Medical systems, devices, and related methods for applying energy, delivering fluids, and / or manipulating tissue

Abstract

A medical system includes a first medical device and a second medical device. The first medical device includes a first handle, a shaft, and an electrode. The first handle includes an electrical connection. The shaft extends from a distal portion of the first handle. The electrode is positioned at a distal end of the shaft. The electrode is electrically connected to the electrical connection via one or more electrically conductive elements that extend through the first handle and the shaft. The second medical device includes a second handle, a sheath, and a tissue manipulator positioned within the sheath. The sheath extends from a distal portion of the second handle. The shaft extends through at least a portion of the second handle and through the sheath.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 608,399, filed December 11, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0002] Various aspects of the present invention generally relate to medical systems, apparatuses, and related methods for applying energy, delivering fluids, and / or manipulating tissues. Embodiments of the present invention relate to medical systems, apparatuses, and related methods for treating tissues by: (1) applying electrical energy to or into tissues using a distal element of a first medical device; (2) delivering or injecting fluids into, under, and / or around tissues using a distal element of the first medical device; and / or (3) manipulating tissues using a distal element of a second medical device. Background Technology

[0003] Medical devices, such as endoscopes or other suitable insertion devices, are used in a wide range of diagnostic and surgical procedures, including endoscopy, laparoscopy, arthroscopy, gynecoscopy, thoracoscopy, cystoscopy, and so on. Many of these procedures involve delivering energy to the tissues of organs or glands to treat lesions (e.g., tumors), infections, etc. Examples of such procedures include endoscopic mucosal resection (EMR), endoscopic submucosal resection (ESR), endoscopic submucosal dissection (ESD), polyp removal, mucosal resection, peroral endoscopic myotomy (POEM), and so on. In particular, such procedures can be performed by inserting the insertion device into the subject through a surgical incision or via natural anatomical openings (e.g., the mouth, vagina, or rectum) and performing the procedure or manipulation at the treatment site using an auxiliary device inserted through the insertion device. Alternatively, the auxiliary device can be delivered to the treatment site without the insertion device.

[0004] In some procedures, the distal portion of a medical device is positioned between layers of tissue to cut, puncture, or perforate one or more layers of tissue or otherwise treat a tissue or treatment site. In some cases, the distal portion of the medical device is positioned between the mucosa and muscularis propria in a portion of the gastrointestinal (GI) tract to reach a target or treatment site. Typically, this positioning is achieved by (1) injecting a lifting agent into the submucosa to separate the mucosa from the muscularis propria, and (2) using a cutting tool to cut through the submucosa. In some cases, tissue that has already been cut, punctured, or perforated at the treatment site may interfere with additional treatment. These issues can increase the duration, cost, and risk of the medical procedure.

[0005] The systems, apparatus, and methods of the present invention can correct some of the above-mentioned defects or solve other aspects of the present technology. Summary of the Invention

[0006] Examples of the present invention relate to medical systems, apparatus, and methods for performing one or more medical procedures. For example, the present invention relates to medical apparatuses and methods for performing one or more procedures between tissue layers. Additionally, in some examples, the present invention relates to medical apparatuses and methods for delivering energy (e.g., for cutting, cauterizing, perforating, puncturing, or otherwise manipulating tissue) and / or delivering fluid to a treatment site. Furthermore, in some examples, the present invention relates to medical systems, apparatus, and methods for lifting or otherwise manipulating one or more portions of tissue or a treatment site. Each of the examples disclosed herein may include one or more features described in conjunction with any of the other disclosed examples.

[0007] In one example, a medical system may include a first medical device and a second medical device. The first medical device may include a first handle, a shaft, and an electrode. The first handle may include an electrical connector. The shaft may extend from a distal portion of the first handle. The electrode may be positioned at the distal end of the shaft. The electrode may be electrically connected to the electrical connector via one or more conductive elements extending through the first handle and the shaft. The second medical device may include a second handle, a sheath, and a tissue manipulator positioned within the sheath. The sheath may extend from a distal portion of the second handle. The shaft may extend through at least a portion of the second handle and through the sheath.

[0008] The medical system may include one or more of the following aspects: A first handle may include at least one actuation mechanism. An electrode may be movable relative to a distal end of an axis based on movement of at least one actuation mechanism. A second handle may include an extender and a slot. The extender may be movable within the slot to control the position of a tissue manipulator relative to the distal end of a sheath. The extender may be locked within the slot to fix the position of the tissue manipulator relative to the distal end of the sheath. The second handle may be adjustably coupled to the first handle and / or to an axis of the first medical device via an adjustable lock. The second handle may include one or more stop surfaces to limit the position of the second handle relative to the first handle. The second handle may be fixedly coupled to the distal end of the first handle. The tissue manipulator may be formed of and / or coated with an electrically insulating material. The sheath may be formed of a braided or coiled sheath. The sheath may include at least two adjacent lumens or channels. The at least two lumens or channels may be connected in a distal opening portion of the sheath.

[0009] The tissue manipulator may include a circular bottom surface and a flat top surface when viewed from the side, and a curved shape when viewed from the distal end. The tissue manipulator may include an inwardly extending widened portion, and the tissue manipulator may include a curved shape when viewed from the distal end. The tissue manipulator may include a generally cylindrical shape. The tissue manipulator may include a widened portion extending outward at the distal end, and the tissue manipulator may include a curved shape when viewed from the distal end. The tissue manipulator may include a generally cylindrical shape, and the tissue manipulator may also include a hook-shaped portion at the distal end.

