Tissue treatment system with fluid delivery console

Abstract

A system for performing a medical procedure in a patient's intestine includes a catheter for insertion into the intestine, a console, and a connector configured to operably attach the catheter to the console. The catheter includes a shaft including a distal portion, and a functional assembly positioned on the distal portion of the shaft. The functional assembly is configured to receive a fluid. The console includes a fluid reservoir configured to supply the fluid, a first syringe pump assembly configured to deliver the fluid to the functional assembly, a second syringe pump assembly configured to deliver the fluid to the functional assembly, a fluid heater configured to heat the fluid, and a waste reservoir configured to receive the fluid. The system is configured to treat a target tissue of the patient's intestine. A method of treating the target tissue is also provided.

Description

[0001] Cross-reference to related applications

[0002] This application is related to the following: This application claims the benefit of U.S. Provisional Patent Application No. 63 / 042,356 (Attorney No. 41714-724.101; Client No. MCT-034-PR1), filed June 22, 2020, entitled “Tissue Treatment System with Fluid Delivery Console,” the entire contents of which are incorporated herein by reference for all purposes.

[0003] This application relates to: U.S. Patent Application No. 16 / 438,362, filed June 11, 2019, entitled "Heat Ablation Systems, Devices and Methods for the Treatment of Tissue" (Attorney No. 41714-704.302; Client No. MCT-002-US-CON1); U.S. Patent Application No. 14 / 515,324, filed October 15, 2014, entitled "Tissue Expansion Devices, Systems and Methods" (Attorney No. 41714-705.301; Client No. MCT-003-US); and U.S. Patent Application No. 16 / 438,362, filed December 11, 2019, entitled "Electrical Energy Ablation Systems, Devices and Methods for the Treatment of Tissue". U.S. Patent Application No. 16 / 711,236, entitled “Methods, Systems and Devices for Performing Multiple Treatments on a Patient” (Attorney No. 41714-706.302; Client No. MCT-004-US-CON1), filed March 30, 2015; and U.S. Patent Application No. 14 / 673,565, entitled “Methods, Systems and Devices for Reducing the Luminal Surface Area of ​​the Gastrointestinal Tissue” (Attorney No. 41714-708.301; Client No. MCT-009-US), filed April 9, 2019; and U.S. Patent Application No. 14 / 673,565, entitled “Methods, Systems and Devices for Reducing the Luminal Surface Area of ​​the Gastrointestinal Tissue” (Attorney No. 41714-706.302; Client No. MCT-004-US-CON1), filed April 30, 2015. The following patent applications were filed: U.S. Patent Application No. 16 / 379,554 for “Tract” (Attorney No. 41714-709.302; Client No. MCT-013-US-CON1); U.S. Patent Application No. 14 / 917,243 for “Systems, Methods and Devices for Treatment of TargetTissue” filed on March 7, 2016 (Attorney No. 41714-710.301; Client No. MCT-023-US); and U.S. Patent Application No. 16 / 742,645 for “Intestinal Catheter Device and System” filed on January 14, 2020 (Attorney No. 41714-715).301; Client Case No. MCT-025-US); U.S. Patent Application No. 16 / 798,117, filed February 21, 2020, entitled "Systems, Devices and Methods for Performing Medical Procedures in the Intestine" (Attorney Case No. 41714-714.303; Client Case No. MCT-028-US-CIP1-CON2); U.S. Patent Application No. 15 / 812,969, filed November 14, 2017, entitled "Systems, Devices and Methods for Performing Medical Procedures in the Intestine" (Attorney Case No. 41714-714.302; Client Case No. MCT-023-US-CIP2-CON1); U.S. Patent Application No. 15 / 812,969, filed May 1, 2019, entitled "Systems, Devices and Methods for Performing Medical Procedures in..." The following patent applications were filed: U.S. Patent Application No. 16 / 400,491 for “the Intestine” (Attorney No. 41714-716.301; Client No. MCT-035-US); U.S. Patent Application No. 16 / 905,274 for “Material Depositing System for Treating a Patient” (Attorney No. 41714-717.301; Client No. MCT-036-US), filed June 18, 2020; International PCT Patent Application No. PCT / US2020 / 025925 for “Systems, Devices and Methods for Treating Metabolic Medical Conditions” (Attorney No. 41714-719.601; Client No. MCT-040-PCT), filed September 15, 2020; and [other patent applications were filed]. The U.S. patent application number for “the Luminal Surface Area of ​​the Gastrointestinal Tract” is 17 / 021,798 (Attorney’s Case No. 41714-709).303; Client Case No. MCT-013-US-CON2); International PCT patent application No. PCT / US2020 / 056627, filed on October 21, 2020, entitled "Systems, Devices, and Methods for Performing Medical Procedures in the Intestine" (Attorney Case No. 41714-720.601; Client Case No. MCT-050-PCT); U.S. patent application No. 17 / 095,108, filed on November 11, 2020, entitled "Systems, Devices and Methods for the Creation of a Therapeutic Restriction in the Gastrointestinal Tract" (Attorney Case No. 41714-711.303; Client Case No. MCT-024-US-CON2); Methods and Systems for Treating Diabetes and Related Diseases, filed on November 12, 2020. U.S. Patent Application No. 17 / 096,855 entitled “Tissue Treatment Devices, Systems, and Methods” (Attorney No. 41714-713.302; Client No. MCT-029-US-CON1); U.S. Patent Application No. 17 / 110,720 entitled “Tissue Treatment Devices, Systems, and Methods” (Attorney No. 41714-712.302; Client No. MCT-027-US-CIP1-CON1) filed on December 3, 2020; International PCT Patent Application No. PCT / US2021 / 013072 entitled “Tissue Treatment Devices, Systems, and Methods” (Attorney No. 41714-721.601; Client No. MCT-039-PCT) filed on January 12, 2021; International PCT Patent Application No. PCT / US2021 / 013072 entitled “Tissue Treatment Devices, Systems, and Methods” (Attorney No. 41714-721.601; Client No. MCT-039-PCT) filed on January 15, 2021; and International PCT Patent Application No. PCT / US2021 / 013072 entitled “Tissue Treatment Devices, Systems, and Methods” (Attorney No. 41714-721.601; Client No. MCT-039-PCT) filed on January 15, 2021. The international PCT patent application for “Methods” is PCT / US2021 / 013600 (Attorney’s Case No. 41714-722.601; Client Case No. MCT-051-PCT); and the U.S. Provisional Patent Application No. 63 / 148,551 (Attorney’s Case No. 41714-725), filed on February 11, 2021.101; Client Case No. MCT-053-PR1), entitled "System for Treating a Patient"; U.S. Patent Application No. 17 / 181,969, entitled "Methods and Systems for Treating Diabetes and Related Diseases and Disorders," filed February 22, 2021 (Attorney Case No. 41714-713.501; Client Case No. MCT-029-US-CIP1); U.S. Patent Application No. 17 / 189,772, entitled "Methods and Systems for Treating Diabetes and Related Diseases and Disorders," filed March 2, 2021 (Attorney Case No. 41714-713.502; Client Case No. MCT-029-US-CIP1-CON1); and U.S. Patent Application No. 17 / 189,772, entitled "Ablation Systems, Devices, and Methods for the Treatment of The following patent applications were filed: U.S. Patent Application No. 14 / 609,334 for “Tissue” (Attorney No. 41714-707.302; Client No. MCT-005-US-CON1); International PCT Patent Application No. PCT / US2021 / 022938 for “Systems, Devices and Methods for Treating Diabetes” filed on March 18, 2021 (Attorney No. 41714-723.601; Client No. MCT-041-PCT); U.S. Patent Application No. 17 / 214,157 for “Systems and Methods for Deposition Material in a Patient” filed on March 26, 2021 (Attorney No. 41714-718.301; Client No. MCT-037-US); and a patent application for “Devices and Methods for the Treatment of” filed on April 5, 2021. The contents of each item of the preceding application, namely U.S. Patent Application No. 17 / 222,480 (Attorney No. 41714-703.303; Client No. MCT-001-US-CON2), for “Tissue”, are incorporated herein by reference in their entirety for all purposes. Technical Field

[0004] The present invention relates generally to tissue processing systems, and more particularly to tissue processing systems comprising a fluid delivery console and processing devices. Background Technology

[0005] Many diagnostic and therapeutic procedures are performed in the small and large intestines, as well as other parts of the gastrointestinal tract. The equipment used in these procedures can be difficult to manipulate and otherwise operate, and its functionality is often limited. There is a need for improved systems and devices for processing and diagnosing intestinal tissue, and for methods to process intestinal tissue to provide improved treatment for a wide range of diseases and disorders. Summary of the Invention

[0006] According to one aspect of the present invention, a system for performing a medical procedure in a patient's intestine includes: a catheter for insertion into the intestine, the catheter comprising: a shaft including a distal portion, and a functional assembly positioned on the distal portion of the shaft such that the functional assembly is configured to receive fluid; a console including a fluid reservoir configured to store fluid, a first syringe pump assembly configured to deliver fluid to the functional assembly, a second syringe pump assembly configured to deliver fluid to the functional assembly, a fluid heater configured to heat the fluid, and a waste fluid reservoir configured to receive the fluid; and a connector configured to operatively attach the catheter to the console. The system can be configured to treat target tissue of a patient's intestine.

[0007] In some implementations, the functional assembly includes a balloon.

[0008] In some embodiments, the system is configured to process target tissue by: providing a first volume of fluid at a temperature below body temperature and recirculating the first volume of fluid within a functional assembly to cool the target tissue and tissue adjacent to the target tissue; and providing a second volume of fluid at an elevated ablation temperature and recirculating the second volume of fluid within the functional assembly to ablate the target tissue. The system may be configured to deliver the first volume of fluid before or after the delivery of the second volume of fluid. The system may also be configured to deliver the first volume of fluid before the delivery of the second volume of fluid, and may further be configured to deliver a third volume of fluid after the delivery of the second volume of fluid, and the third volume of fluid may include fluid at a temperature below body temperature that cools the target tissue and tissue adjacent to the target tissue during its delivery. At least a portion of the first volume of fluid and the second volume of fluid may include the same fluid. The fluid heater may include an inline heater, and the second volume of fluid may be heated by the inline heater via two passes through the inline heater. During the first pass through the inline heater, the inline heater may be powered to a higher level than during the second pass through the inline heater. The control console can operate at peak power levels while the heater is powered to a higher level. A second volume of fluid can be delivered to the functional assembly at a rate of at least 8 mL / s, 9 mL / s, and / or 10 mL / s. The first volume of fluid may include fluid at room temperature. The treatment may also include delivering a third volume of fluid to cool the target tissue after it has been ablated. The control console can be configured to prevent the delivery of a second volume of fluid to the functional assembly unless at least a third volume of fluid is present in the first syringe pump assembly prior to the delivery of the second volume of fluid to the functional assembly.

[0009] In some embodiments, the fluid heater includes an inline heater, and the fluid heater is configured to be preheated before a second volume of fluid passes through it. The system may be configured to perform multiple processing steps, and the fluid heater may be configured to be preheated between each of the multiple processing steps.

[0010] In some implementations, the system also includes a closed-loop control algorithm configured to control the fluid heater.

[0011] In some embodiments, the system includes at least one reusable component, and the system is configured to perform a sterilization procedure on the at least one reusable component. The sterilization procedure may include a low-level sterilization procedure. The sterilization procedure may include a high-level sterilization procedure. The system may be configured to heat at least a portion of at least one reusable component to at least 93°C, at least 95°C, or at least 97°C for a minimum time period of at least 45 seconds, at least 60 seconds, and / or at least 90 seconds, and a maximum time period of no more than 3 minutes, no more than 4 minutes, and / or no more than 5 minutes.

[0012] In some implementations, the console is configured to determine one or more parameters related to the treatment of the target tissue. These one or more treatment parameters are selected from: flow rate; fluid temperature; energy level; pressure; duration; and combinations thereof. These one or more treatment parameters may be based on ambient temperature. At least one of the one or more parameters may be predetermined prior to the treatment procedure.

[0013] In some embodiments, the system is configured to process a first axial segment of the intestine comprising a first portion of the target tissue, and subsequently process a second axial segment of the intestine comprising a second portion of the target tissue. During the medical procedure, the system may not maintain the fluid reservoir at the ablation temperature. Between the processing of the first and second axial segments, the system may not maintain the fluid reservoir at the ablation temperature. The fluid reservoir may include a first reservoir, and the system may include a second reservoir configured to maintain the fluid at the ablation temperature during at least a portion of the medical procedure. A fluid heater may be configured to heat the fluid in the second reservoir to the ablation temperature. The fluid reservoir may include a first reservoir, and the system may include a second reservoir configured to maintain the fluid at the ablation temperature between the processing of the first and second axial segments. A fluid heater may be configured to heat the fluid in the second reservoir to the ablation temperature.

[0014] In some embodiments, the system is configured to heat fluid within the second syringe pump assembly to an ablation temperature and deliver the heated fluid from the second syringe pump assembly to a functional assembly to ablate target tissue.

[0015] In some embodiments, the system also includes a user-activated control, and the system is configured to prevent execution of one or more procedural steps until the user-activated control is activated. The user-activated control may be configured to be activated by an operator of the system when the functional assembly is properly positioned within the patient's intestine. The one or more procedural steps may include a tissue expansion step. The one or more procedural steps may include a tissue ablation step.

[0016] In some embodiments, the first syringe pump assembly and / or the second syringe pump assembly includes at least one syringe operatively attached to a console. The at least one syringe can be configured to rotate to lock into contact with the console. The first syringe pump assembly and / or the second syringe pump assembly can provide user feedback when the at least one syringe is properly connected to the console. The system can be configured to detect when the at least one syringe is properly connected to the console.

[0017] In some embodiments, the first syringe pump assembly and / or the second syringe pump assembly include at least one syringe, the at least one syringe including an integrated rotatable locking connector.

[0018] In some embodiments, the system also includes a cartridge configured to be operatively attached to a control console and / or connector. The system can be configured to detect when the cartridge is properly attached to the control console. The cartridge may include one or more integrated connectors that are securely attached to the wall of the cartridge without the use of any adhesive. At least one of the one or more integrated connectors may be securely attached to the wall of the cartridge using a press-fit connection. At least one of the one or more integrated connectors may be configured to be rotatably attached to a mating connector of the cartridge. The at least one integrated connector may be configured to be rotatably attached in one-handed operation. At least one of the one or more integrated connectors may include a rotatable locking connector. The cartridge may include one or more fluid conduits configured and arranged to withstand one or more functional conditions. The one or more functional conditions may include a vacuum pressure of at least -3 psi, -7 psi, and / or -14.7 psi. At least a portion of at least one of the one or more fluid conduits may be configured and arranged to collapse into a closed state under the compressive force of a pinch valve. The system can be configured to detect whether the pinch valve fails to collapse the conduit into a closed state. One or more functional conditions may include temperatures of at least 60°C, 80°C, and / or 100°C.

[0019] In some embodiments, the fluid reservoir includes a flexible housing. The housing may include softened polyvinyl chloride (PVC). The reservoir may include a handle. The reservoir may include an inlet manifold. The fluid reservoir may include a temperature sensor operatively connected to a control console. The control console may include an infrared temperature sensor configured to measure the temperature of the fluid within the fluid reservoir.

[0020] In some embodiments, the system is configured to perform a medical procedure using a fluid volume not exceeding a target procedure volume, and the target procedure volume includes a fluid volume not exceeding 5L, 4L, 3L, and / or 2L. A first reservoir may be configured to be filled with at least the target procedure volume of fluid before the medical procedure begins.

[0021] In some implementations, the connector comprises two tubes formed during a single extrusion process.

[0022] In some embodiments, the system also includes a first conduit and a second conduit, and a connector includes the second conduit, and the first conduit is fluidly attached between the fluid heater and the second conduit, and the second conduit is further fluidly attached to the functional assembly, and the first conduit includes a length of less than 10 inches, 8 inches, and / or 6 inches.

[0023] In some implementations, the functional assembly includes a balloon made of a non-compliant material.

[0024] In some implementations, the console also includes a backup power supply. This backup power supply may include a battery. The backup power supply may include sufficient energy capacity to allow the system to switch one or more components of the system to a patient-safe mode. The system can be configured to switch from a treatment mode to a patient-safe mode in the event of a power failure during treatment of the target tissue.

[0025] In some implementations, the system includes one or more valves, and when the functional assembly is positioned inside the patient's intestine, a waste reservoir is positioned below the functional assembly, and in the event of a power outage, one or more valves are configured to automatically open to allow fluid within the functional assembly to flow into the waste reservoir.

[0026] In some implementations, the console is configured to monitor one or more parameters of the system to assess the mechanical integrity of the conduit. The console may be configured to identify leaks and / or blockages based on one or more parameters. Identification of leaks and / or blockages may be based on comparing one or more parameters to one or more thresholds. These one or more thresholds may be adjusted based on the temperature of the fluid circulating through the functional assembly. The system may be configured to monitor for leaks as fluid circulates through the functional assembly at an ablation temperature and, upon detecting a leak, deliver cooled fluid to the functional assembly. The system may also be configured to monitor for blockages as fluid circulates through the functional assembly at an ablation temperature and, upon detecting a blockage, remove fluid from the functional assembly.

[0027] In some embodiments, the system is also configured to perform a tissue expansion procedure. The system may be configured to control the volume of fluid within the functional assembly during the tissue expansion procedure and to control the flow rate of fluid to and / or from the functional assembly during the treatment of the target tissue. The system may also include a syringe pump assembly configured to perform control of the volume of fluid within the functional assembly and control of the flow rate of fluid to the functional assembly. The catheter may also include a plurality of fluid delivery elements configured to deliver an injection solution into the tissue to perform the tissue expansion procedure. The system may also include a plurality of fluid delivery assemblies, each configured to independently deliver an injection solution to a corresponding fluid delivery element. Each of the plurality of fluid delivery assemblies includes a syringe pump. The system may be configured to prevent treatment of the target tissue if a tissue expansion procedure has not yet been performed. The system may be configured to treat the target tissue after the tissue expansion procedure has been performed. The system may be configured to prevent treatment of the target tissue if a maximum time period has elapsed since the tissue expansion procedure was performed. The maximum time period may include a duration of no more than 10 minutes and / or no more than 5 minutes.

[0028] In some embodiments, the system does not include two or more syringe pump assemblies configured to deliver fluid to the functional assembly, and the first syringe pump assembly includes a single syringe, and the second syringe pump assembly includes a single syringe. The single syringe of the first syringe pump assembly and the single syringe of the second syringe pump assembly may each include a maximum volume of 500 mL, 300 mL, 200 mL, and / or 150 mL.

[0029] In some implementations, the system is configured to prevent treatment of the target tissue if the fluid in the fluid reservoir does not exceed a minimum volume.

[0030] In some implementations, the system is configured to prevent treatment of the target tissue if the space in the waste liquid reservoir does not exceed a minimum volume.

[0031] In some embodiments, the system further includes at least one microcontroller. The at least one microcontroller may include a first microcontroller configured to control at least the first syringe pump assembly and a second microcontroller configured to control a fluid heater. The system also includes at least one valve assembly, and the at least one microcontroller may include a first microcontroller configured to control at least the first syringe pump assembly and a second microcontroller configured to control the valve assembly.

[0032] In some embodiments, the system also includes an electromechanical safety mechanism configured to prevent fluid pressure from exceeding a safety threshold. This electromechanical safety mechanism may include a device selected from: a load cell; an overpressure valve; a nut on a linear drive mechanism; a clutch on a linear drive mechanism; a current limiter; and combinations thereof.

[0033] In some embodiments, the system also includes an umbilical tube configured to operatively connect a conduit to a control console. The umbilical tube may include one or more insulating layers, insulating conduits, and / or other insulating materials. The umbilical tube may include a heater.

[0034] In some implementations, the system includes at least one user-replaceable assembly secured to a console by hooks, latches, and / or locks.

[0035] The techniques described herein, along with their properties and resulting advantages, will be best understood through the following detailed description of representative embodiments, taken in conjunction with the accompanying drawings.

[0036] Incorporation

[0037] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the extent that each individual publication, patent, or patent application is specifically and individually incorporated herein by reference. The contents of all publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety for all purposes. Attached Figure Description

[0038] Figure 1 The illustration depicts a system for processing and / or diagnosing gastrointestinal tissues, consistent with the concept of this invention.

[0039] Figure 1A The illustration shows a schematic diagram of a system for performing medical procedures in a patient's intestine, in accordance with the concept of the present invention.

[0040] Figure 1B The illustration shows a flowchart of a method for processing a patient's target tissue in accordance with the concept of this invention.

[0041] Figure 1C The illustration shows a representative expansion periphery and ablation periphery consistent with the concept of this invention, consisting of two full circumferential expansions followed by a single full circumferential ablation (each performed via a catheter through a console as described herein).

[0042] Figure 2 The illustration shows a schematic diagram of a tissue processing system in accordance with the concept of the present invention, which includes an elongated device and a control console having a cartridge, a syringe pump assembly and a fluid reservoir that can be attached thereto.

[0043] Figure 3 The illustration shows a schematic diagram of another tissue processing system in accordance with the concept of the present invention, which includes an elongated device and a control console having a cartridge, a syringe pump assembly and a fluid reservoir that can be attached thereto.

[0044] Figure 4 The illustration shows a perspective cross-sectional view of a portion of a cartridge case, consistent with the concept of this invention.

[0045] Figures 5A-5C The illustrations show two side views and an enlarged side view of the syringe pump assembly conforming to the concept of this invention.

[0046] Figure 6 The illustration shows a schematic diagram of the fluid channels of a tissue processing system in accordance with the concept of this invention.

[0047] Figures 6A-6F The diagram illustrates various operating states of system 10 in accordance with the concept of this invention.

[0048] Figure 6G The diagram illustrates a flowchart of a method for processing tissue in accordance with the concept of this invention.

[0049] Figure 7 The illustration shows a perspective view of a cartridge that is operatively attached to a control console, in accordance with the concept of this invention.

[0050] Figure 8A and Figure 8B The illustration shows two perspective views of a cartridge case conforming to the concept of this invention.

[0051] Figures 9A-9D The illustration shows a valve assembly configured to compress the wall of a conduit to control the flow of fluid through a cartridge. Detailed Implementation

[0052] Reference will now be made in detail to current embodiments of the present technology, which are illustrated in the accompanying drawings. Similar reference numerals may be used to denote similar components. However, the description is not intended to limit this disclosure to the particular embodiments, but should be construed as including various modifications, equivalents, and / or substitutions to the embodiments described herein.

[0053] It should be understood that, when used herein, the words “comprising” (and any form thereof), “having” (and any form thereof), “including” (and any form thereof), or “containing” (and any form thereof) indicate the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0054] It should also be understood that while the terms first, second, third, etc., may be used herein to describe various limits, elements, components, regions, layers, and / or portions, these limits, elements, components, regions, layers, and / or portions should not be limited by these terms. These terms are used only to distinguish one limit, element, component, region, layer, or portion from another. Therefore, the first limit, element, component, region, layer, or portion discussed below may be referred to as a second limit, element, component, region, layer, or portion without departing from the teachings of this application.

[0055] It should also be understood that when an element is described as being “on”, “attached,” “connected,” or “coupled” to another element, it may be directly on or above the other element, or connected or coupled to the other element, or there may be one or more intermediate elements. Conversely, when an element is described as being “directly on,” “directly attached,” “directly connected,” or “directly coupled” to another element, there are no intermediate elements. Other terms used to describe relationships between elements should be interpreted in a similar manner (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.).

[0056] It should also be understood that when the first element is referred to as “in,” “on,” and / or “within” the second element, the first element may be located: within the internal space of the second element; within a portion of the second element (e.g., within the wall of the second element); located on the outer and / or inner surface of the second element; and a combination of one or more of the foregoing.

[0057] As used herein, when used to describe the proximity of a first component or location to a second component or location, the term "proximity" should be considered to include one or more locations located near the second component or location, as well as one or more locations located in, above, and / or within the second component or location. For example, a component located near an anatomical site (e.g., a target tissue location) should include components located near the anatomical site, as well as components located in, above, and / or within the anatomical site.

[0058] Spatial terms such as “below,” “under,” “down,” “above,” and “up” are used to describe the relationship between an element and / or feature and another element and / or feature, as shown in the figures. It should also be understood that, in addition to the orientation depicted in the figures, spatial terms are intended to encompass different orientations of the device in use and / or operation. For example, if the device is flipped in the figure, an element described as being “below” and / or “under” another element or feature would then be oriented to be “above” another element or feature. The device may be oriented in other ways (e.g., rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein shall be interpreted accordingly.

[0059] When used herein, the terms “reduction” and the like include reduction in quantity, including reduction to zero. The possibility of reduction occurring should include prevention of its occurrence. Accordingly, the term “prevention” should include the act of “reduction”.

[0060] When used herein, the term “and / or” should be considered as a specific disclosure of each of the two specified features or components, with or without the other feature or component. For example, “A and / or B” should be considered as a specific disclosure of (i) A, (ii) B, and (iii) each of A and B, as if each were stated individually herein.

[0061] When used in this document, the term "one or more" may refer to one, two, three, four, five, six, seven, eight, nine, ten or more, up to any number.

[0062] The terms "and combinations thereof" and "and combinations thereof" may be used after a series of items, individually or collectively. For example, a component, process, and / or other item selected from A; B; C and combinations thereof shall include one or more components comprising: one, two, three, or more of item A; one, two, three, or more of item B; and / or one, two, three, or more of item C.

[0063] In this specification, unless otherwise expressly stated, “and” may mean “or”, and “or” may mean “and”. For example, if a feature is described as having A, B, or C, then the feature may have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, then the feature may have only one or two of A, B, or C.

[0064] As used herein, when a quantifiable parameter is described as having a value "between" a first value X and a second value Y, it should include a parameter having the following values: at least X, not exceeding Y, and / or at least X and not exceeding Y. For example, a length between 1 and 10 should include a length of at least 1 (including values ​​greater than 10), a length of less than 10 (including values ​​less than 1), and / or a value greater than 1 and less than 10.

