Medical devices and related methods

Abstract

A medical device includes an electrode shaft and a tip. The electrode shaft is configured to deliver energy to a target site and includes an electrode shaft lumen configured to deliver fluid to the target site. The tip is coupled to a distal tip of the electrode shaft. The tip includes an interior of electrically conductive material and an outer layer of insulating material. The tip includes a tip lumen fluidically connected to the electrode shaft lumen and configured to deliver fluid to the target site.

Description

Technical Field

[0001] Various aspects of the present invention generally relate to medical devices and related methods. Embodiments of the present invention relate to medical devices and related methods configured to treat tissue by delivering electrical energy to or into tissue and / or injecting fluid into or into tissue using electrodes having insulated distal tips. Background Technology

[0002] Medical devices, such as endoscopes or other suitable insertion devices, are used in a wide range of diagnostic and surgical procedures, including endoscopy, laparoscopy, arthroscopy, gynecoscopy, thoracoscopy, cystoscopy, and so on. Many of these procedures involve delivering energy to the tissues of organs or glands to treat tumors, infections, etc. Examples of such procedures include endoscopic mucosal resection (EMR), endoscopic submucosal resection (ESR), endoscopic submucosal dissection (ESD), polyp removal, mucosal resection, etc. In particular, such procedures can be performed by inserting the device into the subject through a surgical incision or through natural anatomical openings (e.g., the mouth, vagina, or rectum), and by using auxiliary devices inserted through the insertion device to perform the procedure or manipulation at the target site.

[0003] Sometimes, during medical procedures, users may use injection needles and energy delivery devices for purposes such as elevating, separating, flushing, cutting, dissecting, ablating, marking, coagulating, cauterizing, or otherwise treating and / or manipulating tissue. Injection and energy delivery can be performed separately. For example, to deliver energy to tissue, the user may need to remove the injection needle from the insertion device and then deliver the energy delivery device to the target tissue through the insertion device, and vice versa. During the procedure, users may alternate between the injection needle and the energy delivery device, and switching devices may increase the duration and risk of the medical procedure. Additionally, one or more parts of the energy delivery device may inadvertently come into contact with or damage tissue (or the internal channels of the insertion device) when energized.

[0004] The apparatus and method of the present invention can correct one or more of the above-mentioned defects or solve other aspects of the present technology. Summary of the Invention

[0005] Examples of the present invention relate, among others, to medical devices configured to treat tissue by delivering electrical energy to the tissue, and configured to deliver fluid to the tissue and / or beneath the tissue. 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 an electrode shaft and a tip. The electrode shaft may be configured to deliver energy to a target site and may include an electrode shaft cavity configured to deliver fluid to the target site. The tip may be coupled to a distal tip of the electrode shaft. The tip may include an interior of conductive material and an outer layer of insulating material. The tip may include a tip cavity fluidly connected to the electrode shaft cavity and configured to deliver fluid to the target site.

[0007] The medical device may include one or more of the following features: The entire exterior of the tip may include an outer layer. The outer layer may be formed by a sputtering process. The insulating material may be ceramic. The outer layer may be about 300 micrometers thick. The tip may include a rounded distal end and cylindrical sides. The tip may be cylindrical. The tip may include rounded edges.

[0008] The medical device may also include an electrode plate on the proximal end of the tip. The electrode plate may be conductive and electrically connected to the electrode shaft such that when the electrode shaft is energized, the electrode plate is energized. The electrode plate may be circular and may cover the entire proximal end of the tip. The electrode plate may be triangular or star-shaped.

[0009] The electrode shaft may include multiple insulating portions, which may be longitudinally spaced along the length of the electrode shaft. The interior of the electrode shaft and its tip may be formed of a metallic material, and the electrode shaft and its tip may be welded together. Alternatively, the interior of the electrode shaft and its tip may be formed of a single piece of metallic material.

[0010] In another example, a medical device may include a handle, a shaft, a conductive element, and an electrode. The handle may include a fluid port and an energy receiving hub. The shaft may include a shaft cavity configured to guide fluid flow from the fluid port through the shaft. The conductive element may be electrically connected to the energy receiving hub and may be accessible via at least a portion of the handle and / or the shaft. The electrode may be coupled to a distal end of the shaft. The electrode may include an electrode shaft and a tip extending distally from the electrode shaft. The tip may include an interior of conductive material and an outer layer of insulating material. The electrode shaft may be electrically coupled to the conductive element and may include an electrode shaft cavity fluidly connected to the shaft cavity. The tip may include a tip cavity fluidly connected to the electrode shaft cavity and configured to deliver fluid from the distal end of the electrode.

[0011] The medical device may include one or more of the following features. The handle may also include a body and a movable body. Movement of the movable body relative to the body may move the electrode distally relative to the axis. In the position where the movable body is retracted proximally, only the tip may be exposed distally beyond the axis. In the position where the movable body is extended distally, the tip and at least a portion of the electrode axis may be exposed distally beyond the axis.

[0012] In yet another example, a medical device may include an electrode shaft and a tip. The electrode shaft may include an electrode shaft cavity configured to receive fluid. The tip may be coupled to a distal tip of the electrode shaft and may include an interior of conductive material and an outer layer of insulating material. The outer layer may insulate at least the distal portion of the medical device. The tip may include a tip cavity fluidly connected to the electrode shaft cavity to form a channel. The channel may extend along the longitudinal axis of the medical device.

[0013] The medical device may include one or more of the following features: The tip may include a circular distal portion and a cylindrical side portion. The entire exterior of the tip may include an outer layer. The insulating material may be ceramic. The outer layer may be approximately 300 micrometers thick.

[0014] It is understood that the foregoing general description and the following detailed description are merely exemplary and illustrative of the claimed invention, and not restrictive. Attached Figure Description

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

[0016] According to various aspects of the present invention, FIG. 1A An exemplary medical device is shown, and FIG. 1B A cross-sectional view of the medical device is shown, with a magnified view of the distal portion of the device.

[0017] According to various aspects of the present invention, FIG. 2A It shows FIG. 1A and FIG. 1B A side view of the electrode portion of the medical device, and FIG. 2B Shown FIG. 2A A cross-sectional view of the electrode portion;

[0018] According to various aspects of the present invention, FIG. 3A It shows FIG. 1A and FIG. 1B A side view of an alternative exemplary electrode portion of a medical device, and FIG. 3B It shows FIG. 3A A cross-sectional view of the electrode portion;

[0019] According to various aspects of the present invention, FIG. 4A It shows FIG. 1A and FIG. 1B A side view of another alternative exemplary electrode portion of the medical device; FIG. 4B It shows FIG. 4A Partial exploded view of the electrode section; and FIG. 4C It shows FIG. 4A A cross-sectional view of the electrode portion;

[0020] According to various aspects of the present invention, FIG. 5A It shows FIG. 1A and FIG. 1B A perspective view of another alternative exemplary electrode portion of the medical device, and FIG. 5B It shows FIG. 5A A cross-sectional view of the electrode portion;

[0021] According to various aspects of the present invention, FIG. 6A and FIG. 6B It shows FIG. 1A and FIG. 1B A perspective view of another alternative exemplary electrode portion of the medical device; FIG. 6C It shows FIG. 6A and FIG. 6B A cross-sectional view of the electrode portion;

[0022] According to various aspects of the present invention, FIG. 7A and FIG. 7B It shows FIG. 1A and FIG. 1B A perspective view of another alternative exemplary electrode portion of the medical device; FIG. 7C It shows FIG. 7A and FIG. 7B A cross-sectional view of the electrode portion;

[0023] According to various aspects of the present invention, FIG. 8 It shows FIG. 1A and FIG. 1B A perspective view of another alternative exemplary electrode portion of the medical device;

[0024] According to various aspects of the present invention, FIG. 9 It shows FIG. 1A and FIG. 1B A perspective view of another alternative exemplary electrode portion of the medical device;

[0025] According to various aspects of the present invention, FIG. 10A It shows FIG. 1A and FIG. 1B A side view of another alternative exemplary electrode portion of the medical device; and FIG. 10B It shows FIG. 10A A cross-sectional view of the electrode portion;

[0026] According to various aspects of the present invention, FIG. 11A and FIG. 11B It shows FIG. 1A and FIG. 1B A perspective view of another exemplary electrode portion of the medical device;

[0027] According to various aspects of the present invention, FIG. 12A and FIG. 12B It showsFIG. 1A and FIG. 1B A perspective view of another exemplary electrode portion of the medical device;

[0028] According to various aspects of the present invention, FIG. 13 It shows FIG. 1A and FIG. 1B A cross-sectional view of another exemplary electrode portion of a medical device;

[0029] According to various aspects of the present invention, FIG. 14A and FIG. 14B The executable functionality for forming is shown. FIG. 1A and FIG. 1B A cross-sectional view of the formation process of the electrode portion of a medical device;

[0030] According to various aspects of the present invention, FIG. 15A and FIG. 15B The executable functionality for forming is shown. FIG. 1A and FIG. 1B A cross-sectional view of the formation process of the electrode portion of a medical device;

[0031] According to various aspects of the present invention, FIG. 16A and FIG. 16B The executable functionality for forming is shown. FIG. 1A and FIG. 1B A cross-sectional view of the formation process of the electrode portion of a medical device. Detailed Implementation

[0032] Examples of the invention include apparatus and methods for: facilitating and improving the effectiveness, efficiency, and safety of treating and / or manipulating tissue when, for example, electrical energy is applied to tissue with electrodes; delivering fluid to the tissue and / or beneath the tissue during medical procedures via the distal end of the electrodes; and insulating the distal tip of the electrodes. For example, aspects of the invention can 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 with electrodes and to deliver fluid to the tissue and / or beneath the tissue using the same medical device. Aspects of the invention can provide a user with the ability to apply electrical energy or heat and deliver fluid, wherein the likelihood of damaging tissue or contacting unintended portions of tissue is reduced. Aspects of the invention can help a user penetrate a layer of tissue (e.g., the submucosa) to cause perforation. In these aspects, insulating portions of the device can help maintain separation between cut portions of the device. Furthermore, aspects of the invention include steps of manufacturing or otherwise forming one or more electrodes and / or distal tips of the medical device. Some aspects of the invention can be used to perform endoscopic surgery, laparoscopic surgery, arthroscopic surgery, gynecological endoscopic surgery, thoracoscopic surgery, cystoscopic surgery, or other types of surgery.

