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

Abstract

A medical device includes a handle, a shaft, an electrode, and at least one inflatable balloon. The handle includes an electrical connection and a balloon fluid port. A shaft extends from a distal portion of the handle. The electrode is located at the distal end of the shaft. The electrode is electrically connected to the electrical connector by one or more conductive elements extending through the handle and the shaft. At least one inflatable balloon is located on a portion of the shaft. At least one inflatable balloon is fluidly coupled with the balloon fluid port by one or more tubes extending through the handle and the shaft.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 498,381, filed April 26, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] Various aspects of this disclosure generally relate to medical devices and related methods for delivering energy and / or fluid. Embodiments of this disclosure relate to medical devices and related methods for treating tissue by delivering electrical energy to or within tissue and / or injecting fluid into, beneath, and / or around tissue using a therapeutic device. Furthermore, embodiments of this disclosure relate to tissue-therapeutic medical devices and related methods including deflecting a distal portion of the medical device and / or inflating a balloon at a distal portion of the medical device. Background Technology

[0003] Medical devices (such as endoscopes or other suitable insertion devices) are used in a variety of diagnostic and surgical procedures, such as endoscopy, laparoscopy, arthroscopy, gynecoscopy, thoracoscopy, cystoscopy, etc. Many of these procedures require the delivery of energy to the tissues of organs or glands to treat lesions (such as 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), etc. In particular, such procedures can be performed by inserting the insertion device into the subject through a surgical incision or through natural anatomical openings (such as the mouth, vagina, or rectum), and using an auxiliary device inserted through the insertion device to perform the procedure or manipulation at the treatment site. Alternatively, an auxiliary device can be delivered to the treatment site without using the insertion device.

[0004] In some surgeries, the distal portion of a medical device is positioned between layers of tissue, such as for performing “third-space” procedures. In some respects, the distal portion of a medical device is positioned within a portion of the gastrointestinal tract (GI) between the mucosal layer (mucosa) and the muscular layer to reach the target or treatment site. This is typically achieved by: (1) injecting a lifting agent into the submucosa to separate the mucosa from the muscular layer; and (2) cutting the submucosa with a scalpel. These surgeries may require the use of multiple medical devices (such as injection needles and scalpels). Using multiple medical devices may require larger insertion devices and / or device replacements, which can increase the duration of the procedure, require multiple operators, and / or otherwise negatively impact the procedure. Furthermore, medical devices commonly used in “third-space” procedures typically only include one degree of navigation freedom. In some respects, the separation of tissue layers may disappear over time or during the procedure, increasing the risk that the medical device may accidentally come into contact with tissue or other aspects of the treatment site. These issues can increase the duration, cost, and risk of the medical procedure.

[0005] The apparatus and methods disclosed herein can correct some of the above-mentioned defects or solve other problems in the art. Summary of the Invention

[0006] Examples of this disclosure particularly relate to medical devices and methods for performing one or more medical procedures. For example, this disclosure relates to medical devices and methods for performing one or more procedures between tissue layers. Furthermore, in some examples, this disclosure relates to medical devices and methods for delivering energy (e.g., for cutting, cauterizing, perforating, puncturing, or otherwise treating tissue) and / or delivering fluid to a treatment site. Furthermore, in some examples, this 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, this disclosure relates to medical devices and methods for articulating, deflecting, or otherwise manipulating a distal portion of a medical device. Each example disclosed herein may include one or more features described in association with other disclosed examples.

[0007] In one example, the medical device may include a handle, a shaft, electrodes, and at least one inflatable balloon. The handle may include an electrical connector and a balloon fluid port. The shaft extends from a distal portion of the handle. The electrodes may be located at the distal end of the shaft. The electrodes are electrically connected to the electrical connector via one or more conductive elements extending through the handle and the shaft. At least one inflatable balloon may be located on a portion of the shaft. 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.

[0008] The medical device may include one or more of the following features. The handle may also include one or more deflecting elements, and at least a portion of the shaft is deflectable by movement of the one or more deflecting elements. Each of the one or more deflecting elements may be coupled to a wheel connected to one or more cables extending through the handle and secured to one or more internal portions of the shaft, such that movement of the one or more deflecting elements proximally actuates the one or more cables, thereby deflecting a portion of the shaft. The one or more deflecting elements may include two coaxial deflection knobs. The two deflection knobs may each control the deflection of that portion of the shaft in a substantially vertical plane. That portion of the shaft is deflectable within a substantially hemispherical range of motion. That portion of the shaft is deflectable when at least one inflatable balloon is inflated. The handle may also include one or more locking elements to secure one or both of the two deflection knobs in a fixed position.

[0009] The electrode may include an electrode cavity. The handle may also include an electrode fluid port. The electrode fluid port is fluidly connected to the electrode cavity via one or more electrode fluid conduits configured to deliver fluid from the electrode fluid port to the electrode cavity. The electrode may include an electrode shaft and a distal end. The width of the distal end relative to a longitudinal axis may be greater than the width of the electrode shaft. The handle may also include a trigger. By actuating the trigger, the electrode may extend distally and retract proximally relative to the distal end of the shaft. When the electrode is in the retracted position, the distal end of the electrode may still be located distal to the distal end of the shaft. The trigger may be located on the distal portion of the handle. The electrode fluid port may be located on the distal portion of the handle. Electrical connections and a balloon fluid port may be located on the proximal portion of the handle.

