 can have a heat transfer region 128. The heat transfer region 128 can be a length (e.g., a segment) of the conduit 9. The heat transfer region 128 can be a continuous length of the conduit 9. For example, the heat transfer region 128 can be a length of the conduit 9, e.g., length 126 and / or total length 124. For example, the portion of the conduit 9 in the target site 147 can be a heat transfer region 128 and / or the entire length of the conduit 9 can be a heat transfer region 128. As another example, the heat transfer region 128 can be 50% to 100% of the length of the conduit 9 (e.g., conduit length 126), e.g., that can be positioned in 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, for example, 50% to 100% of the length of the catheter 9 (e.g., catheter length 126) in the target site 147 (e.g., in the stomach 2 and / or in the 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, for example, 50% to 100% of the length of the catheter 9 (e.g., catheter length 126) in the body (e.g., in the mouth, nose, esophagus 5, stomach 2, pylorus 65, duodenum 37, jejunum 10, or any combination thereof). Figures 46a to 46z3 It is shown, for example, that heat transfer region 128 may extend continuously along the length of conduit 9 (eg, length 126 ). Figures 46a to 46z3 The heat transfer region 128 is shown to be a conduit 9, for example, a section of the conduit 9 (e.g., length 126 of the conduit 9). The heat transfer region 128 can be, for example, one or more sections (e.g., one or more portions) of the conduit 9. The heat transfer regions 128 can be integrated with each other and / or connected to each other. The heat transfer region 128 can be, for example, a loop 118. Each loop 118 in the configuration 116 can be a different heat transfer region 128 or a different portion of the same heat transfer region 128. For example, Figures 46a to 46z3 The various loops 118 in the illustrated configuration 116 may be different portions of the same heat transfer region 128 .
[0246] Heat transfer region 128 can have a length 130 (also referred to as heat transfer region length 130). Length 130 can be, for example, greater than 10%, greater than 20%, greater than 30%, greater than 40%, greater than 50%, greater than 60%, and / or greater than 70% of length 126 and / or total length 124. Length 130 can be the same as or different from conduit length 126 and / or total length 124. For example, a portion of conduit 9 having length 126 can be heat transfer region 128 (e.g., a continuous heat transfer region), such that the configuration 116 and shape 117 of conduit 9 can be the configuration and shape of heat transfer region 128. For example, heat transfer region 128 can be formed to have configuration 116 having shape 117. Each loop 118 of shape 117 can be a different heat-transfer region 128 (e.g., the circumference of each loop 118 can be the length of each heat-transfer region 128) and / or can be a different portion of the same heat-transfer region 128 (e.g., the portion of the catheter having length 126 can be heat-transfer region 126). The ratio of length 130 to the length of target site 147 can be, for example, 1.5 to 20.0.
[0247] The path (e.g., shape 117) of the heat transfer region 128 in the target site 147 may vary. For example, Figures 46a to 46z3 It is shown that the path (eg, shape 117 ) that heat transfer region 128 may have in target location 147 may depend on length 130 of heat transfer region 128 in target location 147 . Figures 46a to 46z3 The path (eg, shape 117 ) illustrating heat transfer region 128 may change, for example, as catheter 9 is inserted into and / or withdrawn from target site 147 . Figures 46a to 46z3 It is shown that the path (eg, shape 117 ) may be changed, for example, by increasing and / or decreasing the length 126 of the catheter 9 in the target site 147 .
[0248] When the catheter 9 is in the deployed configuration (e.g., configuration 116), the heat transfer region 128 can be located proximal and / or distal to the catheter tip 7. For example, Figures 46a to 46z3 The heat transfer region 128 is shown to be located proximal to the catheter tip 7. When the catheter 9 is in the deployed configuration, the heat transfer region 128 can be located proximal and / or distal to a distal terminal end of the catheter 9. For example, Figures 46a to 46z3 It is shown that the heat transfer region 128 can be located proximal to the distal end of the catheter 9. Figures 46a to 46z3It is shown 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 located along the length of the catheter 9 between the distal end of the catheter 9 and the proximal end of the catheter 9. The heat transfer region 128 can be located along the length of the catheter 9 between the distal end of the catheter 9 and the proximal end of the catheter 9.
[0249] Heat transfer region 128 can be, for example, any portion of catheter 9 having a lumen (e.g., lumen 15 and / or lumen 16). For example, heat transfer region 128 can be any portion of catheter 9 having an inflow lumen and / or an outflow lumen (e.g., lumen 15 and / or lumen 16). The distal end of heat transfer region 128 can be, for example, the merging region 105 of the inflow and outflow lumens. Merging region 105 can be located within catheter 9, for example, within the distal end of catheter 9. Merging region 105 can be located within the distal end of catheter 9 (e.g., within catheter tip 7), for example, 0.10 cm to 10.00 cm proximal the distal terminal end of catheter 9, including every 0.10 cm increment therebetween (e.g., 0.10 cm, 1.00 cm, 2.00 cm, 5.00 cm, 10.00 cm). The heat transfer region 128 may terminate anywhere along the length of the catheter 9. For example, the heat transfer region 128 may terminate where the inflow lumen and the outflow lumen merge (eg, at the merging region 105).
[0250] When a fluid (e.g., fluid 6) is located in the catheter 9, the catheter 9 (e.g., heat transfer region 128) can transfer heat. For example, when the fluid is pumped through the lumens in the catheter 9 (e.g., through the inflow lumen and outflow lumen (e.g., lumen 15 and lumen 16)), the catheter 9 (e.g., the heat transfer region 128) can transfer heat to and / or from the body. For example, when the fluid is located in the catheter 9 (e.g., in the heat transfer region 128) and the temperature of the fluid is greater than or less than the surrounding tissue, heat can be transferred from the surrounding tissue to the fluid and / or from the fluid to the surrounding tissue through the catheter wall. When the fluid is located in the catheter 9 (e.g., in the heat transfer region 128) and the temperature of the fluid is greater than or less than the surrounding tissue, the fluid can dissipate heat and / or absorb heat, for example, through the wall of the catheter 9. The catheter 9 can dissipate heat and / or absorb heat.
[0251] The conduit 9 can have one or more heat transfer zones 132 (also referred to as heating zones 132). The heat transfer zones 132 can extend from the one or more heat transfer regions 128. The heat transfer zones 132 can be, for example, spaces adjacent to the conduit 9. The heat transfer zones 132 can extend (e.g., radially) away from the conduit 9. For example, the heat transfer zones 132 can have a cylindrical shape (e.g., a hollow cylindrical shape) that extends along the length of the conduit 9 (e.g., the total length 124, the length 126, and / or the length of the heat transfer regions 128). The conduit 9 can extend through the heat transfer zones 132. For example, the conduit 9 can extend through the longitudinal center of the heat transfer zones 132. The heat transfer zones 132 can extend, for example, a distance 132d (e.g., a radius) from (e.g., radially away from) the conduit 9 of 1 cm to 10 cm or more (including 1 cm increments within this range (e.g., 1 cm, 2 cm, 5 cm, 10 cm)), for example, as measured from the central longitudinal axis Ac of the conduit 9 or from the outer surface of the conduit 9.
[0252] The heat transfer zones 132 of different lengths (also referred to as segments) of the conduit 9 can overlap with each other. For example, when the conduit is in the configuration 116, a first heating zone of a first length of the heat transfer region 128 can overlap with a second heating zone of a second length of the heat transfer region 128. The first heating zone can be the heating zone 132 of any first length of the conduit 9, and the second heating zone can be the heating zone 132 of any second length of the conduit 9. For example, the first heating zone can be the heating zone 132 that extends from the first loop end 118-1 of one of the loops 118 (e.g., loop 118a) to the second loop end 118-1, and the second heating zone can be the heating zone 132 that extends from the first loop end 118-1 of another loop 118 (e.g., loop 118b, loop 118c, or loop 118d). As another example, the first heating zone may be a heating zone 132 that can extend from one of the loops 118 (e.g., loop 118a), and the second heating zone may be a heating zone 132 that can extend from another of the loops 118 (e.g., loop 118b, loop 118c, or loop 118d). As another example, the first heating zone may be a heating zone 132 that can extend from the loop first end 118-1 of one of the loops 118 (e.g., loop 118a) to the loop second end 118-1, and the second heating zone may be a heating zone 132 that can extend from the loop second end 118-2 of the same or different loop 118 (e.g., loop 118a, loop 118b, loop 118c, or loop 118d).
[0253] The catheter 9 may have various configurations 116 and / or shapes 117 at the target site 147. For example, the catheter 9 may have Figures 46a to 58bThe catheter 9 can have various positions relative to itself, the target site 147 and the surrounding organs. For example, the catheter 9 can have Figures 46a to 58b The loops 118 can have various positions relative to each other. For example, the loops 118 can have Figures 46a to 58b The loops 118 may have various sizes and / or shapes. For example, the loops 118 may have Figures 46a to 58b The chamber 122 may have various sizes, shapes and / or relative positions. For example, the chamber 122 may have Figures 46a to 58b size, shape and / or relative positions shown.
[0254] exist Figures 46b to 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 help identify different portions of the catheter 9 and to help describe the shapes 117 (e.g., shapes 117a through 117z3) and / or loops 118 that the catheter 9 may have. The reference points are used, for example, to refer to different portions of the catheter 9. The different portions can be integrated with each other and / or attached to each other. For example, the different portions of the catheter 9 can be portions of a length of the catheter 9 (e.g., portions of the total length 124 of the catheter 9). Reference points B1, C1, D1, E1, D1, E1, F1, G1, H1, I1, J1, K1, L1, M1, N1, and O1 may mark, for example, the distal tip of catheter 9 and / or the distal tip of heat transfer region 128. Reference points B2, C2, D3, E3, F3, G3, H4, I5, J5, K5, L5, M5N5, and O5 may mark, for example, the location at which catheter 9 enters target site 147.
[0255] Figures 46a to 46o It is shown that when the catheter 9 is in the first through fifteenth configurations 116a - 116o , the catheter 9 can have first through fifteenth shapes 117a - 117o , respectively. Figures 46a to 46o It is shown that the catheter 9 can be changed from the first configuration to the fifteenth configuration 116a - 116o by inserting the catheter 9 into the target site 147 . Figure 46o to Figure 46z3 It is shown that when the catheter 9 is in the fifteenth through twenty-ninth configurations 116o - 116z3, the catheter 9 can have fifteenth through twenty-ninth shapes 117o - 117z3, respectively. Figures 46a to 46z3 It is shown that the catheter 9 can be changed from the fifteenth configuration to the twenty-ninth configuration 116o - 116z3 by withdrawing the catheter 9 from the target site 147 .
[0256] Figure 46a The catheter 9 may not have the loop 118 when the catheter tip 7 is shown in the esophagus 5. As another example, when the catheter tip 7 is in the esophagus 5, the catheter 9 may have a loop that can expand upon entering the target site 147 and / or when the loop is inflated.
[0257] Figure 46b It is shown that the first loop 118a may be formed by the B1-B2 section of the conduit 9. The length of the B1-B2 section of the conduit 9 may be, for example, the length 126.
[0258] Figure 46c It is shown that the first loop 118a can be formed by the C1-C2 section of the catheter 9. The length of the C1-C2 section of the catheter 9 can be, for example, the length 126. Figure 46c It is shown that the size (eg, 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 It is shown that when the catheter 9 is in the third configuration 116c, the gap between the first loop first end 118a-1 and the first loop second end 118a-2 may be smaller than when the catheter 9 is in the second configuration 116b. Figure 46c The position of the catheter tip 7 in the target site 147 when the catheter 9 is in the third configuration 116c is shown to be different from the position of the catheter tip 7 in the target site 147 when the catheter 9 is in the second configuration 116b. Figure 46c It is shown that when the catheter 9 is in the third configuration 116c, the catheter tip 7 may be closer to the upper portion of the stomach 2 and / or the gastroesophageal junction 120 than when the catheter 9 is in the second configuration 116b.
[0259] Figure 46d It is shown that the first loop 118a can be formed by the D1-D3 section of the conduit 9 and the second loop 118b can be formed by the D2-D4 section of the conduit 9. The length of the D1-D3 section of the conduit 9 can be, for example, length 126. The length of the D2-D4 section can be, for example, less than the length of the D1-D3 section. Figure 46d It is shown that the D3 - D4 segment of the second loop 118 b may be located in the esophagus 5 , and the D2 - D3 segment of the second loop 118 b may be located in the target site 147 . Figure 46d The same section of the catheter 9 is shown to define multiple loops 118. For example, Figure 46d The D2-D3 segment of the catheter 9 is shown to be part of the first loop 118a and part of the second loop 118b. Figure 46d It is shown that, for example, the second loop 118b may be formed from a portion of the first loop 118a (eg, segment D2 - D3 ). Figure 46dIt is shown that the size (eg, circumference) of the first loop 118a may be larger when the catheter 9 is in the fourth configuration 116d than when the catheter 9 is in the third configuration 116c. Figure 46d It is shown that when the catheter 9 is in the fourth configuration 116d, the gap between the first loop first end 118a-1 and the first loop second end 118a-2 may be smaller than when the catheter 9 is in the third configuration 116b. Figure 46d It is shown that when the catheter 9 is in the fourth configuration 116d, the position of the catheter tip 7 in the target site 147 may be the same as the position when the catheter 9 is in the third configuration 116c.
[0260] Figure 46e It is shown that the first loop 118a can be formed by the E1-E3 section of the conduit 9 and the second loop 118b can be formed by the E2-E3 section of the conduit 9. The length of the E1-E3 section of the conduit 9 can be, for example, length 126. The length of the E2-E3 section can be, for example, less than the length of the E1-E3 section. Figure 46e It is shown that the size (eg, 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 It is shown that when the catheter 9 is in the fifth configuration 116e, the second loop 118b may be closer to the catheter tip 7 than when the catheter 9 is in the fourth configuration 116d. Figure 46e It is shown that when the catheter 9 is in the fifth configuration 116e, the second loop 118b (e.g., the second loop head 118b-3) can be closer to the first loop 118a (e.g., closer to the first loop first end 118a-1 and / or the first loop head 118a-3) than when the catheter 9 is in the fourth configuration 116d. Figure 46d It is shown that when the catheter 9 is in the fifth configuration 116e, the position of the catheter tip 7 in the target site 147 can be the same as the position when the catheter 9 is in the fourth configuration 116d. Figure 46e It is shown that when the catheter 9 is in the fifth structure 116e, the gap between the first loop first end 118a-1 and the first loop second end 118a-2 (e.g., the gap between reference points E1 and E3) can be smaller than when the catheter 9 is in the fourth structure 116d (e.g., the gap between reference points D1 and D3).
[0261] Figure 46f It is shown that the first loop 118a can be formed by the F1-F3 section of the conduit 9 and the second loop 118b can be formed by the F2-F3 section of the conduit 9. The length of the F1-F3 section of the conduit 9 can be, for example, length 126. The length of the F2-F3 section can be, for example, less than the length of the F1-F3 section. Figure 46fIt is shown that the size (eg, circumference) of the first loop 118a and / or the second loop 118b may be larger when the catheter 9 is in the sixth configuration 116f than when the catheter 9 is in the fifth configuration 116e. Figure 46f It is shown that when the catheter 9 is in the sixth configuration 116f, the second loop 118b (e.g., the second loop head 118b-3) can be closer to the first loop 118a (e.g., closer to the first loop first end 118a-1 and / or the first loop head 118a-3) than when the catheter 9 is in the fifth configuration 116e.
[0262] Figure 46g It is shown that the first loop 118a can be formed by the G1-G3 section of the conduit 9 and the second loop 118b can be formed by the G2-G3 section of the conduit 9. The length of the G1-G3 section of the conduit 9 can be, for example, length 126. For example, the length of the G2-G3 section can be less than the length of the G1-G3 section. Figure 46g It is shown that the size (eg, circumference) 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 It is shown that when the catheter 9 is in the seventh configuration 116g, the second loop 118b (e.g., the second loop head 118b-3) can be closer to the first loop 118a (e.g., closer to the first loop first end 118a-1 and / or the first loop head 118a-3) than when the catheter 9 is in the sixth configuration 116f. Figures 46d to 46g It is shown that increasing the length of the catheter 9 in the target site 147 (eg, the stomach 2) can move the second loop 118b toward the first loop 118a. Figures 46f to 46g It is shown that increasing the length of the catheter 9 in the target site 147 (eg, the stomach 2) can move the second loop 118b through (eg, above or below) the first loop 118a. Figures 46f to 46g It is shown that increasing the length of the catheter 9 in the target site 147 can pinch the first loop 118a closed, which can divide the first chamber 122a into sub-chambers, eg, a first sub-chamber 122a1 and a second sub-chamber 122a2. Figure 46g It is shown that the first sub-chamber 122a1 may be an open chamber, and the second sub-chamber 122a2 may be a closed chamber. Figure 46g For example, it is shown that the second chamber 122b may be located between the first sub-chamber 122a1 and the second sub-chamber 122a2. Figures 46d to 46f It is shown that increasing the length of the catheter 9 in the target site 147 (eg, the stomach 2 ) may move the second loop 118 b (eg, the second loop first end 118 b - 1 ) toward the catheter tip 7 . Figures 46f to 46gIt is shown that increasing the length of the catheter 9 in the target site 147 (eg, the stomach 2 ) may move the second loop 118 b (eg, the second loop first end 118 b - 1 ) away from the catheter tip 7 .
[0263] Figure 46h It is shown that a first loop 118a can be formed by the H1-H4 section of the conduit 9, a second loop 118b can be formed by the H2-H4 section of the conduit 9, and a third loop 118c can be formed by the H3-H4 section of the conduit 9. The length of the H1-H4 section of the conduit 9 can be, for example, a length 126. The lengths of the H2-H4 section and the H3-H4 section can be, for example, less than the length of the H1-H4 section. Figure 46h It is shown that the size (eg, circumference) 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 It is shown that when the catheter 9 is in the eighth configuration 116h, the third loop 118c may be further from the gastroesophageal junction 120 than when the catheter 9 is in the seventh configuration 116g. Figure 46h The same portion of the catheter 9 is shown to define multiple loops 118. For example, Figure 46h The H3-H4 segment of the conduit 9 is shown to be part of the second loop 118b and part of the third loop 118c. Figure 46h It is shown that the first loop 118 can extend back and forth over the target site 147. For example, Figure 46h The first loop first end 118a - 1 is shown as being extendable back and forth through the target site 147 . Figure 46h It is shown that a portion of the first loop 118a can extend through (eg, above or below) the second chamber 122b. Figure 46h The portion of the first loop 118a shown extending through the second chamber 122b may partially block the second chamber 122b. Figure 46h It is shown that the second loop 118b can extend through (eg, above or below) the first loop 118a such that a chamber 134 can be created between the first loop 118a and the second loop 118b. Figure 46h It is shown that the first portion of the conduit 9 (e.g., the second loop head 118b-3) can extend through the second portion of the conduit 9 (e.g., the first loop second end 118a-2 and / or the first loop head 118-3) at two locations (e.g., opposite ends of the chamber 134). Figure 46h It is shown that a cell 134 may be created between, for example, a radially outer surface of the first ring 118a and a radially inner surface of the second ring 118b.
[0264] Figure 46iIt is shown that a first loop 118a can be formed by the I1-I5 section of the conduit 9, a second loop 118b can be formed by the I2-I4 section of the conduit 9, and a third loop 118c can be formed by the I3-I5 section of the conduit 9. The length of the I1-I5 section of the conduit 9 can be, for example, a length 126. The lengths of the I2-I4 section and the I3-I5 section can be, for example, less than the length of the I1-I5 section. Figure 46i It is shown that the size (eg, 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. Figures 46h to 46i It is shown that increasing the length of the catheter 9 in the target site 147 can clamp the second loop 118b closed, which can divide the second chamber 122b into sub-chambers, eg, a first sub-chamber 122b1 and a second sub-chamber 122b2. Figure 46i It is shown that the first sub-chamber 122b1 may be an open chamber, and the second sub-chamber 122b2 may be a closed chamber. Figure 46i For example, it is shown that a first portion of conduit 9 (eg, second loop first end 118b-1 and / or third loop head 118c-3) can be adjacent to and / or contact a second portion of conduit 9 (eg, second loop second end 118b-2) at position Z1. Figures 46h to 46i It is shown that, for example, increasing the length of the catheter 9 at the target site 147 can cause the first portion of the catheter 9 (e.g., the second loop first end 118b-1 and / or the third loop head 118c-3) to move at a first position Z1 to be adjacent to and / or in contact with the second portion of the catheter 9 (e.g., the second loop second end 118b-2).
