Medical devices and related methods

Abstract

The present invention provides a medical device and related method configured to treat tissue by delivering electrical energy to or within tissue using an electrode having an insulated distal tip, and / or by injecting fluid into and / or beneath the tissue. [Solution] The medical device 10 includes an electrode shaft 30 and an insulated tip 28. The electrode shaft 30 includes an electrode shaft lumen 64 configured to deliver energy to a target site and to deliver fluid to the target site. The insulated tip 28 is coupled to the distal tip 60 of the electrode shaft 30. The insulated tip 28 includes an insulated tip lumen 28C, which is fluid-connected to the electrode shaft lumen 64 and configured to deliver fluid to the target site. The insulated tip 28 covers the entire distal tip 60 of the electrode shaft 30.

Description

Technical Field

[0001] Aspects of the present disclosure generally relate to medical devices and related methods. In particular, aspects of the present disclosure relate to medical devices and related methods configured to treat tissue by delivering electrical energy to or within tissue and / or injecting fluid into and / or under tissue using an electrode having an insulated distal tip.

Background Art

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

[0003] Occasionally, during medical procedures, the user may use injection needles and energy delivery devices for the purpose of treating and / or manipulating tissue by methods such as raising, separating, washing, cutting, dissecting, excising, marking, coagulating, cauterizing, or otherwise. Injection and energy delivery may be performed separately. For example, to deliver energy to tissue, the user may need to remove the injection needle from the insertion device and deliver the energy delivery device to the target tissue through the insertion device, and vice versa. During a procedure, the user may alternate between using injection needles and energy delivery devices, and device changes may increase the duration and risk of the medical procedure. Furthermore, when energized, one or more parts of the energy delivery device may unintentionally come into contact with or damage tissue (or the internal channels of the insertion device).

[0004] The devices and methods of this disclosure can correct one or more of the aforementioned drawbacks or address other aspects of the art. [Overview of the project]

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

[0006] In one example, the 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 lumen configured to deliver fluid to the target site. The insulating tip may be coupled to the distal end of the electrode shaft. The insulating tip may include an insulating tip lumen, which may be fluid-connected to the electrode shaft lumen and configured to deliver fluid to the target site. The insulating tip may cover the entire distal end of the electrode shaft.

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

[0008] The insulating tip may be joined to the electrode shaft by solder. The radially inward portion of the insulating tip may include a gap configured to receive at least a portion of the solder. The insulating tip may be joined to the electrode shaft by brazing. When the insulating tip is joined to the electrode shaft, a filler may occupy the space in 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 that are joined together to connect the insulating tip to the 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 halves are connected to the electrode shaft. The grooves of each of the two insulating tip halves may be located between a wide portion of the insulating tip lumen configured to receive a portion of the distal end of the electrode shaft and a narrow portion of the insulating tip lumen extending distally beyond the distal end of the electrode shaft.

[0010] The electrode shaft may include a first longitudinal portion, a second longitudinal portion located proximal to the first longitudinal portion, and a transitional 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 made of stainless steel, and the insulating tip may be made of ceramic or polymer material.

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

[0012] A medical device may include one or more of the following features: The handle may further include a body and a movable part. The movement of the movable part relative to the body may cause the electrode to move relative to the distal end of the shaft. The movable part may be in a proximal retracted position so that only the insulating tip is exposed distally beyond the shaft. The movable part may be in a distally extended position so that the insulating tip and at least a portion of the electrode shaft are exposed distally beyond the shaft.

[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 lumen configured to receive fluid. The insulating tip may be coupled to the distal end of the electrode shaft. The insulating tip may include a rounded distal portion that extends distally beyond the electrode shaft. The insulating tip may include an insulating tip lumen that is fluid-connected to the electrode shaft lumen 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: The insulating tip may be joined to the electrode shaft by soldering or brazing. The insulating tip may include two insulating tip halves that are joined together to join 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 halves are joined to the electrode shaft.

[0015] Both the summary of the invention described above and the embodiments for carrying out the invention described below are merely illustrative and descriptive and should be understood not to limit the claimed disclosure. The accompanying drawings incorporated herein and constituting part thereof illustrate exemplary embodiments of the disclosure and, together with the specification, serve to illustrate the principles of the disclosure. [Brief explanation of the drawing]

[0016] [Figure 1A] An exemplary medical device is shown. [Figure 1B] This diagram shows a cross-sectional view of the distal portion of a medical device according to an aspect of this disclosure. [Figure 2A] Figures 1A and 1B show side views of the electrode portion of the medical device. [Figure 2B] A cross-sectional view of the electrode portion of Figure 2A according to an aspect of this disclosure is shown. [Figure 3A] Figures 1A and 1B show a side view of another exemplary electrode portion of the medical device. [Figure 3B] A cross-sectional view of the electrode portion of Figure 3A according to an aspect of this disclosure is shown. [Figure 4A] Figures 1A and 1B show side views of yet another exemplary electrode portion of the medical device according to aspects of this disclosure. [Figure 4B] Figure 4A shows a partially exploded view of the electrode portion. [Figure 4C] Figure 4A shows a cross-sectional view of the electrode portion. [Modes for carrying out the invention]

[0017] Examples of the present disclosure include devices and methods intended to facilitate and improve the effectiveness, efficiency, and safety of tissue treatment and / or manipulation when applying electrical energy to tissue using electrodes, to deliver fluid into and / or beneath tissue through the distal end of an electrode during a medical procedure, and to insulate the distal tip of an electrode. For example, aspects of the present disclosure may provide a user (e.g., a physician, medical technician, or other healthcare provider) with the ability to apply electrical energy or heat to tissue using a medical device having electrodes and to deliver fluid into and / or beneath tissue using the same medical device. Aspects of the present disclosure may provide a user with the ability to apply electrical energy or heat and deliver fluid while reducing the likelihood of damaging tissue or contacting unintended parts of tissue. Some aspects of the present disclosure may be used in the performance of endoscopic, laparoscopic, arthroscopic, gynecoscopic, thoracoscopic, cystoscopy, or other types of procedures.