[0065] The expression “configured (or set) for” as used in this disclosure may be used interchangeably with expressions such as “suitable for,” “capable of,” “designed for,” “suitable for,” “manufactured for,” and “capable of.” The expression “configured (or set) for” does not simply mean “specifically designed for” in hardware. Alternatively, in some cases, the expression “the device is configured for” may mean that the device “can” operate with another device or component.

[0066] As used herein, the term "threshold" refers to a maximum, minimum, and / or range of values ​​associated with a desired or undesirable state. In some embodiments, system parameters are maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values, thereby achieving the desired effect (e.g., effective treatment) and / or preventing or otherwise reducing (hereinafter "preventing") undesirable events (e.g., device and / or clinical adverse events). In some embodiments, system parameters are maintained above a first threshold (e.g., above a first temperature threshold to achieve the desired therapeutic effect on tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesirable tissue damage). In some embodiments, the threshold is determined to include a safety margin to account for patient variability, system variability, tolerability, etc. As used herein, "exceeding a threshold" refers to a parameter being above a maximum threshold, below a minimum threshold, within a threshold range, and / or outside a threshold range.

[0067] As described herein, “chamber pressure” refers to the ambient pressure surrounding the systems and devices of the present invention. Positive pressure includes pressures above chamber pressure or simply greater than another pressure, such as a positive pressure differential across a fluid passage assembly such as a valve. Negative pressure includes pressures below chamber pressure or less than another pressure, such as a negative pressure differential across a fluid passage assembly such as a valve. Negative pressure may include a vacuum, but does not necessarily mean a pressure below a vacuum. As used herein, the term “vacuum” may be used to refer to a complete or partial vacuum, or any negative pressure as described above.

[0068] The term "diameter" used in this document to describe non-circular geometries should be considered as the diameter of an imaginary circle approximating the geometry being described. For example, when describing a cross-section, such as the cross-section of a component, the term "diameter" should be considered as representing the diameter of an imaginary circle with the same cross-sectional area as the component being described.

[0069] The terms “major axis” and “minor axis” used in this article refer to the length and diameter of the smallest imaginary cylinder that can completely enclose the component.

[0070] As used herein, the term "functional element" should be considered to include one or more elements constructed and arranged to perform a function. A functional element may include sensors and / or transducers. In some embodiments, a functional element is configured to deliver energy and / or otherwise process tissue (e.g., a functional element configured as a processing element). Alternatively or additionally, a functional element (e.g., a functional element including sensors) may be configured to record one or more parameters, such as patient physiological parameters; patient anatomical parameters (e.g., tissue geometry parameters); patient environmental parameters; and / or system parameters. In some embodiments, sensors or other functional elements are configured to perform diagnostic functions (e.g., collecting data for performing a diagnosis). In some embodiments, a functional element is configured to perform therapeutic functions (e.g., delivering therapeutic energy and / or therapeutic agents). In some embodiments, a functional element includes one or more elements constructed and arranged to perform a function selected from: delivering energy; extracting energy (e.g., to cool components); delivering drugs or other agents; manipulating system components or patient tissue; recording or otherwise sensing parameters such as patient physiological parameters or system parameters; and combinations of one or more of these. A functional element may include fluids and / or fluid delivery systems. Functional elements may include reservoirs, such as expandable balloons or other fluid maintenance reservoirs. A “functional assembly” may include assemblies constructed and arranged to perform functions, such as diagnostic and / or therapeutic functions. A functional assembly may include expandable assemblies. A functional assembly may include one or more functional elements.

[0071] As used herein, the term "transducer" should be considered to include any component or combination of components that receives energy or any input and produces an output. For example, a transducer may include electrodes that receive electrical energy and distribute it to tissue (e.g., based on electrode size). In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g., a transducer including a light-emitting diode or light bulb), sound (e.g., a transducer including a piezoelectric crystal configured to deliver ultrasonic energy); pressure (e.g., applied pressure or force); heat; cold; chemical energy; mechanical energy (e.g., a transducer including a motor or solenoid); magnetic energy; and / or a different electrical signal (e.g., an input signal different from that of the transducer). Alternatively or additionally, a transducer may convert a physical quantity (e.g., a change in a physical quantity) into an electrical signal. A transducer may include any component that delivers energy and / or agents to tissue, such as a transducer configured to perform one or more of the following: deliver electrical energy to tissue (e.g., a transducer including one or more electrodes); deliver optical energy to tissue (e.g., a transducer including a laser, a light-emitting diode, and / or optical components such as a lens or prism); deliver mechanical energy to tissue (e.g., a transducer including a tissue manipulation element); deliver acoustic energy to tissue (e.g., a transducer including a piezoelectric crystal); deliver chemical energy; deliver electromagnetic energy; deliver magnetic energy; and combinations of delivering one or more of these.

[0072] As used herein, the term "fluid" can refer to a liquid, gas, gel, or any flowable material, such as a material that can be propelled through a lumen and / or opening.

[0073] As used in this article, the term "material" can refer to a single material or a combination of two, three, four or more materials.

[0074] It is understood that certain features of the inventive concept described in the context of a single embodiment for clarity may also be provided in combination in a single embodiment. Conversely, various features of the inventive concept described in the context of a single embodiment for brevity may also be provided individually or in any suitable sub-combination. For example, it is understood that all features set forth in any claim (whether an independent or dependent claim) can be combined in any given manner.

[0075] It should be understood that at least some of the figures and descriptions illustrating the concept of the invention have been simplified to focus on elements relevant to a clear understanding of the concept, while other elements that also constitute part of the concept and are readily apparent to those skilled in the art have been excluded for clarity. However, since such elements are well-known in the art and do not necessarily contribute to a better understanding of the concept, descriptions of such elements are not provided herein.

[0076] The terms defined in this disclosure are used only to describe specific embodiments of the disclosure and are not intended to limit the scope of the disclosure. Terms provided in the singular are also intended to include the plural unless the context clearly indicates otherwise. Unless otherwise defined herein, all terms used herein, including technical or scientific terms, have the same meaning as understood by one of ordinary skill in the art. Unless otherwise clearly defined herein, terms defined in a general dictionary should be interpreted as having the same or similar meaning as in the context of the relevant art and should not be interpreted as having an idealized or exaggerated meaning. In some cases, the terms defined in this disclosure should not be construed as excluding embodiments of the disclosure.

[0077] This document provides a tissue processing system including a fluid delivery console and a processing device, and a method for processing target tissue. The system can be configured to ablate mucosal tissue, such as mucosal tissue of the duodenum or other intestinal locations. The system may include disposable components and reusable components. The processing device may include catheters or other devices including functional assemblies for receiving fluids, such as fluids at ablation temperatures. The console may include various components for delivering fluids to the processing device and for removing fluids from the processing device. In some embodiments, the console includes one, two, or more pumping assemblies, such as syringe pumping assemblies. The console may include a heater configured to heat the fluid and a waste reservoir configured to store fluids removed from the processing device.

[0078] Now for reference Figure 1The illustration depicts a system for treating and / or diagnosing (hereinafter “treatment”) gastrointestinal tissue, consistent with the inventive concept. System 10 includes a console 100 operatively attached to a catheter 200. System 10 and catheter 200 can be used by an operator (e.g., one or more clinicians) to perform therapeutic and / or diagnostic procedures. Catheter 200 can be configured and positioned to treat and / or diagnose target tissues, such as small intestinal tissue (e.g., mucosal tissue of the duodenum and / or jejunum) and / or other locations within the gastrointestinal (GI) tract. Catheter 200 can be configured and positioned to ablate or remove tissue, for example, by delivering energy to the tissue. Alternatively or additionally, catheter 200 can be configured and positioned to dilate one or more layers of tissue in the GI tract, for example, when a submucosal tissue dilation procedure is performed in one segment of the GI tract, followed by energy delivery to the mucosal tissue in that same segment. The catheter 200 can be constructed and positioned to treat multiple relatively continuous segments (referred to herein as "continuous segments") or discontinuous segments of the GI tract. In some embodiments, two or more axial segments of the submucosal tissue of the intestine are dilated, followed by a single ablation procedure (e.g., ablation of a tissue length similar to or shorter than the cumulative length of the dilated submucosal tissue, such as when the length treated by a single ablation step is greater than the length dilated in a single tissue dilation step), as referenced herein. Figure 1B and Figure 1C As described.

[0079] In some embodiments, system 10 includes one or more body access devices, such as endoscope 50 shown in the figure. Catheter 200 may be configured for insertion through one or more working channels of endoscope 50 and / or side-by-side insertion with endoscope 50. In some embodiments, catheter 200 is inserted via a sheath attached to endoscope 50. Catheter 200 may include a length such that it can be inserted through a patient's mouth into one or more locations within the stomach, duodenum, jejunum, and / or ileum.

[0080] In some embodiments, system 10 includes one or more guidewires, such as guidewire 60 as shown in the figure. In these embodiments, catheter 200 can be advanced through one or more lumens of catheter 200, for example, by using standard over-the-wire techniques on guidewire 60.

[0081] Console 100 may include one or more conduits, conduits 191 configured to deliver fluid to and / or from console 100. Console 100 may include a pump assembly 195 comprising one or more pumps or other fluid delivery mechanisms (referred to herein as "pumps") that deliver fluids (e.g., liquids, gases, and / or gels) into one or more fluid channels or other locations within conduit 200. Console 100 may include one or more reservoirs that store the fluids to be delivered. Alternatively or additionally, console 100 may be attached to a fluid storage reservoir separate from (or located within a second housing of console 100). Pump assembly 195 and / or another component of console 100 may include one or more pumps or other fluid removal mechanisms (referred to herein as "pumps") that extract fluid from one or more lumens or other locations within conduit 200. The console 100 may include one or more reservoirs for storing the transferred fluids, or the fluids may be stored in reservoirs separate from (or located within a second housing of) the console 100. The pump assembly 195 and / or another component of the console 100 may include one or more pumps or other vacuum generating mechanisms (referred to herein as "pumps") that generate a vacuum that may create negative pressure within one or more lumens within the conduit 200 or at other locations.

[0082] The console 100 may include one or more discrete components, such as one or more components each having a discrete (i.e., separate) housing surrounding one or more pumps and / or reservoirs.

[0083] In some embodiments, console 100 includes a vacuum supply 110. Vacuum supply 110 may include one or more pumps configured to generate a vacuum in conduit 200 and / or other components of system 10. In some embodiments, vacuum supply 110 includes one or more reservoirs configured to reduce variations in vacuum pressure. Vacuum supply 110 may provide a vacuum to one, two, three, or more ports configured for engaging tissue, such as tissue capture chamber 510 as described herein. Vacuum supply 110 may be configured to provide a vacuum pressure between -2 psi and -14.7 psi, for example, between -4 psi and -14.7 psi. In some embodiments, system 10 may be configured to operate in conjunction with vacuum supply 110 to provide a vacuum pressure between -6 psi and -12.5 psi. Alternatively or additionally, another component of the vacuum supply 110 and / or control console 100 may include at least one sensor, such as a sensor-based functional element 199, configured to monitor the pressure of the vacuum supply 110 and to provide an alarm (e.g., to provide an alarm to the operator and / or enter a full system alarm mode) if the vacuum pressure is insufficient or otherwise falls short of expectations (e.g., if the vacuum pressure is above or below a desired level, an expected level, and / or other thresholds). In some embodiments, the minimum vacuum threshold may include a threshold of at least -4.4 psi, at least -6 psi, and / or at least -12 psi. In some embodiments, the vacuum supply 110 provides a suction reservoir to remove fluid (e.g., gas or other fluid removed from the GI channel during a venting procedure and / or fluid removed from the distal portion of the conduit 200) from a location near the distal end of the conduit 200.

[0084] In some embodiments, console 100 includes an injection supply 120. The injection supply 120 may include one or more pumps configured to deliver one or more injection solutions (injection solution 125 shown in the figure) to catheter 200 and / or other components of system 10. In some embodiments, the injection supply 120 includes one or more reservoirs configured to store injection solution 125. In some embodiments, the injection supply 120 includes a pump (e.g., a syringe pump configured to simultaneously or sequentially drive 1, 2, 3, or more syringes), such as a pump as part of pump assembly 195. In some embodiments, the injection supply 120 includes injection solution 125. The injection supply 120 may deliver fluid to one, two, three, or more elements configured to deliver injection solution 125 onto and / or within tissue, such as injection delivery element 520 as described herein. In some embodiments, a single syringe pump is configured to deliver fluid to two or more injection delivery elements 520. The injection supply 120 can be configured to deliver fluid at a flow rate of at least 10 mL / min, such as at least 15 mL / min, 20 mL / min, 40 mL / min, 60 mL / min, or 120 mL / min. In some embodiments, the injection supply 120 delivers fluid simultaneously via two or more injection delivery elements 520 (e.g., in a tissue dilation procedure) at a flow rate of at least 10 mL / min for each injection delivery element 520, such as at least 12.5 mL / min, 15 mL / min, 20 mL / min, 40 mL / min, 60 mL / min, or 120 mL / min for each fluid delivery element. In some embodiments, the injection supply 120 is configured to deliver volumes of 2 mL to 20 mL (e.g., about 10 mL) simultaneously to multiple injection delivery elements 520 (e.g., to two, three, or four injection delivery elements 520 simultaneously), such as within time periods of less than 60 seconds, less than 40 seconds, less than 30 seconds, less than 20 seconds, less than 10 seconds, and / or less than 5 seconds (e.g., in tissue dilation procedures). The injection supply 120 may also be configured to deliver fluid at a pressure of at least 40 psi (e.g., to the injection delivery element 520, tubing 521, and / or another component of system 10), such as at a pressure of at least 75 psi, 100 psi, 200 psi, or 300 psi.The injection supply 120 can be configured to (simultaneously or sequentially) provide a dose of injection 125 to two, three or more injection delivery elements 520 to expand axial segments of submucosal tissue (e.g., complete or partial rings of submucosal tissue with a length of at least 0.25 cm, at least 0.5 cm, at least 0.75 cm, at least 1 cm, at least 2 cm or at least 3 cm) to achieve expansion of the submucosal layer (e.g., in the region surrounding the volume of mucosal tissue to be subsequently ablated) to a thickness of at least 250 μm, at least 400 μm or at least 650 μm.

[0085] The injection solution 125 may include one or more fluids, gels, and / or other flowable materials for injection into tissue to, for example, expand one or more layers of tissue (e.g., submucosal tissue expanded prior to a mucosal ablation procedure) and / or narrow the intestinal lumen and / or other segments of the GI tract (e.g., to create therapeutic limitations). Alternatively or additionally, the injection solution 125 may include an agent configured to cause tissue necrosis. Alternatively or additionally, the injection solution 125 may include a warming and / or cooling fluid (e.g., a neutralizing fluid, such as neutralizing fluid 155 configured to limit, stop, and / or at least reduce ablation performed by the functional assembly 500) delivered to and / or into the tissue. In some embodiments, the injection solution 125 comprises one, two, or more materials selected from the following: peptide polymers (e.g., peptide polymers configured to stimulate fibroblasts to produce collagen); polylactic acid; polymethyl methacrylate (PMMA); hydrogel; ethylene-vinyl alcohol (EVOH); materials configured to polymerize EVOH; dimethyl sulfoxide (DMSO); saline; materials derived from mammalian bodies; autologous materials; adipocytes; collagen; autologous collagen; bovine collagen; porcine collagen; bioengineered human collagen; true Skin; dermal fillers; hyaluronic acid; conjugated hyaluronic acid; calcium hydroxyapatite; fibroblasts; sclerosing agents; adhesives; cyanoacrylates; pharmaceutical formulations; visible materials; radiopaque materials; visible dyes; ultrasonically reflective materials; combinations of materials configured to cause an endothermic reaction upon mixing (e.g., when mixed in tissue); combinations of materials configured to cause an exothermic reaction upon mixing (e.g., when mixed in tissue); combinations of materials configured to expand upon mixing (e.g., when mixed in tissue); and combinations of one or more of these. In some embodiments, injection solution 125 comprises beads (e.g., pyrolytic carbon-coated beads) suspended in a carrier (e.g., an aqueous carrier gel). In some embodiments, injection solution 125 comprises a solid siloxane elastomer (e.g., heat-cured polydimethylsiloxane) suspended in a carrier (such as a bio-extruded polyvinylpyrrolidone (PVP) carrier gel). In some embodiments, injection solution 125 has an adjustable degradation rate; for example, injection solution 125 contains one or more crosslinking agents that bind to polyalkylene imides at specific concentrations to form a hydrogel with adjustable degradation properties. In some embodiments, injection solution 125 and / or agent 80 (e.g., as described herein) contain live cells, such as live cells injected into the intestinal mucosa or submucosa to provide therapeutic benefit.

[0086] In some embodiments, the injection solution 125 comprises a visually detectable and / or otherwise detectable (e.g., magnetic) material selected from the following (e.g., in addition to one or more of the materials described above): dyes; visual dyes; indigo carmine; methylene blue; Indian ink; SPOT TM Dyes; visible media; radiopaque materials; radiopaque powders; tantalum; tantalum powder; ultrasonic reflective materials; magnetic materials; iron-containing materials; and combinations thereof.

[0087] In some embodiments, a volume of injection solution 125 is delivered into the tissue to create a therapeutic restriction (e.g., a therapeutic restriction having a directional length between 1 mm and 20 mm), as described herein, and / or as described in co-pending U.S. Patent Application No. 17 / 095,108, filed November 11, 2020, entitled "Systems, Devices and Methods for the Creation of a Therapeutic Restriction in the Gastrointestinal Tract". In some embodiments, as described herein, a volume of injection solution 125 is delivered into the tissue prior to the ablation procedure to create a safety margin in the tissue.

[0088] In some embodiments, the injection solution 125 comprises a fluorescently labeled material or other biomarker configured to identify the presence of a biological substance, such as identifying diseased tissue and / or other tissue to be treated by the functional assembly 500 (e.g., identifying target tissue). For example, the injection solution 125 may contain a material configured to be identified by the imaging device 70 (described below), such as identifying visual changes in the injection solution 125 following contact with one or more biological substances. In these embodiments, the imaging device 70 may include a molecular imaging device, for example, when the imaging device 70 includes a molecular imaging probe and the injection solution 125 contains an associated molecular imaging contrast agent. In these embodiments, the injection solution 125 may be configured to identify diseased tissue and / or identify specific levels of one or more of pH, tissue oxygenation, blood flow, etc. The injection solution 125 may be configured for delivery to the inner surface of the intestine or other tissue, and / or delivery within the tissue (i.e., below the surface).

[0089] In some embodiments, console 100 includes an expansion fluid supply 130. The expansion fluid supply 130 may include one or more pumps configured to deliver one or more fluids (expansion fluid 135 shown in the figure) to expand one or more portions of conduit 200 and / or other components of system 10. In some embodiments, the expansion fluid supply 130 includes one or more reservoirs configured to store expansion fluid 135. In some embodiments, the expansion fluid supply 130 contains expansion fluid 135. The expansion fluid supply 130 may deliver expansion fluid 135 to a balloon or other reservoir (e.g., other fluid-expandable components), such as the expandable element 530 described herein. The expansion fluid supply 130 may be configured to deliver a dose volume of fluid to the expandable element 530, such as a dose between 0.1 mL and 12 mL, such as an operator-selectable dose volume of 6 mL, 8 mL, and / or 10 mL. The expansion fluid supply 130 may be configured to deliver fluid to the expandable element 530 at a pressure between 0.1 psi and 5 psi. In some embodiments, the expansion fluid supply 130 delivers fluid to the expandable element 530 prior to a tissue expansion procedure as described herein, wherein a separate fluid (injection fluid 135) is delivered directly to the submucosal or other tissue via one, two, or more injection fluid delivery elements 520. In these embodiments, the fluid supplied to the expandable element 530 by the expansion fluid supply 130 may include expansion fluid 135 and / or different fluids, such as neutralizing fluid 155. In a submucosal expansion procedure, neutralizing fluid 155 may be delivered to the expandable element 530 to provide, for example, the additional function of precooling or preheating the tissue adjacent to the element 530 prior to a subsequent thermal ablation procedure (e.g., thermal ablation or cryoablation performed accordingly by element 530). Alternatively or additionally, the expansion fluid supply 130 may deliver neutralizing fluid 155 to the element 530 in a tissue expansion procedure performed shortly after the (previous) ablation procedure to perform, for example, post-tissue cooling and / or post-heating configured to limit the effects of thermal ablation or cryoablation. For example, pre-cooling or post-cooling and / or pre-heating or post-heating can be performed to reduce the time in previous and / or subsequent ablation steps.

[0090] In some embodiments, console 100 includes an ablation fluid supply 140. The ablation fluid supply 140 may include one or more pumps configured to deliver one or more ablation fluids (ablation fluid 145 as shown) to one or more portions of catheter 200 and / or other components of system 10. In some embodiments, the ablation fluid supply 140 includes one or more reservoirs configured to store ablation fluid 145. In some embodiments, the ablation fluid supply 140 contains ablation fluid 145. The ablation fluid supply 140 may deliver ablation fluid 145 to a balloon and / or other fluid storage assemblies and / or components of catheter 200, such as an ablation fluid reservoir (e.g., a balloon), an expandable element 540, and / or another expandable element 530 as described herein. Alternatively or additionally, the ablation fluid supply 140 may deliver ablation fluid 145 to one, two, three, or more fluid delivery elements configured to deliver fluid to and / or within tissue, such as an injection delivery element 520 as described herein. The ablation fluid supply 140 can be configured to deliver the ablation fluid at a flow rate of at least 5 mL / s, such as at least 8 mL / s, 9 mL / s, 10 mL / s, 15 mL / s, and / or 20 mL / s. In some embodiments, the catheter 200 includes a hydraulic inflow resistance (resistance to the ablation fluid supply 140 and / or another fluid supply described herein) of less than 0.05 psi / (mL / min), such as less than 0.036 psi / (mL / min) (e.g., when measured at a flow rate of 570 mL / min at 85°C). In some embodiments, the catheter 200 includes a hydraulic inflow resistance of at least 0.020 psi / (mL / min), such as at least 0.030 psi / (mL / min) (e.g., when measured at a flow rate of 570 mL / min at 85°C). In some embodiments, conduit 200 includes a hydraulic outflow resistance of less than 0.070 psi / (mL / min), such as less than 0.63 psi / (mL / min) (e.g., when measured at a flow rate of 570 mL / min at 85°C). In some embodiments, conduit 200 includes a hydraulic outflow resistance of at least 0.040 psi / (mL / min), such as at least 0.53 psi / (mL / min) (e.g., when measured at a flow rate of 570 mL / min at 85°C). Alternatively or additionally, ablation fluid supply 140 may be configured to deliver ablation fluid at a pressure of approximately 40 psi (pressure exiting console 100), such that the pressure of the ablation fluid within expandable element 530 is approximately 20 psi. In some embodiments, ablation fluid supply 140 provides fluid at the ablation temperature (e.g., a sufficiently hot or sufficiently cold temperature) in a recirculating manner.

[0091] In some embodiments, conduit 200 includes an inflow pressure drop (e.g., pressure drop due to flow resistance) between 17 psi and 21 psi (e.g., when water is tested at a flow rate of 10 mL / s at 80°C). Alternatively or additionally, conduit 200 may include an inflow pressure drop between 21 psi and 25 psi (e.g., when water is tested at a flow rate of 10 mL / s at 20°C). In some embodiments, the inflow pressure drop does not exceed 50 psi, such as not exceeding 30 psi, such as not exceeding 20.5 psi. In some embodiments, the inflow pressure drop is at least 0.5 psi, such as at least 1 psi, such as at least 5 psi, such as at least 15 psi. In some embodiments, conduit 200 includes a total pressure drop (e.g., pressure drop due to flow resistance throughout the fluid path) between 30 psi and 40 psi (e.g., when water is tested at a flow rate of 10 mL / s at 80°C). Alternatively or additionally, conduit 200 may include a total pressure drop between 39 psi and 50 psi (e.g., when water is tested at a flow rate of 10 mL / s at 20°C). In some embodiments, the total inflow pressure drop does not exceed 80 psi, such as not exceeding 60 psi, such as not exceeding 50 psi. In some embodiments, the total pressure drop is at least 1 psi, such as at least 5 psi, such as at least 15 psi, such as at least 30 psi, such as at least 35 psi.

[0092] In some embodiments, console 100 includes a neutralizing fluid supply 150. The neutralizing fluid supply 150 may include one or more pumps configured to deliver one or more neutralizing fluids (neutralizing fluid 155 shown in the figure) to one or more portions of catheter 200 and / or other components of system 10 (e.g., fluids configured to neutralize the ablation effect of ablation fluid delivered by ablation fluid supply 140). In some embodiments, the neutralizing fluid supply 150 includes one or more reservoirs configured to store neutralizing fluid 155. In some embodiments, the neutralizing fluid supply 150 contains neutralizing fluid 155. The neutralizing fluid supply 150 may deliver neutralizing fluid 155 to balloons and / or other fluid storage assemblies or components of catheter 200, such as neutralizing fluid reservoirs, expandable elements 550, expandable elements 540, and / or other expandable elements 530 described herein. Alternatively or additionally, the neutralizing fluid supply 150 may deliver neutralizing fluid 155 to one, two, three, or more fluid delivery elements configured for delivering fluid to and / or within tissue, such as the injection delivery element 520 described herein. The neutralizing fluid supply 150 may be configured to deliver the neutralizing fluid at a flow rate of at least 5 mL / s, such as at least 8 mL / s, 9 mL / s, 10 mL / s, 15 mL / s, or 20 mL / s. Additionally or alternatively, the neutralizing fluid supply 150 may be configured to deliver the neutralizing fluid at a pressure of approximately 40 psi (pressure away from console 100), such that the pressure of the neutralizing fluid within the expandable element 530 is approximately 20 psi. In some embodiments, the neutralizing fluid supply 150 is configured to deliver the neutralizing fluid 155 at a pressure between 20 psi and 60 psi, such as between 30 psi and 50 psi. In some embodiments, the neutralizing fluid 155 is delivered at a pressure less than 100 psi. In some embodiments, ablation fluid 145 supplied by ablation fluid supply 140 is delivered to a fluid storage assembly of catheter 200 (e.g., expandable element 530), and neutralization fluid 155 supplied by neutralization fluid supply 150 is delivered onto and / or into tissue (e.g., via one or more injection delivery elements 520). Alternatively or additionally, ablation fluid 145 supplied by ablation fluid supply 140 may be delivered onto and / or into tissue (e.g., via one or more injection delivery elements 520), while neutralization fluid 155 supplied by neutralization fluid supply 150 may be delivered to other fluid storage assemblies or components of balloon and / or catheter 200, such as expandable element 530, expandable element 540, and / or expandable element 550 as described herein.In some embodiments, the ablation fluid supply 140 includes a neutralization fluid supply 150 (e.g., a single assembly includes one or more pumps that supply both ablation fluid 145 and neutralization fluid 155 from one, two, or more reservoirs).

