CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority under 35 U.S.C. §119 to United States Provisional Patent Application Serial No. 62/649,901, filed on March 29, 2018, which is incorporated by reference in its entirety for all purposes.

FIELD

[0002] The present disclosure relates generally to the field of medical devices and treating tissues within body passages. In particular, the present disclosure relates to endoluminal electrosurgical devices, systems and methods for providing treatment of tissue.

BACKGROUND

[0003] Medical devices are often used to extract undesired and/or foreign material from the body. These medical devices use various extraction methods, such as dissection, coagulation, fulguration, ablation, etc., of undesired body matter. An exemplary procedure that uses such methods is electrosurgery. Electrosurgery involves the application of energy to biological tissue to cut, ablate, cauterize, coagulate, desiccate, and/or fulgurate tissue.

Electrosurgery may use various types of high-frequency electrical energy to directly heat the tissue.

[0004] Generally, electrosurgery is performed using a radio frequency electrosurgical generator and a hand piece including one or two electrodes. A monopolar instrument comprises only one active electrode while a bipolar instrument includes two active electrodes at the surgical site, with one of the two active electrodes acting as ground electrode when the other electrode is active, and vice versa. The monopolar instrument requires the application of another instrument called a dispersive or return electrode elsewhere on or otherwise coupled to the patient’ s body to defocus or disperse the radio frequency current and returning the energy to the electrosurgical generator to prevent injury to the underlying tissue. However, often injury to the patient can occur from the energy traveling a large distance from the active electrode through the body to the return electrode. Also, doctors must be careful to avoid complications such as direct coupling, insulation failure, and capacitive coupling, among other potential complications that may result in patient injury.

[0005] A bipolar electrosurgical instrument typically includes forceps or other end effectors with the two tines of the forceps performing the active and return electrode functions. Only the tissue grasped by the forceps may be included in the electrical circuit. Bipolar instruments require less voltage than monopolar instruments, and since the active and return electrodes are at the site of surgery, the risk of accidental injury to the patient with bipolar instruments may be less compared to monopolar devices. Bipolar instruments perform well when sealing vessels, however they include lateral thermal spread that will continue until the device activation is ceased. Bipolar electrosurgical instruments are limited in their application and may provide less precise cutting compared to monopolar instruments. There is a need for a hybrid between monopolar and bipolar electrosurgical instruments that may utilize voltages similar to bipolar instruments and yet have similar cutting power to monopolar instruments.

[0006] Conventional electrosurgical devices often have large profiles and may not be configured to be inserted into difficult to reach areas of the body or for use with endoscopic devices. A variety of advantageous medical outcomes may therefore be realized by the electrosurgical devices, systems, and methods of the present disclosure.

SUMMARY

[0007] In one aspect, the present disclosure relates to a surgical system comprising an elongate tubular body, which may include a proximal end, a distal end and one or more working channels extending therebetween. A working space expanding system may be positioned at a distal portion of the elongate tubular body. The working space expanding system may be movable between a non-expanded insertion position and an expanded position to form an expanded region. A surgical device may be disposed within a first working channel of the elongate tubular body. At least one return electrode may be disposed on an outer surface of the working space expanding system. The surgical system may include a power source configured to deliver energy to the surgical device, and in electrical communication with the at least one return electrode. The surgical device may be electrically connected to (e.g., in electrical communication with) the power source by one or more conductive elements. The at least one return electrode may be electrically connected to the power source by one or more conductive elements. The surgical device may include an insulated portion and an uninsulated active (e.g., performing) electrode. The working space expanding system may include first and second flexible members movable between the non-expanded position and the expanded position to form the expanded region. Each of the first and second flexible members may include an insulated portion and an uninsulated portion. The at least one return electrode may include a first return electrode disposed on the uninsulated portion of the first flexible member, and a second return electrode disposed on the uninsulated portion of the second flexible member. The first return electrode may be configured to contact an inner wall of a body lumen at a first location, and the second return electrode may be configured to contact the inner wall of the body lumen at a second location, when the first and second flexible members move to the expanded position. The surgical device may be configured to contact the inner wall of the body lumen at a third location to deliver energy from the power source, through a portion of the tissue of the body lumen, and to the first and second return electrodes. The energy delivered from the surgical device may manipulate, treat or otherwise affect, tissue of the body lumen. A cover may be disposed around a portion of the working space expanding system. The at least one return electrode may include a first return electrode disposed on an outer surface of the cover at first location, and a second return electrode disposed on the outer surface of the cover at a second location. The cover may include an opening opposite the first and second return electrodes. The first flexible member may be disposed adjacent to a first side of the opening in the cover, and the second flexible member may be disposed adjacent to a second side of the opening in the cover. The first return electrode may be configured to contact an inner wall of a body lumen at the first location, and the second return electrode may be configured to contact the inner wall of the body lumen at the second location, when working space expanding system (e.g., the first and second flexible members) move to the expanded position. The surgical device may be configured to contact the inner wall of the body lumen at a third location to deliver energy from the power source, through a portion of the tissue of the body lumen, and to the first and second return electrodes. The energy delivered from the surgical device may manipulate, treat or otherwise affect, tissue of the body lumen. A distal portion of the working space expanding system may include an endcap, and the at least one return electrode may be disposed on an outer surface of the endcap. The endcap may be configured to contact an inner wall of a body lumen as the working space expanding system (e.g. , first and second flexible members) move to the expanded position, to place the at least one return electrode in contact with the inner wall of a body lumen at a first location. A sleeve may be disposed around a distal portion of the elongate tubular body, and the at least one return electrode may be disposed on an outer surface of the sleeve. The at least one return electrode may be configured to contact an inner wall of a body lumen at a first location when the working space expanding system (e.g., the first and second flexible members) move to the expanded position. The surgical device may be configured to contact an inner wall of the body lumen at a second location to deliver energy from the power source, through a portion of the tissue of the body lumen, and to the at least one return electrode. The energy delivered from the surgical device may manipulate, treat or otherwise affect, a tissue of the body lumen.

