Medical Devices

Abstract

A medical device includes a shaft having a distal end, the distal end including a passive electrode, the distal end defining a central opening extending through the passive electrode; and an active electrode within the central opening. The active electrode is movable between at least an extended position and a retracted position, in which the active electrode does not contact the passive electrode and in which the active electrode contacts the passive electrode.

Description

Technical Field

[0001] Aspects of the present invention generally relate to medical systems, devices and methods. In particular, aspects of the present invention relate to medical systems, devices and procedures for treating tissue by delivering electrical energy to the tissue. Background Art

[0002] Medical devices, such as endoscopes or other suitable insertion devices, are used for various types of diagnostic and surgical procedures, such as endoscopy, laparoscopy, arthroscopy, gynecology, thoracoscopy, cystoscopy, etc. Many of these procedures involve delivering energy to the tissue of an organ or gland to treat a tumor, infection, etc. Examples of these procedures include endoscopic mucosal resection (EMR), endoscopic submucosal resection (ESR), endoscopic submucosal dissection, polypectomy, mucosal resection, etc. In particular, these procedures can be achieved by inserting an insertion device into a subject through a surgical incision or via a natural anatomical opening (e.g., mouth, vagina, or rectum), and performing the surgery or operation at the target site with an auxiliary device inserted through the insertion device.

[0003] Sometimes, during a medical procedure, a user may use an injection needle inserted through an insertion device to form (or reform) a bleb in or under the tissue to be removed. In order to deliver energy to the tissue, the user may be required to remove the injection needle from the insertion device and deliver the energy delivery device to the aligned tissue through the insertion device. In addition, during surgery, the user may provide hemostasis to the aligned tissue or surrounding tissue. The exchange of devices may increase the duration and risk of the medical procedure, and the energy delivery device may not be able to provide adequate energy delivery in both the cutting mode and the hemostasis mode.

[0004] The apparatus and methods of the present invention may remedy some of the above-mentioned deficiencies or address other aspects of the prior art. Summary of the invention

[0005] Examples of the invention relate, among other things, to medical devices for treating tissue by delivering electrical energy to the tissue and related methods of use.Each of the examples disclosed herein may include one or more of the features described in conjunction with any of the other disclosed examples.

[0006] In one example, a medical device may include a shaft having a distal end, the distal end including a passive electrode, the distal end defining a central opening extending through the passive electrode; and an active electrode within the central opening. The active electrode is movable between at least an extended position and a retracted position, in which the active electrode does not contact the passive electrode and in which the active electrode contacts the passive electrode.

[0007] The medical device may include one or more of the following features. The passive electrode may be insulated when the active electrode is in an extended position and energized, and the passive electrode may be energized when the active electrode is in a retracted position and energized. The passive electrode may have a generally cylindrical shape including a flat distal end face and at least one rounded distal edge. The medical device may also include an outer insulating member surrounding at least a portion of the passive electrode. The medical device may also include an inner insulating member within the central opening and between the active electrode and the passive electrode.

[0008] The medical device may also include a handle having a body and a movable portion, and at least one of the body and the movable portion may include a slot such that the active electrode may extend in response to sliding the movable portion in a first direction relative to the body, and the active electrode may retract in response to sliding the movable portion in a second direction relative to the body. At least one of the body and the movable portion may include a fluid port for connecting a fluid source to the handle, and at least one of the body and the movable portion may include a hub for connecting an energy source to the handle. The medical device may also include a drive element that may extend from the handle to the active electrode to electrically connect the energy source to the active electrode, and move the active electrode distally or proximally based on the relative movement between the body and the movable portion.

[0009] The entire distal-most side of the passive electrode may be conductive. The active electrode may include a distal tip and a longitudinal axis. In the retracted position, only the proximal surface of the distal tip of the active electrode may contact the passive electrode. The width of the distal tip may be greater than the width of the longitudinal axis when measured transversely to the longitudinal axis of the medical device. The width of the distal tip may be greater than the diameter of the central opening when measured transversely to the longitudinal axis of the medical device. The shaft may include a central cavity configured to direct a fluid flow through the shaft, and the active electrode may include an electrode cavity in fluid communication with the central cavity. The electrode cavity may be configured to receive a fluid flow from the central cavity and direct the fluid to pass through the opening distally. The distal end may include a cap having a narrowed stop surface radially surrounding a portion of the active electrode, and the active electrode may include a widened portion proximal to the distal tip of the active electrode. The stop surface of the cap and the widened portion of the active electrode may limit the active electrode from extending distally. The medical device may also include an insulating member radially inside the narrowed stop surface of the cap.