[0033] Reference will now be made in detail to the examples of the invention described above and shown in the accompanying drawings. Wherever possible, the same reference numerals will be used in all the drawings to refer to the same or similar parts.

[0034] The terms “proximal” and “distal” are used herein to refer to the relative locations of components of the exemplary medical device. When used herein, “proximal” means a location relatively closer to the exterior of the subject’s body or closer to a user, such as a medical professional, who holds or otherwise uses the medical device. Conversely, “distal” means a location relatively farther from a medical professional or another user who holds or otherwise uses the medical device, or closer to the interior of the subject’s body. As used herein, the terms “comprising,” “including,” “having,” “including,” or other variations thereof are intended to cover non-exclusive contents such that an apparatus or method comprising a list of elements includes not only those elements but may include other elements not expressly listed or not inherent to the apparatus or method. Unless otherwise stated, the term “exemplary” is used in the sense of “example” rather than “conventional.” As used herein, the terms “about,” “substantially,” and “approximately” indicate a range of values ​​within + / - 10% of the stated value.

[0035] FIG. 1A and FIG. 1B A medical device 10 is depicted, comprising 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 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 referred to as "electrode 26"). The electrode 26 is electrically connected to the hub 24 and, as discussed in detail below, may include a channel fluidly connected to or otherwise fluidly communicating with the port 22. Additionally, as... FIG. 1B As shown in the diagram and discussed in detail below, electrode 26 may include an insulating tip 28 that may at least partially surround the distal portion of electrode axis 30.

[0036] The medical device 10 can be inserted into the body cavity of a subject via an insertion device (not shown) or separately, such that at least a portion of the shaft 14 is inside the subject's body, while the handle 12 can be held outside the subject's body. The distal end 16 can be positioned at a target site inside the subject's body. From outside the subject's body, a user can manipulate the handle 12. Movement of the movable body 20 relative to the body 18 in a first direction (e.g., distal direction) can extend the electrode 26 relative to the shaft 14 (e.g., distally moving the electrode 26 relative to the distal end of the shaft 14), while movement of the movable body 20 relative to the body in a second direction (e.g., proximal direction) can retract the electrode 26 relative to the shaft 14 (e.g., proximally moving the electrode 26 relative to the distal end of the shaft 14). Although not shown, other components of the movable body 20 or the handle 12 can hinge the electrode 26 (or the electrode 26 and the distal end 16) to the left or right and / or up or down relative to the shaft 14.

[0037] Handle 12 can be connected to a fluid source (not shown) via port 22. Port 22 can be in fluid communication with electrode 26 via inner cavity 31, which can extend through handle 12. FIG. 1B ) and axis 14. It should be noted that, FIG. 1B The various portions of the handle 12 shown may not be drawn to scale in order to show the various portions of the handle 12 more comprehensively. In one aspect, the cavity 31 may extend longitudinally through the body 18 and shaft 14 of the handle 12 to fluidly connect port 22 to electrode 26. Port 22 may be located on a proximal portion of the body 18, for example, at the proximal end of the body 18. Alternatively, port 22 may be located on a distal or central portion of the body 18. Moreover, port 22 may include a check valve, Luer connector, seal, thread, and / or any suitable element to help maintain a secure connection between the handle 12 and the fluid source, minimize or prevent backflow (e.g., fluid flowing proximal out of port 22) and / or minimize or prevent leakage. In one example, the check valve may include a housing containing an internal elastomer and / or gel-like sealing member (not shown).

[0038] Handle 12 can be coupled to an energy source (not shown) via hub 24. Hub 24 may include one or more forks or pins 32 for coupling to the energy source. Hub 24 may be electrically coupled to electrode 26 via conductive element 33, which may be electrically coupled to pin 32 and extend through handle 12 and through at least a portion of shaft 14. The energy source may be an electrocautery source, a radio frequency generator, a heating source, a current generator, etc. In one aspect, medical device 10 may be used for monopolar electrosurgery and may include a return electrode located remotely from electrode 26 or otherwise adjacent to the subject. In another aspect, medical device 10 may be used for bipolar electrosurgery. In that case, electrode 26 may include an active electrode portion, and the return electrode may be located at or near electrode 26 and / or another portion of shaft 14. In one example, although not shown, two conductive elements may extend through shaft 14, wherein the conductive elements may be electrically isolated from each other, thereby allowing one conductive element to conduct energy to the active electrode while the other conductive element conducts energy from the return electrode.

[0039] Hub 24 may be positioned on body 18, for example, at the proximal end of body 18. In one aspect, port 22 may extend from the proximal end of body 18 in a direction parallel to the longitudinal axis of body 18, and hub 24 may extend from the proximal end of body 18 at an angle laterally (e.g., about 45 degrees) to the longitudinal axis of body 18. In another aspect, hub 24 may be positioned on the distal or central portion of body 18, or on movable body 20. Although not shown, body 18 and / or hub 24 may include one-way valves, Luer joints, seals, threads, and / or any suitable elements to help maintain a secure connection between handle 12 and power source, minimize or prevent backflow (e.g., fluid flowing from port 22 and / or cavity 31 and proximal out of hub 24) and / or minimize or prevent leakage.

[0040] exist FIG. 1B In one aspect shown, pin 32 may extend transversely to the longitudinal axis of handle 12 through hub 24 and may be electrically and physically connected to conductive element 33, such as wire, cable, and / or braided sheath. Conductive element 33 may be conductive or include conductive elements, and conductive element 33 may extend longitudinally through cavity 31 and through shaft 14. FIG. 1B As shown, fluid delivered through port 22 may surround at least a portion of the conductive element 33. In one aspect, the conductive element 33 may include one or more insulating layers to help insulate the conductive element 33 from the fluid in the cavity 31. As described above, a second conductive element (not shown) may be configured as a return path, wherein the medical device 10 has a bipolar configuration. Although not shown, in another aspect, the energy source may be part of the handle 12 (e.g., an internal battery in the handle 12).

[0041] 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. 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 the 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 can help the user grip the body 18. Additionally, the movable body 20 may include one or more ridges 37 that can help the user manipulate the movable body 20. The movable body 20 may be locked in one or more positions relative to the body 18, and / or may be spring-biased in one direction (e.g., toward a position retracted proximally).

[0042] The movable body 20 can be coupled to a driving element, and the driving element can impart distal or proximal movement to at least a portion of the electrode 26 based on the relative movement between the body 18 and the movable body 20. In one aspect, the conductive element 33 can also be used as a driving wire, rod, cable, etc., such that the conductive element 33 imparts distal or proximal movement to at least a portion of the electrode 26, while also coupling the electrode 26 to a hub 24, for example, one or more pins 32, to deliver energy to (and / or from) the electrode 26. FIG. 1B As shown, the movable body 20 can be coupled to the conductive element 33 via a coupling mechanism, such as a connector 38. In one aspect, the connector 38 can be physically coupled (directly or indirectly) to the movable body 20 and also physically coupled (directly or indirectly) to the conductive element 33 such that movement of the movable body 20 causes the conductive element 33 to extend or retract, and thus the electrode 26 to extend or retract. It should be noted that when the conductive element 33 and thus the electrode 26 are in the retracted or extended position, the connector 38 and / or other components within the handle 12 can help maintain the electrical connection between the pin 32 and the conductive element 33. Alternatively, in another aspect, when the conductive element 33 and thus the electrode 26 are in the extended position or at least partially extended, the connector 38 and / or other components within the handle 12 can be configured to electrically connect only the pin 32 and the conductive element 33.

[0043] like FIG. 1AAs shown, the handle 12 may also include one or more indicators, such as indicators 39A and 39B. For example, indicators 39A and 39B can visually indicate to the user the position of the electrode 26 relative to the shaft 14. The positions of indicators 39A and 39B can also correspond to the positions of the movable body 20. For example, indicator 39A can be positioned on the handle 12 at a position corresponding to the retracted position of the movable body 20, and can indicate that the electrode 26 is retracted relative to the shaft 14. Similarly, indicator 39B can be positioned on the handle 12 at a position corresponding to the extended position of the movable body 20, and can indicate that the electrode 26 is extended relative to the shaft 14.

