Patent Description:
Medical devices, such as endoscopes or other suitable insertion devices, are employed for a variety of types of diagnostic and surgical procedures, such as endoscopy, laparoscopy, arthroscopy, gynoscopy, thoracoscopy, cystoscopy, etc. Many of these procedures involve delivering energy to tissue of an organ or a gland to treat tumors, infections, and the like. Examples of such procedures include Endoscopic Mucosal Resection (EMR), Endoscopic Sub-mucosal Resection (ESR), Endoscopic Sub-mucosal Dissection (ESD), polypectomy, mucosectomy, etc. In particular, such procedures may be carried out by inserting an insertion device into a subject's body through a surgical incision, or via a natural anatomical orifice (e.g., mouth, vagina, or rectum), and performing the procedure or operation at a target site with an auxiliary device inserted through the insertion device.

At times, during a medical procedure, a user may use an injection needle and an energy delivery device for purposes of raising, separating, flushing, cutting, dissecting, ablating, marking, coagulating, cauterizing, or otherwise treating tissue. The injection and energy delivery may be performed separately. For example, in order to deliver energy to the tissue, the user may be required to remove the injection needle from the insertion device and deliver the energy delivery device through the insertion device to the tissue being targeted, and vice versa. During the procedure, the user may alternate using the injection needle and the energy delivery device, and exchange of devices may increase the duration and risks of the medical procedure. Additionally, instances may arise where the type of injection needle needed may change. Also, in some instances, the type of energy delivery device needed may change. This may further increase the duration of the medical procedure and/or limit the types of procedures that may be performed.

The devices and methods of the current disclosure may rectify some of the deficiencies described above or address other aspects of the prior art. <CIT> relates to an ultrasound cutting device for attachment to a device for minimally invasive surgery.

Examples of the present disclosure relate to, among other things, medical devices configured for treating tissue by delivering electrical energy to the tissue, and configured for delivering fluid into and/or under the tissue. The devices may involve the use of different electrodes, for example, ones with different fluid flow paths, insulation patterns, and/or other characteristics. The present disclosure also relates to methods of assembling the devices, operating the devices, and/or performing procedures with the devices. Each of the examples disclosed herein may include one or more of the features described in connection with any of the other disclosed examples.

In one example, a medical device may include a shaft including a lumen configured to direct a flow of fluid through the shaft and an electrode. A proximal end of the electrode and a distal end of the shaft may form a coupling configured to releasably couple the proximal end of the electrode with the distal end of the shaft. When the proximal end of the electrode is coupled to the distal end of the shaft, fluid delivered through the lumen may be emitted from the electrode.

The medical device may further include one or more of the following features. The coupling may include one or more arms positioned within the distal end of the shaft. Each of the one or more arms may include a protrusion. Each of the one or more arms may further include at least one of an angled portion at a proximal end of the protrusion and an angled portion at a distal end of the protrusion, and the at least one angled portion may be angled relative to a central longitudinal axis of the distal end of the shaft. The electrode may include one or more receivers configured to receive the one or more arms. The one or more receivers may be radially wider than a portion of the electrode distal to the one or more receivers, and/or than a portion of the electrode proximal to the one or more receivers. The medical device may further include one or more seals configured to form a fluid tight seal between the electrode and the shaft. With the electrode coupled to the one or more arms, the one or more seals may sealingly engage surfaces of the electrode and the shaft to direct fluid from the lumen to the electrode.

The distal end of the shaft may include one or more arms. The one or more arms may be biased to move radially outwardly, and the one or more arms may be longitudinally movable within the distal end. The medical device may further include at least one biasing member configured to bias the arms distally within the distal end of the shaft. The distal end of the shaft may include a central passage with an angled portion that narrows distally. The angled portion may be configured to force the one or more arms radially inwardly as the one or more arms move distally within the distal end of the shaft. The shaft may include a coupling tube with a distal coupling portion configured for securing to the proximal end of the electrode. The distal coupling portion may comprise an elastomeric polymer material configured to couple the coupling tube to the electrode, and to form a seal between coupling tube and the electrode that facilitates fluid flow from the lumen to the electrode. The electrode includes an insulator that only partially covers a distal end face of the electrode. The electrode includes an outlet in the distal end face, and the insulator includes a plurality of protrusions projecting from the distal end face about the outlet. The electrode may include a first conductive member and a second conductive member. The first conductive member and the second conductive member may be electrically separated by an insulating member. The medical device may include a conductor that is longitudinally movable to contact and deliver energy to the first conductive member or to the second conductive member.

In another example, a medical device kit may include a medical device including a handle, and a shaft extending distally from the handle, wherein the shaft includes a lumen. The medical device kit may also include a plurality of electrodes. The shaft may include a distal end having a mechanism therein configured for securing one of the plurality of electrodes to the distal end of the shaft, releasing the one of the electrodes from the distal end of the shaft, and securing another of the electrodes to the distal end of the shaft.

The medical device kit may further include one or more of the following features. At least two of the electrodes may differ in structure, and coupling different electrodes of the plurality of electrodes to the shaft may change a fluid flowpath of the medical device. When one of the at least two electrodes is coupled to the distal end of the shaft, fluid delivered through the central lumen may be delivered through the coupled electrode, movement of a portion of the handle may control movement of the coupled electrode, and electrical energy delivered through the shaft may be delivered to tissue through the coupled electrode. The distal end of the shaft may include one or more arms each including a protrusion, an angled portion proximal to the protrusion, and an angled portion distal to the protrusion. Each of the plurality of electrodes may include a receiver portion that is radially wider than a portion of the electrode distal to the receiver portion and a portion of the electrode proximal to the receiver portion. The protrusion may engage the receiver portion.

In a further example, a method may include coupling a first electrode with a first structure to a distal end of a medical device shaft, and the coupling may include releasably coupling an internal component of the medical device shaft to a portion of the first electrode. The method may further include uncoupling the first electrode from the distal end, and coupling a second electrode with a second structure to the distal end, where the second structure is different than the first structure.

The method may further include one or more of the following features. Uncoupling the first electrode may include an action on a medical device handle coupled to a proximal end of the shaft. The action on the medical device handle may retract one or more arms causing the one or more arms to expand and uncouple the arms from a proximal portion of the first electrode.

It may be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure, as claimed.

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

Examples of the present disclosure include devices and methods for: facilitating and improving the efficacy, efficiency, and safety of treating tissue when, for example, applying electrical energy to tissue, and delivering fluid into and/or under tissue during a medical procedure. For example, aspects of the present disclosure may provide a user (e.g., physician, medical technician, or other medical service provider) with the ability to apply electrical energy or heat to tissue using a medical device having an electrode, and to deliver fluid into and/or under tissue with the same medical device. Additionally, aspects of the present disclosure may provide the user with the ability to deliver fluid through one or more outlets, with the fluid being diverted on its way to the outlets (e.g., delivered at an angle relative to a central longitudinal axis of the electrode), thereby changing the fluid flowpath. Other aspects of the present disclosure may allow the user to change the electrode to a different electrode, for example, one with a different outlet position and/or arrangement, thereby changing the flowpath of fluid from the medical device. Additional aspects of the present disclosure may allow the user to change the electrode to a different electrode with a different insulation pattern, thereby changing the treatment effect on the treated tissue. Additional aspects of the present disclosure may allow the user to change the electrode to any other electrode having at least one different characteristic, even if, for example, the flowpath and/or insulation pattern is similar. Some aspects of the present disclosure may be used in performing an endoscopic, laparoscopic, arthroscopic, gynoscopic, thoracoscopic, cystoscopic, or other type of procedure.

Reference will now be made in detail to examples of the present disclosure described above and illustrated in the accompanying drawings.

The terms "proximal" and "distal" are used herein to refer to the relative positions of the components of an exemplary medical device. When used herein, "proximal" refers to a position relatively closer to the exterior of the body of a subject or closer to a user, such as a medical professional, holding or otherwise using the medical device. In contrast, "distal" refers to a position relatively further away from the medical professional or other user holding or otherwise using the medical device, or closer to the interior of the subject's body. As used herein, the terms "comprises," "comprising," "having," "including," or other variations thereof, are intended to cover a non-exclusive inclusion, such that a device or method that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent thereto. Unless stated otherwise, the term "exemplary" is used in the sense of "example" rather than "ideal. " As used herein, the terms "about," "substantially," and "approximately," indicate a range of values within +/- <NUM>% of a stated value.