[0008] In another aspect, the present disclosure relates to a surgical system comprising an elongate tubular body, which may include a proximal end, a distal end and one or more working channels extending therebetween. A working space expanding system may be positioned at a distal portion of the elongate tubular body. The working space expanding system may be movable between a non-expanded insertion position and an expanded position to form an expanded region. A surgical device may be disposed within a first working channel of the elongate tubular body. At least one return electrode may be disposed on an outer surface of the working space expanding system. The surgical system may include a power source configured to deliver energy to the surgical device, and in electrical communication with the at least one return electrode. The surgical device may be electrically connected to (e.g., in electrical communication with) the power source by one or more conductive elements. The at least one return electrode may be electrically connected to the power source by one or more conductive elements. The surgical device may include an insulated portion and an uninsulated active (e.g., performing) electrode. The working space expanding system may include first and second flexible members movable between the non-expanded position and the expanded position to form the expanded region. Each of the first and second flexible members may include an insulated portion and an uninsulated portion. The at least one return electrode may include a first return electrode disposed on the uninsulated portion of the first flexible member, and a second return electrode disposed on the uninsulated portion of the second flexible member. The first return electrode may be configured to contact an inner wall of a body lumen at a first location, and the second return electrode may be configured to contact the inner wall of the body lumen at a second location, when the working space expanding system (e.g., first and second flexible members) moves to the expanded position. The surgical device may be configured to contact the inner wall of the body lumen at a third location to deliver energy from the power source, through a portion of the tissue of the body lumen, and to the first and second return electrodes. The energy delivered from the surgical device may manipulate, treat or otherwise affect, a tissue of the body lumen. A cover may be disposed around a portion of the working space expanding system. The at least one return electrode may include a first return electrode disposed on an outer surface of the cover at a first location, and a second return electrode disposed on the outer surface of the cover at a second location. The first return electrode may be configured to contact an inner wall of a body lumen at the first location, and the second return electrode may be configured to contact the inner wall of the body lumen at the second location, when the working space expanding system (e.g., first and second flexible members) moves to the expanded position. The cover may include an opening opposite the first and second return electrodes. The first flexible member may be disposed adjacent to a first side of the opening in the cover, and the second flexible member may be disposed adjacent to a second side of the opening in the cover. The surgical device may be configured to contact the inner wall of the body lumen at a third location to deliver energy from the power source, through a portion of the tissue of the body lumen, and to the first and second return electrodes. The energy delivered from the surgical device may manipulate, treat or otherwise affect, a tissue of the body lumen. A distal portion of the working space expanding system may include an endcap, and the at least one return electrode may be disposed on an outer surface of the endcap. The endcap may be configured to contact an inner wall of a body lumen as the first and second flexible members move to the expanded position, to place the at least one return electrode in contact with the inner wall of a body lumen at a first location. The energy delivered from the surgical device may manipulate, treat or otherwise affect, a tissue of the body lumen.