[0093] In some embodiments, the expansion fluid supply 130, the ablation fluid supply 140, the neutralization fluid supply 150, and / or another fluid delivery assembly of the console 100 are configured to supply fluid (e.g., expansion fluid 135, ablation fluid 145, and / or neutralization fluid 155) to the functional assembly 500 (e.g., to one or more expandable elements 530) at a flow rate of at least 2 mL / s, such as at least 5 mL / s, or about 9.5 mL / s. In some embodiments, the console 100 supplies fluid to the functional assembly 500 at a flow rate not exceeding 30 mL / s.

[0094] In some embodiments, console 100 includes a fluid removal pump 160. Fluid removal pump 160 may include one or more pumps configured to remove fluid from one or more portions of catheter 200 or other components of system 10. In some embodiments, fluid removal pump 160 includes one or more reservoirs configured to store one or more removed fluids. In some embodiments, fluid removed by fluid removal pump 160 is recycled to one or more other assemblies of console 100, such as expansion fluid supply 130, ablation fluid supply 140, neutralization fluid supply 150, inflation supply 170 (described herein), and / or functional fluid supply 180 (also described herein). Fluid removal pump 160 may remove fluid from balloons or other fluid storage assemblies or components of catheter 200, such as expandable element 530, expandable element 540, and / or expandable element 550 as described herein. In some embodiments, the fluid removal pump 160 is configured to remove, for example, from the conduit 200 and / or any component of the system 10, the respective injection fluid 125, expansion fluid 135, ablation fluid 145, neutralization fluid 155, gas injection fluid 175, and / or functional fluid 185 described herein. In some embodiments, the conduit 200 includes the hydraulic outflow resistance described herein with reference to the ablation fluid supply 140. In some embodiments, the ablation fluid supply 140 and / or the neutralization fluid supply 150 include the fluid removal pump 160. In some embodiments, the pump assembly 195 includes the fluid removal pump 160.

[0095] In some embodiments, console 100 includes an inflator supply 170. The inflator supply 170 may include one or more pumps configured to deliver gas or other inflator fluid (inflator fluid 175 shown in the figure) to inflate the duodenum or other segment of the patient's GI tract. Alternatively or additionally, the inflator supply 170 may be configured to remove inflator fluid 175 and / or other fluids from the duodenum or other segment of the patient's GI tract (i.e., perform deflation). In some embodiments, the inflator supply 170 includes one or more reservoirs configured to store (to be supplied and / or recently removed) inflator fluid 175. In some embodiments, the inflator supply 170 contains inflator fluid 175. The inflator supply 170 may deliver and / or remove fluid via catheter 200 and / or individual components of system 10 such as an endoscope or other body access device (endoscope 50).

[0096] In some embodiments, console 100 includes a functional fluid supply 180. The functional fluid supply 180 may provide functional fluid 185 to one or more components or assemblies of conduit 200 and / or other components of system 10. In some embodiments, functional fluid 185 includes hydraulic or pneumatic fluids (referred to herein as "hydraulic fluids"). In some embodiments, functional fluid 185 includes conductive fluids, such as fluids configured to transmit electrical power and / or electrical signals between functional assembly 500 and console 100.

[0097] As described herein, console 100 may include one or more pumps, pump assembly 195. Pump assembly 195 may be configured to deliver and / or extract fluid from catheter 200 (e.g., with or without intermediate connecting devices, such as umbilical cord 600 as described herein). In some embodiments, pump assembly 195 is at least fluidly attached to injection fluid supply 120 and / or expansion fluid supply 130 to supply injection fluid 125 and / or expansion fluid 135 to catheter 200, for example, accordingly. In some embodiments, pump assembly 195 is fluidly attached to injection fluid supply 120, expansion fluid supply 130, ablation fluid supply 140, neutralization fluid supply 150, gas supply 170, and / or functional fluid supply 180 to deliver, for example, their associated fluids to and / or remove from catheter 200. In some embodiments, one or more of the injection fluid supply 120, expansion fluid supply 130, ablation fluid supply 140, neutralization fluid supply 150, gas injection supply 170, and / or functional fluid supply 180 include one or more pumps integrated into their assembly (e.g., one or more pumps of pump assembly 195 are integrated into the supply). In some embodiments, reference is made below. Figure 1A The pump assembly 195 is configured as described.

[0098] The console 100 includes one or more connectors (connector 102 shown in the figure) that are fluidly connected via conduits 111, 121, 131, 141, 151, 161, 171, and / or 181 to one or more of the assemblies 110, 120, 130, 140, 150, 160, 170, and / or 180 of the console 100 described herein. In some embodiments, the console 100 includes a pump assembly 195 that fluidly connects conduits 111, 121, 131, 141, 151, 161, 171, and / or 181 to connector 102 via one or more other conduits, such as conduit 191 shown in the figure. Alternatively or additionally, console 100 may include one or more manifolds (manifold 700a shown in the figure) that connect pipes 111, 121, 131, 141, 151, 161, 171, and / or 181 to connector 102 via one or more other pipes (such as pipe 191 shown in the figure). Alternatively, pipes 111, 121, 131, 141, 151, 161, 171, and / or 181 may be directly attached to connector 102 (i.e., without pump assembly 195 and / or without manifold 700a). Manifold 700a may be constructed and arranged to connect one or more pipes of pipes 111, 121, 131, 141, 151, 161, 171, and / or 181. Alternatively or additionally, manifold 700a may be constructed and arranged to split (divide) one or more of pipes 111, 121, 131, 141, 151, 161, 171, and / or 181 into multiple pipes. In some embodiments, manifold 700a includes one or more valves configured to control fluid flow in the pipes. In some embodiments, manifold 700a includes one or more sensors (e.g., temperature and / or pressure sensors) configured to provide signals relating to parameters of the fluid within the pipes (e.g., temperature and / or pressure).

[0099] In some embodiments, system 10 includes a connection device—an umbilical tube 600—that operatively connects (e.g., at least fluidly) the conduit 200 to console 100. Alternatively or additionally, the conduit 200 may be directly attached to console 100 (e.g., connector 102 of console 100 is directly attached to connector 302 of conduit 200). Umbilical tube 600 includes one or more proximal connectors—connector 602a shown in the figure—operatively attached to mating connector 102 of console 100. Umbilical tube 600 includes one or more distal connectors—connector 602b shown in the figure—operatively attached to mating connector 302 of handle assembly 300 of conduit 200. Umbilical tube 600 may include one or more fluid delivery tubes or other fluid delivery conduits, such as conduit 691 shown in the figure. Conduit 691 includes one or more lumens or other conduits configured to allow one or more similar and / or dissimilar fluids to pass between console 100 and conduit 200. Each conduit may be configured to receive one or more shafts or other conduits for delivering one or more fluids. In some embodiments, the umbilical tube 600 further includes one or more of the following: wires or other electrical wires configured to transmit electrical energy and / or signals; optical fibers or other conduits configured to transmit optical energy and / or signals; waveguides or other acoustic conduits configured to transmit acoustic energy and / or signals; mechanical linkages (e.g., translational rods); and / or other elongated structures configured to transmit energy, signals, and / or mechanical motion between the console 100 and the conduit 200. In some embodiments, the umbilical tube 600 includes one or more sensors, transducers, and / or other functional elements, such as functional element 699 as described herein. Functional element 699 may be positioned as shown by proximity conduit 691, proximity connector 602a, and / or proximity connector 602b. In some embodiments, the umbilical tube 600 includes one or more insulating layers, insulating conduits, and / or other insulating materials to prevent heat loss as heated fluid passes through the lumen of the umbilical tube 600. In some embodiments, functional element 699 includes a heating element configured to heat fluid as it enters and / or exits the umbilical conduit 600. For example, functional element 699 may include a heating element and a temperature sensor, and system 10 may be configured to heat fluid exiting the umbilical conduit 600 to a desired temperature, such as in a closed-loop manner. In some embodiments, one or more conduits of the umbilical conduit 600 are manufactured such that one or more dimensions of the umbilical conduit 600 (e.g., at least the entire length) are provided to the user within a tolerance of no more than 10% (e.g., no more than 5% or no more than 3%).

[0100] The catheter 200, including a distal portion 208 and a distal end 209, includes a handle assembly 300, a shaft assembly 400, and a functional assembly 500. The handle assembly 300 is positioned on the proximal end or at least the proximal portion of the shaft assembly 400, and the functional assembly 500 is positioned on the distal portion 208 of the catheter 200 (e.g., on the distal end or at least the distal portion of the shaft assembly 400).

[0101] The shaft assembly 400 includes at least one elongated shaft—shaft 401—which includes one or more lumens or other conduits—conduits 491, each of which can be configured to attach to one or more conduits—conduits 391—of the handle 300. In some embodiments, one or more conduits of conduits 491 simply pass through the handle 300 (e.g., operably attached to the umbilicus 600 and / or the console 100). Each conduit of shaft 401 can be configured to deliver fluid, and / or its dimensions can be set to receive (e.g., slide receive) one or more individual shafts, such as one or more fluid delivery shafts. In some embodiments, one or more lumens of shaft 401 receive individual shafts, and fluid is delivered within the received shaft and / or between the outer diameter of the received shaft and the wall of the lumen of shaft 401, as described herein. Alternatively or additionally, each lumen of the shaft 401 and / or one or more shafts inserted into the lumen may surround (e.g., slidably or fixedly surround) one or more conduits configured to transmit energy, signals, and / or mechanical motion between the console 100 and the conduit 200, as described herein. In some embodiments, one or more conduits 491 are secured to the shaft 401 by an adhesive, such as by one or more adhesive rings positioned around the outer wall of the conduit 491 and the surrounding wall (e.g., the inner wall of a sleeve, lumen, or other tube) to which the conduit 491 is to be secured. For example, two or more adhesive rings may be positioned between the outer wall of the conduit 491 and the surrounding wall (e.g., the surrounding wall of a sleeve) to prevent undesirable translation of the conduit 491.

[0102] The shaft assembly 400 includes a proximal end 405, a proximal portion 406, a middle portion 407, a distal portion 408, and a distal end 409. The distal portion 408 is shown in an enlarged view. Positioned on the distal portion 408 is a functional assembly 500 configured to process assemblies and / or diagnostic assemblies (e.g., assemblies configured to process and / or diagnose intestinal tissue or other GI tract tissues). In some embodiments, the shaft 401 extends through and beyond the functional assembly 500 (e.g., ...). Figure 1As shown, the distal end 209 of the conduit 200 is identical to the distal end 409 of the shaft assembly 400. Alternatively, the functional assembly 500 may be positioned on the distal end of the shaft 401. In some embodiments, the shaft 401 includes torsion, as illustrated below. Figure 4 As described. In some embodiments, shaft 401 includes a ball-shaped tip. In some embodiments, shaft 401 includes a tapered tip, as described below. Figure 3 A and Figure 3 As described in B.

[0103] In some embodiments, the shaft assembly 400 includes a lumen for slidingly receiving a guidewire, such as a passageway including an opening (port 490) at a location near the distal end 409 of the shaft assembly 400 exiting the lumen. In some embodiments, the shaft assembly 400 includes one or more lumens for performing venting and / or deflation (referred to herein as "venting"), such as a conduit 571 including one or more lumens terminating in one or more openings, such as ports 470 each located distal to the functional assembly 500 as shown and described herein. D and port 470 located near the functional assembly 500. P In some implementations, port 470 P and / or port 470 D It is configured to perform either venting or injection only.

[0104] In some embodiments, the shaft assembly 400 includes one or more manifolds—manifolds 700c and / or 700d shown in the figures—that connect one or more piped fluids of pipe 491 to one or more other pipes (e.g., one or more other pipes of pipe 491 or one or more other pipes of conduit 200). Manifolds 700c and / or 700d may be constructed and arranged to combine fluids in one or more lumens of pipe 491. Alternatively or additionally, manifolds 700c and / or 700d may be constructed and arranged to split (divide) one or more lumens of pipe 491 into multiple lumens. In some embodiments, manifolds 700c and / or 700d include one or more valves (e.g., one or more check valves) configured to control the flow of fluid in the pipe. In some embodiments, manifolds 700c and / or 700d include one or more sensors (e.g., temperature and / or pressure sensors) configured to provide signals related to parameters (e.g., temperature and / or pressure) of the fluid within the pipe.

[0105] In some embodiments, the shaft assembly 400 includes one or more sensors, transducers, and / or other functional elements, such as functional element 499a (e.g., located at the middle portion of the shaft 401 and / or near the manifold 700c) and / or functional element 499b (e.g., located near the manifold 700d and / or functional assembly 500) as shown and described herein. In some embodiments, as described herein, functional elements 499a and / or 499b include radiopaque markers and / or other visual markers configured to allow an operator to visualize translation and / or rotation of the shaft assembly 400 (e.g., visualization of translation and / or rotation of functional assembly 500) via, for example, via an imaging device 70 (e.g., a fluoroscope or other imaging device).

[0106] Shaft 401 may include a length of at least 60”, such as at least 72”. In some embodiments, shaft 401 includes an outer diameter of less than 0.3”, such as a diameter of less than 0.256”, 0.1”, or 0.08”. Shaft 401 may contain a material selected from the following: polyether block amides, such as Pebax. TM Thermoplastic elastomers, such as Tygon TM Arnitel TM Or Hytrel TM And combinations of one or more of these. In some embodiments, at least a portion of shaft 401 comprises a radiopaque additive, such as barium sulfate. In some embodiments, at least a portion of shaft 401 comprises a lubricating coating or additive, such as Propeller manufactured by Foster Corporation of Putnam, CT. TM Low-friction compound. In some embodiments, at least a portion of shaft 401 comprises a heat stabilizer, a light stabilizer, and / or other stabilizers, such as HLS manufactured by Foster Corporation of Putnam, CT. TM Heat and light stabilizers.

[0107] Functional assembly 500 includes one or more assemblies configured for processing and / or diagnosing tissue. In some embodiments, functional assembly 500 is configured for simultaneously processing and diagnosing tissue. Functional assembly 500 may be configured for processing and / or diagnosing duodenal tissue or other tissue in the GI tract. Functional assembly 500 may be positioned on the distal portion 408 of shaft assembly 400 as shown. Functional assembly 500 may be configured for radial expansion and / or radial contraction, such as when the functional assembly includes one or more expandable reservoirs—such as one or more of expandable elements 530, 540, and / or 550 shown (individually or collectively, expandable element 530). Each expandable element 530, 540, and / or 550 (individually or collectively, expandable element 530) may include a balloon or other expandable reservoir (referred to herein as a “balloon”), an expandable cage, a coilable element, etc. The expandable element 530 may include one or more balloons circumferentially surrounding the shaft 401 (e.g., in a linear arrangement), or multiple partially circumferential balloons (e.g., in a radial arrangement). The expandable element 530 may include one or more balloons that expand radially outward from the shaft 401 at the same or different axial locations along the shaft 401. The expandable element 530 may include an array of circumferentially spaced balloons in a slat configuration. The expandable element 530 may include one or more inner balloons 540 surrounded by one or more outer balloons 550 (e.g., where the inner balloons receive a first fluid at a first temperature, and the space between the inner and outer balloons receives a second fluid at a second temperature different from the first temperature). The expandable element 530 may include balloons or other elements configured to expand to a diameter less than or equal to 35 mm, such as less than or equal to 30 mm or 25 mm. The expandable element 530 may contain materials as described herein. The expandable element 530 may include balloons having a wall thickness as described herein. In some embodiments, one or more portions of the expandable element 530 comprise a non-compliant material, while one or more other portions of the expandable element 530 comprise a compliant material. In some embodiments, the expandable element 530 is configured to withstand expansion pressures up to 50 psi, such as up to 60 psi, 100 psi, or 200 psi. In some embodiments, the first expandable element 530 includes at least a portion containing a non-compliant material, and the second expandable element 540 includes at least a portion containing a compliant material.

[0108] The functional assembly 500 may include one or more balloons configured to receive one or more fluids, such as an expandable element 540 configured to receive ablation fluid (e.g., fluid at ablation temperature received from ablation fluid supply 140), an expandable element 550 configured to receive neutralizing fluid (e.g., fluid received from neutralizing fluid supply 150 and including fluid configured to cool or warm the tissue to a temperature correspondingly after thermal or cryoablation), or other expandable elements 530. In some embodiments, at least expandable element 540 and expandable element 550 are the same reservoir (e.g., the same one or more balloons) for receiving both ablation fluid and neutralizing fluid.

[0109] In some embodiments, the functional assembly 500 is configured to expand one or more layers of tissue, for example, to expand one or more layers of submucosal tissue prior to a tissue treatment procedure in which the mucosal layer of tissue is treated (e.g., thermal ablation or chemical ablation). In these embodiments, the construction and arrangement of any component of the functional assembly 500, conduit 200, and / or system 10 may be similar to those described in the following: Co-pending U.S. Patent Application No. 14 / 515,324, filed October 15, 2014, entitled “Tissue Expansion Devices, Systems and Methods”; Co-pending U.S. Patent Application No. 17 / 095,108, filed November 11, 2020, entitled “Systems, Devices and Methods for the Creation of a Therapeutic Restriction in the Gastrointestinal Tract”; and Co-pending U.S. Patent Application No. 17 / 110,720, filed December 3, 2020, entitled “Injectate Delivery Devices, Systems and Methods”.

[0110] In some embodiments, the functional assembly 500 is configured to receive an ablation fluid (e.g., a hot or cold fluid recirculated at a tissue ablation temperature) to treat tissue. In some embodiments, the functional assembly 500 is configured to deliver an ablation fluid (e.g., a hot or cold fluid or gas at a tissue ablation temperature, and / or a chemical ablation fluid) directly onto the tissue. In these embodiments, the construction and arrangement of any components of the functional assembly 500, catheter 200, and / or system 10 may resemble those described in co-pending U.S. Patent Application No. 16 / 438,362, filed June 11, 2019, entitled “Heat Ablation Systems, Devices and Methods for the Treatment of Tissue,” and co-pending U.S. Patent Application No. 14 / 917,243, filed March 7, 2016, entitled “Systems, Methods and Devices for Treatment of Target Tissue.”

[0111] The functional assembly 500 may include one or more ports configured to capture and / or engage tissue (individually or collectively, “capture” or “engage”) or otherwise stabilize the functional assembly 500 within a GI lumen, such as a tissue capture chamber 510 shown and described herein. Each tissue capture chamber 510 includes an opening—opening 512. In some embodiments, the functional assembly 500 (or another portion of the catheter 200) includes two, three, four, or more tissue capture chambers 510. Each tissue capture chamber 510 may be attached to a vacuum source, such as a conduit 511, which is fluidly attached to a vacuum source provided by the console 100, such as a vacuum supply 110. Each tissue capture chamber 510 may have a similar construction and arrangement to any chamber 510 described herein. In some embodiments, an injection delivery element 520 is positioned above (radially outward) the vacuum source provided to the tissue capture chamber 510. In some embodiments, one or more tissue capture chambers 510 are constructed of metal or other materials with relatively high thermal conductivity to efficiently transfer heat, for example, from and / or to the expandable element 530 (e.g., from and / or to the temperature ablation fluid within the expandable element 530) to, for example, avoid non-ablated tissue areas approaching the tissue capture chamber 510.

[0112] The functional assembly 500 may include one or more elements configured to deliver fluid to tissue, such as the injection fluid delivery element 520 shown in the figures, each positioned within or at least near the tissue capture chamber 510. In some embodiments, the functional assembly 500 (or another portion of the catheter 200) includes two, three, four, or more injection fluid delivery elements 520. The injection fluid delivery element 520 may include one or more elements selected from: needles; fluid nozzles; iontophoresis elements; and combinations of one or more of these. Each injection fluid delivery element 520 may be operatively attached to one or more conduits of the catheter 200, such as when fluid is connected to the illustrated conduit 521, or when fluid is attached to a separate conduit slidably received by the conduit 521 described herein. Each injection fluid delivery element 520 may be connected to a fluid source, such as fluid supplied by the console 100 via injection fluid supply 120, ablation fluid supply 140, neutralization fluid supply 150, and / or functional fluid supply 180. One or more injection delivery elements 520 may include needles with a diameter between 16 and 34 gauges, such as needles with a diameter of 27 or 29 gauges. One or more injection delivery elements 520 may include needles with a bevel angle of about 10° (e.g., a bevel length of 0.008”), such as at least 5° and / or no greater than 45° or 80°. One or more injection delivery elements 520 may be advanced into tissue contained within an associated tissue capture chamber 510 while avoiding the possibility of the injection delivery elements 520 penetrating the outer layer and / or outside of the GI wall tissue (e.g., the injection delivery elements 520 do not leave the chamber 510). In some embodiments, when a vacuum is applied to the chamber 510, the tissue is penetrated by the needle-based injection delivery elements 520 without advancing the injection delivery elements 520 (e.g., when the distal end of each injection delivery element 520 is positioned within the associated chamber 510). In some embodiments... In this design, one or more injection delivery elements 520 include a fluid nozzle and can deliver injection solution 125 or other fluids into tissue captured in chamber 510 without advancing the fluid nozzle. Each tissue capture chamber 510 may be configured to slidably receive the injection delivery element 520 (e.g., after tissue is captured in chamber 510 and the injection delivery element 520 penetrates the captured tissue upon advancement), such as when the tissue capture chamber 510 is configured to slidably receive at least a 29-gauge needle or at least a 27-gauge needle. Each injection delivery element 520 may be configured to advance a distance of at least 2.5 mm, at least 3.5 mm, or at least 4.5 mm. Each tissue capture chamber 510 may include a width of at least 0.010”, at least 0.040”, or at least 0.060”. Each tissue capture chamber 510 may include a width of no more than 0.25” or no more than 0.35”.Each tissue capture chamber 510 may include a length of at least 0.010”, at least 0.040”, at least 0.060”, at least 0.090”, or at least 0.120”. Each tissue capture chamber 510 may include a length of no more than 0.9”, no more than 0.7”, or no more than 0.5”. Each tissue capture chamber 510 may include a depth of at least 300 μm, at least 500 μm, at least 700 μm, or at least 1000 μm. Each tissue capture chamber 510 may include a depth of no more than 2500 μm, such as no more than 2000 μm.

[0113] Figure 1 The functional assembly 500 may include two tissue capture chambers 510 (e.g., circumferentially separated by about 180°) or three tissue capture chambers 510 (e.g., circumferentially separated by about 120°), and each tissue capture chamber 510 may surround the injection fluid delivery element 520. In some embodiments, four or more tissue capture chambers 510 are included. Each tissue capture chamber 510 may be configured to engage with tissue to, for example, maintain contact between the functional assembly 500 and the tissue (e.g., during the delivery and / or removal of energy to and / or from the tissue). Alternatively or additionally, the tissue capture chambers 510 may be configured to capture tissue within the tissue capture chamber 510 by applying a vacuum, as described herein, to, for example, allow delivery of fluid or a fluid delivery element (e.g., a needle) into the captured tissue.

[0114] The functional assembly 500 may include one or more ports (e.g., openings) in the shaft assembly 400 configured for delivering and / or removing fluid to and / or from the expandable element 530, such as ports 430 and 460 as shown. Ports 430 and 460 may be located at various locations within the expandable element 530. In some embodiments, port 460 is configured to remove fluid from the expandable element 530 and is located in a proximal portion of the functional assembly 500. In some embodiments, port 430 is configured to deliver fluid to the expandable element 530 and may be located in a distal (as shown), intermediate, or proximal portion of the functional assembly 500. Port 430 may include one or more openings fluidly connected to one or more conduits, such as conduits 531, 541, and / or 551 shown in the figures, which are respectively fluidly connected to one or more of the expansion fluid supply 130, ablation fluid supply 140, and / or neutralization fluid supply 150, or other fluid supplies of the console 100 (e.g., functional fluid supply 180). Port 460 may include one or more openings fluidly connected to one or more conduits, such as conduit 561 shown in the figures, which are fluidly connected to the fluid removal pump 160 of the console 100. In some embodiments, port 460 is fluidly connected to conduits 531, 541, and / or 551, which are respectively fluidly connected to one or more of the expansion fluid supply 130, ablation fluid supply 140, and / or neutralization fluid supply 150, or other fluid supplies of the console 100 (e.g., functional fluid supply 180).

[0115] In some embodiments, the functional assembly 500 includes one or more sensors, transducers, and / or other functional elements, such as functional element 599 shown and described herein. In some embodiments, functional element 599 includes radiopaque markers and / or other visual markers as described herein, configured to allow an operator to visualize translation and / or rotation of the functional assembly 500, for example, via an imaging device 70 (e.g., a fluoroscope or other imaging device). In some embodiments, functional element 599 includes a heating transducer, such as an element comprising one, two, or more electrodes through which radio frequency (RF) energy passes to, for example, heat expandable elements 530, 540, and / or 550, and / or heat fluid (e.g., brine) contained within expandable elements 530, 540, and / or 550. Alternatively or additionally, functional element 599 may include a cooling transducer (e.g., a Peltier cooling element) to, for example, cool expandable elements 530, 540 and / or 550, and / or cool the fluid contained within expandable elements 530, 540 and / or 550.

