Apparatus and method for cooling and / or heating an organ

Abstract

Thermal therapy systems, devices, and methods of using the same disclosed. A localized hypothermia of the pancreas with a delivery and placement procedure in the stomach of a patient comprising a cooling balloon system is disclosed that can be used for the treatment of pancreatitis in a patient. The cooling balloon system can have mechanisms for affecting the pancreas without impacting or inducing hypothermia in the patient in a systemic fashion. The localized hypothermia system can have a simplified delivery system and can be intended to reduce patient discomfort while reducing the metabolic activity of the inflamed pancreas of the patient.

Description

TITLEAPPARATUS AND METHOD FOR COOLING AND / OR HEATING AN ORGANCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 574,030 filed April 3, 2024, which is incorporated herein by reference in its entirety for all purposes.BACKGROUND

[0002] Systems that can control and / or regulate a patient’ s core body temperature and / or a local internal temperature of the patient’ s body are disclosed. Systems that can provide localized hypothermia treatment and / or localized cooling therapy that does not cause systemic hypothermia for inflammation of the pancreas and / or pancreatitis and use of the systems for treatments for obesity, pancreatic cancer, hypothermia to other bodily structures and organs, and general regulation of body temperature are disclosed. The methods and apparatus disclosed can be used for hypothermia, for hyperthermia, for temperatures between hypothermia and hyperthermia, or any combination of such thermal applications during a medical procedure.

[0003] Pancreatitis can be classified as acute and / or chronic. Pancreatitis has many etiologies including, but not limited to the following: alcohol induced, gallbladder and / or gallstone related, and / or other causes / idiopathic. In each case, the pancreas can experience inflammation that can impact endocrine and exocrine functions of the patient. Severe pancreatitis occurs in one and four patients with an associated mortality rate of 5%.

[0004] Systems that can provide relief of inflammation of the pancreas with a reduction of metabolic activity can benefit patients, physicians, and / or healthcare systems that require ICU hospitalization for patients suffering from pancreatitis.

[0005] Localized hypothermia that can be provided with internal and external heat exchangers and warming and / or cooling devices to raise and / or lower body temperature are disclosed.

[0006] Systems for localized hypothermia are particularly useful for treating specific bodily injury or inflammation. A common form of localized hypothermia is demonstrated in the placement of ice packs on a sprained ankle or circulating cooling pads following orthopedic procedures.SUMMARY

[0007] Heat therapy systems, devices, and methods are disclosed.

[0008] A system is disclosed. The system can have a catheter assembly and an extension line assembly. The catheter assembly can have a catheter and a catheter connector. The catheter can have a catheter lumen. The catheter lumen can have a catheter lumen inflow port and a catheter lumen outflow port. The extension line assembly can have a first inflow tube, a second inflow tube, a firstreturn tube, a second return tube, and an extension line connector. When the catheter connector and the extension line connector are connected to each other and a recirculating pump is recirculating a fluid, the first inflow tube and the second inflow tube can be in fluid communication with the catheter inflow port. When the catheter connector and the extension line connector are connected to each other and the recirculating pump is recirculating the fluid, the second return tube can be in fluid communication with the catheter outflow port.

[0009] A system is disclosed. The system can have a catheter assembly and an extension line assembly. The catheter assembly can have a catheter and a catheter connector. The catheter can have a catheter lumen. The catheter lumen can have a catheter lumen inflow port and a catheter lumen outflow port. The extension line assembly can have a first inflow tube, a second inflow tube, a first return tube, a second return tube, and an extension line connector. When the catheter connector and the extension line connector are connected to each other, the system can have a first flow path, a second flow path, and a third flow path. The first flow path can include the first inflow tube and the first return tube. The first flow path can be defined by the first inflow tube and the first return tube. The second flow path can include the first inflow tube, the second inflow tube, and the catheter. The second flow path can be defined by the first inflow tube, the second inflow tube, and the catheter. The third flow path can include the second return tube and the catheter. The third flow path can be defined by the second return tube and the catheter.

[0010] A system is disclosed. The system can have a catheter assembly and / or an extension line assembly.

[0011] A method of changing a temperature of a gastrointestinal tract caudal of a gastroesophageal junction of the gastrointestinal tract is disclosed. The method can include inserting a catheter assembly into a stomach of the gastrointestinal tract. The method can include attaching the catheter assembly to an extension line assembly. The method can include transferring heat to and / or from the gastrointestinal tract. Transferring the heat to and / or from the gastrointestinal tract can include recirculating a fluid through the catheter assembly and the extension line assembly.

[0012] A method of changing and / or maintaining a temperature is disclosed. The method can include inserting a catheter assembly into a body lumen. The method can include attaching the catheter assembly to an extension line assembly. The method can include transferring heat to and / or from the catheter assembly. Transferring the heat to and / or from the catheter assembly can include recirculating a fluid through the catheter assembly and the extension line assembly.

[0013] Systems for inducing localized hypothermia are described herein. The pancreas can be warmed and / or cooled directly and / or indirectly. For example, the pancreas can be cooled directly by inserting a needle into the pancreas. The needle and / or catheter can be inserted transabdominally and / or laparoscopically. The needle can remove heat directly from the pancreas. The pancreas can be cooled indirectly by cooling organs, fluids (liquid or gas) and / or tissue adjacent to the pancreas. Forexample, the stomach wall, dermis and / or duodenum adjacent to the pancreas can be cooled, thereby cooling the pancreas.

[0014] The heat exchange process can occur external to the patient and / or inside of the patient. The method of heat exchange 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, fridget gate, vortex tube, pulse tube refrigeration and / or thermoacoustics.

[0015] A catheter can be introduced orally and / or nasally. The catheter can extend into the stomach, duodenum, intestine, jejunum, and / or the Ampulla of Vater. The catheter can transport a cold fluid to cool the stomach, duodenum, intestine, jejunum, and / or the Ampulla of Vater; thereby, the pancreas can be cooled indirectly. The catheter can have one and / or multiple lumens. The catheter can circulate the fluid. For example, the catheter can have an inflow and / or an outflow lumen; the inflow lumen can transport colder fluid than the outflow lumen. The catheter can have one lumen for transporting the cooling fluid in and / or out of the patient; for example, cold fluid can be introduced, remain in the patient for a period of time and then removed once it has heated up.

[0016] The heat transfer fluid can be in direct contact with the patient’s organs, tissue and / or fluids; the heat transfer fluid can have indirect contact with the patient’s organs, tissue and / or fluids; for example, the heat transfer fluid can be in the catheter, a balloon and / or multiple balloons.

[0017] The catheter and / or balloons can be positioned using magnets. Various imaging modalities can be used to visualize the position of the catheter and / or the balloons, including but not limited to: x-ray, CT, MRI and ultrasound. The catheter can include multiple lumens. The catheter can include one or multiple lumens for aspiration, to deliver additional tools, to deliver additional sensors, to deliver medication and / or to deliver nutrients.

[0018] An external cooling pad or pads can be placed on the exterior surface of the patient’ s stomach in close proximity to the patient’ s pancreas to provide a cooling energy that can work in conjunction with the interior cooling system for hypothermia. These pads can be connected to the same cooling box that drives the interior catheter system and / or an independent component from the cooling box.

[0019] The external cooling pad can have a magnetic source that can promote apposition of the catheter and / or balloon to the portion of the stomach immediately adjacent to the pancreas. The external cooling pad can have a magnetic source that facilitates articulation of the distal end of the catheter system for placement of additional balloons within the duodenum of the patient.

[0020] The external cooling pad can provide electromagnetic energy to drive or rotate rods within the balloon system to promote circulation of the cooling media within the balloon. The electromagnetic energy can be used to open or close valves for circulation of cooling media between different sections or chambers of the balloon or multiple balloons, or within the catheter system. The electromagnetic energy can be used to open or close valves for the administration of nutrition to the patient. Theelectromagnetic energy can be used to expand structures or stents within the catheter system to open lumens or deflect and articulate the catheter.

[0021] A mechanical structure can be deployed to aid in positioning the catheter and / or the balloon. Components within the catheter can assist the physician or operator in providing greater apposition of the balloon against the inner wall of the stomach to more efficiently transfer cooling energy to the pancreas. Mechanisms for improving deployment and positioning of the catheter system and balloon include torquing or articulating elements within the catheter that allows for manipulation of the distal end of the catheter system by the operator.

[0022] The catheter system can have inflatable or deployable protrusions that can force the hypothermia balloon portion of the system against the inner wall of the stomach closest to the pancreas. These protrusions can be inflatable balloon extensions to push the balloon towards the pancreas. Other protrusions can be deployed mechanically by pull wires or coils that can protrude upon rotation by the operator.

[0023] The catheter system and balloon can be designed to reduce the amount of distension or mass in the stomach while providing a greater amount of surface area contact with the inner wall of the stomach.

[0024] Multiple sensors can be used to monitor the patient and / or the cooling system. Contact and / or non-contact temperature probes can be used to monitor various tissue, organ and / or fluids of the patient. Contact and / or non-contact temperature probes can be used to monitor the temperature of the heat transfer fluid in one and / or multiple positions. A PH sensor can be used to monitor the acidity of the stomach fluid. Sensors can be used to monitor the position of the patient, catheter and / or the balloon(s). Internal pressure sensors within the catheter system can provide a signal to the operator and physician that the patient is experiencing reflux, cramping, or an integrity failure within the catheter system.

[0025] 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 have an endoscope to provide visualization of the stomach wall. Visualization source can assist the operator in placing additional balloons within the duodenum.

[0026] The catheter can be insulated. An insulated catheter can be more efficient at transporting cold fluid into the patient. An insulated catheter can reduce any unintended cooling to other organs, including, but not limited to the esophagus. The catheter can include material that has a low thermal conductivity. The catheter can be configured such that the cold fluid can be located in the center of the catheter. Air can be circulated outside of the central lumen of the catheter to keep an insulating layer of air between the cooling media and areas of the body to be left untreated.

[0027] The outer surface of the catheter can be insulated and covered with a distensible membrane that can be filled with air or warming media. The distensible membrane can inflate to a diameter thatis greater than the catheter at the time of insertion. This dimension can be 1mm, 5mm, or 10mm in diameter. The insertion diameter of the catheter system can be reduced to improve patient comfort. Once placed in the body, the insulating membrane can be inflated in a section of the catheter that can be insulated. For example, the insulation membrane can be inflated with air or warming media in the esophagus or nasal pharyngeal region.

[0028] The air or warming media for insulation can be dynamic in that once cooled media is introduced into the balloon, non-balloon portions of the system can be isolated with air or warmer media that circulates for active insulation to provide a greater temperature for intended treatment areas of the body.

[0029] Insulation can be provided by isolating the cooling media in the hypothermia balloon from the remaining portions of the catheter system. The isolation process can occur with a valved catheter.Air can be introduced within the system once cooling media is infused.

[0030] The catheter can have communication ports that can provide the operator a mechanism to administer analgesics to soothe or numb the bodily orifice, esophagus, and stomach. The analgesics can be administered to reduce tissue irritation over the duration of the treatment.

[0031] The external surface of the catheter system can be hydrophilically coated to reduce friction for the insertion of the instrument and effects of friction over time while the catheter system is positioned in the body.

[0032] Communication ports to the external surface of the balloon can improve the contact of the balloon to the inner wall of the stomach. The communication ports can deliver finite amounts of cooled media directly to the stomach wall.

[0033] 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 pancreatic head.

[0034] The distal end of the catheter system can have a spiral configuration to facilitate entry into the duodenum.

[0035] The distal end of the catheter system can have a spiral configuration and can be designed to rotate about the central axis of the catheter independently from the proximal portion of the catheter system. This configuration can stabilize the catheter system in the patient’ s nasopharyngeal section whereas the distal end independently rotates to facilitate entry into the duodenum.

[0036] The catheter system can have expandable lumens to reduce the profile of the system for entry.

[0037] The catheter system can have expandable lumens in the distal portion of the catheter to facilitate thermal transfer in the desired section for cooling in the patient’ s anatomy.

[0038] For the localized hypothermia procedure itself, the following steps outline the method for performing the treatment on a patient and variations. Once diagnosed with pancreatitis, the patient can be placed into position for the procedure with the catheter supplies and cooling box prepared for use.

[0039] System Preparation: The hypothermia catheter system package can be prepared for use as per the instructions for use which can include pre-filling the internal lumen of the system, flushing media through any through-lumens, testing the integrity of the balloon, and coating the outside of the catheter system with analgesic prior to insertion in the patient. The cooling box can be prepared with media such as saline and placed into a cooling cycle or mode. The catheter system can be coupled to the cooling box with system checks by sensors for integrity, flow rate, and other sensors.

[0040] Method of Localized Hypothermia of the Pancreas

[0041] Connection to the 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 on-screen displays illustrating the system prep procedure, condition of sensors and other real time temperature, fluid pressure, media flow rate, and other values. The cooling box can have software / firmware for the production of various cooling regimes or programs with general or specific hypothermia parameters. The cooling box can be mounted on a bed-side IV pole, stand, or standalone on the floor or table. The cooling box can be a wearable box that can be miniaturized, battery-powered, and fitted to be worn on the patient to allow for portability. The patient can be transported easily from bedside, or mobile on their own while treatment is occurring. The cooling box can be configured to communicate via Bluetooth or Wi-Fi to be controlled remotely by medical professionals.

[0042] Insertion of Catheter System into Patient: The catheter system can be placed via nasal, oral, or transgastric routes. 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 portions of the catheter system.

[0043] Placement of the Catheter in the Stomach: The catheter system can have the flexibility to be delivered to the stomach. Within the catheter, pull wires can articulate the distal end of the catheter for deflection. Inside the lumen of the catheter, braid material or mandrels can provide stiffness for torque to rotate a curved section of the catheter selectively. The mandrel within the catheter can be removed by the operator once placed in the stomach to provide further flexibility or provide a lumen for fluid, media, aspiration, or the injection of nutrients to the patient. The distal end of the catheter can have an echogenic tip or sonographic sensor that facilitates the identification of the distal tip of the catheter with external ultrasound or audio equipment.

[0044] Deployment of the Balloon in the Stomach: The balloon on the distal end of the catheter can be unrolled or unsheathed by separating, pulling, or rotating a portion of the catheter to unveil the balloon. The deployment of the balloon can be facilitated by internal stents within the balloon to facilitate a predetermined shape for the balloon.

[0045] Filling the Balloon with Media: The catheter system can be coupled to the cooling box to fill the balloon with cooling media. As a precursor step, the balloon can be filled with air to allow the balloon to fully deploy prior to filling with media, or to check and verify the position of the balloon. The cooling box can deliver filtered air, CO2, or other gas, followed by cooling media. The deliveryof cooling media can be followed by air to provide an insulation means to the esophagus and upper nasal and oral passageway.

[0046] Apposition of the Balloon to the Stomach Wall: The balloon can be situated in the lower stomach through the effects of gravity. Further apposition near the area of the pancreas can be achieved by torquing and articulating the distal end of the catheter system in the stomach. Actuating a pull wire or multiple pull wires within the catheter system can articulate the distal end of the catheter system within a curved shape that forces the balloon to be situated nearer the inner stomach wall. The catheter system can have protrusions that can provide an opposing force to position the balloon against the inner stomach wall nearer to the pancreas. These protrusions can be deployed similar to a stent, basket, or deflecting ribs. The protrusions can be inflatable nubs, cones, or balloons that can push the distal end of the catheter nearer to the inner wall of the stomach. The distal end of the catheter system can have a ferromagnetic material that can engage external magnetic forces to allow the balloon nearer to the pancreas.

[0047] Distension of the Balloon: Air, liquid, gas, and media, and combination of these can be used to fill the balloon on the distal end of the catheter. Distension of the balloon can be monitored and measured by pressure and the total volume of air, liquid, gas or media delivered. Distension media can be supplied into the balloon by openings or ports within the catheter that can fluidically communicate with an inner lumen or multiple lumens.

[0048] Distension Methods that Reduce Pressure in the Stomach: Cooling media can be supplied and monitored to the balloon in a manner to reduce overall pressure in the stomach to minimize patient discomfort. Pressure sensors in the cooling balloon can record responsive contractions within the stomach acting on the balloon and catheter system. In response to increases in pressure due to forces acting on the catheter system from the stomach, distension media and pressure and or volume of distension media within the balloon can be reduced, or increased, in response to the monitored and recorded forces in the stomach.

[0049] Monitoring of Hypothermia Treatment: As the hypothermia treatment is being performed, thermocouples on the catheter system can provide feedback of temperatures in the distension media, in the catheter, at the external surface of the balloon, and multiple external surfaces of the balloon that are in contact with the stomach wall nearer to the pancreas and areas away from the pancreas area. Hypothermia treatment can be monitored by time and checked by the body temperature of the patient. Ongoing real-time body temperature of the patient can be coupled to the cooling box by a wearable thermometer thereby providing a feedback to excessive hypothermia, or adding additional cooling media as appropriate.

[0050] Concurrent Procedures Including Endoscopy, Diagnostic Fluid or Content Sampling, Ultrasound and Fluoroscopy, and Drug Delivery during Hypothermia Treatment: The catheter system can allow for an endoscope to be inserted for internal visualization, or can be constructed with anintegrated endoscope. The catheter system can have ports that allow for the sampling of fluid or materials in the stomach for diagnostic purposes. The catheter system can be configured with echogenic or radiopaque materials or members that facilitate ultrasound or fluoroscopic detection. Doppler ultrasound can be used to record the flow of distention media in the catheter system and the vasculature of the stomach and area near the pancreas. The catheter system can be configured with ports that allow for the delivery of drugs to the patient. Ports can be located in specific locations in the catheter system to apply medications or analgesics to the nasal, oral, and esophageal passageways, and the stomach. Ports can be located on the external portions of the balloon to deliver medications and analgesics directly to the inner stomach wall nearer to the pancreas.

[0051] Patient Nutrition During Treatment: The catheter system can have a lumen to supply nutrition, such as nutritional media, to the patient. The nutrient delivery can be supplied with external pressure or mechanical force supplied by the medical professional or the cooling box directly. The catheter system can have an expandable lumen that responds and expands to the mechanical force of the supplied nutrition that then allows the nutrition to reach the gastrointestinal tract of the patient. The expandable lumen allows for a minimal insertion and wearing profile to the catheter system that can be expanded upon use in conjunction with patient nutrition.

[0052] Confirmation of Hypothermia Treatment: Overall enzymatic activity of the pancreas can be monitored during treatment to demonstrate and monitor procedural effectiveness. Metabolic activity of the pancreas can be monitored via a PET scan. Temperature measurements of the stomach wall and other locations in and external to the catheter system in the patient can provide a determination of the amount of hypothermia treatment.

[0053] Continuation or Protocols of Treatment: The duration of hypothermia treatment can be cycled in an on-off fashion, or remain continuous during a procedure. Hypothermia treatment can begin at one cooling temperature, and then profile lower in a stepwise fashion. The stepwise fashion can proceed at one lower temperature setting followed by another after a certain duration of time, or can return to baseline and then back to a lower temperature setting. Protocols of treatment can be preprogrammed within the cooling box, or respond to feedback from temperature sensors in the catheter system or patient body temperature measurements.

[0054] Completion of Treatment: Hypothermia treatment can be stopped by completion of known cooling protocol or a patient body temperature measurement reaching a certain predetermined stopping point. The treatment can be stopped by the patient achieving certain level of improvement in symptoms, enzymatic measurements, or metabolic activity.

[0055] Removal of the Device from the Patient: Once the treatment is completed, all balloons and external protrusions can have distension media and gas removed, and articulations or stiffeners of the distal end of the catheter can be minimized, to reduce stiffness of the system for removal from the patient.

[0056] Local pancreatic hypothermia, without systemic hypothermia, has been shown to reduce severity of acute pancreatitis, induced by different methods in rats.BRIEF DESCRIPTION OF THE DRAWINGS

[0057] The drawings shown and described are exemplary variations and non-limiting. Like reference numerals indicate identical or functionally equivalent features throughout.

[0058] Figure 1 illustrates a schematic of a thermal therapy system deployed in a patient’s digestive system.

[0059] Figures 2a-2d illustrate different cross-sections of a catheter.

[0060] Figure 3 illustrates a schematic of another embodiment of a thermal therapy system deployed in a patient’s digestive system.

[0061] Figures 4a and 4b illustrate a cross-section of the distal end of the cooling device with the balloon partially inflated.

[0062] Figures 5a and 5b illustrate a cross-section of the distal end of additional embodiments of the cooling device with the balloon partially inflated.

[0063] Figure 6 illustrates data from a simulated localized cooling system.

[0064] Figure 7 illustrates a schematic of another embodiment of a thermal therapy system deployed in a patient’s digestive system.

[0065] Figure 8 illustrates a cross-section of the distal end of additional embodiments of the cooling device with the balloon partially inflated.

[0066] Figure 9 illustrates a schematic of another embodiment of a thermal therapy system deployed transabdominally.

[0067] Figure 10 illustrates a mechanical structure that can position and / or fix the cooling balloon at the stomach wall adjacent to the pancreas

[0068] Figure 11 illustrates a pyloric plug in place to prevent cooling fluid from draining into duodenum and illustrates an impermeable and / or semi-permeable membrane and / or coating deposited on the stomach wall that can prevent and / or slow fluid absorption into the stomach wall.

[0069] Figure 12 illustrates that target temperatures of the pancreas can be achieved within a simulated pancreas (using bovine tissue) using a chilled fluid circulating in a cooling balloon placed inside of the simulated stomach (using bovine stomach tissue) in a body temperature (37C) water bath.

[0070] Figures 13a and 13b illustrate the stomach and pancreas in two different isometric views.

[0071] Figures 14a and 14b illustrate the stomach and pancreas in an isometric view with the anterior half removed. Figure 14a illustrates a catheter located in the stomach with an elastic balloon in a deflated configuration. Figure 14b illustrates the catheter located in the stomach with the elastic balloon in an inflated configuration.

[0072] Figures 15a-15c illustrate the stomach and pancreas in an isometric view with the anterior half removed. Figure 15a illustrates a catheter located in the stomach and the duodenum with an inelastic gastric balloon in a deflated configuration and a duodenal balloon in a deflated configuration. Figure 15b illustrates the catheter located in the stomach and the duodenum with the elastic balloon in an inflated configuration and the duodenal balloon in the deflated configuration. Figure 15c illustrates the catheter located in the stomach and the duodenum with the elastic balloon in an inflated configuration and the duodenal balloon in an inflated configuration.

[0073] Figures 16a-16c illustrate the stomach and pancreas in an isometric view with the anterior half removed. Figure 16a illustrates a catheter located in the stomach with 3 inflatable balloons. Figure 16b illustrates a catheter located in the stomach with 6 inflatable balloons. Figure 16c illustrates a catheter located in the stomach with multiple inflatable balloons on the anterior and posterior side.

[0074] Figure 17 illustrates the stomach and pancreas in an isometric view with the anterior half removed. Figure 17 illustrates a catheter extending through the stomach to the duodenum in an unconstrained configuration. The catheter includes catheter barbs and a duodenal device.

[0075] Figure 18 illustrates the stomach and pancreas in an isometric view with the anterior half removed. Figure 18 illustrates a catheter residing in the stomach in a spiral configuration.

[0076] Figure 19 illustrates the stomach and pancreas in an isometric view with the anterior half removed. Figure 19 illustrates a catheter extending through the stomach through a percutaneous port and / or a port on the stomach wall.

[0077] Figure 20 illustrates the stomach and pancreas in an isometric view with the anterior half removed. Figure 20 illustrates a catheter with coils in the stomach and the duodenum.

[0078] Figure 21 illustrates the stomach and pancreas in an isometric view with the anterior half removed. Figure 21 illustrates a catheter extending from an introducer.

[0079] Figure 22 illustrates the stomach and pancreas in an isometric view with the anterior half removed. Figure 22 illustrates a catheter in the stomach with multiple inflatable balloons.

[0080] Figure 23 illustrates the stomach and pancreas in an isometric view with the anterior half removed. Figure 23 illustrates a catheter in the stomach with multiple inflatable lumens and / or balloons.

[0081] Figure 24 illustrates the stomach and pancreas in an isometric view with the anterior half removed. Figure 24 illustrates a catheter in the stomach with an intestinal plug in the duodenum.

[0082] Figure 25 illustrates the stomach and pancreas in an isometric view with the anterior half removed. Figure 25 illustrates a catheter extending through the stomach, through a pylorus plug and into a pancreatic duct.

[0083] Figure 26 illustrates the stomach and pancreas in an isometric view. Figure 26 illustrates a cooling device placed on the surface of the pancreas.

[0084] Figures 27a-27f illustrate various cross-sections of the catheter.

[0085] Figures 28a-28b illustrate cross-sections of the catheter and balloon in an inflated and a deflated configuration.

[0086] Figure 29 illustrates a side-view of the catheter with multiple break lines.

[0087] Figures 30 and 31 are schematics of a system that can provide thermal transfer to the stomach.

[0088] Figure 32 illustrates an exemplary view of the duodenum and the pancreas, with the catheter passing through an artery.

[0089] Figure 33 illustrates data from a simulated localized cooling system

[0090] Figure 34 illustrates the stomach and pancreas in an isometric view with the anterior half removed. Figure 34 illustrates a catheter with the distal end formed into a tapered coil.

[0091] Figures 35a-35d illustrate the stomach, the pancreas and a catheter in an isometric view with the anterior half removed. Figures 35a - 35d illustrate a catheter with an inverting membrane connecting an inner and external catheter. Figure 35a illustrates the catheter proximal to the pylorus; figure 35b illustrates a detailed view of the tip of the catheter illustrated in Figure 35a. Figure 35c illustrates the catheter entering the pylorus; figure 35d illustrates a detailed view of the tip of the catheter illustrated in Figure 35c.

[0092] Figure 36 illustrates the stomach and pancreas in an isometric view with the anterior half removed. Figure 36 illustrates a coiled catheter positioned in the esophagus.

[0093] Figure 37a illustrates a variation of the catheter in the stomach.

[0094] Figure 37b illustrates a variation of the catheter in the stomach.

[0095] Figure 38 illustrates a variation of the catheter with a remote sensor

[0096] Figure 39a-39b illustrates a tip of the device with a proboscis. Figure 39a illustrates a sideview of the proboscis tip and Figure 39b illustrates a cross-sectional side-view of the proboscis tip.

[0097] Figure 40 illustrates a cross-section of the catheter

[0098] Figure 41 illustrates a variation of the catheter inserted over a guidewire with an esophageal valve.

[0099] Figure 42 illustrates how the core body temperature can be impacted using a thermal therapy system.

[0100] Figure 43 illustrates a thermal insulation pad on the face of a patient.

[0101] Figure 44 illustrates a thermal insulation mechanism on the back of the throat.

[0102] Figure 45a and 45b illustrate a variation of the catheter in the stomach with an expandable catheter array.

[0103] Figures 46a, 46b, 46z2, and 46z3 illustrate the stomach, duodenum, and pancreas in an isometric view with the anterior half removed. Figures 46b-46zl illustrate the stomach in an anterior view with the anterior half of the stomach shown transparent. Figures 46a-46o illustrate the catheterbeing introduced to the stomach and Figures 46o-46z3 illustrate the catheter being removed from the stomach.

[0104] Figures 47a-47i illustrate the stomach, duodenum, and pancreas in an isometric view with the anterior half removed. Figures 47a-47e illustrate the catheter being introduced to the stomach and Figures 47e-47i illustrate the catheter being removed from the stomach.

[0105] Figures 48a-48i illustrate the stomach, duodenum, and pancreas in an isometric view with the anterior half removed. Figures 48a-48e illustrate the catheter being introduced to the stomach and Figures 48e-48i illustrate the catheter being removed from the stomach.

[0106] Figures 49a-49i illustrate the stomach, duodenum, and pancreas in an isometric view with the anterior half removed. Figures 49a-49i illustrate the catheter in the body.

[0107] Figures 50a-50i illustrate the stomach, duodenum, and pancreas in an isometric view with the anterior half removed. Figures 50a-50i illustrate the catheter in the body.

[0108] Figures 51a-51e6 illustrate the stomach, duodenum, and pancreas in an isometric view with the anterior half removed. Figures 51a-51e6 illustrate the catheter in the body.

[0109] Figure s 52a-52d illustrate the stomach, duodenum, and pancreas in an isometric view with the anterior half removed. Figures 52a-52d illustrate the catheter in the body.

[0110] Figures 53a-53b illustrate the stomach, duodenum, and pancreas in an isometric view with the anterior half removed. Figures 53a-53b illustrate the catheter in the body.

[0111] Figures 54a-54d illustrate a variation of a catheter bending and unbending.

[0112] Figure 55a illustrates a variation of a catheter.

[0113] Figures 55b illustrates a variation of a catheter.

[0114] Figure 55c illustrates a variation of a cross-section view of the catheter of Figure 55a through the line 55c-55c.

[0115] Figure 55d illustrates a variation of a cross-section view of the catheter of Figure 46g through the line 55d-55d.

[0116] Figure 56 is a schematic of a system that can provide thermal transfer therapy.

[0117] Figures 57a-57d are frontal x-rays of the catheter being introduced into the stomach.

[0118] Figures 58a-58b are frontal x-rays of the catheter being introduced into the stomach.

[0119] Figures 59A-59D illustrate a variation of a catheter.

[0120] Figures 60A-60E illustrate a variation of a catheter.

[0121] Figure 61 A illustrates a graph showing estimated cooling power over time, with Watts on the y-axis and time on the x-axis.

[0122] Figure 61B illustrates a magnified view of a section of figure 61 A showing a dip in thermal power.

[0123] Figure 62 illustrates a variation of a catheter.

[0124] Figure 63A illustrates an exploded view of a variation of a first assembly of a thermal therapy system.

[0125] Figure 63B illustrates the first assembly of figure 63A in a fully assembled configuration.

[0126] Figure 63C illustrates an exploded view of a variation of a second assembly of a thermal therapy system.

[0127] Figure 63D illustrates the second assembly of figure 63C in a fully assembled configuration.

[0128] Figure 63E illustrates the first assembly of figures 63A-63B and the second assembly of figures 63C-63D attached to each other.

[0129] Figure 63F illustrates the first assembly of figures 63A-63B and the second assembly of figures 63C-63D attached to each other, with an enteral system attached to the first assembly.

[0130] Figure 63G illustrates the first assembly of figures 63A-63B and the second assembly of figures 63C-63D attached to each other, with an adapter attached to the first assembly.

[0131] Figure 63H illustrates the first assembly of figures 63A-63B and the second assembly of figures 63C-63D attached to each other, with a suction system attached to the first assembly.

[0132] Figure63I illustrates an exploded view of a variation of a proximal end of the second assembly of figures 63C-63D.

[0133] Figure 63J illustrates a variation of a second assembly of a thermal therapy system.

[0134] Figure 63K illustrates a variation of a heat exchanger and a second assembly of a thermal therapy system.

[0135] Figure 63L illustrates a variation of a heat exchanger and a second assembly of a thermal therapy system.

[0136] Figure 63M illustrates a variation of a first assembly of a thermal therapy system.

[0137] Figure 63N illustrates a variation of a first assembly of a thermal therapy system.

[0138] Figure 630 illustrates a variation of a first assembly of a thermal therapy system.

[0139] Figure 63P illustrates a variation of a first assembly of a thermal therapy system.

[0140] Figure 63Q illustrates a variation of a thermal therapy kit having a first assembly and / or a second assembly.

[0141] Figure 64 illustrates a graph showing various statuses of an indicator, with stomach temperature on the y-axis and time on the x-axis.

[0142] Figure 65A illustrates a schematic of a variation of a thermal therapy system.

[0143] Figure 65B illustrates a schematic of a variation of a thermal therapy system.

[0144] Figure 65C illustrates a schematic of a variation of a thermal therapy system.

[0145] Figure 65D illustrates a schematic of a variation of a thermal therapy system.

[0146] Figure 65E illustrates a variation of a first assembly, a second assembly, and a heat exchanger of a thermal therapy system.

[0147] Figure 65F illustrates a schematic of a variation of a thermal therapy system.

[0148] Figure 66 illustrates a graph showing fluid temperature over time, with temperature in degrees Celsius on the y-axis and time on the x-axis.

[0149] Figures 67A-67F illustrate variations of a catheter.

[0150] Figures 68A-68B illustrate a variation of a catheter.

[0151] Figures 69A-69B illustrate a variation of a catheter.

[0152] Figures 70A-70B illustrate a variation of a catheter.

[0153] Figures 71A-71F illustrate a variation of a catheter.

[0154] Figures 72A-72F illustrate a variation of a catheter.

[0155] Figures 73A-73F illustrate a variation of a catheter.

[0156] Figures 74A-74C illustrate a variation of a catheter and a variation of a method of eliminating, ameliorating, or reducing a kink.

[0157] Figure 75 illustrates a variation of a catheter.

[0158] Figure 76 illustrates a variation of a catheter.

[0159] Figures 77A-77B illustrate a schematic of a variation of a thermal therapy system.

[0160] Figures 78 illustrates a variation of a thermal therapy system.

[0161] Figure s 79A-79JJ illustrate a 360-degree CT scan of a patient’s torso with a catheter in a deployed configuration in the patient’s gastrointestinal tract.

[0162] Figure 79KK illustrates a front X-Ray image of the patient’s torso of figures 79A-79JJ immediately after initial insertion into the gastrointestinal tract of the patient.

[0163] Figures 80A-80C illustrate front images of a CT scan of a patient’s torso with a catheter in a deployed configuration in the patient’s gastrointestinal tract.

[0164] Figures 81 A-81B illustrate an X-Ray image of a patient’s torso with a catheter in a deployed configuration in the patient’ s gastrointestinal tract.DETAILED DESCRIPTION

[0165] The features in figures 1-8 IB and / or the features described herein can be combined with each other in any combination.

[0166] Figure 1 illustrates a variation of a thermal therapy system 33 (also referred to as the system 33). The thermal therapy system 33 can be, for example, a localized 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 warming therapy system and / or a cooling therapy system. For example, the thermal therapy system 33 can deliver thermal therapy (e.g., warming therapy and / or cooling therapy) to a heat transfer target 146 (also referred to as the thermal energy 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 a temperature ofthe heat transfer target 146 and / or warming the heat transfer target 146. Transferring heat from the heat transfer target 146 can include, for example, decreasing a temperature of the heat transfer target146 and / or cooling the heat transfer target 146. The heat transfer target 146 can include, for example, one or multiple organs. The one or multiple organs can include one or more organs of the gastrointestinal tract 110, one or multiple organs adjacent 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 the jejunum 10, or any combination thereof.

[0167] Figure 1 illustrates that the thermal therapy system 33 can include a heat transferer 4 and / or a heat exchanger 13 (also referred to as a heat exchange system 13). Figure 1 illustrates that the heat transferer 4 can be connected (e.g., removably connected) to the heat exchanger 13. The heat exchanger 13 can be, for example, a recirculating heat exchanger. The heat exchanger 13 can be, for example, an external heat exchanger (also referred to as an external heat exchange system). The heat transferer 4 can transfer heat to and / or from the heat transfer target 146. The heat transferer 4 can, for example, increase and / or decrease a temperature of the heat transfer target 146. The heat transferer 4 can, for example, warm and / or cool the heat transfer target 146.