[0010] In another example, a medical system may include a first medical device and a second medical device. The first medical device may include a first handle, a shaft, and an electrode. The handle may include an electrical connector. The shaft may extend from a distal portion of the first handle. The electrode may be positioned at the distal end of the shaft. The electrode may be electrically connected to the electrical connector. The second medical device may include a second handle, a sheath, and a tissue manipulator. The sheath may extend from a distal portion of the second handle, and at least a portion of the shaft may extend through a lumen in the sheath. The tissue manipulator may be at least partially positioned within the sheath and is movable relative to the sheath. The tissue manipulator may be biased toward a radially extending or curved shape as it extends distally toward the sheath, such that when the tissue manipulator extends distally toward the sheath, the tissue manipulator may be positioned near and radially extending away from or curved away from the shaft and / or electrode of the first medical device.

[0011] The medical system may include one or more of the following aspects. The second handle may include an extender and a slot. The extender is movable within the slot to control the position of the tissue manipulator relative to the distal end of the sheath, and the extender may lock within the slot to fix the position of the tissue manipulator relative to the distal end of the sheath. The sheath may include a tissue manipulator lumen to movably receive the tissue manipulator. The sheath may also include a working channel to movably receive the shaft of the first medical device, and the tissue manipulator lumen and the working channel may be connected via a distal opening portion in the sheath.

[0012] In another example, a method of treating a treatment site includes delivering a distal end of a medical system to the treatment site. The medical system may include a first medical device having an axis and electrodes movably positioned within a distal portion of the axis. The medical system may also include a second medical device having a sheath and a tissue manipulator movably positioned within a distal portion of the sheath. The axis is movably positioned within the sheath. The method may further include delivering energy to the treatment site by energizing the electrodes to cut, puncture, or perforate one or more tissue layers at the treatment site; and extending the tissue manipulator distally to engage or manipulate one or more tissue layers at the treatment site, such that the tissue manipulator extends adjacent to or beyond the electrodes. The method may further include extending or advancing the electrodes relative to the axis and / or the sheath, and again delivering energy to the treatment site by energizing the electrodes to cut, puncture, or perforate one or more tissue layers at the treatment site.

[0013] The method may include one or more of the following aspects. The method may also include extending the tissue manipulator distally to engage or manipulate one or more tissue layers at the treatment site. The method may include further extending or advancing the electrode relative to the shaft and / or sheath. The method may also include delivering energy again to the treatment site by energizing the electrode to cut, puncture, or perforate one or more tissue layers at the treatment site.

[0014] It is understood that the foregoing general description and the following detailed description are exemplary and explanatory only, and are not intended to limit the invention as claimed. Attached Figure Description

[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the invention and, together with the description, serve to explain the principles of the invention.

[0016] Figure 1 A perspective view of an exemplary medical device system according to various aspects of the present invention is shown. The exemplary medical device system includes a first medical device and a second medical device, including an enlarged view of the distal portion of the medical device system in the first and second configurations.

[0017] Figures 2A to 2D This illustrates various morphologies of tissue relative to the treatment site according to various aspects of the present invention. Figure 1 The distal part of the traditional Chinese medicine device system.

[0018] Figure 3A and Figure 3B Side and end views or front views of the distal portion of an exemplary second medical device according to various aspects of the present invention are shown respectively.

[0019] Figure 4A and Figure 4B Side and end views or front views of the distal portion of another exemplary second medical device according to various aspects of the present invention are shown respectively.

[0020] Figure 5A and Figure 5B Side and end views or front views of the distal portion of yet another exemplary second medical device according to various aspects of the present invention are shown.

[0021] Figure 6A and Figure 6B Side and end views or front views of the distal portion of another second medical device according to various aspects of the present invention are shown respectively.

[0022] Figure 7A and Figure 7B Side and end views or front views of the distal portion of yet another exemplary second medical device according to various aspects of the present invention are shown.

[0023] Figure 8A and Figure 8B Side and end views or front views of the distal portion of another second medical device according to various aspects of the present invention are shown respectively.

[0024] Figure 9A and Figure 9B End views and cross-sectional views of the distal portion of a medical system according to various aspects of the present invention are shown respectively. Detailed Implementation

[0025] Examples of the present invention include systems, apparatus, and methods for: promoting and improving the effectiveness, efficiency, and safety of treating and / or manipulating tissue when, for example, electrical energy is applied to tissue using electrodes; delivering fluid to, within, and / or around tissue via the distal end of electrodes during medical procedures; lifting, moving, or otherwise manipulating tissue; and cutting, excising, or otherwise treating tissue. Aspects of the present invention enable users to apply electrical energy or heat to tissue using a medical device having electrodes (e.g., as a distal tool), and to deliver fluid to and / or within tissue using the same medical device. Aspects of the present invention enable users to apply electrical energy or heat and deliver fluid simultaneously without switching or replacing the end effector. Aspects of the present invention can help users penetrate tissue layers (e.g., the submucosa) to achieve perforation or otherwise cut, cauterize, or otherwise treat tissue.

[0026] Various aspects of this invention can assist users in cutting, excising, or otherwise removing tissue or other material without switching or replacing the end effector. Various aspects of this invention can assist users in lifting, moving, or otherwise manipulating tissue at or near the treatment site (e.g., already cut tissue), which can assist users in cutting, excising, or otherwise removing additional tissue or other material. Various aspects of this invention can assist users in lifting, moving, or otherwise manipulating tissue without switching or replacing the end effector. Additionally, various aspects of this invention can assist users in performing one or more of these treatments without the need for larger insertion devices and / or replacement of medical devices, as larger insertion devices and / or replacement of medical devices may prolong the procedure, require multiple users, and / or may otherwise adversely affect the procedure. Furthermore, various aspects of this invention can assist users in lifting, moving, or otherwise manipulating tissue that has been cut or otherwise processed, for example, so that the tissue may not interfere with or otherwise hinder the cutting or processing of additional tissue or other parts of the treatment site. Some aspects of this invention can be used to perform endoscopic, laparoscopic, arthroscopic, gynecological, thoracic, cystoscopic, or other types of surgeries.