<FIG> depicts a medical device <NUM> that includes a handle <NUM>, a shaft <NUM>, and a distal end <NUM>. Handle <NUM> may include a main body <NUM> and a movable body <NUM>. Handle <NUM> also may include a port <NUM> configured to receive fluid, and a hub <NUM> configured to receive electrical energy similar to an electrical plug or socket. Distal end <NUM> includes an electrode <NUM>. Electrode <NUM> is electrically connected to hub <NUM>, and may include one or more lumens, passages, recesses, or other surfaces (<FIG>) fluidly connected to, or otherwise in fluid communication with, port <NUM>. Medical device <NUM> may be inserted into a body lumen of a subject, either through an insertion device (not shown) or alone, such that at least a portion of shaft <NUM> may be within the subject, while handle <NUM> may remain outside of the subject. From outside of the subject, a user can manipulate handle <NUM>. Movement of movable body <NUM> relative to main body <NUM> in a first direction (e.g., the distal direction) may extend electrode <NUM> relative to shaft <NUM> (e.g., move electrode <NUM> distally relative to a distal end of shaft <NUM>), while movement of movable body <NUM> relative to main body <NUM> in a second direction (e.g., the proximal direction) may retract electrode <NUM> relative to shaft <NUM> (e.g., move electrode <NUM> proximally relative to a distal end of shaft <NUM>).

Handle <NUM> may be coupled to a fluid source via port <NUM>. Port <NUM> may be in fluid communication with electrode <NUM> via an internal lumen <NUM> in shaft <NUM> (<FIG>). Internal lumen <NUM> may extend longitudinally through main body <NUM> of handle <NUM>, and port <NUM> may include a port lumen 22A that extends through port <NUM> to fluidly connect port <NUM> to internal lumen <NUM>. Port <NUM> may be positioned on a distal portion of main body <NUM>. Alternatively, port <NUM> may be positioned on movable body <NUM>. Moreover, port <NUM> may include a one-way valve <NUM>, a luer, a seal, threading <NUM>, and/or any appropriate element to maintain a secure connection between handle <NUM> and the fluid source, minimize or prevent back-flow (e.g., fluid flowing proximally out of port <NUM>), and/or minimize or prevent leakage. In one example, one-way valve <NUM> may include an outer housing containing an inner elastomeric and/or gelatinous sealing member (not shown).

Handle <NUM> may be coupled to an energy source through hub <NUM>. Hub <NUM> may be electrically coupled to electrode <NUM> via a conductive element <NUM> in shaft <NUM>. The energy source may be an electrocautery source, a radio frequency generator, a heating source, a current generator, etc. In one aspect, medical device <NUM> may be used for monopolar electrosurgery, and may include a return electrode positioned remotely from electrode <NUM> on the subject. In another aspect, medical device <NUM> may be used for bipolar electrosurgery. In that instance, electrode <NUM> may include an active electrode portion, and a return electrode may be provided at or near another portion of electrode <NUM> and/or shaft <NUM>. In one example, two conductive elements may run through shaft <NUM>, where the conductive elements may be electrically isolated from each other, allowing one to conduct energy to the active electrode and the other to conduct energy from a return electrode. Hub <NUM> may be positioned on movable body <NUM> and may include one or more pins or prongs <NUM> to couple to the energy source. Alternatively, hub <NUM> may be positioned on main body <NUM>.

In one aspect shown in FIG. <NUM>, prong <NUM> may extend through hub <NUM> transverse to a longitudinal axis of handle <NUM>, and may be electrically and physically connected to conductive element <NUM>, such as a wire, a cable, and/or a braided sheath. Conductive element <NUM> may be electrically conductive or include an electrically conductive element, and conductive element <NUM> may extend longitudinally through internal lumen <NUM> and through shaft <NUM>. As shown in <FIG>, fluid delivered through port <NUM> may surround at least a portion of conductive element <NUM>. In another aspect, the energy source may be a part of handle <NUM> (e.g., an internal battery in handle <NUM>). As alluded to above, a second conductive element (not shown) may be provided as a return pathway where medical device <NUM> has a bipolar configuration.

As mentioned, handle <NUM> may control the extension or retraction of electrode <NUM> relative to the distal end <NUM> of shaft <NUM>. For example, main body <NUM> may include a slot <NUM> and a thumb ring <NUM>. Movable body <NUM> may be slidably positioned within slot <NUM> and include one or more finger holes <NUM>. Movable body <NUM> may be lockable in one or more positions relative to main body <NUM>. Movable body <NUM> may be coupled to a drive element, and the drive element may impart distal or proximal movement to at least a portion of electrode <NUM> based on relative movement between main body <NUM> and movable body <NUM>. In one aspect, conductive element <NUM> may also act as a drive wire, rod, cable, or the like, such that conductive element <NUM> imparts distal or proximal movement to at least a portion of electrode <NUM> while also coupling electrode <NUM> to hub <NUM>, e.g., the one or more prongs <NUM>, to deliver the energy to (and/or from) electrode <NUM>.

As shown in <FIG>, shaft <NUM> extends from a distal portion of main body <NUM> to distal end <NUM>, and may surround at least a portion of electrode <NUM>. Shaft <NUM> may be coupled to handle <NUM> via a coupler <NUM>, which may surround a portion of shaft <NUM> and screw onto main body <NUM> to secure the elements. Shaft <NUM> may be a sheath that surrounds at least a portion of one or more lumens (e.g., lumen <NUM>) and the drive wire (e.g., conductive element <NUM>). in another aspect, shaft <NUM> may be an extrusion that includes one or more lumens extending from handle <NUM> to distal end <NUM>.

<FIG> illustrate additional aspects of distal end <NUM>. It is noted that <FIG> illustrate the internal components of distal end <NUM>, without showing the distal portion of shaft <NUM> that may radially surround at least a portion of distal end <NUM>. <FIG> show perspective views of a portion of distal end <NUM>, with a portion of electrode <NUM> positioned within an end cap <NUM> of distal end <NUM>. End cap <NUM> may include a distal end face <NUM> and graduated surfaces <NUM>, <NUM>, and <NUM>. End cap <NUM> may be at least partially electrically insulating. For example, end cap <NUM> may be formed of a ceramic material or another non-conductive material. Alternatively, only distal end face <NUM> and an internal portion of end cap <NUM> that contacts and/or surrounds electrode <NUM> may be electrically insulating. Distal end face <NUM> includes a central opening <NUM> (FIG. <NUM>) through which electrode <NUM> may extend and retract.

Electrode <NUM> may be coupled to a proximal support <NUM> of distal end <NUM>, which includes a cylindrical extension <NUM>. Proximal support <NUM> may be coupled to a portion of the drive wire (e.g., conductive element <NUM>) via a wire receiving portion <NUM> (<FIG>). Cylindrical extension <NUM> may extend distally and may receive at least a portion of electrode <NUM>. As discussed in detail below, electrode <NUM> and cylindrical extension <NUM> may be coupled via a snap fit, friction fit, threading, an elastomeric and/or adhesive material, or other suitable coupling. Cylindrical extension <NUM> may allow for different electrodes <NUM> to be removably coupled to distal end <NUM>.

Electrode <NUM> and proximal support <NUM> may be movable relative to end cap <NUM> in response to the relative movement of movable body <NUM> and main body <NUM> of handle <NUM>. For example, with movable body <NUM> in a proximal position relative to main body <NUM>, electrode <NUM> may be substantially retracted within end cap <NUM> with only a distal portion of electrode <NUM> extending distally beyond end cap <NUM> (<FIG>). Then, as movable body <NUM> is translated distally relative to main body <NUM>, electrode <NUM> and proximal support <NUM> translate distally relative to end cap <NUM> such that a greater portion of electrode <NUM> extends distally beyond end cap <NUM> through central opening <NUM> (<FIG>).

Alternatively, although not shown in the figures, with movable body <NUM> in the proximalmost position, electrode <NUM> may be fully retracted within central opening <NUM> of end cap <NUM>. It is noted that while central opening <NUM> is shown in <FIG> as being smaller than a portion of electrode <NUM>, this disclosure is not so limited, and central opening <NUM> and electrode <NUM> may include various sizes and arrangements. For example, central opening <NUM> may be wider than electrode <NUM> such that electrode <NUM> may be fully retracted within central opening <NUM>. Such a configuration may be advantageous, for example, in versions of medical device <NUM> in which fluid flows along the outer surface of electrode <NUM>. Alternatively, central opening <NUM> may be narrower than a distal portion of electrode <NUM> such that the distal portion of electrode <NUM> may always remain partially extended from central opening <NUM>.