[0168] Figure 1 illustrates that the heat transferer 4 can have and / or can be, for example, a catheter 9, a balloon 3, or any combination thereof. For example, the heat transferer 4 include the catheter 9 but not the balloon 3. As another example, the transferer 4 can include the balloon 3 but not the catheter 9. As yet another example, the heat transferer 4 can include the catheter 9 and the balloon 3. As still yet another example, the heat transferer 4 can be the catheter 9. As still yet another example, the heat transferer 4 can be the balloon 3. As still yet another example, the heat transferer 4 can be the catheter 9 and the balloon 3. Figure 1 illustrates that the catheter 9 and / or the balloon 3 can transfer heat to and / or from the heat transfer target 146. Figure 1 illustrates that the catheter 9 and / or the balloon 3 can increase and / or decrease a temperature of the heat transfer target 146. Figure 1 illustrates that the catheter 9 and / or the balloon 3 can warm and / or cool the heat transfer target 146. For example, the balloon 3 can be a warming and / or a cooling balloon and / or the catheter 9 can be a warming and / or a cooling catheter. For example, Figure 1 illustrates that the thermal therapy system 33 can be a heat exchange catheter system and / or a heat exchange balloon system. For example, the catheter 9 can be a heat exchange catheter and / or the balloon 3 can be a heat exchange balloon.

[0169] Figure 1 illustrates that the heat transferer 4 (e.g., the catheter 9 and / or the balloon 3) can be inserted into and / or withdrawn from a target site 147. For example, Figure 1 illustrates that the catheter 9 and / or the balloon 3 can be inserted into the target site 147 as shown by arrow 112 and / or that the catheter 9 and / or the balloon 3 can be withdrawn from the target site 147 as shown by arrow 1 14. The target site 147 can be, for example, one or multiple organs in the body 152. The target site147 can be, for example, the space and / or cavity inside one or multiple organs in the body 152. Forexample, the target site 147 can include the esophagus 5, the stomach 2, the pylorus 65, the duodenum 37, the jejunum 10, any portion along the gastrointestinal tract 110 caudal the jejunum 10, or any combination thereof. The target site 147 can be, for example, the location (e.g., desired location) of the catheter 9 and / or the balloon 3 in the body 152 during heat transfer to and / or from the heat transfer target 146, for example, via the catheter 9 and / or the balloon 3. The heat transfer target 146 can be, for example, the targeted heat transfer location. For example, the heat transfer target 146 can be the stomach 2, the pylorus 65, the duodenum 37, and / or the pancreas 1, and the target site 147 can be the stomach 2, the pylorus 65, the duodenum 37, and / or the jejunum 10.

[0170] Figure 1 illustrates that the balloon 3 can be, for example, a gastric balloon. Figure 1 illustrates that the balloon 3 can be, for example, a lower gastric balloon. Figure 1 illustrates that the balloon 3 can 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.

[0171] The heat transferer 4, the catheter 9, and / or the balloon 3 can be delivered orally and / or nasally, for example, through the nose 11 and / or the mouth 12. For example, Figure 1 illustrates that the heat transferer 4, the catheter 9, and / or the balloon 3 can be delivered nasally through the nose 11. The heat transferer 4, the catheter 9 and / or the balloon 3 can pass through the esophagus 5 of the patient.

[0172] Figure 1 illustrates that the thermal therapy system 33 can include a pump 148, a fluid 6, and / or a fluid reservoir 150. Figure 1 illustrates that the heat exchange system 13 can include the pump 148, the fluid 6, and / or the fluid reservoir 150. The pump 148 can be, for example, a recirculating pump. The fluid 6 can be, for example, a heat transfer fluid. The fluid reservoir 150 hold a volume of the fluid 6. The fluid 6 can be pumped and / or out of the catheter 9 and / or the balloon 3 via the pump 148. The fluid 6 can be pumped through the catheter 9 and / or the balloon 3 via the pump 148. For example, Figure 1 illustrates that the fluid 6 can be circulated and / or recirculated through the catheter 9 and / or the balloon 3 via the pump 148. Figure 1 illustrates, for example, that the pump 148 can pump the fluid 6 from the fluid reservoir 150 into the catheter 9 and / or the balloon 3, and / or that the pump 148 can pump the fluid 6 from the catheter 9 and / or the balloon 3 into the fluid reservoir 150. Figure 1 illustrates, for example, that the thermal therapy system 33 can be a closed loop heat exchange system. The balloon 3 can be inflated, for example, by filling the balloon 3 with fluid 6. Figure 1 illustrates the balloon 3 in an inflated configuration with a portion of the fluid 6 in the balloon 3. The balloon 3 can be deflated, for example, by removing the fluid 6 from the balloon 3.

[0173] Figure 1 illustrates that the balloon 3 can be conformable to the wall 108 of the stomach 2 (also referred to as the stomach wall 108). For example, the balloon 3 can have a high surface area contact with the wall of the stomach 2.

[0174] Figure 1 illustrates that the catheter 9 can have a catheter tip 7. The catheter tip 7 can be, for example, a distal tip of the catheter 9 and / or of the heat transferer 4. The catheter tip 7 can be attached to and / or integrated with the catheter 9. For example, Figure 1 illustrates that the catheter tip 7 can be integrated with the catheter 9. The heat transferer 4, the catheter 9, the catheter tip 7, and / or the balloon 3 can be positioned adjacent and / or near the pancreas 1. The balloon 3 can be positioned near a gastric pancreas wall 8. The gastric pancreas wall 8 can be, for example, a portion of the stomach wall 108 that is adjacent, opposing, and / or near the pancreas 1. The fluid 6 can raise and / or lower the temperature of the gastric pancreas wall 8 and / or the pancreas 1. The fluid 6 can transfer heat to and / or withdraw heat from the pancreas 1 and / or the gastric pancreas wall 8.

[0175] The fluid 6 can be, for example, a liquid, a gas, a plasma, and / or a solid. The fluid 6 can be, for example, water, saline, oil, fat, synthetic, and / or organic.

[0176] The heat transferer 4, the fluid 6, the balloon 3 and / or the catheter 9 can be sterile, clean, unclean, and / or unsterile. The heat transferer 4, the catheter 9, and / or the balloon 3 can be single-use, reusable, cleanable, re-cleanable, sterilizable, and / or re-sterilizable..

[0177] Nutrients, medications, sensors, devices and / or tools can be delivered through the heat transferer 4, the catheter 9, and / or the balloon 3. For example, nutrients, medications, sensors, devices and / or tools can exit from the catheter tip 7. The catheter tip 7 can aspirate the stomach 2. Nutrients, medications, sensors, devices, and / or tools can be delivered to the duodenum 37 and / or the jejunum 10. Figure 1 illustrates that the catheter 9, the balloon 3, and / or the heat transferer 4 can pass through the nose 11. The catheter 9, the balloon 3, and / or the heat transferer 4 can pass through the mouth 12. The catheter 9, the balloon 3, and / or the heat transferer 4 can be connected to (e.g., removably connected to) the heat exchange system 13. The heat exchange system 13 can include, for example, a computer, a user interface, a controller, a control system, the pump 148, and / or a warming and / or cooling system. The heat exchange system 13 can cool and / or remove heat from the fluid 6, the heat exchange system 13 can warm and / or transfer heat to the fluid 6, and / or the heat exchange system 13 can cool and / or remove heat from the fluid 6 and can warm and / or transfer heat to the fluid 6. The catheter 9, the balloon 3, and / or the heat transferer 4 can be connected to (e.g., removably connected to) the heat exchange system 13 at a connector 14. For example, Figure 1 illustrates that the proximal end of the catheter 9 can be removably connected to the connector 14. The connector 14 can provide a fluid, optical, and / or electrical coupling between the heat exchange system 13 and the heat transferer 4, the catheter 9, and / or the balloon 3.

[0178] The catheter 9 can be, for example, a tube having zero, one, or multiple lumens. For example, the catheter 9 can have 0-10 or more lumens, including every 1 lumen increment within this range (e.g., 0 lumens, 1 lumen, 2 lumens, 3 lumens, 4 lumens, 5 lumens, 10 lumens). Figures 2a-2d illustrate that the catheter 9 can have various cross-sections. The cross-section of the catheter 9 can be constant and / or can vary along the length of the catheter 9. Figures 2a- 2d illustrate that the lumens canhave various cross-sections. The cross-sections of the lumens can be constant and / or can vary along the length of the catheter 9. Figures 2a-2d illustrate that the catheter 9 and / or the heat transferer 4 can have 0, 1, or multiple lumens, including, for example, 0-20 or more inflow lumens (e.g., 2 inflow lumens or less, 5 inflow lumens or less, 10 inflow lumens or less, 20 inflow lumens or less), including every 1 inflow lumen increment within this range (e.g., 1 inflow lumen, 2 inflow lumens, 5 inflow lumens, 10 inflow lumens, 20 inflow lumens), 0-20 or more outflow lumens (e.g., 2 outflow lumens or less, 5 outflow lumens or less, 10 outflow lumens or less, 20 outflow lumens or less), including every 1 outflow lumen increment within this range (e.g., 1 outflow lumen, 2 outflow lumens, 5 outflow lumens, 10 outflow lumens, 20 outflow lumens), 0-20 or more accessory lumens (e.g., 2 accessory lumens or less, 5 accessory lumens or less, 10 accessory lumens or less, 20 accessory lumens or less), including every 1 accessory lumen increment within this range (e.g., 1 accessory lumen, 2 accessory lumens, 5 accessory lumens, 10 accessory lumens, 20 accessory lumens), or any combination thereof. For example, figures 2a-2d illustrate that the catheter 9 and / or the heat transferer 4 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-2d illustrate that the catheter 9 and / or the heat transferer 4 can have any combination of the first lumen15, the second lumen 16, the third lumen 17, and / or the fourth lumen 18. The lumens 15, 16, 17, and / or 18 can be heat transfer lumens and / or accessory lumens. For example, the lumens 15 and 16 can be heat transfer lumens and the lumens 17 and 18 can be accessory lumens. For example, the lumen 15 can be a first heat transfer lumen, the lumen 16 can be a second heat transfer lumen, the lumen 17 can be a first accessory lumen, and the lumen 18 can be a second accessory lumen. For example, the lumen 15 can be an inflow lumen and the lumen 16 can be an outflow lumen.

[0179] The first lumen 15 and / or the second lumen 16 can transport the fluid 6. For example, the 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 transferer 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-2c illustrate that the fluid 6 traveling from the heat exchange system 13 (e.g., from the fluid reservoir 150) to the balloon 3 can travel in the first lumen 15 and can return in the second lumen 16, thereby reducing heat transfer from other portions of the body, such as the esophagus 5. The fluid 6 can flow both proximally and distally through the first lumen 15 and / or the second lumen16. For example, the fluid 6 can flow distally through the first lumen 15 to inflate the balloon 3, remain in the balloon 3 for a period of time, and then flow proximally through the first lumen 15. The third lumen 17 and / or the fourth lumen 18 can, for example, transport nutrients, medications, sensors, devices and / or tools. The third lumen 17 and / or the fourth lumen 18 can aspirate the stomach 2, the duodenum 37, and / or the jejunum 10. A thickness 20 of a catheter wall 154 can vary at differentcross-sections of the catheter 9 and / or within the same cross-section of the catheter 9. The catheter 9 can have a catheter outer diameter 19. The catheter outer diameter 19 can be constant and / or vary along the length of the catheter 9. The cross-section of the catheter 9 can be, for example, circular, square, oval, triangular and / or other geometric shapes. The catheter outer diameter 19 can be continuous and / or non-continuous. The catheter outer diameter 19 can have bumps, divots, grooves, splines and / or ridges.

[0180] Figure 3 illustrates that the heat transferer 4, the catheter 9, and / or the plug 28 can be delivered orally through the mouth 12. Figure 3 illustrates that the fluid 6 can be in direct contact with the wall of the stomach 2 and / or the gastric pancreas wall 8. For example, the fluid 6 can be transported through the first lumen 15 and / or the second lumen 16 to the stomach 2. Depending on the orientation of the patient, gravity alone can force the fluid 6 to be adjacent to the gastric pancreas wall 8. The fluid 6 can be naturally occurring fluid present in the stomach 2. For example, the fluid 6 can be gastric acid, gastric juice, stomach acid, blood, and / or abdominal fluid. The fluid 6 can be, for example, compressed gas and / or phase change material. For example, the fluid 6 can be delivered through the catheter 9 in a liquid form and then convert to a gas when it exits the catheter tip 7. When converting from a liquid to a gas, the fluid 6 can absorb energy (e.g., a significant amount of energy), thereby reducing the temperature of the stomach 2, the gastric pancreas wall 8, the pancreas 1, the duodenum 37, and / or the jejunum 10. The catheter tip 7 can be in the stomach 2, the duodenum 37, the jejunum 10, and / or the pancreas 1. The fluid 6 can be, for example, an alcohol, nitrogen, carbon dioxide, a refrigerant (e.g., such as Freon, CFC, HFC, R22, R-290, R-600a, R-717, R-1234, R-744, R- 32, R-134a and / or R-410a). The fluid 6 can be stored and / or transported in the catheter 9 at a pressure higher than ambient pressure. The catheter 9 can transfer heat to and / or from the stomach 2, the gastric pancreas wall 8, the pancreas 1, the duodenum 37, and / or the jejunum 10 via a thermoelectric process. For example, the method of heat exchange can include thermoelectric cooling, vaporcompression refrigeration, phase change, carnot cycle refrigeration, reverse rankine refrigeration, evaporative cooling, thermotunnel cooling, magnetic refrigeration, cyclic refrigeration, non-cyclic refrigeration, sortpion cycle, elastocaloric refrigeration, fridget gate, vortex tube, pulse tube refrigeration, thermoacoustics, or any combination thereof. Figure 3 illustrates that an intestinal plug 28 can be deployed in the target site 147. The intestinal plug 28 can be secured at or near the distal terminal end of the catheter 9 and / or can be disengageable from the catheter 9. The intestinal plug 28 can be delivered through the catheter 9. For example, the intestinal plug 28 can be delivered through the third lumen 17 and / or the fourth lumen 18. The intestinal plug 28 can form an outflow blockage at the interface of stomach 2, the duodenum 37, the jejunum 10, a pyloric sphincter 66 and / or the intestine. The intestinal plug 28 can block fluid from traveling exiting the stomach 2. The intestinal plug 28 can be bioabsorbable. A coating can be delivered to the stomach 2 to alter the rate of absorption and / or adsorption of fluid through the stomach wall 108 and / or the gastric pancreas wall 8. The coating can absorb and / or degrade at a predetermined rate.

[0181] The heat transferer 4, catheter 9, the balloon 3, the catheter tip 7, and / or any components passing through the catheter 9 can include zero, one, or multiple sensors 21 (also referred to as the sensor 21 and the sensors 21), for example, 0-10 or more sensors 21, including every 1 sensor increment within this range (e.g., 0 sensors, 1 sensors, 2 sensors, 3 sensors, 10 sensors). The sensors 21 can monitor, for example, temperature, energy, PH, pressure, motion, gravity, orientation, position, electromagnetic waves, magnetism, light, contact, and / or flow rate. The sensors 21 can monitor, for example, the approximate total heat transfer and / or the heat transfer rate from the patient (e.g., the body 152) to the heat transferer 4, the catheter 9, and / or the balloon 3). For example, one or multiple sensors 21 can monitor the temperature of the fluid 6 entering and exiting from the catheter 9, the heat transferer 4, the heat exchange system 13, and / or the balloon 3. The sensors 21 can be connected to the heat exchange system 13. For example, a sensor 21 can be placed in the patient 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 for localized and / or generalized hypothermia and / or normathermia. The sensor 21 can monitor the stomach fluid contents, including, but not limited to the stomach fluid acidity.

[0182] The sensor 21 can provide an alert to the patient, physicians, nurses and / or other staff. The sensor 21 can determine the orientation of the patient, the fluid 6, the balloon 3, the catheter 9, the heat transferer 4, and / or the catheter tip 7. The sensor 21 can determine if the patient is in an ideal or non-ideal position for efficient localized hypothermia of the pancreas 1. For example, example, the sensor 21 can determine if the balloon 3, the fluid 6 and / or the catheter tip 7 are adjacent to the gastric pancreas wall 8. The patient can move or be moved to improve patient comfort and / or to prevent sores (e.g., pressure ulcers). The patient can move and / or be moved at regular intervals. The heat exchange system 13 can provide manual and / or automatic feedback based on the sensors 21. For example, if the pressure is out of range and / or the patient is not in an ideal therapeutic position, then the balloon 3 can be automatically deflated.

[0183] The balloon 3 can be periodically adjusted, moved, inflated and / or deflated. For example, to help prevent pressure ulcers, 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.

[0184] Figure 4a illustrates that the balloon 3 can fluidically communicate with the first lumen 15 through a balloon port 22. The heat transferer 4 and / or the catheter 9 can have multiple balloon ports 22. The multiple balloon ports 22 can allow for improved flow of the fluid 6. For example, multiple balloon ports 22 can provide redundancy, in case one of the balloon ports 22 becomes occluded. For example, multiple balloon ports 22 can provide redundancy, in case one of the balloon ports 22 is occluded.

[0185] Figure 4b illustrates that the balloon 3 can fluidically communicate with the first lumen 15 and / or the second lumen 16 through the balloon ports 22. For example the fluid 6 can travel distally from the heat exchange system 13 in a lumen flow direction 24a, the fluid 6 can exit the first lumen 15 through the balloon port 22a in a balloon port flow direction 23a, the fluid 6 can circulate in the balloon 3, the fluid 6 can enter the second lumen 16 through the balloon port 22b in the balloon port flow direction 23b, and the fluid 6 can travel proximally toward the heat exchange system 13 in the lumen flow direction 24b. The fluid 6 can be warmed and / or cooled in the heat exchange system 13 and then travel distally toward the balloon 3.

[0186] The balloon 3 can have one or multiple fluids. For example, Figures 5a-5b illustrate that the balloon 3 can be filled with the 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 more, less and / or equal to the density of the insulating fluid 25. For example, the fluid 6 can rest on the bottom of the balloon 3 because of gravity. The bottom of the balloon 3 can be adjacent to the gastric pancreas wall 8. The volume of the balloon 3 can be equal to the volume of the insulating fluid 25 and / or the fluid 6 contained within the balloon 3. The heat transfer through the balloon 3 can primarily occur on surfaces in contact with the fluid 6. The configuration illustrated in Figures 5a-5b can allow the volume and / or position of the balloon to be adjusted independently of the thermal transfer characteristics and / or the thermal 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 warming and / or cooling to a small portion of the stomach 2.

[0187] Figure 5a illustrates that the balloon 3 can have fluidically separated compartments or volumes (e.g., a first compartment can receive the insulating fluid 25, and a second compartment can receive the fluid 6), and / or the heat transferer 4 (e.g., the catheter 9) can have one or more balloons 3 (e.g., which can receive the fluid 6 and / or the insulating fluid 25) and one or more insulating balloons (e.g., which can receive the insulating fluid) adjacent to the balloons 3.

[0188] Figure 5b illustrates that an insulating gastric balloon 26 can be inside and / or outside of the balloon 3. The insulating balloon 26 can be in fluid communication with the first lumen 15 via the balloon port 22a. The balloon 3 can be in fluid communication with the second lumen 16 via the balloon port 22b. The insulating balloon 26 can be filled with the insulating fluid 25.

[0189] The heat transfer rate of the heat transferer 4, the catheter 9, and / or the balloon 3 can be controlled, for example, using various methods. The thermal conductivity of the fluid 6 can be adjusted. The volume of the fluid 6, the volume of the balloon 3, and / or the portion of the balloon 3 in contact with the gastric pancreas wall 8 can be adjusted. The temperature of the fluid 6 exiting theheat exchange system 13 can be adjusted. The flow rate of the fluid 6 traveling through the catheter 9, the heat transferer 4, and / or the balloon 3 can be adjusted.

[0190] Figure 6 illustrates that the pancreas temperature can be reduced by periodically pulsing the fluid 6 proximally and distally through the catheter 9. The fluid 6 can be warmed and / or cooled by the heat exchange system 13. The cold fluid 6 can travel through the catheter 9 and / or inflate the balloon3. The cold fluid 6 can increase in temperature as it removes energy from the gastric pancreas wall 8 and / or the pancreas 1. The fluid 6 can be removed from the balloon 3 and / or the stomach 2 periodically. The frequency of cycling the fluid 6 can be based on time, temperature and / or other parameters. With every cycle, the temperature of the pancreas 1 can decrease until a steady-state equilibrium is reached.

[0191] Figure 7 illustrates that the catheter 9 and / or the heat transferer 4 can have or be attached to a gastric positioning mechanism 27. The gastric positioning mechanism 27 can be a mechanical structure. The gastric positioning mechanism 27 can be deployed alongside a cooling membrane and / or the balloon 3. The gastric positioning mechanism 27 can ensure that the catheter 9, the catheter tip 7 and / or the balloon 3 are properly positioned relative to the gastric pancreas wall 8. The gastric positioning mechanism 27 can be a soft stent, a spiral, a balloon, and / or a mesh. The gastric positioning mechanism 27 can be delivered with a small outside diameter and then expanded when in the stomach 2. The gastric positioning mechanism 27 can be a bioabsorbable and / or biodegradable material. The gastric positioning mechanism 27 can brace against the cardia, fundus, corpus of the stomach, pyloric atrium, pyloric canal, or any combination thereof. The catheter 9, the heat transferer4, the catheter tip 7, the balloon 3 and / or the insulating gastric balloon 26 can include a marker 29 and / or multiple markers 29. The marker 29 can aid visualization via ultrasound, CT, X-RAY, MRI and / or other imaging modalities. The marker 29 can be magnetic. For example, sensor 21 can determine the absolute and / or relative position of the marker 29. The marker 29 can allow an operator to adjust the position of catheter 9, the heat transferer 4, the catheter tip 7, the balloon 3, and / or the insulating gastric balloon 26 via an external magnet and / or magnetic field. The heat exchange system 13, the catheter 9, the heat transferer 4, the catheter tip 7, the balloon 3, and / or the insulating gastric balloon 26 can have a relief valve 30. The relief valve 30 can provide a pressure relief mechanism for the first lumen 15 and / or the second lumen 16. If the pressure in the balloon 3 reaches above a threshold, the excess fluid can exit out of the relief valve 30. For example, the fluid 6 can exit the relief valve 30 if the stomach 2 contracts and compresses the balloon 3 (e.g., this can inhibit and / or prevent damage to the heat transferer 4, the catheter 9, and / or the patient). The set point for the relief valve 30 can be fixed and / or adjustable. The relief valve 30 can be controlled by the heat exchange system 13.

[0192] Figure 8 illustrates that the heat transferer 4 and / or the catheter 9 can have one or multiple insulating ports 31. The insulating port 31 can allow the insulating fluid 25 to pass along the outsideof the catheter 9. The insulating fluid 25 can be warm and / or room temperature. The insulating fluid 25 can be in contact with the stomach 2, the esophagus 5, the mouth 12, the nose 11, and / or other patient tissue. The insulating ports 31 can be at various positions along the catheter 9. A balloon can be positioned over the catheter 9 to have the insulating fluid 25. The outside diameter 19 of the heat transferer 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 polymers. The insulating fluid 25 and the fluid 6 can travel through the first lumen 15 and / or the second lumen 16. For example, the fluid 6 (e.g., wamr and / or cold fluid 6) can be delivered distally to fill the balloon 3 through the first lumen 15, then the insulating fluid 25 can be delivered through the first lumen 15 to remove the cold fluid 6 from other sections of the catheter 9 (e.g., thereby reducing heat transfer to other organs, such as the esophagus 5). An external or internal warming system (e.g., the external pad 32) can be applied to the patient. For example, blankets can be placed over the blanket to prevent generalized hypothermia.

[0193] Figure 9 illustrates that the heat transferer 4 and / or the catheter 9 can be delivered transabdominally and / or laparoscopically. The catheter tip 7 can be inserted directly into the pancreas 1 . The fluid 6 can be delivered directly to the pancreas 1 , the peritoneal cavity and / or other tissue. A compressed gas can be delivered to the pancreas 1 and can cool the pancreas 1 as it evaporates. Figure 9 illustrates that the thermal therapy system 33 can include an external pad 32. Figure 9 illustrates that the external pad 32 can be positioned on the patient. One or multiple external pads 32 can be positioned on the patient. The external pad 32 can include the sensors 21. The external pad 32 can provide heating and / or cooling of the patient. The external pad 32 can have magnets and / or imaging to help position the heat transferer 4.

[0194] Figure 10 illustrates that the gastric positioning mechanism can be or can have a fixation mechanism 34 that can position and / or fix the heat transferer 4 and / or the catheter 9 in the stomach 2. The fixation mechanism 34 can be a mechanical structure, such as a resilient coil. The fixation mechanism 34 can position and / or fix the balloon 3 at the gastric pancreas wall 8. The fixation mechanism 34 can brace against the cardia, fundus, corpus, pyloric atrium, pyloric canal, or any combination thereof.

[0195] Figure 11 illustrates that an impermeable membrane 35 can be deployed in the stomach 2. The impermeable membrane 35 can be a permeable, semi-permeable and / or impermeable membrane and / or coating. The impermeable membrane 35 can be dissolvable and / or resorbable. A pylorus plug 36 can be deposited in the stomach 2. The pylorus plug 36 can be positioned to prevent cooling fluid from draining into the duodenum and / or the jejunum 10. The impermeable membrane 35 can prevent and / or slow fluid absorption into the wall of the stomach 2.

[0196] Figure 12 illustrates that target temperatures of the pancreas can be achieved within a simulated pancreas (using bovine tissue) using a chilled fluid circulating in a cooling balloon placedinside of the simulated stomach (using bovine stomach tissue) in a body temperature (37C) water bath.

[0197] Figures 13a and 13b illustrate that the esophagus 5 can extend to the stomach 2, followed by a pylorus 65 and then to a 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, a pancreas head 38, a pancreas body 64, and / or a pancreas tail 39. The pancreas tail 39 can have direct and / or indirect contact with the stomach 2. The pancreas head 38 can have direct and / or indirect contact with the stomach 2, the pylorus 65 and / or the duodenum 37.

[0198] Figures 14a and 14b illustrate that the balloon 3 can be elastic. The balloon 3 can be connected to the catheter 9. The balloon 3 can be an extruded tube made from a polymer, elastomer and / or rubber. For example, the balloon 3 can be a thin-walled extruded silicone tube. The balloon 3 can have approximately the same outer diameter as the catheter 9 in the deflated configuration illustrated in Figure 14a. The balloon 3 can be inflated with the 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, the stomach contractions can urge and / or force the balloon 3 toward the pylorus 65. The catheter tip 7 can remain in the stomach 2, the esophagus 5, the pylorus 65 and / or the duodenum 37. The catheter tip 7 can have a port for aspiration, decompression, feeding and / or inserting 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 adhesive, ultrasonic welding, heat shrink tubing, metal bands and / or reflow melting. The balloon 3 can be inserted into and / or removed from the esophagus 5 and / or the stomach 2 in the deflated configuration illustrated in Figure 14a. The balloon 3 can be inflated into the inflated configuration illustrated in Figure 14b. A catheter axis 86 can run alongside and / or concentric with the catheter 9. A Sagittal axis 87 (also known as the antero-posterior axis) can run from front to back through the center of the body. For example, when a person performs a cartwheel they are rotating about the sagittal axis 87. A frontal axis 88 can run from left to right through the center of the body. For example, when a person performs a somersault they rotate around the frontal axis 88. The dimensions of the balloon 3 can be shorter and / or longer across these various axes. For example, the balloon 3 can be longer along the frontal axis 88 than the sagittal axis 87.

[0199] Figures 15a-15c illustrate that the balloon 3 can be inelastic. For example, the balloon 3 can be made from a polymer that is flexible but not designed to stretch. For example, the balloon 3 can be made from PET, LDPE, HDPE, mylar and / or nylon. The balloon 3 can be filled to a volume lower than its maximum capacity. A duodenal device 40 can be an elastic and / or inelastic balloon secured to the catheter 9. The duodenal device 40 can act as a reservoir for the balloon 3. For example, if external pressure compresses the balloon 3 (e.g., peristalsis, motility, vomiting, etc.) then the fluid 6 can move from the balloon 3 to the duodenal device 40. The duodenal device 40 can serve as adamper to help regulate, maintain and / or control the volume and / or pressure of the balloon 3. The duodenal device 40 can cycle between a deflated configuration illustrated in Figure 15b and an inflated configuration illustrated in Figure 15c. The duodenal device 40 can help to cool and / or warm the pancreas 1, the pylorus 65 and / or the duodenum 37. The duodenal device 40 can help to cool and / or warm the pancreas head 38. The balloon 3 can help to cool and / or warm the stomach 2 and / or the pancreas 1. The catheter 9, the balloon 3 and / or the duodenal device 40 can help to cool and / or heat a core body temperature and / or specific organs in a body.

[0200] Figures 16a, 16b and 16c illustrate that the balloon 3 can be an inelastic structure that inflates. The balloon 3 can be divided into lobes 89 with bonded zones that can be bonded by heat , or chemically (example ultrasonic welding, ultrasonic welding, heat bonding), mechanically (thread, staples, between polymer sheets to form lobes. The lobes are fluidly connected to the catheter to allow circulation of fluids. The bonded zones can form channels that allow flexibility in one or more directions. Figure 16c illustrates that the bonded zones can surround a lobe 89a allowing for flexibility in all directions. Spacing between bonded sections can determine height of expansion of the lobes limiting height or thickness of the balloon limits expansion or pressure on the stomach towards the anterior-posterior direction.

[0201] Figures 16b and 16c illustrate two layers of lobes or inflation zones. The anterior layer 43 can be inflated with gas or lower temperature fluid compared to the layer 44 closest to the posterior wall of the stomach. This lower temperature zone helps isolate cooling to the anterior wall of the stomach adjacent to the pancreas and to insulate the posterior wall of the stomach. The outer edges of the balloon can be marked with radio-opaque or echogenic markers to indicate complete inflation or full deployment of the balloon. The catheter tip 7 can remain in the stomach 2, the esophagus 5, the pylorus 65 and / or the duodenum 37. The catheter tip 7 can have a port for aspiration, decompression, feeding and / or inserting instruments. The catheter tip 7 can be introduced and / or positioned over a guidewire.

[0202] A balloon radius of curvature 85 can be the same and / or vary over the length of the balloon 3 and / or the catheter 9. The balloon radius of curvature 85 can be inverted. The balloon radius of curvature 85 can be greater than approximately 0.5 in (1.3 cm), yet more narrowly greater than approximately 1 in (2.5 cm), yet more narrowly greater than approximately 2 in (5.1 cm), yet more narrowly greater than approximately 3 in (7.6 cm), yet more narrowly greater than approximately 5 in (12.7 cm), yet more narrowly greater than approximately 7 in (17.8 cm), yet more narrowly greater than approximately 10 in (25.4 cm), yet more narrowly greater than approximately 15 in (38.1 cm) and / or yet more narrowly greater than approximately 20in (50.8 cm). The balloon radius of curvature 85 can be less than approximately 20 in (50.8 cm), yet more narrowly less than approximately 15 in (38.1 cm), yet more narrowly less than approximately 10 in (25.4 cm), yet more narrowly less than approximately 7 in (17.8 cm), yet more narrowly less than approximately 5 in (12.7 cm), yet morenarrowly less than approximately 3 in (7.6 cm), yet more narrowly less than approximately 2 in (5.1 cm), yet more narrowly less than approximately 1 in (2.5 cm), yet more narrowly less than approximately 0.5in (1.3 cm).

[0203] Figure 17 illustrates that the catheter 9 can function as a heat transfer device. The catheter 9 can have adequate surface area to provide heat transfer between the stomach 2 and the fluid 6. A physician can insert a predetermined length of the catheter 9 into the stomach 2. The physician can adjust the length of the catheter 9 located in the stomach 2 to adjust the surface area of the catheter 9 located in the stomach 2 and can thereby control the heat transfer between the heat transferer 4 and the stomach 2. The catheter 9 can be fixed and / or move with respect to the stomach 2. For example, peristalsis and / or motility can move the catheter 9. The catheter 9 can cool the wall of the stomach 2 directly and / or indirectly. For example, the catheter 9, the balloon 3 and / or the heat transferer 4 can cool the gastric juices and / or fluid located in the stomach 2. The catheter 9 can include a catheter barb 45. The catheter 9 can include multiple of the catheter barbs 45. The catheter barbs 45 can be cilia like flaps on the catheter 9. The catheter barbs 45 can be integral to the catheter 9 and / or a separate component from the catheter 9. The catheter barbs 45 can help guide the catheter 9 into the duodenum 37 and / or the pylorus 65. The catheter barbs 45 can help retain the catheter 9 in the duodenum 37 and / or the pylorus 65. A given cross-section of the catheter 9 can include zero, one and / or multiple of the catheter barb 45. The catheter barb 45 can be provide greater axial friction and / or resistance in one direction. For example, the force to push and / or pull the catheter 9 and / or the catheter barb 45 distally can be less than the force to push and / or pull the catheter 9 and / or the catheter barb 45 proximally. The catheter barbs 45 can self-advance the catheter 9 into the duodenum 37. The duodenal device 40 can be a weight. For example, additional weight at and / or near the catheter tip 7 can help to guide and / or urge the catheter 9 into the duodenum 37 and / or the pylorus 65. For example, additional 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 the pylorus 65. The duodenal device 40 can help to guide and / or urge the catheter 9 into the duodenum 37 and / or the pylorus 65. The duodenal device 40 can help to retain and / or maintain the catheter 9 in the duodenum 37 and / or the pylorus 65. The duodenal device 40 can be a balloon. The duodenal device 40 can be inflated to increase friction between the heat transferer 4 and an organ (e.g., the duodenum 37). The duodenal device 40 can be inflated after it has passed through the pyloric sphincter 66 and / or the pylorus 65. For example, if the duodenal device 40 is expanded after it has passed through the pyloric sphincter 66 and / or the pylorus 65 then it can help to keep the catheter tip 7 in the duodenum 37. The duodenal device 40 can be a braid and / or a flexible material that can adjust its diameter based on its length. For example, contracting the axial length of the duodenal device 40 can increase its radial diameter. The catheter barbs 45 can be retractable and / or extendable.

[0204] Figure 18 illustrates that the catheter 9 can have a spiral shape and / or profile. For example, a section of the catheter 9 can be heat set and / or formed into a spiral shape. An additional material and / or component can be used to create and / or adjust the shape of the catheter 9. For example, thecatheter 9 can be manufactured with two materials with different coefficients of thermal expansion; for example, when the catheter 9 is exposed to body temperature and / or the temperature from the fluid 6 it can alter its shape and / or profile. A wire (e.g., metal and / or plastic) can be inserted into a lumen of the catheter 9 to create the spiral shape and / or to straighten the catheter 9. For example, during insertion and / or removal it can be desirable to have the catheter 9 approximately straight. The wire can be shaped like a spiral and remain in the catheter 9 to help maintain the spiral shape. The wire can be secured to the catheter tip 7 and then pulled, torqued, twisted and / or pushed relative to the catheter 9 to adjust the shape of the catheter 9. For example, if the wire is off-axis and pulled taught, it can curl the catheter 9 into a spiral shape. The wire can be made from a shape memory alloy (e.g., nitinol) that can adjust its shape based on temperature. A lumen of the catheter 9 can be placed under high or low pressure to force the catheter to form a spiral shape. The catheter 9 can include one and / or multiple of the sensor 21. The sensor 21a can be different than the sensor 21b. The sensor 21 can measure temperature, pressure, flow, pH, sound, enzymes, proteins, biologic activity and / or motion. The sensor 21 may extend outside of the body of the catheter 9 by a sensor length 103. The sensor 21 may extend at various angles away from the catheter 9, therefore the sensor length 103 may be less than, equal to and / or greater than a sensor radial length 104. The sensor radial length 104 may be the minimum distance from the sensor 21 to the body of the catheter 9. The sensor radial length 104 and / or the sensor length 103 may change and / or be adjusted. For example, the sensor 21 may be adhered to the body of the catheter 9 with a dissolvable and / or releasable adhesive, heat shrink, glue and / or mechanism. For example, changes in temperature, acidity and / or pressure may release the tip of the sensor 21 from the body of the catheter 9.