[0027] Embodiments of the present invention may relate to systems, apparatus, and methods for performing various medical procedures and / or treating portions of the large intestine (colon), small intestine, cecum, esophagus, stomach, any other part of the gastrointestinal tract, lungs, and / or any other suitable patient anatomy. The various embodiments described herein include single-use or disposable medical devices. Some aspects of the invention can be used to perform endoscopy, arthroscopy, bronchoscopy, ureteroscopy, colonoscopy, or other types of procedures. For example, the disclosed aspects can be used with duodenoscopy, bronchoscopy, ureteroscopy, colonoscopy, gastroscopy, endoscopic ultrasound (“EUS”), laparoscope, arthroscopy, cystoscope, thoracoscope, aspiration endoscope, sheath, catheter, diagnostic or therapeutic tool or device, or other types of medical devices. One or more of the elements discussed herein may be metal, plastic, or any combination including shape memory metals (such as, for example, nitinol), shape memory polymers, polymers, or biocompatible materials.

[0028] The terms “proximal” and “distal” are used herein to refer to the relative positions of components of an exemplary medical device. When used herein, “proximal” refers to a position relatively closer to the exterior of the subject’s body or closer to the user holding or otherwise using the medical device, such as a medical professional. Conversely, “distal” refers to a position relatively further away from the medical professional holding or otherwise using the medical device or closer to the interior of the subject’s body. In the accompanying figures, the proximal and distal directions are marked with arrows labeled “P” and “D”, respectively. As used herein, the terms “comprising,” “having,” “including,” or other variations thereof are intended to cover non-exclusive inclusion, such that a device or method that includes a list of elements includes not only those elements but may include other elements not explicitly listed or inherent to it. Unless otherwise stated, the term “exemplary” is used in the meaning of “example” rather than “ideal.” As used herein, the terms “about,” “substantially,” and “approximately” indicate a numerical range within + / -10% of the stated value.

[0029] Reference will now be made in detail to the examples of the invention described above and shown in the accompanying drawings. Where possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts. It should be noted that one or more aspects of the medical systems, devices, or methods discussed herein may be combined with and / or used in conjunction with one or more other aspects of the medical devices or aspects discussed herein.

[0030] Figure 1 A perspective view of an exemplary medical device system 10 including a first exemplary medical device 100 and a second exemplary medical device 160 is shown. The first medical device 100 includes a handle 102 and a shaft 104. The shaft 104 includes a distal end 106. The first medical device 100 also includes a tool, such as an electrode 108 located at the distal end 106. The electrode 108 is movable relative to the shaft 104 (e.g., longitudinally extending and retracting), for example, it may extend and / or retract longitudinally relative to the distal end 106 of the shaft 104. The electrode 108 may be energized to puncture, perforate, cut, excise, cauterize, remove, or otherwise treat other portions of tissue or treatment sites. In some aspects, although not shown, the electrode 108 may include an electrode cavity or central cavity terminating in an electrode outlet or electrode opening to inject or otherwise deliver fluid to a treatment site, e.g., to or between tissue layers. However, in other aspects, the electrode 108 may not include an electrode cavity, and therefore does not provide fluid injection or other delivery.

[0031] The second medical device 160 includes a distal tool, end effector, or tissue manipulator 162, for example, in the form of a rod or lever. The second medical device 160 also includes a sheath 164 and a handle 166. At least a portion of the tissue manipulator 162 may be movably positioned within the sheath 164, for example, extending distally to a distal end 162A of the sheath 164. The proximal end of the sheath 164 may be coupled to the distal end of the handle 166. Additionally, the handle 166 may include an actuation mechanism or extender 168 and a slot 170. As discussed in detail below, the tissue manipulator 162 may be coupled to the extender 168, and the extender 168 may be movable within the slot 170 to control the position and / or morphology of the tissue manipulator 162, for example, relative to the distal end 164A of the sheath 164. Furthermore, the second medical device 160 may be coupled to the first medical device 100. For example, the shaft 104 of the first medical device 100 may be radially positioned within the sheath 164, and one or more portions of the second medical device 160 (e.g., the sheath 164 and / or the handle 166) may be selectively secured or coupled to the handle 102 and / or the shaft 104. In some aspects, the first medical device 100 and the second medical device 160 may be separate devices, for example, movable relative to each other. In other aspects, the first medical device 100 and the second medical device 160 may be integrally formed, for example, attached or otherwise formed together.

[0032] like Figure 1As shown, the handle 102 includes a handle body 112. The distal portion of the handle body 112 may be coupled to the proximal portion of the shaft 104 via a connector or strain relief element (not shown). Additionally, the handle 102 includes one or more actuators or control mechanisms. For example, the handle 102 may include an actuation mechanism, a button, actuator, or trigger 122, which may be movable relative to the distal portion of the handle body 112. The trigger 122 may be movable, for example, slidable (e.g., longitudinally movable), actuated, or pressable, to control the position (e.g., extension and / or retraction) and / or energization of the electrode 108. For example, sliding, actuating, or pressing the trigger 122 may cause the electrode 108 to extend from the distal end 106 of the shaft 104. In these respects, the electrode 108 may extend from the distal end 106 of the shaft 104 by approximately 5.0 mm to approximately 2.0 cm. Trigger 122 may be biased (e.g., spring-biased) so that once pressure is no longer applied to trigger 122, trigger 122 may return to a proximal or non-pressed position. Returning to the proximal or non-pressed position may also retract electrode 108 to a non-extended position. Alternatively or additionally, in some aspects, sliding, actuating, or pressing trigger 122 may control the energization of electrode 108. For example, pressing trigger 122 may energize electrode 108, and releasing pressure on trigger 122 may terminate the energization of electrode 108. In other aspects, the energization of electrode 108 may be controlled by various buttons, actuators, or triggers, for example, via a foot pedal.

