Medical devices and related methods for delivering energy and / or fluids

Abstract

A medical device for delivering energy and / or fluid includes a handle, a shaft extending distally from the handle, a fluid port configured to deliver fluid through at least a portion of the shaft, and an end effector at the distal end of the shaft. The handle includes a hub for electrically connecting the medical device to an energy source. The shaft includes an outer sheath, an inner sheath, and a control wire. The end effector includes a loop and an electrode coupled to the distal end of the loop. The proximal end of the loop is coupled to the distal end of a control wire such that the movement of the control wire controls the position of the end effector relative to the distal end of the shaft.

Description

Technical Field

[0001] Aspects of the present disclosure generally relate to medical devices for delivering energy and / or fluids and related methods. Embodiments of the present disclosure relate to medical devices and related methods for treating tissue by delivering electrical energy to or within tissue and / or injecting fluids within, under, and / or around tissue using a treatment device that includes electrodes and / or loops.

Background Art

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

[0003] Occasionally, during a medical procedure, the user may use an injection needle, energy delivery device, and / or loop or snare for the purpose of treating and / or manipulating tissue, such as raising, separating, washing, incising, dissecting, cutting, marking, coagulating, cauterizing, or otherwise treating and / or manipulating tissue. Injection, energy delivery, and / or excision may be performed separately. For example, to deliver energy to tissue, the user may be required to remove the injection needle from the insertion device and deliver the energy delivery device to the targeted tissue through the insertion device, and vice versa. Furthermore, to excise tissue, the user may be required to remove the energy delivery device from the insertion device and deliver the loop or snare to the targeted tissue through the insertion device, and vice versa. During a procedure, the user may alternate between using the injection needle, energy delivery device, and / or loop or snare, and changing devices may increase the time and risk of the medical procedure.

[0004] The devices and methods of this disclosure can correct one or more of the aforementioned shortcomings or address other aspects of the technology. [Overview of the Initiative]

[0005] Examples of this disclosure relate, among other things, to medical devices configured to treat tissue by applying electrical energy to the tissue via an electrosurgical unit and / or loop, and to methods of using the medical devices. In some examples, the medical devices may also be configured to deliver fluids into, under, and / or around the tissue. Each example disclosed herein may include one or more features described in relation to any of the other examples disclosed herein.

[0006] In one example, a medical device for delivering energy and / or fluid may include a handle, a shaft extending distally from the handle, a fluid port configured to deliver fluid through at least a portion of the shaft, and an end effector at the distal end of the shaft. The handle may include a hub for electrically connecting the medical device to an energy source. The shaft may include an outer sheath, an inner sheath, and a control wire. The end effector may include a loop and an electrode coupled to the distal end of the loop. The proximal end of the loop may be coupled to the distal end of a control wire such that the movement of the control wire controls the position of the end effector relative to the distal end of the shaft.

[0007] A medical device may include one or more of the following features: The medical device may further include an end cap. The end cap may include an opening that extends longitudinally through a portion of the end cap. A portion of the electrode may extend through the opening of the end cap. The end cap may be made of rubber, may be fixedly coupled to a portion of the electrode, and may be movable relative to the distal end of the outer sheath. The electrode may include an electrode lumen fluidly connected to a fluid port. The distal end of the electrode may include an outlet. The proximal portion of the electrode may include one or more inlets fluidly connected to the electrode lumen. The electrode may include a widened distal end. The electrode may include a proximal longitudinal portion, a distal longitudinal portion, and a tapered portion between the proximal and distal longitudinal portions. The tapered portion may be configured to engage with the proximal portion of the end cap to advance the end cap distally. The loop portion may form an opening. The opening may include a wide portion and a tapered or narrowed portion toward the distal end of the loop portion.

[0008] The handle may include a body and a movable body. The movable body may be movable within a slot in the body. A hub may be located on a portion of the movable body. The movable body may be coupled to a control wire to deliver energy to the end effector and to control the movement of the end effector relative to the shaft. The body may include a plurality of contours. The movable body may include one or more stoppers that interact with one or more of the plurality of contours to lock the movable body relative to the body. A fluid port may be coupled to one or more of the inner and outer sheaths at a distal position of the handle. The fluid port may be configured to deliver fluid through a cavity between the inner and outer sheaths. The fluid port may be configured to deliver fluid through a lumen in the inner sheath. The end effector may include a mesh member extending across one or more portions of the loop. The loop of the end effector may include a plurality of wires forming a basket.

[0009] In another embodiment, a medical device for delivering energy and / or fluid may include a handle, a shaft extending distally from the handle, a fluid port, and an end effector. The handle may include a hub for electrically connecting the medical device to an energy source. The shaft may include an outer sheath, an inner sheath, and a control wire. The fluid port may be configured to deliver fluid through at least a portion of the shaft. The end effector may be located at the distal end of the shaft. The end effector may include a loop and an electrode coupled to the distal end of the loop. The proximal end of the loop may be coupled to the distal end of a control wire such that the movement of the control wire controls the position of the end effector relative to the distal end of the shaft.

[0010] A medical device may include one or more of the following features: The medical device may further include a cavity between an inner sheath and an outer sheath. The cavity between the inner and outer sheaths may be fluidly connected to a fluid port to deliver fluid through the cavity. The medical device may also include an end cap at the distal end of the outer sheath. The end cap may include an opening to receive a portion of the electrode. The end cap may be made of rubber, may be fixedly coupled to a portion of the electrode, and may be movable relative to the distal end of the outer sheath. A handle may include a body and a movable part. A hub may be located on a portion of the movable part. The movable part may be coupled to a control wire to deliver energy to the end effector and to control the movement of the end effector relative to the shaft. The body may include a plurality of contours, and the movable part may include one or more stoppers that interact with one or more of the plurality of contours to lock the movable part relative to the body.

[0011] In yet another embodiment, a method for treating a treatment site may include delivering the distal end of a medical device shaft to the treatment site. The medical device may include a handle, a shaft having a distal end, and an end effector movable relative to the distal end of the shaft. The shaft may include an outer sheath and an inner sheath. The end effector may include an electrode and a loop. The handle may include a movable body and a main body, the movement of which may control the position of the end effector. The method may also include delivering energy to the treatment site using the electrode of the end effector and delivering fluid to the treatment site. Delivering fluid may include delivering fluid through a port coupled to one or more of the inner and outer sheaths, delivering fluid distally through a cavity between the inner and outer sheaths so that the fluid distally flows into a distal cavity in the outer sheath and into the electrode lumen through one or more inlets in the proximal portion of the electrode. The method may also include extending the end effector distally. Extending the end effector distally may include advancing the movable part of the handle distally to facilitate distal extension of the end effector. The method may also include delivering energy to the treatment site using the loop portion of the end effector.

[0012] The method may include one or more of the following features: The delivery of energy to the treatment site using electrodes may be configured to incise tissue. The delivery of energy to the treatment site using a loop may be configured to excise tissue.

[0013] It should be understood that both the general description above and the following "Modes for Carrying Out the Invention" are illustrative and descriptive only and do not limit the present disclosure as claimed.

