Tissue treatment devices, systems, and methods

Abstract

Provided herein are devices, systems, and methods for performing a medical procedure on a patient. A system as described herein can treat and / or diagnose one, two, or more medical conditions of the patient. The system includes a treatment device having an elongate shaft assembly, a distal portion with a distal end, and a functional assembly positioned on the distal portion. The functional assembly can treat and / or diagnose tissue. The system can further include a console having a human interface device and a controller. The console can robotically manipulate one or more components of the system.

Description

[0001] TISSUE TREATMENT DEVICES, SYSTEMS, AND METHODS

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003]

[0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 63 / 607,735, filed December 8, 2023, and entitled “TISSUE TREATMENT DEVICES, SYSTEMS, AND METHODS,” which is hereby incorporated by reference herein in its entirety.

[0004]

[0002] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 63 / 610,277, filed December 14, 2023, and entitled “TISSUE TREATMENT DEVICES, SYSTEMS, AND METHODS,” which is hereby incorporated by reference herein in its entirety.

[0005]

[0003] The subject matter of this application is related to that of: United States Patent Application Serial Number 17 / 222,480 (Attorney Docket No. 41714-703.303; Client Docket No. MCT-001-US-CON2), entitled “Devices and Methods for the Treatment of Tissue”, filed April 5, 2021; United States Patent Application Serial Number 17 / 864,855 (Attorney Docket No. 41714-704.303; Client Docket No. MCT-002-US-CON2), entitled “Heat Ablation Systems, Devices and Methods for the Treatment of Tissue”, filed July 14, 2022; United States Patent Application Serial Number 17 / 868,076 (Attorney Docket No. 41714-705.302; Client Docket No. MCT-003-US-CON1), entitled “Tissue Expansion Devices, Systems and Methods”, filed July 19, 2022; United States Patent Application Serial Number 17 / 879,222 (Attorney Docket No. 41714-706.303; Client Docket No. MCT-004-US-CON2), entitled “Electrical Energy Ablation Systems, Devices and Methods for the Treatment of Tissue”, filed August 2, 2022; United States Patent Application Serial Number 17 / 192,671 (Attorney Docket No. 41714-707.302; Client Docket No. MCT-005-US-CON1), entitled “Ablation Systems, Devices, and Methods for the Treatment of Tissue”, filed March 4, 2021; United States Patent Application Serial Number 17 / 568,145 (Attorney Docket No. 41714-708.302; Client Docket No. MCT-009-US-CON1), entitled “Methods, Systems and Devices for Performing Multiple Treatments on a Patient”, filed January 4, 2022; United States Patent Application Serial Number 17 / 021,798 (Attorney Docket No. 41714-709.303; Client Docket No. MCT-013-US-CON2), entitled “Methods, Systems and Devices for Reducing the Luminal Surface Area of the Gastrointestinal Tract”, filed September 15, 2020; United States Patent Application Serial Number 14 / 917,243 (Attorney Docket No. 41714-710.301; Client Docket No. MCT-023-US), entitled “Systems, Methods and Devices for Treatment of Target Tissue”, filed March 7, 2016; United States Patent Application Serial Number 18 / 467,589 (Attorney Docket No. 41714-711.304; Client Docket No. MCT-024-US-CON3), entitled “Systems, Devices and Methods for the Creation of a Therapeutic Restriction in the Gastrointestinal Tract”, filed September 14, 2023; United States Patent Application Serial Number 16 / 742,645 (Attorney Docket No. 41714-715.301; Client Docket No. MCT-025- US), entitled “Intestinal Catheter Device and System”, filed January 14, 2020; United States Patent Application Serial Number 17 / 494,277 (Attorney Docket No. 41714-712.303; Client Docket No. MCT-027-US-CIP1-CON2), entitled “Injectate Delivery Devices, Systems and Methods”, filed October 5, 2021; United States Patent Application Serial Number 16 / 798,117 (Attorney Docket No. 41714-714.303; Client Docket No. MCT-028-US-CIP1-CON2), entitled “Systems, Devices and Methods for Performing Medical Procedures in the Intestine”, filed February 21, 2020; United States Patent Application Serial Number 17 / 384,421 (Attorney Docket No. 41714-714.304; Client Docket No. MCT-028-US-CIP2-CON2), entitled “Systems, Devices and Methods for Performing Medical Procedures in the Intestine”, filed July 23, 2021; United States Patent Application Serial Number 17 / 096,855 (Attorney Docket No. 41714-713.302; Client Docket No. MCT-029-US-CON1), entitled “Methods and Systems for Treating Diabetes and Related Diseases and Disorders”, filed November 12, 2020; United States Patent Application Serial Number 17 / 181,969 (Attorney Docket No. 41714-713.501; Client Docket No. MCT-029-US-CIP1), entitled “Methods and Systems for Treating Diabetes and Related Diseases and Disorders”, filed February 22, 2021; United States Patent Application Serial Number 16 / 400,491 (Attorney Docket No. 41714-716.301; Client Docket No. MCT-035-US), entitled “Systems, Devices and Methods for Performing Medical Procedures in the Intestine”, filed May 1, 2019; United States Patent Application Serial Number 17 / 859,137 (Attorney Docket No. 41714-721.301; Client Docket No. MCT- 039-US), entitled “Tissue Treatment Devices, Systems, and Methods”, filed July 7, 2022; United States Patent Application Serial Number 17 / 490,947 (Attorney Docket No. 41714- 719.301; Client Docket No. MCT-040-US), entitled “Systems, Devices and Methods for Treating Metabolic Medical Conditions”, filed September 30, 2021; United States Patent Application Serial Number 17 / 942,914 (Attorney Docket No. 41714-723.301; Client Docket No. MCT-041-US), entitled “Systems, Devices and Methods for Treating Diabetes”, filed September 12, 2022; United States Patent Application Serial Number 17 / 721,937 (Attorney Docket No. 41714-720.301; Client Docket No. MCT-050-US), entitled “Systems, Devices, and Methods for Performing Medical Procedures in the Intestine”, filed April 15, 2022; United States Patent Application Serial Number 17 / 863,016 (Attorney Docket No. 41714- 722.301; Client Docket No. MCT-051-US), entitled “Automated Tissue Treatment Devices, Systems, and Methods”, filed July 12, 2022; United States Patent Application Serial Number 18 / 062,331 (Attorney Docket No. 41714-724.301; Client Docket No. MCT-034-US), entitled “Tissue Treatment System with Fluid Delivery Console”, filed December 6, 2022; “International PCT Patent Application Serial Number PCT / US2022 / 053531 (Attorney Docket No. 41714-727.601; Client Docket No. MCT-056-PCT), entitled “Methods and Systems for Treating Mucosal Hyperplasia and other Medical Conditions of a Patient”, filed December 20, 2022; United States Provisional Patent Application Serial Number 63 / 385,717 (Attorney Docket No. 41714-728.101; Client Docket No. MCT-057-PR1), entitled “Tissue Treatment Devices, Systems, and Methods”, filed December 1, 2022; United States Provisional Patent Application Serial Number 63 / 499,451 (Attorney Docket No. 41714- 730.101; Client Docket No. MCT-059-PR1), entitled “Methods and Systems for Treating One or More Metabolic Conditions of a Patient”, filed May 1, 2023; and United States Provisional Patent Application Serial Number 63 / 506,574 (Attorney Docket No. 41714- 731.101; Client Docket No. MCT-060-PR1), entitled “Tissue Treatment System”, filed June 6, 2023; the contents of each of which is incorporated herein by reference in its entirety for all purposes.

[0006] TECHNICAL FIELD

[0007]

[0004] The embodiments disclosed herein relate generally to systems, devices and methods for performing a procedure in the gastrointestinal tract of a patient, such as for treating one or more metabolic conditions of the patient.

[0008] BACKGROUND OF THE INVENTION

[0009]

[0005] Numerous diagnostic and therapeutic procedures are performed in the small and large intestine, as well as other locations of the gastrointestinal tract. Devices used in these procedures can be difficult to maneuver and otherwise operate, and they often have limited functionality. There is a need for improved systems and devices for treating and diagnosing tissue of the intestine, as well as a need for methods of treating intestinal tissue to provide an improved therapy for various diseases and disorders.

[0010] BRIEF SUMMARY OF THE INVENTION

[0011]

[0006] According to an aspect of the present inventive concepts, a system for performing a medical procedure on a patient comprises a treatment device comprising an elongate shaft assembly, a distal portion comprising a distal end, and a functional assembly positioned on the distal portion. The functional assembly can be configured to treat and / or diagnose tissue, and the system can be configured to treat and / or diagnose one, two, or more medical conditions of the patient.

[0012]

[0007] In some embodiments, the one, two, or more medical conditions comprise one, two, or more medical conditions selected from the group consisting of: Type 2 diabetes; Type 1 diabetes; Double Diabetes; gestational diabetes; hyperglycemia; pre-diabetes; impaired glucose tolerance; insulin resistance; non-alcoholic fatty liver disease (NAFLD); nonalcoholic steatohepatitis (NASH); obesity; obesity-related disorder; polycystic ovarian syndrome (PCOS); hypertriglyceridemia; hypercholesterolemia; psoriasis; GERD; coronary artery disease; stroke; TIA; cognitive decline; dementia; Alzheimer's Disease; neuropathy; diabetic nephropathy; retinopathy; heart disease; diabetic heart disease; heart failure; diabetic heart failure; and combinations thereof.

[0013]

[0008] In some embodiments, the system further comprises a tissue expansion assembly. The tissue expansion assembly can be positioned on the elongate shaft of the treatment device. The functional assembly can comprise the tissue expansion assembly. The system can further comprise a second device including an elongate shaft, and the tissue expansion assembly can be positioned on the elongate shaft of the second device. The tissue expansion assembly can comprise at least one fluid delivery assembly, and each fluid delivery assembly can comprise a tissue capture port, a fluid delivery element, and a vacuum port. The tissue expansion assembly can comprise at least one fluid delivery element that is advanceable into tissue via a spring, a pneumatic piston, and / or a hydraulic piston. The system can further comprise injectate for delivery into tissue via the tissue expansion assembly, and the injectate can comprise a material selected from the group consisting of: a peptide polymer, such as a peptide polymer configured to stimulate fibroblasts to produce collagen; polylactic acid; polymethylmethacrylate (PMMA); a hydrogel; ethylene vinyl alcohol (EVOH); a material configured to polymerize EVOH; dimethyl sulfoxide (DMSO); saline; a material harvested from a mammalian body; autologous material; fat cells; collagen; autologous collagen; bovine collagen; porcine collagen; bioengineered human collagen; dermis; a dermal filler; hyaluronic acid; conjugated hyaluronic acid; calcium hydroxyapatite; fibroblasts; a sclerosant; an adhesive; cyanoacrylate; a pharmaceutical agent; a visualizable material; a radiopaque material; a visible dye; ultrasonically reflective material; a combination of materials configured to cause an endothermic reaction when mixed, such as when mixed in tissue; a combination of materials configured to cause an exothermic reaction when mixed, such as when mixed in tissue; a combination of materials configured to expand when mixed, such as when mixed in tissue; beads, such as beads coated with pyrolytic carbon, such as beads suspended in a water-based carrier gel or other carrier; a solid silicone elastomer, such as a heat-vulcanized polydimethylsiloxane; a solid silicone elastomer suspended in a carrier, such as a bio-excretable polyvinylpyrrolidone (PVP) carrier gel; and combinations thereof.

[0014]

[0009] In some embodiments, the treatment device is configured to treat, diagnose, or treat and diagnose the one, two, or more medical conditions of the patient.

[0015]

[0010] In some embodiments, the treatment device is configured to be advanced over a guide wire.

[0016] [Oi l] In some embodiments, the treatment device is configured to be inserted through a working channel of a body access device. The working channel can comprise a diameter of no more than 7.5mm, 6.5mm, and / or 6.0mm.

[0017]

[0012] In some embodiments, the treatment device is configured to be translated within a gastrointestinal lumen without a guidewire.

[0018]

[0013] In some embodiments, the treatment device is configured to be translated within a gastrointestinal lumen without the use of fluoroscopy.

[0019]

[0014] In some embodiments, the treatment device is configured to be translated within a gastrointestinal lumen while in the short position of the stomach. The treatment device can be configured to transition from the long position in the stomach to the short portion in the stomach.

[0020]

[0015] In some embodiments, the treatment device is configured to insufflate and / or desufflate a segment of the gastrointestinal tract.

[0021]

[0016] In some embodiments, the treatment device comprises a handle assembly that includes a user interface comprising one or more controls configured to allow an operator to control the treatment device. The user interface can comprise one, two, or more components selected from the group consisting of: rollerball controller; trackball controller; bidirectional controller; omnidirectional controller; joystick; trackpad; mouse; buttons; steering wheel; foot pedal, such as a foot pedal configured to advance or otherwise translate the treatment device when depressed; yoke, such as a yoke configured to steer, rotate, and / or translate the treatment device; touchscreen; motion sensing component; and combinations thereof.

[0022]

[0017] In some embodiments, the system further comprises one or more controls for operating the treatment device, and the treatment device does not include the one or more controls.

[0018] In some embodiments, the treatment device comprises at least one reusable component and at least one disposable component.

[0023]

[0019] In some embodiments, the treatment device comprises a shape sensing assembly configured to provide shape information related to the shape of the treatment device. The shape sensing assembly can comprise a fiber optic shape sensing assembly. The shape sensing assembly can be configured to allow advancement of the functional assembly with a translational accuracy of ±30%, 20%, or 10%. The system can be configured to robotically manipulate the treatment device based on the shape information.

[0024]

[0020] In some embodiments, the treatment device comprises a position sensing assembly configured to provide position information related to the position of the treatment device in the patient’s anatomy. The system can comprise one or more active and / or passive electronic components configured to provide data related to the position of the treatment device. The system can further comprise an electronic field sensor configured to provide the data related to the position of the treatment device.

[0025]

[0021] In some embodiments, the treatment device comprises a force sensing assembly configured to detect a force applied to one or more portions of the treatment device.

[0026]

[0022] In some embodiments, the treatment device comprises at least one functional element.

[0027]

[0023] In some embodiments, the treatment device comprises an imaging assembly including at least one camera. The at least one camera can be positioned on the distal end of the treatment device. The distal portion of the treatment device can comprise a central axis, and the at least one camera can comprise a viewing angle, and the viewing angle can be offset from the central axis. The at least one camera can comprise a movable camera. The at least one camera can comprise multiple cameras. The at least one camera can be configured to provide a forward-facing view, a side-facing view, or both. The treatment device can comprise at least one steerable portion positioned proximal to the functional assembly and / or distal to the functional assembly, and rotation of the steerable portion can change the imaging direction of the at least one camera. The imaging assembly can further comprise a light producing assembly. The treatment device can comprise an irrigation channel for delivering fluid to improve an image produced by the imaging assembly. The treatment device can comprise a lumen, and the irrigation channel can comprise a tube configured to be translated within the lumen. The tube can be configured to be robotically translated, manually translated, or both. The treatment device can comprise a window portion, and the at least one camera can be configured to view tissue via the window portion. The imaging assembly can comprise at least one reusable component. The imaging assembly can comprise one or more mirrors, and each mirror can be positioned to be viewed by the at least one camera. The one or more mirrors can comprise a first mirror configured to be deployed between a flat orientation and an angled orientation. The angled orientation can comprise an angle of at least 25°, 35°, 45°, and / or 60°. The treatment device can comprise a lumen through which the at least one camera translates, and the one or more mirrors can comprise a first mirror positioned in the lumen. The one or more cameras can comprise at least two cameras. The at least two cameras can be each connected to a single cable assembly configured to transfer image information to a component of the system outside of the treatment device.

[0028]

[0024] In some embodiments, the shaft assembly comprises a varying stiffness along its length.

[0029]

[0025] In some embodiments, the shaft assembly comprises a maximum diameter that is less than or equal to 13mm, 11mm, and / or 9mm.

[0030]

[0026] In some embodiments, the functional assembly is configured to deliver energy to tissue. The energy delivered can comprise thermal energy. The functional assembly can comprise a balloon configured to receive hot fluid to deliver the thermal energy. The energy can comprise energy in a form selected from the group consisting of: radiofrequency energy; electroporation energy, such as irreversible electroporation energy; light energy, such as laser light energy; mechanical energy, such as energy configured to abrade and / or remove tissue; thermal energy, such as heat energy and / or cryogenic energy; steam energy; chemical energy; and combinations thereof. The functional assembly can be configured to perform a neutralizing procedure on tissue. The neutralizing procedure can comprise cooling a volume of tissue prior to, during, and / or after the delivery of the energy to tissue proximate the volume of tissue. The cooling procedure can be performed via fluid at room temperature or below. The cooling procedure can be performed by a component of the system other than the functional assembly.

[0031]

[0027] In some embodiments, the functional assembly is configured to expand to a diameter of at least 26mm, 27mm, and / or 28mm, and the functional assembly is further configured to make contact with the luminal wall of an axial segment of the small intestine. The energy delivery can be configured to cause necrosis of at least 75%, 85%, and / or 90% of the cells on the surface of the axial segment. The energy delivery can be configured to cause necrosis of at least 50%, 60%, and / or 70% of the cells located at 600 microns depth from the surface of the axial segment. The energy delivery can be configured to cause necrosis of no more than 20%, 15%, and / or 10% of the cells located at 1000 microns depth from the surface of the axial segment.

[0032]

[0028] In some embodiments, the system further comprises a marker configured to mark tissue. The marker can be configured to mark the papilla.

[0033]

[0029] In some embodiments, the system comprises one or more guidewires. The one or more guidewires can comprise at least one guidewire comprising: a shaft with a relatively stiff material, such as stainless steel or L605 cobalt-chromium; a shaft diameter of no more than 0.035 or 0.032”; a lubricious coating; an atraumatic distal portion, such as a distal portion constructed of nickel titanium alloy and / or a distal portion comprising a centerless- grinding steep tapering; a shaft length of at least 300cm, or at least 340cm; and / or a shaft length of no more than 400cm, or no more than 380cm. The one or more guidewires can comprise at least one guidewire with a proximal portion that is void of a lubricious coating. The one or more guidewires can comprise at least one guidewire including a distal portion configured to transition from a straight geometry to an expandable coil geometry. The one or more guidewires can comprise at least one steerable guidewire. The one or more guidewires can comprise at least one lockable guidewire.

[0034]

[0030] In some embodiments, the system further comprises a controller and a memory module coupled to the controller, and the memory module stores instructions for the controller to perform an algorithm. The algorithm can comprise at least one Al algorithm. The algorithm can comprise an Al algorithm that can be trained using data collected using the system. The data can comprise data selected from the group consisting of: image data; physiologic data; outcome data; other patient data; other procedural data; and combinations thereof. The algorithm can be trained using data collected from one or more images selected from the group consisting of: white light endoscopy images; fluorescence endoscopy images; narrow-band endoscopy images; magnifying endoscopy images; confocal endoscopy images; ultrasonic endoscopy images; optical coherence tomography images; endoscopy images and / or endoscopic images collected using other techniques; and combinations thereof. The images used for training can comprise images collected while bile is being secreted from the papilla. The algorithm can comprise an Al algorithm and / or other algorithm that can be configured to dynamically adapt. The algorithm can comprise an Al algorithm and / or other algorithm that can be based on geometric, non-geometric, topological, and / or colorimetric feature analysis and / or segmentation. The algorithm can comprise an Al algorithm or other algorithm that uses optical flow techniques to track movement of the treatment device or other component of the system. The algorithm can comprise an Al algorithm and / or other algorithm that uses feature-based optical tracking to track movement of the treatment device or other component of the system. The algorithm can be configured to create a 3D map of one or more portions of the patient’s anatomy, to create a 3D image of the shape of the treatment device, or both. The algorithm can be configured to analyze system information. The algorithm can comprise a detection algorithm, and the detection algorithm can be configured to produce detection information. The detection algorithm can perform a detection based on analysis of one or more images captured by the system. The system can be configured to provide the detection information to an operator audibly, visually, and / or tactilely. The detection information can be provided with a confidence factor. The detection algorithm can be configured to identify a tissue type. The detection algorithm can be configured to identify the papilla and / or other non-target tissue. The detection algorithm can be configured to differentiate target tissue from non-target tissue. The detection algorithm can be configured to identify the tissue type on an image displayed by the system. The detection algorithm can be configured to identify a tissue condition. The detection algorithm can be configured to identify ablated tissue and / or expanded tissue. The detection algorithm can be configured to identify the tissue condition on an image displayed by the system. The detection algorithm can be configured to detect a marking on the treatment device and / or another component of the system. The algorithm can be configured to provide one or more augmented images to an operator, such that the system can operate in an augmented reality mode. The one or more augmented images can comprise an augmented image of the papilla and / or other non-target tissue. The one or more augmented images can comprise an image including distance measurements. The one or more augmented images can comprise an image that identifies tissue that has been ablated and / or expanded. The algorithm can be configured to navigate the treatment device by: determining locations of one or more portions of duodenal tissue in 3D space; and determining the location of one or more portions of the treatment device in 3D space. The system can be configured to electromagnetically navigate the treatment device. The system can further comprise a functional element comprising one or more electromagnetically-locatable markers positioned at one or more anatomical locations, and the one or more markers can be sensed by the system. The one or more locations can comprise: the pylorus, the papilla, the ampulla of Vater, and / or the ligament of Treitz. The one or more electromagnetically-locatable markers can comprise passive and / or active markers. The treatment device can comprise a shape-sensing element. The algorithm can be configured to determine the anatomical location of the treatment device based on data previously collected at that anatomical location. The system can be configured to provide a 3D image of the anatomy that includes the current position of the treatment device. The treatment device can comprise one or more optical shape sensing components that each produce a signal, and the algorithm can be configured to use the signals produced to manipulate the functional assembly and / or to manipulate another component of the treatment device. The algorithm can compare the current position of the functional assembly to a previous position of the functional assembly. The algorithm can perform the comparison based on the 3D shape of the treatment device at each position. The algorithm can comprise a simultaneous localization and mapping (SLAM) algorithm. The system can further comprise one or more imaging components configured to capture a sequence of images, and the algorithm can be configured to determine a path of the imaging component and / or a position of the imaging component based on the sequence of images. The algorithm can be configured to alert an operator when the functional assembly has translated a desired distance. The treatment device can comprise a functional element comprising a first inertial measurement unit, and the algorithm can be configured to determine a 3D path of the functional assembly and / or a 3D path of another portion of the treatment device based on signals provided by the first inertial measurement unit. The functional element can be positioned within 3cm, 2cm, and / or 1cm from the distal end of the treatment device. The functional element can further comprise a second inertial measurement unit, and the second inertial measurement unit can be positioned at least 10cm, 15cm, and / or 20cm proximal to the first inertial measurement unit.

[0035]

[0031] In some embodiments, the system further comprises a console configured to operably attach to the treatment device. The console can comprise at least one functional element. The console can comprise a user interface comprising a display. The system can be configured to provide images of the patient’s anatomy on the display. The system can be further configured to allow an operator to annotate the images. The annotation can comprise a marking of the papilla location on the image.

[0036]

[0032] In some embodiments, the system further comprises a body access device including a distal portion with a distal end. The body access device can comprise an endoscope or endoscope-like device. The body access device can comprise a single use disposable endoscope or other single use disposable device. The body access device can comprise a working channel, and the treatment device can be configured to be inserted through the working channel. The treatment device can be configured to pass alongside the body access device. The body access device can comprise a working channel diameter of at least 6.5mm, 7.0mm, and / or 7.5mm. The body access device can comprise an outer diameter of no more than 17mm, 15mm, and / or 13mm. The body access device can comprise a working channel diameter of no more than 2.8mm, 2.5mm, and / or 2.3mm. The body access device can comprise a working length of at least 900mm, or at least 1000mm. The distal portion of the body access device can comprise a central axis, and the distal end of the body access device can comprise a surface that is non-orthogonal to the central axis. The surface can be at an angle of at least 15°, 25°, 35°, and / or 60° to a plane that is orthogonal to the central axis. The surface can be at an angle of no more than 60°, 50°, and / or 40° to a plane that is orthogonal to the central axis. The body access device can comprise a camera oriented in an off-axis arrangement. The camera can be oriented at an angle of at least 20°, 30°, and / or 40° from a central axis of the distal portion of the body access device. The camera can be oriented at an angle no more than 30°, 45°, and / or 60° from a central axis of the distal portion of the body access device. The body access device can comprise a camera and a mirror, and the mirror can be configured to adjust the field of view of the camera to an off- axis alignment. The distal end of the body access device can comprise a surface that is non- orthogonal to a central axis of the distal portion of the body access device, and the camera field of view is orthogonal to the surface. The body access device can comprise a camera that is oriented such that the field of view of the camera is not aligned or otherwise parallel to a central axis of the distal portion of the body access device. The body access device can include a sheath. The sheath can comprise a steerable and / or shape-lockable sheath. The sheath can comprise a sheath with controllable rigidity. The body access device can include a sleeve and / or an overtube. The sleeve and / or overtube can comprise a controllably expandable element. The expandable element can comprise a balloon, a self-retaining tube, and / or an expandable coil. The sleeve and / or overtube can comprise an elastic portion, an inelastic portion, or both. The sleeve and / or overtube can be configured to stretch in a first direction and can be further configured to avoid stretching in a second direction orthogonal to the first direction. The sleeve and / or overtube can include a slidable sealing element. The sleeve and / or overtube can include a port configured for providing insufflation and / or desufflation. The body access device can include a steerable mandrel configured to be inserted into a lumen of the treatment device. The steerable mandrel can be configured to be robotically steered, manually steered, or both. The body access device can include a first cap configured to be removably attached to the distal end of the body access device. The body access device can comprise a camera, and the first cap can include a first mirror at a first angular orientation that is configured to redirect the field of view of the camera. The body access device can further comprise a second cap including a second mirror at a second angular orientation different than the first angular orientation. The first mirror can be partially transmissive, such as to allow viewing of the camera in a forward direction through the first mirror. The body access device can be configured to be removably attached to the treatment device. The body access device and the treatment device collectively can comprise a first set of mating magnetic attachment elements that magnetically attach a first location of the treatment device to a first location of the body access device. The first location of the treatment device can be within 3cm, 2cm, and / or 1cm from the distal end of the body access device. The first set of magnetic attachment elements can be configured to magnetically position the distal end of the body access device: at least 0.3cm from the functional assembly of the treatment device and / or no more than 2cm from the functional assembly of the treatment device. The system can further comprise a second set of magnetic attachment elements that magnetically attach a second location of the treatment device to a second location of the body access device. The first location of the treatment device can be at least 5cm, 10cm, and / or 20cm from the second location of the treatment device. Either or both of the magnetic attachment elements of the treatment device or the body access device can comprise magnetic elements arranged as a Hallbach cylinder with a K equal to 1.

[0037]

[0033] In some embodiments, the system further comprises an imaging assembly. The imaging assembly can comprise an imaging device selected from the group consisting of: endoscope camera; visible light camera; infrared camera; X-ray imager; fluoroscope; CT Scanner; MRI; PET Scanner; ultrasound imaging device; molecular imaging device; and combinations thereof. The treatment device can comprise at least one camera of the imaging assembly. The system can further comprise a body access device, and the body access device can comprise at least one camera of the imaging assembly.

[0038]

[0034] In some embodiments, the system further comprises a robotic assembly configured to robotically manipulate the treatment device and / or to robotically manipulate another component of the system. The treatment device can comprise at least a portion of the robotic assembly. The robotic assembly can be configured to robotically translate the treatment device a fixed distance. The fixed distance can comprise a distance of 0.50cm, 0.75cm, 1.00cm, 1.25cm, 1.50cm, 1.75cm and / or 2.00cm. The robotic assembly can be configured to robotically translate the treatment device based on a tissue detection and / or tissue identification performed by the system. The robotic assembly can be configured to perform the translation based on identification of: the papilla or other non-target tissue; expanded tissue; ablated tissue; and / or combinations thereof. The robotic assembly can be configured to robotically manipulate the functional assembly with a translation accuracy of 5mm, 4mm, and / or 3mm.

[0039]

[0035] In some embodiments, the system further comprises a network and a server, and the server is configured to receive system information from the system. The system information can comprise information selected from the group consisting of: patient information; procedural information; efficacy and / or other clinical outcome information; and combinations thereof. The system information can comprise information selected from the group consisting of: patient ID; description of one or more portions of the anatomy treated; number of treatments performed, such as number of ablations and / or other treatments performed; length of time to perform a procedure; physician ID; clinical site ID; console ID; treatment device ID; ID of a console of the system and / or a component of the console such as the ID of a heater or other component of the console; ID of an umbilical of the system; ID of an injectate or agent of the system; patient baseline data, such as age, gender, diabetes duration, concurrent medications, and / or comorbidities; and combinations thereof. The system information can comprise information selected from the group consisting of: data related to the state of the device, such as current state of the device; usage metrics for key components, such as moving parts and / or energy sources; and combinations thereof. The system can be configured to analyze the system information and provide a system software update based on the analysis. The system can be configured to analyze the system information and determine if a system component has been used improperly. The system can be configured to analyze system information and provide results data related to the analysis, and the results data can be provided to an operator of the system. The system can be configured to analyze the system information and provide a recommendation for repair and / or maintenance.

[0040]

[0036] According to another aspect of the present inventive concepts, a method of treating a patient comprises: selecting a patient having a metabolic disease, and the patient is at a baseline level of a health parameter; performing a chronic treatment to achieve a second level of the health parameter, and the second level represents an improvement in the health parameter as compared to the baseline level. After the second level of the health parameter is achieved, the method further comprises: stopping the chronic treatment; and performing an acute treatment. The acute treatment comprises: performing a tissue treatment procedure on target tissue of the duodenum of the patient, and at the time the acute treatment is performed, the patient is at a third level of the health parameter, and the third level represents an improvement in the health parameter as compared to the baseline level. After a minimum time period since the performance of the acute treatment, the patient is at a fourth level of the health parameter that represents an improvement in the health parameter as compared to the baseline level.

[0041]

[0037] In some embodiments, the minimum time period comprises a time period of at least 3 months. The minimum time period can comprise a time period of at least 6 months. The minimum time period can comprise a time period of at least 9 months. The minimum time period can comprise a time period of at least 12 months.