[0010] The electrodes as a whole may be conductive. At least one inflatable balloon may be fluidly connected to one or more tubes through at least one balloon aperture in the outer surface of the distal portion of the shaft. At least one balloon aperture may include two balloon apertures located on opposite sides of the shaft circumference. The medical device may be configured to perform third-space endoscopic surgery.

[0011] In another aspect, the medical device may include a handle, a shaft extending from a distal portion of the handle, and an electrode located at the distal end of the shaft. The handle may include an electrical connector and one or more deflection controls. The electrode may be electrically connected to the electrical connector via one or more conductive elements extending through the handle and the shaft. At least a portion of the shaft may be deflectable by movement of one or more deflection controls.

[0012] The medical device may include one or more of the following features: An electrode may include an electrode shaft and a distal end. The width of the distal end relative to a longitudinal axis may be greater than the width of the electrode shaft. The electrode may include an electrode cavity. The handle may also include an electrode fluid port. The electrode fluid port may be fluidly connected to the electrode cavity via one or more electrode fluid tubes configured to deliver fluid from the electrode fluid port to the electrode cavity. The medical device may also include at least one inflatable balloon located on a distal portion of the shaft. The handle may also include a balloon fluid port. 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.

[0013] In another aspect, a method of treating a treatment site may include delivering a distal end of an axis of a medical device to the treatment site. The axis may include a deflectable portion, and electrodes may be movably located at the distal end of the axis. The method may also 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 axis between tissue layers and inflating one or more balloons to separate the tissue layers. One or more balloons may be located on the distal portion of the axis and fluidly connected to one or more balloon fluid ports via one or more balloon fluid conduits and one or more balloon orifices. The method may further include positioning and energizing electrodes to deliver energy to one or more portions of the treatment site. One or more portions of the treatment site may be located between the separated tissue layers.

[0014] The method may also include one or more of the following features: The electrode may include an electrode cavity in fluid communication with a fluid source. The method may also include injecting or otherwise delivering fluid through the electrode cavity to the treatment site to separate the tissue layers before positioning the distal end of the shaft between tissue layers. The method may also include hinged or deflecting the distal end of the shaft to further separate the tissue layers before positioning the electrode and energizing it to deliver energy to one or more portions of the treatment site.

[0015] It should be understood that the above general description and the following detailed description are exemplary and interpretive only, and do not constitute a limitation on the claimed disclosure. Attached Figure Description

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of this disclosure and, together with the specification, serve to explain the principles of this disclosure.

[0017] Figure 1 A perspective view of an exemplary medical device according to aspects of the present disclosure is shown, including an enlarged view of the distal portion of the medical device in a first configuration.

[0018] Figure 2 This illustrates a second form of the invention, according to aspects of this disclosure. Figure 1 The distal portion of the medical device;

[0019] Figure 3 This illustrates a second form of the invention, according to aspects of this disclosure. Figure 1 A schematic diagram of a medical device;

[0020] Figure 4 This is a flowchart of an exemplary method according to aspects of this disclosure. Detailed Implementation

[0021] Examples of this disclosure include apparatus and methods for achieving one or more of the following functions: for example, facilitating and improving the effectiveness, efficiency, and safety of treating and / or manipulating tissue when applying electrical energy to tissue using electrodes; delivering fluid into, under, and / or around tissue via the distal end of an electrode during medical procedures; and cutting, removing, or otherwise treating tissue. Aspects of this disclosure enable users to apply electrical or thermal energy to tissue using a medical device with electrodes and deliver fluid into and / or under tissue via the same medical device. Aspects of this disclosure enable users to apply electrical or thermal energy while delivering fluid without changing the end effector. Aspects of this disclosure assist users in penetrating tissue layers (such as the submucosa) to achieve perforation or otherwise cutting, cauterizing, or otherwise treating tissue. Aspects of this disclosure assist users in cutting, removing, or otherwise removing tissue or other material without changing the end effector. Aspects of this disclosure assist users in deflecting the distal portion of the end effector.

[0022] Furthermore, aspects of this disclosure can assist a user in inflating or dilating one or more balloons in the distal portion of an end effector, for example, to help separate tissue layers. For instance, some aspects of this disclosure can assist a user in inflating or dilating one or more balloons to dilate or separate tissue layers and / or help tension one or more tissue layers or tissue fibers. Tensing one or more tissue layers or tissue fibers can help a user identify and / or differentiate between different tissue layers (e.g., between the mucosal layer (mucosa) and the muscle layer), and / or help reduce the likelihood of accidental tissue perforation. Some aspects of this disclosure can be used to perform endoscopic surgery, laparoscopic surgery, arthroscopic surgery, gynecological endoscopic surgery, thoracoscopic surgery, cystoscopic surgery, or other types of surgery.

[0023] Embodiments of this disclosure may relate to apparatus 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 anatomical structure of a patient. The various embodiments described herein include single-use or disposable medical devices. Some aspects of this disclosure can be used to perform endoscopic procedures, arthroscopic procedures, bronchoscopic procedures, ureteroscopic procedures, colonoscopic procedures, or other types of surgical procedures. For example, the disclosed aspects can be used with duodenoscopy, bronchoscopy, ureteroscopy, colonoscopy, catheters, diagnostic or therapeutic tools or devices, or other types of medical devices. One or more elements discussed herein may be made of metal, plastic, or comprise shape memory metals (e.g., nickel-titanium alloys), shape memory polymers, polymers, or combinations of any biocompatible materials.

