Apparatus and Method for Endoluminal Electrosurgery with Grounding

Abstract

The present invention generally relates to the field of medical devices and treating tissue within a body passageway. Specifically, the present invention relates to electrosurgical devices, systems, and methods for treating tissue.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 649,901, filed on Mar. 29, 2018, under 35 U.S.C. § 119, the entire content of which is incorporated herein by reference. Technical Field

[0003] The present invention generally relates to the field of medical devices and treating tissue within a body passage. Specifically, the present invention relates to an intracavitary electrosurgical device, system, and method for treating tissue. Background Art

[0004] Medical devices are often used to extract unwanted substances and / or foreign bodies from the body. These medical devices use various extraction methods, such as dissecting, coagulating, electrocauterizing, ablating, etc. of unwanted body substances. A typical procedure using these methods is electrosurgery. Electrosurgery involves applying energy to biological tissue to cut, ablate, cauterize, coagulate, dry, and / or electrocauterize the tissue. Electrosurgery can use various types of high-frequency electrical energy to directly heat the tissue.

[0005] Typically, electrosurgery is performed using a radiofrequency electrosurgical generator and a treatment device including one or two electrodes. A monopolar instrument only contains one active electrode, while a bipolar instrument includes two active electrodes at the surgical site. When the other electrode is active, one of the two active electrodes serves as a ground electrode, and vice versa. Monopolar instruments require another instrument called a dispersive or return electrode to be connected elsewhere on the patient's body or otherwise to the patient's body to defocus or disperse the radiofrequency current and return the energy to the electrosurgical generator to prevent damage to the underlying tissue. However, due to the relatively large distance that the energy travels from the active electrode through the human body to the return electrode, it often causes harm to the patient. Moreover, doctors must pay attention to avoid complications, such as direct coupling, insulation failure, capacitive coupling, and other potential complications that may cause patient injury.

[0006] Bipolar electrosurgical instruments typically include forceps or other end effectors, where the two tips of the forceps perform the functions of the active electrode and the return electrode. Only the tissue grasped by the forceps is likely to be included in the electrical circuit. Bipolar instruments require lower voltages than monopolar instruments, and since both the active electrode and the return electrode are at the surgical site, the risk of accidental injury to the patient may be smaller compared to monopolar instruments. Bipolar instruments perform well in occluding blood vessels; however, they include lateral thermal spread that continues until the device activation stops. The applications of bipolar electrosurgical devices are limited, and they may provide lower cutting precision compared to monopolar instruments. It is necessary to create a hybrid between monopolar and bipolar electrosurgical instruments that can utilize voltages similar to bipolar instruments but have cutting capabilities similar to monopolar instruments.

[0007] Traditional electrosurgical devices typically have large footprints and may not be configured to be inserted into hard-to-reach areas of the body or used with endoscopic devices. Accordingly, the electrosurgical devices, systems, and methods of the present invention can achieve various advantageous medical outcomes. SUMMARY OF THE INVENTION

[0008] In one aspect, the present invention relates to a surgical system that includes an elongate tubular body that may include a proximal end, a distal end, and one or more working channels extending therebetween. A working space expansion system may be positioned at the distal portion of the elongate tubular body. The working space expansion system may be movable between a non-expanded insertion position and an expanded position to form an expanded region. A surgical device may be located 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 expansion 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 (e.g., in electrical communication) to 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 working (e.g., performing) electrode. The working space expansion system may include a first flexible member and a second flexible member that are movable between a non-expanded position and an expanded position to form an expanded region. Each of the first flexible member and the second flexible member may include an insulated portion and an uninsulated portion. The at least one return electrode may include a first return electrode located on the uninsulated portion of the first flexible member and a second return electrode located on the uninsulated portion of the second flexible member. When the first flexible member and the second flexible member are moved to the expanded position, the first return electrode may be configured to contact an inner wall of the body cavity at a first location, and the second return electrode may be configured to contact an inner wall of the body cavity at a second location. The surgical device may be configured to contact an inner wall of the body cavity at a third location to deliver energy from the power source through a portion of the tissue of the body cavity and to the first return electrode and the second return electrode. The energy delivered from the surgical device may operate, treat, or otherwise affect the tissue of the body cavity. A covering may be disposed around a portion of the working space expansion system. The at least one return electrode may include a first return electrode disposed at a first location on an outer surface of the covering and a second return electrode disposed at a second location on an outer surface of the covering. The covering may include an opening opposite the first return electrode and the second return electrode. The first flexible member may be disposed adjacent a first side of the opening in the covering, and the second flexible member may be disposed adjacent a second side of the opening in the covering. When the working space expansion system (e.g., the first flexible member and the second flexible member) is moved to the expanded position, the first return electrode may be configured to contact an inner wall of the body cavity at a first location, and the second return electrode may be configured to contact an inner wall of the body cavity at a second location. The surgical device may be configured to contact an inner wall of the body cavity at a third location to deliver energy from the power source through a portion of the tissue of the body cavity and to the first return electrode and the second return electrode. The energy delivered from the surgical device may operate, treat, or otherwise affect the tissue of the body cavity.The distal portion of the workspace expansion system may include an end cap, and at least one return electrode may be disposed on an outer surface of the end cap. When the workspace expansion system (e.g., the first flexible member and the second flexible member) moves to the expanded position, the end cap may be configured to contact an inner wall of the body cavity to place at least one return electrode in contact with the inner wall of the body cavity at a first location. A sleeve may be disposed around the distal portion of the elongated tubular body, and at least one return electrode may be disposed on an outer surface of the sleeve. When the workspace expansion system (e.g., the first flexible member and the second flexible member) moves to the expanded position, at least one return electrode may be configured to contact the inner wall of the body cavity at a first location. The surgical device may be configured to contact the inner wall of the body cavity at a second location to deliver energy from a power source through a portion of the tissue of the body cavity and to at least one return electrode. The energy delivered from the surgical device may operate on, treat, or otherwise affect the tissue of the body cavity.

