Resection cap

Abstract

An attachment to be fitted to a flexible endoscope is provided. The attachment, or resection cap, can be positioned at the end of an endoscope to create traction and improve visualization. An electrode or cutting wire allows for the resection of a target tissue plane using electrosurgical energy and is designed to interact with the cap to create cutting zones and insulated zones. A conductive coupling element that is capable of interfacing with a catheter passed through an endoscope to transmit electricity to the electrode. The coupling element is designed so that it may be electrically connected and disconnected interprocedurally without removing the scope, and it does not impede use of other instruments through the scope. A coupling catheter that conducts electricity to the resection cap and can deliver fluid to the resection site is additionally provided.

Description

PATENTDocket No: Cl 124RESECTION CAPBACKGROUND1. FIELD

[0001] The present disclosure relates generally surgical devices and systems and, more specifically to a tissue traction and resection device and / or system for use during interventional endoscopic procedures to remove targeted high risk or cancerous lesions from the gastrointestinal (GI) tract.2. DESCRIPTION OF THE RELATED ART

[0001] Endoscopic Submucosal Dissection (ESD) and Endoscopic Mucosal Resection (EMR) are the two most popular procedures to accomplish polyp or lesion removal today. Smaller pedunculated, or raised, polyps can be removed using standard polypectomy snares. Endoscopic Full Thickness Resection (EFTR) and more recently Submucosal Tunnelling Endoscopic Resection (STER) are evolving and rapidly growing procedures that are also being used to remove lesions.

[0002] Description of the Related Art Section Disclaimer: To the extent that specific patents / publications / products are discussed above in this Description of the Related Art Section or elsewhere in this disclosure, these discussions should not be taken as an admission that the discussed patents / publications / products are prior art for patent law purposes. For example, some or all of the discussed patents / publications / products may not be sufficiently early in time, may not reflect subject matter developed early enough in time and / or may not be sufficiently enabling so as to amount to prior art for patent law purposes. To the extent that specific patents / publications / products are discussed above in this Description of the Related Art Section and / or throughout the application, the descriptions / disclosures of which are all hereby incorporated by reference into this document in their respective entirety(ies).BRIEF SUMMARY

[0003] The inventors recognize that current resection techniques such as ESD and STER can be extremely technically challenging and require a high level of proficiency in scope manipulation, as well as deep experience with these types of pathologies and their local anatomical122101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 interaction. For instance, the manipulation of a flexible endoscope with limited realty and a single working channel, the manipulation of a conventional device with a constantly moving target site, the lack out countertraction on tissue while cutting, and the manipulation of the device without perforating the GI tract; visualization of the margins (especially depth of invasion) of healthy and unhealthy tissue in the submucosa and mucosa; the visualization and selection of a resection plane and perimeter to ensure healthy margins for pathology of curative resection; speed of the resection and procedure (which is approximately 10 cm2 / hour, currently); and ease of the resection (current guidelines recommend a high number of procedures per year to maintain proficiency) are common challenges faced by physicians using current resection techniques. Thus, there is a need for a device that can improve physicians’ abilities to safely conduct these procedures in less time.

[0004] It is therefore a principal object and advantage of embodiments of the present disclosure to provide a resection cap device that eliminates one or more of the problems / issues / deficiencies associated with conventional resection procedures. In particular, the present disclosure is directed to inventive resection cap device embodiments structured and / or configured to improve the ease and speed with which tissue can be resected in the GI tract, for example, especially in cases of resections involving the submucosa and muscularis. The resection cap device can accomplish this by increasing the size of the cutting electrode available to the physician (e.g., from 1.5-4 mm to 6-12 mm), allowing for a larger resection area; coupling the electrode movement directly to the movement of the scope, leading to direct response between scope movement and cutting zone; and introducing a gap between the tissue bed and the cutting electrode using a non-conductive “runner” or sled, offering an insulative barrier in all directions surrounding the electrode. The runners can be designed to prevent more rigid tissue from coming into contact with the electrode while allowing more flexibility tissue to contact said electrode. In addition, the device can allow for the direct visualization of the resection plane; provide an electrode that preferentially delivers more energy in one direction than in other directions; and create traction or tension in the resection plane by a non-conductive cap / hood.

[0005] According to an embodiment, the resection cap device is an attachment to be fitted to a flexible endoscope including a resection cap, or external attachment to the distal end of the endoscope to create traction and improve visualization; an electrode, or cutting wire, that allows for the resection of a target tissue plane using electrosurgical energy and is designed to interact222101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 with the cap to create cutting zones and insulated zones; a conductive coupling element that is capable of interfacing with a catheter passed through an endoscope to transmit electricity to the electrode - the coupling element designed to be electrically connected and disconnected interprocedurally without removing the scope, preventing the impediment of use of other instruments through the scope; and a coupling catheter that conducts electricity to the resection cap and can deliver fluid to the resection site.

[0006] According to a preferred embodiment, the resection cap device is an angled, at least partially substantially circular, and distally extending attachment designed to rigidly attach to the end of an endoscope and extend along the central longitudinal axis of the endoscope. The cap can be designed to apply force to the surrounding tissue, especially to create vertical separation in the cross section of the tissue being resected. An electrode attached to the cap can extend in a substantially perpendicular direction to the central longitudinal axis of the endoscope.

[0007] According to another preferred embodiment, the resection cap device can include a coupling element that may be used to couple to a coupling catheter to provide electricity to the electrode. The coupling element can be oriented such that it aligns with an instrument being passed through a working channel of the endoscope. In this embodiment, the coupling element is able to deflect with a small amount of force, allowing instruments to pass through the scope and be used in a typical fashion (i.e., injection needles, knives, snares, clips, etc.).

[0008] In some embodiments, the resection cap can be energized by a coupling catheter that is passed through the channel of the endoscope. In this embodiment, the catheter can be easily attached and detached from the resection cap to allow for normal use of the working channel. In a preferred embodiment, the catheter can minimally function as an electrical conduit and have the ability to deliver fluid to the resection site. In an alternative embodiment, the coupling catheter can allow for coagulation, injection, or alternate resection techniques.

[0009] The resection cap device offers several advantages over alternate designs, including faster resection times, built-in tissue traction, direct control of the electrode using the scope (electrode is fixed relative to the scope and moves precisely when the scope moves), resection perpendicular to the axis of the scope, which is useful during POEM entry, ESD circumferential incision, and provides an insulative barrier that helps to protected from perforation without completely eliminating cutting along the axis of the scope.322101696.V1-8 / 14 / 25PATENTDocket No: Cl 124

[0010] These and other aspects of the disclosure will be apparent from and elucidated with reference to the embodiment s) described hereinafter.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0011] The present disclosure will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings. The accompanying drawings illustrate only typical embodiments of the disclosed subject matter and are therefore not to be considered limiting of its scope, for the disclosed subject matter may admit to other equally effective embodiments. Reference is now made briefly to the accompanying drawings, in which:

[0012] FIG. 1 A is a close-up perspective view of the resection cap device according to an embodiment of the present disclosure.

[0013] FIG. IB is a perspective view of an electrode according to an embodiment of the present disclosure.

[0014] FIG. 1C is a top view of the resection cap device according to an embodiment of the present disclosure.

[0015] FIG. ID is a section view of the resection cap device according to an embodiment of the present disclosure.

[0016] FIG. 2A depicts a first exemplary spacing relationship of the electrode and insulative runners according to an embodiment of the present disclosure.

[0017] FIG. 2B depicts a second exemplary spacing relationship of the electrode and insulative runners according to an embodiment of the present disclosure.

[0018] FIG. 2C depicts a third exemplary spacing relationship of the electrode and insulative runners according to an embodiment of the present disclosure.

[0019] FIG. 3 A is a side view of the resection cap device according to an embodiment of the present disclosure.

[0020] FIG. 3B is a bottom view of the resection cap device according to an embodiment of the present disclosure.422101696.V1-8 / 14 / 25PATENTDocket No: Cl 124

[0021] FIG. 4A shows an exemplary geometry of the resection cap device according to an embodiment of the present disclosure.

[0022] FIG. 4B shows another exemplary geometry of the resection cap device according to an embodiment of the present disclosure.

[0023] FIG. 4C shows another exemplary geometry of the resection cap device according to an embodiment of the present disclosure.

[0024] FIG. 4D shows another exemplary geometry of the resection cap device according to an embodiment of the present disclosure.

[0025] FIG. 4E shows another exemplary geometry of the resection cap device according to an embodiment of the present disclosure.

[0026] FIG. 4F shows another exemplary geometry of the resection cap device according to an embodiment of the present disclosure.

[0027] FIG. 5A is a schematic representation of how the geometry of the resection cap device shown in FIG. 4A affects the submucosal layer according to an embodiment of the present disclosure.

[0028] FIG. 5B is a schematic representation of how the geometry of the resection cap device shown in FIG. 4B affects the submucosal layer according to an embodiment of the present disclosure.

[0029] FIG. 5C is a schematic representation of how the geometry of the resection cap device shown in FIG. 4C affects the submucosal layer according to an embodiment of the present disclosure.

[0030] FIG. 5D is a schematic representation of how the geometry of the resection cap device shown in FIG. 4D affects the submucosal layer according to an embodiment of the present disclosure.

[0031] FIG. 5E is a schematic representation of how the geometry of the resection cap device shown in FIG. 4E affects the submucosal layer according to an embodiment of the present disclosure.522101696.V1-8 / 14 / 25PATENTDocket No: Cl 124

[0032] FIG. 5F is a schematic representation of how the geometry of the resection cap device shown in FIG. 4F affects the submucosal layer according to an embodiment of the present disclosure.