[0010] In another aspect, a medical device may include: a shaft having a distal cap, the distal cap including a conductive portion; a movable electrode positioned within the shaft and movable relative to the distal cap, wherein the movable electrode is configured to receive energy from an energy source; and a control element configured to control the position of the movable electrode between at least a retracted position and an extended position. In the retracted position, the movable electrode may be in electrical contact with the conductive portion, and in the extended position, the movable electrode may be electrically insulated from the conductive portion.

[0011] The medical device may include one or more of the following features. The medical device may also include a fluid source coupled to the shaft. The shaft may include a shaft lumen fluidly connected to the fluid source, and the movable electrode may include an electrode lumen fluidly connected to the shaft lumen. The medical device may also include an energy source. The energy source may be an RF generator. The movable electrode may be movable through a central opening in the distal cap such that the conductive portion radially surrounds the movable electrode.

[0012] In yet another aspect, a method of treating tissue may include inserting a distal portion of a medical device into a body cavity, wherein the medical device may include a movable electrode and a conductive portion at the distal portion; extending the movable electrode distally so that the movable electrode is electrically isolated from the conductive portion; energizing the movable electrode; applying the movable electrode to a treatment site in the body cavity to deliver electrical energy to the treatment site; retracting the movable electrode proximally so that the movable electrode is electrically connected to the conductive portion; and applying the movable electrode and the conductive portion to the treatment site or another portion of the body cavity to deliver electrical energy.

[0013] The method may include one or more of the following features. The medical device may further include a fluid chamber, and the movable electrode may include a fluid outlet. The method may further include simultaneously delivering a fluid and applying electrical energy to the movable electrode.

[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 invention, as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0016] Figure 1A and Figure 1B Exemplary medical devices according to aspects of the present invention are shown.

[0017] Figure 2A and Figure 2B According to various aspects of the present invention, Figure 1A and Figure 1B A stereoscopic view of the distal portion of a medical device in extended and retracted configurations.

[0018] Figure 3A and Figure 3B According to various aspects of the present invention, Figure 1A and Figure 1B Side view of the distal portion of the medical device in extended and retracted configurations.

[0019] Figure 3C According to various aspects of the present invention, Figure 1A and Figure 1BCross-sectional view of the distal portion of the medical device in a retracted position.

[0020] Figure 4 is a flow chart of an exemplary tissue processing method according to aspects of the present invention. DETAILED DESCRIPTION

[0021] Examples of the present invention include devices and methods that facilitate and improve the effectiveness, efficiency, and / or safety of treating tissues when applying electrical energy to tissues (in some embodiments, delivering fluids into and / or beneath tissues during medical procedures). For example, aspects of the present invention may provide users (e.g., physicians, medical technicians, or other medical service providers) with the ability to apply electrical energy or heat to tissues using a medical device having electrodes and deliver fluids into and / or beneath tissues using the same medical device. In addition, aspects of the present invention may provide users with the ability to deliver energy to tissues using medical devices that excise, cut, dissect, ablate, mark, or otherwise treat tissues with electrodes. Aspects of the present invention may also provide users with the ability to subsequently deliver energy to tissues using medical devices with larger electrode surface areas to coagulate, cauterize, or otherwise treat tissues in hemostasis procedures without removing the medical device from the treatment site. In addition, aspects of the present invention may provide users with the ability to deliver fluids to a treatment site using a medical device without removing the medical device from the treatment site. Some aspects of the present invention may be used to perform endoscopic, laparoscopic, arthroscopic, or other types of procedures.

[0022] Reference will now be made in detail to the examples of the present disclosure described above and illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts.