[0014] The accompanying drawings incorporated herein and constituting part thereof illustrate exemplary embodiments of the disclosure and, together with the description, serve to illustrate the principles of the disclosure. [Brief explanation of the drawing]

[0015] [Figure 1A] This disclosure illustrates an exemplary medical device, including a magnified view of the distal portion of the medical device. [Figure 1B] This disclosure illustrates exemplary medical devices, including an enlarged cross-sectional view of the proximal portion of the medical device. [Figure 2A] Various diagrams of parts of the medical device shown in Figures 1A and 1B, including a multifunctional end effector, are illustrated in the manner of this disclosure. [Figure 2B] Various diagrams of parts of the medical device shown in Figures 1A and 1B, including a multifunctional end effector, are illustrated in the manner of this disclosure. [Figure 2C] Various diagrams of parts of the medical device shown in Figures 1A and 1B, including a multifunctional end effector, are illustrated in the manner of this disclosure. [Figure 2D] Various diagrams of parts of the medical device shown in Figures 1A and 1B, including a multifunctional end effector, are illustrated in the manner of this disclosure. [Figure 2E] Various diagrams of parts of the medical device shown in Figures 1A and 1B, including a multifunctional end effector, are illustrated in the manner of this disclosure. [Figure 3A] Various diagrams illustrating different parts of a multifunctional end-effector of a medical device according to the aspects of this disclosure are provided. [Figure 3B] Various diagrams illustrating different parts of a multifunctional end-effector of a medical device according to the aspects of this disclosure are provided. [Figure 3C] Various diagrams illustrating different parts of a multifunctional end-effector of a medical device according to the aspects of this disclosure are provided. [Figure 3D] Various diagrams illustrating different parts of a multifunctional end-effector of a medical device according to the aspects of this disclosure are provided. [Figure 4A]Illustrative various views of portions of additional exemplary medical devices with multifunctional end effectors, according to aspects of the present disclosure. [Figure 4B] Illustrative various views of portions of additional exemplary medical devices with multifunctional end effectors, according to aspects of the present disclosure. [Figure 4C] Illustrative various views of portions of additional exemplary medical devices with multifunctional end effectors, according to aspects of the present disclosure. [Figure 5] A side view of a distal end of another exemplary medical device including a multifunctional end effector, according to aspects of the present disclosure. [Figure 6] A side view of a distal end of yet another exemplary medical device including another multifunctional end effector, according to aspects of the present disclosure. [Figure 7] A flow diagram of an exemplary method, according to aspects of the present disclosure.

DETAILED DESCRIPTION

[0016] Examples of the present disclosure include devices and methods for one or more of the following: applying electrical energy to tissue using electrodes to enhance and improve the effectiveness, efficiency and safety of treating and / or manipulating tissue; delivering fluid into, beneath, and / or around tissue through the distal end of an electrode during a medical procedure; incising, excising, capturing, or otherwise treating tissue. Aspects of the present disclosure can provide a user with the ability to apply electrical energy or heat to tissue using a medical device having electrodes and to deliver fluid into and / or beneath the tissue using the same medical device. Aspects of the present disclosure can provide a user with the ability to apply electrical energy or heat and deliver fluid without the need to switch or replace end effectors. Aspects of the present disclosure can assist a user in penetrating tissue layers (e.g., submucosa) to cause perforation, or otherwise incising, cauterizing, capturing, or otherwise treating tissue. Aspects of this disclosure can assist the user in cutting, excising, capturing, or otherwise removing tissue or other material without the need to switch or replace end effectors. Some aspects of this disclosure can be used in performing endoscopic procedures, laparoscopic procedures, arthroscopic procedures, gynecological endoscopic procedures, thoracoscopic procedures, cystoscopy procedures, or other types of procedures.

[0017] Herein, we refer in detail to the examples of this disclosure described above and shown in the attached drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or similar parts. The terms "proximal" and "distal" are used herein to refer to the relative positions of the components of an exemplary medical device. As used herein, "proximal" refers to a position that is relatively close to the outside of the subject's body, or close to the user, such as a medical professional holding or otherwise using the medical device. In contrast, "distal" refers to a position that is relatively far from the medical professional or other user holding or otherwise using the medical device, or close to the inside of the subject's body. Throughout the various figures, the proximal and distal directions are indicated by arrows labeled "P" and "D", respectively. As used herein, the terms "comprises", "comprising", "having", "including", or other variations thereof are intended to cover non-exclusive inclusion, so that a device or method comprising a list of elements does not include only those elements but may include other elements not expressly listed or inherent thereto. Unless otherwise specified, the term "exemplary" is used in the sense of "example" rather than "ideal". As used herein, the terms "about", "substantially", and "approximately" indicate values within a range of + / - 10% of the stated value.

[0018] Figures 1A and 1B show a medical device 100 including a handle 102, a shaft 104, and a distal end 106. The handle 102 may include a body 108 and a movable body 110. The handle 102 may also include, or be coupled to, or adjacent to a port 122 (Figure 2A) configured to receive fluid. The handle 102 may also include, or be coupled to, a hub 124 configured to receive electrical energy, similar to an electrical plug or socket. The distal end 106 includes an end effector, e.g., a multifunctional end effector 126. As will be described in detail below, the end effector 126 may include an energy delivery section or electrode section 128 (hereinafter "electrode 128") and a loop section 130 (e.g., forming a snare). Both the electrode 128 and the loop section 130 are conductive to transmit and deliver energy to tissue or other material at the treatment site. The position of the movable body 110 relative to the main body 108 controls the position of the end effector 126 relative to the shaft 104. Furthermore, the position of the end effector 126 relative to the shaft 104 affects whether only the electrode 128, or both the electrode 128 and the loop portion 130, extend distally to the shaft 104. The position of the end effector 126 can also control the delivery of fluid (e.g., through a portion of the electrode 128). In some embodiments, the shaft 104, including the distal end 106, can be delivered to the treatment site via an insertion device (not shown), such as a scope (e.g., an endoscope, duodenoscope, colonoscope, or other type of scope).

[0019] Furthermore, the proximal portion of the electrode 128 can be coupled to the distal portion of the loop 130 (for example, as shown in Figures 2C, 2D, 3A, and 3B). The end effector 126 is electrically connected to the hub 124 and may include one or more channels that are fluidically connected to or in fluid communication with the port 122, as will be described in detail below. The proximal portion of the loop 130 can be coupled to the control wire 132 (Figure 3B), for example, coupling the end effector 126 to the hub 124 (for example, on the movable body 110 of the handle 102). In these embodiments, the end effector 126 (e.g., the electrode 128 and the loop 130) is conductive. In addition, although not shown, one or more portions of the end effector 126 (e.g., the distal portion of the electrode 128) may include, for example, an insulating portion that radially surrounds one or more portions of the end effector 126.