[0205] Figure 19 illustrates that the catheter 9 can be introduced into the stomach 2 via the wall of the stomach 2. For example, the catheter 9 can be introduced via a percutaneous port 46. The catheter 9 can be introduced via the anterior and / or posterior section of the stomach 2. The catheter 9 can be introduced into the stomach cardia, stomach fundus, stomach body, pylorus 65, duodenum 37 and / or the pyloric sphincter 66.

[0206] Figure 20 illustrates that catheter 9 can have one and / or multiple coil and / or helix. For example, a section of the catheter 9 can be heat set and / or formed into a helical shape. An additional material and / or component can be used to create and / or adjust the shape of the catheter 9. For example, the catheter 9 can be manufactured with two materials with different coefficients of thermal expansion; for example, when the catheter 9 is exposed to body temperature and / or the temperature from the fluid 6 it can alter its shape and / or profile. A wire (e.g., metal and / or plastic) can be inserted into a lumen of the catheter 9 to create the helical shape and / or to straighten the catheter 9. For example, during insertion and / or removal it can be desirable to have the catheter 9 approximately straight. The wire can be shaped like a helix and remain in the catheter 9 to help maintain the helical shape. The wire can be secured to the catheter tip 7 and then pulled, torqued, twisted and / or pushed relative to the catheter 9 to adjust the shape of the catheter 9. For example, if the wire is off-axis andpulled taught, it can curl the catheter 9 into a helical shape. The wire can be made from a shape memory alloy (e.g., nitinol) that can adjust its shape based on temperature. A lumen of the catheter 9 can be placed under high or low pressure to force the catheter to form a helical shape. The catheter 9 can have a gastric coil 47 and / or an engager 48. The gastric coil 47 can extend into the duodenum 37. The engager 48 can extend into the stomach 2. The gastric coil 47 can provide additional surface area and / or flexibility. The gastric coil 47 and / or a spiral shape can help prevent the catheter 9 from kinking and / or forming a knot. The engager 48 can help to retain the catheter tip 7 in the duodenum 37. The engager 48 and / or the gastric coil 47 can help increase thermal contact with the fluids and / or tissue. For example, the engager 48 can increase thermal contact with the duodenum 37. The engager 48 and / or the gastric coil 47 can provide some strain relief to counteract and / or resist peristalsis, motility and / or other external forces. The 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 run alongside 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 section of the catheter 9 proximal to the anchor point 74 from traveling distally into the pylorus 65 and / or the duodenum 37. The tether 73 can he pulled taught 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 larger during insertion, use and / or removal. For example, the distance between the anchor point 74 and the anchor port 75 can be larger during insertion / removal than once it is in position in the stomach. The tether 73 can pass inside 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 transferer 4. For example, once the tether 73 is pulled taught it can be secured to a proximal section of the catheter 9 external to the body. For example, during removal, the tether 73 can be released from the proximal section of the catheter 9 external to the body for easier removal of the catheter 9 from the patient. The tether 73 can be made from a natural and / or synthetic polymer. The tether 73 can be made from metal, plastic and / or ceramic. The proximal section of the tether 73, the catheter 9 and / or the heat transferer 4 can be secured to the patient (e.g., the nose 11, the mouth 12 and / or other points on the patient. The proximal end of the tether can be attached to an actuator. The actuator can create translation of the tether and may have a locking portion that is automatic like a ratchet. Alternately the actuator may be locked into position manually. Deployment of this actuator can ensure and / or can enable consistent tension via maintenance of a constant force (via a spring) or distance adjustment. The actuator can be, for example, a lever, motor, and or wheel. The actuator can have visual indicators for feedback on distance traveled or lock status. The tether 73 can be pulled taut. The tether 73 can, for example, pull the anchor point 74 near and / or adjacent to the anchor port 75. Maintaining the anchor point 74 near and / or adjacent to the anchor port 75 can reduce the risk of knotting and / or migration of the catheter9. 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.

[0207] Figure 21 illustrates that an introducer 49 can be inserted into the esophagus 5 and / or the stomach 2. The introducer 49 can allow easier and / or more controlled placement of the heat transferer 4. The catheter 9 and / or an 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, 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 insulation between the catheter 9 and the tissue and / or organs. For example, the introducer 49 can provide thermal insulation between the catheter 9 and the esophagus 5, the nose 1 1 , the mouth 12 and / or the stomach 2. For example, the introducer 49 can provide thermal insulation between the heat transferer 4 and the esophagus 5, the nose 11, the mouth 12 and / or the stomach 2.

[0208] Figure 22 illustrates that the catheter 9 can have balloons, for example, multiple radially expanding balloons. Figure 22 illustrates that the balloons can be fluidly coupled to the catheter. The balloons can be elastic, inelastic, or a combination of elastic and inelastic. Multiple balloons in sequence can allow greater flexibility along the axis of the catheter while creating greater surface area for temperature exchange compared to a singular balloon. The inelastic balloon can be produced so that the balloon is limited in diameter and limits volume of the balloon regardless of pressure. Likewise the self-limiting diameter of the inelastic balloon limits radial outward pressure onto the gastric wall. There can be a combination of elastic and inelastic balloons. The inelastic balloons at low pressure can have a wall thickness thin enough so that it can expand and conform to the rugae or curvature of the stomach to allow more intimate contact and greater heat transfer. The same catheter with inelastic balloons can have elastic regions or bellows that can expand for pressure relief within the there is internal or external pressure on the inelastic balloons to maintain integrity of the inelastic balloon material. Any of the cooling balloons can be an extruded tube made from a polymer, elastomer and / or rubber. For example, the balloon 3 can be a thin-walled extruded silicone tube. The balloon 3 can have approximately the same outer diameter as the catheter 9 in the deflated configuration illustrated in Figure 22. The balloon 3 can be inflated with the 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 most distal balloon 3. For example, the stomach contractions can urge and / or force the balloon 3 toward the pylorus 65. The catheter tip 7 can remain in the stomach 2, the esophagus 5, the pylorus 65 and / or the duodenum 37.The catheter tip 7 can have a port for aspiration, decompression, feeding and / or inserting instruments. The catheter tip 7 can be introduced and / or positioned over a guidewire. The multiple cooling balloons 3 can be secured to the catheter 9 with adhesive, ultrasonic welding, heat shrink tubing, metal bands and / or reflow melting. The multiple balloon 3 can be inserted into and / or removed from the esophagus 5 and / or the stomach 2 in the deflated configuration illustrated in Figure 22. The cooling balloon materials 3 can be made from PET, LDPE, HDPE, mylar and / or nylon or elastic materials such as silicone or urethane. The most distal balloon in series can be sized such that peristaltic movement or guided placement via imaging can place it into the duodenum. Such a balloon in the duodenum can serve both to anchor position as well as provide cooling at the duodenum with the intention of cooling the head of the pancreas adjacent to the duodenum. A duodenal device 40 can be an elastic and / or inelastic balloon secured to the catheter 9. The duodenal device 40 can act as a reservoir for the balloon 3.

[0209] Figure 23 illustrates that lumens of the catheter 9 can expand. For example, the entire catheter wall 20 and / or a section of the catheter wall 20 can expand under pressure. The expandable catheter wall can be the balloon 3. The expandable catheter wall can allow for increased surface area of the catheter 9 during use. The expandable catheter wall can be in the unexpanded configuration during insertion and / or removal. The expandable catheter wall can include an expandable tube and / or balloon secured concentrically around the catheter 9. The catheter 9 can include a catheter port 52 at the catheter tip 7 and / or along the circumference of the catheter 9. The catheter 9 can include multiple catheter ports 52. The catheter ports 52 can provide distributed access for decompression, feeding, tools and / or sensors. The catheter ports 52 can be connected to the first lumen 15, the second lumen 16, the third lumen 17 and / or the fourth lumen 18. The size and / or diameter of the catheter ports 52 can be the same and / or different.

[0210] Figure 24 illustrates an intestine valve 90 at the level of the intestine past the ampulla of vater 41. The intestine valve 90 can be placed endoscopically and anchored by expanding radially or having barb-like retention features. The intestine valve 90 can have barb-like retention features. The intestine valve 90 can be anchored in place by radially expanding the intestine valve 90 and / or by bringing the barb-like retention features into engagement with tissue. The intestine valve 90 can be remotely activated by a signal via an attached wire or wireless through remote control or magnet activation. Cold or warm fluid can be introduced and circulated in the gastric and proximal plugged duodenal region to cool the sections of the stomach 2 and the duodenum 37 adjacent to the pancreas 1 when the valve is in the closed position. Cold or warmed fluid can pass into the pancreatic duct via the ampulla of vater 41. The intestine valve 90 can be programmed to open at a set interval or set temperatures via onboard sensors to allow drainage of fluid after the cooling fluid has warmed due to the surrounding structures. The intestine valve 90 can be manually or automatically opened via remote control.Opening of the intestine valve 90 can allow resident fluids such as secretions or ingested food or liquid to pass.

[0211] Figure 25 illustrates a pylorus valve 91 at the level of the pylorus. The pylorus valve 91 can be placed endoscopically and anchored by expanding radially or having barb-like retention features or having a geometry such that it lodges into the pylorus to seal the stomach 2. The pylorus valve 91 can have barb-like retention features. The pylorus valve 91 can be anchored in place by radially expanding the pylorus valve 91 and / or by bringing the barb-like retention features into engagement with tissue. The pylorus valve 91 can be remotely activated by a signal via an attached wire or wireless through remote control or magnet activation. Cold or warm fluid can be introduced and circulated in the gastric region to cool the sections of the stomach 2 adjacent to the pancreas 1 when the pylorus valve 91 is in the closed position. Closure of the pylorus valve 91 controls how much fluid can be absorbed into the by limiting or stopping fluids to pass into the intestine. Once the cool fluid has transferred from the stomach 2 and surrounding organs such that the fluid has warmed, fluid can be evacuated via aspiration and replaced with cold fluids in automatic cycles. A lumen of the catheter 9 with the catheter tip 7 continues past the pylorus valve 91 so that feeding can occur directly into the intestine and bypassing any stimulation of the stomach 2. The pylorus valve 91 can be programmed to open at a set interval or set temperatures via onboard sensors to allow drainage of fluid after the cooling fluid has warmed due to the surrounding structures. The pylorus valve 91 can be manually or automatically opened via remote control. Opening of the pylorus valve 91 can allow resident fluids such as secretions or ingested food or liquid to pass.

[0212] Figure 26 illustrates a peritoneal cooling device 53 applied to the outer surface of the pancreas 1. The peritoneal cooling device 53 can be a balloon and / or a catheter. Fluid can be circulated with the peritoneal cooling device 53 via a peritoneal cooling device catheter 54. The peritoneal cooling device 53 can be placed laparoscopically or through direct transabdominal placement.

[0213] Figures 27a-27f illustrate that the catheter 9 can include various cross-sectional profiles. The cross-section of the catheter 9 can be the same and / or different along its length. Figure 27a illustrates that the catheter 9 can have circular and / or approximately circular lumens. The diameter and / or area of the first lumen 15, the second lumen 16, the third lumen 17 and / or the fourth lumen 18 can be the same and / or different. Figure 27b illustrates that the cross-section of the first lumen 15 and / or the second lumen 16 can be non-circular. A circular cross-sectional profile for the third lumen 17 and / or fourth lumen 18 can be desirable for improved passage of tools, sensor, food, tissue and / or other matter. A circular cross-sectional profile for the first lumen 15 and / or the second lumen 16 can allow for higher flow and / or a smaller pressure drop. A non-circular cross-sectional profile for the first lumen 15 and / or the second lumen 16 can allow for a larger hydraulic diameter. A non- circular cross- sectional profile for the first lumen 15 and / or the second lumen 16 can increase thermal transfer through the wall of the catheter 9 by providing a larger surface area in contact with the fluid 6. Figure 27c illustrates that the cross-sectional profile of the catheter 9 can be non-circular. Figure 27c illustrates that the wall thickness of the catheter 9 can vary at a given cross-section. A thinner catheterwall 20 can allow for increased thermal transfer through the catheter wall 20. The lumens of the catheter 9 can expand and / or contract under different pressures. For example, under high pressure, the cross-section of the catheter 9 can transform from that illustrated in Figure 27b to that illustrated in Figure 27c. The catheter 9 in Figure 23 can have the cross-section of Figure 27b and Figure 27c. The catheter wall 20 can be elastic and / or inelastic. Figure 27d and Figure 27e illustrates that the cross- sectional profile of the catheter 9 can maximize thermal transfer through the catheter outer diameter 19. For example, a non-circular profile for the first lumen 15 and / or the second lumen 16 can maximize contact with the external wall of the catheter 9 and thereby can increase thermal transfer through the catheter wall 20. Figure 27f illustrates that the diameter and / or area of the third lumen 17 can be different than the diameter and / or area of the fourth lumen 18. The third lumen 17 can benefit from a larger diameter if it is being used for aspiration, decompression, feeding and / or passage of tools. The fourth lumen 18 can be beneficial for venting, feeding, sensing and / or for the passage / installation of small tools / sensors. The first lumen 15, the second lumen 16, the third lumen 17 and / or the fourth lumen 18 can spiral around and / or through the catheter 9. The first lumen 15, the second lumen 16, the third lumen 17 and / or the fourth lumen 18 can spiral and / or twist around each other.

[0214] Figure 28a and Figure 28b illustrate that a tube and / or balloon can be secured concentrically over the catheter 9. The balloon 3 can be secured concentrically over the catheter 9. The catheter 9 in Figure 23 can have the cross-section of Figure 28a and Figure 28b. The balloon 3 can be secured to the catheter 9 at one and / or multiple balloon seal region 55. The balloon seal region 55a and / or 55b can prevent the fluid 6 from transferring between the first lumen 15 and the second lumen 16. The fluid 6 can transfer from the first lumen 15 to the balloon 3 via a 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 exit from one of the catheter hole 65 into the balloon 3 and then enter back into the catheter 9 through a second of the catheter hole 65. The first lumen 15 and / or the second lumen 16 can be occluded at certain regions to force the fluid 6 into the balloon 3. The balloon sealing region 55 can secure the balloon 3 to the catheter 9 via adhesive, brazing, heat shrink tubing, springs, melting and / or ultrasonic welding.

[0215] Figure 29 illustrates that the catheter outer diameter 19 can vary over the length of the catheter 9. For example, the catheter outer diameter 19 can be smaller at the nasal region to minimize discomfort and / or heat transfer to the nasal cavity. The catheter outer diameter 19 can be smaller in areas where heat transfer is not desired. For example, the catheter outer diameter 19 can be smaller in the nose 11, the mouth 12, head and / or the esophagus 5. A smaller catheter outer diameter 19 can reduce risk of knotting and / or kinking and / or allow for improved passage, insertion, removal and / or bending. A larger catheter outer diameter 19 can improve heat transfer, increase the heat transfer surface area, reduce risk of knotting and / or kinking. The distal section of the catheter 9 may not have the third lumen 17 and / or the fourth lumen 18. The distal section of the catheter 9 can have a smallercatheter outer diameter 19 if the distal section of the catheter 9 does not have the third lumen 17 and / or the fourth lumen 18. For example, the distal section of the catheter 9 may only have the first lumen 15 and / or the second lumen 16. As another example, the heat the distal section of the catheter 9 can 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).

[0216] Figure 30 illustrates that a bypass lumen 63 can allow some of the fluid 6 to pass directly from the output port of the heat exchange system 13 to the return port of the heat exchange system 13 without passing through the heat transferer 4 and / or entering the stomach 2. For example, the heat exchange system 13 can have (e.g., can require) a minimum How rate which can be higher than can pass through the catheter 9. The bypass lumen 63 can allow the heat exchange system 13 to maintain a sufficiently high flow rate by allowing a portion of the fluid 6 to pass through the catheter 9 and the remainder to pass through the bypass lumen 63. The bypass lumen 63, the heat exchange system 13, the catheter 9 and / or other components can have sensors, pressure relief valves and / or switches to control the flow through the bypass lumen 63. For example, the user can adjust flow of the fluid 6 through the catheter 9 without adjusting the heat exchange system 13. For example, during startup, all of the fluid 6 can pass through the bypass lumen 6 until it is at the appropriate temperature. Once the fluid 6 is at the appropriate temperature, it can then be switched to flow entirely and / or partially through the catheter 9. During an emergency, all of the fluid 6 can flow through the bypass lumen 63 without turning off and / or adjusting the heat exchange system 13. The bypass lumen 63 can provide some damping and / or pressure relief to the catheter 9. An IV pouch 62 can be secured to an IV pole 57. The IV pouch 62 can include saline, nutrients, food, water, medication and / or other material. The contents of the IV pouch 62 can connect to the catheter 9 via an external accessory lumen 61. The external accessory lumen 61 can connect to the third lumen 17 and / or the fourth lumen 18. The flow rate of contents of the IV pouch 62 can be controlled by adjusting the height of the IV pouch 62 relative to the patient. The IV pouch 62 and / or the contents of the IV pouch 62 can be heated and / or cooled before and / or during the procedure. The contents of the IV pouch 62 can provide additional heating and / or cooling of the stomach 2, the pancreas 1, the duodenum 37 and / or other organs of the patient. The flow rate of contents of the IV pouch 62 can be controlled using a metering device, such as a peristaltic pump, drip chamber and / or valve. The return flow of the fluid 6 from the catheter 9 can pass through a return pouch 60 before returning to the heat exchange system 13. For example, fluid 6 can transfer from the catheter 9 to a catheter-pouch return lumen 58 to the return pouch 60 and then to a pouch-cooler return lumen 59. The height of the return pouch 60 relative to the patient and / or the heat exchange system 13 can be adjusted. The height of the return pouch 60 relative to the stomach 2 can impact the pressure of the fluid 6 in the balloon 3 and / or other elements of the heat transferer 4.

[0217] Figure 31 illustrates that the external accessory lumen can be connected to a vacuum 67. The vacuum 67 can provide aspiration and / or decompression. The vacuum 67 can provide intermittent vacuum and / or pressure. The external accessory lumen 61 can be connected to the vacuum 67, the IVpouch 62 and / or other components / sensors. The heat exchange system 13 can transfer the fluid 6 in a constant direction and / or circuit. The heat exchange system 13 can inject and / or withdraw the fluid 6. For example, the heat exchange system 13 can use a peristaltic pump and / or a syringe pump to inject and / or withdraw the fluid 6. The heat exchange system 13 can heat and / or cool the fluid 6. The heat transferer 4 can heat and / or cool tissue and / or organs. The heat transferer 4, the catheter 9 and / or the balloon 3 can heat and / or cool the stomach 2, the pancreas 1 and / or the duodenum 37.

[0218] Figure 32 illustrates that the catheter 9 and / or the heat transferer 4 can access the pancreas 1 through an artery. For example, the catheter 9 can pass through an aorta 72, a celiac trunk 68, a splenic artery 69, a pancreatic artery 70 and / or a gastroduodenal artery 71. The catheter 9 can provide more efficient and / or localized heat transfer if it is located inside of an artery. For example, the catheter 9 can provide more efficient and / or direct heat transfer to the pancreas 1 by being located inside of the pancreatic artery 70. The catheter 9 can pass through the venous system.

[0219] Figure 33 illustrates that the heat transferer 4 can cool a physical simulation of the stomach 2 and / or the pancreas 1. The model used to obtain the data shown in Figure 33 included a pliable silicone stomach 2 and pancreas 1 placed in a 37 degree Celsius water bath. Thermocouples were placed at different locations in the pancreas 1. Approximately 90cm of the catheter 9 was placed inside of the simulated stomach 2 similar to the configuration illustrated in Figure 18. Approximately lOmL of fluid was placed inside of the stomach 2 to simulate gastric juices. The catheter 9 was connected to an external recirculating cooling system, with approximately lOOmL / min of 5 - 15 degree Celsius fluid flowing through the catheter 9. After approximately 30 minutes, a mechanism gently manipulated the stomach 2 to simulate gentle peristalsis and / or motility of the stomach 2. Figure 33 shows that the thermal therapy system 33 can cool the pancreas 1 in a physical simulation. Figure 33 shows that gentle peristalsis and / or motility of the stomach 2 can help to average the temperatures of the pancreas 1 (e.g., the second half of the graph has a narrower band of max / min temperatures than the first half). The heat transferer 4 used to obtain the data in Figure 33 was removing approximately 20 - 30 Watts of heat at steady state.

[0220] Figure 34 illustrates a catheter that can be rotated to locate and advance via the catheter tip 7 into the pylorus 65 and into the duodenum 37. The catheter 9 can have a tapered coil distal diameter 79 that can be smaller than the tapered coil maximum diameter 78. The coil diameter at the tapered coil proximal diameter 77 can be less than the tapered coil maximum diameter 78 as it transitions to the helical sections of the catheter 9. The coil diameter at the tapered coil proximal diameter 77 can be less than the tapered coil maximum diameter 78 as it tapers to the helical sections of the catheter 9. At the nose or the narrowest sections of nasal-gastric passage, there can be an introducer 49 or an open ended catheter that can provide a bearing surface for the main cooling catheter 9 when the forward and rotational forces are applied to helical section of the catheter through the pylorus and intothe intestine. The introducer can prevent more sensitive portions of the nasal passage from experiencing torque applied to the main heat transfer catheter.

[0221] Figures 35a-35d illustrate a linear everting catheter 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 and with a seal or connecting port, can have an annulus that responds to hydraulic pressure supplied by fluid, media, or a gas. The hydraulic pressure allows the membrane 82 to evert or roll inside out in a frictionless manner. Within the first 80 and second catheter 81, a third catheter can be delivered. The third catheter can have lumens for inflow and outflow of cooling (or heating) media supplied by the external controller, and a lumen for aspiration or delivery of nutritional materials for the patient.

[0222] The linear everting catheter can deliver the catheter system through the nasopharynx and into the esophagus 5. The distal end of the first catheter 80 can be positioned at the nostril of the patient and can be hydraulically pressurized by a fluid, media, or gas by an external source. Once pressurized the second catheter 81 can be advanced to allow the membrane 82 to roll through the nasopharynx and into the esophagus 5. Once the membrane 82 and second catheter are fully extended, within the lumen of the second catheter 81 a third catheter can be delivered to supply the catheter cooling system described herein. The hydraulic fluid, media, or gas can supply a passive or active insulation source to protect the patient’s nasopharynx from the thermal cooling energy from the third catheter. As an active source of insulation, warming fluid, media, or gas can be introduced within the annulus of the membrane to provide insulation from the cooling energy supplied by the internal third catheter. As a passive source of insulation, the annulus of the linear everting catheter can be filled with air or gas to supply an insulator.

[0223] Figure 35b illustrates that the linear everting catheter can be configured at the distal end of the catheter system once delivered within the patient’ s stomach. The distal end 7 of the first catheter 80 can be positioned towards the pylorus of the patient. The first catheter 80 can be connected to a membrane 82 that can be connected to a second catheter and upon pressurization by a fluid, media, 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 self-seeking and conformable to intubate the pylorus 65 and advance into and through the duodenum 37. Within the second catheter 81 can be a lumen for a third catheter that can deliver the thermal cooling energy to this location of the anatomy.

[0224] The entire catheter system can be configured with both a linear everting delivery system to provide access through the patient’s nasopharynx, and a second linear everting delivery system to bring the cooling energy into the duodenum 37 of the patient.

[0225] Figure 35d illustrates that to deliver fluid 6 into the duodenum 37, the membrane 82 can be everted to form two layers that can be always connected at the distal end of the first catheter tip 7 where the inner first catheter 80 layer begins to evert to the second catheter 81 outer layer. Theproximal ends of the layers are temporarily locked together by an annular clamp during initial insertion of the catheter to the desired area. Upon reaching the stomach, the annular clamp can be unlocked at the proximal end and the second catheter 81 can slide proximally relative to the first layer 81. Distal movement of the second catheter 81 along the axis on the first catheter 80 causes the distal end of the catheter to advance forward into the stomach past the pylorus 65 and into the duodenum 37. Heat transfer fluid be introduced at the proximal end and can travel between the first catheter 80 and the second catheter 81 to reach the intestine and stomach. Heat transfer fluid can be cycled for constant heat exchange with the tissue surrounding the catheter. The center of the lumen of the first catheter 80 can serve as an aspiration or feeding tube.

[0226] Figure 35d illustrates a linear everting catheter with single layer catheter that can be everted to form two layers that can be always connected at the catheter tip where the first catheter 80 layer begins to evert to the second catheter 81 outer layer. Figure 35d illustrates that a heat transfer catheter having one or more lumens for a fluid 6 or for feeding and aspiration can be connected to the center of the first catheter 80 inner layer of the linear everting catheter. The proximal ends of the layers are temporarily locked together by an annular clamp during initial insertion of the catheter 9 to the desired area. Upon reaching the stomach, the annular clamp can be unlocked at the proximal end and the outer layer can slide proximally relative to each layer. Distal movement of the outer layer along the axis on the inner layer causes the distal end of the catheter to advance forward into the stomach past the pylorus 65 and into the duodenum 37. After the heat transfer catheter 9 is delivered to the desired location, the first catheter 80 and second catheter 81 at the proximal end can be locked by annular compression to stabilize the position and prevent relative motion.

[0227] Figure 36 illustrates that the catheter 9 can be located in the stomach 2 and / or the 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 and / or longitudinal flexibility. The coiled section of the catheter 9 can expand, contract and / or deform to ensure contact with the esophagus 5. The cross-section of the coil can be circular (e.g., it can look like a standard compression and / or extension spring) or it can be another shape (e.g., oval, square, triangular, etc.). A coiled catheter 9 can maximize thermal contact and / or thermal transfer with the esophagus 5. The fluid 6 can circulate within the catheter 9. The first lumen 15 can be oriented on the external circumference of the coil and the second lumen 16 can be oriented on the internal circumference of the coil to maximize heat transfer with the esophagus 5.

[0228] Figures 37a and 37b illustrate that the catheter 9 can have a lattice shape 103 when the catheter 9 is in a deployed configuration. Figures 37a and 37b illustrate that actuating (e.g., withdrawing, pulling) the tether 73 can change the lattice shape 103, for example, from a lattice first shape 103a to a lattice second shape 103b. Figure 37a illustrates that the catheter 9 can have the lattice first shape 103a before the tether 73 is actuated, for example, when the tether 73 is in a non-actuated position. Figure 37b illustrates that the catheter 9 can have the lattice second shape 103b after the tether 73 is actuated, for example, when the tether 73 is in an actuated position. The catheter 9 can be deployed with or without the tether 73. The catheter 9 can be deployed with or without actuating the tether 73. For example, the deployed configuration of the catheter 9 in Figure 37a can be a partially deployed configuration of the catheter 9, and the deployed configuration of the catheter 9 in Figure 37b can be a fully deployed configuration of the catheter 9. As another example, the deployed configuration of the catheter 9 in Figure 37a can be a fully deployed configuration of the catheter 9. The catheter 9 may not have a tether (e.g., the tether 73). In such cases, the deployed configuration of the catheter 9 in Figure 37a can be a fully deployed configuration.

[0229] Figure 38 illustrates that the catheter 9 can have a remote sensor 93. The remote sensor 93 can be integral to the catheter 9 and / or separate to the catheter 9. For example, the remote sensor 93 can be inserted and / or swallowed separately than the catheter 9. For example, the remote sensor 93 can be adhered and / or secured to the catheter 9 during insertion and then may be separated and / or partially detached from the catheter 9 when the device is in the stomach 2. The remote sensor 93 can be tethered to the catheter 9 with a remote sensor tether 94. The remote sensor 93 can communicate wirelessly and / or without wires. The remote sensor 93 can have a battery source and / or a power generation source (e.g., thermo-electric). The remote sensor 93 can be charged and / or powered wirelessly (e.g., induction charging). The remote sensor tether 94 can be optically and / or electrically communicated to the catheter 9. For example, the remote sensor tether 94 can include electrical wires and / or fiberoptic cables. The remote sensor 93 can monitor temperature, pH, stomach motility and / or other key metrics. The remote sensor 93 can include a camera. The remote sensor 93 can monitor different wavelength (e.g., optical, infrared and / or ultraviolet). The remote sensor 93 can measure the temperature of the stomach 2 and / or the gastric pancreas wall 8. The remote sensor 93 can detect if the surrounding media is solid, liquid and / or gas (e.g., by measuring electrical resistance and / or conductivity across two points).

[0230] Figures 39a and 39b illustrate that the tip of the catheter 9 can feature a proboscis 97. A proboscis diameter 95 can be smaller, larger and / or equal to the catheter OD 19. The stiffness of the proboscis 97 can be the same and / or different than the rest of the catheter 9. For example, the proboscis 97 can provide easier insertion of the catheter 9 into the nose 11 and / or other organs. The proboscis 97 can provide a soft tip to prevent the catheter 9 from irritating the wall of the stomach 2 and / or other organs. The proboscis 97 can prevent the catheter 9 from tunneling into tissue. The proboscis 97 can have a different radiopacity and / or echogenicity than the rest of the catheter 9. For example, the proboscis 97 can include a metal marker band. The proboscis 97 can be denser than the rest of the catheter 9. The catheter 9, the proboscis 97 and / or any portion of the thermal therapy system 33 can include radiopaque additives, such as barium sulfate (i.e., BaSC ). A proboscis length 96 can be approximately 1cm. The proboscis 97 may have an atraumatic proboscis tip 100. The proboscis tip may be rounded and / or dome shaped. The sensor 21 may be embedded and / or secured tothe proboscis 97. For example, the sensor 21 may be a thermistor, thermocouple, RTD and / or another temperature sensor. The sensor 21 may measure pH and / or be a camera. The remote sensor 93 may be the sensor 21. The first lumen 15, the second lumen 16, the third lumen 17 and / or the fourth lumen 18 may and / or may not extend into the proboscis 97. For example, the proboscis 97 may be thermally isolated from the remainder of the catheter 9 so that it can more accurately measure the temperature of the stomach 2. A sensor cable 107 may connect the sensor 21 to an external console, a DAQ, a data acquisition device, the heat exchange system 13, a computer and / or other systems. The sensor cable 107 may be the remote sensor tether 94. The sensor cable 107 may be wires, cables, fiber optics tubes and / or a conduit that can transmit information. The sensor cable 107 may pass through the outside of the catheter 9 and / or through one of the catheter lumens. The catheter 9 may include a merge zone 105. The merge zone 105 can have a merge point that can be anywhere in the merge zone 105. As another example, the merge zone 105 can be a merge point. The merge zone 105 can allow the first lumen 15 to fluidly communicate with the second lumen 16. A sensor proboscis length 106 may be less than, equal to and / or greater than the proboscis length 96. The sensor proboscis length may be sufficiently large to minimize heat transfer between the catheter 9 and the sensor 21. For example, The region of the catheter 9 proximal to the merge zone 105 may be warmer and / or cooler than the region distal to the merge zone 105. The sensor 21 may be an infrared temperature sensor.

[0231] Figure 40 illustrates that the diameters of the first lumen 15, the second lumen 16 and / or the third lumen 17 may be the same and / or different. The pressure at the distal tip of the catheter 9 and / or the balloon 3 can be determined by the ratio of the hydraulic diameter of the first lumen 15 and the hydraulic diameter of the second lumen 16. For example, the ratio of the hydraulic diameters of the first lumen 15 and the second lumen 16 can be directly proportional to the pressure drop across the length of the lumens (and therefore the pressure at the balloon 3). It may be desirable to reduce the pressure of the balloon 3 for improved compliance and / or flexibility.

[0232] Figure 41 illustrates that the catheter 9 can be introduced over a guidewire 99. The guidewire 99 may pass through the third lumen 17 and / or the fourth lumen 18. The guidewire 99 may be coated with a hydrophilic and / or hydrophobic material. The guidewire 99 may be separate and / or integral to the catheter 9. The thermal therapy system 33 can include an esophageal valve 92. The esophageal valve 92 can control the amount and / or rate of fluid passing from the esophagus 5 to the stomach 2 and / or vice-versa. The catheter 9 may pass through the esophageal valve 92. The catheter 9 may be permanently secured to and / or removable from the esophageal valve 92. The esophageal valve 92 may be an anti-reflux valve. The guidewire 99 can guide the catheter 9 to certain regions (e.g., the pylorus and / or antrum of the stomach 2).

[0233] Figure 42 illustrates that the thermal therapy system 33 can actively control the core body temperature of a patient. For this study, approximately 75cm of the catheter 9 was randomly positioned in the stomach (similar to FIG 18), with a cross-section similar to that shown in FIG 27b.The core body temperature of the human patient dropped during active cooling periods 98 and rose when the cooling was terminated. Core body temperature was monitored using a zero-heat flux thermometer (3M Bair Hugger™).

[0234] Figure 43 illustrates that an insulation pad 101 may be placed between the catheter 9 and the patient to prevent any discomfort. The insulation pad 101 may be a soft foam. The insulation pad 101 may be permanently secured to the catheter 9 and / or removable. The insulation pad 101 can have adhesive on one surface to adhere the catheter 9 and / or the insulation pad 101 to the patient.

[0235] Figure 44 illustrates that the catheter 9 may have 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. A guidewire 99 can keep the insulation coil 102 straight during insertion into the nose 11. The insulation coil 102 may have foam insulation to minimize thermal transfer between the catheter 9 and the patient.

[0236] Figure 45a and 45b illustrate a variation of the catheter 9 in the stomach 2 with an expandable catheter array.

[0237] Figures 46a-46z3 illustrate that the catheter 9 can be inserted into and / or withdrawn from the body. For example, Figures 46a-46z3 illustrate that the catheter 9 can be inserted into and / or withdrawn from the gastrointestinal tract 110. For example, Figures 46a-46o illustrate that the catheter 9 can be inserted into the stomach 2 as shown by arrow 112 and Figures 46o-46z3 illustrate that the catheter 9 can be removed from the stomach 2 as shown by arrow 114. The insertion direction as shown by arrow 112 can be, for example, opposite the withdrawal direction as shown by 114. Figures 46a-46z3 illustrate that the catheter 9 can be introduced into and / or removed from the stomach 2, for example, through the esophagus 5. Figures 46a-46z3 illustrate that the target site 147 can be, for example, the stomach 2.

[0238] The catheter 9 can have one or multiple configurations 116 in the body, for example, in the gastrointestinal tract 110. The catheter 9 can be formed into the configurations 116, for example, during insertion of the catheter 9 into the body and / or during withdrawal of the catheter 9 from the body. The catheter 9 can be formed into the configurations 116, for example, by inserting the catheter 9 into the body and / or by withdrawing the catheter 9 from the body. Each one of the configurations 116 can include, for example, an arrangement of the catheter 9 inside the body (e.g., inside the gastrointestinal tract 1 10). For example, Figures 46a-46z3 illustrate twenty-nine configurations 1 16 that the catheter 9 can have in the body, for example, during insertion into and / or withdrawal from the gastrointestinal tract 110, including, for example, configurations 116a-116z3 or any combination thereof. For example, Figures 46a and 46z3 illustrate that configurations 116a and 116z3 can correspond to arrangements that the catheter 9 can have in the esophagus 5, and Figures 46b-46z2 illustrate that configurations 116b- 116z2 can correspond to arrangements that the catheter 9 can have in the stomach 2. The configurations 116a-l 16z3 can be, for example, a first configuration through atwenty-ninth configuration 116a-116z3, respectively, that the catheter 9 can form during insertion of the catheter 9 into the body and / or withdrawal of the catheter 9 from the body.