[0116] Handle assembly 300 includes a handle for operator manipulation of conduit 200, the handle including a housing 301. As shown, handle assembly 300 can be positioned in the proximal end 405 of shaft assembly 400. Handle assembly 300 includes one or more conduits—conduits 391. Conduits 391 can be configured for operably attaching (e.g., at their proximal end or both ends) to connector 102 of console 100 or conduit 691 of umbilical 600. Conduits 391 are configured for operably attaching (e.g., at their distal end or both ends) to conduit 491 of shaft assembly 400. In some embodiments, handle assembly 300 includes one or more manifolds—manifold 700b as shown—that connect one or more conduits in conduit 391 to one or more other conduits (e.g., conduit 391 and / or one or more other conduits of conduit 491). Manifold 700b can be constructed and arranged to combine one or more lumens of conduit 391. Alternatively or additionally, manifold 700b may be constructed and arranged to split one or more lumens of conduit 391 into multiple lumens. In some embodiments, manifold 700b includes one or more valves configured to control the flow of fluid in the conduit. In some embodiments, manifold 700b includes one or more sensors (e.g., temperature and / or pressure sensors) configured to provide signals relating to parameters of the fluid within the conduit (e.g., temperature and / or pressure).

[0117] The handle assembly 300 may include one or more controls—controls 310—configurable for activating, manipulating, and / or otherwise operating one or more functions of the catheter 200. In some embodiments, controls 310 include controls for advancing and / or retracting one or more injection delivery elements 520 (e.g., simultaneously advancing and / or retracting two, three, or more injection delivery elements 520). In some embodiments, controls 310 are configured to adjust one or more operating parameters of the console 100 (e.g., via a wired or wireless connection).

[0118] The handle assembly 300 may include an inlet port, such as port 392, for the passage of a guidewire or other wire, such as guidewire 60. In some embodiments, port 392 is located on a proximal portion of the shaft assembly 400. Port 392 may be operatively connected to a lumen of shaft 401, as described herein.

[0119] In some embodiments, the handle assembly 300 includes one or more sensors, transducers, and / or other functional elements, such as functional element 399 shown and described herein. In some embodiments, functional element 399 includes a tactile transducer configured to alert the operator to a specific state of the catheter 200 (e.g., an alarm or warning state, a "ready" state, a "function complete" state, etc.). For example, functional element 399 may alert the operator to the performance of a specific function, such as a function selected from: performing tissue heating (e.g., via hot fluid present in functional assembly 500); performing tissue cooling (e.g., via cold fluid present in functional assembly 500); delivering an injection solution into tissue (e.g., delivering injection solution 125 to submucosal or other tissue via one, two, three, or more injection solution delivery elements 520); the needle or other injection solution delivery element 520 being advanced into tissue; and combinations of one or more of these. Functional element 399 may include a tactile transducer selected from: a vibration transducer (e.g., a vibration transducer that alerts the operator that an injection solution is being delivered into the tissue and / or that the injection solution delivery element 520 has been advanced into the tissue); a heating element (e.g., a heating element that alerts the operator that tissue thermal ablation and / or warming is in progress); a Peltier element or other cooling element (e.g., a cooling element that alerts the operator that tissue cryoablation and / or cooling is in progress); and combinations of one or more of these. In some embodiments, the handle assembly 300 includes portions configured to alert the operator to one or more specific functional conditions of the catheter 200.

[0120] System 10 may include one or more functional elements, such as functional element 199 of console 100, functional element 399 of handle assembly 300, functional elements 499a and / or 499b of shaft assembly 400, functional element 599 of functional assembly 500, and / or functional element 699 of umbilical tube 600.

[0121] Endoscope 50 may include one or more endoscopes configured to access at least one or more portions of the duodenum from the patient's mouth. In some embodiments, endoscope 50 includes an endoscope similar to the Olympus PCF-PH190 model.

[0122] Guidewire 60 may include an outer diameter of approximately 0.035”. Guidewire 60 may include “stiff” or “extra-stiff” configurations, such as guidewires similar to: Jagwire Stiff Straight guidewire, Wallstent Super Stiff guidewire, Dreamwire Supersiff and / or Savary Gilliard guidewire. Guidewire 60 may include a length at least twice the length of catheter 200 and / or endoscope 50, thereby allowing one or more devices to be “replaced” on guidewire 60. Guidewire 60 may contain materials selected from: nitinol; stainless steel; and combinations of one or more of these. Guidewire 60 may include a hydrophilic or other lubricating coating, such as a Teflon coating.

[0123] In some embodiments, system 10 further includes an imaging device 70, which may include imaging devices constructed and arranged to provide images of patient anatomy (e.g., the inner wall or any part of the patient's intestine) and / or the entire catheter 200 or a portion thereof, or other parts of system 10, as described in detail herein. Imaging device 70 may include imaging devices selected from: endoscopic cameras; visible light cameras; infrared cameras; X-ray imagers; fluorescence microscopes; CT scanners; MRI scanners; PET scanners; ultrasound imaging devices; molecular imaging devices; and combinations of one or more of these. In some embodiments, patient images are used to set, confirm, and / or adjust one or more system 10 parameters, such as when imaging device 70 includes sensors of the inventive concept configured to generate signals.

[0124] In some embodiments, system 10 further includes one or more agents—the agent 80 shown. Agent 80 can be delivered via one or more components of system 10, such as via endoscope 50 (via one or more working channels of endoscope 50) and / or via catheter 200 (e.g., via one or more injection delivery elements 520 or port 470). Agent 80 may include materials selected from: anti-peristaltic agents, such as L-menthol (i.e., peppermint oil); glucagon; hyoscine; scopolamine; somatostatin; diabetes medications; analgesics; opioids; chemotherapeutic agents; hormones; and combinations of one or more of these. In some embodiments, agent 80 comprises cells delivered to the intestine, such as live cells delivered to the intestinal mucosa or submucosa via one or more injection delivery elements 520. In some embodiments, agent 80 comprises one or more agents configured to be delivered into and through at least a portion of the expandable element 530 into the intestine (e.g., when the expandable element 530 includes at least one porous portion). In some embodiments, agent 80 comprises a mucolytic agent configured to remove mucus from the tissue surface.

[0125] In some embodiments, system 10 includes tissue markers—marker 90 shown, which may include dyes or other visual media configured to mark tissue (e.g., dyes delivered using needle-based tools, and / or temporary visual implants for marking tissue, such as small temporary anchors configured to attach to tissue and be removed at the end of the procedure or otherwise excreted shortly after the procedure through the patient's natural digestive process). Marker 90 may be placed or deployed with respect to (e.g., allowing operator identification) non-target tissue (e.g., markers positioned close to the ampulla of Vater of Hepatopancreatic Duct to be examined by the operator to avoid damage to the ampulla of Vater of Hepatopancreatic Duct) and / or to identify target tissue (e.g., tissue to be ablated). In some embodiments, marker 90 is placed or deployed with respect to tissues selected from: gastrointestinal adventitia; duodenal artery adventitia; serosa; muscularis mucosa; a portion of the outermost layer of the submucosa; ampulla of Vater of Hepatopancreatic Duct; pancreas; bile duct; pylorus; and combinations of one or more of these.

[0126] The shaft 401 may include at least six lumens, at least eight lumens, or at least ten lumens. In some embodiments, the shaft 401 includes a single shaft comprising at least six or at least eight lumens. In these embodiments, a first pair of lumens of the shaft 401 may be in fluid communication with a first tissue capture chamber 510, a second pair of lumens of the shaft 401 may be in fluid communication with a second tissue capture chamber 510, and a third pair of lumens of the shaft 401 may be in fluid communication with an expandable element 530 (e.g., via openings in the shaft 401, port 430, and port 460). The first pair of lumens of the shaft 401 may include a vacuum lumen and a lumen that slidably receives a first tube attached to a first injection delivery element 520. The second pair of lumens of the shaft 401 may include a vacuum lumen and a lumen that slidably receives a second tube attached to a second injection delivery element 520. The third pair of lumens of the shaft 401 may include a fluid delivery lumen for delivering fluid to the expandable element 530 and a fluid removal lumen for removing fluid from the expandable element 530 (e.g., via ports 430 and 460 respectively), as described herein. In some embodiments, at least one flexible elongated shaft includes at least eight lumens, and a fourth pair of lumens is in fluid communication with the third tissue capture chamber 510. In some embodiments, as described herein, the shaft 401 further includes one or more of the following: a guidewire lumen; a first air injection lumen; and / or a second air injection lumen. In some embodiments, the shaft 401 includes a plurality of shafts, such as two shafts 401 each including at least one pair of lumens, or three shafts 401 each including at least one pair of lumens.

[0127] In some embodiments, the shaft 401 includes a first lumen for delivering fluid to the expandable element 530 (e.g., delivering one or more of the following to the element 530: expansion fluid 135, ablative fluid 145, and / or neutralizing fluid 150), and a second lumen for removing fluid from the expandable element 530 (e.g., removing one or more of the expansion fluid 135, ablative fluid 145, and / or neutralizing fluid 155 from the element 530). In some embodiments, the shaft 401 includes two, three, or more lumens configured to provide and remove fluid from the expandable element 530 in a recirculating manner.

[0128] Expandable elements 530, 540, and / or 550 (individually or collectively, expandable element 530) may include various materials and sizes configured to optimize the performance of one or more functions, such as optimizing submucosal tissue expansion (e.g., duodenal submucosal tissue expansion), mucosal tissue treatment (e.g., duodenal mucosal tissue ablation or other treatments), and / or substance delivery (e.g., delivery of one or more substances to the mucosa, submucosa, and / or other lumen wall locations of the duodenum, jejunum, ileum, and / or other GI wall locations). In some embodiments, expandable element 530 includes a diameter of at least 5 mm and / or no more than 45 mm (e.g., the expansion diameter of a balloon-based expandable element 530), such as a diameter of at least 18 mm and / or no more than 32 mm, such as a diameter of at least 23.5 mm and / or no more than 26.5 mm, such as a diameter of about 24 mm or 25 mm. In some embodiments, the expandable element 530 includes a balloon having a wall thickness of at least 0.0001 inches and / or no more than 0.01 inches (e.g., the thickness of a single wall of a balloon), such as at least 0.00025 inches and / or no more than 0.003 inches, such as at least 0.0005 inches and / or no more than 0.001 inches, such as about 0.00075 inches. In some embodiments, the expandable element 530 includes a balloon with a variable wall thickness, such as a varied wall thickness having a thickness of at least 0.00025 inches and / or no more than 0.003 inches. For example, the expandable element 530 may include an increased wall thickness near the tissue capture chamber 510. In some embodiments, the expandable element 530 comprises a material selected from the following: compliant materials; non-compliant materials; materials that are both compliant and non-compliant; PET; polyimide; nylon; nylon 12; PEEK; siloxane elastomers; polyether block amides; polyurethanes; thermoplastic elastomers; and combinations thereof. In some embodiments, the expandable element 530 includes a balloon made using a non-compliant material that prevents or at least resists geometrical changes (e.g., the balloon's expansion diameter) caused by pressure changes within the balloon (e.g., pressure changes that may occur when fluid is recirculated within the balloon). In some embodiments, the expandable element 530 (e.g., a balloon-based expandable element 530) comprises at least 0.0001% and / or no more than 200% compliance, such as at least 0.0001% and / or no more than 15% compliance, such as compliance between at least 0.0001% and / or no more than 8%. In some embodiments, the expandable element 530 comprises one or more materials having a thermal conductivity of at least 0.01 and / or no more than 10 (W / (m*K)), such as at least 0.1 and / or no more than 0.6, such as about 0.29.In some embodiments, the expandable element 530 includes a contact length of at least 5 mm and / or no more than 500 mm (e.g., the length of the expandable element 530 in contact with the duodenum or other lumen wall tissue when inflated or otherwise expanded), such as a contact length of at least 10 mm and / or no more than 50 mm, such as a contact length of at least 19 mm and / or no more than 21 mm, such as a contact length of about 20 mm. In some embodiments, the expandable element 530 (e.g., an inflatable balloon-based expandable element 530) includes a tapered proximal and / or distal end, such as having a cone angle of at least 5° and / or no more than 120° (e.g., proximal and / or distal cone angle), such as a cone angle of at least 30° and / or no more than 90°, such as a cone angle of at least 57° and / or no more than 63°, such as a tapered end with a cone angle of about 60°. The expandable element 530 may include similar or dissimilar proximal and distal cones. In some embodiments, the expandable element 530 includes a balloon containing braids, such as metallic braids and / or non-metallic braids (e.g., nylon braids), on and / or within its walls.

[0129] The injection delivery element 520 may include one or more needles or other fluid delivery elements as described herein. The injection delivery element 520 may include one or more needles or other fluid delivery elements configured to deliver fluids or other materials to tissue to perform one or more functions, such as submucosal tissue expansion (e.g., duodenal submucosal tissue expansion), mucosal tissue treatment (e.g., duodenal mucosal tissue ablation or other treatment), and / or substance delivery (e.g., delivery of one or more substances to the mucosa, submucosa, and / or other luminal wall locations of the duodenum, jejunum, ileum, and / or other GI wall locations). In some embodiments, the injection delivery element 520 includes elements (e.g., needles) constructed from materials selected from: metal; stainless steel, plastic; PEEK, liquid crystal polymers; and combinations thereof. In some embodiments, the injection delivery element 520 includes one or more needles having an inner diameter of at least 0.0014 inches and / or no more than 0.033 inches, such as at least 0.00625 inches and / or no more than 0.01325 inches, such as at least 0.0075 inches and / or no more than 0.009 inches, such as about 0.008 inches. In some embodiments, the injection delivery element 520 includes one or more needles constructed and arranged to have an exposure length of at least 0.125 mm and / or no more than 10 mm, such as at least 1 mm and / or no more than 5 mm, such as at least 2 mm and / or no more than 3 mm, such as about 2.5 mm. In some embodiments, the injection delivery element 520 includes one or more needles having a diameter of at least 36 and / or no more than 10 (e.g., Birmingham gauge), such as at least 35 and / or no more than 20, such as at least 27 and / or no more than 26. In some embodiments, the injection delivery element 520 includes one or more needles having a bevel angle of at least 1° and / or no more than 90°, such as at least 5° and / or no more than 45°, such as at least 9° and / or no more than 11°, such as about 10°.

[0130] As described herein, console 100 may include one or more fluid supplies for delivering fluid, for example, to one or more injection delivery elements 520. In some embodiments, console 100 is configured (e.g., during a submucosal tissue dilation procedure) to provide fluid to each injection delivery element 520 at a flow rate of at least 0.1 mL / min and / or no more than 120 mL / min, such as at least 1 mL / min and / or no more than 60 mL / min, such as at least 5 mL / min and / or no more than 20 mL / min, such as about 12.5 mL / min. In some embodiments, the console 100 is configured (e.g., during a submucosal tissue dilation procedure) to provide each injection fluid delivery element 520 with an injection volume of at least 0.1 ml and / or no more than 100 mL (e.g., for delivery at each injection site), such as at least 1 mL and / or no more than 30 mL, such as at least 8 mL and / or no more than 12 mL, such as at least 9 mL and / or no more than 11 mL, such as about 10 mL. In some embodiments, the console 100 is configured to provide fluid to each injection fluid delivery element 520 at a pressure of at least 1 psi and / or no more than 400 psi, such as at least 20 psi and / or no more than 200 psi, such as at least 90 psi and / or no more than 110 psi, such as about 100 psi (e.g., during a submucosal tissue dilation procedure).

[0131] The conduit 200 may include a plurality of fluid transport conduits as described herein. For example, a plurality of conduits 521, also as described herein, may each be attached to the fluid delivery element 520 and travel to a proximal end or at least a proximal portion of the conduit 200 (e.g., a conduit 521 positioned within the shaft 501 and fluidly attached to a port of the handle assembly 300). In some embodiments, one or more conduits 521 include an inner diameter of at least 0.005 inches and / or no more than 0.125 inches, such as an inner diameter of at least 0.04 inches and / or no more than 0.10 inches, such as an inner diameter of at least 0.0177 inches and / or no more than 0.0183 inches, such as an inner diameter of about 0.018 inches. In some embodiments, one or more conduits 521 each include a length of at least 12 inches and / or no more than 250 inches, such as a length of at least 36 inches and / or no more than 120 inches, such as a length of about 78 inches.

[0132] Functional assembly 500 may include one, two, three, or more tissue capture chambers 510, as described herein. Tissue capture chamber 510 may contain one or more materials selected from: plastics; liquid crystal polymers; metals; stainless steel; thermally conductive materials; and combinations thereof. Tissue capture chamber 510 may include a hardness tester with a hardness less than 63D, such as less than 50D, such as about 40D. Each tissue capture chamber 510 may be sized and arranged to capture tissue when a vacuum is applied to the tissue capture chamber 510. Each tissue capture chamber 510 may be attached (e.g., fixedly attached) to expandable element 530 via an adhesive having a glass transition temperature (Tg) of at least -60°C and / or not exceeding 200°C, such as at least 60°C and / or not exceeding 90°C, such as about 77°C. Alternatively or additionally, one or more tissue capture chambers 510 may be attached to expandable element 530 via viscoelastic bands and / or thermal welding. Each tissue capture chamber 510 may be attached (e.g., fixedly attached) to the expandable element 530 via an adhesive configured to support at least 1% and / or no more than 500% elongation (e.g., without failure), such as at least 100% and / or no more than 400% elongation, such as about 300% elongation. Each tissue capture chamber 510 may include an outer diameter of at least 0.1 mm and / or no more than 10 mm, such as a diameter of at least 1 mm and / or no more than 5 mm, such as a diameter of at least 2.28 mm and / or no more than 2.30 mm, such as a diameter of about 2.29 mm. Each tissue capture chamber may include a length of at least 2.5 mm and / or no more than 500 mm, such as a length of at least 10 mm and / or no more than 50 mm, such as a length of at least 17.25 mm and / or no more than 17.75 mm, such as a length of about 17.5 mm. Each tissue capture chamber 510 includes an opening 512. Each opening 512 may include a length of at least 0.25 mm, or at least 0.5 mm, or at least 1 mm and / or no more than 20 mm, such as a length of at least 2 mm and / or no more than 10 mm, such as a length of at least 3.45 mm and / or no more than 3.65 mm, such as a length of about 3.55 mm. Each opening 512 may include a width of at least 0.1 mm and / or no more than 10 mm, such as a width of at least 0.5 mm and / or no more than 4 mm, such as a width of at least 1.48 mm and / or no more than 1.68 mm, such as a width of about 1.58 mm. Each opening 512 may include a depth of at least 0.1 mm and / or no more than 10 mm, such as a depth of at least 1 mm and / or no more than 4 mm, such as a depth of at least 1.9 mm and / or no more than 2.1 mm, such as a depth of about 2.0 mm. Each opening 512 may be defined by a wall extending from the outer surface of the port 510.

[0133] In some embodiments, console 100 includes a control module—controller 1500. Controller 1500 may include one or more processors, algorithms, software routines, and / or electromechanical interfaces. For example, controller 1500 may include one or more electrical and / or mechanical components that interface with one or more components of console 100 and / or another component of system 10. Console 100 may also include one or more user interfaces—user interfaces 1000. User interfaces 1000 may include one or more user input devices, such as a mouse, keyboard, joystick, buttons, switches, microphone, touchscreen, and / or other components configured to allow an operator to provide information to system 10. User interfaces 1000 may also include one or more user output devices, such as a display, speaker, lights, haptic output devices, and / or other components configured to provide information to an operator of system 10. In some embodiments, controller 1500 performs (e.g., controls) one or more console operations as described herein. For example, controller 1500 may perform operations as described herein. Figure 6G The operation of the console 100 as described in method 2300.

[0134] In some embodiments, one or more components of system 10 are reusable (i.e., used in many procedures). Furthermore, one or more components of system 10 may be configured to be redisposable, meaning they are used more than once, but fewer than the fully reusable components of system 10. For example, in some embodiments, catheter 200 may be configured for single use, while umbilical cord 600 and / or cartridge 3500 are redisposable, such that umbilical cord 600 and / or cartridge 3500 are configured to be sterilized before disposal and used a limited number of times. Parts of console 100 (e.g., fluid channels) may be sterilizable, and console 100 may be configured for multiple uses, with these parts sterilized before each use. In some embodiments, system 10 includes one or more assemblies and / or other components configured to sterilize one or more sterilizable components of console 100, cartridge 3500, umbilical cord 600, and / or catheter 200, as described herein. Figure 2 As mentioned above.

[0135] In some embodiments, console 100 includes a backup power source—battery 109. Battery 109 may include sufficient power (e.g., sufficient energy capacity) to maintain the functionality of console 100 (e.g., in the event of a power failure) to perform any actions required to switch one or more components of system 10 to a patient-safe mode. For example, in the event of a power failure, during the ablation procedure step in which hot fluid is positioned in expandable element 530, battery 109 may include sufficient power to allow console 100 to adequately remove hot fluid from expandable element 530. In some embodiments, when relying on power from battery 109, system 10 performs only the functions required to switch one or more components of system 10 to a patient-safe mode (e.g., hot fluid removal is prioritized over non-essential functions of system 10).

[0136] For reference Figure 1 As described elsewhere herein, system 10 can be configured to provide volume expansion of expandable elements (e.g., assembly 530 of catheter 200) (e.g., expansion using a known volume of fluid) to perform tissue expansion procedures (e.g., delivery of fluid to the submucosal tissue of the small intestine), and also to perform flow-controlled tissue ablation procedures via expandable elements (e.g., assembly 530 configured to ablate the mucosal tissue of the small intestine). Tissue expansion and tissue ablation can be performed using a single device (e.g., catheter 200). Volume expansion and flow-controlled ablation can be performed by syringe pump mechanisms (e.g., expansion fluid supply 130, ablation fluid supply 140, and neutralization fluid supply 150 comprising one or more syringe pumps).

[0137] In some embodiments, catheter 200 includes a plurality of injection delivery elements 520 (e.g., two, three, four, or more), and injection supply 120 includes a separate fluid delivery mechanism for each delivery element 520 (e.g., a separate syringe pump or other pumping mechanism for each element 520) and associated fluid channels, such as those described herein. Figure 3 (as described above). This independent fluid delivery can be configured to ensure that each delivery element 520 delivers a desired amount of injection solution 125 (e.g., each delivery element 520 delivers the same amount of injection solution 125). Alternatively, the injection solution supply 120 may include a single syringe pump or other pumping mechanism for supplying injection solution 125 to two or more delivery elements 520, and the associated fluid channels of the console 100 and conduit 200 are constructed and arranged to have similar flow resistance, such that similar volumes of injection solution 125 are delivered by the multiple delivery elements 520. In some embodiments, the injection solution supply 120 is configured to provide pressure-limited delivery of injection solution 125 to avoid overpressure of one or more fluid channels of the console 100 and / or conduit 200.

[0138] In some implementations, system 10 is configured to perform one, two, three, or more ablation cycles during a clinical procedure without maintaining a reservoir of ablation temperature fluid during that procedure. For example, an "ablation cycle" may include heat treatment of an axial segment of the GI tract, as referenced below. Figure 3 As described elsewhere herein, the need to maintain a reservoir of fluid at a temperature sufficient to ablate the tissue throughout the entire tissue treatment procedure can be costly and / or technically complex, and the ability to perform the required number of ablation cycles without such a reservoir can offer numerous advantages. As described herein, in some embodiments, system 10 utilizes a two-pass heating method to provide the ablation temperature hot fluid, thereby avoiding the need to maintain (e.g., continuously maintain) the ablation temperature hot fluid reservoir. Alternatively or additionally, system 10 may include a reservoir configured to maintain the ablation temperature fluid, such as when system 10 includes a reservoir with a low-cost and / or reusable heating element. In some embodiments, system 10 includes an intermediate reservoir (e.g., an inline reservoir positioned between the main fluid reservoir and conduit 200) that includes a heating element configured to heat the fluid within the intermediate reservoir (e.g., only the fluid within the intermediate reservoir) to the ablation temperature between ablation cycles.

[0139] As described herein, system 10 can utilize a two-pass heating method to provide the ablation temperature fluid. In some embodiments, system 10 includes a heater with a power capacity of less than 1200 W, such as less than 1000 W or less than 900 W. Heaters with higher power ratings may be prohibitively expensive and also generate waste heat (e.g., heat not directly applied to the ablation fluid), which needs to be managed by system 10 (e.g., a radiator or other heat dissipation device or method). In a one-pass heating system, the inline heater may require a power rating of 3000 W or higher to provide the ablation fluid at a desired flow rate of at least 8 mL / s, such as at least 9 mL / s or at least 10 mL / s. As described herein, in some embodiments using the two-pass method, the ablation fluid passes through the heating element at a slower rate (e.g., less than 8 mL / s, 7 mL / s, or 6 mL / s) in the first pass and at a faster rate (e.g., at least 8 mL / s, 9 mL / s, or 10 mL / s) in the second pass. In some implementations, system 10 is configured to limit the power supplied to the heater (e.g., limit the power supplied over a period of time) such that the power supplied does not exceed the power required to adequately heat the fluid for a single ablation cycle.

[0140] As described herein, system 10 can be configured to perform two, three, or more ablation cycles in a clinical procedure. In some embodiments, system 10 is configured to perform the tissue processing procedure using a reservoir comprising less than 5 L of fluid, such as less than 4 L, 3 L, or 2 L. As described herein, system 10 can be configured to minimize the fluid used during the tissue processing procedure by reusing fluid already used to pre-cool the target tissue for subsequent ablation of the target tissue (e.g., by recirculating and heating the fluid between pre-cooling and ablation steps, as described herein).