[0023] The terms "proximal" and "distal" are used herein to refer to the relative positions of the components of an exemplary medical device. When used herein, "proximal" refers to a position relatively closer to the outside of the body or to a medical professional using the medical device. Conversely, "distal" refers to a position relatively farther from a medical professional using the medical device or relatively closer to the inside of the body. As used herein, the terms "include," "comprises," "comprising," "having," "containing," or other variations thereof are intended to encompass non-exclusive content, such that a device or method comprising a series of elements includes not only those elements, but may include other elements that are not explicitly listed or inherent to them. Unless otherwise stated, the term "exemplary" is used in the sense of "example" rather than "exemplary." As used herein, the terms "approximately," "substantially," and "approximately" refer to values ​​within the range of ±10% of the value.

[0024] Figure 1A and Figure 1BA medical device 10 is depicted, which includes 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 also include a port 22 configured to receive a fluid, and a hub 24 similar to an electrical plug or socket configured to receive electrical energy. The distal end 16 includes an electrode 26 and an end cap 42. The electrode 26 is an active electrode electrically connected to the hub 24 and includes one or more lumens (eg, a lumen) that are fluidically connected to the port 22. Figure 3C ). As discussed in detail below, the end cap 42 includes a passive conductive portion that can be energized when in contact with the electrode 26. The medical device 10 can be inserted into a body cavity of a subject by an insertion device (not shown) or separately, so that at least a portion of the shaft 14 can be within the subject's body and the handle 12 can remain outside the subject's body. Outside the subject's body, a user can manipulate the handle 12. For example, moving the movable body 20 in a first direction relative to the main body 18 can extend the electrode 26 relative to the shaft 14 (e.g., moving the electrode 26 distally relative to the distal end of the shaft 14 and the end cap 42), while moving the movable body 20 in a second direction relative to the main body 18 can retract the electrode 26 relative to the shaft 14 (e.g., moving the electrode 26 proximally relative to the distal end of the shaft 14 and the end cap 42).

[0025] The handle 12 can be connected to a fluid source via a port 22. The port 22 can be fluidically connected to an electrode 26 via a lumen 27 passing through the shaft 14. For example, Figure 1B As shown, the inner cavity 27 may extend longitudinally through the main body 18 of the handle 12, and the port 22 may include a port cavity 22A extending through the port 22 to connect the port 22 fluid to the inner cavity 27. The fluid source may include a flushing bag, a vial, a syringe, or other containers or reservoirs of saline solution or other fluids. The fluid source may pressurize the fluid via a pump, an injection needle, a gravity drop, or other pressure sources. The fluid source may be controlled by the user via a trigger, a foot pedal, an adjustable dial, or other control device and / or may deliver an automatic or constant perfusion supply. The port 22 may be positioned on the distal portion of the main body 18 or on the movable body 20. Moreover, the port 22 may include a one-way valve 28, a Luer connector, a seal, a thread 30, or any appropriate element to maintain a stable connection between the handle 12 and the fluid source, minimize or prevent backflow (e.g., fluid flows out of the port 22 to the proximal side) and / or minimize or prevent leakage. In one example, the one-way valve 28 may include an outer shell containing an internal elastomer and / or a gel-like sealing member (not shown).

[0026] The handle 12 can be connected to an energy source via a hub 24. The hub 24 can be electrically connected to the electrode 26 via a conductive element in the shaft 14. The energy source can be an electrocautery source, an RF generator, a heating source, a current generator, etc. In one aspect, the medical device 10 can be used for monopolar electrosurgery and may include a return electrode positioned away from the electrode 26. Alternatively, the medical device 10 can be used for bipolar electrosurgery. As discussed with respect to the fluid source, the energy source may include any control elements to allow the user to control the delivery of energy. The hub 24 can be positioned on the movable body 20 or the main body and may include one or more pins or forks 32 to connect to the energy source. Figure 1B In one aspect shown, the prongs 32 may extend through the hub 24 transverse to the longitudinal axis of the handle 12 and may be electrically and physically connected to a conductive element 33, such as a wire, cable, and / or braided sheath. The conductive element 33 may be conductive or include a conductive element and may extend longitudinally through the lumen 27 and through the shaft 14. Figure 1B As shown, fluid delivered through port 22 can surround at least a portion of conductive element 33. In another aspect, the energy source can be part of handle 12.