[0042]

[0038] In some embodiments, the chronic treatment comprises a treatment selected from the group consisting of: low calorie diet; low carbohydrate diet; low fat diet; a diet intended to improve a metabolic disease; an exercise regimen; a diet intended to achieve weight loss; a lifestyle management program; an intensive lifestyle management program; a medication regimen such as a regimen taken daily, weekly, and / or monthly; and combinations thereof. The chronic treatment can comprise two or more treatments selected from the group consisting of: low calorie diet; low carbohydrate diet; low fat diet; a diet intended to improve a metabolic disease; a diet intended to achieve weight loss; an exercise regimen; a lifestyle management program; an intensive lifestyle management program; and / or a medication regimen such as a regimen taken once per day, once per month, once every 3 months, and / or once every six months.

[0043]

[0039] In some embodiments, the chronic treatment comprises a a bariatric endoscopy procedure in which a device is implanted. The device can comprise a device selected from the group consisting of: intragastric balloon; stomach volume-occupying device; gastrointestinal bypass liner; sutures; pledgets; and combinations thereof.

[0044]

[0040] In some embodiments, the chronic treatment is performed for at least 30 days, 60 days, and / or 90 days.

[0045]

[0041] In some embodiments, the chronic treatment is performed for no more than 3 months, 6 months, and / or 1 year.

[0046]

[0042] In some embodiments, the chronic treatment is stopped prior to performing the acute treatment.

[0047]

[0043] In some embodiments, the chronic treatment id stopped after performing the acute treatment. The chronic treatment can be stopped at least 1 week after performing the acute treatment. The chronic treatment can be stopped at least 1 month after performing the acute treatment.

[0048]

[0044] In some embodiments, the fourth level improvement represents at least 10%, 25%, and / or 50% of the third level improvement.

[0045] In some embodiments, the fourth level improvement represents at least 10%, 25%, and / or 50% of the second level improvement.

[0049]

[0046] In some embodiments, an improvement over the baseline level comprises a reduction in the level of the health parameter, and the fourth level improvement represents a reduction in the health parameter comprising a magnitude of at least 5%, 10%, 25%, and / or 50% of the difference between the baseline level and a target level. The target level can represent a normal level for the patient.

[0050]

[0047] In some embodiments, an improvement over the baseline level comprises an increase in the level of the health parameter, and the fourth level improvement represents an increase in the health parameter comprising a magnitude of at least 5%, 10%, 25%, and / or 50% of the difference between a target level and the baseline level. The target level can represent a normal level for the patient.

[0051]

[0048] In some embodiments, the health parameter comprises body weight. The fourth level can represent an improvement over baseline comprising a body weight loss of at least 5 pounds, 10 pounds, and / or 20 pounds. The fourth level can represent an improvement over baseline comprising at least 3%, 5%, and / or 10%, in body weight loss percentage.

[0052]

[0049] In some embodiments, the health parameter comprises HbAlc level. The fourth level can represent an improvement over baseline comprising a reduction in HbAlc level of at least 0.3%, 0.5%, and / or 1.0%.

[0053]

[0050] In some embodiments, the health parameter comprises fasting plasma glucose level. The fourth level can represent an improvement over baseline comprising a reduction in fasting plasma glucose level of at least 9mg / dL, 18mg / dL, and / or 30mg / dL.

[0054]

[0051] In some embodiments, the health parameter comprises a requirement for daily insulin intake. The fourth level can represent an improvement over baseline comprising a reduction in daily insulin intake of at least 10 units / day, 20 units / day, and / or 30 units / day.

[0055]

[0052] In some embodiments, the health parameter comprises level of expression of SGLT1 transporters in the intestinal mucosa. The fourth level improvement can represent an improvement over baseline comprising a reduction of at least 10%, 25%, 30%, 40%, and / or 50% under the baseline level of the level of expression of SGLT1 transporters in the intestinal mucosa.

[0056]

[0053] In some embodiments, the health parameter comprises level of expression of SGLT1 transporters in the enteroendocrine cells. The fourth level improvement can represent an improvement over baseline comprising a reduction of at least 10%, 25%, 30%, 40%, and / or 50% under the baseline level of the level of expression of SGLT1 transporters in the enteroendocrine cells.

[0057]

[0054] In some embodiments, the health parameter comprises level of expression of GLUT2 transporters in the intestinal mucosa. The fourth level improvement can represent an improvement over baseline comprising a reduction of at least a 10%, 25%, 30%, 40%, and / or 50% under the baseline level of the level of expression of GLUT2 transporters in the intestinal mucosa.

[0058]

[0055] In some embodiments, the health parameter comprises level of expression of GLUT2 transporters in the enteroendocrine cells. The fourth level improvement can represent an improvement over baseline comprising a reduction of at least a 10%, 25%, 30%, 40%, and / or 50% under the baseline level of the level of expression of GLUT2 transporters in the enteroendocrine cells.

[0059]

[0056] In some embodiments, the health parameter comprises level of expression of GLUT5 transporters in the intestinal mucosa. The fourth level improvement can represent an improvement over baseline comprising a reduction of at least a 10%, 25%, 30%, 40%, and / or 50% under the baseline level of the level of expression of GLUT5 transporters in the intestinal mucosa.

[0060]

[0057] In some embodiments, the health parameter comprises level of expression of GLUT5 transporters in the enteroendocrine cells. The fourth level improvement can represent an improvement over baseline comprising a reduction of at least a 10%, 25%, 30%, 40%, and / or 50% under the baseline level of the level of expression of GLUT5 transporters in the enteroendocrine cells.

[0061]

[0058] In some embodiments, the health parameter comprises liver fat fraction level. The liver fat fraction can comprise liver fat fraction as measured by MRI-PDFF. The fourth level can represent an improvement over baseline comprising a reduction in liver fat fraction of at least 10%, 20%, and / or 30%.

[0062]

[0059] In some embodiments, the health parameter comprises Homa-IR level. The fourth level can represent an improvement over baseline comprising a reduction in Homa-IR level of at least 10%, 15%, and / or 25%.

[0063]

[0060] In some embodiments, the health parameter comprises a triglyceride level. The fourth level can represent an improvement over baseline comprising a reduction of the triglyceride level of at least 10%, 20%, and / or 25%.

[0061] In some embodiments, the health parameter comprises HDL cholesterol level. The fourth level can represent an improvement over baseline comprising an increase in HDL cholesterol level of at least 5%, 10%, and / or 15%.

[0064]

[0062] In some embodiments, the health parameter comprises systolic blood pressure level. The fourth level can represent an improvement over baseline comprising a reduction in systolic blood pressure level of at least 3mmHg, 5mmHg, and / or lOmmHg.

[0065]

[0063] In some embodiments, the health parameter comprises diastolic blood pressure level. The fourth level can represent an improvement over baseline comprising a reduction in diastolic blood pressure level of at least 2mmHg, 3mmHg, and / or 5mmHg.

[0066]

[0064] In some embodiments, the health parameter comprises two or more health parameters. The two or more health parameters can comprise two or more health parameters selected from the group consisting of: body weight; HbAlc level; fasting plasma glucose level; a requirement for daily insulin intake; expression of SGLT1 transporters in the intestinal mucosa; expression of GLUT2 transporters in the intestinal mucosa; expression of GLUT 5 transporters in the intestinal mucosa; liver fat fraction; Homa-IR; triglyceride levels; HDL cholesterol levels; systolic blood pressure; diastolic blood pressure; and combinations thereof.

[0067]

[0065] In some embodiments, the health parameter comprises three or more health parameters. The three or more health parameters can comprise three or more health parameters selected from the group consisting of: body weight; HbAlc level; fasting plasma glucose level; a requirement for daily insulin intake; expression of SGLT1 transporters in the intestinal mucosa; expression of GLUT2 transporters in the intestinal mucosa; expression of GLUT 5 transporters in the intestinal mucosa; liver fat fraction; Homa-IR; triglyceride levels; HDL cholesterol levels; systolic blood pressure; diastolic blood pressure; and combinations thereof.

[0068]

[0066] In some embodiments, the second level comprises a level that is at least a 5%, 10%, 25%, and / or 50% improvement over the baseline level.

[0069]

[0067] In some embodiments, the third level comprises a level that is at least a 5%, 10%, 25%, and / or 50% improvement over the baseline level.

[0070]

[0068] In some embodiments, the metabolic disease comprises at least insulin resistance.

[0071]

[0069] In some embodiments, the metabolic disease comprises at least type 2 diabetes.

[0072]

[0070] In some embodiments, the metabolic disease comprises at least obesity.

[0073]

[0071] In some embodiments, the metabolic disease comprises one, two, or more medical conditions selected from the group consisting of: insulin resistance; type 2 diabetes; type 1 diabetes; double diabetes; gestational diabetes; hyperglycemia; pre-diabetes; impaired glucose tolerance; non-alcoholic fatty liver disease; non-alcoholic steatohepatitis; obesity; an obesity-related disorder; polycystic ovarian syndrome; hypertriglyceridemia; hypercholesterolemia; psoriasis; GERD; coronary artery disease; stroke; TIA; cognitive decline or dementia, such as Alzheimer’s disease; diabetic nephropathy; neuropathy; retinopathy; diabetic heart disease and / or heart failure; and combinations thereof.

[0074]

[0072] In some embodiments, the patient selected for treatment comprises one, two, three, and / or all of the following criteria: presence of diabetes; daily long-acting insulin requirement of between 20 units and 60 units; receives metformin; and / or an HbAlc level of greater than 7.5.

[0075]

[0073] In some embodiments, after the acute treatment, the method further comprises: a pharmaceutical treatment of SGLT2i / Empagliflozin comprising a lOmg initial dose given to the patient on Day 1 after the tissue treatment, and the dose is increased to 25mg by Day 15 post the tissue treatment.

[0076]

[0074] In some embodiments, the after the acute treatment, the method further comprises a pharmaceutical treatment of GLP- 1.

[0077]

[0075] In some embodiments, the target tissue to be treated comprises duodenal mucosa. The tissue treatment can comprise ablation and / or removal of the duodenal mucosa. The tissue treatment can comprise a hot fluid ablation treatment. The tissue treatment can comprise an irreversible electroporation treatment. The tissue treatment can comprise a treatment with an energy form selected from the group consisting of: electromagnetic energy, such as radiofrequency energy; electroporation energy, such as irreversible electroporation energy; light energy, such as laser light energy; sound energy, such as high intensity focused ultrasound energy and / or other ultrasound energy; mechanical energy, such as mechanical energy configured to abrade and / or remove tissue; thermal energy, such as heat energy and / or cryogenic energy; steam energy; chemical energy; and combinations thereof. The tissue treatment can comprise treatment with a chemical agent. The chemical agent can comprise an acid, base, and / or other chemical agent configured to cause necrosis of tissue.

[0078]

[0076] In some embodiments, the tissue treatment comprised treatment of nerves of the duodenum. The treatment of nerves can comprise treatment of vagal afferent mechanoreceptors and / or vagal afferent chemoreceptors. The treatment of nerves alter vagal afferent nutrient sensing and / or signaling.

[0077] In some embodiments, the tissue treatment comprises treatment of a cumulative axial length of duodenum of at least 3cm. The tissue treatment can comprise treatment of a cumulative axial length of duodenum of at least 6cm, 8cm, and / or 9cm.

[0079]

[0078] In some embodiments, the tissue treatment comprises treatment of at least 30%, 40%, and / or 50% of the post-papillary duodenal mucosa.

[0080]

[0079] In some embodiments, the tissue treatment comprises treatment of cumulative duodenal mucosa surface area of at least 9.42cm2. The tissue treatment can comprise treatment of cumulative duodenal mucosa surface area of at least 18.84cm2 and / or 28.27 cm2.

[0081]

[0080] In some embodiments, the tissue treatment comprised treatment of duodenal mucosal tissue within 5.0cm of the papilla. The tissue treatment can comprise treatment of duodenal mucosal tissue within 3.0cm, 2.0cm, 1.0cm, and / or 0.5cm of the papilla.

[0082]

[0081] In some embodiments, the tissue treatment comprises expanding submucosal tissue proximate the target tissue to be treated.

[0083]

[0082] In some embodiments, the tissue treatment comprises treating two or more axial segments of duodenum. No pairs of the two or more axial segments treated cam overlap. No pairs of the two or more axial segments treated can overlap more than 10% of the length of any axial segment treated. One or more pairs of the two or more axial segments treated can overlap. One or more pairs of the two or more axial segments treated can overlap at least 5% of the length of either axial segment of the pair.

[0084]

[0083] In some embodiments, the tissue treatment is performed using a catheter comprising a treatment assembly configured to expand submucosal tissue and ablate mucosal tissue, and the tissue treatment comprises: translating the treatment assembly to a first location in the duodenum; expanding submucosal tissue at the first location via the treatment assembly; translating the treatment assembly to a second location in the duodenum, the second location neighboring the first location; expanding submucosal tissue at the second location via the treatment assembly; and ablating a first axial segment of the duodenum via the treatment assembly, and the first axial segment comprises the first location and the second location. The tissue treatment can further comprise: translating the treatment assembly to a third location in the duodenum, the third location neighboring the second location; expanding submucosal tissue at the third location via the treatment assembly; and ablating a second axial segment of the duodenum via the treatment assembly, and the second axial segment can comprise the first location and the second location. The second axial segment can overlap the first axial segment by at least 5%, 10%, and / or 15% of the length of the second axial segment. The second axial segment can overlap the first axial segment by at least 30%, 40%, and / or 50% of the length of the second axial segment. The tissue treatment can further comprise: translating the treatment assembly to a third location in the duodenum, the third axial segment neighboring the second axial segment; expanding submucosal tissue at the third axial segment via the treatment assembly; ablating a second axial segment of the duodenum via the treatment assembly, and the second axial segment can comprise the second location and the third location. The tissue treatment can further comprise: translating the treatment assembly to a third location in the duodenum, the third axial segment neighboring the second axial segment; expanding submucosal tissue at the third axial segment via the treatment assembly; translating the treatment assembly to a fourth location in the duodenum, the fourth axial segment neighboring the third axial segment; expanding submucosal tissue at the fourth axial segment via the treatment assembly; ablating a second axial segment of the duodenum via the treatment assembly, and the second axial segment can comprise the third location and the fourth location.

[0085]

[0084] In some embodiments, the tissue treatment is performed using a catheter comprising a treatment assembly configured to ablate and / or otherwise treat mucosal tissue, and the tissue treatment comprises: translating the treatment assembly to a first axial segment of the duodenum; with the treatment assembly in an expanded state, ablating and / or otherwise treating the first axial segment; without compacting the treatment assembly, translating the treatment assembly to a second axial segment; and ablating and / or otherwise treating the second axial segment. The treatment assembly in an expanded state can comprise the treatment assembly being expanded to a diameter of at least 24mm.

[0086]

[0085] According to another aspect of the present inventive concepts, a method of treating a patient comprises: selecting a patient for treatment; performing a chronic treatment comprising: a weight loss diet; a lifestyle program focused on weight loss; and / or a weight loss pharmacotherapy program; performing an acute treatment comprising: performing a tissue treatment procedure on the duodenum of the patient; and stopping the chronic treatment. The patient is at a baseline level of body weight at the time the chronic treatment is initiated, and the patient is at a second level of body weight at the time the chronic treatment is stopped, the second level of body weight less than the baseline level of body weight, and the difference between the baseline level and the second level represents an initial body weight loss. After a minimum time period after the stopping of the chronic treatment, the patient is at a third level of body weight, the third level of body weight less than the baseline level of body weight, and the difference between the baseline level and the third level represents a maintained body weight loss.

[0087]

[0086] In some embodiments, the maintained body weight loss is at least 5% of the initial body weight loss. The minimum time period can comprise a time period of at least 6 months. The minimum time period can comprise a time period of at least 12 months.

[0088]

[0087] In some embodiments, the maintained body weight loss is at least 10% of the initial body weight loss. The minimum time period can comprise a time period of at least 6 months. The minimum time period can comprise a time period of at least 12 months.

[0089]

[0088] In some embodiments, the acute treatment is performed prior to the chronic treatment being stopped.

[0090]

[0089] In some embodiments, the chronic treatment is stopped at least 1 month after the acute treatment is performed. The chronic treatment can be stopped at least 2 weeks and / or at least 4 weeks after the acute treatment is performed.

[0091]

[0090] In some embodiments, the chronic treatment is stopped after the patient has reached a plateau level of weight loss.

[0092]

[0091] In some embodiments, the method is configured to improve a health benefit selected from the group consisting of: HbAlC level; fasting plasma glucose level; requirement for daily insulin intake; level of expression of SGLT1 transporters in the intestinal mucosa; level of expression of SGLT1 transporters in the enteroendocrine cells; level of expression of GLUT2 transporters in the intestinal mucosa; level of expression of GLUT2 transporters in the enteroendocrine cells; level of expression of GLUT5 transporters in the intestinal mucosa; level of expression of GLUT5 transporters in the enteroendocrine cells; liver fat fraction level; Home-IR level; a triglyceride level HDL cholesterol level; systolic blood pressure level; diastolic blood pressure level; and combinations thereof.

[0093]

[0092] In some embodiments, the method is configured to treat a medical conditions selected from the group consisting of: insulin resistance; type 2 diabetes; type 1 diabetes; double diabetes; gestational diabetes; hyperglycemia; pre-diabetes; impaired glucose tolerance; non-alcoholic fatty liver disease; non-alcoholic steatohepatitis; obesity; an obesity- related disorder; polycystic ovarian syndrome; hypertriglyceridemia; hypercholesterolemia; psoriasis; GERD; coronary artery disease; stroke; TIA; cognitive decline or dementia, such as Alzheimer’s disease; diabetic nephropathy; neuropathy; retinopathy; diabetic heart disease and / or heart failure; and combinations thereof

[0094]

[0093] In some embodiments, the patient selected for treatment comprises one, two, three, and / or all of the following criteria: presence of diabetes; daily long-acting insulin requirement of between 20 units and 60 units; receives metformin; and / or an HbAlc level of greater than 7.5.

[0095]

[0094] In some embodiments, the target tissue to be treated comprised duodenal mucosa. The tissue treatment can comprise ablation and / or removal of the duodenal mucosa. The tissue treatment can comprise a hot fluid ablation treatment. The tissue treatment can comprise an irreversible electroporation treatment. The tissue treatment can comprise a treatment with an energy form selected from the group consisting of: electromagnetic energy, such as radiofrequency energy; electroporation energy, such as irreversible electroporation energy; light energy, such as laser light energy; sound energy, such as high intensity focused ultrasound energy and / or other ultrasound energy; mechanical energy, such as mechanical energy configured to abrade and / or remove tissue; thermal energy, such as heat energy and / or cryogenic energy; steam energy; chemical energy; and combinations thereof. The tissue treatment can comprise treatment with a chemical agent. The chemical agent can comprise an acid, base, and / or other chemical agent configured to cause necrosis of tissue.

[0096]

[0095] In some embodiments, the tissue treatment comprises treatment of nerves of the duodenum.

[0097]

[0096] In some embodiments, the tissue treatment comprises treatment of a cumulative axial length of duodenum of at least 3cm. The tissue treatment can comprise treatment of a cumulative axial length of duodenum of at least 6cm, 8cm, and / or 9cm.

[0098]

[0097] In some embodiments, the tissue treatment comprises treatment of at least 30%, 40%, and / or 50% of the post-papillary duodenal mucosa.

[0099]

[0098] In some embodiments, the tissue treatment comprises treatment of cumulative duodenal mucosa surface area of at least 9.42cm2. The tissue treatment can comprise treatment of cumulative duodenal mucosa surface area of at least 18.84cm2 and / or 28.27 cm2.

[0100]

[0099] In some embodiments, the tissue treatment comprises treatment of duodenal mucosal tissue within 5.0cm of the papilla. The tissue treatment can comprise treatment of duodenal mucosal tissue within 3.0cm, 2.0cm, 1.0cm, and / or 0.5cm of the papilla.

[0101]

[0100] In some embodiments, the tissue treatment comprises expanding submucosal tissue proximate the target tissue to be treated.

[0102]

[0101] In some embodiments, the tissue treatment comprises treating two or more axial segments of duodenum. No pairs of the two or more axial segments treated can overlap. No pairs of the two or more axial segments treated can overlap more than 10% of the length of any axial segment treated. One or more pairs of the two or more axial segments treated can overlap. One or more pairs of the two or more axial segments treated can overlap at least 5% of the length of either axial segment of the pair.

[0103]

[0102] In some embodiments, the tissue treatment is performed using a catheter comprising a treatment assembly configured to expand submucosal tissue and ablate mucosal tissue, and the tissue treatment comprises: translating the treatment assembly to a first location in the duodenum; expanding submucosal tissue at the first location via the treatment assembly; translating the treatment assembly to a second location in the duodenum, the second location neighboring the first location; expanding submucosal tissue at the second location via the treatment assembly; and ablating a first axial segment of the duodenum via the treatment assembly, and the first axial segment comprises the first location and the second location. The tissue treatment can further comprise: translating the treatment assembly to a third location in the duodenum, the third location neighboring the second location; expanding submucosal tissue at the third location via the treatment assembly; and ablating a second axial segment of the duodenum via the treatment assembly, and the second axial segment can comprise the first location and the second location. The second axial segment can overlap the first axial segment by at least 5%, 10%, and / or 15% of the length of the second axial segment. The second axial segment can overlap the first axial segment by at least 30%, 40%, and / or 50% of the length of the second axial segment.

[0104]

[0103] According to another aspect of the present inventive concepts, a method of treating a patient comprises: selecting a patient for treatment; and performing an acute treatment. The acute treatment comprises: performing a tissue treatment procedure on target tissue of the duodenum of the patient. The acute treatment is configured to cause a resultant weight loss in the patient.

[0105]

[0104] In some embodiments, the resultant weight loss comprises a weight loss equating to a minimum percentage of the patient’s body weight, such as a percentage of at least 1.0%, 2.0% and / or 3.0% of the patient's body weight. The resultant weight loss can be present at least 1 month, 3 months, 6 months, and / or 9 months after the performance of the acute treatment.

[0106]

[0105] According to another aspect of the present inventive concepts, a method of treating a patient comprises: selecting a patient for treatment; performing a chronic treatment that achieves a first quantity of weight loss; and performing an acute treatment. The acute treatment comprises: performing a tissue treatment procedure on target tissue of the duodenum of the patient. The acute treatment is configured to maintain a minimum portion of the first quantity of weight loss to be maintained for a minimum time period.

[0106] In some embodiments, the chronic treatment comprises a treatment selected from the group consisting of: low calorie diet; low carbohydrate diet; low fat diet; a diet intended to improve a metabolic disease; a diet intended to achieve weight loss; an exercise regimen; a lifestyle management program; an intensive lifestyle management program; a medication regimen such as a regimen taken daily, weekly, and / or monthly; and combinations thereof.

[0107]

[0107] In some embodiments, the first quantity of weight loss comprises a weight loss of at least 5kg, 10kg, 15kg, and / or 20kg.

[0108]

[0108] In some embodiments, the minimum portion of the first quantity of weight loss comprises at least 25%, 50%, or 75% of the first quantity of weight loss. The minimum time period can comprise at least 1 month, 3 months, and / or 6 months.

[0109]

[0109] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example.

[0110] INCORPORATION BY REFERENCE

[0111]

[0110] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. The content of all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety for all purposes.

[0112] BRIEF DESCRIPTION OF THE DRAWINGS

[0113]

[0111] Fig. 1 illustrates a system for treating and / or diagnosing gastrointestinal tissue, consistent with the present inventive concepts.

[0114]

[0112] Fig. 1A illustrates a schematic view of a system for performing a medical procedure in the intestine of a patient, consistent with the present inventive concepts.

[0115]

[0113] Fig. IB illustrates a flow chart of a method of treating target tissue of a patient, consistent with the present inventive concepts.

[0116]

[0114] Fig. 1C illustrates a sectional anatomical view of a treatment device inserted into a gastrointestinal lumen, consistent with the present inventive concepts.

[0117]

[0115] Fig. ID illustrates a schematic view of a robotically controlled system for treating and / or diagnosing gastrointestinal tissue, consistent with the present inventive concepts.

[0116] Figs. 2A and 2B illustrate schematic views of a treatment device inserted into a patient with the treatment device shown in an anatomical shape, consistent with the present inventive concepts.

[0118]

[0117] Figs. 3A and 3B illustrate a side view and an end view of the distal portion of a device for treating tissue, consistent with the present inventive concepts.

[0119]

[0118] Fig. 4 illustrates a perspective view of a portion of a shaft assembly of a device for treating tissue, consistent with the present inventive concepts.

[0120]

[0119] Fig. 5 illustrates a sectional end view of a portion of a shaft assembly of a device for treating tissue, consistent with the present inventive concepts.

[0121]

[0120] Fig. 6A illustrates a flow chart of a method for treating a patient, consistent with the present inventive concepts.

[0122]

[0121] Fig. 6B illustrates a flow chart of another method for treating a patient, consistent with the present inventive concepts.

[0123]

[0122] Figs. 7A-7B illustrate two charts of a data set representing an aggregate of clinical results from five human clinical trials conducted by applicant, consistent with the present inventive concepts.

[0124]

[0123] Figs. 8A-8B illustrate two charts of a data set representing an aggregate of clinical results from three human clinical trials conducted by applicant, consistent with the present inventive concepts.

[0125] DETAILED DESCRIPTION OF THE DRAWINGS

[0126]

[0124] Reference will now be made in detail to the present embodiments of the technology, examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and / or alternatives of the embodiments described herein.

[0127]

[0125] It will be understood that the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") or "containing" (and any form of containing, such as "contains" and "contain") when used herein, specify the presence of 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.

[0126] It will be further understood that, although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers and / or sections, these limitations, elements, components, regions, layers and / or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.

[0128]

[0127] It will be further understood that when an element is referred to as being "on", "attached", "connected" or "coupled" to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being "directly on", "directly attached", "directly connected" or "directly coupled" to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g. "between" versus "directly between," "adjacent" versus "directly adjacent," etc.).

[0129]

[0128] As used herein, the terms “operably attached”, “operably connected”, and similar terms related to attachment of components shall refer to attachment of two or more components that results in one, two, or more of: electrical attachment; fluid attachment; magnetic attachment; mechanical attachment; optical attachment; sonic attachment; and / or other operable attachment arrangements. The operable attachment of two or more components can facilitate the transmission between the two or more components of: power; signals; electrical energy; fluids or other flowable materials; magnetism; mechanical linkages; light; sound such as ultrasound; and / or other materials and / or components.

[0130]

[0129] It will be further understood that when a first element is referred to as being "in", "on" and / or "within" a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g. within a wall of the second element); positioned on an external and / or internal surface of the second element; and combinations of one or more of these.

[0131]

[0130] As used herein, the term “proximate”, when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and / or within the second component or location. For example, a component positioned proximate an anatomical site (e.g. a target tissue location), shall include components positioned near to the anatomical site, as well as components positioned in, on and / or within the anatomical site.

[0132]

[0131] Spatially relative terms, such as "beneath," "below," "lower," "above," "upper" and the like may be used to describe an element and / or feature's relationship to another element(s) and / or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and / or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as "below" and / or "beneath" other elements or features would then be oriented "above" the other elements or features. The device can be otherwise oriented (e.g. rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0133]

[0132] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence. Correspondingly, the terms “prevent”, “preventing”, and “prevention” shall include the acts of “reduce”, “reducing”, and “reduction”, respectively.

[0134]

[0133] The term "and / or" where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example "A and / or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[0135]

[0134] The term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number.

[0136]

[0135] The terms “and combinations thereof’ and “and combinations of these” can each be used herein after a list of items that are to be included singly or collectively. For example, a component, process, and / or other item selected from the group consisting of: A; B; C; and combinations thereof, shall include a set of one or more components that comprise: 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.

[0137]

[0136] In this specification, unless explicitly stated otherwise, “and” can mean “or”, and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature can 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, the feature can have only one or two of A, B, or C.

[0138]

[0137] As used herein, when a quantifiable parameter is described as having a value “between” a first value X and a second value Y, it shall include the parameter having a value of: at least X, no more than Y, and / or at least X and no more than Y. For example, a length of between 1 and 10 shall 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 values greater than 1 and less than 10.

[0139]

[0138] The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of’ according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component.

[0140]

[0139] As used herein, the terms “about” or “approximately” shall refer to ±10%.

[0141]

[0140] As used herein, the term “threshold” refers to a maximum level, a minimum level, and / or range of values correlating to a desired or undesired state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values, such as to cause a desired effect (e.g. efficacious therapy) and / or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g. a device and / or clinical adverse event). In some embodiments, a system parameter is maintained above a first threshold (e.g. above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g. below a second temperature threshold to prevent undesired tissue damage). In some embodiments, a threshold value is determined to include a safety margin, such as to account for patient variability, system variability, tolerances, and the like. As used herein, “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and / or outside of a range of threshold values.

[0142]

[0141] As described herein, “room pressure” shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. Positive pressure includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. Negative pressure includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described hereabove.

[0142] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross sectional area as the cross section of the component being described.

[0143]

[0143] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.

[0144]

[0144] As used herein, the term “functional element” is to be taken to include one or more elements constructed and arranged to perform a function. A functional element can comprise a sensor and / or a transducer. In some embodiments, a functional element is configured to deliver energy and / or otherwise treat tissue (e.g. a functional element configured as a treatment element). Alternatively or additionally, a functional element (e.g. a functional element comprising a sensor) can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter (e.g. a tissue geometry parameter); a patient environment parameter; and / or a system parameter. In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g. to gather data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g. to deliver therapeutic energy and / or a therapeutic agent). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of: deliver energy; extract energy (e.g. to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record or otherwise sense a parameter such as a patient physiologic parameter or a system parameter; and combinations of one or more of these. A functional element can comprise a fluid and / or a fluid delivery system. A functional element can comprise a reservoir, such as an expandable balloon or other fluid-maintaining reservoir. A “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as a diagnostic and / or therapeutic function. A functional assembly can comprise an expandable assembly. A functional assembly can comprise one or more functional elements.

[0145]

[0145] The term “transducer” where used herein is to be taken to include any component or combination of components that receives energy or any input, and produces an output. For example, a transducer can include an electrode that receives electrical energy, and distributes the electrical energy to tissue (e.g. based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g. a transducer comprising a light emitting diode or light bulb), sound (e.g. a transducer comprising a piezo crystal configured to deliver ultrasound energy); pressure (e.g. an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g. a transducer comprising a motor or a solenoid); magnetic energy; and / or a different electrical signal (e.g. different than the input signal to the transducer). Alternatively or additionally, a transducer can convert a physical quantity (e.g. variations in a physical quantity) into an electrical signal. A transducer can include any component that delivers energy and / or an agent to tissue, such as a transducer configured to deliver one or more of: electrical energy to tissue (e.g. a transducer comprising one or more electrodes); light energy to tissue (e.g. a transducer comprising a laser, light emitting diode and / or optical component such as a lens or prism); mechanical energy to tissue (e.g. a transducer comprising a tissue manipulating element); sound energy to tissue (e.g. a transducer comprising a piezo crystal); chemical energy; electromagnetic energy; magnetic energy; and combinations of one or more of these.