[0024] The terms “proximal” and “distal” are used herein to refer to the relative positions of the components of the exemplary medical device. As used herein, “proximal” refers to a position relatively closer to the exterior of the subject’s body or closer to the user (e.g., a medical professional) holding or using the medical device. Conversely, “distal” refers to a position relatively farther from the medical professional or other user holding or using the medical device, or closer to the interior of the subject’s body. In the various figures, the proximal and distal directions are indicated by arrows labeled “P” and “D”, respectively. As used herein, the terms “comprises,” “comprising,” “having,” “including,” or other variations are intended to cover non-exclusive inclusion, such that an apparatus or method comprising a list of elements may include not only those elements but also other elements not expressly listed or inherent to it. Unless otherwise stated, the term “exemplary” is used to mean “example” rather than “ideal.” As used herein, the terms “about,” “approximately,” and “approximately” indicate a numerical range within ±10% of a given value.

[0025] Reference will now be made in detail to the examples of this disclosure described above and illustrated 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 device or method discussed herein may be combined with and / or used with one or more other aspects of the medical device or method discussed herein.

[0026] Figure 1A perspective view of an exemplary medical device 100 is shown, which includes 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, located at the distal end 106. The electrode 108 is movable relative to the shaft 104, for example, it can extend and / or retract longitudinally relative to the shaft 104. The electrode 108 can be energized to puncture, perforate, cut, excise, burn, remove, or otherwise treat tissue or other portions of a treatment site. Furthermore, in some aspects, the electrode 108 may include an electrode cavity 136. Figure 3 The electrode cavity terminates at an electrode outlet or electrode opening 138 for injecting or otherwise delivering fluid to a treatment site (e.g., intratissue or between tissue layers). However, in other respects, electrode 108 may not include an electrode cavity, thus potentially preventing fluid injection or other fluid delivery. As discussed in detail below, handle 102 includes various connections and controls for controlling the position of distal end 106 and electrode 108. Figure 1 As shown in the enlarged portion, at least a portion of the distal end 106 of the shaft 104 (e.g., the deflectable portion 104A) is deflectable, and the deflection can be controlled by one or more portions of the handle 102. Furthermore, as... Figure 1 and Figure 2 As shown, the distal end 106 includes one or more inflatable balloons 110, which, for example, extend radially outward from at least a portion of the shaft 104 when inflated.

[0027] like Figure 1 As shown, the handle 102 includes a handle body 112. The distal portion of the handle body 112 can be coupled to the proximal portion of the shaft 104 via a connector or stress-relieving element 114. Furthermore, the handle 102 includes one or more actuators or control mechanisms, such as one or more deflection elements or controls. The one or more deflection elements or controls may include one or more knobs or levers, such as two knobs 116 and 118. 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., deflectable portion 104A). For example, knob 116 is movable to control the deflection of at least a portion of the shaft 104 (e.g., deflectable portion 104A) in a first plane (e.g., a left-right direction), and knob 118 is movable to control the deflection of at least a portion of the shaft 104 (e.g., deflectable portion 104A) in a second plane (e.g., a up-down direction). In some respects, the first and second planes are substantially perpendicular, for example allowing the deflectable portion 104A of shaft 104 to achieve four-way hinge, such as... Figure 1 The enlarged portion is shown below. As discussed in detail below, knobs 116 and 118 can be connected to one or more corresponding wires (see, for example, discussed below). Figure 3The knobs 116 and 118 are coupled to control the deflection of at least a portion of shaft 104. Knobs 116 and 118 may be coaxial, for example, each coupled to a coaxial shaft or wheel. In some aspects, handle 102 includes a locking element 120, for example, to lock or otherwise secure the position of one or more of knobs 116 and 118, which may help lock or otherwise secure the position or orientation of at least a portion of shaft 104 (e.g., deflectable portion 104A). It should be noted that one or more of knobs 116 and 118 may be coupled to... Figure 1 The diagram shows one or more other actuators, such as levers, sliders, etc.

[0028] It should be noted that, in some aspects, the handle 102 may only allow bidirectional hinge (e.g., within a single plane). For example, the handle 102 may include only one knob or lever for controlling bidirectional hinge. Alternatively, the handle 102 may include two knobs or levers, one of which controls movement in one direction, while the other knob or lever controls movement in another (e.g., the opposite) direction.

[0029] Handle 102 may include a button, actuator, or trigger 122, for example, movable relative to a distal portion of handle body 112. Trigger 122 may be movable (e.g., actuated or pressable) to control the position (e.g., extended and / or retracted) and / or energized state of electrode 108. For example, actuating or pressing trigger 122 may extend electrode 108 from the distal end 106 of shaft 104. Trigger 122 may be biased (e.g., spring-biased) such that once pressure is no longer applied to trigger 122, trigger 122 may return to an unpressed position. Returning to the unpressed position may also retract electrode 108 to an extended position. Alternatively or additionally, in some aspects, pressing trigger 122 may control the energized state 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.