[0020] As shown in the inset of Figure 1A, the shaft 104 includes a sheath, for example, an outer sheath 112. The outer sheath 112 can be at least partially insulating. Furthermore, the distal end 106 includes an end cap 114. The end cap 114 can be coupled to the outer sheath 112 (e.g., releasably or permanently) by welding, adhesive, crimping, friction fitting, or other suitable coupling. The end cap 114 can be at least partially insulating and at least partially flexible. For example, the end cap 114 includes an opening 114A. As shown in Figures 2C and 2D, the opening 114A can extend longitudinally through a portion of the end cap 114, for example, through the radial center of the end cap 114. The end cap 114 includes a proximal face 114B and a distal face 114C, and the opening 114A can extend through the end cap 114 from the proximal face 114B to the distal face 114C. In these embodiments, at least a portion of the end effector 126 may extend through the opening 114A. Furthermore, in some embodiments, at least a portion of the end effector 126 may be movable (e.g., extend distally and retract proximally) through the opening 114A relative to the end cap 114, controlled, for example, by the position of the movable body 110 relative to the body 108. In addition, at least a portion of the end cap 114 (e.g., the proximal face 114B) may be received into and / or coupled to the distal portion of the outer sheath 112, for example, to form a seal at the distal end 106. In some embodiments, the end cap 114 may include a tapered shape, for example, such that the proximal face 114B is smaller than the distal face 114C (e.g., has a smaller cross-sectional area). The tapered shape of the end cap 114 may help allow a portion of the end cap 114 to be inserted into (e.g., reinserted into) the outer sheath 112.

[0021] The shaft 104 may also include an internal sheath, for example, an inner sheath 116. The outer sheath 112 and / or inner sheath 116 may be formed of a biocompatible polymer material, such as a plastic material (for example, including one or more polymer material layers). Note that Figure 1A illustrates the outer sheath 112 and inner sheath 116 as transparent in order to show their respective internal components. However, note that one or more of the outer sheath 112 and / or inner sheath 116 may be opaque or not transparent. Furthermore, the distal end of the inner sheath 116 may be positioned proximal to the end cap 114. Alternatively, although not shown, the inner sheath 116 may be temporarily bonded to or extend to the proximal end of the face of the end cap 114. In some embodiments, the distal end of the inner sheath 116 can be positioned in contact with or adjacent to the proximal surface 114B of the end cap 114 when the end cap 114 is at least partially retracted into the outer sheath 112. Furthermore, the end cap 114 is movable relative to the inner sheath 114.

[0022] In addition, as described below, one or more of the outer sheath 112 and / or inner sheath 116 can be fluidically coupled to a fluid port (e.g., port 122 in Figure 2A) to deliver fluid to a treatment site adjacent to the distal end 106 through the shaft 104 (e.g., through one or more of the outer sheath 112 and / or inner sheath 116). For example, the end effector 126 may include one or more fluid lumens 128C (Figures 2D, 3C, and 3D) and at least one outlet 128D (e.g., at the distal end of the electrode 128). The inner sheath 116 can assist in guiding fluid to a portion of the end effector 126 so that the fluid is delivered to the treatment site through the outlet 128D. In addition, the connection between the end cap 114 and the outer sheath 112, combined with at least some degree of flexibility of the end cap 114, can help form a seal such that when the fluid moves, for example, through the outer sheath 112, the fluid is delivered to the treatment site only through the outlet 128D and not through the opening 114A or other parts of the distal end 106.

[0023] In some embodiments, one or more portions of the end effector 126 can be located within the inner sheath 116. For example, the end effector 126 (including, for example, one or more portions of the electrode 128 and the loop portion 130) can be radially located within the inner sheath 116 in at least some configurations of the end effector 126. The end effector 126 can be longitudinally movable relative to the inner sheath 116. As previously stated, the movement or position of the movable body 110 (for example, the handle 102 relative to the body 108) can control the movement or position of the end effector 126 relative to the distal end 106. In some embodiments, the position of the movable body 110 controls whether a portion of the electrode 128 extends distally into the outer sheath 112 (Figures 1A, 2C, and 2D), and / or whether a portion of the electrode 128 and the loop portion 130 extends distally into the outer sheath 112 (Figure 2E).

[0024] The medical device 100 can be inserted into the body lumen of a subject, either via an insertion device (not shown) or on its own, such that at least a portion of the shaft 104 can be inside the subject while the handle 102 remains outside the subject. The distal end 106 can be positioned at a target site within the subject (e.g., within a portion of the digestive (GI) tract). From outside the subject, the user can operate the handle 102. Movement of the movable body 110 relative to the main body 108 in a first direction (e.g., distal direction) can extend the end effector 126 (e.g., electrode 128) relative to the shaft 104 (e.g., move the end effector 126 distally relative to the outer sheath 112 and the distal end of the shaft 104). The end cap 114 can remain at least partially inside the outer sheath 112 to seal the external / distal region of the outer sheath 112 from any fluid passing through the outer sheath 112. Further movement of the movable body 110 relative to the main body 108 in a first direction (e.g., distal direction) can further extend the end effector 126 (e.g., electrode 128 and loop portion 130) relative to the shaft 104. In some embodiments, the loop portion 130 can expand (e.g., radially outward) when extended distally to the shaft 104 (e.g., distally to one or more of the outer sheath 112 and / or inner sheath 116). In addition, movement of the movable body 110 relative to the main body 108 in a second direction (e.g., proximal direction) can retract the end effector 126 (e.g., electrode 128 and loop portion 130) relative to the shaft 104 (e.g., move electrode 128 proximal to the distal end of the shaft 104). For example, in some embodiments, the loop portion 130 can contract (e.g., radially inward) when retracted into and / or proximal to the shaft 104. Although not shown, additional components of the movable body 110 or handle 102 may articulate the end effector (or end effector 126 and distal end 106) to the left or right and / or up or down relative to the shaft 104.Furthermore, although not shown, a portion of the shaft 104 may be positioned within the lumen of an insertion device (e.g., a scope), and the distal portion of the insertion device may be deflectable to assist in guiding the end effector 126 and the distal end 106.

[0025] Referring to Figures 1A and 1B, the body 108 may include a slot 134, and the movable body 110 may be slidably positioned within the slot 134. In addition, the handle 102 may be configured to be held and operated by the operator's hand. In these embodiments, the body 108 may be configured to be held by the user's hand and may include a thumb ring 136 (for example, at the proximal end of the body 108). In addition, the movable body 110 may include one or more (e.g., two) finger holes 138, so that the movement of one or more fingers relative to the operator's thumb controls the position of the movable body 110 relative to the body 108, and consequently the position of the end effector 126 relative to the shaft 104 and distal end 106. Alternatively, although not shown, the arrangement of the body 108 and the movable body 110 may be reversed, for example, so that the body 108 includes one or more finger holes 138 and the movable body 110 includes a thumb ring 136.

