Medical devices and related methods

Abstract

A medical device includes an electrode shaft and an insulated 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 insulated tip is coupled to a distal tip of the electrode shaft. The insulated tip includes an insulated tip lumen fluidically connected to the electrode shaft lumen and configured to deliver fluid to the target site. The insulated tip covers all of the distal tip of the electrode shaft.

Description

Technical Field

[0001] The present invention relates generally to medical devices and related methods. In particular, aspects 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 beneath 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, 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 to elevate, separate, flush, cut, dissect, ablate, label, coagulate, cauterize, or otherwise treat and / or manipulate 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 in the art. 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 an insulating 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 insulating tip may be coupled to the distal tip of the electrode shaft. The insulating tip may include an insulating tip cavity fluidly connected to the electrode shaft cavity and may be configured to deliver fluid to the target site. The insulating tip may cover the entire distal tip of the electrode shaft.

[0007] The medical device may include one or more of the following features: An insulating tip may include a circular distal end and a cylindrical side portion. The circular distal end may be hemispherical and may extend distally beyond the distal tip of the electrode shaft. The insulating tip cavity may include a wide portion configured to accommodate a portion of the distal tip of the electrode shaft; and a narrow portion extending distally beyond the distal tip of the electrode shaft. The narrow portion of the insulating tip cavity may include a cross-sectional width equal to the cross-sectional width of the electrode shaft cavity, and the narrow portion may include a chamfered distal portion. The electrode shaft cavity and the insulating tip cavity may extend along the longitudinal axis of the medical device.

[0008] The insulating tip can be attached to the electrode shaft via solder. The radial interior of the insulating tip may include a gap configured to accommodate at least a portion of the solder. The insulating tip can be attached to the electrode shaft via brazing. When the insulating tip is attached to the electrode shaft, filler material may occupy the space at the junction between a portion of the electrode shaft and a portion of the insulating tip.

[0009] The insulating tip may include two insulating tip halves joined together to attach the insulating tip to an electrode shaft. The electrode shaft may include a widened distal portion. Each of the two insulating tip halves may include a groove for receiving at least a portion of the widened distal portion when the insulating tip half is attached to the electrode shaft. The groove in each of the two insulating tip halves may be positioned between a wide portion of the insulating tip cavity configured to receive the distal tip of the electrode shaft and a narrow portion of the insulating tip cavity extending distally beyond the distal tip of the electrode shaft.

[0010] The electrode shaft may include a first longitudinal portion, a second longitudinal portion proximal to the first longitudinal portion, and a transition portion between the first and second longitudinal portions. The first longitudinal portion may include a cross-sectional width smaller than that of the second longitudinal portion. The electrode shaft may be formed of stainless steel, and the insulating tip may be formed of a ceramic or polymer material.

[0011] In another example, a medical device may include a handle comprising a fluid port and an energy receiving socket. The medical device may also include a shaft comprising a shaft cavity configured to guide fluid flow from the fluid port through the shaft. The medical device may also include a conductive element and electrodes. The conductive element may be electrically connected to the energy receiving socket and may be accessible through at least a portion of the handle and / or the shaft. The electrodes may be coupled to a distal end of the shaft and include an electrode shaft and an insulating tip coupled to a distal tip of the electrode shaft. 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 insulating tip may include an insulating tip cavity fluidly connected to the electrode shaft cavity and may be configured to deliver fluid from the distal end of the electrode. The insulating tip may cover the entire distal tip of the electrode shaft.

[0012] 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. When the movable body is in a proximal retracted position, only the insulating tip may be exposed distally outside the axis. When the movable body is in a distally extended position, the insulating tip and at least a portion of the electrode axis may be exposed distally outside the axis.

[0013] In yet another example, a medical device may include an electrode shaft and an insulating tip. The electrode shaft may include an electrode shaft cavity configured to receive fluid. The insulating tip may be coupled to a distal tip of the electrode shaft. The insulating tip may include a circular distal portion extending distally beyond the electrode shaft. The insulating tip may include an insulating 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.

[0014] The medical device may include one or more of the following features: An insulating tip may be coupled to an electrode shaft via soldering or brazing. The insulating tip may include two insulating tip halves joined together to couple the insulating tip to the electrode shaft. The electrode shaft may include a widened distal portion, and each of the two insulating tip halves may include a groove for receiving at least a portion of the widened distal portion when the insulating tip half is coupled to the electrode shaft.

[0015] 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

[0016] 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.

