Medical devices and related methods for delivering energy and / or fluids

Abstract

The medical device includes a handle, a shaft, electrodes, and at least one inflatable balloon. The handle includes electrical connections and a balloon fluid port. The shaft extends from the distal end of the handle. The electrodes are located at the distal end of the shaft. The electrodes are electrically connected to the electrical connections via one or more conductive elements extending through the handle and shaft. At least one inflatable balloon is located in part of the shaft. At least one inflatable balloon is fluidly connected to the balloon fluid port via one or more tubes extending through the handle and shaft.

Description

Technical Field

[0001] Various aspects of the present disclosure generally relate to medical devices and related methods for delivering energy and / or fluids. Embodiments of the present disclosure relate to medical devices and related methods for treating tissue by delivering electrical energy to or into tissue and / or injecting fluids into, under, and / or around tissue using a treatment device. Further, embodiments of the present disclosure relate to medical devices and related methods for treating tissue, including flexing a distal portion of a medical device and / or inflating a balloon at the distal portion of the medical device.

Background Art

[0002] Medical devices such as endoscopes or other suitable insertion devices are employed for various types of diagnostic and surgical procedures such as endoscopy, laparoscopy, arthroscopy, hysteroscopy, thoracoscopy, cystoscopy, etc. Many of these procedures involve delivering energy to the tissue of an organ or gland to treat a lesion (e.g., tumor), infection, etc. Examples of such procedures include endoscopic mucosal resection (EMR), endoscopic submucosal resection (ESR), endoscopic submucosal dissection (ESD), polypectomy, mucosal resection, peroral endoscopic myotomy (POEM), etc. In particular, such procedures can be performed by inserting an insertion device into the body of a subject through a surgical incision or through a natural anatomical opening (e.g., mouth, vagina, or rectum) and performing a procedure or surgery 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 an insertion device.

[0003] In some procedures, the distal end of a medical device is positioned between layers of tissue, for example, to perform a “third-space” procedure. In some embodiments, the distal end of a medical device is positioned between the mucosa (or mucosal layer) and muscular layer of a portion of the gastrointestinal (GI) tract to reach the target or treatment site. Often, positioning is achieved by (1) injecting a lifting agent into the submucosa to separate the mucosa from the muscular layer, and (2) using a cutting knife to cut the submucosa. These procedures may require the use of multiple medical devices (e.g., a needle and a cutting knife). The use of multiple medical devices may require a larger insertion device and / or require the exchange of medical devices, which may increase the duration of the procedure, require multiple users, and / or otherwise negatively impact the procedure. Furthermore, medical devices often used in “third-space” procedures often have only one degree of navigation freedom. In some embodiments, the separation of tissue layers may dissipate over time or during the procedure, increasing the risk that the medical device may inadvertently come into contact with other parts of the tissue or treatment site. These concerns can increase the duration, cost, and risks of medical procedures.

[0004] The apparatus and methods of this disclosure may correct some of the defects described above or address other aspects of the art. [Overview of the Initiative]

[0005] Examples of the present disclosure relate, among other things, to medical devices and methods for performing one or more medical procedures. For example, the present disclosure relates to medical devices and methods for performing one or more procedures between layers of tissue. In addition, in some examples, the present disclosure relates to medical devices and methods for delivering energy (for example, to cut, cauterize, perforate, puncture, or otherwise treat tissue) and / or delivering fluid to a treatment site. Furthermore, in some examples, the present disclosure relates to medical devices and methods for inflating and / or deflating one or more balloons at the distal end of a medical device. Furthermore, in some examples, the present disclosure relates to medical devices and methods for articulating, flexing, or otherwise manipulating the distal portion of a medical device. Each example disclosed herein may include one or more features described in relation to any other disclosed example.

[0006] In one example, the medical device may include a handle, a shaft, an electrode, and at least one inflatable balloon. The handle may include an electrical connection and a balloon fluid port. The shaft may extend from the distal end of the handle. The electrode may be located at the distal end of the shaft. The electrode may be electrically connected to the electrical connection via one or more conductive elements extending through the handle and the shaft. The at least one inflatable balloon may be located in part of the shaft. The at least one inflatable balloon may be fluidly connected to the balloon fluid port via one or more tubes extending through the handle and the shaft.

[0007] The apparatus may include one or more of the following features: The handle may further include one or more deflection elements, and at least a portion of the shaft may be deflectable via the movement of the one or more deflection elements. Each of the one or more deflection elements may be coupled to a wheel connected to one or more pull wires extending through the handle and fixed to one or more inner portions of the shaft, such that the movement of the one or more deflection elements may bias the one or more pull wires proximal to deflect the portion of the shaft. The one or more deflection elements may include two coaxial deflection knobs. Each of the two deflection knobs may control the deflection of the portion of the shaft in a plurality of substantially orthogonal planes. The portion of the shaft may be deflectable within a substantially hemispherical range of motion. The portion of the shaft may be deflectable with the at least one inflatable balloon inflated. The handle may further include one or more locking parts for fixing the positions of the two deflection knobs.

[0008] The electrode may include an electrode lumen. The handle may further include an electrode fluid port. The electrode fluid port may be fluid-coupled to the electrode lumen via one or more electrode fluid tubes configured to deliver fluid from the electrode fluid port to the electrode lumen. The electrode includes an electrode shaft and a distal end. The distal end may be wider than the electrode shaft with respect to the longitudinal axis. The handle may further include a trigger. The electrode may be extendable distally relative to the distal end of the shaft and retractable proximally via the activation of the trigger. The distal end of the electrode may remain positioned distal to the distal end of the shaft when the electrode is in the retracted position. The trigger may be located on the distal part of the handle. The electrode fluid port may be located on the distal part of the handle. The electrical connection and the balloon fluid port may be located on the proximal part of the handle.

