US20220096154A1 - Medical devices and related methods - Google Patents

Abstract

A medical device includes 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 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 is emitted from the electrode.

Description

TECHNICAL FIELD
• 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 for the treatment of tissue by delivering electrical energy to or into tissue, and injecting fluid into and/or under tissue, with one or more electrodes.
BACKGROUND
• 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.
SUMMARY
• 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 may include an insulator that only partially covers a distal end face of the electrode. The electrode may include an outlet in the distal end face, and the insulator may include 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.
BRIEF DESCRIPTION OF THE DRAWINGS
• 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.
• FIG. 1A illustrates an exemplary medical device, andFIG. 1B illustrates a cross-sectional view of the medical device, according to aspects of this disclosure.
• FIGS. 2A and 2B illustrate views of a distal portion of the medical device ofFIG. 1A in different operational states, according to aspects of the present disclosure.
• FIGS. 3A-3D illustrate cross-sectional views of various electrodes of the distal portion of the medical device, according to aspects of the present disclosure.
• FIG. 4 illustrates a cross-sectional view of an exemplary coupling arrangement configured for releasably coupling electrodes of the distal portion of the medical device, according to aspects of the present disclosure.
• FIGS. 5A and 5B illustrate partially cutaway views of another exemplary coupling arrangement configured for releasably coupling electrodes of the distal portion of the medical device, according to aspects of the present disclosure.
• FIGS. 6A and 6B illustrate a perspective view and a cross-sectional view, respectively, of an exemplary electrode, according to aspects of the present disclosure.
• FIGS. 7A and 7B illustrate a perspective view and a cross-sectional view, respectively, of another exemplary electrode, according to aspects of the present disclosure.
• FIGS. 8A-8C illustrate perspective views of other exemplary electrodes, according to further aspects of the present disclosure.
• FIGS. 9A and 9B illustrate a perspective view of an exemplary distal portion of the medical device, and a cross-sectional view of the electrode of the distal portion, respectively, according to aspects of the present disclosure.
• FIG. 10 illustrates a perspective view of an exemplary cartridge that may store one or more exemplary electrodes, according to further aspects of the present disclosure.
• FIGS. 11A-11C illustrate exemplary steps to couple one or more exemplary electrodes stored in an exemplary cartridge, similar to the cartridge ofFIG. 10, to a distal end of a medical device, according to further aspects of the present disclosure.
• FIGS. 12A and 12B illustrate a perspective and a cross-sectional view of a further exemplary electrode, according to further aspects of the present disclosure.
• FIG. 13 illustrates a perspective view of a portion of a further exemplary medical device, according to further aspects of the present disclosure.
• FIGS. 14A-14D illustrate various arrangements of an actuator on the medical device ofFIG. 13, and the corresponding configurations of an exemplary electrode, according to further aspects of the present disclosure.
• FIGS. 15A and 15B illustrate perspective views of additional electrode configurations, according to further aspects of the present disclosure.
DETAILED DESCRIPTION
• 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. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
• 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 +/−10% of a stated value.
• FIG. 1 depicts amedical device10 that includes ahandle12, ashaft14, and adistal end16.Handle12 may include amain body18 and amovable body20.Handle12 also may include aport22 configured to receive fluid, and ahub24 configured to receive electrical energy similar to an electrical plug or socket.Distal end16 includes anelectrode26.Electrode26 is electrically connected tohub24, and may include one or more lumens, passages, recesses, or other surfaces (FIGS. 3A-3D) fluidly connected to, or otherwise in fluid communication with,port22.Medical device10 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 ofshaft14 may be within the subject, while handle12 may remain outside of the subject. From outside of the subject, a user can manipulate handle12. Movement ofmovable body20 relative tomain body18 in a first direction (e.g., the distal direction) may extendelectrode26 relative to shaft14 (e.g., moveelectrode26 distally relative to a distal end of shaft14), while movement ofmovable body20 relative tomain body18 in a second direction (e.g., the proximal direction) may retractelectrode26 relative to shaft14 (e.g., moveelectrode26 proximally relative to a distal end of shaft14).
• Handle12 may be coupled to a fluid source viaport22.Port22 may be in fluid communication withelectrode26 via aninternal lumen27 in shaft14 (FIG. 1B).Internal lumen27 may extend longitudinally throughmain body18 ofhandle12, andport22 may include aport lumen22A that extends throughport22 to fluidly connectport22 tointernal lumen27.Port22 may be positioned on a distal portion ofmain body18. Alternatively,port22 may be positioned onmovable body20. Moreover,port22 may include a one-way valve28, a luer, a seal, threading30, and/or any appropriate element to maintain a secure connection betweenhandle12 and the fluid source, minimize or prevent back-flow (e.g., fluid flowing proximally out of port22), and/or minimize or prevent leakage. In one example, one-way valve28 may include an outer housing containing an inner elastomeric and/or gelatinous sealing member (not shown).
• Handle12 may be coupled to an energy source throughhub24.Hub24 may be electrically coupled toelectrode26 via aconductive element33 inshaft14. The energy source may be an electrocautery source, a radio frequency generator, a heating source, a current generator, etc. In one aspect,medical device10 may be used for monopolar electrosurgery, and may include a return electrode positioned remotely fromelectrode26 on the subject. In another aspect,medical device10 may be used for bipolar electrosurgery. In that instance,electrode26 may include an active electrode portion, and a return electrode may be provided at or near another portion ofelectrode26 and/orshaft14. In one example, two conductive elements may run throughshaft14, 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.Hub24 may be positioned onmovable body20 and may include one or more pins orprongs32 to couple to the energy source. Alternatively,hub24 may be positioned onmain body18.
• In one aspect shown inFIG. 1B,prong32 may extend throughhub24 transverse to a longitudinal axis ofhandle12, and may be electrically and physically connected toconductive element33, such as a wire, a cable, and/or a braided sheath.Conductive element33 may be electrically conductive or include an electrically conductive element, andconductive element33 may extend longitudinally throughinternal lumen27 and throughshaft14. As shown inFIG. 1B, fluid delivered throughport22 may surround at least a portion ofconductive element33. In another aspect, the energy source may be a part of handle12 (e.g., an internal battery in handle12). As alluded to above, a second conductive element (not shown) may be provided as a return pathway wheremedical device10 has a bipolar configuration.