[0030] The handle 102 also includes one or more connectors and / or ports, such as 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, a balloon fluid port 126, and / or an electrical connector 128. As discussed below, the electrode fluid port 124 and the balloon fluid port 126 may be fluidly connected to the electrode 108 and the balloon 110, respectively, through corresponding cavities in the handle 102 and the shaft 104. The electrical connector 128 may be electrically connected to the electrode 108 via one or more conductive elements (e.g., wires, cables, filaments, rods, etc.) in the handle 102 and the shaft 104.

[0031] Electrode fluid port 124 may be located on the distal portion of the handle body 112, such as near or opposite to trigger 122. Balloon fluid port 126 and / or electrical connector 128 may be located on the corresponding proximal portion of the handle body 112, such as near or proximal to knobs 116 and 118. TM Fluids such as gels and saline solution can be delivered through cavities in electrode 108 to the space between two tissue layers or otherwise reach the treatment site. Balloon fluid port 126 can receive fluids (e.g., air, water, etc.) that can be delivered to balloon 110 to inflate it, for example. The delivery of fluid to each of electrode fluid port 124 and balloon fluid port 126 can be controlled by a fluid delivery device (e.g., syringe, pump, etc.). Furthermore, electrical connector 128 can receive energy (e.g., ablation energy) from an energy source and deliver it to electrode 108, for example, for cutting, ablation, penetration, perforation, or other treatment of tissue. In some aspects, the delivery of energy to electrical connector 128 can be controlled, for example, by a separate button or trigger, one or more foot pedals, etc.

[0032] Furthermore, although not shown, the handle 102 may include a strap or other connecting element, such as being coupled to or otherwise extending from the handle body 112. In some aspects, the strap or other connecting element may facilitate coupling of the handle body 112 to another medical device, such as the handle or other portion of an endoscope or other insertion device.

[0033] As previously described, shaft 104 includes a steerable or deflectable portion 104A, for example, located at the distal end 106 of shaft 104. The deflectable portion 104A may be, for example, a hinged joint. Shaft 104 and the deflectable portion 104A may include a variety of structures known in the art or likely to emerge in the future. As previously described, movement of knobs 116 and 118 controls the deflection of the deflectable portion 104A, and consequently controls the deflection of the distal end 106. For example, as shown, in the enlarged portion of the distal end 106 of shaft 104, movement of knob 116 can deflect the deflectable portion 104A in a first plane (e.g., vertically), for example, at least between the two positions or orientations of the distal ends 106A and 106B. Furthermore, movement of knob 118 can deflect the deflectable portion 104A in a second plane (e.g., horizontally), for example, at least between the two positions or orientations of the distal ends 106C and 106D. In some respects, the first plane and the second plane are substantially perpendicular. Furthermore, in some respects, movement of one or more of knobs 116 and 118 allows the deflectable portion 104A, including the distal end 106, to deflect within a generally hemispherical range of motion. In other respects, movement of one or more of knobs 116 and 118 allows the distal end 106 to deflect within a smaller range of motion (e.g., a generally conical range of motion) or a larger range of motion (e.g., an approximately spherical range of motion). It should be noted that, for clarity, in Figure 1 In the magnified schematic diagram of the distal end 106 (e.g., the position or orientation of distal ends 106A, 106B, 106C and 106D) in the corresponding deflection positions or orientations, the electrode 108 is not drawn on the distal end 106.

[0034] Figure 2 The distal end 106 of the shaft 104 with the balloon 110 in an inflated state is shown. For example, the distal portion of the balloon 110 may be sealingly coupled to a portion of the shaft 104, and the proximal portion of the balloon 110 may be sealingly coupled 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 that portion of the shaft 104. Alternatively, although not shown, the balloon 110 may extend radially only around a portion of the circumference of the shaft 104. In any of the foregoing aspects, the shaft 104 includes at least one balloon aperture 130, for example, located in the outer surface of the distal portion of the shaft 104. The balloon aperture 130 fluidly connects the balloon fluid port 126 and any balloon cavity in the shaft 104 to the balloon 110. In these aspects, fluids (such as air, water, etc.) can be delivered through the balloon fluid port 126, the cavity in the handle 102, and the cavity in the shaft 104, and finally flow out from the balloon orifice 130 to inflate the balloon 110. It should be noted that, as Figure 1-3As shown, balloon 110 is located on axis 104, proximal to the electrode 108 and the distal end 106 of axis 104. In other words, balloon 110 is located proximal to electrode 108 (electrode 108 is located distal to balloon 110) regardless of whether electrode 108 extends distally or retracts proximally. Furthermore, in some aspects, balloon 110 may be located proximal to the deflectable portion 104A of axis 104. For example, the distal end of balloon 110 may be adjacent to the proximal end of the deflectable portion 104A of axis 104. In these respects, the balloon 110 (and the portion of the shaft 104 around which the balloon 110 surrounds) can remain relatively stationary and / or fixed in position within the body cavity of the subject (e.g., to facilitate the application of tension to tissue and / or the separation of tissue), while the deflectable portion 104A of the shaft 104 and / or the electrode 108 can move within the body cavity (e.g., when the deflectable portion 104A deflects or swings, and / or when the electrode 108 extends and / or retracts).