[0017] According to various aspects of the present invention, Figure 1A An exemplary medical device is shown, and Figure 1B A cross-sectional view of the medical device with an enlarged distal portion is shown.

[0018] According to various aspects of the present invention, Figure 2A It shows Figure 1A and Figure 1B A side view of the electrode portion of the medical device, and Figure 2B It shows Figure 2A A cross-sectional view of the electrode portion.

[0019] According to various aspects of the present invention, Figure 3A It shows Figure 1A and Figure 1B A side view of an alternative exemplary electrode portion of a medical device, and Figure 3B It shows Figure 3A A cross-sectional view of the electrode portion.

[0020] According to various aspects of the present invention, Figure 4A It shows Figure 1A and Figure 1B A side view of another alternative exemplary electrode portion of the medical device. Figure 4B It shows Figure 4A A partial exploded view of the electrode portion, and Figure 4C It shows Figure 4A A cross-sectional view of the electrode portion. Detailed Implementation

[0021] Examples of the present 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 using 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 present invention can provide users (e.g., physicians, medical technicians, or other healthcare providers) 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 present invention can provide users with the ability to apply electrical energy or heat and to deliver fluid, wherein the possibility of damage to tissue or contact with unintended portions of tissue is reduced. Some aspects of the present invention can be used to perform endoscopic examinations, laparoscopic examinations, arthroscopic examinations, gynecological endoscopy, thoracoscopy, cystoscopy, or other types of surgical procedures.

[0022] 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.

[0023] 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 further away 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.

[0024] Figure 1A and Figure 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 socket 24, similar to an electrical plug or receptacle, 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 socket 24 and, as discussed in detail below, may include a channel fluidly connected to or otherwise communicating with the port 22. Additionally, as... Figure 1B As shown and discussed in detail below, electrode 26 may include an insulating tip 28 which may at least partially surround the distal portion of electrode axis 30.

[0025] The medical device 10 can be inserted into a subject's body cavity 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 is 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 move 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 move the electrode 26 relative to the distal end of the shaft 14). Although not shown, additional 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.

[0026] 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. Figure 1B ) and axis 14. It should be noted that, Figure 1B The various parts of the handle 12 shown may not be drawn to scale in order to show the various parts 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, such as 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 elastomeric member and / or a gel-like sealing member (not shown).

[0027] Handle 12 can be coupled to an energy source (not shown) via jack 24. Jack 24 may include one or more teeth or needles 32 for coupling to the energy source. Jack 24 may be electrically coupled to electrode 26 via conductive element 33, which may be electrically coupled to needle 32 and extends through handle 12 and through at least a portion of shaft 14. The energy source may be an electrocautery source, a radiofrequency 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 positioned 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 a 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 to conduct energy to the active electrode and the other to conduct energy from the return electrode.

[0028] The socket 24 may be positioned on the body 18, for example, at the proximal end of the body 18. In one aspect, the port 22 may extend from the proximal end of the body 18 in a direction parallel to the longitudinal axis of the body 18, and the socket 24 may extend laterally from the proximal end of the body 18 at an angle (e.g., about 45 degrees) to the longitudinal axis of the body 18. In another aspect, the socket 24 may be positioned on the distal or central portion of the body 18, or on the movable body 20. Although not shown, the body 18 and / or the socket 24 may include a one-way valve, a Luer connector, a seal, threads, and / or any suitable elements to help maintain a secure connection between the handle 12 and the power source, minimize or prevent backflow (e.g., fluid flowing from the port 22 and / or the cavity 31 and proximal out of the socket 24) and / or minimize or prevent leakage.

[0029] exist Figure 1B In one aspect shown, the needle 32 may extend transversely to the longitudinal axis of the handle 12 through the jack 24 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 conductive elements, and the conductive element 33 may extend longitudinally through the cavity 31 and through the shaft 14. Figure 1B As shown, fluid delivered through port 22 may surround at least a portion of conductive element 33. In one aspect, conductive element 33 may include one or more insulating layers to help insulate conductive element 33 from the fluid in cavity 31. As described above, a second conductive element (not shown) may be configured as a return path when medical device 10 has a bipolar configuration. Although not shown, in another aspect, the power source may be part of handle 12 (e.g., an internal battery in handle 12).

[0030] 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 proximal retracted position).

[0031] 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 socket 24, for example, one or more pins 32, to deliver energy to (and / or from) the electrode 26. Figure 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 needle 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 needle 32 and the conductive element 33.