• As mentioned, handle12 may control the extension or retraction ofelectrode26 relative to thedistal end16 ofshaft14. For example,main body18 may include aslot34 and athumb ring36.Movable body20 may be slidably positioned withinslot34 and include one or more finger holes38.Movable body20 may be lockable in one or more positions relative tomain body18.Movable body20 may be coupled to a drive element, and the drive element may impart distal or proximal movement to at least a portion ofelectrode26 based on relative movement betweenmain body18 andmovable body20. In one aspect,conductive element33 may also act as a drive wire, rod, cable, or the like, such thatconductive element33 imparts distal or proximal movement to at least a portion ofelectrode26 while also couplingelectrode26 tohub24, e.g., the one ormore prongs32, to deliver the energy to (and/or from)electrode26.
• As shown inFIGS. 1A and 1B,shaft14 extends from a distal portion ofmain body18 todistal end16, and may surround at least a portion ofelectrode26.Shaft14 may be coupled to handle12 via acoupler40, which may surround a portion ofshaft14 and screw ontomain body18 to secure the elements.Shaft14 may be a sheath that surrounds at least a portion of one or more lumens (e.g., lumen27) and the drive wire (e.g., conductive element33). In another aspect,shaft14 may be an extrusion that includes one or more lumens extending fromhandle12 todistal end16.
• FIGS. 2A and 2B illustrate additional aspects ofdistal end16. It is noted thatFIGS. 2A and 2B illustrate the internal components ofdistal end16, without showing the distal portion ofshaft14 that may radially surround at least a portion ofdistal end16.FIGS. 2A and 2B show perspective views of a portion ofdistal end16, with a portion ofelectrode26 positioned within anend cap42 ofdistal end16.End cap42 may include adistal end face44 and graduatedsurfaces46,48, and50.End cap42 may be at least partially electrically insulating. For example,end cap42 may be formed of a ceramic material or another non-conductive material. Alternatively, onlydistal end face44 and an internal portion ofend cap42 that contacts and/or surroundselectrode26 may be electrically insulating.Distal end face44 includes a central opening52 (FIG. 2B) through whichelectrode26 may extend and retract.
• Electrode26 may be coupled to aproximal support54 ofdistal end16, which includes acylindrical extension56.Proximal support54 may be coupled to a portion of the drive wire (e.g., conductive element33) via a wire receiving portion57 (FIGS. 3A-3D).Cylindrical extension56 may extend distally and may receive at least a portion ofelectrode26. As discussed in detail below,electrode26 andcylindrical extension56 may be coupled via a snap fit, friction fit, threading, an elastomeric and/or adhesive material, or other suitable coupling.Cylindrical extension56 may allow fordifferent electrodes26 to be removably coupled todistal end16.
• Electrode26 andproximal support54 may be movable relative to endcap42 in response to the relative movement ofmovable body20 andmain body18 ofhandle12. For example, withmovable body20 in a proximal position relative tomain body18,electrode26 may be substantially retracted withinend cap42 with only a distal portion ofelectrode26 extending distally beyond end cap42 (FIG. 2A). Then, asmovable body20 is translated distally relative tomain body18,electrode26 andproximal support54 translate distally relative to endcap42 such that a greater portion ofelectrode26 extends distally beyondend cap42 through central opening52 (FIG. 2B).
• Alternatively, although not shown in the figures, withmovable body20 in the proximalmost position,electrode26 may be fully retracted withincentral opening52 ofend cap42. It is noted that whilecentral opening52 is shown inFIG. 2B as being smaller than a portion ofelectrode26, this disclosure is not so limited, andcentral opening52 andelectrode26 may include various sizes and arrangements. For example,central opening52 may be wider thanelectrode26 such thatelectrode26 may be fully retracted withincentral opening52. Such a configuration may be advantageous, for example, in versions ofmedical device10 in which fluid flows along the outer surface ofelectrode26. Alternatively,central opening52 may be narrower than a distal portion ofelectrode26 such that the distal portion ofelectrode26 may always remain partially extended fromcentral opening52.
• In one aspect,electrode26 is releasably coupled to the rest ofdistal end16. As shown inFIG. 3A,electrode26A may be snap-fit to an internal portion ofdistal end16. For example,distal end16 may include one ormore fastening portions58 extending from and/or coupled tocylindrical extension56. A proximal portion ofelectrode26A may include one ormore reception portions60 including, for example, one or more distal widened portions and/or one or more indentations, which may be shaped to receive the one ormore fastening portions58. For instance, eachfastening portion58 may include a distalangled portion62 and aprotrusion64. Aselectrode26A is inserted into the rest ofdistal end16, a proximal portion ofelectrode26A may contact distalangled portions62, and relative movement between the two may push fastening portion(s)58 radially outward, such that the proximal portion ofelectrode26A may be releasably received within or betweenfastening portions58. Further movement ofelectrode26A proximally (and/or the rest ofdistal end16 distally) may bringprotrusions64 into engagement withreception portion60 ofelectrode26A, thereby securingelectrode26A. In one example, one ormore fastening portions58 may include one or more cantilevered arms extending distally from an annular base envelopingcylindrical extension56, 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 ormore fastening portions58 may include a compliant sheath envelopingcylindrical extension56, the sheath having a distal rim portion with distalangled portions62. It also is contemplated that one ormore fastening portions58 may be integrally formed withproximal support54.
• Distal end16 includes one ormore seals66 to help ensure that fluid delivered throughlumen27 is directed throughelectrode26A. In one aspect,distal end16 may include a compressible and/orexpandable seal66. For example, seal66 may be a circular ring of elastomeric material positioned on a distal end ofcylindrical extension56 such thatpositioning electrode26A within the one ormore fastening portions58 ensures thatelectrode26A abuts and/or compresses seal66. As such, fluid delivered vialumen27 may be delivered through anelectrode lumen70 and out ofoutlets72 ofelectrode26A. In one aspect,proximal support54,cylindrical extension56, andfastening portion58 are conductive such that electrical energy delivered viaconductive element33 may be delivered to or into tissue viaelectrode26A.
• As mentioned,electrode26A is removably coupled todistal end16. For example, pullingelectrode26A distally relative to the rest ofdistal end16, and/or pulling the rest ofdistal end16 proximally relative to electrode26A, may expandfastening portions58 such thatelectrode26A may be removed fromdistal end16. For example,fastening portions58 may include proximal angled portions at location(s)68, and/orreception portions60 may include distal angled portions at location(s)68, which may facilitate the expansion of the onemore fastening portions58. The amount of force required to expandfastening portions58 may be greater than (e.g., approximately two times greater than) the forces that may be imparted toelectrode26A by tissue or other material within a subject during a medical procedure. As such,fastening portions58 may help to ensure thatelectrode26A is only removed from the rest ofdistal end16 by a user or other medical professional whendistal end16 is external to the subject.
• Additionally,electrode26A may be temporarily stored in a delivery cartridge (FIG. 10) before coupling todistal end16 and/or after uncoupling fromdistal end16. For example, the cartridge may surround at least the distal portion ofelectrode26A (and may surround an entirety ofelectrode26A) and may help the user to handle and/orstore electrode26A, for example, in preparation forcoupling electrode26A to the rest ofdistal end16. The cartridge may help theuser align electrode26A withcentral opening52 andposition electrode26A within the rest ofdistal end16 during coupling. As discussed with respect toFIG. 10 below, the cartridge may also store a plurality of electrodes, which may be the same electrode configuration, or may include different electrode configurations.
