Devices and systems for tissue ablation

Abstract

To provide a tissue excision device, system and method in a patient's body lumen.SOLUTION: A tissue excision device comprises: a body 205 extending along an axis 202; and a distal cap 217 arranged on a distal side of the body, the distal cap being coupled to a shaft 210 extending along an axis. The body and the distal cap may be relatively movable each other. A mooring mechanism 215 can approach a selected tissue and engage the body and the distal cap to the tissue, for excision of the tissue in a body lumen. A tissue capture device 235 may be expanded from a tissue excision device 245, so that the selected tissue to be excised may be captured by the tissue capture device. The tissue excision device may further comprise, a tissue excision device for excising the selected tissue to be excised.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a device for performing an endoscopic procedure. and System Mu 1 In general, and more particularly, tissue resection devices for endoscopic mucosal resection (EMR) and / or endoscopic submucosal dissection (ESD) procedures, and such devices and System Mu Regarding such devices or System Mu These include partial or complete circumferential endoscopic full-thickness resection (eFTR), to achieve tissue closure and / or tissue apposition. [Background technology]

[0002] Endoscopic mucosal resection (EMR) and / or endoscopic submucosal dissection (ESD) procedures are used to remove benign or diseased tissue, such as lesions, cancerous tumors, and / or other abnormalities, from a patient's gastrointestinal system. In some patients, a full-thickness resection (FTR), which is a partial or complete circumferential resection within the body lumen, may be necessary to ensure complete removal of the diseased tissue, rather than removing only the mucosal layer of the gastrointestinal system. Summary of the Invention [Problem to be solved by the invention]

[0003] However, full-thickness resection procedures present anatomical challenges in removing tissue adjacent to vital internal organs and other sensitive structures, and may pose a risk of postoperative leakage, potentially increasing health risks for patients undergoing full-thickness resection procedures.

[0004] With respect to these and other considerations, the improvements of the present invention may be useful. [Means for solving the problem]

[0005] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

[0006] According to an exemplary embodiment of the present invention, a device for tissue resection in a body lumen may include a body extending along an axis and a distal cap disposed distally of the body and coupled to a shaft extending along the axis. The body and the distal cap are movable relative to one another. The device for tissue resection may further include an anchoring mechanism that enables the body and the distal cap to engage proximate tissue selected for resection in the body lumen. The device for tissue resection may further include a tissue capturing device deployable from the tissue resection device, wherein the tissue selected for resection is captureable by the tissue capturing device. The device for tissue resection may further include a tissue resection device for resecting the tissue selected for resection.

[0007] In various of the above and other embodiments of the present invention, the tissue resection device may further include a tissue closure device. The anchoring mechanism may include a first balloon disposed on the distal cap and a second balloon disposed on the body. The first and second balloons are expandable to engage the body lumen such that the tissue selected for resection is between the first and second balloons. The tissue capture device may include one or more posts circumferentially disposed around the surface of the body and extendable in an axial direction from the body to secure the tissue selected for resection against the distal cap. The tissue closure device may include a closure mechanism for joining portions of the body lumen. The tissue resection apparatus may include a blade circumferentially disposed around the surface of the body and extendable in an axial direction from the body to resect the tissue selected for resection. The tissue resection device may include a blade circumferentially disposed around the surface of the distal cap and extendable in an axial direction from the distal cap to resect the tissue selected for resection. The tissue resection apparatus may be disposed on the outer shaft, and the distal cap may be disposed on the inner shaft. The tissue excision device is extendable from the distal cap in response to the inner shaft being movable relative to the outer shaft.

[0008] According to an exemplary embodiment of the present invention, a system for tissue resection in a body lumen may include a tissue resection device. The tissue resection device may include a body extending along an axis and a distal cap disposed distally of the body and coupled to a shaft extending along the axis. The body and distal cap are movable relative to one another. The tissue resection device may include an anchoring mechanism capable of engaging the body and the distal cap proximate tissue selected for resection in the body lumen. The system may further include a visualization device for visualizing the placement of the tissue resection device within the body lumen relative to the tissue selected for resection.

[0009] In various above and other embodiments of the present invention, the system may further include a tissue capture device deployable from the tissue resection device, and the tissue selected for resection can be captured by the tissue capture device. The system may further include a tissue resection device for resecting the tissue selected for resection and a tissue closure device. The anchoring mechanism may include a first balloon disposed on the distal cap and a second balloon disposed on the body. The first and second balloons are expandable to engage the body lumen such that the tissue selected for resection is between the first and second balloons. The tissue capture device may include one or more posts circumferentially disposed about the surface of the body and extendable in an axial direction from the body to secure the tissue selected for resection relative to the distal cap. The tissue resection apparatus may include a blade circumferentially disposed about the surface of the body and extendable in an axial direction from the body to resect the tissue selected for resection. The tissue resection device may include a blade circumferentially disposed about the surface of the distal cap and extendable in an axial direction from the distal cap to resect the tissue selected for resection. The tissue resection apparatus may be disposed on the outer shaft, and the distal cap may be disposed on the inner shaft. The tissue excision device is extendable from the distal cap in response to the inner shaft being movable relative to the outer shaft.

[0010] According to an exemplary embodiment of the present invention, a method for resecting tissue within a body lumen may include delivering a tissue resection device to a tissue location within the body lumen selected for resection. The tissue resection device may include a body extending along an axis. The tissue resection device may further include a distal cap disposed distally of the body and coupled to a shaft extending along the axis. The body and distal cap are movable relative to one another. The tissue resection device may further include an anchoring mechanism for engaging the body and the distal cap proximate the tissue selected for resection. The anchoring mechanism may include a first balloon disposed on the distal cap and a second balloon disposed on the body. The method may further include expanding the first balloon to engage the distal cap with the body lumen, extending the distal cap and body away from one another along the axis, and expanding the second balloon to engage the body with the body lumen.

[0011] In various of the above and other embodiments of the present invention, the method may further include closing the distal cap and the body to pleat the selected tissue for resection between the first and second balloons. The method may further include moving the selected tissue inward toward the axis of the tissue resection device to resect the pleated selected tissue. The method may further include securing the pleated selected tissue for resection with the tissue capture device, the securing including extending one or more posts circumferentially arranged around the surface of the body in an axial direction. The method may further include joining portions of the body lumen with the tissue closure device, the tissue closure device including a closure mechanism. The method may further include resecting the selected tissue for resection with the tissue resection device. The tissue resection device may include a blade circumferentially arranged around the surface of the body, and resection may include extending the blade from the body in an axial direction. The tissue resection device may further include a blade circumferentially arranged around the surface of the distal cap. Resection may include extending the blade from the distal cap in an axial direction.