In one aspect, electrode <NUM> is releasably coupled to the rest of distal end <NUM>. As shown in <FIG>, electrode 26A may be snap-fit to an internal portion of distal end <NUM>. For example, distal end <NUM> may include one or more fastening portions <NUM> extending from and/or coupled to cylindrical extension <NUM>. A proximal portion of electrode 26A may include one or more reception portions <NUM> including, for example, one or more distal widened portions and/or one or more indentations, which may be shaped to receive the one or more fastening portions <NUM>. For instance, each fastening portion <NUM> may include a distal angled portion <NUM> and a protrusion <NUM>. As electrode 26A is inserted into the rest of distal end <NUM>, a proximal portion of electrode 26A may contact distal angled portions <NUM>, and relative movement between the two may push fastening portion(s) <NUM> radially outward, such that the proximal portion of electrode 26A may be releasably received within or between fastening portions <NUM>. Further movement of electrode 26A proximally (and/or the rest of distal end <NUM> distally) may bring protrusions <NUM> into engagement with reception portion <NUM> of electrode 26A, thereby securing electrode 26A. In one example, one or more fastening portions <NUM> may include one or more cantilevered arms extending distally from an annular base enveloping cylindrical extension <NUM>, such as a single cantilevered arm, a pair of cantilevered arms projecting from opposite sides of the base, or more than two cantilevered arms projecting from any suitable location on the base. Alternatively, one or more fastening portions <NUM> may include a compliant sheath enveloping cylindrical extension <NUM>, the sheath having a distal rim portion with distal angled portions <NUM>. It also is contemplated that one or more fastening portions <NUM> may be integrally formed with proximal support <NUM>.

Distal end <NUM> includes one or more seals <NUM> to help ensure that fluid delivered through lumen <NUM> is directed through electrode 26A. In one aspect, distal end <NUM> may include a compressible and/or expandable seal <NUM>. For example, seal <NUM> may be a circular ring of elastomeric material positioned on a distal end of cylindrical extension <NUM> such that positioning electrode 26A within the one or more fastening portions <NUM> ensures that electrode 26A abuts and/or compresses seal <NUM>. As such, fluid delivered via lumen <NUM> may be delivered through an electrode lumen <NUM> and out of outlets <NUM> of electrode 26A. In one aspect, proximal support <NUM>, cylindrical extension <NUM>, and fastening portion <NUM> are conductive such that electrical energy delivered via conductive element <NUM> may be delivered to or into tissue via electrode 26A.

As mentioned, electrode 26A is removably coupled to distal end <NUM>. For example, pulling electrode 26A distally relative to the rest of distal end <NUM>, and/or pulling the rest of distal end <NUM> proximally relative to electrode 26A, may expand fastening portions <NUM> such that electrode 26A may be removed from distal end <NUM>. For example, fastening portions <NUM> may include proximal angled portions at location(s) <NUM>, and/or reception portions <NUM> may include distal angled portions at location(s) <NUM>, which may facilitate the expansion of the one more fastening portions <NUM>. The amount of force required to expand fastening portions <NUM> may be greater than (e.g., approximately two times greater than) the forces that may be imparted to electrode 26A by tissue or other material within a subject during a medical procedure. As such, fastening portions <NUM> may help to ensure that electrode 26A is only removed from the rest of distal end <NUM> by a user or other medical professional when distal end <NUM> is external to the subject.

Additionally, electrode 26A may be temporarily stored in a delivery cartridge (<FIG>) before coupling to distal end <NUM> and/or after uncoupling from distal end <NUM>. For example, the cartridge may surround at least the distal portion of electrode 26A (and may surround an entirety of electrode 26A) and may help the user to handle and/or store electrode 26A, for example, in preparation for coupling electrode 26A to the rest of distal end <NUM>. The cartridge may help the user align electrode 26A with central opening <NUM> and position electrode 26A within the rest of distal end <NUM> during coupling. As discussed with respect to <FIG> below, the cartridge may also store a plurality of electrodes, which may be the same electrode configuration, or may include different electrode configurations.

<FIG> illustrate various electrodes <NUM>, 26A, 26B, 26C, and 26D that may be coupled to and removed from distal end <NUM>. Electrode 26A includes an electrode lumen <NUM>, two outlets <NUM>, and a channel <NUM> connecting electrode lumen <NUM> to outlets <NUM>. As shown in <FIG>, when electrode 26A is coupled to distal end <NUM>, one or more fluid paths 100A take a substantially radial flow path out of outlets <NUM>.

Electrode 26B includes an electrode lumen <NUM>, two outlets 72B, and a channel 74B connecting electrode lumen <NUM> to outlets 72B (<FIG>). Channel 74B may include two angled portions connecting electrode lumen <NUM> to outlets 72B. When electrode 26B is coupled to distal end <NUM>, one or more fluid paths <NUM> take a diverted flow path out of outlets <NUM>, at an acute angle relative to, for example, a central longitudinal axis of distal end <NUM>, shaft <NUM>, cap <NUM>, and/or lumen 70B. Fluid flow path(s) 100B may be angled relative to fluid flow path(s) 100A.

Electrode 26C includes an electrode lumen 70C extending to a single outlet 72C (<FIG>). Outlet 72C is substantially aligned with electrode lumen 70C. When electrode 26C is coupled to distal end <NUM>, a fluid path 100C forms a forward flow path out of outlet 72C, substantially aligned with the central longitudinal axis of distal end <NUM>, shaft <NUM>, cap <NUM>, and/or lumen 70C, and/or substantially perpendicular to the distal face of electrode 26C.

Electrode 26D includes at least one side opening, channel, passage, and/or hole <NUM> (<FIG>). Side opening <NUM> may extend from the proximal portion of electrode 26D. Electrode 26D may not include a central lumen. Electrode 26D may, for example, be solid instead of hollow. With electrode 26D coupled to the rest of distal end <NUM>, side opening <NUM> may be in fluid communication with lumen <NUM>. A fluid path 100D forms a flow path out of side opening <NUM> such that fluid delivered through lumen <NUM> exits distal end <NUM> at a position proximal to the distal tip of electrode 26D. For example, the fluid may flow along an exterior surface of electrode 26D, via a gap between the exterior surface of electrode 26D and the surface forming opening <NUM>. At least a portion of side opening <NUM> may be radially inward of the sealing surfaces of seal <NUM>.

As discussed above, electrodes 26A-26D may be releasably coupled to and removed from the rest of distal end <NUM>, such that a user may couple one electrode, for example, electrode 26A, to distal end <NUM>, and may then remove electrode 26A and couple another electrode, for example, electrode 26B, 26C, or 26D to distal end <NUM>. For example, a user may couple electrode 26A to the rest of distal end <NUM> and deliver distal end <NUM> to an internal lumen of a subject for a first portion of a procedure, for example, where fluid path 100A and/or the structural features of electrode 26A is/are favorable or beneficial. The user may then remove distal end <NUM> from the subject, and uncouple electrode 26A from the rest of distal end <NUM>. The user may then couple electrode 26B, 26C, or 26D to the rest of distal end <NUM>, and deliver distal end <NUM> to the internal lumen of the subject for a second portion of a procedure, for example, where fluid path 100B, 100C, or 100D and/or the structural features of electrode 26B, 26C, or 26D, is/are favorable or beneficial. The swapping of electrodes may be repeated as many times as necessary, allowing the user to modify the fluid flow path and/or electrode structural characteristics while treating tissue.

<FIG> illustrates a cross-sectional view of a ball and socket configuration for coupling and removing electrodes, according to one embodiment of this disclosure. For example, an electrode <NUM> may include a reception portion <NUM>, and a proximal support <NUM> within distal end <NUM> may include fastening arms <NUM> extending from a radial extension portion <NUM>. Fastening arms <NUM> may be inherently outwardly biased, such that fastening arms <NUM> may move radially outward away from each other in the absence of a compressing or constraining force holding them in place. Proximal support <NUM> may further include a biasing element or spring <NUM> positioned proximal of radial extension portion <NUM>. Furthermore, distal end <NUM> may include a central passage <NUM>, and central passage <NUM> may include an angled widened portion <NUM>. Proximal support <NUM> may be at least partially moveable longitudinally within central passage <NUM> between the equilibrium position (as shown) and a retracted position wherein radial extension portion <NUM> compresses spring <NUM> and fastening arms <NUM> expand in angled widened portion <NUM>.