[0239] The catheter 9 can transfer heat to and / or from the body (e.g., to and / or from the heat transfer target 146) when the catheter 9 is in the body, including, for example, when the catheter 9 is in any of the configurations 116 (e.g., the configurations 116a-116z3 in Figures 46a-46z3). Any of the configurations 116 can be, for example, an operational state (also referred to as an operational configuration) of the catheter 9. When the catheter 9 is in an operational 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, the fluid 6, and the lumen can be, for example, the lumen 15 and / or the lumen 16. For example, Figures 46a-46z3 illustrate that the catheter 9 can have the lumen 15 and the lumen 16, that the lumen 15 can be an inflow lumen, and that the lumen 16 can be an outflow lumen. Figures 46a- 46z3 illustrate, for example, that configurations 116a-116z3 can each be an operational configuration of the catheter 9.

[0240] 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-46z3 illustrate that the configurations 116a- 116n and 116p- 116z3 can be partially deployed configurations of the catheter 9 and that the configuration 116o can be a fully deployed configuration of the catheter 9. As another example, any of the configurations 116 (e.g., configurations 116a-l 16z3) can be a fully deployed configuration. For example, when the configuration 116f is the fully deployed configuration, the catheter 9 can be inserted into the body to form the configuration 116f and then the catheter 9 can be withdrawn from the body without ever having formed configurations 116g- 116o. When the catheter 9 is in a partially deployed configuration (e.g., configurations 116a-116z3), the catheter 9 can transfer heat to and / or from the body, for example, by pumping the fluid 6 through the lumen 15 and the lumen 16. When the catheter 9 is in a fully deployed configuration (e.g., configurations 116a- 116z3), the catheter 9 can transfer heat to and / or from the body, for example, by pumping the fluid 6 through the lumen 15 and / or the lumen 16.

[0241] The configurations 116 formed by the catheter 9 during withdrawal of the catheter 9 from the body can be the same as or different than the configurations 116 formed by the catheter 9 during insertion of the catheter 9 into the body. Figures 46a-46z3 illustrate, for example, that the configurations 116 formed by the catheter 9 during withdrawal (e.g., configurations 116o- 116z3) can be the same as the configurations 116 formed by the catheter 9 during insertion (e.g., configurations 116a-l 16o). For example, Figures 46a-46z3 illustrate that the configurations 116p- 116z3 can be the same as the configurations 116n-116a, respectively (e.g., the sixteenth configuration 116p can be the same as the fourteenth configuration 1 16n, the twenty-seventh configuration 1 16z 1 can be the same as the third configuration 116c). As another example, the configurations 116 formed by the catheter 9during withdrawal of the catheter 9 from the body can be different from the configurations 116 formed by the catheter 9 during insertion of the catheter 9 into the body.

[0242] The catheter 9 can be formed into one or more of the configurations 116 in the target site 147, for example, before, during, and / or after passing (e.g., pumping) a fluid through a lumen in the catheter 9. The catheter 9 can be formed into a configuration 116 in the target site 147, for example, before, during, and / or after passing (e.g., pumping) a fluid through the first lumen 15 and / or the second lumen 16 in the catheter 9. For example, Figures 46a-46o illustrate that the catheter 9 can be formed into configurations 116a-116o before passing the fluid 6 through the first lumen 15 and / or the second lumen 16, and Figures 46p-46z3 illustrate that the catheter 9 can be formed into configurations 116p- 116z3 after passing (e.g., pumping) the fluid 6 through the first lumen 15 and / or the second lumen 16.

[0243] Passing a fluid through the catheter 9 may or may not change the configuration 116 of the catheter 9. For example, Figures 46a-46z3 illustrate that passing a 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 configurations 116 can remain constant before, during, and / or after a fluid is passed (e.g., pumped) through the catheter 9. For example, Figures 46a-46z3 illustrate that the configurations 116 (e.g., configurations 116a-l 16z3) can remain constant before, during, and after a fluid is passed (e.g., pumped) through the catheter 9.

[0244] 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 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 the stomach 2 (e.g., from the duodenum 37), or any combination thereof.

[0245] The catheter 9 can form one or multiple 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, an arrangement of the catheter 9 inside the body. Each shape 117 can be defined, for example, by the path that the catheter 9 has in the body. For example, each shape 117 can include the path that the catheter 9 traces through the body, for example, through the gastrointestinal tract 110 (e.g., through the stomach 2, the pylorus 65, and / or the 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, Figures 46a-46z3 illustrate that configurations 116a-116z3 can include and / or correspond to shapes 117a-117z3, respectively, such that the shapes 117a-l 17z3 can be the arrangement of the catheter 9 when thecatheter 9 is in configurations 116a- 116z3, respectively. For example, Figures 46a-46z3 illustrate that the catheter 9 can have twenty-nine shapes 117 that the catheter 9 can have in the body, for example, during insertion into and / or withdrawal from the gastrointestinal tract 110, including, for example, shapes 117a-117z3 or any combination thereof. For example, Figures 46a and 46z3 illustrate that shapes 117a and 117z3 can be the shapes (e.g., the paths) that the catheter 9 can have in the esophagus 5, and Figures 46b-46z2 illustrate that shapes 117b- 117z2 can be the shapes (e.g., the paths) that the catheter 9 can have in the stomach 2. The shapes 117a-l 17z3 can be, for example, a first shape through a twenty-ninth shape 117a-l 17z3, respectively, that the catheter 9 can have during insertion of the catheter 9 into the body and / or withdrawal of the catheter 9 from the body.

[0246] The catheter shape 117 in each configuration 116 can depend, for example, on 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 entry angle of the catheter 9 into the stomach 2 (e.g., from the esophagus 5), the entry angle of the catheter 9 into the duodenum 37 (e.g., from the stomach 2), the 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 the stomach 2 (e.g., the pancreas), the size of the organs adjacent the duodenum 37 (e.g., the pancreas), or any combination thereof. For example, based on these factors, a given length of the catheter 9 inserted into the stomach 2 (e.g., 100cm of the catheter 9, 150cm of the catheter 9, 200cm of the catheter) can form various configurations 116 having various shapes 117 in the stomach 2. For example, Figures 46a-46z3 illustrate that the catheter 9 can have shapes 117a- 117z3 in the stomach 2 as 30cm-300cm is inserted, or more narrowly, as 30cm-150cm is inserted, including every 1cm increment within these ranges. As another example, because of these factors, inserting the same length (e.g., 100cm, 150cm, 200cm) of the same catheter 9 (e.g., either literally the same catheter 9 or two different catheters 9 that arc the same make and model) into the same stomach 2 on two different occasions can result in forming the catheter 9 into two different configurations 116 and / or can result in forming the catheter 9 into two identical configurations 116. The catheter 9 can have, for example, a 1.0cm-3.0cm minimum bend radius, including every 0.1cm increment within this range (e.g., 1.0cm, 1.5cm, 1.6cm, 2.5cm). The stiffness of the catheter 9 can be quantified, for example, as the force needed to bend the catheter 9. The axial force to bend the catheter 9 can be, for example, greater than 2.0 Newtons-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. ON, greater than 6. ON). The axial force to bend the catheter 9 can be, for example, 2.0 Newtons-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).

[0247] The shapes 117 formed by the catheter 9 during withdrawal of the catheter 9 from the body can be the same as or different than the shapes 117 formed by the catheter 9 during insertion of the catheter 9 into the body. Figures 46a-46z3 illustrate, for example, that the shapes 117 formed by the catheter 9 during withdrawal (e.g., shapes 117o-l 17z3) can be the same as the shapes 117 formed bythe catheter 9 during insertion (e.g., shapes 117a- 117o). For example, Figures 46a-46z3 illustrate that the shapes 117p-117z3 can be the same as the shapes 117n-117a, respectively (e.g., the sixteenth shape 117p can be the same as the fourteenth shape 117n, the twenty-seventh shape 117zl can be the same as the third shape 117c). As another example, the shapes 117 formed by the catheter 9 during withdrawal of the catheter 9 from the body can be different from the shapes 117 formed by the catheter 9 during insertion of the catheter 9 into the body.

[0248] The shape 117 of the catheter 9 in each configuration 116 can include, for example, one or more straight sections of the catheter 9 and / or one or more curved sections of the catheter 9.

[0249] The catheter shape 117 in a deployed configuration (e.g., the configurations 116) can include, for example, one or more loops 118 formed by the catheter 9. The catheter 9 can have, for example, 1-30 or more loops 118 in a deployed configuration (e.g., the configurations 116), including every 1 loop increment within this range (e.g., 1 loop, 2 loops, 3 loops, 4 loops, 5 loops, 10 loops, 40 loops). The 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 loops 118. For example, Figures 46a-46z3 illustrate that the catheter 9 can have 1-4 or more loops 118 in a deployed configuration (e.g., configurations 116), including, for example, a loop 118a, a loop 118b, a loop 118c, a loop 118d, or any combination thereof. The loops 118a- 118d can be, for example, a first loop through a fourth loop (e.g., a first loop 118a, a second loop 118b, a third loop 118c, a fourth loop 118d).

[0250] Each of the loops 118 can have a loop first end 118-1, a loop second end 118-2, and a loop head 118-3.

[0251] Figures 46a-46z3 illustrate, for example, that the loop 118a can have a loop first end 118a-l, a loop second end 118a-2, and a loop head 118a-3. The loop first end 118a- 1, the loop second end 118a-2, and the loop head 118a-3 can be, for example, a first loop first end 118a- 1, a first loop second end 118a-2, and a first loop head 118a-3, respectively.

[0252] Figures 46a-46z3 illustrate, for example, that the loop 118b can have a loop first end 118b- 1 , a loop second end 118b-2, and a loop head 118b-3. The loop first end 118b-l, the loop second end 118b-2, and the loop head 118b-3 can be, for example, a second loop first end 118b-l, a second loop second end 118b-2, and a second loop head 118b-3, respectively.

[0253] Figures 46a-46z3 illustrate, for example, that the loop 118c can have a loop first end 118c-l, a loop second end 118c-2, and a loop head 118c-3. The loop first end 118c- 1, the loop second end 118c-2, and the loop head 118c-3 can be, for example, a third loop first end 118c-l, a third loop second end 118c-2, and a third loop head 118c-3, respectively.

[0254] Figures 46a-46z3 illustrate, for example, that the loop 118d can have a loop first end 118d- 1 , a loop second end 118d-2, and a loop head 118d-3. The loop first end 118d- 1 , the loop second end 118d-2, and the loop head 118d-3 can be, for example, a fourth loop first end 118d- 1 , a fourth loop second end 118d-2, and a fourth loop head 118d-3, respectively.

[0255] The loop first end 118-1 can be, for example, a first longitudinal end of the loop 118 along the catheter 9 (e.g., along the center longitudinal axis of the catheter 9). The loop second end 118-2 can be, for example, a second longitudinal end of the loop 118 along the catheter 9 (e.g., along the center longitudinal axis of the catheter 9). The loop first end 118-1 and / or the loop second end 118-2 can form a base of the loop 118 (also referred to as the loop base). The loop base can be, for example, the base of the loop first end 118-1, the base of the loop second end 118-2, a straight axis that connects the base of the loop first end 118-1 and the base of the loop second end 118-2, the location where the loop first end 118-1 and the loop second end 118-2 cross each other, or any combination thereof. The loop head 118-3 can be between the loop first end 118-1 and the loop second end 118-2. For example, the loop head 118-3 can be a middle portion of the loop 118 (e.g., of the catheter 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 portion of the loop first end 118-1 and a portion of the loop second end 118-2. The loop head 118-3 can be opposite (e.g., diametrically opposite) the base of the loop 118. The loop head 118-3 can have a loop apex. As another example, the loop head 118-3 can be the loop apex. The loop apex can be the midpoint along the catheter 9 between the loop first end 1 18-1 and the loop second end 118-2 and / or the loop apex can be the farthest point along the loop 118 as measured along a straight line from the loop base to the loop apex. The loop apex can, for example, divide the loop 118 into a first half and a second half (e.g., into two equal or non-equal halves). The first half of the loop 118 can include, for example, the loop first end 118-1 and / or a portion (e.g., half) of the loop head 118-3. The second half of the loop 118 can include, for example, the loop second end 118-2 and / or a portion (e.g., half) of the loop head 118-3. The loop head 118-3 can connect the loop first end 118-1 and the loop second 118-2 to each other. As another example, when the loop head 118-3 is considered the loop apex (e.g., as opposed to another section of the of the catheter 9), the loop first end 118-1 and the loop second end 118-2 can meet at the loop head 118-3 (e.g., at the loop apex). The loops 118 can be symmetrical or asymmetrical about a straight axis that intersects the loop base and the loop head 118-3 (e.g., the loop apex). The loop first end 118-1 can be shorter, longer, or the same length as the loop second end 118-2. The loop second end 118-2 can be shorter, longer, or the same length as the loop first end 118-1.

[0256] The loop first end 118-1, the loop second end 118-2, and the loop head 118-3 for each loop 118 can be, for example, different sections of the catheter 9 along the length of the catheter 9. Different loops 118 can include the same and / or different sections of the catheter 9. A loop 118 can include the same and / or different sections of the catheter 9 as another loop 118. For example, a first loop (e.g., loop 118a) can include the same and / or different sections of the catheter as a second loop (e.g., loop 118b, 118c, and / or 118d). As another example, a first loop (e.g., loop 118b) can include the same and / or different sections of the catheter as a second loop (e.g., loop 118a, 118c, or 118d). The loop first end 118-1, the loop second end 118-2, and the loop head 118-3 can have relative positions to each other along the length of the catheter 9. For example, Figures 46a-46z3 illustratethat the loop first end 118-1 can be proximal the loop second end 118-2 and the loop head 118-3 along the length of the catheter 9, that the loop second end 118-2 can be distal the loop first end 118-1 and the loop head 118-3 along the length of the catheter 9, and the loop head 118-3 can be distal the loop first end 118-1 and proximal the loop second end 118-2 along the length of the catheter 9.

[0257] Each loop 118 can be, for example, a closed loop or an open loop (e.g., one or more of the loops 118 can be an open loop and one or more of the loops 118 can be a closed loop). An open loop can be, for example, a loop 118 that has a loop first end 118-1 that is separated from a loop second end 118-2 by a gap. A closed loop can be, for example, a loop 118 that has a loop first end 118-1 that crosses a loop second end 118-2 or vice versa. The loop first end 118-1 and the loop second end 118- 2 of a closed loop may or may not contact each other.

[0258] The catheter shape 117 in a deployed configuration (e.g., the configurations 116) can include, for example, one or more cells 122. The catheter 9 can have, for example, 1 -30 or more cells 122 in a deployed configuration (e.g., the configurations 116), including every 1 cell increment within this range (e.g., 1 cell, 2 cells, 3 cells, 4 cells, 5 cells, 10 cells, 30 cells). The 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 loops 118 can define the cells 122. The cells 122 can be defined by an external surface of the catheter 9. The boundary of the cells 122 can be the catheter 9, for example, an exterior surface of the catheter 9. The cells 122 can be, for example, the spaces, openings, holes, and / or through holes between sections of the catheter 9 when the catheter is in a deployed configuration (e.g., the configurations 116). For example, Figures 46a-46z3 illustrate that the catheter 9 can have 1-4 or more cells 122 in a deployed configuration (e.g., configurations 116), including, for example, a cell 122a, a cell 122b, a cell 122c, a cell 122d, or any combination thereof. The cells 122a-122d can be, for example, a first cell through a fourth cell (e.g., a first cell 122a, a second cell 122b, a third cell 122c, a fourth cell 122d). Each cell 122 can be, for example, a closed cell or an open cell. An open cell can be, for example, the cell 122 of an open loop. A closed cell can be, for example, the cell 122 of a closed loop.

[0259] The catheter 9 can be formed into the catheter shapes 117, for example, into the loops 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 the stomach 2 (e.g., 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 the stomach 2 (e.g., from the pylorus 65 and / or the duodenum 37), or any combination thereof.

[0260] As the catheter 9 is inserted into the gastrointestinal tract 110, the catheter 9 can engage with, can be pushed against, and / or can be constrained by a wall of the gastrointestinal tract 110 which can, for example, cause the catheter 9 to form bends, form loops (e.g., loops 118), fold over itself, cross over itself, contact itself, or any combination thereof to form the configurations 116 having shapes 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 the duodenum 37, or any combination thereof. Figures 46a-46o illustrate, for example, that the catheter 9 can progressively form more elaborate configurations 116 having more elaborate shapes 117 as the catheter 9 is progressively inserted into the stomach 2 (e.g., through the esophagus 5). Figures 46a-46o illustrate, for example, that the loops 118 can be progressively formed by more proximal portions of the catheter.

[0261] As the catheter 9 is withdrawn from the gastrointestinal tract 110, the catheter 9 can straighten and / or become less curved which can, for example, cause the catheter 9 to unravel, unwind, uncoil, uncurl, unfold, and / or unbend to form the configurations 116 having shapes 117. As the catheter 9 is withdrawn from the gastrointestinal tract 110, the loops 118 can collapse (e.g., unravel, unwind, uncoil, uncurl, unfold, and / or unbend). Figures 46o-46z3 illustrate, for example, that the catheter 9 can progressively form less elaborate configurations 116 having less elaborate shapes 117 as the catheter 9 is progressively withdrawn from the stomach 2 (e.g., through the esophagus 5).

[0262] The loops 118 and the cells 122 can be formed by inserting the catheter 9 into and / or withdrawing the catheter 9 from the target site 147 (e.g., stomach 2, the pylorus 65, the duodenum 37, and / or a portion of the gastrointestinal tract 110 caudal the duodenum 37).

[0263] The loops 118 can change size and / or shape in the target site 147. For example, the size (e.g., the perimeter, length, width, and / or height) of the loops 118 can increase and / or decrease as the catheter 9 is inserted into the target site 147.

[0264] The loops 118 can have a perimeter (also referred to as a loop perimeter). The loop perimeter can be measured, for example, along a center longitudinal axis of the catheter 9 from the loop first end 118-1 to the loop second end 118-2. The loop perimeter can be, for example, 5.0cm-80.0cm, including every 0.5cm increment within this range (e.g., 5.0cm, 9.5cm, 15.0cm, 30.0cm, 50.0cm, 80.0cm). The loop perimeter can be, for example, greater than 9.0-70.0cm, including every 0.5cm increment within this range (e.g., greater than 5.0cm, 9.5cm, 15.0cm, 30.0cm, 50.0cm, 80.0cm). The loop perimeter can be, for example, less than 80.0cm. The loop perimeter can be, for example, greater than the lesser curvature of the stomach 2 and / or greater than the greater curvature of the stomach 2. Figures 46a-46z3 illustrate that the size (e.g., perimeter) of the loops 118 can increase and decrease in the target site 147. Figures 46a-46z3 illustrate, for example, that at least one of the loops 118 (e.g., the loop 118a) can have a perimeter greater than 9.5cm. Figures 46a-46z3 illustrate that the shape of a loop 118 can change, for example, as the sections that form the loop 118 (e.g., that form the loopfirst end 118-1, the loop second end 118-2, and / or the loop head 118-3) straighten and / or form bends and / or curves as the catheter 9 is inserted into and / or withdrawn from the target site 147.

[0265] The loops 118 can have a length, a width, and a height (also referred to as a loop length, a loop width, and a loop height).

[0266] The length of each loop 118 can be measured along a straight axis (also referred to as a straight line) from the base of the loop 118 to the loop head 118-3 of the loop 118 (e.g., to the apex of the loop 118). The loop length can be, for example, 3.0cm-40.0cm, including every 0.5cm increment within this range (e.g., 3.0cm, 9.0cm, 15.0cm, 30.0cm, 40.0cm). The loop length can be, for example, greater than 3.0-30.0cm, including every 0.5cm increment within this range (e.g., greater than 3.0cm, 9.0cm, 15.0cm, 30.0cm). The loop length 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 a length of the duodenum 37. For example, the loop length can be greater than 25%-100% of the length of the duodenum 37. For example, when the loop 118 is in both the stomach 2 and the duodenum, the loop length can be greater than the greater curvature of the stomach 2. The loop length can be greater than 3cm. The loop length can be, for example, less than 20.0cm-40.0cm, including every 0.5cm increment within this range (e.g., less than 20.0cm, 30.0cm, 40.0cm). The loop length can be, for example, less than the width of the widest section of the stomach 2 and / or less than the greater curvature of the stomach 2.

[0267] 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, 3.0cm-40.0cm, including every 0.5cm increment within this range (e.g., 3.0cm, 9.0cm, 15.0cm, 30.0cm, 40.0cm). The loop width can be, for example, greater than 3.0-30.0cm, including every 0.5 increment within this range (e.g., greater than 3.0cm, 9.0cm, 15.0cm, 30.0cm). 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 a width of the duodenum 37. For example, the loop width can be greater than 25%-100% of the width of the duodenum 37. The loop width can be greater than 3cm. The loop width can be, for example, less than 20.0cm-40.0cm, including every 0.5cm increment within this range (e.g., less than 20.0cm, 30.0cm, 40.0cm). The loop width can be, for example, less than the width of the widest section of the stomach 2 and / or less than the greater curvature of the stomach 2. The loop width can be the same as or different than the loop length.

[0268] The height of each loop 118 can be the 1.0-7.0 or more times the diameter of the catheter 9. The height of each loop 118 can be, for example, the height a flat plane that the loop extends through loop first end 118-1, the loop second end 118-2, and the loop head 118-3.

[0269] Figures 46a-46z3 illustrate that the loops 118 can have various sizes, shapes, and relative positions. Figures 46a-46z3 illustrate that some of the loops 118 can be smaller than another one ofthe loops 118. Figures 46a-46z3 illustrate that some of the loops 118 can be larger than another one of the loops 118.

[0270] The loops 118 can have one or multiple straight sections and / or curved sections of the catheter 9. The curved sections of the loops 118 can have a constant or a variable radius. Each loop 118 can have the same radius and / or a different radius than another one of the loops.

[0271] The loops 118 can change from an open loop to a closed loop inside the target site 147 (e.g., inside the stomach 2, the pylorus 65, and / or the duodenum 37) and / or can change from a closed loop to an open loop inside the target site 147 (e.g., inside the stomach 2, the pylorus 65, and / or the duodenum 37), 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. A loop 118 can have a closed section and an open section.

[0272] Each loop 118 can have the same size as or a different size than another one of the loops 118. A first loop (e.g., one of the loops 118) can have the same size as or a different size than a second loop (e.g., another one of the loops 118).

[0273] Each loop 118 can have the same shape as or a different shape than another one of the loops 118. A first loop (e.g., one of the loops 118) can have the same shape as or a different shape than a second loop (e.g., another one of the loops 118). The loops 118 can have, for example, a bulbous shape, an oblong shape, a teardrop shape, an irregular shape, or any combination thereof.

[0274] The catheter 9 can be moved relative to the loops 118 in the target site 147, for example, by inserting and / or withdrawing the catheter 9 from the target site 147. For example, Figures 46a-46z3 illustrate that catheter 9 inside the target site 147 can be moved (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 unwind. 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 against (e.g., slid against) one or more of the loops 118 in the target site 147. The catheter 9 can be pushed and / or pulled into a loop 118 which can cause the loop 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 of the loops 118 in the target site 147.

[0275] The loops 118 can be moved relative to each other in the target site 147, for example, by inserting and / or withdrawing the catheter 9 from the target site 147. For example, Figures 46a-46z3 illustrate that the loops 118a-l 18d can be moved relative to each other in in the target site 147. The loops 118 can be moved into and / or out of contact with each other in the target site 147. The loops 118 can be moved against (e.g., slid against) each other in the target site 147. The loops 118 can be moved toward and / or away from each other in the target site 147. The loops 118 can be moved over and / or under each other in the target site 147.

[0276] The cells 122 can change size and / or shape in the target site 147. For example, the size (e.g., the area, length, and / or height) of a cell 122 can increase and / or decrease as the catheter 9 is inserted into the target site 147 (e.g., the stomach 2 and / or the duodenum 37).

[0277] The cells 122 can have an area (also referred to as a cell area). The cell area can be the space bounded (e.g., enclosed) by the loops 118. For example, the cell area of the cell 122a can be the area of the space enclosed by the loop 118a. The loop area can be, for example, 7cm2-300cm2, including every 1cm2increment within this range (e.g., 7cm2, 50cm2, 100cm2, 300cm2). The loop area can be, for example, greater than 7cm2-300cm2, including ever 1cm2increment within this range (e.g., greater than 7cm2, 50cm2, 100cm2, 300cm2). Figures 46a-46z3 illustrate that the size of the cells 122 can increase and / or decrease in the target site 147, for example, as the loops 118 increase and / or decrease in size in the target site 147, respectively. Figures 46a-46z3 illustrate that the shape of a cell 122 can change, for example, as the shape of the loops 118 change.

[0278] The cells 122 can have a length, a width, and a height (also referred to as a cell length, a cell width, and a cell height).

[0279] The cell length can be measured along the same axis that the loop length can be measured along. For example, the cell length can be measured along the straight axis from the base of the loop 118 to the loop head 118-3 of the loop 118. The cell length can be the same as or different than the loop length. For example, when the loop length is measured from the base of the loop 118 to an external surface of the loop head 118-3, the cell length can be the same as the loop length. As another example, when the loop length is measured from the base of the loop 118 to a center longitudinal axis of the of the catheter 9 in the loop head 118-3, the cell length can be, for example, the loop length minus the radius or the diameter of the catheter 9.

[0280] The cell width can be measured along the same axis that the loop width can be measured along. For example, the cell width can be measured along the straight axis 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 cell width can be the same as or different than the loop width. For example, when the point on the loop first end 118-1 and the point on the loop second end 118-2 are on an external surface (e.g., a radial inner surface of the loop 118), the cell width can be the same as the loop width. As another example, when the point on the loop first end 118-1 and the point on the loop second end 118-2 are on a center longitudinal axis of the of the catheter 9, the cell width can be, for example, the loop width minus the diameter of the catheter 9.

[0281] The cell height can be, for example, the same as the loop height.

[0282] Figures 46a-46z3 illustrate that the cells 122 can have various sizes, shapes, and relative positions. Figures 46a-46z3 illustrate that some of the cells 122 can be smaller than another one of the cells 122. Figures 46a-46z3 illustrate that some of the cells 122 can be larger than another one of the cells 122.

[0283] The cells 122 can change from an open cell to a closed cell inside the target site 147 (e.g., inside the stomach 2, the pylorus 65, and / or the duodenum 37) and / or can change from a closed cell to an open cell inside the target site 147 (e.g., inside the stomach 2, the pylorus 65, and / or the duodenum37), 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 loops 118 can define open and / or closed cells 122. For example, open loops 118 can define open cells 122 and closed loops 122 can define open cells 122. As another example, loops 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 cells 122 and one or more closed cells 122 (e.g., the tip of the loop 118 can define a closed cell 122 and the base of the loop 118 can define an open cell 122).

[0284] Each cell 122 can have the same size as or a different size than another one of the cells 122. A first cell (e.g., one of the cells 122) can have the same size as or a different size than a second cell (e.g., another one of the cells 122).

[0285] Each cell 122 can have the same shape as or a different shape than another one of the cells 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 one of the cells 122). The cells 122 can have, for example, a bulbous shape, an oblong shape, a teardrop shape, an irregular shape, or any combination thereof.

[0286] The cells 122 can be aligned with each other, can be offset with each other, can overlap each other, or any combination thereof. For example, Figures 46a-46z3 illustrate that the cells 122 can be offset with each other and / or can overlap each other. Each of the cells 122 can have a cell central axis that extends through a center cell 122. When two cells 122 are aligned with each other, the central axis of the two cells 122 can be aligned with (e.g., coincident with) each other such that the catheter 9 can have a helical shape. When two cells 122 are offset with each other, the central axis of the two cells 122 can be offset from each other. For example, when two cells 122 are offset with each other, the central axis of the two cells 122 can be separated by a gap (also referred to as the cell axis gap). The central axes of the cells 122 can extend through the cells 122 at an angle perpendicular to the face of the of the cell. The cell axis gap between the cell central axis of a first cell (e.g., one of the cells 122) and the cell central axis of a second cell (e.g., another one of the cells 122) can be, for example, lcm-40cm or more, including every 1cm increment within this range (e.g., 1cm, 5cm, 10cm, 20cm, 40cm). The cell axis gap can be, for example, greater than lcm-40cm, including every 1cm increment within this range (e.g., greater than 1cm, 3cm, 4cm, 5cm, 40cm). The cell axis gap 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 of the cell central axes can be parallel with another cell central axis. One or more of the cell central axes can be at an angle (e.g., less than 180 degrees) relative to another cell central axis. The cells 122 can be separated from each other by gaps between loops and / or the cells 122 can overlap each other.

[0287] The cells 122 can be moved relative to each other (e.g., over and / or under each other) in the target site 147, for example, by inserting and / or withdrawing the catheter 9 from the target site 147. The cells 122 can be moved into and / or out of alignment with each other in the target site 147. Thecells 122 can be moved from first offset positions to second offset positions. The cells 122 may or may not be moved into and / or out of alignment with each other.

[0288] The catheter 9 (e.g., a portion of one of the loops 118) can be moved across one or more of the cells 122. The portion of the catheter 9 that extends across the cell 122 can partially occlude (also referred to as partially obstruct) the cell 122. The cells 122 can be obstructed and / or unobstructed by moving the catheter 9 over a cell 122 and / or by moving the catheter 9 away from the cell 122, respectively. Moving the catheter 9 across a cell 122 can, for example, split the cell 122 into two or more subcells.

[0289] Figures 46a-46z3 illustrate that the catheter 9 (e.g., the loops 118) and / or the cells 122 can have various arrangements and orientations in the target site 147, for example, 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 along a path having a curved axis that does not contact the stomach wall 108 from a gastroesophageal junction 120 of the gastrointestinal tract 110, through the stomach 2, to the pylorus 65. Figures 46a-46z3 illustrate that when the catheter 9 is in a deployed configuration (e.g., a configuration 116), the catheter 9 can obstruct a center of the flow path through the target site 147 (e.g., the flow path that extends through the stomach 2, the pylorus 65, and / or the duodenum 37). Figures 46a-46z3 illustrate that when the catheter 9 is in a deployed configuration (e.g., a configuration 116), the catheter 9 can extend across a center of the flow path through the target site 147 (e.g., the flow path that extends through the stomach 2, the pylorus 65, and / or the duodenum 37). When the catheter 9 is in a deployed configuration, the catheter 9 (e.g., the loops 118) can contact an anterior wall of the stomach 2, a posterior wall of the stomach 2, a superior wall of the stomach 2, an inferior wall of the stomach 2, a lateral wall of the stomach 2, a proximal wall of the stomach 2, a distal wall of the stomach 2, or any combination thereof. When the catheter 9 is in a deployed configuration, the cells 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-46z3 illustrate that the cells 122 can face the anterior wall of the stomach 2 and the posterior wall of the stomach 2. The cell central axis of the cells 122 can be at an angle of 70 degrees- 110 degrees relative to a longitudinal axis of the flow path through the target site 147 (e.g., relative to a flow path along having a curved axis from a gastroesophageal junction 120 of the gastrointestinal tract 110 to the pylorus 65), including every 1 degree increment within this range (e.g., 70 degrees, 90 degrees, 110 degrees). For example, the cells 122 can be perpendicular to the flow path through the target site 147.

[0290] The loops 118 and / or the cells 122 can be formed and / or collapsed in the target site 147 in any order. For example, Figures 46a-46o illustrate that the loops 1 18 (e.g., 1 18a, 1 18b, 1 18c, and / or 118d) can be formed in the order shown and Figures 46o-46z3 illustrate that the loops 118 (e.g., 118a,118b, 118c, and / or 118d) can be collapsed in the order shown. A loop 118 can be considered to collapse, for example, when the size (e.g., the perimeter) of the loop 118 decreases, the loop length of the loop 118 decreases, the loop width of the loop 118 decreases, the loop height of the loop 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 the cells 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-46c illustrate that during a first phase of loop formation, the loop 118a can be formed before the loop 118b, and Figures 46d-46f illustrate that during a second phase of loop formation, the loop 118a and the loop 118b can be formed simultaneously. As another example, Figures 46x-46z illustrate that during a first phase of loop collapse, the loop 118a and the loop 118b can simultaneously collapse, and Figures 46d-46f illustrate that during a second phase of loop collapse, the loop 118a can be collapsed after the loop 118 is collapsed.

[0291] Figures 46a-46z3 illustrate that the catheter 9 can be packed into and / or unpacked from a target site 147 in the body such that the catheter 9 crisscrosses and / or extends across the target site 147 in multiple directions. Figures 46a-46z3 illustrate that the target site 147 can be the stomach 2. The catheter 9 can be packed into a target site 147 by inserting the catheter 9 into the target site 147. The catheter 9 can be unpacked from the target site 147 by withdrawing the catheter 9 from the target site 147.

[0292] Figures 46a-46z3 illustrate that when the catheter 9 is in a deployed configuration (e.g., a configuration 116), the catheter 9 can define a mesh having cells (e.g., cells 122), a lattice structure having cells (e.g., cells 122), a matting having cells (e.g., cells 122), a path (e.g., a tortuous path) defining cells (e.g., cells 122) and nodes (e.g., the nodes can be where the catheter 9 crosses over itself — the catheter 9 may or may not contact itself at the nodes), a meandering path defining cells (e.g., cells 122), a serpentine path defining cells (e.g., cells 122), a scaffold having cells (e.g., cells 122), a 3D structure having cells (e.g., cells 122), an amorphous 3D structure having cells (e.g., cells 122), an arrangement having cells (e.g., cells 122), a web having cells (e.g., cells 122), a network having cells (e.g., cells 122), a labyrinth having cells (e.g., cells 122), a patchwork of sections of the catheter 9 that can crisscross each other, a tangled structure, a coil, a coiled structure, or any combination thereof. For example, Figures 46a-46z3 illustrate that the catheter 9 can form a coil 138 inside the target site 147 such that the catheter 9 winds back and forth in multiple directions across (e.g., longitudinally across and / or transversely across) the target site 147. Figures 46a-46z3 illustrate, for example, that the catheter 9 can extend across the target site 147 in multiple directions and / or zigzag across the target site 147.

[0293] The catheter 9 can have a total length 124 (also referred to as the total catheter total length 124). The catheter total length 124 can be, for example, 100cm-900cm or more, including every 1 cm increment within this range (e.g., 100cm, 200cm, 300cm, 500cm, 900cm). The total length 124 canbe, for example, the total length of the catheter 9 from a proximal end of the catheter 9 to a distal end of the catheter 9. The total length 124 can be, for example, the total length of the catheter 9 from a 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 a proximal terminal end of the catheter 9 to a distal terminal end of the catheter 9 (e.g., to a distal terminal end of the catheter tip 7). For example, total length 124 can be, for example, the total length of the catheter 9 from the connector 14 to a distal terminal end of the catheter 9. As another example, the total length 124 can be, for example, the total length of the catheter 9 from a handle of the catheter 9 to a distal terminal end of the catheter 9 (e.g., to a distal terminal end of the catheter tip 7).