[0009] The entire electrode may be conductive. The at least one inflatable balloon may be fluidly coupled to one or more tubes via at least one balloon hole on the outer surface of the distal end of the shaft. The at least one balloon hole may include two balloon holes located on opposite sides in the circumferential direction of the shaft. The medical device may be configured to perform third-space endoscopic procedures.

[0010] In other embodiments, the medical device may include a handle, a shaft extending from the distal end of the handle, and an electrode positioned at the distal end of the shaft. The handle may include an electrical connection and one or more flexure control units. The electrode may be electrically connected to the electrical connection via one or more conductive elements extending through the handle and the shaft. At least a portion of the shaft may be flexible via the movement of the one or more flexure control units.

[0011] The medical device may include one or more of the following features: The electrode may include an electrode shaft and a distal end. The distal end may be wider than the electrode shaft with respect to the longitudinal axis. The electrode may include an electrode lumen. The handle may further include an electrode fluid port. The electrode fluid port may be fluid-coupled to the electrode lumen via one or more electrode fluid tubes configured to deliver fluid from the electrode fluid port to the electrode lumen. The medical device may further include at least one inflatable balloon located distal to the shaft. The handle may further include a balloon fluid port. The at least one inflatable balloon may be fluid-coupled to the balloon fluid port via one or more tubes extending through the handle and the shaft.

[0012] In other embodiments, a method for treating a treatment site may include delivering the distal end of a medical device shaft to the treatment site. The shaft may include a flexible portion, and an electrode may be movably positioned at the distal end of the shaft. The method may include delivering energy to the treatment site to cut, puncture, or perforate one or more layers of tissue at the treatment site. The method may further include positioning the distal end of the shaft between layers of tissue and inflating one or more balloons to separate the layers of tissue. The one or more balloons may be positioned at the distal end of the shaft and may be fluidly connected to one or more balloon fluid ports via one or more balloon fluid tubes and one or more balloon holes. The method may include positioning the electrode and energizing the electrode to deliver energy to one or more portions of the treatment site. The one or more portions of the treatment site may be between separated layers of tissue.

[0013] The method may include one or more of the following features: The electrode may include an electrode lumen that fluidly connects to a fluid source. The method may include injecting fluid into the treatment site through the electrode lumen or delivering fluid in another manner to separate layers of tissue before positioning the distal end of the shaft between layers of tissue. The method may include articulating or flexing the distal end of the shaft to further separate layers of tissue before positioning the electrode to deliver energy to one or more portions of the treatment site and energizing the electrode.

[0014] It should be understood that both the above summary and the following detailed description are illustrative and descriptive, and do not limit the disclosure as described in the claims. [Brief explanation of the drawing]

[0015] The accompanying drawings incorporated herein and constituting part thereof illustrate exemplary embodiments of the present disclosure and, together with the description, help to illustrate the principles of the present disclosure. [Figure 1]Figure 1 illustrates an exemplary perspective view of a medical device, including an enlarged view of the distal portion of the medical device in a first configuration relating to an aspect of the present disclosure. [Figure 2] Figure 2 illustrates the distal portion of the medical device shown in Figure 1 in a second configuration according to an aspect of this disclosure. [Figure 3] Figure 3 illustrates a schematic diagram of the medical device shown in Figure 1 in a second configuration relating to an aspect of this disclosure. [Figure 4] Figure 4 is a flowchart illustrating an exemplary method relating to an aspect of this disclosure. [Modes for carrying out the invention]

[0016] Examples of the present disclosure include apparatus and methods for one or more of the following: promoting and improving the effectiveness, efficiency and safety of treating and / or manipulating tissue by applying electrical energy to the tissue using electrodes; delivering fluid in, under, and / or around tissue during a medical procedure through the distal end of an electrode; and cutting, excising, or otherwise treating tissue. Aspects of the present disclosure may provide a user with the ability to apply electrical energy or heat to tissue using a medical device having electrodes, and to deliver fluid in and / or under the tissue using the same medical device. Aspects of the present disclosure may provide a user with the ability to apply electrical energy or heat and deliver fluid without the need to switch or replace end effectors. Aspects of the present disclosure may help a user penetrate layers of tissue (e.g., submucosa) to cause perforation, or otherwise cut, cauterize, or otherwise treat tissue. Aspects of the present disclosure may help a user cut, excise, or otherwise remove tissue or other material without the need to switch or replace end effectors. Aspects of this disclosure may help a user flex the distal portion of an end effector.

[0017] Furthermore, aspects of the present disclosure may assist a user in inflating or expanding one or more balloons distal to the end effector, for example, in separating tissue layers. For example, some aspects of the present disclosure may assist a user in inflating or expanding one or more balloons to expand or separate tissue layers and / or in tensing one or more tissue layers or tissue fibers. Tensing one or more tissue layers or tissue fibers may assist a user in identifying and / or distinguishing between tissue layers, for example, between mucosa (or mucosal layer) and muscular layer, and / or in reducing the possibility of accidental tissue perforation. Some aspects of the present disclosure may be used when performing endoscopy, laparoscopy, arthroscopy, gynecoscopy, thoracoscopy, cystoscopy, or other types of procedures.