In the retracted position, spring <NUM> biases radial extension portion <NUM> distally. As radial extension portion <NUM> moves distally, angled widened portion <NUM> forces fastening arms <NUM> radially inward. As fastening arms <NUM> move radially inward, fastening arms <NUM> may engage reception portion <NUM> of electrode <NUM>. Similarly, a user may retract proximal support <NUM>, for example, via a mechanism on the handle (not shown), such that fastening arms <NUM> may retract and expand, allowing a user to uncouple electrode <NUM>.

It is noted that, fastening arms <NUM> may form a circular, or partially circular, socket configured to receive a portion of electrode <NUM>, for example, reception portion <NUM>. Fastening arms <NUM> may be a plurality of individual arm members spaced apart in the retracted and expanded configuration, or may be a single member that is radially expanded in the retracted and expanded configuration. Additionally, although not shown, the configuration illustrated in <FIG> may include one or more seals in distal end <NUM> to maintain the fluidic connections between lumen <NUM> and the electrode lumen when electrode <NUM> is coupled to distal end <NUM>. For example, one or more seals may be positioned radially within fastening arms <NUM> such that, with electrode <NUM> coupled to the rest of distal end <NUM>, the seals are positioned between fastening arms <NUM> and reception portion <NUM>. The one or more seals may be positioned at any one or more positions along the overlap of fastening arms <NUM> and reception portion <NUM>. Alternatively or additionally, one or more seals may be positioned within distal end <NUM> distal to angled widened portion <NUM>.

<FIG> illustrate additional aspects of the disclosure. <FIG> are partial sectional views of another exemplary mechanism to couple and remove electrodes. For example, a distal end <NUM> may include a coupling tube <NUM> that is longitudinally movable with proximal support <NUM>. Coupling tube <NUM> includes a coupling portion <NUM> configured to contact the proximal end of electrode <NUM> and couple electrode <NUM> to coupling tube <NUM>. Coupling tube <NUM> may be coupled to a distal end of the fluid lumen and may include an inner lumen <NUM>. Coupling tube <NUM> may include an elastomeric polymer material that forms or is positioned within coupling portion <NUM>. For example, the elastomeric polymer material may be neoprene, Santoprene™ (thermoplastic vulcanizate), Viton, rubber, etc. Coupling tube <NUM> may be longitudinally movable between at least a retracted position (<FIG>) and an extended position (<FIG>). For example, a user may insert electrode <NUM> into distal end <NUM> (<FIG>), and may extend coupling tube <NUM> with proximal support <NUM> from the retracted position to the extended position. Extending coupling tube <NUM> to the extended position may bring coupling portion <NUM> into contact with the proximal end of electrode <NUM>. Further extension of coupling tube <NUM> moves a portion of coupling tube <NUM> onto and over the proximal portion of electrode <NUM> such that the proximal portion of electrode <NUM> is coupled within a portion of inner lumen <NUM>, thus coupling proximal support <NUM> with electrode <NUM> (<FIG>). Proximal portion of electrode <NUM> may include one or more contours, for example, a radially narrower portion that widens distally to help in the coupling and/or stretching of coupling tube <NUM> over the proximal portion of electrode <NUM>. Coupling tube <NUM> and electrode <NUM> may securely engage one another in a manner similar to fastening portions <NUM> and electrodes 26A-26D, and/or similar to fastening arms <NUM> and electrode <NUM>.

Still further distal movement of coupling tube <NUM> from the position shown in <FIG> may extend electrode <NUM> distally from the rest of distal end <NUM>. During this movement, coupling tube <NUM> may extend distally into a lumen or passage in an end cap of distal end <NUM> (the end cap being similar to cap <NUM>). The wall of coupling tube <NUM> may be squeezed between the outer surface of electrode <NUM> and the inner surface of the end cap, thereby enhancing sealing of coupling tube <NUM> around electrode <NUM> to facilitate fluid flow through coupling tube <NUM> into electrode <NUM>.

The elastomeric polymer material within coupling portion <NUM> may expand around the proximal end of electrode <NUM> and releasably couple coupling portion <NUM> to the proximal end of electrode <NUM>. The elastomeric polymer material within coupling portion <NUM> may also form a seal around the proximal end of electrode <NUM> such that fluid may be delivered through coupling tube <NUM> and into electrode <NUM>. Additionally, retracting coupling tube <NUM> proximally and/or pulling electrode <NUM> distally may cause the elastomeric polymer material within coupling portion <NUM> to disconnect from the proximal end of electrode <NUM>, allowing for the user to change electrode <NUM>, as discussed above. Although not shown, it is noted that coupling tube <NUM> and proximal support <NUM> may be coupled to a mechanism on the handle in order for a user to extend and/or retract coupling tube <NUM>.

Alternatively or additionally, electrodes <NUM>, 26A, 26B, 26C, 26D, <NUM>, <NUM>, or any other suitable electrodes, may be coupled to the rest of distal end <NUM> via another form of coupling. For example, any of the electrodes may be screw-fit into the rest of distal end <NUM> via corresponding (engaging) threading on the proximal portion of electrode <NUM> and distal portion <NUM> of proximal support <NUM>. It also is contemplated that any of the electrodes may be coupled to the rest of distal end <NUM> via a receptacle, and an element to be received (and, in some instances, locked) within the receptacle. For example, the coupling between any of the electrodes and the rest of distal end <NUM> may include a post, a plug, a pin, a spiral, a lever, a bayonet, etc. on one of the electrode(s) and proximal support <NUM>, and the receptacle may include a ring, an orifice, or another correspondingly shaped connection element on the other of the electrode(s) and proximal support <NUM>. The lockable coupling may further include a detent mechanism, an interference element, and/or a quick connect mechanism. Furthermore, the coupling may include a lever lock, a taper lock, a pin, and/or a keying component, and the coupling may be operably and/or releasably controlled via a mechanism in handle <NUM>.

Other examples of electrodes are described in the paragraphs below. It should be understood that any feature described in connection with electrodes <NUM>, 26A, 26B, 26C, 26D, <NUM>, and/or <NUM> may be found in any of the other electrodes, and vice-versa. Aspects of the other electrodes also may be shared between them. In particular, any of the examples of electrodes discussed herein may include any of the fluid paths and coupling mechanisms discussed above. Similarly, any of the examples of electrodes discussed herein may include any of the insulation patterns discussed below.

<FIG> depict perspective and cross-sectional views, respectively, of another electrode <NUM> that may be positioned and function within medical device <NUM>. Electrode <NUM> includes an insulator <NUM>, which may form a rounded annular insulation pattern on a distal end face <NUM> of electrode <NUM>. For example, insulator <NUM> may be ring or donut shaped, and an outer edge of insulator <NUM> may be flush with a radially outer edge of electrode <NUM>. As shown in <FIG>, electrode <NUM> may include an annular cavity <NUM> extending proximally from distal end face <NUM>, and a proximal portion of insulator <NUM> may be received within cavity <NUM>. Although not illustrated, electrode <NUM> may include a lumen and one or more outlets as discussed above, to facilitate fluid flow through electrode <NUM>. Alternatively, electrode <NUM> may be solid as shown, and fluid may flow along its outer surface.

Insulator <NUM> may provide a buffer or stand off from distal end face <NUM> and any tissue. in aspect, insulator <NUM> may abut tissue such that electrode <NUM> may be energized while insulator <NUM> helps to insulate the tissue. Additionally, electrode <NUM> may be advanced further distally and a portion of the abutted tissue may contact the portion of distal end face <NUM> radially interior of insulator <NUM> or otherwise not including insulator <NUM>.