[0146]

[0146] As used herein, the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and / or opening.

[0147]

[0147] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials.

[0148]

[0148] As used herein, the term “normal level” refers to the level of a physiologic parameter that would be expected to be found in human subjects that are not afflicted with the disease or disorder being treated by the systems and / or methods of the present inventive concepts. The normal level can be associated with human subjects (e.g. healthy human subjects) that are of similar age, race, and / or sex as the patient being treated by the systems and / or methods of the present inventive concepts.

[0149]

[0149] As used herein, the term “plateau level” refers to a stable level of a physiologic parameter that results after a period of adjustment or treatment, and which remains relatively constant over a period of time (e.g., a period of time above a threshold). A plateau level does not necessarily align with a normal level typically observed in healthy individuals, but is indicative of a state of equilibrium in the patient's condition (e.g., a state of equilibrium of a particular health parameter of a patient). The plateau level may reflect a new baseline for the patient, particularly in the context of chronic conditions or following long-term therapy, and a plateau level can vary based on individual factors such as age, race, sex, and specific health circumstances. A plateau level is significant in assessing the effectiveness of a treatment or the progression of a disease and / or disorder being treated (e.g., treated by the systems and / or methods of the present inventive concepts).

[0150]

[0150] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.

[0151]

[0151] It is to be understood that at least some of the figures and descriptions of the invention have been simplified to focus on elements that are relevant for a clear understanding of the invention, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the invention. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the invention, a description of such elements is not provided herein.

[0152]

[0152] Terms defined in the present disclosure are only used for describing specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in singular forms are intended to include plural forms as well, unless the context clearly indicates otherwise. All of the terms used herein, including technical or scientific terms, have the same meanings as those generally understood by an ordinary person skilled in the related art, unless otherwise defined herein. Terms defined in a generally used dictionary should be interpreted as having meanings that are the same as or similar to the contextual meanings of the relevant technology and should not be interpreted as having ideal or exaggerated meanings, unless expressly so defined herein. In some cases, terms defined in the present disclosure should not be interpreted to exclude the embodiments of the present disclosure.

[0153]

[0153] Provided herein are systems, devices and method for performing medical procedures in the intestine of a patient. A system can comprise an elongate device and a console. The elongate device can comprise a proximal portion, a middle portion, and a distal portion. The elongate device can further comprise a functional assembly positioned on the distal portion, where the functional assembly is configured to treat and / or diagnose target tissue. The console can be configured to robotically manipulate one or more of portions of the elongate device and / or the functional assembly.

[0154] Referring now to Fig. 1, a system for treating and / or diagnosing (“treating” herein) gastrointestinal tissue is illustrated, consistent with the present inventive concepts. System 10 is configured to treat and / or diagnose a patient such as a human or other mammal. System 10 includes console 100 that operably attaches to one or more elongate treatment devices, device 200, as shown. In some embodiments, device 200 comprises one or more treatment devices configured to be robotically manipulated by console 100 (e.g. by an operator using console 100), such as when a device 200 comprises one or more mechanical linkages, control cables, actuators (e.g. linear and / or rotary actuators), and / or other activatable motion-causing components. In some embodiments, device 200 is configured to be robotically manipulated as described in applicant’s co-pending United States Patent Application Serial Number 17 / 863,016 (Attorney Docket No. 41714-722.301; Client Docket No. MCT-051-US), entitled “Automated Tissue Treatment Devices, Systems, and Methods”, filed July 12, 2022 and / or otherwise herein. Console 100 comprises controller 1500 shown, comprising one or more electronic assemblies for controlling one or more assemblies and / or other components of console 100. System 10 and device 200 can be used by an operator (e.g. one or more clinicians) to perform a medical procedure, such as a therapeutic procedure and / or a diagnostic procedure. Device 200 can comprise a treatment device that is constructed and arranged to treat and / or diagnose target tissue, such as tissue of the small intestine (e.g. mucosal tissue of the duodenum and / or jejunum) and / or other locations within the gastrointestinal (GI) tract. Device 200 can be constructed and arranged to ablate or remove tissue, such as by delivering energy to tissue. Alternatively or additionally, device 200 can be constructed and arranged to expand one or more layers of tissue of the GI tract, such as when a submucosal tissue expansion procedure is performed in one axial segment of the GI tract after which an energy delivery to mucosal tissue is performed in that same axial segment. Device 200 can be constructed and arranged to treat multiple relatively contiguous axial segments (“contiguous segments” or “contiguous axial segments'4herein) or non-contiguous axial segments of the GI tract. In some embodiments, two or more axial segments of submucosal tissue of intestine are expanded, after which a single ablation procedure is performed (e.g. an ablation of a length of tissue of similar or lesser length as compared to the cumulative length of submucosal tissue expanded, such as when the length treated by a single ablation step is greater than the length expanded in a single tissue expansion step).

[0154]

[0155] Device 200 and / or other components of system 10 can be of similar construction and arrangement to the corresponding components described in applicant’ s co-pending United States Patent Application Serial Number 17 / 721,937 (Attorney Docket No. 41714- 720.301; Client Docket No. MCT-050-US), entitled “Systems, Devices, and Methods for Performing Medical Procedures in the Intestine”, filed April 15, 2022 and / or applicant’s copending United States Patent Application Serial Number 17 / 859,137 (Attorney Docket No. 41714-721.301; Client Docket No. MCT-039-US), entitled “Tissue Treatment Devices, Systems, and Methods”, filed July 7, 2022.

[0155]

[0156] In some embodiments, device 200 comprises two or more elongate devices, such as device 200a and device 200b shown in Fig. 1. In these embodiments, device 200a can comprise a body access device, such as an endoscope or other body access device (e.g. a device including one or more working channels and / or a device similar to body access device 50 described herein). Device 200b can comprise a catheter or other elongate flexible device, such as a device configured to be inserted through one or more working channels of device 200a and / or alongside device 200a. In some embodiments, device 200b is inserted through a sheath (e.g. body access device 50 described herein) that is attached to device 200a.

[0156]

[0157] In some embodiments, system 10 includes body access device 50 shown. Body access device 50 can comprise one or more body access devices, such as one, two, or more endoscopes, laparoscopic ports, sheaths, and / or other devices insertable into the patient (e.g. and providing access to one or more internal locations of the patient to a separate device inserted therethrough). In some embodiments, body access device 50 comprises a robotically manipulatable device, such as when console 100 is configured to robotically manipulate all or a portion of body access device 50, device 200, and / or one or more other system 10 components. In some embodiments, system 10 is constructed and arranged such that a single command provided to console 100 by an operator results in motion of both device 50 and one or more devices 200. In some embodiments, device 200a and device 50 comprise the same device.

[0157]

[0158] Device 200, 200a, and / or 200b (generally device 200) can comprise a length such that it can be inserted through the patient’ s mouth and into one or more locations within the stomach, the duodenum, the jejunum and / or the ileum. Device 200 can comprise a distal portion onto which an assembly, functional assembly 500, is positioned. Functional assembly 500 can comprise a treatment assembly, a diagnostic assembly, or both, and assembly 500 can be configured to diagnose, treat (e.g. expand and / or ablate), and / or otherwise perform any function on tissue, such as target tissue identified for diagnosis and / or treatment, and / or non-target tissue to be protected from ablation and / or other undesired effects.

[0159] In some embodiments, system 10 comprises one or more guidewires, such as guidewire 60 shown. In these embodiments, device 200 can be advanced over guidewire 60, such as by using standard over-the-wire manipulation techniques, with guidewire 60 passing through one or more lumens of device 200. In some embodiments, system 10, via console 100, is configured to robotically manipulate one or more guidewires 60. In some embodiments, body access device 50 and / or another component of system 10 is advanced over guide wire 60.

[0158]

[0160] System 10 can further comprise a sheath (e.g. body access device 50 described herein), such as a sheath that is configured to slidingly receive at least a portion of device 200. In some embodiments, the sheath is configured to shorten the trans-gastric distance between the gastroesophageal junction (GEJ) and the pylorus. In some embodiments, the sheath is configured to transition between a flexible and a rigid state, such that the sheath can remain flexible until a point in the procedure when the operator desires and / or console 100 can benefit from (e.g. requires) increased stiffness, such as to provide greater control of device 200. In some embodiments, body access device 50 comprises a sheath that is robotically manipulatable via console 100, such as when device 200 is also robotically manipulatable. Console 100 can include one or more graphical and / or other user interfaces, such as user interface 1000 shown. User interface 1000 of console 100 can comprise one or more user input components and / or user output components, such as a component selected from the group consisting of: joystick and / or other human interface device; keyboard; mouse; keypad; switch; membrane switch; touchscreen; display; audio transducer such as a speaker or buzzer; vibrational transducer; light such as an LED; track ball; scroll wheel; and combinations of one or more of these. In some embodiments, user interface 1000 comprises a joystick and / or other human interface device, HID 1010, which can be used to record operator input commands used (e.g. by algorithm 11 as described herein) to robotically manipulate (e.g. control the motion of, the state of, the activation of, and / or the function of) one or more portions of system 10, as described herein. In some embodiments, HID 1010 allows a user or other operator (“user” or “operator” herein) to perform operations in one frame of reference, and to control one or more portions of device 200 in another frame of reference. Alternatively or additionally, HID 1010 can be configured to record operator information related to setting or modifying (“modifying” herein) a system 10 parameter, such as a temperature, pressure, timing, and / or other system 10 parameter.

[0159]

[0161] Console 100 can include one or more conduits, such as conduit 191 shown, which can be configured to transport fluid to and / or from console 100. Console 100 can include pump assembly 195 shown, such as an assembly that includes one or more pumps or other fluid delivery mechanisms (“pump” herein) that deliver fluid (e.g. a liquid, a gas, and / or a gel) into one or more fluid pathways or other locations within device 200. Console 100 can include one or more reservoirs that store these fluids to be delivered. Alternatively or additionally, console 100 can be attachable to a fluid-storing reservoir separate from console 100 (or positioned in a second housing of console 100). Pump assembly 195 and / or another component of console 100 can include one or more pumps or other fluid removal mechanisms (“pump” herein) that extract fluid from one or more lumens or other locations within device 200. Console 100 can include one or more reservoirs that store these removed fluids, or these fluids can be stored in a reservoir separate from console 100 (or positioned in a second housing of console 100). Pump assembly 195 and / or another component of console 100 can include one or more pumps or other vacuum generating mechanisms (“pump” herein) that generate a vacuum that can cause a negative pressure within one or more lumens or other locations within device 200. Pump assembly 195 can comprise one or more pumps that deliver a fluid (e.g. a hydraulic and / or pneumatic fluid), such as to robotically manipulate one or more portions of device 200 and / or another component of system 10.

[0160]

[0162] Console 100 can be configured to thermally prime device 200, such as by delivering cooling and / or warming fluids that cool and / or warm one or more portions (e.g. fluid pathway portions) of device 200, for example, without significantly cooling and / or warming tissue during the priming process. In some embodiments, system 10 is configured to prevent robotic advancement and / or retraction of functional assembly 500 until a thermal priming procedure has been performed. In some embodiments, system 10 is configured to automatically perform a thermal priming procedure of device 200 prior to, during, and / or after robotic manipulation (e.g. robotic advancement and / or retraction) of functional assembly 500 and / or another robotic manipulation of a system 10 component.

[0161]

[0163] Console 100 can comprise one or more “discrete components”, such as one or more components each with a discrete (i.e. separate) housing that surrounds one or more pumps, reservoirs and / or other components.

[0162]

[0164] In some embodiments, console 100 comprises one or more supplies of vacuum, vacuum supply 110 shown. Vacuum supply 110 can comprise one or more pumps configured to generate a vacuum within device 200 and / or other component of system 10. In some embodiments, vacuum supply 110 includes one or more reservoirs configured to reduce variations in vacuum pressure. Vacuum supply 110 can provide a vacuum to one, two, three or more ports configured to engage tissue, such as tissue capture chambers 510 described herein. Vacuum supply 110 can be configured to provide a vacuum pressure of between -2psi and -14.7psi, such as between -4psi and -14.7psi, or between -6psi and -12.5psi. Additionally or alternatively, vacuum supply 110 and / or another component of console 100 can comprise at least one sensor, such as a sensor-based functional element 199 of console 100, configured to monitor the pressure of vacuum supply 110, and provide an alert (e.g. an alert to the operator and / or enter a system wide alert mode) if the vacuum pressure is insufficient or otherwise undesired (e.g. if the vacuum pressure is above or below a desired level, an expected level, and / or other threshold). In some embodiments, a minimum vacuum threshold can comprise a threshold of at least -4.4 psi, at least -6psi, and / or at least -12psi. In some embodiments, vacuum supply 110 provides an aspiration reservoir, such as to remove a fluid from locations proximate the distal end of device 200 (e.g. gas or other fluid within the GI tract removed in a desufflation procedure and / or a fluid within a distal portion of device 200). In some embodiments, vacuum supply 110 is configured to apply a vacuum to robotically manipulate one or more portions of device 200 and / or another component of system 10.

[0163]

[0165] In some embodiments, console 100 comprises one or more assemblies configured to supply one or more fluids, injectate fluid supply 120 shown. Injectate supply 120 can comprise one or more pumps configured to deliver one or more injectates, injectate 125 shown, to device 200 and / or other component of system 10. In some embodiments, injectate supply 120 includes one or more reservoirs configured to store injectate 125. In some embodiments, injectate supply 120 comprise a pump (e.g. a syringe pump configured to drive 1, 2, 3 or more syringes simultaneously or sequentially), such as a pump that is part of pump assembly 195. In some embodiments, injectate supply 120 comprises injectate 125. Injectate supply 120 can deliver fluid to one, two, three or more needles, fluid jets (e.g. nozzles), and / or other fluid delivery elements configured to deliver injectate 125 onto and / or into tissue, such as injectate delivery element 520 described herein. In some embodiments, a single syringe pump is configured to deliver fluid to two or more injectate delivery elements 520. In some embodiments, console 100 is configured to cause injectate supply 120 to automatically deliver (e.g. deliver into tissue) injectate 125, such as an automatic delivery of injectate 125 prior to, during, and / or after a robotic manipulation of a device 200 and / or another component of system 10 by console 100. Injectate supply 120 can be configured to deliver fluid at a flow rate of at least lOmL / min, such as at a flow rate of at least 15mL / min, 20mL / min, 40mL / min, 60mL / min, or 120mL / min. In some embodiments, injectate supply 120 delivers fluid via two or more injectate delivery elements 520 simultaneously (e.g. in a tissue expansion procedure), at a rate of at least lOmL / min per injectate delivery element 520, such as at a rate of at least 12.5mL / min, 15mL / min, 20mL / min, 40mL / min, 60mL / min, or 120mL / min per fluid delivery element. In some embodiments, injectate supply 120 is configured to deliver a volume between 2mL and 20mL (e.g. approximately lOmL) to multiple injectate delivery elements 520 simultaneously (e.g. two, three or four injectate delivery elements 520 simultaneously) in a time period 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 a tissue expansion procedure). Injectate supply 120 can be further configured to deliver fluid (e.g. to injectate delivery elements 520, a conduit of device 200, and / or another component of system 10) at a pressure of at least 40psi, such as at a pressure of at least 75psi, lOOpsi, 200psi, or 300psi. Injectate supply 120 can be configured to provide a bolus of injectate 125 to two, three or more injectate delivery elements 520 (simultaneously or sequentially) in order to expand an axial segment of submucosal tissue (e.g. a full or partial circumferential band of submucosal tissue with a length of at least 0.25cm, at least 0.50cm, at least 0.75cm, at least 1cm, at least 2cm, or at least 3cm) to achieve an expansion of the submucosal layer to a resultant thickness of at least 250pm, at least 400pm, or at least 650pm (e.g. in the area surrounding the volume of mucosal tissue to be subsequently ablated).

[0166] Injectate 125 can comprise one or more liquids, gels, and / or other flowable materials for injecting into tissue, such as to expand one or more layers of tissue (e.g. submucosal tissue expanded prior to a mucosal ablation procedure) and / or to narrow a lumen of the intestine and / or other axial segment of the GI tract (e.g. to create a therapeutic restriction). Alternatively or additionally, injectate 125 can comprise an agent configured to cause tissue necrosis. Alternatively or additionally, injectate 125 can comprise a warming and / or cooling fluid delivered onto and / or into tissue (e.g. a neutralizing fluid such as a neutralizing fluid 155 described herein that is configured to limit, stop and / or at least reduce ablation performed by functional assembly 500). In some embodiments, injectate 125 comprises one, two or more materials selected from the group consisting of: a peptide polymer (e.g. a peptide polymer configured to stimulate fibroblasts to produce collagen); polylactic acid; polymethylmethacrylate (PMMA); a hydrogel; ethylene vinyl alcohol (EVOH); a material configured to polymerize EVOH; dimethyl sulfoxide (DMSO); saline; a material harvested from a mammalian body; autologous material; fat cells; collagen; autologous collagen; bovine collagen; porcine collagen; bioengineered human collagen; dermis; a dermal filler; hyaluronic acid; conjugated hyaluronic acid; calcium hydroxyapatite; fibroblasts; a sclerosant; an adhesive; cyanoacrylate; a pharmaceutical agent; a visualizable material; a radiopaque material; a visible dye; ultrasonically reflective material; a combination of materials configured to cause an endothermic reaction when mixed (e.g. when mixed in tissue); a combination of materials configured to cause an exothermic reaction when mixed (e.g. when mixed in tissue); a combination of materials configured to expand when mixed (e.g. when mixed in tissue); and combinations of one or more of these. In some embodiments, injectate 125 comprises beads (e.g. pyrolytic carbon-coated beads) suspended in a carrier (e.g. a water-based carrier gel). In some embodiments, injectate 125 comprises a solid silicone elastomer (e.g. heat- vulcanized polydimethylsiloxane) suspended in a carrier, such as a bio-excretable polyvinylpyrrolidone (PVP) carrier gel. In some embodiments, injectate 125 has an adjustable degradation rate, such as an injectate 125 comprising one or more cross linkers in combination with polyalkyleneimines at specific concentrations that result in hydrogels with adjustable degradation properties. In some embodiments, injectate 125 and / or agent 80, each described herein, comprises living cells, such as living cells injected into the mucosa or submucosa of the intestine to provide a therapeutic benefit.

[0164]

[0167] In some embodiments, injectate 125 comprises a visualizable and / or otherwise detectable (e.g. magnetic) material (e.g. in addition to one or more materials of above) selected from the group consisting of: a dye; a visible dye; indigo carmine; methylene blue; India ink; SPOT™ dye; a visualizable media; radiopaque material; radiopaque powder; tantalum; tantalum powder; ultrasonically reflective material; magnetic material; ferrous material; and combinations of one or more of these. In some embodiments, console 100 is configured to perform a robotic manipulation of a device 200 and / or other system 10 component based on a measurement of injectate 125 (e.g. a measurement made by a camera or other visualization and / or other imaging device of system 10, such as imaging device 70 described herein). For example, robotic manipulation performed by console 100 can be initiated, maintained, terminated, and / or prevented based on a measurement of the presence of injectate 125 (e.g. a sufficient amount of injectate 125) within and / or on tissue.

[0165]

[0168] In some embodiments, injectate 125 comprises a fluorescent-labeled material and / or other biomarker configured to identify the presence of a biological substance, such as to identify diseased tissue and / or other tissue for treatment by functional assembly 500 (e.g. to identify target tissue). For example, injectate 125 can comprise a material configured to be identified by one or more imaging devices, imaging device 70 shown, such as to identify a visualizable change to injectate 125 that occurs after contacting one or more biological substances. In these embodiments, imaging device 70 can comprise a molecular imaging device, such as when imaging device 70 comprises a molecular imaging probe and injectate 125 comprises an associated molecular imaging contrast agent. In these embodiments, injectate 125 can be configured to identify diseased tissue and / or to identify a particular level of one or more of pH, tissue oxygenation, blood flow, and the like. Injectate 125 can be configured to be delivered onto the inner surface of intestinal or other tissue, and / or to be delivered into tissue (i.e. beneath the surface).

[0166]

[0169] In some embodiments, a volume of injectate 125 is delivered into tissue to create a therapeutic restriction (e.g. a therapeutic restriction with an axial length between 1mm and 20mm), as described herein, and / or as is described in applicant’s co-pending United States Patent Application Serial Number 18 / 467,589 (Attorney Docket No. 41714-711.304; Client Docket No. MCT-024-US-CON3), entitled “Systems, Devices and Methods for the Creation of a Therapeutic Restriction in the Gastrointestinal Tract”, filed September 14, 2023. In some embodiments, a volume of injectate 125 is delivered into tissue to create a safety margin of tissue prior to an ablation procedure, as is described herein.

[0167]

[0170] In some embodiments, console 100 comprises one or more supplies of fluid for inflation, inflation fluid supply 130 shown. Inflation fluid supply 130 can comprise one or more pumps configured to deliver one or more fluids, inflation fluid 135 shown, to inflate one or more portions of device 200 and / or other component of system 10. In some embodiments, inflation fluid supply 130 includes one or more reservoirs configured to store inflation fluid 135. In some embodiments, inflation fluid supply 130 comprises inflation fluid 135. Inflation fluid supply 130 can deliver inflation fluid 135 to a balloon or other reservoir (e.g. other fluid expandable component), such as expandable element 530 of functional assembly 500 described herein. In some embodiments, system 10 is configured to automatically cause inflation fluid supply 130 to deliver inflation fluid 135, such as a delivery performed prior to, during, and / or after robotic manipulation of functional assembly 500 and / or another robotic manipulation of a system 10 component. Inflation fluid supply 130 can be configured to deliver a bolus volume of fluid to expandable element 530, such as a bolus of between O.lmL and 12mL, such as an operator selectable bolus volume of 6mL, 8mL, and / or lOmL. Inflation fluid supply 130 can be configured to deliver fluid to expandable element 530 at a pressure of between O.lpsi and 5psi. In some embodiments, inflation fluid supply 130 delivers fluid to expandable element 530 prior to a tissue expansion procedure as described herein, in which a separate fluid, injectate 125, is delivered directly into submucosal or other tissue via one, two or more injectate delivery elements 520. In these embodiments, the fluid provided to expandable element 530 by inflation fluid supply 130 can comprise inflation fluid 135 and / or a different fluid, such as neutralizing fluid 155 shown (e.g. a cooling or warming fluid). Neutralizing fluid 155 can be delivered to expandable element 530 in a submucosal expansion procedure, such as to provide the additional function of pre-cooling or pre-warming tissue proximate element 530 prior to a subsequent thermal ablation procedure (e.g. a heat ablation or cryogenic ablation, respectively, performed by element 530). Alternatively or additionally, inflation fluid supply 130 can deliver neutralizing fluid 155 to element 530 in a tissue expansion procedure performed shortly after a (previous) ablation procedure, such as to perform a post-cooling and / or post-warming of tissue configured to limit the effects of a heat ablation or cryogenic ablation, respectively. For example, pre or post-cooling, and / or pre or post-warming can be performed to reduce time in a previous and / or subsequent ablation step.

[0168]

[0171] In some embodiments, console 100 comprises one or more supplies of ablative fluid, ablative fluid supply 140 shown. Ablative fluid supply 140 can comprise one or more pumps configured to deliver one or more ablative fluids, ablative fluid 145 shown, to one or more portions of device 200 and / or other component of system 10. In some embodiments, ablative fluid supply 140 includes one or more reservoirs configured to store ablative fluid 145. In some embodiments, ablative fluid supply 140 comprises ablative fluid 145. Ablative fluid supply 140 can deliver ablative fluid 145 to a balloon and / or other fluid storing assembly and / or component of device 200, such as expandable element 530. Alternatively or additionally, ablative fluid supply 140 can deliver ablative fluid 145 to one, two, three or more fluid delivery elements configured to deliver fluid onto and / or within tissue, such as injectate delivery elements 520 described herein. In some embodiments, system 10 is configured to automatically cause ablative fluid supply 140 to deliver ablative fluid 145, such as a delivery performed prior to, during, and / or after robotic manipulation of functional assembly 500 and / or another robotic manipulation of a system 10 component. Ablative fluid supply 140 can be configured to deliver ablative fluid at a flow rate of at least 5mL / s, such as at least 8mL / s, 9mL / s, lOmL / s, 15mL / s, and / or 20mL / s. In some embodiments, device 200 comprises a hydraulic inflow resistance (resistance to ablative fluid supply 140 and / or another fluid supply described herein) of less than 0.05 psi / (mL / min), such as less than 0.036psi / (mL / min) (e.g. when measured at 85°C at a flow rate of 570mL / min). In some embodiments, device 200 comprises a hydraulic inflow resistance of at least 0.020 psi / (mL / min), such as at least 0.030psi / (mL / min) (e.g. when measured at 85°C at a flow rate of 570mL / min). In some embodiments, device 200 comprises a hydraulic outflow resistance less than 0.070 psi / (mL / min), such as less than 0.63psi / (mL / min) (e.g. when measured at 85°C at a flow rate of 570mL / min). In some embodiments, device 200 comprises a hydraulic outflow resistance of at least 0.040psi / (mL / min), such as at least 0.53psi / (mL / min) (e.g. when measured at 85°C at a flow rate of 570mL / min). Additionally or alternatively, ablative fluid supply 140 can be configured to deliver ablative fluid at a pressure of approximately 40psi (pressure leaving console 100), such that the pressure of the ablative fluid within expandable element 530 is approximately 20psi. In some embodiments, ablative fluid supply 140 provides fluid at an ablative temperature (e.g. sufficiently hot or sufficiently cold temperature) in a recirculating manner.

[0169]

[0172] In some embodiments, device 200 comprises an inflow pressure drop (e.g. a pressure drop due to flow resistance) of between 17psi and 21psi, such as when tested with a flow rate of lOmL / s of water at 80°C. Additionally or alternatively, device 200 can comprise an inflow pressure drop of between 21psi and 25psi, such as when tested with a flow rate of lOmL / s of water at 20°C. In some embodiments, the inflow pressure drop is no more than 50psi, such as no more than 30psi, such as no more than 20.5psi. In some embodiments, the inflow pressure drop is at least 0.5psi, such as at least Ipsi, such as at least 5psi, such as at least 15psi. In some embodiments, device 200 comprises a total pressure drop (e.g. a pressure drop due to the flow resistance throughout the entire fluid path) of between 30psi and 40psi, such as when tested with a flow rate of lOmL / s of water at 80°C. Additionally or alternatively, device 200 can comprise a total pressure drop of between 39psi and 50psi, such as when tested with a flow rate of lOmL / s of water at 20°C. In some embodiments the total inflow pressure drop is no more than 80psi, such as no more than 60psi, such as no more than 50psi. In some embodiments, the total pressure drop is at least Ipsi, such as at least 5psi, such as at least 15psi, such as at least 30psi, such as at least 35psi.

[0170]

[0173] In some embodiments, console 100 comprises one or more supplies of neutralizing fluid, neutralizing fluid supply 150 shown. Neutralizing fluid supply 150 can comprise one or more pumps configured to deliver one or more neutralizing fluids, neutralizing fluid 155 shown, to one or more portions of device 200 and / or other component of system 10 (e.g. a fluid configured to neutralize ablative effects of an ablative fluid delivered by ablative fluid supply 140). In some embodiments, neutralizing fluid supply 150 includes one or more reservoirs configured to store neutralizing fluid 155. In some embodiments, neutralizing fluid supply 150 comprises neutralizing fluid 155. Neutralizing fluid supply 150 can deliver neutralizing fluid 155 to a balloon and / or other fluid storing assembly or component of device 200, such as expandable element 530 described herein. Alternatively or additionally, neutralizing fluid supply 150 can deliver neutralizing fluid 155 to one, two, three or more fluid delivery elements configured to deliver fluid onto and / or within tissue, such as injectate delivery elements 520 described herein. In some embodiments, system 10 is configured to automatically cause neutralizing fluid supply 150 to deliver neutralizing fluid 155, such as a delivery performed prior to, during, and / or after robotic manipulation of functional assembly 500 and / or another robotic manipulation of a system 10 component. Neutralizing fluid supply 150 can be configured to deliver neutralizing fluid at a flow rate of at least 5mL / s, such as at least 8mL / s, 9mL / s, lOmL / s, 15mL / s, or 20mL / s. Additionally or alternatively, neutralizing fluid supply 150 can be configured to deliver neutralizing fluid at a pressure of approximately 40psi (pressure leaving console 100), such that the pressure of the neutralizing fluid within expandable element 530 is approximately 20psi. In some embodiments, neutralizing fluid supply 150 is configured to deliver neutralizing fluid 155 at a pressure of between 20psi and 60psi, such as between 30psi and 50psi. In some embodiments, neutralizing fluid 155 pressure is delivered at less than lOOpsi. In some embodiments, ablative fluid 145 provided by ablative fluid supply 140 is delivered to a fluid storing component of device 200 (e.g. expandable element 530) and neutralizing fluid 155 provided by neutralizing fluid supply 150 is delivered onto and / or within tissue (e.g. via one or more injectate delivery elements 520). Alternatively or additionally, ablative fluid 145 provided by ablative fluid supply 140 can be delivered onto and / or within tissue (e.g. via one or more injectate delivery elements 520), while neutralizing fluid 155 provided by neutralizing fluid supply 150 is delivered to a balloon and / or other fluid storing assembly or component of device 200, such as expandable element 530. In some embodiments, ablative fluid supply 140 comprises neutralizing fluid supply 150 (e.g. a single assembly comprising one or more pumps that provide both ablative fluid 145 and neutralizing fluid 155 from one, two or more reservoirs).

[0171]

[0174] In some embodiments, inflation fluid supply 130, ablative fluid supply 140, neutralizing fluid supply 150 and / or another fluid delivery assembly of console 100 is configured to provide fluid (e.g. inflation fluid 135, ablative fluid 145 and / or neutralizing fluid 155) to functional assembly 500 (e.g. to one or more expandable elements 530) at a flow rate of at least 2mL / sec, such as at least 5mL / sec, or at a flow rate of approximately 9.5mL / sec. In some embodiments, console 100 provides fluid to functional assembly 500 at a flow rate of no more than 30mL / sec.