[0033] The handle 102 also includes one or more connectors and / or ports, for example, extending from or otherwise coupled to the handle body 112. For example, the handle 102 may include one or more of an electrode fluid port 124 and / or an electrical connector 128. As discussed below, the electrode fluid port 124 may be fluidly connected to the electrode 108, for example, via one or more cavities in the handle 102 and the shaft 104. The electrical connector 128 may be electrically connected to the electrode 108, for example, via one or more conductive elements (e.g., wires, cables, filaments, rods, etc.) in the handle 102 and the shaft 104.

[0034] Electrode fluid ports 124 and / or electrical connections 128 may be positioned on a corresponding proximal portion of the handle body 112, for example, adjacent to or proximal to knobs 116 and 118. Electrode fluid ports 124 may receive fluids (e.g., water, Orise™ gel, saline, etc.) for delivery via cavities in electrodes 108, for example, between two tissue layers, or otherwise to the treatment site. The delivery of fluid to each of the electrode fluid ports 124 may be controlled by a fluid delivery device, such as a syringe, pump, etc. Furthermore, electrical connections 128 may receive energy from an energy source (e.g., ablation energy) to deliver to electrodes 108, for example, to cut, ablate, penetrate, puncture, or otherwise treat tissue. In some aspects, the energy delivery to electrical connections 128 may be controllable, for example, via a separate button or trigger, one or more foot pedals, etc.

[0035] Furthermore, although not shown, the handle 102 may include a strap or other connecting element, for example, which is coupled to or otherwise extends from the handle body 112. In some aspects, the strap or other connecting element may facilitate allowing the handle body 112 to be coupled to another medical device, such as the handle or other part of a mirror or other insertion device.

[0036] As mentioned, the second medical device 160 may include a tissue manipulator 162, for example, located at the distal end of the second medical device 160. The second medical device 160 also includes a sheath 164 (e.g., an outer sheath). The shaft 104 may be at least partially positioned within the lumen of the sheath 164. The proximal portion of the sheath 164 may include a handle 166 or another control mechanism or otherwise coupled thereto. The handle 166 may include a knob or an extender 168, for example, movable (e.g., longitudinally movable) within a slot 170 of the handle 166. The position of the extender 168 controls the position of the tissue manipulator 162, for example, relative to the distal end 164A of the sheath 164. In some aspects, the extender 168 may be locked or otherwise secured within the slot 170, for example, by rotating the extender 168, by friction engagement, etc. The locking or otherwise securing position of the extender 168 within the slot 170 may also help to lock or otherwise secure the position of the tissue manipulator 162 relative to the distal end 164A of the sheath 164. Additionally, although not shown, in some aspects, the second medical device 160 may include one or more springs or biasing elements, for example, located in the handle 166, to bias the extender 168 (and thus the tissue manipulator 162) toward a proximal or at least partially retracted position or shape.

[0037] In some aspects, the second medical device 160 may be secured to the first medical device 100 via one or more locks 172. The one or more locks 172 may be a Tuy-Bost lock. The one or more locks 172 may facilitate securing the proximal portion of the sheath 164 and / or the proximal portion of the handle 166 to the shaft 104 and / or handle 102 of the first medical device 100 (e.g., to the strain relief portion). For example, the lock 172 may be rotated in one direction (e.g., clockwise) to help secure the second medical device 160 to the first medical device 100. Additionally, the lock 172 may be rotated in another direction (e.g., counterclockwise) to help release / remove the second medical device 160 from the first medical device 100, for example, to adjust the relative position of the second medical device 160 and the first medical device 100.

[0038] Furthermore, in some aspects, one or more portions of the second medical device 160 may include one or more stops or stop surfaces 174. For example, one or more portions of the handle 166 may include an enlarged surface (e.g., a larger diameter) that may form the stop surface 174, which helps to restrict the position or movement of the second medical device 160 relative to the first medical device 100. In other aspects, one or more portions of the handle 166 may include one or more knobs, for example, for locking, restricting, or otherwise controlling movement and / or relative positioning between the first medical device 100 and the second medical device 160. In these examples, the stop surface 174 may help prevent the lock 172 from being positioned distal to the stop surface 174. In other words, the stop surface 174 may help prevent a portion of the second medical device 160 including the stop surface 174 (e.g., a portion of the handle 166) from being positioned proximal to the lock 172. However, in any of these aspects, the shaft 104 of the first medical device 100 may be movable relative to the sheath 164 (e.g., longitudinally), and / or the sheath 164 may be movable relative to the shaft 104 (e.g., longitudinally). For example, the distal end 106 of the shaft 104 (e.g., including the electrode 108) may extend from the distal end 164A of the sheath 164 through a range of about 0 cm to about 20.0 cm, for example, up to about 5.0 cm, up to about 3.0 cm, etc.