[0009] In yet another aspect, the present disclosure relates to a surgical system comprising an elongate tubular body, which may include a proximal end, a distal end and one or more working channels extending therebetween. A working space expanding system may be positioned at a distal portion of the elongate tubular body. The working space expanding system may movable between a non-expanded insertion position and an expanded position to form an expanded region. A surgical device may be disposed within a first working channel of the elongate tubular body. The surgical device may include an insulated portion and an uninsulated active (e.g., performing) electrode. At least one return electrode may be disposed on an outer surface of the working space expanding system. The surgical system may include a power source configured to deliver energy to the surgical device, and in electrical communication with the at least one return electrode. A sleeve may be disposed around a distal portion of the elongate tubular body, and the at least one return electrode may be disposed on an outer surface of the sleeve. The working space expanding system may include first and second flexible members movable between the non-expanded position and the expanded position to form the expanded region. The at least one return electrode may be configured to contact an inner wall of a body lumen at a first location when the first and second flexible members move to the expanded position. The surgical device may be configured to contact an inner wall of the body lumen at a second location to deliver energy from the power source, through a portion of the tissue of the body lumen, and to the at least one return electrode. The energy delivered from the surgical device may manipulate, treat or otherwise affect, tissue of the body lumen.

[0010] In yet another aspect, the present disclosure relates to a surgical system comprising an elongate tubular body, which may include a proximal end, a distal end and one or more working channels extending therebetween. The surgical system may include an elongate insulated sheath configured to extend over at least a portion of an outer surface of the elongate tubular body. An expandable member may be positioned at a distal portion of the insulated sheath. The expandable member may be configured to move between a non-expanded insertion position and an expanded position to form an expanded region. A surgical device may be movably disposed within a first working channel of the elongate tubular body. The surgical device may include an insulated portion and an uninsulated active (e.g., performing) electrode. The expandable member may include an opening into/through which a distal portion of the surgical device may extend. At least one return electrode may be disposed on an outer surface of the expandable member. The surgical system may include a power source configured to deliver energy to the surgical device, and in electrical communication with the at least one return electrode. The at least one return electrode may be configured to contact an inner wall of a body lumen at a first location when the expandable member moves to the expanded position. The surgical device may be configured to contact an inner wall of the body lumen at a second location to deliver energy from the power source, through a portion of the tissue of the body lumen, and to the at least one return electrode. The energy delivered from the surgical device may manipulate, treat or otherwise affect, tissue of the body lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Non- limiting embodiments of the present disclosure are described by way of example with reference to the accompanying figures, which are schematic and not intended to be drawn to scale. In the figures, each identical or nearly identical component illustrated is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure. In the figures:

[0012] FIGS. 1A-1D provide perspective views of a medical device, according to one embodiment of the present disclosure.

[0013] FIG. 2 provides a perspective view of a medical device, according to one embodiment of the present disclosure.

[0014] FIG. 3 provides a perspective view of a medical device, according to one embodiment of the present disclosure.

[0015] FIG. 4 provides a perspective view of a medical device, according to one embodiment of the present disclosure.

[0016] FIG. 5 provides a perspective view of a medical device, according to one embodiment of the present disclosure.

DETAILED DESCRIPTION

[0017] The present disclosure is not limited to the particular embodiments described. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs. [0018] Although embodiments of the present disclosure are described with specific reference to medical devices and systems configured to be inserted into a body lumen of a patient for intraluminal treatment of tissues, e.g., within the gastrointestinal tract, it should be appreciated that such medical devices and systems may be used in a variety of medical procedures within various luminal body passages, including, by way of non-limiting example, the vascular system, pulmonary system, respiratory system, urogenital system, upper GI tract, and the like. The devices and system can be inserted via different access points and approaches, e.g. , percutaneously, endoscopically, laparoscopically, or some combination thereof.

[0019] As used herein, the singular forms“a,”“an,” and“the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms“comprises” and/or“comprising,” or“includes” and/or“including” when used herein, specify the presence of stated features, regions, steps, elements and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and/or groups thereof.

[0020] As used herein, the term“distal” refers to the end farthest away from the medical professional when introducing a device into a patient, while the term“proximal” refers to the end closest to the medical professional when introducing a device into a patient.

[0021] In various embodiments, the present disclosure relates to intraluminal surgical systems and related methods for providing treatment energy to body tissues. For example, the surgical systems disclosed herein generally relate to luminal surgical devices configured to perform monopolar or bipolar electrosurgical procedures within a variety of body lumens or passageways.

[0022] Referring to FIG. 1A, in one embodiment, a surgical system 100 of the present disclosure may include a flexible elongate tubular body 110 (e.g., endoscope, gastroscope, colonoscope, delivery catheter, or other device for delivering a medical tool to a treatment site) comprising a proximal end (not shown), a distal end 114 and one or more working channels H6a-c extending therebetween (FIGS. 1C-1D). A working space expanding system 120 may be attached to, and extend distally beyond, a distal portion 112 of the elongate tubular body 110.