<FIG> depict perspective and cross-sectional views, respectively, of another electrode <NUM> that may be positioned and function within medical device <NUM>. Electrode <NUM> includes an insulator <NUM>, which includes a dotted insulation pattern. Insulator <NUM> may include substantially hemispherical distal portions 401A and substantially cylindrical proximal portions <NUM> B (<FIG>) extending proximally of respective hemispherical distal portions 401A. For example, insulator <NUM> may include four hemispherical portions 401A positioned on a distal end face <NUM> of electrode <NUM>. Fewer or more hemispherical distal portions 401A may be used. As shown in <FIG>, electrode <NUM> may include cylindrical cavities <NUM>, and the cylindrical proximal portions <NUM> B of insulator <NUM> may extend into cylindrical cavities <NUM>. As illustrated, electrode <NUM> may include a lumen <NUM> and one or more outlets <NUM> to deliver fluid, as discussed above. For example, electrode <NUM> may include a central outlet <NUM> in distal end face <NUM>, and the hemispherical distal portions 401A of insulator <NUM> may be positioned radially around outlet <NUM>. Electrode <NUM> may include a similar flow path for fluid.

<FIG> illustrate additional electrodes <NUM>, <NUM>, and <NUM>. For example, as shown in <FIG>, electrode <NUM> may include a cross-shaped insulator <NUM> on a distal end face <NUM>. Electrode <NUM> may include an outlet <NUM> positioned within cross-shaped insulator <NUM>, or may include one or more outlets as discussed above. Furthermore, cross-shaped insulator <NUM> may be formed by intersecting semicylindrical insulation portions. Other portions of insulator <NUM> may be positioned within one or more cavities (not shown) in distal end face <NUM>. Alternatively, cross-shaped insulator <NUM> may include intersecting polygonal (e.g., rectangular) insulation portions positioned on distal end face <NUM>.

As shown in <FIG>, electrode <NUM> may include a line-shaped insulator <NUM> on distal end face <NUM>. Line-shaped insulator <NUM> may bisect distal end face <NUM> (i.e., with ends of line-shaped insulator <NUM> positioned <NUM> degrees apart). Alternatively, line-shaped insulator <NUM> may be offset and/or not span distal end face <NUM> (e.g., with ends of line-shaped insulator <NUM> positioned approximately <NUM>, <NUM>, <NUM>, etc. degrees apart). Although not shown, electrode <NUM> may include an outlet positioned within line-shaped insulator <NUM>, or may include one or more outlets as discussed above. Furthermore, line-shaped insulator <NUM> may be formed by a semicylindrical insulation portion. Other portions of insulator <NUM> may be positioned within one or more cavities (not shown) in distal end face <NUM>. Alternatively, insulator <NUM> may include a polygonal (e.g., rectangular) insulation portion positioned on distal end face <NUM>.

As shown in <FIG>, electrode <NUM> may include an annular insulator <NUM> at distal end face <NUM>. Annular insulator <NUM> may be substantially cylindrical with an open cylindrical middle portion. Annular insulator <NUM> may include cylindrical inner and outer walls. Annular insulator <NUM> may include a flat distal portion, and/or may include a rounded radially exterior distal portion on the distal face of annular insulator <NUM>. As shown, the outer wall of annular insulator <NUM> may be substantially aligned with (flush with) the outer surface of a distal end portion of electrode <NUM>. Annular insulator <NUM> may extend proximally beyond distal end face <NUM>. For example, electrode <NUM> may include a narrowed distalmost portion extending proximal of distal end face <NUM>, forming a ledge for annular insulator <NUM>. Annular insulator <NUM> may be coupled to electrode <NUM> over the narrowed distalmost portion, with the remainder of the distal portion of electrode <NUM> being uninsulated. Although not shown, electrode <NUM> may include an outlet positioned interior to annular insulator <NUM>, or may include one or more outlets as discussed above.

In the aforementioned aspects of this disclosure, the various insulators may be formed by a ceramic, fluoropolymer, polyether ether ketone (PEEK), or other heat resistant and non-conductive material. The insulators provide one or more standoffs of material raised from the distal end face of the electrode. The various electrodes allows for a device that may be used to both cut tissue and mark around an area of tissue. The various electrodes also allow the device to provide hemostasis to control small bleeds. Such electrodes include insulated portions that allow for at least a portion of the distal end face to be exposed to contact tissue. The insulated portions help to minimize the risk of thermal damage and perforation of the tissue by still allowing for the electrode to perform marking and providing hemostasis.

The various electrodes discussed herein are capable of modifying physical properties of tissue when in contact with tissue by delivering energy (e.g., radio frequency energy). The energy delivered may be monopolar or bipolar energy. The various electrodes may be coupled to a shaft, with the shaft configured to extend into a body lumen or cavity of a subject. The shaft includes an electrical element traversing the shaft and connecting the electrode to an energy source, for example, in the handle or coupled to the handle.

The electrodes discussed above include at least two distinct portions: (<NUM>) a cutting shaft with a primary axis that is coincident or parallel to a longitudinal axis of the shaft, and (<NUM>) a distal portion that includes a cross-sectional area greater than the cutting shaft. The distal portion includes a distal face (e.g., distal end face <NUM>) including a partially insulated portion and an exposed portion. The insulated portions are positioned on the distal end face of the electrode, such that the insulated portions are not positioned along the cutting shaft. The exposed portion may be used to provide energy to a portion of tissue. For example, the electrode may be advanced toward tissue. With a first force applied pushing the electrode distally, the partially insulated portion may abut the portion of tissue but may prevent the exposed portion from contacting the tissue. With a second force greater than the first force applied pushing the electrode distally, the exposed portion may contact a portion of the tissue. Additionally, the distal portion of the electrode may include a length to allow a user to use the greater cross-sectional area of the distal portion to deliver energy to a portion of tissue to provide hemostasis.

The electrode may also be coupled to an actuation member, for example, in the handle or coupled to the handle, that allows a user to translate the electrode relative to the shaft. The electrode may be translatable between at least a first position in which the cutting shaft of the electrode is retracted within the shaft (<FIG>), and a second position in which the cutting shaft is extended beyond the shaft and exposed (<FIG>). In both the first and second positions, the distal portion that includes the insulated portions are extended and exposed beyond the shaft, and not retracted within the shaft.

As such, a user may position the partially insulated distal end face to abut tissue, and may apply energy via the distal end face to mark. The user may position the radial exterior of the distal portion to perform hemostasis to cauterize or coagulate tissue. The user may also position the uninsulated electrode shaft to abut or contact tissue and apply energy to cut, dissect, or ablate tissue. Different insulators with different insulation patterns may be appropriate for different medical procedures. Therefore, each electrode may be releasably coupled to distal end <NUM> as discussed above. Moreover, the electrode may include one or more distal outlets to provide any of the fluid flowpaths discussed above with respect to <FIG>.

<FIG> illustrate an additional example of an electrode <NUM>. As shown, electrode <NUM> may include an insulator <NUM> on a distal end portion <NUM> of electrode <NUM>. In one aspect, insulator <NUM> may be deposited on distal end portion <NUM> via ceramic deposition. Insulator <NUM> may be annular, having a passage therein for receiving distal end portion <NUM>. Insulator <NUM> may be substantially cylindrical.

Electrode <NUM> may include one or more outlets <NUM> fluidly connected to electrode lumen <NUM>, for example, as shown, electrode <NUM> may include a distal end outlet <NUM>' and a side outlet <NUM>". In one aspect, side outlet <NUM>" may be smaller than distal end outlet <NUM>' such that a majority of delivered fluid exits via distal end outlet <NUM>', However, if distal end outlet <NUM>' is blocked, for example, by abutting tissue, fluid may still exit electrode lumen <NUM> via side outlet <NUM>". Electrode <NUM> may be coupled to the rest of distal end <NUM> and may be movable relative to an end cap <NUM> as discussed above. Furthermore, electrode <NUM> may be releasably coupled within distal end <NUM> with any of the mechanisms discussed above.

Electrode <NUM> includes an electrode body <NUM>, which may form a cutting shaft for electrode <NUM>. As shown in <FIG>, electrode <NUM> also includes a distal end portion <NUM>, which has a reduced cross-sectional area (reduced relative to electrode body <NUM>). Moreover, insulator <NUM> may be applied on the radial exterior of distal end portion <NUM> such that the diameter of distal end portion <NUM> and insulator <NUM>, together, is less than or equal to the diameter of electrode body <NUM>. In one example, the radially outer surfaces of insulator <NUM> and electrode body by <NUM> are flush. Although not shown, insulator <NUM> may also be provided circumferentially around distal end face <NUM> of electrode <NUM> to form an insulated distal end portion <NUM>. In one example, the distal faces of insulator <NUM> and distal end portion <NUM> are flush. Alternatively, insulator <NUM> may narrow as it approaches the distal face of distal end portion <NUM>. In either aspect, distal end portion <NUM> may be at least partially insulated, and electrode body <NUM> may be uninsulated. Accordingly, distal end portion <NUM> may be nonconductive to avoid stray electrical energy being directed to tissue, for example, when electrode <NUM> is retracted within the rest of distal end <NUM>, but distal end portion <NUM> remains outside of the rest of distal end <NUM>.