[0172]

[0175] In some embodiments, console 100 comprises one or more pumps for evacuating fluid, fluid removal pump 160 shown. Fluid removal pump 160 can comprise one or more pumps configured to remove fluid from one or more portions of device 200 or other component of system 10. In some embodiments, fluid removal pump 160 includes one or more reservoirs configured to store the one or more removed fluids. In some embodiments, fluid removed by fluid removal pump 160 is recirculated to one or more other assemblies of console 100, such as inflation fluid supply 130, ablative fluid supply 140, neutralizing fluid supply 150, insufflation supply 170 (described herebelow) and / or functional fluid supply 180 (also described herebelow). Fluid removal pump 160 can remove fluid from a balloon or other fluid storing assembly or component of device 200, such as expandable element 530. In some embodiments, fluid removal pump 160 is configured to remove (e.g. from device 200 and / or any component of system 10) injectate 125, inflation fluid 135, ablative fluid 145, neutralizing fluid 155, insufflation fluid 175, and / or functional fluid 185, each as described herein. In some embodiments, device 200 comprises a hydraulic outflow resistance as described herein in reference to ablative fluid supply 140. In some embodiments, ablative fluid supply 140 and / or neutralizing fluid supply 150 comprise fluid removal pump 160. In some embodiments, pump assembly 195 comprises fluid removal pump 160. In some embodiments, system 10 is configured to automatically cause fluid removal pump 160 to remove fluid from device 200, such as a fluid removal performed prior to, during, and / or after robotic manipulation of functional assembly 500 and / or another robotic manipulation of a system 10 component.

[0173]

[0176] In some embodiments, console 100 comprises one or more supplies of insufflation fluid, insufflation supply 170 shown. Insufflation supply 170 can comprise one or more pumps configured to deliver a gas or other insufflation fluid, insufflation fluid 175 shown, such as to inflate the duodenum or other axial segment of the patient’s GI tract. Alternatively or additionally, insufflation supply 170 can be configured to remove insufflation fluid 175 and / or other fluid from the duodenum or other axial segment of the patient’s GI tract (i.e. perform a desufflation). In some embodiments, insufflation supply 170 includes one or more reservoirs configured to store insufflation fluid 175 (to be provided and / or recently removed). In some embodiments, insufflation supply 170 comprises insufflation fluid 175. Insufflation supply 170 can deliver and / or remove fluids via device 200 (e.g. via a device 200a and / or 200b as described herein) and / or a separate component of system 10. In some embodiments, system 10 is configured to automatically cause insufflation supply 170 to deliver and / or remove insufflation fluid 175, such as a delivery and / or removal performed prior to, during, and / or after robotic advancement of functional assembly 500 and / or another robotic manipulation of a system 10 component.

[0174]

[0177] In some embodiments, console 100 comprises one or more supplies of a functional fluid, functional fluid supply 180 shown. Functional fluid supply 180 can provide one or more fluids that provide a function, functional fluid 185 shown. Fluid 185 can be delivered to one or more components or assemblies of device 200 and / or other component of system 10. In some embodiments, functional fluid 185 comprises a hydraulic or pneumatic fluid (“hydraulic fluid” herein), such as a fluid configured to perform a robotic manipulation (e.g. control a mechanical linkage) of a portion of a device 200 and / or other component of system 10. In some embodiments, functional fluid 185 comprises a conductive fluid, such as a fluid configured to transmit electrical power and / or electrical signals between device 200 (e.g. functional assembly 500 or other component of device 200) and console 100.

[0175]

[0178] As described herein, console 100 can comprise one or more pumps, pump assembly 195. Pump assembly 195 can be configured to deliver and / or extract fluids from device 200 (e.g. with or without an intermediate connection device such as umbilical 600 described herein). In some embodiments, pump assembly 195 is fluidly attached to at least injectate supply 120 and / or inflation supply 130, such as to supply injectate 125 and / or inflation fluid 135, respectively, to device 200. In some embodiments, pump assembly 195 is fluidly attached to injectate supply 120, inflation fluid supply 130, ablative fluid supply 140, neutralizing fluid supply 150, insufflation supply 170, and / or functional fluid supply 180, such as to deliver and / or remove their associated fluids to and / or from device 200. In some embodiments, one or more of injectate supply 120, inflation fluid supply 130, ablative fluid supply 140, neutralizing fluid supply 150, insufflation supply 170, and / or functional fluid supply 180 comprise 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, pump assembly 195 is configured as described herein in reference to Fig. 1A. In some embodiments, system 10 is configured to automatically cause pump assembly 195 to be activated (e.g. to deliver and / or remove fluids from a device 200 or otherwise), such as an activation performed prior to, during, and / or after robotic advancement of functional assembly 500 and / or another robotic manipulation of a system 10 component.

[0176]

[0179] Console 100 comprises one or connectors, connector 102 shown, which fluidly connects to one or more of assemblies 110, 120, 130, 140, 150, 160, 170, and / or 180 of console 100 described herein, via a corresponding set of conduits, conduits 111, 121, 131, 141, 151, 161, 171, and / or 181, respectively, as shown. In some embodiments, console 100 comprises pump assembly 195, which 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. Alternatively or additionally, console 100 can comprise one or more manifolds, manifold 700a shown, which 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. Alternatively, conduits 111, 121, 131, 141, 151, 161, 171, and / or 181 directly attach to connector 102 (i.e. without pump assembly 195 and / or without manifold 700a). Manifold 700a can be constructed and arranged to fluidly combine one or more of conduits 111, 121, 131, 141, 151, 161, 171 and / or 181. Alternatively or additionally, manifold 700a can be constructed and arranged to split (divide) one or more of conduits 111, 121, 131, 141, 151, 161, 171, and / or 181 into multiple conduits. In some embodiments, manifold 700a includes one or more valves (e.g. one or more functional elements of system 10 comprising a valve), such as one or more valves configured to control flow of fluid in a conduit. In some embodiments, manifold 700a includes one or more sensors (e.g. temperature and / or pressure sensors) configured to provide a signal related to a parameter (e.g. temperature and / or pressure) of fluid within a conduit.

[0177]

[0180] In some embodiments, system 10 comprises a connecting device, umbilical 600 shown, which operably connects (e.g. at least fluidly connects) device 200 to console 100. Alternatively or additionally, device 200 can attach directly to console 100 (e.g. connector 102 of console 100 attaches directly to a connector, connector 302, of device 200). Umbilical 600 comprises one or more proximal connectors, connector 602a shown, which operably attaches to mating connector 102 of console 100. Umbilical 600 comprises one or more distal connectors, connector 602b shown, which operably attaches to mating connector 302 of a handle assembly, handle assembly 300 shown, of device 200. Umbilical 600 can comprise one or more fluid delivery tubes or other fluid-transporting conduits, conduit 691 shown. Conduit 691 comprises one or more lumens or other conduits configured to allow passage of one or more similar and / or dissimilar fluids between console 100 and device 200. Each conduit can be configured to receive one or more shafts or other conduits which transport one or more fluids. In some embodiments, umbilical 600 further comprises one or more of: wires or other electrical filaments configured to transmit electrical power and / or signals; optical fibers or other conduits configured to transmit optical power and / or signals; waveguides or other sound conduits configured to transmit sonic power and / or signals; mechanical linkages (e.g. translatable rods); and / or other elongate structures configured to transmit energy, signals, and / or mechanical motion between console 100 and device 200. In some embodiments, umbilical 600 comprises one or more sensors, transducers, and / or other functional elements, such as functional element 699 described herein. Functional element 699 can be positioned proximate conduit 691 as shown, positioned proximate connector 602a, and / or positioned proximate connector 602b. In some embodiments, umbilical 600 is configured to be robotically manipulated by console 100, such as when umbilical 600 comprises one or more mechanical linkages, control cables, actuators (e.g. linear and / or rotary actuators), and / or other activatable motion-causing components.

[0178]

[0181] Device 200, including distal portion 208 and distal end 209, comprises shaft assembly 400 and functional assembly 500, each as shown. In some embodiments, device 200 further comprises handle assembly 300. Handle assembly 300 can be positioned on the proximal end or at least a proximal portion of shaft assembly 400, and functional assembly 500 is positioned on device 200 distal portion 208 (e.g. on the distal end or at least a distal portion of shaft assembly 400). In some embodiments, device 200 does not comprise a handle, or handle 300 does not include any controls. In these embodiments, one or more controls used to operate device 200 can be included in console 100 and / or another component of system 10.

[0179]

[0182] Shaft assembly 400 includes at least one elongate shaft, shaft 401 shown, which comprises one or more lumens or other conduits, conduit 491 shown, each of which can be configured to attach to one or more conduits of handle 300, conduit 391 shown. In some embodiments, one or more conduits of conduit 491 simply passes through the proximal end of device 200 (e.g. through handle 300, if present, to operably attach device 200 to umbilical 600 and / or console 100). Each conduit of shaft 401 can be configured to transport fluid and / or it can be sized to receive (e.g. slidingly receive) one or more separate shafts, such as one or more shafts that transport fluid. In some embodiments, one or more lumens of shaft 401 receive a separate shaft, and fluid is transported within the received shaft and / or between the outer diameter of the received shaft and the wall of the lumen of shaft 401, such as is described herein. Alternatively or additionally, each lumen of shaft 401 and / or one or more shafts inserted within the lumen can surround (e.g. slidingly or fixedly surround) one or more conduits configured to transmit energy, signals, and / or mechanical motion between console 100 and device 200, as described herein. In some embodiments one or more conduits 491 are fixedly attached within shaft 401 with adhesive, such as with one or more rings of adhesive positioned about the outer wall of a conduit 491 and a surrounding wall (e.g. the inner wall of a sleeve, lumen, or other tube) onto which conduit 491 is to be fixedly attached. For example, two or more rings of adhesive can be positioned between the outer wall of a conduit 491 and a surrounding wall (e.g. a surrounding wall of a sleeve) to prevent undesired translation of the conduit 491.

[0180]

[0183] Shaft assembly 400 comprises proximal end 405, proximal portion 406, middle portion 407, distal portion 408, and distal end 409, each as shown. Distal portion 408 is shown in a magnified view in Fig. 1. Positioned on distal portion 408 is functional assembly 500, which can be configured as a treatment assembly and / or diagnostic assembly (e.g. an assembly configured to treat and / or diagnose, respectively, tissue of the intestine and / or other GI tract tissue). In some embodiments, shaft 401 extends through and beyond functional assembly 500 (as shown in Fig. 1, where device 200 distal end 209 is the same as shaft assembly 400 distal end 409). Alternatively, functional assembly 500 can be positioned on the distal end of shaft 401. In some embodiments, shaft 401 comprises a twist, such as is described herein in reference to Fig. 4. In some embodiments, shaft 401 comprises a bulbous tip. In some embodiments, shaft 401 comprises a tapered tip, such as is described herein in reference to Figs. 3A and 3B. In some embodiments, shaft assembly 400 comprises an outer diameter that does not exceed a maximum diameter of 13mm, 11mm, and / or 9mm, such as when shaft assembly 400 is configured to be inserted through a working channel of device 50 (e.g. a device 50 comprising an endoscope or other body access device).

[0181]

[0184] In some embodiments, device 200 is configured for over-the-wire manipulation and shaft assembly 400 comprises a lumen to slidingly receive a guidewire, such as a passageway including a lumen which exits at a location proximate the distal end 409 of shaft assembly 400 at an opening, such as port 490 shown and described herein. In other embodiments, device 200 is configured to be translated in the GI tract without using a guidewire. In some embodiments, shaft assembly 400 comprises one or more lumens for performing insufflation and / or desufflation (“insufflation” herein), such as conduit 571 shown and comprising one or more lumens which terminate in one or more openings, such as port 470D positioned distal to functional assembly 500, and port 470p positioned proximal to functional assembly 500, each as shown and described herein. In some embodiments, port 470p and / or port 470D is configured to perform desufflation only, or insufflation only. In some embodiments, shaft assembly 400 is configured to be robotically translated through a lumen, such as is described in applicant’ s co-pending United States Patent Application Serial Number 17 / 863,016 (Attorney Docket No. 41714-722.301; Client Docket No. MCT-051- US), entitled “Automated Tissue Treatment Devices, Systems, and Methods”, filed July 12, 2022 and / or otherwise herein.

[0182]

[0185] In some embodiments, shaft assembly 400 comprises one or more manifolds, such as manifold 700c and / or manifold 700d shown, each of which can be configured to fluidly connect one or more conduits of conduit 491 to one or more other conduits (e.g. one or more other conduits of conduit 491 or one or more other conduits of device 200). Manifolds 700c and / or 700d can be constructed and arranged to fluidly combine one or more of lumens of conduit 491. Alternatively or additionally, manifolds 700c and / or 700d can be constructed and arranged to split (divide) one or more of lumens of conduit 491 into multiple lumens. In some embodiments, manifolds 700c and / or 700d includes one or more valves (e.g. one or more functional element of system 10 comprising one-way valves) configured to control flow of fluid in a conduit. In some embodiments, manifolds 700c and / or 700d includes one or more sensors (e.g. temperature and / or pressure sensors and / or other sensor-based functional element as described herein) configured to provide a signal related to a parameter (e.g. temperature and / or pressure) of fluid within a conduit.

[0183]

[0186] In some embodiments, shaft assembly 400 comprises one or more sensors, transducers, and / or other functional elements, such as functional element 499a (e.g. positioned in a mid-portion of shaft 401 and / or proximate manifold 700c) and / or functional element 499b (e.g. positioned proximate manifold 700d and / or functional assembly 500) as shown and described herein. In some embodiments, functional element 499a and / or 499b comprises a radiopaque marker and / or other visualizable marker, as described herein, which can be configured to allow an operator to visualize translation and / or rotation of shaft assembly 400 (e.g. to visualize translation and / or rotation of functional assembly 500), such as via imaging device 70 (e.g. a fluoroscope or other imaging device). In some embodiments, shaft assembly 400 and / or another portion of device 200 is configured to be robotically manipulated based on a signal provided by a sensor-based functional element 499a and / or 499b.

[0184]

[0187] Shaft 401 can comprise a length of at least 60”, such as at least 72”. In some embodiments, shaft 401 comprises an outer diameter of less than 0.3”, such as a diameter less than 0.256”, 0.1”, or 0.08”. Shaft 401 can comprise a material selected from the group consisting of: a polyether block amide such as Pebax™; a thermoplastic elastomer, such as Tygon™, Arnitel™, or Hytrel™; 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 lubricious coating or lubricious additive, such as Propell™ low friction compound manufactured by Foster Corporation of Putnam, CT. In some embodiments, at least a portion of shaft 401 comprises a heat stabilizer, a light stabilizer, and / or other stabilizing agent, such as an HLS™ heat and light stabilizer manufactured by the Foster Corporation of Putnam, CT.

[0185]

[0188] Functional assembly 500 can comprise one or more elements, assemblies, and / or other components that are configured to treat and / or diagnose tissue. In some embodiments, functional assembly 500 is configured to both treat and diagnose tissue. Functional assembly 500 can be configured to treat and / or diagnose duodenal tissue or other tissue of the GI tract. Functional assembly 500 can be positioned on distal portion 408 of shaft assembly 400 as shown. Functional assembly 500 can be configured to radially expand and / or radially contract, such as when functional assembly 500 comprises one or more expandable reservoirs, such as one or more of expandable elements 530 shown. Expandable element 530 can comprise one or more balloons or other expandable reservoirs (“balloon” herein), expandable cages, furlable elements, and the like. Expandable element 530 can comprise one or more balloons that circumferentially surround shaft 401 (e.g. in a linear arrangement), or multiple partially circumferential balloons (e.g. in a radial arrangement). Expandable element 530 can comprise one or more balloons that expand radially out from shaft 401, at the same or different axial locations along shaft 401. An expandable element 530 can comprise an array of balloons in a lobed configuration, circumferentially spaced. An expandable element 530 can comprise one or more inner balloons surrounded by one or more outer balloons (e.g. where the inner balloon receives 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 than the first temperature). Expandable element 530 can comprise a balloon or other element configured to expand to a diameter of less than or equal to 35mm, such as less than or equal to 30mm or 25mm. Expandable element 530 can comprise a material as described herein. Expandable element 530 can comprise a balloon with a wall thickness as described herein. In some embodiments, one or more portions of expandable element 530 comprise a non-compliant material and one or more other portions of expandable element 530 comprises a compliant material. In some embodiments, expandable element 530 is configured to withstand an inflation pressure of up to 50psi, such as up to 60psi, lOOpsi, or 200psi. In some embodiments, a first expandable element 530 comprises at least a portion comprising a non-compliant material and a second expandable element 530 comprises at least a portion comprising a compliant material.

[0186]

[0189] Functional assembly 500 can comprise one or more balloons configured to receive one or more fluids, such as a first expandable element 530 configured to receive an ablative fluid (e.g. a fluid at an ablative temperature received from ablative fluid supply 140), a second expandable element 530 configured to receive a neutralizing fluid (e.g. a fluid received from neutralizing fluid supply 150 and comprising a temperature configured to cool or warm tissue after a heat or cryogenic ablation, respectively), and / or another expandable element 530 configured to receive a fluid. In some embodiments, at least the first expandable element 530 and the second expandable element 530 are the same reservoir (e.g. the same one or more balloons) that receive both ablative fluid and neutralizing fluid.

[0190] In some embodiments, functional assembly 500 is configured to expand one or more layers of tissue, such as to expand one or more layers of submucosal tissue prior to a tissue treatment procedure in which a mucosal layer of tissue is treated (e.g. thermally or chemically ablated). In these embodiments, functional assembly 500, device 200 and / or any component of system 10 can be of similar construction and arrangement to that described in: applicant’s co-pending United States Patent Application Serial Number 17 / 868,076 (Attorney Docket No. 41714-705.302; Client Docket No. MCT-003-US-CON1), entitled “Tissue Expansion Devices, Systems and Methods”, filed July 19, 2022; applicant’s co-pending United States Patent Application Serial Number 18 / 467,589 (Attorney Docket No. 41714- 711.304; Client Docket No. MCT-024-US-CON3), entitled “Systems, Devices and Methods for the Creation of a Therapeutic Restriction in the Gastrointestinal Tract”, filed September 14, 2023; and applicant’s co-pending United States Patent Application Serial Number 17 / 494,277 (Attorney Docket No. 41714-712.303; Client Docket No. MCT-027-US-CIP1- CON2), entitled “Injectate Delivery Devices, Systems and Methods”, filed October 5, 2021.

[0187]

[0191] In some embodiments, functional assembly 500 is configured to receive an ablative fluid (e.g. a recirculating hot or cold fluid at a tissue-ablating temperature) to treat tissue. In some embodiments, functional assembly 500 is configured to deliver an ablation fluid directly onto tissue (e.g. a hot or cold liquid, gas, and / or gel at a tissue-ablating temperature, and / or a chemically ablative fluid). In these embodiments, functional assembly 500, device 200 and / or any component of system 10 can be of similar construction and arrangement to that described in: applicant’s co-pending United States Patent Application Serial Number 17 / 864,855 (Attorney Docket No. 41714-704.303; Client Docket No. MCT- 002-US-CON2), entitled “Heat Ablation Systems, Devices and Methods for the Treatment of Tissue”, filed July 14, 2022 and applicant’s co-pending United States Patent Application Serial Number 14 / 917,243 (Attorney Docket No. 41714-710.301; Client Docket No. MCT- 023-US), entitled "Systems, Methods and Devices for Treatment of Target Tissue", filed March 7, 2016.

[0188]

[0192] Functional assembly 500 can include one or more ports configured to capture and / or engage tissue (singly or collectively “capture” or “engage” herein) or otherwise stabilize functional assembly 500 within a GI lumen, such as tissue capture chambers 510 shown and described herein. Each tissue capture chamber 510 includes an opening, opening 512 shown. In some embodiments, functional assembly 500 (or another portion of device 200) includes two, three, four or more tissue capture chambers 510. Each tissue capture chamber 510 can be attached to a source of vacuum, such as conduit 511 shown which is fluidly attached to a source of vacuum provided by console 100, such as vacuum supply 110. Each tissue capture chamber 510 can be of similar construction and arrangement to any one or more chambers 510 described herein. In some embodiments, inj ectate delivery element 520 is positioned above (radially out from) a source of vacuum that is provided to tissue capture chamber 510. In some embodiments, one or more tissue capture chambers 510 is constructed of a metal or other material with a relatively high thermal conductance, such as to efficiently transfer heat from and / or to expandable element 530 (e.g. from and / or to temperature- ablative fluid within expandable element 530), such as to avoid non-ablated tissue regions proximate tissue capture chambers 510 being present after an ablation procedure is performed. In some embodiments, one or more tissue capture chambers 510 is configured to be robotically manipulated by console 100.

[0189]

[0193] Functional assembly 500 can comprise one or more elements configured to deliver fluid into tissue, such as injectate delivery elements 520 shown, each positioned within or at least proximate a tissue capture chamber 510. In some embodiments, functional assembly 500 (or another portion of device 200) includes two, three, four or more injectate delivery elements 520. Injectate delivery elements 520 can comprise one or more elements selected from the group consisting of: needle; fluid jet (e.g. a nozzle); iontophoretic element; and combinations of one or more of these. Each injectate delivery element 520 can be operably attached to one or more conduits of device 200, such as when fluidly connected to a conduit, conduit 521 shown, or when fluidly attached to a separate conduit slidingly received by conduit 521 as described herein. Each injectate delivery element 520 can be configured to be robotically manipulated by console 100, such as a robotic manipulation to advance, retract, rotate, and / or angularly orient the element 520. Each injectate delivery element 520 can be connected to a source of fluid, such as one or more fluids provided by console 100 via injectate supply 120, ablative fluid supply 140, neutralizing fluid supply 150, and / or functional fluid supply 180. One or more injectate delivery elements 520 can comprise a needle with a diameter between 16 gauge and 34 gauge, such as a needle with a 27 gauge or 29 gauge diameter. One or more injectate delivery elements 520 can comprise a needle with a bevel angle of approximately 10° (e.g. with a bevel length of 0.008”), such as a bevel angle of at least 5° and / or a bevel angle no more than 45° or no more than 80°. One or more injectate delivery elements 520 can be advanced into the tissue contained in the associated tissue capture chambers 510, while avoiding the potential of the injectate delivery elements 520 penetrating into an outer layer of the GI wall and / or passing outside of the GI axial segment (e.g. injectate delivery elements 520 are prevented from exiting the associated chamber 510). In some embodiments, tissue is penetrated by a needle-based injectate delivery element 520 at the time of the application of the vacuum to chamber 510, without the advancement of injectate delivery elements 520 (e.g. when the distal end of each injectate delivery element 520 is positioned within the associated chamber 510). In some embodiments, one or more injectate delivery elements 520 comprises a fluid jet, and injectate 125 or other fluid can be delivered into tissue captured within chamber 510 without advancement of the fluid jet. Each tissue capture chamber 510 can be configured to slidingly receive an injectate delivery element 520 (e.g. at a time in which tissue is captured within chamber 510 and the injectate delivery element 520 penetrates the captured tissue upon advancement), such as when a tissue capture chamber 510 is configured to slidingly receive at least a 29 gauge needle, or at least a 27 gauge needle . Each injectate delivery element 520 can be configured to be advanced a distance of at least 2.5mm, at least 3.5mm, or at least 4.5mm. Each tissue capture chamber 510 can comprise a width of at least 0.010”, at least 0.040” or at least 0.060”. Each tissue capture chamber 510 can comprise a width of no more than 0.25”, or no more than 0.35”. Each tissue capture chamber 510 can comprise 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 can comprise a length of no more than 0.9”, no more than 0.7”, or no more than 0.5”. Each tissue capture chamber 510 can comprise a depth of at least 300pm, at least 500pm, at least 700pm, or at least 1000pm. Each tissue capture chamber 510 can comprise a depth of no more than 2500pm, such as no more than 2000pm. In some embodiments, one or more tissue capture chambers 510 comprise an opening whose length, width, and / or depth can be robotically manipulated (e.g. increased and / or decreased) by console 100.

[0190]

[0194] Functional assembly 500 of Fig. 1 can comprise two tissue capture chambers 510 (e.g. separated circumferentially at approximately 180°) or it can comprise three tissue capture chambers 510 (e.g. separated circumferentially at approximately 120°), and each chamber 510 can surround at least one injectate delivery element 520. In some embodiments, four or more tissue capture chambers 510 are included. Each tissue capture chamber 510 can be configured to engage with tissue, such as to maintain contact between functional assembly 500 and tissue (e.g. during delivery and / or removal of energy to and / or from tissue, such as when vacuum is applied to chamber 510). Alternatively or additionally, tissue capture chamber 510 can be configured to capture a portion of tissue within tissue capture chamber 510, via application of a vacuum as described herein, such as to allow delivery of fluid or a fluid delivery element (e.g. a needle) into the captured tissue.

[0195] Functional assembly 500 can comprise one or more ports (e.g. openings) in shaft assembly 400 that are configured to deliver fluid into and / or remove fluid from expandable element 530, such as port 430 and port 460 shown. Ports 430 and 460 can be positioned in various locations within expandable element 530. In some embodiments, port 460 is configured to remove fluid from expandable element 530, and it can be positioned in a proximal portion of functional assembly 500. In some embodiments, port 430 is configured to deliver fluid into expandable element 530, and it can be positioned in a distal (as shown), middle or proximal portion of functional assembly 500. Port 430 can comprise one, two, or more openings which are fluidly attached to one or more conduits, such as conduits 531 shown, each of which are fluidly connected to one or more of inflation fluid supply 130, ablative fluid supply 140 and / or neutralizing fluid supply 150, respectively, or other fluid supply of console 100 (e.g. functional fluid supply 180). Port 460 can comprise one, two, or more openings fluidly connected to one or more conduits, such as conduit 561 shown, which is fluidly connected to fluid removal pump 160 of console 100. In some embodiments, port 460 is fluidly attached to conduits 531, which are fluidly connected to one or more of inflation fluid supply 130, ablative fluid supply 140 and / or neutralizing fluid supply 150, respectively, or other fluid supply of console 100 (e.g. functional fluid supply 180). In some embodiments, port 430 and / or port 460 comprise multiple ports, such as multiple ports that are equidistantly spaced apart along a circumference of shaft assembly 400 (e.g. two ports spaced 180° apart, three ports spaced 120° apart, or four ports spaced 90° apart).

[0191]

[0196] In some embodiments, functional assembly 500 comprises 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 comprises a radiopaque marker and / or other visualizable marker, as described herein, which can be configured to allow an operator to visualize translation and / or rotation of functional assembly 500, such as via imaging device 70 (e.g. a fluoroscope, ultrasound imager, and / or other imaging device configured to produce image information 75 described herein). In some embodiments, functional element 599 comprises a heat-generating transducer, such as an element comprising one, two, or more electrodes through which radiofrequency (RF) energy is passed, such as to heat expandable element 530, and / or to heat fluid (e.g. saline) contained within expandable element 530. Alternatively or additionally, functional element 599 can comprise a cooling transducer (e.g. a Peltier cooling element), such as to cool expandable element 530, and / or to cool fluid contained within expandable element 530.

[0197] As described herein, in some embodiments, device 200 comprises a handle, such as handle assembly 300 shown. Handle assembly 300 can comprise a handle for an operator to manipulate device 200, and it can include a housing, housing 301 shown. Handle assembly 300 can be positioned in proximal end 405 of shaft assembly 400 as shown. Handle assembly 300 comprises one or more conduits, conduit 391. Conduit 391 can be configured to operably attach (e.g. on its proximal end or ends) to connector 102 of console 100 or to conduit 691 of umbilical 600. Conduit 391 can be configured to operably attach (e.g. on its distal end or ends) to conduit 491 of shaft assembly 400. In some embodiments, handle assembly 300 comprises one or more manifolds, manifold 700b shown, which can be configured to fluidly connect one or more conduits of conduit 391 to one or more other conduits (e.g. one or more other conduits of conduit 391 and / or conduit 491). Manifold 700b can be constructed and arranged to fluidly combine one or more lumens of conduit 391. Alternatively or additionally, manifold 700b can be constructed and arranged to split one or more of lumens of conduit 391 into multiple lumens. In some embodiments, manifold 700b includes one or more valves (e.g. one or more functional elements of system 10 comprising a valve), such as one or more valves configured to control flow of fluid in a conduit. In some embodiments, manifold 700b includes one or more sensors (e.g. one or more functional elements of system 10 comprising a temperature and / or pressure sensor) configured to provide a signal related to a parameter (e.g. temperature and / or pressure) of fluid within a conduit.

[0192]

[0198] Handle assembly 300 can include one or more controls, control 310 shown, which can be configured to activate, manipulate and / or otherwise operate one or more functions of device 200. In some embodiments control 310 comprises a control for advancing and / or retracting one or more injectate delivery elements 520 (e.g. simultaneously advancing and / or retracting two, three or more injectate delivery elements 520). In some embodiments, control 310 is configured to adjust one or more operating parameters of console 100 (e.g. via a wired or wireless connection).

[0193]

[0199] Handle assembly 300 can include an entry port, such as port 392 shown, for passage of a guidewire or other filament, such as guidewire 60. In some embodiments, port 392 is positioned on a proximal portion of shaft assembly 400. Port 392 can be operably connected to a lumen of shaft 401, such as is described herein.

[0194]

[0200] In some embodiments, handle assembly 300 comprises 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 comprises a tactile transducer configured to alert an operator of a particular state of device 200 (e.g. an alert, alarm or warning state, a “ready” state, a “function completed” state, and the like). For example, functional element 399 can alert an operator that a particular function is being performed, such as a function selected from the group consisting of: heating of tissue is being performed (e.g. via hot fluid present in functional assembly 500); a cooling of tissue is being performed (e.g. via cold fluid present in functional assembly 500); injectate is being delivered into tissue (e.g. injectate 125 is being delivered into submucosal or other tissue via one, two, three or more injectate delivery elements 520); needles or other injectate delivery elements 520 have been advanced into tissue; and combinations of one or more of these. Functional element 399 can comprise a tactile transducer selected from the group consisting of: a vibrational transducer (e.g. a vibrational transducer that alerts an operator that injectate 125 is being delivered into tissue and / or injectate delivery elements 520 are presently advanced into tissue); a heating element (e.g. a heating element that alerts an operator that a heat ablation and / or warming of tissue is in process); a Peltier element or other cooling element (e.g. a cooling element that alerts an operator that a cryogenic ablation and / or cooling of tissue is in process); and combinations of one or more of these. In some embodiments, handle assembly 300 includes a sensing portion configured to alert an operator that device 200 is presently in a particular functional state (e.g. ablating, delivering fluid, advancing, retracting, rotating, and the like).