The working space expanding system 120 may be configured to move between a non-expanded (e.g. , unexpanded, collapsed, etc.) insertion position, and an expanded (e.g., unconstrained, deployed, etc.) position to form an expanded region within a body lumen of patient. A surgical device 130 (e.g., electrosurgical device, surgical catheter, first electrode, cutting electrode, end effector, etc.) may be movably (e.g., slidably, rotatably, etc.) disposed within a first working channel H6a of the elongate tubular body 110. The surgical device 130 may include an insulated outer portion 132 and an uninsulated (e.g., conductive) active electrode portion 134. For example, the insulated outer portion 132 may extend along a length of the surgical device 130 extending through the first working channel 116a, and active electrode 134 may extend through/within the insulated outer portion 132. A distal end (e.g., distal tip) of the active electrode 134 may extend distally beyond the insulated outer portion 132 of the surgical device 130, e.g. , into the working space expanding system 120.

[0023] At least one return electrode (e.g. , second electrode, grounding electrode, intraluminal grounding element, etc.) may be attached to, or otherwise disposed on or along (e.g. , integrally formed with, etc.) an outer surface of the working space expanding system 120. For example, in one embodiment, the working space expanding system 120 may include first and second flexible members 122, 124 configured to move (e.g., bow, flex or bend, etc.) between the non-expanded insertion position and the expanded position to form the expanded region. The first and second flexible members 122, 124 may each include an insulated portion l23a, l25a, and an uninsulated portion l23b, l25b. A first return electrode l40a may be disposed on or along an outer surface of the uninsulated portion l23b of the first flexible member 122, and a second return electrode l40b may be disposed on or along an outer surface of the uninsulated portion l25b of the second flexible member 124.

[0024] In various embodiments, the first and second flexible members 122, 124 may extend along an inner and/or outer surface of the elongate tubular body 110, such that a proximal portion (not shown) of each flexible member may be actuated by a medical professional, e.g., using a suitable handle, actuator or the like. Similarly, the surgical device 130 may extend through an entire length of the elongate tubular body 110, such that a proximal portion (not shown) of the surgical device 130 may be actuated by a medical professional, e.g., using a suitable handle, actuator or the like. The insulated portions l23a, l25a may extend along an entire length of the respective first and second flexible members 122, 124 along and/or through the elongate tubular body 110.

[0025] The surgical system 100 may further include a power source (not shown) configured to transmit or deliver energy to the active electrode 134 of the surgical device 130, and in electrical communication with the return electrode(s) l40a, l40b. In various

embodiments, the power source may be incorporated within a portion of the elongate tubular body 110, e.g., at or near the proximal end (not shown). Alternatively, the power source may include an external unit or module, e.g., a standalone device, electrically connected to surgical system 100. The power source may supply any suitable energy, such as electrical, laser, thermal, ultrasound, etc. For example, in one embodiment, the power source may generate

radiofrequency energy. The power source may include a controller and a user interface with various components, such as processors for processing instructions (e.g. program instructions), memory, and user input devices. In various embodiments, the controller and the user interface may modulate the characteristics of the energy supplied to the surgical system 100. The user interface may display the energy output of the surgical device, and/or may display an image of the body lumen and/or lesion, such as an image from an imaging sensor present at the distal tip of the elongate tubular body 110. One or more actuation mechanisms, such as buttons, dials, sensors, etc., may be present on the power source, the controller and/or the user interface. In various examples, a medical professional may adjust the energy output of the surgical device via one or more actuators on the power source, the controller and/or the user interface.

[0026] In one embodiment, a proximal end (not shown) of the active electrode 134 of the surgical device 130 may be electrically connected to the power source. In addition, the first and second return electrodes l40a, l40b, may be electrically connected to the power source by the conductive materials which comprise the first and second flexible members 122, 124 extending extend along an inner and/or outer surface of the elongate tubular body 110.

[0027] Still referring to FIG. 1A, in use and by way of example, the surgical system 100 may be advanced through a body lumen 150 of a patient in the non-expanded insertion position to the site of a known or suspected tissue lesion 152 within a tissue wall of the body lumen 150. The surgical system may be oriented (e.g., rolled, twisted, etc.) such that the first and second flexible members 122, 124 are positioned on opposite sides of a tissue lesion 152.