As such, electrode <NUM> may be coupled to an electrical element and an actuation member, as discussed above, in order to deliver energy and extend or retract electrode <NUM>. Electrode body <NUM> includes a primary axis that is coincident to a longitudinal axis of the shaft. As mentioned, distal end portion <NUM> includes a cross-sectional area less than or equal to the cross-sectional area of electrode body <NUM>. Moreover, insulator <NUM> on distal end portion <NUM> does not have the longest axis of a cross-section of electrode <NUM>, and insulator <NUM> does not extend over a majority of electrode <NUM>.

<FIG> illustrates an exemplary cartridge <NUM> with a plurality of electrodes 913A-913E stored within a plurality of openings <NUM>. In this figure, different electrodes 913A-913E are shown within the plurality of openings <NUM>, but it also is contemplated that any number of identical electrodes may be contained in cartridge <NUM>. Cartridge <NUM> may also include one or more indications 917A-917E (e.g., text, diagrams, symbols, or the like) substantially aligned with each opening <NUM> to indicate the type or configuration of each of electrodes 913A-913E stored in the respective openings <NUM>. For example, electrodes 913A-913E may include different shapes, conductive pathways, and/or fluid flowpaths, and indications 917A-917E may include a shape, silhouette, arrows, and/or an exemplary fluid flowpath of the electrodes 913A-913E stored in the respective openings <NUM>. Although five electrodes 913A-913E and openings <NUM> are shown, this disclosure is not so limited. Cartridge <NUM> may include any number of electrodes stored in any number of respective openings, and the electrodes may include any of the configurations disclosed herein.

<FIG> illustrate steps that may be performed to couple an exemplary electrode <NUM> (e.g., any of electrodes 913A-913E or other electrodes disclosed herein) stored within one opening <NUM> of cartridge <NUM> to a distal end <NUM> of a shaft <NUM> of a medical device. Distal end <NUM> may include any of the medical device distal end aspects disclosed herein. As shown in <FIG>, a proximal portion <NUM> of electrode <NUM> may include one or more grooves and/or graduated portions, which may help secure the physical, electrical, and fluid connections between electrode <NUM> and distal end <NUM>, as discussed above with respect to <FIG>, <FIG>. Distal end <NUM> may be inserted into opening <NUM> and may surround proximal portion <NUM> of electrode <NUM>, as shown in <FIG>. Opening <NUM> may be larger than a cross-sectional area of distal end <NUM> to facilitate its entry into opening <NUM> and positioning circumferentially around at least a portion of proximal portion <NUM> of electrode <NUM>, to couple electrode <NUM> to distal end <NUM>. Distal end <NUM> may then be removed from opening <NUM>, with electrode <NUM> coupled to distal end <NUM>, as shown in <FIG>.

In one aspect, cartridge <NUM> may be configured to retain each electrode <NUM> in a specific position or arrangement. For example, cartridge <NUM> may include one or more cavities or protrusions within opening <NUM> that may engage with one or more portions of electrode <NUM>. The cavities and/or protrusions within opening <NUM> may define a recess with a shape complementary to the shape of electrode <NUM>. Additionally, material that forms or is within cavity <NUM> may be flexible to allow electrode <NUM> to be inserted into opening <NUM> and withdrawn from opening <NUM>. In one aspect, cavity <NUM> and electrode <NUM> may be coupled via a friction fit, a snap-fit, or another type of engagement. Cartridge <NUM> and distal end <NUM> of medical device <NUM> may each include one or more markings, protrusions, grooves, etc. that may help a user to align electrode <NUM> in a proper orientation while coupling electrode <NUM> to the rest of distal end <NUM>. For example, an inner wall of opening <NUM> may include one or more protrusions that may align with one or more grooves on an outer wall of distal end <NUM>. In one aspect, a width of opening <NUM> may be slightly larger than a width of distal end <NUM>, such that the interior walls of opening <NUM> may abut or engage one or more exterior portions of distal end <NUM>, thereby ensuring that distal end <NUM> is properly aligned to receive electrode <NUM>. Additionally or alternatively, the walls forming opening <NUM> may be tapered inwardly toward electrode <NUM>, which may help guide distal end <NUM> into alignment to receive electrode <NUM>.

The user may insert distal end <NUM> into opening <NUM> to surround at least a portion of proximal portion <NUM> of electrode <NUM> such that the coupling mechanism (e.g., one or more fastening portions <NUM>, <FIG>) within distal end <NUM> couples electrode <NUM> to the rest of distal end <NUM>. The user may then remove electrode <NUM> from cartridge <NUM> (<FIG>). For example, the force necessary to uncouple electrode <NUM> from cartridge <NUM> may be weaker than the force necessary to uncouple electrode <NUM> from the coupling mechanism within distal end <NUM>. Although not shown, electrode <NUM> may be uncoupled from distal end <NUM> and repositioned within opening <NUM> in cartridge <NUM> for storage, cleaning, and/or later use. For example, distal end <NUM> may include a mechanism to uncouple electrode <NUM> from distal end <NUM>, as discussed with respect to <FIG> above. Additionally, a different electrode <NUM> may then be coupled to distal end <NUM>.

<FIG> illustrate an additional exemplary electrode <NUM> coupled to a distal end <NUM> of a shaft <NUM>. Electrode <NUM> may be coupled to distal end <NUM> via any of the mechanisms discussed herein, and may also include any of the shapes and fluid flowpaths discussed herein. Furthermore, electrode <NUM> may be used for monopolar or bipolar electrosurgery. Electrode <NUM> may include at least a first conductive member <NUM> and a second conductive member <NUM>. First conductive member <NUM> and second conductive member <NUM> may be electrically separated by an insulating member <NUM>. Insulating member <NUM> may include, for example, an annular member at a distal end of first conductive member <NUM> that may be received in a recess in second conductive member <NUM>. First conductive member <NUM> may form a proximal portion of electrode <NUM>, and second conductive member <NUM> may form a distal end portion of electrode <NUM>. First conductive member <NUM> and second conductive member <NUM> may be formed of, for example, titanium or another medically safe and conductive material. Insulating member <NUM> may be formed of a ceramic, for example, aluminum oxide (Al<NUM>O<NUM>).

As shown in the cross-sectional view of <FIG>, electrode <NUM> may include, or may receive, a first conductor <NUM> and a second conductor <NUM>. First conductor <NUM> may be connected to first conductive member <NUM>, and second conductor <NUM> may be connected to second conductive member <NUM>. Each conductor may be either permanently coupled to its corresponding conductive member, for example, by soldering, adhering, and/or mechanical fixing, or may be selectively coupled, for example, by use of a plug and socket arrangement or a pin(s) and hole(s) arrangement used for mechanical and electrical coupling.

First conductor <NUM> and second conductor <NUM> may be electrically insulated, and may each be connected to one or more energy sources, for example, in a handle connected to shaft <NUM> or in an electrosurgical generator coupled to the handle. Each of first conductive member <NUM> and second conductive member <NUM> may be configured to receive energy in various modes, for example, radio frequency energy in a cutting mode, a coagulation mode, etc. First conductive member <NUM> and second conductive member <NUM> may thus be separately energized in order to treat tissue selectively with different portions of electrode <NUM>.

Although <FIG> illustrate electrode <NUM> having first conductive member <NUM> and second conductive member <NUM>, this disclosure is not so limited. Electrode <NUM> may include three, four, five, or more separate conductive members that are separated by insulating members. Additionally, the conductive members may be longitudinally spaced on electrode <NUM>, may be circumferentially spaced around electrode <NUM>, or may be both longitudinally spaced and circumferentially spaced around electrode <NUM>. The respective conductive members may include respective conductors to individually energize the conductive members.