[0044] As in FIG. 1A and FIG. 1B As shown, shaft 14 extends from a distal portion of body 18 to distal end 16 and may surround at least a portion of electrode 26. Shaft 14 may be a sheath surrounding at least a portion of one or more cavities (e.g., cavity 31) and drive wires (e.g., conductive element 33). In another aspect, shaft 14 may be a compression member that includes one or more cavities extending from handle 12 to distal end 16.

[0045] FIG. 1B The enlarged portion shows additional features of shaft 14 and distal end 16. Electrode 26 includes an insulated tip 28 surrounding the distal portion of electrode shaft 30. Electrode 26 may be positioned within a portion of end cap 42 of distal end 16. End cap 42 may include a distal surface 44 and graduated surfaces 46, 48, and 50. For example, the first graduated surface 46 may be located at the distalmost portion of end cap 42. FIG. 1B As shown, with shaft 14 coupled to distal end 16, the first graduated surface 46 of end cap 42 may protrude distally beyond shaft 14, while the second graduated surface 48 may be received within shaft 14. For example, a third graduated surface may be tapered to facilitate insertion of end cap 42 into shaft 14. In another example, shaft 14 may completely enclose the radial exterior of end cap 42. End cap 42 may be at least partially electrically insulated. For example, end cap 42 may be formed of a ceramic material or another non-conductive material. Alternatively, only the distal end face 44 and the interior of end cap 42 that contacts and / or surrounds electrode 26 may be electrically insulated. Distal end face 44 includes a central opening 52 through which electrode 26 extends and retracts.

[0046] Electrode 26 may be coupled to a proximal support 54 of distal end 16, which may include a cylindrical extension 56. Proximal support 54 may be coupled to a portion of a drive wire (e.g., conductive element 33) via a drive wire receiving portion 58. Cylindrical extension 56 may extend distally and may receive at least a portion of electrode 26. Electrode 26 and cylindrical extension 56 may be coupled via welding, adhesive, crimping, friction fit, or other suitable connection. In one aspect, cylindrical extension 56 may allow different electrodes 26 to be removably coupled to distal end 16. Proximal support 54 includes a support cavity 70, and support cavity 70 fluidly connects port 22 to electrode 26, for example, via a cavity (e.g., cavity 31) through shaft 14.

[0047] The proximal support 54 includes a proximal connection portion 72, which includes a drive wire receiving portion 58. The drive wire receiving portion 58 may be a notch extending parallel to at least a portion of the support cavity 70. The drive wire receiving portion 58 may receive a portion of a drive wire (not shown), and the drive wire and / or inner sheath 40 may be coupled to the movable body 20 such that movement of the movable body 20 toward the proximal support 54, and thereby imparting distal or proximal movement to the electrode 26. The drive wire may be coupled to the drive wire receiving portion 58 within the connection portion 72 by welding, adhesive, crimping, friction fit, or any other permanent or temporary connection. The proximal support 54 may also be coupled to the electrode 26 by welding, adhesive, crimping, friction fit, or any other permanent or temporary connection. In one aspect, the drive wire and the proximal support 54 are conductive to electrically connect one or more forks 32 of the hub 24 to the electrode 26. In another aspect, the proximal support 54 may be at least partially insulated and may include wires or other conductive elements for electrically connecting the drive wires to the electrode 26. Similarly, in one aspect, the drive wires may be at least partially insulated and may include wires or other conductive elements. Moreover, at least a portion of the drive wires may be located within the inner sheath 40. Alternatively, the drive wires may be located in a separate cavity within the shaft 14 (e.g., a cavity separate from the cavity penetrating the inner sheath 40).

[0048] End cap 42 includes a central portion 74 through which electrode shaft 30 can move during extension and retraction. End cap 42 may also include a narrow portion or stop surface 76 at the distal end of the central portion 74. Electrode shaft 30 may include a transition portion 78 between a first longitudinal portion 80 and a second longitudinal portion 82. Stop surface 76 and transition portion 78 may limit distal extension of electrode 26 through end cap 42. In the fully extended position, first longitudinal portion 80 may protrude from end cap 42 and may form an exposed portion that can be used for cutting or otherwise treating tissue. Additionally, although not shown, end cap 42 may be securely coupled to shaft 14 via welding, adhesive, crimping, friction fit, or other suitable coupling.

[0049] Electrode 26 and proximal support 54 can move relative to end cap 42 in response to relative movement of movable body 20 of handle 12 and body 18. For example, when movable body 20 is in a proximal position relative to body 18, electrode shaft 30 can be substantially retracted within end cap 42, with only the distal portion of electrode 26 (e.g., insulating tip 28) extending distally beyond end cap 42. Then, as movable body 20 translates distally relative to body 18, electrode 26 and proximal support 54 translate distally relative to end cap 42 such that a larger portion of electrode 26 (e.g., electrode shaft 30) extends distally beyond end cap 42 through central opening 52.

[0050] Alternatively, although not shown, the central opening 52 may be larger than the insulating tip 28, and in which the movable member 20 is in the closest position, the electrode 26 (including the insulating tip 28) may be fully retracted into the central opening 52 of the end cap 42. Moreover, in one aspect, the movable member 20 may have a balanced position relative to the body 18, and this balanced position may correspond to the electrode shaft 30 extending from the end cap 42 portion.

[0051] like FIG. 1B As shown in the enlarged portion, the electrode shaft 30 includes a distal tip 60 and a longitudinal portion 62. The distal tip 60 and the longitudinal portion 62 may be formed by a first longitudinal portion 80. The distal tip 60 may be received within and covered by the insulating tip 28, and the longitudinal portion 62 may be proximal to the insulating tip 28 and not covered by the insulating tip 28.

[0052] The electrode shaft 30 also includes an electrode shaft cavity 64 extending through the electrode shaft 30, for example, extending longitudinally through the central portion of the electrode shaft 30. The electrode shaft cavity 64 is in fluid communication with the port 22 via a support cavity 70 through a proximal support 54. In one aspect, an inner sheath 40 may form at least a portion of the fluid connection between the cavity 70 and the port 22. Additionally, the electrode shaft cavity 64 is in fluid communication with an insulating tip cavity 28C to form a channel for delivering fluid from the distal end of the electrode 26.

[0053] like FIG. 1B As shown, the insulating tip 28 may include a distal end 28A and a side portion 28B. The distal end 28A may be circular, for example, substantially hemispherical, and the side portion 28B may include straight sides, for example, may be substantially cylindrical. In one aspect, the shape of the distal end 28A and the side portion 28B may help to make the distal end 16 non-invasive and / or help to abut, position, manipulate, or otherwise treat tissue, while the electrode 30 may be used to cut, dissect, ablate, mark, coagulate, cauterize, or otherwise treat tissue. However, the invention is not limited thereto, and the insulating tip 28, including the distal end 28A and the side portion 28B, may include other shapes. For example, the insulating tip 28 may be truncated conical, tapered, chamfered, rounded, beveled, or a combination thereof. In one aspect, the insulating tip 28 completely surrounds or covers the distal portion of the electrode shaft 30 (e.g., the distal tip 60). For example, the insulating tip 28 may cover about one-quarter of the length of the first longitudinal portion 80 of the electrode shaft 30. In another example, the insulating tip 28 may cover approximately one-third or half the length of the first longitudinal portion 80 of the electrode shaft 30. In this aspect, the insulating tip 28 may provide insulation from the distal portion of the electrode shaft 30 and at least a portion of the tissue adjacent to the insulating tip 28. For example, the insulating tip 28 may abut against the tissue, and the electrode shaft 30 may be energized, while the insulating tip 28 helps to insulate the tissue against which the insulating tip 28 abuts. Moreover, the insulating tip 28 may receive the distal tip 60 along the longitudinal axis within approximately half of the insulating tip 28, which can help to securely connect the insulating tip 28 and the electrode 30. Additionally, approximately half of the insulating tip 28 may extend distally beyond the distal tip 60, which can help to insulate the tissue adjacent to the distal portion 28A of the insulating tip 28 when the electrode 30 is energized.

[0054] As discussed below, the insulating tip 28 and the electrode shaft 30 can be physically connected, for example, via one or more of soft soldering, hard soldering, welding, bonding, or one or more other connection mechanisms. Furthermore, the insulating tip 28 and the electrode shaft 30 form a fluid channel extending through both to deliver (e.g., inject) fluid to a target site (e.g., to elevate, separate, flush, or otherwise treat tissue within or between tissue layers). The electrode shaft 30 can be energized, and the exposed portion of the electrode shaft 30 (e.g., longitudinal portion 62) can be used to cut, dissect, ablate, mark, coagulate, burn, or otherwise treat tissue.

[0055] FIG. 2A and FIG. 2B Another aspect of the electrode 26, which can form part of the medical device 10, is shown. FIG. 2A A side view of electrode 26 is shown, and FIG. 2B A cross-sectional view of electrode 26 is shown. As mentioned, electrode 26 includes an insulating tip 28 surrounding electrode axis 30. The insulating tip 28 may include a distal portion 28A and a side portion 28B. FIG. 1B and FIG. 2B As shown, the insulating tip 28 includes an insulating tip cavity 28C. In this aspect, fluid delivered through the electrode shaft cavity 64 can be delivered distally through the insulating tip cavity 28C. In one aspect, the electrode shaft cavity 64 and the insulating tip cavity 28C may have substantially the same dimensions. In another aspect, the electrode shaft cavity 64 and the insulating tip cavity 28C may be tapered distally such that the distal portion of the cavity is narrower than the proximal portion. Alternatively, the electrode shaft cavity 64 and the insulating tip cavity 28C may be tapered proximally such that the proximal portion of the cavity is narrower than the distal portion. In these aspects, changing the dimensions of the electrode shaft cavity 64 and the insulating tip cavity 28C can help increase or decrease the pressure of the fluid delivered through the fluid channel. The distal portion 28D of the insulating tip cavity 28C may include a chamfered or angled portion, which can help disperse, guide, or otherwise deliver the fluid to a target site, thereby reducing the likelihood of tissue damage. Additionally, the distal end 28A of the insulating tip 28 may include an inner surface 28E. When the insulating tip 28 and the electrode 30 are connected together, the distal end face of the electrode 20 can abut against the inner surface 28E.