[0039] In other respects, one or more portions of the second medical device 160 may be integrally formed with or otherwise connected to one or more portions of the first medical device 100, for example, attached or otherwise formed together. For example, the handle 166 of the second medical device 160 may be integrated with or otherwise connected to the handle 102 of the first medical device 100 (e.g., welded, bonded, integrally formed from the same material, etc.). In one aspect, the proximal portion of the handle 166 may be fixedly connected to the distal portion of the handle 102. If the handle 166 is fixedly connected to the handle 102, the handle 166 may not include one or more stops or stop surfaces 174.

[0040] The tissue manipulator 162 may be extendable, for example, to facilitate lifting tissue (e.g., cutting tissue) or other portions of a treatment site. Although not shown, the tissue manipulator 162 may be coupled to a knob or extender 168, for example, via one or more connectors (e.g., rods, shafts, wires, drive wires, etc.). The distal ends of one or more connectors may be coupled (e.g., welded, bonded, press-fitted, crimped, etc.) to the proximal end of the tissue manipulator 162. In these respects, the position of the extender 168 within or along the slot 170 may facilitate control of the position of the tissue manipulator 162, for example, the position of the distal portion of the tissue manipulator 162 relative to the distal end 164A of the shaft 164. For example, the extender 168 may control the position of the tissue manipulator 162 relative to the distal end 164A of the shaft 164. In these respects, the tissue manipulator 162 may be movable (e.g., longitudinally) between at least the following positions: a position in which the tissue manipulator 162 is at least partially retracted (e.g., proximal to the distal end 164A of the axis 164); and one or more positions in which the tissue manipulator 162 extends (e.g., distal to the distal end 164A of the axis 164). For example, the tissue manipulator 162 may extend from the distal end 164A by about 0 cm to about 20.0 cm, for example, from about 3.0 cm to about 5.0 cm. In some aspects, the tissue manipulator 162 may extend distal to the distal end 164A by about 5.0 mm to about 2.0 cm.

[0041] Additionally, at least a distal portion of the tissue manipulator 162 may be radially outwardly biased (e.g., away from the electrode 108 of the first medical device) to help propel tissue away from the first medical device 100 (e.g., away from the electrode 108). In some aspects, the tissue manipulator 162 may be formed of one or more materials, such as nitinol, plastic materials, steel (e.g., stainless steel), etc. For example, at least a distal portion of the tissue manipulator 162 may deform such that the tissue manipulator 162 can be received within the sheath 164, and at least a distal portion of the tissue manipulator 162 may expand and / or move radially outward as it extends distally toward the sheath 164. In these aspects, at least a portion of the tissue manipulator 162 may be formed of steel and may be stamped into a desired predetermined shape. In some other aspects, at least a portion of the tissue manipulator 162 may be formed of a shape memory material (e.g., nitinol, plastic, etc.) and may be shaped into a desired predetermined shape.

[0042] Furthermore, one or more portions of the tissue manipulator 162, one or more portions of one or more connectors, and / or one or more portions connecting the tissue manipulator 162 to one or more connectors may be insulating or non-conductive (e.g., formed of plastic, elastomer, etc.). In some aspects, one or more portions or all of the tissue manipulator 162 may be formed of plastic or other non-conductive materials. In another example, one or more portions or all of the tissue manipulator 162 may be coated with an insulating or other non-conductive material (e.g., a dielectric coating). In some examples, the tissue manipulator 162 may be formed of a metallic material (e.g., stainless steel, nitinol, etc.), for example, to impart a desired shape, stiffness (e.g., for actuating tissue or otherwise interacting with it), shape memory, etc., and the tissue manipulator 162 may be coated with a coating or a non-conductive material (e.g., a dielectric coating). In other examples, the connectors may be formed of plastic or other non-conductive materials. In these respects, the energy delivered to the treatment site (e.g., via electrode 108) may not be transmitted proximally via tissue manipulator 162 and / or applied in other ways to the treatment site (e.g., other parts or locations of the treatment site or near the treatment site).

[0043] In some aspects, the second medical device 160 may be rotatable, for example, rotating together with the first medical device 102 or rotating independently of the first medical device 102. In an example, the second medical device 160 may be rotatable relative to the first medical device 102. For example, the second medical device 160 may be fixed or otherwise coupled to the first medical device 100, and the first medical device 100 and the second medical device 160 may rotate together, thereby rotating the axis 104 (including, distal end 106), electrode 108, sheath 164, tissue manipulator 162, etc. In some aspects, the second medical device 160 may be detached from the first medical device 100 (e.g., via release or unlocking lock 172), and the second medical device 160 may be rotatable, for example, via rotating handle 166. In any of these aspects, the construction, material, or other aspects of the sheath 164 may facilitate the transmission of rotation, for example, from handle 166 to distal end 164A and tissue manipulator 162. For example, in some aspects, the sheath 164 may be formed of or include a braided sheath, one or more coils, one or more braids or coils with sheaths, an extruded sheath, an extruded coil, etc.

[0044] In addition, in some aspects, such as Figure 9A and Figure 9B As shown, the sheath 164 may include multiple lumens or recesses. In some aspects, the sheath 164 may include a tissue manipulator lumen 180, for example, to movably receive a tissue manipulator 162 ( Figure 1 ) and / or connect the tissue manipulator 162 to the extender 168 ( Figure 1 One or more connectors. The sheath 164 may also include a main lumen 182 or working channel, for example, to movably receive the shaft 104 of the first medical device 100. Figure 1 The tissue manipulator cavity 180 and the main cavity 182 may be at least partially separated by the wall 186. In these respects, the tissue manipulator cavity 180 and / or the main cavity 182 may help ensure that the tissue manipulator 162 rotates with the sheath 164.