[0035] In some respects, the balloon 110 may inflate to a size substantially the same as or smaller than the diameter of the corresponding body cavity (e.g., the esophagus if the distal end 106 of the shaft 104 is configured to deliver into the esophagus). For example, in the deflated state, the balloon 110 may be close to the shaft 104, or otherwise approach the size of the shaft 104. Furthermore, in the inflated state, the diameter of the balloon 110 may be from about 3 mm to about 30 mm, for example, about 15 mm. In the inflated state, the length of the balloon 110 may be from 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 be generally circular (e.g., in a transverse cross-section). Alternatively or additionally, at least a portion of the balloon 110 (i.e., in the inflated state) may be generally oval or elliptical (e.g., in a transverse cross-section), having a major axis and a minor axis. In some aspects, 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 aspects, the balloon 110 may include at least a partial conical shape, for example, having one or more conical or funnel-shaped portions that gradually increase in diameter from a smaller diameter to a larger diameter (e.g., the distal portion of the balloon 110 is smaller than its proximal portion, and vice versa). Additionally, in some aspects, suction or negative pressure may be applied to the balloon fluid port 126, for example, to shrink the balloon 110. The balloon 110 may be made of flexible, medically safe materials (e.g., plastic or silicone materials or combinations thereof, such as nylon, polyether block amide (Pebax), nylon / polyether block amide mixtures, latex, polyethylene terephthalate (PET), etc.).

[0036] although Figure 2Not shown, but shaft 104 may include a plurality of balloon orifices 130, for example, fluidly connected to a plurality of balloons 110. The plurality of balloons 110 and their respective balloon orifices 130 may be longitudinally positioned along shaft 104. Alternatively, the plurality of balloons 110 and their respective balloon orifices 130 may be radially positioned about the circumference of shaft 104. In these aspects, the plurality of balloon orifices 130 may be fluidly connected to the same balloon cavity in shaft 104, for example, such that the plurality of balloons 110 may inflate and / or deflate simultaneously and / or at the same rate. In another aspect, the plurality of balloon orifices 130 (or a subset of the plurality of balloon orifices 130) may be fluidly connected to different balloon fluid ports 126 and / or handles 102 and / or different balloon cavities in shaft 104, for example, such that the plurality of balloons 110 (or a subset of the plurality of balloons) may inflate or deflate at different times and / or at different rates.

[0037] Furthermore, although not shown, shaft 104 may include a plurality of balloon cavities connected to corresponding balloon orifices 130. The corresponding balloon cavities may, for example, be connected via corresponding balloon fluid ports 126 to one or more fluid or expansion sources (e.g., air, water, etc.) and / or contraction sources (e.g., suction). In these respects, balloon 110 can be inflated via one or more balloon fluid ports 126, one or more balloon cavities, and one or more balloon orifices 130, and balloon 110 can be contracted via one or more balloon fluid ports 126, one or more other balloon cavities, and one or more other balloon orifices 130.

[0038] like Figure 2 and Figure 3 As shown, electrode 108 includes an electrode shaft 132 and a distal end 134. The electrode shaft 132 may typically be cylindrical, for example, having a constant width. Alternatively, although not shown, the electrode shaft 132 may include one or more tapered portions, for example, tapered portions disposed between portions of different widths. The width of the distal end 134 (e.g., extending radially outward relative to the longitudinal axis of electrode 108) may be greater than the width of the electrode shaft 132. In this case, even in the retracted position, the distal end 134 may still protrude and be exposed distal to the distal end 106. As shown, the distal end 134 may include a flat distal surface. Alternatively, the distal end 134 may include a circular (e.g., hemispherical or semi-spherical) distal end. Although not shown, one or more portions of electrode 108 (e.g., distal end 134) may include one or more insulating materials. Alternatively, the electrode 108 as a whole may be conductive.

[0039] Furthermore, as described above, in some aspects, electrode 108 includes an electrode cavity 136 that terminates distally at an electrode opening 138. In these aspects, fluids (e.g., water, Orisea) TMGel, saline, etc., can be delivered through the electrode fluid port 124 (e.g., from a syringe or other fluid source), the lumen or tube in the handle 102, the lumen or tube in the shaft 104, and the electrode cavity 136, ultimately flowing out from the electrode opening 138. The fluid can be delivered to tissue (e.g., injected between tissue layers) or otherwise delivered to the treatment site. Alternatively, in other aspects, the electrode 108 may not include the electrode cavity 136 or the electrode opening 138.

[0040] Figure 3 This is a schematic diagram of the various parts of the medical device 100. As discussed above, the medical device 100 includes a handle 102 having a handle body 112 and a shaft 104 extending from the handle body 112. It should be noted that, for clarity, the stress relief element 114 and the trigger 122 are omitted. Furthermore, for clarity, only a knob 116 is shown, indicated by a lever, to illustrate the internal portion of the handle 102.