[0056] As mentioned, the electrode shaft 30 may include a transition portion 78, a first longitudinal portion 80, and a second longitudinal portion 82. In one aspect, the distal portion of the electrode shaft 30 (e.g., the first longitudinal portion 80) may include a uniform width. In another aspect, and as in... FIG. 4B and FIG. 4CAs shown, the distal end of the distal portion of the electrode shaft 30 may include an increased thickness (e.g., a widened end 292) relative to the remaining distal portion of the electrode shaft 30.

[0057] As in FIG. 2B As shown, the insulating tip 28 can be coupled to the distal portion of the electrode shaft 30 via solder 66. In one aspect, the insulating tip 28 may include a gap 68, such as a radial notch or cut, within the radial interior 28F of the insulating tip 28. The gap 68 may occupy approximately one-quarter of the longitudinal length of the insulating tip 28. In this aspect, the insulating tip 28 can be coupled to the electrode shaft 30 by placing molten solder 66 in the gap 68 and then inserting the electrode shaft 30 into the insulating tip 28. The solder 66 helps to connect the insulating tip 28 and the electrode shaft 30. Additionally, as in... FIG. 2B As shown, the radial interior 28F forming the insulating tip cavity 28C can transition from a wider proximal cavity (e.g., where the insulating tip 28 overlaps with the electrode shaft 30) to a narrower distal cavity (e.g., where the insulating tip 28 does not overlap with the electrode shaft 30). In this respect, the transition can correspond to the distal end of the gap 68 and can also help form a stop surface for the distal end face of the distal tip 60 against the inner surface 28E of the insulating tip 28.

[0058] The insulating tip 28 may be formed of ceramic (e.g., zirconium oxide, zirconium-containing alloys (e.g., ZrO2), alumina (Al2O3), ceramic alloys, etc.), polymeric materials (e.g., fluoropolymers, polyetheretherketone (PEEK), etc.), or another medically safe, heat-resistant, and non-conductive material. The electrode shaft 30 may be formed of a conductive material, such as stainless steel (e.g., 316L stainless steel), titanium, or another medically safe and conductive material. In one aspect, the electrode shaft 30 may include a surface finish, for example, passivation according to ASTM A967 Nitric 2.

[0059] Although not shown, electrode 26 may include an electrode plate. The electrode plate may be positioned near the side of side 28B and / or may surround a portion of electrode shaft 30 just near the insulating tip 28. In one aspect, the electrode plate may be conductive and energized when electrode shaft 30 is energized. In another aspect, the electrode plate may be non-conductive. In either aspect, the electrode plate may help support the insulating tip 28 and / or electrode shaft 30, and / or help connect the insulating tip 28 to electrode shaft 30.

[0060] Various portions of the insulating tip 28 may include a height and width, for example, as measured relative to the longitudinal axis of the insulating tip 28. The insulating tip 28 may include a width of about 2.0 to 3.0 mm, for example, about 2.2 mm (e.g., at the proximal end of side 28B). The insulating tip 28 may have a height of about 2.0 mm to 3.0 mm, for example, about 2.1 mm (e.g., from the proximal end of side 28B to the distal end face of distal end 28A). For example, the distal end 28A of the insulating tip 28 may be circular (e.g., substantially hemispherical) and may include a radius of about 0.5 mm to 2.0 mm, for example, about 1.1 mm. In another aspect, and as follows related to… FIG. 6A to FIG. 6C as well as FIG. 7A to FIG. 7C As discussed in detail, the insulating tip 28 may include a cylindrical tip portion or another shape. The side portion 28B may have a height of about 0.5 to 1.0 mm, for example, about 0.9 mm. If the electrode 26 includes an electrode plate (not shown), the electrode plate may include a height of 0.05 to 0.2 mm, for example, about 0.1 mm.

[0061] In other words, such as FIG. 2B As shown, the wider portion of the insulating tip cavity 28C formed by the radial interior 28F (e.g., where the insulating tip 28 overlaps with the electrode shaft 30) may include a height of about 0.5 to 1.5 mm, for example, about 1.0 mm, and the narrower portion of the insulating tip cavity 28C (e.g., where the insulating tip 28 does not overlap with the electrode shaft 30) may include a height of about 0.5 to 1.5 mm, for example, about 1.0 mm. The wider portion of the insulating tip cavity 28C formed by the radial interior 28F (e.g., where the insulating tip 28 overlaps with the electrode shaft 30) may include a width of about 0.3 to 0.7 mm, for example, about 0.5 mm, and the narrower portion of the insulating tip cavity 28C (e.g., where the insulating tip 28 does not overlap with the electrode shaft 30) may include a width of about 0.2 to 0.5 mm, for example, about 0.3 mm. As mentioned, the distal portion 28D may include a chamfered or angled portion that transitions from a narrower cavity width, for example, about 0.3 mm, to a wider width, for example, about 0.37 mm. In this respect, the chamfered or angled portion of the distal portion 28D may include an angle of about 60 degrees relative to the longitudinal axis.

[0062] Various portions of the electrode shaft 30 may include height and width, for example, as measured relative to the longitudinal axis of the electrode shaft 30. The electrode shaft 30 may include a total height of about 4.0 to 6.0 mm, for example, about 5.2 mm. The first longitudinal portion 80 may include a height of about 2.0 to 4.0 mm, for example, about 3.0 mm. The second longitudinal portion 82 may include a height of about 1.0 to 2.0 mm, for example, about 1.7 mm. The transition portion 78 may include a height of about 0.2 to 1.0 mm, for example, about 0.5 mm. The first longitudinal portion 80 may include a width of about 0.4 to 0.7 mm, for example, about 0.5 mm. The second longitudinal portion 82 may include a width of about 0.5 to 0.7 mm, for example, about 0.6 mm. In this aspect, the transition portion 78 may include an angle of about 7 degrees relative to the longitudinal axis. In one aspect, the electrode shaft cavity 64 and the insulating tip cavity 28C may have substantially the same width (e.g., in a direction transverse to the longitudinal axis of the electrode shaft cavity 64 and the insulating tip cavity 28C). For example, the electrode shaft cavity 64 and the insulating tip cavity 28C may include a constant width of about 0.3 mm. In this aspect, the second longitudinal portion 82 may include a radial thickness of about 0.5 mm (e.g., from the radial outside to the radial inside defining the electrode shaft cavity 64), and the first longitudinal portion 80 may include a radial thickness of about 0.3 mm (e.g., from the radial outside to the radial inside defining the electrode shaft cavity 64).

[0063] FIG. 3A and FIG. 3B A view of another electrode 126, similar to electrode 26, is shown, with similar elements indicated by reference numeral 100. As shown, electrode 126 includes an insulating tip 128 and an electrode shaft 130. The insulating tip 128 may include a distal portion 128A, which may be circular; and a side portion 128B, which may be cylindrical. FIG. 3A and FIG. 3BIn the aspects shown, the insulating tip 128 and the electrode shaft 130 can be joined via brazing, for example, by melting and flowing a filler metal (e.g., aluminum-silicon, copper, copper-silver, copper-zinc (brass), copper-tin (bronze), gold, gold-copper, gold-nickel, gold-chromium, gold-silver, nickel alloy, silver, amorphous brazing foil using nickel, iron, copper, silicon, boron, phosphorus and / or other materials) between the insulating tip 128 and the electrode shaft 130 (e.g., by capillary action). Brazing may also include an initial step of sputtering the insulating tip 128 with a material that aids adhesion (e.g., Cr, Mo, Ti, etc.). The insulating tip 128 and the electrode shaft 130 can also be joined by applying a filler material using ink (e.g., molybdenum-manganese based ink) and subsequently by using an active brazing alloy. Once the insulating tip 128 and the electrode shaft 130 are connected, they form a fluid connection through the electrode shaft cavity 164 and the insulating tip cavity 128C to deliver fluid to the target site, as discussed above. Furthermore, the exposed portion of the electrode shaft 130 can be energized to treat tissue, while the insulating tip 128 covers and insulates the distal portion of the electrode shaft 130, which helps prevent or minimize damage and / or unintended contact with tissue.