• FIGS. 3A-3D illustratevarious electrodes26,26A,26B,26C, and26D that may be coupled to and removed fromdistal end16.Electrode26A includes anelectrode lumen70, twooutlets72, and achannel74 connectingelectrode lumen70 tooutlets72. As shown inFIG. 3A, whenelectrode26A is coupled todistal end16, one or morefluid paths100A take a substantially radial flow path out ofoutlets72.
• Electrode26B includes anelectrode lumen70B, twooutlets72B, and a channel74B connectingelectrode lumen70B tooutlets72B (FIG. 3B). Channel74B may include two angled portions connectingelectrode lumen70B tooutlets72B. When electrode26B is coupled todistal end16, one or morefluid paths100B take a diverted flow path out ofoutlets72B, at an acute angle relative to, for example, a central longitudinal axis ofdistal end16,shaft14,cap42, and/orlumen70B. Fluid flow path(s)100B may be angled relative to fluid flow path(s)100A.
• Electrode26C includes an electrode lumen70C extending to a single outlet72C (FIG. 3C). Outlet72C is substantially aligned with electrode lumen70C. When electrode26C is coupled todistal end16, afluid path100C forms a forward flow path out of outlet72C, substantially aligned with the central longitudinal axis ofdistal end16,shaft14,cap42, and/or lumen70C, and/or substantially perpendicular to the distal face of electrode26C.
• Electrode26D includes at least one side opening, channel, passage, and/or hole76 (FIG. 3D).Side opening76 may extend from the proximal portion of electrode26D. Electrode26D may not include a central lumen. Electrode26D may, for example, be solid instead of hollow. With electrode26D coupled to the rest ofdistal end16,side opening76 may be in fluid communication withlumen27. A fluid path100D forms a flow path out ofside opening76 such that fluid delivered throughlumen27 exitsdistal end16 at a position proximal to the distal tip of electrode26D. For example, the fluid may flow along an exterior surface of electrode26D, via a gap between the exterior surface of electrode26D and thesurface forming opening52. At least a portion ofside opening76 may be radially inward of the sealing surfaces ofseal66.
• As discussed above,electrodes26A-26D may be releasably coupled to and removed from the rest ofdistal end16, such that a user may couple one electrode, for example, electrode26A, todistal end16, and may then removeelectrode26A and couple another electrode, for example, electrode26B,26C, or26D todistal end16. For example, a user may coupleelectrode26A to the rest ofdistal end16 and deliverdistal end16 to an internal lumen of a subject for a first portion of a procedure, for example, wherefluid path100A and/or the structural features ofelectrode26A is/are favorable or beneficial. The user may then removedistal end16 from the subject, and uncoupleelectrode26A from the rest ofdistal end16. The user may then couple electrode26B,26C, or26D to the rest ofdistal end16, and deliverdistal end16 to the internal lumen of the subject for a second portion of a procedure, for example, wherefluid path100B,100C, or100D and/or the structural features of electrode26B,26C, or26D, 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. 4 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, anelectrode126 may include areception portion160, and aproximal support154 withindistal end116 may include fasteningarms180 extending from aradial extension portion182. Fasteningarms180 may be inherently outwardly biased, such thatfastening arms180 may move radially outward away from each other in the absence of a compressing or constraining force holding them in place.Proximal support154 may further include a biasing element orspring184 positioned proximal ofradial extension portion182. Furthermore,distal end116 may include acentral passage186, andcentral passage186 may include an angled widenedportion188.Proximal support154 may be at least partially moveable longitudinally withincentral passage186 between the equilibrium position (as shown) and a retracted position whereinradial extension portion182 compressesspring184 andfastening arms180 expand in angled widenedportion188.
• In the retracted position,spring184 biasesradial extension portion182 distally. Asradial extension portion182 moves distally, angled widenedportion188forces fastening arms180 radially inward. Asfastening arms180 move radially inward, fasteningarms180 may engagereception portion160 ofelectrode126. Similarly, a user may retractproximal support154, for example, via a mechanism on the handle (not shown), such thatfastening arms180 may retract and expand, allowing a user to uncoupleelectrode126.
• It is noted that, fasteningarms180 may form a circular, or partially circular, socket configured to receive a portion ofelectrode126, for example,reception portion160. Fasteningarms180 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 inFIG. 4 may include one or more seals indistal end116 to maintain the fluidic connections betweenlumen127 and the electrode lumen whenelectrode126 is coupled todistal end116. For example, one or more seals may be positioned radially withinfastening arms180 such that, withelectrode126 coupled to the rest ofdistal end116, the seals are positioned betweenfastening arms180 andreception portion160. The one or more seals may be positioned at any one or more positions along the overlap offastening arms180 andreception portion160. Alternatively or additionally, one or more seals may be positioned withindistal end116 distal to angled widenedportion188.
• FIGS. 5A and 5B illustrate additional aspects of the disclosure.FIGS. 5A and 5B are partial sectional views of another exemplary mechanism to couple and remove electrodes. For example, adistal end216 may include acoupling tube290 that is longitudinally movable withproximal support254. Couplingtube290 includes acoupling portion292 configured to contact the proximal end ofelectrode226 and couple electrode226 tocoupling tube290. Couplingtube290 may be coupled to a distal end of the fluid lumen and may include aninner lumen293. Couplingtube290 may include an elastomeric polymer material that forms or is positioned withincoupling portion292. For example, the elastomeric polymer material may be neoprene, Santoprene™ (thermoplastic vulcanizate), Viton, rubber, etc. Couplingtube290 may be longitudinally movable between at least a retracted position (FIG. 5A) and an extended position (FIG. 5B). For example, a user may insertelectrode226 into distal end216 (FIG. 5A), and may extendcoupling tube290 withproximal support254 from the retracted position to the extended position. Extendingcoupling tube290 to the extended position may bringcoupling portion292 into contact with the proximal end ofelectrode226. Further extension ofcoupling tube290 moves a portion ofcoupling tube290 onto and over the proximal portion ofelectrode226 such that the proximal portion ofelectrode226 is coupled within a portion ofinner lumen293, thus couplingproximal support254 with electrode226 (FIG. 5B). Proximal portion ofelectrode226 may include one or more contours, for example, a radially narrower portion that widens distally to help in the coupling and/or stretching ofcoupling tube290 over the proximal portion ofelectrode226. Couplingtube290 andelectrode226 may securely engage one another in a manner similar tofastening portions58 andelectrodes26A-26D, and/or similar tofastening arms180 andelectrode126.
• Still further distal movement ofcoupling tube290 from the position shown inFIG. 5B may extendelectrode226 distally from the rest ofdistal end216. During this movement,coupling tube290 may extend distally into a lumen or passage in an end cap of distal end216 (the end cap being similar to cap42). The wall ofcoupling tube290 may be squeezed between the outer surface ofelectrode226 and the inner surface of the end cap, thereby enhancing sealing ofcoupling tube290 aroundelectrode226 to facilitate fluid flow throughcoupling tube290 intoelectrode226.