[0141] Now for reference Figure 1A The illustration shows a schematic diagram of a system for performing medical procedures in a patient's intestine, in accordance with the concept of the present invention. System 10 includes a console 100 and a catheter 200. The console 100, catheter 200, and / or Figure 1A The construction and arrangement of other components of system 10 can be similar to those described in the reference above. Figure 1 The description of the structure and layout. Figure 1A The console 100 includes at least a vacuum supply 110, an injection fluid supply 120, an ablation fluid supply 140, and a neutralization fluid supply 150, each of which may be contained within a single housing or multiple housings of the console 100. The console 100 may include other fluid supplies and assemblies as described herein. The console 100 is fluidly and otherwise operably attached to a conduit 200, such as via an umbilical cord or other conduit—not shown in the figures but such as an umbilical cord 600 as described herein. The console 100 includes one or more pumps—pump assemblies 195—that actuate fluid between the console 100 and the conduit 200, also as described herein.

[0142] The catheter 200 includes a distal portion 208 and a functional assembly 500 positionable on the distal portion 208. The functional assembly 500 includes one or more balloons or other expandable reservoirs, such as the reservoir 5301 shown in the figure. As described herein, the console 100 can be configured to deliver fluid to and from the reservoir 5301, to expand and contract the reservoir 5301 accordingly, for example.

[0143] The catheter 200 also includes a tissue expansion subsystem 201 configured to expand subsurface tissue, such as submucosal tissue of the GI tract. The tissue expansion subsystem 201 may include conduits within the catheter 200 that deliver tissue expansion fluid to the functional assembly 500 and provide a vacuum to the functional assembly 500, each as described herein. The tissue expansion subsystem 201 may include at least two tissue capture chambers 510 configured to capture tissue when a vacuum is applied via at least two vacuum delivery conduits 511 (e.g., provided by a vacuum supply 110 of the console 100). The tissue expansion subsystem 201 may include at least two injection fluid delivery elements 520 (e.g., needles or fluid nozzles) that can receive tissue expansion fluid (e.g., injection fluid 125 provided by an injection fluid supply 120 of the console 100) via at least two injection fluid delivery conduits 521. The injection delivery element 520 may be configured to deliver tissue-expanding fluid to tissue captured by the tissue capture chamber 510. One or more injection delivery elements 520 may each include a needle configured to penetrate the tissue (e.g., through advance into the chamber 510 when the tissue is captured by an applied vacuum), thereby delivering fluid into the tissue. Alternatively or additionally, one or more injection delivery elements 520 may each include a fluid nozzle configured to pass through the surface of the captured tissue within the chamber 510 and deliver fluid into that tissue.

[0144] The catheter 200 also includes a tissue ablation subsystem 202, which includes conduits within the catheter 200 for delivering ablation fluid and neutralizing fluid to and from the functional assembly 500. The tissue ablation subsystem 202 includes a first conduit—conduit 531—configured to supply fluid to the functional assembly 500 (e.g., to a reservoir 5301); and a second conduit—conduit 561—configured to remove fluid from the functional assembly 500 (e.g., from the reservoir 5301). Conduit 531 may be configured to supply ablation fluid (e.g., fluid at the ablation temperature supplied by the ablation fluid supply 140 of the console 100) and neutralizing fluid (e.g., neutralizing fluid supplied by the neutralizing fluid supply 150 of the console 100 for cooling or heating tissue accordingly before and / or after thermal or cryoablation). Conduit 561 may be configured to remove ablation fluid and neutralizing fluid from the functional assembly 500. In some embodiments, console 100 is configured to recirculate ablation fluid within functional assembly 500 (e.g., within one or more reservoirs of functional assembly 500) and also to recirculate neutralization fluid within functional assembly 500 (e.g., within similar or dissimilar reservoirs of functional assembly 500). In some embodiments, console 100 is configured to sequentially recirculate ablation fluid and neutralization fluid in a single reservoir (e.g., reservoir 5301) of functional assembly 500 to, for example, thermally ablate tissue (e.g., target tissue) and subsequently cool tissue (e.g., target tissue and / or tissue close to the target tissue), or pre-cool tissue and subsequently ablate tissue. In some embodiments, console 100 is configured to sequentially recirculate ablation fluid and neutralization fluid in functional assembly 500 to pre-cool tissue, then ablate tissue, and then cool tissue.

[0145] Now for reference Figure 1B The illustration shows a flowchart of a method for processing a patient's target tissue, consistent with the concept of this invention. In some embodiments, Figure 1B Method 2200 uses Figure 1System 10 or other methods as described herein are used to implement this. In step 2210, a patient to be treated is selected, such as a patient selected to be treated and / or diagnosed (“treated” herein) with a disease or condition selected from the following: type 2 diabetes; type 1 diabetes; “double diabetes”; gestational diabetes; hyperglycemia; prediabetes; impaired glucose tolerance; insulin resistance; non-alcoholic fatty liver disease (NAFLD); non-alcoholic steatohepatitis (NASH); obesity; obesity-related diseases; polycystic ovary syndrome (PCOS); hypertriglyceridemia; hypercholesterolemia; psoriasis; GERD; coronary artery disease (e.g., as secondary prevention); stroke; TIA; cognitive decline; dementia; Alzheimer's disease; neuropathy; diabetic nephropathy; retinopathy; heart disease; diabetic cardiomyopathy; heart failure; diabetic heart failure; and combinations thereof. In some implementations, patients are selected to treat two or more of the aforementioned diseases or conditions, such as patients selected to treat two or more of diabetes, insulin resistance, NAFLD, NASH, and / or PCOS.

[0146] The selected patient may be taking one or more medications to manage their diabetes. The selected patient may have an HbA1c level between 7.5% and 12.0%, between 7.5% and 10%, or between 7.5% and 9.0%. In some embodiments, the selected patient may have an HbA1c level between 6.0% and 12.0%. Patients with higher HbA1c levels and / or other higher disease burden may receive more aggressive treatment (e.g., treatment of more tissues and / or more repeated treatments over time), as described below with reference to step 2250.

[0147] Patient selection can be based on the current level of one or more parameters, which represent one or more various biomarkers or other representative values ​​of physiological conditions (e.g., compared to the mean between diabetic and / or non-diabetic patients), such as parameter levels selected from: body mass index (BMI) level; waist circumference; HbA1c level; fasting blood glucose; insulin resistance; liver fibrosis; cholesterol or triglyceride level; duration of type 2 diabetes; fasting insulin, fasting C-peptide, or postprandial C-peptide stimulation; age; and combinations thereof.

[0148] One or more pharmaceutical agents may be introduced into a patient before or at any time thereafter (e.g., during or after a procedure) the insertion of one or more devices (e.g., catheter 200). In some embodiments, one or more pharmaceutical agents are introduced directly into the GI tract, as described above. Figure 1 The agent 80 is described above. In some embodiments, agent 80 comprises L-menthol (i.e., peppermint oil) or other agents formulated to provide anti-peristaltic effects. In these embodiments, a few drops of agent 80 may be placed in a flush or in another lumen of the inserted device (e.g., endoscope 50). In some embodiments, about 8 mL of L-menthol is mixed with about 0.2 mL of Tween 80 (polysorbate 80) in about 500 mL of distilled water (i.e., to produce a solution of about 1.6%). About 20 mL of this mixture may be sprayed through the working channel of endoscope 50, or more may be sprayed as needed, to inhibit peristalsis. In some embodiments, the solution may vary between about 1.6% and 3.2%. Tween and / or sorbitan monostearate may be used as emulsifiers.

[0149] Once the endoscope 50 or any other drug delivery device of the system 10 is inserted into the duodenum, one or more drugs 80 can be delivered. In some embodiments, the drug 80 includes one or more intravenously delivered drugs and may include glucagon and / or bismuth subcitrate.

[0150] As described herein, in some embodiments, the endoscope is inserted into the patient's body (e.g., Figure 1 (Endoscope 50). In these embodiments, subsequently inserted devices may be placed through the working channel of endoscope 50 and / or alongside endoscope 50. In some embodiments, both endoscope 50 and the attachable sheath are inserted into the patient, and subsequently inserted devices may be placed through the working channel of endoscope 50, through the attachable sheath, and / or alongside endoscope 50 and the attached sheath. Each device placed in the patient can be inserted via a guidewire. In some embodiments, an endoscopic enhancement device, such as the endoscopic enhancement system provided by Zutron Medical of Lenexa, Kansas, USA, is used.

[0151] In some embodiments, non-target tissue is identified. Visualization devices, such as the endoscope 50 and / or imaging device 70 described herein, can be used to identify non-target tissue. Non-target tissue may include the ampulla of Vater of Hepatopancreatic Duct, the pancreas, and / or other tissue that may adversely affect the patient due to treatment (e.g., ablation). Non-target tissue (or tissue adjacent to non-target tissue) may be marked, such as using tattoos, ink, or other visual materials, such as visual agents or clips placed in or near the mucosa and / or submucosa of the ampulla of Vater of Hepatopancreatic Duct. In some embodiments, the same as described above is deployed within the patient's body. Figure 1 One or more markers similar to the described marker 90 are used to provide a reference location relative to non-target tissue. Tissue expansion and / or tissue treatment performed in subsequent steps may avoid treating non-target tissue that has been identified and may be tagged (e.g., using one or more markers 90) (e.g., avoiding delivery of ablation energy to it).

[0152] Next, in step 2210, the catheter will be processed, such as Figure 1 The catheter 200 is inserted through the patient's mouth and advanced through the stomach and into the small intestine. Step 2210 may include selecting a specific type of catheter 200, such as a specific size of catheter 200 (e.g., treatment element length and / or diameter) or other configuration. Catheter 200 can be inserted via guidewire 60, for example, as referenced above. Figure 1 As described herein, the guidewire 60 can be advanced to position its distal end in the jejunum or further. During the advancement of the catheter 200, the guidewire 60 can be kept taut to prevent the catheter 200 from forming a loop in the stomach. As described herein, the catheter 200 can be inserted through the working channel of the endoscope 50 and / or alongside the endoscope 50.

[0153] Advancing catheter 200 (e.g., via guidewire 60) positions functional assembly 500 in the duodenum (or other GI location). One or more tissue capture chambers 510 (e.g., three tissue capture chambers 510 positioned on the expandable element 530 of functional assembly 500) may be positioned at a first location in the intestine. The first location may be the nearest-side target location to be treated, such as a location in the duodenum at least 0.5 cm or at least 1 cm but no more than 5 cm or 10 cm from the ampulla of Vater of the hepatopancreatic duct. In some embodiments, the tissue capture chambers 510 are positioned based on the location of previously placed markers such as marker 90 as described herein. A reinforcing suture may be inserted within catheter 200 before and / or during catheter 200 insertion. Endoscope 50 may be positioned near catheter 200 such that its distal end is positioned outside the ampulla of Vater of Vater of the hepatopancreatic duct (e.g., outside marker 90).

[0154] In some implementations, method 2200 does not continue after step 2210 until a positive operator confirmation is received (e.g., via operator input to system 10), such as when the functional assembly 500 is in place relative to the tissue to be expanded.

[0155] In step 2220, submucosal tissue dilation is performed or at least attempted at a first location (e.g., a first axial segment of the duodenum). Saline and / or other fluids or materials (injection solution 125) are injected into the submucosal tissue. In some embodiments, injection solution 125 is delivered (e.g., simultaneously injected) by a plurality of injection solution delivery elements 520 of the functional assembly 500, each element 520 being positioned in a corresponding tissue capture chamber 510 (e.g., three chambers 510 spaced approximately 120° apart circumferentially). Each injection (performed by a single injection solution delivery element 520) may include at least 1 mL per injection solution delivery element 520, such as at least 2 mL, at least 5 mL, or at least 8 mL (e.g., when the cumulative fluid volume delivered by the plurality of injection solution delivery elements 520 includes at least 3 mL, such as at least 6 mL, at least 15 mL, or at least 24 mL). Each injection may include no more than 20 mL, such as no more than 15 mL, or when each injection includes about 10 mL (e.g., when the cumulative fluid volume delivered by the plurality of injection delivery elements 520 includes no more than 60 mL, such as no more than 45 mL, or when the cumulative volume includes about 30 mL). In some embodiments, each injection includes at least 4 mL, at least 6 mL, or at least 8 mL. In some embodiments, the amount of injection fluid delivered (e.g., delivered via three circumferentially positioned injection delivery elements 520) may be configured to achieve a submucosal expansion of at least 250 μm or about 400 μm in thickness in the area surrounding the volume of mucosal tissue to be ablated. The console 100 may be configured to deliver injection fluid 125 at a flow rate of at least 1 mL / min or at least 10 mL / min, such as 50 mL / min or 100 mL / min. In some embodiments, the console 100 is configured to deliver the full volume of injection fluid to a single injection fluid delivery element 520 at a single site within a time period not exceeding 2 minutes, 1 minute, or 30 seconds. In some embodiments, the injection fluid 125 is injected into the tissue in a closed-loop manner, for example until a pressure threshold is reached (e.g., the pressure within the delivery element), until the pressure within a balloon or other functional element placed near the injection site increases above the threshold, and / or until the inner diameter of the duodenum is reduced to a certain size or a certain percentage of its pre-injection size.

[0156] The volume injected by multiple injection delivery elements 520 can be selected to achieve near-full circumferential expansion of the submucosal tissue (e.g., gapless, full 360° expansion). As described herein, each submucosal tissue expansion step is configured to create a safety margin for the expanded submucosal tissue, such that the expanded tissue volume (e.g., a portion or all of the circumferential tubular volume of the intestine) defines an "expanded tissue periphery." In some embodiments, the functional assembly 500 is constructed and arranged (e.g., to define the dimensions of the ablation portion) such that submucosal tissue expansion performed at a single axial location of the small intestine (e.g., by delivery of injection fluid 125 via two, three, or more injection delivery elements 520 simultaneously or sequentially at that single axial location) creates an expanded tissue periphery large enough to surround the "ablation periphery" created during ablation via the functional assembly 500 (as described below with reference to step 2250). Such a sufficiently large expanded tissue periphery avoids the transfer of a large amount of energy beyond the submucosal layer (e.g., avoiding the transfer of energy at a level sufficient to ablate the deeper muscular layer of the GI tract). For example, in the case of circumferential submucosal expansion, if the axial length of the expanded submucosal tissue delivered by the injection solution 125 in step 2220 is greater than the axial length of the tissue to be ablated, then the expanded submucosal tissue is sufficient to provide a safety margin for ablation (e.g., during ablation, the functional assembly 500 is relatively centered within the length of the expanded tissue).

[0157] In some embodiments, the size of the expanded tissue periphery created in a single submucosal tissue dilation step is insufficient to support the ablation periphery created by the functional assembly 500, and an optional step 2225 (e.g., once or multiple times) is performed, which includes additional submucosal tissue dilation. For example, a second submucosal tissue dilation may be performed on an adjacent (e.g., relatively adjacent and distal) axial segment of the duodenum, such as by translating (e.g., advancing) the catheter 200 to reposition the functional assembly 500. In some embodiments, step 2225 is not performed until positive operator confirmation is received (e.g., via operator input to system 10 through user-activated controls), such as when the functional assembly 500 is in place relative to the tissue to be dilated. The functional assembly 500 may collapse at least partially before translation (e.g., removal of ablation fluid 145, neutralization fluid 155, and / or other fluids from the functional assembly 500). Translation of catheter 200 (advancement and / or retraction of functional assembly 500 or other portions of catheter 200) can be performed under visual guidance, such as when functional elements 499a, 499b, and / or 599 described herein include radiopaque strips or other visual markers that can be visualized by imaging device 70 (e.g., a fluorescence microscope). Alternatively or additionally, rotation of catheter 200 (e.g., rotation of functional assembly 500 or other portions of catheter 200) can be performed under similar visual guidance. In step 2225, catheter 200 may be translated (e.g., advanced) a predetermined distance (e.g., at least 0.3 cm or at least 0.6 cm), after which delivery of injection solution 125 can begin. As described above with reference to step 2220, the delivery of injection fluid 125 via injection fluid delivery element 520 creates a second (e.g., adjacent) volume of expanded submucosal tissue, which, together with the first expanded volume of submucosal tissue, defines a larger expanded tissue perimeter than the expanded tissue perimeter created in a single tissue expansion step. Such a larger expanded tissue perimeter can support a larger ablation perimeter (e.g., a longer circumferential length of the tissue to be ablated), which may be required by functional assembly 500 in a single ablation. For example, in the case of circumferential submucosal tissue expansion, if the axial length of the expanded submucosal tissue achieved by the injection fluid 125 delivered in the combined delivery of steps 2220 and 2225 is greater than the axial length of the tissue to be ablated, the expanded submucosal tissue is sufficient to provide a safety margin for ablation.

[0158] For further reference Figure 1CThe illustration shows representative expansion and ablation peripheries for two full circumferential expansions and a subsequent single full circumferential ablation performed via console 100 and catheter 200, as described herein. The first and second circumferential submucosal tissue expansions are combined to form an expansion tissue periphery of the indicated length. Functional assembly 500 can deliver energy to the ablation periphery positioned within the expansion tissue periphery.

[0159] Optional step 2225 may be performed two or more times, resulting in three or more injections of fluid into the tissue (e.g., submucosal tissue) with or without intermediate ablation performed via step 2250. The sequential injections of injection solution 125 may be performed at axial intervals of 1 to 2 cm from the previous injection (e.g., 1 to 2 cm distally in the duodenum, jejunum, or other GI locations). In some embodiments, multiple injections are positioned at intervals of at least 0.5 cm along the axis of the small intestine, such as between 1.0 cm and 5.0 cm, for example, approximately 1.0 cm, 2.0 cm, 3.0 cm, 4.0 cm, and / or 5.0 cm along the axis of the small intestine. In some embodiments, the axial interval of the injection sites (i.e., the translational distance of the catheter 200 between injections) may approximate half the length of the expandable element 530 to which the injection solution delivery element 520 is mounted, such as... Figure 1 The length of the expandable element 530 is half that of the other element. In some embodiments, a series of 5-15 sets (e.g., 8-12 sets) of injections (e.g., each set including injections from 2, 3 or more injection delivery elements 520) can be performed by delivering an injection solution 125 (e.g., a fluid containing a visualization dye) to the tissue to be expanded and subsequently (e.g., after visually confirmed adequate tissue expansion as described below in steps 2230 and 2235 or elsewhere) to the new axial position (with or without an intermediate ablation step). Each advance and / or retraction of the catheter 200 can be synchronized with the advance and / or retraction of an endoscope positioned adjacent to the catheter 200.

[0160] As described herein, tissue dilation can begin at a location near but distal to the ampulla of Vater of the hepatopancreatic duct, such as at least 1 cm but no more than 5 cm or 10 cm distal to the ampulla of Vater. A series of relatively contiguous circumferential submucosal tissue dilations (e.g., distal movement) can be performed, for example, at locations distal to the Treitz ligament. In an alternative embodiment, multiple circumferential tissue dilations are performed by moving the catheter 200 from a distal location to a proximal location or in a discontinuous (back-and-forth) manner.

[0161] The injection volume and / or axial spacing at the injection site can be selected to avoid axial gaps between adjacent expanded tissue volumes (e.g., when performing an ablation step at approximately one or both expanded tissue volumes). After injection, gaps marked by circumferential and / or axial markers (e.g., via an endoscopic camera, fluorescein, or ultrasound imaging device) can be filled if necessary via additional injection (e.g., with or without rotation and / or translation of catheter 200).

[0162] In some embodiments, the console 100 is configured to reduce the amount of fluid (e.g., a fluid such as water, or a gas such as air or carbon dioxide) in the expandable element 530 supporting the injection delivery element 520 when delivering the injection solution 125 into the tissue, for example to prevent excessive force from being applied to the tissue near the expanded tissue (i.e., due to the reduction of the lumen of the intestine near the expanded tissue in contact with the expandable element 530).

[0163] Multiple injections (e.g., two, three, or more injections from two, three, or more equidistant injection delivery elements 520) can be performed simultaneously or sequentially in a single axial segment of the intestine (e.g., without moving the functional assembly 500). Prior to delivery of the injection fluid 125, a vacuum (e.g., deflation) can be applied to the intestinal lumen (e.g., automatically or otherwise via system 10, such as via the working channel of endoscope 50 and / or via port 470P or port 470D of catheter 200) to, for example, pull tissue toward each injection delivery element 520 (e.g., into the associated chamber 510). After delivery of the injection fluid 125, the vacuum can be removed and ablation performed (e.g., in step 2250 below without additional translation or other movement of the functional assembly 500), or catheter 200 can be advanced (or retracted) for subsequent (additional) tissue dilation.

[0164] In step 2230, an assessment of submucosal tissue expansion is performed (e.g., manually by the operator and / or automatically by system 10). Figure 1B As shown, step 2230 may be performed after step 2225 (e.g., if step 2225 is performed), and / or directly after step 2220 (e.g., when a single tissue expansion is sufficient for subsequent ablation, or simply when evaluation is desired immediately following tissue expansion). In some embodiments, submucosal tissue expansion is evaluated via a camera view provided by endoscope 50 (e.g., an endoscope having a camera positioned for viewing submucosal tissue expansion). Alternatively or additionally, submucosal tissue expansion may be performed using visualization devices of system 10, such as those mentioned above. Figure 1When the imaging device 70 provides one or more images for performing an evaluation, the injection solution 125 delivered in steps 2220 and / or 2225 may include agents that can be directly inspected by the operator and / or whose location (e.g., the volume of tissue expanded by the injection solution 125) can be (at least partially) evaluated by the system 10 (e.g., via the image processing algorithm of the console 100 or other components of the system 10). For example, the injection solution 125 may contain materials selected from: visible materials (e.g., Indian ink, indigo carmine, etc.) visualized by the endoscope 50 camera, the catheter 200 camera (e.g., when the functional element 599 includes a camera), or other cameras; radiopaque materials visualized by the imaging device 70 including a fluoroscope or other X-ray imaging device; reflective ultrasound materials visualized by the imaging device 70 including an ultrasound imaging device; any visualized material; and combinations of one or more of these. Visualization of the expanded tissue can be used to determine (e.g., automatically by an algorithm of system 10) that an appropriate volume of injection fluid has been delivered and that sufficient tissue expansion has been achieved, to ensure, for example, adequate thickness, elimination of gaps, sufficient axial length, and / or sufficient circumferential (e.g., full or near-full circumferential) tissue expansion has occurred. The pressure of the expandable element 530 or the fluid volume within the expandable element 530 can also be monitored to determine whether an appropriate volume of injection fluid has been delivered to achieve sufficient tissue expansion. In particular, the expanded tissue can be analyzed to identify areas of relatively poor expansion, such as areas of adherent submucosal tissue (e.g., scar and / or fibrotic submucosal tissue unsuitable for tissue expansion).

[0165] As described above, in some embodiments, at least the camera of endoscope 50 is used to perform the assessment of submucosal tissue dilation performed in step 2230. In these embodiments, before and / or during the assessment of submucosal tissue dilation performed in step 2230, the functional assembly 500 may be at least partially collapsed (e.g., the expansion fluid 135 and / or other fluids may be removed from the functional assembly 500) to provide a larger view of the dilated tissue. Alternatively or additionally, the functional assembly 500 may be at least partially collapsed to allow endoscope 50 to advance toward and potentially enter the axial segment of the intestinal tissue to which the submucosal tissue has dilated, thereby providing a closer view of the dilated tissue.

[0166] In step 2235, the adequacy of submucosal tissue expansion is determined (e.g., a qualitative assessment performed by a clinician and / or a quantitative assessment performed automatically and / or semi-automatically using system 10). If submucosal tissue expansion is determined to be insufficient, step 2240 is performed, in which a new (alternative) area is selected for tissue expansion and subsequent ablation, or the procedure is terminated (e.g., after limited ablation has been performed or no ablation has been performed). In some embodiments, Figure 1B Method 2200 includes performing a medical procedure on the same patient after a similar procedure (e.g., a similar ablation procedure in the duodenum or other locations in the patient's small intestine or GI tract) has been performed on the patient (e.g., at least 24 hours later). The submucosal dilatation assessment performed in step 2230 can be an important diagnostic test confirming that performing repeated, similar procedures (e.g., the procedures of the present invention) is safe. Alternatively, the assessment can support the identification of patients with: active infection in their small intestine; a history of infection (e.g., tuberculosis) and / or malignancy that can lead to GI segment damage (e.g., conditions that make submucosal dilatation challenging or even impossible); and combinations of these, such as patients for whom ablation should not be performed or for whom limited ablation should be performed. For example, there may be significant fibrosis and / or significant scarring (from previous procedures or other sources) at the target location, which may hinder proper submucosal tissue dilatation. In these cases, ablation should not be performed, at least not at that location in the intestine.

[0167] If the submucosal tissue dilation is determined to be sufficient, step 2250 is performed, in which the target tissue is treated (e.g., ablated) by the functional assembly 500 of the catheter 200. The target tissue may include one or more portions of the mucosal layer of the duodenum or jejunum and / or other GI locations located near (e.g., above) submucosal tissue that has been previously dilated (e.g., dilated in one or more dilation steps 2220 and / or 2225). The treated tissue may also include at least the inner layer of adjacent submucosal tissue (e.g., the local depth of the previously dilated submucosal tissue layer). In some embodiments, the ablation of step 2250 is performed without repositioning (e.g., without translation) the functional assembly 500, such as without repositioning after step 2220 or after step 2225 (if optional steps are performed), to ensure, for example, that ablation is performed on the area of ​​dilated submucosal tissue (e.g., the periphery of dilated tissue of sufficient size as defined herein), thus providing a safety margin to avoid adverse effects on tissue layers beyond the submucosal layer (deeper layers). One or more circumferential ablation, partial circumferential ablation, and / or other treatments may be performed along the length of the GI pathway (e.g., along one or more axial segments of the GI pathway), such as along the length of the duodenum at least 1 cm distal to the ampulla of Vater of Hepatopancreatic Duct, or at locations at least 1 cm distal to the ampulla of Vater of Hepatopancreatic Duct but within 3 cm, 5 cm, or 10 cm. In some embodiments, all ablation is performed at least 2 cm or at least 3 cm distal to the ampulla of Vater of Hepatopancreatic Duct (e.g., tissue within 1 cm, 2 cm, or 3 cm of the ampulla of Vater of Hepatopancreatic Duct is not ablated). In some embodiments, tissue treatment is performed only at locations where submucosal tissue dilation has been performed and / or confirmed (e.g., visual confirmation described above with reference to steps 2230 and 2235).