[0032] As in Figure 1A As 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.

[0033] As in Figure 1A and Figure 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 an extrusion including one or more cavities extending from handle 12 to distal end 16.

[0034] Figure 1BThe 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 face 44 and graded surfaces 46, 48, and 50. For example, the first graded surface 46 may be the distal portion of end cap 42. Figure 1B As shown, with shaft 14 coupled to distal end 16, the first graded surface 46 of end cap 42 may be exposed distally outside shaft 14, while the second graded surface 48 may be received within shaft 14. For example, the third graded 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 insulating. 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 insulating. Distal end face 44 includes a central opening 52 through which electrode 26 extends and retracts.

[0035] 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 accommodate 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.

[0036] 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, 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 teeth 32 of the socket 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).

[0037] 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.

[0038] 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.

[0039] Alternatively, although not shown, the central opening 52 may be larger than the insulating tip 28, and in the position of the movable member 20 on the nearest side, the electrode 26 (including the insulating tip 28) may be fully retracted within the central opening 52 of the end cap 42. Furthermore, in one aspect, the movable member 20 may have an equilibrium position relative to the body 18, and this equilibrium position may correspond to the electrode shaft 30 extending from the end cap 42 portion.

[0040] As in Figure 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 accommodated 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.

[0041] 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 may be in fluid communication with the port 22 via a support cavity 70 extending through the proximal support 54. In one aspect, the 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 the insulating tip cavity 28C to form a channel for delivering fluid from the distal end of the electrode 26.

[0042] like Figure 1BAs 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 allow the distal end 16 to avoid damage 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 abutting the distal portion 28A of the insulating tip 28 when the electrode 30 is energized.

[0043] As discussed below, the insulating tip 28 and the electrode shaft 30 can be physically connected, for example, via soldering, brazing, arc 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 into a target site (e.g., within or between tissue layers to elevate, separate, flush, or otherwise treat tissue). 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.

[0044] Figure 2A and Figure 2B Additional aspects of the electrode 26, which can form part of the distal end 16 of the medical device 10, are shown. Figure 2A A side view of electrode 26 is shown, and Figure 2BA 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. Figure 1B and Figure 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 approximately 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.

[0045] 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... Figure 4B and Figure 4C As 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.

[0046] As in Figure 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... Figure 2BAs 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.

[0047] 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.

[0048] 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.

[0049] Various portions of the insulating tip 28 may include 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 to 3.0 mm, for example, about 2.1 mm (e.g., from the proximal end of side 28B to the 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 to 2.0 mm, for example, about 1.1 mm. Side 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.

[0050] In other places, such as in Figure 2BAs 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 29 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 aspect, the chamfered or angled portion of the distal portion 28D may include an angle of about 60 degrees relative to the longitudinal axis.

[0051] 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).

[0052] Figure 3A and Figure 3BA 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. Figure 3A and Figure 3B In 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-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). Once the insulating tip 128 and the electrode shaft 130 are joined, they form a fluid channel through the electrode shaft cavity 164 and the insulating tip cavity 128C to deliver fluid to the target site, as discussed above. Moreover, 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.

[0053] 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 above 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 above 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 above 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 above 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 connect the insulating tip 128 and the electrode shaft 130.

[0054] It is important to note that, in Figure 3A and Figure 3B In the aspects shown, the insulating tip 128 may not be included, as in Figure 2A and Figure 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.

[0055] Figure 4A and Figure 4C A view of another electrode 226, similar to electrode 26, is shown, with similar elements indicated by the addition of reference numeral 200. As shown, electrode 226 includes an insulating tip 228 and an electrode shaft 230.

[0056] 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 Figure 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...]). Figure 2A and Figure 2B (as discussed), such as regarding Figure 3A and Figure 3B The brazing, welding, one or more adhesives, or any other joining mechanism discussed may be used. In one aspect, the halves 228', 228" may also be joined to the electrode shaft 230 by means of the distal portion of 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.

[0057] In one aspect, such as in Figure 4B and Figure 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. The shape of each groove 294 in the halves 228', 228" may correspond to the shape of the widened end portion 292.

[0058] 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. Figure 4B and Figure 4C As shown, the groove 294 may be wider than the proximal portion 296 (e.g., extending radially further 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 chamfered or angled portions, as mentioned above. The dimensions of the groove 294, the proximal portion 296, and the 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 the 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.