[0265] Figure 46j It is shown that a first loop 118a can be formed by the J1-J5 section of the conduit 9, a second loop 118b can be formed by the J2-J4 section of the conduit 9, and a third loop 118c can be formed by the J3-J5 section of the conduit 9. The length of the J1-J5 section of the conduit 9 can be, for example, a length 126. The lengths of the J2-J4 section and the J3-J5 section can be, for example, less than the length of the J1-J5 section. Figure 46j It is shown that the size (eg, 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. Figures 46i to 46j It is shown that increasing the length of the catheter 9 in the target site 147 can cause the first portion of the catheter 9 (e.g., the second loop first end 118b-1 and / or the third loop head 118c-3) to move (e.g., push) the second portion of the catheter 9 (e.g., the second loop second end 118b-2) from the first position Z1 to the second position Z2. Figure 46jIt is shown that position Z2 can be farther from the esophagus 5 (by distance Z3) and / or closer to the pylorus 65 (by distance Z3). Distance Z3 can be, for example, 1 cm to 5 cm or more, including every 1 cm increment therein (e.g., 1 cm, 2 cm, 3 cm, 5 cm). Figures 46i to 46j It is shown that, for example, as the catheter 9 is inserted into the target site 147, the first part of the catheter 9 (e.g., the second loop first end 118b-1 and / or the third loop head 118c-3) can be deformed by moving the first part to the second part of the catheter 9 (e.g., the second loop second end 118b-2). Figures 46i to 46j It is shown that, for example, as the catheter 9 is pushed (e.g., inserted) into the target site 147, the second portion of the catheter 9 (e.g., the second loop second end 118b-2) can resist the first portion of the catheter 9 (e.g., the second loop first end 118b-1 and / or the third loop head 118c-3) from moving to the target site 147.
[0266] Figure 46k It is shown that the first loop 118a can be formed by the K1-K5 section of the conduit 9, the second loop 118b can be formed by the K2-K4 section of the conduit 9, and the third loop 118c can be formed by the K3-K5 section of the conduit 9. The length of the K1-K5 section of the conduit 9 can be, for example, a length of 126. The lengths of the K2-K4 section and the K3-K5 section can be, for example, less than the length of the K1-K5 section. Figure 46k It is shown that the size (eg, circumference) of the third loop 118c may be larger when the catheter 9 is in the eleventh configuration 116k than when the catheter 9 is in the tenth configuration 116j. Figure 46k It is shown that a portion of the second loop 118b (eg, the second loop second end 118b-2) can extend through the third chamber 122c. Figure 46k The portion of the second loop 118b shown extending through the third chamber 122c may partially block the third chamber 122c. Figure 46k It is shown that the first portion of the conduit 9 (e.g., the second loop first end 118b-1 and / or the third loop head 118c-3) can extend through (e.g., above or below) the second portion of the conduit 9 (e.g., the second loop second end 118b-2) at two locations. Figure 46k It is shown that the third chamber 122c can overlap with the first chamber 122a (eg, overlap with the second sub-chamber 122a2).
[0267] Figure 46lIt is shown that a first loop 118a can be formed by the L1-L5 section of the conduit 9, a second loop 118b can be formed by the L2-L4 section of the conduit 9, and a third loop 118c can be formed by the L3-L5 section of the conduit 9. The length of the L1-L5 section of the conduit 9 can be, for example, a length 126. The lengths of the L2-L4 section and the L3-L5 section can be, for example, less than the length of the L1-L5 section. Figure 46l It is shown that a greater portion of the third chamber 122c may overlap with the first chamber 122a (eg, overlap with the second sub-chamber 122a2) when the conduit 9 is in the twelfth configuration 1161 than when the conduit 9 is in the eleventh configuration 116k. Figure 46l It is shown that the first portion of the conduit 9 (eg, the second loop first end 118b-1 and / or the third loop head 118c-3) can be adjacent to and / or in contact with the second portion of the conduit 9 (eg, the first loop head 118a-3). Figures 46k to 46l It is shown that, for example, increasing the length of catheter 9 in target site 147 can cause a first portion of catheter 9 (e.g., second loop first end 118b-1 and / or third loop head 118c-3) to move adjacent to and / or contact a second portion of catheter 9 (e.g., first loop head 118a-3). Figures 46h to 46l It is shown that increasing the length of the catheter 9 in the target site 147 (eg, the stomach 2 ) may cause the third loop 118 c to move toward the boundary of the shape 117 .
[0268] Figure 46m It is shown that the first loop 118a can be formed by the M1-M5 section of the conduit 9, the second loop 118b can be formed by the M2-M4 section of the conduit 9, the third loop 118c can be formed by the M3-M5 section of the conduit 9, and the fourth loop 118d can be formed by the M4-M5 section. The length of the M1-M5 section of the conduit 9 can be, for example, length 126. The lengths of the M2-M4 section, the M3-M5 section, and the M4-M5 section can be, for example, less than the length of the M1-M5 section. Figure 46m It is shown that a greater portion of the third chamber 122c may overlap with the first chamber 122a (eg, with the second sub-chamber 122a2) when the conduit 9 is in the thirteenth configuration 116m than when the conduit 9 is in the twelfth configuration 1161. Figure 46m The second loop 118b and the third loop 118c are shown to define an infinite shape. For example, Figure 46m The M2 - M4 segment of the catheter 9 is shown to comprise an infinity shape.
[0269] Figure 46nAs shown, first loop 118a can be formed by the N1-N5 section of conduit 9, second loop 118b can be formed by the N2-N4 section of conduit 9, third loop 118c can be formed by the N3-N5 section of conduit 9, and fourth loop 118d can be formed by the N4-N5 section. The length of the N1-N5 section of conduit 9 can be, for example, length 126. The lengths of the N2-N4 section, the N3-N5 section, and the N4-N5 section can be, for example, less than the length of the N1-N5 section. Figure 46n It is shown that when the catheter 9 is in the fourteenth configuration 116n, the size (eg, circumference) of the fourth loop 118d may be larger than when the catheter 9 is in the thirteenth configuration 116m. Figures 46m to 46n It is shown that increasing the length of the catheter 9 in the target site 147 can pinch the third loop 118c closed, which can divide the third chamber 122c into sub-chambers, eg, a first sub-chamber 122c1 and a second sub-chamber 122c2. Figure 46n It is shown that the first sub-chamber 122c1 may be an open chamber, and the second sub-chamber 122c2 may be a closed chamber. Figure 46n It is shown that, for example, a first portion of the conduit 9 (eg, third loop first end 118c-1 and / or fourth loop head 118d-3) can be adjacent to and / or in contact with a second portion of the conduit 9 (eg, third loop second end 118c-2). Figures 46m to 46n It is shown that, for example, increasing the length of the catheter 9 in the target site 147 can cause a first portion of the catheter 9 (e.g., the third loop first end 118c-1 and / or the fourth loop head 118d-3) to move adjacent to and / or contact a second portion of the catheter 9 (e.g., the third loop second end 118c-2).
[0270] Figure 46o It is shown that the first loop 118a can be formed by the O1-O5 section of the conduit 9, the second loop 118b can be formed by the O2-O4 section of the conduit 9, the third loop 118c can be formed by the O3-O5 section of the conduit 9, and the fourth loop 118d can be formed by the O4-O5 section. The length of the O1-O5 section of the conduit 9 can be, for example, a length 126. Figure 46o It is shown that, for example, the length 126 may be 110 cm. The lengths of the O2-O4, O3-O5, and O4-O5 segments may be, for example, less than the length of the O1-O5 segment. Figure 46o It is shown that when the catheter 9 is in the fifteenth configuration 116o, the size (eg, circumference) of the fourth loop 118c may be larger than when the catheter 9 is in the fourteenth configuration 116n. Figure 46o It is shown that the first portion of the conduit (eg, the third loop first end 118c-1 and / or the fourth loop head end 118d-3) can extend through the second chamber 122b. Figure 46o It is shown that the portion of the conduit 9 extending through the second chamber 122b may partially block the second chamber 122b. Figure 46o It is shown that the first portion of the conduit (e.g., third loop first end 118c-1 and / or fourth loop head end 118d-3) can extend through (e.g., above or below) the second portion of the conduit 9 (e.g., third loop second end 118c-2) at two locations. Figure 46o It is shown that the fourth chamber 122d may overlap with the second chamber 122b (eg, with the second sub-chamber 122b2). Figures 46a to 46o It is shown that the first loop 118a may include a second loop 118b, a third loop 118c, and a fourth loop 114b.
[0271] The loop 118 may be formed proximally and / or distally of the catheter tip 7 in the target site 147. For example, Figures 46a to 46z3 It is shown that the loop 118 can be formed at the distal end of the catheter tip 7 in the target site 147. For example, Figures 46a to 46z3 It is shown that loops 118 (eg, second loop 118 b , third loop 118 c , and fourth loop 118 d ) may be formed between the catheter tip 7 and the pylorus 65 .
[0272] Figure 46o to Figure 46z3 The catheter 9 is shown as being able to be withdrawn from the target site 147 . Figure 46o to Figure 46z3 The loop 118 is shown as being collapsible within and / or removable from the target site 147 . Figure 46o to Figure 46z3 It is shown that collapsing the loop 118 may include straightening the loop 118, reducing the curvature of the loop, reducing the circumference 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 46a to 46z3 It is shown that the loop 118 can be collapsed in the target site 147 by withdrawing the catheter 9 from the target site 147 .
[0273] Figures 46a to 46o The catheter 9 is shown to be capable of forming a coil (eg, coil 138 ) in the target site 147 , for example, by inserting the catheter 9 into the target site 147 . Figures 46a to 46o 147, the coils 138 (e.g., the length 126 of the catheter 9 in the target site 147) may become more tangled, may become larger, may extend through the target site 147 more times, and / or may become more dense (e.g., more catheters 9 per unit volume of the target site 147, such as 1 cm per 1 cm of the target site 147). 3 More tubes in the ). Figures 46a to 46z3 The catheter 9 is shown as being able to form (eg, step-form) a coil 138 . Figure 46o to Figure 46z3It is shown that, for example, as the catheter 9 is withdrawn from the target site 147 , the coils 138 may become less tangled, decrease in size, extend fewer times through the target site 147 , and / or become less dense in the target site 147 . Figure 46o to Figure 46z3 It is shown that the catheter 9 may be expanded (eg, gradually expanded) as the catheter 9 is withdrawn from the target site 147 . Figure 46o to Figure 46z3 It is shown that, for example, as the catheter 9 is withdrawn from the target site 147 , the coil 138 may uncoil (eg, gradually unravel) in the target site 147 .
[0274] Figures 46a to 46z3 It is shown that when the catheter 9 is in a deployed configuration (eg, configuration 116 ), the heat transfer region 128 may be located in the stomach 2 and esophagus 5 .
[0275] Figures 47a to 47i It is shown that the catheter 9 can be inserted into the stomach 2 and / or withdrawn from the stomach 2 . Figures 47a to 47i It is shown that various lengths of catheter 9 (e.g. Figures 47b to 47h Length 126 shown in FIG is introduced into and / or removed from the stomach 2 . Figures 47a to 47i Various configurations 116 and shapes 117 are shown that the catheter 9 can have. Figures 47a to 47i The configuration 116 and shape 117 in the embodiment may be, for example, different from Figures 46a to 46z3 The structure 116 and shape 117 in. Figures 47a to 47i For example, when the catheter 9 is in the first to ninth configurations 116a-116i, the catheter 9 can have first to ninth shapes 117a-117i, respectively. As another example, the catheter 9 in the target site 147 can have Figures 46b to 46z2 and Figures 47b to 47i Any combination of the rings 118 and / or chambers 122 shown in FIG.
[0276] Figures 47a to 47e It is shown that the catheter 9 can be inserted into the target site 147 as shown by arrow 112.
[0277] Figure 47a It is shown that when the catheter tip 7 is located in the esophagus 5 , the catheter 9 may not have the loop 118 .
[0278] Figure 47b It is shown that the first loop 118a may be an open loop. Figure 47b Shown in the illustrated configuration 116 , the length 126 may be, for example, 15 cm to 40 cm (eg, 25 cm).
[0279] Figure 47c It is shown that the first loop 118a may be a closed loop. Figures 47b to 47cIt is shown that the first loop 118 can be changed from an open loop to a closed loop, for example, by inserting the catheter 9 into the target site 147 . Figures 47b to 47c It is shown that when the catheter 9 is in the third configuration 116c, the size (eg, circumference) of the first loop 118a may be larger than when the catheter 9 is in the second configuration 116b. Figure 47c Shown in the illustrated configuration 116 , the length 126 may be, for example, 20 cm to 90 cm (eg, 50 cm).
[0280] Figure 47d It is shown that the first loop 118a and the second loop 118b may be closed loops, and the third loop 118c may be an open loop. Figure 47d It is shown that the first loop 118a may overlap with the second loop 118b. Figure 47d It is shown that the second loop 118b may overlap the first loop 118a. Figure 47d A portion of the second loop 118b is shown as being located posterior to the first loop 118a. Figure 47d The first chamber 122a and the second chamber 122b are shown to be overlapped and offset from each other. Figure 47d It is shown that a lower portion of the first cell 122b may overlap (eg, be aligned with) an upper portion of the second cell 122b. Figure 47d Shown in the illustrated configuration 116 , the length 126 may be, for example, 70 cm to 200 cm (eg, 80 cm).
[0281] Figure 47e It is shown that the first loop 118a, the second loop 118b, and the third loop 118c may be closed loops. Figures 47d to 47e It is shown that the third loop 118 can be changed from an open loop to a closed loop, for example, by inserting the catheter 9 into the target site 147 . Figures 47d to 47e It is shown that when the catheter 9 is in the fifth configuration 116e, the size (eg, circumference) of the third loop 118c may be larger than when the catheter 9 is in the fourth configuration 116d. Figures 47d to 47e It is shown that the size (eg, circumference) of the second and third loops 118c can be increased and / or decreased independently of the size of the first loop 118 and / or the second loop 118b. Figure 47e Shown in the illustrated configuration 116 , the length 126 may be, for example, 80 cm to 180 cm (eg, 90 cm).
[0282] Figures 47d to 47e It is shown that after forming the proximal loops (eg, first loop 118a ) in the target site 147 , the distal loops (eg, second loop 118b and / or third loop 118c ) may be formed in the target site 147 . Figure 47eIt is shown that after forming the proximal chamber (eg, first chamber 122a ) in the target site 147 , the distal chamber (eg, second chamber 122b and / or third chamber 122c ) may be formed in the target site 147 .
[0283] Figures 47a to 47e It is shown that the loop 118 and the chamber 122 can be formed by inserting the catheter 9 into the target site 147. The loop 118 can be formed in any order, such as sequentially and / or simultaneously in the target site 147. For example, Figures 47a to 47e It is shown that the first loop 118a, the second loop 118b and the third loop 118c can be formed sequentially. Figures 47a to 47e It is shown that a first loop 118a can be formed in the target site 147, then a second loop 118b can be formed in the target site 147, and then a third loop 118c can be formed in the target site 147. For example, Figures 47a to 47e It is shown that the second loop 118b may be formed after the first loop 118a is formed, and the third loop 118c may be formed after the first loop 118a and / or the second loop 118b are formed.
[0284] Figures 47a to 47e For example, during the first stage of loop formation, loop 118a may be formed; during the second stage of loop formation, loop 118b may be formed; and during the third stage of loop formation, loop 118c may be formed. The first stage of loop formation may be before the second stage of loop formation. The second stage of loop formation may be after the first stage of loop formation. The third stage of loop formation may be after the second stage of loop formation. When forming second loop 118b (e.g., during the second stage of loop formation), first loop 118a may have a constant size and / or shape. As another example, when forming second loop 118b (e.g., during the second stage of loop formation), the size (e.g., circumference) of first loop 118a may increase and / or decrease, the shape of first loop 118a may change, or any combination thereof. When forming third loop 118c (e.g., during the third stage of loop formation), first loop 118a and / or second loop 118b may have a constant size and / or shape. As another example, while forming the third loop 118c (e.g., during a third stage of loop formation), the size (e.g., circumference) 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.
[0285] Figures 47a to 47eIt is shown that different sections of the catheter 9 can form different loops 118 at different times and / or at different stages of loop formation. For example, Figures 47a to 47e It is shown that when the conduit 9 is in the third configuration 116c, the first portion of the conduit 9 can form a first loop 118a, and when the conduit 9 is in the fourth configuration 116d, the first portion of the conduit 9 can form a third loop 118c, and the second portion of the conduit 9 can form the first loop 118a. As another example, Figures 47a to 47e It is shown that when the conduit 9 is in the third configuration 116c, the first portion of the conduit 9 can form a first loop 118a, when the conduit 9 is in the fifth configuration 116e, the first portion of the conduit 9 can form a third loop 118c, and the second portion of the conduit 9 can form the first loop 118a. When the conduit 9 is in the third configuration 116c, the fourth configuration 116d, and the fifth configuration 116e, the first portion of the conduit 9 can have the same length. Figures 47a to 47e The first portion of the catheter 9 is shown to be distal to the second portion of the catheter along its length. Figures 47a to 47e The first portion of the catheter 9 is shown, for example, which may be the distal end of the catheter 9 . Figures 47a to 47e For example, the first portion of the catheter 9 is shown to have a catheter tip 7. As another example, during the first stage of loop formation, the first portion of the catheter 9 can form a first loop 118a; during the second stage of loop formation, the first portion of the catheter 9 can form a second loop 118b, and the second portion of the catheter 9 can form the first loop 118a; during the third stage of loop formation, the first portion of the catheter 9 can form a third loop 118c, the second portion of the catheter 9 can form the second loop 118b, and the third portion of the catheter 9 can form the first loop 118a. Figures 47a to 47e It is shown that, for example, as the catheter 9 is inserted into the target site 147 , the catheter tip 7 can trace out the path of the catheter 9 in the target site 147 . Figures 47a to 47e For example, as the catheter 9 is advanced into the target site 147, one or more portions of the catheter 9 proximal to the catheter tip 7 can follow the path of the distal portion (e.g., distal tip 7) through the target site 147 (e.g., as the catheter 9 is inserted into the target site 147, the proximal portion of the catheter 9 can follow the path of the distal portion of the catheter 9 in the target site 147). Figures 47a to 47e It is shown that the second loop 118b may be formed at the distal end of the first loop 118a, and the third loop 118c may be formed at the distal ends of the first and second loops 118a, 118b. Figures 47a to 47eFor example, when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the third loop 118c can be the most distal loop along the catheter 9 in the target site 147, and the first loop 118a can be the most proximal loop along the catheter 9 in the target site 147. Figure 47d and 47e For example, when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first loop 118a can be located proximal to the second loop 118b and the third loop 118c in the target site 147, and the second loop 118b can be located proximal to the third loop 118c in the target site 147.
[0286] Figures 47e to 47i It is shown that the catheter 9 can be withdrawn from the target site 147 as shown by arrow 114 . Figures 47e to 47i The loop 118 is shown as being collapsible within and / or removable from the target site 147 . Figures 47e to 47i It is shown that collapsing the loop 118 may include straightening the loop 118, reducing the curvature of the loop, reducing the circumference 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 to 47i It is shown that the loop 118 can be collapsed in the target site 147 by withdrawing the catheter 9 from the target site 147 as indicated by arrow 114 . Figures 47e to 47i It is shown that, for example, as the catheter 9 is withdrawn (eg, pulled) from the target site 147 into the esophagus 5 , the catheter 9 may straighten and / or become less tortuous in the target site 147 .
[0287] The loops 118 may be collapsed in and / or removed from the target site 147 in any order, such as sequentially and / or simultaneously. For example, Figures 47e to 47i It is shown that the first loop 118a, the second loop 118b, and the third loop 118c can be sequentially collapsed and / or sequentially removed from the target site 147. Figures 47e to 47i For example, as the first loop 118a, the second loop 118b, and the third loop 118c are shown collapsed (eg, as their sizes are reduced), the first loop 118a, the second loop 118b, and the third loop 118c can be removed from the target site 147. For example, Figures 47e to 47i It is shown 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, Figures 47e to 47iIt is shown that after the first loop 118a is collapsed and removed from the target site 147, the second loop 118b can be collapsed and removed from the target site 147, and after the first and second loops 118a and 118b are collapsed and removed from the target site 147, the third loop 118c can be collapsed and removed from the target site 147. Figures 47e to 47i It is shown that as the catheter 9 is withdrawn from the target site 147, the loops 118 can collapse independently of each other, starting with the most proximal loop (eg, loop 118a) and ending with the most distal loop (eg, loop 118c). Figures 47e to 47i It is shown that as the first loop 118a is collapsed and removed from the target site 147 , the second and third loops 118b , 118c may be moved (eg, pulled) toward the gastroesophageal junction 120 . Figures 47e to 47i It is shown that as the second loop 118b is collapsed and removed from the target site 147 , the third loop 118c can be moved (eg, pulled) toward the gastroesophageal junction 120 .
[0288] Figures 47e to 47iFor example, during the first stage of catheter removal, the portion of catheter 9 defining first loop 118a can be removed from target site 147; during the second stage of catheter removal, the portion of catheter 9 defining second loop 118b can be removed from target site 147; and during the third stage of catheter removal, the portion of catheter 9 defining third loop 118c can be removed from target site 147. During the first stage of catheter removal, first loop 118a can collapse at target site 147. During the second stage of catheter removal, second loop 118b can collapse at target site 147. During the third stage of catheter removal, third loop 118c can collapse at target site 147. As another example, if the size of first loop 118a, second loop 118b, and / or third loop 118c is smaller than the passage through esophagus 5, first loop 118a, second loop 118b, and / or third 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. When the first loop 118a is 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, when the first loop 118a is removed (e.g., during the first stage of catheter removal), the size (e.g., circumference) 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. When the second loop 118b is 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, upon removal of second loop 118b (e.g., during the second stage of catheter removal), the size (e.g., circumference) of third loop 118c may increase and / or decrease, the shape of third loop 118c may change, or any combination thereof. Figures 47e to 47i It is shown that, for example, as the catheter 9 is withdrawn from the target site 147, one or more distal portions of the catheter 9 can travel along the path of the proximal portion through the target site 147 (for example, as the catheter 9 is inserted into the target site 147, the distal portion of the catheter 9 can travel along the path of the proximal portion of the catheter 9 in the target site 147).