[0195]

[0201] One or more functional elements can be included in system 10, such as functional element 199 of console 100, functional element 299 of device 200, functional element 399 of handle assembly 300, functional element 499a and / or 499b of shaft assembly 400, functional element 599 of functional assembly 500, and / or functional element 699 of umbilical 600. In some embodiments, one or more of these functional elements is configured to be robotically controlled by console 100.

[0196]

[0202] Device 200 (e.g. device 200a and / or device 50) can comprise one or more endoscopes configured to reach at least one or more portions of the duodenum from the patient’s mouth. In some embodiments, device 200 comprises an endoscope similar to Olympus model number PCF-PH190.

[0197]

[0203] Guidewire 60 can comprise an outside diameter of approximately 0.035”. Guidewire 60 can comprise a “stiff’ or “super stiff’ configuration. Guidewire 60 can comprise a length of at least twice the length of device 200 (e.g. twice the length of device 200a and / or 200b), such that one or more devices 200 can be “exchanged” over guidewire 60. Guidewire 60 can comprise a material selected from the group consisting of: nitinol; stainless steel; and combinations of one or more of these. Guidewire 60 can comprise a hydrophilic or other lubricious coating.

[0198]

[0204] In some embodiments, system 10 further comprises imaging device 70, which can comprise an imaging device constructed and arranged to provide image information 75 shown, which can comprise an image of the patient’s anatomy (e.g. inner wall or any part of the intestine of the patient) and / or an image of all or part of device 200 and / or other portion of system 10, as described in detail herein. In some embodiments, imaging device 70 is configured to be robotically manipulated by console 100, such as to change the orientation of imaging device 70 relative to the patient and / or a system 10 component prior to and / or during imaging. Imaging device 70 can comprise an imaging device selected from the group consisting of: endoscope camera; visible light camera; infrared camera; X-ray imager; fluoroscope; CT Scanner; MRI; PET Scanner; ultrasound imaging device; molecular imaging device; and combinations of one or more of these. In some embodiments, image information 75 comprising a patient image and / or a device 200 image is used to set, confirm and / or adjust one or more system 10 parameters, such as when imaging device 70 comprises a sensor of the present inventive concepts configured to produce a signal. In some embodiments, device 200 comprises imaging device 70 (e.g. device 200 includes one or more integrated imaging devices). In some embodiments, console 100 is configured to robotically manipulate a device 200 and / or other system 10 component based on image information 75 (e.g. a robotic manipulation based on anatomical position and / or geometric configuration of the component being robotically manipulated).

[0199]

[0205] Shaft 401 can comprise at least six lumens, at least eight lumens, or at least ten lumens. In some embodiments, shaft 401 comprises a single shaft comprising the at least six lumens or at least eight lumens. In these embodiments, a first pair of lumens of shaft 401 can be in fluid communication with a first tissue capture chamber 510, a second pair of lumens of shaft 401 can be in fluid communication with a second tissue capture chamber 510, and a third pair of lumens of shaft 401 can be in fluid communication with expandable element 530 (e.g. via openings in shaft 401, ports 430 and 460). The first pair of lumens of shaft 401 can comprise a vacuum lumen and a lumen that slidingly receives a first tube attached to a first injectate delivery element 520. The second pair of lumens of shaft 401 can comprise a vacuum lumen and a lumen that slidingly receives a second tube attached to a second injectate delivery element 520. The third pair of lumens of shaft 401 can comprise a fluid delivery lumen that delivers fluid to expandable element 530 and a fluid removal lumen that removes fluid from expandable element 530 (e.g. via ports 430 and 460, respectively), as described herein. In some embodiments, the at least one flexible elongate shaft comprises at least eight lumens, and a fourth pair of lumens are in fluid communication with a third tissue capture chamber 510. In some embodiments, shaft 401 further comprises, as described herein, one or more of: a guidewire lumen; a first insufflation lumen; and / or a second insufflation lumen. In some embodiments, shaft 401 comprises multiple shafts, such as two shafts 401 that each include at least a pair of lumens, or three shafts 401 that each include at least a pair of lumens.

[0200]

[0206] In some embodiments, shaft 401 comprises a first lumen for delivering fluid to expandable element 530 (e.g. delivering to element 530 one or more of: inflation fluid 135, ablative fluid 145 and / or neutralizing fluid 150), and a second lumen for removing fluid from expandable element 530 (e.g. removing from element 530 one or more of inflation fluid 135, ablative fluid 145 and / or neutralizing fluid 155). In some embodiments, shaft 401 comprises two, three or more lumens configured to provide and remove fluid from expandable element 530 in a recirculating manner.

[0201]

[0207] Expandable element 530 can comprise various materials and dimensions that are configured to optimize the performance of one or more procedures supported by element 530, such as tissue expansion (e.g. submucosal tissue expansion such as duodenal submucosal tissue expansion), tissue treatment (e.g. duodenal tissue treatment such as duodenal mucosal tissue ablation or other duodenal tissue treatment), and / or substance delivery (e.g. delivery of one or more substances into the mucosa, submucosa, and / or other luminal wall location of the duodenum, jejunum, ileum, and / or other GI wall location). In some embodiments, expandable element 530 comprises a diameter (e.g. an expanded diameter of a balloon-based expandable element 530) of at least 5mm and / or of no more than 45mm, such as a diameter of at least 18mm and / or of no more than 32mm, such as a diameter of at least 23.5mm and / or no more than 26.5mm, such as a diameter of approximately 24mm or 25mm. In some embodiments, expandable element 530 comprises a balloon with a wall thickness (e.g. thickness of a single wall of the balloon) of at least O.OOOlin and / or of no more than O.Olin, such as a wall thickness of at least 0.00025in and / or no more than 0.003in, such as a wall thickness of at least 0.0005in and / or no more than O.OOlin, such as a wall thickness of approximately 0.00075in. In some embodiments, expandable element 530 comprises a balloon with varied wall thickness, such as wall thickness that varies and has a thickness of at least 0.00025in and / or no more than 0.003in. For example, expandable element 530 can comprise an increased wall thickness proximate tissue capture cambers 510. In some embodiments, expandable element 530 comprises a material selected the group consisting of: a compliant material; a non-compliant material; both a compliant and a non-compliant material; PET; polyimide; nylon, such as nylon 12; PEEK; a silicone elastomer; polyether block amide; a polyurethane; a thermoplastic elastomer; and combinations thereof. In some embodiments, expandable element 530 (e.g. a balloon-based expandable element 530) comprises a compliance of at least 0.0001% and / or no more than 200%, such as a compliance of at least 0.0001% and / or no more than 15%, such as a compliance between at least 0.0001% and / or no more than 8%. In some embodiments, expandable element 530 comprises one or more materials with a thermal conductivity (W / (m*K)) of at least 0.01 and / or nor more than 10, such as a thermal conductivity of at least 0.1 and / or no more than 0.6, such as a thermal conductivity of approximately 0.29. In some embodiments, expandable element 530 comprises a contact length (e.g. a length of expandable element 530 in contact with duodenal or other luminal wall tissue when inflated or otherwise expanded) of at least 5mm and / or no more than 500mm, such as a contact length of at least 10mm and / or no more than 50mm, such as a contact length of at least 19mm and / or no more than 21mm, such as a contact length of approximately 20mm. In some embodiments, expandable element 530 (e.g. an inflated balloon-based expandable element 530) comprises a tapered proximal and / or distal end, such as a tapered end with a taper angle (e.g. a proximal and / or distal taper angle) of at least 5° and / or no more than 120°, such as a taper angle of at least 30° and / or no more than 90°, such as a taper angle of at least 57° and / or no more than 63°, such as a taper angle of approximately 60°. Expandable element 530 can comprise proximal and distal tapers that are similar or dissimilar. In some embodiments, expandable element 530 comprises a balloon which includes a braid on and / or within its wall, such as a metal braid and / or non-metal braid (e.g. a nylon braid).

[0202]

[0208] Injectate delivery elements 520 can comprise one or more needles or other fluid delivery elements as described herein. Injectate delivery elements 520 can comprise one or more needles or other fluid delivery elements that are configured to deliver fluid and / or other material to tissue to perform one or more procedures, such as tissue expansion (e.g. submucosal tissue expansion such as duodenal submucosal tissue expansion), tissue treatment (e.g. mucosal treatment such as duodenal mucosal tissue ablation or other duodenal tissue treatment), and / or substance delivery (e.g. delivery of one or more substances into the mucosa, submucosa, and / or other luminal wall location of the duodenum, jejunum, ileum, and / or other GI wall location). In some embodiments, injectate delivery elements 520 comprise elements (e.g. needles) constructed of a material selected from the group consisting of: metal; stainless steel, plastic; PEEK, liquid crystal polymer; and combinations of these. In some embodiments, injectate delivery element 520 comprises one or more needles with an inner diameter of at least 0.0014in and / or no more than 0.033in, such as an inner diameter of at least 0.00625in and / or no more than 0.01325in, such as an inner diameter of at least 0.0075in and / or no more than 0.009in, such as an inner diameter of approximately 0.008in. In some embodiments, injectate delivery element 520 comprises one or more needles constructed and arranged to have an exposed length of at least 0.125mm and / or no more than 10mm, such as an exposed length of at least 1mm and / or no more than 5mm, such as an exposed length of at least 2mm and / or no more than 3mm, such as an exposed length of approximately 2.5mm. In some embodiments, injectate delivery element 520 comprises one or more needles with a diameter (e.g. Birmingham gauge) of at least 36gauge and / or no more than lOgauge, such as a gauge of at least 35 and / or no more than 20, such as a gauge of at least 27 and / or no more than 26. In some embodiments, injectate delivery element 520 comprises one or more needles with a bevel angle of at least 1° and / or no more than 90°, such as a bevel angle of at least 5° and / or no more than 45°, such as a bevel angle of at least 9° and / or no more than 11°, such as a bevel angle of approximately 10°.

[0203]

[0209] Console 100 can comprise one or more fluid supplies, as described herein, such as to deliver fluid to one or more injectate delivery elements 520. In some embodiments, console 100 is configured (e.g. during a submucosal tissue expansion procedure) to provide fluid to each injectate delivery element 520 at a flow rate of at least 0. ImL / min and / or no more than 120mL / min, such as a flow rate of at least ImL / min and / or no more than 60mL / min, such as a flow rate of at least 5mL / min and / or no more than 20mL / min, such as a flow rate of approximately 12.5mL / min. In some embodiments, console 100 is configured (e.g. during a submucosal tissue expansion procedure) to provide, to each injectate delivery element 520, an injection volume (e.g. for delivery at each injection site) of at least O.lmL and / or no more than lOOmL, such as an injection volume of at least ImL and / or no more than 30mL, such as an injection volume of at least 8mL and / or no more than 12mL, such as an injection volume of at least 9mL and / or no more than 1 ImL, such as an injection volume of approximately lOmL. In some embodiments, console 100 is configured to provide fluid, to each injectate delivery element 520 (e.g. during a submucosal tissue expansion procedure), at a pressure of at least Ipsi and / or no more than 400psi, such as at a pressure of at least 20psi and / or no more than 200psi, such as at a pressure of at least 90psi and / or no more than

[0204] 1 lOpsi, such as at a pressure of approximately lOOpsi.

[0205]

[0210] Device 200 can comprise multiple fluid-carrying conduits as described herein. For example, multiple conduits 521, also described herein, can each attach to an injectate delivery element 520 and travel to the proximal end or at least a proximal portion of device 200 (e.g. conduits 521 positioned within shaft 501 and fluidly attached to a port of handle assembly 300). In some embodiments, one or more conduits 521 comprises an inner diameter of at least 0.005in and / or no more than 0.125in, such as an inner diameter of at least 0.04in and / or no more than O.lOin, such as an inner diameter of at least 0.0177in and / or no more than 0.0183in, such as an inner diameter of approximately 0.018in. In some embodiments, one or more conduits 521 each comprises a length of at least 12in and / or no more than 250in, such as a length of at least 36in and / or no more than 120in, such as a length of approximately 78in.

[0206]

[0211] Functional assembly 500 can comprise one, two, three, or more tissue capture chambers 510, such as are described herein. Tissue capture chambers 510 can comprise one or more materials selected from the group consisting of: a plastic; a liquid crystal polymer; a metal; stainless steel; a thermally conductive material; and combinations of these. Tissue capture chambers 510 can comprise a durometer of less than 63D, such as less than 50D, such as approximately 40D. Each tissue capture chamber 510 can be sized and arranged to capture tissue when a vacuum is applied to tissue capture chamber 510. Each tissue capture chamber 510 can be attached (e.g. fixedly attached) to expandable element 530 via an adhesive with a glass transition temperature (Tg) of at least -60°C and / or no more than 200°C, such as a Tg of at least 60°C and / or no more than 90°C, such as a Tg of approximately 77 °C. Alternatively or additionally, one or more tissue capture chambers 510 can be attached to expandable element 530 via tape (e.g. viscoelastic tape) and / or a welding process (e.g. thermal welding). Each tissue capture chamber 510 can be attached (e.g. fixedly attached) to expandable element 530 via an adhesive configured to support an elongation (e.g. without failure) of at least 1% and / or no more than 500%, such as an elongation of at least 100% and / or no more than 400%, such as an elongation of approximately 300%. Each tissue capture chamber 510 can comprise an outer diameter of at least 0.1mm and / or no more than 10mm, such as a diameter of at least 1mm and / or no more than 5mm, such as a diameter of at least 2.28mm and / or no more than 2.30mm, such as a diameter of approximately 2.29mm. Each tissue capture chamber can comprise a length of at least 2.5mm and / or no more than 500mm, such as a length of at least 10mm and / or no more than 50mm, such as a length of at least 17.25mm and / or no more than 17.75mm, such as a length of approximately 17.5mm. Each tissue capture chamber 510 comprises an opening 512. Each opening 512 can comprise a length of at least 0.25mm, or at least 0.5mm, or at least 1mm, and / or no more than 20mm, such as a length of at least 2mm and / or no more than 10mm, such as a length of at least 3.45mm and / or no more than 3.65mm, such as a length of approximately 3.55mm. Each opening 512 can comprise a width of at least 0.1mm and / or no more than 10mm, such as a width of at least 0.5mm and / or no more than 4mm, such as a width of at least 1.48mm and / or no more than 1.68mm, such as a width of approximately 1.58mm. Each opening 512 can comprise a depth of at least 0.1mm and / or no more than 10mm, such as a depth of at least 1mm and / or no more than 4mm, such as a depth of at least 1.9mm and / or no more than 2.1mm, such as a depth of approximately 2.0mm. Each opening 512 can be defined by walls that extend from the outer surface of port 510.

[0207]

[0212] In some embodiments, system 10 further comprises one or more agents, agent 80 shown. Agent 80 can be delivered by one or more components of system 10, such as by device 200 (via one or more working channels of device 200a or other device 200, and / or via one or more injectate delivery elements 520 or ports 470 of device 200b or other device 200). Agent 80 can comprise a material selected from the group consisting of: anti-peristaltic agent, such as L-menthol (i.e. oil of peppermint); glucagon; buscopan; hyoscine; somatostatin; a diabetic medication; an analgesic agent; an opioid agent; a chemotherapeutic agent; a hormone; and combinations of one or more of these. In some embodiments, agent 80 comprises cells delivered into the intestine, such as living cells delivered into intestinal mucosa or submucosa via one or more injectate delivery elements 520. In some embodiments, agent 80 comprises one or more agents configured to be delivered into expandable element 530 and to pass through at least a portion of expandable element 530 and into the intestine (e.g. when expandable element 530 comprises at least a portion that is porous). In some embodiments, agent 80 comprises a mucolytic agent configured to remove mucus from a tissue surface.

[0208]

[0213] In some embodiments, system 10 comprises a tissue marker, marker 90 shown, which can comprise a dye or other visualizable media configured to mark tissue (e.g. using a needle-based tool), and / or a visualizable temporary implant used to mark tissue, such as a small, temporary anchor configured to be attached to tissue and removed at the end of the procedure or otherwise passed by the natural digestive process of the patient shortly after procedure completion. One or more markers 90 can be deposited or deployed in reference to non-target tissue and / or target tissue. The markers 90 can be identified by an operator of system 10 (e.g. visually via a camera-based sensor of system 10), and / or by system 10 (e.g. via a camera, material-detector, and / or other sensor of system 10). Use of markers 90 can be included to avoid damage to non-target tissue (e.g. the papilla and / or tissue proximate the ampulla of Vater), and / or to cause sufficient ablation of target tissue (e.g. a sufficient amount of duodenal mucosa and / or other duodenal tissue proximate yet distal to the papilla and / or the ampulla of Vater). In some embodiments, marker 90 is deposited or deployed in reference to tissue selected from the group consisting of: gastrointestinal adventitia; duodenal adventitia; the tunica serosa; the tunica muscularis; the outermost partial layer of the submucosa; papilla; ampulla of Vater; pancreas; bile duct; pylorus; and combinations of one or more of these. In some embodiments, marker 90 is positioned in tissue and / or removed from tissue by a robotically manipulatable component of system 10.

[0209]

[0214] System 10 can include one or more functional elements, such as functional element 299 of device 200, as described herein.

[0210]

[0215] In some embodiments, console 100 is configured to robotically manipulate (e.g. advance, retract, and / or rotate) one or more portions of device 200, such as the proximal portion of device 200, the middle portion of device 200, and / or the distal portion of device 200. In some embodiments, console 100 is configured to robotically manipulate (e.g. advance, retract, rotate, orient, deliver fluid to, deliver energy to, control the temperature of, control the length, width, and / or diameter of) functional assembly 500. In some embodiments, system 10 is configured as described herein in reference to Fig. ID. As used herein, a “robotic manipulation” and its derivatives, shall include system 10 performing an automated (performed autonomously by system 10) or semi-automated (performed with both operator input and system 10 control) operation (e.g. set of one or more steps in which device 200 is manipulated and / or system 10 parameters are changed). These automated or at least semi-automated (“automated”, “automatic”, and the like herein) operations include but are not limited to: advancements; retractions; extensions; elongations; rotations (e.g. rotation about an axis); orientations (e.g. rotations of an axis); fluid delivery (e.g. into tissue and / or into functional assembly 500); energy delivery (e.g. into tissue and / or into functional assembly 500); expansions and / or contractions (e.g. of functional assembly 500); and / or other system 10 component manipulations and / or activations (“manipulations” herein).

[0211]

[0216] Console 100 (e.g. controller 1500), and / or another component of system 10, can include one or more algorithms, algorithm 11 shown. Algorithm 11 can comprise one, two, or more algorithms that each comprise a machine learning algorithm, a deep learning algorithm, a deep learning, convolutional, recurrent, or other neural network, and / or other artificial intelligence algorithm (“Al” algorithm herein). Algorithm 11 can comprise a learning algorithm such as an algorithm that adapts using machine-learning and / or artificial intelligence routines. Alternatively or additionally, algorithm 11 can comprise an algorithm that is developed using machine learning and / or artificial intelligence routines. Algorithm 11 can comprise one or more algorithms that are used to allow an operator to robotically manipulate device 200 and / or another system 10 component, and / or to use device 200 and / or another system 10 component in an automated (e.g. autonomous) fashion. Console 100 can comprise a memory module, memory 1600 shown. Memory 1600 can comprise a memory module that stores instructions for performing algorithm 11. Memory 1600 can be coupled to a controller, such as controller 1500. Controller 1500 can be configured to perform algorithm 11 via one or more sets of instructions stored in memory 1600. Memory 1600 can store one or more system 10 settings, such as settings that are adjustable by an operator of system 10 and settings that are not adjustable (e.g. settings that are only adjustable by the manufacturer of system 10). Memory 1600 can store patient data, such as patient image data (e.g. patient image data collected by a camera or other imaging device of system 10) and / or other patient data. Memory 1600 can store data recorded during one or more clinical procedures performed using system 10.

[0212]

[0217] In some embodiments, functional element 299 comprises a sensor that provides data that is used by algorithm 11 to assess (e.g. adjust the fluid delivery of and / or assess the acceptability of) a tissue expansion procedure performed by functional assembly 500, such as data that is used by algorithm 11 to robotically manipulate a device 200 during a tissue expansion procedure. For example, a sensor-based functional element 299 can comprise a sensor configured to detect in the expanded tissue a dye or other optically detectable substance included in injectate 125, such as when functional element 299 comprises a reflectance, absorption, and / or fluorescence-based sensor. Inadequate expansion, once detected by algorithm 11, can result in a secondary expansion procedure, and / or system 10 entering an alert state.

[0213]

[0218] In some embodiments, functional element 299 comprises a sensor that provides data that is used by algorithm 11 to assess (e.g. adjust the energy delivery of and / or assess the acceptability of) a tissue ablation procedure performed by functional assembly 500, such as data that is used by algorithm 11 to robotically manipulate a device 200 during a tissue ablation procedure. For example, a sensor-based functional element 299 can comprise a sensor configured to detect in the treated tissue a color change (e.g. a change from a reddish color to a white color), such as when functional element 299 comprises a reflectance, absorption, and / or fluorescence-based sensor. Alternatively or additionally, functional element 299 can comprise a temperature sensor (e.g. an infrared temperature sensor) used to measure temperature (e.g. tissue temperature and / or functional assembly 500 temperature) used to assess the acceptability of ablation of tissue. Inadequate tissue ablation, once detected by algorithm 11, can result in a secondary ablation step, and / or system 10 entering an alert state.

[0214]

[0219] Controller 1500 can include various electronic and / or other components, such as those used to control electrical, mechanical, fluidic, and other assemblies, and components used to store and / or process data. Controller 1500 can be configured to interface (e.g. robotically interface) with other devices, such as via a wired and / or wireless connection, connections not shown in Fig. 1.

[0215]

[0220] Console 100 can include an assembly, control assembly 1100 shown, which can be configured to manipulate one or more portions of device 200 (e.g. robotically manipulate, as described herein, one or more portions of device 200a, device 200b, and / or another device 200). In some embodiments, control assembly 1100 controls the tensions of one or more cables (e.g. cables 2101 described herein), such as to steer, translate, rotate, and / or actuate at least a portion of a device 200. Alternatively or additionally, control assembly 1100 can be configured to frictionally and / or slidingly engage a portion of device 200, such as the outer wall of shaft assembly 400 at locations along shaft assembly 400 that are proximal to functional assembly 500. Control assembly 1100 can include one or more force-applying components configured to apply a pushing, pulling, and / or twisting force to a portion of device 200 located outside of the patient, such as to advance, retract, and / or rotate device 200 (e.g. advance, retract, and / or rotate the more distal portion of device 200 that is in the patient). For example, control assembly 1100 can include one or more rotating wheels (e.g. two or more wheels circumferentially spaced around shaft assembly 400) that can be frictionally engaged with shaft assembly 400 and rotated to cause a patient-inserted (e.g. partially inserted) device 200 to advance, retract, and / or rotate within the patient’ s GI tract. At least a portion of control assembly 1100 (e.g. the shaft assembly 400 engaging portion) can be positioned proximate a bite block, such as bite block 40 described herein in reference to Fig. 2A. In some embodiments, control assembly 1100 comprises bite block 40 (e.g. a bite block is integrated into a portion of control assembly 1100 that is configured to robotically manipulate a proximal portion of a device 200). In some embodiments, functional assembly 500 and / or other portions of each device 200 is advanced, retracted, and / or rotated by a robotic assembly included in a distal portion of the device 200 (e.g. and controlled by an associated assembly of console 100), such as robotic assembly 900 shown and / or another robotic assembly of system 10. All operator-based controlling of a device 200 can be performed using interface 1000 of console 100, such as by using HID 1010 of interface 1000.

[0221] Device 200 (e.g. device 200a and / or device 200b) can include one or more visualization and / or other imaging assemblies, imaging assembly 270. For example, imaging assembly 270 can comprise imaging assembly 270a located proximal to functional assembly 500, and imaging assembly 270b located within functional assembly 500, each as shown. Similar to imaging device 70, imaging assembly 270 can be configured to provide image information 75, such as patient anatomy information, device 200 image information (e.g. device 200 shape or position within the patient information), and / or other information capable of being captured by imaging assembly 270. Imaging assembly 270 can comprise one or more visualization and / or other imaging devices positioned proximal to functional assembly 500 (as shown in Fig. 1), within functional assembly 500, and / or at another device 200 location. Imaging assembly 270 can comprise a visual light camera, an ultrasound imager, a magnetic imaging device, and / or another form of imaging device. Imaging assembly 270 can be configured to provide information to an operator, such as via a screen portion of user interface 1000. Alternatively or additionally, imaging assembly 270 can provide information to algorithm 11 of system 10, such that algorithm 11 can perform an analysis of the visual information and use the results of that analysis to robotically manipulate (as defined herein) device 200 or another component of system 10. Imaging assembly 270 can work in cooperation with imaging device 70 in providing image information 75 (shown), such as anatomy or other image information to system 10 (e.g. to algorithm 11). Imaging assembly 270 can be configured to be robotically manipulated (e.g. oriented) by console 100.

[0216]

[0222] Algorithm 11 can use the provided visual information to create a three- dimensional (3D) map of one or more portions of the patient’ s anatomy and / or the shape of device 200 in the patient’s anatomy, to determine the location of device 200 (e.g. to determine an intended location for functional assembly 500 to treat tissue), and / or to robotically manipulate device 200 to a desired location (e.g. to compact and / or expand functional assembly 500, and / or to translate functional assembly 500 to an intended location), also as described herein.

[0217]

[0223] In some embodiments, algorithm 11, such as by using the image information 75 provided by imaging assembly 270 and / or imaging device 70, robotically manipulates device 200 (e.g. automatically manipulates) to perform two tissue expansion procedures, at two neighboring axial segments of the GI tract (e.g. two neighboring sections of the duodenum). In these embodiments, algorithm 11 can further robotically control imaging assembly 270 and / or imaging device 70, such as to change the location being imaged by either or both.

[0224] In some embodiments, algorithm 11, such as by using the image information 75 provided by imaging assembly 270 and / or imaging device 70, detects non-target tissue and / or non-target tissue, such as to robotically manipulate (e.g. automatically position) functional assembly 500 at a desired (also referred to as “intended”) treatment location. For example, the image information 75 can include the presence of one or more markers 90 that were previously placed in the patient, with their anatomical locations included in the image information 75, and algorithm 11 can include this marker 90 information as well as patient anatomy and / or device 200 information to perform the robotic manipulation.

[0218]

[0225] In some embodiments, device 200 comprises robotic assembly 900 shown, such as an assembly that is configured to allow console 100 to robotically manipulate one or more portions of device 200. Robotic assembly 900 can comprise one or more mechanical linkages, control cables, actuators (e.g. linear and / or rotary actuators), and / or other activatable motion-causing components. Robotic assembly 900 can comprise one or more robotic assemblies, such as one or more assemblies positioned in one or more locations of device 200 (e.g. locations proximal to, as shown, and / or distal to functional assembly 500). Robotic assembly 900 can include one or more portions that are located within device 200 (e.g. within shaft assembly 400 as shown), and / or assembly 900 can include one or more portions that are located external to device 200. In some embodiments, robotic assembly 900 is configured to robotically manipulate device 200 and another component of system 10 (e.g. body access device 50). Robotic assembly 900 can be constructed and arranged as the similar components described in applicant’s co-pending United States Patent Application Serial Number 17 / 863,016 (Attorney Docket No. 41714-722.301; Client Docket No. MCT-051- US), entitled “Automated Tissue Treatment Devices, Systems, and Methods”, filed July 12, 2022.

[0219]

[0226] In some embodiments, device 200 comprises at least a distal portion that is configured to be robotically manipulated, such as via a manipulation performed by robotic assembly 900 shown.

[0220]

[0227] Referring now to Fig. 1A, a schematic view of a system for performing a medical procedure in the intestine of a patient is illustrated, consistent with the present inventive concepts. System 10 comprises console 100 and device 200. Console 100, device 200, and / or other components of system 10 of Fig. 1 A can be of similar construction and arrangement to those described hereabove in reference to Fig. 1. Console 100 of Fig. 1A comprises at least vacuum supply 110, injectate supply 120, ablative fluid supply 140, and neutralizing fluid supply 150, each of which can be included within a single housing or multiple housings of console 100. Console 100 can include other fluid supplies and assemblies as described herein. Console 100 can be fluidly and / or otherwise operatively attached to device 200, such as via an umbilical or other conduit, not shown but such as umbilical 600 described herein. Console 100 can comprise one or more pumps, pump assembly 195, which propel fluids between console 100 and device 200, also as described herein.

[0221]

[0228] Device 200 comprises a distal portion 208 and can comprise a functional assembly 500 which can be positioned on distal portion 208. Functional assembly 500 can comprise one or more balloons and / or other expandable reservoirs, such as reservoir 5301 shown. Console 100 can be configured to transport fluids into and out of reservoir 5301, such as to expand and contract, respectively, reservoir 5301, as described herein.

[0222]

[0229] Device 200 further comprises tissue expansion subsystem 201 shown, a subsystem of device 200 that can be configured to expand sub-surface tissue, such as submucosal tissue of the GI tract. Tissue expansion subsystem 201 can be a robotically manipulatable subsystem and can comprise conduits within device 200 which transport tissue expansion fluids to functional assembly 500 and provide a vacuum to functional assembly 500, each as described herein. Tissue expansion subsystem 201 can comprise at least two tissue capture chambers 510 configured to capture tissue when vacuum is applied via at least two vacuum delivery conduits 511 (e.g. vacuum provided by vacuum supply 110 of console 100). Tissue expansion subsystem 201 can comprise at least two injectate delivery elements 520 (e.g. needles or fluid jets) which can receive the tissue expansion fluid (e.g. injectate 125 provided by injectate supply 120 of console 100) via at least two injectate delivery conduits 521. Injectate delivery elements 520 can be configured to deliver the tissue expansion fluid to tissue captured by tissue capture chambers 510. One or more injectate delivery elements 520 can each comprise a needle configured to penetrate tissue (e.g. via advancement of the needle into chamber 510 when tissue is captured within the chamber 510 via the applied vacuum), after which fluid can be delivered into the tissue. Alternatively or additionally, one or more injectate delivery elements 520 can each comprise a fluid jet configured to deliver fluid through a surface of and into tissue captured within chamber 510.

