Medical Devices and Associated Methods for Delivery of Electrical Energy and / or Infusion of Fluids

Abstract

The medical device includes a handle including a movable body, a shaft extending from the handle, and an electrode at a distal end of the shaft, and movement of the movable portion of the handle controls the position of the electrode relative to the distal end of the shaft, and at least a portion of the shaft includes a braid.

Description

[Technical Field]

[0001] Aspects of the present disclosure relate generally to medical devices and associated methods, and more particularly to medical devices and associated methods configured for the treatment of tissue by delivering electrical energy to or into the tissue via electrodes or by injecting fluid into and / or under the tissue. [Background technology]

[0002] Medical devices, such as endoscopes or other suitable insertion devices, are used in various types of diagnostic and surgical procedures, such as, for example, endoscopy, laparoscopy, arthroscopy, gynecological endoscopy, thoracoscopy, cystoscopy, etc. Many of these procedures involve the delivery of energy to organ or glandular tissue to treat tumors, infections, etc. Examples of such procedures include endoscopic mucosal resection (EMR), endoscopic submucosal resection (ESR), endoscopic submucosal dissection (ESD), polypectomy, mucosal resection, etc. In particular, such procedures may be performed by inserting the insertion device into a subject's body through a surgical incision or through a natural anatomical orifice (e.g., the mouth, vagina, or rectum) to perform the procedure or surgery at the target site along with auxiliary devices inserted through the insertion device.

[0003] At times, during a medical procedure, a user may use an injection needle and / or energy delivery device to lift, separate, cleanse, cut, dissect, ablate, mark, coagulate, cauterize, or otherwise treat and / or manipulate tissue. The injection needle and / or energy delivery device may be required to traverse tortuous paths or anatomical structures while being maneuvered or otherwise delivered to the treatment site and / or tissue being treated.

[0004] The apparatus and methods of this disclosure may correct one or more of the deficiencies discussed above or address other aspects of the art. Summary of the Invention

[0005] Examples of the present disclosure relate, inter alia, to medical devices configured to treat tissue by delivering electrical energy to the tissue and to deliver fluid into and / or beneath the tissue. Each example disclosed herein may include one or more of the features described in connection with any of the other disclosed examples.

[0006] In some embodiments, the medical device includes a handle, a shaft extending from the handle, and an electrode located at a distal end of the shaft. The handle may include a movable body. Movement of the movable body of the handle controls the position of the electrode relative to the distal end of the shaft. At least a portion of the shaft includes a braid.

[0007] The medical device may include one or more of the following features. The braid may be a polymer. The medical device may be an electrocautery. The shaft may further include an outer coating. The braid may be embedded within the outer coating. The braid may include a plurality of threads along at least a portion of the shaft. The medical device may include an inner shaft. The plurality of threads may be attached along at least a portion of the inner shaft. The braid may extend along the entire length of the inner shaft. The outer coating may be formed from polyetheretherketone (PEEK).

[0008] The handle may include ports and electrical connections. The handle and shaft may connect the ports and electrical connections to the electrodes. Movement of the movable body of the handle may control the position of the electrode relative to the distal end of the shaft without delay. The braid may be configured to minimize twisting of the drive element connecting the shaft or movable body to the electrode.

[0009] The distal portion of the shaft may further include a ring radially surrounding a portion of the braid. The ring may be a radiopaque marker band. The medical device may further include an end cap coupled to the distal end of the shaft. A portion of the end cap may extend distally of the distal end of the shaft to form an exposed portion of the end cap. The end cap may be at least partially insulative. The ring may be located proximal to the exposed portion of the end cap. The handle may include one or more indicators. The one or more indicators may indicate one or more configurations of the electrodes relative to the distal end of the shaft. The one or more indicators may include a first indicator and a second indicator. The first indicator may indicate a retracted configuration of the electrodes. The second indicator may indicate an extended configuration of the electrodes.