[0064] The filler metal (not shown) may have a lower melting point than the material forming the insulating tip 128 and the electrode shaft 130. In one aspect, the insulating tip 128 may be positioned on the distal portion of the electrode shaft 130 (or the electrode shaft 130 may be inserted into the insulating tip 128) such that the electrode shaft 130 abuts against the inner surface 128E of the insulating tip 128. Then, for example, the filler metal, heated to a temperature slightly above its melting temperature (e.g., its liquidus temperature), may flow on the outer surface of the electrode shaft 130 and / or the inner surface of the insulating tip 128. In another example, the filler metal may flow on the outer surface of the electrode shaft 130 and / or the inner surface of the insulating tip 128, and subsequently the insulating tip 128 may be positioned on the distal portion of the electrode shaft 130 (or the electrode shaft 130 may be inserted into the insulating tip 128) such that the electrode shaft 130 abuts against the inner surface 128E of the insulating tip 128. In the above aspects, cooling of the filler metal helps to physically bond the insulating tip 128 and the electrode shaft 130.

[0065] It should be noted that, FIG. 3A and FIG. 3B In the aspects shown, the insulating tip 128 may not include, as in FIG. 2A and FIG. 2BThe gap 68 in the insulating tip 28. Conversely, filler metal can connect the inner surface of the insulating tip cavity 28C to the outer surface of the electrode 130 at the joint 184. In this respect, the joint 184 (or the space between the inner surface of the insulating tip cavity 28C and the outer surface of the electrode shaft 130 filled with filler) can be about 0.1 mm or less, for example, about 0.03 to 0.08 mm.

[0066] FIG. 4A to FIG. 4C A view of another electrode 226, similar to electrode 26, is shown, with similar elements indicated by reference numeral 200. As shown, electrode 226 includes an insulating tip 228 and an electrode shaft 230.

[0067] The insulating tip 228 may be formed by two halves 228' and 228" . Half 228' may include a partially circular distal portion 228A' (e.g., a quarter of a sphere) and a partially cylindrical side portion 228B', and half 228" may include a partially circular distal portion 228A (e.g., a quarter of a sphere) and a partially cylindrical side portion 228B". Halfs 228' and 228" may be divided along a longitudinal centerline 290. For example, as in FIG. 4B As shown, halves 228', 228" can be separated. Halfs 228', 228" can be positioned around the distal portion of electrode shaft 230 (e.g., distal tip 260) and can be bonded or joined together, for example, via soldering (although not shown, it may include one or more gaps to receive solder, as per [reference to...]). FIG. 2A and FIG. 2B (as discussed), such as regarding FIG. 3A and FIG. 3B The brazing, welding, one or more adhesives, or any other joining mechanism discussed may be used. In one aspect, the joining halves 228', 228" surrounding the distal portion of the electrode shaft 230 may also join the halves 228', 228" (and thus the insulating tip 228) to the electrode shaft 230. Alternatively or additionally, the halves 228', 228" may be joined to the electrode shaft 230 individually or together via any of the aforementioned joining mechanisms.

[0068] In one aspect, such as FIG. 4B and FIG. 4CAs shown, the distal end of the electrode shaft 230 may include a widened end portion 292. The halves 228', 228" of the insulating tip 228 may each include a groove 294 to receive at least a portion of the widened end portion 292. For example, the widened end portion 292 may be a generally cylindrical extension extending radially outward relative to the longitudinal axis of the electrode 230. In one aspect, the widened end portion 292 may include a flat distal end and a curved proximal end. The halves 228', 228" of the insulating tip 228 may each include a groove 294 to receive portions (e.g., halves) of the widened end portion 292. Each groove 294 in the halves 228', 228" may include a shape corresponding to the shape of the widened end portion 292.

[0069] The insulating tip 228 (e.g., formed by the joined halves 228', 228") may include an insulating tip cavity 228C having a proximal portion 296 and a distal portion 298. A recess 294 may be positioned between the proximal portion 296 and the distal portion 298. The proximal portion 296 may be wider than the distal portion 298. FIG. 4B and FIG. 4C As shown, the groove 294 may be wider than the proximal portion 296 (e.g., extending further radially away from the longitudinal axis of the insulating tip 228). The distal portion 298 may have approximately the same width as the electrode shaft cavity 264, and the distal portion 298 and the electrode shaft cavity 264 may form a fluid channel. Furthermore, the insulating tip cavity 228C may terminate distally at the distal portion 228D, which may include beveled or angled portions, as mentioned above. The dimensions of the groove 294, proximal portion 296, and distal portion 298 may be configured to accommodate any shape or configuration of the electrode 230 such that the distal tip 260 can be received within the insulating tip 228. Additionally, in some aspects, the dimensions of portions of the insulating tip 228 (e.g., the groove 294 and proximal portion 296) may be configured to form a space between the overlapping portions of the insulating tip 228 and the electrode 230, for example, to help accommodate differences in the coefficients of thermal expansion between the materials of the electrode 230 at the insulating tip 228.

[0070] Once the insulating tip 228 and the electrode shaft 230 are coupled, they form a fluid channel through the electrode shaft cavity 264 and the insulating tip cavity 228C to deliver fluid from the distal end of the electrode 226 to the target site and / or tissue, as discussed above. Furthermore, the exposed portion of the electrode shaft 230 can be energized to treat tissue, while the insulating tip 228 covers the distal portion of the electrode shaft 230 (e.g., distal tip 260), which helps prevent or minimize damage and / or unintended contact with tissue.

[0071] FIG. 5A and FIG. 5BA view of another electrode 326, similar to electrode 26, is shown, with similar elements indicated by reference numeral 300. As shown, electrode 326 includes a tip 328 and an electrode shaft 330, the size and shape of which may be similar to the insulating tip and electrode shaft discussed above. For example, tip 328 may include a distal portion 328A and a side portion 328B. Furthermore, insulating layer 303 may cover at least a portion of tip 328, thereby forming the exterior of tip 328. It should be noted that in the aspects discussed below, tip 328 (other than insulating layer 303) may be formed of a conductive material, and insulating layer 303 may include an insulating material and may insulate at least a portion of tip 328, and thus also insulate the distal portion of electrode 326.

[0072] The electrode shaft 330 may include a tapered transition portion 378 between a first longitudinal portion 380 and a second longitudinal portion 382. The first longitudinal portion 380 has a smaller outer diameter than the second longitudinal portion 382, ​​and the first longitudinal portion 380 and the second longitudinal portion 382 may have the same inner diameter. Additionally, the electrode 326 may include an electrode plate 301 positioned near the side of the side portion 328B and surrounding a portion of the electrode shaft 330. The electrode plate 301 may be substantially circular and cover the entire near end face of the top end 328, or may cover a portion of the near end face of the top end 328. The electrode plate 301 may be conductive and energized when the electrode shaft 330 is energized, as discussed above.

[0073] like FIG. 5B As shown, the tip 328 includes a tip cavity 328C, and the electrode shaft 330 includes an electrode shaft cavity 364. Fluid can be delivered through the electrode shaft cavity 364 and the tip cavity 328C to deliver fluid distally, for example, from the distal portion 328D, as discussed above. It should be noted that even though the insulating layer 303 covers at least a portion of the tip 328, the insulating layer 303 does not cover the distal portion 328D.

[0074] like FIG. 5BAs shown, a portion of the tip 328 (excluding the insulating layer 303) and the electrode shaft 330 can be formed from a single piece of material, such as stainless steel. Alternatively, although not shown, a portion of the tip 328 and the electrode shaft 330 can be made of different materials, such as different metal blocks, and the tip 328 and the electrode shaft 330 can be welded (e.g., laser welded) together or otherwise joined together. In one aspect, forming a portion of the tip 328 and the electrode shaft 330 from the same material can, for example, disconnect the ceramic insulating tip from the metal electrode shaft, which helps prevent failure and / or reduce the chance of failure between the tip 328 and the electrode shaft 330. In another aspect, welding the tip 328 and the electrode shaft 330 together also helps prevent failure and / or reduce the chance of failure between the tip 328 and the electrode shaft 330.

[0075] The insulating layer 303 may be deposited on the exterior of a portion of the top end 328. For example, the insulating layer 303 may be deposited via physical vapor deposition (e.g., sputtering), chemical vapor deposition, micro-arc oxidation, sol-gel coating, thermal spraying (e.g., cold spraying, warm spraying, arc spraying), electrodeposition, electrolytic deposition, electrophoretic deposition, high-velocity oxygen fuel coating, plasma spraying, powder coating and varnishing, laser-based deposition of one or more powders, or another coating mechanism. The insulating layer 303 may be from about 0.5 to 500 micrometers thick, for example, about 300 micrometers thick. In one aspect, the thickness of the insulating layer 303 may be based at least in part on the dielectric properties of the insulating material, breakdown voltage requirements, and / or one or more other parameters. For example, the minimum thickness of the insulating layer 303 may be approximately equal to the maximum applied voltage divided by the dielectric breakdown strength of the material. In this example, the alumina has a dielectric breakdown strength of about 13.4 MV / m (or 13.4 V / micrometer). Therefore, if electrode 326 is configured to and / or capable of delivering a maximum voltage of approximately 5000 volts, the minimum thickness of insulating layer 303 will be approximately 373 micrometers. Similarly, if electrode 326 is configured to and / or capable of delivering a maximum voltage of approximately 500 volts, the minimum thickness of insulating layer 303 will be approximately 37.3 micrometers.