[0027] As mentioned, the handle 12 can control the extension or retraction of the electrode 26 relative to the distal end 16 of the shaft 14 and the end cap 42. For example, the body 18 can include a slot 34 and a thumb ring 36. The movable body 20 can be slidably positioned in the slot 34 and include one or more finger holes 38. The movable body 20 can be connected to a drive element, and the drive element can move at least a portion of the electrode 26 distally or proximally based on the relative movement between the body 18 and the movable body 20. In one aspect, the conductive element 33 can also be a drive wire, rod, cable, etc., so that the conductive element 33 connects the electrode 26 to the hub 24 (e.g., one or more forks 32) to deliver energy to the electrode 26 while also moving at least a portion of the electrode 26 distally or proximally. Although not shown, the handle 12 may also include a locking mechanism to selectively fix the movable body 20 at a predetermined position along the narrow slot 34, and / or fix it within a predetermined range of positions along the narrow slot 34 to releasably fix the relative position of the main body 18 and the movable body 20, and thereby releasably fix the relative position of the electrode 26 and the shaft 14.

[0028] The shaft 14 extends from the distal portion of the body 18 to the distal end 16 and can surround at least a portion of the electrode 26. The shaft 14 can be connected to the handle 12 via a connector 40, which can surround a portion of the shaft 14 and screw onto the body 18 to secure the elements. The shaft 14 can be a sheath surrounding at least a portion of the central lumen and the drive wires. In another aspect, the shaft 14 can be an extrusion including one or more lumens extending from the handle 12 to the distal end 16. In either aspect, the shaft 14 can be electrically insulated and fluidly isolated from the elements positioned within the shaft 14 to protect the user and the subject.

[0029] Figure 2A and Figure 2B Other aspects of the distal end 16 are shown. It should be noted that Figure 2A and Figure 2B A portion of the shaft 14 is shown transparent to illustrate the internal components of the distal end 16 .

[0030] Figure 2A and Figure 2B A perspective view of a portion of the distal end 16 is shown, wherein a portion of the electrode 26 is positioned within the end cap 42 of the distal end 16. The end cap 42 may include a distal portion 44 and one or more inner portions 46. The end cap 42 may be a separate component attached to the shaft 14 or may be integrally formed with the shaft 14. Although not shown, the inner portion 46 may include one or more gradual surfaces having different radii or sizes, which may help to attach the end cap 42 to the shaft 14. In one aspect, the distal portion 44 is conductive, while the one or more inner portions 46 are at least partially electrically insulating. For example, the distal portion 44 may be formed of a metal or other conductive material, while the inner portion 46 may be a ceramic material or another non-conductive material. In another aspect, the distal portion 44 may include a metal or conductive coating on the outside of the ceramic material or other non-conductive material. The distal portion 44 may be a passive electrode without a dedicated conductive element. For example, when the electrode 26 is energized and extended as discussed above, the electrode 26 does not contact the distal portion 44, so the distal portion 44 is not energized. However, when the electrode 26 is energized and retracted, the electrode 26 contacts the distal portion 44, and the distal portion 44 is then energized. As shown, the distal portion 44 can have a generally cylindrical shape including a flat distal face and a rounded distal edge. In one aspect, the entire distal-facing surface of the end cap 42 is conductive. The end cap 42 and the distal portion 44 also include a central opening 52, as discussed below.

[0031] The end cap 42 may include an outer insulating member 48 that may radially surround a portion of the distal portion 44. The end cap 42 may also include an inner insulating member 50. The inner insulating member 50 may be positioned radially within the end cap 42, such as radially within the distal portion 44 and surrounding the central opening 52, to at least partially insulate the distal portion 44 from a portion of the electrode 26 positioned within the central opening 52. The outer insulating member 48 and the inner insulating member 50 may each be formed of a ceramic material, an elastomeric polymer material, or another non-conductive material.

[0032] In addition, if Figure 2A As shown, the end cap 42 includes a central opening 52 through which the electrode 26 can be positioned. The central opening 52 can be larger than the electrode 26 (e.g., have a larger diameter) to form a gap between the distal portion 44, the inner insulating member 50, and the electrode 26. When the electrode 26 is in the extended position, the gap formed by the central opening 52 can help to electrically insulate the distal portion 44 from the electrode 26.