[0289] Figures 47a to 47e The catheter 9 is shown to be capable of forming a coil (eg, coil 138 ) in the target site 147 , for example, by inserting the catheter 9 into the target site 147 . Figures 47e to 47iIt is shown that the coil 138 may unwind (eg, gradually unwind) within the target site 147 as the catheter 9 is withdrawn from the target site 147 .
[0290] Figures 47a to 47i For example, 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 can be different from the configuration 116 formed by the catheter 9 during insertion of the catheter 9 into the body.
[0291] Figures 48a to 48i It is shown that the catheter 9 can be inserted into the stomach 2 and / or removed from the stomach 2. Figures 48a to 48i It is shown that various lengths of catheter 9 (e.g. Figures 48b to 48h The length 126 shown in FIG. 1 is introduced into the stomach 2 and / or removed from the stomach 2. Figures 48a to 48i Various configurations 116 and shapes 117 are shown that the catheter 9 can have. Figures 48a to 48i The configuration 116 and shape 117 in may be different from, for example Figures 46a to 46z3 The structure 116 and shape 117 in. Figures 48a to 48i It is shown that, for example, when the catheter 9 is in first through ninth configurations 116a - 116i , the catheter 9 can have first through ninth shapes 117a - 117i , respectively.
[0292] Figures 48a to 48i Shown with Figures 47a to 47i The same configuration 116 and shape 117 are shown, but illustrate that the loops 118 may be formed differently and / or may be collapsed and / or removed in a different order. For example, Figures 48a to 48e The coil 138 may have a predetermined shape. For example, Figures 48a to 48i It is shown that the catheter 9 and / or the guidewire 99 may have a predetermined shape in the shape of a coil 138 . Figures 48a to 48i The illustrated coil 138 may be, for example, a loose coil (eg, a coil having loops 118 and / or cells 122 that are offset from one another). Figures 48a to 48iVarious shapes 117 of the coil 138 are shown. As the catheter 9 is inserted into the target site 147, the catheter 9 can be biased to form a predetermined shape (e.g., the shape of the coil 138) so that once the catheter 9 is no longer constrained by the esophagus 5, the catheter 9 can, for example, automatically form the predetermined shape after being inserted into the target site 147. As another example, as the guidewire 99 is withdrawn from the catheter 9 as shown by arrow 111, the catheter 9 can be biased to form a predetermined shape (e.g., the shape of the coil 138) so that once the guidewire 99 is withdrawn from the catheter 9 in the target site 147, the catheter can, for example, automatically form the current shape. The catheter 9 can form the loop 118 and the chamber 122 by forming the predetermined shape in the target site 147. The predetermined shape can have the loop 118 and the chamber 122. The predetermined shape can be, for example Figures 48b to 48h For example, as the catheter 9 enters the target site 147 and / or as the guidewire 99 is withdrawn from the catheter 9 in the target site 147, the catheter 9 may form a current shape in the target site 147. The guidewire 99 may be removed and / or introduced into the catheter 9 to adjust the shape of the catheter 9 in the target site 147.
[0293] Figures 48a to 48e It is shown that the first loop 118a may be formed by a section of the catheter 9 that is distal to the sections of the catheter that form the second and third loops 118b, 118c, respectively. Figures 48a to 48e It is shown that the second loop 118b can be formed by a section of the catheter 9, which is located distal to a section of the catheter 9 that forms the third loop 118c. Figure 48d and 48e It is shown that, for example, when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first loop 118a can be located distally of the second loop 118b and the third loop 118c along the length 126 of the catheter 9, and the second loop 118b can be located distally of the third loop 118c along the length 126 of the catheter 9. Figures 48a to 48e For example, 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 in the target site 147, and the third loop 118c can be the most proximal loop along the catheter 9 in the target site 147. Figure 48d and 48e For example, when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first loop 118a can be located distal to the second loop 118b and the third loop 118c in the target site 147, and the second loop 118b can be located distal to the third loop 118c in the target site 147.
[0294] Figures 48a to 48eIt is shown that the loop 118 and the chamber 122 can be formed by inserting the catheter 9 into the target site 147 and / or withdrawing the guidewire 99 from the catheter 9. The loop 118 can be formed in the target site 147 in any order, such as sequentially and / or simultaneously. For example, Figures 48a to 48e It is shown that the first loop 118a, the second loop 118b and the third loop 118c can be formed sequentially. Figures 48a to 48e It is shown that a first loop 118a can be formed in the target site 147, then a second loop 118b can be formed in the target site 147, and then a third loop 118c can be formed in the target site 147. For example, Figures 48a to 48e It is shown that the second loop 118b may be formed after the first loop 118a is formed, and the third loop 118c may be formed after the first loop 118a and / or the second loop 118b are formed.
[0295] Figures 48a to 48e For example, during the first stage of loop formation, loop 118a may be formed; during the second stage of loop formation, loop 118b may be formed; and during the third stage of loop formation, loop 118c may be formed. The first stage of loop formation may be before the second stage of loop formation. The second stage of loop formation may be after the first stage of loop formation. The third stage of loop formation may be after the second stage of loop formation. When forming second loop 118b (e.g., during the second stage of loop formation), first loop 118a may have a constant size and / or shape. As another example, when forming second loop 118b (e.g., during the second stage of loop formation), the size (e.g., circumference) of first loop 118a may increase and / or decrease, the shape of first loop 118a may change, or any combination thereof. When forming third loop 118c (e.g., during the third stage of loop formation), first loop 118a and / or second loop 118b may have a constant size and / or shape. As another example, while forming the third loop 118c (e.g., during a third stage of loop formation), the size (e.g., circumference) of the first loop 118a and / or the second loop 118b may increase and / or decrease, the shape of the first loop 118a and / or the second loop 118b may change, or any combination thereof.
[0296] Figures 48a to 48e Different portions of the catheter 9 are shown to form the loop 118 at different times and / or at different stages of loop formation. For example, Figures 48a to 48eIt is shown that when the catheter 9 is in the third structure 116c, the first part of the catheter 9 can form a first loop 118a, when the catheter 9 is in the fourth structure 116d and the fifth structure 116e, the first part of the catheter 9 can form a first loop 118a, the second part of the catheter 9 can form a second loop 118b, and the third part of the catheter 9 can form a third loop 118c.
[0297] Figures 48e to 48i It is shown that the catheter 9 can be withdrawn from the target site 147 . Figures 48e to 48i The loop 118 is shown as being collapsible within and / or removable from the target site 147 . Figures 48e to 48i It is shown that collapsing the loop 118 may include straightening the loop 118, reducing the curvature of the loop, reducing the circumference 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 48e to 48i It is shown that the loop 118 can be collapsed in the target site 147 by withdrawing the catheter 9 from the target site 147, by inserting the guidewire 99 through the catheter 9 into the esophagus 5 and / or the target site 147, and withdrawing the catheter 9 from the target site 147 over the guidewire 99, or by any combination thereof. As the catheter 9 is pulled back (e.g., pulled) into the esophagus 5 as shown by arrow 114, as the guidewire 99 is inserted into the catheter 9 as shown by arrow 113, and / or as the catheter 9 is pulled back (e.g., pulled) over the guidewire 99 as shown by arrow 114, the catheter 9 can straighten and / or become less curved at the target site 147.
[0298] The loops 118 may be collapsed in and / or removed from the target site 147 in any order, such as sequentially and / or simultaneously. For example, Figures 48e to 48i It is shown that the third loop 118c, the second loop 118b, and the first loop 118a may be sequentially collapsed and / or sequentially removed from the target site 147. Figures 48e to 48i It is shown that, for example, as they collapse (e.g., as their sizes decrease), the third loop 118c, the second loop 118b, and the first loop 118a can be removed from the target site 147. For example, Figures 48e to 48i It is shown 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, Figures 48e to 48iIt is shown 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 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. Figures 48e to 48i It is shown that as the catheter 9 is withdrawn from the target site 147, the loops 118 can collapse independently of each other, starting with the most proximal loop (eg, loop 118c) and ending with the most distal loop (eg, loop 118a). Figures 48e to 48i It is shown that as the third loop 118c is collapsed and removed from the target site 147 , the second loop 118b and the first loop 118a may be moved (eg, pulled) toward the gastroesophageal junction 120 . Figures 48e to 48i It is shown that as the second loop 118b is collapsed and removed from the target site 147, the first loop 118a can be moved (eg, pulled) toward the gastroesophageal junction 120.
[0299] Figures 48e to 48iFor example, during the first stage of catheter removal, the portion of catheter 9 defining third loop 118c can be removed from target site 147; during the second stage of catheter removal, the portion of catheter 9 defining second loop 118b can be removed from target site 147; and during the third stage of catheter removal, the portion 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 at target site 147. During the second stage of catheter removal, second loop 118b can collapse at target site 147. During the third stage of catheter removal, first loop 118a can collapse at 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 precede the second stage of catheter removal. The second stage of catheter removal can follow the first stage of catheter removal. The third stage of catheter removal can follow the second stage of catheter removal. When the third loop 118c is removed (e.g., during the first stage of catheter removal), the second loop 118b and / or the first loop 118a can have a constant size and / or shape. As another example, when the third loop 118c is removed (e.g., during the first stage of catheter removal), the size (e.g., circumference) of the second loop 118b and / or the first loop 118a can increase and / or decrease, the shape of the second loop 118b and / or the third loop 118c can change, or any combination thereof. When the second loop 118b is removed (e.g., during the second stage of catheter removal), the first loop 118a can have a constant size and / or shape. As another example, when the second loop 118b is removed (e.g., during the second stage of catheter removal), the size (e.g., circumference) of the first loop 118a can increase and / or decrease, the shape of the third loop 118c can change, or any combination thereof.
[0300] Figures 48a to 48i For example, 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 can be different from the configuration 116 formed by the catheter 9 during insertion of the catheter 9 into the body.
[0301] Figures 49a to 49i It is shown that the catheter 9 can be inserted into and / or removed from the stomach 2 and / or the duodenum 37 . Figures 49a to 49i It is shown that the target site 147 may be the stomach 2 and / or the duodenum 37 , for example. Figures 49a to 49iIt is shown that various lengths of catheter 9 (e.g. Figures 49b to 49h The length 126 shown in FIG is introduced into the stomach 2 and / or duodenum 37 and / or removed from the stomach 2 and / or duodenum 37. Figures 49a to 49i Various configurations 116 and shapes 117 are shown that the catheter 9 can have. Figures 49a to 49i It is shown that, for example, when the catheter 9 is in first through ninth configurations 116a - 116i , the catheter 9 can have first through ninth shapes 117a - 117i , respectively.
[0302] The catheter tip 7 and / or beak tube 97 can be moved into and / or out of contact with the stomach 2, duodenum 37, and / or another organ. Figures 49a to 49i The beak tube 97 is shown as being movable into and out of contact with the stomach 2. For example, Figures 49a to 49b It is shown that during insertion the beak tube 97 can be moved into contact with the stomach 2, Figures 49h to 49i It is shown that the beak tube 97 can be moved out of contact with the stomach 2 during the withdrawal process. Figures 49a to 49b It is shown that the beak tube 97 can be moved into contact with the stomach 2, for example by advancing the catheter 9 in the stomach 2 as shown by arrow 112, Figures 49h-49i It is shown that the beak tube 97 can be moved out of contact with the stomach 2, for example, by withdrawing the catheter 9 from the stomach 2 as shown by arrow 114. When the catheter 9 is in the expanded configuration (e.g., configuration 116), the beak tube 97 may or may not be in contact with the wall of the stomach 2. For example, Figures 49b to 49h It is shown that the beak tube 97 can contact the stomach wall 108 when the catheter 9 is in the expanded configuration (eg, configurations 116b - 116h ).
[0303] The catheter tip 7 and / or beak tube 97 can be permanently and / or temporarily engaged with the wall of the stomach 2, duodenum 37, and / or another other organ. The stomach wall 108 can include features naturally present in the stomach 2, such as gastric rugae, ulcers, or any combination thereof. Figures 49b to 49hThe beak tube 97 is shown to be permanently and / or temporarily engaged with the stomach wall 108, for example, with a gastric fold, a gastric plica, an ulcer, or any combination thereof. When the catheter 9 is located in the stomach 2, the beak tube 97 can, for example, releasably anchor the distal end of the catheter 9 (e.g., the catheter tip 7) to the stomach wall 108 and / or releasably engage the stomach wall 108. The catheter 9 can be releasably anchored to and / or releasably engaged with the stomach wall 108, for example, by the beak tube 97 by friction between the beak tube 97 and the stomach wall 108, by wedging the beak tube 97 between two gastric folds (e.g., between two adjacent gastric folds), or any combination thereof. The catheter 9 can be unanchored and / or disengaged from the stomach wall 108, for example, by withdrawing the catheter 9 from the stomach 2 as shown by arrow 114, by moving the beak tube 97 away from the stomach wall 108.
[0304] Figures 49a to 49b The beak tube 97 is shown as being able to engage (e.g., move into contact with) the stomach wall 108 as the catheter 9 is introduced into the stomach 2. While the beak tube 97 is engaged with the stomach wall 108, the beak tube 97 can remain engaged (e.g., can remain in contact with) the stomach wall 108, can be disengaged (e.g., can be moved out of contact with) the stomach wall 108, can reengage with the stomach wall 108, or any combination thereof, while the catheter 9 is advanced into the stomach 2, while the catheter 9 is withdrawn from the stomach 2, and / or while the catheter 9 is moved within the stomach 2 and / or duodenum 37. Figures 49d to 49e It is shown that natural stomach motility and / or peristalsis of the stomach 2 can cause the catheter 9 to move within the stomach 2 and / or the duodenum 37 . Figures 49a to 49e The movement and / or deployment of the illustrated catheter 9 can include inserting the catheter 9 into the stomach 2 and / or duodenum 37, moving the catheter 9 in the stomach 2 and / or duodenum 37, withdrawing the catheter 9 from the stomach 2 and / or duodenum 37, or any combination thereof. As the catheter 9 moves in the stomach 2 and / or duodenum 37, for example, during the insertion, withdrawal, and / or movement of the catheter 9, the beak tube 97 can move and / or remain in a fixed position relative to the stomach wall 108. For example, the beak tube 97 can move and / or remain in a fixed position relative to the stomach wall 108 when the catheter 9 is pushed into the stomach 2, when the catheter 9 is forced into and / or moved into the duodenum 37, when the catheter 9 is withdrawn from the stomach 2, when the catheter 9 is withdrawn from the duodenum 37, or any combination thereof. For example, Figures 49b to 49hIt is shown that the beak tube 97 can remain in a fixed position relative to the stomach wall 108 when the catheter 9 is pushed into the stomach 2, when the catheter 9 is moved to the duodenum 37, when the catheter 9 is withdrawn from the stomach 2, and when the catheter 9 is withdrawn from the duodenum 37.
[0305] The beak tube 97 may be moved from an engagement position (e.g., along any direction of the stomach wall 108), along any direction away from the stomach wall 108 (e.g., perpendicularly away), along any direction toward the stomach wall 108 (e.g., perpendicularly toward), or any combination thereof, when the catheter 9 is pushed into the stomach 2, when the catheter 9 is forced into and / or moved into the duodenum 37, when the catheter 9 is withdrawn from the stomach 2, when the catheter 9 is withdrawn from the duodenum 37, or when any combination thereof. Figure 49b ) moves away from the engaged position shown in 0.00 to 5.0 cm or more, including every 0.1 cm increment 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 beak tube 97 can correspond to the beak tube 97 remaining stationary relative to the stomach wall 108. For example, Figures 49b to 49h It is shown that the beak tube 97 can remain stationary relative to the stomach wall 108 (e.g., 0.0 cm movement) when the catheter 9 is pushed into the stomach 2, when the catheter 9 is forced into and / or moved into the duodenum 37, when the catheter 9 is withdrawn from the stomach 2, when the catheter 9 is withdrawn from the duodenum 37, or any combination thereof. Figures 49h to 49i The catheter 9 is shown as being detachable from the stomach wall 108 (eg, being movable out of contact with the stomach wall 108). Figures 49h to 49i It is shown that the beak tube 97 can be detached from the stomach wall 108, for example, by withdrawing the catheter 9 from the stomach 2. Withdrawing the catheter 9 from the stomach 2 can, for example, comprise pulling the beak tube 97 away from the stomach wall 108 towards the gastroesophageal junction 120.
[0306] Once the beak tube 97 and / or the catheter tip 7 contacts the stomach wall 108, the beak tube 97 and / or the catheter tip 7 may or may not pivot on the stomach wall 108. For example, Figures 49b to 49h It is shown that when the beak tube 97 is in contact with the stomach wall 108, the beak tube 97 and the catheter tip 7 may not rotate on the stomach wall 108. As another example, when the beak tube 97 is in contact with the stomach wall 108, the catheter tip 7 may rotate on the stomach wall 108.
[0307] During insertion of the catheter 9 into the stomach 2, the beak tube 97 may or may not be forced (eg, pressed) into contact with the stomach wall 108. For example, Figures 49a to 49b It is shown that during insertion of the catheter 9 into the stomach 2, the beak tube 97 can be forced into the stomach wall 108. During insertion into the stomach 2, when the beak tube 97 is pressed into the stomach wall 108, the beak tube 97 can inhibit and / or prevent the catheter tip 7 from tunneling into and / or passing through the stomach wall 108, for example, by deflecting. Figures 49b to 49c The beak tube 97 is shown to be flexible and / or may be a flexible tip that can deform (eg, bend) as it is advanced into the stomach wall 108 .
[0308] Figures 49d to 49e The catheter 9 is shown as being able to enter the duodenum 37. Inserting the catheter 9 into the stomach 2 may force the catheter 9 into the duodenum 37, natural gastric motility and / or peristalsis may prompt and / or force the catheter 9 into the duodenum 37 and / or the intestine caudal to the duodenum 37, or any combination thereof. The catheter 9 may be moved from the stomach 2 through the pylorus 65 to the duodenum 37, for example, by the natural motility and / or peristalsis of the stomach 2. For example, Figures 49d to 49e It is shown that inserting the catheter 9 into the stomach 2 can force the catheter 9 into the duodenum 37. As another example, Figures 49d to 49e It is shown that natural gastric motility and / or peristalsis can prompt and / or force the catheter 9 into the duodenum 37. As another example, Figures 49d to 49e It is shown that inserting the catheter 9 into the stomach 2 can force the catheter 9 into the duodenum 37 , and natural gastric motility and / or peristalsis can promote and / or force the catheter 9 into the duodenum 37 .
[0309] The catheter 9 and / or the catheter tip 7 may enter the duodenum before, during, and / or after a fluid (e.g., fluid 6) passes through the lumen in the catheter 9. For example, Figures 49d to 49e It is shown that catheter 7 may be moved into the duodenum 37 while fluid 6 is pumped (eg, recirculated) through the inflow and outflow lumens in catheter 9 .
[0310] The catheter 9 may enter the duodenum 37 before, during, and / or after the catheter tip 7 enters the stomach 2. For example, Figures 49a to 49e After the catheter tip 7 is shown to have entered the stomach 2, the catheter 9 can enter the duodenum 37. The catheter 9 can enter the duodenum 37 when the catheter tip 7 is located within the stomach 2, the esophagus 5, the pylorus 65, the duodenum 37, and / or outside the body. For example, Figures 49a to 49e It is shown that when the catheter tip 7 is located in the stomach 2, the catheter 9 can enter the duodenum 37. The catheter 9 can enter the duodenum 37 before, during and / or after the beak tube 97 enters the stomach 2. For example, Figures 49a to 49eIt is shown that the catheter 9 can enter the duodenum 37 after the beak tube 97 enters the stomach 2. When the beak tube 97 is located 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, Figures 49a to 49e The catheter 9 is shown as being able to enter the duodenum 37 when the beak tube 97 is located in the stomach 2. The catheter 9 can enter the duodenum 37 before, during, and / or after the catheter tip 7 and / or beak tube 97 engage the stomach wall 108. For example, Figures 49a to 49e It is shown that the catheter 9 can enter the duodenum 37 after the beak tube 97 is pushed into engagement with (e.g., contact with) the stomach wall 108. The catheter 9 can enter the duodenum 37 when the catheter tip 7 and / or the beak tube 97 are engaged with the stomach wall 108 (e.g., when the catheter tip 7 and / or the beak tube 97 are in contact with the stomach wall 108) and / or when the catheter tip 7 and / or the beak tube 97 are disengaged from the stomach wall 108 (e.g., when the catheter tip 7 and / or the beak tube 97 are not in contact with the stomach wall 108). For example, Figures 49a to 49e The catheter 9 is shown as being able to enter the duodenum 37 while the beak tube 97 is engaged with (e.g., in contact with) the stomach wall 108. The catheter tip 7 may or may not remain in the stomach 2 during insertion and / or movement of the catheter 9. For example, Figures 49a to 49e It is shown that the catheter tip 7 can remain in the stomach 2 during insertion and / or movement of the catheter 9 .