• The elastomeric polymer material withincoupling portion292 may expand around the proximal end ofelectrode226 and releasablycouple coupling portion292 to the proximal end ofelectrode226. The elastomeric polymer material withincoupling portion292 may also form a seal around the proximal end ofelectrode226 such that fluid may be delivered throughcoupling tube290 and intoelectrode226. Additionally, retractingcoupling tube290 proximally and/or pullingelectrode226 distally may cause the elastomeric polymer material withincoupling portion292 to disconnect from the proximal end ofelectrode226, allowing for the user to changeelectrode226, as discussed above. Although not shown, it is noted thatcoupling tube290 andproximal support254 may be coupled to a mechanism on the handle in order for a user to extend and/or retractcoupling tube290.
• Alternatively or additionally,electrodes26,26A,26B,26C,26D,126,226, or any other suitable electrodes, may be coupled to the rest ofdistal end16 via another form of coupling. For example, any of the electrodes may be screw-fit into the rest ofdistal end16 via corresponding (engaging) threading on the proximal portion ofelectrode26 anddistal portion56 ofproximal support54. It also is contemplated that any of the electrodes may be coupled to the rest ofdistal end16 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 ofdistal end16 may include a post, a plug, a pin, a spiral, a lever, a bayonet, etc. on one of the electrode(s) andproximal support54, and the receptacle may include a ring, an orifice, or another correspondingly shaped connection element on the other of the electrode(s) andproximal support54. 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 inhandle12.
• Other examples of electrodes are described in the paragraphs below. It should be understood that any feature described in connection withelectrodes26,26A,26B,26C,26D,126, and/or226 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.
• FIGS. 6A and 6B depict perspective and cross-sectional views, respectively, of anotherelectrode326 that may be positioned and function withinmedical device10.Electrode326 includes aninsulator394, which may form a rounded annular insulation pattern on adistal end face396 ofelectrode326. For example,insulator394 may be ring or donut shaped, and an outer edge ofinsulator394 may be flush with a radially outer edge ofelectrode326. As shown inFIG. 6B,electrode326 may include anannular cavity398 extending proximally fromdistal end face396, and a proximal portion ofinsulator394 may be received withincavity398. Although not illustrated,electrode326 may include a lumen and one or more outlets as discussed above, to facilitate fluid flow throughelectrode326. Alternatively,electrode326 may be solid as shown, and fluid may flow along its outer surface.
• Insulator394 may provide a buffer or stand off fromdistal end face396 and any tissue. In aspect,insulator394 may abut tissue such thatelectrode326 may be energized whileinsulator394 helps to insulate the tissue. Additionally,electrode326 may be advanced further distally and a portion of the abutted tissue may contact the portion ofdistal end face396 radially interior ofinsulator394 or otherwise not includinginsulator394.
• FIGS. 7A and 7B depict perspective and cross-sectional views, respectively, of anotherelectrode426 that may be positioned and function withinmedical device10.Electrode426 includes aninsulator401, which includes a dotted insulation pattern.Insulator401 may include substantially hemisphericaldistal portions401A and substantially cylindricalproximal portions401B (FIG. 7B) extending proximally of respective hemisphericaldistal portions401A. For example,insulator401 may include fourhemispherical portions401A positioned on a distal end face498 ofelectrode426. Fewer or more hemisphericaldistal portions401A may be used. As shown inFIG. 7B,electrode426 may includecylindrical cavities403, and the cylindricalproximal portions401B ofinsulator401 may extend intocylindrical cavities403. As illustrated,electrode426 may include alumen470 and one ormore outlets472 to deliver fluid, as discussed above. For example,electrode426 may include acentral outlet472 in distal end face498, and the hemisphericaldistal portions401A ofinsulator401 may be positioned radially aroundoutlet472.Electrode326 may include a similar flow path for fluid.
• FIGS. 8A-8C illustrateadditional electrodes526,626, and726. For example, as shown inFIG. 8A,electrode526 may include across-shaped insulator505 on adistal end face596.Electrode526 may include anoutlet572 positioned withincross-shaped insulator505, or may include one or more outlets as discussed above. Furthermore,cross-shaped insulator505 may be formed by intersecting semicylindrical insulation portions. Other portions ofinsulator505 may be positioned within one or more cavities (not shown) indistal end face596. Alternatively,cross-shaped insulator505 may include intersecting polygonal (e.g., rectangular) insulation portions positioned ondistal end face596.
• As shown inFIG. 8B,electrode626 may include a line-shapedinsulator607 ondistal end face696. Line-shapedinsulator607 may bisect distal end face696 (i.e., with ends of line-shapedinsulator607 positioned 180 degrees apart). Alternatively, line-shapedinsulator607 may be offset and/or not span distal end face607 (e.g., with ends of line-shapedinsulator607 positioned approximately 150, 120, 90, etc. degrees apart). Although not shown,electrode626 may include an outlet positioned within line-shapedinsulator607, or may include one or more outlets as discussed above. Furthermore, line-shapedinsulator607 may be formed by a semicylindrical insulation portion. Other portions ofinsulator607 may be positioned within one or more cavities (not shown) indistal end face696. Alternatively,insulator607 may include a polygonal (e.g., rectangular) insulation portion positioned ondistal end face696.
• As shown inFIG. 8C,electrode726 may include anannular insulator709 atdistal end face796.Annular insulator709 may be substantially cylindrical with an open cylindrical middle portion.Annular insulator709 may include cylindrical inner and outer walls.Annular insulator709 may include a flat distal portion, and/or may include a rounded radially exterior distal portion on the distal face ofannular insulator709. As shown, the outer wall ofannular insulator709 may be substantially aligned with (flush with) the outer surface of a distal end portion ofelectrode726.Annular insulator709 may extend proximally beyonddistal end face796. For example,electrode726 may include a narrowed distalmost portion extending proximal ofdistal end face796, forming a ledge forannular insulator709.Annular insulator709 may be coupled toelectrode726 over the narrowed distalmost portion, with the remainder of the distal portion ofelectrode726 being uninsulated. Although not shown,electrode726 may include an outlet positioned interior toannular insulator709, 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: (1) a cutting shaft with a primary axis that is coincident or parallel to a longitudinal axis of the shaft, and (2) 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 face396) 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. 2A), and a second position in which the cutting shaft is extended beyond the shaft and exposed (FIG. 2B). 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 todistal end16 as discussed above. Moreover, the electrode may include one or more distal outlets to provide any of the fluid flowpaths discussed above with respect toFIGS. 1A-3D.
• FIGS. 9A and 9B illustrate an additional example of anelectrode826. As shown,electrode826 may include aninsulator811 on adistal end portion813 ofelectrode826. In one aspect,insulator811 may be deposited ondistal end portion813 via ceramic deposition.Insulator811 may be annular, having a passage therein for receivingdistal end portion813.Insulator811 may be substantially cylindrical.