[0012] Non-limiting embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, which are schematic and are not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown will generally be represented by a single reference numeral. For purposes of clarity, not every component will be labeled in every drawing, nor will every component of each embodiment be shown unless illustration is necessary to enable those skilled in the art to understand the disclosure. [Brief explanation of the drawings]

[0013] [Figure 1] 1 illustrates a body lumen of a patient. [Figure 2] 1 is a perspective view illustrating an exemplary embodiment of a tissue excision device according to the present invention. [Figure 3] 1 is a perspective view illustrating an exemplary embodiment of a tissue excision device according to the present invention. [Figure 4A] 1 is a perspective view illustrating an exemplary embodiment of a tissue resection device and a visualization device according to the present invention. [Figure 4B] 1 is a perspective view illustrating an exemplary embodiment of a tissue resection device and a visualization device according to the present invention. [Figure 5A] 1 is a perspective view of an exemplary embodiment of an anchoring mechanism according to the present invention; [Figure 5B] 1 is a perspective view of an exemplary embodiment of an anchoring mechanism according to the present invention; [Figure 5C] 1 is a perspective view of an exemplary embodiment of an anchoring mechanism according to the present invention; [Figure 6A] 1A-1C illustrate an exemplary embodiment of a tissue excision device according to the present invention. [Figure 6B] 1A-1C illustrate an exemplary embodiment of a tissue excision device according to the present invention. [Figure 7A] 1A-1C are cross-sectional views illustrating an exemplary embodiment of a tissue excision device, in accordance with the present invention. [Figure 7B] 1A-1C are cross-sectional views illustrating an exemplary embodiment of a tissue excision device, in accordance with the present invention. [Figure 7C] 1A-1C are cross-sectional views illustrating an exemplary embodiment of a tissue excision device, in accordance with the present invention. [Figure 8A] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 8B] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 8C] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 8D] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 8E] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 8F] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 8G] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 8H] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 8I] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 8J] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 9A] 1 illustrates an exemplary tissue excision device according to the present invention. [Figure 9B] 1 illustrates an exemplary tissue excision device according to the present invention. [Figure 10A] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 10B] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 10C] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 10D] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 10E] 1A-1C illustrate an exemplary process for ablating tissue using a tissue ablation device in accordance with the present invention. [Figure 11A] 1A-1D illustrate an exemplary tissue excision device and process for excising tissue in accordance with the present invention. [Figure 11B] 1A-1D illustrate an exemplary tissue excision device and process for excising tissue in accordance with the present invention. [Figure 11C] 1A-1D illustrate an exemplary tissue excision device and process for excising tissue in accordance with the present invention. [Figure 12A] 1A-1D illustrate an exemplary tissue excision device and process for excising tissue in accordance with the present invention. [Figure 12B] 1A-1D illustrate an exemplary tissue excision device and process for excising tissue in accordance with the present invention. [Figure 12C] 1A-1D illustrate an exemplary tissue excision device and process for excising tissue in accordance with the present invention. [Figure 13A] 1A-1D illustrate an exemplary tissue excision device and process for excising tissue in accordance with the present invention. [Figure 13B] 1A-1D illustrate an exemplary tissue excision device and process for excising tissue in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0014] The present invention is not limited to the specific embodiments described herein. The terms used herein are intended only to describe specific embodiments and are not intended to limit the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by those skilled in the art to which the present invention belongs.

[0015] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. As used herein, the terms "comprises" and / or "comprising" or "includes" and / or "including" specify the presence of stated features, regions, step elements and / or components, but do not exclude one or more other features, regions, integers, steps, operations, elements, components, and / or combinations or additions thereof.

[0016] It should be understood that the term "proximal" can be defined as the end of the system and device closest to the entry point into the patient, and the term "distal" can be defined as the end of the system and device closest to the desired location within the patient (e.g., the patient's gastrointestinal system).

[0017] As described above, patients with diseased tissue in the gastrointestinal system or other tissue may require resection. Referring to FIG. 1 , various sizes of lesions are shown in a patient's body lumen (e.g., the gastrointestinal system). As shown in this figure, early stages of diseased tissue may not extend through all layers of the body lumen, allowing for resection of only the affected tissue layer. However, as tissue disease progresses to later stages, resection of the entire tissue portion (e.g., full-thickness resection) may be necessary to completely remove the diseased tissue from the patient. Exemplary embodiments of devices, systems, and methods for partial or full-thickness tissue resection according to the present invention allow a selected tissue section containing the diseased tissue to be contained and resected from surrounding tissue, which is then joined together to close the gap created by the resection of the selected tissue. In some embodiments, the tissue resection may be circumferential, e.g., extending 360° around the body lumen. In other embodiments, the tissue resection may be partial circumferential, e.g., extending less than 360° around the body lumen. Although the term "ablation" is used throughout this specification, exemplary embodiments of the present invention may encompass resection, dissection, removal, ablation, cutting, vaporization, freezing, etc., and may be full-thickness, partial-thickness, and may be circumferential, partial- and / or full-thickness within a body lumen where the procedure occurs.

[0018] Referring now to FIG. 2 , an exemplary embodiment of a resection device 200, e.g., an endoluminal resection device, in accordance with the present invention is shown. The device 200 may be delivered to a site in a patient to resect a selected portion of tissue. In some embodiments, the selected tissue may be within a body lumen, such as the intestine, colon, and / or other parts of the gastrointestinal system. The resection device 200 may be configured for full-thickness resection of the large intestine, although it is envisioned that the resection device 200 may be configured for other anatomical resections. The device 200 may include a body 205 extending along an axis 202 and having a proximal end 205 a and a distal end 205 b. In some embodiments, the body 205 may be a lumen or hollow tube. A handle (not shown) may be coupled to the proximal end 205 a for actuation of the distal end 205 b by a medical professional. While the body lumen is described with respect to the gastrointestinal system, including, but not limited to, the intestine, colon, duodenum, and / or other parts of the gastrointestinal system, exemplary embodiments of the devices, systems, and methods of the present invention may be applied to any body lumen of a patient.