[0311] When at least 10 cm to 150 cm or more of the catheter 9 is located in the stomach 2 (including every 1 cm increment 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)), the catheter 9 can enter the duodenum 37. For example, Figures 49a to 49e It is shown that when at least 30 cm of the catheter 9 is located in the stomach 2 , the catheter 9 can enter the duodenum 37 .
[0312] Figures 49e to 49f It is shown that the catheter 9 can be removed from the duodenum 37 , for example, by withdrawing (eg, pulling) the catheter 9 from the stomach 2 as shown by arrow 114 .
[0313] The catheter 9 may be withdrawn from the duodenum 37 before, during, and / or after the catheter tip 7 is withdrawn from the stomach 2. For example, Figures 49e to 49i It is shown that the catheter 9 can be withdrawn from the duodenum 37 before the catheter tip 7 is withdrawn from the stomach 2. The catheter 9 can be withdrawn from the duodenum 37 when the catheter tip 7 is located in the stomach 2, esophagus 5, pylorus 65, duodenum 37 and / or outside the body. For example, Figures 49e to 49i It is shown that when the catheter tip 7 is located in the stomach 2, the catheter 9 can be withdrawn from the duodenum 37. The catheter 9 can be withdrawn from the duodenum 37 before, during and / or after the beak tube 97 is withdrawn from the stomach 2. For example, Figures 49e to 49iIt is shown that the catheter 9 can be withdrawn from the duodenum 37 before the beak tube 97 is withdrawn from the stomach 2. The catheter 9 can be withdrawn from the duodenum 37 when the beak tube 97 is located in the stomach 2, esophagus 5, pylorus 65, duodenum 37 and / or outside the body. For example, Figures 49e to 49i It is shown that when the beak tube 97 is located in the stomach 2, the catheter 9 can be withdrawn from the duodenum 37. The catheter 9 can be withdrawn from the duodenum 37 before, during and / or after the beak tube 97 engages the stomach wall 108. For example, Figures 49e to 49i It is shown that after the beak tube 97 is pushed into engagement with (e.g., contact with) the stomach wall 108, the catheter 9 can be withdrawn from the duodenum 37. The catheter 9 can be withdrawn from the duodenum 37 while the catheter tip 7 and / or the beak tube 97 are engaged with the stomach wall 108 (e.g., when the catheter tip 7 and / or the beak tube 97 are in contact with the stomach wall 108) and / or while the catheter tip 7 and / or the beak tube 97 are disengaged from the stomach wall 108 (e.g., when the catheter tip 7 and / or the beak tube 97 are not in contact with the stomach wall 108). For example, Figures 49e to 49i It is shown that when the beak tube 97 is engaged with (eg, in contact with) the stomach wall 108 , the catheter 9 can be withdrawn from the duodenum 37 .
[0314] When at least 10 cm to 150 cm or more of the catheter 9 is located in the stomach 2, including every 1 cm increment 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), the catheter 9 can be withdrawn from the duodenum 37. For example, Figures 49e to 49i It is shown that when at least 30 cm of the catheter 9 is located in the stomach 2 , the catheter 9 can be withdrawn from the duodenum 37 .
[0315] When the catheter 9 is located in the duodenum 37, the catheter tip 7 may be located in the stomach 2 and / or the duodenum 37. For example, Figure 49e It is shown that when the catheter 9 is located in the duodenum 37 , the catheter tip 7 may be located in the stomach 2 .
[0316] When the catheter 9 is located in the duodenum 37, the beak tube 97 may be located in the stomach 2 and / or the duodenum 37. For example, Figure 49e It is shown that when the catheter 9 is located in the duodenum 37, the beak tube 97 can be located in the stomach 2.
[0317] When the catheter 9 is in the expanded configuration, the catheter 9 may or may not be located in the stomach 2 and / or duodenum 37. For example, Figures 49b to 49d and 49f to Figure 49h The catheter 9 is shown to be in an expanded configuration (e.g., configuration 116b to configuration 116d and configuration 116f to configuration 116h), Figure 49eThe catheter 9 is shown as being positionable within the stomach 2 and duodenum 37 when the catheter is in an expanded configuration (eg, configuration 116e ).
[0318] Figures 49b to 49h It is shown that the catheter 9 can be formed into an expanded structure by inserting the catheter 9 into the stomach 2, by inserting the catheter 9 into the duodenum 37, by moving the catheter 9 out of the stomach 2 through the pylorus 65 and into the duodenum 37 with the help of natural gastric movement and / or peristalsis, by withdrawing the catheter 9 from the stomach 2, by withdrawing the catheter 9 from the duodenum 37, or any combination thereof.
[0319] When the catheter 9 is in the expanded configuration (e.g., configuration 116), none, one, or more portions of the catheter 9 may be located in the stomach 2, and none, one, or more portions of the catheter 9 may be located in the duodenum 37. For example, Figure 49e It is shown that when the catheter 9 is in the expanded configuration (e.g., configuration 116e), the first portion of the catheter 9 (e.g., portion e1-e2) can be located in the stomach 2, the second portion of the catheter 9 (e.g., portion e2-e3) can be located in the duodenum 37, and the third portion of the catheter 9 (e.g., portion e3-e4) can be located in the stomach 2. The second portion of the catheter 9 can be forced into the duodenum 37 (e.g., by inserting the catheter 9 into the stomach 2), prompted and / or forced into the duodenum 37 by natural gastric motility and / or peristalsis, or any combination thereof. For example, Figures 49d to 49e It is shown that the second portion of the catheter 9 can be introduced into the duodenum 37 by natural gastric motility and / or peristalsis prompting and / or forcing the second portion of the catheter 9 through the pylorus 65 into the duodenum 37 . Figure 49e The second portion of the conduit 9 is shown to be located between the first portion of the conduit 9 and the second portion of the conduit 9 along the length of the conduit 9 . Figure 49e It is shown that, for example, when the catheter 9 is in a straight configuration, the first portion of the catheter 9 can be distal to the second portion of the catheter 9 and the third portion of the catheter 9 , and the second portion of the catheter 9 can be distal to the first portion of the catheter 9 . Figure 49e It is shown that when the catheter 9 is in configuration 116e, the first portion of the catheter 9 may be closer to the pancreas 1 than the third portion of the catheter 9, the third portion of the catheter 9 may be closer to the gastroesophageal junction 120 than the first portion of the catheter 9, and vice versa.
[0320] Figure 49e It is shown that the loops 118 (eg, the first loop 118 a ) may be formed by the portions e1 - e4 of the conduit 9 . Figure 49e It is shown that, for example, the first loop 118a can be located in the stomach 2 and the duodenum 37. For example, Figure 49e It is shown that the loop head can be located in the duodenum 37 and the loop base can be located in the stomach 2. Figure 49e It is shown that chambers 122 (eg, first chamber 122a) may be located in the stomach 2 and the duodenum 37. The length of the e1-e4 portion of the catheter 9 may be, for example, length 126. Figure 49e The length 126 shown may be, for example, 50 cm to 120 cm (eg, 80 cm). Figures 49d to 49e It is shown that the size (eg, circumference) of the first loop 118a when the catheter 9 is in the fifth configuration 116e may be larger than when the catheter 9 is in the fourth configuration 116d. Figure 49e It is shown that a first gap can be located between the e1-e2 portion and the e3-e4 portion in the stomach 2, and a second gap can be located between a first end of the second portion e2-e3 (e.g., an end closer to point e2) and a second end of the second portion e2-e3 (e.g., an end closer to point e3) in the duodenum 37, and the second gap can be smaller than the first gap. The second gap can be, for example, at least 1 cm to 10 cm smaller than the first gap, including every 1 cm increment within this range (e.g., at least 1 cm, at least 5 cm, at least 10 cm). For example, Figure 49e It is shown that the second gap may be at least 4 cm smaller than the first gap. Figures 49d to 49e It is shown that when the catheter tip 7 and / or beak tube 97 are located in the stomach 2 , the middle portion of the catheter 9 between points e1 and e4 can enter the duodenum 37 .
[0321] exist Figure 49e , reference points e1-e4 are provided to help identify the first, second, and third portions of the catheter 9. The first, second, and third portions of the catheter 9 (e.g., portion e1-e2, portion e2-e3, and portion e3-e4) may be integrated with each other and / or connected to each other. For example, Figure 49e It is shown that the e1-e2 portion can be integrated with the e2-e3 portion, which can be integrated with the e3-e4 portion, which can be integrated with the portion of the catheter 9 in the esophagus 5. For example, Figure 49e The first, second, and third portions of the catheter 9 are shown to be portions of a single length of the catheter 9 (e.g., portions of the total length 124 of the catheter 9). Reference point e1 can mark, for example, the distal end of the catheter 9, the distal end of the beak tube 97, the distal end of the heat transfer region 128, or any combination thereof. Reference point e2 can mark, for example, a first location where the catheter 9 passes through the pylorus 65. Reference point e3 can mark, for example, a second location where the catheter 9 passes through the pylorus 65. Reference point e4 can mark, for example, a location where the catheter 9 enters the target site 147 (e.g., the stomach 2).
[0322] The catheter 9 can pass through the pylorus 65, for example, 0 to 10 times or more, including every increment within this range (e.g., 0, 1, 2, 3, 4, 10 times). Figures 49b to 49d and Figures 49f to 49h It is shown that when the catheter 9 is located in the stomach 2, the catheter 9 can pass through the pylorus 65 zero times. As another example, Figure 49e It is shown that when the catheter 9 is located in the stomach 2, the catheter 9 may pass through the pylorus twice (eg, at a first position and a second position marked by reference point e2 and reference point e3, respectively). Figure 49e It is shown that two different parts of the catheter 9 can be passed through the pylorus 65 simultaneously.
[0323] When the catheter 9 is located 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, including every 1 cm increment therein (e.g., 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, Figure 49e It is shown that when the catheter 9 is located 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 located 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 longer, including every 1 cm increment in this range (e.g., 20 cm, 50 cm, 100 cm, 150 cm, 300 cm). For example, Figure 49e It is shown that when the catheter 9 is located in the duodenum 37, the length 126 of the catheter 9 in the stomach 2 may be 55 cm. Figure 49e The length 126 of the catheter 9 shown in the stomach 2 may be, for example, the length of the e1 - e2 section and the e3 - e4 section.
[0324] When the catheter 9 is located 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, including every 1 cm increment therein (e.g., 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, Figure 49e It is shown that when the catheter 9 is located 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 located in the duodenum 37, the length 126 of the catheter 9 in the duodenum 37 can be, for example, 1 cm to 80 cm or longer, including every 1 cm increment within this range (e.g., 1 cm, 10 cm, 30 cm, 50 cm, 80 cm). For example, Figure 49e It is shown that when the catheter 9 is located in the duodenum 37 , the length 126 of the catheter 9 in the duodenum 37 may be 25 cm. Figure 49e The length 126 of the catheter 9 shown in the duodenum 37 may be, for example, the length of the portion e2 - e3 .
[0325] When the catheter 9 is located 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, including every 1 cm increment within this range (e.g., 40 cm, 50 cm, 60 cm, 100 cm, 200 cm, 300 cm).
[0326] Figures 49a to 49i It is shown that the catheter 9 can be extended through the target site 147 multiple times, for example, a first time from the stomach from proximal to distal into the duodenum 37 and a second time from the duodenum 37 from distal to proximal into the stomach 2 .
[0327] Figure 49e It is shown that the catheter 9 may have undulations along the length of the catheter 9 when the catheter 9 is in the expanded configuration. Figure 49e The undulations shown may be, for example, bends in the conduit 9. The undulations may have, for example, a sinusoidal form, a serpentine form, a zigzag form or any combination thereof. Figures 49e to 49f It is shown that as the catheter 9 is withdrawn from the body, the undulations may straighten.
[0328] Figures 49e to 49f It is shown that as the total length of the catheter 9 in the duodenum 37 decreases, the total length of the catheter 9 in the stomach 2 can be reduced simultaneously.
[0329] Figures 49a to 49e It is shown that the target site 147 can be the stomach 2, for example, and the catheter 9 can enter the duodenum 37. As another example, Figures 49a to 49e It is shown that the target site 147 may be the stomach 2 and the duodenum 37 .
[0330] When the catheter 9 is located in the stomach 2, duodenum 37, and / or in the intestine caudal to the duodenum 37, the catheter 9 can transfer heat to and / or from the surrounding tissue. Figures 49b to 49d and Figures 49f to 49h The catheter 9 is shown to be capable of transferring heat to and / or from the stomach 2. Figure 49e The catheter 9 is shown to be able to transfer heat to and / or from the stomach 2 and duodenum 37 .
[0331] Figures 49a to 49i The catheter 9 is shown to have a beak tube 97. The beak tube 97 can be connected to the catheter tip 7 and / or integrated with the catheter tip 7. For example, Figures 49a to 49i The beak tube 97 is shown to be the distal end of the catheter tip 7 .
[0332] Figures 49a to 49i For example, 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 can be different from the configuration 116 formed by the catheter 9 during insertion of the catheter 9 into the body.
[0333] Figures 50a to 50i It is shown that the catheter 9 can be inserted into and / or removed from the stomach 2 and / or the duodenum 37 . Figures 50a to 50i It is shown that the target site 147 may be the stomach 2 and the duodenum 37 , for example. Figures 50a to 50i It is shown that various lengths of catheter 9 (e.g. Figures 50b to 50h The length 126 shown in FIG is introduced into the stomach 2 and / or duodenum 37 and / or removed from the stomach 2 and / or duodenum 37. Figures 50a to 50i Various configurations 116 and shapes 117 are shown that the catheter 9 can have. Figures 50a to 50i It is shown that, for example, when the catheter 9 is in first through ninth configurations 116a - 116i , the catheter 9 can have first through ninth shapes 117a - 117i , respectively.
[0334] Figures 50a to 50i The catheter tip 7 is shown as being movable into and out of contact with the duodenum 37. For example, Figures 50a to 50b It is shown that during insertion the catheter tip 7 can be moved into contact with the duodenum 37, Figures 50h to 50i It is shown that the catheter tip 7 can be moved out of contact with the duodenum 37 during withdrawal. Figures 50a to 50b It is shown that the catheter tip 7 can be moved into contact with the duodenum 37, for example by pushing the catheter 9 into the stomach 2 as indicated by arrow 112. Figures 50h to 50i It is shown that, for example, the catheter tip 7 can be moved out of contact with the duodenum 37 by withdrawing the catheter 9 from the stomach 2 as indicated by arrow 114. When the catheter 9 is in the expanded configuration (e.g., configuration 116), the catheter tip 7 may or may not be in contact with the wall 136 of the duodenum 37 (also referred to as the duodenal wall 136). For example, Figures 50b to 50h It is shown that the beak tube 97 can contact the duodenal wall 136 when the catheter 9 is in the expanded configuration (eg, configurations 116b to 116h).
[0335] The duodenal wall 136 may include features naturally occurring in the duodenum 37 including, for example, one or more duodenal folds (also known as Kerckring folds). Figures 50b to 50hThe catheter tip 7 is shown to be permanently and / or temporarily engaged with the duodenal wall 136, for example, with the duodenal folds. For example, when the catheter 9 is located in the duodenum 37, the catheter tip 7 can releasably anchor the distal end of the catheter 9 to the duodenal wall 136 and / or releasably engage the distal end of the catheter 9 to the duodenal wall 136. The catheter 9 can be releasably anchored to and / or releasably engaged with the duodenal wall 136, for example, by friction between the catheter tip 7 and the duodenal wall 136, by wedging the catheter tip 7 between two duodenal folds (e.g., between two adjacent duodenal folds), or any combination thereof. The catheter 9 can be unanchored and / or disengaged from the duodenal wall 136, for example, by withdrawing the catheter 9 from the duodenum 37, as shown by arrow 114, thereby moving the catheter tip 7 away from the duodenal wall 136.
[0336] Figures 50a to 50b The catheter tip 7 is shown as it can engage (e.g., move into contact with) the duodenal wall 136 as the catheter 9 is introduced into the duodenum 37. When the catheter tip 7 is engaged with the duodenal wall 136, the catheter tip 7 can remain engaged (e.g., maintain contact with) the duodenal wall 136, disengage (e.g., move out of contact with) the duodenal wall 136, or reengage (e.g., move out of contact with) the duodenal wall 136 while the catheter 9 is advanced into the stomach 2, withdrawn from the stomach 2, inserted into the duodenum 37, withdrawn from the duodenum, moved within the stomach 2 and / or duodenum 37, or any combination thereof. For example, during insertion, withdrawal, and / or movement of the catheter 9, the catheter tip 7 can move and / or remain in a fixed position relative to the duodenal wall 136 as the catheter 9 is moved in the stomach 2 and / or duodenum 37. The catheter tip 7 can, for example, move and / or remain in a fixed position relative to the duodenal wall 136 while pushing the catheter 9 into the stomach 2, while forcing the catheter 9 into and / or moving it into the duodenum 37, while withdrawing the catheter 9 from the stomach 2, while withdrawing the catheter 9 from the duodenum 37, or any combination thereof. For example, Figures 50b to 50h It is shown that the catheter tip 7 can remain in a fixed position relative to the duodenal wall 136 when the catheter 9 is advanced into the stomach 2, when the catheter 9 is inserted into the duodenum 37, when the catheter 9 is withdrawn from the stomach 2, and when the catheter 9 is withdrawn from the duodenum 37.
[0337] The catheter tip 7 may be moved from the engagement position (e.g., in any direction along the duodenal wall 136, in any direction away from the duodenal wall 136 (e.g., perpendicularly away from the duodenal wall 136), in any direction toward the duodenal wall 136 (e.g., perpendicularly toward the duodenal wall 136), or any combination thereof, when the catheter 9 is advanced into the stomach 2, when the catheter 9 is forced into and / or moved into the duodenum 37, when the catheter 9 is withdrawn from the stomach 2, when the catheter 9 is withdrawn from the duodenum 37, or when any combination thereof. Figure 50b ) moves away from the engagement position shown in 0.00 to 5.0 cm or more, including each 0.1 cm increment 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, Figures 50b to 50h It is shown that the catheter tip 7 can remain in the same position relative to the duodenal wall 136 (e.g., 0.0 cm movement) when the catheter 9 is pushed into the stomach 2, when the catheter 9 is forced into and / or moved into the duodenum 37, when the catheter 9 is withdrawn from the stomach 2, when the catheter 9 is withdrawn from the duodenum 37, or when any combination thereof. Figures 50h to 50i The catheter 9 is shown as being disengageable from the duodenal wall 136 (eg, as being moveable out of contact with the duodenal wall 136 ). Figures 50h to 50i It is shown that the catheter tip 7 can be detached from the duodenal wall 136, for example by withdrawing the catheter 9 from the stomach 2. Withdrawing the catheter 9 from the stomach 2 can, for example, comprise pulling the catheter tip 7 from the duodenal wall 136 towards the gastroesophageal junction 120.
[0338] Once the beak tube 97 and / or the catheter tip 7 contacts the duodenal wall 136, the beak tube 97 and / or the catheter tip 7 may or may not pivot on the duodenal wall 136. For example, Figures 50b to 50c It is shown that during insertion, when the catheter tip 7 is in contact with the duodenal wall 136, the catheter tip 7 can be rotated on the duodenal wall 136, Figures 50g to 50h It is shown that during withdrawal, when the catheter tip 7 is in contact with the duodenal wall 136 , the catheter tip 7 can be rotated on the duodenal wall 136 .
[0339] During insertion of the catheter 9 into the stomach 2, the catheter tip 7 may or may not be forced (eg, pressed) into contact with the duodenal wall 136. For example, Figures 50a to 50b It is shown that during insertion of the catheter 9 into the stomach 2, the catheter tip 7 can be forced into the duodenal wall 136. During insertion into the stomach 2, when the catheter tip 7 is pressed into the duodenal wall 136, the catheter tip 7 can be pressed into the duodenal wall 136, for example, by Figures 50b to 50cBending the catheter 9 and / or rotating the catheter tip 7 on the duodenal wall 136 inhibits and / or prevents the catheter tip 7 from entering and / or passing through the duodenal wall 136. For example, Figures 50b to 50c The catheter tip 7 shown may be flexible and / or may be a flexible tip that may deform (eg, bend) as it is advanced into the duodenal wall 136 .
[0340] Figures 50a to 50e The catheter tip 7 and catheter 9 are shown as being insertable into the duodenum 37. For example, Figures 50a to 50e It is shown that inserting the catheter tip 7 and the catheter 9 into the stomach 2 as indicated by arrow 112 may force the catheter tip 7 and the catheter 9 into the duodenum 37 .