[0294] 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, 20cm-600cm, 20cm-300cm, 30cm-300cm, 50cm-300cm, 70cm-300cm, or 110cm-300cm, including every 1cm increment within these ranges (e.g., 20cm, 30cm, 40cm, 50cm, 60cm, 100cm, 110cm, 150cm, 300cm, 600cm). The length 126 can be, for example, 5%-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, 10% or more, 20% or more 30% or more, 40% or more, 50% or more, 60% or more, and / or 70% or more of the total length 124. The length 126 of the catheter 9 in the target site 147 can include a distal portion of the catheter 9. For example, 50% or less of the total length 124 can be in the target site 147. As another example, the length 126 of the catheter 9 in the target site 147 can include a proximal portion of the catheter 9 and a distal portion of the catheter 9. For example, greater than 50% of the total length 124 can be in the target site 147. For example, the catheter 9 can have a midpoint between the proximal terminal end of the catheter 9 and the distal terminal end of the catheter 9. The proximal portion of the catheter 9 can be the portion of the catheter 9 proximal the midpoint and the distal portion of the catheter 9 can be the portion of the catheter 9 distal 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).

[0295] Different lengths (e.g., any length 126) of the catheter 9 can be introduced into and / or removed from the target site 147. The length 126 of the catheter 9 in the target site 147 can be increased and / or decreased. For example, more and / or less length of the catheter 9 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 in the target site 147 can be adjusted, for example, before, during, and / or after transferring heat to and / or from the catheter 9 (e.g., before, after, and / or while passing the fluid 6 through the catheter 9). For example, the catheter length 126 in the target site 147 can be increased and / or decreased. Adjusting the length of the catheter 9 in the target site 147 can, for example, impact the surface area of the catheter 9 that contacts the stomach 2 and / or impact the total heat transfer to the stomach 2 and / or other organs. Figures 46a-46o illustrate, for example, that increasing the length 126 of thecatheter 9 in the target site 147 can increase the surface area of the catheter 9 inside the target site 147 and can increase the total heat transfer to and / or from the stomach 2 and / or other organs. Figures 46o- 46z3 illustrate, for example, that decreasing the length 126 of the catheter 9 in the stomach 2 can decrease the surface area of the catheter 9 inside the stomach 2 and can decrease the total heat transfer to and / or from the stomach 2 and / or other organs. The configuration 116 and the 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 the 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, any of the configurations 116 and shapes 117 in Figures 46a-46z3 can be a first configuration and a first shape, respectively, and any of the configurations 116 and shapes 117 in Figures 46a-46z3 can be a second configuration and a second shape, respectively. For example, Figures 46a-46z3 that the arrangement and / or path (e.g., the shape 117) that the catheter 9 can have in the target site 147 can depend on the length of the catheter 9 that is in the target site 147. Figures 46a-46z3 illustrate that the arrangement and / or path (e.g., the shape 117) of the catheter 9 can change, for example, as the catheter 9 is inserted into and / or withdrawn from the target site 147. Figures 46a-46z3 illustrate, for example, that the arrangement and / or path (e.g., the shape 117) of the catheter 9 can be changed by increasing and / or decreasing the length 126 of the catheter 9 in the target site 147.

[0296] The catheter 9 can have one or multiple heat transfer regions 128, for example, 1-30 or more heat transfer regions 128, including every 1 heat transfer region increment within this range (e.g., 1 heat transfer region, 2 heat transfer regions, 30 heat transfer regions). One or more portions of the catheter 9 can be a heat transfer region 128. One or more portions of the catheter 9 can have a heat transfer region 128. The heat transfer region 128 can be a length (e.g., a section) of the catheter 9. The heat transfer region 128 can be a continuous length of the catheter 9. For example, the heat transfer region 128 can be a length of the catheter 9, for example, the length 126 and / or the total length 124. For example, the portion of the catheter 9 in the target site 147 can be a heat transfer region 128 and / or the entire length of the catheter 9 can be a heat transfer region 128. As another example, the heat transfer region 128 can be, for example, 50%-100% of a length (e.g., the catheter length 126) of the catheter 9 positionable in the target site 147. As another example, when the catheter 9 is in a deployed configuration (e.g., a configuration 116), the heat transfer region 128 can be, for example, 50%-100% of a length (e.g., the catheter length 126) of the catheter 9 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 a deployed configuration (e.g., a configuration 116), the heat transfer region 128 can be, for example, 50%-100% of a length (e.g., the catheter length 126) of the catheter 9 inside the body (e.g., inside the mouth, a nasal passageway, a nasal cavity, the esophagus 5, the stomach 2, the pylorus 65, the duodenum 37, the jejunum 10, or any combination thereof). Figures 46a-46z3 illustrate, forexample, that the heat transfer region 128 can extend continuously along a length (e.g., the length 126) of the catheter 9. Figures 46a-46z3 illustrate that the heat transfer region 128 can be the catheter 9, for example, a length of the catheter 9 (e.g., the length 126 of the catheter 9). The heat transfer regions 128 can be, for example, one or more lengths (e.g., one or more sections) of the catheter 9. The heat transfer regions 128 can be integrated with and / or attached to each other. The heat transfer regions 128 can be, for example, the loops 118. Each loop 118 in a 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-46z3 illustrate that each loop 118 in a configuration 116 can be a different portion of the same heat transfer region 128.

[0297] The heat transfer regions 128 can have a length 130 (also referred to as the heat transfer region length 130). The length 130 can be, for example, 10% or more, 20% or more 30% or more, 40% or more, 50% or more, 60% or more, and / or 70% or more of the length 126 and / or the total length 124. The length 130 can be the same as or different than the catheter length 126 and / or the total length 124. For example, the portion of the catheter 9 having the length 126 can be a heat transfer region 128 (e.g., a continuous heat transfer region) such that the configurations 1 16 and the shapes 117 of the catheter 9 can be the configurations and shapes of the heat transfer region 128. For example, the heat transfer region 128 can be formed into the configurations 116 having shapes 117. Each loop 118 of a shape 117 can be a different heat transfer region 128 (e.g., the perimeter of each loop 118 can be the length of each heat transfer region 128) amd / or can be different portions of the same heat transfer region 128 (e.g., the portion of the catheter having the length 126 can be the heat transfer region 126). A ratio of the length 130 to a length of the target site 147) can be, for example, 1.5 to 20.0.

[0298] The path (e.g., the shape 117) of the heat transfer region 128 in the target site 147 can vary. For example, Figures 46a-46z3 that the path (e.g., the shape 117) that the heat transfer region 128 can have in the target site 147 can depend on the length 130 of the heat transfer region 128 that is in the target site 147. Figures 46a-46z3 illustrate that the path (e.g., the shape 117) of the heat transfer region 128 can change, for example, as the catheter 9 is inserted into and / or withdrawn from the target site 147. Figures 46a-46z3 illustrate, for example, that the path (e.g., the shape 117) can be changed by increasing and / or decreasing the length 126 of the catheter 9 in the target site 147.

[0299] When the catheter 9 is in a deployed configuration (e.g., a configuration 116), the heat transfer region 128 can be proximal and / or distal the catheter tip 7. For example, Figures 46a-46z3 illustrate that the heat transfer region 128 can be proximal the catheter tip 7. When the catheter 9 is in a deployed configuration, the heat transfer region 128 can be proximal and / or distal a distal terminal end of the catheter 9. For example, Figures 46a-46z3 illustrate that the heat transfer region 128 can be proximal the distal terminal end of the catheter 9. Figures 46a-46z3 illustrate that the heat transfer region 128 can extend proximally away from the catheter tip 7. As another example, the heat transferregion 128 can extend proximally away from the catheter tip 7 and / or distally away from the catheter tip 7. The heat transfer region 128 can be between a distal end of the catheter 9 and a proximal end of the catheter 9 along the length of the catheter 9. The heat transfer region 128 can be between a distal terminal end of the catheter 9 and a proximal terminal end of the catheter 9 along the length of the catheter 9.

[0300] The heat transfer region 128 can be, for example, any portion of the catheter 9 that has a lumen (e.g., the lumen 15 and / or the lumen 16). For example, the heat transfer region 128 can be any portion of the catheter that has an inflow lumen and / or an outflow lumen (e.g., the lumen 15 and / or the lumen 16). The distal terminal end of the heat transfer region 128 can be, for example, the merge zone 105 of the inflow lumen and the outflow lumen. The merge zone 105 can be inside the catheter 9, for example, inside a distal end of the catheter 9. The merge zone 105 can be inside the distal end of the catheter (e.g., inside the catheter tip 7), for example, 0.10cm- 10.00cm proximal the distal terminal end of the catheter 9, including every 0.10cm increment within this range (e.g., 0.10cm, 1.00cm, 2.00cm, 5.00cm, 10.00cm). The heat transfer region 128 can terminate anywhere along the length of the catheter 9. For example, the heat transfer region 128 can terminate, for example, where the inflow lumen and the outflow lumen merge (e.g., at the merge zone 105).

[0301] The catheter 9 (e.g., the heat transfer region 128) can transfer heat when a fluid (e.g., the fluid 6) is in the catheter 9. For example, the catheter 9 (e.g., the heat transfer region 128) can transfer heat to and / or from the body when a fluid is pumped through a lumen in the catheter 9, for example, through an inflow lumen and an outflow lumen (e.g., the lumen 15 and the lumen 16). For example, when a fluid is in the catheter 9 (e.g., in the heat transfer region 128) and the fluid has a temperature greater than or less than the surrounding tissue, heat can be transferred to and / or from the fluid through the catheter wall to and / or from the surrounding tissue. When a fluid is in the catheter 9 (e.g., in the heat transfer region 128) and the fluid has a temperature greater than or less than the surrounding tissue, the fluid can emit and / or absorb heat, for example, through the wall of the catheter 9. The catheter 9 can emit and / or absorb heat.

[0302] The catheter 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 zone 132 can be, for example, a space adjacent the catheter 9. The heat transfer zone 132 can extend (e.g., radially extend) away from the catheter 9. For example, the heat transfer zone 132 can have a cylindrical shape (e.g., a hollow cylindrical shape) that extends along a length of the catheter 9 (e.g., the total length 124, the length 126, and / or the length of the heat transfer region 128). The catheter 9 can extend through the heat transfer zone 132. For example, the catheter 9 can extend through a longitudinal center of the of the heat transfer zone 1 2. The heat transfer zone 132 can extend, for example, a distance 132d (e.g., a radius) of 1 cm- 10cm or more away (e.g., radially away) from the catheter 9, for example, as measured from a center longitudinal axis Ac of the catheter 9 orfrom the exterior surface of the catheter 9, including every 1cm increment within this range (e.g., 1cm, 2cm 5cm, 10cm).

[0303] The heat transfer zone 132 of different lengths (also referred to as sections) of the catheter 9 can overlap with each other. For example, when the catheter is in a configuration 116, a first heating zone of a first length of the heat transfer region 128 can overlap 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 catheter 9 and the second heating zone can be the heating zone 132 of any second length of the catheter 9. For example, the first heating zone can be a heating zone 132 that can extend from the loop first end 118-1 to the loop second end 118-1 of one of the loops 118 (e.g., the loop 118a) and the second heating zone can be a heating zone 132 that can extend from the loop first end 118-1 to the loop second end 118-1 of another one of the loops 118 (e.g., the loop 118b, 118c, or 118d). As another example, the first heating zone can be the heating zone 132 that can extend from one of the loops 118 (e.g., loop 118a) and the second heating zone can be the heating zone 132 that can extend from another one of the loops 118 (e.g., loop 118b, 118c, or 118d). As yet another example, the first heating zone can be a heating zone 1 2 that can extend from the loop first end 1 18-1 to the loop second end 118-1 of one of the loops 118 (e.g., the loop 118a) and the second heating zone can be a heating zone 132 that can extend from the loop second end 118-2 of the same or a different loop 118 (e.g., the loop 118a, 118b, 118c, or 118d).

[0304] The catheter 9 can have various configurations 116 and / or shapes 117 in the target site 147. For example, the catheter 9 can have the configurations 116 and the shapes 117 shown in Figures 46a- 58b. The catheter 9 can have various positions relative to itself, the target site 147, and the surrounding organs. For example, the catheter 9 can have the various positions relative to itself, the target site 147, and the surrounding organs shown in Figures 46a-58b. The loops 118 can have various relative positions to each other. For example, the loops 118 can have the relative positions between each other shown in Figures 46a-58b. The loops 118 can have various sizes and / or shapes. For example, the loops 118 can have the sizes and / or shapes shown in Figures 46a-58b. The cells 122 can have various sizes, shapes, and / or relative positions. For example, the cells 122 can have the sizes, shapes, and / or relative positions shown in Figures 46a-58b.

[0305] In Figures 46b-46z2, reference points B1-B2, C1-C2, D1-D4, E1-E3, F1-F3, G1-G3, H1-H4, 11-15, J1-J5, K1-K5, L1-L5, M1-M5, N1-N5, O1-O5 are provided to assist in the identification of different sections of the catheter 9 and to assist in the description of the shapes 117 (e.g., shapes 117a- 117z3) and / or the loops 118 that the catheter 9 can have. The reference points are used, for example, to refer to different sections of the catheter 9. The different sections can be integral with each other and / or attached to each other. For example, the different sections of the catheter 9 can be sections of a single length of the catheter 9 (e.g., sections of the total length 124 of the catheter 9). Reference points Bl, Cl, DI, El, DI, El, Fl, Gl, Hl, II, JI, KI, LI, Ml, Nl, and O1 can mark, for example,the distal terminal end of the catheter 9 and / or the distal terminal end of the heat transfer region 128. Reference points B2, C2, D3, E3, F3, G3, H4, 15, J5, K5, L5, M5 N5, and 05 can mark, for example, the location that catheter 9 enters the target site 147.

[0306] Figures 46a-46o illustrate that when the catheter 9 is in the first through the fifteenth configuration 116a-l 16o, the catheter 9 can have the first through the fifteenth the shape 117a-l 17o, respectively. Figures 46a-46o illustrate that the catheter 9 can change from the first to through the fifteenth configuration 116a-l 16o by inserting the catheter 9 into the target site 147. Figures 46o- 46z3 illustrate that when the catheter 9 is in the fifteenth through the twenty-ninth configuration 116o- 116z3, the catheter 9 can have the fifteenth through the twenty-ninth shape 117o-l 17z3, respectively. Figures 46a-46z3 illustrate that the catheter 9 can change from the fifteenth to the twenty-ninth configuration 116o-l 16z3 by withdrawing the catheter 9 from the target site 147.

[0307] Figure 46a illustrates that when the catheter tip 7 is in the esophagus 5, the catheter 9 may not have a loop 118. As another example, when the catheter tip 7 is in the esophagus 5, the catheter 9 can have loops that can expand upon entry into the target site 147 and / or when the loops are inflated.

[0308] Figure 46b illustrates that the first loop 118a can be formed by section B1-B2 of the of the catheter 9. The length of section B1-B2 of the catheter 9 can be, for example, the length 126.

[0309] Figure 46c illustrates that the first loop 118a can be formed by section C1-C2 of the of the catheter 9. The length of section C1-C2 of the catheter 9 can be, for example, the length 126. Figure 46c illustrates that the size (e.g., the perimeter) of the first loop 118a can 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 illustrates that the gap between the first loop first end 118a-l and the first loop second end 118a-2 can be smaller when the catheter 9 is in the third configuration 116c than when the catheter 9 is in the second configuration 116b. Figure 46c illustrates that the catheter tip 7 can be in a different position in the target site 147 when the catheter 9 is in the third configuration 116c than when the catheter 9 is in the second configuration 116b. For example, Figure 46c illustrates that the catheter tip 7 can be closer to a superior portion of the stomach 2 and / or to the gastroesophageal junction 120 when the catheter 9 is in the third configuration 116c than when the catheter 9 is in the second configuration 116b.

[0310] Figure 46d illustrates that the first loop 118a can be formed by section D1-D3 of the of the catheter 9 and that the second loop 1 18b can be formed by section D2-D4 of the catheter 9. The length of section D1-D3 of the catheter 9 can be, for example, the length 126. The length of section D2-D4 can be, for example, less than the length of section D1-D3. Figure 46d illustrates that section D3-D4 of the second loop 118b can be in the esophagus 5 and that section D2-D3 of the second loop 118b can be in the target site 147. Figure 46d illustrates that the same section of the catheter 9 can define multiple loops 118. For example, Figure 46d illustrates that section D2-D3 of the catheter 9 can be a section of the first loop 118a and a section of the second loop 118b. Figure 46d illustrates,for example, that the second loop 118b can be formed from a section (e.g., section D2-D3) of the first loop 118a. Figure 46d illustrates that the size (e.g., the perimeter) of the first loop 118a can be larger when the catheter 9 is in the fourth configuration 116d than when the catheter 9 is in the third configuration 116c. Figure 46d illustrates that the gap between the first loop first end 118a-l and the first loop second end 118a-2 can be smaller when the catheter 9 is in the fourth configuration 116d than when the catheter 9 is in the third configuration 116b. Figure 46d illustrates that when the catheter 9 is in the fourth configuration 116d, the catheter tip 7 can be in the same position in the target site 147 as when the catheter 9 is in the third configuration 116c.

[0311] Figure 46e illustrates that the first loop 118a can be formed by section E1-E3 of the of the catheter 9 and that the second loop 118b can be formed by section E2-E3 of the catheter 9. The length of section E1-E3 of the catheter 9 can be, for example, the length 126. The length of section E2-E3 can be, for example, less than the length of section E1-E3. Figure 46e illustrates that the size (e.g., the perimeter) of the first loop 118a and / or the second loop 118b can 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 illustrates that the second loop 1 18b can be closer to the catheter tip 7 when the catheter 9 is in the fifth configuration 116e than when the catheter 9 is in the fourth configuration 116d. Figure 46e illustrates that the second loop 118b (e.g., the second loop head 118b-3) can be closer to the first loop 118a (e.g., to the first loop first end 118a-l and / or to the first loop head 118a-3) when the catheter 9 is in the fifth configuration 116e than when the catheter 9 is in the fourth configuration 116d. Figure 46d illustrates that when the catheter 9 is in the fifth configuration 116e, the catheter tip 7 can be in the same position in the target site 147 as when the catheter 9 is in the fourth configuration 116d. Figure 46e illustrates that the gap between the first loop first end 118a-l and the first loop second end 118a-2 can be smaller when the catheter 9 is in the fifth configuration 116c (e.g., the gap between reference points El and E3) than when the catheter 9 is in the fourth configuration 116d (e.g., the gap between reference points DI and D3).

[0312] Figure 46f illustrates that the first loop 118a can be formed by section F1-F3 of the of the catheter 9 and that the second loop 118b can be formed by section F2-F3 of the catheter 9. The length of section F1-F3 of the catheter 9 can be, for example, the length 126. The length of section F2-F3 can be, for example, less than the length of section F1-F3. Figure 46f illustrates that the size (e.g., the perimeter) of the first loop 118a and / or the second loop 118b can 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 illustrates that the second loop 118b (e.g., the second loop head 118b-3) can be closer to the first loop 118a (e.g., to the first loop first end 118a-l and / or to the first loop head 118a-3) when the catheter 9 is in the sixth configuration 116f than when the catheter 9 is in the fifth configuration 116e.

[0313] Figure 46g illustrates that the first loop 1 18a can be formed by section G1 -G3 of the of the catheter 9 and that the second loop 118b can be formed by section G2-G3 of the catheter 9. Thelength of section G1-G3 of the catheter 9 can be, for example, the length 126. The length of section G2-G3 can be, for example, less than the length of section G1-G3. Figure 46g illustrates that the size (e.g., the perimeter) of the first loop 118a and / or the second loop 118b can 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 illustrates that the second loop 118b (e.g., the second loop head 118b-3) can be closer to the first loop 118a (e.g., to the first loop first end 118a- 1 and / or to the first loop head 118a-3) when the catheter 9 is in the seventh configuration 116g than when the catheter 9 is in the sixth configuration 116f. Figures 46d-46g illustrate that increasing the length of the catheter 9 in the target site 147 (e.g., the stomach 2) can move the second loop 118b toward the first loop 118a. Figures 46f- 46g illustrate that increasing the length of the catheter 9 in the target site 147 (e.g., the stomach 2) can move the second loop 118b across (e.g., over or under) the first ioop 118a. Figures 46f-46g illustrate that increasing the length of the catheter 9 in the target site 147 can pinch the first loop 118a closed which can split the first cell 122a into subcells, for example, a first subcell 122al and a second subcell 122a2. Figure 46g illustrates that the first subcell 122al can be an open cell and that the second subcell 122a2 can be a closed cell. Figure 46g illustrates, for example, that the second cell 122b can be between the first subcell 122al and the second subcell 122a2. Figures 46d-46f illustrate that increasing the length of the catheter 9 in the target site 147 (e.g., the stomach 2) can move the second loop 118b (e.g., the second loop first end 118b- 1 ) toward the catheter tip 7. Figures 46f-46g illustrate that increasing the length of the catheter 9 in the target site 147 (e.g., the stomach 2) can move the second loop 118b (e.g., the second loop first end 118b- 1 ) away from the catheter tip 7.

[0314] Figure 46h illustrates that the first loop 118a can be formed by section H1-H4 of the of the catheter 9, that the second loop 118b can be formed by section H2-H4 of the catheter 9, and that the third loop 118c can be formed by section H3-H4 of the catheter 9. The length of section H1-H4 of the catheter 9 can be, for example, the length 126. The length of sections H2-H4 and H3-H4 can be, for example, less than the length of section H1-H4. Figure 46h illustrates that the size (e.g., the perimeter) of the third loop 118c can 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 illustrates that the third loop 118c can be farther from the gastroesophageal junction 120 when the catheter 9 is in the eighth configuration 116h than when the catheter 9 is in the seventh configuration 116g. Figure 46h illustrates that the same section of the catheter 9 can define multiple loops 118. For example, Figure 46h illustrates that section H3-H4 of the catheter 9 can be a section of the second loop 118b and a section of the third loop 118c. Figure 46h illustrates that the first loop 118 can extend back and forth across the target site 147. For example, Figure 46h illustrates that the first loop first end 118a-l can extend back and forth across the target site 147. Figure 46h illustrates that a portion of the first loop 118a can extend across (e.g., over or under) the second cell 122b. Figure 46h illustrates that the portion of the first loop 118a that extends across the second cell 122b can partially obstruct the second cell 122b. Figure 46h illustrates that the second loop 118b can extend across (e.g., over or under) thefirst loop 118a such that a cell 134 can be created between the first loop 118a and the second loop 118b. Figure 46h illustrates that a first section of the catheter 9 (e.g., the second loop head 118b-3) can extend across a second section of the catheter 9 (e.g., the first loop second end 118a-2 and / or the first loop head 118-3) at two locations, for example, at opposite ends of the cell 134. Figure 46h illustrates that the cell 134 can be created, for example, between a radial outer surface of the first loop 118a and a radial inner surface of the second loop 118b.

[0315] Figure 46i illustrates that the first loop 118a can be formed by section 11-15 of the of the catheter 9, that the second loop 118b can be formed by section 12-14 of the catheter 9, and that the third loop 118c can be formed by section 13-15 of the catheter 9. The length of section 11-15 of the catheter 9 can be, for example, the length 126. The length of sections 12-14 and 13-15 can be, for example, less than the length of section 11-15. Figure 46i illustrates that the size (e.g., the perimeter) of the third loop 118c can 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-46i illustrate that increasing the length of the catheter 9 in the target site 147 can pinch the second loop 118b closed which can split the second cell 122b into suhcells, for example, a first subcell 122b 1 and a second suhcell 122b2. Figure 46i illustrates that the first subcell 122bl can be an open cell and that the second subcell 122b2 can be a closed cell. Figure 46i illustrates, for example, that a first section of the catheter 9 (e.g., the second loop first end 118b- 1 and / or the third loop head 118c-3) can be adjacent to and / or in contact with a second section of the catheter 9 (e.g., second loop second end 118b-2) at a location Zl. Figures 46h- 46i illustrate, for example, that increasing the length of the catheter 9 in the target site 147 can cause a first section of the catheter 9 (e.g., the second loop first end 118b- 1 and / or the third loop head 118c-3) to move adjacent to and / or in contact with a second section of the catheter 9 (e.g., second loop second end 118b-2) at the first location Zl.

[0316] Figure 46j illustrates that the first loop 118a can be formed by section J1-J5 of the of the catheter 9, that the second loop 118b can be formed by section J2-J4 of the catheter 9, and that the third loop 118c can be formed by section J3-J5 of the catheter 9. The length of section J1-J5 of the catheter 9 can be, for example, the length 126. The length of sections J2-J4 and J3-J5 can be, for example, less than the length of section JI -J5. Figure 46j illustrates that the size (e.g., the perimeter) of the third loop 118c can 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-46j illustrate that increasing the length of the catheter 9 in the target site 147 can cause a first section 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) a second section of the catheter 9 (e.g., second loop second end 118b-2) from the first location Zl to a second location Z2. Figure 46j illustrates that location Z2 can be farther from the esophagus 5 and / or closer to the pylorus 65 by a distance Z3. The distance Z3 can be, for example, lcm-5cm or more, including every 1cm increment within this range (e.g., 1cm, 2cm, 3cm, 5cm). Figures 46i-46j illustrate, for example, that a first section of the catheter 9 (e.g., the second loop first end 118b- 1 and / or the third loop head 118c-3) candeform a second section of the catheter 9 (e.g., second loop second end 118b-2), for example, by the first section moving into the second section as the catheter 9 is packed into the target site 147.Figures 46i-46j illustrate, for example, that the second section of the catheter 9 (e.g., second loop second end 118b-2) can resist movement of the first section of the catheter 9 (e.g., the second loop first end 118b- 1 and / or the third loop head 118c-3) into the target site 147 as the catheter 9 is packed into (e.g., inserted into) the target site 147.

[0317] Figure 46k illustrates that the first loop 118a can be formed by section K1-K5 of the of the catheter 9, that the second loop 118b can be formed by section K2-K4 of the catheter 9, and that the third loop 118c can be formed by section K3-K5 of the catheter 9. The length of section K1-K5 of the catheter 9 can be, for example, the length 126. The length of sections K2-K4 and K3-K5 can be, for example, less than the length of section K1-K5. Figure 46k illustrates that the size (e.g., the perimeter) of the third loop 118c can 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 illustrates that a portion of the second loop 118b (e.g., the second loop second end 118b-2) can extend across the third cell 122c. Figure 46k illustrates that the portion of the second loop 1 18b that extends across the third cell 122c can partially obstruct the third cell 122c. Figure 46k illustrates that a first section of the catheter 9 (e.g., the second loop first end 118b- 1 and / or the third loop head 118c-3) can extend across (e.g., over or under) a second section of the catheter 9 (e.g., second loop second end 118b-2) at two locations. Figure 46k illustrates that the third cell 122c can overlap with the first cell 122a (e.g., with the second subcell 122a2).

[0318] Figure 461 illustrates that the first loop 118a can be formed by section L1-L5 of the of the catheter 9, that the second loop 118b can be formed by section L2-L4 of the catheter 9, and that the third loop 118c can be formed by section L3-L5 of the catheter 9. The length of section L1-L5 of the catheter 9 can be, for example, the length 126. The length of sections L2-L4 and L3-L5 can be, for example, less than the length of section L1-L5. Figure 461 illustrates that more of the third cell 122c can overlap with the first cell 122a (e.g., with the second subcell 122a2) when the catheter 9 is in the twelfth configuration 1161 than when the catheter 9 is in the eleventh configuration 116k. Figure 461 illustrates that a first section of the catheter 9 (e.g., the second loop first end 118b- 1 and / or the third loop head 118c-3) can be adjacent to and / or in contact with a second section of the catheter 9 (e.g., the first loop head 118a-3). Figures 46k-461 illustrate, for example, that increasing the length of the catheter 9 in the target site 147 can cause a first section of the catheter 9 (e.g., the second loop first end 118b- 1 and / or the third loop head 118c-3) to move adjacent to and / or in contact with a second section of the catheter 9 (e.g., the first loop head 118a-3). Figures 46h-461 illustrate that increasing the length of the catheter 9 in the target site 147 (e.g., the stomach 2) can move the third loop 118c toward a boundary of the shape 117.

[0319] Figure 46m illustrates that the first loop 118a can be formed by section M1-M5 of the of the catheter 9, that the second loop 118b can be formed by section M2-M4 of the catheter 9, that the third loop 118c can be formed by section M3-M5 of the catheter 9, and that the fourth loop 118d can be formed by section M4-M5. The length of section M1-M5 of the catheter 9 can be, for example, the length 126. The length of sections M2-M4, M3-M5, and M4-M5 can be, for example, less than the length of section M1-M5. Figure 46m illustrates that more of the third cell 122c can overlap with the first cell 122a (e.g., with the second subcell 122a2) when the catheter 9 is in the thirteenth configuration 116m than when the catheter 9 is in the twelfth configuration 1161. Figure 46m illustrates that the second loop 118b and the third loop 118c can define an infinity shape. For example, Figure 46m illustrates that section M2-M4 of the catheter 9 can include the infinity shape.

[0320] Figure 46n illustrates that the first loop 118a can be formed by section N1-N5 of the of the catheter 9, that the second loop 1 18b can be formed by section N2-N4 of the catheter 9, that the third loop 118c can be formed by section N3-N5 of the catheter 9, and that the fourth loop 118d can be formed by section N4-N5. The length of section N1-N5 of the catheter 9 can be, for example, the length 126. The length of sections N2-N4, N3-N5, and N4-N5 can be, for example, less than the length of section N1-N5. Figure 46n illustrates that the size (e.g., the perimeter) of the fourth loop 118d can be larger when the catheter 9 is in the fourteenth configuration 116n than when the catheter 9 is in the thirteenth configuration 116m. Figures 46m-46n illustrate that increasing the length of the catheter 9 in the target site 147 can pinch the third loop 118c closed which can split the third cell 122c into subcells, for example, a first subcell 122c 1 and a second subcell 122c2. Figure 46n illustrates that the first subccll 122c 1 can be an open cell and that the second subccll 122c2 can be a closed cell. Figure 46n illustrates, for example, that a first section of the catheter 9 (e.g., the third loop first end 118c- 1 and / or the fourth loop head 118d-3) can be adjacent to and / or in contact with a second section of the catheter 9 (e.g., the third loop second end 118c-2). Figures 46m-46n illustrate, for example, that increasing the length of the catheter 9 in the target site 147 can cause a first section 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 in contact with a second section of the catheter 9 (e.g., the third loop second end 118c-2).

[0321] Figure 46o illustrates that the first loop 118a can be formed by section 01-05 of the of the catheter 9, that the second loop 118b can be formed by section 02-04 of the catheter 9, that the third loop 118c can be formed by section 03-05 of the catheter 9, and that the fourth loop 118d can be formed by section 04-05. The length of section 01-05 of the catheter 9 can be, for example, the length 126. Figure 46o illustrates, for example, that the length 126 can be 110cm. The length of sections 02-04, 03-05, and 04-05 can be, for example, less than the length of section 01-05. Figure 46o illustrates that the size (e.g., the perimeter) of the fourth loop 118c can be larger when the catheter 9 is in the fifteenth configuration 1 16o than when the catheter 9 is in the fourteenth configuration 116n. Figure 46o illustrates that a first section of the catheter (e.g., the third loop firstend 118c-l and / or the fourth loop head end 118d-3) can extend across the second cell 122b. Figure 46o illustrates that the portion of the catheter 9 that extends across the second cell 122b can partially obstruct the second cell 122b. Figure 46o illustrates that a first section of the catheter (e.g., the third loop first end 118c- 1 and / or the fourth loop head end 118d-3) can extend across (e.g., over or under) a second section of the catheter 9 (e.g., the third loop second end 118c-2) at two locations. Figure 46o illustrates that the fourth cell 122d can overlap with the second cell 122b (e.g., with the second subcell 122b2). Figures 46a-46o illustrate that the first loop 118a can include the second loop 118b, the third loop 118c, and the fourth loop 114b.

[0322] The loops 118 can be formed proximal and / or distal the catheter tip 7 in the target site 147. For example, Figures 46a-46z3 illustrate that the loops 118 can be formed distal the catheter tip 7 in the target site 147. For example, Figures 46a-46z3 illustrate that the loops 118 (e.g., the second loop 118b, the third loop 118c, and the fourth loop 118d) can be formed between the catheter tip 7 and the pylorus 65.

[0323] Figures 46o-46z3 illustrate that the catheter 9 can be withdrawn from the target site 147. Figures 46o-46z3 illustrate that the loops 118 can be collapsed in and / or removed from the target site 147. Figures 46o-46z3 illustrate that collapsing the loops 118 can include straightening the loop 118, decreasing the curve of a loop, decreasing the perimeter of the loop 118, decreasing the loop length of the loops 118, decreasing the width of the loops 118, decreasing the height of the loops 118, or any combination thereof. Figures 46a-46z3 illustrate that the loops 118 can be collapsed in the target site 147 by withdrawing the catheter 9 from the target site 147.

[0324] Figures 46a-46o illustrate that the catheter 9 can form a coil (e.g., the coil 138) in the target site 147, for example, by inserting the catheter 9 into the target site 147. Figures 46a-46o illustrate, for example, that the coil 138 (e.g., the length 126 of the catheter 9 in the target site 147) can become more tangled, can become larger, can extend across the target site 147 more times, and / or can become more dense (e.g., more of the catheter 9 per unit of volume of the target site 147 such as more of the catheter per 1cm3of the target site 147) as the catheter 9 is inserted into the target site 147. Figs. 46a- 46z3 illustrate that the catheter 9 can form (e.g., progressively form) the coil 138. Figures 46o-46z3 illustrate, for example, that the coil 138 can become less tangled, decrease in size, extend across the target site 147 less times, and / or become less dense in the target site 147 as the catheter 9 is withdrawn from the target site 147. Figures 46o-46z3 illustrate that the catheter 9 can uncoil (e.g., progressively uncoil) as the catheter 9 is withdrawn from the target site 147. Figures 46o-46z3 illustrate, for example, that the coil 138 can uncoil (e.g., progressively uncoil) in the target site 147 as the catheter 9 is withdrawn from the target site 147.

[0325] Figures 46a-46z3 illustrate that when the catheter 9 is in a deployed configuration (e.g., a configuration 116), the heat transfer region 128 can be in the stomach 2 and the esophagus 5.

[0326] Figures 47a-47i illustrate that the catheter 9 can be inserted into and / or removed from the stomach 2. Figures 47a-47i illustrate that various lengths of the catheter 9 (e.g., the length 126 shown in Figures 47b-47h) can be introduced into and / or removed from the stomach 2. Figures 47a-47i illustrate various configurations 116 and shapes 117 that the catheter 9 can have. The configurations 116 and shapes 117 in Figures 47a-47i can be, for example, different than the configurations 116 and shapes 117 in Figures 46a-46z3. Figures 47a-47i illustrate, for example, that when the catheter 9 is in a first through a ninth configuration 116a-l 16i, the catheter 9 can have the first through the ninth shape 117a-l 17i, respectively. As another example, the catheter 9 in the target site 147 can have any combination of the loops 118 and / or cells 122 shown in Figures 46b-46z2 and 47b-47i.

[0327] Figures 47a-47e illustrate that the catheter 9 can be inserted into the target site 147 as shown by arrow 112.

[0328] Figure 47a illustrates that when the catheter tip 7 is in the esophagus 5, the catheter 9 may not have the loops 118.

[0329] Figure 47b illustrates that the first loop 118a can be an open loop. Figure 47b illustrates that in the configuration 116 shown, the length 126 can be, for example, 15cm-40cm (e.g., 25cm).

[0330] Figure 47c illustrates that the first loop 118a can be a closed loop. Figures 47b-47c illustrate 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-47c illustrate that the size (e.g., the perimeter) of the first loop 118a can be larger when the catheter 9 is in the third configuration 116c than when the catheter 9 is in the second configuration 116b. Figure 47c illustrates that in the configuration 116 shown, the length 126 can be, for example, 20cm-90cm (e.g., 50cm).