[0019] Body 205 may include a shaft 210 extending coaxially with body 205 along axis 202. In embodiments, shaft 210 is movable relative to body 205 along axis 202. An anchoring mechanism 215 may be coupled to body 205, for example, to secure device 200 to an inner surface of a body lumen. In embodiments, a portion of anchoring mechanism 215 may be coupled to distal end 210b of shaft 210 as distal cap 217 extending distally of distal end 205b of body 205. For example, as shaft 210 moves along axis 202, a portion of anchoring mechanism 215 coupled to shaft 210, e.g., on distal cap 217, may be movable relative to another portion of anchoring mechanism 215 coupled to body 205, for example.

[0020] In some embodiments, the anchoring mechanism 215 may be one or more expandable balloons 220a, 220b,... 220n. While a first balloon 220a and a second balloon 220b are shown in FIG. 2, it is understood that any number "n" of balloons may be utilized in the anchoring mechanism. The first balloon 220a may be disposed on a portion of the body 205 proximal to the distal end 205b, e.g., coupled to the body 205. The second balloon 220b may be disposed on a distal portion of the distal end 205b distal to the first balloon 220a, e.g., coupled to the shaft 210 on the distal cap 217. The first and second balloons 220a, 220b may be deployable along the axis 202, e.g., by the body 205 and / or the shaft 210. For example, the shaft 210 can extend the distal cap 217 and the second balloon 220b away from the first balloon 220a on the body 205.

[0021] As described below, anchoring mechanisms, such as first and second balloons 220a, 220b, can surround and / or encapsulate selected tissue sub-sites. For example, first and second balloons 220a, 220b can engage body 205 and distal cap 217 proximate selected tissue for resection within a body lumen. First and second balloons 220a, 220b can be spaced a distance "d" apart from one another. When first and second balloons 220a, 220b are at a desired site or location, the balloons can be expanded radially relative to shaft 202 to fill the body lumen and contact the inner surface of the body lumen. The expanded balloons may be held by friction against the inner surface of the body lumen, and movement of shaft 210 and / or body with balloons 220a, 220b in the expanded position can pleat or otherwise fold the selected diseased tissue, separating the selected tissue. In some embodiments, balloons 220a, 220b may be formed from a material that maximizes frictional contact with the body lumen. It is contemplated that first and / or second balloons may be formed from the same or similar materials, and in some embodiments, may be formed from different materials. It is understood that balloons 505a, 505b, 510a, 510b, 515a, 515b may be formed from any combination of materials. As shown in FIG. 5A, first and / or second balloons 505a, 505b may be formed from a material 520 having a smooth flexible surface. FIG. 5B illustrates first and / or second balloons 510a, 510b formed from a material 525 having a textured flexible surface. FIG. 5C illustrates first and / or second balloons 515a, 515b having a mesh-covered surface 530. The mesh-covered surface 530 may be an integrally formed material of the balloons 515a, 515b, or in other embodiments, may be a separate cover over the balloons 515a, 515b formed from a different material.

[0022] In some embodiments, the anchoring mechanism 215 may include a tracking device to ensure accurate positioning within the body lumen. For example, the device 300 may include one or more markers 305 on the anchoring mechanism 215. As shown in FIG. 3 , the first balloon 220a may include a first marker 305a, and the second balloon 220b may include a second marker 305b. It is understood that any number “n” of markers 305a, 305b,... 305n may be used in combination with any number “n” of balloons 220a, 220b,... 220n and / or anchoring mechanisms 215. The first marker 305a may be disposed on the first balloon 220a such that the shaft 210 and distal cap 217 extend from the body 205 such that the second marker 305b disposed on the second balloon 220b is separated by a distance “d.”

[0023] In embodiments, the one or more markers 305 may be radiopaque and / or echogenic markers. A medical professional may use direct visualization, fluoroscopic imaging, and / or ultrasound-guided navigation via the one or more markers 305 to guide the device 200, 300 to a desired location within a patient's body lumen. Using one or more markers 305 may be advantageous to ensure accurate positioning of the patient. A medical professional may wish to ablate the diseased tissue and a portion of the healthy tissue surrounding the diseased tissue to ensure complete ablation of cancerous cells. By accurately positioning the device 200, 300, e.g., by selecting an accurate distance "d," the medical professional may be able to minimize the amount of healthy tissue required for ablation.

[0024] 2, in some embodiments, device 200 can further include one or more working channels 225 for extending additional accessories 230 to the site of interest. For example, a visualization device, such as a camera, fiber optic cable, and / or other imaging device, or endoscope, can be delivered to the desired location, while other accessory devices for use during the procedure, including, but not limited to, illumination devices, grasping tools, fluid delivery devices, suction devices, etc., can utilize working channel 225. The accessories can be controlled and / or actuated by a medical professional at proximal end 205a of apparatus 200. In some embodiments, the accessories can lock their handles to maintain a selected position while the medical professional is free to manipulate other accessories and / or adjust device 200 to securely select diseased tissue for resection.

[0025] In some embodiments, accessories may be delivered through device 200 in a variety of ways. As shown in FIG. 4A, device 400 may include a working channel 410 extending along the interior of a shaft (not shown). Accessory 415 may then extend along this central working channel 410 and out of distal cap 420. This may be advantageous because an accessory, such as a visualization accessory, such as an endoscope or other visualization device, may be utilized when distal cap 420 is retracted. For example, the visualization accessory may be operable even when the shaft is not extended, such that there is no gap or distance "d" between the first and second balloons. In other embodiments, as shown in FIG. 4B, accessory 425, such as an endoscope or other visualization device, may be attached to device 405 on its exterior surface 430. For example, a mechanical fastener, such as a ring 435, may be coupled to exterior surface 430 of device 405 to attach accessory 425. This configuration can be advantageous because the accessory can be utilized when the distal cap 440 is in both the extended and / or retracted positions. For example, a medical professional may be able to utilize a visualization accessory when the device 405 is deployed within a body lumen and when the distal cap 440 is deployed against the tissue selected for ablation. It is understood that the tissue selected for ablation can be, for example, an area of ​​diseased tissue including a tumor and / or a lesion, as well as a portion of healthy tissue immediately adjacent to the diseased tissue. In some embodiments, the tissue selected for ablation can include a benign cyst or legion. By ablating a portion of the healthy tissue, the risk of not completely capturing the diseased tissue and / or removing diseased tissue cells and potentially contaminating another tissue area can be minimized.