[0026] As described above, the movable body 110 can be coupled to a control wire 132 to control the movement and / or position of the end effector 126. A portion of the movable body 110 can be coupled to the proximal end of the control wire 132, for example, in a slot 134. Furthermore, in some examples, the control wire 132 can be conductive and electrically connected to the end effector 126, for example, a hub 124, so that energy from an energy source (not shown) can be delivered to the end effector 126. For example, the hub 124 may include one or more pins or prongs for coupling to the energy source. The energy source may be an electrocautery source, a high-frequency generator, a heating source, a current generator, etc. In one embodiment, the medical device 100 can be used in monopolar electrosurgery and may include a return electrode positioned on or adjacent to the patient, away from the electrode 128. In another embodiment, the medical device 100 can be used in bipolar electrosurgery. In this case, electrode 128 may include an active electrode portion, and the return electrode may be provided on or near electrode 128 and / or another portion of shaft 104. In one example, although not shown, two conductive elements may extend through shaft 104, where the conductive elements may be electrically insulated from each other, allowing one to conduct energy to the active electrode and the other to conduct energy from the return electrode. In another embodiment, although not shown, the energy source may be part of the handle 102 (e.g., an internal battery within the handle 102).

[0027] The movable body 110 can be locked in one or more positions relative to the body 108, or can be fixed at least partially or temporarily. For example, a portion of the body 108 (e.g., a lateral portion adjacent to the side defining the slot 134) may include a plurality of contours 140 (e.g., serrated portions, grooves, extensions, recesses, etc.). The contours 140 may be arranged in rows to form a contoured surface 142. Furthermore, the movable body 110 may include one or more stoppers 144 (e.g., pins, prongs, extensions, etc.). One or more stoppers 144 may extend radially inward from an internal portion of the movable body 110 to engage or interact with the contours 140 on the body 108, for example. In some embodiments, one or more stoppers 144 may be biased (e.g., spring biased, cantilevered, etc.) to fix at least partially the position of the movable body 110 relative to the body 108. For example, the biasing can help ensure that the minimum or required amount of operator force is needed to overcome the interaction between the stopper 144 and the contour 140 in order to move the movable body 110 relative to the body 108 (e.g., proximal or distal). In some embodiments, only one side (e.g., the left side) of the handle 102 (e.g., the body 108 and the movable body 110) includes the contoured surface 142 and one or more stoppers 144. In other embodiments, multiple sides (e.g., the left and right sides) of the handle 102 (e.g., the body 108 and the movable body 110) include the contoured surface 142 and one or more stoppers 144.

[0028] Although not shown, one or more parts of the handle 102 may include one or more markings (e.g., visual markings, tactile markings, etc.). For example, one or more markings on the body 108 may correspond to the position of the movable body 110 with the end effector 126 fully retracted relative to the shaft 104. In addition, one or more markings on the body 108 may correspond to the position of the movable body 110 with the end effector 126 partially extending relative to the shaft 104, for example, with the electrode 128 extending from the shaft 104 and the loop portion 130 held within the shaft 104. Furthermore, one or more markings on the body 108 may correspond to the position of the movable body 110 with the end effector 126 fully extending relative to the shaft 104, for example, with the electrode 128 and the loop portion 130 extending from the shaft 104.

[0029] Figures 2A to 2E illustrate various additional features of the medical device 100. Figure 2A illustrates various features of the proximal portion of the medical device 100. As shown in Figure 2A, the distal portion of the body 108 of the handle 102 can be coupled to the inner sheath 116, for example, via a coupler 146, which helps to secure the inner sheath 116 to the handle 102. The inner sheath 116 can enclose at least a portion of the control wire 132 (Figure 2C). Furthermore, as described above, the end effector 126 can be movable relative to the outer sheath 112 and the shaft 104, as shown in Figures 2C to 2E.

[0030] The medical device 100 may include a fluid port 122. For example, the fluid port 122 may be coupled to a fluid source 148 containing fluid 200, such as a syringe, pump (not shown), reservoir, etc. The fluid port 122 may be coupled to a fluid hub 150. The fluid hub 150 may, for example, at least partially enclose the inner sheath 116 distal to or spaced apart from the coupler 146. The fluid hub 150 (e.g., the distal portion of the fluid hub 150) may be coupled to the outer sheath 112. One or more of the fluid port 122 and the fluid hub 150 may include one-way valves, Luer connectors, seals, threads, and / or any suitable elements to maintain a secure connection between the shaft 104 and the fluid source 148, minimize or prevent backflow (e.g., fluid flowing proximally from the port 122 toward the fluid source 148), and / or minimize or prevent leakage. In these embodiments, the fluid 200 delivered from the fluid source 148 (e.g., a syringe) can be delivered through the fluid port 122, the fluid hub 150, to the shaft cavity 152 (Figure 2B) between the inner sheath 116 and the outer sheath 112. Thus, the shaft 104 can deliver fluid to the treatment site. In addition, the inner sheath 116 can help isolate the fluid delivered through the shaft cavity 152 between the inner sheath 116 and the outer sheath 112 from the energy delivered by the control wire 132. As described above, the distal end of the inner sheath 116 can abut against or be adjacent to the proximal surface 114B of the end cap 114 when the end cap 114 is retracted and at least partially positioned within the outer sheath 112, although the end cap 114 is movable relative to the inner sheath 116.

[0031] For example, Figure 2B is a lateral cross-sectional view of a portion of Figure 2A along line 2B-2B. As shown, the inner sheath 116 encloses the control wire 132 at least partially. Furthermore, the outer sheath 112 encloses and separates from the inner sheath 116, forming a shaft cavity 152. In some embodiments, the outer sheath 112 and the inner sheath 116 can be coaxial. Furthermore, in some embodiments, the inner sheath 116 can enclose and separate from the control wire 132, forming, for example, a wire cavity 154. Alternatively, although not shown, the inner portion of the inner sheath 116 may abut the outer portion of the control wire 132. For example, the inner sheath 116 can be an insulating coating on at least a portion of the control wire 132.

[0032] Figures 2C to 2E illustrate various distal features of the distal end 106 of the medical device 100. As shown, the end effector 126, including the electrode 128 and the loop portion 130, and the end cap 114 can be arranged together with the outer sheath 112 of the shaft 104. In some embodiments, the end cap 114 can be formed of rubber or another biocompatible and at least partially flexible material. In some embodiments, the end cap 114 can be fixedly coupled to the electrode 128 (e.g., the proximal portion of the electrode 128). Alternatively, in other embodiments, the electrode 128 may be at least partially movable relative to the end cap 114. In any embodiment, the end cap 114 can be positioned within a portion of the outer sheath 112 to form a distal cavity 156. In addition, the inner sheath 116 can terminate proximal to the end cap 114, for example, adjacent to a portion of the loop portion 130. Therefore, the shaft cavity 152 can be fluidly connected to the distal cavity 156.

[0033] As shown in Figures 2C and 2D, the electrode 128 includes an electrode shaft 128A. Figure 2C illustrates the internal components of the distal end 106, and Figure 2D illustrates a cross-sectional view of the electrode 128 illustrating the flow of fluid 200. In addition, Figure 2E illustrates a perspective view of the distal end 106 in another configuration, for example, in which an end effector 126 extends from the shaft 104 and the outer sheath 112. In some embodiments, the electrode 128 may include a distal end 128B, which may be wider than the electrode shaft 128A and extend radially with respect to the longitudinal axis of the electrode 128, for example. Furthermore, the electrode shaft 128A (for example, the proximal portion of the electrode shaft 128A) includes one or more inlets 158, for example, two inlets 158. The inlets 158 may be formed, for example, on the radially outer surface of the electrode shaft 128A. As described above, the electrode 128 includes an electrode lumen 128C that terminates distally, for example, at the electrode outlet 128D. The proximal end of the electrode 128 can be closed, for example, by being fixed to the distal end of the loop portion 130. Thus, the fluid 200 delivered through the shaft cavity 152 can flow into the distal cavity 156, then through the inlet 158, through the electrode lumen 128C, and out from the electrode outlet 128D. In at least some embodiments, the inner sheath 114 can help cover and / or insulate the control wire 132 and the loop portion 130 when the control wire 132 and the loop portion 130 are retracted proximal.