[0033] FIG. 6A is a perspective view of the resection cap device being pushed against the muscularis according to an embodiment of the present disclosure.

[0034] FIG. 6B is a perspective view of the resection cap device in an inverted anterior entry position relative to the muscularis according to an embodiment of the present disclosure.

[0035] FIG. 7A depicts a rotational position of the cutting wire according to an embodiment of the present disclosure.

[0036] FIG. 7B depicts another rotational position of the cutting wire according to an embodiment of the present disclosure.

[0037] FIG. 7C depicts another rotational position of the cutting wire according to an embodiment of the present disclosure.

[0038] FIG. 8 A is a perspective view of the cap of the resection cap device according to an embodiment of the present disclosure.

[0039] FIG. 8B is a perspective view of the anti-rotational feature of the cap according to an embodiment of the present disclosure.

[0040] FIG. 8C is a side view of the scope stop and proximal taper of the resection cap device according to an embodiment of the present disclosure.

[0041] FIG. 8D is a rear view of the cap of the resection cap device according to an embodiment of the present disclosure.

[0042] FIG. 8E is a close-up view of an alternate proximal attachment feature according to an embodiment of the present disclosure.

[0043] FIG. 8F is a perspective view of smother alternate proximal attachment feature according to an embodiment of the present disclosure.

[0044] FIG. 9A is a perspective view of an insulative runner of the resection cap device according to an embodiment of the present disclosure.622101696.V1-8 / 14 / 25PATENTDocket No: Cl 124

[0045] FIG. 9B is a close-up view of an insulative runner of the resection cap device according to an embodiment of the present disclosure.

[0046] FIG. 9C is a side view of an insulative runner of the resection cap device according to an embodiment of the present disclosure.

[0047] FIG. 9D is a close-up perspective view of the insulative runner of the resection cap device according to an embodiment of the present disclosure.

[0048] FIG. 10A is a close-up view of the electrode of the resection cap device according to an embodiment of the present disclosure.

[0049] FIG. 10B depicts the temperature induced in tissue directly adjacent to different portions of the electrode when subjected to a high voltage according to an embodiment of the present disclosure.

[0050] FIG. 10C depicts the temperature induced in tissue directly adjacent to different portions of the electrode when subjected to a high voltage according to an embodiment of the present disclosure.

[0051] FIG. 10D depicts varying widths and thicknesses of the cutting and coagulating surfaces according to an embodiment of the present disclosure.

[0052] FIG. 12A depicts a configuration of an electrode of the resection cap device according to an embodiment of the present disclosure.

[0053] FIG. 12B depicts another configuration of an electrode of the resection cap device according to an embodiment of the present disclosure.

[0054] FIG. 12C depicts a chart showing the knife-edge average temperature for two configurations according to an embodiment of the present disclosure.

[0055] FIG. 12D depicts a chart showing the knife-edge average temperature for two additional configurations according to an embodiment of the present disclosure.

[0056] FIG. 12E is a schematic representation showing the width, thickness, and radius of an electrode, according to an embodiment of the present disclosure.722101696.V1-8 / 14 / 25PATENTDocket No: Cl 124

[0057] FIG. 12F depicts the knife-edge average temperature for various configurations and their corresponding dimensions according to an embodiment of the present disclosure.

[0058] FIG. 12G depicts temperatures of various configurations according to an embodiment of the present disclosure.

[0059] FIG. 13 depicts a simulated thermal map and current density gradient in tissue according to an embodiment of the present disclosure.

[0060] FIG. 14A depicts a chart detailing the ratio of center to radii temperature for various configurations according to an embodiment of the present disclosure.

[0061] FIG. 14B depicts the temperature contour of a configuration of the electrode of the resection cap according to an embodiment of the present disclosure.

[0062] FIG. 14C depicts the temperature contour of another configuration of the electrode of the resection cap according to an embodiment of the present disclosure.

[0063] FIG. 14D depicts the temperature contour of another configuration of the electrode of the resection cap according to an embodiment of the present disclosure.

[0064] FIG. 14E depicts a chart detailing various shapes of the electrode and the corresponding temperatures according to an embodiment of the present disclosure.

[0065] FIG. 14F depicts the temperature contour of another configuration of the electrode of the resection cap according to an embodiment of the present disclosure.

[0066] FIG. 14G depicts the temperature contour of another configuration of the electrode of the resection cap according to an embodiment of the present disclosure.

[0067] FIG. 15 A depicts a chart detailing the temperatures of the electrodes of various configurations according to an embodiment of the present disclosure.

[0068] FIG. 15B depicts a triangular cross sectional view of a configuration of an electrode of the resection cap device according to an embodiment of the present disclosure.

[0069] FIG. 15C depicts another triangular cross sectional view of a configuration of an electrode of the resection cap device according to an embodiment of the present disclosure.822101696.V1-8 / 14 / 25PATENTDocket No: Cl 124

[0070] FIG. 16A depicts the proximal electrode edge of the resection cap device according to an embodiment of the present disclosure.

[0071] FIG. 16B depicts energy being directed more distally in the resection plane according to an embodiment of the present disclosure.

[0072] FIG. 17A is a perspective view of the electrode assembly according to an embodiment of the present disclosure.

[0073] FIG. 17B depicts a form of a coupling feature according to an embodiment of the present disclosure.

[0074] FIG. 17C depicts an alternate form of a coupling feature according to an embodiment of the present disclosure.

[0075] FIG. 17D depicts an alternate form of a coupling feature according to an embodiment of the present disclosure.

[0076] FIG. 17E depicts an alternate form of a coupling feature according to an embodiment of the present disclosure.

[0077] FIG. 17F is a close-up view of the resection cap device according to an embodiment of the present disclosure.

[0078] FIG. 17G is a perspective view of the resection cap device according to an embodiment of the present disclosure.

[0079] FIG. 17H depicts the electrode, coupling element, and connecting member combing into a single wire-form component according to an embodiment of the present disclosure.

[0080] FIG. 18A is a perspective view of the resection cap device according to an alternative embodiment of the present disclosure.

[0081] FIG. 18B is a side view of the resection cap device according to an alternative embodiment of the present disclosure.

[0082] FIG. 18C is a top view of the resection cap device according to an embodiment of the present disclosure.922101696.V1-8 / 14 / 25PATENTDocket No: Cl 124

[0083] FIG. 19A is a perspective view of the resection cap device according to an alternative embodiment of the present disclosure.

[0084] FIG. 19B is a side view of the resection cap device according to an alternative embodiment of the present disclosure.

[0085] FIG. 19C is a top view of the resection cap device according to an embodiment of the present disclosure.

[0086] FIG. 20A is a perspective view of the resection cap device according to an alternative embodiment of the present disclosure.

[0087] FIG. 20B is a side view of the resection cap device according to an alternative embodiment of the present disclosure.

[0088] FIG. 20C is a top view of the resection cap device according to an embodiment of the present disclosure.

[0089] FIG. 21 A is a perspective view of the resection cap device according to an alternative embodiment of the present disclosure.

[0090] FIG. 21B is a side view of the resection cap device according to an alternative embodiment of the present disclosure.

[0091] FIG. 21 C is a top view of the resection cap device according to an embodiment of the present disclosure.

[0092] FIG. 22A is a perspective view of the resection cap device according to an alternative embodiment of the present disclosure.

[0093] FIG. 22B is another perspective view of the resection cap device according to an alternative embodiment of the present disclosure.

[0094] FIG. 22C is another perspective view of the resection cap device according to an alternative embodiment of the present disclosure.

[0095] FIG. 22D is another perspective view of the resection cap device according to an alternative embodiment of the present disclosure.1022101696.V1-8 / 14 / 25PATENTDocket No: Cl 124

[0096] FIG. 22E is another perspective view of the resection cap device according to an alternative embodiment of the present disclosure.

[0097] FIG. 22F is another perspective view of the resection cap device according to an alternative embodiment of the present disclosure.

[0098] FIG. 22G is a rear perspective view of the resection cap device according to an alternative embodiment of the present disclosure.

[0099] FIG. 23 A is a perspective view of a coupling catheter according to an aspect of the present disclosure.

[0100] FIG. 23B is a rear view of a flushing tip of a coupling catheter according to an aspect of the present disclosure.

[0101] FIG. 23 C is a cross-sectional view of the coupling feature of the resection cap device according to an aspect of the present disclosure.

[0102] FIG. 23D is a perspective view of the coupling catheter in the closed state in communication with the resection cap according to an aspect of the present disclosure.

[0103] FIG. 23E depicts the flushing tip in the flushing state inside of a cavity according to an aspect of the present disclosure.

[0104] FIG. 23F depicts a schematic representation of the flushing tip in the flushing state according to an aspect of the present disclosure.

[0105] FIG. 23 G depicts the various stages of the coupling catheter according to an aspect of the present disclosure.

[0106] FIG. 24A is a front view of the coupling catheter according to an aspect of the present disclosure.

[0107] FIG. 24B is a close-up view of the conductive hook according to an aspect of the present disclosure.

[0108] FIG. 24C is a close-up view of a conductive electrode according to an aspect of the present disclosure.1122101696.V1-8 / 14 / 25PATENTDocket No: Cl 124

[0109] FIG. 24D is another close-up view of a conductive electrode according to an aspect of the present disclosure.

[0110] FIG. 24E is a close-up view of the conductive electrode in the open state according to an aspect of the present disclosure.

[0111] FIG. 24F is another close-up view of the conductive electrode according to an aspect of the present disclosure.