[0028] Referring to FIG. 1B, the first and second flexible members 122, 124 may then be actuated, e.g., from a handle or actuator at a proximal end thereof, as discussed above, such that the first and second flexible members 122, 124 bow or flex outward to form the expanded region of the working space expanding system 120. In the expanded position, the first and second flexible members 122, 124 may apply radial outward force to at least a portion of the tissue wall of the body lumen 150 such that the first and/or second return electrodes l40a, l40b are placed in firm contact (e.g., direct contact, intimate contact, etc.) with the tissue wall of the body lumen 150 at first and second locations, respectively. Although the lesion 152 of FIG. 1B is depicted as fitting within the space between the first and second flexible members 122, 124, in various embodiments the lesion 152 may include a variety of different sizes and/or shapes. In addition, or alternatively, the first and second flexible members 122, 124 are not strictly required to contact respective portions of the tissue wall on opposite sides of the tissue lesion 152, but may contact any portion of the tissue wall in the general vicinity of the tissue lesion 152. In various embodiments, in addition to placing the first and second return electrodes l40a, l40b in firm contact with the tissue wall of the body lumen 150, in order to facilitate electrosurgical manipulation, or treatment of the tissue lesion (as discussed below), the expanded region of the working space expanding system 120 may also provide an increased working space within which one or more tools or other medical instruments may operate.

[0029] Referring to FIG. 1C, with the first and second return electrodes l40a, l40b placed in firm contact with the tissue wall of the body lumen 150, the surgical device 130 may be advanced within/through the first working channel 116a of the elongate tubular body 110 such that the active electrode 134 is placed in contact with the tissue wall of the body lumen 150 at a third location.

[0030] Referring to FIG. 1D, with the first and second return electrodes l40a, l40b, and the active electrode 134 of the surgical device 130, in contact with their respective first, second and third portions of the tissue wall of the body lumen 150, energy may be delivered from the power source to the surgical device 130. As indicated by the dashed-lines, the energy may then be locally emitted from the active electrode 134 of the surgical device, into and through a portion of the tissue wall of the body lumen 150, and received by the first and second return electrodes l40a, l40b. The energy may then be returned to the first and second return electrodes l40a, l40b to the power source, thereby preventing energy from travelling through other portions of the body lumen and/or patient’s body. The energy emitted from the active electrode 134 of the surgical device may then be used to electrosurgically manipulate the tissue wall of the body lumen to remove or otherwise treat (e.g., mark, cut, dissect, resect, coagulate, ablate, etc.), the tissue lesion 152.

[0031] Referring to FIG. 2, in one embodiment, a surgical system 200 of the present disclosure may include similar or identical features of the surgical system 100, with the exception that the at least one return electrode is disposed on an endcap 128 positioned at or near the distal end of the working space expanding system 120. For example, the endcap 128 may provide a distal nexus at which a distal end of the first and second flexible members 122, 124 may be joined or connected. In one embodiment, the at least one return electrode may include a plurality of return electrodes 240 disposed uniformly or non-uniformly around a full or partial circumference of an outer surface of the endcap 128. One or more conductive elements 236 (e.g., conductive wires) may extend along an inner or outer surface of the working space expanding system and/or elongate tubular body 110 to electrically connect each of the return electrodes 240 to the power source. In various embodiments, the endcap 128 may include an outer dimension configured to place at least one of the return electrodes 240 in firm contact with a tissue wall of the body lumen 150. For example, as the first and second flexible members 122, 124 move from the non-expanded insertion position to the expanded position to form the expanded region, as discussed above, the endcap 128 may deflect in an opposite direction within the body lumen 150, e.g., toward a portion of the tissue wall opposite the lesion 152. With the return electrodes 240 of the endcap 128 in contact with the tissue wall of the body lumen, the surgical device 130 may be advanced and placed in contact with a separate portion of the tissue wall, as discussed above.

The energy emitted from the active electrode 134 of the surgical device 130 may then be used to manipulate the tissue wall of the body lumen to remove or otherwise treat (e.g., mark, cut, dissect, resect, coagulate, ablate, etc.) the tissue lesion 152, as discussed above.

[0032] Referring to FIG. 3, in one embodiment, a surgical system 300 of the present disclosure may include similar or identical features of the surgical system 100, with the exception that the at least one return electrode is disposed on or along a cover 326 extending around (e.g. , partially enclosing) the working space expanding system 120. For example, one or more first return electrode 340a may be disposed on an outer surface of the cover 326 at a first location, and one or more second return electrodes 340b may be disposed on an outer surface of the cover at a second location, e.g. , adjacent to the first location. In various embodiments, the first and second return electrodes 340a, 340b may be permanently attached to (e.g., wedged, swaged, painted, glued, embedded, etc.), or integrally formed with, the cover 326 using a suitable glue, adhesive, resin, solder, or other bonding techniques, as are commonly known in the art. One or more conductive elements 336 (e.g., conductive wires) may extend along an inner or outer surface of the elongate tubular body 110 to electrically connect the first and second return electrodes 340a, 340b to the power source. In various embodiments, the cover 326 may include an outer dimension (e.g., when the working space expanding system is in the expanded position) configured to place one or more of the first and/or second return electrodes 340a, 340b in firm contact with a tissue wall of the body lumen 150. For example, as the first and second flexible members 122, 124 move from the non-expanded insertion position to the expanded position to form the expanded region, all or a portion of the cover 326 may deflect in an opposite direction within the body lumen, e.g., toward a portion of the tissue wall opposite the lesion 152. In one embodiment, a portion of the cover 326 opposite the first and second return electrodes 340a,