[0034] Furthermore, as shown in Figure 2E, the end effector 126 can extend distally to the outer sheath 112. For example, the movement of the movable body 108 (Figures 1A and 1B) can move the control wire 132 through the inner sheath 116, causing the end effector 126 to extend out of the outer sheath 112. In these embodiments, the loop portion 130 can extend distally to the outer sheath 112, and the loop portion 130 can be expanded. In some embodiments, as shown in Figure 2E, the loop portion 130 can abut against a portion of the end cap 114 (e.g., the proximal surface 114B, Figures 2C and 2D) as the end effector 126 is advanced distally, pushing the end cap 114 distally out of the outer sheath 112. In other embodiments, the loop portion 130 can be movable relative to the end cap 114, for example, through the opening 114A of the end cap 114. In these embodiments, the loop portion 130 can be expanded when extended distally. Furthermore, the loop portion 130 can be energized (for example, via the hub 124 and control wire 132) to excise tissue at the treatment site or one or more other areas.

[0035] It should be noted that in other embodiments, the end cap 114, inlet 158, electrode lumen 128C, and electrode outlet 128D are not included. For example, instead of the fluid being delivered through the electrode 128, the fluid may be delivered around the electrode 128. However, in some embodiments, the electrode 128 (e.g., electrode shaft 128A) can assist in guiding the fluid to the treatment site, for example, via capillary action.

[0036] As described above, the electrode 128 and the loop portion 130 are formed of a conductive material, such as stainless steel (e.g., 316L stainless steel), titanium, or another medically safe conductive material. In some embodiments, one or more of the electrode 128 and the loop portion 130 may include a surface finish, which may be passivated, for example, according to ASTM A967 Nitric 2.

[0037] As described above, the medical device 100, including the end effector 126, can be used to deliver energy and / or fluid to a treatment site. For example, the distal end 106 can be delivered to the treatment site, for example, through a working channel of an insertion device (e.g., a scope). The end effector 126 can be at least partially located within the outer sheath 112, for example, as shown in Figures 1A, 2C, and 2D. As shown, the distal portion 128B of the electrode can extend distally to the outer sheath 112 and the end cap 114, while the inlet 158 ​​and the proximal portion of the electrode shaft 128A are located within the outer sheath 112 proximal to the end cap 114. In other embodiments, the distal portion 128B (e.g., the proximal surface of the distal portion 128B) may contact the distal end 114C of the end cap 114 when the medical device 100 is delivered to the treatment site, and when the distal end 106 is at the treatment site, a portion of the electrode 128 may extend distal to the end cap 114 (e.g., via the movement of the movable body 108). Alternatively, the electrode 128 may not include the widened distal portion 128B, and the entire electrode 128 may be proximal to the end cap 114 (e.g., within the shaft 104) during delivery to the treatment site, and then the electrode 128 may extend through the opening 114A of the end cap 114. In these embodiments, with a portion of the electrode 128 distal to the end cap 114, the electrode 128 can be energized by energy being delivered to the electrode 128, for example, through the hub 124, the control wire 132, and the loop portion 130. One or more portions of the electrode 128 can be applied to the tissue or other parts of the treatment site, for example, to incise one or more tissue layers.

[0038] In addition, or alternatively, with a portion of the electrode 128 extending proximal to the end cap 114, the medical device 100 can be used to deliver fluid to the treatment site. For example, fluid 200 from a fluid source 148 can be delivered through the shaft cavity 152. The fluid 200 can flow from the shaft cavity 152 into the distal cavity 156. With the end cap 114 forming a seal on the distal portion of the outer sheath 112, the fluid 200 can flow from the distal cavity 156 into the electrode lumen 128C through one or more inlets 158. The fluid 200 can then flow through the electrode lumen 128C and out through the electrode outlet 128D. In some embodiments, the user can energize the electrode 128 to incise one or more tissue layers, and then position the distal end 128B of the electrode 128 between the tissue layers. The user can then deliver fluid through the electrode 128 as described above to deliver fluid between the tissue layers. The fluid between tissue layers can help separate the tissue layers, lift one or more upper tissue layers, and form blebs, etc. The user can then re-energize the electrode 128, for example, to further incise the tissue at the treatment site or one or more other parts.

[0039] The user can also extend the end effector 126 distally, for example, by advancing the movable body 108 distally. In these embodiments, the loop portion 130 can abut against the proximal surface 114B of the end cap 114, thereby pushing the end cap 114 distally out of the outer sheath 112, exposing at least a portion of the loop portion 130 distal to the outer sheath 112, as shown in Figure 2E. Alternatively, the loop portion 130 may advance distally through the opening 114A of the end cap 114 to expose the loop portion 130 distal to the outer sheath 112. In either embodiment, exposing the loop portion 130 allows the loop portion 130 to transition from a retracted configuration to an extended configuration. Furthermore, with the loop portion 130 exposed, the end effector 126 can be energized, for example, via the hub 124 and control wire 132. The loop portion 130 can be applied to the tissue of the treatment site or one or more other parts in order to excise the tissue of the treatment site or other parts.

[0040] The end effector 126 may be removed proximal to, for example, remove the excised tissue or other portion of the treatment site. Alternatively, the user may extend the end effector 126 distally to expose and expand the loop portion 130 to release the excised tissue or other portion of the treatment site. The user may operate the handle 102, the movable body 108, or the insertion device to position the end effector 126 throughout these steps. In addition, the steps described above can be performed as many times as necessary to treat the treatment site. For example, the end effector 126 may be retracted proximal to reposition the end cap 114 within the outer sheath (for example, as shown in Figures 2C and 2D), allowing the user to deliver fluid again through the electrode 128. Furthermore, the steps described above can be repeated and / or performed in various orders to treat the treatment site, and / or one or more of the steps described above can be omitted during the treatment.

[0041] Figures 3A to 3D illustrate additional features of the multifunctional end effector 226. Figure 3A is an enlarged view of the distal portion of the end effector 226, including the electrode 228 and the distal portion of the loop 230. As shown, the electrode 228 includes one or more inlets 258 in a portion of the electrode shaft 228A (e.g., the proximal portion), and the electrode 228 includes a widened distal end 228B. In some embodiments, the electrode 228 includes two inlets 258, which are spaced apart longitudinally on the electrode shaft 228A. Furthermore, the inlets 258 can be positioned on opposite sides of the electrode shaft 228A. As described above, the electrode 228 may include an electrode lumen (not shown) that fluidically couples the inlets 258 to the electrode outlet 228D to deliver fluid through the electrode 228.