[0018] Embodiments of this disclosure may relate to devices and methods for performing various medical procedures and / or treating the large intestine (colon), small intestine, cecum, esophagus, stomach, any other part of the gastrointestinal tract, lungs, and / or any other suitable part of a patient's anatomical structure. Various embodiments described herein include single-use or disposable medical devices. Some embodiments of this disclosure may be used when performing endoscopy, arthroscopes, bronchoscopes, ureteroscopes, colonoscopes, or other types of procedures. For example, the embodiments disclosed may be used with duodenoscopes, bronchoscopes, ureteroscopes, colonoscopes, catheters, diagnostic or therapeutic tools or devices, or other types of medical devices. One or more of the elements discussed herein may be metals, plastics, or any combination of shape memory metals (e.g., nitinol), shape memory polymers, polymers, or biocompatible materials.

[0019] The terms “proximal” and “distal” are used herein to refer to the relative locations of components of an exemplary medical device. As used herein, “proximal” refers to a location relatively close to the outside of the body of the subject, or relatively close to a user, such as a medical professional, who holds or otherwise uses the medical device. In contrast, “distal” refers to a location relatively further away from the medical professional or other user who holds or otherwise uses the medical device, or closer to the inside of the body of the subject. The proximal and distal directions are labeled with arrows marked “P” and “D” respectively throughout the various diagrams. As used herein, the terms “comprises,” “comprising,” “having,” “including,” or other variations thereof, are intended to cover non-exclusive inclusion, such that a device or method comprising a list of elements may include other elements not explicitly enumerated or inherent to them, rather than including only those elements. Unless otherwise stated, the term “exemplary” is used in the sense of “example” rather than “ideal.” As used herein, the terms “about,” “substantially,” and “approximately” indicate a range of values ​​within + / - 10% of the stated value.

[0020] Next, we will refer in detail to the examples of this disclosure described above and shown in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or similar parts. It should be noted that one or more embodiments of the medical devices or methods discussed herein may be combined with and / or used in conjunction with one or more other embodiments of the medical devices or methods discussed herein.

[0021] Figure 1 shows a perspective view of an exemplary medical device 100 including a handle 102 and a shaft 104. The shaft 104 includes a distal end 106. The medical device 100 also includes an electrode 108, for example, at the distal end 106. The electrode 108 may be movable relative to the shaft 104, and may, for example, be longitudinally extendable and / or retractable relative to the shaft 104. The electrode 108 may be energized to puncture, perforate, cut, excise, cauterize, remove, or otherwise treat tissue or other parts of the treatment site. Furthermore, in some embodiments, the electrode 108 may include an electrode lumen 136 (Figure 3) terminated at an electrode outlet or electrode opening 138 to inject or otherwise deliver a fluid to the treatment site, for example, into or between layers of tissue. However, in other embodiments, the electrode 108 may not include an electrode lumen and therefore may not provide fluid injection or other delivery. As will be discussed in detail below, the handle 102 includes various connections and controls for controlling the position of the distal end 106 and the electrode 108. As shown in the enlarged portion of Figure 1, at least a portion of the distal end 106 of the shaft 104 (e.g., the flexible portion 104A) is flexible, and the flexibility can be controlled by one or more portions of the handle 102. Furthermore, as shown in Figures 1 and 2, the distal end 106 includes, for example, one or more inflatable balloons 110 that, when inflated, extend radially outward from at least a portion of the shaft 104.

[0022] As shown in Figure 1, the handle 102 includes a handle body 112. The distal end of the handle body 112 may be connected to the proximal end of the shaft 104 via a connector or strain relief element 114. In addition, the handle 102 includes one or more actuators or control mechanisms, for example, one or more deflection elements or control units. One or more deflection elements or control units may include one or more knobs or levers, for example, two knobs 116 and 118. The knobs 116 and 118 are movable (e.g., rotatable or pivotable) to control the deflection of at least a portion of the shaft 104 (e.g., a flexible portion 104A). For example, knob 116 may be movable to control the deflection of at least a portion (e.g., the flexible portion 104A) of shaft 104 in a first plane (e.g., left / right), and knob 118 may be movable to control the deflection of at least a portion (e.g., the flexible portion 104A) of shaft 104 in a second plane (e.g., up / down). In some embodiments, the first and second planes are substantially orthogonal to allow four-way articulation of the flexible portion 104A of shaft 104, for example, as shown in the enlarged portion of Figure 1. As will be discussed in detail below, knobs 116 and 118 may be coupled to one or more wires (e.g., see Figure 3, as discussed below) to control the deflection of at least a portion of shaft 104. Knobs 116 and 118 may be coaxial, and each may be coupled to a coaxial shaft or wheel, for example. In some embodiments, the handle 102 includes, for example, a locking portion 120 for locking or otherwise fixing the position of one or more knobs 116 and 118, which may serve to lock or otherwise fix the position or orientation of at least a portion of the shaft 104 (e.g., a flexible portion 104A). Note that the one or more knobs 116 and 118 may be one or more other actuators different from those shown in Figure 1, such as levers, sliders, etc.

[0023] Note that in some embodiments, the handle 102 may only allow two - directional articulation (e.g., in one plane). For example, the handle 102 may include only one knob or lever for controlling two - directional articulation. Alternatively, the handle 102 may include two knobs or levers, where one knob or lever controls movement in one direction and the other knob or lever controls movement in another (e.g., opposite) direction.

[0024] The handle 102 may include, for example, a button, actuator, or trigger 122 that is movable relative to the distal portion of the handle body 112. The trigger 122 may be movable, e.g., actuatable or depressible, to control the position (e.g., extension and / or retraction) and / or energization of the electrode 108. For example, actuating or depressing the trigger 122 may extend the electrode 108 from the distal end 106 of the shaft 。The trigger 122 may be biased (e.g., spring - biased) so that once the pressure on the trigger 122 is removed, the trigger 122 can return to its non - depressed position. Returning to the non - depressed position may also retract the electrode 108 to its non - extended position. Alternatively, or in addition, in some embodiments, depressing the trigger 122 may control the energization of the electrode 108. For example, depressing the trigger 122 may energize the electrode 108, and releasing the pressure on the trigger 122 may de - energize the electrode 108.