[0009] In another aspect, the present invention relates to a surgical system that includes an elongate tubular body that may include a proximal end, a distal end, and one or more working channels extending therebetween. A working space expansion system may be positioned at the distal portion of the elongate tubular body. The working space expansion 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 expansion 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 (e.g., in electrical communication) to the power source through one or more conductive elements. The at least one return electrode may be electrically connected to the power source through one or more conductive elements. The surgical device may include an insulated portion and an uninsulated working (e.g., performing) electrode. The working space expansion system may include a first flexible member and a second flexible member that are movable between a non-expanded position and an expanded position to form an expanded region. Each of the first flexible member and the second flexible member 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. When the working space expansion system (e.g., the first flexible member and the second flexible member) is moved to the expanded position, the first return electrode may be configured to contact the inner wall of the body cavity at a first location, and the second return electrode may be configured to contact the inner wall of the body cavity at a second location. The surgical device may be configured to contact the inner wall of the body cavity at a third location to deliver energy from the power source through a portion of the tissue of the body cavity and to the first return electrode and the second return electrode. The energy delivered from the surgical device may operate, treat, or otherwise affect the tissue of the body cavity. A covering may be disposed around a portion of the working space expansion system. The at least one return electrode may include a first return electrode located at a first location on an outer surface of the covering and a second return electrode located at a second location on an outer surface of the covering. When the working space expansion system (e.g., the first flexible member and the second flexible member) is moved to the expanded position, the first return electrode may be configured to contact the inner wall of the body cavity at the first location, and the second return electrode may be configured to contact the inner wall of the body cavity at the second location. The covering may include an opening opposite the first return electrode and the second return electrode. The first flexible member may be disposed adjacent to a first side of the opening in the covering, and the second flexible member may be disposed adjacent to a second side of the opening in the covering. The surgical device may be configured to contact the inner wall of the body cavity at a third location to deliver energy from the power source through a portion of the tissue of the body cavity and to the first return electrode and the second return electrode. The energy delivered from the surgical device may operate, treat, or otherwise affect the tissue of the body cavity.The distal portion of the workspace expansion system may include an end cap, and at least one return electrode may be located on the outer surface of the end cap. When the first flexible member and the second flexible member move to the expanded position, the end cap may be configured to contact the inner wall of the body cavity to contact the at least one return electrode with the inner wall of the body cavity at a first position. Energy delivered from the surgical device may operate on, treat, or otherwise affect the tissue of the body cavity.

[0010] In another aspect, the present invention relates to a surgical system that includes an elongate tubular body that may include a proximal end, a distal end, and more than one working channel extending therebetween. The workspace expansion system may be positioned in the distal portion of the elongate tubular body. The workspace expansion 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. The surgical device may include an insulated portion and an uninsulated working (e.g., performing) electrode. At least one return electrode may be located on the outer surface of the workspace expansion 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 the distal portion of the elongate tubular body, and at least one return electrode may be disposed on the outer surface of the sleeve. The workspace expansion system may include a first flexible member and a second flexible member that are movable between a non-expanded position and an expanded position to form an expanded region. When the first flexible member and the second flexible member move to the expanded position, the at least one return electrode may be configured to contact the inner wall of the body cavity at a first position. The surgical device may be configured to contact the inner wall of the body cavity at a second position to deliver energy from the power source through a portion of the tissue of the body cavity and to the at least one return electrode. Energy delivered from the surgical device may operate on, treat, or otherwise affect the tissue of the body cavity.