[0223]

[0230] Device 200 can further comprise tissue ablation subsystem 202 shown, a subsystem of device 200 that can comprise conduits within device 200 which transport ablation fluids and / or neutralizing fluids (e.g., ablative fluid 145 and / or neutralizing fluid 155, respectively) to and from functional assembly 500. Tissue ablation subsystem 202 can be a robotically manipulatable subsystem and can comprise a first conduit, conduit 531, configured to provide fluid to functional assembly 500 (e.g. to reservoir 5301) and a second conduit, conduit 561, configured to remove fluid from functional assembly 500 (e.g. from reservoir 5301). Conduit 531 can be configured to provide to functional assembly 500 ablative fluid (e.g. an ablative fluid 145 at an ablative temperature that is provided by ablative fluid supply 140 of console 100), as well as neutralizing fluid (e.g. a neutralizing fluid 155 provided by neutralizing fluid supply 150 of console 100 for cooling or warming of tissue prior to and / or after heat ablation or cryogenic ablation, respectively). Conduit 561 can be configured to remove ablative fluid and neutralizing fluid from functional assembly 500. In some embodiments, console 100 is configured to recirculate ablative fluid within functional assembly 500 (e.g. within one or more reservoirs of functional assembly 500), and to also recirculate neutralizing 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 ablative fluid and neutralizing fluid in a single reservoir (e.g. reservoir 5301) of functional assembly 500, such as to heat ablate tissue and subsequently cool tissue, or to pre-cool tissue and subsequently ablate tissue. In some embodiments, console 100 is configured to sequentially recirculate ablative fluid and neutralizing fluid in functional assembly 500 to pre-cool tissue, then ablate tissue, and then cool tissue.

[0224]

[0231] Algorithm 11, which can be integral to console 100 as shown, can robotically manipulate one or more components of device 200, such as to perform an automated operation (e.g. an operation with limited or no operator input) and / or to perform robotically controlled movement of device 200, each as described herein. In some embodiments, algorithm 11 uses image information 75 to perform one or more automated operations and / or other robotic manipulations, such as information 75 produced by one or more imaging devices, such as imaging assembly 270 of device 200, and / or imaging device 70, as described herein. In these embodiments, algorithm 11 can further robotically control imaging assembly 270 and / or imaging device 70, such as to change the location being imaged by either or both.

[0225]

[0232] Referring now to Fig. IB, a flow chart of a method of treating target tissue of a patient is illustrated, consistent with the present inventive concepts. In some embodiments, the Method 1000 of Fig. IB is accomplished using system 10 of Fig. 1 or otherwise as described herein. In Step 1010, a patient is selected for treatment, such as a patient selected to treat and / or diagnose (“treat” herein) a patient disease or disorder selected from the group consisting of: Type 2 diabetes; Type 1 diabetes; "Double Diabetes"; gestational diabetes; hyperglycemia; pre-diabetes; impaired glucose tolerance; insulin resistance; non-alcoholic fatty liver disease (NAFLD); non-alcoholic steatohepatitis (NASH); obesity; obesity-related disorder; polycystic ovarian syndrome (PCOS); hypertriglyceridemia; hypercholesterolemia; psoriasis; GERD; coronary artery disease (e.g. as a secondary prevention); stroke; TIA; cognitive decline; dementia; Alzheimer’s Disease; neuropathy; diabetic nephropathy; retinopathy; heart disease; diabetic heart disease; heart failure; diabetic heart failure; and combinations of these. In some embodiments, the patient is selected to treat two or more of the above diseases or disorders, such as a patient selected to treat two or more of diabetes, insulin resistance, NAFLD, NASH, and / or PCOS.

[0226]

[0233] The patient selected can be taking one or more medicines to treat their diabetes. The patient selected can have an HbAlc level between 7.5% and 12.0%, between 7.5% and 10%, or between 7.5% and 9.0%. In some embodiments, the patient selected can have an HbAlc level between 6.0% and 12.0%. Patients with higher HbAlc levels and / or other higher disease burden can receive more aggressive treatments (e.g. more tissue treated and / or higher number of repeated treatments over time) as described herebelow in reference to Step 1050.

[0227]

[0234] Patient selection can be based on the current level of one or more parameters representing one or more various biomarkers or other representative values of physiologic conditions (e.g. as compared to an average among diabetic and / or non-diabetic patients), such as a level of a parameter selected from the group consisting of: body mass index (BMI) level; waist circumference; HbAlc level; fasting glucose; insulin resistance; liver fibrosis; cholesterol or triglyceride level; duration of years exhibiting type 2 diabetes; fasting insulin, fasting C-peptide or C-Peptide stimulation in response to a meal; age; and combinations of these.

[0228]

[0235] Prior to placing one or more devices into the patient (e.g. device 200), or at any time thereafter (e.g. during or after the procedure), one or more agents can be introduced into the patient. In some embodiments, one or more agents are introduced into the GI tract directly, such as agent 80 described herein in reference to Fig. 1. In some embodiments, agent 80 comprises E-menthol (i.e. oil of peppermint) or other agent configured to provide an anti-peristalsis effect. In these embodiments, a few drops of agent 80 can be placed in an irrigation or other lumen of an inserted device 200 and / or 50 (e.g. an endoscope). In some embodiments, approximately 8mE of E-menthol is mixed with approximately 0.2mE of Tween 80 (polysorbate 80) in approximately 500mE of distilled water (i.e. to create an approximately 1.6% solution). Approximately 20mE of this mixture can be sprayed through a working channel of device 200, or more as required to dampen peristalsis. In some embodiments, the solution can vary between approximately 1.6% and 3.2%. Tween and / or sorbitan monostearate can be used as an emulsifier.

[0229]

[0236] One or more agents 80 can be delivered once device 200 (e.g. device 200, 200a and / or 200b described herein) or any other agent delivery device of system 10 enters the duodenum. In some embodiments, agent 80 comprises one or more agents that are delivered intravenously, and can include glucagon and / or buscopan.

[0230]

[0237] As described herein, in some embodiments, an endoscope-based device 200 is inserted into the patient (e.g. device 200a described herein). In these embodiments, subsequently inserted devices can be placed through a working channel of device 200 and / or alongside device 200. In some embodiments, device 200a and an attachable sheath (e.g. device 50 described herein) are both inserted into the patient, and subsequently inserted devices (e.g. device 200b) can be placed through a working channel of device 200a, through the attachable sheath, and / or alongside device 200a. Each patient-inserted device can be inserted over a guidewire. In some embodiments, an elongate stiffening device is used (e.g. inserted into a device 200), such as an endoscope stiffening system provided by Zutron Medical of Lenexa, Kansas, USA.

[0231]

[0238] In some embodiments, non-target tissue is identified (e.g. identified by the operator and / or automatically by system 10, such as by algorithm 11 described herein). Nontarget tissue can be identified using image information 75 produced by a visualization and / or other imaging device, such as by imaging device 70 and / or an imaging component of device 200, imaging assembly 270. The non-target tissue can comprise the papilla, tissue proximate the ampulla of Vater, the pancreas, and / or other tissue to which treatment (e.g. ablation) may adversely affect the patient. Marking of the non-target tissue (or tissue proximate the non- target tissue) can be performed, such as with a tattoo, ink or other visualizable substance, such as a visual agent or clip placed in and / or on the mucosa and / or submucosa in or proximate the papilla and / or the ampulla of Vater. In some embodiments, one or more markers similar to marker 90 described hereabove in reference to Fig. 1 are deployed in the patient to provide a reference location relative to non-target tissue. The marking of the tissue can be performed manually by an operator, automatically by system 10 (e.g. using algorithm 11), or semi-automatically (e.g. marking performed with both operator input and system 10 automation). Tissue expansion and / or tissue treatment performed in subsequent steps can avoid treating (e.g. avoiding delivering ablative energy to) the non-target tissue identified and potentially marked (e.g. with one or more markers 90). The tissue expansion and / or tissue ablation can also be performed manually by an operator, automatically by system 10 (e.g. via robotic control provided by console 100), and / or semi-automatically. For example, manual and / or automatic detection of one or more markers can be performed, and the results used in manual and / or automatic selection of one or more treatment locations, and / or positioning of functional assembly 500 at the one or more treatment locations (e.g. positioning provided via robotic control of device 200 by console 100). In some embodiments, system 10 (e.g. console 100) automatically prevents treatment at an undesired location, such as when system 10 prevents an operator from (manually) treating tissue proximate a non-target location identified by algorithm 11 (e.g. a non-target location identified by one or more markers 90).

[0232]

[0239] Next in Step 1010, a treatment device, such as device 200 (e.g. treatment device 200b described herein), is inserted through the patient’s mouth and advanced through the stomach and into the small intestine (if not already in place). Step 1010 can include selecting a particular model of device 200, such as a particular size (e.g. treatment element length and / or diameter) or other configuration of device 200b. Device 200b can be inserted over guidewire 60, such as is described herein. Guidewire 60 can be advanced such that its distal end is in the jejunum or a more distal location. During advancement of device 200 (e.g. manually by an operator or automatically by system 10), guidewire 60 can be held taut (e.g. via robotic manipulation via console 100) in order to prevent device 200 from forming a loop in the stomach. As described herein, a device 200b can be inserted through a working channel of a device 200a and / or alongside device 200a. In some embodiments, a single device 200 includes both endoscopic components (e.g. steering, integrated camera, and the like) as well as a functional assembly 500 and its associated fluid pathways (conduits) and other associated componentry.

[0233]

[0240] Device 200 can be advanced (e.g. over guidewire 60 or not, via an operator, or robotically via console 100) such that functional assembly 500 is positioned in the duodenum (or another GI location) comprising target tissue to be treated. One or more tissue capture chambers 510 (e.g. three tissue capture chambers 510 positioned on expandable element 530 of functional assembly 500) can be positioned at a first target tissue location in the intestine. The first location can be a most-proximal target location to be treated, such as a location in the duodenum at least 0.5cm or at least 1cm, but not more than 5cm or 10cm from the papilla and / or the ampulla of Vater. In some embodiments, tissue capture chambers 510 are positioned in the patient’s anatomy (e.g. manually by an operator and / or automatically by system 10) based on the location of a previously placed marker, such as marker 90 described herein. Prior to and / or during insertion of device 200, a stiffening wire can be inserted within device 200. In some embodiments, device 200a is positioned adjacent a device 200b, such that the distal ends of each are positioned beyond the papilla and / or the ampulla of Vater (e.g. beyond marker 90).

[0234]

[0241] In Step 1020, submucosal tissue expansion is performed, or at least attempted, at the first location (e.g. a first axial segment of the duodenum). Saline and / or other fluid or material (injectate 125) is injected (e.g. manually and / or automatically, as described herein) into submucosal tissue. In some embodiments, injectate 125 is delivered (e.g. simultaneously injected) by multiple injectate delivery elements 520 of functional assembly 500, each element 520 positioned in a corresponding tissue capture chamber 510 (e.g. three chambers 510 spaced approximately 120° apart along a circumference). Each injection (by a single injectate delivery element 520) can comprise a volume of at least ImL, such as at least 2mL, at least 5mL or at least 8mL per each injectate delivery element 520 (e.g. when the cumulative amount of fluid delivered by the multiple injectate delivery element 520 comprises at least 3mL, such as at least 6mL, at least 15mL, or at least 24mL). Each injection can comprise a volume no more than 20mL, such as no more than 15mL, and / or an injection with a volume of approximately lOmL (e.g. when the cumulative amount of fluid delivered by the multiple injectate delivery element 520 comprises a volume no more than 60mL, such as no more than 45mL, or when the cumulative volume delivered comprises approximately 30mL). In some embodiments, each injection comprises a volume of at least 4mL, at least 6mL, or at least 8mL. In some embodiments, the volume of injectate delivered (e.g. via three circumferentially positioned injectate delivery elements 520) can be configured to achieve an expansion of the submucosal layer to a resultant thickness of at least 250pm, or approximately 400pm, in the area surrounding the volume of mucosal tissue to be ablated. Console 100 can be configured to deliver injectate 125 at a flow rate of at least ImL / min, or at least lOmL / min, such as a flow rate of 50mL / min, or lOOmL / min. In some embodiments, console 100 is configured to deliver the full volume of injectate for a single injectate delivery element 520 at a single site within a time period of no more than 2 minutes, no more than 1 minute, or no more than 30 seconds. In some embodiments, injectate 125 is injected into tissue in a closed loop fashion, such as until a pressure threshold is reached (e.g. pressure within a delivery element 520), until the pressure within a balloon or other functional element placed proximate the injection site increases above a threshold, and / or until the inner diameter of the duodenum is reduced to a certain size or reduced a particular percentage of its pre-injection size. In some embodiments, one or more injectate delivery elements 520 are robotically advanced into tissue (e.g. by console 100), prior to the delivery of injectate 125 into the tissue.

[0242] Volumes injected by the multiple injectate delivery elements 520 can be selected to achieve near full circumferential expansion of submucosal tissue (e.g. without gaps, full 360° expansion). Each submucosal tissue expansion step or procedure (“step” or “procedure” herein) can be configured to create a safety margin of expanded submucosal tissue, as described herein, this expanded tissue volume (e.g. a partial or full circumferential tubular volume of the intestine) defining an “expanded tissue periphery”. In some embodiments, functional assembly 500 is constructed and arranged (e.g. the ablative portion is sized) such that a submucosal tissue expansion performed at a single axial location of the small intestine (e.g. via delivery of injectate 125 via two, three or more injectate delivery elements 520, simultaneously or sequentially at the single axial location) creates an expanded tissue periphery that is sufficiently sized to fully surround an “ablation periphery” (periphery of a volume of ablated tissue) that is created during ablation via functional assembly 500 (as described herebelow in reference to Step 1050). This sufficiently sized expanded tissue periphery avoids transmission of significant energy beyond the submucosal layer (e.g. avoids transmission of energy at a level sufficient to ablate the deeper, muscular layers of the GI tract). For example, in cases of full circumferential submucosal tissue expansion, if the axial length of the expanded submucosal tissue achieved by injectate 125 delivery in Step 1020 is greater than the axial length of the tissue to be ablated, the submucosal tissue expanded is sufficient to provide a safety margin for the ablation (e.g. when during ablation functional assembly 500 is relatively centered within the expanded length of tissue).

[0235]

[0243] In some embodiments, the expanded tissue periphery created in a single submucosal tissue expansion step may not be sufficiently sized to support the ablation periphery created by functional assembly 500, and an optional Step 1025 is performed (e.g. one or more times), comprising additional submucosal tissue expansion. For example, a second submucosal tissue expansion can be performed at a neighboring (e.g. relatively adjacent and more distal) axial segment of the duodenum, such as by translating (e.g. advancing) device 200 to reposition functional assembly 500 (e.g. a translation performed manually by an operator and / or automatically by system 10). Functional assembly 500 can be at least partially collapsed (e.g. ablative fluid 145, neutralizing fluid 155, and / or other fluid is removed from functional assembly 500) prior to translation. Translations of device 200 (e.g. manual and / or system 10 controlled advancements and / or retractions of functional assembly 500 or other portion of device 200) can be performed under visualized guidance, such as when functional elements 499a, 499b and / or 599 described herein comprise a radiopaque band, ultrasonically reflective marker, and / or other visualization marker that can be visualized by imaging device 70 (e.g. a fluoroscope or ultrasound imager) or by imaging assembly 270 of device 200, with the location of the markers (e.g. marker 90) captured in the image information 75. Alternatively or additionally, rotations of device 200 (e.g. rotations of functional assembly 500 or other portion of device 200) can be performed manually by an operator or automatically by system 10 under similar visualized guidance. In Step 1025, device 200 can be translated (e.g. advanced) a pre- determined distance (e.g. a distance of at least 0.3cm, or at least 0.6cm), after which delivery of injectate 125 can begin. Delivery of injectate 125 via the injectate delivery elements 520, as described hereabove in reference to Step 1020, creates a second (e.g. contiguous) volume of expanded submucosal tissue that in combination with the first expanded volume of submucosal tissue defines a larger expanded tissue periphery than that which is created in a single tissue expansion step. This larger expanded tissue periphery can support larger ablation peripheries (e.g. longer full circumferential lengths of tissue to be ablated), such as may be required by functional assembly 500 in a single ablation. For example, in cases of full circumferential submucosal tissue expansion, if the axial length of the expanded submucosal tissue achieved by injectate 125 delivery in the combined deliveries of Step 1020 and Step 1025 is greater than the axial length of the tissue to be ablated, the submucosal tissue expanded provides a sufficient safety margin for the ablation.

[0236]

[0244] Referring additionally to Fig. 1C, a representative expanded periphery and ablation periphery of two full circumferential expansions followed by a single full circumferential ablation, each performed by device 200 via console 100 as described herein, are illustrated. First and second circumferential submucosal tissue expansions combine to form an expanded tissue periphery with a length as shown. Functional assembly 500 can deliver energy to tissue, creating an ablation periphery that is positioned within the expanded tissue periphery.

[0237]

[0245] Optional Step 1025 can be performed two or more times (e.g. manually by an operator and / or automatically by system 10), resulting in three or more injections of fluid into tissue (e.g. submucosal tissue), with or without an intervening ablation performed via Step 1050. Sequential injections of injectate 125 can be performed at an axial separation distance of between 1cm and 2cm apart from a previous injection (e.g. 1cm to 2cm distally in the duodenum, jejunum, or other GI location). In some embodiments, multiple injections are positioned (e.g. robotically positioned) at least 0.5cm apart along the central axis (“axis” herein) of the small intestine, such as between 1.0cm and 5.0cm apart, such as approximately 1.0cm, 2.0cm, 3.0cm, 4.0cm and / or 5.0cm apart from one another along the axis of the small intestine. In some embodiments, axial separation of injection sites (i.e. translation distance of device 200 between injections) can approximate half the length of expandable element 530 (e.g. when expanded) onto which injectate delivery elements 520 are mounted, such as half the length of expandable element 530 of Fig. 1. In some embodiments, a series of 5-15 sets (e.g. 8-12 sets) of injections (e.g. each set comprising injections from 2, 3 or more injectate delivery elements 520) can be performed (with or without an intervening ablation step) by delivering injectate 125 (e.g. a fluid containing a visualizable dye) to the tissue to be expanded and subsequently translating device 200 to a new axial location (e.g. after proper expansion of tissue is confirmed manually by an operator and / or automatically by system 10, such as is described herebelow in Steps 1030 and 1035, or otherwise). Each advancement and / or retraction of a device 200b (e.g. including a functional assembly 500) can be made in unison with advancement and / or retraction (e.g. a robotic advancement and / or retraction, as described herein) of a device 200 (e.g. comprising a steerable device including imaging assembly 270) that is positioned alongside device 200.

[0238]

[0246] As described herein, tissue expansion can begin at a location proximate but distal to the papilla and / or the ampulla of Vater, such as at a location at least 1cm distal to but not more than 5cm or 10cm from the papilla and / or the ampulla of Vater. A series of full circumferential submucosal tissue expansions can be performed (e.g. moving distally), for example to a distal location up to the Ligament of Treitz. In alternate embodiments, multiple full circumferential tissue expansions are performed by retracting device 200 (e.g. automatically by system 10) from distal to proximal locations, or in a discontinuous (back and forth) manner. In some embodiments, console 100 is configured to robotically position functional assembly 500 to reside at locations in the small intestine that are distal to the papilla and / or the ampulla of Vater (e.g. a positioning performed prior to an ablation procedure).

[0239]

[0247] Volumes of injections and / or axial separation of injection sites can be chosen (e.g. via algorithm 11) to avoid axial gaps between neighboring expanded volumes of tissue (e.g. when an ablation step is to be performed proximate one or both expanded volumes of tissue, such as within both volumes of tissue). After injections, gaps identified circumferentially and / or axially (e.g. identified automatically via algorithm 11 using data from imaging assembly 270 and / or imaging device 70), can be filled in as deemed necessary (e.g. automatically by system 10 via algorithm 11 and / or by an operator) via additional injection (e.g. with or without rotation and / or translation of device 200).

[0248] In some embodiments, console 100 is configured to reduce the amount of fluid (e.g. liquid such as water or gas such as air or carbon dioxide) in expandable element 530 supporting injectate delivery elements 520 as the injectate 125 is delivered into tissue, such as to prevent excessive force being applied to tissue proximate the expanding tissue (i.e. due to the decreasing lumen of the intestine proximate the expanding tissue in contact with expandable element 530).

[0240]

[0249] Multiple injections (e.g. two, three or more injections from two, three or more equally separated injectate delivery elements 520) can be performed simultaneously or sequentially in a single axial segment of the intestine (e.g. without moving functional assembly 500). A vacuum can be applied (e.g. automatically or otherwise via system 10, such as via a working channel of device 200 and / or via ports 47 OP or 470D) to the intestinal lumen (e.g. desufflation) prior to delivery of injectate 125, such as to draw tissue toward each injectate delivery element 520 (e.g. into the associated chambers 510). After injectate 125 delivery, the vacuum can be removed (e.g. automatically by system 10, without operator action needed) and an ablation performed (e.g. in Step 1050 below without additional translation or other movement of functional assembly 500), or device 200 can be advanced (or retracted) for a subsequent (additional) tissue expansion.

[0241]

[0250] In Step 1030, an optional assessment of submucosal tissue expansion can be performed (e.g. manually by an operator and / or automatically by algorithm 11 of system 10). Optional Step 1030 can be performed after Step 1025, as shown in Fig. IB (e.g. if Step 1025 is performed), and / or directly after Step 1020 (e.g. when a single tissue expansion is sufficient for the subsequent ablation or simply when an assessment is desired directly after a tissue expansion). In some embodiments, assessment of submucosal tissue expansion is performed via imaging assembly 270, which produces image information 75 comprising data related to the quantity and / or quality of the tissue expansion. Alternatively or additionally, submucosal tissue expansion can be assessed using a different visualization and / or other imaging device of system 10, such as when imaging device 70 described hereabove in reference to Fig. 1 provides image information 75 comprising one or more images used to perform the assessment. Injectate 125 delivered in Steps 1020 and / or 1025 can include an agent that is directly visualizable by an operator and / or an agent whose location (e.g. a volume of tissue that has been expanded by injectate 125) can be (at least partially) assessed by system 10 (e.g. via an image processing algorithm of algorithm 11). For example, injectate 125 can comprise a material selected from the group consisting of: a visible material (such as India ink, indigo carmine, and the like) visualized by imaging assembly 270, or imaging device 70, or other camera; a radiopaque material visualizable by an imaging device 70 comprising a fluoroscope or other X-ray imaging device; an ultrasonically reflectable material visualizable by imaging assembly 270 and / or an imaging device 70 comprising an ultrasound imaging device; any visualizable material; and combinations of one or more of these. Visualization of the expanded tissue can be used to determine (e.g. automatically determine by algorithm 11) that a proper volume of injectate has been delivered as well as sufficient tissue expansion has been achieved, such as to ensure sufficient thickness, sufficient elimination of gaps, sufficient axial length, and / or sufficient circumferentiality (e.g. full or near-full circumferential nature) of tissue expansion has occurred. The pressure of expandable element 530 or the volume of fluid within expandable element 530 can also be monitored (e.g. via a pressure-sensor based functional element of device 200 and / or console 100) to determine if a proper volume of injectate has been delivered to achieve adequate tissue expansion. In particular, the expanded tissue can be analyzed (e.g. by algorithm 11) to identify areas of relatively poor expansion which may indicate regions of adherent submucosal tissue (such as scarred and / or fibrotic submucosal tissue not amenable to tissue expansion).

[0242]

[0251] As described above, in some embodiments, assessment of submucosal tissue expansion performed in optional Step 1030 can be performed (at least) using imaging assembly 270 (e.g. of a device 200a). In these embodiments, prior to and / or during the assessment of submucosal tissue expansion performed in Step 1030, functional assembly 500 (e.g. of a different device, device 200b) can be at least partially collapsed (e.g. inflation fluid 135, and / or other fluid is removed from functional assembly 500), to provide an increased view of the expanded tissue. Alternatively or additionally, a functional assembly 500 of a device 200b is at least partially collapsed to allow advancement of device 200a toward and potentially into the axial segment of intestinal tissue to which the submucosal tissue has been expanded, to provide a closer view of the expanded tissue.

[0243]

[0252] In Step 1035, an optional step of assessing the adequacy of submucosal tissue expansion can be performed (e.g. a qualitative assessment performed by a clinician and / or a quantitative assessment performed automatically by system 10). If submucosal tissue expansion is determined to be inadequate, Step 1040 is performed, in which a new (alternative) area for tissue expansion and subsequent ablation is selected, or the procedure is terminated (e.g. after limited or no ablations have been performed). In some embodiments, the Method 1000 of Fig. IB is included in a medical procedure that is performed on a patient after (e.g. at least 24 hours after) a similar procedure has been performed on that same patient (e.g. a similar ablation procedure in the duodenum or other location of the patient’s small intestine or GI tract). The assessment of submucosal expansion performed in Step 1030 can be an important diagnostic test that can confirm that it is safe to perform a repeated, similar procedure (e.g. the procedure of the present inventive concepts). Alternatively, the assessment may enable the identification of patients who may have: an active infection in their small intestine; a history of infection (such as tuberculosis) and / or malignancy that can cause a GI segment injury (e.g. a condition that may make submucosal expansion challenging or even impossible); and combinations of these, such as patients to which no or limited ablations should be performed. For example, there may be significant fibrosis and / or significant scar present at a target location (from a previous procedure or otherwise), which could prevent proper submucosal tissue expansion. In these instances, ablation should not be performed, at least not at that location of the intestine.

[0244]

[0253] If the submucosal tissue expansion is determined to be adequate (e.g. by algorithm 11), Step 1050 is performed in which target tissue is treated (e.g. ablated) by functional assembly 500 of device 200 (e.g. device 200b). The target tissue can comprise one or more portions of the mucosal layer of the duodenum, jejunum, and / or other GI location proximate (e.g. on top of) the submucosal tissue that has been previously expanded (e.g. in one or more expansion Steps 1020 and / or 1025). Treated tissue can further comprise at least an inner layer of neighboring submucosal tissue (e.g. a partial depth of the submucosal tissue layer previously expanded). In some embodiments, the ablation of Step 1050 is performed without repositioning (e.g. without translating) functional assembly 500, such as without repositioning after Step 1020 or without repositioning after Step 1025 (if the optional step is performed), such as to ensure that ablation is performed over an area of expanded submucosal tissue (e.g. over a sufficiently sized expanded tissue periphery as defined herein) that provides a safety margin to avoid adversely affecting tissue layers beyond (deeper than) the submucosal layer. One or more circumferential ablations, partial circumferential ablations, and / or other treatments can be performed along a length of the GI tract (e.g. along one or more axial segments of the GI tract), such as along a length of the duodenum at least 1cm distal to the papilla and / or the ampulla of Vater, such as at a location at least 1cm distal to but within 3cm, 5cm or 10cm of the papilla and / or the ampulla of Vater. In some embodiments, all ablations are performed at least 2cm or at least 3cm distal to the papilla and / or the ampulla of Vater (e.g. tissue within 1cm, 2cm or 3cm of the papilla and / or the ampulla of Vater is not ablated). In some embodiments, tissue treatments are only performed at locations that have had submucosal tissue expansion performed and / or confirmed (e.g. visually as described hereabove in reference to optional Steps 1030 and 1035).

[0245]

[0254] In some embodiments, a thermal ablation is provided by sufficiently hot or sufficiently cold fluid introduced into expandable element 530 to ablate tissue. Alternatively or additionally, different forms of energy delivery or other tissue treatments can be performed (e.g. electromagnetic energy such as radiofrequency energy, electroporation energy such as irreversible electroporation energy, light energy such as laser light energy, mechanical energy such as energy configured to abrade and / or remove tissue, thermal energy such as heat energy and / or cryogenic energy, steam energy, and / or chemical energy).

[0246]

[0255] Device 200 and console 100 can be configured to treat a series of axial segments of GI tract tissue comprising lengths between 1cm and 5cm each, such as approximately 2cm in length each. Device 200 and console 100 can be configured to treat a cumulative axial length of GI tract tissue (e.g. an axial length of the duodenum) of less than or equal to 3cm, 6cm, 9cm, 15cm, or 20cm. Device 200 and console 100 can be configured to treat more than 3cm of axial length of the duodenum, such as more than 3.4cm, more than 6cm, more than 7cm, more than 8cm or more than 9cm (e.g. approximately 9.3cm). In some embodiments, at least 10%, 15%, 25%, 30% and / or 50% of the duodenum distal to the papilla and / or the ampulla of Vater is treated. The axial length and / or overall volume of tissue treated can correspond to a patient parameter, such as the longevity of the disease or other disease parameter as described herein (e.g. higher disease burden correlating to larger volumes of tissue treated).

[0247]

[0256] In some embodiments, at least 3 axial segments of the duodenum are treated (e.g. sequentially ablated, such as a sequential treatment including at least one submucosal tissue expansion step performed before each ablation), such as with a functional assembly 500 configured to deliver energy to a delivery zone with a length between 0.5cm and 4.0cm (e.g. tissue contacting length of expandable element 530 filled with ablative fluid), such as a delivery zone length (e.g. tissue contacting length) between 0.5cm and 4.0cm, between 1.5cm and 3.3 cm, or approximately 2cm in length. In some embodiments, at least 4 axial segments of the duodenum are treated, such as when at least 6 axial segments of the duodenum are treated. In these embodiments, functional assembly 500 can be configured to deliver energy to a delivery zone with a length between 0.7cm and 2.0cm (e.g. tissue contacting length of expandable element 530 filled with ablative fluid). In some embodiments, functional assembly 500 comprises ablative fluid delivered into expandable element 530 (e.g. ablative fluid 145 provided by console 100). Multiple tissue treatments are performed by repositioning functional assembly 500, which can further include contracting expandable element 530 to reposition functional assembly 500. Contact between the target tissue and functional assembly 500 can be accomplished using desufflation techniques (e.g. performed automatically by system 10) to bring the tissue toward expandable element 530 and / or via expansion of expandable element 530. Tissue treatment is performed, such as by filling expandable element 530 with ablative temperature fluid and / or delivering any form of energy to the target tissue. In embodiments where device 200 is delivered over a guidewire, the guidewire can be retracted (e.g. at least retracted to a location proximal to the treatment element) prior to any tissue treatments (e.g. prior to any energy deliveries).