[0010] In another aspect, the medical device may include a handle, a shaft extending from the handle, and an electrocautery device located at a distal end of the shaft. At least a portion of the shaft may include a braid including a plurality of polymer threads.

[0011] The medical device may include one or more of the following features: The handle may include a movable body. Movement of the movable body may control the position of the electrocautery relative to the distal end of the shaft. The medical device may include an inner shaft. The plurality of polymer threads may be attached along at least a portion of the inner shaft. The shaft may further include an outer coating formed from polyetheretherketone (PEEK). The braid may be embedded within the outer coating.

[0012] In yet another aspect, a medical device may include a handle, a shaft extending from the handle, and an electrode located at a distal end of the shaft. The handle may include a movable body. Movement of the movable body may control the position of the electrode relative to the distal end of the shaft. At least a portion of the shaft may include a braid including a plurality of threads extending over at least a portion of the shaft.

[0013] The medical device may include one or more of the following features: The medical device may include an inner shaft; The plurality of threads may be attached over at least a portion of the inner shaft; The shaft may further include an outer coating; The braid may be embedded within the outer coating.

[0014] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure, as claimed. [Brief explanation of the drawings]

[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and, together with the description, serve to explain the principles of the disclosure. [Figure 1] FIG. 1 illustrates an exemplary medical device according to an embodiment of the present disclosure. [Figure 2] FIG. 2 illustrates a distal portion of the exemplary medical device of FIG. 1 according to an embodiment of the present disclosure. [Figure 3] FIG. 3 is a longitudinal cross-sectional view of a portion of a distal portion of the exemplary medical device of FIG. 1 according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016] Examples of the present disclosure include devices and methods for facilitating and improving the effectiveness, efficiency, and safety of tissue treatment and / or manipulation, for example, when applying electrical energy to tissue using electrodes; delivering fluids into and / or under tissue through or around the distal end of an electrode during a medical procedure; and insulating the distal tip of an electrode. For example, aspects of the present disclosure may provide a user (e.g., a physician, medical technician, or other healthcare provider) with the ability to apply electrical energy or heat to tissue using a medical device having electrodes and deliver fluids into and / or under tissue with the same medical device. Aspects of the present disclosure may provide a user with the ability to apply electrical energy or heat and deliver fluids while reducing the likelihood of damaging or contacting unintended portions of tissue. Some aspects of the present disclosure may be used when performing endoscopy, laparoscopy, arthroscopy, gynecological endoscopy, thoracoscopy, cystoscopy, or other procedures. Additionally, some aspects of the present disclosure may aid in manipulating or otherwise delivering medical devices to a treatment site.

[0017] Reference will now be made in detail to the examples of the present disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. The terms "proximal" and "distal" are used herein to refer to the relative locations of components of exemplary medical devices. As used herein, "proximal" refers to a location relatively close to the outside of a subject's body or a location relatively close to a user, such as a medical professional, who will hold or otherwise use the medical device. In contrast, "distal" refers to a location relatively far from a medical professional or a user who will hold or otherwise use the medical device, or a location relatively close to the inside of a subject's body. As used herein, the terms "comprises," "comprising," "has," "having," "includes," "including," and variations thereof are intended to cover non-exclusive inclusions, such as when a device or method comprising a list of elements does not include only those elements, but may also include other elements not expressly listed or inherent thereto. 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.

[0018] FIG. 1 illustrates a medical device 10 including a handle 12, a shaft 14, and a distal end 16. The handle 12 may include a body 18 and a movable body 20. The handle 12 may include a port 22 configured to receive fluid and a hub 24, similar to an electrical plug or socket, configured to receive electrical energy. The distal end 16 includes an end effector, such as an electrode portion 26 (hereinafter, electrode 26). The electrode 26 is electrically connected to the hub 24. As described in more detail below, the electrode 26 may include a channel fluidly connected to or otherwise in fluid communication with the port 22. In these embodiments, the electrode 26 may form an electrocautery device. Additionally, the electrode 26 may include one or more indicia or indicators 39A and 39B on the handle 12. The indicators 39A and 39B may be capable of indicating the position of the electrode 26. For example, electrode 26 may be positioned in at least a first or proximally retracted configuration relative to distal end 16 (e.g., as shown by indicator 39A) and a second or distally extended configuration relative to distal end 16 (e.g., as shown by indicator 39B). Electrode 26 may be movable between at least the first and second configurations via movement of movable body 20. Additionally, as described below, one or more portions of shaft 14 may include braid 60 (FIGS. 2 and 3). For example, in at least some embodiments, the entire shaft 14 may include braid 60 such that braid 60 extends along the entire length of shaft 14.