[0011] In another aspect, the present invention relates to a surgical system that includes an elongate tubular body that may include a proximal end, a distal end, and one or more working channels extending therebetween. The surgical system may include an elongate insulating sheath configured to extend over at least a portion of the outer surface of the elongate tubular body. An expandable member may be positioned at the distal portion of the insulating 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 insulating portion and a non-insulating working (e.g., performing) electrode. The expandable member may include an opening through which a distal portion of the surgical device may extend. At least one return electrode may be disposed on the 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. When the expandable member moves to the expanded position, at least one return circuit may be configured to contact the inner wall of the body cavity at a first location. The surgical device may be configured to contact the inner wall of the body cavity at a second location to deliver energy from the power source through a portion of the tissue of the body cavity and to the at least one return electrode. Energy delivered from the surgical device may operate on, treat, or otherwise affect the tissue of the body cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Non-limiting embodiments of the present invention are described with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the figures, each identical or nearly identical component that is illustrated is typically represented by a single numeral. For clarity, not every component is labeled in every figure, nor is every component of each embodiment shown where illustration is not necessary for an ordinary skilled artisan to understand the invention. In

[0013] FIGURES:

[0014] Figures 1A - 1D A perspective view of a medical device according to one embodiment of the present invention is provided.

[0015] Figure 2 A perspective view of a medical device according to one embodiment of the present invention is provided.

[0016] Figure 3 A perspective view of a medical device according to one embodiment of the present invention is provided.

[0017] Figure 4 A perspective view of a medical device according to one embodiment of the present invention is provided.

[0018] Figure 5 A perspective view of a medical device according to one embodiment of the present invention is provided. DETAILED DESCRIPTION

[0019] The present invention is not limited to the specific embodiments described herein. The terms used herein are for the purpose of describing particular embodiments only and are not intended to limit the scope beyond 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 this invention belongs.

[0020] While embodiments of the present invention are described specifically with reference to medical devices and systems configured to be inserted into a patient's body cavity for performing intraluminal treatment of tissue, e.g., within the gastrointestinal tract, it should be understood that such medical devices and systems can be used for a variety of medical procedures within various luminal body cavities, by way of non-limiting example, including the vascular system, pulmonary system, respiratory system, urogenital system, upper gastrointestinal tract, etc. The device and system can be inserted through different access points and methods, e.g., percutaneously, endoscopically, laparoscopically, or some combination thereof.

[0021] As used herein, the singular forms "a", "an", and "the" are also intended to include the plural forms unless the context clearly dictates otherwise. It will be further understood that the terms "comprising" and / or "comprises", or "including" and / or "includes" when used herein, specify the presence of the 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.

[0022] As used herein, the term "distal" refers to the end that is farthest from the medical professional when the device is introduced into the patient, while the term "proximal" refers to the end that is closest to the medical professional when the device is introduced into the patient.

[0023] In various embodiments, the present invention relates to intraluminal surgical systems and related methods for delivering therapeutic energy to body tissue. For example, the surgical systems of the present invention generally relate to intraluminal surgical devices configured to perform monopolar or bipolar electrosurgical procedures within various body cavities or passageways.

[0024] Refer to Figure 1A , in one embodiment, the surgical system 100 of the present invention may include a flexible, elongated tubular body 110 (e.g., an endoscope, gastroscope, colonoscope, delivery catheter, or other device for delivering a medical tool to a treatment site), which includes a proximal end (not shown), a distal end 114, and one or more working channels 116a-c extending therebetween ( Figures 1C - 1D)。The workspace expansion system 120 can be attached to the distal portion 112 of the elongate tubular body 110 and extend distally beyond the distal portion 112 of the elongate tubular body 110. The workspace expansion system 120 can be configured to move between a non-expanded (e.g., unexpanded, contracted, etc.) insertion position and an expanded (e.g., unconstrained, deployed, etc.) position to form an expanded region within a patient's body cavity. The surgical device 130 (e.g., an electrosurgical device, a surgical catheter, a first electrode, a cutting electrode, an end effector, etc.) can be movably (e.g., slidably, rotatably, etc.) disposed within the first working channel 116a of the elongate tubular body 110. The surgical device 130 can include an insulated outer portion 132 and a non-insulated (e.g., conductive) active electrode portion 134. For example, the insulated outer portion 132 can extend along the length of the surgical device 130 through the first working channel 116a, and the active electrode 134 can extend through / within the insulated outer portion 132 of the surgical device 130. The distal end (e.g., distal tip) of the active electrode 134 can extend distally beyond the insulated outer portion 132 of the surgical device 130, e.g., into the workspace expansion system 120.

[0025] At least one return electrode (e.g., a second electrode, a ground electrode, an intraluminal ground element, etc.) can be attached to or otherwise mounted on the outer surface of the workspace expansion system 120 or along the outer surface of the workspace expansion system 120 (e.g., integrally formed with the workspace expansion system 120, etc.). For example, in one embodiment, the workspace expansion system 120 can include a first flexible member and a second flexible member 122, 124 that are configured to move (e.g., bend, flex, or fold, etc.) between a non-expanded insertion position and an expanded position to form an expanded region. The first flexible member and the second flexible member 122, 124 can each include an insulated portion 123a, 125a and a non-insulated portion 123b, 125b. The first return electrode 140a can be disposed on or along the outer surface of the non-insulated portion 123b of the first flexible member 122, and the second return electrode 140b can be disposed on or along the outer surface of the non-insulated portion 125b of the second flexible member 124.