[0168] In some implementations, step 2250 must be performed within a predetermined timeframe of the most recent submucosal tissue dilation step (e.g., step 2220 or 2225). For example, in some implementations, console 100 only allows step 2250 to be performed within 10 minutes (e.g., within 5 minutes) of step 2220 or 2225. In some implementations, if the predetermined timeframe has elapsed, console 100 needs to perform additional submucosal dilation before allowing the tissue processing step to be performed.

[0169] In some embodiments, thermal ablation is provided by introducing a sufficiently hot or sufficiently cold fluid into the expandable element 530 to ablate the tissue. Alternatively or additionally, different forms of energy delivery or other tissue treatments (e.g., electromagnetic, optical, mechanical, and / or chemical energy) may be performed.

[0170] The catheter 200 and console 100 can be configured to treat a series of axial segments of GI tract tissue, each comprising a length between 1 cm and 5 cm, such as approximately 2 cm in length. The catheter 200 and console 100 can be configured to treat the cumulative axial length of GI tract tissue (e.g., the axial length of duodenal mucosa tissue) less than or equal to 3 cm, 6 cm, 9 cm, 15 cm, or 20 cm. The catheter 200 and console 100 can be configured to treat duodenal mucosal axial lengths greater than 3 cm, such as greater than 3.4 cm, greater than 6 cm, greater than 7 cm, greater than 8 cm, or greater than 9 cm (e.g., approximately 9.3 cm). In some embodiments, at least 10%, 15%, 25%, 30%, and / or 50% of the duodenal mucosa distal to the ampulla of Vater of Vater is treated. The axial length and / or total volume of the treated tissue may correspond to patient parameters, such as the duration of disease or other disease parameters described herein (e.g., a higher disease burden associated with larger volumes of treated tissue).

[0171] In some embodiments, at least three axial segments of duodenal mucosal tissue are treated (e.g., sequential ablation, such as sequential treatment including at least one submucosal tissue expansion step performed before each ablation) – for example, using a functional assembly 500 configured to deliver energy to a delivery zone having a length between 0.5 cm and 4.0 cm (e.g., the tissue contact length of the expandable element 530 filled with ablation fluid), such as a delivery zone length (e.g., between 0.5 cm and 4.0 cm, 1.5 cm and 3.3 cm, or about 2 cm in length). In some embodiments, at least four axial segments of duodenal mucosal tissue are treated, for example when at least six axial segments of duodenal mucosal tissue are treated. In these embodiments, the functional assembly 500 may be configured to deliver energy to a delivery zone having a length between 0.7 cm and 2.0 cm (e.g., the tissue contact length of the expandable element 530 filled with ablation fluid). In some embodiments, the functional assembly 500 includes an ablation fluid (e.g., ablation fluid 145 provided by the console 100) delivered into the expandable element 530. Multiple tissue treatments are performed by repositioning the functional assembly 500, which may further include repositioning the functional assembly 500 by contracting the expandable element 530. Contact between the target tissue and the functional assembly 500 can be achieved using a degassing technique that brings the tissue toward the expandable element 530 and / or via expansion of the expandable element 530. Tissue treatments are performed, such as by filling the expandable element 530 with an ablation-temperature fluid and / or delivering any form of energy to the target tissue. In embodiments where the catheter 200 is delivered via a guidewire, the guidewire may be retracted (e.g., at least retracted to a position proximal to the treatment element) before any tissue treatment (e.g., before any energy delivery).

[0172] Multiple procedures can be performed by advancing or retracting the functional assembly 500 and / or catheter 200. In some embodiments, the functional assembly 500 is positioned distally and a series of tissue procedures are performed, such as performing at least three tissue procedures—whereby the catheter 200 is retracted substantially to the length of the tissue contact portion of the functional assembly 500 to, for example, treat relatively contiguous, non-overlapping circumferential axial segments of the duodenum (e.g., where at least one submucosal tissue dilation is performed prior to each ablation or other procedure). As described herein, an assessment of adequate submucosal tissue dilation can be performed prior to each procedure. Confirmation of any non-target tissue (e.g., distal to the marker and / or otherwise identified) remote from the marker and / or otherwise identified can also be performed prior to each tissue procedure (e.g., by examining the previously placed marker 90). In some embodiments, the marker 90 is placed to avoid any damage to the ampulla of Vater of Hepatopancreatic Duct. In some implementations, after treating (e.g., from distal to proximal) three axial segments of the duodenal mucosa, an assessment of the straight-line distance between the nearest treated segment and the ampulla of Vater of the hepatopancreatic duct is performed (e.g., using one or more components of System 10 to determine the distance). If a sufficient length is determined (e.g., the determined distance is above a threshold), additional (more proximal) axial tissue segments can be treated. During the translation of catheter 200 through the guidewire, undesirable movement of the guidewire is prevented or otherwise reduced by the operator.

[0173] In some embodiments, the system conceived in this invention (e.g., Figure 1 System 10) is configured to allow only one ablation per (predetermined) time period, to prevent, for example, two ablations within that time period, to prevent, for example, repeated ablation in the same or at least similar (e.g., overlapping) portions of the GI channel (e.g., rapid processing of similar processing areas).

[0174] In some embodiments, the tissue treatment in step 2250 should be completed within approximately 120 minutes or approximately 60 minutes after the initiation of tissue dilation performed in steps 2220 and / or 2225, such as within approximately 45 minutes, 30 minutes, and / or 20 minutes. The execution of tissue treatment within this time window prevents an unacceptable amount of injection fluid 125 from leaking outside the dilated submucosal tissue space (e.g., preventing insufficient submucosal tissue dilation during tissue treatment). In some embodiments, system 10 is configured to block tissue treatment (e.g., ablation) before a sufficient submucosal dilation step has been performed and / or confirmed (e.g., as described in step 2230). After ablation of one or more duodenal axillary segments or other GI segments in step 2250, additional axillary segments to be treated are identified in step 2260. In some embodiments, a single axial segment is ablated in step 2250, followed by expansion of additional submucosal tissue (e.g., in one or more of steps 2220 and / or 2225), and additional ablation is performed near the additionally expanded submucosal tissue. In some embodiments, for each single mucosal tissue axial segment ablated, two axial segments of the submucosal tissue are expanded. In some embodiments, a first ablation is performed near the area of ​​two submucosal expansions (e.g., immediately after performing two submucosal expansions), and a subsequent ablation is performed after (e.g., immediately after) two or fewer (e.g., one) submucosal expansions (e.g., expansion performed in the area of ​​the subsequent ablation).

[0175] The cumulative amount of target tissue treated and / or the number of treatments performed may be correlated with one or more patient conditions (e.g., proportionally) (e.g., more severe conditions are associated with more tissue treatment and / or more treatments over time). Such increased treatment may include increased axial length of treated tissue (e.g., increased cumulative axial length of ablated duodenum), increased volume of treated tissue (e.g., increased volume of duodenal mucosa treated via increased mucosal surface area receiving ablation energy from functional assembly 500), deeper treatment depth, and / or more treatments performed over time to achieve a sustained treatment response. In some embodiments, tissue treatment is modified to avoid duodenal stenosis or constriction by limiting, for example, one or more of the following: the amount of energy delivered; the peak energy delivered; the duration of energy delivered; the length of treated tissue; the depth of treated tissue; and combinations thereof.

[0176] Now for reference Figure 2The illustration shows a schematic diagram of a tissue processing system conforming to the inventive concept, comprising an elongated device and a console having a cartridge, a syringe pump assembly, and a fluid reservoir attachable thereto. System 10 includes a console 100 and a processing device—a catheter 200. A lumen assembly—an umbilical cord 600—operably attaches the catheter 200 to the console 100. In some embodiments, the console 100 includes an operator-attachable fluid channel connection assembly—a cartridge 3500. For example, the cartridge 3500 can be attached to the console 100 by an operator of system 10 before performing a tissue processing procedure using the catheter 200. In some embodiments, such as when the console 100 includes a reusable fixation device, the console 100 can be configured for use with two or more cartridges 3500, umbilical cords 600, and / or catheters 200 (e.g., sequential use). Reference Figure 2 The components are configured and arranged to control, guide, manage, and / or otherwise manipulate (as used herein, “control,” “guide,” “manage,” or “manipulate”) a fluid—fluid 3001—to supply fluid to an expandable element, illustrated element 530, for processing tissue adjacent to the expandable element 530 (e.g., mucosal tissue of the GI tract) (similar to references herein). Figure 1 The fluid 3001 may be similar to ablative fluid 145, neutralizing fluid 155, and / or functional fluid 185, each of which is referred to herein. Figure 1 As stated above.

[0177] The console 100 may include one or more heating assemblies—assemblies 3200. In some embodiments, the heater assembly 3200 includes an inline heater—heater 3210. Heater 3210 may include a first port 3211 and a second port 3212 fluidly connected through a lumen 3213. Heater 3210 may be configured to heat fluid 3001 as it flows through lumen 3213, or from port 3211 to port 3212 and / or from port 3212 to port 3211 (e.g., heater 3210 may support bidirectional flow of fluid). In some embodiments, heater 3200 is configured to preheat fluid 3001 before a heating step in which fluid 3001 passes through heater 3200 (e.g., before ablation) (e.g., heating elements, heater body, and / or other fluid contact portions are preheated). Heater 3200 may be preheated to improve the system's temperature response (e.g., reduce the time required for fluid 3001 to reach a target temperature). In some embodiments, heater 3200 may be preheated between heating steps, such as between ablation steps (e.g., heated to a desired preheating temperature). In some embodiments, system 10 includes a closed-loop control algorithm (e.g., a control algorithm for a PID controller of system 10) configured to adjust the power of heater 3200 in a closed-loop arrangement to achieve a desired temperature of fluid 3001. For example, each manufactured system 10 may include a closed-loop control algorithm (e.g., the same closed-loop control algorithm) that minimizes variations in the heating performance of heater 3200 from one system 10 to another (e.g., variations caused by manufacturing variations).

[0178] System 10 may include one or more vacuum supplies, such as vacuum supply 110 shown and described herein. In some embodiments, vacuum supply 110 includes a vacuum source provided by console 100. Alternatively or additionally, console 100 may be configured to attach to a vacuum source provided within a patient room (such as an operating room), the operating room including one or more attachment locations for attaching to the vacuum supply. In some embodiments, console 100 is configured to check (e.g., via pressure sensors or other sensors) for the presence of a sufficient level of vacuum pressure before performing one or more steps of a procedure, as described herein.

[0179] System 10 may include one or more reservoir assemblies—reservoir assemblies 3300a and 3300b shown herein (reservoir assemblies 3300 individually or collectively). Each reservoir assembly 3300 may be similar or dissimilar, such as when including one or more similar or dissimilar components as described herein. Reservoir assembly 3300 may include a chamber—reservoir 3310, configured to store fluid 3001, supply fluid 3001 to and / or receive fluid 3001 from console 100. In some embodiments, reservoir 3310 includes a flexible housing (e.g., softened polyvinyl chloride or other flexible material arranged in a bag-like structure). Reservoir assembly 3300 may include an attachment mechanism—handle 3315. Handle 3315 may be attached to reservoir 3310 and it may be configured to attach reservoir 3310 to console 100. In some embodiments, console 100 includes one or more attachment mechanisms—hooks 3320a and 3320b shown (hook 3320 individually or collectively herein). Hook 3320 may be configured to engage handle 3315 such that reservoir 3310 can be detachably attached to one side of console 100. Alternatively or additionally, console 100 may include one or more recesses configured to slidably receive reservoir assembly 3300, and / or reservoir assembly 3300 may be fixedly attached to console 100 (e.g., fixedly attached but detachable by a technician or operator of console 100). In some embodiments, console 100 and / or hook 3320 include a sensor—sensor 3321—configured to monitor the fluid level within reservoir 3310. For example, sensor 3321 may include a weighing sensor or other weight-sensing device configured to determine the fluid level within reservoir 3310 based on the current weight of reservoir 3310 and the fluid around it. The reservoir assembly 3300 may include one or more functional elements—functional element 3319. In some embodiments, functional element 3319 includes a fluid level sensor configured to monitor the level (e.g., volume or weight) of fluid 3001 within the reservoir 3310. In some embodiments, functional element 3319 includes a temperature sensor, such as a temperature sensor configured to be electrically, optically, and / or otherwise operably connected to the console 100. In some embodiments, the console 100 includes an infrared temperature sensor configured to measure the temperature of the fluid within the reservoir 3310.

[0180] The reservoir assembly 3300 may include an inlet manifold—inlet 3311—which may be fluidly attached to a lumen—inlet lumen 3312. Inlet lumen 3312 may be fluidly attached to a connector—connector 3313. In some embodiments, connector 3313 is "integrated" with the wall of reservoir 3310 (e.g., molded and / or otherwise fixedly attached). Alternatively or additionally, lumen 3312 may extend from inside reservoir 3310 to outside reservoir 3310 (e.g., via a fluid-air seal), such that a portion of lumen 3312 extends outside reservoir 3310 and is fluidly attached to connector 3313 (e.g., in a pigtail arrangement). Connector 3313 may be configured to be fluidly attached to a connector of cartridge 3500 as described herein. In some embodiments, connector 3313 is integrated into reservoir 3310 and positioned near the top of reservoir 3310, and does not include lumen 3312 and / or inlet 3311, such that fluid supplied to connector 3313 is delivered directly into reservoir 3310 (e.g., when reservoir 3310 includes a “waste” reservoir, and fluid is delivered into reservoir 3310 but not from reservoir 3310).

[0181] Console 100 may include one or more syringe pump assemblies 3100, such as syringe pump assemblies 3100a and 3100b shown herein (syringe pump assemblies 3100 individually or collectively). In some embodiments, console 100 includes no more than two syringe pump assemblies 3100. Each syringe pump assembly 3100 may be similar or dissimilar to one another, such as when the assembly 3100 includes one or more similar or dissimilar components as described herein. Syringe pump assembly 3100 may include syringe 3110 having a first connector 3113 positioned at the top of syringe 3110 and a second connector 3123 positioned at the bottom of syringe 3110. The second connector 3123 may mate with a connector 3122 of console 100. Connectors 3122 and 3123 form connector assembly 3120. Connector assembly 3120 is configured to allow syringe 3110 to be operatively and detachably connected to console 100. Connector assembly 3120 may be as referenced herein. Figures 5A-5CThe syringe pump assembly 3100 may also include a syringe drive assembly 3130, wherein the assembly 3130 may be configured to actuate a plunger assembly 3140 including a plunger 3141. The plunger 3141 may retract and / or advance within the syringe 3110 to draw fluid into the syringe 3110 and / or force fluid out of the syringe 3110, respectively. In some embodiments, each syringe 3110 includes a maximum volume of 500 mL, such as 300 mL, 200 mL, or 150 mL (e.g., the maximum fluid volume that the syringe can accept).

[0182] The cartridge 3500 can be configured to be operatively attached to the console 100. The cartridge 3500 may include a housing 3501 surrounding at least a portion of one or more conduits (e.g., fluid-carrying conduits) – illustrated conduit 3510. Conduits 3510 may extend beyond the housing 3501, each terminating in a connector 3010 and configured for fluid attachment to a corresponding connector as described herein. In some embodiments, one or more of the connectors 3010 include a rotatably locking fluid connector, such as one including an O-ring seal, twisted to lock at a quarter turn, allowing free rotation of the attached lumen, and / or providing tactile and / or audible feedback when properly connected. In some embodiments, the connector 3010 may be similar to connectors from the SMC series of miniature couplings supplied by Colder Products Company, St. Paul, Minnesota. Connectors 3010 may include connectors 620, 3514, 3512, 3113, 3516, 3214, 3215, and / or other connectors described herein. Cartridge 3500 may include one or more valves and / or other fluid control elements—valve assembly 3520. Valve assembly 3520 may be configured to manipulate the geometry of the wall of conduit 3510 (e.g., clamp the wall of conduit 3510) to control the path of fluid through cartridge 3500. Various conduits 3510 and connectors 3010 of cartridge 3500 are fluidly attached via umbilical 600 to reservoir assembly 3300, vacuum supply 110, heater assembly 3200, syringe pump assembly 3100, and conduit 200 to enable fluid to travel along a path from reservoir assembly 3300a, through various components of system 10, and to reservoir assembly 3300b. Valve assembly 3520 may be configured as described herein. Figures 9A-9D As stated above.

[0183] In some embodiments, one or more connectors 3010 are integrated into the wall of the housing 3501 of the cartridge 3500, i.e., integrated connectors 3010. I For example, in some embodiments, the conduit 3510 is fluid-attached to the integrated connector 3010 within the housing 3501.I On one side, integrated connector 3010 I A portion extends through housing 3501 and integrates connector 3010. I The opposite side extends from housing 3501 (e.g., providing a fluid connection to another component of system 10). In some embodiments, integrated connector 3010 I At least a portion of the cartridge 3500 is rotated and fixed relative to the cartridge 3500, such that the operator of the system 10 can attach the mating connector 3010 to the integrated connector 3010 by twisting the mating connector 3010 relative to a portion of the cartridge 3500, for example, during one-handed operation. I In some implementations, the integrated connector 3010 I Through friction mating (e.g., connector 3010) I The flange of the connector 3010 is securely attached to the housing 3501 via a press fit with a portion of the attached conduit 3510, without the use of adhesive. In some embodiments, the connector 3010 I Configured as described in this article. Figure 4 As stated above.

[0184] The conduit 3510 can be constructed and arranged to withstand a variety of functional conditions that may occur during the operation of system 10 without adverse effects. For example, the conduit 3510 may include radial stiffness sufficient to withstand (e.g., withstand without collapsing) a vacuum pressure of at least -1 psi, such as at least -3 psi, such as at least -7 psi, such as -14.7 psi. Additionally or alternatively, the conduit 3510 may include radial stiffness low enough to completely collapse (e.g., collapse to a clogging condition) when a valve assembly 3520 including a pinch valve applies a compressive force to the conduit 3510 to block or otherwise reduce the flow of fluid through it. In some embodiments, the conduit 3510 includes a material capable of withstanding heat of at least 60°C, such as at least 80°C, or at least 100°C (e.g., without permanent deformation). The conduit 3510 may include a construction sufficient to achieve impact pressures of at least 20 psi, such as at least 50 psi, such as at least 100 psi, such as at least 200 psi. In some implementations, system 10 is configured to detect (e.g., via one or more sensors and / or algorithms of system 10) a condition where the valve assembly fails to sufficiently collapse (e.g., shut off) the pipe (e.g., detecting a condition where valve assembly 3520 fails to completely collapse pipe 3510). Once system 10 detects such an undesirable condition, system 10 can enter an alarm state (e.g., notify the operator and can stop and / or modify the delivery of ablation energy).

[0185] In some implementations, the console 100 and its associated components are configured as follows: Figure 6As shown, and as referenced in this article Figures 6A-6F The fluid 3001 is transported through system 10.

[0186] In some embodiments, two conduits 3510 extend from housing 3501 and terminate at connectors 3512a and 3512b, as shown. Connectors 3512a and 3512b are each configured to be operably attached to first connectors 3113a and 3113b of syringe pump assembly 3100, respectively. Connectors 3512 and 3113 may include connectors configured to be operably (e.g., locking and fluid) connected to each other. Connectors 3512 and 3113 may be configured to form a locking and / or otherwise secure connection by rotation of at least a portion of connector 3512 relative to connector 3113, such as by rotation less than 360° (e.g., less than 180°). Connectors 3512 and 3113 may be configured to provide tactile and / or audible (e.g., ticking) feedback to the operator to confirm that a proper connection has been made (e.g., sufficient rotation and / or engagement has been achieved). In some embodiments, connector 3512 may be integrated into syringe 3110. The syringe 3110 can be rotatably fixed relative to the console 100, allowing the operator of the system 10 to attach the connector 3512 to the connector 3113 by twisting the connector 3512 relative to the syringe 3110, for example, in one-handed operation (e.g., due to the integrated structure of the connector 3512 to the syringe 3110). In some embodiments, connectors 3512 and 3113 include rotatably lockable fluid connectors, such as the rotatably lockable fluid connectors described herein.

[0187] In some embodiments, two conduits 3510 extend from housing 3501 and terminate at connectors 3516a and 3516b, as shown. Connectors 3516a and 3516b are each configured to be operatively attached to connector 3214 fluidly attached to a first port 3211 and connector 3215 fluidly attached to a second port 3212 of heater assembly 3200, respectively. Connectors 3516a, 3516b and 3214 and 3215 may include connectors configured to be operatively connected to each other. Connectors 3516a, 3516b and 3214 and 3215 may be similar to other connectors 3010 described herein. In some embodiments, connectors 3214 and / or 3215 may be integrated into a wall of console 100 (e.g., into a wall of the housing of console 100). At least a portion of connectors 3214 and / or 3215 can be rotated and fixed relative to console 100, such that the operator of system 10 can attach connectors 3516a, 3516b to connectors 3214 or 3215 respectively by twisting at least a portion of connectors 3516a, 3516b relative to connectors 3214 or 3215, for example, in one-handed operation.

[0188] In some embodiments, two conduits 3510 extend from housing 3501 and terminate at connectors 3514a and 3514b, as shown. Connectors 3514a and 3514b are each configured to be operatively attached to connectors 620a and 620b, respectively, attached to the proximal end of umbilical 600. In some embodiments, connector 620a is fluidly attached to an inflow lumen of umbilical 600—lumen 605, and connector 620b is fluidly attached to an outflow lumen of umbilical 600—lumen 606. In some embodiments, lumens 605 and lumens 606 are defined by a shaft having two conduits arranged side-by-side, such as a shaft formed by a single extrusion. In some embodiments, the functional length of the conduit 3510 between connector 3514a and connector 3516a (e.g., the conduit 3510 connecting the first port 3211 of heater assembly 3200 and the input lumen 605 of umbilical tube 600) includes lengths less than 10”, such as less than 8”, such as about 6”.

[0189] In some embodiments, console 100 also includes an injection assembly 3600, which may include one or more fluid delivery assemblies configured to supply one or more injection solutions (e.g., injection solution 125 described herein) to tissue via catheter 200. The injection assembly 3600 may be similar to or dissimilar to one or more components described herein, such as injection solution supply 120. In some embodiments, the injection assembly 3600 is configured as referenced herein. Figure 3 The injection assembly 3600 may include one, two, three, or more syringes fluidly attached to one, two, three, or more injection delivery elements (such as the injection delivery element 520 described herein).

[0190] In some implementations, console 100 includes controller 1500. Controller 1500 may be similar to that described herein. Figure 1 The controller 1500 is described above. The console 100 may also include an electrical and / or mechanical connector—connector 1510. Connector 1510 may be electrically and / or mechanically connected to a mating connector—connector 3530—of the cartridge 3500. The cartridge 3500 may also include an electronic module 3535 operatively connected to connector 3530. The cartridge 3500 may include a functional element 3599. Functional element 3599 may include elements selected from: pressure sensors; temperature sensors; flow sensors; optical sensors; transducers; ID providing elements such as RFID; accelerometers; and combinations thereof. In some embodiments, functional element 3599 is operatively attached to electronic module 3535, which may be operatively attached to controller 1500 via connectors 3530 and 1510.

[0191] In some embodiments, system 10 is configured to perform sterilization operations on at least a portion of console 100, cartridge 3500, umbilical cord 600, and / or conduit 200. For example, console 100 may include one or more fluid contact components, such as one or more fluid channels and / or functional elements (e.g., sensors or heaters), that will be sterilized prior to each treatment procedure. The ability to position high-precision, expensive components (e.g., sensors) close to (e.g., internally and / or nearby) re-sterilizable fluid channels within console 100 allows for monitoring of the fluid characteristics within these channels at a level of precision difficult to achieve using removable interfaces (e.g., between disposable components and sensors in console 100), while avoiding the cost of including these components in disposable portions of system 10 (e.g., cartridge 3500). Furthermore, the ability to sterilize (or, for example, sterilize after a procedure) the fluid contact portions of high-precision, expensive functional elements of console 100 can reduce the cost of including these components in disposable portions of system 10 (e.g., cartridge 3500). The ability to sterilize or re-sterilize reconfigurable components of system 10 also helps reduce the cost of continuing to operate system 10. System 10 can be configured to be in an operational state during which fluid is heated to a temperature of at least 85°C, such as at least 95°C, and the fluid circulates in the portion of console 100 (or other components of system 10) that requires sterilization. In some embodiments, the fluid passages to be sterilized by system 10 do not include any "blind segment" length greater than 1 inch, such as no more than 0.5 inches (e.g., for 1 / 16-inch ID silicone tubing). Alternatively or additionally, any blind segment length of the fluid passage to be sterilized may include a conductive material such that the fluid passage included in the blind segment length is adequately heated by the sterilization process to ensure sterilization of the blind segment. In some implementations, the sterilization procedure may be similar to that described in co-pending international PCT patent application number PCT / US2020 / 056627, filed on October 21, 2020, entitled “Systems, Devices, and Methods for Performing Medical Procedures in the Intestine,” the contents of which are incorporated herein by reference in their entirety for all purposes.

[0192] In some embodiments, system 10 is configured to perform low-level sterilization on at least a portion of console 100, cartridge 3500, umbilical cord 600, and / or catheter 200 (e.g., reusable components of these). Alternatively or additionally, system 10 may be configured to perform high-level sterilization on one or more of these components. In some embodiments, system 10 is configured to heat at least a portion of these components to at least 90°C, such as at least 93°C, at least 95°C, at least 97°C, or at least 101°C, for a minimum duration such as at least 45 seconds, at least 60 seconds, and / or at least 90 seconds, and / or a maximum duration such as no more than 3 minutes, no more than 4 minutes, and / or no more than 5 minutes.

[0193] In some implementations, one or more (e.g., all or at least most) fluid connections of the system 10 described herein are completed prior to use in a clinical setting (e.g., at least most of the fluid connections of the system 10 are completed during the manufacturing process), such that the operator of the system 10 is required to complete a minimum number of fluid connections (e.g., none) such as fewer than 5 fluid connections, fewer than 3 fluid connections, or fewer than one fluid connection prior to use.