[0019] The medical device 10 may be inserted into a body lumen of a subject through an insertion device (not shown) or alone, with at least a portion of the shaft 14 remaining within the subject while the handle 12 remains outside the subject. The distal end 16 may be positioned at a target site within the subject. For example, the distal end 16 may traverse a tortuous path or anatomical structure while being navigated or otherwise delivered to the treatment site and / or tissue being treated. From outside the subject, a user may manipulate the handle 12. Movement of the moveable body 20 relative to the body 18 in a first direction (e.g., the distal direction) may extend the electrode 26 relative to the shaft 14 (e.g., move the electrode 26 distally relative to the distal end of the shaft 14). For example, movement of the moveable body 20 relative to the body 18 in the first or distal direction may transition the electrode 26 from a retracted configuration (e.g., the configuration indicated by indicator 39A) to an extended configuration (e.g., the configuration indicated by indicator 39B). Similarly, movement of the moveable body 20 relative to the body 18 in a second direction (e.g., the proximal direction) retracts the electrode 26 relative to the shaft 14 (e.g., moving the electrode 26 proximally relative to the distal end of the shaft 14). For example, movement of the moveable body 20 relative to the body 18 in the second or proximal direction may transition the electrode 26 from an extended configuration (e.g., the configuration indicated by indicator 39B) to a retracted configuration (e.g., the configuration indicated by indicator 39A). Although not shown, additional components of the moveable body 20 or handle 12 may articulate the electrode 26 and / or distal end 16 side to side and / or up and down relative to the shaft 14.

[0020] The handle 12 may be coupled to a fluid source (not shown) via a port 22. The port 22 may be in fluid communication with the electrode 26 via a lumen (not shown), which may extend through the handle 12 ( FIG. 1 ) and shaft 14. Note that the various portions of the handle 12 shown in FIG. 1 may not be to scale in order to more fully illustrate the various portions of the handle 12. In one embodiment, a lumen may extend longitudinally through the body 18 and shaft 14 of the handle 12 to fluidly connect the port 22 to the electrode 26. The port 22 may be located in a proximal portion of the body 18, e.g., at the proximal end of the body 18. Alternatively, the port 22 may be located in a distal portion or a central portion of the body 18. Additionally, the port 22 may include a one-way valve, a luer, a seal, threading, and / or any suitable element. These help to maintain a secure connection between the handle 12 (and particularly the port 22) and the fluid source, minimize or prevent backflow (fluid flowing proximally from the port 22), and / or minimize or prevent leakage. In one example, the one-way valve may include an outer housing containing an elastomeric and / or gelatinous sealing member (not shown) therein.

[0021] The handle 12 may be coupled to an energy source (not shown) via a hub 24. The hub 24 may include one or more protrusions or pins 32 for coupling to the energy source. The hub 24 may be electrically coupled to the electrode 26 via a conductive element (not shown). The conductive element may be electrically coupled to the pin 32 and extend through at least a portion of the handle 12 and shaft 14. The energy source may be an electrocautery source, a radiofrequency generator, a heat source, a current generator, or the like. In one embodiment, the medical device 10 may be used for monopolar electrosurgery and may include a return electrode located remotely from the electrode 26 or otherwise adjacent to the subject. In another embodiment, the medical device 10 may be used for bipolar electrosurgery. In that example, the electrode 26 may include an active electrode portion, and the return electrode may be located on or near another portion of the electrode 26 and / or shaft 14. In one example, although not shown, two conductive elements may extend through the shaft 14. The conductive elements are electrically isolated from each other, allowing one to conduct energy to the active electrode and the other to conduct energy from the return electrode.