[0026] Referring again to FIG. 2 , in some embodiments, device 200 may further include tissue capture device 235. In some embodiments, the tissue capture device may be a suction device, a mechanical grasping tool, and / or additional components for capturing tissue. For example, suction may be applied to grasp tissue and / or may be used in combination with attachment 230, such as a mechanical grasping tool, to engage and hold (e.g., grasp and / or aspirate) tissue (e.g., diseased tissue portion) inward toward the center of body 205. Once selected tissue is grasped and held between balloons 220 a, 220 b, tissue capture device 235 may be extended to hold the tissue in place. In some embodiments, one or more posts may extend from the body to capture tissue (see FIG. 8G ). The posts may extend from body 205 parallel to axis 202. The posts may be arranged in a circumferential pattern around body 205 and may be individually actuable such that tissue may be captured between the posts and distal cap 217.

[0027] In some embodiments, device 200 can further include one or more tissue closure devices 240 for closing the body lumen together before the diseased tissue is resected. In embodiments, tissue closure device 240 can be staples, although other types of closure systems are contemplated. In some embodiments, tissue closure device 240 can be part of tissue capture device 235. For example, as the posts extend toward distal cap 217 to capture tissue, staples can be deployed from distal cap 217 and / or tissue capture device 235, or from other portions of the body, such as within the edge of a capture line with the capture device, or from other portions of the body, such as within the periphery of a capture line with the capture device but outside the resection line of the resection device (e.g., the cut line in the case of a blade). The staples can conform to a closed shape by force against tissue capture device 235 and / or distal cap 217 to secure the selected tissue.

[0028] Device 200 may further include one or more tissue resection devices 245 for separating diseased tissue. As described below (see FIGS. 6A-7C ), tissue resection device 245 may be one or more blades, knives, cutting tools, cauterization tools, etc., and may be configured to extend from body 205 once device 200 is in place and selected tissue is positioned for resection. For example, in embodiments, one or more blades are extendable in a direction parallel to axis 202, e.g., from a proximal portion of distal end 205 b of body 205 toward a distal portion of distal end 205 b of body 205. The blades may be movable circumferentially around body 205, e.g., to resect selected tissue within the stapled portion, or may be in a punch or cookie cutter configuration that resects the entire circumference in a single motion. To prevent undesired tissue separation, it may be advantageous to resect the selected tissue after staples have been deployed to secure the selected tissue. In other embodiments, it is envisioned that tissue resection device 245 resects tissue before tissue closure device 240 secures the tissue.

[0029] As shown in FIGS. 6A-6B , the resection device 600 may include a tissue resection device 645 extending from the body 605 in a direction parallel to the axis 602. In embodiments, the tissue resection device 645 may be disposed around the circumference of the body 605 such that tissue selected for resection can be resected when positioned between the anchoring mechanisms 615. For example, the anchoring mechanisms may engage tissue adjacent to the tissue selected for resection. In embodiments, the tissue resection device 645 may be in a retracted position, as indicated by reference numeral 650. In the retracted position, the tissue resection device 645 is fully retracted within the body 605 (e.g., below the surface 655) such that no tissue can be resected. In the extended position, as indicated by reference numeral 660, the tissue resection device 645 can extend from the surface 655 of the body 605 toward the distal cap 617. As described above, one or more tissue capture devices may hold the tissue selected for resection against the distal cap 617. Once the tissue is secured by the tissue capture device, the tissue resection device 645 is extended to cut the selected tissue for resection. In some embodiments, the tissue resection device 645 may be a single blade circumferentially disposed within the body 605 that is actuable with a single motion. In other embodiments, multiple tissue resection devices may be utilized and positioned and actuated individually around the body 605.

[0030] It is further contemplated that the tissue resection device may extend from the body 605, 705, as shown in Figures 6A-6B and 7A, and / or from the distal cap 617, 717, as shown in Figures 7B-7C. The tissue resection device 645, 745, 745' may be the same or similar tool as the tissue resection device 245 of Figure 2. In embodiments in which the tissue resection device 245, 645, 745, 745' is a blade, the blade may be formed in any shape, including, but not limited to, a straight blade edge, a tapered blade edge, serrated edges, and / or sawtooth edges. For example, the tissue resection device 745 may extend from the body 705 in the direction indicated by arrow 750.

[0031] The tissue resection device 745 is extendable and / or retractable in a direction parallel to the axis 702. In other embodiments, the tissue resection device 745' may be disposed in the distal cap 717'. The tissue resection device 745' may be extendable and / or retractable by an outer shaft 755, within which the tissue resection device 745' is coupled, and an inner shaft 760, which is coupled to the distal cap 717'. In the retracted position, the tissue resection device 745' may be nested in a gap 770 in the distal cap 717'. To expose the tissue resection device 745', the inner shaft 760 can be moved distally, for example, as indicated by arrow 765, while the outer shaft 755 and the tissue resection device 745' remain stationary. In some embodiments, the inner shaft 760 can remain stationary while the outer shaft 755 and the tissue resection device 745' move proximally toward the body 705. In other embodiments, the inner shaft 760 can move distally and the outer shaft 755 and tissue excision device 745' can move proximally.

[0032] 7A-7B. For example, device 700'' may include a tissue resection device 745 disposed in body 705 and a tissue resection device 745' disposed in distal cap 717'. The tissue resection devices 745, 745' may be resectable to resect selected tissue from both directions; for example, tissue resection device 745 may extend distally from body 705 and tissue resection device 745' may extend proximally from distal cap 717'. In embodiments in which tissue resection devices 745, 745' are blades, the blades may be formed in any shape, as described above, and in some embodiments, may be configured to mate with one another.

[0033] 8A-8J, a method of tissue resection using an exemplary embodiment of a tissue resection device 800 in accordance with the present invention is shown. It should be understood that any of the features described in the exemplary embodiments shown in FIGS. 2-7C may be incorporated into device 800. In step 805a, a scope, such as an endoscope, gastroscope, colonoscope, or duodenoscope, may be inserted into a patient and delivered to a body lumen 815 containing tissue to be resected. In some embodiments, a visualization device 810, e.g., an accessory such as a camera, fiber optics, or other device, may be used to visualize the tissue for resection. Device 810 may extend into body lumen 815 in a direction along axis 802. As described above, the tissue may have a tumor, a lesion, and / or be otherwise diseased. A medical professional may mark the tissue to be resected, as indicated by arrow 820, for example. The tissue may be marked with ink, radiopaque contrast, echogenic contrast, or other known techniques. In some embodiments, a medical professional may utilize fluoroscopic imaging and / or ultrasound-guided navigation techniques to visualize the tissue selected for resection. The tissue for resection may be marked as two circumferential bands, e.g., 825a and 825b, to demarcate the region of tissue for resection. It is understood that when tissue is resected from the body lumen 815, it may be completely resected, separating the body lumen into two portions. To prevent separation of the edges of the body lumen 815, e.g., the boundaries of markers 825a and 825b, tissue closure devices, such as staples and / or adhesives, may be used to join the edges of the body lumen 815. This may minimize and / or prevent contamination of the body lumen 815 by surrounding bodily fluids.