[0045] Alternatively or additionally, one or more portions of the tissue manipulator 162 and / or the connector linking the tissue manipulator 162 to the extender 168 may help ensure that the tissue manipulator 162 rotates with rotation of the proximal portion of the second medical device 160 (e.g., with rotation of the handle 166). For example, one or more portions of the tissue manipulator 162 and / or the connector may include one or more surfaces with a flat or wavy profile. For example, the connector may include a flat surface that may be generally triangular, square, etc. Alternatively or additionally, one or more portions of the tissue manipulator 162 and / or the connector may include a friction surface (e.g., formed by a friction coating) to help ensure that the tissue manipulator and / or the connector rotates with rotation of the sheath 164 (e.g., controlled by rotating the handle 166). In any of these aspects, rotation of the tissue manipulator 162 may help the user position the tissue manipulator 162 relative to the treatment site, for example, to help lift the cut tissue or other portions of the treatment site.

[0046] Figures 2A to 2D The distal portion 12 of a medical device system 10 is shown, relative to tissue at the treatment site, in various morphologies or methodological steps to aid in the application of energy, delivery of fluids, and / or manipulation of tissue. (See also:) Figure 2A As shown, in the initial step, the distal portion 12 may be positioned at the treatment site, for example, at or near the ESD injection blister 190. In these respects, the shaft 104 and the electrode 108 may extend distally to the sheath 164. In some respects, although not shown, the electrode 108 may include a fluid cavity, and fluid may be delivered to the tissue via the fluid cavity of the electrode 108 to aid in the formation of the blister 190. Moreover, the tissue manipulator 162 may extend at least partially distally to the sheath 164, for example, adjacent to the distal end 106 of the shaft 104.

[0047] like Figure 2B As shown, in the next step, one or more aspects of the distal portion 12 may be movable (e.g., advanced distally) to make an initial cut, penetration, perforation, or incision at the treatment site (e.g., blister 190). For example, the first medical device 100, including shaft 104 and electrode 108, may be advanced distally. Alternatively or additionally, both the first medical device 100 and the second medical device 160 (e.g., tissue manipulator 162 and sheath 164) may be advanced distally. In these aspects, electrode 108 may extend distally to the distal end 106 of shaft 104 and / or be energized. When energized, electrode 108 may be positioned near blister 190 to apply or deliver energy to the tissue, for example, to at least partially cut the tissue of blister 190. Moreover, tissue manipulator 162 may be positioned near electrode 108, for example, to facilitate lifting tissue adjacent to electrode 108 (e.g., cutting tissue).

[0048] Figure 2CThe next step is illustrated, which includes moving the tissue manipulator 162 (e.g., extending it distally). In these respects, the tissue manipulator 162 may extend distally to the sheath 164 (e.g., by distally advancing the extender 168 within the slot 170 of the handle 166). Figure 1 Additionally, as shown, when the tissue manipulator 162 extends distally to the sheath 164, the tissue manipulator 162 may extend radially outward. At least a portion of the tissue manipulator 162 (e.g., a distal or distal portion) may abut, engage, or otherwise interact with tissue (e.g., cut tissue of the blister 190), and the tissue manipulator 162 may assist in lifting or otherwise distally pushing tissue and / or radially pushing tissue away from the electrode 108, shaft 104, and / or other portions of the first medical device 100.

[0049] Figure 2D Another step is shown, which includes further cutting the tissue of the blister 190 and / or advancing the electrode 108. In some respects, Figure 2D The steps shown may include advancing one or more components of the medical system 10, for example, advancing one or more of handles 102 and 166 distally to move axis 104 (including distal end 106), electrode 108, tissue manipulator 162, and / or sheath 164 distally. In some aspects, Figure 2D The illustrated steps may include moving the first medical device 100 relative to the second medical device 160, thereby distally advancing the shaft 104 (including the distal end 106) and the electrode 108 relative to the tissue manipulator 162 and / or sheath 164. For example, it may release ( Figure 1 The lock 172 allows the second medical device 160 to move relative to the first medical device 100. In these respects, the electrode 108 may extend distally to the distal end 106 of the shaft 104 and / or be energized. When energized, the electrode 108 may be repositioned near the blister 190 to apply or deliver energy to the tissue, for example, to at least partially cut the tissue of the blister 190 again. Additionally or alternatively, in some respects, the position of the tissue manipulator 162 may be secured, for example, relative to the sheath 164. As mentioned above, the extender 168 may be secured within the slot 170 of the handle 166, for example, to help secure the position of the tissue manipulator 162 relative to the sheath 164. In these respects, when electrode 108 cuts blister 190 or other parts of the treatment site or otherwise applies energy to it, tissue manipulator 162 can help lift or otherwise push tissue distally and / or radially away from electrode 108, shaft 104 and / or other parts of the first medical device 100.

[0050] It should be noted that Figures 2A to 2DOne or more steps may be repeated multiple times as needed, for example, to help remove tissue from blister 190 or otherwise treat the treatment site. For example, one or more of shaft 104, electrode 108, tissue manipulator 162 and / or sheath 164 may be advanced distally or otherwise manipulated relative to the treatment site to progressively cut tissue from blister 190 until blister 190 is removed from the treatment site.

[0051] Figures 3A to 8B The distal portion of an additional exemplary tissue manipulator is shown. It should be noted that... Figures 3A to 8B Any of the organization manipulators shown can be used as or in place of organization manipulator 162.