[0022] The hub 24 may be located on the body 18, for example, at the proximal end of the body 18. In one embodiment, the port 22 may extend from the proximal end of the body 18 in a direction parallel to the longitudinal axis of the body 18, and the hub 24 may extend from the proximal end of the body 18 at a transverse angle (e.g., approximately 45 degrees) relative to the longitudinal axis of the body 18. In other embodiments, the hub 24 may be located on a distal or central portion of the body 18, or on the movable body 20. Although not shown, the body 18 and / or hub 24 may include one-way valves, luers, seals, threads, and / or any suitable elements that help maintain a secure connection between the handle 12 and a fluid source, minimize or prevent backflow (e.g., fluid flowing from the port 22 and / or lumen and proximally from the hub 24), and / or minimize or prevent leakage. Additionally, although not shown, the pin 32 may extend through the hub 24 transversely to the longitudinal axis of the handle 12 and may be electrically and physically connected to a conductive element (not shown), such as a wire, cable, or the like. The conductive element may extend longitudinally through the lumen of the handle 12 and the lumen of the shaft 14, or otherwise through the shaft 14. In one embodiment, the conductive element may include one or more insulating layers, such as insulated wires, to help insulate the conductive element from fluid within the lumen. As noted above, if the medical device 10 has a bipolar configuration, a second conductive element (not shown) may be provided as a return path. Although not shown, in other embodiments, the energy source may be part of the handle 12 (e.g., an internal battery within the handle 12).

[0023] As described above, the handle 12 may control the extension or retraction of the electrode 26 relative to the distal end 16 of the shaft 14. For example, the body 18 may include a slot 34, and the movable body 20 may be slidably positioned within the slot 34. For example, the body 18 may be configured to be held by a user's hand, and the movable body 20 may be configured to be controlled by movement of the user's thumb. For example, the side of the body 18 opposite the movable body 20 may include one or more contours 36 that may help the user grip the body 18. Additionally, the movable body 20 may include one or more ridges 37 that may help the user manipulate the movable body 20. The movable body 20 may be lockable in one or more positions relative to the body 18 and / or may be spring biased in a certain direction (e.g., toward a proximally retracted position).

[0024] The movable body 20 may be coupled to a drive element (not shown). The drive element may impart distal or proximal movement to at least a portion of the electrode 26 based on relative motion between the body 18 and the movable body 20. In one embodiment, the conductive element (not shown) also functions as a drive wire, rod, cable, or the like. In this embodiment, the conductive element imparts distal or proximal movement to at least a portion of the electrode 26 while coupling the electrode 26 to the hub 24, e.g., one or more pins 32, for delivering energy to (and / or from) the electrode 26.

[0025] 1 , the handle 12 may include one or more indicators, such as indicators 39A and 39B. For example, the indicators 39A and 39B may visually indicate to the user the position of the electrode 26 relative to the shaft 14. The positions of the indicators 39A and 39B may correspond to the position of the moveable body 20. For example, the indicator 39A may be located at a position on the handle 12 that corresponds to the retracted position of the moveable body 20 and indicate that the electrode 26 is retracted relative to the shaft 14. Similarly, the indicator 39B may be located at a position on the handle 12 that corresponds to the extended position of the moveable body 20 and indicate that the electrode 26 is extended relative to the shaft 14.

[0026] 1, the shaft 14 may extend from the distal portion of the body 18 to the distal tip 16 and may enclose at least a portion of the electrode 26. The shaft 14 may be a sheath that encloses one or more lumens and at least a portion of the drive element (not shown). In other embodiments, the shaft 14 may be an extrusion that includes one or more lumens that extend from the handle 12 to the distal tip 16. The lumens may receive the proximal portions of the electrodes 26, the drive element, the conductive element, and any other elements of the device 10 described above, and the lumens extend between the handle 12 and the distal tip 16.