[0331] Figure 47d illustrates that the first loop 118a and the second loop 118b can be closed loops and that the third loop 118c can be an open loop. Figure 47d illustrates that the first loop 118a can overlap with the second loop 118b. Figure 47d illustrates that the second loop 118b can overlap with the first loop 118a. Figure 47d illustrates that a portion of the second loop 118b can be posterior to the first loop 118a. Figure 47d illustrates that the first cell 122a and the second cell 122b can overlap and be offset from each other. For example, Figure 47d illustrates that an inferior portion of the first cell 122b can overlap with (e.g., be aligned with) a superior portion of the second cell 122b. Figure 47d illustrates that in the configuration 116 shown, the length 126 can be, for example, 70cm-200cm (e.g., 80cm).

[0332] Figure 47e illustrates that the first loop 118a, the second loop 118b, and the third loop 118c can be closed loops. Figures 47d-47e illustrate 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-47c illustrate that the size (e.g., the perimeter) of the third loop 118c can be larger when the catheter 9 is in the fifth configuration 116e than when the catheter 9 is in the fourth configuration 116d. Figures 47d- 47e illustrate that the size (e.g., the perimeter) of the second third loop 118c can be increased and / ordecreased independently of the size of the first loop 118 and / or of the second loop 118b. Figure 47e illustrates that in the configuration 116 shown, the length 126 can be, for example, 80cm- 180cm (e.g., 90cm).

[0333] Figures 47d-47e illustrates that a distal loop (e.g., the second loop 118b and / or the third loop 118c) can be formed in the target site 147 after a proximal loop (e.g., the first loop 118a) loop is formed in the target site 147. Figure 47e illustrates that a distal cell (e.g., the second cell 122b and / or the third cell 122c) can be formed in the target site 147 after a proximal cell (e.g., the first cell 122a) is formed in the target site 147.

[0334] Figures 47a-47e illustrate that the loops 118 and the cells 122 can be formed by inserting the catheter 9 into the target site 147. The loops 118 can be formed in the target site 147 in any order, for example, sequentially and / or simultaneously. For example, Figures 47a-47e illustrate that the first loop 1 18a, the second loop 1 18b, and the third loop 1 18c can be sequentially formed. For example, Figures 47a-47e illustrate that the first loop 118a can be formed in the target site 147, then the second loop 118b can be formed in the target site 147, and then the third loop 118c can be formed in the target site 147. For example, Figures 47a-47e illustrate that the second loop 118b can be formed after the first loop 118a is formed and that the third loop 118c can be formed after the first loop 118a and / or the second loop 118b are formed.

[0335] Figures 47a-47e illustrate, for example, that during a first phase of loop formation, the loop 118a can be formed, that during a second phase of loop formation, the loop 118b can be formed, and that during a third phase of loop formation, the loop 118c can be formed. The first phase of loop formation can be before the second phase of loop formation. The second phase of loop formation can be after the first phase of loop formation. The third phase of loop formation can be after the second phase of loop formation. While the second loop 118b is being formed (e.g., during the second phase of loop formation), the first loop 118a can have a constant size and / or shape. As another example, while the second loop 118b is being formed (e.g., during the second phase of loop formation), the size (e.g., perimeter) of the first loop 118a can increase and / or decrease, the shape of the first loop 118a can change, or any combination thereof. While the third loop 118c is being formed (e.g., during the third phase of loop formation), the first loop 118a and / or the second loop 118b can have a constant size and / or shape. As another example, while the third loop 118c is being formed (e.g., during the third phase of loop formation), the size (e.g., perimeter) of the first loop 118a and / or the second loop 118b can increase and / or decrease, the shape of the first loop 118a and / or the second loop 118b can change, or any combination thereof.

[0336] Figures 47a-47e illustrate 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-47e illustrate that when the catheter 9 is in the third configuration 116c, a first section of the catheter 9 can form the first loop 118a, and that when the catheter 9 is in the fourth configuration 116d, the first section of thecatheter 9 can form the third loop 118c and a second section of the catheter 9 can form the first loop 118a. As another example, Figures 47a-47e illustrate that when the catheter 9 is in the third configuration 116c, a first section of the catheter 9 can form the first loop 118a, and that when the catheter 9 is in the fifth configuration 116e, the first section of the catheter 9 can form the third loop 118c and a second section of the catheter 9 can form the first loop 118a. The first section of the catheter 9 can have the same length when the catheter 9 is in the third configuration 116c, the fourth configuration 116d, and the fifth configuration 116e. Figures 47a-47e illustrate that the first section of the catheter 9 can be distal the second section of the catheter along the length of the catheter 9. Figures 47a-47e illustrate, for example, that the first section of the catheter 9 can be a distal end of the catheter 9. Figures 47a-47e illustrate, for example, that the first section of the catheter 9 can have the catheter tip 7. As yet another example, during the first phase of loop formation, a first section of the catheter 9 can form the first loop 118a, during the second phase of loop formation, the first section of the catheter 9 can form the second loop 118b and a second section of the catheter 9 can form the first loop 118a, during the third phase of loop formation, the first section of the catheter 9 can form the third loop 118c, the second section of the catheter 9 can form the second loop 118b, and a third section of the catheter 9 can form the first loop 118a. Figures 47a-47e illustrate, for example, that the catheter tip 7 can trace out the path of the catheter 9 in the target site 147 as the catheter 9 is inserted into the target site 147. Figures 47a-47e illustrate, for example, that one or more sections of the catheter 9 proximal the catheter tip 7 can follow the path of a distal section (e.g., the distal tip 7) through the target site 147 as the catheter 9 is advanced into the target site 147 (e.g., proximal sections of the catheter 9 can follow the path of distal sections of the catheter 9 in the target site 147 as the catheter 9 is inserted into the target site 147). For example, Figures 47a-47e illustrate that the second loop 118b can be formed distal the first loop 118a and that the third loop 118c can be formed distal the first loop 118a and the second loop 118b. Figures 47a-47e illustrate, for example, that when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the third loop 118c can be the distal most loop along the catheter 9 in the target site 147 and the first loop 118a can be the proximal most loop along the catheter 9 in the target site 147. Figures 47d and 47e illustrate, for example, that when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first loop 118a can be proximal the second loop 118b and the third loop 118c in the target site 147 and the second loop 118b can be proximal the third loop 118c in the target site 147.

[0337] Figures 47e-47i illustrate that the catheter 9 can be withdrawn from the target site 147 as shown by arrow 114. Figures 47e-47i illustrate that the loops 118 can be collapsed in and / or removed from the target site 147. Figures 47e-47i illustrate that collapsing the loops 118 can include straightening the loop 118, decreasing the curve of a loop, decreasing the perimeter of the loop 118, decreasing the loop length of the loops 118, decreasing the width of the loops 118, decreasing the height of the loops 118, or any combination thereof. Figures 47e-47i illustrate that the loops 118 can be collapsed in the target site 147 by withdrawing the catheter 9 from the target site 147 as shown byarrow 114. Figures 47e-47i illustrate, for example, that the catheter 9 can straighten and / or become less curved in the target site 147 as the catheter 9 is withdrawn (e.g., pulled) from the target site 147 into the esophagus 5.

[0338] The loops 118 can be collapsed in and / or removed from the target site 147 in any order, for example, sequentially and / or simultaneously. For example, Figures 47e-47i illustrate 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-47i illustrate, for example, that the first loop 118a, the second loop 118b, and the third loop 118c can be removed from the target site 147 as they are collapsing (e.g., as they are decreasing in size). For example, Figures 47e-47i illustrate 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-47i illustrate that the second loop 118b can be collapsed and removed from the target site 147 after the first loop 118a is collapsed and removed from the target site 147 and that the third loop 118c can be collapsed and removed from the target site 147 after the first loop 1 18a and the second loop 1 18b are collapsed and removed from the target site 147. Figures 47e-47i illustrate that the loops 118 can be collapsed independently from one another as the catheter 9 is withdrawn from the target site 147, starting with the proximal most loop (e.g., the loop 118a) and ending with the distal most loop (e.g., the loop 118c). Figures 47e-47i illustrate that as the first loop 118a is being collapsed and removed from the target site 147, the second loop 118b and the third loop 118c can move (e.g., be pulled) toward the gastroesophageal junction 120. Figures 47e-47i illustrate that as the second loop 118b is being collapsed and removed from the target site 147, the third loop 118c can move (e.g., be pulled) toward the gastroesophageal junction 120.

[0339] Figures 47e-47i illustrate, for example, that during a first phase of catheter removal, the section of the catheter 9 defining the first loop 118a can be removed from the target site 147, that during a second phase of catheter removal, the section of the catheter 9 defining the second loop 118b can be removed from the target site 147, and that during a third phase of catheter removal, the section of the catheter 9 defining the third loop 118c can be removed from the target site 147. During the first phase of catheter removal, the first loop 118a can collapse in the target site 147. During the second phase of catheter removal, the second loop 118b can collapse in the target site 147. During the third phase of catheter removal, the third loop 118c can collapse in the target site 147. As another example, the first loop 118a, the second loop 118b, and / or the third loop 118c can be removed from the target site 147 without collapsing, for example, if the size of the first loop 118a, the second loop 118b, and / or the third loop 118c is smaller than the passageway through the esophagus 5. The first phase of catheter removal can be before the second phase of catheter removal. The second phase of catheter removal can be after the first phase of catheter removal. The third phase of catheter removal can be after the second phase of catheter removal. While the first loop 118a is being removed (e.g., duringthe first phase of catheter removal), the second loop 118b and / or the third loop 118c can have a constant size and / or shape. As another example, while the first loop 118a is being removed (e.g., during the first phase of catheter removal), the size (e.g., perimeter) of the second loop 118b and / or the third loop 118c can increase and / or decrease, the shape of the second loop 118b and / or the third loop 118c can change, or any combination thereof. While the second loop 118b is being removed (e.g., during the second phase of catheter removal), the third loop 118c can have a constant size and / or shape. As another example, while the second loop 118b is being removed (e.g., during the second phase of catheter removal), the size (e.g., perimeter) of the third loop 118c can increase and / or decrease, the shape of the third loop 118c can change, or any combination thereof. Figures 47e-47i illustrate, for example, that one or more distal sections of the catheter 9 can follow the path of a proximal section through the target site 147 as the catheter 9 is withdrawn from the target site 147 (e.g., distal sections of the catheter 9 can follow the path of proximal sections of the catheter 9 in the target site 147 as the catheter 9 is inserted into the target site 147).

[0340] Figures 47a-47e illustrate that the catheter 9 can form a coil (e.g., the coil 138) in the target site 147, for example, by inserting the catheter 9 into the target site 147. Figures 47e-47i illustrate that the coil 138 can uncoil (e.g., progressively uncoil) in the target site 147 as the catheter 9 is withdrawn from the target site 147.

[0341] Figures 47a-47i illustrate, for example, that the configurations 116 formed by the catheter 9 during withdrawal can be the same as the configurations 116 formed by the catheter 9 during insertion. As another example, the configurations 116 formed by the catheter 9 during withdrawal of the catheter 9 from the body can be different from the configurations 116 formed by the catheter 9 during insertion of the catheter 9 into the body.

[0342] Figures 48a-48i illustrate that the catheter 9 can be inserted into and / or removed from the stomach 2. Figures 48a-48i illustrate that various lengths of the catheter 9 (e.g., the length 126 shown in Figures 48b-48h) can be introduced into and / or removed from the stomach 2. Figures 48a-48i illustrate various configurations 116 and shapes 117 that the catheter 9 can have. The configurations 116 and shapes 117 in Figures 48a-48i can be, for example, different than the configurations 116 and shapes 117 in Figures 46a-46z3. Figures 48a-48i illustrate, for example, that when the catheter 9 is in a first through a ninth configuration 116a-l 16i, the catheter 9 can have the first through the ninth shape 117a-l 17i, respectively.

[0343] Figures 48a-48i illustrate the same configurations 116 and shapes 117 as Figures 47a-47i but illustrate that the loops 118 can be formed differently and / or can be collapsed and / or removed in a different order. For example, Figures 48a-48e illustrate that the coil 138 can have a preset shape. For example, Figures 48a-48i illustrate that the catheter 9 and / or the guidewire 99 can have a preset shape in the shape of the coil 138. Figures 48a-48i illustrate that the coil 138 can be, for example, a loose coil (e.g., a coil with loops 118 and / or cells 122 offset from each other). Figures 48a-48i illustratevarious shapes 117 of the coil 138. As the catheter 9 is inserted into the target site 147, the catheter 9 can be biased to form the preset shape (e.g., of the coil 138) such that the catheter 9 can, for example, automatically form the preset shape upon insertion into the target site 147 once the catheter 9 is no longer constrained by the esophagus 5. 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 the preset shape (e.g., the shape of the coil 138) such that the catheter can, for example, automatically form the present shape upon withdrawal of the guidewire 99 from the catheter 9 in the target site 147. The catheter 9 can form the loops 118 and the cells 122 by forming the preset shape in the target site 147. The preset shape can have the loops 118 and the cells 122. The preset shape can be, for example, the shapes in Figures 48b-48h. The catheter 9 can form the present shape in the target site 147, 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 guidewire 99 can be removed and / or introduced to the catheter 9 to adjust the shape of the catheter 9 in the target site 147.

[0344] Figures 48a-48e illustrate that the first loop 118a can be formed by a section of the catheter 9 that is distal the sections of the catheter that form the second loop 1 18b and the third loop 1 18c, respectively. Figures 48a-48e illustrate that the second loop 118b can be formed by a section of the catheter 9 that is distal the section of the catheter 9 that forms the third loop 118c. Figures 48d and 48e illustrate, for example, that when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first loop 118a can be distal the second loop 118b and the third loop 118c along the length 126 of the catheter 9 and the second loop 118b can be distal the third loop 118c along the length 126 of the catheter 9. Figures 48a-48e illustrate, for example, that when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first loop 118a can be the distal most loop along the catheter 9 in the target site 147 and the third loop 118c can be the proximal most loop along the catheter 9 in the target site 147. Figures 48d and 48e illustrate, for example, that when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first loop 118a can be distal the second loop 118b and the third loop 118c in the target site 147 and the second loop 118b can be distal the third loop 118c in the target site 147.

[0345] Figures 48a-48e illustrate that the loops 118 and the cells 122 can be formed by inserting the catheter 9 into the target site 147 and / or by withdrawing the guidewire 99 from the catheter 9. The loops 118 can be formed in the target site 147 in any order, for example, sequentially and / or simultaneously. For example, Figures 48a-48e illustrate that the first loop 118a, the second loop 118b, and the third loop 118c can be sequentially formed. For example, Figures 48a-48e illustrate that the first loop 118a can be formed in the target site 147, then the second loop 118b can be formed in the target site 147, and then the third loop 118c can be formed in the target site 147. For example, Figures 48a-48e illustrate that the second loop 118b can be formed after the first loop 118a is formed and that the third loop 118c can be formed after the first loop 118a and / or the second loop 118b are formed.

[0346] Figures 48a-48e illustrate, for example, that during a first phase of loop formation, the loop 118a can be formed, that during a second phase of loop formation, the loop 118b can be formed, and that during a third phase of loop formation, the loop 118c can be formed. The first phase of loop formation can be before the second phase of loop formation. The second phase of loop formation can be after the first phase of loop formation. The third phase of loop formation can be after the second phase of loop formation. While the second loop 118b is being formed (e.g., during the second phase of loop formation), the first loop 118a can have a constant size and / or shape. As another example, while the second loop 118b is being formed (e.g., during the second phase of loop formation), the size (e.g., perimeter) of the first loop 118a can increase and / or decrease, the shape of the first loop 118a can change, or any combination thereof. While the third loop 118c is being formed (e.g., during the third phase of loop formation), the first loop 118a and / or the second loop 118b can have a constant size and / or shape. As another example, while the third loop 118c is being formed (e.g., during the third phase of loop formation), the size (e.g., perimeter) of the first loop 118a and / or the second loop 118b can increase and / or decrease, the shape of the first loop 118a and / or the second loop 118b can change, or any combination thereof.

[0347] Figures 48a-48e illustrate that different sections of the catheter 9 can form the loops 118 at different times and / or at different stages of loop formation. For example, Figures 48a-48e illustrate that when the catheter 9 is in the third configuration 116c, a first section of the catheter 9 can form the first loop 118a, and that when the catheter 9 is in the fourth configuration 116d and the fifth configuration 116e, the first section of the catheter 9 can form the first loop 118a, a second section of the catheter 9 can form the second loop 118b, and a third section of the catheter 9 can form the third loop 118c.

[0348] Figures 48e-48i illustrate that the catheter 9 can be withdrawn from the target site 147. Figures 48e-48i illustrate that the loops 118 can be collapsed in and / or removed from the target site 147. Figures 48e-48i illustrate that collapsing the loops 118 can include straightening the loop 118, decreasing the curve of a loop, decreasing the perimeter of the loop 118, decreasing the loop length of the loops 118, decreasing the width of the loops 118, decreasing the height of the loops 118, or any combination thereof. Figures 48e-48i illustrate that the loops 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 into the target site 147 and withdrawing the catheter 9 out of the target site 147 over the guidewire 99, or by any combination thereof. The catheter 9 can straighten and / or become less curved in the target site 147 as the catheter 9 is withdrawn (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 withdrawn (e.g. pulled) onto the guidewire 99 as shown by arrow 1 14.

[0349] The loops 118 can be collapsed in and / or removed from the target site 147 in any order, for example, sequentially and / or simultaneously. For example, Figures 48e-48i illustrate that the third loop 118c, the second loop 118b, and the first loop 118a can be sequentially collapsed and / or sequentially removed from the target site 147. Figures 48e-48i illustrate, for example, that the third loop 118c, the second loop 118b, and the first loop 118a can be removed from the target site 147 as they are collapsing (e.g., as they are decreasing in size). For example, Figures 48e-48i illustrate 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-48i illustrate that the second loop 118b can be collapsed and removed from the target site 147 after the third loop 118c is collapsed and removed from the target site 147 and that the first loop 118a can be collapsed and removed from the target site 147 after the second loop 118b and the third loop 118c are collapsed and removed from the target site 147. Figures 48e-48i illustrate that the loops 118 can be collapsed independently from one another as the catheter 9 is withdrawn from the target site 147, starting with the proximal most loop (e.g., the loop 1 18c) and ending with the distal most loop (e.g., the loop 1 18a). Figures 48e-48i illustrate that as the third loop 118c is being collapsed and removed from the target site 147, the second loop 118b and the first loop 118a can move (e.g., be pulled) toward the gastroesophageal junction 120. Figures 48e-48i illustrate that as the second loop 118b is being collapsed and removed from the target site 147, the first loop 118a can move (e.g., be pulled) toward the gastroesophageal junction 120.

[0350] Figures 48c-48i illustrate, for example, that during a first phase of catheter removal, the section of the catheter 9 defining the third loop 118c can be removed from the target site 147, that during a second phase of catheter removal, the section of the catheter 9 defining the second loop 118b can be removed from the target site 147, and that during a third phase of catheter removal, the section of the catheter 9 defining the first loop 118a can be removed from the target site 147. During the first phase of catheter removal, the third loop 118c can collapse in the target site 147. During the second phase of catheter removal, the second loop 118b can collapse in the target site 147. During the third phase of catheter removal, the first loop 118a can collapse in the target site 147. As another example, the third loop 118c, the second loop 118b, and / or the first loop 118c can be removed from the target site 147 without collapsing. The first phase of catheter removal can be before the second phase of catheter removal. The second phase of catheter removal can be after the first phase of catheter removal. The third phase of catheter removal can be after the second phase of catheter removal. While the third loop 118c is being removed (e.g., during the first phase of catheter removal), the second loop 118b and / or the first loop 118a can have a constant size and / or shape. As another example, while the third loop 118c is being removed (e.g., during the first phase of catheter removal), the size (e.g., perimeter) 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 anycombination thereof. While the second loop 118b is being removed (e.g., during the second phase of catheter removal), the first loop 118a can have a constant size and / or shape. As another example, while the second loop 118b is being removed (e.g., during the second phase of catheter removal), the size (e.g., perimeter) of the first loop 118a can increase and / or decrease, the shape of the third loop 118c can change, or any combination thereof.

[0351] Figures 48a-48i illustrate, for example, that the configurations 116 formed by the catheter 9 during withdrawal can be the same as the configurations 116 formed by the catheter 9 during insertion. As another example, the configurations 116 formed by the catheter 9 during withdrawal of the catheter 9 from the body can be different from the configurations 116 formed by the catheter 9 during insertion of the catheter 9 into the body.

[0352] Figures 49a-49i illustrate that the catheter 9 can be inserted into and / or removed from the stomach 2 and / or the duodenum 37. Figures 49a-49i illustrate, for example, that the target site 147 can be the stomach 2 and / or duodenum 37. Figures 49a-49i illustrate that various lengths of the catheter 9 (e.g., the length 126 shown in Figures 49b-49h) can be introduced into and / or removed from the stomach 2 and / or the duodenum 37. Figures 49a-49i illustrate various configurations 116 and shapes 117 that the catheter 9 can have. Figures 49a-49i illustrate, for example, that when the catheter 9 is in a first through a ninth configuration 116a-l 16i, the catheter 9 can have the first through the ninth shape 117a-l 17i, respectively.

[0353] The catheter tip 7 and / or the proboscis 97 can be moved into and / or out of contact with the stomach 2, the duodenum 37, and / or another organ. For example, Figures 49a-49i illustrate that the proboscis 97 can be moved into and out of contact with the stomach 2. For example, Figures 49a-49b illustrate that the proboscis 97 can be moved into contact with the stomach 2 during insertion and Figures 49h-49i illustrate that the proboscis 97 can be moved out of contact with the stomach 2 during withdrawal. Figures 49a-49b illustrate, for example, that the proboscis 97 can be moved into contact with the stomach 2 by advancing the catheter 9 in the stomach 2 as shown by arrow 112 and Figures 49h-49i illustrate, for example, that the proboscis 97 can be moved out of contact with the stomach 2 by withdrawing the catheter 9 from the stomach 2 as shown by arrow 114. The proboscis 97 may or may not contact a wall of the stomach 2 when the catheter 9 is in a deployed configuration (e.g., a configuration 116). For example, Figures 49b-49h illustrate that the proboscis 97 can contact the stomach wall 108 when the catheter 9 is in a deployed configuration (e.g., the configurations 116b- 116h).

[0354] The catheter tip 7 and / or the proboscis 97 can be permanently and / or temporarily engaged with a wall of the stomach 2, the duodenum 37, and / or another other organ. The stomach wall 108 can include a naturally occurring feature in the stomach 2, including, for example, a gastric ruga, gastric rugae, an ulcer, or any combination thereof. Figures 49b-49h illustrate that the proboscis 97 can be permanently and / or temporarily engageable with the stomach wall 108, for example, with agastric ruga, gastric rugae, an ulcer, or any combination thereof. The proboscis 97 can, for example, releasably anchor and / or releasably engage the distal end of the catheter 9 (e.g., the catheter tip 7) to the stomach wall 108 when the catheter 9 is in the stomach 2. The catheter 9 can, for example, be releasably anchored and / or releasably engaged to the stomach wall 108 via the proboscis 97 via friction between the proboscis 97 and the stomach wall 108, via the proboscis 97 being wedged between two gastric rugae (e.g., between two adjacent gastric rugae), or any combination thereof. The catheter 9 can be unanchored and / or disengaged from the stomach wall 108, for example, by moving (e.g., pulling) the proboscis 97 away from the stomach wall 108 by withdrawing the catheter 9 from the stomach 2 as shown by arrow 114.

[0355] Figures 49a-49b illustrate that as the catheter 9 is introduced into the stomach 2, the proboscis 97 can become engaged with (e.g., can be moved into contact with) the stomach wall 108. When the proboscis 97 is engaged with the stomach wall 108, the proboscis 97 can remain engaged with (e.g., can remain in contact with) the stomach wall 108, can disengage from (e.g., can move out of contact with) the stomach wall 108, can re-engage 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 migrates in the stomach 2 and / or in the duodenum 37. Figures 49d-49e illustrate that the natural stomach motility and / or peristalsis of the stomach 2 can cause the catheter 9 to migrate in the stomach 2 and / or in the duodenum 37. Figures 49a-49e illustrate that movement and / or deployment of the catheter 9 can include insertion of the catheter 9 into the stomach 2 and / or the duodenum 37, migration of the catheter 9 in the stomach 2 and / or the duodenum 37, withdrawal of the catheter 9 from the stomach 2 and / or the duodenum 37, or any combination thereof. The proboscis 97 can move and / or remain in a fixed position relative to the stomach wall 108 as the catheter 9 moves in the stomach 2 and / or in the duodenum 37, for example, during insertion, withdrawal, and / or migration of the catheter 9. The proboscis 97 can, for example, move and / or remain in a fixed position relative to the stomach wall 108 while the catheter 9 is advanced into the stomach 2, while the catheter 9 is forced into and / or migrates into the duodenum 37, while the catheter 9 is withdrawn from the stomach 2, while the catheter 9 is withdrawn from the duodenum 37, or any combination thereof. For example, Figures 49b-49h illustrate that the proboscis 97 can remain in a fixed position relative to the stomach wall 108 while the catheter 9 is advanced into the stomach 2, while the catheter 9 migrates into the duodenum 37, while the catheter 9 is withdrawn from the stomach 2, and while the catheter 9 is withdrawn from the duodenum 37.

[0356] The proboscis 97 can move 0.00-5.0cm or more away from the engaged position (e.g., the engaged position shown in Figure 49b) in any direction along the stomach wall 108, in any direction away from the stomach wall 108 (e.g., perpendicularly away), in any direction toward the stomach wall 108 (e.g., perpendicularly toward), or any combination thereof while the catheter 9 is advanced into the stomach 2, while the catheter 9 is forced into and / or migrates into the duodenum 37, while the catheter 9 is withdrawn from the stomach 2, while the catheter 9 is withdrawn from the duodenum 37,or any combination thereof, including every 0.1cm increment within this range (e.g., 0.0cm, 0.1cm, 1.0cm, 2.0cm, 3.0cm, 5.0cm). A 0.0cm movement of the proboscis 97 can correspond to the proboscis 97 remaining stationary relative to the stomach wall 108. For example, Figures 49b-49h illustrate that the proboscis 97 can remain stationary (e.g., 0.0cm movement) relative to the stomach wall 108 while the catheter 9 is advanced into the stomach 2, while the catheter 9 is forced into and / or migrates into the duodenum 37, while the catheter 9 is withdrawn from the stomach 2, while the catheter 9 is withdrawn from the duodenum 37, or any combination thereof. Figures 49h-49i illustrate that the catheter 9 can become disengaged from (e.g., can be moved out of contact with) the stomach wall 108. Figures 49h-49i illustrate, for example, that the proboscis 97 can be disengaged from the stomach wall 108 by withdrawing the catheter 9 from the stomach 2. Withdrawing the catheter 9 from the stomach 2 can, for example, include pulling the proboscis 97 away from the stomach wall 108 toward the gastroesophageal junction 120.

[0357] The proboscis 97 and / or the catheter tip 7 may or may not pivot on the stomach wall 108 once the proboscis 97 and / or the catheter tip 7 contacts the stomach wall 108. For example, Figures 49b- 49h illustrate that the proboscis 97 and the catheter tip 7 may not pivot on the stomach wall 108 when the proboscis 97 is in contact with the stomach wall 108. As another example, the catheter tip 7 can pivot on the stomach wall 108 when the proboscis 97 is in contact with the stomach wall 108.

[0358] The proboscis 97 may or may not be forced into (e.g., pressed into) contact with the stomach wall 108 during insertion of the catheter 9 into the stomach 2. For example, Figures 49a-49b illustrate that the proboscis 97 can be forced into the stomach wall 108 during insertion of the catheter 9 into the stomach 2. When the proboscis 97 is pressed into the stomach wall 108 during insertion into the stomach 2, the proboscis 97 can inhibit and / or prevent the catheter tip 7 from tunneling into and / or through the stomach wall 108, for example, by deflecting. For example, Figures 49b-49c illustrate that the proboscis 97 can be flexible and / or can be a flexible tip that can deform (e.g., bend) when pushed into the stomach wall 108.

[0359] Figures 49d-49e illustrate that the catheter 9 can enter the duodenum 37. The insertion of the catheter 9 into the stomach 2 can force the catheter 9 to enter the duodenum 37, the natural stomach motility and / or peristalsis can urge and / or force the catheter 9 to enter the duodenum 37 and / or the intestine caudal the duodenum 37, or any combination thereof. The catheter 9 can, for example, migrate into the duodenum 37 from the stomach 2 through the pylorus 65 by the natural motility and / or peristalsis of the stomach 2. For example, Figures 49d-49e illustrate that the insertion of the catheter 9 into the stomach 2 can force the catheter 9 to enter the duodenum 37. As another example, Figures 49d-49e illustrate that the natural stomach motility and / or peristalsis can urge and / or force the catheter 9 to enter the duodenum 37. As yet another example, Figures 49d-49e illustrate that the insertion of the catheter 9 into the stomach 2 can force the catheter 9 to enter the duodenum 37 andthe natural stomach motility and / or peristalsis can urge and / or force the catheter 9 to enter the duodenum 37.

[0360] The catheter 9 and / or the catheter tip 7 can enter the duodenum before, during, and / or after passing (e.g., pumping) a fluid (e.g., the fluid 6) through a lumen in the catheter 9. For example, Figures 49d-49e illustrate that the catheter 7 can migrate into the duodenum 37 while the fluid 6 is being pumped (e.g., recirculated) through an inflow lumen and an outflow lumen in the catheter 9.

[0361] The catheter 9 can enter the duodenum 37 before, during, and / or after the catheter tip 7 enters the stomach 2. For example, Figures 49a-49e illustrate that the catheter 9 can enter the duodenum 37 after the catheter tip 7 enters the stomach 2. The catheter 9 can enter the duodenum 37 when the catheter tip 7 is in the stomach 2, in the esophagus 5, in the pylorus 65, in the duodenum 37, and / or outside the body. For example, Figures 49a-49e illustrate that the catheter 9 can enter the duodenum 37 when the catheter tip 7 is in the stomach 2. The catheter 9 can enter the duodenum 37 before, during, and / or after the proboscis 97 enters the stomach 2. For example, Figures 49a-49e illustrate that the catheter 9 can enter the duodenum 37 after the proboscis 97 enters the stomach 2. The catheter 9 can enter the duodenum 37 when the proboscis 97 is in the stomach 2, in the esophagus 5, in the pylorus 65, in the duodenum 37, and / or outside the body. For example, Figures 49a-49e illustrate that the catheter 9 can enter the duodenum 37 when the proboscis 97 is in the stomach 2. The catheter 9 can enter the duodenum 37 before, during, and / or after the catheter tip 7 and / or the proboscis 97 becomes engaged with the stomach wall 108. For example, Figures 49a-49e illustrate that the catheter 9 can enter the duodenum 37 after the proboscis 97 is pushed into engagement with (e.g., into contact with) the stomach wall 108. The catheter 9 can enter the duodenum 37 while the catheter tip 7 and / or the proboscis 97 are engaged with the stomach wall 108 (e.g., when the catheter tip 7 and / or the proboscis 97 is in contact with the stomach wall 108) and / or while the catheter tip 7 and / or the proboscis 97 are disengaged from the stomach wall 108 (e.g., when the catheter tip 7 and / or the proboscis 97 is not in contact with the stomach wall 108). For example, Figures 49a-49e illustrate that the catheter 9 can enter the duodenum 37 while the proboscis 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 migration of the catheter 9. For example, Figures 49a-49e illustrate that the catheter tip 7 can remain in the stomach 2 during insertion and / or migration of the catheter 9.

[0362] The catheter 9 can enter the duodenum 37 when at least 10cm-150cm or more of the catheter 9 is in the stomach 2, including every 1cm increment within this range (e.g., at least 10cm, at least 30cm, at least 40cm, at least 70cm, at least 100cm). For example, Figures 49a-49e illustrate that the catheter 9 can enter the duodenum 37 when at least 30cm of the catheter 9 is in the stomach 2.

[0363] Figures 49e-49f illustrate that the catheter 9 can be removed from the duodenum 37, for example, by withdrawing (e.g., pulling) the catheter 9 out of the stomach 2 as shown by arrow 114.

[0364] The catheter 9 can 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-49i illustrate 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 in the stomach 2, in the esophagus 5, in the pylorus 65, in the duodenum 37, and / or outside the body. For example, Figures 49e-49i illustrate that the catheter 9 can be withdrawn from the duodenum 37 when the catheter tip 7 is in the stomach 2. The catheter 9 can be withdrawn from the duodenum 37 before, during, and / or after the proboscis 97 is withdrawn from the stomach 2. For example, Figures 49e-49i illustrate that the catheter 9 can be withdrawn from the duodenum 37 before the proboscis 97 is withdrawn from the stomach 2. The catheter 9 can be withdrawn from the duodenum 37 when the proboscis 97 is in the stomach 2, in the esophagus 5, in the pylorus 65, in the duodenum 37, and / or outside the body. For example, Figures 49e-49i illustrate that the catheter 9 can be withdrawn from the duodenum 37 when the proboscis 97 is in the stomach 2. The catheter 9 can be withdrawn from the duodenum 37 before, during, and / or after the proboscis 97 becomes engaged with the stomach wall 108. For example, Figures 49e-49i illustrate that the catheter 9 can be withdrawn from the duodenum 37 after the proboscis 97 is pushed into engagement with (e.g., into contact with) the stomach wall 108. The catheter 9 can be withdrawn from the duodenum 37 while the catheter tip 7 and / or the proboscis 97 are engaged with the stomach wall 108 (e.g., when the catheter tip 7 and / or the proboscis 97 is in contact with the stomach wall 108) and / or while the catheter tip 7 and / or the proboscis 97 are disengaged from the stomach wall 108 (e.g., when the catheter tip 7 and / or the proboscis 97 is not in contact with the stomach wall 108). For example, Figures 49e-49i illustrate that the catheter 9 can be withdrawn from the duodenum 37 while the proboscis 97 is engaged with (e.g., is in contact with) the stomach wall 108.

[0365] The catheter 9 can be withdrawn from the duodenum 37 when at least 10cm- 150cm or more of the catheter 9 is in the stomach 2, including every 1cm increment within this range (e.g., at least 10cm, at least 30cm, at least 40cm, at least 70cm, at least 100cm). For example, Figures 49e-49i illustrate that the catheter 9 can be withdrawn from the duodenum 37 when at least 30cm of the catheter 9 is in the stomach 2.

[0366] When the catheter 9 is in the duodenum 37, the catheter tip 7 can be in the stomach 2 and / or the duodenum 37. For example, Figure 49e illustrates that when the catheter 9 is in the duodenum 37, the catheter tip 7 can be in the stomach 2.

[0367] When the catheter 9 is in the duodenum 37, the proboscis 97 can be in the stomach 2 and / or the duodenum 37. For example, Figure 49e illustrates that when the catheter 9 is in the duodenum 37, the proboscis 97 can be in the stomach 2.

[0368] The catheter 9 may or may not be in the stomach 2 and / or the duodenum 37 when the catheter 9 is in a deployed configuration. For example, Figures 49b-49d and 49f-49h illustrate that thecatheter 9 can be in the stomach 2 in a deployed configuration (e.g., the configurations 116b-l 16d and 116f- 116h) and Figure 49e illustrates that the catheter 9 can be in the stomach 2 and the duodenum 37 when the catheter is in a deployed configuration (e.g., the configuration 116e).