[0026] In various embodiments, the first flexible member and the second flexible members 122, 124 may extend along the inner surface and / or outer surface of the elongated tubular body 110 such that the proximal portion (not shown) of each flexible member may be actuated by a medical professional, e.g., using a suitable handle, actuator, etc. Similarly, the surgical device 130 may extend through the entire length of the elongated tubular body 110 such that the proximal portion (not shown) of the surgical device 130 may be actuated by a medical professional, e.g., using a suitable handle, actuator, etc. The insulating portions 123a, 125a may extend along the entire length of the respective first and second flexible members 122, 124 along and / or through the elongated tubular body 110.

[0027] 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 electrodes 140a, 140b. In various embodiments, the power source may be incorporated into a portion of the elongated tubular body 110, e.g., at or near the proximal end (not shown). Additionally, the power source may include an external unit or module, e.g., a separate device electrically connected to the surgical system 100. The power source may provide any suitable energy, such as electrical, laser, thermal, ultrasonic, etc. For example, in one embodiment, the power source may generate radiofrequency energy. The power source may include a controller and a user interface having various components, such as a processor for processing instructions (e.g., program instructions), a memory, and a user input device. In various embodiments, the controller and the user interface may modulate the characteristics of the energy provided to the surgical system 100. The user interface may display the energy output of the surgical device, and / or may display images of the body cavity and / or lesion, e.g., images from an imaging sensor present at the distal tip of the elongated tubular body 110. More than one actuation mechanism, such as buttons, dials, sensors, etc., may be present on the power source, controller, and / or user interface. In various examples, a medical professional may adjust the energy output of the surgical device via more than one actuator on the power source, controller, and / or user interface.

[0028] In one embodiment, the proximal end (not shown) of the active electrode 134 of the surgical device 130 may be electrically connected to the power source. Additionally, the first return electrode and the second return electrodes 140a, 140b, may be electrically connected to the power source via a conductive material that includes the first and second flexible members 122, 124 extending along the inner surface and / or outer surface of the elongated tubular body 110.

[0029] Still referring to Figure 1A, in use and by way of example, the surgical system 100 can be advanced through the patient's body cavity 150 in a non-expanded insertion position to a site of a known or suspected tissue lesion 152 within the tissue wall of the body cavity 150. The surgical system can be oriented (e.g., curled, twisted, etc.) such that the first flexible member and the second flexible member 122, 124 are positioned on opposite sides of the tissue lesion 152.

[0030] See Figure 1B , then, as discussed above, the first flexible member and the second flexible member 122, 124 can be actuated, for example, from a handle or actuator at their proximal ends such that the first flexible member and the second flexible member 122, 124 bend or flex outwardly to form an expansion region of the workspace expansion system 120. In the expanded position, the first flexible member and the second flexible member 122, 124 can apply a radially outward force to at least a portion of the tissue wall of the body cavity 150 such that the first return electrode and / or the second return electrode 140a, 140b are placed in firm contact (e.g., direct contact, close contact, etc.) with the tissue wall of the body cavity 150 at a first position and a second position, respectively. Although Figure 1B the lesion 152 is depicted as being disposed within the space between the first flexible member and the second flexible member 122, 124, in various embodiments, the lesion 152 can include a variety of different sizes and / or shapes. Additionally, or alternatively, the first flexible member and the second flexible member 122, 124 are not strictly required to contact the corresponding portions of the tissue wall on opposite sides of the tissue lesion 152, but can generally contact any portion of the tissue wall near the tissue lesion 152. In various embodiments, in addition to placing the first return electrode and the second return electrode 140a, 140b in firm contact with the tissue wall of the body cavity 150 to facilitate electrosurgical procedures or treatment of tissue lesions (as described below), the expansion region of the workspace expansion system 120 can also provide an increased workspace within which one or more tools or other medical devices can be operated.

[0031] See Figure 1C , since the first return electrode and the second return electrode 140a, 140b are placed in firm contact with the tissue wall of the body cavity 150, the surgical device 130 can be advanced / advanced through the first working channel 116a of the elongated tubular body 110 such that the active electrode 134 is placed in contact with the tissue wall of the body cavity 150 at a third position.