[0341] The catheter 9 may enter the duodenum 37 before, during, and / or after the catheter tip 7 and / or beak tube 97 enter the duodenum 37. For example, Figures 50a to 50b The catheter tip 7 is shown as being able to enter the duodenum 37 before the body of the catheter 9 (eg, the body of the catheter 9 may be, for example, the portion of the catheter 9 proximal to the catheter tip 7 ). Figures 50a to 50e It is shown that, for example, the catheter 9 can be entered into the duodenum 37 after the catheter tip 7 has entered the duodenum 37 . Figures 50a to 50e For example, the catheter 9 is shown as being able to enter the duodenum 37 when the catheter tip 7 is located in the duodenum 37. The catheter 9 can enter the duodenum 37 before, during, and / or after the catheter tip 7 and / or beak 97 engage the duodenal wall 136. For example, Figures 50a to 50e The catheter 9 is shown as being able to enter the duodenum 37 before the catheter tip 7 is advanced into engagement with (e.g., contact with) the duodenal wall 136. The catheter 9 can enter the duodenum 37 while the catheter tip 7 and / or beak tube 97 are engaged with the duodenal wall 136 (e.g., when the catheter tip 7 and / or beak tube 97 are in contact with the stomach wall 108) and / or while the catheter tip 7 and / or beak tube 97 are disengaged from the stomach wall 108 (e.g., when the catheter tip 7 and / or beak tube 97 are not in contact with the stomach wall 108). For example, Figures 50a to 50e The catheter 9 is shown as being able to enter the duodenum 37 when the catheter tip 7 is engaged with (e.g., in contact with) the duodenal wall 136. The catheter tip 7 may or may not remain in the duodenum 37 during insertion and / or movement of the catheter 9. For example, Figures 50a to 50e It is shown that the catheter tip 7 may remain in the duodenum 37 during insertion and / or movement of the catheter 9 .
[0342] When any length of the catheter 9 is located in the stomach 2, the catheter tip 7 and / or the beak tube 97 can enter the duodenum 37. For example, when at least 10 cm to 150 cm or more of the catheter 9 is located in the stomach 2, including every 1 cm increment 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), the catheter tip 7 and / or the beak tube 97 can enter the duodenum 37.
[0343] Figures 50e to 50i It is shown that the catheter 9 can be removed from the duodenum 37 , for example, by withdrawing (eg, pulling) the catheter 9 from the stomach 2 as shown by arrow 114 .
[0344] The catheter 9 may be withdrawn from the duodenum 37 before, during, and / or after the catheter tip 7 and / or beak tube 97 are withdrawn from the duodenum 2. For example, Figures 50e to 50i It is shown that the catheter 9 can be withdrawn from the duodenum 37 before the catheter tip 7 is withdrawn from the stomach 2 . Figures 49e to 49i It is shown that, for example, the catheter 9 can be withdrawn from the duodenum 37 while the catheter tip 7 is located in the duodenum 37 .
[0345] The catheter 9 may be withdrawn from the duodenum 37 before, during, and / or after engagement of the catheter tip 7 and / or beak 97 with the duodenal wall 136. For example, Figures 50e to 50i It is shown that the catheter 9 can be withdrawn from the duodenum 37 after the catheter tip 7 is pushed into engagement with (e.g., contact with) the duodenal wall 136. The catheter 9 can be withdrawn from the duodenum 37 when the catheter tip 7 and / or the beak tube 97 are engaged with the duodenal wall 136 (e.g., when the catheter tip 7 and / or the beak tube 97 are in contact with the duodenal wall 136) and / or when the catheter tip 7 and / or the beak tube 97 are disengaged from the duodenal wall 136 (e.g., when the catheter tip 7 and / or the beak tube 97 are not in contact with the duodenal wall 136). For example, Figures 50e to 50i It is shown that the catheter 9 can be withdrawn from the duodenum 37 while the catheter tip 7 is engaged with (eg, in contact with) the duodenal wall 136 .
[0346] When at least 10 cm to 150 cm or more of the catheter 9 is located in the stomach 2, including every 1 cm increment 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), the catheter tip 7 and / or the catheter 9 can be withdrawn from the duodenum 37. For example, Figures 50e to 50i It is shown that the catheter tip and / or the catheter 9 can be withdrawn from the duodenum 37 when at least 20 cm of the catheter 9 is located in the stomach 2 .
[0347] Figures 50b to 50hIt is shown that when the catheter 9 is located in the duodenum 37 , the catheter tip 7 may be located in the duodenum 37 .
[0348] Figures 50b to 50h The catheter 9 is shown as being positionable within the stomach 2 and duodenum 37 when the catheter is in an expanded configuration (eg, configurations 116b through 116h).
[0349] Figures 50b to 50h It is shown that the catheter 9 can be brought into the expanded configuration by inserting the catheter 9 into the stomach 2, inserting the catheter 9 into the duodenum 37, withdrawing the catheter 9 from the stomach 2, withdrawing the catheter 9 from the duodenum 37, or any combination thereof.
[0350] Figures 50b to 50h It is shown that when the catheter 9 is located in the stomach 2, the catheter 9 can pass through the pylorus 65 once (for example, at Figure 50e at the reference point x in ).
[0351] Figures 50b to 50h It is shown that when the catheter 9 is in the expanded configuration (e.g., configuration 116b to configuration 116h), the first portion of the catheter 9 can be located in the duodenum 37 (e.g., the portion of the catheter 9 distal to the pylorus 65), and the second portion of the catheter 9 can be located in the stomach 2 (e.g., the portion of the catheter 9 proximal to the pylorus 65). The portion of the catheter 9 distal to the pylorus 65 can be forced into the duodenum 37 and / or can be moved to the duodenum 37. For example, Figures 50a to 50e It is shown that the portion of the catheter 9 distal to the pylorus 65 can be forced into the duodenum 37 by inserting the catheter 9 into the stomach 2 .
[0352] Figures 50a to 50i It is shown that, for example, as the catheter 9 is inserted into and / or withdrawn from the target site 147 , the catheter 9 may form the loop 118 and chamber 122 as shown. Figures 50b to 50h The loop 118 is shown to be an open loop. Figures 50a to 50i The target site 147 is shown to be, for example, the stomach 2 and the duodenum 37 .
[0353] Figures 50a to 50b The catheter tip 7 is shown as it may enter the duodenum ahead of the main body of the catheter.
[0354] Figures 50a to 50b It is shown that as the catheter 9 is inserted into the stomach 2 and duodenum 37 , the catheter 9 may form a first loop 118 a and a second loop 118 b . Figures 50a to 50b It is shown that a first loop 118a can be formed in the stomach 2 and a second loop 118b can be formed in the stomach 2 and the duodenum 37. For example, Figure 50bIt is shown that the first end and second end of the first loop may be located in the stomach 2 , the first end of the second loop may be located in the stomach 2 , and the second end of the second loop may be located in the duodenum 37 . Figure 50b It is shown that the lesser curvature of the stomach 2 can be located in the first chamber 122a, and the pancreatic head 38 and the pylorus 65 can be located in the second chamber 122b.
[0355] Figure 50c It is shown that the loops 118 (eg, the third loop 118c ) may be positioned in the duodenum 37 . Figures 50b to 50c It is shown that as the catheter 9 is inserted into the stomach 2 and duodenum 37 , the catheter 9 may form a third loop 118 c . Figures 50b to 50c It is shown that a third loop 118c may be formed in the duodenum 37 . Figures 50b to 50c It is shown that when the catheter tip 7 is located in the duodenum 37 , a third loop 118 c may be formed in the duodenum 37 , for example by pushing the catheter 9 into the duodenum 37 as indicated by arrow 112 . Figure 50c It is shown that the third loop first end, the third loop second end, and the third loop head may be located in the duodenum 37 . Figures 50b to 50c It is shown that when the catheter tip 7 is engaged with the duodenal wall 136 (e.g., engaged to the Kerklin folds) and the catheter 9 continues to be inserted into the stomach 2 as shown by arrow 112, for example, as the catheter tip 7 is rotated against the duodenal wall 136, the portion of the catheter 9 proximal to the catheter tip 7 can move beyond (e.g., distally, caudally) the catheter tip 7. Figure 50c The portion of the catheter 9 shown advancing past the catheter tip 7 may be the third loop 118c. Figure 50c It is shown that the third loop 118c may be located distal to the catheter tip 7 when the catheter 9 is in the expanded configuration (eg, when the catheter 9 is in the third configuration 116c ). Figure 50b It is shown that before the third ring 118c is formed, the Figure 50c The portion of the catheter 9 that includes the third loop 118c can be located proximal to the catheter tip 7. As another example, when the catheter 9 is in a straight configuration, the portion defining the third loop 118c can be located proximal to the catheter tip 7. Figure 50c The portion of the catheter 9 in the third loop 118 c may be located proximal to the catheter tip 7 . Figure 50c It is shown that the lesser curvature of the stomach 2 may be located in the first chamber 122a, and the pancreatic head 38, the ampulla of Vater 41, and the pylorus 65 may be located in the second chamber 122b.
[0356] As the catheter 9 is inserted into the target site 147 , the circumference of the loop 118 may increase, decrease, and / or remain constant. Figures 50b to 50c It is shown that the size (eg, circumference) of the first loop 118a may be smaller when the catheter 9 is in the third configuration 116c than when the catheter 9 is in the second configuration 116b. Figures 50b to 50cIt is shown that the size (eg, circumference) of the second loop 118b may be larger when the catheter 9 is in the third configuration 116c than when the catheter 9 is in the second configuration 116b. Figures 50b to 50c It is shown that when the catheter 9 is in the third configuration 116c there is less catheter 9 in the stomach 2 than when the catheter 9 is in the second configuration 116b. Figures 50b to 50c It is shown that as the catheter 9 is inserted into the duodenum 37 , 1 cm to 10 cm or more of the catheter 9 , including every 1 cm increment therein (eg, 1 cm, 5 cm, 10 cm), can be moved out of the stomach 2 through the pylorus 65 . Figures 50b to 50c It is shown that the size (eg, area) of the second chamber 122b may be larger when the conduit 9 is in the third configuration 116c than when the conduit 9 is in the second configuration 116b.
[0357] Figures 50c to 50d It is shown that when the catheter 9 is in the fourth configuration 116d, the size (eg, circumference) of the first loop 118a and the third loop 118c may be larger than when the catheter 9 is in the third configuration 116c. Figures 50c to 50d It is shown that when the catheter 9 is in the fourth configuration 116d, the third loop second end (eg, catheter tip 7) and the third loop first end (eg, Figures 50c to 50d The gap between the portion of the catheter 9 adjacent to the ampulla of Vater 41 can be larger than when the catheter 9 is in the third configuration 116c.
[0358] Figures 50d to 50e It is shown that as the catheter 9 is inserted into the stomach 2 and duodenum 37 , the catheter 9 may form a fourth loop 118 d . Figures 50d to 50e It is shown that a fourth loop 118d may be formed in the stomach 2 . Figures 50d to 50e It is shown that when the catheter tip 7 is located in the duodenum 37 , a fourth loop 118 d may be formed in the stomach 2 , for example by advancing the catheter 9 into the stomach 2 as indicated by arrow 112 . Figure 50d It is shown that the fourth loop first end, the fourth loop second end and the fourth loop head can be located in the stomach 2. Figures 50d to 50e It is shown that the size (eg, circumference) of the first loop 118a may be smaller when the catheter 9 is in the fifth configuration 116e than when the catheter 9 is in the fourth configuration 116d. Figures 50d to 50e It is shown that when the catheter 9 is in the fifth configuration 116e, the size (eg, circumference) of the second loop 118b and the third loop 118c may be larger than when the catheter 9 is in the fourth configuration 116d.
[0359] The third loop 118c can wedge the catheter 9 into the duodenum 37, can inhibit and / or prevent the portion of the catheter 9 in the duodenum 37 from moving further into the duodenum 37, can inhibit or prevent the portion of the catheter 9 in the stomach 2 from moving into the duodenum 37, can inhibit or prevent more catheters 9 from being inserted into the duodenum 37, or any combination thereof. Figures 50c to 50e It is shown that the third loop 118c can inhibit (eg, can begin to inhibit) further insertion of the catheter 9 into the duodenum 37, for example by Figures 50c to 50e In FIG. 3 , more of the catheter 9 is inserted into the stomach 2 rather than the duodenum 37 .
[0360] Figure 50b and 50h It is shown that when the catheter 9 is in the second configuration 116b and the eighth configuration 118h, the portion of the catheter 9 length 126 in the stomach 2 can be, for example, 10 cm to 30 cm (for example, 20 cm), and the portion of the catheter 9 length 126 in the duodenum 37 can be, for example, 1 cm to 20 cm (for example, 10 cm).
[0361] Figure 50c and 50g It is shown that when the catheter 9 is in the third configuration 116c and the seventh configuration 118g, the portion of the catheter 9 length 126 in the stomach 2 can be, for example, 10 cm to 30 cm (for example, 15 cm), and the portion of the catheter 9 length 126 in the duodenum 37 can be, for example, 1 cm to 30 cm (for example, 15 cm).
[0362] Figure 50d and 50f It is shown that when the catheter 9 is in the fourth configuration 116d and the sixth configuration 118f, the portion of the catheter 9 length 126 in the stomach 2 can be, for example, 20 cm to 80 cm (for example, 50 cm), and the portion of the catheter 9 length 126 in the duodenum 37 can be, for example, 1 cm to 30 cm (for example, 18 cm).
[0363] Figure 50e It is shown that when the catheter 9 is in the fifth configuration 118e, the portion of the catheter 9 length 126 in the stomach 2 can be, for example, 20cm to 300cm (e.g., 90cm), and the portion of the catheter 9 length 126 in the duodenum 37 can be, for example, 1cm to 30cm (e.g., 25cm).
[0364] When the catheter 9 is located 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, including every 1 cm increment within this range (e.g., 40 cm, 50 cm, 60 cm, 100 cm, 200 cm, 300 cm).
[0365] Figure 50e It is shown that the catheter 9 can be extended back and forth through the target site 147 multiple times in different directions.
[0366] Figure 50e It is shown that the catheter 9 may have undulations along the length of the catheter 9 when the catheter 9 is in the expanded configuration. Figure 50e The undulations shown may be, for example, bends in the conduit 9. The undulations may have, for example, a sinusoidal form, a serpentine form, a zigzag form or any combination thereof. Figures 50e to 50f It is shown that as the catheter 9 is withdrawn from the body, the undulations may straighten.
[0367] Figures 50e to 50f It is shown that as the length of the catheter 9 in the stomach 2 decreases, the length of the catheter 9 in the duodenum can be simultaneously decreased.
[0368] When the catheter 9 is located in the stomach 2, duodenum 37, and / or in the intestine caudal to the duodenum 37, the catheter 9 can transfer heat to and / or from the surrounding tissue. Figures 50b to 50h The catheter 9 is shown to be able to transfer heat to and / or from the stomach 2 and duodenum 37 .
[0369] Figures 50a to 50i The catheter 9 is shown to not have the beak tube 97. As another example, Figures 50a to 50i The catheter 9 in can have a beak tube 97.
[0370] Figures 50a to 50e It is shown that the loop 118 and the chamber 122 can be formed by inserting the catheter 9 into the target site 147. The loop 118 can be formed in the target site 147 in any order, such as sequentially and / or simultaneously. For example, Figures 50a to 50e It is shown that the first loop 118a, the second loop 118b, the third loop 118c and the fourth loop 118d can be formed sequentially. Figures 50a to 50e It is shown that a first loop 118a may be formed in the target site 147, then a second loop 118b may be formed in the target site 147, then a third loop 118c may be formed in the target site 147, and then a fourth loop 118d may be formed in the target site 147. For example, Figures 50a to 50e It is shown that the second loop 118b can be formed after the first loop 118a is formed, the third loop 118b can be formed after the first loop 118a and / or the second loop 118b are formed, and the fourth loop 118d can be formed after the first loop 118a, the second loop 118b and / or the third loop 118c are formed. During the formation of each loop 118, one or more other loops 118 can change size and / or shape. For example, Figures 50a to 50eThe loops 118 shown already formed may change in size and / or shape while forming one or more other loops 118. For example, Figures 50b to 50c It is shown that the first loop 118a and / or the second loop 118b can change size and / or shape while forming the third loop 118c. Figures 50d to 50e It is shown that the first loop 118a and / or the third loop 118c may change in size and / or shape while the fourth loop 118d is being formed.
[0371] Figures 50a to 50e It is shown that, for example, during the first stage of loop formation, loop 118a can be formed; during the second stage of loop formation, loop 118b can be formed; during the third stage of loop formation, loop 118c can be formed; and during the fourth stage of loop formation, loop 118d can be formed. 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. The fourth stage of loop formation can be after the second stage of loop formation. While the third loop 118c is being formed (for example, 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, Figures 50b to 50e It is shown that while forming the third loop 118c (e.g., during the third stage of loop formation), the size (e.g., circumference) 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. While forming the fourth loop 118d (e.g., during the fourth stage of loop formation), the first loop 118a, the second loop 118b, and / or the third loop 118c can have a constant size and / or shape. As another example, Figures 50d to 50e It is shown that while the fourth loop 118d is being formed (e.g., during the fourth stage of loop formation), the size (e.g., circumference) of the first loop 118a, the second loop 118b, and / or the third loop 118c can increase and / or decrease, the shape of the first loop 118a, the second loop 118b, and / or the third loop 118c can change, or any combination thereof.
[0372] Figures 50e to 50i It is shown that the catheter 9 can be withdrawn from the target site 147 . Figures 50e to 50i The loop 118 is shown as being collapsible within and / or removable from the target site 147 . Figures 50e to 50iIt is shown that collapsing the loop 118 may include straightening the loop 118, reducing the curvature of the loop, reducing the circumference 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 50e to 50i It is shown that by withdrawing the catheter 9 from the target site 147 as indicated by arrow 114 , the loop 118 may be collapsed in the target site 147 . Figures 50e to 50i It is shown that, for example, as the catheter 9 is withdrawn (eg, pulled) from the target site 147 into the esophagus 5 as indicated by arrow 114 , the catheter 9 may straighten and / or become less tortuous in the target site 147 .
[0373] The loops 118 may be collapsed in and / or removed from the target site 147 in any order, such as sequentially and / or simultaneously. For example, Figures 50e to 50i The first loop 118a, the second loop 118b, the third loop 118c, and the fourth loop 118d are shown as being collapsible from the target site 147 in the order shown. Figures 50e to 50i It is shown that, for example, the fourth loop 118d may be collapsed, then the first loop 118a may be collapsed a first time, then the third loop 118c may be collapsed, then the second loop 118b may be collapsed, and then the first loop 118a may be collapsed a second time. Figures 50e to 50f It is shown that as the fourth loop 118d collapses (eg, decreases in size), the size of the first loop 118a may increase and / or the size of the third loop 118c may decrease. Figures 50f to 50g It is shown that as the first loop 118a collapses (eg, decreases in size), the third loop 118c may have a constant size and / or shape. Figures 50g to 50i It is shown that the third loop 118c can be collapsed by withdrawing the catheter 9 from the target site 147 as shown by arrow 114, followed by the collapse of the second loop 118b and then the collapse of the first loop 118a.
[0374] Figures 50e to 50iFor example, during the first stage of catheter removal, the portion of catheter 9 defining fourth loop 118d in configuration 116e can be removed from stomach 2; during the second stage of catheter removal, a portion of the portion of catheter 9 defining first loop 118a in configuration 116f can be removed from stomach 2; during the third stage of catheter removal, the portions of catheter 9 defining third loop 118c in configurations 116e through 116g can be removed from duodenum 37; and during the fourth stage of catheter removal, the portions of catheter 9 defining first loop 118a and second loop 118b can be removed from stomach 2. The first stage of catheter removal can precede the second stage of catheter removal. The second stage of catheter removal can follow the first stage of catheter removal. The third stage of catheter removal can follow the second stage of catheter removal. The fourth stage of catheter removal can follow the third stage of catheter removal.
[0375] Figures 50a to 50i It is shown that, for example, during withdrawal, the configuration 116 formed by the catheter 9 can be the same as the configuration 116 formed by the catheter 9 during insertion. As another example, during withdrawal of the catheter 9 from the body, the configuration 116 formed by the catheter 9 can be different from the configuration 116 formed by the catheter 9 during insertion into the body.
[0376] Figures 51a to 51d It is shown that the catheter 9 can be inserted into and / or removed from the stomach 2. For example, Figures 51a to 51d It is shown that the catheter 9 can be inserted into the stomach 2 as shown by arrow 112, Figure 51d to Figure 51a It is shown that the catheter 9 can be withdrawn from the stomach 2 as indicated by arrow 114 . Figures 51a to 51d It is shown that various lengths of catheter 9 (e.g. Figures 51b to 51d Length 126 shown in FIG is introduced into and / or removed from the stomach 2 . Figures 51a to 51d Various configurations 116 and shapes 117 are shown that the catheter 9 can have. Figures 51a to 51d It is shown that, for example, the conduit 9 can have first to fourth shapes 117a - 117d , respectively, when the conduit 9 is in first to fourth configurations 116a - 116d .
[0377] Figures 51a to 51d The catheter 9 is shown to form a coil 138 within a target site 147 (eg, the stomach 2 ), for example, by inserting the catheter 9 into the target site 147 as indicated by arrow 112 . Figures 51a to 51d For example, coil 138 may have Figure 51a The first shape 117a shown, Figure 51b The second shape 117b shown, Figure 51c The third shape 117c shown and / or Figure 51d A fourth shape 117d is shown. Figures 51a to 51d It is shown that as the catheter 9 is inserted into the target site 147, the catheter 9 can form a coil 138 in the target site 147 by forming a bend, forming a loop (e.g., loop 118), folding over itself, crossing over itself and / or crossing under itself, contacting itself, extending longitudinally through the target site 147, extending laterally through the target site 147, extending vertically through the target site 147, extending forward through the target site 147, extending backward through the target site 147, extending upward through the target site 147, extending downward through the target site 147, extending proximally through the target site 147, extending distally through the target site 147, wrapping back and forth through the target site 147 in multiple directions, extending around the target site 147, undulating (e.g., zigzag) on the target site 147, or any combination thereof. Figures 51a to 51d It is shown that, for example, as the catheter 9 is inserted into the target site 147, the catheter 9 can engage with, advance against and / or be constrained by the wall of the target site 147 (e.g., the stomach wall 108), which can, for example, cause the catheter 9 to assemble into a coil 138 in the target site 147. Figures 51a to 51d It is shown that, for example, as the catheter 9 is inserted into the stomach 2 , the coils 138 may become progressively more complex and / or dense. Figures 51a to 51d It is shown that when the catheter 9 is in the straight configuration, the portion of the catheter 9 forming the coil 138 can be straight.