[0034] In step 805b, as shown in FIG. 8B, apparatus 810 is removed from the patient, and tissue resection device 800, having proximal end 800a and distal end 800b and formed with body 813, can be inserted and delivered to body lumen 815, the tissue marked for resection. Distal end 800b of device 800 can have distal cap 817 and be positioned distal to the tissue marked for resection (second marker band 825b). It can be understood that proximal end 800a of device 800 can be external to the patient, and distal end 800b of device 800 can be at the site for tissue resection. In step 805c, as shown in FIG. 8C, an anchoring mechanism, such as balloon 819b, can be expanded to secure device 800 in body lumen 815. A balloon 819b can be disposed on the distal cap 817 and can contact the inner surface 821 of the body lumen 815, for example, in a region distal to the tissue marked for resection by the markers 825a, 825b. The balloon 819b is radially expandable about the axis 802.

[0035] In step 805d, as shown in FIG. 8D , device 800 can be expanded so that the anchoring mechanism surrounds the tissue for resection defined by markers 825a, 825b. For example, the anchoring mechanism can engage tissue within the body lumen adjacent to the tissue selected for resection. As described above, shaft 823 can be coupled to distal cap 817 and movable relative to body 813 along axis 802. In some embodiments, body 813 can be movable relative to shaft 823 and / or distal cap 817. For example, when balloon 819b is expanded to secure distal cap 817 to inner surface 821 of body lumen 815, body 813 can be moved proximally away from distal cap 817, exposing shaft 823. Body 813 can be positioned in an area within the body lumen outside (e.g., proximal to) the tissue boundary marked by markers 825a, 825b. Balloon 819a may be expanded to secure device 800 in body lumen 815. Body 813 and distal cap 817 may be separated along axis 802 by a distance "d2" corresponding to the tissue selected for ablation, for example, between markers 825a, 825b.

[0036] 8E, distal cap 817 and / or body 813 may be drawn together to compress the tissue selected for resection between markers 825a, 825b. For example, distal cap 817 may be moved proximally while body 813 remains stationary, or distal cap 817 may be moved distally while body 813 remains stationary, or both body 813 and distal cap 817 may be moved. When distal cap 817 and / or body 813 are moved with balloons 819a, 819b in an expanded state, friction between each balloon 819a, 819b and the inner surface 821 of body lumen 815 is minimized and / or slippage of balloons 819a, 819b is prevented, allowing them to fold as shown by reference numeral 827 into the tissue selected for resection, and the distance "d3" between body 813 and distal cap 817 is shorter than the distance "d2" shown in FIG. 8D.

[0037] In step 805f, as shown in FIG. 8F, the folded tissue 827, e.g., tissue for resection, may be pulled radially inward toward the shaft 823. In some embodiments, an attachment 829, such as a suction device or mechanical grasper, may be utilized as a tissue capture device. The attachment may be circumferentially movable to rotate about the axis 802, pulling the selected tissue inward for resection, resulting in the entire area being retracted inward circumferentially. As noted above, this procedure may be advantageous for full-thickness resection, e.g., resecting all tissue layers from a portion of a body lumen. In step 805g (see FIG. 8G), one or more tissue capture devices 831 may extend distally from the body 813 to capture and hold the selected tissue for resection against the inner surface 833 of the distal cap 817, as indicated by reference numeral 830. The tissue capture devices 831 may be positioned circumferentially of the device 800 about the axis 802. In embodiments, portions of the tissue circumference may be retracted or the entire tissue circumference may be retracted by the attachment before the capture device is activated and then the retracted tissue is captured by the tissue capture device. In embodiments, the tissue capture device 831 may be, for example, a post with a blunt distal end to hold the tissue in place without damaging the tissue.

[0038] In some embodiments, when the posts extend into the distal cap 817, the tissue closure device can close or seal the tissue demarcated by the markers 825a, 825b. For example, staples 840 can be deployed circumferentially against the posts to secure the tissue, e.g., define the boundaries of the tissue to be resected by the markers 825a, 825b (see FIG. 8J). In other embodiments, adhesives or other closure mechanisms can be used to secure the tissue. In some embodiments, the staples are preloaded into the body 813, and the distal cap 817 may include or incorporate a forming anvil. The force applied to the staples as the body 813 and cap 817 close and the staples are driven into the anvil can close the staples around the tissue. In embodiments, for example, when the body 813 and distal cap 817 are moved together along the axis 802, multiple staples can be simultaneously stapled with an axially translating clamping mechanism or staple driving mechanism. In other embodiments, multiple staples can be sequentially stapled, for example, by a rotating wedge clamp or staple driving mechanism, whereby staples are formed one at a time as the wedge mechanism rotates around the body 813, with the wedges sequentially contacting, driving, and forming each staple. Such mechanisms may require reduced staple formation forces compared to other forming mechanisms and techniques. In some embodiments, the staples may be pre-loaded in the distal cap 817 with the body 813 acting as a forming anvil, and the staples may be spring-loaded, hydraulically actuated, or a combination thereof. Alternatively, simultaneous or sequential (e.g., wedge) driving mechanisms can be used. The tissue capture device 831, e.g., posts, can temporarily hold the tissue prior to stapling. Prior to stapling and / or resection, the medical professional can verify with tissue markers that the tissue selected for resection encompasses all of the desired tissue for resection and can make adjustments as needed. The tissue capture device 831, e.g., posts, can form an anvil, and can include a tissue closure device 240.When the staples are deployed, they may be formed by a force acting against the forming anvil, encircling the tissue selected for resection with the staples.