Alternatively, one conductor may be longitudinally movable within at least a portion of the electrode and controllable via the handle or another proximally located element. For example, instead of conductive members <NUM> and <NUM>, a single moveable conductor may extend from the handle to the electrode. The conductor may be at least partially insulated such that energy is only delivered from a distal end portion of the conductor. Movement of the handle may control the position of the distal end of the single moveable conductor such that the distal end of the single moveable conductor may contact different portions of the electrode. The portions of the electrode may be insulated from the other portions of the electrodes. Therefore, a user may deliver energy through the conductor, and the longitudinal position of the conductor relative to the electrode may control which portion or portions of the electrode are energized.

<FIG> illustrates an additional exemplary medical device <NUM> with a handle <NUM> and a shaft <NUM>. Although not shown, any of the electrodes discussed herein may be coupled to a distal end of shaft <NUM>. In one aspect, handle <NUM> includes an activation control <NUM>, for example, on a main body <NUM> of handle <NUM>. Activation control <NUM> may include a plurality of buttons, switches, or other user input mechanisms that control the delivery of energy to one or more portions of the electrode coupled to shaft <NUM>. For example, activation control <NUM> may include a slide switch <NUM> that may be positioned in a plurality of positions to allow a user to control the energization of an electrode coupled to medical device <NUM>.

<FIG> illustrate various positions for activation control <NUM> and the corresponding configurations of electrode <NUM>. For example, slide switch <NUM> may be longitudinally movable (e.g., slidable) within a portion of handle <NUM>, and the position of slide switch <NUM> corresponds to different operational states or configurations of electrode <NUM>. Slide switch <NUM> may include one or more pads or protrusions 1137A-1137D, which may be electrically conductive pads or protrusions, for setting and/or indicating a configuration of electrode <NUM>. For example, slide switch <NUM> may include a first protrusion 1137A on a first side of slide switch. Slide switch <NUM> may include a second protrusion <NUM> on a second side of slide switch <NUM>. Slide switch <NUM> may include a third protrusion 1137C on the first side of slide switch <NUM> and a fourth protrusion 1137D, aligned with third protrusion 1137C, on the second side of slide switch <NUM>. Each of protrusion 1137A-1137D may be electrically coupled to an electrosurgical generator (not shown) via one or more conductive wires and/or cables (not shown) running through handle <NUM>, and running from handle <NUM> to the electrosurgical generator.

Handle <NUM> may include one or more arrows 1139A and 1139B, which may be positioned on the first and second sides of slide switch <NUM>. Arrows 1139A and 1139B may indicate the locations of pads or protrusions on or coupled to conductors <NUM> and <NUM>, respectively. When the pads or protrusions 1137A-1137D of slide switch <NUM> contact pads or protrusions at arrows 1139A and 1139B, a circuit is completed that may direct electrosurgical energy to one or more portions of electrode <NUM>.

<FIG> illustrates activation control <NUM> in an inactive configuration. For example, slide switch <NUM> may be in a first position where none of protrusions 1137A-1137D are aligned with arrows 1139A and 1139B. There is a break in a circuit between an energy source (e.g., an electrosurgical generator) and electrode <NUM> due to an air gap between pads or protrusions at arrows 1139A and 1139B, so current cannot flow to conductors <NUM> and <NUM>. Accordingly, electrode <NUM> may be inactive, with no energy being delivered to first conductive member <NUM> or second conductive member <NUM>.

<FIG> illustrates activation control <NUM> in a first active configuration. For example, slide switch <NUM> may be in a second position, with first protrusion 1137A aligned with arrow 1139A. In this first active configuration, a circuit is completed between the energy source and electrode <NUM> due to an electrical connection between protrusion 1137A and arrow 1139A. Therefore, energy may be delivered to first conductive member <NUM>, for example, via first conductor <NUM> (<FIG>), such that first conductive member <NUM> is energized. A circuit is not completed between one of protrusions 1137A-1137D and arrow 1139B, so no current is delivered to second conductive member <NUM> via second conductor <NUM>.

<FIG> illustrates activation control <NUM> in a second active configuration. For example, slide switch <NUM> may be in a third position, with second protrusion <NUM> aligned with arrow 1139B. In this second active configuration, a circuit is completed between the energy source and electrode <NUM> due to an electrical connection between protrusion 1137B and arrow 1139B. Therefore, energy may be delivered to second conductive member <NUM>, for example, via second conductor <NUM> (<FIG>), such that second conductive member <NUM> is energized. A circuit is not completed between one or protrusions 1137A-1137D and arrow 1139A, so no current is delivered to first conductive member <NUM> via first conductor <NUM>.

<FIG> illustrates activation control <NUM> in a third active configuration. For example, slide switch <NUM> may be a fourth position, with both third protrusion 1137C and fourth protrusion 1137D aligned with arrows 1139A and 1139B. In this third active configuration, a circuit is completed between the energy source and electrode <NUM> due to an electrical connection between protrusions 1137C and 1137D and arrows 1139A and 1139B. Therefore, energy may be delivered to both first conductive member <NUM> and second conductive member <NUM>, for example, via first conductor <NUM> and second conductor <NUM> (<FIG>), such that both first conductive member <NUM> and second conductive member <NUM> are energized.

Although slide switch <NUM> on handle <NUM> is discussed above, this disclosure is not so limited. In another aspect, medical device <NUM> may include a plurality of buttons, switches, user interfaces, foot pedals, etc. that may be manipulated to selectively energize different portions of electrode <NUM>. For example, a first foot pedal may be depressed to energize first conductive member <NUM>, and a second foot pedal may be depressed to energize second conductive member <NUM>. A third foot pedal may be depressed to energize both first conductive member <NUM> and second conductive member <NUM>, or simultaneously depressing both the first and second foot pedals may energize both first conductive member <NUM> and second conductive member <NUM>. In this aspect, depressing one or more foot pedals may complete a circuit between an energy source and the respective portions of electrode <NUM>.

In another aspect, medical device <NUM> may be coupled to a touch screen, and various user inputs on the touch screen may allow a user to control the circuitry connections, and thus energy delivery, to respective portions of electrode <NUM>. Furthermore, medical device <NUM> may be coupled to an electrosurgical generator, and one or more switches may be positioned on the electrosurgical generator and/or on handle <NUM> to control the circuitry connections and energy delivery to respective portions of electrode <NUM>. Conductors <NUM> and <NUM> may run all the way from electrode <NUM> to electrosurgical generator or another energy source. Electrode <NUM> may include any number of regions, and any of the control elements discussed herein may allow a user to selectively energize individual regions or groups of regions of electrode <NUM>. Moreover, any of the control elements may allow a user to energize different electrode regions to varying degrees (e.g., by controlling voltage, current, etc.) due to the use of separate circuitry to each region and insulation between the regions of electrode <NUM>.

Additionally or alternatively, slide switch <NUM> may extend from handle <NUM> to a distal end of device <NUM>. In such a configuration, pads or protrusions 1137A-1137D may be at the distal end, while a proximal portion of slide switch <NUM> may extend proximally back to handle <NUM>, such that the user may still move pads or protrusions 1137A-1137D from handle <NUM>. One or more arrows 1139A and 1139B also may be positioned at the distal end of device <NUM>. In one example, one or more arrows 1139A and 1139B may be at, or otherwise electrically coupled to, one or more portions of electrode <NUM>. When the pads or protrusions 1137A-1137D of slide switch <NUM> contact pads or protrusions at arrows 1139A and <NUM>, a circuit is completed that may direct electrosurgical energy to one or more portions of electrode <NUM>. As noted above, the energy may be selectively directed to a portion of electrode <NUM> while leaving another portion of electrode <NUM> unenergized.

Energizing only the first conductive member <NUM> may be useful when cutting tissue, as only energizing the shaft of electrode <NUM> may help to reduce the risk of tissue perforation or other thermal damage to tissue because the blunt distal end of electrode <NUM>, which may be abutting tissue, is not energized. Energizing the second conductive member <NUM> may be useful during an initial tissue marking, an incision, a hemostasis to increase coagulation, etc. For example, energizing the second conductive member <NUM> may allow the energized distal end to deliver immediate and effective thermal treatment of tissue without the need to exchange electrode <NUM> or the medical device, and may also increase the accuracy of electrode <NUM>. Moreover, energizing only a portion of electrode <NUM> at a time may help to concentrate the delivered energy or heat in one region, which may increase the efficacy of the delivered energy or heat. As such, electrode <NUM> may be used to perform various different procedures, reducing procedure time and costs.