[0027] 2 shows the distal portion of the shaft 14, including the distal end 16. As shown in FIG. 2, the shaft 14 may include or otherwise be coupled to an end cap 50. The end cap 50 may be partially insulating. For example, the end cap 50 may be formed from a ceramic (e.g., zirconia, zirconium-containing alloys (e.g., ZrO), aluminum oxide (AlO), ceramic alloys, etc.), a polymeric material (e.g., fluoropolymers, polyetheretherketone (PEEK), etc.), or other medically safe, heat-resistant, non-conductive material.

[0028] Additionally, the distal portion of electrode 26 may be larger (i.e., wider) than the lumen within shaft 14 and / or end cap 50. For example, as shown in FIG. 2, when electrode 26 is fully retracted proximally, the distal portion of electrode 26 remains distal to shaft 14 and / or end cap 50. One or more portions of electrode 26 may be formed of an electrically conductive material, such as stainless steel (e.g., 316L stainless steel), titanium, or other medically safe and electrically conductive material. In one embodiment, electrode 26 may include a surface finish, e.g., passivated in accordance with ASTM A967 Nitric 2.

[0029] Additionally, as shown in FIG. 2 , the shaft 14 may include a braid 60. The braid 60 may include, for example, a plurality of threads 62 woven across one or more portions of the shaft 14. The threads 62 may be formed of a plastic material (e.g., a polymeric material) or a non-metallic material. Alternatively, the threads 62 may be formed of a metallic material. In some embodiments, the braid 60 may include approximately 12 to 40 threads 62, e.g., approximately 16 or 32 threads 62. In some embodiments, the threads 62 may include one wire or strand, or multiple wires or strands (e.g., two, three, four, or more wires or strands). The one wire or strand, or multiple wires or strands, may be wound, twisted, adjacent, or otherwise connected or positioned together. As described in more detail below, the braid 60 and its threads 62 may be in an intermediate layer of the shaft 14.

[0030] The threads 62 may include constant or consistent spacing and / or braid angle throughout at least a distal portion of the shaft 14. In some embodiments, the threads 62 include constant or consistent spacing and / or braid angle throughout the entire shaft 14. Additionally, the threads 62 may terminate proximal to the end cap 50. The end cap 50 may help insulate the threads 62 (e.g., if the threads 62 are metallic). In some embodiments, the threads 62 may be attached to one or more portions (e.g., the entirety) of the shaft 14 with a braiding machine. Each thread 62 may have a size (i.e., cross-sectional size) of approximately 0.0005 inches (0.0127 mm) to approximately 0.005 inches (0.127 mm). Each thread 62 may include a circular cross-section including a circular cross-sectional diameter of approximately 0.0005 inches (0.0127 mm) to approximately 0.005 inches (0.127 mm). Alternatively, one or more of the threads 62 may include a "D"-shaped cross-sectional shape, an elliptical or oval cross-sectional shape, or other non-circular cross-sectional shape. In some embodiments, the threads 62 may each include a thickness (e.g., cross-sectional diameter) of approximately 0.001 inches (0.0254 mm) to 0.003 inches (0.0762 mm), e.g., approximately 0.002 inches (0.0508 mm). In some embodiments, the thickness of the threads 62 may help to optimize or balance the flexibility and wall thickness of the shaft 14 having the braid 60. Furthermore, in some embodiments, the braid 60 may include a pick spacing ranging from approximately 70 p.pi (picks per inch) to approximately 110 p.pi, e.g., 90 p.pi. In these embodiments, the picks per inch of the braid 60 on the shaft 14 may help to control the stiffness and / or flexibility of the shaft 14.