[0018] Hereinafter, examples of the present disclosure shown above and in the accompanying drawings will be described in detail. Wherever possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts. The terms “proximal” and “distal” are used herein to refer to the relative locations of components of an exemplary medical device. As used herein, “proximal” refers to a location that is relatively closer to the outside of the body of the subject, or closer to the user, such as a medical professional, who grasps or otherwise uses the medical device. Conversely, “distal” refers to a location that is further relative to the medical professional or other user who grasps or otherwise uses the medical device, or closer to the inside of the body of the subject. As used herein, the terms “comprises,” “comprising,” “having,” and “including,” or other variations thereof, are intended to include non-exclusive inclusion, such that a device or method containing elements of a given list may not contain only those elements, but may also contain other elements not expressly described or specific to such a device or method. Unless otherwise specified, the term “exemplary” is used in the sense of “example” rather than “ideal.” As used herein, the terms “about,” “substantially,” and “approximately” refer to values ​​within a range of + / - 10% of the indicated value.

[0019] Figures 1A and 1B show a medical device 10 including a handle 12, a shaft 14, and a distal end 16. The handle 12 may include a body 18 and a movable body 20. The handle 12 may also include a port 22 configured to receive fluid and a hub 24 configured to receive electrical energy, similar to an electrical plug or socket. The distal end 16 includes an end effector, for example, an electrode portion 26 (hereinafter, “electrode 26”). The electrode 26 is electrically connected to the hub 24 and may include channels fluidly connected to or otherwise in fluid communication with the port 22, as described in detail below. Additionally, as shown in FIG. 1B and as described in detail below, the electrode 26 may include an insulating tip 28, which may at least partially surround a distal portion of the electrode shaft 30.

[0020] The medical device 10 may be inserted into a body lumen of a subject through an insertion device (not shown) or alone such that the handle 12 can remain outside the subject while at least a portion of the shaft 14 can be inside the subject. The distal end 16 may be positioned at a target site within the subject. The user can operate the handle 12 from outside the subject. Movement of the movable body 20 in a first direction (e.g., distal direction) with respect to the body 18 may cause the electrode 26 to extend with respect to the shaft 14 (e.g., the electrode 26 may move distally with respect to the distal end of the shaft 14), while movement of the movable body 20 in a second direction (e.g., proximal direction) with respect to the body 18 may cause the electrode 26 to retract with respect to the shaft 14 (e.g., the electrode 26 may move proximally with respect to the distal end of the shaft 14). Although not shown, the movable body 20 or additional components of the handle 12 may articulate the electrode 26 (or the electrode 26 and the distal end 16) left or right and / or up or down with respect to the shaft 14.

[0021] The handle 12 may be coupled to a fluid supply source (not shown) via a port 22. The port 22 may be in fluid communication with the electrode 26 via an internal lumen 31 that may extend through the handle 12 (Figure 1B) and shaft 14. Note that the various parts of the handle 12 shown in Figure 1B may not be to a uniform scale in order to illustrate the various parts of the handle 12 in more detail. In one embodiment, the internal lumen 31 may extend longitudinally through the body 18 and shaft 14 of the handle 12 to fluidly connect the port 22 to the electrode 26. The port 22 may be located in the proximal portion of the body 18, for example, at the proximal end of the body 18. Alternatively, the port 22 may be located in the distal or central portion of the body 18. Furthermore, port 22 may include a one-way valve, luer, seal, thread, and / or any suitable elements to help maintain a secure connection between handle 12 and the fluid supply source, minimize or prevent backflow (e.g., fluid flowing proximal to port 22), and / or minimize or prevent leakage. In one example, the one-way valve may include an external housing containing an internal elastomer and / or gel-like sealing member (not shown).

[0022] The handle 12 may be coupled to an energy source (not shown) via the hub 24. The hub 24 may include one or more prongs or pins 32 for coupling to the energy source. The hub 24 may be electrically connected to the electrode 26 via a conductive element 33, and the conductive element 33 may be electrically connected to the pin 32 and extend through at least a portion of the handle 12 and the shaft 14. The energy source may be an electrocautery source, a high-frequency generator, a heating source, a current generator, or the like. In one aspect, the medical device 10 may be used for monopolar electrosurgery and may include a return electrode disposed away from the electrode 26, on or adjacent to the subject. In another aspect, the medical device 10 may be used for bipolar electrosurgery. In that case, the electrode 26 may include an active electrode portion, and the return electrode may be provided on another portion of the electrode 26 and / or the shaft 14 or in the vicinity of another portion of the electrode 26 and / or the shaft 14. In one example, although not shown, two conductive elements may extend through the shaft 14, in which case the conductive elements are electrically insulated from each other and one may be capable of conducting energy to the active electrode and the other may be capable of conducting energy from the return electrode.