[0194] In some embodiments, system 10 includes one or more microcontrollers configured to control various assemblies of the system. In some embodiments, each assembly of system 10 includes a unique microcontroller, such as a microcontroller configured to control a specific function of that assembly. In some embodiments, one or more microcontrollers of system 10 act as servers, and one or more other microcontrollers of system 10 each act as clients. In some embodiments, the server microcontroller monitors the client microcontrollers to detect any problems with the client microcontrollers, thereby detecting the problem and putting system 10 into a safe mode (e.g., a state where operation is maintained but some functions are limited) and / or other alarm states. Alternatively or additionally, the client microcontrollers may be configured to monitor the server microcontrollers and, if a fault is detected in the server microcontrollers, enter a safe mode and / or other alarm states. Each of the syringe assembly 3100, valve assembly 3520, heater assembly 3200, and / or other assemblies of system 10 may include a unique microcontroller (e.g., configured to monitor another microcontroller and / or monitored by one or more microcontrollers).

[0195] In some embodiments, system 10 includes one or more hardware-based (e.g., electromechanical) safety mechanisms for preventing fluid pressure from exceeding a safety threshold. For example, console 100 may include a load cell operatively attached to syringe assembly 3100, wherein the load cell is configured to disconnect power to syringe assembly 3100 if a pressure threshold is reached (e.g., the force on the load cell exceeds a force threshold associated with a desired pressure threshold). Alternatively or additionally, console 100 may include an overpressure prevention mechanism selected from: an overpressure valve; an absolute nut on a linear drive mechanism; a clutch on a linear drive mechanism; a current limiter; and combinations thereof.

[0196] In some embodiments, one or more assemblies of console 100 are provided to the user as multiples of the same assembly (e.g., two or more assemblies 3100 and / or 3200 are provided to the user). In these embodiments, console 100 may be configured such that the user can replace a first-provided assembly (e.g., provided at the time of console 100 delivery) with a second-provided assembly (e.g., provided as an additional assembly at or after the delivery of console 100). Replacement may be performed to replace a damaged first assembly, and / or to provide an upgrade to console 100 via the installation of a second assembly. One or more replaceable assemblies (e.g., assemblies 3100 and / or 3200) may be operably attached to console 100 using hooks, latches, and / or locks. In some embodiments, one or more sensors of console 100 may be configured to confirm the acceptability of the replacement in order to confirm the acceptability of the software and / or hardware associated with the replacement, and / or to confirm the proper attachment of the new assembly. If an unacceptable replacement is completed (e.g., detected by a sensor), system 10 (e.g., console 100) can enter an alarm state.

[0197] In some implementations, system 10 is configured to operate at a pressure equal to or higher than the boiling point of the fluid 3001, based on the height of the execution program.

[0198] Now for reference Figure 3 The illustration shows a schematic diagram of another tissue processing system in accordance with the concept of the present invention, which includes an elongated device and a console having a cartridge, a syringe pump assembly and a fluid reservoir that can be attached thereto. Figure 3 The construction and arrangement of the control console 100, catheter 200, and / or other components of system 10 may be similar to those described with reference to the other accompanying drawings. The schematic diagrams shown illustrate the fluid connection between the catheter 200, control console 100, and cartridge 3500.

[0199] The catheter 200 may include one, two, or more tissue capture chambers, such as the three tissue capture chambers 510a-510c shown, each tissue capture chamber 510a-510c being fluidly attached to connector 321. In some embodiments, each tissue capture chamber 510a-510c is connected to a unique connector 321, such that each tissue capture chamber 510a-510c can be independently fluidly attached to a vacuum source (e.g., when each unique connector 321 is fluidly attached to a vacuum source). Alternatively, as described herein, each tissue capture chamber 510a-510c is connected to the same connector 321, such that when connector 321 is fluidly attached to a vacuum source, a vacuum is applied to each tissue capture chamber 510a-510c. In some embodiments, the catheter 200 includes one, two, or more ports, such as port 470 shown. P and 470 D (For example, ports located proximal and distal to the expandable element 530, respectively). In some embodiments, each port 470 P 470 D Connected to a single connector 322, making each port 470 P 470 D It can be independently fluid-attached to a vacuum source. Alternatively, as described herein, each port is 470°. P 470 D It can be connected to the same connector 322 such that when connector 322 is fluidly attached to a vacuum source (e.g., a suction can), a vacuum is applied to each port 470. P 470 D .

[0200] Cartridge 3500 may include connectors, conduits, and / or valves fluidly connected to connectors 321 and 322 to vacuum assembly 110. Cartridge 3500 may include connectors 3517 and 3518 fluidly connected to connectors 321 and 322 of conduit 200, respectively. Cartridge 3500 may include connector 3519 fluidly connected to connector 112 of vacuum assembly 110. For controlling port 470... P and 470 D A valve that applies vacuum pressure—valve V A It can be internally positioned between connectors 3518 and 3519. Valve V is used to control the vacuum pressure applied to the tissue capture chambers 510a-510c. S It can be internally positioned between connectors 3517 and 3519. Valve V is used to control the venting of tissue capture chambers 510a-510c to atmospheric pressure (e.g., chamber pressure). vIt can be positioned between connector 3517 and a vent that is open to external environmental pressures such as atmospheric pressure in an operating room. In some embodiments, console 100 includes a positive pressure source (not shown), but is operatively connected to a port of conduit 200 (e.g., port 470). P and / or 470 D This allows for the execution of an inflation procedure. Alternatively or additionally, the endoscope can be used in conjunction with the catheter 200 during the procedure, and the endoscope can be used to access the dilatational element 530 to perform inflation and / or aspiration.

[0201] The conduit 200 may include one, two, or more injection delivery elements, such as the three injection delivery elements 520a-520c shown, each of which is fluidly attached to connectors 327a-327c. In some embodiments, each injection delivery element 520a-520c is fluidly attached to a corresponding connector 327a-327c via a conduit including a one-way valve (e.g., a one-way check valve), the conduit being configured to allow fluid to flow from connectors 327a-327c to injection delivery elements 520a-520c in a single direction. Each connector 327a-327c may additionally be fluidly connected to a fourth connector—connector 326. In some embodiments, each connector 327a-327c is fluidly attached to connector 326 via a conduit including a one-way valve (e.g., a one-way check valve), the conduit being configured to allow fluid to flow from connector 326 to connectors 327a-327c in a single direction. System 10 may include one, two, or more injectors, such as the three injectors 3610a-3610c shown. Each injector 3610 may be fluidly connected to connectors 327a-327c, respectively. In some embodiments, each injector 3610 includes an integrated connector, such as a rotatable locking connector, operatively connected to a mating rotatable locking connector, for example when connectors 327a-327c include rotatable locking fluid connectors such as those described herein. System 10 may also include an injectable supply 120, which may be fluidly connected to connector 326 via mating connector 3621. Figure 3As shown, a one-way valve positioned between injection delivery elements 520a-520c, connectors 327a-327c, and connector 326 is configured such that syringes 3610a-3610c can both draw injection fluid 125 from injection supply 120 (e.g., fill the syringe when the plunger is retracted) and deliver injection fluid 125 to injection delivery element 520 (e.g., when the plunger is advanced) without altering the fluid connections between these elements. Alternatively or additionally, syringes 3610a-3610c can be pre-filled with injection fluid 125, and / or syringes 3610a-3610c can be filled and / or refilled with injection fluid 125 by automatically and / or manually altering the fluid passage connections of injection assembly 3600.

[0202] The conduit 200 may include an expandable element 530 fluidly attached to a first lumen—an inflow lumen 265—and a second lumen—an outflow lumen 266. Lumens 265 and 266 extend from the expandable element 530 proximal to the shaft of the conduit 200 and to a handle of the conduit 200, respectively, and terminate at connectors 330a and 330b. Connectors 330a and 330b are fluidly connected to connectors 630a and 630b of the umbilical tube 600, respectively. The umbilical tube 600 may include two lumens—an inflow lumen 605 and an outflow lumen 606—each extending between connectors 630a and 620a and between connectors 630b and 620b, respectively.

[0203] The cartridge 3500 may include connectors 3512a, 3512b, 3513a, 3513b, 3514a, 3514b, and 3516a, 3516b. These connectors may be similar to those described herein with reference to other accompanying drawings, such as those in this document. Figure 2As described herein. These connectors can be fluidly interconnected via a network of pipes and valves illustrated and described herein. Connectors 3513a and 3513b are respectively connected to connectors 3313a and 3313b that fluidly attach the conduit of cartridge 3500 to reservoirs 3310a and 3310b. In some embodiments, reservoirs 3310a and / or 3310b include vents to allow pressure within the reservoir to equal the room pressure when fluid is added to and / or removed from the reservoir. Connectors 3512a and 3512b are respectively connected to connectors 3113a and 3113b that fluidly attach the conduit of cartridge 3500 to syringes 3110a and 3110b. Connectors 3514a and 3514b are respectively connected to connectors 620a and 620b that fluidly attach the conduit of cartridge 3500 to umbilical cord 600 and then to expandable element 530. Connectors 3516a and 3516b are respectively connected to connectors 3214 and 3215 of the heater assembly 3200, which fluidly attaches the piping network of cartridge 3500 to the control console 100. As shown and described herein, valves V1-V5 can be internally positioned within the piping network of cartridge 3500.

[0204] In some embodiments, cartridge 3500 does not include a temperature sensor. Control console 100 may include one or more temperature sensors, such as sensors T-1, T-2, T-3, and T-4, which are shown and located near heater assembly 3200. In some embodiments, sensor T-1 is located at a first port of heater assembly 3200, while T-2 is located at a second port of heater assembly 3200 (e.g., Figure 2 (Ports 3211 and 3212 shown). Sensors T-1 and T-2 may be configured to record the temperature of fluid entering and / or exiting the respective ports of the heater assembly 3200. In some embodiments, sensors T-3 and / or T-4 are positioned on the heater assembly 3200 to monitor the temperature of a portion of the heater assembly 3200 and / or the fluid flowing through the assembly 3200. In some embodiments, two or more of sensors T-1 to T-4 may be positioned such that system 10 can analyze the recorded values ​​of the sensors to confirm the functionality of one or more of sensors T-1 to T-4. In some embodiments, cartridge 3500 includes one or more pressure sensors, such as the sensor PS shown. V and PS O PS sensor V It can be located close to connector 3519 and the vacuum level at that location can be monitored. (Sensor PS) V System 10 can be used to verify that the vacuum source 110 is properly connected and operated before and / or during the procedure. Sensor PS OThe fluid exiting the cartridge 3500 as it flows toward the expandable element 530 can be located accessible to connector 3514a and its pressure can be monitored. In some embodiments, cartridge 3500 does not include a pressure sensor. In some embodiments, console 100 includes a pressure sensor configured to fluidly attach (e.g., via a connection not shown) to a conduit of cartridge 3500, such as a conduit near and fluidly connected to connector 3519. In some embodiments, console 100 includes a pressure sensor near connector 3214 configured to monitor the pressure of fluid exiting the heating assembly 3200 as it flows toward the expandable element 530.

[0205] Now for reference Figure 4 The illustration shows a perspective cross-sectional view of a portion of a cartridge case conforming to the inventive concept. The cartridge case 3500 may include one or more integrated connectors 3010. I As described herein. In some embodiments, one or more connectors 3010 I At least a portion is fixedly attached to the wall of the housing 3501 of the cartridge 3500. For each integrated connector 3010 I The housing 3501 may include an opening—a hole 3502. The hole 3502 may include radial protrusions—edges 3503. Connector 3010 I The device includes a connecting element 3015, which includes a protrusion 3016 (such as a barbed protrusion) at a first end and a connecting element 3017 (such as a locking connecting element) at an opposite end. The connecting element 3015 may include a protruding element—a flange 3018—extending radially between the protrusion 3016 and the connecting element 3017. In some embodiments, the connecting element 3017 may include a rotatable locking fluid connector as described herein. The connecting element 3015 may include a lumen extending between the protrusion 3016 and the connecting element 3017 to provide a fluid conduit through the connecting element 3015.

[0206] In some embodiments, as shown, connector 3010 is assembled by inserting connecting element 3015 through hole 3502. I (For example, during manufacturing). The conduit 3510 is slidably received on the protrusion 3016 such that the housing 3501 (e.g., a portion of the edge 3503) is engaged between the end of the conduit 3510 and the flange 3018, thereby securing the connecting element 3015 within the bore 3502. In some embodiments, the connecting element 3015 is secured within the bore 3502 via friction engagement without the use of glue or other adhesive elements.

[0207] Now for reference Figures 5A-5CThe figures show two side views and an enlarged side view of a syringe pump assembly conforming to the concept of the present invention. Figure 5B The diagram shows the image after being rotated 90°. Figure 5A Syringe 3110. Figure 5C An enlarged view of the tip of syringe 3110 is illustrated. As described herein, syringe pump assembly 3100 may include syringe 3110, with a first connector 3113 at the tip of syringe 3110 and a second connector 3123 at the bottom of syringe 3110. Connector 3123 may include one or more connecting elements—flanges 3124a and 3124b as shown. Flanges 3124a and 3124b may be configured to releasably attach to mating portions of connector assembly 3120, such as connector 3122 of console 100, which is not shown herein but is described. For example, syringe 3110 may be configured to rotate (e.g., by an operator of system 10) to lockably engage with connector 3122. In some embodiments, connector assembly 3120 is configured to provide user feedback, such as haptic feedback or audible feedback such as a click, upon completion of proper connection. Figure 5C As shown, connector 3113 may include a locking feature—protrusion 3114. Protrusion 3114 may be configured to lockably engage with a mating connector (e.g., a rotatable locking connector similar to that described herein). In some embodiments, system 10 is configured to detect when syringe 3110 has been properly attached to console 100 (e.g., via one or more sensors of console 100). Alternatively or additionally, system 10 may be configured to detect whether syringe 3110 has been improperly and / or incompletely attached to console 100, and system 10 may be configured to enter an alarm mode, such as warning the system operator, if incorrect attachment is detected.

[0208] Now for reference Figure 6 The illustration shows a schematic diagram of the fluid channels of a tissue processing system conforming to the concept of this invention. (Reference) Figure 6 The valves, syringes, reservoirs, heaters, lumens, sensors, and other components described herein are also referenced. Figure 1 Describe it in conjunction with Figure C. Figure 6 The illustration shows syringe pump assemblies 3100a and 3100b, heater assembly 3200, reservoir assemblies 3300a and 3300b, and vacuum source 110, each of which is fluidly interconnected via one or more conduits 3510. The conduits 3510 are fluidly connected to expandable element 530 via inlet and outlet lumens of umbilical tube 600. In some embodiments, one or more connectors fluidly attach various conduits of system 10, with the various conduits of system 10 sequentially fluidly attached. Figure 6 The associated components. For clarity, these connectors are not in Figure 6 As shown in the document, but referenced in this article Figure 2 Detailed description.

[0209] The illustration shows five valve assemblies 3520, each configured to manipulate the flow of fluid 3001 through conduit 3510. Figure 6 In this embodiment, conduit 3510 includes four fittings, fittings 3511a-3511d shown, each fitting 3511 fluidly connected to three or more components illustrated. A first valve—valve V1—is positioned to control the flow of fluid 3001 between reservoir assembly 3300a and fitting 3511a. Syringe pump assembly 3100a is also fluidly connected to fitting 3511a. A second valve—valve V2—is positioned to control the flow of fluid 3001 between fittings 3511a and 3511b. The inlet conduit of umbilical 600 is fluidly connected to fitting 3511b, such that fitting 3511b is fluidly connected to expandable element 530. A third valve—valve V3—is positioned to control the flow of fluid 3001 between fittings 3511b and 3511c. Syringe pump assembly 3100b is fluidly connected to fitting 3511c via heater assembly 3200. The fourth valve—valve V4—is positioned to control the flow of fluid 3001 between connectors 3511c and 3511d. The outflow conduit of umbilical 600 is fluidly connected to connector 3511d, such that connector 3511d is fluidly connected to expandable element 530. The fifth valve—valve V5—is positioned to control the flow of fluid 3001 between connector 3511d and syringe pump assembly 3300b. The sixth valve—valve V... EVAC The fluid 3001 is positioned to control the flow between the control connector 3511d and the vacuum source 110.

[0210] In some implementations, valve V EVAC It is normally open (e.g., in the open state when no power is applied). The console 100 can be configured to remain open during normal operation of the system 10, as described in this document's references. Figures 6A-6F During the aforementioned state, to valve V EVAC Provides power. In some implementations, the control panel 100 opens valve V in an alarm state. EVAC This allows the vacuum source 110 to be fluidly attached to the conduit 3510 and fluid to be drawn from within the conduit 3510 and / or from other fluid connection assemblies of the system 10. For example, in the event of a power outage during a processing step (e.g., the step in which the expandable element 530 is fluidly attached to the conduit 3510), the normally open valve V... EVAC In the event of a power outage, the expandable element 530 will be fluidly connected to the vacuum source 110, allowing the vacuum source 110 to extract fluid 3001 from the expandable element 530. In some embodiments, no fluid is attached to the conduit 3510 to the vacuum source 110 (e.g., via valve V).EVAC (See references in this article) Figure 6D In some embodiments, one or more valves 3520 may include a "last-failure" valve (e.g., a valve configured to remain in its current state in the event of a power failure). In some embodiments, certain valves 3520 include normally open valves, normally closed valves, and / or last-failure valves, such that, in any state of console 100, any ablation fluid near the patient is automatically extracted in the event of a power failure. In some embodiments, console 100 may be configured to adjust the state of one or more valves 3250 based on the state of console 100 in the event of a power outage (e.g., using a backup power supply integrated with console 100, not shown).

[0211] Now for reference Figures 6A-6F The diagram illustrates various operational states of the system 10, which conforms to the inventive concept. The console 100 can be configured to circulate fluid 3001 through the expandable element 530 of the conduit 200 to implement various steps of a tissue processing procedure, as described herein. References herein... Figures 6A-6F In the described operating mode, catheter 200 is routed via, for example, via the reference herein. Figure 2 The umbilical tube 600, such as the connection, is operatively attached (e.g., at least fluidly attached) to the console 100.

[0212] For details, please refer to the following: Figure 6A The illustration shows the operating state of system 10 in accordance with the inventive concept and associated with a first operating mode—mode F1. In mode F1, the plunger of syringe pump assembly 3100a is retracted, and valve V1 is opened, allowing fluid from reservoir 3300a to be drawn into syringe pump assembly 3100a. Valve V2 is closed, thereby fluidly isolating syringe pump assembly 3100a from connector 3511b.

[0213] For details, please refer to the following: Figure 6B The illustration shows the operating state of system 10 in accordance with the inventive concept and associated with a second operating mode—mode P1. In mode P1, valve V1 is closed, isolating reservoir 3300 from connector 3511a, and valve V2 is opened, allowing fluid communication between syringe pump assembly 3100a and expandable element 530 (via the inflow lumen of umbilical tube 600). Furthermore, valves V3, V4, V5, and V... EVAC Both are closed. The plunger of syringe pump assembly 3100a is advanced, forcing fluid 3001 to be drawn into syringe pump assembly 3100a in mode F1, so as to flow through the inflow lumen of umbilical tube 600 to expandable element 530. Expandable element 530 is configured to expand from a first compressed state to a second expanded state as fluid 3001 fills the expandable element.

[0214] For details, please refer to the following: Figure 6C The diagram illustrates the operational state of system 10 in accordance with the inventive concept and associated with a third operating mode—mode P2. In mode P2, fluid 3001 continues to flow from syringe pump assembly 3100a to expandable element 530. Valve V4 is opened, allowing syringe pump assembly 3100b to be in fluid communication with expandable element 530 via heater assembly 3200. If fluid 3001 is delivered to expandable element 530 via syringe pump assembly 3100a, the plunger of syringe pump assembly 3100b is retracted, thereby withdrawing fluid 3001 from expandable element 530. As fluid 3001 passes through heater assembly 3200 and enters syringe pump assembly 3100b, heater assembly 3200 activates, heating fluid 3001 to a first temperature, causing syringe pump assembly 3100b to fill with heated fluid 3001W. As fluid 3001 circulates through expandable element 530, it provides a cooling effect to tissue approaching expandable element 530. As described herein, the cooling effect of circulating fluid 3001 can pre-treat tissue prior to the thermal ablation step, thereby improving the outcome of the ablation procedure.

[0215] In an alternative embodiment, with the expandable element 530 filled with a dose of fluid 3001 (e.g., filled to a set pressure and / or a set volume), additional fluid 3001 is drawn from the syringe pump assembly 3100a, passes through the heater assembly 3200, and enters the syringe pump assembly 3100b (as described above), without passing through the expandable element 530. In this embodiment, the dose of fluid 3001 within the expandable element 530 provides a cooling effect to the tissue prior to the thermal ablation described herein.

[0216] For details, please refer to the following: Figure 6DThe illustration depicts the operational state of system 10 in accordance with the inventive concept and associated with a fourth operating mode—mode T1. In mode T1, valves V3 and V5 are opened, allowing the syringe pump assembly 3100b to be fluidly connected to the reservoir 3300b via the heater assembly 3200 and the expandable element 530. Valve V2 is closed, isolating connector 3511b from connector 3511a, and valve V4 is closed, allowing connector 3511c to be fluidly connected to connector 3511d only via the expandable element 530. The plunger of the syringe pump assembly 3100b is advanced, forcing fluid 3001W to flow through the heater assembly 3200. The heater assembly 3200 operates, heating the warm fluid 3001W to its ablation temperature (e.g., an elevated ablation temperature, such as at least 37°C, at least 78°C, at approximately 98°C, at least 100°C, or at least 120°C). The ablation fluid—thermal fluid 3001H—leaving the heater assembly 3200 flows through the inlet lumen of the umbilicus 600, the expandable element 530, and the outlet lumen of the umbilicus 600, and enters the reservoir 3300b.

[0217] In an alternative embodiment, syringe pump assembly 3100b may include a heating element configured to heat fluid within syringe pump assembly 3100b. Fluid 3001 may be drawn into syringe pump assembly 3100b, heated to an ablation temperature, and then forced through expandable element 530, with or without first passing through heater assembly (e.g., heater assembly 3200).

[0218] As described in this article, if system 10 enters an alarm state, valve V... EVAC It can be configured to open automatically, causing the vacuum source 110 to fluidly attach to the expandable element 530. In this state, the vacuum source 110 extracts fluid 3001H from the expandable element 530 to protect the patient from accidental burns caused by fluid 3001H remaining in the expandable element 530 (e.g., during a power failure). Alternatively or additionally, in some embodiments, the reservoir 3300b is positioned below the expandable element 530 (e.g., closer to the ground) such that, in an alarm state (e.g., a power outage), gravity can siphon fluid 3001H from the expandable element 530. In these embodiments, valve V5 may include a normally open valve to maintain a fluid path between the expandable element 530 and the reservoir 3300b in the event of a power failure. In some embodiments, one or more valves between the reservoir 3300a, the expandable element 530, and the reservoir 3300b are normally open (e.g., valves V1, V2, and V5), while other system valves (e.g., valves V3, V4, and V5) are normally open. EVACThe siphon tube is normally closed, allowing fluid 3001 to be drawn from reservoir 3300a and through expandable element 530, thereby displacing fluid 3001H. In some embodiments, one or more valves between reservoir 3300a, expandable element 530, and vacuum assembly 110 are normally open (e.g., valves V1, V2, and V3). EVAC In the event of a power failure, the vacuum assembly 110 pulls fluid 3001 from the reservoir 3300a and through the expandable element 530, thereby displacing fluid 3001H.

[0219] For details, please refer to the following: Figure 6E The illustration shows the operating state of system 10 associated with a fifth operating mode—mode C1—in accordance with the concept of this invention. In mode C1, valves V1, V3, V4, and V... EVAC Valves V2 and V5 are opened, allowing the syringe pump assembly 3100a to be fluidly connected to the reservoir 3300b via the expandable element 530. The plunger of the syringe pump assembly 3100a is advanced, forcing fluid 3001 through the expandable element 530 to the reservoir 3300b.

[0220] For details, please refer to the following: Figure 6F The illustration shows the operating state of system 10 associated with a sixth operating mode—mode D1—in accordance with the concept of the present invention. In mode D1, valves V1, V3, V4, V5, and V6 are closed. EVAC Open valve V2 to provide fluid communication between syringe pump assembly 3100a and expandable element 530. Retract the plunger of syringe pump assembly 3100a to draw fluid 3001 remaining in expandable element 530 into syringe pump assembly 3100a. Connector 3511d is isolated from syringe pump assembly 3100a (via expandable element 530) so that syringe pump assembly 3100a can apply negative pressure to expandable element 530, thereby causing expandable element 530 to change to its compressed state.

[0221] Now for reference Figure 6G The diagram illustrates a flowchart of a method for treating tissue in accordance with the inventive concept—method 2300. As described herein, method 2300 is described using components of system 10. In step 2310, preparation for ablation treatment is performed. In some embodiments, as referenced herein... Figure 1BThe procedure described above involves steps similar to steps 2210 to 2230 of method 2200. In some embodiments, catheter 200 is introduced into the patient's small intestine so that the expandable element 530 is close to the site to be thermally ablated, and at least one submucosal dilation procedure is performed. In some embodiments, such as when the expandable element 530 is properly positioned relative to the target tissue to be treated, method 2300 does not continue after step 2310 until positive operator confirmation is received (e.g., via operator input to system 10).