• Electrode826 may include one ormore outlets868 fluidly connected toelectrode lumen870, for example, as shown,electrode826 may include adistal end outlet868′ and aside outlet868″. In one aspect,side outlet868″ may be smaller thandistal end outlet868′ such that a majority of delivered fluid exits viadistal end outlet868′, However, ifdistal end outlet868′ is blocked, for example, by abutting tissue, fluid may still exitelectrode lumen870 viaside outlet868″.Electrode826 may be coupled to the rest ofdistal end816 and may be movable relative to anend cap842 as discussed above. Furthermore,electrode826 may be releasably coupled withindistal end816 with any of the mechanisms discussed above.
• Electrode826 includes anelectrode body815, which may form a cutting shaft forelectrode826. As shown inFIG. 9B,electrode826 also includes adistal end portion813, which has a reduced cross-sectional area (reduced relative to electrode body815). Moreover,insulator811 may be applied on the radial exterior ofdistal end portion813 such that the diameter ofdistal end portion813 andinsulator811, together, is less than or equal to the diameter ofelectrode body815. In one example, the radially outer surfaces ofinsulator811 and electrode body by815 are flush. Although not shown,insulator811 may also be provided circumferentially arounddistal end face896 ofelectrode826 to form an insulateddistal end portion813. In one example, the distal faces ofinsulator811 anddistal end portion813 are flush. Alternatively,insulator811 may narrow as it approaches the distal face ofdistal end portion813. In either aspect,distal end portion813 may be at least partially insulated, andelectrode body815 may be uninsulated. Accordingly,distal end portion813 may be nonconductive to avoid stray electrical energy being directed to tissue, for example, whenelectrode826 is retracted within the rest ofdistal end816, butdistal end portion813 remains outside of the rest ofdistal end816.
• As such,electrode826 may be coupled to an electrical element and an actuation member, as discussed above, in order to deliver energy and extend or retractelectrode826.Electrode body815 includes a primary axis that is coincident to a longitudinal axis of the shaft. As mentioned,distal end portion813 includes a cross-sectional area less than or equal to the cross-sectional area ofelectrode body815. Moreover,insulator811 ondistal end portion813 does not have the longest axis of a cross-section ofelectrode826, andinsulator811 does not extend over a majority ofelectrode826.
• FIG. 10 illustrates anexemplary cartridge911 with a plurality ofelectrodes913A-913E stored within a plurality ofopenings915. In this figure,different electrodes913A-913E are shown within the plurality ofopenings915, but it also is contemplated that any number of identical electrodes may be contained incartridge911.Cartridge911 may also include one ormore indications917A-917E (e.g., text, diagrams, symbols, or the like) substantially aligned with each opening915 to indicate the type or configuration of each ofelectrodes913A-913E stored in therespective openings915. For example,electrodes913A-913E may include different shapes, conductive pathways, and/or fluid flowpaths, andindications917A-917E may include a shape, silhouette, arrows, and/or an exemplary fluid flowpath of theelectrodes913A-913E stored in therespective openings915. Although fiveelectrodes913A-913E andopenings915 are shown, this disclosure is not so limited.Cartridge911 may include any number of electrodes stored in any number of respective openings, and the electrodes may include any of the configurations disclosed herein.
• FIGS. 11A-11C illustrate steps that may be performed to couple an exemplary electrode913 (e.g., any ofelectrodes913A-913E or other electrodes disclosed herein) stored within oneopening915 ofcartridge911 to adistal end916 of ashaft914 of a medical device.Distal end916 may include any of the medical device distal end aspects disclosed herein. As shown inFIG. 11A, aproximal portion919 ofelectrode913 may include one or more grooves and/or graduated portions, which may help secure the physical, electrical, and fluid connections betweenelectrode913 anddistal end916, as discussed above with respect toFIGS. 3A-3D, 4, 5A, and 5B.Distal end916 may be inserted intoopening915 and may surroundproximal portion919 ofelectrode913, as shown inFIG. 11B. Opening915 may be larger than a cross-sectional area ofdistal end916 to facilitate its entry intoopening915 and positioning circumferentially around at least a portion ofproximal portion919 ofelectrode913, to coupleelectrode913 todistal end916.Distal end916 may then be removed from opening915, withelectrode913 coupled todistal end916, as shown inFIG. 11C.
• In one aspect,cartridge911 may be configured to retain eachelectrode913 in a specific position or arrangement. For example,cartridge911 may include one or more cavities or protrusions within opening915 that may engage with one or more portions ofelectrode913. The cavities and/or protrusions withinopening915 may define a recess with a shape complementary to the shape ofelectrode913. Additionally, material that forms or is withincavity915 may be flexible to allowelectrode913 to be inserted intoopening915 and withdrawn from opening915. In one aspect,cavity915 andelectrode913 may be coupled via a friction fit, a snap-fit, or another type of engagement.Cartridge911 anddistal end916 of medical device910 may each include one or more markings, protrusions, grooves, etc. that may help a user to alignelectrode913 in a proper orientation while couplingelectrode913 to the rest ofdistal end916. For example, an inner wall of opening915 may include one or more protrusions that may align with one or more grooves on an outer wall ofdistal end916. In one aspect, a width ofopening915 may be slightly larger than a width ofdistal end916, such that the interior walls of opening915 may abut or engage one or more exterior portions ofdistal end916, thereby ensuring thatdistal end916 is properly aligned to receiveelectrode913. Additionally or alternatively, thewalls forming opening915 may be tapered inwardly towardelectrode913, which may help guidedistal end915 into alignment to receiveelectrode913.
• The user may insertdistal end916 intoopening915 to surround at least a portion ofproximal portion919 ofelectrode913 such that the coupling mechanism (e.g., one ormore fastening portions58,FIGS. 3A-3D) withindistal end916 couples electrode913 to the rest ofdistal end916. The user may then removeelectrode913 from cartridge911 (FIG. 11C). For example, the force necessary to uncoupleelectrode913 fromcartridge911 may be weaker than the force necessary to uncoupleelectrode913 from the coupling mechanism withindistal end916. Although not shown,electrode913 may be uncoupled fromdistal end916 and repositioned within opening915 incartridge911 for storage, cleaning, and/or later use. For example,distal end916 may include a mechanism to uncoupleelectrode913 fromdistal end916, as discussed with respect toFIG. 4 above. Additionally, adifferent electrode913 may then be coupled todistal end916.
• FIGS. 12A and 12B illustrate an additionalexemplary electrode1021 coupled to adistal end1016 of ashaft1014.Electrode1021 may be coupled todistal end1016 via any of the mechanisms discussed herein, and may also include any of the shapes and fluid flowpaths discussed herein. Furthermore,electrode1021 may be used for monopolar or bipolar electrosurgery.Electrode1021 may include at least a firstconductive member1023 and a secondconductive member1025. Firstconductive member1023 and secondconductive member1025 may be electrically separated by an insulatingmember1027. Insulatingmember1027 may include, for example, an annular member at a distal end of firstconductive member1023 that may be received in a recess in secondconductive member1025. Firstconductive member1023 may form a proximal portion ofelectrode1021, and secondconductive member1025 may form a distal end portion ofelectrode1021. Firstconductive member1023 and secondconductive member1025 may be formed of, for example, titanium or another medically safe and conductive material. Insulatingmember1027 may be formed of a ceramic, for example, aluminum oxide (Al₂O₃).