[0112] FIG. 25A depicts an isometric view of a cap positioned on a distal end of an endoscope according to an alternative embodiment of the present disclosure.

[0113] FIG. 25B depicts a top-down view of the cap shown in FIG. 25A according to an alternative embodiment of the present disclosure.

[0114] FIG. 26 depicts the cap positioned on the endoscope in gel according to an alternative embodiment of the present disclosure.

[0115] FIG. 27A depicts an isometric view of the cap positioned on the endoscope according to an alternative embodiment of the present disclosure.

[0116] FIG. 27B depicts an isometric view of the cap positioned on the endoscope according to an alternative embodiment of the present disclosure.

[0117] FIG. 27C depicts a perspective view of the cap positioned on an endoscope according to an alternative embodiment of the present disclosure.

[0118] FIG. 28 depicts a perspective view of the coupling mechanism of the cap according to an alternative embodiment of the present disclosure.

[0119] FIG. 29 depicts a schematic representation of the various skin layers.DETAILED DESCRIPTION

[0120] Aspects of the present disclosure and certain features, advantages, and details thereof, are explained more fully below with reference to the non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures are omitted so as not to unnecessarily obscure the disclosure in detail. It should be understood, however, that the detailed description and the specific non-limiting examples, while indicating aspects of the disclosure, are1222101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 given by way of illustration only, and are not by way of limitation. Various substitutions, modifications, additions, and / or arrangements, within the spirit and / or scope of the underlying inventive concepts will be apparent to those skilled in the art from this disclosure.

[0121] While embodiments of the present disclosure have been particularly shown and described with reference to certain exemplary embodiments, it will be understood by one skilled in the art that various changes in detail may be affected therein without departing from the spirit and scope of the disclosure as defined by claims that can be supported by the written description and drawings. Further, where exemplary embodiments are described with reference to a certain number of elements it will be understood that the exemplary embodiments can be practiced utilizing either less than or more than the certain number of elements. If elements shown in a particular Figure discussed below are not specifically identified with respect to that Figure, the elements should be sufficiently identified with respect to at least one other Figure.

[0122] This disclosure includes embodiments that focus on tissue traction and resection during interventional endoscopic procedures to remove targeted high risk or cancerous legions from the GI tract. It is targeted towards ESD and STER procedures but could also be used for EMR and polypectomy procedures (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). Referring now to the figures, wherein like reference numerals refer to like parts throughout, FIGS. 1 A-1D show the resection cap device that can be attached and detached from the tip of an endoscope, such as a flexible endoscope. The resection cap can further include a proximal portion that interfaces with the endoscope to retain the cap in position, a distal portion that extends distally from the scope to effect cutting and traction, a cutting element within the distal portion, extending substantially perpendicular to the axis of the endoscope, and an insulative element, or runners, that can create separation between adjacent tissue and the cutting element.

[0123] Referring specifically to FIG. 1 A, the resection cap can include an electrode 3 that can pass current to adjacent tissue, insulative runners 2 that can house the electrode 3, a coupling element 4 that can facilitate electrical transmission from a delivery catheter, and a cap 1 that is connected to the insulative runners 2 and facilitates coupling to an endoscope 6.

[0124] Referring to FIG. IB, the electrode 3 can be mechanically and electrically connected to the coupling element 4 via a connecting member 5.1322101696.V1-8 / 14 / 25PATENTDocket No: Cl 124

[0125] Referring to FIG. 1C, electrode 3 can be spaced proximally from the distal end and vertically from the base of insulative runners 2. According to an embodiment, the coupling element 4 can be spaced distally from the end of the endoscope 6, but proximally from electrode 3.

[0126] Referring to FIG. ID, electrode 3 can also be spaced from the front face of the cap 1 and in non-contacting relation to cap 1. This is advantageous because the insulative runners 2 can have a low thermal conductivity and high melting / degradation point, while the cap 1 is optimally made of a flexible polymer or elastomer with some degree of optical transparency. The dies of electrode 3, connecting member 5, and base of coupling element 4 can be embedded in the insulated runners 2, which can be preferably insert molded for ease of manufacture and to limit electrically conductive elements from exposure outside of the intended cutting region.

[0127] Referring to FIGS. 2A-2C, several different spacing relationships between electrode 3 and insulative runners 2 are shown. The insulative spacing 7 is defined as the minimum normal distance between the outer surface of the electrode and a corresponding parallel surface coincident with the outer surfaces of the insulative runners 2 at a given point. Put simply, the insulative spacing 7 is how far electrode 6 is spaced proximally from the end of the insulative runners 2. There is an inverse relationship between insulative spacing 7 and cutting speed. There is a direct positive relationship between insulative spacing and protection of the surrounding tissue from exposure to electrosurgical energy. It is posited that according to one embodiment, an optimal insulation spacing 7 is a measurement between and including 0.5mm and 2.0mm, and may vary depending on the targeted tissue being resected and level of submucosal “lift” in a given scenario. Importantly, the insulative spacing 7 may vary depending on the direction from the electrode. Referring to FIG. 2B, the arrow shows an axially oriented spacing and a ‘vertically’ oriented spacing. In typical use, the axially oriented component of 7 can primarily affect cut speed (since it is aligned with the narrow front face of electrode 3, discussed later) and the vertically oriented component of 7 can affect the height of the resection plane. Electrode 3 dissects by delivering electrosurgical currents to the tissue; the shape and tissue effect induced by 3 are discussed further below.

[0128] Referring to FIGS. 3A-3B, the shape of the resection cap is angled to transmit force to the tissue along a non-axial vector during forward movement of the scope. The degree of the lead-in angle 10 and taper angle 9 will dictate the proportions of force in the horizontal and vertical1422101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 directions with respect to the tissue directly in front of the resection cap. The top curvature 8 encourages tissue to slide over the cap and onto the scope 6. It can be preferred that the configuration will balance creating tension in the dissection plane (perpendicular to the axis of the endoscope) and axial pressure on the tissue in contact with the distal portion of insulative runners 2. Importantly, the insulative runners 2 have little ability to dissect via direct forward pressure as front curvature 11 is not ‘sharp’ enough to pierce through the muscular or serosal layer of the GI tract. Instead, the overall tapered form (1+2) of the resection cap stretches tissue up and over the cap 1. This stretching leads to I) tension in the tissue fibers directly in front of the electrode and II) possible delamination of the tissue fibers. In failure mechanics, delamination typically occurs between materials of different stiffness or orientation, as is the case between the muscularis (stiff) and submucosa (more flexible). If enough forward force is exerted on the tissue via the resection cap, the tension induced in the submucosal layer from the non-axial forces generated by insulative runners 2 and cap 1 may lead to delamination between the submucosal fibers and muscularis fibers. However, the intent of the resection cap is to cut the tissue electrosurgically, so although the cap 1 and insulative runners 2 may create some delamination independently, an energized electrode 3 is critical to the resection cap’s function. See FIG. 29 for a detailed depiction of the various layers.

[0129] Still referring to FIGS. 3A-3B, insulative runners 2 can also be tapered inwards or converging slightly towards the central longitudinal axis (A- A) of scope 6. This width-taper 14 further aids in creating tension in the resection plane and encourages smooth forward motion of the scope 6 along the direction of resection. It prevents either side of insulative runners 2 from diverging or dragging in the tissue. In addition, it creates tactile feedback to the physician by way of a resistive force required to deform the tissue from cutting width 13 to maximum width 15. This horizontal deformation is largely elastic and lets the physician advance scope 6 in a controlled motion without skipping or lurching with each pulse of cutting current from the generator. Finally, it ensures that the full cutting width 13 is within the view of the camera.

[0130] Referring to FIGS. 4A-4F, many geometries can be created by varying top curvature 8, taper angle 9, lead-in angle 10, and front curvature 11, and how varying these elements could adjust the shape of the cap and therefore the mechanical interaction and electrode positioning with the tissue. It is posited that according to one embodiment, optimal values for lead-in angle (L) 10 and taper angle (T) 9 can be between and include about 25 and 60 degrees with respect to the axis1522101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 of the scope (where R refers to front runner radius). As shown, the lead-in angle 9 is at a steeper inclination or slope than lead-in angle 10. Additionally, a base angle 12 may be advantageous to target specific resection planes within the GI tract. POEM (per oral endoscopic myotomy) is a particular procedure in which base angle 12 can help centralize electrode 3 between the muscularis and the mucosa, especially in the case of an anterior tunnel. Base angle 12 can also help the resection cap during oblique entry into the tissue, as it positions the base of insulative runners 2 more substantially parallel to the layer of the muscularis despite a non-parallel entry angle of the scope. Front curvature 11 is typically an arc with a radius, although it could be a non-circular curve. A larger radius of front curvature 11 leads to a blunter form of insulative runners 11 that will limit the local deformation of tissue around the runner. The local deformation of the tissue around the runners (proximally inward) can bring the cutting wire into contact with tissue. For substantially rigid tissues (thick muscularis, serosa) the increased stiffness can prevent the insulative runners 2 from embedding deeply into the tissue wall, thus limiting the ability of the electrode 3 to be brought into sufficient proximity with those tissues to electrosurgically dissect them. FIGS. 5A-5F provide an illustration of how varying values of 9, 10, and 11 can affect the amount of submucosa and muscularis allowed to enter the insulative envelope.

[0131] Referring to FIGS. 5A-5F, smaller radii of front curvature 11 and lower lead-in angle 10 and taper angle 9 can offer less of a ‘tent’ effect when pushed against the muscularis, bringing more of the submucosa into the insulative envelope and in contact with electrode 3. Blunter ends can lead to less tissue contact with the electrode and thus slower cutting, though likely with a decreased risk of perforation. It is posited that the radius of front curvature 11 can preferably be between and include about 0.04” inches and 0.15” inches, depending on the tissue type being resected and the desired cutting speed.