[0025] The handle 102 also includes, for example, one or more connection parts and / or ports that extend from or are otherwise coupled to the handle body 112. For example, the handle 102 may include one or more electrode fluid ports 124, balloon fluid ports 126, and / or electrical connections 128. As described below, the electrode fluid ports 124 and the balloon fluid ports 126 may be fluidly connected to the electrodes 108 and the balloon 110, respectively, via, for example, the lumens of the handle 102 and the shaft 104. The electrical connection 128 may be electrically connected to the electrode 108 via, for example, one or more conductive elements (such as wires, cables, filaments, rods, etc.) of the handle 102 and the shaft 104.

[0026] The electrode fluid port 124 may be positioned at the distal portion of the handle body 112, for example, adjacent and / or opposite to the trigger 122. The balloon fluid port 126 and / or the electrical connection 128 may be positioned adjacent to or proximal to the respective proximal portions of the handle body 112, for example, adjacent to the knobs 116 and 118. The electrode fluid port 124 may receive a fluid (such as water, Orise (registered trademark) gel, saline, etc.) that is delivered, for example, between two layers of tissue or otherwise to the treatment site via the lumen of the electrode 108. The balloon fluid port 126 may receive a fluid (such as air, water, etc.) that is delivered to the balloon 110 for inflating the balloon. The delivery of fluid to each of the electrode fluid port 124 and the balloon fluid port 126 may be controlled by a fluid delivery device, such as a syringe, a pump, etc. Further, the electrical connection 128 may receive energy (such as ablation energy) that is delivered to the electrode 108 for cutting, ablating, penetrating, perforating, or otherwise treating tissue from an energy source. In some embodiments, the delivery of energy to the electrical connection 128 may be controllable via, for example, a separate button or trigger, one or more foot pedals, etc.

[0027] Furthermore, although not shown, the handle 102 may include, for example, a strap or other connecting element that is coupled to the handle body 112 or otherwise extends from it. In some embodiments, the strap or other connecting element may help to allow the handle body 112 to be coupled to another medical device, such as a scope or other insertion device handle or part.

[0028] As described above, the shaft 104 includes, for example, a steerable or flexible portion 104A at the distal end 106 of the shaft 104. The flexible portion 104A may be, for example, a joint. The shaft 104 and the flexible portion 104A may have various structures known or may become known in the art. As described above, the movement of the knobs 116 and 118 controls the deflection of the flexible portion 104A, and therefore the deflection of the distal end 106. For example, as shown in the enlarged portion of the distal end 106 of the shaft 104, the movement of the knob 116 can cause the flexible portion 104A to bend in a first plane (e.g., up and down) between at least a number of positions or orientations of the distal end 106A and 106B. Furthermore, movement of the knob 118 can cause the flexible portion 104A to flex in a second plane (e.g., left and right) between at least a number of positions or orientations of the distal ends 106C and 106D. In some embodiments, the first and second planes are substantially orthogonal. Furthermore, in some embodiments, movement of one or more knobs 116 and 118 can allow the flexible portion 104A, including the distal end 106, to flex through a substantially hemispherical range of motion. In other embodiments, movement of one or more knobs 116 and 118 can allow the distal end 106 to flex through a smaller range of motion (e.g., a substantially conical range of motion) or through a larger range of motion (e.g., a roughly spherical range of motion). For clarity, please note that electrode 108 is omitted from the illustration of the distal end 106 in the enlarged portion of Figure 1 at each bending position or orientation (for example, the positions or orientations of distal ends 106A, 106B, 106C, and 106D).

[0029] Figure 2 shows the distal end 106 of the shaft 104 with the balloon 110 inflated. For example, the distal portion of the balloon 110 may be sealed and connected to a portion of the shaft 104, and the proximal portion of the balloon 110 may be sealed and connected to another portion of the shaft 104. As shown, the balloon 110 may radially surround a portion of the shaft 104. For example, the balloon 110 may extend radially around the entire circumference of a portion of the shaft 104. Alternatively, although not shown, the balloon 110 may extend radially around only a portion of the circumference of the shaft 104. In any of these embodiments, the shaft 104 includes, for example, at least one balloon hole 130 on the outer surface of the distal portion of the shaft 104. The balloon hole 130 fluidly connects the balloon fluid port 126 and any balloon lumen of the shaft 104 to the balloon 110. In these embodiments, a fluid (e.g., air, water, etc.) can be delivered out of the balloon hole 130 through the balloon fluid port 126, through the lumen of the handle 102, and through the lumen of the shaft 104 in order to inflate the balloon 110. Note that, as shown in Figures 1 to 3, the balloon 110 is positioned on the shaft 104 at a location proximal to the distal end of the electrode 108 and the distal end 106 of the shaft 104. In other words, the balloon 110 is proximal to the electrode 108 (the electrode 108 is distal to the balloon 110) both when the electrode 108 is extended distally and when the electrode 108 is retracted proximal. Furthermore, in some embodiments, the balloon 110 may be proximal to the flexible portion 104A of the shaft 104. For example, the distal end of the balloon 110 may be adjacent to the proximal end of the flexible portion 104A of the shaft 104. In these embodiments, the balloon 110 (and the portion of the shaft 104 surrounding the balloon 110) may remain relatively stationary and / or fixed in place within the body cavity of the target (e.g., while the flexible portion 104A and / or the electrode 108 move within the body cavity (e.g., while the flexible portion 104A bends or oscillates, and / or while the electrode 108 is extended and / or retracted)).