• As shown in the cross-sectional view ofFIG. 12B,electrode1021 may include, or may receive, afirst conductor1029 and asecond conductor1031.First conductor1029 may be connected to firstconductive member1023, andsecond conductor1031 may be connected to secondconductive member1025. 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 conductor1029 andsecond conductor1031 may be electrically insulated, and may each be connected to one or more energy sources, for example, in a handle connected toshaft1014 or in an electrosurgical generator coupled to the handle. Each of firstconductive member1023 and secondconductive member1025 may be configured to receive energy in various modes, for example, radio frequency energy in a cutting mode, a coagulation mode, etc. Firstconductive member1023 and secondconductive member1025 may thus be separately energized in order to treat tissue selectively with different portions ofelectrode1021.
• AlthoughFIGS. 12A and 12B illustrateelectrode1021 having firstconductive member1023 and secondconductive member1025, this disclosure is not so limited.Electrode1021 may include three, four, five, or more separate conductive members that are separated by insulating members. Additionally, the conductive members may be longitudinally spaced onelectrode1021, may be circumferentially spaced aroundelectrode1021, or may be both longitudinally spaced and circumferentially spaced aroundelectrode1021. 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 ofconductive members1029 and1031, 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. 13 illustrates an additional exemplarymedical device1110 with ahandle1112 and ashaft1114. Although not shown, any of the electrodes discussed herein may be coupled to a distal end ofshaft1114. In one aspect, handle1112 includes anactivation control1133, for example, on amain body1118 ofhandle1112.Activation control1133 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 toshaft1114. For example,activation control1133 may include aslide switch1135 that may be positioned in a plurality of positions to allow a user to control the energization of an electrode coupled tomedical device1110.
• FIGS. 14A-14D illustrate various positions foractivation control1133 and the corresponding configurations ofelectrode1021. For example,slide switch1135 may be longitudinally movable (e.g., slidable) within a portion ofhandle1112, and the position ofslide switch1135 corresponds to different operational states or configurations ofelectrode1021.Slide switch1135 may include one or more pads orprotrusions1137A-1137D, which may be electrically conductive pads or protrusions, for setting and/or indicating a configuration ofelectrode1021. For example,slide switch1135 may include afirst protrusion1137A on a first side of slide switch.Slide switch1135 may include a second protrusion11376 on a second side ofslide switch1135.Slide switch1135 may include athird protrusion1137C on the first side ofslide switch1135 and afourth protrusion1137D, aligned withthird protrusion1137C, on the second side ofslide switch1135. Each ofprotrusion1137A-1137D may be electrically coupled to an electrosurgical generator (not shown) via one or more conductive wires and/or cables (not shown) running throughhandle1112, and running fromhandle1112 to the electrosurgical generator.
• Handle1112 may include one ormore arrows1139A and11396, which may be positioned on the first and second sides ofslide switch1135.Arrows1139A and11396 may indicate the locations of pads or protrusions on or coupled toconductors1029 and1031, respectively. When the pads orprotrusions1137A-1137D ofslide switch1135 contact pads or protrusions atarrows1139A and1139B, a circuit is completed that may direct electrosurgical energy to one or more portions ofelectrode1021.
• FIG. 14A illustratesactivation control1133 in an inactive configuration. For example,slide switch1135 may be in a first position where none ofprotrusions1137A-1137D are aligned witharrows1139A and11396. There is a break in a circuit between an energy source (e.g., an electrosurgical generator) andelectrode1021 due to an air gap between pads or protrusions atarrows1139A and11396, so current cannot flow toconductors1029 and1031. Accordingly,electrode1021 may be inactive, with no energy being delivered to firstconductive member1023 or secondconductive member1025.
• FIG. 14B illustratesactivation control1133 in a first active configuration. For example,slide switch1135 may be in a second position, withfirst protrusion1137A aligned witharrow1139A. In this first active configuration, a circuit is completed between the energy source andelectrode1021 due to an electrical connection betweenprotrusion1137A andarrow1139A. Therefore, energy may be delivered to firstconductive member1023, for example, via first conductor1029 (FIG. 12B), such that firstconductive member1023 is energized. A circuit is not completed between one ofprotrusions1137A-1137D andarrow1139B, so no current is delivered to secondconductive member1025 viasecond conductor1031.
• FIG. 14C illustratesactivation control1133 in a second active configuration. For example,slide switch1135 may be in a third position, withsecond protrusion1137B aligned witharrow1139B. In this second active configuration, a circuit is completed between the energy source andelectrode1021 due to an electrical connection betweenprotrusion1137B andarrow1139B. Therefore, energy may be delivered to secondconductive member1025, for example, via second conductor1031 (FIG. 12B), such that secondconductive member1025 is energized. A circuit is not completed between one orprotrusions1137A-1137D andarrow1139A, so no current is delivered to firstconductive member1023 viafirst conductor1029.
• FIG. 14D illustratesactivation control1133 in a third active configuration. For example,slide switch1135 may be a fourth position, with boththird protrusion1137C andfourth protrusion1137D aligned witharrows1139A and1139B. In this third active configuration, a circuit is completed between the energy source andelectrode1021 due to an electrical connection betweenprotrusions1137C and1137D andarrows1139A and1139B. Therefore, energy may be delivered to both firstconductive member1023 and secondconductive member1025, for example, viafirst conductor1029 and second conductor1031 (FIG. 12B), such that both firstconductive member1023 and secondconductive member1025 are energized.
• Althoughslide switch1135 onhandle1112 is discussed above, this disclosure is not so limited. In another aspect,medical device1110 may include a plurality of buttons, switches, user interfaces, foot pedals, etc. that may be manipulated to selectively energize different portions ofelectrode1021. For example, a first foot pedal may be depressed to energize firstconductive member1023, and a second foot pedal may be depressed to energize secondconductive member1025. A third foot pedal may be depressed to energize both firstconductive member1023 and secondconductive member1025, or simultaneously depressing both the first and second foot pedals may energize both firstconductive member1023 and secondconductive member1025. In this aspect, depressing one or more foot pedals may complete a circuit between an energy source and the respective portions ofelectrode1021.
• In another aspect,medical device1110 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 ofelectrode1021. Furthermore,medical device1110 may be coupled to an electrosurgical generator, and one or more switches may be positioned on the electrosurgical generator and/or onhandle1112 to control the circuitry connections and energy delivery to respective portions ofelectrode1021.Conductors1029 and1031 may run all the way fromelectrode1021 to electrosurgical generator or another energy source.Electrode1021 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 ofelectrode1021. 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 ofelectrode1021.