[0041] As described above, the handle 102 includes at least one knob 116 and multiple fluid or electrical connections. As shown, the knob 116 is connected to a rotatable or pivotable element (e.g., a wheel 140 or pulley), such that rotation of the knob 116 causes rotation of the wheel 140. Furthermore, one or more pull cables, such as two pull cables 142 and 144, may be connected to the wheel 140 and extend distally therefrom. Each of the pull cables 142, 144 may extend through the handle body 112 and through a corresponding portion of the shaft 104, for example, terminating distally at a distal connector 146, 148 in the internal portion of the distal end 106 of the shaft. Each of the pull cables 142, 144 may be secured to the distal connector 146, 148. The distal connectors 146 may be offset from each other (e.g., 180 degrees, 90 degrees, or any other suitable angle). In these aspects, rotation of knob 116 causes wheel 140 to rotate, such that rotation of wheel 140 pulls or actuates one of wires 142 or 144 proximally to, for example, assist in deflection of the deflectable portion 104A of shaft 104. For example, rotation of wheel 140 in a first direction may pull or actuate wire 142 proximally to assist in deflection of the deflectable portion 104A of shaft 104 in the first deflection direction, while rotation of wheel 140 in a second direction (e.g., opposite to the first direction) may pull or actuate wire 144 proximally to assist in deflection of the deflectable portion 104A of shaft 104 in the second deflection direction (e.g., opposite to the first deflection direction). Although not shown, other and / or additional deflection or hinge mechanisms may be incorporated into or integrated into medical device 100 to, for example, control the position of distal end 106 of shaft 104 by controlling the position and / or orientation of the deflectable portion 104A of shaft 104.

[0042] Furthermore, the handle 102 may include an electrode fluid port 124, a balloon fluid port 126, and an electrical connector 128. As shown, the electrode fluid port 124 is in fluid communication with the electrode 108 through one or more electrode fluid cavities or tubes 150, which extend, for example, at least from the electrode fluid port 124 to the electrode 108, so that the electrode fluid port 124 is in fluid connection with the electrode cavity 136. It should be noted that... Figure 3 The electrode 108 is shown extending proximally into the handle body 112. However, this disclosure is not limited thereto. For example, the electrode 108 may be located within a shaft cavity 152 of the shaft 104, with the electrode 108 positioned distally from and spaced apart from the handle body 112. In this aspect, an electrode fluid conduit 150 may extend through a portion of the shaft 104 to fluidly connect the electrode fluid port 124 to the electrode cavity 136. Furthermore, in some aspects, the handle 102 may include a first electrode fluid cavity, and the shaft 104 may include a second electrode fluid cavity, which, for example, is fluidly connected to the first electrode fluid cavity to fluidly connect the electrode fluid port 124 to the electrode cavity 136. Additionally, in some aspects, one or more of the electrode fluid port 124 and the electrode fluid conduit 150 may be movable to, for example, extend and / or retract the electrode 108 relative to the distal end 106 of the shaft 104. Alternatively, the extension / retraction of the electrode 108 may also be achieved using other actuation mechanisms (e.g., wires, rods, etc.).

[0043] Furthermore, the balloon fluid port 126 is in fluid communication with the balloon 110 via one or more balloon fluid cavities or tubes 154. For example... Figure 3 As shown, 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 reach the balloon orifice 130. The balloon fluid tubes 154 may extend through separate cavities in the shaft 104. For example, the electrode 108 may be located within a first cavity or working channel in the shaft 104, and the balloon fluid tubes 154 may be located within a second cavity or auxiliary channel in the shaft 104. Furthermore, the balloon fluid tubes 154 may extend to more than one balloon orifice 130, for example, two balloon orifices 130. Figure 3As shown, the two balloon orifices 130 may be located on opposite circumferential sides of the distal end 106 of the shaft 104. For example, the distal portion of the balloon fluid tube 154 may include a branching or bifurcated structure, such that fluid delivered through the balloon fluid tube 154 or applied suction may be delivered to / applied to more than one balloon orifice 130, thereby inflating or deflating the balloon 110. Furthermore, in some aspects, the handle 102 may include a first balloon fluid tube, and the shaft 104 may include a second balloon fluid tube, which, for example, is fluidly connected to the first balloon fluid tube, such that the balloon fluid port 126 is fluidly connected to the balloon orifices 130 and the balloon 110. In some aspects, the handle 102 may include the balloon fluid tube 154, and the balloon fluid tube 154 may be fluidly connected to a cavity (e.g., an auxiliary cavity or channel) in the shaft 104. The cavity in the shaft 104 is then fluidly connected to the balloon orifice 130.

[0044] Furthermore, the electrical connector 128 is electrically connected to the electrode 108 via one or more wires or conductive elements 156. For example... Figure 3 As shown, one or more conductive elements 156 (e.g., wires, cables, filaments, rods, etc.) may extend from the electrical connector 128, pass through a portion of the handle body 112, and reach the electrode 108. As discussed above, it should be noted that... Figure 3 The electrode 108 is shown extending proximally into the handle body 112. This disclosure is not limited thereto. For example, the electrode 108 may be located within a shaft cavity 152 of the shaft 104, spaced distally from the handle body 112. In this aspect, a conductive element 156 may extend through a portion of the shaft 104 to electrically connect the electrical connector 128 to the electrode 108. Furthermore, in some aspects, 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 connector 128 to the electrode 108. Furthermore, in some aspects, the conductive element 156 may be movable relative to one or more of the handle 102 and / or the shaft 104, for example, by applying an operation to a trigger 122. In these aspects, the movement of the conductive element 156 may allow the electrode 108 to extend and / or retract relative to the distal end 106 of the shaft 104.