340b may include an opening through which the surgical device 130 (and accessory tools, discussed below) may access the tissue wall of the body lumen 150 and/or tissue lesion 152. For example, in one embodiment, the first flexible member 122 may be disposed along or adjacent to a first side of the opening of the cover 326, and the second flexible member 124 may be disposed along or adjacent to a second side of the opening of the cover 326.

[0033] With the first and second return electrodes 340a, 340b on the outer surface of the cover 326 in contact with the tissue wall of the body lumen 150, the surgical device 130 may be advanced and placed in contact with a separate portion of the tissue wall, as discussed above.

The energy emitted from the active electrode 134 of the surgical device 130 may then be used to manipulate the tissue wall of the body lumen to remove or otherwise treat (e.g., mark, cut, dissect, resect, coagulate, ablate, etc.) the tissue lesion 152, as discussed above.

[0034] Referring to FIG. 4, in one embodiment, a surgical system 400 of the present disclosure may include the identical features of the surgical system 100, with the exception that the at least one return electrode may be disposed on or along a sleeve 450 extending around a distal portion 112 of the elongate tubular body 110. For example, the at least one return electrode may include a plurality of return electrodes 440 disposed uniformly or non-uniformly around a full or partial circumference of an outer surface of the sleeve 450. One or more conductive elements 436 may extend along an inner or outer surface of the elongate tubular body 110 to electrically connect each of the return electrodes 440 to the power source.

[0035] In various embodiments, the plurality of return electrode(s) 440 may be permanently attached to (e.g., wedged, swaged, painted, embedded), or integrally formed with, the outer surface of the sleeve 450 using a suitable glue, adhesive, resin, solder, or other bonding techniques, as are commonly known in the art. In addition, or alternatively, an outer surface of the sleeve 450 may be formed from or include one or more conductive materials such that the entire sleeve 450 may serve as the return electrode. One or more conductive elements (not shown), (e.g., conductive wires) may extend along an inner or outer surface of the elongate tubular body 110 to electrically connect each return electrode(s) to the power source.

[0036] In various embodiments, the sleeve 450 may include an outer dimension configured to place at least one of the return electrodes 440 in firm contact with a tissue wall of the body lumen 150. For example, as the first and second flexible members 122, 124 move from the non-expanded insertion position to the expanded position to form the expanded region, as discussed above, at least a portion of the sleeve 450 may deflect in an opposite direction within the body lumen 150, e.g., toward a portion of the tissue wall opposite the lesion 152. In other embodiments, the sleeve 450 may be configured to expand or inflate within the body lumen 150 to place at least one of the return electrodes 440 in firm contact with a tissue wall of the body lumen. For example, one or more inflation/deflation lumens (not shown) may run along an inner or outer surface of the elongate tubular body 110 to deliver a suitable inflation medium (e.g., normal saline, a biologically inert gas, etc.) into a lumen of the sleeve 450 to move the sleeve from a first non-expanded position to a second expanded position.

[0037] With the return electrodes 440 on the outer surface of the sleeve 450 in contact with the tissue wall of the body lumen 150, the surgical device 130 may be advanced and placed in contact with a separate portion of the tissue wall, as discussed above. The energy emitted from the active electrode 134 of the surgical device may then be used to manipulate the tissue wall of the body lumen to remove or otherwise treat (e.g., mark, cut, dissect, resect, coagulate, ablate, etc.) the tissue lesion 152, as discussed above.

[0038] Although the working space expanding system 120 of FIGS. 1A-4 is generally depicted as including first and second flexible members 122, 124 configured to bow, flex or bend in a substantially“U-shaped” configuration, in various embodiments, the working space expanding system may include a single flexible member, or more than two flexible members (e.g. , three or more) configured to move to a variety of different shapes when in the non- expanded configuration. By way of non-limiting example, such flexible members may move to a “T-shaped” configuration, an“L-shaped” configuration, a circular or oval shaped configuration, and various symmetric or asymmetric variations thereof. Similarly, the number, arrangement and/or orientation of the return electrodes disposed on or along such flexible member(s) is not limited to the configuration of FIGS. 1A-4, but may vary.