[0132] Referring again to FIGS. 4A-4F, thicker, tougher tissues like that of the stomach can benefit from a smaller radius of front curvature 11 and more aggressive lead-in angle 10 and taper angle 9 resulting in forms like 21 and 22. Thinner, more delicate anatomies (such as the esophagus and colon) can benefit from larger radius of front curvature 11 and more gradual lead- in and taper angles resulting in forms like 17 and 19. Forms like 18 which mix smaller front curvatures 11 with more gradual values of 9 and 10 may be useful in niche scenarios such as1622101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 resections in the cardia or GEJ as they offer a sharper front profile for entry but maintain a short overall cap length for maneuverability.

[0133] Balanced forms like 20 might be beneficial for training, or for non-standard resection approaches such as inverted anterior entry (see FIG. 6B). Inverted entry as pictured in FIG. 6B differs from traditional entry as pictured in FIG. 6A in that insulative runners 2 are oriented towards the mucosal side and the cap 1 is oriented towards the submucosa. This can be beneficial in difficult entry situations as the overhang created by insulative runners 2 can be used as a “hood” to lift the mucosal flap and enter the initial incision, exposing the submucosal space for further resection. The physician may or may not re-orient the resection cap to a traditional position before continuing the submucosal resection, depending on the anatomy at hand.

[0134] Referring to FIGS. 7A-7C, physicians may choose to rotate the resection cap around the central axis of the scope 6 such that the cutting wire 3 is oriented between and can include about -45 and 90 degrees relative to the horizontal plane or central longitudinal axis of the camera. Due to the bias of the working channel towards one side of the scope axis, the resection cap is designed such that it may be rotated so that a perpendicular line extending radially outward from the center-point of the cutting wire 3 can transect any clock positions between and including 4:30 and 9:00 o’clock with respect to the camera’s view (looking along the axis of the scope in a distal direction). In some embodiments, the resection cap is rotatable about an axis of the endoscope. In some embodiments, the cap 1 portion of the resection cap connects to the scope via a compression / friction fit, and thus may be adjusted interprocedurally to meet the physician’s needs. It might be useful to rotate the cutting wire 3 during a circumferential mucosal resection, for example, to position one insulative runner 2 in the submucosal plane while the other rides along the mucosal surface.

[0135] Referring to FIG. 8A, in accordance with an embodiment, cap 1 can include a distal housing 24, proximal attachment feature 26, transition loft 28, distal housing apex 27, forward aperture 25, and mating slots 23. The distal housing 24 in combination with insulative runners 2 creates the angles described in FIGS. 3A-4F, for example. Referring to FIGS. 8B-8D, the cap 1 can be further defined by optional anti-rotation feature 29, scope-stop 37, proximal taper 30, cap base 36, face curvature 32, and connecting features 31. In some embodiments, the distal housing 24 can be substantially transparent and allow the physician to visualize the surrounding anatomy.1722101696.V1-8 / 14 / 25PATENTDocket No: Cl 124Front aperture 25 can offer a clear view of the resection site and allow exchange and use of common endoscopic tools through the working channel of scope 6. It is critical for the physician to have a sufficiently clear view of the resection site to properly identify resection direction, blood vessels, and tissue layers. Distal housing apex 27 allows tissue to pass over the cap unimpeded and is the intersection of top curvature 8 and front curvature 32. Front curvature 32 forms a smooth transition between the distal facing surface of distal housing 24 and the radially oriented surface of distal housing 24. In the embodiment shown in FIG. 8A, distal housing apex 27 can include a V-shaped cutout to avoid creating an overhang that could trap a mucosal flap within forward aperture 25. In alternate embodiments such as FIG. 20A, distal housing apex 27 may extend downwards over at least a portion of the scope face to create a partial front face to cap 1. This design can be used to lift a mucosal flap out of the way further from the face of the scope than the previous design, but at the cost of increased risk of flap entrapment should the flap not make it over the distal most edge of 27.

[0136] Referring again to FIG. 8A, mating slots 23 interface with corresponding geometry on insulative runners 2 to hold the runners 2 in place in relation to cap 1. Mating slots 23 can prevent horizontal displacement of the runners and ensure a smooth transition between the outer surfaces of 2 and 1. In this embodiment, the slots are shown as stepped L-shaped tracks for ease of molding, although they could feasibly be constructed using a traditional groove or dovetail design for added mechanical stability. Optional connecting features 31 can further locate insulative runners 2 by way of interconnecting apertures and posts that mechanically resist vertical displacement between the runners 2 and cutting wire 3. It is contemplated that insulative runners 2 may be joined to cap 1 by several traditional methods, including ultrasonic welding, adhesive, over molding, heat staking, etc. It is important to note that cap 1 and insulative runners 2 are two distinctive design elements requiring separate material and mechanical properties. It can be preferred that cap 1 has good flexural strength, elongation, and optical clarity. Polycarbonate, Acrylic, Polypropylene or ABS are all contemplated materials for the cap 1, although many more materials could be used if they meet the aforementioned requirements. It is conceivable that a material such as moldable fluoropolymer or silicone might achieve both the optical clarity and temperature resistance required by the cap 1 and insulative runners 2, respectively. If such a material were selected, the walls of insulative runners 2 and distal housing 24 can be thickened to1822101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 maintain a rigid support structure for electrode 7 relative to the intentionally flexible proximal attachment feature 26.

[0137] Proximal attachment feature 26 can take several different forms but it is preferred that it minimally: A) Align the cap to the axis of scope 6, B) Space the cutting wire 3 a specified distance from the scope 6 tip, and C) Resist unwanted motion between the scope 6 and resection cap during the procedure. Referring again to FIGS. 8A-8D, proximal attachment feature 26 is configured as a C-shaped spring that expands to accept scope 6. The spring can function similarly to a shaft collar, providing radial compression and securing the cap 1 to the scope via friction. The inner diameter of 26 can be tapered to match the outer profile of scope 6. As the C-shaped spring expands to accept the scope tip, scope stop 37 does not expand and therefore cannot accept the tip of scope 6. When the cap is correctly attached to the scope, a proximal face of scope stop 37 is coincident with a small portion of the distal face of scope 6. Scope stop 36 could be a flat face, an internal ring, at least one internal protrusion, or anything that creates an aperture smaller than the distalmost cross section of the scope or misaligns the aperture slightly from the front cross section of the scope. Given, for example, a rubber-like outer surface of scope 6, the friction from the spring of proximal attachment feature 26 ca be sufficient to prevent unwanted rotation. The narrow gap between the two spring “arms” of 26 expands as scope 6 is accepted, and the lack of compression on this region of the outer diameter may create a small abutment with the edges of the spring arms. An optional anti-rotation feature 29 could be added in the form of internal ridges or notches on the ID of 26, but it is not necessary with sufficient compression and might complicate the physician’s ability to rotate the cap interprocedurally.

[0138] Proximal taper 30 can create a gradual transition from the outer diameter of the scope 6 to the maximum width 15 of cap 1. Transition loft 28 can create a smooth surface between the substantially circular proximal attachment feature 26 and the substantially flat cap base 36. The insulative runners 2 can create a substantially flat region of tissue between them, and cap base 36 can match the mating geometry of the proximal portion of 2. The flat geometry applies some tension to the tissue plane post resection, exposing the resected muscularis / submucosa for inspection, especially to inspect margins or vasculature.

[0139] Referring to FIG. 8E, an alternate proximal attachment feature 26 is disclosed. In this configuration, cantilever arms 33 deflect outwards to accept scope 6. Each arm 33 can have a1922101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 retention notch 35 that is shaped to apply more axial resistance when removing the resection cap than when installing it. A triangular tab is one such arrangement, although additional mechanisms are contemplated. Flange recession groove 34 prevents the end of outwardly deflecting arm 33 from extending radially outwards past the interpolated angle of proximal taper 30, thus reducing the risk of catching / scraping during proximal motion of the scope within the GI tract. Scope stop 37 takes the form of at least a portion of an annular ring in this configuration.

[0140] Referring to FIG. 8F, another alternate proximal attachment feature 26 is disclosed. In this configuration, 26 is comprised of a closed cylinder that expands to accept scope 6. To accommodate slight variations in scope tip geometry, it can likely be preferrable to use a much softer material with low compression set such as an elastomer. Urethane and silicone are both contemplated materials, although silicone presents bonding challenges despite its advantageous temperature resistance. The abutment of the tip of scope 6 on scope stop 37 can help to stabilize the cap in this configuration.