[0076] When the electrode shaft 330 (including the interior of the tip 328) is energized, the insulating layer 303 can insulate at least a portion of the tip 328. In one aspect, such as FIG. 5A and FIG. 5BAs shown, insulating layer 303 may be deposited over an entire portion of the tip 328, thereby forming the exterior of tip 328 except for the proximal end face of tip 328. In another aspect, although not shown, insulating layer 303 may be deposited only on the distal portion, for example, on the distal end 328A of tip 328. In yet another aspect, although not shown, insulating layer 303 may be deposited over an entire portion of tip 328, thereby forming the exterior of tip 328, including the proximal end face of tip 328. In these aspects, electrode 326 may not include electrode plate 301, or electrode plate 301 may be positioned proximal to the insulating layer 303 on the proximal end face of tip 328.

[0077] The insulating layer 303 may be formed of ceramics (e.g., zirconium oxide, zirconium-containing alloys (e.g., ZrO2), alumina (Al2O3), ceramic alloys, etc.). Alternatively or additionally, the insulating layer 303 may be formed of polymeric materials (e.g., fluoropolymers, polyetheretherketone (PEEK), etc.) or another biocompatible, heat-resistant, and non-conductive material, such as, for example, glass (silicon-based, boron-based, etc.).

[0078] FIG. 6A to FIG. 6C A view of another electrode 426, similar to electrode 26, is shown, with similar elements indicated by reference numeral 400. As shown, electrode 426 includes a tip 428 and an electrode shaft 430. The size and shape of the electrode shaft 430 may be similar to those discussed above. Additionally, electrode 426 may include an electrode plate 401 positioned near the proximal side of tip 428. As shown, tip 428 may be substantially cylindrical. For example, tip 428 may include a distal side 428A and a side portion 428B. Insulating layer 403 may cover at least a portion of tip 428, thereby forming an outer layer of tip 428.

[0079] As discussed above, at least a portion of the tip 428 and the electrode shaft 430 can be formed of the same material or can be joined together (e.g., via laser welding). FIG. 6C As shown, tip 428 includes tip cavity 428C, and electrode shaft 430 includes electrode shaft cavity 464. Fluid can be delivered through electrode shaft cavity 464 and tip cavity 428C to deliver fluid distally, for example, from distal portion 428D, as discussed above. Furthermore, insulating layer 403 may cover at least a portion of tip 428 and insulate it, as discussed above. The distal corner 405 of insulating layer 403 may be non-invasive, for example, rounded or otherwise smooth, to help prevent or minimize damage to tissue. Alternatively, although not shown, at least a portion of the distal facet of tip 428 may not include insulating layer 403 to expose the conductive material of tip 428. For example, a portion of distal facet 428A may not include insulating layer 403.

[0080] In one aspect, the tip 428 may comprise approximately one-eighth to one-quarter of the total height of the electrode 426. For example, the electrode 426 may comprise a total height of approximately 4.0 to 6.0 mm, such as approximately 5.2 mm, and the tip 428 may comprise a total height of approximately 0.5 to 1.5 mm, such as approximately 0.9 mm. The electrode shaft 430 may comprise the remaining height of the electrode 426.

[0081] FIG. 7A to FIG. 7C A view of another electrode 526, similar to electrode 26, is shown, with similar elements indicated by reference numeral 500. As shown, electrode 526 includes a tip 528 and an electrode shaft 530. The size and shape of the electrode shaft 530 may be similar to those discussed above. Additionally, electrode 526 may include an electrode plate 501 positioned near the proximal side of tip 528. As shown, tip 528 may be substantially cylindrical. For example, tip 528 may include a distal side 528A and a side portion 528B. Insulating layer 503 may cover at least a portion of tip 528, thereby forming an outer layer of tip 528.

[0082] Additionally, the tip 528 may be larger, for example, having a greater height in the longitudinal direction than the tip 428. For example, the electrode 526 may include a total height of about 4.0 to 6.0 mm, for example, about 5.2 mm, and the tip 528 may include a total height of about 1.0 to 3.0 mm, for example, about 2.0 mm. The electrode shaft 530 may include the remaining height of the electrode 526. As a result, the tip 528, having an insulating layer 503 forming the outer layer of the tip 528, can insulate a larger portion of the electrode 526, extending further distally from the distal end of the shaft 14 when coupled to the medical device 10, and / or extending further distally beyond the electrode shaft 530. When the electrode 526 is energized, one or more of these features can help insulate tissue from the electrode 526.

[0083] FIG. 8 Another electrode 626, similar to electrode 26, is shown, with similar elements indicated by reference numeral 600. As shown, electrode 626 includes a tip 628 and an electrode shaft 630. As discussed above, an insulating layer 603 may cover at least a portion of the tip 628, thereby forming an outer layer of the tip 628. Furthermore, electrode 626 includes an electrode plate 601.

[0084] As shown in the figure, the electrode plate 601 can be substantially triangular, for example, comprising three points 607. The points 607 of the electrode plate 601 can be circular, which can help prevent or reduce damage to tissue. Alternatively, the electrode plate 601 can be an equilateral triangle (as shown in the figure), or it can be another arrangement, for example, where the two points 607 are closer together than the distance between the two points 607 and the third point 607. FIG. 8 As shown, point 607 can be substantially aligned with the edge of tip 628. In this way, when tip 628 includes an insulating layer 603 forming the exterior of tip 628 and the edge of tip 628 is adjacent to tissue, one or more points 607 can contact the tissue when electrode 630 and thus electrode plate 601 is energized, for example, to mark tissue. Alternatively, one or more points 607 can be located radially within the edge of tip 628, which can help to insulate the tissue in contact with tip 628. In these respects, the exposed proximal portion 609 of tip 628 can be coated (e.g., by sputtering), wherein the insulating layer 603 forms the exterior of tip 628 on the proximal portion 609.

[0085] FIG. 9 Another electrode 726, similar to electrode 26, is shown, with similar elements indicated by reference numeral 700. As shown, electrode 726 includes a tip 728 and an electrode shaft 730. As discussed above, an insulating layer 703 may cover at least a portion of the tip 728, thereby forming an outer layer of the tip 728. Furthermore, electrode 726 includes an electrode plate 701.

[0086] As shown in the figure, the electrode plate 701 can be substantially star-shaped, for example, comprising five, six (as shown), seven or more points 707. Alternatively, the electrode plate 701 can be star-shaped with the points 707 evenly spaced (as shown), or it can be arranged in another way, for example, with two or more points 707 positioned closer together compared to the spacing of other points 707. The points 707 of the electrode plate 701 can be circular, which can help prevent or reduce damage to tissues. FIG. 9 As shown, point 707 can be substantially aligned with the edge of tip 728. In this way, when tip 728 includes an insulating layer 703 forming the exterior of tip 728 and the edge of tip 728 is adjacent to tissue, one or more points 707 can contact the tissue when electrode 730 and thus electrode plate 701 is energized, for example, to mark tissue. Alternatively, one or more points 707 can be located radially within the edge of tip 728, which can help to insulate the tissue in contact with tip 728. In these respects, the exposed proximal portion 709 of tip 728 can be coated (e.g., by sputtering), wherein the insulating layer 703 forms the exterior of tip 728 on the proximal portion 709.

[0087] Electrode plates 601 and 701 can be connected to any of the electrodes discussed herein. As mentioned, electrode plates 601 and 701 can be conductive and can be energized when the respective electrodes are energized. In addition to electrode plates 601 and 701 discussed above, it is conceivable that any of the electrodes disclosed herein may include electrode plates of various shapes. For example, although not shown, electrodes may include square electrode plates, pentagonal electrode plates, hexagonal electrode plates, etc.

[0088] FIG. 10A and FIG. 10B A view of another electrode 826, similar to electrode 26, is shown, with similar elements indicated by reference numeral 800. Electrode 826 includes a tip 828 and an electrode shaft 830. FIG. 10B As shown, electrode 826 includes a fluid delivery channel formed by electrode shaft cavity 864 and tip cavity 828C. In one aspect, tip 828 may be partially spherical (e.g., in...). FIG. 10B In the cross-sectional view shown, the portion is circular. Although not shown, the tip 828 may include an insulating layer forming the exterior of the tip 828, as discussed above.

[0089] Electrode 826 can be formed by an extrusion process. In this respect, the electrode can be formed by pushing hot metal through an extrusion die to form a shaft 830. The electrode can then be pressed or joined against the die, such that a portion of the extrusion is forced outward to form a widened portion, such as a tip 828. Additionally, although not shown, electrode 826 may include an insulating layer, for example, on the outer surface of tip 828.

[0090] FIG. 11A and FIG. 11B A view of another electrode 926, similar to electrode 26, is shown, with similar elements indicated by reference numeral 900. FIG. 11A Electrode 926 is shown in the intermediate manufacturing step, and FIG. 11B The completed electrode 926 is shown. Electrode 926 includes a tip 928 and an electrode shaft 930. The electrode shaft 930 may be substantially cylindrical and / or may include one or more profiles discussed above. Electrode 926 includes a fluid delivery channel formed by an electrode shaft cavity (not shown) and a tip cavity 928C. The tip 928 includes a distal end 928A, and as... FIG. 11B As shown, insulating portion 903 may cover at least a portion of the side of tip 928. For example, insulating portion 903 may include multiple insulating layers deposited on at least a portion of tip 928, as discussed above. Alternatively or additionally, insulating tip (e.g., having the shape discussed herein) may be coupled to distal end 928A.