[0030] In some embodiments, the balloon 110 may be inflatable to a size substantially the same as or smaller than the diameter of the respective body lumen (for example, the esophagus if the distal end 106 of the shaft 104 is configured to be delivered into the esophagus). For example, in the deflated state, the balloon 110 may abut the shaft 104, or otherwise approximate the size of the shaft 104. Furthermore, in the inflated state, the balloon 110 may have a diameter of about 3 mm to about 30 mm, for example, about 15 mm. In the inflated state, the balloon 110 may have a length of about 5 mm to about 30 mm, for example, about 15 mm. At least a portion of the balloon 110 (i.e., in the inflated state) may have a substantially circular shape (for example, in a lateral cross-section). Alternatively, or in addition, at least a portion of the balloon 110 (i.e., in the inflated state) may have a substantially oval or elliptical shape with a long axis and a short axis (for example, in a lateral cross-section). In some embodiments, the long axis of the elliptical balloon may range from about 5 mm to about 30 mm (e.g., about 20 mm), and the short axis may range from about 5 mm to about 30 mm (e.g., about 15 mm). Furthermore, in some embodiments, the balloon 110 may have at least a partially conical shape, for example, having one or more tapers or funnels from a smaller diameter to a larger diameter (e.g., the distal part of the balloon 110 is smaller than the proximal part of the balloon 110, or vice versa). In addition, in some embodiments, suction or negative pressure may be applied to the balloon fluid port 126 to deflate the balloon 110, for example. The balloon 110 may be formed from a flexible, medically safe material (e.g., plastic or silicone material, or a combination thereof, e.g., nylon, Pebax, nylon / Pebax blend, latex, polyethylene terephthalate (PET), etc.).

[0031] Although not shown in Figure 2, the shaft 104 may include, for example, multiple balloon holes 130 fluidly connected to multiple balloons 110. The multiple balloons 110 and their corresponding balloon holes 130 may be positioned longitudinally along the shaft 104. Alternatively, the multiple balloons 110 and their corresponding balloon holes 130 may be positioned radially around the circumference of the shaft 104. In these embodiments, the multiple balloon holes 130 may be fluidly connected to the same balloon lumen of the shaft 104, for example, so that the multiple balloons 110 inflate and / or deflate at the same time and / or rate. In another embodiment, the multiple balloon holes 130 (or a subset of the multiple balloon holes 130) may be fluidly connected to different balloon fluid ports 126 and / or handles 102 and / or different balloon lumen of the shaft 104, for example, so that the multiple balloons 110 (or a subset of the multiple balloons) inflate or deflate at different times and / or different rates.

[0032] Furthermore, although not shown, the shaft 104 may include a plurality of balloon lumens connected to each balloon hole 130. Each balloon lumen may be connected, for example, to one or more fluids or inflation sources (e.g., air, water, etc.) and / or deflation sources (e.g., suction) via each balloon fluid port 126. In these embodiments, the balloon 110 may be inflated via one or more balloon fluid ports 126, one or more balloon lumens, and one or more balloon holes 130, and the balloon 110 may be deflated via one or more balloon fluid ports 126, one or more other balloon lumens, and one or more other balloon holes 130.

[0033] As shown in Figures 2 and 3, the electrode 108 includes an electrode shaft 132 and a distal end 134. The electrode shaft 132 may be, for example, substantially cylindrical with a constant width. Alternatively, although not shown, the electrode shaft 132 may include, for example, one or more tapered portions between portions having different widths. The distal end 134 may be wider than the electrode shaft 132 (for example, extending radially outward with respect to the longitudinal axis of the electrode 108). In this embodiment, the distal end 134 may extend distally to the distal end 106 in the retracted position and remain exposed. The distal end 134 may include a flat distal surface, as shown. Alternatively, the distal end 134 may include a rounded (e.g., hemispherical or hemispherical) distal end. Although not shown, one or more portions of the electrode 108 (e.g., the distal end 134) may include one or more insulating materials. Alternatively, the entire electrode 108 may be conductive.

[0034] Furthermore, as described above, in some embodiments, the electrode 108 includes an electrode lumen 136 distally terminating at an electrode opening 138. In these embodiments, a fluid (e.g., water, Orise® gel, saline, etc.) can be delivered through the electrode fluid port 124 (e.g., from a syringe or other fluid source), the lumen or tube of the handle 102, the lumen or tube of the shaft 104, and the electrode lumen 136, and out through the electrode opening 138. The fluid can be delivered to tissue (e.g., injected between layers of tissue) or otherwise delivered to the treatment site. Alternatively, in other embodiments, the electrode 108 does not include an electrode lumen 136 or an electrode opening 138.

[0035] Figure 3 is a schematic diagram of various parts of the medical device 100. As described above, the medical device 100 includes a handle 102 having a handle body 112 and a shaft 104 extending from the handle body 112. Note that the strain relief element 114 and trigger 122 have been omitted for clarity. Furthermore, for clarity only one knob 116 is shown, and the knob 116 is represented by a lever to show the inside of the handle 102.