[0023] The hub 24 may be disposed on the body 18, for example, on the proximal end of the body 18. In one aspect, the port 22 may extend in a direction parallel to the longitudinal axis of the body 18 from the proximal end of the body 18, and the hub 24 may extend at an angle (e.g., about 45 degrees) transverse to the longitudinal axis of the body 18 from the proximal end of the body 18. In another aspect, the hub 24 may be disposed on the distal portion or central portion of the body 18 or on the movable body 20. Although not shown, the body 18 and / or the hub 24 may include a one-way valve, a luer, a seal, a thread, and / or any suitable element to assist in maintaining a secure connection between the handle 12 and the energy source, minimizing or preventing backflow (e.g., fluid flowing from the port 22 and / or the internal lumen 31 and exiting proximally from the hub 24), and / or minimizing or preventing leakage.

[0024] In one embodiment shown in Figure 1B, the pin 32 may extend through the hub 24 across the longitudinal axis of the handle 12 and may be electrically and physically connected to a conductive element 33 such as a wire, cable, and / or braided sheath. The conductive element 33 may be electrically conductive or may include an electrically conductive element, and the conductive element 33 may extend longitudinally through the internal lumen 31 and shaft 14. As shown in Figure 1B, the fluid delivered through the port 22 may surround at least a portion of the conductive element 33. In one embodiment, the conductive element 33 may include one or more insulating layers to help insulate the conductive element 33 from the fluid in the internal lumen 31. If the medical device 10 has a bipolar configuration as mentioned above, a second conductive element (not shown) may be provided as a return path. In another embodiment, though not shown, the energy source may be a component of the handle 12 (e.g., an internal battery in the handle 12).

[0025] 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 grasped by the user's hand, and the movable body 20 may be configured to be controlled by the user's thumb movement. For example, the side of the body 18 opposite to the movable body 20 may include one or more protrusions 36 that can help the user grip the body 18. Furthermore, the movable body 20 may include one or more protrusions 37 that can help the user operate the movable body 20. The movable body 20 may be lockable in one or more positions relative to the body 18 and / or may be spring-biased in a certain direction (e.g., towards a proximal retracted position).

[0026] The movable body 20 may be coupled to a drive element, which may impart distal or proximal movement to at least a portion of the electrode 26 based on the relative motion between the body 18 and the movable body 20. In one embodiment, the conductive element 33 may also function as a drive wire, rod, cable, etc., to couple the electrode 26 to the hub 24, for example, one or more pins 32, in order to deliver energy to (and / or from) the electrode 26, while the conductive element 33 imparts distal or proximal movement to at least a portion of the electrode 26. As shown in Figure 1B, the movable body 20 may be coupled to the conductive element 33 via a coupling mechanism, for example, a coupler 38. In one embodiment, the coupler 38 may be physically coupled (directly or indirectly) to the movable body 20 and also to the conductive element 33, such that the movement of the movable body 20 extends or retracts the conductive element 33, and therefore extends or retracts the electrode 26. It should be noted that the coupler 38 and / or other components in the handle 12 may help maintain the electrical connection between the pin 32 and the conductive element 33 when the conductive element 33, and therefore the electrode 26, is in a retracted or extended position. Alternatively, in another embodiment, the coupler 38 and / or other components in the handle 12 may be configured to electrically connect the pin 32 and the conductive element 33 only when the conductive element 33, and therefore the electrode 26, is in an extended position or at least partially extended position.

[0027] As shown in Figure 1A, the handle 12 may also include one or more indicators, for example, indicators 39A and 39B. For example, indicators 39A and 39B may visually indicate to the user the position of the electrode 26 relative to the shaft 14. The positions of indicators 39A and 39B may also correspond to the position of the movable body 20. For example, indicator 39A may be positioned on the handle 12 in a position corresponding to the retracted position of the movable body 20, indicating that the electrode 26 is retracted relative to the shaft 14. Similarly, indicator 39B may be positioned on the handle 12 in a position corresponding to the extended position of the movable body 20, indicating that the electrode 26 is extended relative to the shaft 14.

[0028] As shown in Figures 1A and 1B, the shaft 14 may extend from the distal portion of the body 18 to the distal end 16 and surround at least a portion of the electrode 26. The shaft 14 may also be a sheath surrounding at least a portion of one or more lumens (e.g., lumen 31) and a drive wire (e.g., conductive element 33). In another embodiment, the shaft 14 may be an extruded product including one or more lumens extending from the handle 12 to the distal end 16.

[0029] The enlarged view in Figure 1B shows additional features of the shaft 14 and distal end 16. The electrode 26 includes an insulating tip 28 that surrounds the distal portion of the electrode shaft 30. The electrode 26 may be located within a portion of the end cap 42 of the distal end 16. The end cap 42 may include a distal end face 44 and stepped surfaces 46, 48, and 50. For example, the first stepped surface 46 may be on the most distal portion of the end cap 42. As shown in Figure 1B, with the shaft 14 coupled to the distal end 16, the first stepped surface 46 of the end cap 42 may be exposed distally beyond the shaft 14, while the second stepped surface 48 may be received within the shaft 14. The third stepped surface 50 may be tapered, for example, to facilitate insertion of the end cap 42 into the shaft 14. In another example, the shaft 14 may completely enclose the radially outer portion of the end cap 42. The end cap 42 may be at least partially electrically insulating. For example, the end cap 42 may be formed of a ceramic material or another non-conductive material. Alternatively, only the distal end face 44 and the inner portion of the end cap 42 that contacts and / or surrounds the electrode 26 may be electrically insulating. The distal end face 44 includes a central opening 52 through which the electrode 26 can be extended and retracted.