[0222] In step 2320, as described herein, console 100 is configured as follows: Figure 6A As shown. In step 2320, valve V1 is opened and the plunger of syringe pump assembly 3100a is retracted to draw a first volume—volume VOL1—of fluid 3001 from reservoir assembly 3300a and into syringe pump assembly 3100a. In some embodiments, fluid 3001 is drawn into syringe pump assembly 3100a at a rate of at least 4 ml / s, such as at least 6 ml / s, such as at least 8 ml / s. In some embodiments, at least 10 ml, such as at least 50 ml, such as at least 70 ml, such as at least 90 ml, such as at least 200 ml, is drawn into syringe pump assembly 3100a. In some embodiments, fluid 3001 comprises a room temperature fluid, for example, a fluid with a temperature of approximately 20°C. In some embodiments, fluid 3001 comprises a fluid with a temperature below body temperature. In some embodiments, the performance of system 10 is independent of the temperature of fluid 3001. Additionally or alternatively, the temperature of fluid 3001 may be uncontrolled (e.g., not controlled by system 10, such as being allowed to use room temperature fluid), and one or more parameters of the processing described herein are determined based on the measured (but uncontrolled) temperature of fluid 3001. In some embodiments, fluid 3001 is cooled by system 10, such as by cooling the fluid within reservoir assembly 3300a, cooling the fluid within syringe pump assembly 3100a, and / or by cooling the fluid as it passes through a freezer assembly (not shown but, for example, inlined between reservoir assembly 3300a and syringe pump assembly 3100a).

[0223] In step 2330, as described herein, console 100 is configured as follows: Figure 6BAs illustrated. Following step 2320, in step 2330, valve V1 is closed and valve V2 is opened. The plunger of syringe pump assembly 3100a is driven forward, driving a first portion—part P1—of a first volume VOL1 of fluid 3001 from syringe pump assembly 3100a to expandable element 530. As fluid 3001 is delivered from syringe pump assembly 3100a, expandable element 530 expands radially. In some embodiments, fluid 3001 is driven into expandable element 530 at a rate of at least 2 ml / s, such as at least 3 ml / s, such as 3.75 ml / s.

[0224] In step 2340, as described herein, console 100 is configured as follows: Figure 6CAs illustrated. Following step 2330, in step 2340, valve V4 is opened and the plunger of syringe pump assembly 3100b is retracted to draw a second volume—volume VOL2—of fluid 3001 from expandable element 530 into syringe pump assembly 3100b. The second volume VOL2 comprises at least some of a portion P1 of the first volume VOL1 and a second portion, portion P2, of the first volume VOL1 driven from syringe pump assembly 3100a during step 2340. This reuse of one or more portions of volume VOL1 and / or other reuse of fluid previously circulated through expandable element 530 results in a reduction of the total fluid 3001 required to perform the ablation procedure described herein. Fluid 3001 drawn from expandable element 530 into syringe pump assembly 3100b passes through heater assembly 3200. The heater assembly 3200 is configured to a first level (e.g., a first level power) and heats the fluid 3001 as it passes through, such that warm fluid 3001W is drawn into the syringe pump assembly 3100b (e.g., the second volume VOL2 includes fluid 3001 that has been heated to warm fluid 3001W). In some embodiments, the console 100 operates at peak power (e.g., the maximum power of the console 100 will be drawn from a power source, such as a standard wall outlet), while the first level power is delivered to the heater assembly 3200. By ensuring peak power consumption during step 2340, it can be assumed that power consumption of the console 100 during subsequent steps of method 2300 will not cause any fuses or other circuit breakers (e.g., circuit breakers in hospitals or other clinical settings) that did not trip during step 2340, thereby minimizing the possibility of circuit breaker tripping during steps where the hot fluid is positioned close to the patient (e.g., step 2350 as described herein). In some embodiments, the warm fluid 3001W is heated to a temperature of at least 40°C, such as at least 50°C, such as at least 75°C, such as at least 100°C. Additionally or alternatively, the warm fluid 3001W is heated to a temperature of at least 10°C, such as at least 50°C, such as at least 90°C higher than the temperature of the fluid 3001. In some embodiments, the plunger of the syringe pump assembly 3100b retracts at the same rate as the plunger of the syringe pump assembly 3100a is advanced (e.g., when syringe pump assemblies 3100a and 3100b comprise similar diameters), such that the fluid 3001W is drawn into the syringe pump assembly 3100b at the same rate that the fluid driven from the syringe pump assembly 3100a is drawn in.

[0225] In some embodiments, in step 2340, console 100 is configured to monitor one or more parameters of system 10 (e.g., the pressure of fluid 3001 recorded by a pressure sensor of console 100 or cartridge 3500) to determine the mechanical and / or clinical integrity of catheter 200. For example, if the pressure of fluid 3001 falls below a expected threshold, console 100 may enter an alarm state during which no further steps are performed and the operator is informed that expandable element 530 may be damaged (e.g., ruptured). In some embodiments, console 100 is configured to identify leaks and / or fluid blockages based on the monitored parameters. In some embodiments, console 100 continues to monitor these parameters during the subsequent steps described herein. In some embodiments, the criteria (e.g., one or more thresholds or other limits) used for leak or blockage detection may be adjusted based on the temperature of the fluid circulating through catheter 200. For example, the pressure threshold used to detect blockage (e.g., a threshold indicating that a blockage exceeds this threshold) may include a relatively low threshold when a colder fluid is circulating, in contrast to a relatively high threshold when a warmer fluid is circulating. In some implementations, the standard is adjusted based on the temperature of the fluid 3001 within the reservoir 3310a.

[0226] In some implementations, prior to step 2350, console 100 is configured to ensure that syringe 3110a holds a sufficient volume of fluid 3001 to perform step 2360 (e.g., to cool and ablate tissue). If it is determined that there is not a sufficient volume of fluid 3001 in syringe 3110a, console 100 may enter an alarm state and, for example, prevent hot fluid 3001H from being delivered to expandable element 530.

[0227] In step 2350, as described herein, console 100 is configured as follows: Figure 6DAs illustrated. After step 2340, in step 2350, valves V2 and V4 are closed, and valves V3 and V5 are opened. The plunger of syringe pump assembly 3100a is stopped, and the plunger of syringe pump assembly 3100b is driven forward, thereby driving a second volume VOL2 of fluid (e.g., warm fluid 3001W) from syringe pump assembly 3100b through heater assembly 3200. In some embodiments, all of the second volume VOL2 has previously been circulated through expandable element 530 (e.g., in steps 2330 and / or 2340). Alternatively, in some embodiments, at least a portion of the second volume VOL2 has previously been circulated through expandable element 530 (e.g., in step 2330). In some embodiments, fluid 3001W is driven from syringe pump assembly 3100b at a rate of at least 8 ml / s, such as at least 10 ml / s, such as 10.5 ml / s. In some embodiments, fluid 3001W is driven from syringe pump assembly 3100b at a rate at least twice the rate at which fluid 3001W is drawn into syringe pump assembly 3100b in step 2340. Heater assembly 3200 is powered to a second level and heats the warm fluid 3001W as it passes through, causing hot fluid 3001H to exit heater assembly 3200 and continue to expandable element 530. In some embodiments, the second level is smaller than the first level in step 2340 (e.g., the heater assembly consumes less power when powered to the second level than when powered to the first level). In some embodiments, the second level is at least 25% smaller than the first level, such as at least 50% smaller. Alternatively, the second level may be larger than the first level, such as at least 25% larger. From expandable element 530, hot fluid 3001H flows freely through valve V5 and into reservoir assembly 3300b. In some embodiments, the hot fluid 3001H is heated to a temperature of at least 37°C, such as at least 78°C, such as about 98°C, such as at least 100°C, such as at least 120°C. Additionally or alternatively, the hot fluid 3001H is heated to a temperature at least 5°C higher than the temperature of the warm fluid 3001W (such as at least 15°C, at least 30°C, or at least 80°C higher than the temperature of the warm fluid 3001W). The hot fluid 3001H can be circulated through the expandable element 530 for at least 1 second, such as at least 5 seconds, such as about 10 seconds. In some embodiments, the duration of step 2350 is based on the temperature of fluid 3001, the temperature of warm fluid 3001W, and / or the temperature of hot fluid 3001H.

[0228] In some embodiments, console 100 is configured to monitor one or more parameters of system 10 to detect the presence or occurrence of any leaks or other problems during step 2350 (or other steps of method 2300). In some embodiments, if a leak is detected during step 2350, method 2300 automatically continues and immediately proceeds to step 2360, during which fluid 3001 (e.g., fluid at or below room temperature) is flushed through expandable element 530. Additionally or alternatively, console 100 may be configured to monitor one or more parameters of system 10 to detect the presence and / or occurrence of any blockages during step 2350 (and / or other steps of method 2300). If a blockage is detected, system 10 may be configured to enter an alarm state, such as an alarm state in which console 100 tightens expandable element 530 and / or delivers neutralizing fluid to expandable element 530.

[0229] In step 2360, as described herein, console 100 is configured as follows: Figure 6E As illustrated. After step 2350, in step 2360, valve V3 is closed and valve V2 is opened. The plunger of syringe pump assembly 3100b is stopped, and the plunger of syringe pump assembly 3100a is driven forward again, thereby driving a third portion—part P3—of the first volume VOL1 of fluid 3001 from syringe pump assembly 3100a. The third portion P3 of the first volume VOL1 of fluid 3001 is driven by expandable element 530 and flows freely through valve V5 and into reservoir assembly 3300b. In some embodiments, fluid 3001 is driven from syringe pump assembly 3100a at a rate of at least 8 ml / s, such as at least 10 ml / s, such as at least 12 ml / s. In some embodiments, fluid 3001 is driven from syringe pump assembly 3100a at a rate at least 1 ml / s faster than the rate at which fluid 3001H is driven from syringe pump assembly 3100b in step 2350. Fluid 3001 may circulate through expandable element 530 for at least 10 seconds, such as at least 25 seconds, such as at least 60 seconds. In some embodiments, the duration of step 2360 is based on the temperature of fluid 3001 and / or the temperature of hot fluid 3001H. In some embodiments, fluid 3001 circulates through expandable element 530 for no more than 15 seconds, such as no more than 25 seconds, such as no more than 60 seconds.

[0230] In step 2370, as described herein, console 100 is configured as follows: Figure 6FAs illustrated. After step 2360, in step 2370, valve V5 is closed and the plunger of syringe pump assembly 3100a is reversed, thereby drawing fluid 3001 from expandable element 530 back into syringe pump assembly 3100a (e.g., at least some of the third part P3). In some embodiments, fluid 3001 is drawn from expandable element 530 into syringe pump assembly 3100a at a rate of at least 4 ml / s, such as at least 6 ml / s, such as at least 8 ml / s. In step 2370, valves V1, V3, V4, V5, and V... EVAC When fully closed, drawing fluid from the expandable element 530 can cause the expandable element 530 to contract radially.

[0231] In some embodiments, method 2300 can be repeated multiple times in a single procedure so that sufficient amount of mucosal tissue can be thermally ablated to achieve the desired therapeutic benefit in the patient, as described herein. In some embodiments, system 10 is configured to perform all necessary ablation to achieve the desired therapeutic effect while requiring a target procedure volume of less than 5 L of fluid, such as less than 4 L, 3 L, 2 L, or 1 L (e.g., reservoir 3310a is filled with less than this volume of fluid to initiate the procedure).

[0232] In some embodiments, console 100 is configured to determine appropriate parameters for the actions described in the various steps of method 2300. For example, console 100 may be configured to determine appropriate flow rates, fluid temperatures, energy levels, pressures, durations, and / or other system 10 operating parameters for performing method 2300. In some embodiments, console 100 includes a predetermined set of operating parameters (e.g., parameters predetermined during manufacturing). In some embodiments, a set of operating parameters is determined close to the time of procedure execution (e.g., relatively close before and / or during the procedure). In some embodiments, the procedure is executed in an open-loop manner after these sets of operating parameters are determined. Alternatively or additionally, console 100 may be configured to monitor one or more conditions of system 10 during the procedure and adjust one or more operating parameters (e.g., execute the procedure in a closed-loop manner). In some embodiments, system 10 is configured to independently adjust two or more operating parameters, such as when flow rates and fluid temperatures are independently controllable. In some embodiments, one or more operating parameters are controlled to achieve a precise intestinal tissue ablation depth. In some implementations, console 100 is configured to determine one or more parameters based on one or more user inputs or operational conditions. For example, console 100 may determine parameters based on information selected from: ambient temperature (e.g., room temperature); temperature of fluid 3001; and the temperature of hot fluid 3001. HTemperature; altitude; treatment location; and combinations thereof. Alternatively or additionally, console 100 may determine parameters based on one or more user inputs selected from the following: desired ablation power; desired ablation depth; duodenal wall thickness; time since previous ablation; desired ablation duration; desired ablation temperature; and combinations thereof.

[0233] In some embodiments, the heat fluid 3001H is heated via a two-stage heating cycle (e.g., reducing the need for high power), which avoids the need for a heat storage tank that maintains high temperatures for extended periods. The heat fluid 3001H can be driven at a flow rate of at least 5 mL / s and a temperature close to 100°C. The two-stage heating cycle can include two passes through a single heater, such as when the first pass is performed at a slower flow rate than the second pass. In some embodiments, the heater is configured to deliver power up to at least 900 W, such as at least 1000 W or at least 1100 W. In some embodiments, the first pass through heater 3210 heats the heat fluid 3001H to at least 75°C, such as at least 80°C or at least 85°C. In these embodiments, during the second pass (e.g., through heater 3210), the heat fluid 3001H is heated to a desired temperature in a closed-loop manner (e.g., using a temperature sensor). The heat fluid 3001H can be heated to a desired temperature of at least 93°C, such as at least 95°C or 97°C. The heat transfer fluid 3001H can be heated to the desired temperature within a time period of no more than 2 seconds, such as no more than 1.5 seconds or no more than 1 second. The heat transfer fluid 3001H can be heated to within 0.5°C, such as 0.3°C, or such as 0.1°C, of ​​the desired temperature. In some embodiments, the heat transfer fluid 3001H can be heated a second time at a rate of at least 9 ml / min, such as at least 10 ml / min or at least 10.5 ml / min during flow.

[0234] Now for reference Figure 7 The illustration shows a perspective view of a cartridge operatively attached to a control console in accordance with the inventive concept. A portion of the housing 101 of the control console 100 is shown. The control console 100 may include retaining mechanisms, such as the tracks 104a and 104b shown. Tracks 104a and 104b may be configured to slidably receive at least a portion of the cartridge 3500. For example, the cartridge 3500 may include protrusions 3505a and 3505b (…). Figure 7 The protrusion 3505a in the cartridge case is partially obscured by the cartridge housing 3501. The console 100 and cartridge 3500 may have a similar construction and arrangement to similar components described herein. In some embodiments, the cartridge 3500 may be, as per reference herein... Figures 9A-9DThe one or more locking mechanisms are securely attached to the control console 100. In some embodiments, the system 10 is configured to detect when the cartridge 3500 has been correctly attached to the control console 100 (e.g., via one or more sensors). Alternatively or additionally, the system 10 may detect whether the cartridge 3500 has been incorrectly attached to the control console 100, and if incorrect attachment is detected, the system 10 may be configured to enter an alarm mode to alert the system operator.

[0235] Now for reference Figure 8A and Figure 8B The illustration shows two perspective views of a cartridge case conforming to the concept of this invention. Figure 8B In this image, the rear wall portion of the housing 3501 of the cartridge 3500 has been removed, revealing the conduit 3510 and other components within the housing 3501. As shown, the cartridge 3500 includes eight valve assemblies 3520. Each valve assembly 3520 includes a port 3521 within the housing 3501. Each port 3521 includes an opening 3522 through the housing 3501 and a wall 3523 surrounding the port. Figure 8B As shown, each valve assembly includes a portion of a conduit 3510 extending through it.

[0236] For further reference Figures 9A-9D The figures illustrate a portion of a valve assembly 3520 conforming to the inventive concept and three cross-sectional views of the valve assembly in various configurations. In some embodiments, the cartridge 3500 is configured to slide into a portion of the control console 100 (e.g., as referenced herein). Figure 7 The valve assembly 3500 is then locked into the console 100. In some embodiments, the console 100 includes one or more extendable protrusions (e.g., a portion of the piston assembly 3525 described below) configured to engage with one or more corresponding recesses (e.g., port 3521 described below) of the cartridge 3500. These mating protrusions and recesses may be constructed and arranged to prevent the cartridge 3500 from sliding within a receiving portion of the console 100 (e.g., to prevent the cartridge 3500 from being removed from the console 100). In some embodiments, one or more valve assemblies 3520 include protrusions extending from the console 100 and recesses positioned within the cartridge 3500 (e.g., as described below). Figures 9B-9D It is along Figure 9A A cross-sectional view of section AA. Figure 9A The illustration shows a portion of a cartridge 3500, including a portion of a valve assembly 3520. Figure 9B The illustration shows valve assembly 3520 in an unlocked configuration, which allows cartridge 3500 to be attached to and / or removed from console 100 in the unlocked configuration. Figure 9CThe diagram illustrates the valve assembly 3520 in a locked and open configuration, such that the cartridge 3500 is attached to the control panel 100 in a locked state, and the valve assembly 3520 is open, allowing fluid to flow freely through the conduit 3510. Figure 9D The diagram illustrates valve assembly 3520 in a locked and closed configuration, such that cartridge 3500 is attached to console 100 in a locked state and valve assembly 3520 is closed to prevent fluid from flowing through pipe 3510.

[0237] Each valve assembly 3520 may include a port 3521 surrounding an opening 3522 in the housing 3501, wherein the opening 3522 exposes a portion of a conduit 3510 extending through the port 3521. The port 3521 is surrounded by a wall 3523. The valve assembly 3520 may include one or more retaining mechanisms, such as clips 3524a and 3524b as shown, that retain the exposed portion of the conduit 3510 within the center of the port 3521. The valve assembly 3520 may include a piston assembly 3525 including a shaft 3528 extending from a portion of the console 100 toward the port 3521. The shaft 3528 may include a piston head 3527 at its distal end. The piston head 3527 is slidably received within the port 3521. Figure 9C As shown, in the locked configuration, the piston assembly 3525 extends from the console 100 such that a portion of the piston head 3527 extends into the port 3521.

[0238] Within each port 3521 and positioned opposite the opening 3522, a protrusion—a ridge 3526—extends toward the opening 3522. A conduit 3510 may rest against the ridge 3526 (e.g., held in contact with the ridge 3526 by a clamp 3524). In some embodiments, a piston assembly 3525 is configured to extend further into the port 3521 such that a piston head 3527 presses the conduit 3510 against the ridge 3526 (e.g., effectively turning the valve assembly 3520 into a closed configuration).

[0239] The above embodiments should be understood as illustrative examples only; further embodiments are also contemplated. Any feature described herein with respect to any embodiment may be used alone or in combination with other described features, and may also be used in combination with one or more features of any other embodiment or any combination of any other embodiment. Furthermore, equivalents and modifications not described above may be employed without departing from the scope of the inventive concept, which is defined in the appended claims.

Claims

1. A system for performing a medical procedure in a patient's intestine, the system comprising: A catheter for insertion into the intestine, the catheter comprising: Including the distal portion of the shaft, and A functional assembly positioned on the distal portion of the shaft, wherein the functional assembly is configured to receive fluid; The console includes: A fluid reservoir configured to store the fluid. A first syringe pump assembly includes a first syringe and a first plunger, the first plunger being configured to retract to draw fluid into the first syringe and to advance to deliver the fluid from the first syringe to the functional assembly. A second syringe pump assembly includes a second syringe and a second plunger, the second plunger being configured to retract to draw fluid into the second syringe and to advance to deliver the fluid from the second syringe to the functional assembly. A fluid heater includes a flow path configured to receive fluid in a first direction and an opposing second direction, the fluid heater being configured to heat the fluid flowing through the flow path. A waste liquid reservoir configured to receive the fluid from the functional assembly; and A connector configured to operably attach the conduit to the console; The control console is operable in a heating and delivery arrangement, wherein (i) retraction of the second plunger draws fluid from the functional assembly in the first direction through the flow path of the fluid heater, while the fluid heater heats the fluid to generate heated fluid within the second syringe, and (ii) thereafter, advancement of the second plunger forces the heated fluid from the second syringe through the flow path of the fluid heater in the second direction, while the fluid heater heats the heated fluid to generate ablation temperature fluid delivered to the functional assembly; and The system is configured to process the target tissue of the patient's intestine.

2. The system of claim 1, wherein the functional assembly comprises a balloon.

3. The system of claim 1, wherein the system is configured to process the target organization in the following manner: A first volume of the fluid is provided at a temperature below body temperature, and the first volume of the fluid is recirculated within the functional assembly to cool the target tissue and tissue adjacent to the target tissue; and A second volume of the fluid is provided at an elevated ablation temperature, and the second volume of the fluid is recirculated within the functional assembly to ablate the target tissue.

4. The system of claim 3, wherein the system is configured to deliver a first volume of the fluid before or after delivering a second volume of the fluid.

5. The system of claim 3, wherein the system is configured to deliver a first volume of the fluid prior to delivering a second volume of the fluid, wherein the system is further configured to deliver a third volume of the fluid after delivering the second volume of the fluid, and wherein the third volume of the fluid comprises a fluid at a temperature below body temperature that cools the target tissue and tissues adjacent to the target tissue during its delivery.

6. The system of claim 3, wherein the fluid heater comprises an inline heater, and wherein the console is operable such that a second volume of the fluid is heated by the inline heater via two passes through the inline heater during a filling stroke of the second syringe pump assembly in a first direction and during a dispensing stroke of the second syringe pump assembly in an opposing second direction.

7. The system of claim 6, wherein during the first pass through the inline heater, the inline heater is configured to be powered at a higher level than during the second pass through the inline heater.

8. The system of claim 3, wherein the first volume of the fluid comprises a fluid at room temperature.

9. The system of claim 3, wherein the console is operable such that the process further includes delivering a third volume of the fluid to cool the target tissue after the target tissue has been ablated.

10. The system of claim 9, wherein the console is configured to prevent delivery of a second volume of the fluid to the functional assembly unless a third volume of the fluid is present in the first syringe pump assembly prior to delivery of the second volume of the fluid to the functional assembly.

11. The system of claim 1, wherein the fluid heater includes an inline heater, and wherein the fluid heater is configured to be preheated before the heated fluid is delivered to the functional assembly.

12. The system of claim 11, wherein the system is configured to perform a plurality of processing steps, and wherein the fluid heater is configured to be preheated between each of the plurality of processing steps.

13. The system of claim 1, further comprising a closed-loop control algorithm configured to control the fluid heater.

14. The system of claim 1, wherein the console is configured to determine one or more parameters relating to the processing of the target organization.

15. The system of claim 14, wherein the one or more processing parameters are selected from: flow rate; fluid temperature; energy level; pressure; duration; and combinations thereof.

16. The system of claim 1, wherein the console further includes a backup power supply.

17. The system of claim 16, wherein the backup power supply includes sufficient energy capacity to allow the system to switch one or more components of the system to a patient-safe mode.

18. The system of claim 17, wherein the system is configured to switch from a processing mode to a patient-safe mode in the event of a power failure during the processing of the target tissue.

19. The system of claim 1, wherein the console is configured to monitor one or more parameters of the system to assess the mechanical integrity of the catheter.

20. The system of claim 19, wherein the system is configured to monitor for leakage as fluid circulates through the functional assembly at the ablation temperature, and to deliver cooling fluid to the functional assembly upon detection of a leakage.

21. The system of claim 1, wherein the system does not include two or more syringe pump assemblies configured to deliver fluid to the functional assembly, and wherein the first syringe pump assembly comprises a single syringe, and the second syringe pump assembly comprises a single syringe.

22. The system of claim 1, wherein the system is configured to prevent the treatment of the target tissue if the fluid in the fluid reservoir does not exceed a minimum volume.

23. The system of claim 1, wherein the system is configured to prevent the treatment of the target tissue if the space in the waste reservoir does not exceed a minimum volume.

24. The system of claim 1, wherein the console includes a first temperature sensor located near a first port of the fluid heater and a second temperature sensor located near a second port of the fluid heater, the first and second temperature sensors being configured to sense the temperature of fluid entering and leaving the fluid heater; and wherein the console controls the power supply to the fluid heater based on the sensed temperature.

25. The system of claim 1, wherein the fluid heater operates at a first power level during the second plunger retraction and at a second power level during the second plunger advance, the second power level being less than the first power level.

26. A console for performing a medical procedure in a patient's intestine, the console comprising: A connector configured to be operatively attached to a catheter that can be inserted into the intestine and includes a balloon configured to receive fluid for thermal ablation; A fluid reservoir interface configured to receive a fluid reservoir containing the fluid; A first syringe pump assembly includes a first syringe and a first plunger, the first plunger being configured to retract to draw the fluid into the first syringe and to advance to deliver the fluid from the first syringe to the catheter; The second syringe pump assembly includes a second syringe and a second plunger, the second plunger being configured to retract to draw the fluid into the second syringe and to advance to deliver the fluid from the second syringe to the catheter; A fluid heater includes a flow path in fluid communication with the second syringe pump assembly, the flow path being configured to deliver fluid in a first direction and an opposing second direction, and the fluid heater being configured to heat the fluid flowing through the flow path; and A waste liquid reservoir interface configured to receive a waste liquid reservoir, the waste liquid reservoir being configured to receive the fluid from the conduit; The control console is operable in a heating and delivery arrangement, wherein (i) retraction of the second plunger draws fluid from the catheter in the first direction through the flow path of the fluid heater while the fluid heater heats the fluid to generate heated fluid within the second syringe, and (ii) thereafter, advancement of the second plunger forces the heated fluid from the second syringe through the flow path of the fluid heater in the second direction while the fluid heater heats the heated fluid to generate ablation temperature fluid delivered to the catheter; The console is configured to process the patient’s target intestinal tissue when the catheter is connected to the connector.

27. The console of claim 26, further comprising a first temperature sensor located near a first port of the fluid heater and a second temperature sensor located near a second port of the fluid heater, the first and second temperature sensors being configured to sense the temperature of fluid entering and leaving the fluid heater; wherein the console is configured to control power supply to the fluid heater based on the sensed temperature.

28. The console of claim 26, wherein the console is operable such that the fluid heater is powered at a first power level when the second plunger retracts to extract fluid through the flow path in the first direction, and is powered at a second power level, the second power level being less than the first power level, when the second plunger advances to force fluid through the flow path in the second direction.

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