[0039] Once tissue has been captured by the tissue capture device 831 and / or the tissue closure device, in step 805h, a tissue resection device 835 may be extended from the body 813 and / or the distal cap 817, as shown in FIG. 8H. As described above with respect to FIGS. 2, 6A-7C, the tissue resection device may be circumferentially disposed around the body 813 and / or the distal cap 817 about the axis 802. In embodiments, the tissue resection device 835 may be disposed radially inward from the tissue capture device 831 and / or the tissue closure device, such that as the tissue is resected, the captured tissue is held by the staples of the tissue capture device 831 and / or the tissue closure device. In this manner, the resected portion of the body lumen 815 may be prevented from separating during the procedure. As shown in FIG. 8I, in step 805i, once the tissue has been resected or otherwise severed, the distal cap 817 and the body 813 may be withdrawn together. The tissue capture device 831 and / or the tissue closure device may be retracted. The excised tissue may be removed from the patient through the working channel (see FIG. 2), for example, by a mechanical grasping tool or other retrieval device.

[0040] As shown in FIG. 8J , in step 805j, once the procedure is complete, balloons 819a, 819b are deflated so that device 800 is no longer secured to inner surface 821 of body lumen 815. Device 800 may then be removed from the patient, for example, by retracting proximally from body lumen 815. Staples 840 or other closure mechanisms, such as sutures and / or adhesives, may secure the ends of body lumen 815 from the tissue bounded by markers 825a, 825b. In embodiments, the closure mechanism may be formed from a bioabsorbable and / or biodegradable material. As tissue regrowth occurs, the closure mechanism may naturally deteriorate. In some embodiments, the closure mechanism is removable from the patient.

[0041] 9A-9B, there is shown another exemplary embodiment of a tissue excision device 900 in accordance with the present invention. In FIG. 9A, the device 900 is shown in an extended position 905, and FIG. 9B shows the device 900 in a retracted position 910.

[0042] The device 900 may include a body portion 915 and a distal cap portion 920. The body 915 may be tubular in shape extending along an axis 902, and the distal cap 920 may be coupled to a shaft 925 such that the shaft 925 is movable along the axis 902. The shaft 925 may be coaxial with the body 915 along the axis 902. In embodiments, the distal cap 920 may be at least partially spherical, e.g., dome-shaped, and may be coaxial with the body 915 and shaft 925. The shaft 925 may be movable relative to the body 915, such that the distal cap 920 and body 915 may be spaced a distance "d4" apart from one another to receive tissue to be excised, similar to the embodiment described with reference to FIGS. 2-8J, for example.

[0043] The device 900 may be configured to extend along the exterior of a scope 930, such as, for example, an endoscope, colonoscope, gastroscope, and / or duodenoscope. For example, the distal end 930b of the scope 930 can be initially positioned at a desired location within a body lumen, with the proximal end 930a outside the patient. The device 900 can then be delivered to the distal end 930b. In embodiments, the scope 930 can be within the shaft 925 of the device 900. In embodiments, the scope 930 can have a visualization device 955 (e.g., a camera, a fiber optic cable, etc.). In embodiments, the visualization device 955 can be positioned at the distal end of the scope 930, although it is envisioned that the visualization device 955 can be positioned on the side of the scope 930. In some embodiments, a visualization device independent of the scope 930 can be used to visualize the placement of the device 900.

[0044] In embodiments, once device 900 is delivered to a patient's body lumen, device 900 may be secured to the inner surface of the body lumen, for example, by suction via anchoring mechanism 935. The anchoring mechanism 935 may be within the body 915 and / or distal cap 920 to engage body lumen tissue. In some embodiments, the anchoring mechanism 935 may be configured with multiple suction channels 940 extending along the periphery 945 of the body 915 and / or distal cap 920. The vacuum may draw and hold tissue into the body 915 and / or distal cap 920, thereby initiating suction as a tissue capture device (see FIG. 10C ). It is also understood that other attachment mechanisms may be used as anchoring mechanism 935 to engage the distal cap 920 and / or body 915 to the inner surface of the body lumen. For example, to secure the device 900, mechanical fasteners such as hooks, needles (e.g., j-needles), sutures, and / or T-tags can be configured to extend radially from openings in the outer periphery 945 of the distal cap 920 and / or body 915. The mechanical fasteners can extend circumferentially to engage a body lumen.

[0045] 10A-10E, a process for resecting tissue using an exemplary embodiment of a tissue resection device 1000 according to the present invention is shown. It is understood that any of the features described in FIGS. 2-9B may be included in the device 1000. As shown in FIG. 10A, in step 1005a, an endoscope 1010 may be delivered to a body lumen 1015 having a tissue section for resection. As described above, a full-thickness tissue portion may be resected by circumferentially resecting selected tissue in the body lumen 1015. When the endoscope 1010 is in a desired position, for example, when a medical professional has visually determined tissue for resection by the endoscope 1010, the device 1000 may be extended to an open position. As shown in step 1005b of FIG. 10B, the distal cap 1020 and / or the body 1030 may be extended by the shaft 1025, such that the distal cap 1020 and the body 1030 are spaced apart by a distance "d5." Distance "d5" may encompass the tissue of the body lumen 1015 selected for ablation.

[0046] When the device 1000 is in the desired position, suction can be initiated by the suction device 1035 in the body 1030 and / or the distal cap 1020 as a tissue capturing device. The inner surface 1040 of the body lumen 1015 can be drawn toward and engaged with the suction device 1035. In some embodiments, multiple suction channels 1037 can engage the inner surface 1040 of the body lumen 1015 to circumferentially engage the device 1000. In embodiments, the suction device 1035 can be disposed on both the distal cap 1020 and the body 1030, and the tissue selected for resection can be defined by a distal portion of the tissue engaging the distal cap 1020 and a proximal portion of the tissue engaging the body 1030. When the device 1000 engages the distal cap 1020 and the body 1030, the device 1000 can be engaged or anchored in the body lumen 1015.

[0047] As shown in FIGS. 10D-10E , in step 1005d, the distal cap 1020 and the body 1030 can be drawn together to gather the body lumen tissue bounded by the distal and proximal engaged tissue portions, as indicated by reference numeral 1045. As described above in FIG. 8F , an accessory such as a mechanical grasper or an additional suction device can be utilized to pull the tissue radially inward. Once the tissue selected for resection is positioned between the body 1030 and the distal cap 1020, the tissue closure device 1050 and / or tissue resection device 1055 can be used as described above with respect to FIGS. 8G-8J . For example, the tissue closure device 1050 can be a circular ring, e.g., having blunt edges, disposed on the distal cap 1020 and / or the body 1030. Once the distal cap 1020 and / or the body 1030 are secured together, the tissue selected for resection can be held by the tissue closure device, clamping the tissue closure device against the tissue.