[0378] Figure 51d to Figure 51a It is shown that the catheter 9 can be withdrawn (eg, pulled) from the coil 138 within the target site 147 , for example, by withdrawing the catheter 9 from the target site 147 as shown by arrow 114 . Figure 51d to Figure 51a It is shown that coil 138 can be unwound in target site 147, for example, by withdrawing catheter 9 from target site 147 as shown by arrow 114. Catheter 9 can be withdrawn from outside coil 138 and / or inside coil 138. For example, withdrawing a portion of the catheter outside coil 138 and / or inside coil 138 can unwound coil 138. Figure 51d to Figure 51a For example, the outer portion of the coil 138 may be the portion of the catheter 9 that can contact the target site 147 , and the inner portion of the coil 138 may be the portion of the catheter 9 that is shielded by the outer portion of the coil and thus does not contact the target site 147 . Figure 51d to Figure 51a It is shown that the catheter 9 can be unwound from the coil 138 at the target site 147, for example, by straightening and / or becoming less curved, which can, for example, cause the coil 138 to unwind, unfold, loosen, stretch, open, and / or become straight. Figure 51d to Figure 51a It is shown that the coils 138 may become progressively less complex and / or less dense, for example, as the catheter 9 is withdrawn from the stomach 2 .
[0379] Figures 51a to 51d A first axis A1 , a second axis A2 , and a third axis A3 are shown, which may intersect one another at, for example, the center of the target site 147 . Figures 51a to 51d It is shown that, for example, the point where the first axis A1, the second axis A2, and the third axis A3 intersect may be closer to the lesser curvature 21c of the stomach 2 than to the greater curvature 2gc of the stomach 2. Figures 51a to 51d It is shown that the first axis A1 , the second axis A2 , and the third axis A3 may be orthogonal to each other. Figures 51a to 51d The first axis A1, the second axis A2, and the third axis A3 are shown to be straight axes. As another example, one or more of the first axis A1, the second axis A2, and the third axis A3 may be curved axes. Figures 51a to 51d For example, the first axis A1 , the second axis A2 , and the third axis A3 may be the longitudinal axis, the transverse axis, and the vertical axis, respectively.
[0380] Figures 51a to 51d For example, it is shown that the first axis A1 can pass through the fundus 2f, the stomach body 2b, and the gastric antrum 2a. Figures 51a to 51d For example, it is shown that the second axis A2 can pass through the greater curvature 2gc...
Claims
1. A device for changing the temperature of an organ, the device comprising: a tube having a lumen, a first tube portion, and a second tube portion, wherein a fluid can flow through the lumen; as well as A tether, wherein a distance between the tube first portion and the tube second portion can be maintained by the tether.
2. A device for changing the temperature of an organ, the device comprising: a tube having a lumen, a first tube portion, and a second tube portion, wherein a fluid can flow through the lumen; as well as Tether, wherein the tube has a first configuration and a second configuration, Wherein when the tube is in the second configuration, the tether is subjected to a greater tension than when the tube is in the first configuration.
3. A device for changing the temperature of an organ, the device comprising: a tube having a lumen, a first tube portion, and a second tube portion, wherein a fluid can flow through the lumen; as well as A tether, wherein the distance between the tube first portion and the tube second portion can be varied by the tether.
4. A device for changing the temperature of an organ, the device comprising: a tube having a lumen, a first tube portion, and a second tube portion, wherein a fluid can flow through the lumen; as well as A tether, wherein movement of the tube second portion away from the tube first portion can be limited by the tether.
5. A device for changing the temperature of a first organ, the device comprising: A tube having a lumen, a tube first portion and a tube second portion, wherein a fluid can flow through the lumen, wherein 50 cm to 150 cm of the tube is positionable in a second organ adjacent to the first organ.
6. A device for changing the temperature of an organ, the device comprising: A tube having a lumen, a tube first portion, and a tube second portion, wherein a fluid can flow through the lumen, wherein the tube can be formed into a grid shape.
7. A method of changing the temperature of a first organ, the method comprising: positioning a tube having a lumen, a first tube portion, and a second tube portion in a second organ; positioning the tether in the second organ; as well as A distance between the first tube portion and the second tube portion is maintained by the tether.
8. A method of changing the temperature of a first organ, the method comprising: positioning a tube having a lumen, a first tube portion, and a second tube portion in a second organ; positioning the tether in the second organ; as well as changing the tube from a first configuration to a second configuration or allowing the tube to change from the first configuration to the second configuration, Wherein when the tube is in the second configuration, the tether is subjected to a greater tension than when the tube is in the first configuration.
9. A method of changing the temperature of a first organ, the method comprising: positioning a tube having a lumen, a first tube portion, and a second tube portion in a second organ; positioning the tether in the second organ; as well as The distance between the first tube portion and the second tube portion is varied by the tether.
10. A method of changing the temperature of a first organ, the method comprising: positioning a tube having a lumen, a first tube portion, and a second tube portion in a second organ; positioning the tether in the second organ; as well as Movement of the second tube portion away from the first tube portion is restricted by the tether.
11. A method of changing the temperature of a first organ, the method comprising: A 50 cm to 150 cm tube having a lumen, a first tube portion, and a second tube portion is positioned in a second organ adjacent to the first organ.
12. A method of changing the temperature of a first organ, the method comprising: positioning a tube having a lumen, a first tube portion, and a second tube portion in a second organ; as well as The tubes are formed into a grid shape in the second organ.
13. An apparatus or method according to any preceding claim, wherein the tubes are formable into a grid shape.
14. Apparatus or method according to any preceding claim, wherein a distance between the tube first portion and the tube second portion can be maintained by the tether when the tether is in a tensioned state.
15. An apparatus or method as claimed in any preceding claim, wherein movement of the tube second portion away from the tube first portion can be restricted by the tether when the tether is in tension.
16. The apparatus or method of any preceding claim, wherein the tube has a tube distal end, wherein the tether has a tether distal end, wherein the tube distal end is capable of moving up to a threshold distance away from the tether distal end when the tether is in tension.
17. The apparatus or method of any preceding claim, wherein the tube has a tube distal end, wherein the tether has a tether distal end, wherein the tube distal end is capable of moving up to a threshold distance away from the tether distal end when the tether is in tension.
18. An apparatus or method according to any preceding claim, wherein the second tube portion has a second tube portion proximal end and a second tube portion distal end, wherein 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, wherein the distance between the first tube portion and the proximal end of the second tube portion can be maintained by the tether when the tether is in a tensioned state, and wherein the second tube portion distal end can be moved away from the first tube portion by a maximum threshold distance when the tether is in a tensioned state.
19. An apparatus or method according to any preceding claim, wherein the threshold distance is from 1 cm to 50 cm.
20. An apparatus or method according to any preceding claim, wherein the threshold distance is between 1 cm and 25 cm.
21. An apparatus or method according to any preceding claim, wherein the threshold distance is between 1 cm and 10 cm.
22. An apparatus or method according to any preceding claim, wherein the threshold distance is between 1 cm and 5 cm.
23. An apparatus or method according to any preceding claim, wherein the threshold distance is measured between the tether distal end and the tube distal end along the central longitudinal axis of the tube.
24. An apparatus or method according to any preceding claim, wherein the threshold distance is measured along a straight line between the tether distal end and the tube distal end.
25. An apparatus or method according to any preceding claim, wherein 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 is permitted, wherein when the distal end of the tube is 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 is prevented by tension in the tether and / or the tube.
26. An apparatus or method according to any preceding claim, wherein the tube has a first configuration and a second configuration, wherein when the tube is in the second configuration, the distal end of the tether is closer to the tube first portion than when the tube is in the first configuration.
27. An apparatus or method according to any preceding claim, wherein when the tube is in the second configuration, the tube second portion is closer to the tube first portion than when the tube is in the first configuration.
28. An apparatus or method according to any preceding claim, wherein the tube is movable from the first configuration to the second configuration by the tether.
29. An apparatus or method according to any preceding claim, wherein when the tube is in the first configuration, the second portion of the tube is a first distance away from the first portion of the tube, wherein when the tube is in the second configuration, the second portion of the tube is a second distance away from the first portion of the tube, wherein the second distance is less than the first distance.
30. An apparatus or method according to any preceding claim, wherein the second distance comprises the distance between the tube first portion and the tube second portion.
31. An apparatus or method according to any preceding claim, wherein when the tube is in the second configuration, the tether is subjected to a greater tension than when the tube is in the first configuration.
32. An apparatus or method according to any preceding claim, wherein when the tube is in the second configuration, the tether is in tension.
33. An apparatus or method according to any preceding claim, wherein when the tube is in the first configuration, the tether is in an untensioned state.
34. An apparatus or method according to any preceding claim, wherein the tube has a third configuration, wherein the tube is movable from the second configuration to the third configuration, wherein when the tube is in the third configuration, the distal end of the tube is the threshold distance from the distal end of the tether.
35. An apparatus or method according to any preceding claim, wherein the tube second portion comprises the tube distal end.
36. A device or method according to any preceding claim, wherein when the tube is in the first configuration, the second tube portion is located distal to the first tube portion, and wherein when the tube is in the second configuration, the second tube portion is located distal to the first tube portion.
37. An apparatus or method according to any preceding claim, wherein the tube first portion comprises a first port, and wherein the tube second portion comprises a second port.
38. An apparatus or method according to any preceding claim, wherein when the tube is in the second configuration, the second port is closer to the first port than when the tube is in the first configuration.
39. An apparatus or method according to any preceding claim, wherein when the tube is in the third configuration, the second port is further from the first port than when the tube is in the second configuration.
40. An apparatus or method as claimed in any preceding claim, wherein the tether is connected to the tube between the first port and the second port.
41. An apparatus or method as claimed in any preceding claim, wherein the tether is connected to the tube second portion between the first port and the second port.
42. An apparatus or method according to any preceding claim, wherein the tether is movable through the first port.
43. An apparatus or method according to any preceding claim, wherein when the tube is in the first configuration, the tether is located in the first port, wherein when the tube is in the second configuration, the tether is located in the first port.
44. An apparatus or method as claimed in any preceding claim, wherein when the tube is in the third configuration, the tether is located in the first port.
45. An apparatus or method according to any preceding claim, wherein the second port is located at the distal end of the tube or at the distal tip of the tube.
46. An apparatus or method according to any preceding claim, wherein a tool is deliverable through the second port.
47. An apparatus or method according to any preceding claim, wherein nutrients are deliverable through the second port.
48. An apparatus or method according to any preceding claim, wherein when the tube is in the first configuration, the tether is loose, and wherein when the tube is in the second configuration, the tether is taut.
49. An apparatus or method according to any preceding claim, wherein when the tube is in the first configuration, a portion of the tether has a bend, and wherein when the tube is in the second configuration, the portion of the tether is straight.
50. An apparatus or method according to any preceding claim, wherein when the tube is in the first configuration, the tether is under zero tension.
51. An apparatus or method according to any preceding claim, wherein when the tube is in the first configuration, the tether has a first tension, wherein when the tube is in the second configuration, the tether has a second tension, wherein the second tension is greater than the first tension.
52. An apparatus or method according to any preceding claim, wherein the first tension is zero tension.
53. An apparatus or method according to any preceding claim, wherein when the tube is in the first configuration, the tether is in a non-tensioned state, wherein when the tube is in the second configuration, the tether is in a tensioned state.
54. An apparatus or method as claimed in any preceding claim, wherein movement of the tube second portion away from the tube first portion is preventable by the tether when the tether is in a tensioned state.
55. An apparatus or method as claimed in any preceding claim, wherein the tube second portion is movable towards the tube first portion by the tether when the tether is in tension.
56. An apparatus or method as claimed in any preceding claim, wherein the tube second portion is capable of being pulled towards the tube first portion by the tether when the tether is in a tensioned state.
57. An apparatus or method according to any preceding claim, wherein the tube has a port, wherein the tether has a tether distal end, wherein when the tube is in the second configuration, the tether distal end is farther from the port than when the tube is in the first configuration.
58. An apparatus or method according to any preceding claim, wherein the port is located proximal to the distal end of the tether when the tube is in the first configuration and when the tube is in the second configuration.
59. An apparatus or method according to any preceding claim, wherein the tether is located in the port when the tube is in the first configuration and when the tube is in the second configuration.
60. An apparatus or method according to any preceding claim, wherein the tether is movable from a non-actuated position to an actuated position.
61. A device or method according to any preceding claim, wherein the tether is movable from the non-actuated position to the actuated position by a control on a handle of the device.
62. An apparatus or method according to any preceding claim, wherein when the tether is in the non-actuated position, the distance between the first tube portion and the second tube portion can be reduced by tightening the tether.
63. An apparatus or method according to any preceding claim, wherein the non-actuated position is a non-retracted position of the tether.
64. An apparatus or method according to any preceding claim, wherein when the tether is in the actuated position, the distance between the first tube portion and the second tube portion can be increased by loosening the tether.
65. An apparatus or method according to any preceding claim, wherein the actuated position is a retracted position of the tether.
66. An apparatus or method according to any preceding claim, wherein the tether has a distal end, wherein when the tether is in the actuated position, the tether distal end is closer to the first portion of the tube than when the tether is in the non-actuated position.
67. An apparatus or method according to any preceding claim, wherein when the tether is in the actuated position, the tube second portion is closer to the tube first portion than when the tether is in the non-actuated position.
68. An apparatus or method according to any preceding claim, wherein when the tether is in the actuated position, the tether is subjected to a greater tension than when the tether is in the non-actuated position.
69. An apparatus or method according to any preceding claim, wherein a distance between the tube first portion and the tube second portion can be maintained by the tether when the tether is in the actuated position.
70. An apparatus or method according to any preceding claim, wherein the tube comprises a heat transfer region.
71. An apparatus or method according to any preceding claim, wherein a portion of the tube comprises a heat transfer region.
72. An apparatus or method according to any preceding claim, wherein the heat transfer zone has a heat transfer zone length, wherein a ratio of the heat transfer length to the length of the organ, the length of the first organ, or the length of the second organ comprises 1.5 to 20.
0.
73. An apparatus or method according to any preceding claim, wherein the heat transfer region comprises 80% to 100% of the length of the tube positionable adjacent the organ or the first organ.
74. An apparatus or method according to any preceding claim, wherein the heat transfer zone has a heat transfer zone length including the tube of 20 cm to 200 cm.
75. An apparatus or method according to any preceding claim, wherein the heat transfer zone has a heat transfer zone length of 20 cm to 150 cm.
76. An apparatus or method according to any preceding claim, wherein the heat transfer zone has a heat transfer zone length of 75 cm to 150 cm.
77. An apparatus or method according to any preceding claim, wherein the heat transfer zone has a heat transfer zone length of 50 cm to 150 cm.
78. An apparatus or method according to any preceding claim, wherein the heat transfer zone has a heat transfer zone length of 50 cm to 100 cm.
79. An apparatus or method according to any preceding claim, wherein the heat transfer region comprises a length of the tube.
80. An apparatus or method as claimed in any preceding claim, wherein the heat transfer zone comprises a continuous length of the tube.
81. An apparatus or method as claimed in any preceding claim, wherein the heat transfer region comprises the tube first portion and the tube second portion.
82. An apparatus or method as claimed in any preceding claim, wherein the heat transfer region comprises the tube second portion.
83. An apparatus or method according to any preceding claim, wherein the heat transfer zone is located at the distal end of the first portion of the tube.
84. An apparatus or method according to any preceding claim, wherein the tube has a tube distal end, wherein the heat transfer region includes the tube distal end.
85. An apparatus or method according to any preceding claim, wherein when the tube is in an expanded configuration, the heat transfer zone intersects itself 0 to 15 times.
86. An apparatus or method according to any preceding claim, wherein when the tube is in an expanded configuration, the heat transfer zone intersects itself 0 to 10 times.
87. An apparatus or method according to any preceding claim, wherein when the tube is in an expanded configuration, the heat transfer zone intersects itself 0 to 5 times.
88. An apparatus or method according to any preceding claim, wherein when the tube is in the expanded configuration, a first outer portion of the heat transfer region contacts a second outer portion of the heat transfer region.
89. An apparatus or method according to any preceding claim, wherein the first outer portion of the heat transfer zone comprises a first portion of the outer surface of the tube, and wherein the second outer portion of the heat transfer zone comprises a second portion of the outer surface of the tube.
90. An apparatus or method as claimed in any preceding claim, 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. An apparatus or method according to any preceding claim, wherein the heat transfer region has 0 to 15 bends when the tube is in an expanded configuration.
92. An apparatus or method according to any preceding claim, wherein the heat transfer region has 0 to 10 bends when the tube is in an expanded configuration.
93. An apparatus or method according to any preceding claim, wherein the heat transfer region has 0 to 5 bends when the tube is in an expanded configuration.
94. An apparatus or method according to any preceding claim, wherein when the tube is in an expanded configuration, the heat transfer region has more curvature than when the tube is in a non-expanded configuration.
95. An apparatus or method according to any preceding claim, wherein the tube is capable of expanding from an expanded first configuration to an expanded second configuration such that the tube has more curvature when the tube is in the expanded second configuration than when the tube is in the expanded first configuration.
96. An apparatus or method according to any preceding claim, wherein the tube is capable of expanding from an expanded second configuration to an expanded third configuration such that the tube has more curvature when the tube is in the expanded third configuration than when the tube is in the expanded second configuration.
97. A device or method according to any preceding claim, wherein when the tube is in a first, expanded structure, the tube includes 1 bend, wherein when the tube is in a second, expanded structure, the tube includes 2 bends, and when the tube is in a third, expanded structure, the tube includes 3 bends.
98. A device or method according to any preceding claim, wherein when the tube is in a first, expanded structure, the tube includes 1 to 2 bends, wherein when the tube is in a second, expanded structure, the tube includes 3 to 4 bends, and when the tube is in the third, expanded structure, the tube includes 5 to 10 bends.
99. An apparatus or method according to any preceding claim, wherein when the tube is in an expanded configuration, the heat transfer region has 0 to 15 rings.
100. An apparatus or method according to any preceding claim, wherein the heat transfer region has 0 to 10 rings when the tube is in an expanded configuration.
101. An apparatus or method according to any preceding claim, wherein when the tube is in an expanded configuration, the heat transfer region has 0 to 5 rings.
102. An apparatus or method according to any preceding claim, wherein when the tube is in an expanded configuration, the heat transfer region has more loops than when the tube is in a non-expanded configuration.
103. An apparatus or method according to any preceding claim, wherein when the tube is in an expanded configuration, the tube defines a grid having cells.
104. An apparatus or method according to any preceding claim, wherein a grid having cells can be formed from the tube.
105. An apparatus or method according to any preceding claim, wherein when the tube is in an expanded configuration, the tube defines a lattice structure having cells.
106. An apparatus or method according to any preceding claim, wherein a lattice structure having cells can be formed from the tube.
107. An apparatus or method according to any preceding claim, wherein the tube is capable of expanding from a first expanded configuration to a second expanded configuration such that the tube has more loops when the tube is in the second expanded configuration than when the tube is in the first expanded configuration.
108. An apparatus or method according to any preceding claim, wherein the tube is capable of expanding from an expanded second configuration to an expanded third configuration such that the tube has more loops when the tube is in the expanded third configuration than when the tube is in the expanded second configuration.
109. An apparatus or method according to any preceding claim, wherein when the tube is in a first, expanded configuration, the tube comprises 0 loops, wherein when the tube is in a second, expanded configuration, the tube comprises 1 loop, and when the tube is in the third, expanded configuration, the tube comprises 2 loops.
110. A device or method according to any preceding claim, wherein when the tube is in a first, expanded structure, the tube includes 0 to 2 loops, wherein when the tube is in a second, expanded structure, the tube includes 3 to 4 loops, and when the tube is in the third, expanded structure, the tube includes 5 to 10 loops.
111. An apparatus or method according to any preceding claim, wherein the deployed configuration is the second configuration.
112. An apparatus or method according to any preceding claim, wherein the heat transfer region is straight when the tube is in a non-expanded configuration.
113. An apparatus or method according to any preceding claim, wherein the tether is movable along the tube outside the tube.
114. An apparatus or method according to any preceding claim, wherein the tether is movable into the tube.
115. An apparatus or method according to any preceding claim, wherein the tether is flexible or rigid.
116. An apparatus or method according to any preceding claim, wherein the tube is movable by the tether.
117. An apparatus or method according to any preceding claim, wherein when the tether is in a non-actuated state, the first portion of the tube and the second portion of the tube are separated by a first distance, wherein when the tether is in an actuated state, the first portion of the tube and the second portion of the tube are separated by a second distance, wherein the second distance is less than the first distance.