[0033] The electrode 26 may be coupled to a proximal support 54 of the distal end 16, which includes a cylindrical extension 56. The proximal support 54 may be coupled to a portion of the electrode 26, may extend distally thereof, and may receive at least a portion of the electrode 26 to partially overlap. The electrode 26 and the cylindrical extension 56 may be coupled via welding, adhesives, crimping, friction fit, or other suitable coupling. The electrode 26 and the proximal support 54 may move relative to the end cap 42 in response to relative movement of the movable body 20 and the main body 18 of the handle 12. For example, when the movable body 20 is in a proximal position relative to the main body 18, the electrode 26 may be substantially retracted within the end cap 42, with only the distal portion of the electrode 26 (e.g., the distal tip 60) extending distally beyond the end cap 42 ( Figure 2B ).exist Figure 2B In the retracted position shown, a portion of the electrode 26 contacts and is electrically connected to the distal portion 44. Then, as the movable body 20 translates distally relative to the main body 18, the electrode 26 and the proximal support 54 translate distally relative to the end cap 42, causing more of the electrode 26 to extend distally through the central opening 52 beyond the end cap 42 ( Figure 2A ).

[0034] Electrode 26 includes a distal tip 60 and a longitudinal portion 62. Distal tip 60 may be wider than longitudinal portion 62, and distal tip 60 may be wider than central opening 52 through end cap 42, as discussed above, where the width is measured transverse to longitudinal portion 62 and the longitudinal axis of medical device 10. Figure 3CAs shown, electrode 26 also includes an electrode cavity 64 extending through longitudinal portion 62. Electrode cavity 64 is in fluid communication with port 22 via at least one cavity 70 through proximal support 54. In one aspect, inner sheath 41 can form at least a portion of the fluid connection between cavity 70 and port 22. In addition, electrode cavity 64 is in fluid communication with an outlet 66 in distal tip 60 that allows fluid to flow out of electrode cavity 64. In one aspect, outlet 66 is circular and centrally located on the distal-most side of distal tip 60.

[0035] Although not shown, the electrode 26 may include any number of outlets 66, and the outlets 66 may be arranged at any location and in any direction on the electrode 26 to deliver the fluid to the body cavity. In addition, although the present invention discusses that the contact between the electrode 26 and the distal portion 44 is formed by the proximal portion (e.g., the most proximal side) of the distal tip 60 contacting the distal face of the distal portion 44, the present invention is not limited thereto. For example, in one aspect, the longitudinal portion 62 of the electrode 26 may have a radial extension that is configured to extend through the opening in the inner insulating member 50 when the electrode 26 is retracted or otherwise electrically connect the electrode 26 and the distal portion 44.

[0036] Figure 3A and 3B A side view showing a portion of the distal end 16, Figure 3C A cross-sectional view of a portion of the distal end 16 is shown. Again, it should be noted that Figure 3A and Figure 3B A portion of the shaft 14 is shown transparent to illustrate the internal components of the distal end 16 .

[0037] like Figure 3A and 3B As shown, the electrode 26 may include an extended form ( Figure 3A ) and retracted forms ( Figure 3B ). In the extended configuration, the distal tip 60 extends distally beyond the distal portion 44. In the retracted configuration, a portion of the distal tip 60 (e.g., the annular proximal surface) abuts and is electrically connected to the distal portion 44. Additionally, it should be noted that the relative sizes of the electrode proximal support 54 and the inner portion 46 of the end cap 42 may limit the distal extension of the electrode 26 ( Figure 3A ).

[0038] Electrode 26 has a shape in which distal tip 60 is wider than longitudinal portion 62, when measured transversely to the longitudinal axis of medical device 10. For example, electrode 26 may have a substantially T-shaped cross-sectional profile. Electrode 16 may also have a different shape. In either aspect, distal tip 60 may contact distal portion 44 in a retracted position so that when electrode 26 is in a retracted configuration and energized, distal portion 44 is also energized. On the other hand, when electrode 26 is in an extended configuration and energized, the gap formed by central opening 52 together with inner insulating member 50 prevents distal portion 44 from also being energized.