[0030] The electrode 26 may be coupled to a proximal support portion 54 at the distal end 16, the proximal support portion 54 may include a cylindrical extension portion 56. The proximal support portion 54 may be coupled to a portion of a drive wire (e.g., a conductive element 33) via a drive wire receiving portion 58. The cylindrical extension portion 56 may extend distally and may receive at least a portion of the electrode 26. The electrode 26 and the cylindrical extension portion 56 may be coupled by welding, adhesive, crimping, friction fitting, or other suitable coupling. In one embodiment, the cylindrical extension portion 56 may allow different electrodes 26 to be detachably coupled to the distal end 16. The proximal support portion 54 includes a support lumen 70, the support lumen 70 which fluidly connects a port 22 to the electrode 26 via a lumen (e.g., lumen 31) through a shaft 14, for example.

[0031] The proximal support portion 54 includes a proximal coupling portion 72 which includes a drive wire receiving portion 58. The drive wire receiving portion 58 may be a recess extending parallel to at least a portion of the support lumen 70. The drive wire receiving portion 58 may receive a portion of a drive wire (not shown), and the drive wire and / or internal sheath 40 may be coupled to the movable body 20 such that the movement of the movable body 20 imparts distal or proximal movement to the proximal support portion 54, and therefore to the electrode 26. The drive wire may be coupled to the drive wire receiving portion 58 in the coupling portion 72 by welding, adhesive, crimping, friction fitting, or any other permanent or temporary coupling. The proximal support portion 54 may also be coupled to the electrode 26 by welding, adhesive, crimping, friction fitting, or any other permanent or temporary coupling. In one embodiment, both the drive wire and the proximal support portion 54 are conductive in order to electrically connect one or more prongs 32 of the hub 24 to the electrode 26. In another embodiment, the proximal support portion 54 may be at least partially insulated and may include a wire or other conductive element for electrically connecting the drive wire to the electrode 26. Similarly, in one embodiment, the drive wire may be at least partially insulated and may include a wire or other conductive element. Furthermore, at least a portion of the drive wire may be located within the internal sheath 40. Alternatively, the drive wire may be located within a separate lumen in the shaft 14 (for example, a lumen separate from the lumen extending through the internal sheath 40).

[0032] The end cap 42 includes a central portion 74 through which the electrode shaft 30 can move during extension and retraction. The end cap 42 may also include a narrowed portion or a stop surface 76 at the distal end of the central portion 74. The electrode shaft 30 may include a transition portion 78 between the first longitudinal portion 80 and the second longitudinal portion 82. The stop surface 76 and the transition portion 78 may limit the distal extension of the electrode 26 through the end cap 42. In the fully extended position, the first longitudinal portion 80 may protrude from the end cap 42, forming an exposed portion that can be used to excise or otherwise treat tissue. Furthermore, although not shown, the end cap 42 may be fixedly attached to the shaft 14 by welding, adhesive, crimping, friction fitting, or other suitable coupling.

[0033] The electrode 26 and the proximal support portion 54 may be movable relative to the end cap 42 in accordance with the relative movement of the movable body 20 and the main body 18 of the handle 12. For example, when the movable body 20 is in a proximal position relative to the main body 18, the electrode shaft 30 may be substantially retracted into the end cap 42, with only the distal portion of the electrode 26 (e.g., the insulating tip 28) extending distally beyond the end cap 42. Subsequently, as the movable body 20 is translated distally relative to the main body 18, the electrode 26 and the proximal support portion 54 are translated distally relative to the end cap 42 such that more of the electrode 26 (e.g., the electrode shaft 30) extends distally beyond the end cap 42 through the central opening 52.

[0034] Alternatively, although not shown, the central opening 52 may be larger than the insulating tip 28, and with the movable body 20 in its nearest position, the electrode 26 (including the insulating tip 28) can be fully retracted into the central opening 52 of the end cap 42. Furthermore, in one embodiment, the movable member 20 may have a balance position relative to the main body 18, which may correspond to the electrode shaft 30 partially extending from the end cap 42.

[0035] As shown in the enlarged portion of Figure 1B, 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 an insulating tip 28, and the longitudinal portion 62 may be located proximal to the insulating tip 28 and may not be covered by the insulating tip 28.

[0036] The electrode shaft 30 also includes an electrode shaft lumen 64 extending through the electrode shaft 30, for example, longitudinally through the central portion of the electrode shaft 30. The electrode shaft lumen 64 may be in fluid communication with the port 22 via a support lumen 70 through a proximal support portion 54. In one embodiment, an internal sheath 40 may form at least part of the fluid connection between the lumen 70 and the port 22. Furthermore, the electrode shaft lumen 64 is in fluid communication with an insulated tip lumen 28C, forming a channel for delivering fluid from the distal end of the electrode 26.