[0036] As described above, the handle 102 includes at least one knob 116 and a plurality of fluid or electrical connections. As shown, the knob 116 is coupled to a rotatable or pivotable element, e.g., the wheel 140 or a pulley, such that the rotation of the knob 116 rotates the wheel 140. In addition, one or more pull wires, e.g., two pull wires 142 and 144, may be coupled to the wheel 140 and extend distally therefrom. Each of the pull wires 142, 144 extends through the handle body 112 and through each portion of the shaft 104, and may terminate distally, for example, at distal couplings 146, 148 on the inner portion of the distal end 106 of the shaft. Each of the pull wires 142, 144 may be fixed at the distal couplings 146, 148. The distal couplings 146 may be offset from each other (e.g., 180 degrees apart, 90 degrees apart, or by any other preferred amount). In these embodiments, rotation of the knob 116 rotates the wheel 140, and as a result, rotation of the wheel 140 pulls or biases one of the pull wires 142 or 144 proximally, which helps to deflect, for example, the flexible portion 104A of the shaft 104. For example, rotating the wheel 140 in a first direction may pull or bias the pull wire 142 proximally so as to help deflect the flexible portion 104A of the shaft 104 in a first deflection direction, and rotating the wheel 140 in a second direction (for example, opposite to the first direction) may pull or bias the pull wire 144 proximally so as to help deflect the flexible portion 104A of the shaft 104 in a second deflection direction (for example, opposite to the first deflection direction). Although not shown, other and / or additional bending or joint movement mechanisms may also be incorporated into the medical device 100, for example, to control the position of the distal end 106 of the shaft 104 by controlling the position and / or orientation of the flexible portion 104A of the shaft 104.

[0037] In addition, the handle 102 may include an electrode fluid port 124, a balloon fluid port 126, and an electrical connection 128. As shown, the electrode fluid port 124 is in fluid communication with the electrode 108 via one or more electrode fluid lumens or tubes 150 that extend, for example, at least from the electrode fluid port 124 to the electrode 108 and fluidly connect the electrode fluid port 124 and the electrode lumen 136. Note that Figure 3 shows the electrode 108 extending proximal to the handle body 112. The disclosure is not limited thereto. For example, the electrode 108 may be positioned distally from the handle body 112 within the shaft lumen 152 of the shaft 104. In this embodiment, the electrode fluid tube 150 may extend through a portion of the shaft 104 to fluidly connect the electrode fluid port 124 to the electrode lumen 136. Furthermore, in some embodiments, the handle 102 may include a first electrode fluid lumen, and the shaft 104 may include a second electrode fluid lumen, for example, fluidly connected to the first electrode fluid lumen, to fluidly connect the electrode fluid port 124 to the electrode lumen 136. In addition, in some embodiments, one or more electrode fluid ports 124 and electrode fluid tubes 150 may be movable, for example, to provide extension and / or retraction of the electrode 108 relative to the distal end 106 of the shaft 104. Alternatively, other operating mechanisms (e.g., wires, rods, or equivalent) may be used to extend / retract the electrode 108.

[0038] Furthermore, the balloon fluid port 126 is in fluid communication with the balloon 110 via one or more balloon fluid lumens or tubes 154. As shown in Figure 3, one or more balloon fluid tubes 154 may extend from the balloon fluid port 126, through the handle body 112, and through at least a portion of the shaft 104 to the balloon hole 130. The balloon fluid tubes 154 may extend through separate lumens of the shaft 104. For example, the electrode 108 may be located in a first lumen or working channel of the shaft 104, and the balloon fluid tubes 154 may be located in a second lumen or auxiliary channel of the shaft 104. In addition, the balloon fluid tubes 154 may extend to one or more balloon holes 130, for example, two balloon holes 130. As shown in Figure 3, the two balloon holes 130 may be located on opposite sides of the circumferential direction of the distal end 106 of the shaft 104. For example, the distal portion of the balloon fluid tube 154 may include branching or splitting so that the fluid delivered or suction applied through the balloon fluid tube 154 is delivered / applied to one or more balloon holes 130 to inflate or deflate the balloon 110. Furthermore, in some embodiments, the handle 102 may include a first balloon fluid tube, and the shaft 104 may include a second balloon fluid tube, for example, fluid-connected to the first balloon fluid tube, to fluid-connect the balloon fluid port 126 to the balloon holes 130 and the balloon 110. In some embodiments, the handle 102 may include a balloon fluid tube 154, and the balloon fluid tube 154 may be fluid-connected to a lumen (e.g., an auxiliary lumen or channel) of the shaft 104. The lumen of the shaft 104 is then fluid-connected to the balloon holes 130.

[0039] Furthermore, the electrical connection 128 is electrically connected to the electrode 108 via one or more conductive wires or elements 156. As shown in Figure 3, one or more conductive elements 156 (e.g., wires, cables, filaments, rods, etc.) may extend from the electrical connection 128 through a portion of the handle body 112 to the electrode 108. Note that, as stated above, Figure 3 shows the electrode 108 extending proximal to the handle body 112. The disclosure is not limited thereto. For example, the electrode 108 may be positioned within the shaft lumen 152 of the shaft 104 at a position distally spaced from the handle body 112. In this embodiment, the conductive element 156 may extend through a portion of the shaft 104 to electrically connect the electrical connection 128 to the electrode 108. Furthermore, in some embodiments, the handle 102 may include a first conductive element, and the shaft 104 may include a second conductive element, for example, electrically connected to the first conductive element, to electrically connect the electrical connection 128 to the electrode 108. Furthermore, in some embodiments, the conductive element 156 may be movable relative to one or more handles 102 and / or shafts 104, for example, via action on a trigger 122. In these embodiments, movement of the conductive element 156 may result in extension and / or retraction of the electrode 108 relative to the distal end 106 of the shaft 104.