[0031] The shaft 14 may include an outer coating 70 (e.g., a thermoplastic polymer coating). For example, the outer coating 70 may include or be formed from polyetheretherketone (PEEK), Pebax®, Hyrel, Arnitel, polyurethane (PU), or polytetrafluoroethane (PTFE) and may at least partially radially surround the braid 60. For example, the braid 60 may be completely embedded within the coating 70. In some embodiments, each thread 62 of the braid 60 may be entirely radially surrounded by the coating 70. In other embodiments, portions of each thread 62 of the braid 60 (e.g., outer and / or inner portions) may be covered by the coating 70. In any of these embodiments, the outer coating 70 may include a high dielectric strength and / or may be formed from or include one or more fluoropolymers. If the threads 62 are formed from a metal, the outer coating 70 may serve to insulate the threads 62. For example, the outer coating 70 may help ensure that energy delivered by the electrodes 26 to the treatment site is not transmitted to the threads 62. As described above, the threads 62 may terminate proximal to the end cap 50. In this embodiment, the outer coating 70 may at least partially encapsulate the distal ends of the threads 62. This may help, for example, to insulate the threads 62 (if the threads 62 are formed from a metallic material). Alternatively, the outer coating 70 may encapsulate the threads 62 so that they do not interfere with the delivery, movement, or manipulation of the shaft 14 and / or electrodes 26, or the treatment of tissue at the treatment site.

[0032] In some embodiments, the shaft 14 may comprise an extrusion. For example, the extrusion may form an inner portion of the shaft 14. The extrusion may include one or more working channels or lumens, as described above. The braid 60 may be braided (e.g., by a braiding machine) around the extrusion. An outer coating 70 may then be extruded, applied, formed, or otherwise positioned radially outward of the braid 60. The coating 70 may flow around and within the braid 60, filling the openings between the threads 62 to encapsulate the braid 60.

[0033] Additionally, in some embodiments, the distal portion of the shaft 14 may include a ring 80, e.g., a marking ring such as a radiopaque marker band. The ring 80 may be located radially around the distal portion of the shaft 14, e.g., proximal to the exposed portion of the end cap 50. In some embodiments, the ring 80 may be located radially around the outer side of the coating 70. In other embodiments, at least a portion of the ring 80 may be covered or encapsulated by the coating 70. The ring 80 may aid the user in visualizing the position of the shaft 14 and / or the electrode 26, e.g., relative to the distal end of an insertion device (not shown). Alternatively or additionally, the distal portion of the shaft 14 may include one or more other non-radiopaque visual indicators, such as one or more etched (e.g., laser-etched) visual indicators. For example, the shaft 14 may include one or more non-radiopaque visual indicators, which may be formed using Keyence ultraviolet (UV) laser marking or etching. In some embodiments, the insertion device may include a lumen for receiving the shaft 14, and the distal end of the insertion device may include a visualization device (e.g., a camera) and / or an illumination device (e.g., one or more light-emitting diodes). The visualization device and / or illumination device may assist the user in visualizing the extension, movement, position, manipulation, etc. of the shaft 14 and / or electrodes 26. In these embodiments, the ring 80 may assist the user in determining the position of the shaft 14 and / or electrodes 26 relative to the insertion device and / or visualization device. The ring 80 may, for example, assist the user in ensuring that the shaft 14 and electrodes 26 are positioned a safe distance and / or location relative to the insertion device and / or visualization device at the treatment site.