[0248]

[0257] Multiple treatments can be performed by advancing or retracting functional assembly 500 and / or device 200 (e.g. in an automated and / or robotic fashion by system 10 via algorithm 11). In some embodiments, functional assembly 500 is positioned at a distal location and a series of tissue treatments are performed, such as at least 3 tissue treatments performed in which device 200 is retracted approximately the length of the tissue contacting portion of functional assembly 500 such as to treat relatively contiguous (e.g. but nonoverlapping), full circumferential axial segments of the duodenum (e.g. where at least one, or at least two submucosal tissue expansions are performed prior to each ablation or other treatment of target tissue). Prior to each treatment, an assessment of adequate submucosal tissue expansion can be performed (e.g. automatically by system 10 as described herein). Also prior to each tissue treatment, confirmation of being away from (e.g. distal to) any nontarget tissue marked and / or otherwise identified can be performed (e.g. automatically by system 10 by visualizing and identifying a previously placed marker 90). In some embodiments, a marker 90 is placed (e.g. robotically placed) to assist in avoiding damaging the papilla and / or the ampulla of Vater. In some embodiments, after three axial segments of the duodenum are treated (e.g. treated distally to proximally), an assessment of the linear distance between the most proximal treatment segment and the papilla and / or the ampulla of Vater is performed (e.g. one or more components of system 10 is used to determine the distance). If sufficient length is determined (e.g. the determined distance is above a threshold), additional (more proximal) axial tissue segments may be treated. If translation of device 200 is performed over a guidewire, undesired movement of the guidewire is prevented or otherwise reduced (e.g. by the operator and / or by system 10, such as when system 10 is configured to detect undesired guidewire movement).

[0249]

[0258] In some embodiments, the system of the present inventive concepts (e.g. system 10 of Fig. 1) is configured to allow only one ablation per (pre-determined) time period, such as to prevent two ablations within a minimum period of time, such as to prevent repetitive ablation in the same or at least similar (e.g. overlapping) portions of the GI tract (e.g. rapid treatment of similar treatment zones that can result in excessive heat present in a volume of tissue that is proximate two or more of the ablation locations).

[0250]

[0259] In some embodiments, the tissue treatment of Step 1050 should be completed within approximately 120 minutes or within approximately 60 minutes of the initiation of tissue expansion performed in Step 1020 and / or Step 1025, such as within approximately 45 minutes, 30 minutes and / or 20 minutes. Performance of tissue treatment within this time window prevents an unacceptable amount of tissue expansion due to dissipation of injectate 125 from the expanded submucosal tissue space over time. In some embodiments, system 10 is configured to prevent a tissue treatment (e.g. ablation) until an adequate submucosal expansion step has been performed and / or confirmed, such as is described in Step 1030.

[0251] After one or more axial segments of duodenum or other GI segment is ablated in Step 1050, a determination is made in Step 1060 regarding additional axial segments to be treated. In some embodiments, a single axial segment is ablated in Step 1050, after which additional submucosal tissue is expanded (e.g. in one or more of Steps 1020 and / or 1025) and an additional ablation is performed proximate the additionally expanded submucosal tissue. In some embodiments, two axial segments of submucosal tissue are expanded for each single axial segment of mucosal tissue ablated. In some embodiments, a first ablation is performed proximate an area of two submucosal expansions (e.g. directly after the two submucosal expansions are performed), and subsequent ablations are performed after (e.g. directly after) two or less (e.g. one) submucosal expansions are performed (e.g. expansions performed in the area of the subsequent ablations).

[0252]

[0260] The cumulative amount of target tissue treated and / or the number of treatments performed can correlate to (e.g. be proportional to) one or more patient conditions (e.g. more severe conditions correlates to more tissue treated and / or more treatments performed over time). An increased treatment can comprise an increased axial length of tissue treated (e.g. an increased cumulative axial length of duodenum ablated), an increased volume of tissue treated (e.g. an increased volume of duodenal mucosa treated via an increased mucosal surface area receiving ablation energy from functional assembly 500), a deeper depth of treatment, and / or a larger number of treatments performed over time in order to achieve a sustained treatment response. In some embodiments, the tissue treatment is modified to avoid creation of a duodenal stenosis or stricture, such as to limit one or more of: amount of energy delivered; peak energy delivered; duration of energy delivered; length of tissue treated; depth of tissue treated; and combinations of these.

[0253]

[0261] In some embodiments, device 200 includes one or more imaging assemblies 270, such as imaging assembly 270b (shown Fig. 1C) positioned within functional assembly 500, and / or imaging assembly 270a shown positioned proximate but proximal to functional assembly 500. Imaging assembly 270 can be configured to provide image information 75 that is used by console 100 (e.g. algorithm 11) to robotically manipulate a device 200 and / or another component of system 10.

[0254]

[0262] Referring now to Fig. ID, a schematic view of a robotically controlled system for treating and / or diagnosing gastrointestinal tissue is illustrated, consistent with the present inventive concepts. System 10 of Fig. ID includes console 100 and device 200 as shown. System 10 and / or one or more of its components can be of similar construction and arrangement as system 10 of Fig. 1 described herein. Device 200 can comprise one or more devices, such as an endoscope-based device, such as device 200a as described herein (e.g. including an integrated camera such as an imaging assembly 270 comprising a camera), and a catheter-based device, such as device 200b also as described herein (e.g. including functional assembly 500). Console 100 can be configured to robotically manipulate (e.g. control the operation of in an automated way and / or robotically control the movement of) one or more of: a proximal portion of device 200 (e.g. one or more devices 200), a middle portion of device 200, a distal portion of device 200, functional assembly 500; and / or another component and / or portion of a component of system 10.

[0255]

[0263] Algorithm 11 can be configured to collect information from one or more components of system 10, such as image information 75 provided by imaging device 70 and / or imaging assembly 270, and / or information from one or more functional elements of device 200 and / or other component of system 10 including a sensor-based functional element as described herein. Algorithm 11 can be further configured to control a robotic manipulation of device 200 or other component of system 10 based on this collected information.

[0256]

[0264] System 10 (e.g. via algorithm 11) can be configured to detect a system 10 procedure state, where the procedure state comprises a system 10 state (e.g. a system 10 condition, arrangement, and / or other state) and / or a patient state (e.g. a patient physiologic condition and / or other patient state). Algorithm 11 can be configured to determine (e.g. define, provide and / or perform) a robotic manipulation based on the detected procedure state. In some embodiments, the algorithm 11 determined robotic manipulation is based on both a system 10 state and a patient state. System 10 can include one or more sensor-based functional elements, such as functional elements 199 and / or 299 shown, and the algorithm 11 determined robotic manipulation can be based on data provided by the one or more sensors (e.g. the sensor provides information regarding the procedure state). The robotic manipulation can comprise a manipulation of functional assembly 500, such as translation of functional assembly 500, expansion and / or contraction of functional assembly 500, orientation of functional assembly 500, advancement and / or retraction of an injectate delivery element 520, delivery of injectate 125 into tissue by functional assembly 500, and / or ablation or other treatment of tissue by functional assembly 500. The information provided by the one or more sensors can comprise information related to: submucosal tissue expansion (information related to thickness or circumferentiality of tissue expansion); tissue ablation (e.g. information related to completeness of ablation, such as based on a change in color of tissue performed via analysis of a color change prior to, during, and / or after delivery of ablation energy); lumen diameter (e.g. at a desired treatment site); presence of mucus (e.g. at a desired treatment site); and / or length and / or quantity of villi (e.g. at a desired treatment site).

[0257]

[0265] System 10 (e.g. via algorithm 11) can be configured to advance functional assembly 500 through the stomach and into the duodenum in an automated and / or otherwise robotically manipulated fashion.

[0258]

[0266] System 10 (e.g. via algorithm 11) can be configured to retract the distal portion of device 200 along an axial segment of the intestine, and system 10 can gather intestinal segment information (e.g. as image information 75). The intestinal segment information can be gathered prior to, during, and / or after the retraction of device 200. This intestinal segment information can comprise information regarding the location of the papilla, the ampulla of Vater, and / or the ligament of Treitz. System 10 can be configured to confirm the acceptability of tissue within the axial segment of the intestine intended for a subsequent treatment. System 10 can be configured to “tag” an anatomical location in the intestinal segment information (e.g. electronically “tag” one or more portions of image information 75 with particular details, such as location of the papilla, the ampulla of Vater, and / or the ligament of Treitz). System 10 (e.g. via algorithm 11) can be configured to identify anatomical locations in the intestinal segment information (e.g. identify the location of a particular anatomical location in image information 75 not previously known or at least not confirmed). System 10 can be configured (via algorithm 11) to advance the functional assembly 500 to a determined location within the axial segment of the intestine. The advancement can comprise an automated advancement by system 10 with minimal or no operator navigational input (e.g. without steering commands provided by an operator).

[0259]

[0267] Device 200 (e.g. a distal portion of device 200) can comprise imaging assembly 270 and / or an imaging-based functional element 299 that is configured to gather the intestinal segment information described hereabove (e.g. as image information 75). The intestinal segment information can be based on the 3D shape of device 200 prior to and / or during the retraction. In some embodiments, functional element 299 comprises one or more fiber optic elements (e.g. a fiber Bragg device and / or including internal reflectors) that are configured to gather device 200 3D shape information. In these embodiments, console 100 can include a laser or other light source provided to the fiber optic elements. Alternatively or additionally, functional element 299 can comprise one or more magnetic elements, and imaging device 70 can comprise an electromagnetically based shaped detector configured to produce device 200 shape information based on a magnetic interaction between imaging device 70 and the functional elements 299. As described herein, shape information of device 200 and / or the tortuous anatomy of the small intestine and other GI tract locations, can be used by system 10 to translate and / or otherwise robotically manipulate device 200 while being introduced into and / or manipulated within the patient.

[0260]

[0268] Image information 75 can be collected by imaging device 70 and / or imaging assembly 270 while the imaged portion of the patient’s anatomy is illuminated, such as illumination provided by imaging assembly 70 and / or an illumination-based functional element 299 (e.g. a light emitting diode or other light producing component). Image information 75 can be gathered while the segment of the GI tract being visualized is insufflated. In some embodiments, imaging device 70 and / or imaging assembly 270 include a wide angle lens and / or comprise a side-viewing camera. In some embodiments, imaging device 70 and / or imaging assembly 270 are configured to be steered (e.g. automated steering provided by system 10 and / or manual steering provided by an operator).

[0261]

[0269] As described herein, system 10 can be configured to advance functional assembly 500 to one or more determined locations (e.g. intended treatment sites) within the axial segment of the intestine. These advancements of functional assembly 500 can comprise “automated” advancements, as described herein. The determined location can comprise a location distal to the papilla. The determined location can comprise a location relatively proximate (yet distal) to the papilla, such as location distal but within 5cm of the papilla (e.g. to avoid damaging the papilla and / or to increase the therapeutic benefit of a subsequent tissue treatment). System 10 can be configured to cause functional assembly 500 to treat tissue, and to subsequently translate the functional assembly a fixed increment (e.g. where all or a portion of the steps are performed in an automated arrangement, without any required operator input). The fixed increment can comprise a length of approximately 1cm (e.g. a length between multiple tissue expansion steps), and / or approximately 2cm (e.g. a length between sequential ablations, or an ablation followed by a tissue expansion step). The incremental length can comprise a length similar to the length of functional assembly 500, or the effective treatment length of functional assembly 500 (e.g. such as to align a border of a second treatment with an adjacent border of a first treatment in a non-overlapping fashion). The incremental length can comprise a length that is variable, such as a variation made by an operator of system 10 via user interface 1000. The increment length can have an accuracy (e.g. a margin of error) of no more than ±5mm, or no more than ±3mm (e.g. final location is within 5mm, or 3mm of intended location). The translation can comprise an advancement of the functional assembly to a location more distal in the intestine. System 10 can be configured to allow an operator to adjust the position of functional assembly 500 (e.g. after an automated translation). System 10 can be configured to detect the position of functional assembly 500 within the patient’s GI tract (e.g. identify the current position of functional assembly 500 relative to image information 75).

[0262]

[0270] Device 200 can comprise an assembly, manipulation assembly 2100 shown, for robotically and / or otherwise manipulating one or more portions of device 200. Manipulation assembly 2100 can include one or more elongate filaments, cables 2101 shown, for steering, translating (e.g. retracting and / or advancing), actuating (e.g. actuating a valve or other component of device 200), and / or otherwise manipulating device 200. Console 100 can comprise a controlling assembly, control assembly 1100, that interfaces with manipulation assembly 2100, such as to control the tension of cables 2101, such as to translate, rotate, and / or steer the distal portion of device 200 (e.g. with an accuracy of no more than ± 5mm, or nor more than ±3mm). Cables 2101 can be slidingly positioned within one or more conduits, lumens 297 shown of shaft assembly 400, such as lumens with a helical geometry to minimize changes in path length (e.g. as described herein). System 10 can be configured such that an operator interfaces with control assembly 1100 via HID 1010 to robotically manipulate one or more components and / or other portions of device 200.

[0263]

[0271] Manipulation assembly 2100 and / or control assembly 1100 can be configured to record the tension in one or more cables 2101 (e.g. via a tension-recording functional element 299 and / or 199 respectively, such as to record a tension to steer, retract, and / or otherwise manipulate one or more portions of device 200). Algorithm 11 can be configured to compare a measured tension (e.g. a current tension) to a previously measured tension and / or a predicted measured tension (e.g. related to the current or other shape of device 200, and / or the tortuosity of the anatomy into which device 200 is positioned). Algorithm 11 can compare two sets of one or more cable tensions between two similar anatomical locations of device 200. Algorithm 11 can be configured to cause system 10 to enter an alert state if the comparison of cables tensions, and / or the absolute (current) cable tension is above a threshold (e.g. a threshold including a safety margin). For example, system 10 can adjust the cable tensions (e.g. reduce the tensions to cause device 200 to enter a “limp” state) when a particular alert state is entered.

[0264]

[0272] Shaft assembly 400 can comprise a variable stiffness, such as a stiffness that is greater in more proximal portions as compared to more distal portions (i.e. more flexible distally), as described herein. In some embodiments, device 200 comprises an elongate filament, mandrel 298 shown, for insertion into at least a portion of shaft assembly 400, via a lumen 297, such that at least that portion is stiffened as a result of the insertion. Mandrel 298 can be inserted into a lumen 297 that is surrounded by a wall of shaft assembly 400. In some embodiments, mandrel 298 comprises an assembly including a first portion 298a, and a second portion 298b that is rotatably attached to first portion 298a. Portions 298a and 298b can comprise rotatably coupled coils where rotation from a first position to a second position increases the stiffness of the assembly, and vice versa. Mandrel 298 can comprise a variable stiffness, such as when its proximal portion is stiffer than its distal portion. Mandrel 298 can be configured to be steered, such as when a cable 2101 is attached to a distal portion of mandrel 298, the cable arranged to be manipulated (e.g. robotically manipulated) by control assembly 1100 of console 100 to steer the distal portion of mandrel 298.

[0265]

[0273] In some embodiments, system 10 is configured to determine the shape (e.g. the 2D and / or 3D shape) of device 200. For example, device 200 can comprise shape sensor assembly 2200 shown, which can include one or more sensors, transducers, markers, and / or other functional elements, shape element 2201, and console 100 can include shape sensing assembly 1200 which can be configured for interfacing with shape sensor assembly 2200 (e.g. sending drive signals and / or power to and / or receiving data signals from shape sensor assembly 2200). Shape sensing assembly 1200 can be configured to produce shape information (e.g. stored as image information 75) related to the current geometry of device 200 and / or a portion of device 200 (e.g. shaft assembly 400, functional assembly 500, and / or an inserted mandrel 298). Shape element 2201 can comprise one or more fiber optic-based sensors, such as a fiber Bragg grating sensor (e.g. when shape sensing assembly 1200 comprises a source of light provided to shape element 2201). Shape element 2201 can comprise one or more magnets, coils, and / or other electromagnetic components, such as when shape sensing assembly 1200 is configured to determine the shape (e.g. a 2D and / or 3D shape) of device 200 based on an analysis of electromagnetic fields produced by shape elements 2201. Shape element 2201 can comprise one, two, or more elements selected from the group consisting of: a visualizable element such as a radiopaque element and / or an ultrasonically reflective element; an electromagnetic element; a fiber optic; a fiber Bragg grating sensor; an accelerometer; a strain gauge; and combinations of one, two, or more of these. In some embodiments, shape element 2201 comprises one or more accelerometers that provide one or more motion signals to algorithm 11 in which to determine the shape of device 200.

[0266]

[0274] In some embodiments, shape information of device 200 is determined by measuring strain on the device by means of electrical resistance in one or more wires placed along its length.

[0267]

[0275] In some embodiments, system 10 is configured to determine the position of device 200 within the patient (e.g. the 2D and / or 3D position of at least a portion of device 200 within the patient). For example, device 200 can comprise position sensor assembly 2300 including one or more sensors, transducers, markers, and / or other functional elements, position elements 2301, and console 100 can include position sensing assembly 1300 for interfacing with position sensor assembly 2300. Position sensing assembly 1300 can be configured to produce anatomical position information (e.g. and stored as image information 75) related to the current position of device 200 and / or a portion of device 200 (e.g. shaft assembly 400, a distal portion of device 200, functional assembly 500, and / or an inserted mandrel 298) within the patient (e.g. position of a portion of device 200 relative to the patient’s anatomy). Position element 2301 can comprise one or more magnets, coils, and / or other electromagnetic components, such as when position sensing assembly 1300 is configured to determine the position (e.g. 2D and / or 3D position in the patient’s anatomy) of device 200 based on an analysis of electromagnetic fields produced by position elements 2301. In these embodiments, position element 2301 can comprise one or more active and / or passive electromagnetic components that are positioned on and / or within device 200, such as components that produce a signal and / or otherwise provide information related to the position of device 200. In these embodiments, functional element 99 can comprise an electronic field sensor (e.g. a planar array sensor) that is positioned proximate the patient during use. The functional element 99 can further comprise an electrical field source (e.g. when position element 2301 comprises passive elements). Position element 2301 can comprise one or more elements selected from the group consisting of: a visualizable element such as a radiopaque element and / or an ultrasonically reflective element; an electromagnetic element; a fiber optic; a fiber Bragg grating sensor; and combinations thereof. In some embodiments, position element 2301 comprises one or more accelerometers that provide one or more motion signals to algorithm 11 in which to determine the position of device 200 relative to the patient’s anatomy.

[0268]

[0276] In some embodiments, system 10 is configured to provide feedback to an operator of system 10 regarding the force applied on tissue by functional assembly 500 and / or another portion of device 200. For example, device 200 can comprise force sensor assembly 2400 including one or more sensors, transducers, markers, and / or other functional elements, force sensors 2401, and console 100 can include force sensing assembly 1400 for interfacing with force sensor assembly 2400. Force sensing assembly 1400 can be configured to produce one or more forms of feedback (e.g. quantitative and / or qualitative force information) related to the detected force, such as: visual feedback (e.g. visual force feedback information provided on a display of user interface 1000); haptic feedback (e.g. force feedback information provided via a vibrational feedback element of device 200 or other component of system 10); and / or audio feedback (e.g. speech or other sound force feedback information provided by a speaker of user interface 1000). Force sensor 2401 can comprise one or more strain gauges and / or other force transducers for providing force information to force sensing assembly 1400. Force sensor 2401 can comprise one or more components selected from the group consisting of: strain gauge; accelerometer; magnets, coils, and / or other electromagnetic components; fiber optic force sensor; and combinations of these.

[0269]

[0277] In some embodiments, system 10 is configured to navigate device 200 through the patient’s anatomy (e.g. robotically advancing functional assembly 500 through the mouth and into the duodenum of the small intestine) without using a guidewire and / or without traversing a working channel of a separate device (e.g. an endoscope as described herein).

[0270]

[0278] In some embodiments, system 10 is configured to navigate device 200 through the patient’s anatomy (e.g. robotically advancing functional assembly 500 through the mouth and into the duodenum of the small intestine) without using fluoroscopy (e.g. without using intraprocedural fluoroscopy).

[0271]

[0279] In some embodiments, as described herein, device 200 can comprise a first device 200a and a second device 200b. Device 200a can comprise a first shaft with a proximal portion, a middle portion, and a distal portion, and one or more of these portions can be configured to be robotically manipulated by console 100 (e.g. by control assembly 1100 as described herein). Device 200b can comprise a second shaft with a distal portion onto which functional assembly 500 is positioned. Console 100 can be configured to robotically manipulate functional assembly 500 of device 200b.

[0272]

[0280] As described herein, console 100 or another component of system 10 can include one or more algorithms, algorithm 11 shown. Algorithm 11 can comprise a machine-learning algorithm.

[0273]

[0281] In some embodiments, algorithm 11 comprises a machine-learning algorithm configured to analyze images (e.g. image information 75 described herein) to automatically determine where the papilla and / or ampulla of Vater (either or both, “papilla” herein) is located and relay information to the operator and / or to console 100. This information can be used by the operator and / or by console 100 to manually and / or automatically avoid ablating the papilla and / or tissue proximate the ampulla of Vater. In some embodiments, algorithm 11 is configured to: analyze image information 75 (e.g. endoscopic image data) in real time or near real time (“real time” herein); determine whether the anatomical location (e.g. current functional assembly 500 location) in the image data contains the papilla; and / or notify the operator that the anatomical location (e.g. the current functional assembly 500 location) contains the papilla (e.g. by sound or by visual notification). Algorithm 11 can comprise a machine-learning algorithm that is trained on at least 1000 images of the papilla and / or at least 1000 images of the intestine that do not contain the papilla. Algorithm 11 can be configured to store information related to the location of where the papilla is identified (e.g. on a 3D map of the path of device 200 in the patient). Algorithm 11 can be configured to alert the operator in the case that device 200 (e.g. functional assembly 500) is positioned at a location too close to the papilla. Algorithm 11 can be configured to disable the ablation capability of device 200 when functional assembly 500 is positioned at a location too close to the papilla.

[0274]

[0282] In some embodiments, algorithm 11 comprises a machine-learning algorithm configured to analyze images to provide the operator with an “augmented reality” or an overlay on a display (e.g. a display of user interface 1000 of console 100 described herein), such as to show distance markers, key anatomical features, target tissue, and / or other reference points to an operator.

[0275]

[0283] In some embodiments, algorithm 11 comprises a machine-learning algorithm configured to analyze images to gather information related to the GI tract position in free space. In these embodiments, algorithm 11 can be configured to actively (e.g. automatically) guide device 200 along a path to target tissue while avoiding the papilla (e.g. avoiding positioning device 200 in any location for energy delivery that risks damaging the papilla).

[0276]

[0284] Algorithm 11 can be configured to cause a ratiometric movement of functional assembly 500 (and / or another portion of device 200), such as to cause a movement based on operator input to HID 1010. For example, a movement of a portion (e.g. a joystick or trigger) of HID 1010 through a distance X causes a corresponding movement of a portion of device 200 a distance of X times Y (e.g. where when Y is less than one a scaled reduction in movement of the device 200 portion results, or where when Y is greater than one a scaled increase in movement of the device 200 portion results). Similar scaling can be performed by system 10 relating to forces applied to inputs of HID 1010 (e.g. to increase or decrease an operator applied force as subsequently applied by the portion of device 200 being controlled). Algorithm 11 can use information provided by one or more of: shape sensing assembly 1200, position sensing assembly 1300, and / or force sensing assembly 1400 to produce a ratiometric movement and / or application of force of functional assembly 500 and / or another portion of device 200.

[0277]

[0285] Algorithm 11 can be configured to produce a 3D map of the path that device 200 is positioned (or previously has been positioned) within the patient’s anatomy, such as when algorithm 11 processes information provided by shape sensing assembly 1200, based on information provided by position sensing assembly 1300, and / or based on image information 75.

[0278]

[0286] Algorithm 11 can be configured to detect undesired motion of one or more portions of device 200, such as undesired movement of functional assembly 500. In some embodiments, algorithm 11 is configured to cause system 10 to enter an alert, warning, and / or alarm state ( “alert” state herein) when undesired motion exceeds a threshold, such as when device 200 is configured to enter a relatively limp state when excessive undesired motion occurs. In some embodiments, algorithm 11 is configured to detect peristalsis and / or coughing of the patient, and to adjust accordingly.

[0279]

[0287] Algorithm 11 can be configured to compensate for peristalsis of the intestine.

[0280]

[0288] In some embodiments, system 10 can be operated in an autonomous mode in which multiple tissue treatment steps are performed (e.g. distal to a previously identified location of the papilla) in succession, without the requirement of operator input (e.g. multiple tissue expansion and / or tissue ablation steps performed autonomously). In these embodiments, algorithm 11 can be configured to detect an undesirable state (e.g. condition), after which system 10 can enter an alert state (e.g. an alert state in which future autonomous steps are not performed without operator intervention).

[0281]

[0289] In some embodiments, algorithm 11 is configured to automatically (e.g. autonomously) perform at least a tissue expansion procedure, such as when algorithm 11 uses image information 75 (e.g. as provided by imaging device 70 and / or imaging assembly 270) and / or data provided by a sensor-based functional element 299 to confirm that the current position of functional assembly 500 is at a site in which a tissue expansion procedure is desirable to be performed.

[0282]

[0290] In some embodiments, algorithm 11 is configured to automatically (e.g. autonomously) perform at least a tissue ablation procedure, such as when algorithm 11 uses image information 75 (e.g. as provided by imaging device 70 and / or imaging assembly 270) and / or data provided by a sensor-based functional element 299 to confirm that the current position of functional assembly 500 is at a site in which a tissue expansion procedure is desirable to be performed, and that sufficient expansion of submucosal tissue is present.

[0283]

[0291] In some embodiments, algorithm 11 is configured to automatically (e.g. autonomously) reposition functional assembly 500 prior to performing a tissue ablation procedure, such as when algorithm 11 uses image information 75 (e.g. as provided by imaging device 70 and / or imaging assembly 270) and / or data provided by a sensor-based functional element 299 to confirm that the current position of functional assembly 500 is too close to non-target tissue (e.g. too close to the papilla, such as when algorithm 11 causes functional assembly 500 to be distally advanced to an acceptable distance from the papilla).

[0284]

[0292] In some embodiments, a first device 200, such as device 200a described herein (e.g. an endoscope-based device and comprising at least imaging assembly 270) can perform a first procedure. In this first procedure, the device 200 is inserted into the patient (e.g. through the patient’s mouth), and device 200 is then advanced through the patient’s GI tract to a desired location. During advancement (and / or other translations) imaging assembly 270 is collecting and / or providing images of the patient’s GI tract (e.g. the stomach, the duodenum, and / or more distal locations). This advancement of device 200 can be performed relatively manually by an operator of system 10 (e.g. a clinician). Alternatively, the advancement of the first procedure can be performed in an automated fashion by system 10. Based on the image information 75 collected, an assessment of acceptability for treatment can be performed. For example, a range of mucosal tissue of the duodenum or other small intestine location is accessed for its acceptability for treatment, in other words, one or more axial segments of the small intestine are screened for being an acceptable “treatment zone”. This assessment can be performed manually by the operator, and / or via a tissue assessment algorithm of algorithm 11. The image information 75 collected in the first procedure can also include a 2D and / or 3D map of the patient’s anatomy (e.g. as created by algorithm 11). Alternatively or additionally, image information 75 can include a 2D and / or 3D map of the patient’s anatomy that is created (e.g. by algorithm 11) based on information collected by an external imaging device (e.g. imaging device 70), such as an X-ray imaginer, a CT-Scanner, and / or an MRI (e.g. image information 75 collected using imaging device 70 prior to and / or during the first procedure). The first procedure can further include the placement of one or more markers 90, such as a marker 90 placed to identify the papilla, and / or a marker 90 placed to identify the ligament of Treitz. If an acceptable treatment zone is confirmed, a second procedure can be performed. The second procedure can be performed shortly or immediately after the first procedure is completed (e.g. within an hour), or at a later time or date. The second procedure can be performed using the same device 200 as the first procedure (e.g. when the device 200 further comprises a functional assembly 500), with a second device 200 (e.g. a device 200b that includes at least a functional assembly 500 and potentially a imaging assembly 270, such as a catheter-based device that includes those components), or by a combination of the device of the first procedure (e.g. a device 200 including a imaging assembly 270 as described herein), and a second device 200 (e.g. a device 200b that can be operably attached and / or otherwise translate in a coordinated way with the also inserted device 200a). The second procedure can comprise the treatment of one or more axial segments of small intestine mucosa. All or a portion of the translations one or more devices 200 performed during the second procedure (e.g. initial advancement of functional assembly 500 to a first treatment location, and subsequent advancements and / or retractions to additional treatment locations) can be performed automatically (e.g. automatically or semi-automatically as described herein) by system 10 based on the 2D and / or 3D map created in the first procedure. In some embodiments, the mucosal treatments comprise a tissue ablation procedure as described herein (e.g. a delivery of one or more different forms of energy or agents to mucosal tissue). In these embodiments, each ablation of an axial segment of mucosal tissue can be preceded by one, two, or more submucosal tissue expansion steps, also as described herein. Steering, translation, rotation, and / or other manipulations of device 200 in the second procedure (and / or the first procedure) can be performed by control assembly 1100 of console 100, such as when control assembly 1100 is configured to frictionally and slidingly engage a portion of device 200, such as the outer wall of shaft assembly 400 at locations along shaft assembly 400 that are proximal to functional assembly 500. Control assembly 1100 can include one or more force- applying components configured to apply a pushing, pulling, elongating, expanding, contracting, and / or twisting force to a portion of device 200 located outside of the patient, such as to advance, retract, elongate, expand, contract, and / or rotate one or more portions of a device 200 (e.g. advance, retract, and / or rotate the more distal portion of device 200 that is in the patient). For example, control assembly 1100 can include one or more rotating wheels (e.g. two or more wheels circumferentially spaced around shaft assembly 400) that can be frictionally engaged with shaft assembly 400 and rotated to cause a patient-inserted (e.g. partially inserted) device 200 to advance, retract, and / or rotate within the patient’s GI tract. At least a portion of control assembly 1100 (e.g. the shaft assembly 400 engaging portion) can be positioned proximate a bite block, such as bite block 40 described herein in reference to Fig. 2A. In some embodiments, control assembly 1100 comprises bite block 40 (e.g. a bite block is integrated into a portion of control assembly 1100). In some embodiments, functional assembly 500 and / or other portions of each device 200 is advanced, retracted, and / or rotated by a robotic assembly included in a distal portion of the device 200 (e.g. and controlled by an associated assembly of console 100), such as robotic assembly 900 shown. All operatorbased controlling of a device 200 can be performed using interface 1000 of console 100, such as by using HID 1010 of interface 1000.