[0032] See Figure 1D, due to the first return electrode and the second return electrodes 140a, 140b and the working electrode 134 of the surgical device 130 contacting the first, second and third portions of the tissue wall of their respective body cavities 150, energy can be delivered from a power source to the surgical device 130. As shown by the dashed lines, the energy can then be locally emitted from the working electrode 134 of the surgical device, enter and pass through a portion of the tissue wall of the body cavity 150, and be received by the first return electrode and the second return electrodes 140a, 140b. Then, the energy can return from the first return electrode and the second return electrodes 140a, 140b to the power source, thereby preventing the energy from passing through other portions of the body cavity and / or the patient's body. Then, the energy emitted from the working electrode 134 of the surgical device can be used to electro-surgically operate on the tissue wall of the body cavity to remove or otherwise treat (e.g., mark, cut, dissect, excise, coagulate, ablate, etc.) the tissue lesion 152.

[0033] See Figure 2 , in one embodiment, the surgical system 200 of the present invention can include features similar or identical to those of the surgical system 100, except that at least one return electrode is disposed on the end cap 128, which is placed at or near the distal end of the workspace expansion system 120. For example, the end cap 128 can provide a distal connection point at which the distal ends of the first flexible member and the second flexible member 122, 124 can be joined or connected. In one embodiment, at least one return electrode can include a plurality of return electrodes 240, which are disposed uniformly or non-uniformly around all or part of the entire outer surface circumference of the end cap 128. More than one conductive element 236 (e.g., a wire) can extend along the inner or outer surface of the workspace expansion system and / or the elongated tubular body 110 to electrically connect each return electrode 240 to a power source. In various embodiments, the end cap 128 can include an outer dimension configured to place at least one of the return electrodes 240 in firm contact with the tissue wall of the body cavity 150. For example, when the first flexible member and the second flexible member 122, 124 move from a non-expanded insertion position to an expanded position to form an expanded area, as described above, the end cap 128 can deflect in the opposite direction within the body cavity 150, e.g., towards a portion of the tissue wall opposite the lesion 152. With the return electrodes 240 of the end cap 128 in contact with the tissue wall of the body cavity, as described above, the surgical device 130 can be advanced and placed in contact with a separate portion of the tissue wall. Then, as described above, the energy emitted from the working electrode 134 of the surgical device can be used to operate on the tissue wall of the body cavity to remove or otherwise treat (e.g., mark, cut, dissect, excise, coagulate, ablate, etc.) the tissue lesion 152.

[0034] See Figure 3, in one embodiment, the surgical system 300 of the present invention may include similar or identical features of the surgical system 100, except that at least one return electrode is disposed on or along the covering 326 that extends around (e.g., partially encloses) the workspace expansion system 120. For example, more than one first return electrode 340a may be disposed on the outer surface of the covering 326 at a first location, and more than one second return electrode 340b may be disposed on the outer surface of the covering at a second location (e.g., adjacent to the first location). In various embodiments, the first return electrode and the second return electrodes 340a, 340b may be permanently attached to (e.g., wedged, forged, colored, glued, embedded, etc.) or integrally formed with the covering 326 using suitable glues, adhesives, resins, solders, or other bonding processes known in the art. More than one conductive element 336 (e.g., a wire) may extend along the inner or outer surface of the elongated tubular body 110 to electrically connect the first return electrode and the second return electrodes 340a, 340b to a power source. In various embodiments, the covering 326 may include an outer dimension (e.g., when the workspace expansion system is in the expanded position) configured to firmly contact one or more of the first return electrode and / or the second return electrodes 340a, 340b with the tissue wall of the body cavity 150. For example, when the first flexible member and the second flexible member 122, 124 move from the non-expanded insertion position to the expanded position to form an expanded region, all or a portion of the covering 326 may be offset in the body cavity in an opposite direction, e.g., toward a portion of the tissue wall opposite the lesion 152. In one embodiment, a portion of the covering 326 opposite the first return electrode and the second return electrodes 340a, 340b may include an opening through which the surgical device 130 (and accessory tools, discussed below) may enter the body cavity 150 and / or the tissue wall of the 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 in the covering 326, and the second flexible member 124 may be disposed along or adjacent to a second side of the opening in the covering 326.

[0035] Using the first return electrode and the second return electrodes 340a, 340b on the outer surface of the covering 326 to contact the tissue wall of the body cavity 150, as described above, the surgical device 130 may be advanced and placed in contact with a separate portion of the tissue wall. Then, as described above, the energy emitted from the active electrode of the surgical device 130 may be used to manipulate the tissue wall of the body cavity to remove or otherwise treat (e.g., mark, cut, dissect, excise, coagulate, ablate, etc.) the tissue lesion 152.

[0036] See Figure 4, in one embodiment, the surgical system 400 of the present invention may include the same features as the surgical system 100, except that at least one return electrode may be disposed on or along a sleeve 450 extending around the distal portion 112 of the elongated tubular body 110. For example, the at least one return electrode may include a plurality of return electrodes 440, and the plurality of return electrodes 440 are disposed around all or part of the circumference of the outer surface of the sleeve 450 uniformly or non-uniformly. One or more conductive elements 436 may extend along the inner surface or the outer surface of the elongated tubular body 110 to electrically connect each return electrode 440 to a power source.