[0369] Figures 49b-49h illustrate that the catheter 9 can form a deployed configuration by inserting the catheter 9 into the stomach 2, by inserting the catheter 9 into the duodenum 37, by the catheter 9 migrating out of the stomach 2 through the pylorus 65 and into the duodenum 37 via the natural stomach motility 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.

[0370] When the catheter 9 is in a deployed configuration (e.g., a configuration 116), zero, one, or more sections of the catheter 9 can be in the stomach 2 and zero, one, or more sections of the catheter 9 can be in the duodenum 37. For example, Figure 49e illustrates that when the catheter 9 is in a deployed configuration (e.g., configuration 1 16e), a first section of the catheter 9 (e.g., section el -e2) can be in the stomach 2, a second section of the catheter 9 (e.g., section e2-e3) can be in the duodenum 37, and a third section of the catheter 9 (e.g., section e3-e4) can be in the stomach 2. The second section of the catheter 9 can enter the duodenum 37 by forcing the second section of the catheter 9 to enter the duodenum 37 (e.g., by inserting the catheter 9 into the stomach 2), by the natural stomach motility and / or peristalsis urging and / or forcing the second section of the catheter 9 to enter the duodenum 37, or any combination thereof. For example, Figures 49d-49e illustrate that the second section of the catheter 9 can enter the duodenum 37 by the natural stomach motility and / or peristalsis urging and / or forcing the second section of the catheter 9 into the duodenum 37 through the pylorus 65. Figure 49c illustrates that the second section of the catheter 9 can be between the first section and the second section of the catheter 9 along the length of the catheter 9. Figure 49e illustrates, for example, that when the catheter 9 is in a straight configuration, the first section of the catheter 9 can be distal the second section and the third section of the catheter 9 and that the second section of the catheter 9 can be distal the first section of the catheter 9. Figure 49e illustrates that when the catheter 9 is in the configuration 116e, the first section of the catheter 9 can be closer to the pancreas 1 than the third section of the catheter 9 and that the third section of the catheter 9 can be closer to the gastroesophageal junction 120 than the first section of the catheter 9 or vice versa.

[0371] Figure 49e illustrates that the loop 118 (e.g., the first loop 118a) can be formed by section el- 64 of the of the catheter 9. Figure 49e illustrates, for example, that the first loop 118a can be in the stomach 2 and the duodenum 37. For example, Figure 49e illustrates that the loop head can be in the duodenum 37 and that the loop base can be in the stomach 2. Figure 49e illustrates that the cell 122 (e.g., the first cell 122a) can be in the stomach 2 and the duodenum 37. The length of section el-e4 of the catheter 9 can be, for example, the length 126. Figure 49e illustrates that the length 126 can be, for example, 50cm-120cm (e.g., 80cm). Figures 49d-49e illustrate that the size (e.g., the perimeter) of the first loop 118a can be larger when the catheter 9 is in the fifth configuration 116e than when thecatheter 9 is in the fourth configuration 116d. Figure 49e illustrates that a first gap can be between section el-e2 and section e3-e4 in the stomach 2, that a second gap can be between a first end of the second section e2-e3 (e.g., the end closer to point e2) and a second end of the second section e2-e3 (e.g., the end closer to point e3) in the duodenum 37, and that the second gap can be less than the first gap. The second gap can be, for example, at least 1cm- 10cm less than the first gap, including every 1cm increment within this range (e.g., at least 1cm, at least 5cm, at least 10cm). For example, Figure 49e illustrates that the second gap can be at least 4cm less than the first gap. Figures 49d-49e illustrate that a middle portion of the catheter 9 between points el and e4 can enter the duodenum 37 while the catheter tip 7 and / or the proboscis 97 are in the stomach 2.

[0372] In Figure 49e, reference points el-e4 are provided to assist in the identification of the first, second, and third sections of the catheter 9. The first, second, and third sections of the catheter 9 (e.g., sections el-e2, e2-e3, and e3-e4) can be integral with each other and / or attached to each other. For example, Figure 49e illustrates that section el-e2 can be integral with section e2-e3, that section e2-e3 can be integral with section e3-e4, and that section e3-e4 can be integral with the portion of the catheter 9 in the esophagus 5. For example, Figure 49e illustrates that the first, second, and third sections of the catheter 9 can be sections of a single length of the catheter 9 (e.g., sections of the total length 124 of the catheter 9). Reference point el can mark, for example, the distal terminal end of the catheter 9, the distal terminal end of the proboscis 97, the distal terminal end of the heat transfer region 128, or any combination thereof. Reference point e2 can mark, for example, a first location that the catheter 9 passes through the pylorus 65. Reference point e3 can mark, for example, a second location that the catheter 9 passes through the pylorus 65. Reference point e4 can mark, for example, the location that catheter 9 enters the target site 147 (e.g., the stomach 2).

[0373] The catheter 9 can pass through the pylorus 65, for example, 0-10 or more times, including every 1 increment within this range (e.g., 0 times, 1 time, 2 times, 3 times, 4 times, 10 times). For example, Figures 49b-49d and 49f-49h illustrate that when the catheter 9 is in the stomach 2, the catheter 9 can pass through the pylorus 65 zero times. As another example, Figure 49e illustrates that the when the catheter 9 is in the stomach 2, the catheter 9 can pass through the pylorus 2 times (e.g., at the first and second locations marked by reference points e2 and e3, respectively). For example, Figure 49e illustrates that two different sections of the catheter 9 can simultaneously pass through the pylorus 65.

[0374] When the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the stomach 2 can be, for example, at least 20cm-300cm, including every 1cm increment within this range (e.g., at least 30cm, at least 40cm, at least 50cm, at least 60cm, at least 70cm, at least 80cm, at least 90cm, at least 100cm). For example, Figure 49e illustrates that when the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the stomach 2 can be at least 50cm. When the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the stomach 2 can be, for example, 20cm-300cm ormore, including every 1cm increment within this range (e.g., 20cm, 50cm, 100cm, 150cm, 300cm). For example, Figure 49e illustrates that when the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the stomach 2 can be 55cm. Figure 49e illustrates that the length 126 of the catheter 9 in the stomach 2 can be, for example, the length of section el-e2 and section e3-e4.

[0375] When the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the duodenum 37 can be, for example, at least lcm-80cm, including every 1cm increment within this range (e.g., at least 1cm, at least 5cm, at least 10cm, at least 20cm, at least 30cm, at least 40cm, at least 60cm, at least 80cm). For example, Figure 49e illustrates that when the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the duodenum 37 can be at least 20cm. When the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the duodenum 37 can be, for example, lcm-80cm or more, including every 1cm increment within this range (e.g., 1cm, 10cm, 30cm, 50cm, 80cm). For example, Figure 49e illustrates that when the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the duodenum 37 can be 25cm. Figure 49e illustrates that the length 126 of the catheter 9 in the duodenum 37 can be, for example, the length of section e2-e3.

[0376] When the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the stomach 2 can be, for example, 40cm-300cm greater than the length 126 of the catheter 9 in the duodenum 37, including every 1cm increment within this range (e.g., 40cm, 50cm, 60cm, 100cm, 200cm, 300cm).

[0377] Figures 49a-49i illustrate that the catheter 9 can extend across the target site 147 multiple times, for example, a first time proximally to distally from the stomach into the duodenum 37 and a second distally to proximally from the duodenum 37 into the stomach 2.

[0378] Figure 49e illustrates that the catheter 9 can have undulations along the length of the catheter 9 when the catheter 9 is in a deployed configuration. Figure 49e illustrates that the undulations can be, for example, bends in the catheter 9. The undulations can have, for example, a sinusoidal pattern, a serpentine pattern, a zig-zag pattern, or any combination thereof. Figures 49e-49f illustrate that the undulations can straighten as the catheter 9 is withdrawn from the body.

[0379] Figures 49e-49f illustrate that as the total length of the catheter 9 in the duodenum 37 is decreased, the total length of the catheter 9 in the stomach 2 can simultaneously decrease.

[0380] Figures 49a-49e illustrate, for example, that the target site 147 can be the stomach 2 and that the catheter 9 can enter the duodenum 37. As another example, Figures 49a-49e illustrate that the target site 147 can be the stomach 2 and the duodenum 37.

[0381] The catheter 9 can transfer heat to and / or from surrounding tissue when the catheter 9 is in the stomach 2, in the duodenum 37, and / or in the intestine caudal the duodenum 37. For example, Figures 49b-49d and 49f-49h illustrate that the catheter 9 can transfer heat to and / or from the stomach 2 and Figure 49e illustrates that the catheter 9 can transfer heat to and / or from the stomach 2 and the duodenum 37.

[0382] Figures 49a-49i illustrate that the catheter 9 can have the proboscis 97. The proboscis 97 can be attached to the and / or integrated with the catheter tip 7. For example, Figures 49a-49i illustrate that the proboscis 97 can be a distal end of the catheter tip 7.

[0383] Figures 49a-49i illustrate, for example, that the configurations 116 formed by the catheter 9 during withdrawal can be the same as the configurations 116 formed by the catheter 9 during insertion. As another example, the configurations 116 formed by the catheter 9 during withdrawal of the catheter 9 from the body can be different from the configurations 116 formed by the catheter 9 during insertion of the catheter 9 into the body.

[0384] Figures 50a-50i illustrate that the catheter 9 can be inserted into and / or removed from the stomach 2 and / or the duodenum 37. Figures 50a-50i illustrate, for example, that the target site 147 can be the stomach 2 and the duodenum 37. Figures 50a-50i illustrate that various lengths of the catheter 9 (e.g., the length 126 shown in Figures 50b-50h) can be introduced into and / or removed from the stomach 2 and / or the duodenum 37. Figures 50a-50i illustrate various configurations 116 and shapes 117 that the catheter 9 can have. Figures 50a-50i illustrate, for example, that when the catheter 9 is in a first through a ninth configuration 116a-l 16i, the catheter 9 can have the first through the ninth shape 117a-l 17i, respectively.

[0385] Figures 50a-50i illustrate that the catheter tip 7 can be moved into and out of contact with the duodenum 37. For example, Figures 50a-50b illustrate that the catheter tip 7 can be moved into contact with the duodenum 37 during insertion and Figures 50h-50i illustrate that the catheter tip 7 can be moved out of contact with the duodenum 37 during withdrawal. Figures 50a-50b illustrate, for example, that the catheter tip 7 can be moved into contact with the duodenum 37 by advancing the catheter 9 in the stomach 2 as shown by arrow 112 and Figures 50h-50i illustrate, for example, that the catheter tip 7 can be moved out of contact with the duodenum 37 by withdrawing the catheter 9 from the stomach 2 as shown by arrow 114. The catheter tip 7 may or may not contact the wall 136 of the duodenum 37 (also referred to as the duodenum wall 136) when the catheter 9 is in a deployed configuration (e.g., a configuration 116). For example, Figures 50b-50h illustrate that the proboscis 97 can contact the duodenum wall 136 when the catheter 9 is in a deployed configuration (e.g., the configurations 116b- 116h) .

[0386] The duodenum wall 136 can include a naturally occurring feature in the duodenum 37, including, for example, one or more duodenal folds (also referred to as Kerckring folds). Figures 50b- 50h illustrate that the catheter tip 7 can be permanently and / or temporarily engageable with the duodenum wall 136, for example, with a duodenal fold. The catheter tip 7 can, for example, releasably anchor and / or releasably engage the distal end of the catheter 9 to the duodenum wall 136 when the catheter 9 is in the duodenum 37. The catheter 9 can, for example, be releasably anchored and / or releasably engaged to the duodenum wall 136 via the catheter tip 7 via friction between the catheter tip 7 and the duodenum wall 136, via the catheter tip 7 being wedged between two duodenalfolds (e.g., between two adjacent duodenal folds), or any combination thereof. The catheter 9 can be unanchored and / or disengaged from the duodenum wall 136, for example, by moving (e.g., pulling) the catheter tip 7 away from the duodenum wall 136 by withdrawing the catheter 9 from the duodenum 37 as shown by arrow 114.

[0387] Figures 50a-50b illustrate that as the catheter 9 is introduced into the duodenum 37, the catheter tip 7 can become engaged with (e.g., can be moved into contact with) the duodenum wall 136. When the catheter tip 7 is engaged with the duodenum wall 136, the catheter tip 7 can remain engaged with (e.g., can remain in contact with) the duodenum wall 136, can disengage from (e.g., can move out of contact with) the duodenum wall 136, can re-engage with the duodenum wall 136, or any combination thereof while the catheter 9 is advanced into the stomach 2, while the catheter 9 is withdrawn from the stomach 2, while the catheter 9 is inserted into the duodenum 37, while the catheter 9 is withdrawn from the duodenum, while the catheter 9 migrates in the stomach 2 and / or in the duodenum 37, or any combination thereof. The catheter tip 7 can move and / or remain in a fixed position relative to the duodenum wall 136 as the catheter 9 moves in the stomach 2 and / or in the duodenum 37, for example, during insertion, withdrawal, and / or migration of the catheter 9. The catheter tip 7 can, for example, move and / or remain in a fixed position relative to the duodenum wall 136 while the catheter 9 is advanced into the stomach 2, while the catheter 9 is forced into and / or migrates into the duodenum 37, while the catheter 9 is withdrawn from the stomach 2, while the catheter 9 is withdrawn from the duodenum 37, or any combination thereof. For example, Figures 50b-50h illustrate that the catheter tip 7 can remain in a fixed position relative to the duodenum wall 136 while the catheter 9 is advanced into the stomach 2, while the catheter 9 is inserted into the duodenum 37, while the catheter 9 is withdrawn from the stomach 2, and while the catheter 9 is withdrawn from the duodenum 37.

[0388] The catheter tip 7 can move 0.00-5.0cm or more away from the engaged position (e.g., the engaged position shown in Figure 50b) in any direction along the duodenum wall 136, in any direction away from the duodenum wall 136 (e.g., perpendicularly away), in any direction toward the duodenum wall 136 (e.g., perpendicularly toward), or any combination thereof while the catheter 9 is advanced into the stomach 2, while the catheter 9 is forced into and / or migrates into the duodenum 37, while the catheter 9 is withdrawn from the stomach 2, while the catheter 9 is withdrawn from the duodenum 37, or any combination thereof, including every 0.1cm increment within this range (e.g., 0.0cm, 0.1cm, 1.0cm, 2.0cm, 3.0cm, 5.0cm). A 0.0cm movement of the catheter tip 7 can correspond to the catheter tip 7 remaining stationary relative to the duodenum wall 136. For example, Figures 50b-50h illustrate that the catheter tip 7 can remain in the same location (e.g., 0.0cm movement) relative to the duodenum wall 136 while the catheter 9 is advanced into the stomach 2, while the catheter 9 is forced into and / or migrates into the duodenum 37, while the catheter 9 is withdrawn from the stomach 2, while the catheter 9 is withdrawn from the duodenum 37, or any combination thereof. Figures 50h-50i illustrate that the catheter 9 can become disengaged from (e.g., can be moved out ofcontact with) the duodenum wall 136. Figures 50h-50i illustrate, for example, that the catheter tip 7 can be disengaged from the duodenum wall 136 by withdrawing the catheter 9 from the stomach 2. Withdrawing the catheter 9 from the stomach 2 can, for example, include pulling the catheter tip 7 away from the duodenum wall 136 toward the gastroesophageal junction 120.

[0389] The proboscis 97 and / or the catheter tip 7 may or may not pivot on the duodenum wall 136 once the proboscis 97 and / or the catheter tip 7 contacts the duodenum wall 136. For example, Figures 50b-50c illustrate that the catheter tip 7 can pivot on the duodenum wall 136 when the catheter tip 7 is in contact with the duodenum wall 136 during insertion, and Figures 50g-50h illustrate that the catheter tip 7 can pivot on the duodenum wall 136 when the catheter tip 7 is in contact with the duodenum wall 136 during withdrawal.

[0390] The catheter tip 7 may or may not be forced into (e.g., pressed into) contact with the duodenum wall 1 6 during insertion of the catheter 9 into the stomach 2. For example, Figures 50a- 50b illustrate that the catheter tip 7 can be forced into the duodenum wall 136 during insertion of the catheter 9 into the stomach 2. When the catheter tip 7 is pressed into the duodenum wall 136 during insertion into the stomach 2, the catheter tip 7 can inhibit and / or prevent the catheter tip 7 from tunneling into and / or through the duodenum wall 136, for example, by the catheter 9 bending and / or the catheter tip 7 pivoting on the duodenum wall 136 as shown Figures 50b-50c. For example, Figures 50b-50c illustrate that the catheter tip 7 can be flexible and / or can be a flexible tip that can deform (e.g., bend) when pushed into the duodenum wall 136.

[0391] Figures 50a-50e illustrate that the catheter tip 7 and the catheter 9 can be inserted into the duodenum 37. For example, Figures 50a-50e illustrate that inserting the catheter tip 7 and the catheter 9 in the stomach 2 as shown by arrow 112 can force the catheter tip 7 and the catheter 9 to enter the duodenum 37.

[0392] The catheter 9 can enter the duodenum 37 before, during, and / or after the catheter tip 7 and / or the proboscis 97 enters the duodenum 37. For example, Figures 50a-50b illustrate that the catheter tip 7 can enter the duodenum 37 before the body of the catheter 9 (e.g., the body of the catheter 9 can be, for example, the portion of the catheter 9 proximal the catheter tip 7). Figures 50a-50e illustrate, for example, that the catheter 9 can enter the duodenum 37 after the catheter tip 7 enters the duodenum 37. Figures 50a-50e illustrate, for example, that the catheter 9 can enter the duodenum 37 when the catheter tip 7 is in the duodenum 37. The catheter 9 can enter the duodenum 37 before, during, and / or after the catheter tip 7 and / or the proboscis 97 becomes engaged with the duodenum wall 136. For example, Figures 50a-50e illustrate that the catheter 9 can enter the duodenum 37 before the catheter tip 7 is pushed into engagement with (e.g., into contact with) the duodenum wall 136. The catheter 9 can enter the duodenum 37 while the catheter tip 7 and / or the proboscis 97 are engaged with the duodenum wall 136 (e.g., when the catheter tip 7 and / or the proboscis 97 is in contact with the stomach wall 108) and / or while the catheter tip 7 and / or proboscis 97 are disengaged from thestomach wall 108 (e.g., when the catheter tip 7 and / or the proboscis 97 is not in contact with the stomach wall 108). For example, Figures 50a-50e illustrate that the catheter 9 can enter the duodenum 37 while the catheter tip 7 is engaged with (e.g., in contact with) the duodenum wall 136. The catheter tip 7 may or may not remain in the duodenum 37 during insertion and / or migration of the catheter 9. For example, Figures 50a-50e illustrate that the catheter tip 7 can remain in the duodenum 37 during insertion and / or migration of the catheter 9.

[0393] The catheter tip 7 and / or the proboscis 97 can enter the duodenum 37 when any length of the catheter 9 is in the stomach 2. For example, the catheter tip 7 and / or the proboscis 97 can enter the duodenum 37 when at least 10cm-150cm or more of the catheter 9 is in the stomach 2, including every 1cm increment within this range (e.g., at least 10cm, at least 30cm, at least 40cm, at least 70cm, at least 100cm).

[0394] Figures 50e-50i illustrate that the catheter 9 can be removed from the duodenum 37, for example, by withdrawing (e.g., pulling) the catheter 9 out of the stomach 2 as shown by arrow 114.

[0395] The catheter 9 can be withdrawn from the duodenum 37 before, during, and / or after the catheter tip 7 and / or the proboscis 97 are withdrawn from the duodenum 2. For example, Figures 50e- 50i illustrate that the catheter 9 can be withdrawn from the duodenum 37 before the catheter tip 7 is withdrawn from the stomach 2. Figures 49e-49i illustrate, for example, that the catheter 9 can be withdrawn from the duodenum 37 when the catheter tip 7 is in the duodenum 37.

[0396] The catheter 9 can be withdrawn from the duodenum 37 before, during, and / or after the catheter tip 7 and / or the proboscis 97 becomes engaged with the duodenum wall 136. For example, Figures 50e-50i illustrate that the catheter 9 can be withdrawn from the duodenum 37 after the catheter tip 7 is pushed into engagement with (e.g., into contact with) the duodenum wall 136. The catheter 9 can be withdrawn from the duodenum 37 while the catheter tip 7 and / or the proboscis 97 are engaged with the duodenum wall 136 (e.g., when the catheter tip 7 and / or the proboscis 97 is in contact with the duodenum wall 136) and / or while the catheter tip 7 and / or the proboscis 97 are disengaged from the duodenum wall 136 (e.g., when the catheter tip 7 and / or the proboscis 97 is not in contact with the duodenum wall 136). For example, Figures 50e-50i illustrate that the catheter 9 can be withdrawn from the duodenum 37 while the catheter tip 7 is engaged with (e.g., is in contact with) the duodenum wall 136.

[0397] The catheter tip 7 and / or the catheter 9 can be withdrawn from the duodenum 37 when at least 10cm-150cm or more of the catheter 9 is in the stomach 2, including every 1cm increment within this range (e.g., at least 10cm, at least 30cm, at least 40cm, at least 70cm, at least 100cm). For example, Figures 50e-50i illustrate that the catheter tip and / or the catheter 9 can be withdrawn from the duodenum 37 when at least 20cm of the catheter 9 is in the stomach 2.

[0398] Figures 50b-50h illustrate that when the catheter 9 is in the duodenum 37, the catheter tip 7 can be in the duodenum 37.

[0399] Figures 50b-50h illustrate that the catheter 9 can be in the stomach 2 and the duodenum 37 when the catheter is in a deployed configuration (e.g., the configurations 116b-l 16h).

[0400] Figures 50b-50h illustrate that the catheter 9 can form a deployed configuration by inserting the catheter 9 into the stomach 2, by inserting the catheter 9 into the duodenum 37, by withdrawing the catheter 9 from the stomach 2, by withdrawing the catheter 9 from the duodenum 37, or any combination thereof.

[0401] Figures 50b-50h illustrate that when the catheter 9 is in the stomach 2, the catheter 9 can pass through the pylorus 65 one time (e.g., at the reference point x in Figure 50e).

[0402] Figures 50b-50h illustrate that when the catheter 9 is in a deployed configuration (e.g., configurations 116b-l 16h), a first section of the catheter 9 can be in the duodenum 37 (e.g., the portion of the catheter 9 distal the pylorus 65) and a second section of the catheter 9 can be in the stomach 2 (e.g., the portion of the catheter proximal the pylorus 65). The portion of the catheter 9 distal the pylorus 65 can be forced into the duodenum 37 and / or can migrate into the duodenum 37. For example, Figures 50a-50e illustrate that the portion of the catheter 9 distal the pylorus 65 can be forced into the duodenum 37 by inserting the catheter 9 into the stomach 2.

[0403] Figures 50a-50i illustrate that the catheter 9 can form the loops 118 and cells 122 shown, for example, as the catheter 9 is inserted into and / or withdrawn from the target site 147. Figures 50b-50h illustrate that the loops 118 can be open loops. Figures 50a-50i illustrate that the target site 147 can be, for example, the stomach 2 and the duodenum 37.

[0404] Figures 50a-50b illustrate that the catheter tip 7 can enter the duodenum before the body of the catheter.

[0405] Figures 50a-50b illustrate that the catheter 9 can form the first loop 118a and the second loop 118b as the catheter 9 is inserted into the stomach 2 and the duodenum 37. Figures 50a-50b illustrate that the first loop 118a can be formed in the stomach 2 and that the second loop 118b can be formed in the stomach 2 and the duodenum 37. For example, Figure 50b illustrates that the first loop first and second ends can be in the stomach 2, that the second loop first end can be in the stomach 2, and that the second loop second end can be in the duodenum 37. Figure 50b illustrates that the lesser curvature of the stomach 2 can be in the first cell 122a and that the pancreas head 38 and the pylorus 65 can be in the second cell 122b.

[0406] Figure 50c illustrates that a loop 118 (e.g., the third loop 118c) can be in the duodenum 37. Figures 50b-50c illustrate that the catheter 9 can form the third loop 118c as the catheter 9 is inserted into the stomach 2 and the duodenum 37. Figures 50b-50c illustrate that the third loop 118c can be formed in the duodenum 37. Figures 50b-50c illustrate that when the catheter tip 7 is in the duodenum 37, the third loop 118c can be formed in the duodenum 37, for example, by advancing the catheter 9 into the duodenum 37 as shown by arrow 112. Figure 50c illustrates that the third loop first end, third loop second end, and the third loop head can be in the duodenum 37. Figures 50b-50cillustrate that when the catheter tip 7 is engaged with the duodenum wall 136 (e.g., to a Kerckring rold) and the catheter 9 continues to be inserted into the stomach 2 as shown by arrow 112, a section of the catheter 9 proximal the catheter tip 7 can be advanced past (e.g., distal, caudal) the catheter tip 7, for example, as the catheter tip 7 pivots against the duodenum wall 136. Figure 50c illustrates that the section of the catheter 9 advanced past the catheter tip 7 can be the third loop 118c. Figure 50c illustrates that the third loop 118c can be distal the catheter tip 7 when the catheter 9 is in a deployed configuration (e.g., when the catheter 9 is in the third configuration 116c). Figure 50b illustrates that before the third loop 118c is formed, the portion of the catheter 9 that defines the third loop 118c in Figure 50c can be proximal to the catheter tip 7. As another example, when the catheter 9 is in a straight configuration, the portion of the catheter 9 that defines the third loop 118c in Figure 50c can be proximal to the catheter tip 7. Figure 50c illustrates that the lesser curvature of the stomach 2 can be in the first cell 122a and that the pancreas head 38, the ampulla of vater 41, and the pylorus 65 can be in the second cell 122b.

[0407] The perimeters of the loops 118 can increase, decrease, and / or remain constant as the catheter 9 is inserted into the target site 147. Figures 50h-50c illustrate that the size (e.g., the perimeter) of the first loop 118a can 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-50c illustrate that the size (e.g., the perimeter) of the second loop 118b can 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-50c illustrate that less of the catheter 9 can be in the stomach 2 when the catheter 9 is in the third configuration 116c than when the catheter 9 is in the second configuration 116b. For example, Figures 50b-50c illustrate that as the catheter 9 is inserted into the duodenum 37, Icm-lOcm or more of the catheter 9, including every 1cm increment within this range (e.g., 1cm, 5cm, 10cm) can move out of the stomach 2 through the pylorus 65. Figures 50b-50c illustrate that the size (e.g., the area) of the second cell 122b can be larger when the catheter 9 is in the third configuration 116c than when the catheter 9 is in the second configuration 116b.

[0408] Figures 50c-50d illustrate that the size (e.g., the perimeter) of the first loop 118a and the third loop 118c can be larger when the catheter 9 is in the fourth configuration 116d than when the catheter 9 is in the third configuration 116c. Figures 50c-50d illustrate that the gap between the third loop second end (e.g., the catheter tip 7) and the third loop first end (e.g., the portion of the catheter 9 in Figures 50c-50d adjacent the ampulla of vater 41) can be larger when the catheter 9 is in the fourth configuration 116d than when the catheter 9 is in the third configuration 116c.

[0409] Figures 50d-50e illustrate that the catheter 9 can form the fourth loop 118d as the catheter 9 is inserted into the stomach 2 and the duodenum 37. Figures 50d-50e illustrate that the fourth loop 118d can be formed in the stomach 2. Figures 50d-50e illustrate that when the catheter tip 7 is in the duodenum 37, the fourth loop 118d can be formed in the stomach 2, for example, by advancing thecatheter 9 into the stomach 2 as shown by arrow 112. Figure 50d illustrates that the fourth loop first end, fourth loop second end, and the fourth loop head can be in the stomach 2. Figures 50d-50e illustrate that the size (e.g., the perimeter) of the first loop 118a can 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-50e illustrate that the size (e.g., the perimeter) of the second loop 118b and the third loop 118c can be larger when the catheter 9 is in the fifth configuration 116e than when the catheter 9 is in the fourth configuration 116d.

[0410] 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 migrating further into the duodenum 37, can inhibit or prevent the portion of the catheter 9 in the stomach 2 from migrating into the duodenum 37, can inhibit or prevent more of the catheter 9 from being inserted into the duodenum 37, or any combination thereof. For example, Figures 50c-50e illustrate that the third loop 118c can inhibit (e.g., can start to inhibit) more of the catheter 9 from being inserted into the duodenum 37, which is shown, for example, by more of the catheter 9 being inserted into the stomach 2 than in the duodenum 37 in Figures 50c-50e.

[0411] Figures 50b and 50h illustrate that when the catheter 9 is in the second configuration 116b and the eighth configuration 118h, the portion of the length 126 of the catheter 9 in the stomach 2 can be, for example, 10cm-30cm (e.g., 20cm) and the portion of the length 126 of the catheter 9 in the duodenum 37 can be, for example, lcm-20cm (e.g., 10cm).

[0412] Figures 50c and 50g illustrate that when the catheter 9 is in the third configuration 116c and the seventh configuration 118g, the portion of the length 126 of the catheter 9 in the stomach 2 can be, for example, 10cm-30cm (e.g., 15cm) and the portion of the length 126 of the catheter 9 in the duodenum 37 can be, for example, lcm-30cm (e.g., 15cm).

[0413] Figures 50d and 50f illustrate that when the catheter 9 is in the fourth configuration 116d and the sixth configuration 118f, the portion of the length 126 of the catheter 9 in the stomach 2 can be, for example, 20cm-80cm (e.g., 50cm) and the portion of the length 126 of the catheter 9 in the duodenum 37 can be, for example, lcm-30cm (e.g., 18cm).

[0414] Figure 50e illustrates that when the catheter 9 is in the fifth configuration 118e, the portion of the length 126 of the catheter 9 in the stomach 2 can be, for example, 20cm-300cm (e.g., 90cm) and the portion of the length 126 of the catheter 9 in the duodenum 37 can be, for example, 1 cm-30cm (e.g., 25cm).

[0415] When the catheter 9 is in the duodenum 37, the length 126 of the catheter 9 in the stomach 2 can be, for example, 40cm-300cm greater than the length 126 of the catheter 9 in the duodenum 37, including every 1cm increment within this range (e.g., 40cm, 50cm, 60cm, 100cm, 200cm, 300cm).

[0416] Figure 50e illustrates that the catheter 9 can extend multiple times back and forth in different directions across the target site 147.

[0417] Figure 50e illustrates that the catheter 9 can have undulations along the length of the catheter 9 when the catheter 9 is in a deployed configuration. Figure 50e illustrates that the undulations can be, for example, bends in the catheter 9. The undulations can have, for example, a sinusoidal pattern, a serpentine pattern, a zig-zag pattern, or any combination thereof. Figures 50e-50f illustrate that the undulations can straighten as the catheter 9 is withdrawn from the body.

[0418] Figures 50e-50f illustrate that as the length of the catheter 9 in the stomach 2 is decreased, the length of the catheter 9 in the duodenum can simultaneously decrease.

[0419] The catheter 9 can transfer heat to and / or from surrounding tissue when the catheter 9 is in the stomach 2, in the duodenum 37, and / or in the intestine caudal the duodenum 37. For example, Figures 50b-50h illustrate that the catheter 9 can transfer heat to and / or from the stomach 2 and the duodenum 37.

[0420] Figures 50a-50i illustrate that the catheter 9 may not have the proboscis 97. As another example, the catheter 9 in Figures 50a-50i can have the proboscis 97.

[0421] Figures 50a-50e illustrate that the loops 118 and the cells 122 can be formed by inserting the catheter 9 into the target site 147. The loops 118 can be formed in the target site 147 in any order, for example, sequentially and / or simultaneously. For example, Figures 50a-50e illustrate that the first loop 118a, the second loop 118b, the third loop 118c, and the fourth loop 118d can be sequentially formed. For example, Figures 50a-50e illustrate that the first loop 118a can be formed in the target site 147, then the second loop 118b can be formed in the target site 147, then the third loop 118c can be formed in the target site 147, and then the fourth loop 118d can be formed in the target site 147. For example, Figures 50a-50e illustrate that the second loop 118b can be formed after the first loop 118a is formed, that the third loop 118b can be formed after the first loop 118a and / or the second loop 118b are formed and that 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 of the other loops 118 can change size and / or shape. Figures 50a-50e illustrate, for example, that already formed loops 118 can change size and / or shape while one more other loops 118 are formed. For example, Figures 50b-50c illustrate that the first loop 118a and / or the second loop 118b can change size and / or shape while the third loop 118c is formed, and Figures 50d-50e illustrate that the first loop 118a and / or the third loop 118c can change size and / or shape while the fourth loop 118d is formed.

[0422] Figures 50a-50e illustrate, for example, that during a first phase of loop formation, the loop 118a can be formed, that during a second phase of loop formation, the loop 118b can be formed, that during a third phase of loop formation, the loop 118c can be formed, and that during a fourth phase of loop formation, the loop 118d can be formed. The first phase of loop formation can be before the second phase of loop formation. The second phase of loop formation can be after the first phase of loop formation. The third phase of loop formation can be after the second phase of loop formation. The fourth phase of loop formation can be after the second phase of loop formation. While the thirdloop 118c is being formed (e.g., during the third phase 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-50e illustrate that while the third loop 118c is being formed (e.g., during the third phase of loop formation), the size (e.g., perimeter) of the first loop 118a and / or the second loop 118b can increase and / or decrease, the shape of the first loop 118a and / or the second loop 118b can change, or any combination thereof. While the fourth loop 118d is being formed (e.g., during the fourth phase 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-50e illustrate that while the fourth loop 118d is being formed (e.g., during the fourth phase of loop formation), the size (e.g., perimeter) 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 ioop 118a, the second loop 118b, and / or the third loop 118c can change, or any combination thereof.

[0423] Figures 50e-50i illustrate that the catheter 9 can be withdrawn from the target site 147. Figures 5...

Claims

CLAIMSWe Claim:

1. A device for changing a temperature of an organ, the device comprising: a tube having a lumen, a tube first portion, and a tube second portion, wherein a fluid is flowable through the lumen; and a tether, wherein a distance between the tube first portion and the tube second portion is maintainable via the tether.

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

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

4. A device for changing a temperature of an organ, the device comprising: a tube having a lumen, a tube first portion, and a tube second portion, wherein a fluid is flowable through the lumen; and a tether, wherein movement of the tube second portion away from the tube first portion is limitable via the tether.

5. A device for changing a 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 is flowable through the lumen, and wherein 50cm-150cm of the tube is positionable in a second organ adjacent the first organ.

6. A device for changing a temperature of an organ, the device comprising: a tube having a lumen, a tube first portion, and a tube second portion, wherein a fluid is flowable through the lumen, and wherein the tube is formable into a lattice shape.

7. A method of changing a temperature of a first organ, the method comprising: positioning a tube having a lumen, a tube first portion, and a tube second portion in a second organ; positioning a tether in the second organ; and maintaining a distance between the tube first portion and the tube second portion via the tether.

8. A method of changing a temperature of a first organ, the method comprising: positioning a tube having a lumen, a tube first portion, and a tube second portion in a second organ; positioning a tether in the second organ; and 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 the tether is under more tension when the tube is in the second configuration than when the tube is in the first configuration.

9. A method of changing a temperature of a first organ, the method comprising: positioning a tube having a lumen, a tube first portion, and a tube second portion in a second organ; positioning a tether in the second organ; and changing a distance between the tube first portion and the tube second portion via the tether.

10. A method of changing a temperature of a first organ, the method comprising: positioning a tube having a lumen, a tube first portion, and a tube second portion in a second organ; positioning a tether in the second organ; and limiting movement of the tube second portion away from the tube first portion via the tether.