118. An apparatus or method according to any preceding claim, wherein the first tube portion is movable closer to the second tube portion by the tether.
119. An apparatus or method according to any preceding claim, wherein the tube first portion is movable into contact with the tube second portion by the tether.
120. An apparatus or method according to any preceding claim, wherein the tube is capable of changing from a first shape to a second shape by the tether.
121. An apparatus or method according to any preceding claim, wherein a bend can be formed in the tube by the tether.
122. An apparatus or method according to any preceding claim, wherein the tether is connected to the tube.
123. An apparatus or method according to any preceding claim, wherein the tether has a non-actuated state and an actuated state, wherein when the tether is in the non-actuated state, the distal end of the tether is located further outside of the tube than when the tether is in the actuated state.
124. An apparatus or method according to any preceding claim, wherein the tether has a non-actuated state and an actuated state, wherein when the tether is in the actuated state, the distal end of the tether is located further inside the tube than when the tether is in the non-actuated state.
125. An apparatus or method according to any preceding claim, wherein the tether is retractable through the tube.
126. An apparatus or method according to any preceding claim, wherein the tether has a tether distal end, wherein the tether distal end is connected to the tube, wherein when the tether is in an actuated state the tether distal end is closer to a port in the tube than when the tether is in a non-actuated state.
127. An apparatus or method according to any preceding claim, wherein the tether is configured to prevent the tube from becoming tangled.
128. An apparatus or method according to any preceding claim, wherein the tether is configured to limit or prevent movement of the tube.
129. An apparatus or method according to any preceding claim, wherein the tether is configured to limit or prevent distal movement of the tube from the distal end of the tether.
130. An apparatus or method according to any preceding claim, wherein the tether is configured to restrict or prevent a tube portion proximal to the tether distal end from moving away from a tube portion distal to the tether distal end.
131. An apparatus or method according to any preceding claim, wherein when the tube and the tether are located in a first internal body space, the tether is configured to inhibit or prevent movement of the tube from the first internal body space to a second internal body space.
132. An apparatus or method according to any preceding claim, wherein when the tube and the tether are located in a first internal body space, the tether is configured to restrict movement of the tube from the first internal body space to a second internal body space.
133. The device or method of any preceding claim, further comprising an adapter, wherein the adapter has a lumen.
134. An apparatus or method according to any preceding claim, wherein the adapter comprises the distal end of the tube.
135. A device or method according to any preceding claim, wherein the adapter comprises a distal coil having 1 to 5 turns in the tube.
136. A device or method according to any preceding claim, wherein the distal coil has a helical profile.
137. A device or method according to any preceding claim, wherein the distal coil has a helical profile.
138. An apparatus or method according to any preceding claim, wherein the adapter is configured to retain the distal end of the catheter in the duodenum.
139. An apparatus or method according to any preceding claim, wherein the tube is insertable into a patient such that when the adapter is located in the patient's duodenum, the tether is located in the patient's stomach.
140. An apparatus or method according to any preceding claim, wherein the adapter comprises the heat transfer region.
141. An apparatus or method according to any preceding claim, wherein the adapter comprises a distal end of the heat transfer region.
142. An apparatus or method according to any preceding claim, wherein the adapter has an adapter length of 2 cm to 10 cm.
143. An apparatus or method according to any preceding claim, wherein the adapter has an adapter length of 2 cm to 20 cm.
144. An apparatus or method according to any preceding claim, wherein the adapter has an adapter length of 2 cm to 40 cm.
145. An apparatus or method according to any preceding claim, wherein the lumen comprises a first lumen, wherein the tube has a second lumen, wherein fluid is able to flow through the first lumen to the distal end of the tube, wherein fluid is able to flow through the second lumen to the proximal end of the tube.
146. An apparatus or method according to any preceding claim, wherein the tube comprises a catheter.
147. An apparatus or method according to any preceding claim, wherein the tether comprises a wire or rope.
148. An apparatus or method according to any preceding claim, wherein the fluid comprises a liquid or a gas.
149. An apparatus or method according to any preceding claim, wherein the fluid is capable of flowing through the lumen at a temperature greater than 37 degrees Celsius.
150. An apparatus or method according to any preceding claim, wherein the fluid is capable of flowing through the lumen at a temperature of 37 degrees Celsius to 50 degrees Celsius.
151. An apparatus or method according to any preceding claim, wherein the fluid is capable of flowing through the lumen at a temperature of 37 degrees Celsius to 45 degrees Celsius.
152. An apparatus or method according to any preceding claim, wherein the fluid is capable of flowing through the lumen at a temperature of 37 degrees Celsius to 40 degrees Celsius.
153. An apparatus or method according to any preceding claim, wherein the fluid is capable of flowing through the lumen at a temperature of 37.1 degrees Celsius to 45.0 degrees Celsius.
154. An apparatus or method according to any preceding claim, wherein the fluid is capable of flowing through the lumen at a temperature of less than 37 degrees Celsius.
155. An apparatus or method according to any preceding claim, wherein the fluid is capable of flowing through the lumen at a temperature of 2 degrees Celsius to 20 degrees Celsius.
156. An apparatus or method according to any preceding claim, wherein the fluid is capable of flowing through the lumen at a temperature of 4 degrees Celsius to 20 degrees Celsius.
157. An apparatus or method according to any preceding claim, wherein the fluid is capable of flowing through the lumen at a temperature of 5 degrees Celsius to 15 degrees Celsius.
158. An apparatus or method according to any preceding claim, wherein the fluid is capable of flowing through the lumen at a temperature of 5 degrees Celsius to 8 degrees Celsius.
159. An apparatus or method according to any preceding claim, wherein the fluid is capable of flowing through the lumen at a temperature of 10 degrees Celsius.
160. An apparatus or method according to any preceding claim, wherein the fluid is capable of flowing through the first lumen at a temperature of 5 degrees Celsius to 8 degrees Celsius, wherein the fluid is capable of flowing through the second lumen at a temperature of 11 degrees Celsius to 13 degrees Celsius.
161. An apparatus or method according to any preceding claim, wherein the tube is configured to remain flexible under pressure.
162. An apparatus or method according to any preceding claim, wherein the tube is configured to limit the maximum volume.
163. An apparatus or method according to any preceding claim, wherein the tube is configured to limit a maximum volume.
164. The device or method of any preceding claim, further comprising a balloon.
165. A device or method according to any preceding claim, wherein the balloon is elastic or inelastic.
166. A device or method according to any preceding claim, wherein the balloon is capable of being inflated with the fluid.
167. A device or method according to any preceding claim, wherein the balloon comprises bubbles, ridges, ribs or dots.
168. A device or method according to any preceding claim, wherein the balloon comprises a first cavity and a second cavity.
169. An apparatus or method according to any preceding claim, wherein 50 cm to 150 cm of the tube is inserted into the stomach.
170. An apparatus or method according to any preceding claim, wherein the lumen is expandable.
171. An apparatus or method according to any preceding claim, further comprising a temperature sensor, a pressure sensor, an enzyme sensor and / or a motion sensor.
172. An apparatus or method according to any preceding claim, further comprising a visualization aid.
173. An apparatus or method according to any preceding claim, wherein the visualization aid comprises a magnet, a radiopaque marker and / or an echogenic marker.
174. An apparatus or method according to any preceding claim, further comprising a bypass lumen to allow pre-cooling of the fluid to allow a cooler to remain operational without flow to the tube, and / or to avoid a low flow alarm.
175. An apparatus or method according to any preceding claim, wherein the return height of the fluid is adjustable to improve pressure control of the apparatus.
176. An apparatus or method according to any preceding claim, wherein the tube has a first portion and a second portion, the first portion having a first diameter and the second portion having a second diameter, wherein the first diameter is smaller than the second diameter for improved comfort during insertion into the nose or mouth, and wherein the second diameter is larger than the first diameter for improved flow or surface area in the organ.
177. An apparatus or method according to any preceding claim, wherein the tube is configured to change the temperature of the organ from the stomach and / or duodenum.
178. An apparatus or method according to any preceding claim, wherein the first organ comprises a pancreas.
179. An apparatus or method according to any preceding claim, wherein the lumen comprises a first lumen, wherein the tube further comprises a second lumen and a third lumen, wherein the first lumen comprises an inflow lumen for the fluid, and wherein the second lumen comprises an outflow lumen for the fluid.
180. An apparatus or method according to any preceding claim, wherein the third lumen comprises a working channel.
181. An apparatus or method according to any preceding claim, wherein the third lumen comprises a suction lumen.
182. An apparatus or method according to any preceding claim, wherein a tool can be delivered through the third lumen.
183. An apparatus or method according to any preceding claim, wherein nutrients can be delivered through the third lumen.
184. An apparatus or method according to any preceding claim, wherein the diameter of the first lumen is smaller than the diameter of the second lumen.
185. An apparatus or method according to any preceding claim, wherein the first lumen and the second lumen have the same diameter.
186. An apparatus or method according to any preceding claim, wherein the tube comprises a shaft, a weighted tip and / or a coiled tip.
187. An apparatus or method according to any preceding claim, wherein between 1 cm and 30 cm of the tube is capable of being positioned in a third organ, wherein the third organ is adjacent to the first organ.
188. An apparatus or method according to any preceding claim, wherein the 1 cm to 30 cm of the tube positionable in the third organ is located distal to the 50 cm to 150 cm of the tube positionable in the second organ.
189. An apparatus or method according to any preceding claim, wherein the second organ comprises a stomach.
190. An apparatus or method according to any preceding claim, wherein the third organ comprises the duodenum.
191. An apparatus or method according to any preceding claim, wherein the first organ comprises a pancreas.
192. An apparatus or method according to any preceding claim, wherein the grid shape comprises struts and chambers.
193. An apparatus or method according to any preceding claim, wherein the chamber comprises holes in the grid shape.
194. An apparatus or method according to any preceding claim, wherein the first portion of the tube or the second portion of the tube comprises the strut.
195. An apparatus or method according to any preceding claim, wherein a portion of the tube comprises the strut.
196. An apparatus or method according to any preceding claim, wherein the grid shape comprises a first strut and a second strut.
197. An apparatus or method according to any preceding claim, wherein the grid shape comprises a first chamber and a second chamber.
198. An apparatus or method according to any preceding claim, wherein the first chamber comprises a first hole in the grid shape, and wherein the second chamber comprises a second hole in the grid shape.
199. An apparatus or method according to any preceding claim, wherein the first portion of the tube comprises the first strut, and wherein the second portion of the tube comprises the second strut.
200. An apparatus or method according to any preceding claim, wherein the tube first portion comprises the first strut and the second strut.
201. An apparatus or method according to any preceding claim, wherein the second portion of the tube comprises the first strut and the second strut.
202. An apparatus or method according to any preceding claim, wherein the first portion of the tube comprises the first strut.
203. An apparatus or method according to any preceding claim, wherein the second portion of the tube comprises the second strut.
204. An apparatus or method according to any preceding claim, wherein the grid shape includes joints.
205. An apparatus or method according to any preceding claim, wherein the joint comprises a portion of the grid shape where the first struts and the second struts intersect each other.
206. An apparatus or method according to any preceding claim, wherein the joint comprises a portion where a first strut intersects below or above the second strut in the grid shape.
207. An apparatus or method according to any preceding claim, wherein the joint comprises a portion of the grid shape where the first strut contacts the second strut.
208. An apparatus or method according to any preceding claim, wherein the joint includes a friction point, and the friction point is configured to resist movement of the second support post away from the first support post.
209. An apparatus or method according to any preceding claim, wherein the joint includes a friction point, and the friction point is configured to resist movement of the tube.
210. An apparatus or method according to any preceding claim, wherein the first strut and the second strut are continuous with each other.
211. An apparatus or method according to any preceding claim, wherein a third strut is located between the first strut and the second strut.
212. An apparatus or method according to any preceding claim, wherein the strut comprises a length of the tube between two joints.
213. An apparatus or method according to any preceding claim, wherein the first strut comprises a length of the tube between two joints.
214. An apparatus or method according to any preceding claim, wherein the second strut comprises a length of the tube between two joints.
215. An apparatus or method according to any preceding claim, wherein the struts are straight or have a curve.
216. An apparatus or method according to any preceding claim, wherein the first strut is straight or has a curve.
217. An apparatus or method according to any preceding claim, wherein the second strut is straight or has a curve.
218. An apparatus or method according to any preceding claim, wherein the chamber comprises an open chamber or a closed chamber.
219. An apparatus or method according to any preceding claim, wherein the first chamber comprises an open chamber or a closed chamber.
220. An apparatus or method according to any preceding claim, wherein the second chamber comprises an open chamber or a closed chamber.
221. An apparatus or method according to any preceding claim, wherein the tube has a non-grid shape and a grid shape.
222. An apparatus or method according to any preceding claim, wherein the tube is capable of being formed from a non-grid shape to a grid shape.
223. An apparatus or method according to any preceding claim, wherein the tube is capable of changing from a non-grid shape to a grid shape.
224. An apparatus or method according to any preceding claim, wherein the tube is capable of changing from a grid shape to a non-grid shape.
225. An apparatus or method according to any preceding claim, wherein the tube has a distal end of the tube, wherein when the tube has a non-grid shape, the portion of the tube that defines the first strut when the tube has a grid shape is farther from the distal end of the tube than the portion of the tube that defines the second strut when the tube has a grid shape.
226. An apparatus or method according to any preceding claim, wherein when the tube has a grid shape, the first struts are farther from the distal end of the tube than the second struts.
227. An apparatus or method according to any preceding claim, wherein when the tube has the grid shape, the first strut is closer to the distal end of the tube than the second strut.
228. An apparatus or method according to any preceding claim, wherein when the tube has the grid shape, the distance between the first struts and the second struts is increaseable or decreaseable.
229. An apparatus or method according to any preceding claim, wherein when the tube has the grid shape, the first strut is capable of moving toward and away from the second strut.
230. An apparatus or method according to any preceding claim, wherein the grid shape is capable of being formed using a tube of 20 cm to 200 cm.
231. An apparatus or method according to any preceding claim, wherein the organ comprises a first organ, wherein the mesh shape is formable in a second organ.
232. An apparatus or method according to any preceding claim, wherein the second organ is the stomach.
233. An apparatus or method according to any preceding claim, wherein the non-grid shape comprises a straight configuration of the tubes or a linear configuration of the tubes.
234. An apparatus or method according to any preceding claim, wherein the joint comprises a portion where the first portion of the tube and the second portion of the tube intersect each other in a grid shape.
235. An apparatus or method according to any preceding claim, wherein the grid shape is capable of being formed by the tube in the second organ.
236. An apparatus or method according to any preceding claim, wherein the grid shape can be formed by the tube by bending the tube during advancement of the tube into the second organ.
237. An apparatus or method according to any preceding claim, wherein when the tube has the grid shape, the tube comprises 1 to 50 bends.
238. An apparatus or method according to any preceding claim, wherein when the tube has the grid shape, the tube comprises 1 to 30 bends.
239. An apparatus or method according to any preceding claim, wherein when the tube has the grid shape, the tube comprises 10 to 50 bends.
240. An apparatus or method according to any preceding claim, further comprising a tether, wherein the size of the chamber, the first chamber or the second chamber can be changed by the tether.
241. An apparatus or method according to any preceding claim, further comprising a tether, wherein the shape of the chamber, the first chamber or the second chamber can be changed by the tether.
242. An apparatus or method according to any preceding claim, wherein another fluid is capable of flowing through the chamber, the first chamber or the second chamber.
243. An apparatus or method according to any preceding claim, wherein nutrients are able to flow through the chamber, the first chamber or the second chamber.
244. An apparatus or method according to any preceding claim, wherein the chamber, the first chamber or the second chamber is configured to provide a space for nutrients to pass through.
245. An apparatus or method according to any preceding claim, wherein when the tube is in the first configuration, the tube has the grid shape.
246. An apparatus or method according to any preceding claim, wherein when the tube is in the second configuration, the tube has the grid shape.
247. An apparatus or method according to any preceding claim, wherein when the tube is in the third configuration, the tube has the grid shape.
248. An apparatus or method according to any preceding claim, wherein when the tubes have the grid shape, the grid shape comprises 20 cm to 200 cm of the tubes.
249. An apparatus or method according to any preceding claim, wherein when the tube is in an expanded configuration, the tube has the grid shape, wherein the grid shape is defined by 20 cm to 200 cm of the tube.
250. An apparatus or method according to any preceding claim, wherein the grid shape includes the heat transfer area.
251. An apparatus or method according to any preceding claim, wherein when the tube has the grid shape, the fluid is able to flow through the lumen.
252. An apparatus or method according to any preceding claim, wherein the tube has the grid shape when the tube is in a fully expanded configuration.
253. An apparatus or method according to any preceding claim, wherein when the tube is in a fully expanded configuration, the tether is in an actuated position and the tube has the grid shape.
254. The method of any preceding claim, wherein forming the tube into the lattice shape in the second organ comprises pushing the tube into the second organ.
255. The method of any preceding claim, wherein forming the tube into the lattice shape in the second organ comprises gradually advancing the tube into the second organ.
256. The method of any preceding claim, wherein forming the tube into the lattice shape in the second organ comprises bending the tube in the second organ.
257. The method of any preceding claim, further comprising changing the tube from the mesh shape to a non-mesh shape by retracting the tube from the second organ.
258. The method of any preceding claim, further comprising changing the tube from the mesh shape to a non-mesh shape by gradually retracting the tube from the second organ.
259. The method of any preceding claim, further comprising changing the tube from the mesh shape to a non-mesh shape by straightening the tube in the second organ.
260. The method of any preceding claim, further comprising changing the temperature of the first organ by flowing the fluid through the lumen in the second organ.
261. The method of any preceding claim, further comprising changing the temperature of the first organ by flowing the fluid through the heat transfer zone in the second organ.
262. The method of any preceding claim, further comprising changing the temperature of the first organ by flowing the fluid through the lumen in the third organ.
263. The method of any preceding claim, further comprising preventing the tube from becoming tangled by the tether.
264. The method of any preceding claim, further comprising preventing kinking of the tube by the tether.
265. The method of any preceding claim, further comprising limiting or preventing movement of the tube from the second organ to the third organ via the tether.
266. The method of any preceding claim, wherein positioning the tube in the second organ comprises positioning 50 cm to 150 cm of the tube in the second organ.
267. The method of any preceding claim, further comprising positioning the tube in a third organ.
268. The method of any preceding claim, wherein the first organ is the pancreas, wherein the second organ comprises the stomach, and wherein the third organ comprises the duodenum.
269. The method of any preceding claim, wherein positioning the tube in the third organ comprises positioning 1 cm to 40 cm of the tube in the third organ.
270. The method of any preceding claim, further comprising adding or removing the tube from the second organ to adjust the cooling power of the tube.
271. An apparatus or method according to any preceding claim, wherein 50 cm to 150 cm of the heat transfer area is positionable in the second organ.
272. An apparatus or method according to any preceding claim, wherein the heat transfer area of 1 cm to 40 cm is positionable in the third organ.
273. An apparatus or method according to any preceding claim, wherein the total length of the tube is 30 cm to 250 cm.
274. An apparatus or method according to any preceding claim, wherein 50 cm to 150 cm of the tube is located in the second organ when the tube is in a fully expanded configuration.
275. An apparatus or method according to any preceding claim, wherein 0 cm to 40 cm of the tube is located in the third organ when the tube is in a fully expanded configuration.
276. An apparatus or method according to any preceding claim, wherein when the tube is in a fully expanded configuration, 50 cm to 150 cm of the heat transfer area is located in the second organ.
277. An apparatus or method according to any preceding claim, wherein when the tube is in a fully expanded configuration, 0 cm to 40 cm of the heat transfer area is located in the third organ.
278. Any combination of claims 1 to 277.
279. Any combination of features disclosed herein.
280. A system or apparatus having any combination of the features of any of the drawings or any combination of the drawings.
281. A method having any combination of the steps disclosed herein.
282. An apparatus, product, process, system, kit, assembly or use, characterized in that It comprises one or more of the features disclosed herein.
283. A method of changing the temperature of the gastrointestinal tract caudal to the gastroesophageal junction via a catheter, the method comprising: inserting a 50 cm to 300 cm catheter into the stomach of the gastrointestinal tract; Fluid is added or removed from the conduit through inflow and outflow ports having 10 watts to 100 watts of cooling power or heating power.
284. The method of claim 283, further comprising changing the temperature of the gastrointestinal tract caudal to the gastroesophageal junction in the gastrointestinal tract via 50 cm to 300 cm of the catheter inserted into the stomach.
285. The method of claim 283, further comprising circulating the fluid through an inflow lumen and an outflow lumen extending through 50 cm to 300 cm of the catheter inserted into the stomach.
286. The method of claim 285, wherein the temperature of the fluid is greater than 37 degrees Celsius or wherein the temperature of the fluid is less than 37 degrees Celsius.
287. The method of claim 286, further comprising increasing and / or decreasing the temperature of the gastrointestinal tract caudal to the gastroesophageal junction by 1 to 20 degrees Celsius.
288. The method of claim 286, further comprising increasing and / or decreasing the temperature of the gastrointestinal tract wall in the gastrointestinal tract caudal to the gastroesophageal junction by 1 to 20 degrees Celsius.