[0039] Figure 3C A cross-sectional view of the distal portion 16 is shown. As shown, the electrode 26 can be supported proximally by the proximal support 54. The proximal support 54 can include a drive wire receiving portion 58. The drive wire receiving portion 58 can be a notch or recess extending parallel to at least a portion of the cavity 70. The drive wire receiving portion 58 can receive a portion of the drive wire (e.g., wire 33), and the drive wire and / or the inner sheath 41 can be connected to the movable body 20 so that movement of the movable body 20 imparts distal or proximal movement to the proximal support 54, and thus to the electrode 26. The drive wire can be connected to the drive wire receiving portion 58 in the connecting portion 72 by welding, adhesive, crimping, friction fit, or any other permanent or temporary connection. The proximal support 54 can also be connected to the electrode 26 by welding, adhesive, crimping, friction fit, or any other permanent or temporary connection. In one aspect, both the drive wire and the proximal support 54 are electrically conductive to electrically connect the one or more prongs 32 of the hub 24 to the electrode 26. In another aspect, the proximal support 54 can be at least partially insulated and can include a wire or other conductive element that electrically connects the drive wire to the electrode 26. Similarly, in one aspect, the drive wire can be at least partially insulated and can include a wire or other conductive element. Moreover, at least a portion of the drive wire can be positioned within the inner sheath 41. Alternatively, the drive wire can be positioned within a separate lumen in the shaft 14 (e.g., a lumen separate from the lumen extending through the inner sheath 41).

[0040] The end cap 42 includes a central lumen 74 through which the electrode 26 can move during extension and retraction. The end cap 42 may also include a narrow portion or stop surface 76 at the distal end of the central lumen 74. The electrode 26 may include a widened portion 78 between the first longitudinal portion 80 and the second longitudinal portion 82 of the longitudinal portion 62. The diameter of at least a portion of the widened portion 78 is greater than the diameter of the stop surface 76. The stop surface 76 and the widened portion 78 can limit the electrode 26 from extending distally through the end cap 42. In addition, the inner insulating member 50 can extend proximally to the stop surface 76, thereby insulating the distal portion 44 from the electrode 26 when the electrode 26 is in the extended position. In addition, although not shown, the end cap 42 can be fixedly attached to the shaft 14 via welding, adhesive, crimping, friction fit, or other suitable attachment.

[0041] When the electrode 26 is in the extended position ( Figure 2A ), the first longitudinal portion 80 of the electrode 26 may protrude from the end cap 42 and may form an exposed portion. The electrode 26 may be energized so that the exposed portion may be used to excise, cut, dissect, ablate, mark, or otherwise treat tissue. Figure 2B ) and energized so that both the electrode 26 and the distal portion 44 are energized, the distal tip 60 and the distal portion 44 can form a larger energized portion of the medical device 10 that can be used to coagulate, cauterize, or otherwise treat tissue. For example, the electrode 26 can be extended and energized to perform an accurate excision or marking procedure. The size and shape of the electrode 26 can help reduce the risk of energy delivery to an unintended portion of the tissue. For example, the distal tip 60 may include an outer diameter of approximately 0.8 mm, when measured transversely to the longitudinal axis of the medical device 10, and the electrode outlet 66 may include a diameter of approximately 0.3 mm, when measured transversely to the longitudinal axis of the medical device 10. In addition, the electrode 26 can be retracted and energized to perform a hemostasis procedure. The size of the energized portion formed by the distal tip 60 and the distal portion 44 can be equal to or greater than the diameter of a vessel in the tissue being treated. In one aspect, the distal portion 44 can include a major diameter (e.g., extending from opposite sides of the radially outer portion) of about 1.55 mm, when measured transversely to the longitudinal axis of the medical device 10, and can include a minor diameter (e.g., extending from opposite sides of the distal face), when measured transversely to the longitudinal axis of the medical device 10, of about 0.75 mm. The central opening 52 can have a diameter slightly larger than the longitudinal portion 62 of the electrode 26, but can also be slightly smaller than the diameter of the distal tip 60. In this aspect, the distal portion 44 can include a minor diameter (e.g., extending from opposite sides of the distal face), when measured transversely to the longitudinal axis of the medical device 10. 2The end cap 42 may have a surface area (e.g., a distal face of the distal portion 44). In addition, the end cap 42 may have a diameter of about 2.2 mm when measured transverse to the longitudinal axis of the medical device 10. Thus, the medical device 10 may be used to perform resection procedures and hemostasis procedures without removing the medical device 10 from the body cavity, thereby reducing surgical time and minimizing risk to the subject.