[0048] Once the tissue selected for resection is clamped between the distal cap 1020 and the body 1030, a tissue resection device 1055 may be utilized to resect the selected tissue. For example, in some embodiments, a blade or other resection device, such as an electrocautery device, and / or a radially expandable wire, is extendable from the distal cap 1020 and / or the body 1030. The tissue resection device 1055 is circumferentially movable about the axis 1002 around the distal cap 1020 and / or the body 1030. For example, the tissue resection device 1055 may begin resection of tissue at 0° and finish resection of tissue at 360° for full-circumferential tissue resection in a portion of the body lumen 1015. In embodiments, the blade may be similar to a hole punch, as described above.

[0049] In some embodiments, a tissue closure device 1060 can be used to join the edges of the body lumen 1015 from the portion to be resected. For example, the tissue closure device 1060 can include staples, sutures, clips, and / or adhesives as a closure mechanism. The closure mechanism may be pre-loaded onto the device 1000 to be deployed. The tissue closure device 1060 may be deployed circumferentially around the tissue, similar to FIGS. 8G-8J. It is understood that the tissue closure device 1060 can insert staples or other closure mechanisms before the tissue is resected by the tissue resection device 1055. Sealing the body lumen before resecting the selected portion of tissue can minimize and / or prevent contamination of the body lumen from bodily fluids and / or fluids within the body lumen by enclosing the surrounding area. Once the selected tissue to be resected has been resected, the device 1000 can be disengaged from the inner surface 1040 of the body lumen 1015, for example, by turning off the vacuum. The device 1000 may then be removed from the patient by retracting it proximally.

[0050] 11A-11C, 12A-12C, and 13A-13B, another embodiment of a tissue resection device 1100, 1200 and method for resecting tissue is shown. The device 1100, 1200 can include a body portion 1110 extending along an axis 1102. The body portion 1110 can be substantially cylindrical and, in embodiments, can be, for example, a hollow tube for receiving a portion of a body lumen 1120. A distal cap 1115 can be disposed distal to the body 1110 along the axis 1102 and can be substantially round, cylindrical, or any other shape configured to couple with the body 1110. In some embodiments, the distal cap 1115 is coupled to a sheath or lumen 1117 that is extendable along the axis 1102a and is manipulable at a proximal end (e.g., outside the patient) for positioning relative to the body 1110. In some embodiments, the lumen 1117 may be coupled to a connector 1118 of the distal cap 1115. The connector 1118 may be integrally formed on the proximal distal cap 1115 for coupling to the lumen 1117. In some embodiments, the connector 1118 may be attached to the distal cap 1115. The body 1110 and / or the distal cap 1115 may be formed from materials such as steel, nitinol, plastic, an expandable balloon, and / or any other material configured to accommodate tissue selected for resection. In some embodiments, the proximal end 1110a of the body 1110 may have an opening 1220 that may be utilized for delivery of additional tools and / or devices, including, but not limited to, a resection device such as a knife, an attachment tool such as a t-tag, or other components of the tissue resection device 1100, 1200. For example, a scope such as an endoscope, gastroscope, colonoscope, or duodenoscope can receive one or more tools for tissue resection in one or more working channel openings 1220 and can include one or more tools for tissue resection and one or more working channels.

[0051] In embodiments, the body 1110 and distal cap 1115 may be delivered to the body lumen 1120 in a coupled position, and then the distal cap 1115 and body 1110 may be separated into position for tissue resection. For example, in steps 1105a and 1205a, the distal cap 1115 may be positioned in the body lumen 1120 distal to the selected tissue 1125 to be resected, and the body 1110 may be positioned in the body lumen 1120 proximal to the selected tissue 1125 to be resected, such that the body portion 1110 and the distal cap 1115 are separated by a distance "d6." In some embodiments, a medical professional visualizes the selected tissue to be resected, for example, by ink, radiopaque contrast, echogenic contrast, or other known techniques, and / or utilizing fluoroscopic imaging and / or ultrasound-guided navigation techniques, as described above. Additionally, the medical professional may visualize the location of the devices 1100, 1200 with a visualization device such as a camera, fiber optic cable, and / or other imaging device may be delivered to the desired location.

[0052] As described above, in some embodiments, the devices 1100, 1200 may be deliverable over an endoscope 1240, and a visualization device may be used by delivering it to a treatment site through the working channel of the endoscope. For example, the endoscope 1240 may be extendable along the shaft 1102a and receivable within the opening 1220. As shown in FIG. 12C , the endoscope 1240 may include one or more working channels for delivering lumens 1117, resection devices such as knives, and / or mechanical fasteners 1225, such as T-tags. In some embodiments, the devices 1100, 1200 may be separate attachments to the endoscope. In other embodiments, the body 1110 and distal cap 1115 may be deliverable to a treatment site through the working channel of an endoscope and may extend to fit the inner diameter of a body lumen. The lumen 1117, in some embodiments, may be a guidewire or other rigid or semi-rigid push tool, allowing a medical professional to articulate the body 1110 and / or distal cap 1115. In some embodiments, the body 1110 and / or cap 1115 may be delivered to the treatment site by being pushed over an imaging device, such as an endoscope. In this manner, the endoscope acts as a guidewire to allow a medical professional to position the body 1110 and cap 1115 as needed, and the endoscope may include one or more working channels that can be used to deliver additional instruments / accessories to the treatment site. In some embodiments, the cap 1115 can be manipulated by a medical professional from the proximal end (e.g., external to the patient) via forceps or other accessories inserted into the working channel of the endoscope. In some embodiments, the device and / or accessories can be manipulated through an external access point by percutaneous insertion via a laparoscopic approach to the target tissue.

[0053] The body 1110 and / or the distal cap 1115 may include an anchoring mechanism 1130 for engaging the inner surface 1120a of the body lumen 1120. The anchoring mechanism 1130 may be disposed about the outer circumferential surface 1135, 1140 of the body 1110 and / or the distal cap 1115, respectively. The anchoring mechanism 1130 may be embedded to secure and stabilize the body 1110 and / or the distal cap 1115 to the inner surface 1120a of the body lumen 1120, but does not pierce, e.g., extend beyond the outer surface 1120b of the body lumen 1120. The body 1110 and / or distal cap 1115 may be capable of engaging with healthy tissue portions within the body lumen 1120, such that the entire diseased tissue can be included in the tissue selected for resection 1125 (whereby the body arrangement 1110 and distal cap 1115 are positioned a distance "d6" from each other and surround the tissue selected for resection) and removed by the device 1100.