[0045] Figure 4A method 400, which may be performed by or in part by the medical device 100 discussed herein, is illustrated. Specifically, method 400 includes an initial step 402, which includes delivering the distal end 106 of shaft 104 to a treatment site. Shaft 104 may be delivered to the treatment site via an insertion device (e.g., endoscope, insertion device, sheath, etc.), through a surgical incision or natural anatomical opening. In some aspects, shaft 104 may be delivered through the subject's mouth and to other parts of their esophagus, stomach, and / or gastrointestinal tract. In some aspects, a distal portion of the insertion device may be deflected to, for example, assist in positioning the distal end 106 of medical device 100 relative to the treatment site. Furthermore, step 402 may include positioning the distal end 106 at the treatment site. Step 402 may include extending electrode 108 distally via trigger 122. Furthermore, step 402 may include deflecting, for example, a deflectable portion 104A of shaft 104 via one or more of knobs 116, 118.

[0046] Next, method 400 includes step 404, which includes, for example, cutting, puncturing, perforating, or otherwise delivering energy to the treatment site via electrode 108. As described above, electrode 108 can be energized by pressing trigger 122, which can also extend electrode 108. Alternatively or additionally, electrode 108 can be energized by actuating one or more other buttons, triggers, foot pedals, etc. Delivering energy to the treatment site can facilitate cutting, puncturing, perforating, or otherwise treating one or more layers of tissue at the treatment site, such as the mucosal layer of a portion of the subject's gastrointestinal tract.

[0047] Optional step 406 may include injecting or otherwise delivering fluid to the treatment site. For example, optional step 406 may include positioning or at least partially inserting a portion (e.g., distal end 134) of electrode 108 adjacent to or into cut, punctured, or perforated tissue, and delivering fluid through electrode lumen 136 and out of electrode opening 138. As previously described, in some aspects, electrode 108 may be fluidly connected to electrode fluid port 124. In some aspects, injecting or otherwise delivering fluid to the treatment site may include connecting a syringe or other fluid delivery device to electrode fluid port 124 and delivering fluid (e.g., water, or Orisea). TM (Gel, saline, etc.) is delivered through electrode fluid port 124 and electrode fluid tube 150. Fluid can be delivered between tissue layers (e.g., to the submucosal space between the mucosal layer and the muscle layer) to aid in the separation of tissue layers.

[0048] Next, step 408 includes positioning the distal end of shaft 104 between tissue layers and inflating one or more balloons 110. In this respect, inflating one or more balloons 110 when the distal end 106 is positioned between tissue layers (e.g., between the mucosal layer and the muscle layer) can help to more quickly and / or more effectively separate and / or tension tissue layers and / or tissue fibers, for example, by blunt dissection. Inflating one or more balloons 110 can also help, for example, stabilize the distal end 106 of shaft 104 and / or provide traction to the distal end 106 of shaft 104 when positioning the distal end 106. Inflating one or more balloons 110 can also help to stabilize the distal end 106 of shaft 104 and / or provide traction to the distal end 106 of shaft 104 when, for example, energy and / or fluid are delivered via electrode 108. Furthermore, in some respects, one or more balloons 106 can help the user identify and / or differentiate different tissue layers, such as differentiating the mucosal layer from the muscle layer, and / or can help reduce the likelihood of accidental tissue perforation.

[0049] Optional step 410 includes hinged or deflected distal end of the shaft. In this aspect, hinged or deflected distal end 106 (e.g., by controlling the deflectable portion 104A of shaft 104 via one or more of knobs 116, 118) when distal end 106 is located between tissue layers can also facilitate faster and / or more efficient separation of tissue layers. Furthermore, hinged or deflected operation can be performed while one or more balloons 110 are inflated, further facilitating tissue layer separation. As previously described, one or more balloons 110 are located proximal to electrode 108 and distal to shaft 104 regardless of whether electrode 108 is extended or retracted. Additionally, one or more balloons 110 may at least partially (longitudinally) overlap with the deflectable portion 104A of shaft 104, such that when the deflectable portion 104A is deflected (e.g., by one or more of knobs 116, 118), one or more balloons 110 move at least partially with the deflectable portion 104A. Alternatively, one or more balloons 110 may be located proximal to the deflectable portion 104A of axis 104 (e.g., the distal end of balloon 110 is located proximal to or adjacent to the proximal end of the deflectable portion 104A) such that when the deflectable portion 104A is deflected, one or more balloons 110 remain stationary or fixed within the body cavity.

[0050] Furthermore, in some aspects, step 410 may include advancing or pushing the distal end 106 distally (e.g., in addition to articulation or deflection) to further separate tissue layers, for example, by blunt tissue dissection. The position of the distal end 106 may help maintain the separation of tissue layers. Additionally, the inflation of one or more balloons 110 may help maintain the separation and / or tension of tissue layers. Also, in some aspects, additional fluids (e.g., water, orrise) may be delivered. TMGel, saline, etc.) are passed through electrode 108, which can also help maintain the separation of tissue layers.

[0051] Furthermore, step 412 includes positioning and energizing the electrode to deliver energy to one or more portions of the treatment site. In some aspects, the one or more portions of the treatment site may be one or more portions of one or more layers of separated tissue. The electrode 108 can be extended and / or retracted relative to the distal end 106 of the shaft 104 by trigger 122. Additionally, the electrode 108 can be positioned by deflection of the distal end 106 of the shaft 104 (e.g., by controlling the deflectable portion 104A using one or more knobs 116, 118). Furthermore, if the shaft 104 delivers an endoscope through an insertion device, the distal portion of the endoscope or insertion device can be deflected to aid in positioning the distal end 106 of the shaft 104 and / or the electrode 108.