[0042] In addition, the medical device 10 can be used to deliver fluids to a body cavity. For example, the medical device 10 can inject fluids into the submucosal plane of the treatment site through the outlet 66, which can help provide a blister or cushion under the treated tissue. The fluid can be injected before, during, or after the excision or hemostasis procedure, and does not require any device exchange.

[0043] Figure 4 4 is a flow chart depicting an exemplary tissue treatment method 400 for applying energy for at least one tissue resection or cauterization procedure. Method 400 includes step 402, in which a user positions a distal portion of a medical device proximate to or within tissue. Step 402 may include a preliminary step of injecting a fluid into the tissue with a separate conventional needle syringe or through outlet 66. The preliminary injection may separate or expand one or more layers of tissue underlying or containing a diseased portion of the tissue, thereby lifting the diseased tissue away from underlying tissue layers, thereby creating a tissue blister. Step 402 may also include delivering the medical device through an insertion device.

[0044] At step 404, the user may extend the electrode distally from the distal portion of the medical device. For example, the medical device may be delivered to tissue via the insertion device with the electrode proximally retracted. Step 404 may include extending the electrode 26 by acting on the movable body 20 of the handle 12 relative to the body 18, as discussed above.

[0045] In step 406, the user may deliver energy to the electrode and may apply the powered electrode to the tissue to excise, cut, dissect, ablate, mark or otherwise treat the tissue. In addition, energy may be delivered to the electrode 26 from an energy source that may be controlled by a user interface.

[0046] At step 408, the user may retract the electrode proximally toward the distal portion of the medical device. For example, step 408 may include retracting the electrode 26 by acting on the movable body 20 of the handle 12 relative to the main body 18, as discussed above. At step 408, the electrode 26 may be retracted so that one or more portions of the distal tip 60 contact the distal portion 44. As a result, any energy delivered to the electrode 26 also energizes the distal portion 44, thereby dispersing the delivered energy and increasing the energized portion of the medical device 10. The larger energized portion formed by the electrode 26 and the distal portion 44 may be larger than a vessel in the tissue being treated.

[0047] Subsequently, method 400 may include step 410, wherein the user may again deliver energy to the electrode. With electrode 26 in the retracted position, energy is delivered through electrode 26 and distal portion 44. Electrode 26 and distal portion 44 may be applied to tissue to coagulate, cauterize, or otherwise treat the tissue.

[0048] In one aspect, the user can extend the electrode 26 and deliver energy to the electrode 26 (the distal portion 44 is insulated) to accurately cut tissue, reducing the risk of thermal perforation of the area surrounding the body cavity. When hemostasis is required, the user can retract the electrode 26 proximally so that a portion of the electrode 26 (e.g., the distal tip 60) contacts the distal portion 44, thereby energizing the distal portion 44 that was previously not energized. In the case where both the electrode 26 and the distal portion 44 are energized, the medical device 10 provides a larger energized surface area, which in turn can allow for more effective hemostasis. For example, the surface area of ​​the distal tip 60 and the distal portion 44 can be larger than the blood vessel that needs hemostasis, and therefore can more effectively cauterize or coagulate the bleeding point than when only the electrode 26 is energized and applied to the tissue.

[0049] Based on the type of medical surgery and the progress of tissue treatment, the user can repeat the steps of method 400 as many times as needed to perform the tissue treatment procedure. For example, the user can loop back to step 402 from step 410. The user can extend and retract the electrode 26 to alternate between the excision and coagulation procedures. The user can also reposition the distal end 16 and perform method 400 as many times as needed to perform the tissue treatment procedure. In addition, during any of the aforementioned steps, the user can deliver fluid to the tissue. The fluid can be delivered from the fluid source through the port 22, the port cavity 22A, the inner cavity 27, the support cavity 70 and the electrode cavity 64 to one or more outlets 66 in the electrode 26. For example, the delivery fluid can form, re-form, maintain and / or increase the blister in the tissue. The energy and fluid delivery discussed in method 400 can be performed simultaneously or can be staggered according to the medical procedure. In addition, the medical device 10 can be used to perform any of the above-mentioned procedures without removing or replacing the medical device 10 from the body cavity, which can reduce the total operation time and / or reduce the risk to the subject.