[0039] In various embodiments, the working space expanding system may include proximal and distal balloons expandable to form the expanded regions. An outer surface of either (or both) of the proximal and distal balloons may include one or more return electrodes in electrical communication with a power source, and configured to be placed in firm contact with the tissue wall of the body lumen, in order to facilitate electrosurgical manipulation, or treatment of the tissue lesion (as discussed above). In addition, the proximal and/or distal balloons may expand to provide an increased working space within which one or more tools or other medical instruments may operate.

[0040] Referring to FIG. 5, in one embodiment, a surgical system 500 of the present disclosure may include a flexible elongate tubular body 110 (e.g., endoscope, gastroscope, colonoscope, delivery catheter, etc.) comprising a proximal end (not shown), a distal end 114 and one or more working channels 1 l6a-c extending therebetween. An elongate insulated sheath 550 may extend over and along all or a portion of an outer surface of the elongate tubular body 110. An expandable member 526 (e.g. , balloon, etc.) may be attached to and extend distally beyond a distal end of the insulated sheath 550. In various embodiments, an inflation/deflation lumen (not shown) may extend along an inner or outer surface of the insulated sheath 550, and may be configured to deliver a suitable inflation fluid/medium into an interior region of the expandable member 526. The expandable member 526 may be configured to move between a non-expanded (e.g., collapsed, delivery, etc.) insertion position and an expanded position to form an expanded region, e.g., by introducing or removing the inflation fluid from within the interior region of the expandable member 526. In addition, or alternatively, the expandable member 526 may be configured to move between the non-expanded and expanded positions using a mechanical, rather than fluidic, actuation mechanism, e.g., one or more expandable/collapsible arms, collapsible/expandable framework, etc. (not shown).

[0041] A surgical device 130 (e.g., first electrode, cutting electrode, end effector, etc.) may be movably (e.g., slidably, rotatably, etc.) disposed within a first working channel H6a of the elongate tubular body 110. The surgical device 130 may include an insulated outer portion 132 and an uninsulated (e.g. , conductive) active electrode portion 134. For example, the insulated outer portion 132 may extend along a length of the surgical device 130 extending through the first working channel H6a, and the active electrode 134 may extend through/within the insulated outer portion 132. A distal end (e.g., distal tip) of the active electrode 134 may extend distally beyond the insulated outer portion 132 of the surgical device 130, e.g., into an interior portion of the expandable member 526.

[0042] At least one return electrode may be attached to, or otherwise disposed on or along (e.g., integrally formed with, etc.) an outer surface of the expandable member 526. For example, the at least one return electrode may include a plurality of return electrodes 540 uniformly or non-uniformly disposed around a full or partial circumference of a distal end of the expandable member 526. The surgical system 500 may further include a power source, as discussed above (not shown), configured to transmit or deliver energy to the surgical device 130, and in electrical communication with the plurality of return electrodes 540, as discussed above.

[0043] In use and by way of example, the surgical system 500 may be advanced through a body lumen 150 of a patient in the non-expanded insertion position to the site of a known or suspected tissue lesion 152 within a tissue wall of the body lumen 150. The expandable member 526 may then be moved to the expanded (e.g., inflated) position, thereby applying radial outward force to at least a portion of the tissue wall of the body lumen 150 such that one or more of the plurality of return electrodes 540 are placed in firm contact (e.g., direct contact, intimate contact, etc.) with the tissue wall of the body lumen 150. In various embodiments, in addition to placing the plurality of return electrodes 540 in firm contact with the tissue wall of the body lumen 150, e.g., to facilitate electrosurgical manipulation of the tissue lesion (as discussed below), the expandable member 526 may also provide an increased working space within which one or more tools or other medical instruments may operate.

[0044] With one or more of the return electrodes 540 placed in firm contact with the tissue wall of the body lumen 150, the surgical device 130 may be advanced within/through the first working channel H6a of the elongate tubular body 110 such that the active electrode 134 extends through an opening in the expandable member 526 and is placed in contact with the tissue wall of the body lumen 150. With one or more of the return electrodes 540, and the active electrode 134 of the surgical device 130, in contact with their respective portions of the tissue wall of the body lumen 150, energy may be delivered from the power source to the surgical device 130. The energy may then be locally emitted from the active electrode 134 of the surgical device, into and through a portion of the tissue wall of the body lumen 150, and received by one or more of the return electrodes 540, as discussed above. The energy may then be returned from the plurality of return electrodes to the power source. The energy emitted from the active electrode 134 of the surgical device may then be used to electrosurgically manipulate the tissue wall of the body lumen to remove or otherwise treat (e.g. , mark, cut, dissect, resect, coagulate, ablate, etc.) the tissue lesion 152, as discussed above.