[0034] FIG. 3 illustrates a longitudinal cross-sectional view of a portion of the shaft 14, e.g., a distal portion of the shaft 14. Note, however, that internal elements of the medical device 10, such as the electrodes 26 and / or other mechanical and / or fluid connections, are omitted. Nevertheless, as shown, the portion of the medical device 10 (e.g., the shaft 14) may include an inner layer of the shaft 14 formed, for example, via extrusion. In some embodiments, the inner shaft 14A may be formed from a polymeric and / or fluoropolymeric material, such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), or the like. Additionally, multiple threads 62 may be braided, attached, formed, or otherwise positioned on the radially outer side of at least a portion of the inner shaft 14A, e.g., to form a braid 60. As discussed above, each thread 62 may comprise one or more wires or strands. In some embodiments, two or more threads 62 may be attached, formed, or otherwise positioned adjacent to one another on the inner shaft 14A. Further, as shown in FIG. 2 , threads 62 may be alternately positioned (e.g., braided) over or under other threads to form braid 60. In some embodiments, threads 62 may be braided in a “one over, one under” pattern. In other embodiments, threads 62 may be braided in a “two over, two under” pattern. The braid pattern may help influence the mechanical properties of braid 60 and / or shaft 14. Furthermore, in some embodiments, one or more portions of shaft 14 (e.g., inner shaft 14A) may be formed with or otherwise include a hydrophilic coating. For example, one or more interior portions of shaft 14 (e.g., the inner diameter of inner shaft 14A) and / or one or more exterior portions of shaft 14 (e.g., the outer diameter of inner shaft 14A) may include a hydrophilic coating.

[0035] In that case, the outer coating 70 may be extruded, deposited, formed, or otherwise positioned on the threads 62 and radially outward of the inner shaft 14A. In some embodiments, the outer coating 70 may be deposited, formed, or otherwise positioned to surround one or more threads 62, e.g., radially between the inner shaft 14A and the threads 62 and radially outward of the threads 62. The outer coating 70 may be deposited, formed, or otherwise positioned between the threads 62 to fill spaces / openings between adjacent threads 62. As mentioned above, the ring 80 may be positioned radially outward of the outer coating 70, or alternatively, may be at least partially encapsulated by the outer coating 70. In these embodiments, the ring 80 may be formed of a non-conductive and / or non-metallic material. Additionally, in some embodiments, the shaft 14 may include one or more non-radiopaque markers formed, for example, by laser etching, on one or more portions of the shaft 14 (e.g., on the outer diameter of the outer coating 70).

[0036] Various aspects of the present disclosure may help improve the column strength of the shaft 14 or electrodes 26 or otherwise improve the usability of the shaft 14 and / or electrodes 26. For example, various aspects of the present disclosure (e.g., braid 60 with threads 62) may help enable the shaft 14 and / or electrodes 26 to be delivered to a treatment site, for example, through an insertion device, deflected by the insertion device, and / or otherwise manipulated with the insertion device. Additionally, various aspects of the present disclosure (e.g., braid 60 with threads 62) may help enable the shaft 14 and / or electrodes 26 to be extended and / or retracted (e.g., actuated) relative to the insertion device. Similarly, various aspects of the present disclosure (e.g., braid 60 with threads 62) may help enable the electrodes 26 to be extended and / or retracted (e.g., actuated) relative to the shaft 14.

[0037] In some aspects, when the distal portion of the insertion device is in a recoiled position or orientation, various aspects of the present disclosure (e.g., the braid 60 with the threads 62) can be useful in allowing the shaft 14 and / or electrodes 26 to be extended and / or retracted (e.g., actuated) relative to the insertion device. For example, various aspects of the present disclosure (e.g., the braid 60 with the threads 62) can be useful in allowing a user to more precisely and / or predictably extend, retract, or otherwise actuate the shaft 14 and / or electrodes 26, e.g., by extending and / or retracting the medical device 10 and / or by extending and / or retracting the moveable body 20. In these aspects, the braid 60 with the threads 62 can be useful in allowing a consistent correlation (e.g., a one-to-one, real-time, non-delayed relationship) between the extension and / or retraction of the handle 12 (e.g., relative to the proximal end of the insertion device (not shown)) and the extension and / or retraction of the shaft 14 and electrodes 26 (e.g., relative to the distal end of the insertion device and / or treatment site). Additionally, in these embodiments, the braid 60 with the threads 62 can help enable a consistent correlation (e.g., a one-to-one, real-time, non-delayed relationship) between the extension and / or retraction of the movable body 20 (e.g., relative to the main body 18) and the extension and / or retraction of the electrode 26 (e.g., relative to the end cap 50 and / or shaft 14).