[0091] In one aspect, such as FIG. 11A As shown, electrode 926 can be formed as a single material part, as discussed above. One or more masks 911 can be positioned on and / or around electrode 926 at various locations. Electrode 926 with masks 911 on and / or around it can then be exposed to a deposition process, such as sputtering, to deposit one or more insulating materials on the exposed portion 913. The insulating material can be formed into a uniform, impermeable insulating film or layer. In one aspect, the insulating material can include a permeable film comprising sufficiently small dimensions to prevent fluids and thus prevent charge penetration or otherwise through the insulating material. The insulating material can be deposited in one or more layers, and the insulating material can match or substantially match the coefficient of thermal expansion and / or heat capacity of electrode 926 and / or the insulating tip that can be coupled to electrode 926. The insulating material can be one or more of metals, metal alloys, metal oxides (Al2O3, glass, etc.), and can be selected to help reduce or minimize thermal stress between electrode 926 and the insulating material. Furthermore, the thickness of the insulating material (film, layer, etc.) can depend on the dielectric strength and / or other properties of the insulating material.

[0092] Mask 911 helps prevent insulating material from depositing on the portion of electrode 926 covered by mask 911. Mask 911 can be annular or ring-shaped, covering a portion of electrode 926. For example, mask 911 can be formed of organic materials, such as, for example, polyimide, or inorganic materials, such as, for example, ceramics, metals, etc. The material forming mask 911 may depend on the coating process. Mask 911 can be attached to electrode 926 via one or more methods. For example, mask 911 can be attached to electrode 926 via a close-contact mechanical fastener, electroplated metal subsequently removed by etching, photoresist coating (e.g., coating via thin film fluid), adhesive (e.g., tape), impregnation coating, physical vapor deposition coating, chemical vapor deposition coating (or pyrene coating), etc. Alternatively or additionally, mask 911 can be attached to the entire electrode 926, and portions can be removed where not needed, for example, by laser etching, chemical etching, machining, grinding, etc. After the deposition process, the mask 911 can be removed, thereby forming an electrode 926 having an insulating portion 903 (derived from the deposited insulating material) and an uninsulated portion 915 (derived from the masked portion). The insulating portion 903 may be annular or ring-shaped, covering the unmasked portion of the electrode 926. The uninsulated portion 915 may be annular or ring-shaped, covering the masked portion of the electrode 926. The mask 911 may be longitudinally spaced along the length of the electrode 926, for example, along the length of the electrode axis 930. Thus, the insulating portions 903 and the uninsulated portions 915 may be longitudinally spaced along the length of the electrode axis 930. For example, adjacent uninsulated portions 915 may be separated by the insulating portions 903. Although not shown, the mask 911 may have any suitable shape and / or spacing to form an electrode 926 with an appropriate shape and / or spacing of the insulating portions 903 and the uninsulated portions 915. It should be noted that, although not shown, the distal end 928A and / or the tip cavity 928C may be masked or otherwise covered to help prevent the insulating layer 903 from blocking the tip cavity 928C.

[0093] like FIG. 11B As shown, in addition to the top 928, an insulating layer 903 may be deposited on one or more portions of the electrode 926. In this respect, reducing the uninsulated portions 915 of the electrode 926 can help control and / or reduce heat buildup on and / or around the electrode 926, which can help the user perform controlled cutting and / or otherwise treat tissue.

[0094] FIG. 12A and FIG. 12B A view of another electrode 1026, similar to electrode 26, is shown, with similar elements indicated by reference numeral 1000. FIG. 12A Electrode 1026 is shown in the intermediate manufacturing step, and FIG. 11BA completed electrode 1026 is shown. Electrode 1026 includes a tip 1028 and an electrode shaft 1030. The electrode shaft 1030 may be substantially cylindrical and / or may include one or more profiles discussed above. Electrode 1026 includes a fluid delivery channel formed by an electrode shaft cavity (not shown) and a tip cavity 1028C. Tip 1028 includes a distal end 1028A and a side portion 1028B, and an insulating portion 1003 may cover at least a portion of the side portion 1028B of tip 1028. For example, the insulating portion 1003 may be deposited on at least a portion of tip 1028, as discussed above. Alternatively or additionally, an insulating tip (e.g., having the shape discussed herein) may be coupled to distal end 1028A.

[0095] In one aspect, such as FIG. 12A As shown, electrode 1026 can be formed as a single material component, as discussed above. One or more masks 1011 can be positioned on and / or around electrode 1026 at one or more locations, and masks 1011 can help prevent insulating material from depositing on portions of electrode 1026 that are masked by masks 1011.

[0096] like FIG. 12A As shown, a mask 1011 may extend longitudinally and span the outer circumferential portion of the electrode 1026. For example, the mask 1011 may span approximately 15 to 90 degrees beyond the circumference of the electrode 1026, for example, the electrode axis 1030. In another aspect, the mask 1011 may span up to approximately 180 degrees beyond the circumference of the electrode 1026. Thus, when the electrode 1026 is exposed to the deposition process, an insulating portion 1003 may be formed, for example, by depositing one or more insulating layers on the portion of the electrode 1026 not covered by the mask 1011, for example, the exposed portion 1013, which may span approximately 180 to 345 degrees around the circumference of the electrode 1026. In this aspect, the insulating portion 1003 may form circumferential insulation and one or more uninsulated portions 1015. The uninsulated portions 1015 may span the entire length of the electrode 1026, or may only span a portion of the length of the electrode 1026. Furthermore, the dimensions and / or width of the mask 1011 can vary along the length of the electrode 1026 to form uninsulated portions 1015 of varying widths, such as when measured around a circumference. In these respects, the user can use the electrode 1026 and the uninsulated portions 1015 to perform controlled cutting and / or otherwise process tissue.

[0097] FIG. 13A partial cross-sectional view of another alternative electrode 1126, similar to electrode 26, is shown, with similar elements indicated by reference numeral 1100. Electrode 1126 includes a tip 1128 and an electrode shaft 1130. Electrode shaft 1130 includes an electrode shaft cavity 1164. Electrode shaft 1130 may be a conduit, such as a thiocyanate tube, which may be formed of a suitable material, such as stainless steel. As shown, tip 1128 may be secured within shaft 1130, for example, via circumferential laser welding member 1117 or another suitable coupling mechanism. For example, the proximal portion of tip 1128 may include a reduced diameter or width, and the proximal portion of tip 1128 may be positioned within shaft 1130. Tip 1128 may be formed of machined metal and may include a tip cavity 1128C fluidly connected to electrode shaft cavity 1164, as discussed above.

[0098] As shown below FIG. 14A , FIG. 14B , FIG. 15A , FIG. 15B , FIG. 16A and FIG. 16B As discussed, the tip 1128 may be formed to include a widened end 1192. The widened end 1192 may include a circular or spherical distal portion. The widened end 1192 may include a cross-sectional diameter or width greater than the cross-sectional diameter or width of the electrode shaft cavity 1164. At least a portion of the tip 1128 may be coated in an insulating material, as discussed above.

[0099] FIG. 14A and FIG. 14B One method for forming a widened end 1192 at the tip of the electrode is shown. For example, FIG. 14A A cross-sectional view of the top end 1128 without the widened end 1192 is shown, and FIG. 14B A cross-sectional view of a tip 1128 having a widened end 1192 is shown. One end of the tip 1128 can be coupled to a plug 1119, and the other end of the tip 1128 can be positioned within a mold 1121. The mold 1121 may include an internal shape corresponding to the desired shape of the widened end 1192. In one aspect, mechanical pressure can be applied to push a portion of the tip 1128 to conform to the shape of the mold 1121. For example, an incompressible material (e.g., rubber or other materials, for example, having a Poisson's ratio of about 0.5), a sacrificial compressible material, or a molding tool can be inserted into the portion of the tip 1128 within the mold 1121. Thus, as FIG. 14B As shown, a portion of the tip 1128 within the mold 1121 can expand radially outward to take the shape of the mold 1121. In another aspect, pressurized fluid can be delivered through the tip 1128, for example, as... FIG. 14AAs indicated by the arrow, the pressure from the fluid pushes a portion of the tip 1128 radially outward to form the shape of the mold 1121, as shown. FIG. 14B As shown in the diagram. Therefore, a portion of the top end 1128 within the mold 1121 can be formed into a widened end 1192. The widened end 1192 can be semi-circular, hemispherical, etc. However, it should be noted that the resulting shape of the widened end 1192 depends on the shape of the mold 1121. As discussed above, the insulating layer 1103 can be deposited on a portion of the top end 1128, for example, at least on the widened end 1192. FIG. 14B As shown, the insulating layer 1103 can also be deposited on the inner surface of the widened end 1192.

[0100] FIG. 15A and FIG. 15B Another method for forming the widened end 1192 is shown. For example, FIG. 15A A cross-sectional view of the top end 1128 without the widened end 1192 is shown, and FIG. 15B A cross-sectional view of the top end 1128 with a widened end 1192 is shown. FIG. 15A As shown, the tip 1128 may be forged or otherwise compressed to form the narrow portion 1123, as... FIG. 15A As indicated by the arrow, this leaves a width of 1125. Then, as... FIG. 15B As shown, a force can be applied to the wide portion 1125, for example, at the end of the wide portion 1125, such as... FIG. 15B As indicated by the arrow, a widened end 1192 is formed, which may be rounded. However, it should be noted that the applied force leaves an opening at the farthest end of the widened end 1192, for example, to allow fluid transport. As discussed above, an insulating layer (not shown) may be deposited on a portion of the top end 1128, for example, at least on the widened end 1192.