[0059] Once the insulating tip 228 and the electrode shaft 230 are connected, 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 to the tissue, as discussed above. Furthermore, the exposed portion of the electrode shaft 230 can be energized to treat the 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 the tissue.

[0060] Electrodes, including insulated tips and electrode shafts, 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 the device 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.

[0061] The various electrodes discussed herein are capable of modifying the physical properties of tissue upon contact by delivering energy (e.g., radiofrequency energy). The delivered energy can be unipolar 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, such as in or coupled to a handle.

[0062] As discussed, the electrode may also be coupled to an actuating member (e.g., movable body 20), such as 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., insulating tip 28), may extend and be exposed beyond the axis, rather than being retracted within the axis. Furthermore, 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).

[0063] In this way, the insulated distal end (e.g., the insulated tip 28) can abut against tissue and help prevent or minimize damage or unintended contact between the electrode and tissue. 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 it to be coupled to an existing uninsulated electrode shaft and subsequently used in surgery.

[0064] In one example, an electrosurgical generator coupled to (or within) a handpiece can generate and receive energy in various modes, such as radiofrequency energy in cutting, coagulation, etc., so that electrodes can deliver this energy to 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 tissue and / or target sites. 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.).

[0065] The medical devices and methods discussed above allow users to treat tissue by simultaneously or sequentially delivering electrical energy to the tissue and then 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. Insulated tips help prevent or minimize damage and / or unintended 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 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.

[0066] 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 additional 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: A shaft, the shaft including a distal end; An end cap, the end cap being located at the distal end of the shaft; An electrode shaft configured to deliver energy to a target location and including an electrode shaft cavity configured to deliver fluid to the target location; as well as An insulating tip, which is connected to the distal tip of the electrode shaft. The insulating tip includes an insulating tip cavity that is fluidly connected to the electrode shaft cavity and configured to deliver fluid to the target site. The insulating tip covers the entire distal tip of the electrode shaft. The end cap includes a central portion through which the electrode shaft can move, and the end cap also includes a stop surface. The electrode shaft includes a first longitudinal portion, a second longitudinal portion proximal to the first longitudinal portion, and a transition portion between the first and second longitudinal portions, the transition portion being configured to engage the stop surface to limit the distal extension of the electrode shaft. The first longitudinal portion includes a cross-sectional width that is smaller than the cross-sectional width of the second longitudinal portion.

2. The medical device of claim 1, wherein the insulating tip comprises a circular distal end and a cylindrical side portion.

3. The medical device of claim 2, wherein the circular distal end is hemispherical and extends distally beyond the distal tip of the electrode axis.

4. The medical device of claim 2 or 3, wherein the insulating tip cavity includes a wide portion configured to receive a portion of the distal tip of the electrode shaft; and a narrow portion extending distally beyond the distal tip of the electrode shaft.

5. The medical device of claim 4, wherein the narrow portion of the insulating tip cavity includes a cross-sectional width equal to the cross-sectional width of the electrode shaft cavity, and wherein the narrow portion includes a chamfered distal portion.

6. The medical device according to any one of claims 1 to 3, wherein the electrode shaft cavity and the insulating tip cavity extend along the longitudinal axis of the medical device.

7. The medical device according to any one of claims 1 to 3, wherein the insulating tip is connected to the electrode shaft via solder.

8. The medical device of claim 7, wherein the radial interior of the insulating tip includes a gap configured to accommodate at least a portion of the solder.

9. The medical device according to any one of claims 1 to 3, wherein the insulating tip is brazed to the electrode shaft.

10. The medical device according to claim 9, wherein, When the insulating tip is attached to the electrode shaft, the filler material occupies the space at the junction between a portion of the electrode shaft and a portion of the insulating tip.

11. The medical device of claim 4, wherein the insulating tip comprises two insulating tip halves joined together to connect the insulating tip to the electrode shaft.

12. The medical device of claim 11, wherein the electrode shaft includes a widened distal portion, and wherein each of the two insulating tip halves includes a groove for receiving at least a portion of the widened distal portion when the insulating tip halves are engaged with the electrode shaft.

13. The medical device of claim 12, wherein the groove in each of the two insulating tip halves is positioned between the wide portion of the insulating tip cavity of the portion configured to receive the distal tip of the electrode shaft and the narrow portion of the insulating tip cavity extending distally beyond the distal tip of the electrode shaft.

14. The medical device according to any one of claims 1 to 3, wherein the electrode shaft is formed of stainless steel, and wherein the insulating tip is formed of ceramic or polymer material.

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