[0038] Additionally, various embodiments of the present disclosure may help enable the shaft 14 and / or electrodes 26 to be more flexible and / or strong for use in endoscopic mucosal resection (EMR), endoscopic submucosal resection (ESR), endoscopic submucosal dissection (ESD), polypectomy, mucosal resection procedures, or peroral endoscopic myotomy (POEM) procedures. In these embodiments, the braid 60 with threads 62 may help prevent and / or minimize the drive elements connecting the shaft 14 or moveable body 20 and the electrodes 26 from kinking or otherwise deforming in a manner that may impair extension or retraction of the shaft 14 and / or electrodes 26. In some embodiments, the braid 60 with threads 62 may help prevent or minimize axial elongation and / or help maximize luminal patency (e.g., due to the tendency of the shaft to flare out like a "fish eye" around arches or bends). Additionally, the outer coating 70 may help to insulate or otherwise encapsulate the braid 60 and threads 62 (or other portions of the shaft 14 member), which may help protect tissue at the treatment site and / or help protect the user. In some embodiments, the outer coating 70, formed of, for example, PEEK, may help to bias or create a partial shape memory property for the shaft 14. Furthermore, if the threads 62 of the braid 60 are formed of a plastic or non-metallic material (e.g., a polymeric material), the threads 62 may further help protect tissue at the treatment site and / or help protect the user by helping to prevent energy from being transferred from the electrodes 26 to the shaft 14, the treatment site, and / or the user.

[0039] While the principles of the present disclosure are described herein with reference to illustrative embodiments for particular applications, it should be understood that the present disclosure is not limited thereto. Those skilled in the art and with access to the teachings provided herein will recognize that additional modifications, applications, embodiments, and equivalent substitutions all fall within the scope of the embodiments described herein. Accordingly, the present disclosure should not be deemed limited by the foregoing description.

Claims

1. It is a medical device, A handle including a movable part, A shaft extending from the aforementioned handle, An electrode located at the distal end of the shaft, Equipped with, The movement of the movable body of the handle controls the position of the electrode relative to the distal end of the shaft. At least a portion of the shaft includes a braid. Medical device.

2. The braid is a polymer, and the medical device is an electrosurgical unit. The medical device according to claim 1.

3. The shaft further includes an outer coating, and the braid is embedded within the outer coating. The medical device according to claim 1.

4. The braid includes a plurality of threads over at least a portion of the shaft. The medical device according to claim 3.

5. The inner shaft is further provided, and the plurality of threads are attached over at least a portion of the inner shaft. The medical device according to claim 4.

6. The braid extends along the entire length of the inner shaft. The medical device according to claim 5.

7. The outer coating is formed from polyetheretherketone (PEEK). The medical device according to claim 3.

8. The handle includes a port and an electrical connection, and the handle and the shaft connect the port and the electrical connection to the electrode. The medical device according to claim 1.

9. The movement of the movable body of the handle controls the position of the electrode relative to the distal end of the shaft without delay. The medical device according to claim 1.

10. The braid is configured to minimize twisting of the drive element connecting the shaft or the movable body to the electrode. The medical device according to claim 1.

11. The distal portion of the shaft further includes a ring that radially surrounds a part of the braid. The medical device according to claim 1.

12. The aforementioned ring is a radiopaque marker band. The medical device according to claim 11.

13. The shaft further comprises an end cap connected to the distal end, a portion of which extends distally to the distal end of the shaft so as to form an exposed portion of the end cap, the end cap is at least partially insulating, and the ring is located proximal to the exposed portion of the end cap. The medical device according to claim 12.

14. The handle includes one or more indicators, each of which indicates one or more configurations of the electrode relative to the distal end of the shaft. A medical device according to any one of claims 1 to 13.

15. The one or more indicators include a first indicator and a second indicator, the first indicator showing a retracted configuration of the electrode and the second indicator showing an extended configuration of the electrode. The medical device according to claim 14.

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