[0052] In addition, such as Figure 4 As shown, in some aspects, method 400 may optionally include repeating one or more of steps 402-412. For example, as Figure 4 As shown, after step 412, method 400 may include repeating one or more of steps 406-412. In these aspects, after step 412, the user may again perform one or more of the following operations: perform optional step 406, injecting or otherwise delivering fluid to the treatment site; perform step 408, positioning the distal end of the shaft between tissue layers and inflating one or more balloons; perform optional step 410, hinged or deflecting the distal end of the shaft; and / or perform optional step 412, positioning and energizing the electrodes to deliver energy to one or more portions of the treatment site. Repeating one or more steps of method 400 may facilitate the dissection of additional tissue or tissue layers through or otherwise.

[0053] As discussed above, the separation and / or tensioning of tissue layers facilitates the positioning of electrode 108 (including the positioning of distal end 106). The separation and / or tensioning of tissue layers also facilitates positioning electrode 108 within the field of vision, for example, of an endoscope or insertion device, without requiring repositioning or repositioning of the endoscope or insertion device. As discussed, electrode 108 can be energized via electrical connection 128 and conductive element 156. The energized electrode 108 can be applied to one or more portions of a treatment site to cut, separate, ablate, mark, coagulate, cauterize, or otherwise treat the treatment site. Furthermore, in some aspects, step 412 may include delivering fluid into or between additional tissue layers, for example, to assist in lifting or separating tissue layers for removal or treatment. In these aspects, electrode 108 can be used to deliver energy and fluid to the treatment site without removing electrode 108 or replacing it with another end effector.

[0054] The various aspects discussed herein enable medical devices (such as medical device 100) to be delivered to a treatment site (e.g., delivered separately or via an endoscope or insertion device) to perform endoscopic submucosal dissection (ESD) or otherwise treat the treatment site. The various aspects discussed herein enable users to perform “third-space” procedures (e.g., “third-space” endoscopic procedures). Furthermore, the various aspects discussed herein can contribute to improving treatment effectiveness and / or surgical recovery, such as procedures treating the treatment site. The various aspects discussed herein can help shorten and / or minimize procedure time, and / or help reduce the risk of accidental contact with tissue or other substances during the delivery, repositioning, or removal of the medical device during the procedure.

[0055] While the principles of this disclosure have been described herein with reference to exemplary aspects for various applications, it should be understood that this disclosure is not limited thereto. Those skilled in the art, upon receiving the teachings provided herein, will recognize that all additional modifications, applications, aspects, and equivalent substitutions fall within the scope of the aspects described herein. Therefore, this disclosure should not be considered as limited by the foregoing description.

Claims

1. A medical device comprising: Handle, the handle comprising: Electrical connectors; and balloon fluid port; A shaft extending from the distal portion of the handle; An electrode, located 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 handle and the shaft; and At least one inflatable balloon is located on a portion of the shaft, wherein the at least one inflatable balloon is fluidly connected to a balloon fluid port via one or more tubes extending through the handle and the shaft.

2. The medical device according to claim 1, wherein, The handle also includes one or more deflecting elements, and wherein at least a portion of the shaft is deflectable by movement of the one or more deflecting elements.

3. The medical device according to claim 2, wherein, Each of the one or more deflecting elements is connected to a wheel, which is connected to one or more pull cables that extend through the handle and are secured to one or more internal portions of the shaft, such that movement of the one or more deflecting elements proximally drives the one or more pull cables to deflect a portion of the shaft.

4. The medical device according to claim 3, wherein, The one or more deflection elements include two coaxial deflection knobs, wherein the two deflection knobs respectively control the deflection of the portion of the shaft in a substantially vertical plane.

5. The medical device according to claim 4, wherein, The portion of the shaft is capable of deflecting within a generally hemispherical range of motion, and Wherein, when the at least one inflatable balloon is inflated, the portion of the shaft is deflectable.

6. The medical device according to claim 4 or 5, wherein, The handle also includes one or more locking elements to secure one or both of the two deflection knobs in a fixed position.

7. The medical device according to any one of the preceding claims, wherein, The electrode includes an electrode cavity, the handle further includes an electrode fluid port, and wherein the electrode fluid port is fluidly connected to the electrode cavity via one or more electrode fluid tubes configured to deliver fluid from the electrode fluid port to the electrode cavity.

8. The medical device according to claim 7, wherein, The electrode includes an electrode shaft and a distal end, wherein the width of the distal end relative to the longitudinal axis is greater than the width of the electrode shaft.

9. The medical device according to claim 7, wherein, The handle also includes a trigger, and wherein, by actuating the trigger, the electrode is capable of extending distally and retracting proximally relative to the distal end of the shaft.

10. The medical device according to claim 9, wherein, When the electrode is in the retracted position, the distal end of the electrode remains located far from the distal end of the shaft.

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

12. The medical device according to any one of claims 7-11, wherein, The electrode as a whole is conductive.

13. The medical device according to any one of the preceding claims, wherein, The at least one inflatable balloon is fluidly connected to one or more tubes through at least one balloon hole in the outer surface of the distal portion of the shaft.

14. The medical device according to claim 13, wherein, The at least one balloon aperture includes two balloon apertures located on opposite sides of the circumference of the axis.

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

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