289. The method of claim 288, wherein the gastrointestinal wall in the gastrointestinal tract caudal to the gastroesophageal junction is adjacent to the pancreas.
290. A method of altering the temperature of the gastrointestinal tract caudal to the gastroesophageal junction in the gastrointestinal tract, the method comprising: positioning a first portion of the catheter within a stomach of the gastrointestinal tract; as well as transferring heat to or from the gastrointestinal tract comprising recirculating fluid through an inflow lumen and an outflow lumen in the first portion of the catheter, The length of the first portion of the conduit is greater than the length of the greater curvature of the stomach.
291. The method of claim 290, wherein transferring heat to and / or from the gastrointestinal tract comprises: Heat is transferred to and / or from the gastrointestinal tract through the first portion of the catheter in the stomach.
292. The method of claim 290, wherein the first portion of the conduit has a length greater than the greater curvature of the stomach while transferring heat to and / or from the gastrointestinal tract.
293. The method of claim 290, wherein the length of the first portion of the catheter is 10 cm to 300 cm longer than the greater curvature of the stomach.
294. The method of claim 290, wherein the length of the first portion of the catheter in the stomach (Lc) is N times the length of the greater curvature of the stomach (Ls), as shown in the formula Lc=NLs, wherein N is a positive real number ranging from 1.00 to 20.
00.
295. The method of claim 290, wherein the distal end of the catheter comprises the first portion of the catheter, and wherein the proximal end of the catheter comprises the first portion of the catheter.
296. A method according to claim 290, wherein the temperature of the fluid is greater than 37 degrees Celsius or wherein the temperature of the fluid is less than 37 degrees Celsius.
297. A method of altering the temperature of the gastrointestinal tract caudal to the gastroesophageal junction in the gastrointestinal tract, the method comprising: Positioning a length of lumen in the stomach of the gastrointestinal tract; as well as allowing a fluid to flow through the length of lumen at a flow rate during a treatment period, wherein the flow rate is at least 20 mL / minute and the treatment period is at least 2 hours, The length of the lumen in the stomach includes 30 cm to 150 cm.
298. The method of claim 297, wherein the volume of the lumen of the length of the gastrointestinal tract comprises 2.0 mL to 50.0 mL.
299. The method of claim 297, wherein the flow rate is less than 200 mL / min and / or wherein the treatment period comprises 2 hours to 31 days.
300. The method of claim 297, further comprising passing 4 L to 9000 L of the fluid through the length of lumen.
301. The method of claim 297, further comprising flowing the fluid through the length of the lumen in the stomach at a flow rate of 20 mL / min to 200 mL / min.
302. The method of claim 297, wherein the lumen comprises a first lumen, the method further comprising: positioning a length of the second lumen in the stomach; as well as allowing the fluid to flow through the length of the second lumen at a certain flow rate during treatment, wherein the length of the second lumen in the stomach comprises 30 cm to 150 cm, wherein the first lumen comprises an inflow lumen, wherein the second lumen comprises an outflow lumen, and The first lumen and the second lumen merge into each other at a merging point, wherein the merging point is located inside the catheter.
303. An apparatus comprising: a conduit comprising a heat transfer region, wherein a heating zone extends radially from said heat transfer region, wherein the heat transfer zone comprises a length of 50 cm to 300 cm, and Wherein 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 when the catheter is in the expanded configuration.
304. The device according to claim 303 also includes a circulation pump.
305. The device of claim 303, further comprising an inflow port and an outflow port located at the proximal end of the catheter.
306. The device of claim 303, wherein the heat transfer zones are self-intersecting when the catheter is in an expanded configuration.
307. The device of 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 an expanded configuration.
308. The device of claim 303, wherein the first length of the heat transfer region and the second length of the heat transfer region are at least 10 cm apart when the conduit is in a straight configuration.
309. The device of claim 303, wherein 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, and Wherein when the catheter is in the expanded configuration, the first length of the heat transfer region is distal to the second length of the heat transfer region.
310. An apparatus comprising: Circulation pump; as well as 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, wherein the inflow port and the outflow port are in fluid communication with the circulation pump when the circulation pump recirculates fluid, wherein an adhesive is attached to the catheter when the catheter is in an expanded configuration, wherein when the catheter is in the expanded configuration, the lumen volume distal to the inflow port and the outflow port is less than 50 mL, and Wherein when the catheter is in the expanded configuration, the length of the catheter between the adhesion and the distal tip of the catheter is at least 80 cm.
311. The device of claim 310, wherein when the catheter is in an expanded configuration, the lumen volume distal to the inflow port and the outflow port is less than 20 mL or 10 mL.
312. The device of claim 310, wherein the length of the catheter between the adhesion and the distal tip of the catheter is less than 175 cm or 300 cm when the catheter is in the expanded configuration.
313. The device of claim 310, wherein when the catheter is in an expanded 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 of 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 of claim 310, wherein the adherent comprises an adhesive.
316. The device of claim 310, wherein the adhesive comprises tape.
317. An apparatus comprising: Circulation 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, wherein the inflow port and the outflow port are located at the first end of the catheter, wherein the inflow port and the outflow port are in fluid communication with the circulation pump when the circulation pump recirculates fluid; and wherein an adhesive is attached to the catheter when the catheter is in an expanded configuration, wherein when the catheter is in the expanded configuration, the length of the catheter between the adherent and the distal end of the catheter is greater than 90 cm from the adherent, and Wherein when the catheter is in the expanded configuration, a distance measured along a straight line from the adhesion to the distal end of the catheter is less than 60 cm.
318. The device of claim 317, wherein the length of the catheter between the adhesion and the distal end of the catheter is less than 175 cm or 300 cm when the catheter is in an expanded configuration.
319. A device according to claim 317, wherein the expansion structure includes a first expansion structure, the straight line includes the first straight line, and when the catheter is in a second expansion structure, the distance measured along the second straight line from the adhesion to the distal end of the catheter is greater than 60 cm.
320. The device of claim 319, wherein a distance measured along a second straight line from the adherent to the distal end of the catheter is 1 cm to 15 cm greater than a distance measured along a first straight line from the adherent to the distal end of the catheter.
321. The device of claim 317, wherein a length of catheter between the adhesion and the distal end of the catheter self-crosses 1 to 5 times when the catheter is in the expanded configuration.
322. The device of claim 317, wherein the adherend comprises an adhesive and / or a length of tape.
323. A method of altering the temperature of the gastrointestinal tract caudal to the gastroesophageal junction, the method comprising: forming the first length of conduit into a first loop within a stomach of the gastrointestinal tract, wherein the first loop includes a first loop first end intersecting a first loop second end, wherein a width of the first loop is greater than 3 cm; and Transferring heat to and / or from the gastrointestinal tract includes recirculating a fluid through an inflow lumen and an outflow lumen in 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 catheter into the first loop comprises advancing the catheter into the stomach.
325. The method of claim 323, wherein forming the first length of conduit into the first loop comprises gradually forming the first length of conduit into the first loop within the stomach as the conduit is advanced into the stomach.
326. The method of claim 323, wherein the first loop first end contacts the first loop second end.
327. The method of claim 323, wherein the first loop first end and the first loop second end are capable of being moved into contact with each other and / or out of contact with each other by peristalsis of the stomach.
328. The method of claim 323, wherein forming the first length of conduit into the first loop comprises crossing the conduit over itself within the stomach, folding the conduit over itself within the stomach, and / or forming a bend in the conduit within the stomach.
329. The method of claim 323, further comprising forming a second length of conduit into a second loop in the stomach after forming the first loop in the stomach.
330. A method of altering the temperature of the gastrointestinal tract caudal to the gastroesophageal junction in the gastrointestinal tract, the method comprising: forming a first portion of the catheter into a first loop by advancing the catheter into the stomach, the first loop defining a first chamber in the stomach of the gastrointestinal tract; and Transferring heat to and / or from the gastrointestinal tract includes recirculating fluid through an inflow lumen and an outflow lumen in the catheter when the first chamber is distal to the distal end of the catheter.
331. The method of claim 330, wherein forming the conduit into the first loop in the stomach comprises crossing the conduit over itself in the stomach and / or forming a bend in the conduit within the stomach.
332. The method of claim 330, wherein forming the catheter into the first loop of the first chamber in the stomach defining the gastrointestinal tract by advancing the catheter into the stomach comprises advancing the catheter against the stomach wall.
333. The method of claim 330, wherein the inflow lumen and the outflow lumen are located in the first portion of the catheter.
334. The method of claim 330, wherein the first portion of the catheter is straight when the catheter is in a straight configuration.
335. The method of claim 330, further comprising forming a second portion of the catheter into a second loop by advancing the catheter into the stomach, the second loop defining a second chamber in the stomach.
336. The method of 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 altering the temperature of the gastrointestinal tract caudal to the gastroesophageal junction, the method comprising: forming a first portion of the conduit into a first loop in a stomach of the gastrointestinal tract; forming a second portion of the conduit into a second loop in the stomach, including forming the second loop distal to the first loop or moving the second loop distal to the first loop, wherein the first portion of the conduit is distal to the second portion of the conduit when the conduit is in a straight configuration; and Heat is transferred to and / or from the gastrointestinal tract via the catheter.
338. The method of claim 337, further comprising forming the first portion of the catheter into the first loop in the stomach by advancing the first portion of the catheter into the stomach.
339. The method of claim 338, wherein forming the catheter into the first loop in the stomach by advancing the catheter into the stomach comprises advancing the catheter against the stomach wall.
340. The method of claim 337, further comprising forming the second portion of the catheter into the second loop in the stomach by advancing the second portion of the catheter into the stomach.
341. The method of claim 340, wherein forming the catheter into the second loop in the stomach by advancing the catheter into the stomach comprises advancing the catheter against the stomach wall.
342. A method according to claim 337, wherein forming the second portion of the conduit into the second loop includes moving the second portion of the conduit against the first portion of the conduit and / or moving the second portion of the conduit above or below the first portion of the conduit.
343. An apparatus comprising: a catheter having a first portion, wherein the first portion has a first portion first configuration and a first portion second configuration, wherein the first portion is straight when the first portion is in the first portion first configuration, Wherein when the first part is in the first part second structure, the first part includes a first loop having a first loop first end, the first loop first end intersects with the first loop second end at a first position along the catheter, wherein the width of the first loop measured along an axis perpendicular to the central longitudinal axis of the catheter is greater than 3 cm.
344. The device of claim 343, further comprising a circulation pump, wherein the conduit comprises an inflow lumen and an outflow lumen, wherein the inflow lumen and the outflow lumen are in fluid communication with the circulation pump when the circulation pump recirculates fluid.
345. The device of claim 343, wherein the catheter comprises an inflow lumen and an outflow lumen through which fluid can flow.
346. The device of claim 345, wherein heat can be absorbed or dissipated by the fluid when the fluid is located in the inflow lumen and the outflow lumen.
347. A device according to claim 343, wherein the first loop first end contacts the first loop second end at the first position.
348. The device of claim 343, wherein the first loop first end is separated from the first loop second end by a first loop gap at the first position.
349. A device according to claim 343, wherein the length of the first loop measured along a straight line from the bottom of the first loop to the top of the first loop is greater than 3 cm.
350. The device of claim 343, wherein a circumference of the first loop measured from a first end of the first loop to a second end of the first loop along a central longitudinal axis of the catheter is greater than 9.5 cm.
351. The apparatus of claim 343, wherein the conduit further comprises a second portion, wherein the second portion has a second portion first configuration and a second portion second configuration, wherein when the second portion is in the second portion first configuration, the second portion is straight, wherein when the second portion is in the second portion second configuration, the second portion comprises a second loop having a second loop first end and a second loop second end.
352. The device of claim 351, wherein the second loop first end intersects the second loop second end at a second position along the conduit when the second portion is in the second portion second configuration.
353. An apparatus comprising: a conduit having a first portion and a second portion, wherein the catheter has a first configuration and a second configuration, wherein when the catheter is in the first configuration, the first portion and the second portion are less curved than when the catheter is in the second configuration and the first portion is located distal to the second portion, and Wherein when the catheter is in the second configuration, the first portion comprises a first loop, the second portion comprises a second loop, and the second portion is located at a distal end of the first portion such that the second loop is located at a distal end of the first loop.
354. The device of claim 353, wherein when the catheter is in the first configuration, the first portion and the second portion are straight.
355. The device of claim 353, wherein when the catheter is in the second configuration, the first loop comprises an open loop or a closed loop and the second loop comprises an open loop or a closed loop.
356. The device of claim 353, further comprising a circulation pump, wherein the conduit comprises an inflow lumen and an outflow lumen, wherein the inflow lumen and the outflow lumen are fluidically connected to the circulation pump when the circulation pump recirculates the fluid.
357. A device according to claim 353, wherein when the catheter is in the second structure, the circumference of the first loop measured along the central longitudinal axis of the catheter is less than or greater than the circumference of the first loop measured along the central longitudinal axis of the catheter when the catheter is in the first structure.
358. A device according to claim 353, wherein the first ring defines a first chamber having a first chamber central axis, wherein the second ring defines a second chamber having a second chamber central axis, and wherein the first chamber central axis is offset from the second chamber central axis.
359. The device of claim 353, wherein when the catheter is in the second structure, the first loop is closer to or farther away from the second loop than when the catheter is in a third structure, wherein the first structure, the second structure, and the third structure are expanded structures.
360. A device according to claim 353, wherein when the catheter is in the second structure, the circumference of the second loop measured along the central longitudinal axis of the catheter is less than or greater than the circumference of the second loop measured along the central longitudinal axis of the catheter when the catheter is in the third structure, wherein the first structure, the second structure and the third structure are expanded structures.
361. The device of claim 353, wherein when the catheter is in the second structure, the first loop comprises an open loop; wherein when the catheter is in the third structure, the first loop comprises a closed loop, wherein the first structure, the second structure, and the third structure are expanded structures.
362. The device of claim 353, wherein when the catheter is in the second structure, the second loop comprises a closed loop; wherein when the catheter is in the third structure, the first loop comprises an open loop, wherein the first structure, the second structure, and the third structure are expanded structures.
363. A method of changing stomach temperature via a catheter, wherein the catheter comprises an inflow channel, an outflow channel, a first temperature sensor, a second temperature sensor, and a beak tube, wherein the beak tube comprises the first temperature sensor, wherein when the catheter is in a straight configuration, the beak tube and the first temperature sensor are located distal to the inflow channel, the outflow channel, and the second temperature sensor, the method comprising: positioning the catheter in the stomach, wherein positioning the catheter in the stomach comprises positioning the first temperature sensor and the beak tube closer to the pylorus than the second temperature sensor; and Heat is transferred to and / or from the stomach via the catheter positioned in the stomach.
364. A method according to claim 363, wherein when the catheter is in a straight structure, the first temperature sensor and the second temperature sensor are separated by a first distance, wherein when the catheter is in an expanded structure, the first temperature sensor and the second temperature sensor are separated by a second distance, wherein the first distance is greater than the second distance.
365. The method of claim 364, wherein the first distance is 50 cm to 300 cm, and wherein the second distance is 5 cm to 40 cm.
366. The method of claim 363, wherein positioning the catheter in the stomach comprises positioning the first temperature sensor and the beak tube 1 cm to 20 cm from the pylorus.
367. The method of claim 363, wherein positioning the catheter in the stomach comprises positioning the second temperature sensor closer to the lower esophageal sphincter than the first temperature sensor and the beak tube.
368. The method of claim 367, wherein positioning the catheter in the stomach comprises positioning the second temperature sensor 1 cm to 20 cm from the lower esophageal sphincter.
369. The method of claim 363, wherein the second temperature sensor is located 50 cm to 300 cm proximal to the first temperature sensor when the catheter is in a straight configuration.
370. The method according to claim 363 further includes measuring the temperature of the stomach with the first temperature sensor and / or measuring the temperature of the stomach with the second temperature sensor, wherein the first temperature sensor is embedded in the beak tube, and wherein transferring heat to the stomach and / or transferring heat from the stomach through the catheter positioned in the stomach includes passing fluid through the inflow channel and the outflow channel.
371. A method of changing stomach temperature via a catheter, wherein the catheter comprises an inflow channel, an outflow channel, a first temperature sensor, a second temperature sensor, and a beak tube, wherein the beak tube comprises the first temperature sensor, wherein when the catheter is in a straight configuration, the beak tube and the first temperature sensor are located distal to the inflow channel, the outflow channel, and the second temperature sensor, the method comprising: positioning the catheter in the stomach, wherein positioning the catheter in the stomach comprises positioning the first temperature sensor and the beak tube farther from the pylorus than the second temperature sensor; and Heat is transferred to and / or from the stomach via the catheter positioned in the stomach.
372. A method according to claim 371, wherein when the catheter is in a straight structure, the first temperature sensor and the second temperature sensor are separated by a first distance, wherein when the catheter is in an expanded structure, the first temperature sensor and the second temperature sensor are separated by a second distance, wherein the first distance is greater than the second distance.
373. The method of claim 371, wherein positioning the catheter in the stomach comprises positioning the second temperature sensor 1 cm to 20 cm from the pylorus.
374. The method of claim 371, wherein positioning the catheter in the stomach comprises positioning the second temperature sensor farther from a lower esophageal sphincter than the first temperature sensor and the beak tube.
375. The method of claim 374, wherein positioning the catheter in the stomach comprises positioning the first temperature sensor and the beak tube 1 cm to 20 cm from a lower esophageal sphincter.
376. The method of claim 371, wherein the second temperature sensor is located 50 cm to 300 cm proximal to the first temperature sensor when the catheter is in a straight configuration.
377. The method according to claim 371 also includes measuring the temperature of the stomach with the first temperature sensor and / or measuring the temperature of the stomach with the second temperature sensor, wherein the first temperature sensor is embedded in the beak tube, and wherein transferring heat to the stomach and / or transferring heat from the stomach through the catheter positioned in the stomach includes passing fluid through the inflow channel and the outflow channel.
378. A method of changing stomach temperature via a catheter, wherein the catheter comprises an inflow channel, an outflow channel, a first temperature sensor, a second temperature sensor, and a beak tube, wherein the beak tube comprises the first temperature sensor, the method comprising: The catheter is positioned 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 located in the stomach, wherein the catheter is moved from the first operating configuration to a second operating configuration, wherein when the catheter is in the second operating configuration, the first temperature sensor is located in the pylorus or the duodenum and the second temperature sensor is located in the stomach.
379. The method of claim 378, wherein moving the catheter from the first operating configuration to the second operating configuration comprises moving a portion of the catheter out of the stomach, through the pylorus, and into the duodenum.
380. The method of claim 378, wherein movement of the catheter from the first operating configuration to the second operating configuration comprises passively moving a portion of the catheter out of the stomach, through the pylorus, and into the duodenum.
381. The method of claim 378, further comprising: transferring heat to and / or from the stomach when the catheter is in the first operating configuration; as well as transferring heat to and / or from the stomach, pylorus and duodenum when the catheter is in the second operating configuration, wherein transferring heat to and / or from the stomach when the catheter is in the first operating configuration comprises: causing a fluid to flow through an inflow lumen and an outflow lumen in the catheter when the catheter is in the first operating configuration, and wherein transferring heat to and / or from the stomach, pylorus and duodenum when the catheter is in the second operating configuration comprises: causing the fluid to flow through the inflow lumen and the outflow lumen in the catheter when the catheter is in the second operating configuration, and / or 382. The method of claim 381 further comprising: As the catheter moves from the first operating configuration to the second operating configuration, heat is transferred to the stomach and / or from the stomach, wherein as the catheter moves from the first operating configuration, heat is transferred to the stomach and / or from the stomach, comprising: causing the fluid to flow through the inflow lumen and the outflow lumen in the catheter as the catheter moves from the first operating configuration to the second operating configuration.
383. An apparatus comprising: a catheter having an inflow channel, an outflow channel, a first temperature sensor, a second temperature sensor and a beak tube, wherein the beak tube comprises the first temperature sensor, wherein when the catheter is in a straight configuration, the beak tube and the first temperature sensor are located distal to the inflow channel, the outflow channel and the second temperature sensor, wherein when the conduit is in a straight configuration, the first temperature sensor and the second temperature sensor are separated by a first distance, wherein when the catheter is in a first operating configuration, the first temperature sensor and the second temperature sensor are separated by a second distance, and The first distance is greater than the second distance.
384. The device according to claim 383, wherein the first distance is 50 cm to 300 cm, and wherein the second distance is 5 cm to 40 cm.
385. The device of 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, wherein the third distance is greater than the second distance.
386. An apparatus according to claim 385, wherein the third distance is 5 cm to 30 cm greater than the second distance.
387. The device of claim 384, wherein the second temperature sensor is located 50 cm to 300 cm proximal to the first temperature sensor when the catheter is in a straight configuration.
388. The device of claim 383, wherein the first temperature sensor is embedded in the beak tube.
389. The device of claim 383, wherein the first temperature sensor comprises the first thermocouple, and wherein the second temperature sensor comprises a second thermocouple.
390. The device of claim 383, wherein fluid is capable of flowing through the inflow lumen and the outflow lumen.
391. The device of claim 390, wherein the fluid is capable of absorbing heat or dissipating heat through the catheter as the fluid flows through the inflow lumen and the outflow lumen.
392. Any combination of claims 1 to 391.
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