[0042] As shown in Figures 3A and 3B, the loop portion 230 can be formed from one or more conductive materials into shapes such as a coil, tangled wire or strand 260, or one or more wires. In some embodiments, the loop portion 230 can be formed from a shape memory material (e.g., Nitinol), so that as the loop portion 230 extends from the shaft 204 (e.g., the outer sheath 212), the loop portion 230 expands at least partially into an expanded configuration. As shown in Figure 3B, the expanded configuration can be at least partially teardrop-shaped to form a snare loop, for example. In some embodiments, the loop portion 230 forms an opening 262, which may have a broad portion 262A and a tapered or narrowed portion 262B toward, for example, the distal end of the loop portion 230. The opening 262 may also have another tapered or narrowed portion 262C toward, for example, the proximal end of the loop portion 230. Furthermore, the proximal end of the loop portion 230 is coupled to the distal end of the control wire 232. In some embodiments, a portion of the loop portion 230 may be surrounded by or overlap with a portion of the control wire 232.

[0043] In any of these embodiments, the proximal end of the electrode 228 is fixedly coupled to the distal end of the loop portion 230. For example, the proximal end of the electrode 228 can be welded to the distal end of the loop portion 230. Thus, energy (e.g., electrical energy) can be delivered from the control wire 232 through the loop portion 230 to the electrode 228.

[0044] Figures 3C and 3D are different side views of the electrode 228. For example, Figure 3C is a side view of the electrode 228 in a first orientation, and Figure 3D is a side view of the electrode 228 rotated (e.g., around the longitudinal axis A) compared to Figure 3C. As described above, the electrode 228 includes an electrode shaft 228A and a distal end 228B (e.g., a widened distal end). The electrode 228 includes an electrode lumen 228C that extends longitudinally through at least a portion of the electrode 228, for example, by fluidly connecting the inlet 258 to the electrode outlet 228D. Furthermore, as shown, the electrode lumen 228C does not have to extend proximal to the proximal end 228E of the electrode 228. Instead, the proximal end 228E of the electrode 228 may be closed and coupled (e.g., welded) to the distal end of the loop portion 230, as described above with respect to Figures 3A and 3B.

[0045] The electrode shaft 228A may include a first or proximal longitudinal portion 264 ("proximal portion 264"), a second or distal longitudinal portion 266 ("distal portion 266"), and, for example, an angled or tapered portion 268 between the proximal portion 264 and the distal portion 266. As shown in the figure, the inlet 258 may be located in the proximal portion 264. Furthermore, in some embodiments, although not shown, an end cap may be coupled or positioned on the tapered portion 268 or adjacent to it on the electrode shaft 228A, for example, on a portion of the distal portion 266 adjacent to the tapered portion 268. In some embodiments, the electrode 228 may be movable relative to the end cap. In these embodiments, the tapered portion 268 may be at least partially engaged with the end cap. For example, when the electrode 228 is advanced distally, the electrode 228 may move within the opening of the end cap. However, when the tapered portion 268 engages with the end cap, the electrode 228 can push the end cap distally, for example, out of the outer sheath. With the end cap disengaged from the outer sheath, the electrode 228 can continue to advance distally, for example, exposing the loop portion 230 from the shaft.

[0046] Figures 4A to 4C illustrate various embodiments of another medical device 300. The medical device 300 includes a shaft 304 having a distal end 306. Although not shown, the shaft 304 can be coupled to a handle, for example, similar to the handle 104 described above. The shaft 304 includes an outer sheath 312 and an inner sheath 316, for example, similar to the sheath described above. Furthermore, the medical device 300 includes a multifunctional end effector 326 including an electrode 328 and a loop portion 330. As shown in Figure 4A, the end effector 326 can be positioned, for example, within the outer sheath 312 adjacent to the inner sheath 316. In other words, the end effector 326 is not radially positioned within the inner sheath 316, and the end effector 326 can extend along the inner sheath 316 such that the longitudinal axis of the end effector 326 and / or the control wire 332 (see Figure 4B) is substantially parallel to the longitudinal axis of the inner sheath 316. Furthermore, the distal end 316A of the inner sheath 316 can be aligned with and / or close to the distal end 312A of the outer sheath 312. In some embodiments, a portion of the inner sheath 316 can be bonded to a portion of the outer sheath 312 (e.g., via laser welding, adhesive, etc.). For example, the exterior of the inner sheath 316 can be bonded to the interior of the outer sheath 312 (e.g., over at least a portion of its longitudinal length or the distal portion of the inner sheath 316).

[0047] For example, Figure 4B illustrates a cross-sectional view of the proximal portion of the shaft 304. As shown, a control wire 332, capable of controlling the movement and / or position of the end effector 326 and / or delivering energy to the end effector 326, can be located in the lumen 312B of the outer sheath 312, adjacent to the inner sheath 316. The proximal end of the outer sheath 312 can be fixedly coupled to the distal end of the handle, for example, to the body or fixed body of the handle. The proximal end of the control wire 332 can be coupled to the movable body of the handle, as described above. In addition, the proximal end of the inner sheath 316 can be coupled (for example, movably or fixedly) to another part of the medical device 300, for example, to a port adjacent to the handle (e.g., Figure 2A), a port on the body of the handle, etc. The inner sheath 316 includes a lumen 316B, which can receive fluid through a port.

[0048] In these embodiments, the end effector 326 can be movable relative to the shaft 304. For example, as shown in Figure 4A, the end effector 326 can be positioned within the outer sheath 312 during delivery of the distal end 306 and / or placement at the treatment site. Then, as shown in Figure 4C, one or more portions of the end effector 326 can extend distally to the shaft 304. For example, the electrode 328 can be extended distally to the distal end 312A of the outer sheath 312 by distal movement of the control wire 332. The electrode 328 can be energized, for example, via the control wire 332 and the loop portion 330 to incise tissue. Further distal movement of the control wire 332 can also extend the loop portion 330 out of the outer sheath 312. The loop portion 330 can be energized, for example, via the control wire 332 to excise tissue (e.g., a lesion). The movement of the end effector 326 can be controlled via one or more portions (e.g., movable parts) of a handle coupled to the proximal end of the shaft 304. As shown in Figure 4A, the distal end 328B of the electrode 228 can be closed or solid, for example, without an outlet. Nevertheless, the end effector 326 can be energized (e.g., via a control wire 332) using one or more of the electrode 328 and / or the loop portion 330 to deliver energy to the treatment site.

[0049] Furthermore, the fluid can be delivered to the treatment site via the inner sheath 316, for example, via the inner sheath membrane 316B. In this embodiment, the fluid can be delivered to the inner sheath 316, for example, as described above with respect to Figure 2A. In addition, the fluid can be delivered simultaneously with energy delivery via the end effector 326, or the fluid can be delivered alternately with energy delivery via the end effector 326. For example, the end effector 326 can be retracted into the outer sheath 312 during fluid delivery via the inner sheath 316 (for example, so that the distal end 328B of the electrode 328 is proximal to the distal end 312A of the outer sheath 312). Retracting the end effector 326 during fluid delivery can help avoid or minimize interference with fluid delivery. Furthermore, in some embodiments, although not shown, the inner sheath 316 may be movable relative to the outer sheath 312, for example, to extend the inner sheath 316 distal to the distal end 312A of the outer sheath 312.