<FIG> illustrate electrodes 1021A and 1021B coupled to distal end <NUM> of shaft <NUM>, according to further aspects of this disclosure. Electrode 1021A includes a first conductive member 1023A and a second conductive member 1025A spaced apart by an insulating member 1027A. First conductive member 1023A and second conductive member 1025A may be separately energized via any of the mechanisms discussed herein to treat tissue. Additionally, first conductive member 1023A includes one or more first conductive regions 1041A. First conductive regions 1041A may be metallic deposits on a ceramic or insulating base material to form an integral first conductive member 1023A that has alternating conductive and non-conductive regions. First conductive regions 1041A may be substantially parallel lines extending along the longitudinal axis of electrode 1021A. First conductive regions 1041A may be evenly spaced. Alternatively, one side of electrode 1021A may include a denser concentration of first conductive regions 1041A than another side, providing for different energy delivering capabilities of the respective sides of electrode 1021A. First conductive regions 1041A are coupled to conductor <NUM>, or other similar conductors. Furthermore, all first conductive regions 1041A may be energized together, or one or more of first conductive regions 1041A may be energized individually using any of the above-described selection arrangements.

Second conductive member 1025A may include one or more second conductive regions 1043A. For example, second conductive regions 1043A may be metallic deposits on a ceramic or insulating base material to form an integral second conductive member 1025A that includes alternating conductive and non-conductive regions. Second conductive regions 1043A may be radial extensions spaced around a distal face of second conductive member 1025A. Second conductive regions 1043A are coupled to conductor <NUM>, or other similar conductors. Furthermore, all second conductive regions 1043A may be energized together, or one or more of second conductive regions 1043A may be energized individually using any of the above-described selection arrangements.

Electrode 1021B includes a first conductive member 1023B and a second conductive member 1025B spaced apart by an insulating member 1027B. First conductive member 1023B and second conductive member 1025B may be separately energized via any of the mechanisms discussed herein to treat tissue. Additionally, first conductive member 1023B includes one or more first conductive regions <NUM> B, which are coupled to conductor <NUM> or similar conductors. First conductive regions 1041B may be metallic deposits on a ceramic or insulating base material to form an integral first conductive member 1023B that has alternating conductive and non-conductive regions. First conductive regions <NUM> B may be helical or spiral lines positioned on an exterior of first conductive member 1023B. First conductive regions 1041B may be evenly spaced. Alternatively, one portion of electrode <NUM> B may include a denser concentration of first conductive regions 1041B than another portion, providing for different energy delivering capabilities of the respective portions of electrode 1021B.

Furthermore, second conductive member 1025B may include one or more second conductive regions 1043B, which may be coupled to conductor <NUM> or similar conductors. For example, second conductive regions 1043B may be metallic deposits on a ceramic or insulating base material to form an integral second conductive member 1025B that has alternative conductive and non-conductive regions. Second conductive regions 1043B may be circular lines spaced around a distal face of second conductive member 1025B. As such, the conductive and non-conductive regions may be annular, for example, in the form of concentric rings. As discussed above with respect to first conductive regions 1041A and second conductive regions 1043A, first conductive regions <NUM> B and second conductive regions 1043B may be energized together, or one or more of first conductive regions 1041B or second conductive regions 1043B may be energized individually using any of the above-described selection arrangements.

Any of the aforementioned electrodes may be selectively coupled to and uncoupled from a medical device. Similarly, once coupled to the medical device, each electrode may include separate portions that are insulated from one another, and the separate portions of the electrode may be individually energized to treat tissue.

The medical devices and methods discussed above allow a user to treat tissue by delivering electrical energy into the tissue, and delivering fluid, either simultaneously or sequentially. Additionally, the user may select one of a plurality of electrodes, including, for example, electrodes <NUM>, 26A-26D, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, 1021A and <NUM> B, to deliver the electrical energy and/or fluid, with the electrodes each having varying fluid flowpaths and/or insulators. It also is contemplated that the user may select between electrodes having similar flowpaths and/or insulation patterns, that differ in some other way. For example, electrodes having different shapes, dimensions, material properties, level(s) of use (e.g., newer versus older, or replacing worn or damaged electrodes), and/or any other characteristics. Similarly, the user may select between shafts and/or handles having different characteristics, including shapes, dimensions, material properties, level(s) of use, flexibility, operation, and/or any other characteristics.

Distal ends <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> may allow for releasably coupling the electrodes, so a user may easily couple a first electrode to the distal end to prepare for one portion of the procedure, then remove it to prepare for another portion of the procedure. For example, a user may couple a first electrode to the distal end and deliver the distal end to an interior lumen of a subject to deliver medical therapy in a first portion of a procedure (e.g., mark, cauterize, or resect tissue). The user may then remove the distal end from the interior lumen and uncouple the first electrode from the distal end. The user may then couple a second electrode to the distal end and deliver the distal end to the lumen to deliver medical therapy for a second portion of the procedure. The second electrode may include a different fluid flowpath and/or insulation pattern than the first electrode, which may be more suitable for the second portion of the procedure than the first electrode. These steps may be repeated as many times as necessary during the procedure, using as many different types of electrodes as needed. Additionally, the user may use the same medical device <NUM> to deliver the various types of medical therapy by simply swapping and/or changing the electrodes coupled to distal end <NUM>. The various fluid flowpaths and/or insulation patterns may help the user to more quickly and efficiently deliver the medical therapy, for example, cut, dissect, ablate, mark, coagulate, cauterize, or otherwise treat tissue.

Additionally or alternatively, the securing and/or removing of electrodes may be performed prior to performing a medical procedure, in preparation for performing the medical procedure. For example, the securing and/or removing of electrodes may be performed by an assembler of the medical device, and the device may then be delivered to the user for performance of a medical procedure.

Moreover, as discussed with respect to <FIG>, a single electrode <NUM>, 1021A, or 1021B may allow the user to perform different tissue treatment procedures with the same electrode coupled to the distal end <NUM> of the medical device. For example, a user may energize first conductive members <NUM>, 1023A, and 1023B to perform a cutting procedure with a reduced risk of tissue perforation because insulating members <NUM>, 1027A, and 1027B may help to prevent energy flowing through second conductive member <NUM>, 1025A, and <NUM> or the distal end of electrode <NUM>, 1021A, and 1021B. Similarly, a user may energize second conductive members <NUM>, 1025A, and 1025B to perform a marking or hemostasis procedure. Lastly, a user may energize the entirety of electrodes <NUM>, 1021A, and 1021B for another portion of a procedure. A proximal control, for example, activation control <NUM>, a single moveable conductor, a slide switch, one or more actuators or foot pedals, etc, may allow the user to control the energization of electrodes <NUM>, 1021A, and <NUM> B without removing the medical device from the patient, which may help to reduce the costs and duration of the procedure, also potentially reducing the risks to the patient.

Claim 1:
A medical device (<NUM>) comprising:
a shaft (<NUM>; <NUM>; <NUM>; <NUM>) including a lumen (<NUM>) configured to direct a flow of fluid through the shaft (<NUM>); and
an electrode (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>),
wherein a proximal end of the electrode (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) and a distal end (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) of the shaft (<NUM>) form a coupling (<NUM>) configured to releasably couple the proximal end of the electrode (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) with the distal end (<NUM>) of the shaft (<NUM>), and wherein when the proximal end of the electrode (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>) is coupled to the distal end (<NUM>) of the shaft (<NUM>), fluid delivered through the lumen (<NUM>) is emitted from the electrode (<NUM>; <NUM>; <NUM>; <NUM>; <NUM>),
characterized in that
the electrode (<NUM>; <NUM>; <NUM>; <NUM>) includes an insulator (<NUM>; <NUM>; <NUM>; <NUM>) that only partially covers a distal end face (<NUM>; <NUM>; <NUM>; <NUM>) of the electrode (<NUM>; <NUM>; <NUM>; <NUM>), and wherein the electrode (<NUM>; <NUM>; <NUM>; <NUM>) includes an outlet (<NUM>; <NUM>; <NUM>; <NUM>) in the distal end face (<NUM>; <NUM>; <NUM>; <NUM>), and wherein the insulator (<NUM>; <NUM>; <NUM>; <NUM>) includes a plurality of protrusions projecting from the distal end face (<NUM>; <NUM>; <NUM>; <NUM>) about the outlet (<NUM>; <NUM>; <NUM>; <NUM>).