[0037] As shown in Figure 1B, the insulating tip 28 may include a distal end 28A and a side portion 28B. The distal end 28A may be rounded, for example, substantially hemispherical, and the side portion 28B may include a straight side portion, for example, substantially cylindrical. In one embodiment, the shape of the distal end 28A and the side portion 28B may help to make the distal end 16 non-traumatic and / or help to contact, position, manipulate, or otherwise treat tissue while the electrode 30 may be used to cut, dissect, excise, mark, coagulate, cauterize, or otherwise treat tissue. Nevertheless, the disclosure is not limited in this way, 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 frustoconical, tapered, chamfered, filleted, beveled, or a combination thereof. In one embodiment, 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 a quarter of the length of the first longitudinal portion 80 of the electrode shaft 30. In another embodiment, the insulating tip 28 may cover about a third or half of the length of the first longitudinal portion 80 of the electrode shaft 30. In this embodiment, the insulating tip 28 can provide insulation from the distal portion of the electrode shaft 30 and at least a portion of the tissue near the insulating tip 28. For example, the insulating tip 28 may be in contact with tissue, and the electrode shaft 30 may be energized while the insulating tip 28 assists in insulating the tissue in contact with it. Furthermore, the insulating tip 28 may receive the distal tip 60 within about half of the insulating tip 28 along the longitudinal axis. This can help to securely bond the insulating tip 28 to the electrode 30. Furthermore, approximately half of the insulating tip 28 may extend distally beyond the distal tip 60, which can help insulate the tissue that comes into contact with the distal position 28A of the insulating tip 28 when the electrode 30 is energized.

[0038] As described below, the insulating tip 28 and the electrode shaft 30 may be physically joined, for example, by soldering, brazing, welding, joining, or one or more other bonding mechanisms. Furthermore, the insulating tip 28 and the electrode shaft 30 form fluid channels extending through both the electrode shaft 30 and the insulating tip 28 for delivering (e.g., injecting) fluid to a target site (e.g., within or between layers of tissue to raise, separate, clean, or otherwise treat the tissue). The electrode shaft 30 may be energized, and the exposed portion of the electrode shaft 30 (e.g., the longitudinal portion 62) may be used to cut, dissect, excise, mark, coagulate, cauterize, or otherwise treat the tissue.

[0039] Figures 2A and 2B show further embodiments of the electrode 26 which may form part of the distal end 16 of the medical device 10. Figure 2A shows a side view of the electrode 26, and Figure 2B shows a cross-sectional view of the electrode 26. As mentioned, the electrode 26 includes an insulating tip 28 surrounding the electrode shaft 30. The insulating tip 28 may include a distal portion 28A and a side portion 28B. As shown in Figures 1B and 2B, the insulating tip 28 includes an insulating tip lumen 28C. In this embodiment, the fluid delivered through the electrode shaft lumen 64 may be delivered distally through the insulating tip lumen 28C. In one embodiment, the electrode shaft lumen 64 and the insulating tip lumen 28C may be substantially the same size. In another embodiment, the electrode shaft lumen 64 and the insulating tip lumen 28C may be tapered distally such that the distal portion of the lumen is narrower than the proximal portion of the lumen. Alternatively, the electrode shaft lumen 64 and the insulating tip lumen 28C may be tapered proximal to a certain extent, such that the proximal portion of the lumen is narrower than the distal portion of the lumen. In these embodiments, the different sizes of the electrode shaft lumen 64 and the insulating tip lumen 28C may help to increase or decrease the pressure of the fluid delivered through the fluid channel. The distal end portion 28D of the insulating tip lumen 28C may include a chamfered or angled portion, which may help to spray, guide, or otherwise deliver the fluid to the target site with reduced likelihood of tissue damage. Furthermore, 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 coupled to each other, the distal end face of the electrode 20 may abut against the inner surface 28E.

[0040] 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 embodiment, the distal portion of the electrode shaft 30 (e.g., the first longitudinal portion 80) may include a constant width. In another embodiment, as shown in Figures 4B and 4C, the distal end of the distal portion of the electrode shaft 30 may include an increased thickness (e.g., an extended end portion 292) relative to the rest of the distal portion of the electrode shaft 30.

[0041] As shown in Figure 2B, the insulating tip 28 may be joined to the distal portion of the electrode shaft 30 by solder 66. In one embodiment, the insulating tip 28 may include a gap 68, for example, a radial recess or notch, in the radially inner portion 28F of the insulating tip 28. The gap 68 may occupy about one-quarter of the longitudinal length of the insulating tip 28. In this embodiment, the insulating tip 28 may be joined 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 can help to join the insulating tip 28 and the electrode shaft 30. Furthermore, as shown in Figure 2B, the radially inner portion 28F forming the insulating tip lumen 28C may transition from a wider proximal lumen (e.g., where the insulating tip 28 overlaps with the electrode shaft 30) to a narrower distal lumen (e.g., where the insulating tip 28 does not overlap with the electrode shaft 30). In this embodiment, this transition may correspond to the distal end of the gap 68 and may also serve to form a stop surface for the distal end face of the distal tip 60 to contact the inner surface 28E of the insulating tip 28.

[0042] The insulating tip 28 may be formed of a ceramic (e.g., zirconia, an alloy containing zirconium (e.g., ZrO2), aluminum oxide (Al2O3), a ceramic alloy, etc.), a polymer material (e.g., a fluoropolymer, polyether ether ketone (PEEK), etc.), or another medically safe, heat-resistant, 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 conductive material. In one embodiment, the electrode shaft 30 may include a surface finish, for example, passivation according to ASTM A967 Nitric 2.