[0037] In various embodiments, the plurality of return electrodes 440 may be permanently attached to (e.g., wedged, forged, colored, embedded, etc.) the outer surface of the sleeve 450 or integrally formed with the outer surface of the sleeve 450 using a suitable glue, adhesive, resin, solder, or other bonding techniques known in the art. Additionally, or alternatively, the outer surface of the sleeve 450 may be formed of or include more than one conductive material such that the entire sleeve 450 may act as a return electrode. One or more conductive elements (not shown), e.g., conductive wires, may extend along the inner surface or the outer surface of the elongated tubular body 110 to electrically connect each return electrode to a power source.

[0038] In various embodiments, the sleeve 450 may include an outer dimension configured to firmly contact the tissue wall of the body cavity 150 with at least one return electrode 440. For example, as described above, when the first flexible member and the second flexible member 122, 124 move from the non-expanded insertion position to the expanded position to form an expanded region, at least a portion of the sleeve 450 may deflect in the opposite direction within the body cavity 150, e.g., towards 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 cavity 150 to place at least one return electrode 440 in firm contact with the tissue wall of the body cavity. For example, one or more inflation / deflation cavities (not shown) may travel along the inner surface or the outer surface of the elongated tubular body 110 to deliver a suitable inflation medium (e.g., normal saline, biocompatible gas, etc.) into the cavity of the sleeve 450 to move the sleeve from the first non-expanded position to the second expanded position.

[0039] With the return electrode 440 on the outer surface of the sleeve 450 in contact with the tissue wall of the body cavity 150, as discussed above, the surgical device 130 may be advanced and placed in contact with a separate portion of the tissue wall. Then, as described above, the energy emitted from the active electrode 134 of the surgical device may be used to operate on the tissue wall of the body cavity to remove or otherwise treat (e.g., mark, cut, dissect, excise, coagulate, ablate, etc.) the tissue lesion 152.

[0040] Although Figures 1A - 4 the workspace expansion system 120 is generally depicted as including a first flexible member and a second flexible member 122, 124 configured to bend, flex, or fold in a substantially "U-shaped" configuration, in various embodiments, the workspace expansion system can include a single flexible member, or more than two flexible members (e.g., more than three) configured to move into various different shapes when in a non-expanded configuration. By way of non-limiting example, such flexible members can move into a "T-shaped" configuration, an "L-shaped" configuration, a circular or oval configuration, and various symmetric or asymmetric variations thereof. Similarly, the number, arrangement, and / or orientation of return electrodes disposed on or along such flexible members is not limited to Figures 1A - 4 the configuration of, but can vary.

[0041] In various embodiments, the workspace expansion system can include proximal and distal balloons that are expandable to form an expansion region. The outer surface of one (or both) of the proximal and distal balloons can include more than one return electrode that is in electrical communication with a power source and is configured to be placed in firm contact with the tissue wall of a body cavity to facilitate electrosurgical procedures or treatment of tissue lesions (as described above). Additionally, the proximal and / or distal balloons can be expanded to provide an enlarged workspace within which more than one tool or other medical device can be operated.

[0042] See Figure 5 , in one embodiment, the surgical system 500 of the present invention can include a flexible, elongated tubular body 110 (e.g., an endoscope, a gastroscope, a colonoscope, a delivery catheter, etc.) that includes a proximal end (not shown), a distal end 114, and more than one working channel 116a-c extending therebetween. An elongated insulating sheath 550 can extend over and along all or a portion of the outer surface of the elongated tubular body 110. An expandable member 526 (e.g., a balloon, etc.) can be attached to the distal end of the insulating sheath 550 and extend distally beyond the insulating sheath 550. In various embodiments, an inflation / deflation lumen (not shown) can extend along the inner or outer surface of the insulating sheath 550 and can be configured to deliver a suitable inflation fluid / medium to an interior region of the expandable member 526. The expandable member 526 can be configured to move between a non-expanded (e.g., collapsed, delivery, etc.) insertion position and an expanded position to form an expansion region, e.g., by introducing or removing inflation fluid from an interior region of the expandable member 526. Additionally, or alternatively, the expandable member 526 can be configured to move between a non-expanded position and an expanded position using a mechanical rather than a fluid actuation mechanism, e.g., more than one expandable / collapsible arm, a collapsible / expandable frame, etc. (not shown).

[0043] The surgical device 130 (e.g., the first electrode, cutting electrode, end effector, etc.) is movably (e.g., slidably, rotatably, etc.) disposed within the first working channel 116a of the elongate tubular body 110. The surgical device 130 may include an insulated outer portion 132 and a non-insulated (e.g., conductive) active electrode portion 134. For example, the insulated outer portion 132 may extend along the length of the surgical device 130 through the first working channel 116a, and the active electrode 134 may extend through / extend within the insulated outer portion 132. The 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 inner portion of the expandable member 526.