[0052] Figure 3A and Figure 3B Side and end views or front views of the distal portion of an exemplary second medical device including tissue manipulator 362 are shown, respectively. Figure 3A As shown, the tissue manipulator 362 may be generally rectangular in its side view. For example, the distal end 362A of the tissue manipulator 362 may include a flat exterior and a circular interior. Figure 3B As shown, the distal end 362A may include a generally rectangular shape, for example, including a generally flat top, a generally flat bottom, and generally flat sides.

[0053] Figure 4A and Figure 4B Side and end views or front views of the distal portion of an exemplary second medical device including tissue manipulator 462 are shown, respectively. Figure 4A As shown, the tissue manipulator 462 may be generally rectangular in its side view. For example, the distal end 462A of the tissue manipulator 462 may include a flat exterior and a circular interior. Figure 4B As shown, the distal end 462A may include a generally circular or semi-circular shape, for example, having a curved bottom surface and / or a curved top surface.

[0054] Figure 5A and Figure 5B Side and end views or front views of the distal portion of an exemplary second medical device including tissue manipulator 562 are shown, respectively. Figure 5A As shown, the proximal portion of the tissue manipulator 562 may be generally rectangular in its side view, and the distal portion or distal end 562A of the tissue manipulator 562 may include a widened portion. For example, the distal end 562A may extend downward (or radially inward) toward the first medical device 100 (e.g., toward the electrode 108). Additionally, various portions of the tissue manipulator 562, including the distal end 562A, may include a flat exterior and one or more circular interiors. Figure 5BAs shown, the distal end 562A may include a generally circular or semi-circular shape, for example, having a curved bottom surface and / or a curved top surface.

[0055] Figure 6A and Figure 6B Side and end views or front views of the distal portion of an exemplary second medical device including tissue manipulator 662 are shown, respectively. Figure 6A As shown, the tissue manipulator 662 may be generally cylindrical or rod-shaped in its side view. For example, as Figure 6B As shown, the distal end 662A of the tissue manipulator 662 may include a generally circular shape. Alternatively, although not shown, the distal end 662A may alternatively include a generally oval, elliptical, or other circular shape.

[0056] Figure 7A and Figure 7B Side and end views or front views of the distal portion of an exemplary second medical device including tissue manipulator 762 are shown, respectively. Figure 7A As shown, the proximal portion of the tissue manipulator 762 may be generally rectangular in its side view, and the distal portion or distal end 762A of the tissue manipulator 762 may include a widened portion. For example, the distal end 762A may extend upward (or radially upward) away from the first medical device 100 (e.g., away from electrode 108) to include an outwardly flared portion. Additionally, various portions of the tissue manipulator 762, such as the distal end 762A, may include a flat exterior and one or more circular interiors. Figure 7B As shown, the distal end 762A may include a generally circular or semi-circular shape, for example, having a curved bottom (or radially inward) surface and / or a curved top (or radially outward) surface. It should be noted that, for example, the thickness of the distal end 762A may be greater than the distal ends of other tissue manipulators (see, for example, distal ends 462A and 562A) due to the outward flaring portion. In some aspects, the outward flaring portion may retract within the distal end 164A of the sheath 164. In other aspects, the outward flaring portion may not retract within the distal end 164A of the sheath 164, for example, forming a stop surface that helps limit the retraction of the tissue manipulator 762 relative to the sheath 164.

[0057] Figure 8A and Figure 8B Side and end views or front views of the distal portion of an exemplary second medical device including tissue manipulator 862 are shown, respectively. Figure 8AAs shown, the proximal portion of the tissue manipulator 862 may be generally cylindrical in its side view, and the distal portion or distal end 862A of the tissue manipulator 862 may include a widened or curved portion. For example, the distal end 862A may extend upward (or radially upward) away from the first medical device 100 (e.g., away from electrode 108) to include a hook or hook-like portion. Additionally, various portions of the tissue manipulator 862, such as the distal end 862A, may include a flat exterior and one or more circular interiors. Figure 8B As shown, distal end 862A may include a bottom (or radially inward) surface, which may include a generally curved, circular, or semi-circular shape, and distal end 862A may include a flat top (or radially outward) surface. Alternatively, although not shown, distal end 862A may include a top (or radially outward) surface having a generally curved, circular, or semi-circular shape. It should be noted that, for example, the thickness of distal end 862A may be greater than the thickness of the distal ends of other tissue manipulators (see, for example, distal end 662A) due to the hook or hook-like portion. In some aspects, the hook or hook-like portion may retract within the distal end 164A of sheath 164. In other aspects, the hook or hook-like portion may not retract within the distal end 164A of sheath 164, for example, forming a stop surface that helps limit the retraction of tissue manipulator 862 relative to sheath 164.

[0058] It should be noted that tissue manipulators 362, 462, 562, 662, 762, and 862 are shown in a holding or restrained configuration, i.e., in a straight configuration when the tissue manipulator is at least partially restrained or held within the sheath 164. It should also be noted that tissue manipulators 362, 462, 562, 662, 762, and 862 may be bent or otherwise deformed such that when exposed from the sheath 164 (e.g., towards radial extension or biased towards a bent configuration), at least the corresponding distal portion extends radially outward. The radius of curvature of tissue manipulators 162, 362, 462, 562, 662, 762, and 862 may vary, for example, between about 0 degrees and about 90 degrees. Additionally, the radius of curvature of tissue manipulators 162, 362, 462, 562, 662, 762, and 862 may depend on the amount by which the tissue manipulator protrudes distally beyond the distal end 164A of the sheath 164 (e.g., a portion of its length).