[0045] In various embodiments, any of the surgical systems 100, 200, 300, 400, 500, disclosed herein may operate in a monopolar mode or a bipolar mode. In particular, the power source may include a monopolar mode or bipolar mode. In some examples, the bipolar mode may use lower voltages while the monopolar mode may require higher voltages. Since the surgical systems of the present disclosure generally include one or more return electrodes positioned in the general proximity of the site of treatment within the body lumen 150, e.g., at or near the lesion 152, the power density away from the treatment site may be lower than a conventional monopolar electrosurgery, e.g., in which the return electrode(s) is/are positioned somewhere on the patient’s exterior skin, typically not proximate to the site of surgery. By positioning the one or more return electrodes proximate to the target lesion 152, the surgical systems of the present disclosure may have similar efficiency and effectiveness as conventional monopolar electrosurgical techniques while outputting significantly lower energy levels and with a much lower risk of unwanted thermal damage to collateral tissue.

[0046] In addition, the ability of the surgical systems of the present disclosure to mitigate thermal damage by directing the electrosurgical energy superficially and subcutaneously (e.g., endoluminally) may allow the active electrode 134 to include a smaller size or profile, thereby providing the medical professional with more refined control while manipulating, treating or otherwise affecting tissues of a body lumen.

[0047] In addition, the ability of the surgical systems of the present disclosure to mitigate thermal damage to collateral tissue by locally deploying the active electrode and the return electrode(s) at or near the site of the target lesion, may enable the medical professional to perform intraluminal procedures (e.g., an endoscopic submucosal dissection (ESD) procedure) with a higher energy density (e.g., Joules/area) or power density (e.g., Watts/area) at the tissue manipulation site, but with a lower overall amount of energy emitted into or through the surrounding tissues. This may enable the medical professional to employ smaller and more finely controlled instruments, and/or provide a more efficient quantum of energy to the tissue lesion. For example, an intraluminal procedure ordinarily performed using an energy level associated with monopolar electrosurgery may be performed using a surgical system with an energy level typically associated with bipolar electrosurgery.

[0048] In various embodiments, the elongate tubular body 110 of any of the surgical systems 100, 200, 300, 400, 500, disclosed herein may further be configured to receive one or more additional medical devices (e.g., scissors, forceps, graspers, scalpels, etc.) through additional working channels (e.g., 116b, 116c). In addition, or alternatively, one or more of the additional working channels may include a lumen for delivery of various fluids, imaging lumens for components of one or more image sensors, vacuum lumens for suctioning air, liquid, or other material from within the body lumen. In addition, or alternatively, a variety of additional medical tools (e.g., scissors, graspers, forceps, knives, needles, balls, hooks, spatulas, etc.) may extend through, or along an outer surface of, the elongate tubular body to further manipulate the tissue wall of the body lumen.

[0049] The surgical systems 100, 200, 300, 400, 500, of the present disclosure are not intended to be described or depicted as mutually exclusive embodiments. For example, any or all of the various configurations of return electrodes disposed on or along any of the flexible members, cover, endcap, sleeve and/or expandable member described herein, may be combined into a single surgical system. In addition, any of the return electrodes disclosed herein may be disposed on or along the respective flexible members, cover, endcap, sleeve and/or expandable member of the respective surgical systems in a variety of different numbers, locations, sizes, shapes, patterns and/or orientations.

[0050] Non-limiting examples of conductive materials which may comprise the flexible members, surgical device, return electrode(s) and/or conductive elements of any of the surgical systems 100, 200, 300, 400, 500, disclosed herein, may include stainless steel, tungsten alloys, copper, nitinol, titanium, aluminum-based materials, or other suitable conductive materials as are known in the art. Similarly, non-limiting examples of insulative materials, which are described herein, and which may comprise components of the elongate tubular body, working space expanding system, cover, balloon, sheath, distal portion, endcap and/or active electrodes of any of the surgical systems 100, 200, 300, 400, 500, disclosed herein, may include a non-conductive thermoplastic, fluoropolymer, or elastomer such as polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), silicone, perfluoroalkoxy polymer resin (PFA), ceramic or any other suitable non-conductive material.

[0051] All of the devices and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of this disclosure have been described in terms of preferred embodiments, it may be apparent to those of skill in the art that variations can be applied to the devices and/or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the disclosure as defined by the appended claims.