[0044] At least one return electrode may be attached to or otherwise disposed on or along the outer surface of the expandable member 526 (e.g., integrally formed therewith, etc.). For example, at least one return electrode may include a plurality of return electrodes 540 disposed uniformly or non-uniformly around all or a portion of the circumference of the distal end of the expandable member 526. The surgical system 500 may also include a power source (not shown as above) configured to transmit or deliver energy to the surgical device 130 and electrically communicate with the plurality of return electrodes 540 as described above.

[0045] In use and by way of example, the surgical system 500 may be advanced through the patient's body cavity 150 to a site of a known or suspected tissue lesion 152 within the tissue wall of the body cavity 150 at a non-expanded insertion position. Then, the expandable member 526 may be moved to an expanded (e.g., inflated) position, thereby applying a radially outward force to at least a portion of the tissue wall of the body cavity 150 such that more than one of the plurality of return electrodes 540 makes firm contact (e.g., direct contact, close contact, etc.) with the tissue wall of the body cavity 150. In various embodiments, in addition to positioning the plurality of return electrodes 540 to make firm contact with the tissue wall of the body cavity 150, e.g., to facilitate electrosurgical procedures on the tissue lesion (discussed below), the expandable member 526 may also provide an increased working space within which more than one tool or other medical device may be operated.

[0046] By placing one or more return electrodes 540 in firm contact with the tissue wall of the body cavity 150, the surgical device 130 can be advanced within the first working channel 116a of the elongate tubular body 110 / advanced through the first working channel 116a 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 cavity 150. Since one or more return electrodes 540 of the surgical device 130 and the active electrode 134 are in contact with corresponding portions of the tissue wall of the body cavity 150, energy can be delivered from a power source to the surgical device 130. Then, as described above, the energy can be locally emitted from the active electrode 134 of the surgical device, enter and pass through a portion of the tissue wall of the body cavity 150, and be received by one or more return electrodes 540. Then, the energy can return from the plurality of return electrodes to the power source. Then, as described above, the energy emitted from the active electrode 134 of the surgical device can be used for electrosurgical operation of the tissue wall of the body cavity to remove or otherwise treat (e.g., mark, cut, dissect, excise, coagulate, ablate, etc.) the tissue lesion 152.

[0047] In various embodiments, any of the surgical systems 100, 200, 300, 400, 500 disclosed herein can operate in monopolar or bipolar mode. Specifically, the power source can include a monopolar mode or a bipolar mode. In some examples, the bipolar mode can use a lower voltage, while the monopolar mode may require a higher voltage. Since the surgical system of the present invention generally includes one or more return electrodes, typically positioned near the treatment site within the body cavity 150, e.g., at or near the lesion 152, the power density far from the treatment site may be lower than that of conventional monopolar electrosurgery, e.g., where the return electrode is positioned somewhere on the external skin of the patient, typically not close to the surgical site. By positioning one or more return electrodes near the target lesion 152, the surgical system of the present invention may have similar efficiency and effectiveness to conventional monopolar electrosurgical techniques while outputting significantly lower energy levels and having a lower risk of unnecessary thermal damage to surrounding tissue.

[0048] Furthermore, the ability of the surgical system of the present invention to reduce thermal damage by directing electrosurgical energy to the surface and subcutaneous (e.g., intraluminal) layers can enable the active electrode 134 to have a smaller size or profile, thereby providing medical professionals with more precise control when operating on, treating, or otherwise affecting the tissue of the body cavity.

[0049] In addition, the surgical system of the present invention can reduce the thermal damage to surrounding tissues by locally arranging the active electrode and the return electrode at or near the target lesion site, enabling medical professionals to perform endoluminal surgeries (such as endoscopic submucosal dissection (ESD)) at a higher energy density (e.g., joules / area) or power density (e.g., watts / area), but with a lower total energy emitted to or through the surrounding tissues. This allows medical professionals to use smaller and more precisely controlled instruments, and / or deliver more effective energy quanta to tissue lesions. For example, endoluminal surgeries that are typically performed using energy levels associated with monopolar electrosurgery can be performed using a surgical system with energy levels typically associated with bipolar electrosurgery.

[0050] In various embodiments, the elongated tubular body 110 of any one of the surgical systems 100, 200, 300, 400, 500 disclosed by the present invention can be further configured to accommodate more than one additional medical device (such as scissors, forceps, graspers, scalpels, etc.) through additional working channels (such as 116b, 116c). Additionally, or alternatively, more than one of the additional working channels can include a cavity for delivering various fluids, an imaging cavity for components of more than one image sensor, and a vacuum cavity for aspirating air, liquid, or other materials from the body cavity. Additionally, or alternatively, various additional medical tools (such as scissors, graspers, forceps, knives, needles, balls, hooks, scrapers, etc.) can pass through or extend along the outer surface of the elongated tubular body to further manipulate the tissue wall of the body cavity.