[0050] Although the principles of the present invention are described herein with reference to illustrative aspects for specific applications, it should be understood that the present invention is not limited thereto. Personnel with ordinary skill in the art and aware of the teachings provided herein will appreciate that additional modifications, applications, aspects, and replacements of equivalents fall within the scope of the various aspects described herein. Therefore, the present invention should not be considered to be limited by the foregoing description.

Claims

1. A medical device comprising: a shaft having a distal end, the distal end including a passive electrode, the distal end defining a central opening extending through the passive electrode; an active electrode within the central opening; wherein the active electrode is movable between at least the following positions: an extended position wherein the active electrode does not contact the passive electrode, and a retracted position wherein the active electrode contacts the passive electrode, wherein the shaft includes a central lumen configured to direct fluid flow through the shaft, wherein the active electrode comprises an electrode cavity in fluid communication with the central cavity, and Wherein the electrode lumen is configured to receive the fluid flow from the central lumen and direct the fluid distally through an opening.

2. The medical device of claim 1, wherein when the active electrode is energized in the extended position, the passive electrode is not energized, and When the active electrode is energized in the retracted position, the passive electrode is energized.

3. The medical device of claim 1 or 2, wherein the passive electrode has a generally cylindrical shape including a flat distal face and at least one rounded distal edge. 4 . The medical device of claim 1 , further comprising an outer insulating member surrounding at least a portion of the passive electrode.

5. The medical device of claim 4, further comprising an inner insulating member within the central opening and between the active electrode and the passive electrode.

6. The medical device of claim 1 , further comprising a handle having a body and a movable portion, wherein at least one of the body and the movable portion comprises a slot such that the active electrode is extendable in response to sliding the movable portion in a first direction relative to the body, and is retractable in response to sliding the movable portion in a second direction relative to the body.

7. The medical device of claim 6, wherein at least one of the body and the movable portion comprises a fluid port for connecting a fluid source to the handle, wherein at least one of the body and the movable portion comprises a hub for connecting an energy source to the handle.

8. The medical device according to claim 7 further includes a drive element, wherein the drive element extends from the handle to the active electrode to electrically connect the energy source to the active electrode and move the active electrode distally or proximally based on the relative movement between the body and the movable part.

9. The medical device of claim 1, wherein the entire distal-most side of the passive electrode is conductive.

10. The medical device of claim 1, wherein the active electrode comprises a distal tip and a longitudinal axis.

11. The medical device of claim 10, wherein in the retracted position, only a proximal surface of the distal tip of the active electrode contacts the passive electrode.

12. The medical device of claim 10, wherein the width of the distal tip is greater than the width of the longitudinal axis when measured transverse to the longitudinal axis of the medical device.

13. The medical device of claim 10, wherein the width of the distal tip is greater than the diameter of the central opening when measured transverse to the longitudinal axis of the medical device.

14. The medical device of claim 1 , wherein the distal end comprises a cap having a narrowed stop surface radially surrounding a portion of the active electrode, wherein the active electrode comprises a widened portion proximal to the distal end of the active electrode, wherein the stop surface of the cap and the widened portion of the active electrode limit distal extension of the active electrode, and wherein the medical device further comprises an insulating member radially inward of the narrowed stop surface of the cap.

15. The medical device according to claim 7, further comprising: a proximal support coupled to and partially overlapping the active electrode, wherein the proximal support includes a proximal support lumen that fluidly couples the lumen of the shaft to the electrode lumen both when the active electrode is in the extended position and when the active electrode is in the retracted position; an inner insulating member within the central opening and between the active electrode and the passive electrode; an outer insulating member surrounding at least a portion of the passive electrode; as well as a drive element, wherein the drive element extends from the handle to the active electrode to electrically connect the energy source to the active electrode and to move the active electrode distally or proximally based on relative movement between the body and the movable portion, The proximal support includes a receiving portion extending parallel to the proximal support lumen, and the receiving portion is configured to receive a distal portion of the drive element.

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