• Additionally or alternatively,slide switch1135 may extend fromhandle1112 to a distal end ofdevice1110. In such a configuration, pads orprotrusions1137A-1137D may be at the distal end, while a proximal portion ofslide switch1135 may extend proximally back to handle1112, such that the user may still move pads orprotrusions1137A-1137D from handle112. One ormore arrows1139A and1139B also may be positioned at the distal end ofdevice1110. In one example, one ormore arrows1139A and11396 may be at, or otherwise electrically coupled to, one or more portions ofelectrode1021. When the pads orprotrusions1137A-1137D ofslide switch1135 contact pads or protrusions atarrows1139A and11396, a circuit is completed that may direct electrosurgical energy to one or more portions ofelectrode1021. As noted above, the energy may be selectively directed to a portion ofelectrode1021 while leaving another portion ofelectrode1021 unenergized.
• Energizing only the firstconductive member1023 may be useful when cutting tissue, as only energizing the shaft ofelectrode1021 may help to reduce the risk of tissue perforation or other thermal damage to tissue because the blunt distal end ofelectrode1021, which may be abutting tissue, is not energized. Energizing the secondconductive member1025 may be useful during an initial tissue marking, an incision, a hemostasis to increase coagulation, etc. For example, energizing the secondconductive member1025 may allow the energized distal end to deliver immediate and effective thermal treatment of tissue without the need to exchangeelectrode1021 or the medical device, and may also increase the accuracy ofelectrode1021. Moreover, energizing only a portion ofelectrode1021 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,electrode1021 may be used to perform various different procedures, reducing procedure time and costs.
• FIGS. 15A and 15B illustrateelectrodes1021A and1021B coupled todistal end1016 ofshaft1014, according to further aspects of this disclosure.Electrode1021A includes a firstconductive member1023A and a secondconductive member1025A spaced apart by an insulatingmember1027A. Firstconductive member1023A and secondconductive member1025A may be separately energized via any of the mechanisms discussed herein to treat tissue. Additionally, firstconductive member1023A includes one or more firstconductive regions1041A. Firstconductive regions1041A may be metallic deposits on a ceramic or insulating base material to form an integral firstconductive member1023A that has alternating conductive and non-conductive regions. Firstconductive regions1041A may be substantially parallel lines extending along the longitudinal axis ofelectrode1021A. Firstconductive regions1041A may be evenly spaced. Alternatively, one side ofelectrode1021A may include a denser concentration of firstconductive regions1041A than another side, providing for different energy delivering capabilities of the respective sides ofelectrode1021A. Firstconductive regions1041A are coupled toconductor1029, or other similar conductors. Furthermore, all firstconductive regions1041A may be energized together, or one or more of firstconductive regions1041A may be energized individually using any of the above-described selection arrangements.
• Secondconductive member1025A may include one or more secondconductive regions1043A. For example, secondconductive regions1043A may be metallic deposits on a ceramic or insulating base material to form an integral secondconductive member1025A that includes alternating conductive and non-conductive regions. Secondconductive regions1043A may be radial extensions spaced around a distal face of secondconductive member1025A. Secondconductive regions1043A are coupled toconductor1031, or other similar conductors. Furthermore, all secondconductive regions1043A may be energized together, or one or more of secondconductive regions1043A may be energized individually using any of the above-described selection arrangements.
• Electrode1021B includes a firstconductive member1023B and a secondconductive member1025B spaced apart by an insulatingmember1027B. Firstconductive member1023B and secondconductive member1025B may be separately energized via any of the mechanisms discussed herein to treat tissue. Additionally, firstconductive member1023B includes one or more firstconductive regions1041B, which are coupled toconductor1029 or similar conductors. Firstconductive regions1041B may be metallic deposits on a ceramic or insulating base material to form an integral firstconductive member1023B that has alternating conductive and non-conductive regions. Firstconductive regions1041B may be helical or spiral lines positioned on an exterior of firstconductive member1023B. Firstconductive regions1041B may be evenly spaced. Alternatively, one portion ofelectrode1021B may include a denser concentration of firstconductive regions1041B than another portion, providing for different energy delivering capabilities of the respective portions ofelectrode1021B.
• Furthermore, secondconductive member1025B may include one or more secondconductive regions1043B, which may be coupled toconductor1031 or similar conductors. For example, secondconductive regions1043B may be metallic deposits on a ceramic or insulating base material to form an integral secondconductive member1025B that has alternative conductive and non-conductive regions. Secondconductive regions1043B may be circular lines spaced around a distal face of secondconductive member1025B. 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 firstconductive regions1041A and secondconductive regions1043A, firstconductive regions1041B and secondconductive regions1043B may be energized together, or one or more of firstconductive regions1041B or secondconductive regions1043B 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,electrodes26,26A-26D,126,226,326,426,526,626,727,826,913,1021,1021A and1021B, 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 ends16,116,216,816,916, and1016 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 samemedical device10 to deliver the various types of medical therapy by simply swapping and/or changing the electrodes coupled todistal end16. 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 toFIGS. 12-15B, asingle electrode1021,1021A, or1021B may allow the user to perform different tissue treatment procedures with the same electrode coupled to thedistal end1016 of the medical device. For example, a user may energize firstconductive members1023,1023A, and1023B to perform a cutting procedure with a reduced risk of tissue perforation because insulatingmembers1027,1027A, and1027B may help to prevent energy flowing through secondconductive member1025,1025A, and1025B or the distal end ofelectrode1021,1021A, and1021B. Similarly, a user may energize secondconductive members1025,1025A, and1025B to perform a marking or hemostasis procedure. Lastly, a user may energize the entirety ofelectrodes1021,1021A, and1021B for another portion of a procedure. A proximal control, for example,activation control1133, a single moveable conductor, a slide switch, one or more actuators or foot pedals, etc, may allow the user to control the energization ofelectrodes1021,1021A, and1021B 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.
• While principles of the present disclosure are described herein with reference to illustrative aspects for particular applications, it should be understood that the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, aspects, and substitution of equivalents all fall within the scope of the aspects described herein. Accordingly, the disclosure is not to be considered as limited by the foregoing description.