[0051] The surgical systems 100, 200, 300, 400, 500 of the present invention are not intended to be described or depicted as mutually exclusive embodiments. For example, various configurations of any one or all of the return electrodes provided on or along any one of the flexible members, covers, end caps, sleeves, and / or expandable members described herein can be combined into a single surgical system. In addition, any of the return electrodes disclosed herein can be provided on or along the corresponding flexible member, cover, end cap, sleeve, and / or expandable member of the corresponding surgical system in various different quantities, positions, sizes, shapes, patterns, and / or orientations.

[0052] Non-limiting examples of conductive materials can include flexible members, surgical devices, return electrodes, and / or conductive elements of any of the surgical systems 100, 200, 300, 400, 500 disclosed herein. The conductive materials can include stainless steel, tungsten alloy, copper, nitinol, titanium, aluminum-based materials, or other suitable conductive materials known in the art. Similarly, non-limiting examples of the insulating materials described herein can include assemblies comprising elongate tubular bodies, working space expansion systems, covers, balloons, sheaths, distal portions, end caps, and / or active electrodes of any of the surgical systems 100, 200, 300, 400, 500 disclosed herein. The insulating materials can include non-conductive thermoplastics, fluoropolymers, or synthetic rubbers, such as polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), silicone, perfluoroalkoxy polymer resin (PFA), ceramics, or any other suitable non-conductive materials.

[0053] All devices and / or methods disclosed and claimed herein according to the present invention can be made and executed without undue experimentation. While the devices and methods of the present invention have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that various changes can be applied to the devices and / or methods of the present invention and to the steps or the order of the steps of the methods of the present invention without departing from the concept, spirit, and scope of the present invention. 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 defined by the appended claims.

Claims

1. A surgical system, comprising: An elongate tubular body, which includes a proximal end, a distal end, and more than one working channel extending therebetween; A working space expansion system, which is located at the distal portion of the elongate tubular body, the working space expansion system includes a first flexible member and a second flexible member, the first flexible member and the second flexible member are capable of moving between a non-expanded insertion position and an expanded position to form an expanded area; A surgical device, which is disposed within a first working channel of the elongate tubular body; At least one return electrode, which is disposed on an outer surface of the working space expansion system; And A power source, which is configured to deliver energy to the surgical device and is in electrical communication with the at least one return electrode; Wherein a distal portion of the working space expansion system includes an end cap, and the at least one return electrode is disposed on an outer surface of the end cap; and Wherein the end cap provides a distal connection point, and distal ends of the first flexible member and the second flexible member are joined or connected at the connection point; wherein when the first flexible member and the second flexible member move to the expanded position, the end cap is configured to contact an inner wall of a body cavity to place the at least one return electrode on the outer surface of the end cap in contact with the inner wall of the body cavity.

2. The surgical system according to claim 1, wherein the surgical device includes an insulating portion and an uninsulated active electrode.

3. The surgical system according to claim 1, wherein each of the first flexible member and the second flexible member includes an insulating portion and an uninsulated portion, and wherein the at least one return electrode includes 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.

4. The surgical system according to claim 3, wherein when the first flexible member and the second flexible member move to the expanded position, the first return electrode is configured to contact an inner wall of the body cavity at a first position, and the second return electrode is configured to contact the inner wall of the body cavity at a second position.

5. The surgical system according to claim 4, wherein the surgical device is configured to contact an inner wall of the body cavity at a third position to deliver energy from the power source through a portion of the tissue of the body cavity and to the first return electrode and the second return electrode.

6. The surgical system according to any one of claims 1-2, further comprising a covering, which is disposed around a portion of the working space expansion system, wherein the at least one return electrode includes a first return electrode disposed at a first position on an outer surface of the covering, and a second return electrode disposed at a second position on an outer surface of the covering.

7. The surgical system according to claim 6, wherein when the working space expansion system moves to the expanded position, the first return electrode is configured to contact an inner wall of the body cavity at the first position, and the second return electrode is configured to contact the inner wall of the body cavity at the second position.

8. The surgical system according to claim 7, wherein the surgical device is configured to contact an inner wall of the body cavity at a third position to deliver energy from the power source through a portion of the tissue of the body cavity and to the first return electrode and the second return electrode.

9. The surgical system according to any one of claims 1-2, further comprising a sleeve disposed around a distal portion of the elongated tubular body, and wherein the at least one return electrode is disposed on an outer surface of the sleeve.

10. The surgical system according to claim 9, wherein when the workspace expansion system moves to the expanded position, the at least one return electrode is configured to contact an inner wall of the body cavity at a first position.

11. The surgical system according to claim 10, wherein the surgical device is configured to contact an inner wall of the body cavity at a second position to deliver energy from the power source through a portion of the tissue of the body cavity and to the at least one return electrode.

12. The surgical system according to claim 5, wherein the energy delivered from the surgical device affects the tissue of the body cavity.

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