[0141] Referring to FIG. 9A, insulative runner 2 can include a base portion 39, inner electrode insulation 38, and corresponding mating slot 40. Base portion 39 can rigidly connect the two insulative runners 2 at a predefined distance from one another. Optional pegs or apertures on the proximal face of 39 could interface with optional connecting features 31 on cap 1 when coupling component 1 to 2. Corresponding mating slots 40 can couple to mating slots 23 to align insulative runners 2 with cap 1. Front curvature 11 and base angle 12 are both features derived primarily from the geometry of 2. Referring to FIG. 9D, inner electrode insulation 38 can provide an electrically non-conductive barrier between proximally extending portions 42 of electrode 3 (FIG. 10 A), the entire portion of connecting member 5, and the distally extending portion 58 of coupling element 4. Referring to FIG. 17A, the electrode 3, coupling element 4, and connecting member 5 can also be defined as the electrode assembly 57. Inner electrode insulation 38 can also fixedly hold electrode assembly 57 relative to insulative runners 2. It is posited that electrode assembly 57 is optimally insert-molded directly into insulative runners 2. It can be preferred that portions of electrode assembly 57 that are enclosed by inner electrode insulation 38 be hermetically encapsulated. Insert molding is superior to assembly and adhesive joining as the adhesive is more susceptible to dielectric heating and voids. It can be preferred that inner electrode insulation 38 maintains a minimum dielectric breakdown strength of at least 6,000 volts. Similarly, it can be preferred that the external surfaces of insulative runners 2 maintain insulation of at least 6,0002022101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 volts with respect to any enclosed portions of 57. Referring to FIG. 9D, inner electrode insulation 38 terminates to allow the proximally extending portion 41 of coupling element 4 sufficient room to flex. It is contemplated that the proximally extending portion 41 could extend substantially inward from 38 with respect to the axis of the scope. It can be preferred that the material for insulative runners 2 be electrically insulative, have high thermal resistance, and good mechanical strength. If a thin wall is desired on the insulative runners 2, high stiffness can also be required. Decent thermal insulation is preferable. PEEK or Polyetherimide can be preferred candidates. A moldable PTFE can also be preferred. It can be preferred that the polymer have a minimum rated service temperature of 200C, and a preferred melt temperature above 300C. The preferred polymer can also be fire resistant and have a high heat deflection temperature. A darker material with low reflectivity in the visible spectrum (either through a rough surface finish or intrinsic material property) is preferred to avoid creating a glare from the scope 6 lighting system.

[0142] Referring to FIG. 10A and FIG. 12A, electrode 3 can have a proximally extending portion 42, a corner radius 43, electrode length 53, cross section 46, cutting surface 44, and coagulating surface 45. Unlike conventional ESD knives which are circular, or at least symmetric about the central axis, electrode 3 is intentionally designed to concentrate higher current density along its cutting surface 44, and lower current density along its coagulating edge 45. FIGS. 10B and 10C depict the temperature induced in tissue directly adjacent to different portions of electrode 3 via resistive heating when subjected to a high voltage, high frequency electrosurgical source. It is important to note that the electrode 3 experiences negligible resistive heating due to its high conductivity; almost all temperature rise in the electrode is from heat exchange with surrounding tissue. Since electrosurgical tissue effect is achieved primarily through resistive heating, higher current densities mean more heat is generated (P = I2R according to Ohms and Watts law).

[0143] Therefore, by selectively increasing current density on cutting surface 44 versus coagulating surface 45, the tissue can reach critical temperatures more quickly along the cutting surface. Referring to FIGS. 10B-10D, the ‘thickness’ defining cutting surface 44 is less than the ‘width’ defining coagulating surface 45. Electrostatic repulsion will lead charge to concentrate more on surfaces with smaller ‘curvature’ . If the cross section of the electrode were a perfect circle, the curvature can be constant and there can preferably be no geometrically induced current concentration at 44. Conversely, if the electrode cross section were an oval with a high aspect ratio2122101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 such that the thickness was significantly less than the width, the cutting surface 44 can have a smaller radius with higher curvature and thus a current concentration. The rectangular cross section in FIGS. 10B and IOC follows this pattern (average curvature across the cutting surface 44 is higher) with even higher current concentrations being seen at the edges intersecting the cutting surface 44 and coagulating surface 45. Thus, an average temperature of ~100°C is reached at the cutting surface 44 while the coagulating surface 45 has only reached a temperature of ~55°C in the same period. Since water boils at 100°C, continued energy delivery will result in vaporization and rupture (cutting) at cutting surface 44 and desiccation (coagulation) at coagulating surface 45.

[0144] This phenomenon can hold true for a variety of possible non-limiting cross sections disclosed in FIG. 10D in which the cutting surface 44 (the distal facing portion of electrode 3) has higher average curvature than the coagulating surface (the surface of the electrode oriented substantially perpendicular to the axis of the resection cap). It could even be achieved when ‘thickness’ t and ‘width’ w of a cross section 46 were equal, as long as sharp edges, protrusions, or small radii r on the cutting surface 44 maintained higher average curvature than coagulating surface 45. FIG. 13 depicts a simulated thermal map and current density gradient in tissue surrounding the cutting surface 44 and coagulating surface 45. It is posited that an optimal configuration of electrode 3 will be comprised of substantially ovular or rectangular cross section in which the ratio of average width:thickness is at least 2:1. To ensure mechanical integrity of the electrode 3, it is also important that the flexural strength and section modulus of the cross section are of sufficient strength to resist bending when contacting tissue, so the thickness is bounded on the lower end by material yield strength limitations. In some embodiments, the electrode 3 disclosed in FIGS. 4A- C, 5A-C, 5E-F, and 6A-D is a rectangle of thickness = 0.010”, width = 0.020” and edge radii = 0.002”.

[0145] Referring to FIGS. 12A-12G, increasing the aspect ratio of electrode cross section 46 leads to higher temperature deltas between the cutting surface tissue boundary temperature 47 and the coagulating surface tissue boundary temperature 48. The electrode temperature delta 51 steadily grows with energy activation time until it reaches a maximum and then begins to shrink again as the cutting surface tissue boundary temperature 47 approaches 100°C. For efficient cutting, it is advantageous to maximize the ratio of 47:48 such that the coagulating surface tissue boundary temperature 48 can be between and can include 60°C and 99°C whilst the cutting tissue2222101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 boundary plateaus at 100°C. By rapidly reaching 100°C, the resultant plateau at 47 means continued energy is causing vaporization of water in the adjacent cells and thus causing a “cut” effect, while 48 is simultaneously causing desiccation and thus a “coagulating” effect. Minimizing 48 towards the lower 60°C is advantageous as it limits excess thermal damage to surrounding tissues. Both the cutting surface tissue boundary temperature 47 and the coagulating surface tissue boundary 48 are dependent on the waveform of electrosurgical energy being applied, the surrounding impedance of the tissue, and the heat transfer to the surrounding environment. To this end, the electrode cross section 46 should be of sufficient volume to maintain an electrode temperature delta 51 in the surrounding tissue. Referring to FIG. 13, if the electrode cross section 46 was too small, the hot spots created at the edges might grow so close together that they could eclipse the difference in surface adjacent temperatures 47 and 48. Conversely, referring again to FIGS. 12A-12G, Configuration 7 in the table (hence named “52”) demonstrates a scenario in which a large electrode 3 heats up very slowly due to excess mass and surface area. Because most electrosurgical generators modulate output power to a certain maximum level for a given setting, such a configuration as 52 might not be able to reach the requisite energy density at cutting surface 44 to create a cut effect within a single pulse width, especially with longer electrodes 3 (in the 10mm+ range). Excepting continuous waveforms like “Purecut”, most modem electrosurgical waveforms are pulsed and thus apply a high voltage duration of power for cutting, a lower voltage duration of power for coagulating, and (sometimes) a duration of no energy application. It is beneficial to limit the overall surface area of cutting surface 44 and coagulating surface 45 to achieve a cutting surface boundary temperature 47 of 100°C within 100 milliseconds or less. Physicians are accustomed to overall pulse widths of a few hundred milliseconds to over a second. The electrode configuration disclosed in FIG. 10A (0.010” x 0.020” cross section 46, 9mm electrode length 53, and 0.025” comer radius 43) achieved a cutting surface tissue boundary surface temperature 47 of 100°C within ~25ms (FIGS. 12A-12G) in an electrothermal simulation using a 400 kHz, 950Vpeak waveform. This electrode has been shown to perform well in corresponding tissue effect testing.

[0146] Referring to FIGS. 14A-14G, the same current concentration effect from curvature can lead to a current density gradient along the length of electrode 3, meaning that both cutting surface 44 and coagulating surface 45 can induce higher temperatures in the comer radius 43. A small current gradient is acceptable, as the comer radius 43 curves away from the distal most face2322101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 of the insulative runners and higher current can help negate this added insulation depth. A large current gradient is undesirable, however, as it can result in premature arcing at comer radius 43. As shown in FIGS. 14A-14G, this gradient can be managed by maintaining a sizable comer radius 43. Although the simulations have different thermal color scales, temperature probes along the length of cutting surface 44 show a temperature ratio between the cutting center temperature 49 and the cutting corner temperature 50. It is posited that the comer radius 43 be greater than the average ‘width’ of electrode cross section 46 to avoid excessive current concentration at the comers of electrode 3.

[0147] Referring to FIGS. 15A-15C, a triangular cross section was investigated to encourage preferential cutting in the distal direction by increasing current density along a leading edge 54. The leading edge 54 is synonymous with the previously defined cutting surface 44. Although higher electrode temperature deltas 51 could be achieved with this cross section, the comer radius curvature 43 compounded with the high curvature of leading edge 54, resulting in a very high peak in cutting comer temperature 50 relative to cutting center temperature 49. The geometry of the resection cap can be adjusted (including an additional shielding or recession around corner radius 43) to accommodate for the increased temperature ratio.

[0148] Referring again to FIG. 13, the proximal electrode edge 55 thermal spikes seen on electrode 3 in an electrothermal simulation are partially a result of modeling boundary conditions. Although the tissue was simulated to stop at the proximal electrode edge 55, a lack of mass and cooling created hot spots in that region. Nevertheless, as depicted in FIGS. 5A-5F, it is feasible that some submucosa could deform around the electrode or that a mucosal flap could contact said proximal electrode edge. Therefore, it can be advantageous to electrically insulate the proximal electrode edge 55 and any proximally facing electrode surfaces 56 as shown in FIG. 16A. An insulative, high temp coating such as polyimide or ceramic can be used to this effect, although other coatings that meet these criteria could be used. A diamond coating, for example, can offer high electrical resistance but be extremely thermally conductive, which could help to cool the electrode during activation. Referring to FIG. 16B, this can result in energy being directed more distally in the resection plane.