[0050] In addition, although not shown, one or more portions of the control wire 332 may be coated with an insulating material. For example, an insulating coating on the control wire 332 can replace the role and / or functionality of the inner sheath. In some embodiments, the insulating coating on the control wire 332 can help insulate the charged wire from the fluid delivered to the treatment site. In these embodiments, the medical device 300 may still include an inner sheath 316 to assist, for example, the delivery of fluid to the treatment site. Alternatively, in other embodiments, the medical device 300 may not include an inner sheath 316, and the fluid is delivered through the outer sheath 312. The fluid can be delivered around the electrode 328 and the end effector 326. In further alternatives, as shown in Figures 2C and 2D, the distal end 306 includes an end cap, and the electrode 328 includes lumens connected to an inlet and outlet, so that the fluid can be delivered to the treatment site through the electrode.

[0051] Figure 5 illustrates an end effector 426 that can be used with any of the medical devices described herein. The end effector 426 includes an electrode 428, for example, including a widened distal portion 428B. The end effector 426 also includes a loop portion 430, for example, as described above, with the distal end of the loop portion 430 coupled to the proximal end of the electrode 428. The loop portion 430 includes two arms 470 that can be expandable and / or retractable, as described above. Furthermore, as shown in Figure 5, the loop portion 430 includes a mesh member 472. The mesh member 472 can be a retrieval net and is non-conductive in some embodiments. In these embodiments, the electrodes 428 and / or the arms 470 of the loop portion 430 can be energized to cut, excise, or otherwise treat tissue. Furthermore, the mesh member 472 can be positioned to capture or otherwise hold tissue or other material (e.g., tissue or material separated from the treatment site). For example, the loop portion 430 can be energized to excise tissue or material, and the mesh member 472 can assist in capturing the excised tissue or material. Retracting the end effector 426 can contract the loop portion 430, and the contracted loop portion 430 and mesh member 472 can assist in holding the excised tissue or material.

[0052] The end effector 426 can be controlled to move by the movement of a control wire 432. As described above, the control wire 432 can be coupled to a movable body of a handle (not shown) to control the movement and / or position of the end effector 426. Furthermore, in some embodiments, the control wire 432 can be at least partially covered and / or insulated by a sheath 416. Although not shown, a portion of the end effector 426 (e.g., an electrode 428) can be coupled to and / or extend through an end cap, as described above. The end effector 426 can include one or more shapes and / or materials of the end effectors 126, 226, and 326 described above. In addition, a portion of the end effector 426 (e.g., an electrode 428) can include one or more inlets, internal lumens, and outlets, as described above, to deliver fluid to the treatment site.

[0053] Figure 6 illustrates another end effector 526 that can be used with any of the medical devices described herein. The end effector 526 includes an electrode 528, for example, an expanded distal portion 528B. The end effector 526 also includes a loop portion 530, for example, as described above, with the distal end of the loop portion 530 coupled to the proximal end of the electrode 528. The loop portion 530 includes a plurality of wires 580 (e.g., three or more wires) that can be expandable and / or contractible, as described above. In an expanded configuration, the plurality of wires 580 can form a basket shape. Each wire 580 can be formed from one or more conductive materials into shapes such as a coil, tangled wire or strand, one or more wires, or from a shape memory material (e.g., nitinol). As shown in Figure 6, the loop portion 530 may include four wires 580. Nevertheless, the loop 530 may contain fewer or more wires 580, and the wires 580 may be spaced evenly or unevenly, for example in an extended configuration. One or more of the wires 580 may be conductive, for example, to transmit energy from the control wire 532 to the electrode 528. In these embodiments, the electrode 528 and / or one or more wires 580 of the loop 530 may be energized to cut, excise, or otherwise treat tissue. Furthermore, the wires 580 of the loop 430 may be positioned to capture or otherwise hold tissue or other material (e.g., tissue or material separated from the treatment site). For example, the loop 530 may be energized to excise tissue or material, and the wires 580 may assist in capturing the excised tissue or material. Retracting the end effector 526 may cause the loop 530 to contract, and the contracted wires 580 of the loop 530 may assist in holding the excised tissue or material.

[0054] The end effector 526 can be movably controlled by the movement of a control wire 532. As described above, the control wire 532 can be coupled to a movable body of a handle (not shown) to control the movement and / or position of the end effector 526. Furthermore, in some embodiments, the control wire 532 can be at least partially covered and / or insulated by a sheath 516 or an insulating coating. Although not shown, a portion of the end effector 526 (e.g., electrode 528) can be coupled to and / or extend through an end cap, as described above. The end effector 526 can include the shape and / or material of the end effectors 126, 226, 326 described above. In addition, a portion of the end effector 526 (e.g., electrode 528) can include one or more inlets, internal lumens, and outlets, as described above, to deliver fluid to the treatment site.

[0055] Figure 7 illustrates a method 700 that can be performed using either a medical device or a part of a medical device as described herein. Specifically, the method 700 includes an initial step 702, which includes delivering the distal end of the medical device to a treatment site. The shaft 104 can be delivered to the treatment site via an insertion device (e.g., an endoscope, insertion device, sheath, etc.). In some embodiments, the distal portion of the insertion device may be deflectable to assist in positioning, for example, the distal end 106 of the medical device 100 to the treatment site. In addition, step 702 may include positioning the distal end 106 to the treatment site. Step 702 may include extending the movable body 110 distally relative to the body 108 to extend, for example, a control wire 132 and an end effector 126 distally. Furthermore, the stopper 144 and contoured surface 142 may assist in controlling and / or locking (e.g., lockably positioning) the position of the movable body 110 on the body 108.

[0056] Next, the method 700 includes step 704, which involves delivering energy to the treatment site using the electrode portion of the end effector. As previously stated, the energy can be delivered to the electrode 128 via the hub 124, through the control wire 132, and through the loop portion 130. Furthermore, step 702 may include extending only a portion of the electrode 128 distal to the end cap 114 or distally from the shaft 104. Step 704 may be performed to incise one or more tissue layers at the treatment site.

[0057] Method 700 also includes step 706, which includes delivering fluid to the treatment site. Step 706 may include delivering fluid from a fluid source 148 through the shaft cavity 152 to the distal cavity 156. As described, the electrode 128 may include one or more inlets 158, and fluid in the distal cavity 156 may pass through the inlets 158, through the electrode lumen 128C, and out through the electrode outlet 128D. In these embodiments, the end cap 114 may help seal the distal cavity 156, so that the fluid flows only through the electrode 128 and not out through the outer sheath 112. Step 706 may be performed with the distal portion of the electrode 128 positioned within tissue (e.g., between tissue layers). In this embodiment, step 706 may include delivering fluid within the tissue, for example, to separate tissue layers and / or to form a bleb. In some embodiments, step 706 may include repositioning the end effector 126. For example, as described with respect to Figures 4A to 4C, step 706 may include retracting the end effector 326 and delivering fluid through the inner sheath 316.