[0101] FIG. 16A and FIG. 16B Another method for forming the widened end 1192 is shown. For example, FIG. 16A A cross-sectional view of the top end 1128 without the widened end 1192 is shown, and FIG. 16B A cross-sectional view of the top end 1128 with a widened end 1192 is shown. FIG. 16A As shown, the top 1128 can be compressed, for example, as FIG. 16A Proceeding longitudinally as indicated by the arrow in the diagram to form a protrusion 1135, which is wider than the narrow ends 1141, 1143. Then, as... FIG. 16B As shown, as FIG. 16BThe force indicated by the arrow, for example, a cutting force, can be applied to the end of protrusion 1135 (e.g., at the interface or transition portion between protrusion 1135 and end 1141) to form a widened end 1192, which may be rounded. In one aspect, the cutting force can cut the end 1141 from protrusion 1135, and the cutting force can also bend and / or shape the electrode 1128 to include the widened end 1192. Alternatively, the cutting force can cut the end 1141 from protrusion 1135, and additional forces can subsequently be applied to protrusion 1135 to bend and / or shape the electrode 1128 to include the widened end 1192. However, as per [the relevant clause]... FIG. 15A and FIG. 15B As mentioned above, the applied force leaves an opening at the farthest end of the widened end 1192, for example, to allow fluid transport. As discussed above, an insulating layer (not shown) may be deposited on a portion of the top end 1128, for example, at least on the widened end 1192.

[0102] The aspects mentioned above allow electrode 1126 to include flared or widened ends 1192 without requiring separate additive or subtractive manufacturing processes. FIG. 13 to FIG. 16B The flared or widened end 1192 shown and discussed throughout the invention helps the user separate tissue or other materials from the cutting surface of the electrode 1126, which helps prevent or minimize damage and / or accidental contact between the electrode 1126 and the tissue. Furthermore, the above-described forming method can be modified to form widened ends 1192 of different sizes, shapes, etc.

[0103] Although the above aspects (including FIG. 13 to FIG. 16B While it has been discussed that the tip 1128 and the electrode shaft 1130 are separate components, it is conceivable that the tip 1128 and the electrode shaft 1130 can be integrally formed. For example, a single piece of material (e.g., a sodium hypochlorite tube) can be formed to have a shape corresponding to the electrode 1126, and only a portion of the electrode 1126, for example, the tip 1128 can be insulated with an insulating material. Moreover, the widened end 1192 of the tip 1128 can be formed by depositing an insulating material on the tip 1128. In another aspect, the widened end 1192 of the tip 1128 can be formed by adding material to the tip 1128 (e.g., by soldering, machining, etc.).

[0104] It should be noted that different electrodes can treat and / or manipulate tissue differently (e.g., based on electrode size and / or shape). For example, different electrodes can be attached to distal end 16 for different surgical procedures. In one aspect, a first electrode, such as electrode 326, may be useful for a first type of surgery, and a second electrode, such as electrode 426, may be useful for a second type of surgery. Similarly, a third electrode, such as electrode 526, may be useful for a third type of surgery. However, as discussed above with respect to electrode 26, the electrodes discussed herein can be used to treat or manipulate tissue (e.g., by delivering energy via the electrode axis) and deliver fluid distally, wherein the distal end of the electrode is insulated.

[0105] Electrodes and electrode shafts, including insulating tips (or tips having an insulating layer forming the exterior of the tip), help provide isolation or insulation between the distal portion of the electrode and the tissue at the target site. Additionally, various electrodes can help allow devices to be used to cut, dissect, ablate, label, or otherwise treat tissue, and can also deliver fluid to the target site. Fluid can be delivered distally from the distal end of the electrode to the target site. Furthermore, in at least some aspects, the fluid delivered to the target site can be non-conductive.

[0106] The various electrodes discussed herein are capable of modifying the physical properties of tissue by delivering energy (e.g., radiofrequency energy) upon contact with the tissue. The delivered energy can be monopolar or bipolar. The electrodes can be coupled to an axis configured to extend into a body cavity or chamber of the subject. The axis includes electrical components that traverse the axis and connect the electrodes to an energy source, for example, in or coupled to a handle.

[0107] As discussed, the electrode may also be coupled to an actuating member (e.g., movable body 20), for example, in or coupled to a handle, which allows the user to translate the electrode relative to an axis. The electrode can be translated between at least a first position and a second position, in which the cutting axis of the electrode (e.g., longitudinal portion 62) is retracted within the axis, and in the second position, the cutting axis extends beyond the axis and is exposed. In both the first and second positions, the distal portion including the insulating portion (e.g., the insulating tip 28 or the tip having an insulating layer forming an outer layer of the tip) may extend and be exposed outside the axis, rather than retracted within it. Moreover, the handle may allow the electrode to be positioned in one or more intermediate positions (i.e., positions where only a portion of the longitudinal portion 62 is exposed).

[0108] Therefore, the insulated distal end face (e.g., the insulated tip 28 or the tip with an insulating layer forming the outer layer of the tip) can abut against tissue and help prevent or minimize damage to tissue or accidental contact with the electrode. Users can also position the uninsulated electrode shaft against or in contact with tissue and apply energy to cut, dissect, ablate, mark, or otherwise treat tissue. The insulated tip can be coupled to the electrode shaft in various ways, allowing the insulated tip to be coupled to an existing uninsulated electrode shaft and subsequently used in surgery.

[0109] In one example, an electrosurgical generator coupled to (or within) a handpiece can generate various modes of received energy, such as radiofrequency energy in cutting, coagulation, etc., so that electrodes can deliver these different modes of energy to the tissue. In one aspect, the electrosurgical generator and / or handpiece may include one or more knobs, dials, buttons, etc., for selecting energy modes. Additionally, in one example, a fluid source (e.g., a saline source) coupled to the handpiece can provide fluid (e.g., saline) for delivery via electrodes to the tissue and / or target site. The fluid can be delivered at a constant rate, pulse rate, user-controlled rate, etc. In these aspects, one or more of the energy delivery and / or fluid delivery can be controlled by one or more actuators (e.g., triggers, buttons, touchscreens, foot pedals, etc.).

[0110] The medical devices and methods discussed above allow users to treat tissue by delivering electrical energy to it, and simultaneously or sequentially delivering fluid. For example, a user can attach electrodes to a distal end and deliver the distal end into a subject's cavity to deliver medical treatments (e.g., marking, cauterizing, or removing tissue) as part of a surgical procedure. Insulating tips (or an insulating layer forming the exterior of the tips) can help prevent or minimize damage and / or accidental contact between the electrodes and tissue. Users can also deliver fluid distally from the distal end of the electrodes simultaneously or sequentially with the delivered energy, which can help users deliver medical treatments, such as cutting, dissecting, ablation, marking, coagulation, cauterizing, or otherwise treating tissue more quickly and efficiently. Furthermore, users can deliver fluid and energy without removing the medical device from the patient or subject, which can help reduce the cost and duration of procedures and potentially reduce the risk to the subject.

[0111] Although the principles of the invention have been described herein with reference to illustrative aspects for specific applications, it should be understood that the invention is not limited thereto. Those skilled in the art and who access the teachings provided herein will recognize that other modifications, applications, aspects, and equivalents fall within the scope of the aspects described herein. Therefore, the invention should not be considered limited to the foregoing description.

Claims

1. A medical device comprising: An electrode shaft, configured to deliver energy to a target location, includes: An electrode shaft cavity configured to deliver fluid to the target site; and A widened end, the widened end being at the distal end of the electrode shaft, wherein the widened end extends radially outward relative to the longitudinal axis of the electrode shaft; and The tip, which is connected to the distal tip of the electrode shaft and is formed of an insulating material, is formed of two halves. Each of the two halves has at least one groove on its radially inner surface, the groove being configured to receive at least a portion of the widened end of the electrode shaft. Each groove extends radially outward relative to the longitudinal axis of the electrode shaft. The tip includes a tip cavity that is fluidly connected to the electrode shaft cavity and is configured to deliver fluid to the target site.

2. The medical device of claim 1, wherein the entire exterior of the tip comprises an outer layer.

3. The medical device of claim 2, wherein the two halves are joined by welding or adhesive.

4. The medical device according to claim 3, wherein the welding is soft soldering or hard soldering.

5. The medical device according to any one of claims 1-4, wherein the insulating material is ceramic.

6. The medical device according to any one of claims 2-4, wherein the outer layer is about 300 micrometers thick.

7. The medical device according to any one of claims 1-4, wherein the tip comprises a circular distal end and a cylindrical side portion.

8. The medical device according to any one of claims 1-4, wherein the top end is cylindrical.

9. The medical device of claim 8, wherein the top end includes a rounded edge.

10. The medical device according to any one of claims 1-4, further comprising an electrode plate on the proximal end of the tip.

11. The medical device of claim 10, wherein the electrode plate is conductive and electrically connected to the electrode shaft such that the electrode plate is energized when the electrode shaft is energized.

12. The medical device of claim 11, wherein the electrode plate is circular and covers the entire proximal end of the apex.

13. The medical device of claim 11, wherein the electrode plate is triangular or star-shaped.

14. The medical device according to any one of claims 1-4, wherein the interior of the electrode shaft and the tip is formed of a metallic material, and wherein the electrode shaft and the tip are welded together.

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