[0149] A preferred material for electrode 3 will have a high melting point, be resistant to eschar buildup, and have good electrical and thermal conductivity. Stainless steels can work well2422101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 in this application, specifically 316L or another alloy containing chromium and molybdenum to lend high corrosion resistance. Because the electrode will see high temperatures when an electrosurgical spark is created, and be operating in a saline environment, corrosion resistance is critical. In addition, the material can preferably be non-toxic and non-reactive to the surrounding tissue, especially at elevated temperatures. To avoid material degradation and dissolution, certain coatings may be applied. A gold coating is highly inert and can help prevent eschar buildup and protect against oxidation and corrosion. The high electrical and thermal conductivity of gold can also be beneficial in this application, so a stainless steel electrode plated in gold can perform well. Alternate plating materials could include platinum, rhodium, copper or silver, although tarnishing is of concern with copper and silver so a secondary coating can be preferrable to prevent this effect. Specialty coatings already used on electrosurgical resection devices could also be used, though the proprietary formulations of these blends (fluoropolymers, silicones, etc.) are not claimed here. However, a polymer coating that is electrically conductive and resists tissue eschar buildup is a desirable feature in this design. Certain alternate materials may offer niche benefits. With extremely high power or high voltage waveforms (those used for continuous pure-cutting and fulguration / arc coagulation) a tungsten electrode could be used due to its exceptionally high melting temperature.

[0150] Referring to FIG. 17A, electrode assembly 57 is comprised of electrode 3, coupling element 4, and optionally, connecting member 5. The coupling element contains a distally extending portion 58 and a coupling feature 59. The connecting member 5 creates an electrical and mechanical connection between the proximally extending portion 42 of electrode 3 and the distally extending portion 58 of coupling element 4. Referring to FIGS. 17B-17D, coupling feature 59 can take many forms besides a wire or post, including: a loop, a yoke, a hook, or a spring form. The purpose of the coupling feature 59 is to provide a conductive coupling through selective contact with a proximal delivery catheter. Importantly, the portion of coupling element 4 between the distally extending portion 58 (which is insulated and encapsulated by inner electrode insulation 38) and the coupling feature 59 could be insulated with a polymer jacket or dielectric coating. This can help prevent energy leakage from resecting portion of the electrode. Referring to FIG. 17H, the electrode 3, coupling element 4, and connecting member 5 could all be combined into a single wire-form component. Each critical feature (such as 59, 42, etc.) can be preserved, but the joining method between the different elements can be simplified.2522101696.V1-8 / 14 / 25PATENTDocket No: Cl 124

[0151] Referring to FIGS. 17E-17F, coupling element 4 could take on a variety of forms between distally extending portion 58 and coupling feature 59. In its present embodiment, coupling element 4 can consist of a wire form with three right angles to position coupling feature 59 in front of scope working channel outlet 61. This can increase the overall length and thus flexibility of coupling element 4, as it is intended to deflect out of the way if traditional endoscopic instruments exit scope working channel outlet 61 (this can be seen clearly in FIGS. 23E-23F). It also can allow the cap to rotate as described in FIGS. 7A-7C while coupling feature 59 is conductively engaged and / or mechanically coupled to a coupling catheter such as that disclosed in FIGS. 23A-24F. Referring to FIG. 17E, coupling member 4 could take a shorter pathway from 58 to 59 as depicted by the green arrows, as long as the selected material was flexible enough. Coupling element 4 could take the form of a multifilament conductive wire made of stainless steel or a similarly corrosion resistant material. Alternatively, in some embodiments, coupling element 4 could be made of a small monofilament wire, a flat ribbon, or a conductive high temperature polymer. It is important that the component has low electrical resistance, and a high degree of elastic flexibility. If stainless steel is used, 316 or 304 can be good candidates, preferably work-hardened to increase to a spring temper.

[0152] Referring to FIG. 17F, the resting position of coupling feature 59 can preferably be aligned with the scope working channel outlet 61 when the electrode 3 is in horizontal orientation with respect to the camera’s view. The exact position may change slightly to optimize coupling depending on the form of 59. In a typical wire termination, a slightly off-center alignment with the central axis of 61 towards the outside diameter of scope 6 will encourage the coupling element 4 to deflect radially outwards when an instrument is passed through the resection cap. A contrasting configuration is shown in FIGS. 23E-23G in which a slight inward bias to the position of 59 relative to the central axis of 61 encourages radially inward deflection of coupling element 4. The former configuration is perhaps desirable to limit visualization impact from coupling element 4, while the latter configuration may be easier to couple rotated states described in FIGS. 7A-7C. However, if the cap is rotated whilst a proximal catheter is already engaged, the radially outward biased position of coupling feature 59 is optimal.

[0153] Referring to FIG. 17F, an embodiment of a packaging scheme including a plastic form capsule 62 with integrated alignment post 63 is disclosed. Integrated alignment post 63 is2622101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 designed to slot into the working channel 61 of scope 6 during initial resection cap installation. Plastic for capsule 62 can support the outward surfaces of insulative runners 2 and cap 1, and provide a protective barrier to prevent damage. Capsule 62 can be designed such that some clearance exists around proximal attachment feature 26. This enables the resection cap to be coupled to the scope 6 while still in the packaging, which allows integrated alignment post 63 to orient the packaging and resection cap, which can be preferably during installation. When plastic form capsule is removed, the resection cap will stay oriented relative to the scope 6.

[0154] Referring to FIG. 23A, a coupling catheter 70 is disclosed that can contain a proximal sheath 69, a proximal drive wire 79, a conductive loop 72 and an insulated flushing tip 71. Referring to FIG. 23B, the flushing tip contains a coupling slot 80 and a sheath stop 78. Referring to FIG. 23C, a cross section displays tip taper 74, nozzle funnel 73, nozzle 77, distal tip body 76, and sheath seat 75. The cross section bisecting coupling feature 59 shows how a wire embodiment of 59 could sit within coupling slot 80 and be held in place between sheath 69 and insulated flushing tip 71. The contact between conductive loop 72 and coupling feature 59 of coupling element 4 denotes how coupling catheter 70 communicates electrically with the resection cap and electrode 3. A small compression fit between the inner surfaces of conductive loop 72 and coupling element 59 ensures consistent continuity while the coupling catheter 70 is in a closed state. Sheath stop 78 can prevent insulated flushing tip 71 from receding further into proximal sheath 69 and create a distal stop to resist additional compression of coupling catheter 70. FIG. 23D depicts coupling catheter 70 in said closed state in communication with the resection cap.

[0155] The coupling catheter 70 can be designed such that it may be used in a coupled state or a flushing state. Insulated flushing tip 71 is depicted in a coupled state in FIGS. 23C-23D. Referring to FIG. 23E, insulated flushing tip 71 is depicted in a flushing state. The top image shows a real scenario in tissue testing in which dyed saline or a viscous lifting agent is injected via a high velocity jet through nozzle 77. The saline penetrates the fibrous submucosa and creates a “lift” or fluid cushion that aids in separating the tissue layers and facilitating consistent tissue effect. Referring to FIGS. 23C and 23E, nozzle funnel 73 minimizes minor loss and directs fluid around the end of conductive loop 72 and through a small diameter nozzle 77. Nozzle 77 accelerates the fluid and focuses it into a jet with limited dispersion. The end of conductive loop 72 is optionally formed into a closed loop and mechanically connected to insulated flushing tip 71, which can be2722101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 preferably formed via an insert mold. When coupling catheter 70 is retracted to flushing mode, proximal sheath 69 expands to accept insulated flushing tip 71 via tip taper 74. Because proximal sheath 69 contains some degree of flexibility, it forms a compression seal around sheath seat 75 and enables a leak free conduit from the proximal end of the device to nozzle 77.

[0156] Referring to FIGS. 23E-23G, coupling catheter 70 is shown in a typical use cycle where it cycles between flushing and energizing. It is important to allow the physician to rapidly swap between these two modes, as they will frequently “inject” via high velocity jet to maintain the fluid cushion around the resection site, improving procedural ease and safety. FIGS. 23E-23F depict how coupling catheter 70 can deliver a high velocity jet sufficient to initiate a submucosal lift. FIG. 23G shows a typical coupling process. State 1 (top) depicts retracting the catheter to align the end of proximal sheath 69 with coupling element 4. State 2 (below State 1) shows opening the device, which is accomplished by forward movement of conductive loop 72 which separates insulated flushing tip 71 from proximal sheath 69. State 3 (below State 2) shows aligning conductive loop 72 so that it overlaps coupling feature 59 of coupling element 4. In this instance, drive wire 79 is rotated to bring conductive loop to a substantially perpendicular plane to the axis of 59. State 4 (bottom State) shows conductive loop 72 retracting into proximal sheath 69 until coupling feature 59 is captured within coupling slot 80 and compressed between 71 and the distal end of 69. Tip taper 74 extends into the inner diameter of 69, creating an insulated barrier on the sides of coupling feature 59. Referring to FIG. 17A, the optionally insulated portion of coupling element 4 can optimally terminate just below the point where coupling feature 59 contacts conductive loop 72. Referring again to FIG. 23G State 4, the distal tip of coupling feature 59 could terminate just after the contact point between 59 and 72, but prior to extending past the outer surface of insulated flushing tip 71.