[0058] Next, step 708 includes extending the end effector distally. As described above, the end effector 126 includes a loop portion 130, and extending the end effector 126 distally allows at least a portion of the loop portion 130 to be exposed. Once exposed, at least a portion of the loop portion 130 can be expanded. In addition, as described above, extending the end effector 126 distally can assist in extending the end cap 114 distally, allowing the loop portion 130 to be exposed. Alternatively, the loop portion 130 may advance through the opening 114A of the end cap 114 to expose the loop portion 130.

[0059] Furthermore, step 710 includes delivering energy to the treatment site using the loop portion of the end effector. As described, the loop portion 130 is conductive and can deliver energy to the treatment site, for example, for excision. The loop portion may include a mesh member 472 (Figure 5) supported by the arm 470, or may include a plurality of wires 580, for example, to help hold tissue or material.

[0060] Furthermore, the various steps of method 700 can be repeated as many times as necessary to treat the treatment site. In addition, in some embodiments, the medical device 100 can be removed from the treatment site (for example, through the lumen or working channel of the insertion device) and another medical device can be delivered to further treat the treatment site.

[0061] The various end-effectors described herein can alter the physical properties of tissue upon contact by delivering energy (e.g., high-frequency energy). The delivered energy may be monopolar or bipolar energy. The various end-effectors can be coupled to a shaft, which is configured to extend into a body cavity or duct of a subject. The shaft includes an electrical element that crosses the shaft and connects electrodes to an energy source, for example, an energy source in or coupled to a handle.

[0062] As described, the end effector can also be coupled to an actuarial member (e.g., a movable body 110), for example, in or coupled to a handle, thereby allowing the user to move the end effector relative to the shaft. The end effector can be movable between at least a first position in which the incision shaft of the end effector (e.g., electrode shaft 128A) is retracted into the shaft and a second position in which the incision shaft extends beyond the shaft and is exposed. Furthermore, the end effector can be positioned in a third position in which the loop portion extends beyond the shaft and is exposed. In addition, the end effector or medical device can be used, for example, to deliver fluid to the treatment site in any of the aforementioned positions.

[0063] In one example, an electrosurgical generator coupled to (or located within) the handle can generate energy in various modes, such as incision mode, coagulation mode, etc., and can generate high-frequency energy for the end effector to deliver these different modes of energy to the tissue. In one embodiment, the electrosurgical generator and / or handle may include one or more knobs, dials, buttons, etc., for selecting the energy mode. In addition, in one embodiment, a fluid source coupled to the medical device (e.g., a saline supply source) can provide a fluid (e.g., saline) to be delivered to the tissue and / or treatment site through the end effector. The fluid can be delivered at a constant speed, pulsed speed, user-controlled speed, etc. In these embodiments, one or more of the energy delivery and / or fluid delivery may be controlled by one or more actuators (e.g., triggers, buttons, touchscreens, foot pedals, etc.).

[0064] Some of the medical devices and methods described above allow a user to treat tissue by delivering electrical energy and / or fluids to the tissue simultaneously or sequentially. For example, a user can selectively position end-effectors such that one of them is delivered to the treatment site, and one or more portions of the end-effectors are exposed and configured to deliver energy to the treatment site. Different portions of the end-effector (e.g., electrodes and loops) can also be configured to treat the treatment site in different ways (e.g., incision by electrodes and excision by loops). Furthermore, various embodiments of the end-effector (e.g., mesh members and wires in Figures 5 and 6) can be configured to assist in retaining tissue or material removed from the treatment site.

[0065] The user can also deliver fluid distally (e.g., through electrodes) from the distal end of the end effector simultaneously with or sequentially with the delivered energy, which can help the user perform medical treatments more quickly and efficiently, such as dissecting, peeling, cutting, marking, coagulating, cauterizing, or otherwise treating tissue. Furthermore, the user can deliver fluid and energy without removing the medical device from the patient or subject, which can help reduce the cost and time of the procedure and potentially reduce the risk to the subject.

[0066] The principles of this disclosure are described herein with reference to exemplary embodiments of certain uses, but it should be understood that this disclosure is not limited thereto. Those skilled in the art and those with access to the teachings provided herein will recognize that additional modifications, applications, embodiments, and substitutions of equivalents all fall within the scope of the embodiments described herein. Therefore, this disclosure should not be considered limited by the foregoing description.

Claims

1. A medical device for delivering energy and / or fluids, A handle including a hub for electrically connecting the medical device to an energy source, A shaft extending distally from the handle, comprising an outer sheath, an inner sheath, and a control wire, A fluid port configured to deliver fluid through at least a portion of the shaft, The shaft comprises an end effector at the distal end, The end effector includes a loop portion and an electrode coupled to the distal end of the loop portion. A medical device in which the proximal end of the loop portion is coupled to the distal end of the control wire such that the movement of the control wire controls the position of the end effector relative to the distal end of the shaft.

2. The medical device according to claim 1, further comprising an end cap, the end cap including an opening extending longitudinally through a portion of the end cap, and a portion of the electrode extending through the opening of the end cap.

3. The medical device according to claim 2, wherein the end cap is made of rubber, is fixedly coupled to a portion of the electrode, and is movable relative to the distal end of the outer sheath.

4. The medical device according to claim 3, wherein the electrode includes an electrode lumen fluidly connected to the fluid port, and the distal end of the electrode includes an outlet.

5. The medical device according to claim 4, wherein the proximal portion of the electrode includes one or more inlets fluidly connected to the electrode lumen.

6. The medical device according to claim 3, wherein the electrode includes a widened distal end.

7. The medical device according to claim 3, wherein the electrode includes a proximal longitudinal portion, a distal longitudinal portion, and a tapered portion between the proximal longitudinal portion and the distal longitudinal portion, and the tapered portion is configured to engage with the proximal portion of the end cap to advance the end cap distally.

8. The medical device according to claim 1, wherein the loop portion forms an opening, and the opening includes a wide portion and a tapered or narrowed portion toward the distal end of the loop portion.

9. The medical device according to claim 1, wherein the handle includes a body and a movable body, the movable body being movable within a slot of the body, the hub being positioned on a portion of the movable body, and the movable body being coupled to a control wire for delivering energy to the end effector and controlling the movement of the end effector relative to the shaft.

10. The medical device according to claim 9, wherein the main body includes a plurality of contours, and the movable body includes one or more stoppers that interact with one or more of the plurality of contours in order to position the movable body in a lockable manner relative to the main body.

11. The medical device according to claim 1, wherein the fluid port is coupled to one or more of the inner sheath and the outer sheath at a distal position of the handle.

12. The medical device according to claim 11, wherein the fluid port is configured to deliver fluid through a cavity between the inner sheath and the outer sheath.

13. The medical device according to claim 11, wherein the fluid port is configured to deliver fluid through a lumen in the inner sheath.

14. The medical device according to claim 1, wherein the end effector includes a mesh member extending across one or more portions of the loop portion.

15. The medical device according to claim 1, wherein the loop portion of the end effector includes a plurality of wires forming a basket.

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