[0043] Although not shown, the electrode 26 may include an electrode plate. The electrode plate may be positioned on the proximal surface of the side portion 28B and / or surround a portion of the electrode shaft 30 immediately proximal to the insulating tip 28. In one embodiment, the electrode plate may be conductive and may conduct electricity when the electrode shaft 30 is energized. In another embodiment, the electrode plate may not be conductive. In either embodiment, the electrode plate may help to support the insulating tip 28 and / or the electrode shaft 30, and / or help to couple the insulating tip 28 to the electrode shaft 30.

[0044] Various parts of the insulating tip 28 may include, for example, height and width measured with respect 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 (for example, at the proximal end of the side portion 28B). The insulating tip 28 may have a height of about 2.0 to 3.0 mm, for example, about 2.1 mm (for example, from the proximal end of the side portion 28B to the distal end face of the distal end portion 28A). For example, the distal end 28A of the insulating tip 28 may be rounded (for example, substantially hemispherical) and may include a radius of about 0.5 to 2.0 mm, for example, about 1.1 mm. 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.

[0045] Furthermore, as shown in Figure 2B, the wider portion of the insulating tip lumen 28C formed by the radially inner portion 28F (for example, where the insulating tip 28 overlaps with the electrode shaft 30) may include a height of approximately 0.5 to 1.5 mm, for example, approximately 1.0 mm, and the narrower portion of the insulating tip lumen 28C (for example, where the insulating tip 28 does not overlap with the electrode shaft 30) may include a height of approximately 0.5 to 1.5 mm, for example, approximately 1.0 mm. The wider portion of the insulating tip lumen 28C formed by the radially inner portion 28F (for example, where the insulating tip 28 overlaps with the electrode shaft 30) may include a width of approximately 0.3 to 0.7 mm, for example, approximately 0.5 mm, and the narrower portion of the insulating tip lumen 28C (for example, where the insulating tip 28 does not overlap with the electrode shaft 30) may include a width of approximately 0.2 to 0.5 mm, for example, approximately 0.3 mm. As mentioned, the distal end portion 28D may include a chamfered or angled portion, which may transition from a narrowing lumen width, for example, about 0.3 mm, to a wider width, for example, about 0.37 mm. In this embodiment, the chamfered or angled portion of the distal portion 28D may include an angle of about 60 degrees with respect to the longitudinal axis.

[0046] Various parts of the electrode shaft 30 may include, for example, height and width measured with respect 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 embodiment, the transition portion 78 may include an angle of about 7 degrees with respect to the longitudinal axis. In one embodiment, the electrode shaft lumen 64 and the insulating tip lumen 28C may have substantially the same width (for example, in a direction transverse to the longitudinal axis of the electrode shaft lumen 64 and the insulating tip lumen 28C). For example, the electrode shaft lumen 64 and the insulating tip lumen 28C may include a constant width of about 0.3 mm. In this embodiment, the second longitudinal portion 82 may include a radial thickness of about 0.5 mm (for example, from the radially outer to the radially inner portion defining the electrode shaft lumen 64), and the first longitudinal portion 80 may include a radial thickness of about 0.3 mm (for example, from the radially outer to the radially inner portion defining the electrode shaft lumen 64).

[0047] Figures 3A and 3B show diagrams of another electrode 126 similar to electrode 26, where similar elements are indicated by adding 100 to the reference number. 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 rounded and a side portion 128B which may be cylindrical. In the embodiments shown in Figures 3A and 3B, the insulating tip 128 and the electrode shaft 130 may be joined by brazing, for example, by melting a filler material (e.g., an amorphous brazing foil using aluminum-silicon, copper, copper-silver, copper-zinc (brass), copper-tin (bronze), gold-silver, nickel alloy, silver, nickel, iron, copper, silicon, boron, phosphorus, and / or other materials) and flowing it between the insulating tip 128 and the electrode shaft 130 (e.g., by capillary action). When the insulated tip 128 and the electrode shaft 130 are coupled, the insulated tip 128 and the electrode shaft 130 form a fluid channel through the electrode shaft lumen 164 and the insulated tip lumen 128C to deliver fluid to the target site as described above. Furthermore, the exposed portion of the electrode shaft 130 may be energized to treat the tissue, while the insulated tip 128 covers and insulates the distal portion of the electrode shaft 130. This can help prevent or minimize tissue damage and / or unintended contact with the tissue.

[0048] The filler material (not shown) may have a lower melting point than the material forming the insulating tip 128 and the electrode shaft 130. In one embodiment, the insulating tip 128 may be positioned on the distal portion of the electrode shaft 130 so that the electrode shaft 130 abuts against the inner surface 128E of the insulating tip 128 (or the electrode shaft 130 may be inserted into the insulating tip 128). Subsequently, the filler material, heated to a temperature slightly above its melting point (e.g., its liquidus temperature), may be flowed onto the outer surface of the electrode shaft 130 and / or the inner surface of the insulating tip 128. In another example, the filler material may be flowed onto the outer surface of the electrode shaft 130 and / or the inner surface of the insulating tip 128, after which the insulating tip 128 may be positioned on the distal portion of the electrode shaft 130 so that the electrode shaft 130 abuts against the inner surface 128E of the insulating tip 128 (or the electrode shaft 130 may be inserted into the insulating tip 128). In the above embodiment, cooling the filler material helps to physically bond the insulating tip 128 and the electrode shaft 130.