[0157] Referring to FIGS. 23A-23G, insulated flushing tip 71 is most optimally made of a material with high temperature and electrical resistance. PEEK, PTFE, Polyetherimide, silicone or another such polymer are contemplated. The material can optimally be injection moldable, but it is not a critical feature. A ceramic form can work but may be more difficult to fabricate in the required geometry. Proximal sheath 69 can be comprised of a semi-flexible polymer with high temperature resistance and low coefficient friction, such as PTFE, FEP, PFA, Polyimide to name a few. Conductive loop 72 and any additional conducting elements can optimally be made of stainless steel in a spring temper, but could optionally be made with copper, brass, silver, or may2822101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 be an alloy or combination of both. In some embodiments, a braided construction of conductive loop 72 (sometimes referred to as wire rope or multifilament cable) is used to increase flexibility as the loop deforms in an effort to prevent unwanted friction.

[0158] Referring to FIGS. 18A-18C, an alternate embodiment of the resection cap is disclosed in which proximal attachment feature 26 is instead connected to the insulative runners 2. In addition, front aperture 25 of cap 1 has been shrunk to a slot of radius slightly larger than working channel outlet 61 and in coaxial alignment with 61. In this embodiment, distal housing 24 extends distally and frontally past distal housing apex 27. This shield could be helpful in keeping tissue out of the interior region of the cap 1, especially in the case of first entering the submucosal space by lifting the mucosal flap after initial incision. The more enclosed form of the resection cap could, however, make cleaning and visualization more difficult.

[0159] Referring to FIGS. 18A-22G, all embodiments can contain a proximal attachment feature 26 as either a portion of cap 1 (as in the primary embodiment) or as a portion of insulative runners 2 (as pictured in FIG. 18 A) regardless of how the embodiment is graphically represented.

[0160] Referring to FIGS. 19A-19C, an alternate embodiment of the resection cap is disclosed in which at least a portion of distal housing 24 extends distally and frontally past distal housing apex 27. Similar to FIGS. 18A-18C, this embodiment could help with mucosal flap manipulation and submucosal entry, although it is not expected to impact visualization to as great a degree. In this embodiment, top curvature 8 can have a much larger radius and extend over a larger portion of distal housing 24. This can give the resection cap the appearance of a bullet train and may help create a more perpendicular view of the submucosal resection plane. Because taper angle 9 and lead-in angle 10 are more vertical, the scope is positioned in a more an-face fashion compared to the deformed submucosal plane.

[0161] Referring to FIGS. 20A-20C, an alternate embodiment discloses tissue combs 64 to create additional horizontal tension in the resection plane. The tissue combs 64 can spread the mucosal flap or submucosal tunnel over and outward from the insulative runners 2 to help maintain a clear field of view in front aperture 25.

[0162] Referring to FIGS. 21A-21C, lead-in angle 10 and taper angle 9 are inverted across the vertical plane, leading to an overhang created by distal housing 24. In this embodiment, distal2922101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 housing apex 27 is the most distal portion of cap 1 , and in fact of the entire resection cap, including insulative runners 2. This configuration could be beneficial for inverted entry as described in FIG. 6B. It could also be used in a partial or full retroflex in which the camera is oriented upside down relative to the intended plane of resection.

[0163] Referring to FIGS. 22B-22D, alternate forms of the resection cap are contemplated by varying the elements discussed previously. As should be understood, increasing the surface area of the distal surface of the cap (shown in some of these examples) allows for a greater amount of cut tissue area to be positioned and moved up and over the distal portion of the endoscope. This larger distal surface or shield could be helpful in keeping tissue out of the interior region of the cap 1, especially in the case of first entering the submucosal space by lifting the mucosal flap after initial incision. The more enclosed form of the resection cap could, however, make cleaning and visualization a bit more difficult. As such, a particular embodiment used will depend on the functionality desired (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure).

[0164] Referring to FIG. 22E, an alternate embodiment contemplates cap 1 containing lead-in angle 10 and taper angle 9 at 90° relative to the axis of scope 6. This embodiment is perhaps the most similar to a traditional, non-resecting endoscope distal attachment. The cross section of this resection cap can take the form of a rectangle with a dome top. While this may provide the most familiar in-face view of the resection plane once the submucosal space is accessed, it may struggle to provide a vertical component of force to the tissue with forward motion of scope 6. In this configuration, distal housing apex 27 is almost directly vertical to electrode 3.

[0165] Referring to FIG. 22F, an alternate embodiment describes a design in which insulative runners have a curved base portion. In this embodiment, proximal attachment feature 26 is comprised of at least 2 spring arms that deflect radially outward to accept scope 6. In addition, a new instrument channel 65 is introduced in the cap and may be used for alternate devices passed outside of the scope 6 working channel outlet 61. Such devices could include graspers, thermal hemostatic devices, mechanical clips, suture line, needles, or any other endoscopic device that can aid in completion of the resection.

[0166] Referring to FIG. 22G, an alternate embodiment proposes a coupling element 4 that can extend through an aperture 67 in the proximal portion of either the insulative runners 2 or cap3022101696.V1-8 / 14 / 25PATENTDocket No: Cl 1241. Conductive wire 66 can connect to coupling element 4 in a hermetic manner, most likely insert molding directly into the rear of cap 1 or insulative runners 2. In another embodiment, it is contemplated that 66 could be removably connected and disconnected through an exposed aperture 67, albeit a leak-tight and insulative seal can need to be made such that no electrically communicative path (including conductive fluid ingress) could be made between coupling element 4 and the surrounding tissue on the exterior surfaces of cap 1 or insulative runners 2. A press fit connection with a semi-flexible coating material of conductive wire 66 can suffice. Scope retention mechanisms 68 can hold the wire largely parallel with the central axis of the scope 6 throughout the procedure until the proximal portion of scope 6 that is outside of the patient. At that point, conductive wire 66 can be allowed to deviate from the axis of the scope to connect to an electrosurgical generator via any number of standard monopolar electrical plugs. It is contemplated that scope retention mechanisms 68 could be semi-flexible bands, or semi-rigid clamps. If presenting as bands, scope retention mechanisms 68 can expand to slip over the outer diameter of scope 6 and be positioned at intervals of 10-40cm along the scope exterior until the aforementioned proximal deviation. If presenting as clamps, scope retention mechanisms 68 can deflect outwards towards an open configuration in which they could be connected by snapping directly onto the scope 6 outer diameter. A polymer clamp in a c-shaped cross section encircling more than 180° of the circumference of scope 6 while in a collapsed state can be sufficient to hold the conductive wire 66 parallel to the axis of scope 6.

[0167] Referring to FIG. 24A, an alternate embodiment of coupling catheter 30 is disclosed in which conductive extension 81 is positioned between conductive loop 72 and insulated flushing tip 71. Conductive extension 81 can be rigidly connected to 71 biased towards one side coupling slot 80. Together they form a “hook” which captures coupling feature 79. The rest of the device is similar to the embodiment described in FIG. 23 A above. Conductive extension 81 could also directly couple to drive wire 79, which can remove the need for conductive loop 72. It may be advantageous to keep conductive loop 72, however, to allow coupling catheter 70 to function in a third state as a standard endoscopic snare (used for marking, resection, or foreign body removal).

[0168] Referring to FIG. 24B, a conductive hook 82 could be positioned distally to insulated flushing tip 71. In this embodiment, the conductive hook 82 can still be coupled to either; conductive extension 81 which is either an extension of or directly coupled to drive wire 79, or;3122101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 conductive loop 72, which is either an extension of or directly coupled to drive wire 79. In this embodiment, coupling feature 59 can be trapped between conductive hook 82 and a distal face or aperture of insulated flushing tip 71. While the device was in a retracted state (such that 71 is coupled via friction / compression to proximal sheath 69) axial translation of drive wire 79 can actuate conductive hook 82 through an enlarged nozzle 77 between an open and closed state. In an open state, coupling hook 82 could be used for marking or resection like a standard ESD knife, but in a closed state, conductive hook 82 can provide electricity to the resection cap via coupling element 4. By continued forward movement of conductive hook 82, tensile force between insulative flushing tip 71 and proximal sheath 69 generated by distal force from an enlarged joint at the base of 82 can overcome the friction between sheath seat 75 and the inner diameter of 69, thus decoupling 71 from 69. If conductive hook 82 were coupled to a conducting loop 72, then 72 could be used as a standard snare for marking, resection, grasping, etc. in this open state. Fluid can still flush through nozzle 77, albeit around conductive hook 82 (and thus there can be some dispersion in the jet).

[0169] Referring to FIG. 24C, an alternate embodiment of FIG. 24A is disclosed in which conductive hook 82 is replaced by conductive electrode 83. Referring to FIG. 24D, the primary difference between this embodiment and that shown in FIG. 24A is that the connection between coupling feature 59 and the coupling catheter 70 occurs at the coupling slot 80 by conductive loop 72, as described in FIG. 23 A. In this instance, conductive electrode 83 may be actuated between a closed state, open state (FIG. 24E), and coupling state. Conductive electrode 83 can have a central lumen to replace the flushing function of nozzle 77 and could take on any variety of distal end geometries commonly seen in endoscopic electrosurgical knives today (triangle, square, insulated, or L-shaped).

[0170] FIGS. 25A-28 depict alternative embodiments to the embodiments described above and function the same or similarly, unless indicated otherwise.