[0285]

[0293] In some embodiments, console 100 and / or another component of system 10 is configured to operably connect (e.g. to facilitate information transfer) to a computer network, network 2001 shown. Network 2001 can be operably connected (e.g. to facilitate information transfer), to a computer server, server 2010 shown. Network 2001 can comprise the Internet and / or other wired and / or wireless network of computers and communication devices. Server 2010 can comprise a computer server of the manufacturer of system 10, and / or another third party that provides administrative, clinical, and / or technical services regarding system 10. In some embodiments, multiple consoles 100 (e.g. at least 2, 5, 10, 50, and / or 100 consoles 100) are operably connected to network 2001, such as consoles 100a, 100b, and 100c shown (e.g. each console 100 configured to operably attach to multiple devices 200 and / or multiple other system 10 components). In these embodiments, network 2001, and server 2010 can receive procedural and other data, “system information” herein, from one, two, or more consoles 100, such as to create, improve, and / or otherwise modify one or more system 10 parameters and / or one or more system 10 algorithms (e.g. algorithm 11 shown). In some embodiments, server 2010 is located in a hospital or other clinical setting. System information transferred via network 2001 (e.g. and uploaded to server 2010) can comprise patient and / or other information collected during and / or otherwise related to a clinical procedure performed using system 10 (e.g. procedural information, efficacy and / or other clinical outcome information, and / or other information related to a tissue treatment procedure of the present inventive concepts). In some embodiments, the system information transferred and / or uploaded comprises: a patient identification (ID); description of one or more portions of the anatomy treated; number of treatments (e.g. ablations and / or other treatments) performed; length of time to perform a procedure; physician ID; clinical site identification; console identification (e.g. model number, serial number or other ID); device 200 identification (e.g. model number, serial number, or other ID); console 100 component ID (e.g. ID of a heater or other component of console 100); umbilical 600 ID (e.g. model number, serial number, or other ID); injectate 125 and / or agent 80 ID (e.g. model number, serial number, or other ID); patient baseline data (e.g. age, gender, diabetes duration, concurrent medications, and / or comorbidities); and the like. This transferred and / or uploaded system information can comprise data related to the state of the device (e.g. the current state of the device), such as usage metrics for key components such as moving parts (e.g. motors, actuators, valves and the like) and / or energy sources (e.g. heaters, optical sources, electrical sources, microwave sources, ultrasound sources, cryogen usage, chemical agent sources, and the like). The uploaded information can be stored in a database (e.g. of server 2010) with information from other products (e.g. other system 10 products, other medical products, and / or other products). The uploaded information can be analyzed to produce “results data”. The uploaded information can be used to determine if a system 10 component is in potential need of repair or maintenance. The uploaded information can be used to determine if a system 10 component is being used improperly (e.g. as determined by procedures taking too much time or insufficient treatments are being performed per patient). Network 2001 and server 2010 enable the downloading of system 10 procedure information from single or multiple clinical locations. In some embodiments, information transferred from server 2010 to one or more consoles 100 comprise system 10 software update information (e.g. software update information that results from an analysis of the one or more forms of the above system information by algorithm 11). In some embodiments, information transferred from server 2010 to one or more consoles 100 is information displayed on user interface 1000 to one or more users of system 10. The downloaded and displayed information can provide recommendations for repair and / or maintenance of one or more system 10 components. The downloaded and displayed information can comprise recommendations for improved use of one or more system 10 components.

[0294] System 10 can be configured such that device 200 can be advanced into a patient and used to perform a tissue treatment procedure of the present inventive concepts in the small intestine, without the use of a guidewire, and without the use of fluoroscopy. In some embodiments, device 200 is configured to be inserted through a working channel of a body access device 50 comprising an endoscope or a device similar to an endoscope (e.g. a steerable body access device with integrated visualization and / or other imaging). In some embodiments, device 200 comprises an imaging assembly, such as an assembly including a camera (e.g. a CMOS imager), a light source, and / or other imaging assembly (e.g., imaging assembly 270a, 270b, and / or other imaging assembly 270) as described herein. In some embodiments, a source of insufflation (e.g. insufflation supply 170) is fluidly connected to device 200 and is activated prior to obtaining images via the imaging assembly (e.g. to inflate the GI tract to provide a better view for imaging). In some embodiments, device 200 and / or one or more other components of system 10 are configured to be robotically steered, advanced, retracted, tracked, and / or otherwise manipulated (“robotically manipulated” herein), such as is described in applicant’s co-pending United States Patent Application Serial Number 17 / 863,016 (Attorney Docket No. 41714-722.301; Client Docket No. MCT-051- US), entitled “Automated Tissue Treatment Devices, Systems, and Methods”, filed July 12, 2022. In some embodiments, device 200 is configured to operate in the “short position” of the stomach, as described herein. In some embodiments, device 200 comprises a shapesensing assembly (e.g. a fiber optic shape-sensing assembly), as described herein. In some embodiments, handle assembly 300 includes a user interface, user interface 350 shown, and / or console 100 includes a user interface, user interface 1000 shown. User interface 350 and / or 1000 can be configured similar to a videogame controller. For example, user interface 350 and / or 1000 can include one, two, or more components selected from the group consisting of: rollerball controller; trackball controller; bidirectional controller; omnidirectional controller; joystick; trackpad; mouse; buttons; steering wheel; foot pedal (e.g. a foot pedal configured to advance or otherwise translate device 200 when depressed); yoke (e.g. to steer, rotate, and / or translate device 200); touchscreen; motion sensing component; and combinations of these. In some embodiments, system 10 (e.g. via algorithm 11) is configured to automatically and / or semiautomatically (“automatically” herein) identify a tissue type, such as a non-target tissue type such as the papilla and / or tissue proximate the ampulla of Vater, such as to prevent undesired damage to non-target tissue, as described herein. In some embodiments, system 10 (e.g. via algorithm 11) is configured to be operated in an augmented reality arrangement. For example, device 200 and / or other components of system 10 can include markings that are displayed on one or more images that are currently being provided (e.g. “live images”) by system 10 (e.g. via a camera of device 200 or device 50 as described herein). Alternatively or additionally, the markings can be displayed on one or more images that were captured at an earlier time in the procedure (e.g. markings whose 3D position was determined by algorithm 11). Certain portions of the provided images could be augmented (e.g. such as to augment the location of the papilla). In some embodiments, distance markings can be added to one or more images (e.g. distance markings along the wall of the duodenum or other GI location). In some embodiments, locations that have been expanded and / or ablated can be augmented (e.g. through use of colors, shading, and / or other graphical differentiation).

[0286]

[0295] In some embodiments, device 200 comprises an expandable functional assembly 500 and is configured to be inserted through a body access device 50 (e.g. an endoscope or endoscope-like device) through a working channel of device 50 with a diameter of no more than 7.5mm, 6.5mm, and / or 6.0mm (e.g. when device 200 comprises an outer profile, or maximum outer diameter, that can be slidingly received by a working channel of device 50 of that diameter). In some embodiments, device 50 comprises an endoscope or other device with a working channel diameter of at least 6.5mm, at least 7.0mm, or at least 7.5mm, such as when the endoscope is less than 17mm in diameter, such as less than 15mm, or less than 13mm in diameter. In some embodiments, body access device 50 further comprises a steerable and / or lockable (e.g. shape lockable) sheath, as described herein, such as a sheath with a length to reach, at least, the pylorus of the patient (e.g. when inserted through the patient’s mouth). In some embodiments, device 200 comprise at least two, or at least three injectate delivery elements 520 for performing a submucosal tissue expansion (e.g. a circumferential submucosal tissue expansion) as described herein. In these embodiments, shaft assembly 400 can include a helical geometry (e.g. include multiple shafts and / or multiple lumens in a helical geometry), or shaft assembly 400 can be void of a helical arrangement (e.g. one or more shafts and one or more lumens are in a relatively straight arrangement). Injectate delivery elements 520 can be advanced into tissue via springs, and / or advanceable pistons (e.g. pneumatic and / or hydraulic pistons) that are positioned proximate elements 520. In some embodiments, shaft assembly 400 is configured to compensate for pathlength changes that affect injectate delivery elements 520 via slack that is maintained at the proximal end of the working length of the catheter. As described herein, in some embodiments, device 200 is configured for insertion in the patient without the use of a guidewire, and without comprising a variable stiffness shaft assembly 400.

[0296] In some embodiments, system 10 comprises one or more guidewires, guidewire 60, for example as shown in Fig. 1 and described herein. In some embodiments, device 200 is configured for over-the-wire manipulation (e.g. advancement and retraction) using guidewire 60. In these embodiments, guidewire 60 can comprise a guidewire with a construction comprising: a shaft with a relatively stiff material, such as stainless steel or L605 cobalt-chromium; a shaft diameter of no more than 0.035” or 0.032”; a lubricious coating; an atraumatic distal portion, such as a distal portion constructed of nickel titanium alloy and / or a distal portion comprising a centerless-grinding steep tapering; a shaft length of at least 300cm, or at least 340cm; a shaft length of no more than 400cm, or no more than 380cm; and combinations of these. In some embodiments, guidewire 60 comprises a proximal portion (e.g. a portion that is repeatedly grasped by an operator of system 10) that is void of a lubricious coating (e.g. on its outer surface), while the more distal portion of guidewire 60 comprises a lubricious coating, such as to improve fine control of guidewire 60 by the operator. In some embodiments, guidewire 60 comprises a distal portion that is configured to transition from a straight geometry (e.g. a relatively straight geometry), to an expandable coil geometry, such as a coil with sufficient hoop strength to resist motion of guidewire 60 when the expandable coil is positioned in the intestine (e.g. in the jejunum or other location of the small intestine), and device 200, body access device 50, and / or another component of system 10 is being advanced and / or retracted over guidewire 60.

[0287]

[0297] In some embodiments, device 200 comprises a functional assembly 500 that is expandable (e.g. substantially circumferentially expandable) and operably connected (e.g. at least fluidly connected) to the proximal end of device 200 (e.g. via one or more lumens, tubes, wires, cables, linkages, optical fibers, waveguides, and / or other conduits and / or filaments of shaft assembly 400). Shaft assembly 400 of device 200 can comprise one or more steerable portions. For example, shaft assembly 400 can comprise one, two, or more steerable portions, such as a steerable portion proximal to functional assembly 500, distal to functional assembly 500, or at both of these locations. In some embodiments, device 200 comprises at least one imaging assembly (e.g. a functional element 299CAM comprising an imaging assembly), such as is described herein. Steering of the steerable portion can change the imaging direction of the at least one imaging assembly. The imaging assembly can further comprise an assembly configured to produce light, such as to improve the quality of images produced by the imaging assembly (e.g. images included in image information 75). The camera (e.g. including a light-producing assembly) can be positioned on a distal-facing end of device 200. In some embodiments, device 200 comprises an irrigation channel (e.g. one or more lumens and / or tubes of shaft assembly 400) from the proximal end of device 200 to a distal portion of device 200, such as to deliver irrigation fluid (e.g. to clear debris or otherwise improve an image provided by the imaging assembly). In some embodiments, device 200 comprises one or more lumens or tubes configured to: provide insufflation; provide desufflation and / or suction; and / or allow passage of an instrument through shaft assembly 400. In some embodiments, shaft assembly 400 comprises one or more shafts and / or lumens that comprise a “twist” (e.g. a helical arrangement of shafts and / or lumens), such as is described in applicant’s co-pending United States Patent Application Serial Number 16 / 742,645 (Attorney Docket No. 41714-715.301; Client Docket No. MCT-025- US), entitled “Intestinal Catheter Device and System”, filed January 14, 2020. In some embodiments, shaft assembly 400 comprises a varying stiffness along all or a portion (e.g. one or more portions) of its length, such as is described in applicant’s co-pending United States Patent Application Serial Number 16 / 742,645 (Attorney Docket No. 41714-715.301; Client Docket No. MCT-025-US), entitled “Intestinal Catheter Device and System”, filed January 14, 2020. In some embodiments, device 200 comprises an assembly configured to inject fluid into tissue (e.g. into submucosal tissue prior to ablation or other treatment of the neighboring mucosal tissue), as described herein. In these embodiments, this fluid injection assembly can be integral to functional assembly 500, also as described herein. In other embodiments, device 200 is void of a fluid injection assembly (e.g. when ablation or other treatment is performed without expansion of submucosal or other tissue).

[0288]

[0298] In some embodiments, device 200 comprises an imaging assembly (e.g. a functional element 299CAM comprising an imaging assembly) that can be translated within a lumen or other longitudinal portion of device 200, such as a translation performed manually by an operator, by a robotic assembly of system 10, or both. For example, a functional element 299CAM comprising an imaging assembly (e.g. an imaging assembly including a light source) can be positioned on a translatable filament (e.g. a translatable shaft, linkage, and / or other filament) configured to translate within shaft assembly 400. In some embodiments, the functional element 299CAM can be translated between a viewing position distal to functional assembly 500 and a viewing position proximal to functional assembly 500. Shaft assembly 400 can include one or more openings and / or transparent portions, “windows” and / or “window portions” herein, that facilitate imaging by functional element 299CAM (e.g. windows positioned proximal to functional assembly 500). In some embodiments, functional element 299CAM comprises a reusable component, such as a component that is used in at least 2, 5, 10, or 20 clinical procedures. In some embodiments, device 200 comprises one or more mirrors, functional element 299MIRROR. Functional element 299MIRROR can be mounted to a side of shaft assembly 400 which is proximal to a distal viewing position of functional element 299CAM (e.g. proximal to a location distal to functional assembly 500), and distal to a proximal viewing position of functional element 299CAM (e.g. distal to a location proximal to functional assembly 500). In some embodiments, functional element 299MIRROR comprises one or more mirrors that are deployable between a flat orientation (e.g. positioned along an outer wall of shaft assembly 400) and an angled orientation (e.g. with an outer edge deflected out from the wall of shaft assembly 400), such as an angled orientation at an angle of at least 25 degrees, 35 degrees, 45 degrees, and / or 60 degrees. Functional element 299MIRROR can comprise one or more mirror portions that can be positioned for viewing (e.g. line of site viewing) by functional element 299CAM, such as to allow viewing of tissue at various locations via reflections provided by a reflective mirror portion of functional element 299MIRROR. Functional element 299MIRROR can comprise a mounting element that comprises a bent element and / or spring component that is biased in the flat or deflected orientations. Functional element 299MIRROR can comprises a “pull wire” comprising a translatable filament used to angularly orient one or more mirror portions of functional element 299MIRROR. In some embodiments, functional element 299MIRROR can comprise a mirror portion that is mounted within a lumen of shaft assembly 400, such as the same lumen in which functional element 299CAM translates, such as when the lumen has a window portion (e.g. in the outer wall of shaft assembly 400) that facilitates viewing of a gastrointestinal wall by element 299CAM via the mirror portion of element 299MIRROR when device 200 is inserted into the small intestine or other portion of the GI tract of a patient. In some embodiments, functional element 299MIRROR comprises a mirror portion that is mounted on or is integral to a proximal portion of functional assembly 500 (e.g. an angled proximal portion of assembly 500), such that element 299CAM can view tissue by the one or more mirrors positioned on functional assembly 500. In some embodiments, functional element 299CAM comprises at least two cameras, such as a first camera that is positioned (e.g. is permanently positioned or can be positioned via translation) at a location distal to functional assembly 500 and a second camera that is positioned (e.g. is permanently positioned or can be positioned via translation) at a location proximal to functional assembly 500. In these embodiments, device 200 can comprise a functional element 299MIRROR positioned for viewing by the first camera, the second camera, or both. System 10 can include multiple cameras, and each camera can collect one or more images that are transferred via a single cable assembly (e.g. an electronic bus arrangement) to console 100.

[0299] In some embodiments, system 10 is configured such that an operator can manipulate (e.g. advance, retract, rotate, and / or steer) device 200 through a patient’s anatomy (e.g. through the GI tract in order to perform a tissue ablation and / or other tissue treatment procedure), without the use of fluoroscopy. Alternatively or additionally, system 10 can be configured such that an operator can manipulate device 200 through a patient’s anatomy without device 200 being positioned on a guidewire. In some embodiments, body access device 50 and device 200 collectively comprise an integrated device. In these and other embodiments, body access device 50 and / or device 200 can comprise an imaging assembly (e.g. a functional element comprising a camera, ultrasound imager, and / or other imaging assembly). The imaging assembly can comprise an operator-movable imaging assembly comprising one, two, or more imaging components (e.g. one, two, or more cameras, ultrasound imaging assemblies, and / or other imaging components). These one, two, or more imaging assemblies can be configured to provide a forward-facing view, a side-facing view, or both.

[0289]

[0300] In some embodiments, device 200 is configured to be inserted (e.g. manually by a clinician, and / or in an automated or semi- automated way via a robotic assembly of system 10) into the duodenum of a patient in the “long position” (a position passing through the greater curvature of the stomach, as shown in Fig. 2A), and then maneuvered into the “short position” (a position passing through the lesser curvature of the stomach, as shown in Fig. 2A). For example, device 200 (e.g. shaft assembly 400) can comprise a torsional stiffness and / or other torsional property that is sufficient to enable device 200 to be maneuvered from the long position to the short position. Alternatively, system 10 can be configured to allow device 200 to be inserted into the duodenum in the short position (e.g. avoiding having to transition from the long position), such as when device 200 is inserted through and / or alongside a body access device 50 comprising a steerable sheath, and / or a sheath whose rigidity can be controlled, where the sheath extends into the stomach, and directs a device 200 being advanced to be in the short position. The body access device 50 can be advanced into the stomach and steered toward the pylorus, and subsequently locked into position (e.g. the short position). Subsequently device 200 can be advanced through device 50 and into the duodenum of the patient. Alternatively or additionally, body access device 50 can comprise a steerable mandrel, mandrel 55 (e.g., as shown in Fig. 1), which can be inserted into a lumen of device 200 (e.g. a lumen of shaft assembly 400), such as when mandrel 55 is in a flexible state.- With the distal portions of device 200 and mandrel 55 inserted into the stomach of the patient, mandrel 55 can be steered toward the pylorus, causing a corresponding motion of device 200 toward the pylorus. Device 200 can be advanced over mandrel 55 into the duodenum (e.g. in the short position). Alternatively or additionally, device 200 can comprise a steering mechanism configured to facilitate insertion of device 200 into the duodenum while in the short position. For example, device 200 can comprise a steering mechanism that allows steering manually by an operator, by a robotic mechanism of system 10, or both. Device 200 can comprise a steering mechanism comprising a single translatable steering filament (e.g. to achieve steering via single plane deflection plus rotation), or via multiple translatable steering filaments (e.g. three or four steering filaments). In these embodiments, device 200 can comprise a functional element 299SHAPE comprising a shape- sensing assembly configured to detect the current geometric shape of shaft assembly 400. For example, the element 299SHAPE can comprise a fiber-optic shape-sensing assembly (e.g. that is positioned along a majority of the length of shaft assembly 400) and provides real time shape, position, and / or other information related to at least the distal portion of device 200 (e.g. shape, position, and / or other information provided on a display of user interface 1000). In some embodiments, device 200 is robotically manipulated based on the information provided by element 299SHAPE, such as when the distal portion of device 200 is robotically translated (e.g. advanced and / or retracted) and / or rotated within the small intestine of the patient, such as to precisely control advancement of functional assembly 500 with an accuracy of +- 30%, 20%, or 10%. For example, a 1cm advancement of functional assembly 500 can be performed with an accuracy of ±0.3cm, ±0.2cm, and / or ±0.1cm (e.g. 30%, 20% and / or 10% accuracy respectively).

[0290]

[0301] In some embodiments, a body access device 50 is introduced into the patient (e.g. in the long or short position) and advanced such that its distal end is in the duodenum of the patient. Inspection (e.g. visual inspection via a camera of device 50) of the duodenum can be performed to confirm there are no contraindications present preventing a mucosal treatment procedure of the present inventive concepts. In some embodiments, the patient is contraindicated based on presence of one, two, or more of: an ulcer; a cyst; a polyp; telangiectasia; a stricture; diverticulum; pre-cancerous and / or cancerous lesions; and / or other diseased tissue proximate target tissue or otherwise present in the GI tract. The papilla can be marked (e.g. with a clip, ablation, and / or dye injection). Prior to or after the marking of the papilla, device 50 can be transitioned (e.g. using standard techniques) into the short position (e.g. if not already in that position). A guidewire 60 can be introduced through a lumen (e.g. a working channel) of device 50. Optionally, a second body access device 50, device 50’ comprising an introducer, is introduced with the guidewire 60. The device 50, and the optional device 50’ if present, are removed, leaving guidewire 60 in place in the short position. Subsequently, device 200 can be advanced over the guidewire 60, while maintaining tension on guidewire 60 to keep guidewire 60 and device 200 in the short position, until the distal end of device 200 is in the proximal portion of the duodenum. Body access device 50 can be advanced into the duodenum and manipulated into the short position (e.g. using standard techniques) and device 50 can be positioned to visualize the proximal end of functional assembly 500 of device 200. Device 50 and device 200 can be arranged (e.g. aligned) such that these devices can be translated in unison, while maintaining the short position, to a first treatment location of the duodenum for functional assembly 500. In some embodiments, the first treatment location comprises a location at least 0.5cm distal to the papilla. In some embodiments, a tissue treatment at the first location comprises an ablation (e.g. an ablation via hot fluid as described herein and / or other treatment causing necrosis of mucosal tissue). In these embodiments, a prior step comprising one or more deliveries of injectate 125 via one or more injectate delivery elements 520 (e.g. three elements 520) can be performed to cause circumferential submucosal tissue expansion at the location of future treatment (e.g. future ablation). Device 200 and device 50 can be subsequently advanced to sequentially treat multiple axial segments of mucosa of the small intestine, with or without submucosal tissue expansion at the treatment location. In some embodiments, device 200 and device 50 are first advanced to a more distal location, and multiple axial segments are treated via retraction of device 200 and device 50 (e.g. while both device 200 and device 50 are maintained in the short position). In these distal-to-proximal embodiments, guidewire 60 can be fed forward (distally) as device 200 is retracted (e.g. rather than being held in tension as performed during forward advancement of device 200). In proximal-to-distal, distal-to- proximal, and / or other advancement and retraction scenarios, duodenal tissue (e.g. duodenal mucosal tissue) at least 0.5cm distal to the papilla, and up to the ligament of Treitz or duodenal flexure, can be treated (e.g. ablated). In some embodiments, a minimum axial length, a minimum surface area, and / or a minimum volume of mucosal tissue is treated. In some embodiments, target tissue is treated at locations at least 0.5cm from the papilla, such as when target tissue is treated within 3cm, 2cm, or 1cm from the papilla. In some embodiments, a cumulative length of at least 6cm, 9cm or 12cm of the duodenum is treated (e.g. via one, two, three, four, five, or more axial segments in which at least 70% of the circumferential portion of each axial segment is treated). In some embodiments, the most distal axial segment treated has a distal end that is positioned proximal to the ligament of Treitz.

[0302] In some embodiments, a method (e.g. a proximal-to-distal treatment method) of manipulating device 200, body access device 50, and / or other components of system 10 to perform a tissue treatment of the present inventive concepts comprises: advancing device 50 (e.g. an endoscope or endoscope-like device) into the duodenum; inspecting the duodenum for contra-indications (e.g. as described herein) using device 50 (e.g. via images provided by a camera of device 50); maneuvering device 50 into the short position; using device 50 to identify the papilla and / or ampulla of Vater (either or both, “papilla” herein); optionally, if the papilla cannot be found, withdrawing device 50, inserting a device 50’ comprising a duodenoscope, finding the papilla, marking the papilla (e.g. with a clip, dye, energy and / or other means), withdrawing device 50’, re-inserting device 50 into the duodenum and maneuvering device 50 into the short position; positioning device 50 just past the papilla, if visualized, otherwise just past the mark identifying the papilla; advancing device 200 through a working channel of device 50 with functional assembly 500 unexpanded, and advancing functional assembly 500 to a location outside of device 50 and at a first treatment location; performing treatment via functional assembly 500 (e.g. performing mucosal tissue ablation, potentially preceded by submucosal tissue expansion as described herein); contracting functional assembly 500; advancing device 50 to the next treatment location and repeating treatment; repeating advancements and treatments until a target amount of mucosal tissue is treated (e.g. to a location at least 9cm past the starting location, or until positioned at the end of the duodenum).

[0291]

[0303] In some embodiments, a method (e.g. a distal-to-proximal treatment method) of manipulating device 200, body access device 50, and / or other components of system 10 to perform a tissue treatment of the present inventive concepts comprises: advancing device 50 (e.g. an endoscope or endoscope-like device) into the duodenum; inspecting the duodenum for contra-indications (e.g. as described herein) using device 50 (e.g. via images provided by a camera of device 50); maneuvering device 50 into the short position; using device 50 to identify the papilla and / or ampulla of Vater (either or both, “papilla” herein); optionally, if the papilla cannot be found, withdrawing device 50, inserting a device 50’ comprising a duodenoscope, finding the papilla, marking the papilla (e.g. with a clip, dye, energy, and / or other means), withdrawing device 50’; re-inserting device 50 into the duodenum and maneuvering device 50 into the short position; positioning device 50 near the distal end of the target length of duodenum to be treated (such as at a location at least 9cm past the papilla and / or mark identifying the papilla, or at a location proximate the end of the duodenum); advancing device 200 through a working channel of device 50 with functional assembly 500 unexpanded, and advancing functional assembly 500 to a location outside of device 50 and at a first treatment location; performing treatment via functional assembly 500 (e.g. performing mucosal tissue ablation, potentially preceded by submucosal tissue expansion as described herein), contracting functional assembly 500; retracting device 50 to the next treatment location and repeating treatment; repeating retractions and treatments until a target amount of mucosal tissue is treated, but not treating locations that are proximal to a location at least 0.5cm distal to the papilla and / or the ampulla of Vater (e.g. to avoid treating the papilla and / or tissue of the ampulla of Vater, as determined by visualizing the papilla and / or the ampulla of Vater, and / or by visualizing the marker positioned proximate the papilla and / or ampulla of Vater).

[0292]

[0304] In some embodiments, device 200 and / or another system 10 component is disposable (e.g. configured for use in a single clinical procedure), and / or has one, two, or more disposable portions. For example, all or a portion ...

Claims

WHAT IS CLAIMED IS:

1. A system for performing a medical procedure on a patient, the system comprising: a treatment device comprising: an elongate shaft assembly; a distal portion comprising a distal end; and a functional assembly positioned on the distal portion, wherein the functional assembly configured to treat duodenal mucosal tissue, wherein the treatment device is configured to be inserted through a working channel of a body access device.

2. The system of claim 1, further comprising a tissue expansion assembly positioned on the elongate shaft of the treatment device.

3. The system of claim 2, further comprising a second device including an elongate shaft, and wherein the tissue expansion assembly is positioned on the elongate shaft of the second device.

4. The system of claim 2, wherein the tissue expansion assembly comprises at least one fluid delivery assembly, and wherein each fluid delivery assembly comprises a tissue capture port, a fluid delivery element, and a vacuum port.

5. The system of claim 1, wherein the working channel comprises a diameter of no more than 7.5mm.

6. The system of claim 1, wherein the treatment device is configured to insufflate and / or desufflate a segment of the gastrointestinal tract.

7. The system of claim 1, wherein the treatment device comprises a shape sensing assembly configured to provide shape information related to the shape of the treatment device.

8. The system of claim 7, wherein the system is configured to automatically manipulate the treatment device based on the shape information.

9. The system of claim 1, wherein the treatment device comprises a position sensing assembly configured to provide position information related to the position of the treatment device in the patient’s anatomy.

10. The system of claim 1, wherein the system comprises one or more electronic components configured to provide data related to the position of the treatment device.

11. The system of claim 1, wherein the treatment device comprises a force sensing assembly configured to detect a force applied to one or more portions of the treatment device.

12. The system of claim 1, wherein the treatment device comprises a camera assembly including at least one camera.

13. The system of claim 12, wherein the at least one camera is positioned on the distal end of the treatment device.

14. The system of claim 13, wherein the distal portion of the treatment device comprises a central axis, wherein the at least one camera comprises a viewing angle, and wherein the viewing angle is offset from the central axis.

15. The system of claim 13, wherein the treatment device comprises at least one steerable portion positioned proximal to the functional assembly and / or distal to the functional assembly, and wherein rotation of the steerable portion changes the imaging direction of the at least one camera.

16. The system of claim 13, wherein the treatment device comprises an irrigation channel for delivering fluid to improve an image produced by the camera assembly.

17. The system of claim 1, wherein the functional assembly is configured to deliver energy to tissue.

18. The system of claim 17, wherein the energy delivered comprises thermal energy.

19. The system of claim 18, wherein the functional assembly comprises a balloon configured to receive hot fluid to deliver the thermal energy.

20. The system of claim 17, wherein the energy comprises energy in a form selected from the group consisting of: radiofrequency energy; electroporation energy, such as irreversible electroporation energy; light energy, such as laser light energy; mechanical energy, such as energy configured to abrade and / or remove tissue; thermal energy, such as heat energy and / or cryogenic energy; steam energy; chemical energy; and combinations thereof.

21. The system of claim 1, further comprising a controller and a memory module coupled to the controller, and wherein the memory module stores instructions for the controller to perform an algorithm.

22. The system of claim 21, wherein the algorithm is configured to track movement of the treatment device or other component of the system.

23. The system of claim 21, wherein the algorithm comprises a detection algorithm, and wherein the detection algorithm is configured to produce detection information based on analysis of one or more images captured by the system.

24. The system of claim 23, wherein the detection algorithm is configured to differentiate target tissue from non-target tissue or to identify a papilla.

25. The system of claim 1, further comprising a body access device including a distal portion with a distal end.

26. The system of claim 25, wherein the body access device comprises an endoscope or endoscope-like device.

27. The system of claim 25 herein, wherein the body access device includes a sheath.

28. The system of claim 27, wherein the sheath comprises a steerable and / or shape-lockable sheath.

29. The system of claim 28, wherein the sheath comprises a sheath with controllable rigidity.

30. The system of claim 25, wherein the body access device includes a sleeve and / or an overtube.

31. The system of claim 30, wherein the sleeve and / or overtube comprises a controllably expandable element.

32. The system of claim 31, wherein the expandable element comprises a balloon, a self-retaining tube, and / or an expandable coil.

Images