[0049] In the embodiments shown in Figures 3A and 3B, it should be noted that the insulating tip 128 does not need to include a gap 68, as in the insulating tip 28 in Figures 2A and 2B. Instead, the filler material can bond the inner surface of the insulating tip lumen 28C to the outer surface of the electrode 130 at the joint 184. In this embodiment, the joint 184 (or the space between the inner surface of the insulating tip lumen 28C filled with filler material and the outer surface of the electrode shaft 130) may be about 0.1 mm or less, for example, about 0.03 to 0.08 mm.

[0050] Figures 4A to 4C show diagrams of another electrode 226 similar to electrode 26, where similar elements are indicated by adding 200 to the reference number. As shown, electrode 226 includes an insulating tip 228 and an electrode shaft 230.

[0051] The insulating tip 228 may be formed of two halves 228', 228''. One half 228' may include a partially rounded distal portion 228A' (e.g., a quarter of a sphere) and a partially cylindrical side portion 228B', and one half 228'' may include a partially rounded distal portion 228A'' (e.g., a quarter of a sphere) and a partially cylindrical side portion 228B''. The halves 228', 228'' may be divided along the longitudinal centerline 290. For example, as shown in Figure 4B, the halves 228', 228'' may be separated. The halves 228', 228” may be positioned around the distal portion of the electrode shaft 230 (e.g., the distal end 260) and may be joined or bonded together by, for example, soldering (which may include one or more gaps for receiving solder, as described with respect to Figures 2A and 2B, though not shown), brazing as described with respect to Figures 3A and 3B, welding, one or more adhesives, or any other bonding mechanism. In one embodiment, if the halves 228', 228” are bonded around the distal portion of the electrode shaft 230, the halves 228', 228” (and thus the insulating tip 228) may also be bonded to the electrode shaft 230. Alternatively or additionally, the halves 228', 228” may be bonded to the electrode shaft 230 individually or together by any of the bonding mechanisms described above.

[0052] In one embodiment, as shown in Figures 4B and 4C, the distal end of the electrode shaft 230 may include an expanded end portion 292. Each half 228', 228'' of the insulating tip 228 may include a groove 294 for receiving at least a portion of the expanded end portion 292. For example, the expanded end portion 292 may be a substantially cylindrical extension extending radially outward with respect to the longitudinal axis of the electrode 230. In one embodiment, the expanded end portion 292 may include a flat distal end and a curved proximal end. Each half 228', 228'' of the insulating tip 228 may include a groove 294 for receiving each portion (e.g., half) of the expanded end portion 292. Each groove 294 of the half 228', 228'' may include a shape corresponding to the shape of the expanded end portion 292.

[0053] The insulating tip 228 (formed by joined halves 228', 228") may include an insulating tip lumen 228C having a proximal portion 296 and a distal portion 298. The groove 294 may be located between the proximal portion 296 and the distal portion 298. The proximal portion 296 may be wider than the distal portion 298. As shown in Figures 4B and 4C, the groove 294 may be wider than the proximal portion 296 (for example, it may extend further radially away from the longitudinal axis of the insulating tip 228). The distal portion 298 may be approximately the same width as the electrode shaft lumen 264, and the distal portion 298 and the electrode shaft lumen 264 may form a fluid channel. Furthermore, insulation The tip lumen 228C may be distally terminated with a distal end portion 228D which may include a chamfered or angled portion, as mentioned above. The groove 294, proximal portion 296, and distal portion 298 may be sized to accommodate any shape or configuration of the electrode 230 so that the distal tip 260 can be received into the insulating tip 228. Furthermore, in some embodiments, a portion of the insulating tip 228 (e.g., the groove 294 and proximal portion 296) may be sized to form a space between the insulating tip 228 and the overlapping portion of the electrode 230, for example, to help accommodate the difference in the coefficient of thermal expansion between the insulating tip 228 material and the electrode 230 material.

[0054] When the insulated tip 228 and the electrode shaft 230 are coupled, the insulated tip 228 and the electrode shaft 230 form a fluid channel through the electrode shaft lumen 264 and the insulated tip lumen 228C to deliver fluid from the distal end of the electrode 226 to the target site and / or tissue, as described above. Furthermore, while the exposed portion of the electrode shaft 230 can be energized to treat tissue, the insulated tip 228 covers the distal portion of the electrode shaft 230 (e.g., distal tip 260), which can help prevent or minimize tissue damage and / or unintended contact with tissue.

[0055] Electrodes, including an insulated tip and electrode shaft, help provide a standoff or insulator between the distal portion of the electrode and the tissue at the target site. Furthermore, various electrodes can help enable devices that can be used for both cutting, dissecting, excising, marking, or otherwise treating tissue, and also for delivering fluids to a target site. The fluid may be delivered distally from the distal end of the electrode to the target site.

[0056] The various electrodes described herein can alter the physical properties of tissue by delivering energy (e.g., high-frequency energy) when in contact with the tissue. The delivered energy may be monopolar or bipolar energy. The various electrodes may be coupled to a shaft, which is configured to extend into a body lumen or cavity of the target. The shaft includes an electrical element that traverses the shaft and connects the electrodes to an energy source, for example, in or coupled to a handle.