[0040] Figure 4 illustrates a method 400 that may be performed using the medical device 100 or a part of the medical device 100 discussed herein. Specifically, the method 400 includes an initial step 402, which includes delivering the distal end 106 of a shaft 104 to the treatment site. The shaft 104 may be delivered to the treatment site via an insertion device (e.g., an endoscope, insertion device, sheath, etc.) through a surgical incision or a natural anatomical opening. In some embodiments, the shaft 104 may be delivered through the mouth of the subject into the esophagus, stomach, and / or other part of the GI tube of the subject. In some embodiments, the distal portion of the insertion device may be flexible, for example, to help position the distal end 106 of the medical device 100 relative to the treatment site. In addition, step 402 may include positioning the distal end 106 at the treatment site. Step 402 may include extending an electrode 108 distally via a trigger 122, for example. Furthermore, step 402 may include, for example, bending the flexible portion 104A of the shaft 104 via one or more knobs 116, 118.

[0041] Next, method 400 includes step 404, which includes, for example, using electrode 108 to cut, puncture, perforate, or otherwise deliver energy to the treatment site. As described above, electrode 108 may be energized by pressing trigger 122, which may also extend electrode 108. Alternatively, or in addition, electrode 108 may be energized by activating one or more other buttons, triggers, foot pedals, etc. Delivering energy to the treatment site may help to cut, puncture, perforate, or otherwise treat one or more layers of tissue at the treatment site, for example, the mucosa of a portion of the target GI duct.

[0042] Optional step 406 may include injecting or otherwise delivering a fluid to the treatment site. For example, optional step 406 may include positioning a portion of the electrode 108 (e.g., the distal end 134) adjacent to, or at least partially within, the cut, punctured, or perforated tissue, and delivering the fluid out of the electrode opening 138 through the electrode lumen 136. As described above, in some embodiments, the electrode 108 may be fluid-connected to the electrode fluid port 124. In some embodiments, the step of injecting or otherwise delivering the fluid to the treatment site may include connecting a syringe or other fluid delivery device to the electrode fluid port 124 and delivering the fluid (e.g., water, Orise® gel, saline, etc.) through the electrode fluid port 124 and the electrode fluid tube 150. The fluid may be delivered between layers of tissue (e.g., in the submucosal space between the mucosa and the muscular layer) to help separate the layers of tissue.

[0043] Next, step 408 includes positioning the distal end of the shaft 104 between layers of tissue and inflating one or more balloons 110. In this embodiment, inflating one or more balloons 110 with the distal end 106 positioned between layers of tissue (e.g., between the mucosa and the muscle layer) may help to separate and / or impart tension to the layers of tissue and / or tissue fibers more quickly and / or more effectively, for example, through blunt dissection. Inflating one or more balloons 110 may also help to stabilize the distal end 106 of the shaft 104 and / or provide traction thereto, for example, when positioning the distal end 106. Inflating one or more balloons 110 may further help to stabilize the distal end 106 of the shaft 104 and / or provide traction thereto, for example, when delivering energy and / or fluid via the electrode 108. Furthermore, in some embodiments, one or more balloons 106 may help the user identify and / or distinguish between tissue layers, for example, between the mucosa (or mucosal layer) and the muscular layer, and / or reduce the possibility of accidental perforation of tissue.

[0044] An optional step 410 includes articulating or flexing the distal end of the shaft. In this embodiment, articulating or flexing the distal end 106 (e.g., via control of the flexible portion 104A of the shaft 104 using one or more knobs 116, 118) while the distal end 106 is between layers of tissue may further assist in separating the layers of tissue more quickly and / or effectively. In addition, the articulation or flexing may be performed with one or more balloons 110 inflated, which may further assist in separating the layers of tissue. As previously stated, one or more balloons 110 are located proximal to the electrode 108 and the distal end of the shaft 104, both in the extended and retracted states of the electrode 108. In addition, one or more balloons 110 may overlap at least partially (i.e., longitudinally) with the flexible portion 104A of the shaft 104, and therefore, one or more balloons 110 move at least partially with the flexible portion 104A as the flexible portion 104A is bent (e.g., via one or more knobs 116, 118). Alternatively, one or more balloons 110 may be proximal to the flexible portion 104A of the shaft 104 (e.g., the distal end of a balloon 110 is proximal to or adjacent to the proximal end of the flexible portion 104A), and as a result, one or more balloons 110 remain stationary or fixed within the body lumen even when the flexible portion 104A is bent.

[0045] Furthermore, in some embodiments, step 410 may include advancing or biasing the distal end 106 distally (in addition to articular movement or flexure) to further separate the tissue layers, for example, via blunt tissue detachment. The position of the distal end 106 may help maintain the separation of the tissue layers. Furthermore, inflation of one or more balloons 110 may help maintain the separation of the tissue layers and / or impart tension to the tissue layers. In addition, in some embodiments, an additional fluid (e.g., water, Orise® gel, saline, etc.) may be delivered through the electrode 108, which may also help maintain the separation of the tissue layers.

[0046] Furthermore, step 412 includes positioning the electrodes and energizing the electrodes to deliver energy to one or more portions of the treatment site. In some embodiments, one or more portions of the treatment site may be one or more portions of isolated layers of one or more tissues. The electrode 108 may be extended and / or retracted relative to the distal end 106 of the shaft 104, for example, via a trigger 122. In addition, the electrode 108 may be positioned via the flexure of the distal end 106 of the shaft 104 (for example, via control of the flexible portion 104A using one or more knobs 116, 118). Furthermore, if the shaft 104 is delivered through a scope of an insertion device, the scope or the distal portion of the insertion device may be flexible to assist in positioning the distal end 106 of the shaft 104 and / or the electrode 108.