[0171] Referring to FIG. 25 A, an isometric view of a cap 10’ positioned on a distal end / tip of an endoscope 100’ is shown, according to an embodiment. The cap 10’ can be attached or detached or integrally formed on the distal end of the endoscope 100’. The cap 10’ can include, but is not limited to, a proximal portion 2’ that interfaces with the scope to retain the cap in position; a distal portion 4’ that extends distally from the scope to effect cutting and traction; a cutting3222101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 element 6’ within the distal portion, extending substantially perpendicular to the central longitudinal axis of the endoscope; and insulating elements (i.e., runners) 8’ that create separation between adjacent tissue and the cutting element 6’, as explained above.

[0172] The shape of the distal portion 4’ can be angled to transmit force to the tissue along a non-axial vector during forward motion of the scope during use. The degree of the angle 0 will dictate the proportions of force in the horizonal and vertical directions with respect to the tissue directly in front of the cap. An ideal configuration can balance creating tension in the dissection plane (perpendicular to the axis of the endoscope as shown) and axial deformation of the tissue in contact with the front runners 8’. The front runners 8’ are structured and configured to have little ability to dissect by themselves (as they are not mechanically sharp enough and have no electrical or other form of cutting ability to generate the requisite pressure to pierce through the serosal layer of the GI tract). The local deformation of the tissue (submucosa resembling a fibrous gel) at the location of the runners 8’ during use brings the cutting wire 6 into contact with the tissue. For substantially rigid tissues (e.g., thick muscularis or fibrotic scar tissue), the increased stiffness will prevent the runners 8’ from embedding deeply into the tissue wall, thus limiting the ability of the electrode to be brought into sufficient contact with those tissues.

[0173] The cutting element 6’ can be comprised of an electrode that passes current to adjacent tissue during use. The size of the electrode 6’ can be maximized to increase resection time, but can still fit within the insulative ‘window’ created by the front runners 8’. An ideal electrode of an embodiment can maximize cutting in the horizontal plane, and minimize cutting in the vertical plane. The configuration shown has a rectangular cross section. The smaller front face of the wire, in addition to the two “sharps” created at the rectangular comers can create a current density spike that increases the thermal impact in those locations of the wire. The wider, smoother base of the electrode can encourage uniform (layer) current density for coagulation. The cutting wire could also have round, triangular, braided, helical, or knurled form to accomplish the desired resection direction. An oblong shape (narrower in the vertical plane than in the horizontal plane) will maximize performance according to another embodiment.

[0174] Referring to FIG. 25B, a top down view of the cap 10’ positioned on a distal end / tip of an endoscope 100’ is shown, according to an embodiment. A slight taper can be seen when viewing the scope from “above” related to the perspective of the scope itself. This taper can help3322101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 to widen the incision made by the cutting element. If the cutting element creates a horizontal separation, the angle shown in FIG. 25A and the taper shown in FIG. 25B can guide the ‘hood’ of the tissue over the scope. A photographic depiction of a prototype in gel demonstrates this (see FIG. 26). A relatively aggressive forward angle in this instance (e.g., about 30°) can lead to easy forward motion, at the expense of slightly less separation in the visible portion of the tissue plan. More aggressive angles can lead to more tension created in the dissection plane (also known as traction) at the expense of increased forward force required to advance the distal runners and distend the tunnel being created.

[0175] Turning to FIG. 27 A, another isometric view of the cap 10’ positioned on a distal end / tip of an endoscope 100’ is shown, according to an embodiment. Insulative elements 12’ (e.g., ceramic anchors) are shown in the cap 10’ to protect the cap 10’ from high temperatures created during tissue dissection. In FIG. 25A, the embodiment shown has a ceramic or high temperature plastic (e.g., PEEK) base, as an example. In FIG. 26, the entire cap can be printed out of a high temp plastic (comparable to PEEK). A configuration which preserves the optical clarity of all cap portions not in contact or direct adjacency to the cutting zone can be desirable to maximize physicians’ ability to orient and examine the tissue plane.

[0176] Referring to FIGS. 27B and 27C, different profiles for the distal portion of the cap 10’ are shown, according to an embodiment. The convex profiles can maximize insulation and perpendicular traction while the concave profiles maximize forward motion. Importantly, according to an embodiment, the front radii of the front runners may be adjusted depending on the target tissue site (a saleable configuration for the colon would likely have more “blunt” force runners than a saleable configuration for the stomach due to the thinner nature of the tissue in the colon), as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure. In addition to the front angle and radii of the runners (insulative portions), the relative position of the cutting electrode may be adjusted to optimize the target tissue plane. For deeper lesions, the cutting electrode can be spaced closer to the base of the cap. For more superficial legions, the electrode may be spaced further from the base to decrease the risk of perforation. It should be understood that the radius of the front runners and the height of the electrode can be variable depending on the needs of the user / type of surgery.3422101696.V1-8 / 14 / 25PATENTDocket No: Cl 124

[0177] The cap may be energized by a catheter passed through a channel of the endoscope. The catheter can be easily coupled and decoupled from the cap to allow use of instruments (e.g., clips injection needles, probes, graspers, etc.) through the working channel. The catheter can have a plurality of elements that address the needs of injection, selective coagulation, and manipulation of tissue in addition to its function as an electrical conduit. Referring to FIG. 28, a representation of the coupling mechanism on the cap is shown. The coupling mechanism may be a wire, loop, V- shaped, or J-shaped wire (distally extending), or a bar that can be attached or bypassed selectively by instrumentation through the scope’s working channel. It can also be an annular spring or conductive tube that interfaced with the coupling catheter.

[0178] In an alternative embodiment, the resection cap could be fully circular in diameter. The primary electrode could also be positioned at any plane within the view field of the endoscope being used. The electrode could have a non-linear shape in order to better match the topography of the GI tract being resected (e.g., an arc extending outward / downward from the cap that would more closely conform to the diameter of the lumen).

[0179] According to an embodiment, the devices and systems described herein can be used during advanced interventional endoscopy and during EMR or polypectomy, for example.

[0180] It should be understood that any of the features of any of the above embodiments can be combined in any way mechanically possible.

[0181] While various embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the function and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the teachings is / are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, embodiments may be practiced otherwise than as3522101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 specifically described and claimed. Embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the scope of the present disclosure.

[0182] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. 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 “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as, “has” and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises”, “has”, “includes” or “contains” one or more steps or elements. Likewise, a step of method or an element of a device that “comprises”, “has”, “includes” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

[0183] The corresponding structures, materials, acts and equivalents of all means or step plus function elements in the claims below, if any, are intended to include any structure, material or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present disclosure has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the disclosure in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the disclosure. The embodiment was chosen and described in order to best explain the principles of one or more aspects of the disclosure and the practical application, and to enable others of ordinary skill in the art to understand one or more aspects of the present disclosure for various embodiments with various modifications as are suited to the particular use contemplated.3622101696.V1-8 / 14 / 25

Claims

PATENTDocket No: Cl 124CLAIMSWhat is claimed is:

1. A resection cap device, comprising: a resection cap configured to be coupled to a distal end of an endoscope; an electrode configured to interact with the resection cap; and a coupling element that is capable of interfacing with a coupling catheter that is configured to be passed through the endoscope to transmit electricity to the electrode; wherein the coupling catheter is configured to be removably coupled to the coupling element independent of the endoscope.

2. The resection cap device of claim 1 , wherein a front surface of the resection cap comprises a first portion having a first slope relative to a central axis of the resection cap and a second portion having a second, separate slope relative to the central axis of the resection cap.

3. The resection cap device of claim 2, wherein the first slope exhibits a steeper inclination than the second slope relative to the central axis of the resection cap.

4. The resection cap device of claim 3, wherein the first slope is about 60°.

5. The resection cap device of claim 3, wherein the second slope is about 25°.

6. The resection cap device of claim 1 , wherein the resection cap is rotatable about an axis of the endoscope.

7. The resection cap device of claim 1, wherein a width of the electrode is between about 6- 12 mm.

8. The resection cap device of claim 1, wherein the resection cap is formed of a non- conductive material.

9. The resection cap device of claim 1, wherein the coupling element is integrally formed with the electrode.

10. The resection cap device of claim 1, wherein a base of the resection cap extends at an angle with respect to a longitudinal axis of the endoscope.

11. A resection cap, comprising: a housing having a longitudinal axis;3722101696.V1-8 / 14 / 25PATENTDocket No: Cl 124 a pair of insulated runners comprising a first runner and a second runner, each coupled to and extending from the housing; and an elongated electrode connected to and extending from the first runner to the second runner.

12. The resection cap of claim 11, wherein at least one of the pair of insulated runners has a first surface and a second surface, the first and second surfaces extending toward each other at an angle to the longitudinal axis and converging at a most distal surface of the at least one of the pair of insulated runners.

13. The resection cap of claim 11, wherein the electrode is in non-contacting relation with the housing.

14. The resection cap of claim 11, wherein the electrode is spaced proximally from a distal end of each of the first runner and the second runner.

15. The resection cap of claim 11 , wherein a front surface of the resection cap comprises a first portion having a first slope relative to a central axis of the resection cap and a second portion having a second, separate slope relative to the central axis of the resection cap.

16. The resection cap of claim 15, wherein the first slope exhibits a steeper inclination than the second slope relative to the central axis of the resection cap.

17. The resection cap of claim 15, wherein the first slope is about 60°.

18. The resection cap of claim 15, wherein the second slope is about 25°.

19. The resection cap of claim 11 , wherein the housing is formed of a non-conductive material.

20. The resection cap of claim 11, wherein the electrode extends substantially perpendicularly with respect to the pair of insulated runners.3822101696.V1-8 / 14 / 25

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