[0057] As described, the electrode may also be coupled to an actuator (e.g., a movable body 20) in or coupled to the handle, for example, which allows the user to translate the electrode relative to the shaft. The electrode may be able to translate at least between a first position in which the cutting shaft of the electrode (e.g., the longitudinal portion 62) is retracted into the shaft and a second position in which the cutting shaft extends beyond the shaft and is exposed. In both the first and second positions, the distal portion, including the insulating portion (e.g., the insulating tip 28), may extend beyond the shaft and be exposed, or it may not be retracted into the shaft. Furthermore, the handle may allow the electrode to be positioned in one or more intermediate positions (i.e., positions in which only a portion of the longitudinal portion 62 is exposed).

[0058] Therefore, an insulated distal end face (e.g., an insulated tip 28) may come into contact with tissue and help prevent or minimize tissue damage or unintended contact of the electrode with tissue. The user may also position an uninsulated electrode shaft to come into contact with tissue and apply energy to cut, dissect, excise, mark, or otherwise treat the tissue. The insulated tip may be coupled to the electrode shaft in various ways that may allow the insulated tip to be coupled to an existing uninsulated electrode shaft and subsequently used in treatment.

[0059] In one example, an electrosurgical generator coupled to the handle (or within the handle) can generate and / or receive high-frequency energy in various modes, such as cutting mode and coagulation mode, so that electrodes can deliver these different modes of energy to tissue. In one embodiment, the electrosurgical generator and / or handle may include one or more knobs, dials, buttons, etc., for selecting the energy mode. Furthermore, in one embodiment, a fluid source (e.g., a saline source) coupled to the handle may provide a fluid (e.g., saline) to be delivered through the electrodes to the tissue and / or target site. The fluid may be delivered at a constant speed, pulsed speed, user-controlled speed, etc. In these embodiments, one or more of the energy delivery and / or fluid delivery may be controlled by one or more actuators (e.g., triggers, buttons, touchscreens, foot pedals, etc.).

[0060] The medical devices and methods described above enable a user to treat tissue by delivering electrical energy and fluids to the tissue simultaneously or sequentially. For example, a user may connect an electrode to its distal end, deliver the distal end to the internal lumen of the subject, and deliver a medical treatment (e.g., marking, cauterizing, or excising tissue) as part of the procedure. Insulated tips may help prevent or minimize damage and / or unintended contact between the electrode and the tissue. The user may also deliver fluid distally from the distal end of the electrode simultaneously or sequentially with the delivery of energy, which may help the user deliver medical treatments, e.g., cutting, dissection, excision, marking, coagulation, cauterization, or other methods of treating tissue more quickly and efficiently. Furthermore, the user may deliver fluids and energy without removing the medical device from the patient or subject, which may help reduce costs and the time required for the procedure, and may also reduce the risk to the subject.

[0061] The principles of this disclosure are described herein with reference to examples of specific uses, but it should be understood that this disclosure is not limited thereto. Anyone with ordinary skill in the art and access to the teachings provided herein will recognize that all additional modifications, uses, embodiments, and equivalent substitutes fall within the scope of the embodiments described herein. Therefore, the present invention is not to be considered limited by the foregoing description.

Claims

1. An electrode shaft including an electrode shaft lumen configured to deliver energy to a target site and to deliver fluid to the target site, The electrode shaft includes an insulating tip coupled to its distal end, The insulating tip includes an insulating tip lumen, which is fluid-connected to the electrode shaft lumen and configured to deliver fluid to the target site. The insulating tip covers the entire distal tip of the electrode shaft. Medical devices.

2. The medical device according to claim 1, wherein the insulating tip includes a rounded distal end and a cylindrical side portion.

3. The medical device according to claim 2, wherein the rounded distal end is hemispherical and extends distally beyond the distal tip of the electrode shaft.

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

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

6. The medical device according to any one of claims 1 to 5, wherein the electrode shaft lumen and the insulating tip lumen extend along the longitudinal axis of the medical device.

7. The medical device according to any one of claims 1 to 6, wherein the insulating tip is coupled to the electrode shaft by solder.

8. The medical device according to claim 7, wherein the radially inner portion of the insulating tip includes a gap configured to receive at least a portion of the solder.

9. The medical device according to any one of claims 1 to 6, wherein the insulating tip is joined to the electrode shaft by brazing.

10. The medical device according to claim 9, wherein when the insulating tip is coupled to the electrode shaft, the filler occupies the space in the joint between a part of the electrode shaft and a part of the insulating tip.

11. The medical device according to any one of claims 1 to 10, wherein the insulating tip includes two insulating tip halves that are joined together to connect the insulating tip to the electrode shaft.

12. The medical device according to claim 11, wherein the electrode shaft includes a widened distal portion, and 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 halve is coupled to the electrode shaft.

13. The medical device according to claim 12, wherein the grooves of each of the two insulating tip halves are positioned between a wide portion of the insulating tip lumen configured to receive a portion of the distal end of the electrode shaft and a narrow portion of the insulating tip lumen extending distally beyond the distal end of the electrode shaft.

14. The electrode shaft includes a first longitudinal portion, a second longitudinal portion located proximal to the first longitudinal portion, and a transitional portion between the first longitudinal portion and the second longitudinal portion. The medical device according to any one of claims 1 to 13, wherein the first longitudinal portion includes a cross-sectional width smaller than the cross-sectional width of the second longitudinal portion.

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

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