Claims (21)

1-18. (canceled)

19. A method, comprising:

coupling a first electrode with a first structure to a distal end of a medical device shaft, wherein the coupling includes releasably coupling an internal component of the medical device shaft to a portion of the first electrode;

uncoupling the first electrode from the distal end; and

coupling a second electrode with a second structure to the distal end, wherein the second structure is different than the first structure.

20. The method ofclaim 19, wherein uncoupling the first electrode includes an action on a medical device handle coupled to a proximal end of the shaft, wherein the action on the medical device handle retracts one or more arms causing the one or more arms to expand and uncouple the arms from a proximal portion of the first electrode.

21. The method ofclaim 20, wherein the one or more arms are biased radially outward.

22. The method ofclaim 19, wherein the first electrode includes a first fluid flow path, and wherein the second electrode includes a second fluid flow path having a shape different from a shape of the first fluid flow path.

23. The method ofclaim 22, wherein the first fluid flow path includes a radial flow path, and wherein the second fluid flow path extends at an acute angle relative a central longitudinal axis of the distal end of the medical device shaft.

24. The method ofclaim 19, wherein the first electrode includes a first insulation pattern, and wherein the second electrode includes a second insulation pattern different from the first insulation pattern.

25. The method ofclaim 24, wherein the first insulation pattern includes a rounded annular insulation pattern on a distal end face of the first electrode, and wherein the second insulation pattern includes a dotted insulation pattern on a distal end face of the second electrode.

26. The method ofclaim 19, wherein uncoupling the first electrode from the distal end includes an action on a medical device handle, and wherein coupling the second electrode to the distal end includes inserting the distal end of the medical device shaft into an opening of a cartridge, wherein the opening of the cartridge retains the second electrode.

27. The method ofclaim 26, wherein the cartridge includes a plurality of openings, with each opening retaining a different electrode with a different fluid flow path and/or a different insulation pattern.

28. The method ofclaim 19, further comprising, before uncoupling the first electrode from the distal end, energizing at least a portion of the first electrode.

29. The method ofclaim 28, wherein energizing at least a portion of the first electrode includes an action on a switch on a handle.

30. The method ofclaim 29, wherein the switch is a slide switch that is movable between different positions, wherein the different positions of the slide switch correspond to different operational states of the first electrode.

31. The method ofclaim 30, wherein the first electrode includes a first conductive member and a second conductive member, wherein the different operational states include a first operational state in which neither the first conductive member nor the second conductive member of the first electrode is energized, a second operational state in which the first conductive member of the first electrode is energized and the second conductive member of the first electrode is not energized, a third operational state in which the second conductive member of the first electrode is energized and the first conductive member of the first electrode is not energized, and a fourth operational state in which both the first conductive member and the second conductive member of the first electrode are energized.

32. A method, comprising:

coupling a first electrode with a first structure to a distal end of a medical device shaft, wherein the coupling includes releasably coupling an internal component of the medical device shaft to a portion of the first electrode;

uncoupling the first electrode from the distal end; and

coupling a second electrode with a second structure to the distal end, wherein the second structure includes a shape of a fluid flow path and/or an insulation pattern that is different from a shape of a fluid flow path and/or an insulation pattern than the first structure.

33. The method ofclaim 32, wherein uncoupling the first electrode includes an action on a medical device handle coupled to a proximal end of the medical device shaft, wherein the action on the medical device handle retracts a plurality of arms causing the plurality of arms to expand and uncouple the plurality of arms from a proximal portion of the first electrode, and wherein the plurality of arms are biased radially outward.

34. The method ofclaim 32, wherein the first electrode includes a radial flow path, and wherein the second electrode includes a fluid flow path that extends at an acute angle relative a central longitudinal axis of the distal end of the medical device shaft

35. The method ofclaim 34, wherein the first electrode includes a rounded annular insulation pattern on a distal end face of the first electrode, and wherein the second electrode includes a dotted insulation pattern on a distal end face of the second electrode.

36. The method ofclaim 35, further comprising, before uncoupling the first electrode from the distal end, energizing at least a portion of the first electrode, and

after coupling the second electrode to the distal end, energizing at least a portion of the second electrode.

37. A method, comprising:

coupling a first electrode with a first structure to a distal end of a medical device shaft, wherein the coupling includes releasably coupling one or more radially biased arms of the medical device shaft to a portion of the first electrode;

energizing at least a portion of the first electrode; and

uncoupling the first electrode from the distal end by retracting the one or more radially biased arms.

38. The method ofclaim 37, further comprising:

coupling a second electrode with a second structure to the distal end via the one or more radially biased arms, wherein the second structure is different than the first structure; and

energizing at least a portion of the second electrode,

wherein the first electrode includes a rounded annular insulation pattern on a distal end face of the first electrode, and wherein the second electrode includes a dotted insulation pattern on a distal end face of the second electrode.

Images