[0047] Furthermore, as shown in Figure 4, in some embodiments, Method 400 may optionally include repeating one or more steps 402-412. For example, as shown in Figure 4, after step 412, Method 400 may include repeating one or more steps 406-412. In these embodiments, after step 412, the user may again perform one or more of the following steps: optional step 406, injecting or otherwise delivering fluid to the treatment site; step 408, positioning the distal end of the shaft between layers of tissue and inflating one or more balloons; optional step 410, articulating or flexing the distal end of the shaft; and / or positioning and energizing electrodes to deliver energy to one or more parts of the treatment site. Repeating one or more steps of Method 400 may help to form tunnels through additional tissue or layers of tissue, or otherwise separate them.

[0048] Separation of tissue layers and / or tensioning may help enable the positioning of the electrode 108, including the positioning of the distal end 106, as discussed above. Separation of tissue layers and / or tensioning may also help enable the electrode 108 to be positioned, for example, in the field of view of the scope or insertion device without the need to reposition or move the scope or insertion device. As discussed, the electrode 108 may be energized via the electrical connection 128 and the conductive element 156. The energized electrode 108 may be applied to one or more parts of the treatment site to cut, incise, excise, mark, coagulate, cauterize, or otherwise treat the treatment site. Furthermore, in some embodiments, step 412 may include delivering fluid within or between additional layers of tissue to help elevate or separate layers of tissue for removal or treatment, for example. In these embodiments, the electrode 108 may be used to deliver energy and fluid to the treatment site without the need to remove or replace the electrode 108 for another end effector.

[0049] Various embodiments discussed herein may enable a medical device (e.g., medical device 100) to be delivered to a treatment site, for example, alone or via a scope or insertion device, to perform endoscopic submucosal dissection (ESD) or otherwise treat the treatment site. Various embodiments discussed herein may enable a user to perform “third-space” procedures, for example, “third-space” endoscopic procedures. In addition, various embodiments discussed herein may help improve the effectiveness of treatment and / or recovery from the procedure, for example, a procedure to treat the treatment side. Various embodiments discussed herein may help reduce and / or minimize the duration of the procedure and / or help reduce the risk of inadvertent contact with tissue or other materials during the delivery, repositioning, or removal of the medical device for the procedure.

[0050] The principles of this disclosure are described herein with reference to exemplary embodiments for various applications, but it should be understood that this disclosure is not limited thereto. Those skilled in the art and those accessing the teachings provided herein will recognize that all additional modifications, applications, embodiments, and substitutions of equivalents fall within the scope of the embodiments described herein. Therefore, this disclosure should not be considered limited by the foregoing description.

Claims

1. A handle including electrical connections and balloon fluid ports, A shaft extending from the distal part of the handle, An electrode positioned at the distal end of the shaft, electrically connected to the electrical connection via one or more conductive elements extending through the handle and the shaft, At least one inflatable balloon positioned in part of the shaft, the at least one inflatable balloon being fluidly connected to the balloon fluid port via the handle and one or more tubes extending through the shaft, A medical device equipped with the following features.

2. The handle further includes one or more bending elements, The medical device according to claim 1, wherein at least a portion of the shaft is flexible via the movement of one or more flexing elements.

3. The medical device according to claim 2, wherein each of the one or more flexible elements is coupled to a wheel connected to one or more pull wires that extend through the handle and are fixed to one or more inner portions of the shaft, and as a result, the movement of the one or more flexible elements biases the one or more pull wires proximal to cause a portion of the shaft to bend.

4. The medical device according to claim 3, wherein the one or more deflection elements include two coaxial deflection knobs, each of the two deflection knobs controlling the deflection of the portion of the shaft in a plurality of substantially orthogonal planes.

5. The aforementioned portion of the shaft is capable of bending within a substantially hemispherical range of motion. The medical device according to claim 4, wherein the portion of the shaft is flexible when the at least one inflatable balloon is inflated.

6. The medical device according to claim 4 or 5, wherein the handle further includes one or more locking parts for fixing the positions of the two flexible knobs.

7. The electrode includes an electrode tube lumen, The handle further includes an electrode fluid port, The medical device according to any one of claims 1 to 6, wherein the electrode fluid port is fluidly coupled to the electrode lumen via one or more electrode fluid tubes configured to deliver fluid from the electrode fluid port to the electrode lumen.

8. The electrode includes an electrode shaft and a distal end. The medical device according to claim 7, wherein the distal end is wider than the electrode shaft with respect to the longitudinal axis.

9. The handle further includes a trigger, The medical device according to claim 7, wherein the electrode is extendable distally to the distal end of the shaft and retractable proximal to the distal end via the activation of the trigger.

10. The medical device according to claim 9, wherein the distal end of the electrode remains positioned distal to the distal end of the shaft when the electrode is in the retracted position.

11. The trigger is located distal to the handle, The electrode fluid port is located at the distal end of the handle. The medical device according to claim 9 or 10, wherein the electrical connection and the balloon fluid port are located proximal to the handle.

12. The medical device according to any one of claims 7 to 11, wherein the entire electrode is conductive.

13. The medical device according to any one of claims 1 to 12, wherein the at least one inflatable balloon is fluidly coupled to one or more tubes through at least one balloon hole on the outer surface of the distal end of the shaft.

14. The medical device according to claim 13, wherein the at least one balloon hole includes two balloon holes located on opposite sides in the circumferential direction of the shaft.

15. The medical device according to any one of claims 2 to 14, wherein the medical device is configured to perform a third-space endoscopic examination procedure.

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