[0059] Although not shown, tissue manipulators may include one or more other shapes or sizes that can help the tissue manipulator push, engage, or otherwise manipulate tissue at the treatment site. Various shapes and / or morphologies of the various tissue manipulators can help enhance gripping of tissue when engaged with tissue (e.g., cut tissue of blister 190). For example, the distal end (e.g., distal facet) of the tissue manipulator may include one or more points, gripping features (e.g., surface texture, spikes, protrusions, etc.), or other features for grasping or otherwise interacting with and / or manipulating tissue. Additionally or alternatively, various shapes and / or morphologies of the various tissue manipulators can help facilitate shared or abutment surface areas when engaged with tissue, for example, to help push or otherwise move tissue away from electrode 108 or other aspects of the first medical device 100.

[0060] As mentioned above and as... Figure 9A and Figure 9B As shown, the sheath 164 may include multiple lumens, channels, or recesses. In some aspects, the sheath 164 may include a tissue manipulator lumen 180, for example, to movably receive a tissue manipulator 162 and / or to connect the tissue manipulator 162 to one or more connectors to the extender 168. The sheath 164 may also include a main lumen 182 or a working channel, for example, to movably receive the shaft 104 of the first medical device 100. The tissue manipulator lumen 180 and the main lumen 182 may be at least partially separated by a wall 186. Additionally, the tissue manipulator lumen 180 and the main lumen 182 may be connected or otherwise communicated via a distal opening 184. The length of the opening 184 may be slightly longer than the length of the tissue manipulator (e.g., tissue manipulator 162) such that the tissue manipulator can be fully retracted into the sheath 164 and positioned within the opening 184.

[0061] The aspects discussed herein may allow the delivery of one or more medical devices (e.g., first medical device 100 and second medical device 160) to a treatment site, for example, along or via an endoscope or insertion device, to perform endoscopic submucosal dissection (“ESD”) or otherwise manipulate the treatment site. The aspects discussed herein may allow a user to engage or otherwise manipulate tissue at the treatment site (e.g., cut tissue), which may assist the user in further cutting or otherwise manipulating the treatment site, reducing the risk of unintentional contact with non-target tissue or non-target portions of the treatment site. The aspects discussed herein may help allow a user to apply energy, cut, or otherwise manipulate tissue more effectively or efficiently, for example, reducing the likelihood of cut tissue or other aspects of the treatment site interfering with the treatment. Additionally, the aspects discussed herein may help improve the efficacy of the treatment and / or recovery from surgery (e.g., surgery to manage the treatment site). The aspects discussed herein may help reduce and / or minimize the duration of the procedure, and / or may help reduce the risk of unintentional contact with tissue or other materials during the delivery, repositioning, or removal of medical devices during the procedure.

[0062] While the principles of the invention have been described with reference to illustrative aspects applicable to various applications, it should be understood that the invention is not limited thereto. Those skilled in the art and who are able to access the teachings provided herein will recognize that additional modifications, applications, aspects, and substitutions of equivalents fall within the scope of the aspects described herein. Therefore, the invention should not be considered as limited to the foregoing description.

Claims

1. A medical system comprising: A first medical device, the first medical device comprising: A first handle, the first handle including an electrical connector; A shaft extending from the distal portion of the first handle; and An electrode positioned at the distal end of the shaft, wherein the electrode is electrically connected to the electrical connector via one or more conductive elements extending through the first handle and the shaft; and A second medical device, the second medical device comprising: second handle; A sheath extending from the distal portion of the second handle; and Tissue manipulator positioned within the sheath, The shaft extends through at least a portion of the second handle and through the sheath.

2. The medical system of claim 1, wherein the first handle includes at least one actuation mechanism, and wherein the electrode is movable relative to the distal end of the shaft based on movement of the at least one actuation mechanism.

3. The medical system of claim 1 or 2, wherein the second handle includes an extender and a slot, and wherein the extender is movable within the slot to control the position of the tissue manipulator relative to the distal end of the sheath.

4. The medical system of claim 3, wherein the extender can be locked within the slot to fix the position of the tissue manipulator relative to the distal end of the sheath.

5. The medical system according to any one of the preceding claims, wherein the second handle is adjustablely coupled to the first handle and / or to the axis of the first medical device via an adjustable lock.

6. The medical system of claim 5, wherein the second handle includes one or more stop surfaces to limit the position of the second handle relative to the first handle.

7. The medical system according to any one of claims 1 to 4, wherein the second handle is fixedly coupled to the distal end of the first handle.

8. The medical system according to any one of the preceding claims, wherein the tissue manipulator is formed of and / or coated with an electrically insulating material.

9. The medical system according to any one of the preceding claims, wherein the sheath is formed by braiding or coiling a sheath.

10. The medical system according to any one of the preceding claims, wherein the sheath comprises at least two adjacent cavities or channels, wherein the at least two cavities or channels are connected in the distal opening portion of the sheath.

11. The medical system according to any of the preceding claims, wherein the tissue manipulator includes a circular bottom surface and a flat top surface when viewed from the side, and a curved shape when viewed from the distal end.

12. The medical system according to any one of claims 1 to 10, wherein the tissue manipulator includes an inwardly extending widened portion, and wherein the tissue manipulator includes a curved shape when viewed from a distal end.

13. The medical system according to any one of claims 1 to 10, wherein the tissue manipulator comprises a generally cylindrical shape.

14. The medical system according to any one of claims 1 to 10, wherein the tissue manipulator includes a widened portion extending outward from a distal end, and wherein the tissue manipulator includes a curved shape when viewed from the distal end.

15. The medical system according to any one of claims 1 to 10, wherein the tissue manipulator comprises a generally cylindrical shape, and wherein the tissue manipulator further comprises a hook-shaped portion at a distal end.

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