11. A method of changing a temperature of a first organ, the method comprising: positioning 50cm- 150cm of a tube having a lumen, a tube first portion, and a tube second portion in a second organ adjacent the first organ.

12. A method of changing a temperature of a first organ, the method comprising:positioning a tube having a lumen, a tube first portion, and a tube second portion in a second organ; and forming the tube into a lattice shape in the second organ.

13. A method of changing a temperature of a gastrointestinal tract caudal of a gastroesophageal junction of the gastrointestinal tract via a catheter, the method comprising: inserting 50cm-300cm of the catheter into a stomach of the gastrointestinal tract; and adding or removing a fluid from the catheter through an inflow port and an outflow port with 10-100 Watts of cooling or warming power.

14. A method of changing a temperature of a gastrointestinal tract caudal of a gastroesophageal junction of the gastrointestinal tract, the method comprising: positioning a first section of a catheter in a stomach of the gastrointestinal tract; and transferring heat to or from the gastrointestinal tract comprising recirculating a fluid through an inflow lumen and an outflow lumen in the first section of the catheter, wherein a length of the first section of the catheter is greater than a length of a greater curvature of the stomach.

15. A method of changing a temperature of a gastrointestinal tract caudal of a gastroesophageal junction of the gastrointestinal tract, the method comprising: positioning a length of a lumen in a stomach of the gastrointestinal tract; and passing a fluid through the length of the lumen at a flow rate over a treatment period, wherein the flow rate is at least 20mL / min and the treatment period is at least 2 hours, wherein the length of the lumen in the stomach comprises 30cm- 150cm.

16. A device comprising: a catheter comprising a heat transfer region, wherein a heating zone extends radially from the heat transfer region, wherein the heat transfer region comprises a length of 50cm-300cm, and wherein when the catheter is in a deployed configuration, a first heating zone of a first length of the heat transfer region overlaps a second heating zone of a second length of the heat transfer region.

17. A device comprising: a catheter having a lumen, wherein a first end of the lumen comprises an inflow port and a second end of the lumen comprises an outflow port, and wherein when a heat exchanger isrecirculating fluid, the inflow port and the outflow port are in fluid communication with a heat exchanger, wherein when the catheter is in a deployed configuration, an adherer is attached to the catheter, wherein when the catheter is in the deployed configuration, a volume of the lumen distal to the inflow port and the outflow port is less than 50mL, and wherein when the catheter is in the deployed configuration, a length of the catheter between the adherer and a distal tip of the catheter is at least 80cm.

18. A device comprising: a catheter having a having lumen, wherein a first end of the lumen comprises an inflow port and a second end of the lumen comprises an outflow port, wherein the inflow port and the outflow port are at a first end of the catheter, and wherein when a heat exchanger is recirculating fluid, the inflow port and the outflow port are in fluid communication with the heat exchanger; and wherein when the catheter is in a deployed configuration, an adherer is attached to the catheter, wherein when the catheter is in the deployed configuration, a length of the catheter between the adherer and a distal terminal end of the catheter is greater than 90cm from the adherer, and wherein when the catheter is in the deployed configuration, a distance as measured along a straight line from the adherer to the distal terminal end of the catheter is less than 60cm.

19. A method of changing a temperature of a gastrointestinal tract caudal of a gastroesophageal junction of the gastrointestinal tract, the method comprising: forming a first length of a catheter into a first loop inside a stomach of the gastrointestinal tract, wherein the first loop comprises a first loop first end that crosses a first loop second end, and wherein a width of the first loop is greater than 3cm; and transferring heat to and / or from the gastrointestinal tract comprising 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.

20. A method of changing a temperature of a gastrointestinal tract caudal of a gastroesophageal junction of the gastrointestinal tract, the method comprising: forming a first section of a catheter into a first loop defining a first cell in a stomach of the gastrointestinal tract by advancing the catheter into the stomach; andtransferring heat to and / or from the gastrointestinal tract comprising recirculating a fluid through an inflow lumen and an outflow lumen in the catheter when the first cell is distal to a distal terminal end of the catheter.

21. A method of changing a temperature of a gastrointestinal tract caudal of a gastroesophageal junction of the gastrointestinal tract, the method comprising: forming a first section of a catheter into a first loop in a stomach of the gastrointestinal tract; forming a second section of the catheter into a second loop in the stomach comprising forming or moving the second loop distal the first loop, wherein when the catheter is in a straight configuration, the first section of the catheter is distal the second section of the catheter; and transferring heat to and / or from the gastrointestinal tract via the catheter.

22. A device comprising: a catheter having a first section, wherein the first section has a first section first configuration and a first section second configuration, wherein when the first section is in first section first configuration, the first section is straight, wherein when the first section is in the first section second configuration, the first section comprises a first loop having a first loop first end that crosses a first loop second end at a first location along the catheter, and wherein a width of the first loop is greater than 3cm as measured from an axis perpendicular to a center longitudinal axis of the catheter.

23. A device comprising: a catheter having a first section and a second section, wherein the catheter has a first configuration and a second configuration, wherein when the catheter is in the first configuration, the first section and the second section are less curved than when the catheter is in the second configuration and the first section is distal the second section, and wherein when the catheter is in the second configuration, the first section comprises a first loop, the second section comprises a second loop, and the second section is distal the first section such that the second loop is distal the first loop.

24. A method of changing a temperature of a stomach via a catheter, wherein the catheter comprises an inflow channel, an outflow channel, a first temperature sensor, a second temperature sensor, and a proboscis, wherein the proboscis comprises the first temperature sensor, and wherein when the catheter is in a straight configuration, the proboscis and the first temperature sensor aredistal 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 proboscis closer to the pylorus than the second temperature sensor; and transferring heat to and / or from the stomach via the catheter positioned in the stomach.

25. A method of changing a temperature of a stomach via a catheter, wherein the catheter comprises an inflow channel, an outflow channel, a first temperature sensor, a second temperature sensor, and a proboscis, wherein the proboscis comprises the first temperature sensor, and wherein when the catheter is in a straight configuration, the proboscis and the first temperature sensor are distal 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 proboscis farther from the pylorus than the second temperature sensor; and transferring heat to and / or from the stomach via the catheter positioned in the stomach.

26. A method of changing a temperature of a stomach via a catheter, wherein the catheter comprises an inflow channel, an outflow channel, a first temperature sensor, a second temperature sensor, and a proboscis, wherein the proboscis comprises the first temperature sensor, the method comprising: positioning the catheter in the stomach in a first operational configuration, wherein when the catheter is in the first operational configuration, the first temperature sensor and the second temperature sensor are in the stomach, wherein the catheter moves from the first operational configuration to a second operational configuration, wherein when the catheter is in the second operational configuration, the first temperature sensor is in the pylorus or the duodenum and the second temperature sensor is in the stomach.

27. A device comprising: a catheter having an inflow channel, an outflow channel, a first temperature sensor, a second temperature sensor, and a proboscis, wherein the proboscis comprises the first temperature sensor, wherein when the catheter is in a straight configuration, the proboscis and the first temperature sensor are distal the inflow channel, the outflow channel, and the second temperature sensor,28. wherein when the catheter is in the 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 operational configuration, the first temperature sensor and the second temperature sensor are separated by a second distance, and wherein the first distance is greater than the second distance.

29. A triple-lumen catheter device comprising a closed-loop system for therapeutic cooling, a thermochromic fluid with a color-changing property for real-time temperature feedback, and a multifunctional lumen for gastrointestinal support.

30. The system, device, or method of any preceding claim, wherein the closed-loop system comprises an integrated heat exchanger for precise temperature control of the circulating thermochromic fluid.

31. The system, device, or method of any preceding claim, comprising a transparent or translucent section for visual monitoring of the thermochromic fluid's color change, indicating the achievement of therapeutic temperature levels.

32. The system, device, or method of any preceding claim, wherein the third lumen serves for enteral nutrition delivery, gastric emptying, or decompression, facilitating comprehensive patient care alongside therapeutic cooling.

33. A triple-lumen catheter device equipped with a closed-loop cooling system and a multifunctional feedback system comprising acid-sensitive thermochromic dyes and a time -responsive indicator, enabling real-time and cumulative monitoring of therapeutic treatment conditions and durations.

34. The system, device, or method of any preceding claim, wherein the time-responsive indicator is integrated alongside the acid-sensitive thermochromic dyes, designed to provide a visual indication of the cumulative duration of exposure to a therapeutic temperature and / or acidic environment, facilitating precise monitoring of treatment efficacy over time.

35. The system, device, or method of any preceding claim, comprising a transparent or translucent section for the visual assessment of both the environment-sensitive and time-responsive indicators, offering comprehensive feedback on catheter placement, therapeutic temperature achievement, and treatment duration.

36. The system, device, or method of any preceding claim, further comprising a third lumen for enteral support functions, integrating advanced therapeutic cooling with essential gastrointestinal care and innovative treatment monitoring technologies.

37. A therapeutic cooling system comprising a triple-lumen catheter with integrated temperature, acidity, and time-responsive indicators, and a Thermochromic Liquid Crystal Polymer patch for external application to the organ area, designed to visually indicate the therapeutic cooling effect achieved internally.

38. The system, device, or method of any preceding claim, where the TLC Polymer patch changes color in response to specific temperature thresholds indicative of therapeutic cooling, providing a non-invasive, visual confirmation of treatment efficacy on the targeted organ.

39. The system, device, or method of any preceding claim, incorporating a closed-loop cooling system, acid-sensitive thermochromic dyes, a time-responsive indicator within the catheter, and complemented by the external TLC Polymer patch, offering dual internal and external monitoring capabilities.

40. The system, device, or method of any preceding claim, further equipped with a third lumen for enteral support functions, enhancing patient care by integrating advanced therapeutic cooling, comprehensive monitoring technologies, and essential gastrointestinal care functionalities.

41. A comprehensive therapeutic cooling system, comprising a triple-lumen catheter with integrated temperature, acidity, and time-responsive indicators; a Thermochromic Liquid Crystal Polymer patch for external application; and an infrared camera for non-invasive temperature verification, collectively designed to monitor and confirm the achievement of therapeutic temperatures within the stomach or targeted organs.

42. The system, device, or method of any preceding claim, wherein the infrared camera is utilized to externally capture and analyze temperature variations on the skin surface above the targeted organ area, correlating these external temperature readings with internal therapeutic conditions achieved through the catheter's operation.

43. The system, device, or method of any preceding claim, featuring a multi-modal monitoring approach that combines direct internal feedback (catheter indicators), tactile external feedback (TLC Polymer patch), and visual external feedback (IR camera), ensuring comprehensive and accurate verification of therapeutic cooling effectiveness.

44. The system, device, or method of any preceding claim, further including a third lumen within the catheter for enteral support functionalities, thereby integrating advanced therapeutic cooling, multidimensional monitoring technologies, and essential gastrointestinal care into a singular, innovative patient care system.

45. A system comprising: a catheter assembly and an extension line assembly, wherein the catheter assembly comprises a catheter and a catheter connector, wherein the catheter comprises a catheter lumen having a catheter lumen inflow port and a catheter lumen outflow port, wherein the extension line assembly comprises a first inflow tube, a second inflow tube, a first return tube, a second return tube, and an extension line connector, wherein when the catheter connector and the extension line connector are connected to each other and a recirculating pump is recirculating a fluid, the first inflow tube and the second inflow tube are in fluid communication with the catheter inflow port, and wherein when the catheter connector and the extension line connector are connected to each other and the recirculating pump is recirculating the fluid, the second return tube is in fluid communication with the catheter outflow port.

46. A system comprising: a catheter assembly and an extension line assembly, wherein the catheter assembly comprises a catheter and a catheter connector, wherein the catheter comprises a catheter lumen having a catheter lumen inflow port and a catheter lumen outflow port, wherein the extension line assembly comprises a first inflow tube, a second inflow tube, a first return tube, a second return tube, and an extension line connector, wherein when the catheter connector and the extension line connector are connected to each other, the system comprises a first flow path, a second flow path, and a third flow path, wherein the first flow path comprises the first inflow tube and the first return tube, wherein the second flow path comprises the first inflow tube, the second inflow tube, and the catheter, and wherein the third flow path comprises the second return tube and the catheter.

47. A system comprising a catheter assembly and / or an extension line assembly.

48. A method of changing a temperature of a gastrointestinal tract caudal of a gastroesophageal junction of the gastrointestinal tract, the method comprising: inserting a catheter assembly into a stomach of the gastrointestinal tract; attaching the catheter assembly to an extension line assembly; and transferring heat to and / or from the gastrointestinal tract comprising recirculating a fluid through the catheter assembly and the extension line assembly.

49. A method of changing and / or maintaining a temperature, the method comprising: inserting a catheter assembly into a body lumen; attaching the catheter assembly to an extension line assembly; and transferring heat to and / or from the catheter assembly comprising recirculating a fluid through the catheter assembly and the extension line assembly.

50. The system, device, or method of any preceding claim, wherein when the catheter connector and the extension line connector are connected to each other and the recirculating pump is recirculating the fluid, the first inflow tube is in fluid communication with the second inflow tube.

51. The system, device, or method of any preceding claim, wherein when the catheter connector and the extension line connector are connected to each other and the recirculating pump is recirculating the fluid, the first inflow tube is in fluid communication with the first return tube.

52. The system, device, or method of any preceding claim, wherein when the catheter connector and the extension line connector are connected to each other and the recirculating pump is recirculating the fluid, the first inflow tube is in fluid communication with the second inflow tube and the first return tube.

53. The system, device, or method of any preceding claim, further comprising a bypass loop comprising the first inflow tube and the first return tube.

54. The system, device, or method of any preceding claim, wherein the first inflow tube and the first return tube comprise a bypass loop.

55. The system, device, or method of any preceding claim, further comprising a bypass loop comprising a bypass inflow tube and a bypass return tube, wherein the bypass inflow tube comprises the first inflow tube, and wherein the bypass return tube comprises the first return tube.

56. The system, device, or method of any preceding claim, further comprising a tube connector, wherein the first inflow tube, the first return tube, and the second inflow tube are connected to the tube connector.

57. The system, device, or method of any preceding claim, wherein the tube connector comprises a first branch, a second branch, and third branch, wherein the first inflow tube is connected to the first branch, wherein the first return tube is connected to the second branch, and wherein the second inflow tube is connected to the third branch.

58. The system, device, or method of any preceding claim, wherein the tube connector comprises a three-way connector.

59. The system, device, or method of any preceding claim, further comprising an accessory tube.

60. The system, device, or method of any preceding claim, wherein the accessory tube is connected to the catheter.

61. The system, device, or method of any preceding claim, wherein the catheter lumen comprises a catheter first lumen, wherein the catheter comprises a catheter second lumen, and wherein the accessory tube comprises an accessory tube lumen.

62. The system, device, or method of any preceding claim, wherein the accessory tube lumen is connected to the catheter second lumen.

63. The system, device, or method of any preceding claim, wherein the accessory tube lumen is in fluid communication with the catheter second lumen.

64. The system, device, or method of any preceding claim, further comprising a flow path comprising the accessory tube lumen and the catheter second lumen.

65. The system, device, or method of any preceding claim, wherein when a feed material is flowing through the accessory tube lumen, the catheter second lumen is in fluid communication with the accessory tube lumen.

66. The system, device, or method of any preceding claim, wherein when a negative pressure is transmitted to the accessory tube lumen, the catheter second lumen is in fluid communication with the accessory tube lumen.

67. The system, device, or method of any preceding claim, further comprising a enteral system and / or a suction system.

68. The system, device, or method of any preceding claim, further comprising a first flow path, a second flow path, and / or a third flow path.

69. The system, device, or method of any preceding claim, wherein when the catheter assembly and the extension line assembly are connected to each other, the system comprises a first flow path, a second flow path, and / or a third flow path.

70. The system, device, or method of any preceding claim, further comprising a first flow path, a second flow path, and a third flow path, wherein the first flow path comprises the first inflow tube and the first return tube, wherein the second flow path comprises the first inflow tube, the second inflow tube, and / or the catheter lumen, and wherein the third flow path comprises the second return tube and the catheter lumen.

71. The system, device, or method of any preceding claim, wherein the catheter lumen comprises a catheter lumen first end and a catheter lumen second end, wherein the catheter lumen first end comprises the catheter lumen inflow port, and wherein the catheter lumen second end comprises the catheter outflow port.

72. The system, device, or method of any preceding claim, wherein the catheter lumen first end and the catheter lumen second end merge with each other at a merge point, and wherein the merge point is inside the catheter.

73. The system, device, or method of any preceding claim, further comprising a first flow path, a second flow path, and a third flow path, wherein the first flow path comprises the first inflow tube and the first return tube, wherein the second flow path comprises the first inflow tube, the second inflow tube, and the catheter lumen first end, and wherein the third flow path comprises the second return tube and the catheter lumen second end.

74. The system, device, or method of any preceding claim, wherein the catheter lumen comprises a catheter lumen inflow portion and a catheter lumen outflow portion, wherein the catheter lumen inflow portion comprises the catheter lumen inflow port, and wherein the catheter lumen outflow portion comprises the catheter lumen outflow port.

75. The system, device, or method of any preceding claim, wherein the catheter lumen inflow portion and the catheter lumen outflow portion merge with each other at a merge point, and wherein the merge point is inside the catheter.

76. The system, device, or method of any preceding claim, wherein when the catheter assembly and the extension line assembly are connected to each other, the extension line assembly comprises the first flow path, a first portion of the second flow path, and a first portion of the third flow path, and wherein when the catheter assembly and the extension line assembly are connected to each other, the catheter assembly comprises a second portion of the second flow path and a second portion of the third flow path.

77. The system, device, or method of any preceding claim, wherein when the catheter assembly and the extension line assembly are disconnected from each other, the extension line assembly comprises the first flow path, a first portion of the second flow path, and a first portion of the third flow path, and wherein when the catheter assembly and the extension line assembly are disconnected to each other, the catheter assembly comprises a second portion of the second flow path and a second portion of the third flow path.

78. The system, device, or method of any preceding claim, wherein the first portion of the second flow path comprises the first inflow tube and / or the second inflow tube, wherein the second portion of the second flow path comprises the catheter lumen inflow portion, wherein the first portion of the third flow path comprises the second return tube, and wherein the second portion of the third flow path comprises the catheter lumen outflow portion.

79. The system, device, or method of any preceding claim, further comprising a first flow path, a second flow path, and a third flow path, wherein the first flow path comprises the first inflow tube and the first return tube, wherein the second flow path comprises the first inflow tube, the second inflow tube, and the catheter lumen first portion, and wherein the third flow path comprises the second return tube and the catheter lumen second portion.

80. The system, device, or method of any preceding claim, wherein the first flow path comprises a bypass loop, wherein the second flow path comprises an inflow path, and wherein the third flow path comprises a return flow path.

81. The system, device, or method of any preceding claim, wherein the first flow path comprises a bypass loop for the fluid, wherein the second flow path comprises an inflow path for the fluid, and wherein the third flow path comprises a return flow path for the fluid.

82. The system, device, or method of any preceding claim, wherein the first flow path bypasses the catheter.

83. The system, device, or method of any preceding claim, wherein the first flow path bypasses the second flow path and / or the third flow path.

84. The system, device, or method of any preceding claim, wherein the second flow path comprises a portion of the bypass loop.

85. The system, device, or method of any preceding claim, wherein the second flow path comprises an inflow portion of the bypass loop.

86. The system, device, or method of any preceding claim, wherein the catheter comprises a catheter first end and a catheter second end, and wherein the catheter first end comprises the catheter inflow port and the catheter lumen outflow port.

87. The system, device, or method of any preceding claim, wherein catheter first end comprises a proximal end of the catheter, and wherein the catheter second end comprises a distal end of the catheter.

88. The system, device, or method of any preceding claim, wherein the catheter second end comprises a tip of the catheter.

89. The system, device, or method of any preceding claim, further comprising a patient connector.

90. The system, device, or method of any preceding claim, wherein the patient connector comprises a clip.

91. The system, device, or method of any preceding claim, wherein the catheter comprises a working channel.

92. The system, device, or method of any preceding claim, wherein the catheter comprises working channel openings.

93. The system, device, or method of any preceding claim, wherein the working channel openings comprise suction openings and / or enteral openings.

94. The system, device, or method of any preceding claim, wherein the catheter comprises an insertion mark.

95. The system, device, or method of any preceding claim, wherein the catheter assembly comprises a first manifold having a first manifold connector, and wherein the extension line assembly comprises a second manifold having a second manifold connector.

96. The system, device, or method of any preceding claim, wherein the catheter is connected to the first manifold, and wherein the second inflow tube, the first outflow tube, and / or an electrical connector are connected to the second manifold.

97. The system, device, or method of any preceding claim, wherein when the catheter connector and the extension line connector are connected to each other, the first manifold and the second manifold are connected to each other.

98. The system, device, or method of any preceding claim, wherein when the catheter connector and the extension line connector are connected to each other, the first manifold connector and the second manifold connector are connected to each other.

99. The system, device, or method of any preceding claim, wherein the catheter assembly comprises a first manifold, wherein the first manifold comprises a first manifold inflow port, a first manifold outflow port, a first manifold electrical connector, and / or a first manifold catheter port.

100. The system, device, or method of any preceding claim, wherein the catheter connector comprises a catheter connector inflow port, a catheter connector outflow port, a catheter connector electrical connector, and / or catheter connector catheter port.

101. The system, device, or method of any preceding claim, wherein the catheter comprises a catheter accessory port.

102. The system, device, or method of any preceding claim, wherein when the catheter assembly is in a fully assembled configuration, the catheter is attached to the first manifold catheter port.

103. The system, device, or method of any preceding claim, wherein when the catheter assembly is in a fully assembled configuration, a proximal end of the catheter is attached to the first manifold catheter port.

104. The system, device, or method of any preceding claim, wherein when the catheter assembly is in a fully assembled configuration, the catheter lumen inflow port and the catheter lumen outflow port are inside the first manifold catheter port.

105. The system, device, or method of any preceding claim, wherein the extension line assembly comprises a second manifold, wherein the second manifold comprises a second manifold inflow port, a second manifold return port, and / or a second manifold electrical connector port.

106. The system, device, or method of any preceding claim, wherein when the catheter assembly is in a fully assembled configuration, the second inflow tube is attached to the second manifold inflow port, the second return tube is attached to the second manifold return port, and / or an electrical connector is attached to the second manifold electrical connector port.

107. The system, device, or method of any preceding claim, further comprising a suction adapter.

108. The system, device, or method of any preceding claim, wherein the catheter assembly comprises the suction adapter.

109. The system, device, or method of any preceding claim, wherein the extension line assembly comprises an extension sleeve.

110. The system, device, or method of any preceding claim, wherein the extension sleeve comprises the first inflow tube, the second inflow tube, the first return tube, the second return tube, and / or a tube connector.

111. The system, device, or method of any preceding claim, wherein the first inflow tube, the second inflow tube, the first return tube, the second return tube, and / or a tube connector are inside the extension sleeve.

112. The system, device, or method of any preceding claim, wherein the first assembly comprises a sensor.

113. The system, device, or method of any preceding claim, wherein the second assembly comprises a sensor.

114. The system, device, or method of any preceding claim, wherein the sensor comprises a temperature sensor.

115. The system, device, or method of any preceding claim, wherein the catheter comprises the sensor.

116. The system, device, or method of any preceding claim, wherein the extension line assembly comprises an extension line.1 17. The system, device, or method of any preceding claim, wherein the extension line comprises the sensor.

118. The system, device, or method of any preceding claim, wherein the extension line comprises the first inflow tube, the second inflow tube, the first return tube, and / or the second return tube.

119. The system, device, or method of any preceding claim, wherein the first assembly comprises a first sensor and / or wherein the second assembly comprises a second sensor.

120. The system, device, or method of any preceding claim, wherein the first sensor comprises a first temperature sensor, and wherein the second sensor comprises a second temperature sensor.

121. The system, device, or method of any preceding claim, further comprising an external sensor.

122. The system, device, or method of any preceding claim, further comprising a core body temperature sensor.

123. The system, device, or method of any preceding claim, wherein the catheter assembly comprises an indicator.

124. The system, device, or method of any preceding claim, wherein the catheter connector comprises the indicator.

125. The system, device, or method of any preceding claim, wherein the extension line assembly comprises an indicator.

126. The system, device, or method of any preceding claim, wherein the extension line connector comprises the indicator.

127. The system, device, or method of any preceding claim, further comprising a temperature monitor.

128. The system, device, or method of any preceding claim, further comprising the fluid.

129. The system, device, or method of any preceding claim, wherein the fluid comprises water.

130. The system, device, or method of any preceding claim, wherein when the catheter connector and the extension line connector are connected to each other and the recirculating pump is recirculating the fluid, the first inflow tube, the first return tube, the second inflow tube, and / or the second return tube are in fluid communication with the recirculating pump.

131. The system, device, or method of any preceding claim, further comprising a recirculating pump.

132. The system, device, or method of any preceding claim, further comprising a heat exchanger.

133. The system, device, or method of any preceding claim, wherein the heat exchanger comprises the recirculating pump.

134. The system, device, or method of any preceding claim, wherein the heat exchanger comprises a recirculating pump.

135. The system, device, or method of any preceding claim, wherein the second flow path comprises the catheter lumen inflow port.

136. The system, device, or method of any preceding claim, wherein the second flow path comprises the catheter lumen first end.

137. The system, device, or method of any preceding claim, wherein the second flow path comprises the catheter lumen first portion.

138. The system, device, or method of any preceding claim, wherein the third flow path comprises the catheter lumen outflow port.

139. The system, device, or method of any preceding claim, wherein the third flow path comprises the catheter lumen second end.

140. The system, device, or method of any preceding claim, wherein the third flow path comprises the catheter lumen second portion.

141. The system, device, or method of any preceding claim, wherein the first flow path comprises a bypass loop for a fluid, wherein the second flow path comprises an inflow path for the fluid, and wherein the third flow path comprises a return flow path for the fluid.

142. The system, device, or method of any preceding claim, wherein the first inflow tube comprises a bypass inflow tube of a bypass loop, and wherein the first return tube comprises a bypass return tube of the bypass loop.

143. The system, device, or method of any preceding claim, wherein when the catheter connector and the extension line connector are connected to each other and a recirculating pump is recirculating the fluid, the first inflow tube and the second inflow tube are in fluid communication with the catheter inflow port.

144. The system, device, or method of any preceding claim, wherein when the catheter connector and the extension line connector are connected to each other and the recirculating pump is recirculating the fluid, the second return tube is in fluid communication with the catheter outflow port.

145. The system, device, or method of any preceding claim, wherein the catheter assembly comprises a catheter and / or a catheter connector.

146. The system, device, or method of any preceding claim, wherein the catheter comprises a catheter lumen having a catheter lumen inflow port and a catheter lumen outflow port.

147. The system, device, or method of any preceding claim, wherein the extension line comprises an first inflow tube, a second inflow tube, a first return tube, a second return tube, and / or an extension line connector.

148. The system, device, or method of any preceding claim, wherein the extension line assembly comprises an extension line and / or an extension line connector.

149. The system, device, or method of any preceding claim, wherein the extension line comprises an first inflow tube, a second inflow tube, a first return tube, and / or a second return tube.

150. The system, device, or method of any preceding claim, wherein when the catheter connector and the extension line connector are connected to each other, the catheter and the extension line are in fluid communication with each other.

151. The system, device, or method of any preceding claim, wherein when the catheter connector and the extension line connector are disconnected from each other, the catheter and extension line are not in fluid communication with each other.

152. The system, device, or method of any preceding claim, further comprising an adherer.

153. The system, device, or method of any preceding claim, wherein when the catheter is in a deployed configuration, an adherer is attached to the catheter.

154. The system, device, or method of any preceding claim, wherein when the catheter is in a deployed configuration, the patient connector is attached to the patient’s clothing, gown, and / or body.

155. The system, device, or method of any preceding claim, wherein when the catheter is in a deployed configuration, a volume of the catheter lumen distal to the catheter lumen inflow port and the catheter lumen outflow port is less than 50mL.

156. The system, device, or method of any preceding claim, wherein when the catheter is in a deployed configuration, a length of the catheter between the adherer and a distal tip of the catheter is at least 80cm.

157. The system, device, or method of any preceding claim, wherein when the catheter is in a deployed configuration, a length of the catheter between the insertion mark and a distal tip of the patient connector is at least 80cm.

158. The system, device, or method of any preceding claim, wherein when the catheter is in a deployed configuration, a length of the catheter between the adherer and a distal terminal end of the catheter is greater than 90cm from the adherer.

159. The system, device, or method of any preceding claim, wherein when the catheter is in a deployed configuration, a distance as measured along a straight line from the adherer to a distal terminal end of the catheter is less than 60cm.

160. The system, device, or method of any preceding claim, wherein when the catheter is in a deployed configuration, a length of the catheter between the insertion mark and a distal terminal end of the catheter is greater than 90cm from the adherer.

161. The system, device, or method of any preceding claim, wherein when the catheter is in a deployed configuration, a distance as measured along a straight line from the insertion mark to a distal terminal end of the catheter is less than 60cm.

162. The system, device, or method of any preceding claim, wherein the catheter assembly comprises a catheter and / or a catheter connector.

163. The system, device, or method of any preceding claim, wherein the catheter comprises a catheter lumen having a catheter lumen inflow port and a catheter lumen outflow port.

164. The system, device, or method of any preceding claim, wherein the extension line comprises an first inflow tube, a second inflow tube, a first return tube, a second return tube, and / or an extension line connector.

165. The system, device, or method of any preceding claim, wherein the extension line assembly comprises an extension line and / or an extension line connector.

166. The system, device, or method of any preceding claim, wherein the extension line comprises an first inflow tube, a second inflow tube, a first return tube, and / or a second return tube.

167. The system, device, or method of any preceding claim, wherein when the catheter connector and the extension line connector are connected to each other, the catheter and the extension line are in fluid communication with each other.

168. The system, device, or method of any preceding claim, wherein when the catheter connector and the extension line connector are disconnected from each other, the catheter and extension line are not in fluid communication with each other.

169. The system, device, or method of any preceding claim, wherein the catheter lumen comprises a catheter lumen inflow portion and a catheter lumen outflow portion, wherein the catheter lumen inflow portion comprises the catheter lumen inflow port, and wherein the catheter lumen outflow portion comprises the catheter lumen outflow port.

170. The system, device, or method of any preceding claim, wherein the catheter lumen inflow portion and the catheter lumen outflow portion merge with each other at a merge point, and wherein the merge point is inside the catheter.

171. The system, device, or method of any preceding claim, wherein when the catheter assembly and the extension line assembly are attached to each other, the catheter assembly and the extension line assembly comprise a first flow path, a second flow path, and a third flow path.

172. The system, device, or method of any preceding claim, wherein the first flow path comprises the first inflow tube and the first return tube, wherein the second flow path comprises the first inflow tube, the second inflow tube, and the catheter lumen first end, and wherein the third flow path comprises the second return tube and the catheter lumen second end.

173. The system, device, or method of any preceding claim, wherein when the catheter assembly and the extension line assembly are attached to each other, the extension line assembly comprises the first flow path, a first portion of the second flow path, and a first portion of the third flow path, and wherein when the catheter assembly and the extension line assembly are attached to each other, the catheter assembly comprises a second portion of the second flow path and a second portion of the third flow path.

174. The system, device, or method of any preceding claim, wherein when the catheter assembly and the extension line assembly are detached from each other, the extension line assembly comprises the first flow path, a first portion of the second flow path, and a first portion of the third flow path, and wherein when the catheter assembly and the extension line assembly aredetached from each other, the catheter assembly comprises a second portion of the second flow path and a second portion of the third flow path.

175. The system, device, or method of any preceding claim, wherein the first portion of the second flow path comprises the first inflow tube and / or the second inflow tube, wherein the second portion of the second flow path comprises the catheter lumen inflow portion, wherein the first portion of the third flow path comprises the second return tube, and wherein the second portion of the third flow path comprises the catheter lumen outflow portion.

176. The system, device, or method of any preceding claim, further comprising attaching the catheter assembly to the extension line assembly before, during, or during inserting the catheter assembly into the stomach of the gastrointestinal tract.

177. The system, device, or method of any preceding claim, further comprising attaching the catheter assembly to the extension line assembly before, during, or during inserting the catheter assembly into the body lumen.

178. The system, device, or method of any preceding claim, further comprising detaching the catheter assembly from the extension line assembly before, during, or after recirculating the fluid through the catheter assembly and the extension line assembly.

179. The system, device, or method of any preceding claim, wherein recirculating the fluid through the catheter assembly and the extension line assembly comprises recirculating the fluid through the catheter lumen, the first inflow lumen, the second inflow lumen, the first return lumen, the second return lumen, and the catheter lumen.

180. The system, device, or method of any preceding claim, further comprising recirculating the fluid through the extension line assembly after detaching the catheter assembly from the extension line assembly.

181. The system, device, or method of any preceding claim, wherein recirculating the fluid through the extension line assembly after detaching the catheter assembly from the extension line assembly comprises recirculating the fluid through the first inflow lumen and the first return lumen.The system, device, or method of any preceding claim, further comprising recirculating the fluid through the extension line assembly when the catheter assembly and the extension line assembly are detached from each other.

182. The system, device, or method of any preceding claim, wherein recirculating the fluid through the extension line assembly when the catheter assembly and the extension line assembly are detached from each other comprises recirculating the fluid through the first inflow lumen and the first return lumen.

183. The system, device, or method of any preceding claim, wherein the body lumen comprises a lumen of a patient.

184. The system, device, or method of any preceding claim, wherein the body lumen comprises a gastrointestinal tract.

185. The system, device, or method of any preceding claim, wherein the organ comprises a nose, a mouth, an esophagus, a stomach, a duodenum, a jejunum, an ilium, a large intestine, and / or an anus.

186. The system, device, or method of any preceding claim, further comprising attaching the catheter assembly to the extension line assembly before, during, or during inserting the catheter assembly into the body lumen.

187. The system, device, or method of any preceding claim, wherein inserting the catheter assembly into the stomach of the gastrointestinal tract comprises inserting 30cm-300cm of the catheter into the stomach of the gastrointestinal tract.

188. The system, device, or method of any preceding claim, wherein inserting the catheter assembly into the body lumen comprises inserting 30cm-300cm of the catheter into the body lumen.

189. The system, device, or method of any preceding claim, further comprising adding or removing the fluid from the catheter through a catheter inflow port and a catheter outflow port with 10-100 Watts of cooling power or warming power.

190. The system, device, or method of any preceding claim, wherein recirculating the fluid through the catheter assembly and the extension line assembly comprises passing the fluid through the catheter lumen at a flow rate over a treatment period, wherein the flow rate is at least 20mL / min and the treatment period is at least 2 hours.

191. The system, device, or method of any preceding claim, wherein the catheter lumen has a catheter lumen total length, and wherein the catheter lumen total length comprises 15cm-150cm.

192. The system, device, or method of any preceding claim, wherein the catheter lumen has a catheter lumen total length, and wherein the catheter lumen total length comprises 30cm-600cm.

193. The system, device, or method of any preceding claim, wherein the catheter lumen inflow portion has a catheter lumen inflow portion total length, wherein the catheter lumen outflow portion has a catheter lumen outflow portion total length, wherein the catheter lumen inflow portion total length comprises 30cm-300cm, and wherein the catheter lumen outflow portion total length comprises 30cm-300cm.

194. Any combination of features disclosed herein.

195. A system or a device having any combination of features in any figure and / or in any combination of the figures.

196. A method having any combination of steps disclosed herein.

197. A system, device, product, process, kit, component or use, characterized in that it comprises one or more features disclosed herein.

198. Any combination of claims 1-197.

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