[0054] The anchoring mechanism 1130 may be one or more mechanical fasteners, including, but not limited to, clips, clamps, quills, barbs, etc. In some embodiments, the anchoring mechanism 1130 may be a suture or other device for securing the body portion 1110 and / or distal cap 1115 to the inner surface 1120a of the body lumen 1120. In some embodiments, the anchoring mechanism 1130 may be a quill oriented such that the body portion 1110 and / or distal cap 1115 rotates about the axis 1102 in a first direction, indicated by arrow 1145, to embed or lock the quill into the inner surface 1120a of the body lumen 1120. If the main body 1110 and / or the distal cap 1115 require readjustment, the main body 1110 and / or the distal cap 1115 can be rotated about the axis 1102 in a second direction opposite to the first direction (arrow 1145) to release the quill from the inner surface 1120a of the body lumen 1120.

[0055] Once the body 1110 and distal cap 1115 are positioned within the body lumen 1120 along the axis 1102 and secured to the inner surface 1120a of the body lumen 1120, the tissue 1125 selected to be resected may be drawn into the interior of the body 1110 by suction, which may be in addition to and / or supplemented by mechanical grasping methods such as those described with respect to FIGS. 2, 8F, 9A-9B, and 10A-10E. In some embodiments, as shown in step 1105b of FIG. 11B, a grasping tool may grasp the inner surface 1120a of the tissue 1125 selected to be resected and pull the tissue radially inward from the body lumen 1120. For example, as described above, in some embodiments, the grasping tool may be delivered to the treatment site through a working channel of an endoscope. The endoscope may allow articulation of the grasping tool a distance "d6" between the distal cap 1115 and the body 1110. The medical professional can articulate the grasping tool to grasp selected tissue and retract the tool inside the body 1110 .

[0056] In some embodiments, the inner circumferential surface 1150 can include one or more fasteners, such as hooks, barbs, etc., to secure the tissue 1125 selected to be resected (see FIG. 11C ). In some embodiments, a suction device, such as a tissue capture device, can be engaged with the body 1110 and initiated to draw the tissue 1125 selected to be resected radially inward into the body 1110. For example, suction can be applied to pull the tissue 1125 selected to be resected proximally along the axis 1102, as shown by arrow 1155.

[0057] In some embodiments, an expandable ring 1305 (see FIGS. 13A-13B) can be deployed on the selected tissue 1125 to be resected. The ring 1305 can be attached to the inner surface 1120a of the tissue, for example, by hooks, rings, or other mechanical fasteners. The ring 1305 can have a variable diameter and can be formed, for example, from a flexible material so that the ring 1305 is collapsible and expandable. The ring 1305 can be attached to the selected tissue to be removed (see FIG. 13B) and can be retracted into the body 1110. In some embodiments, a grasping tool 1310 having a proximal end outside the patient, for example for articulation by a medical professional, can be used to retract the selected tissue inward. The grasping tool 1310 can be extendable along the axis 1102 and can be pulled proximally (see FIG. 13B) such that the ring radially contracts and retracts into the body 1110, thereby retracting the selected tissue into the body 1110.

[0058] In some embodiments, one or more balloons can be utilized to draw the tissue 1125 selected to be resected into the body 1110. Referring now to FIGS. 12A-12C, the balloon 1210 can be expanded within the body lumen 1120 and engaged with the tissue 1125 selected to be resected. The balloon 1210 can include an anchoring mechanism 1215 for engaging the inner surface 1120a of the body lumen at the tissue 1125 selected to be resected, for example, by one or more mechanical fasteners, clips, clamps, barbs, hooks, etc. Once the balloon 1210 engages the tissue 1125 selected to be resected, the balloon 1210 can be deflated or super-deflated (e.g., by applying a vacuum to completely empty the balloon) (see step 1205b of FIG. 12B), so that the balloon 1210 has a webbing effect. For example, as shown in Figures 12B-12C, the deflated balloon, designated by reference numeral 1210' and still engaged with the inner surface 1120a of the body lumen near the selected tissue 1125 to be excised, can then be retracted proximally in a direction to draw the tissue into the body 1110.

[0059] 11C , in step 1105c, the distal cap 1115 may be moved proximally toward the body 1110 to secure the tissue 1125 selected for resection within the body 1110. In some embodiments, the distal cap 1115 and the body 1110 may be coupled together. For example, the distal cap 1115 and the body 1110 may be coupled together by a mechanical fastener 1160 such as a clip, a rivet (e.g., a POP® rivet), a snap, or the like. In some embodiments, T-tags, barbs, and / or hooks may couple the distal cap 1115 and the body 1110.

[0060] 12C , the distal cap 1115 can be moved proximally toward the body 1110 to secure the tissue 1125 selected for resection within the body 1110. In some embodiments, the tissue may be captured by a mechanical fastener 1225, such as a t-tag, for confinement within the body 1110 and cap 1115. The mechanical fastener 1225 is deliverable through at least one cavity 1235 in the body 1110. In some embodiments, the mechanical fastener 1225 is deliverable as an accessory by an endoscope, as described above with respect to other accessories such as tissue resection devices, tissue grasping tools, etc.

[0061] In embodiments, the tissue resection device is deployable to resect tissue selected for resection 1125 in the body 1110. As described above with respect to Figures 6A-6B, 7A-7C, 8H, 9A-9B, and 10A-10E, the tissue resection device may be a blade extendable from the distal cap 1115, an electrocautery device, and / or a radially expanding wire, and similarly operable to resect the tissue 1125 selected to be resected from the body lumen 1120. As described above, the tissue resection device is deliverable to the treatment site through the working channel of the endoscope.

[0062] Numerous specific details are set forth herein to provide a thorough understanding of the embodiments. However, it will be understood by those skilled in the art that the embodiments may be practiced differently from the description of these specific details. In other instances, well-known operations, components, and circuits have not been described in detail so as not to obscure the embodiments. It will be understood that specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of the embodiments.

[0063] Some embodiments may be described using the terms "coupled" and "connected," along with their derivatives. These terms are not intended as synonyms for each other. For example, some embodiments may be described using the terms "connected" and / or "coupled" to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" can also mean that two or more elements are not in direct contact with each other, but yet still cooperate or interact with each other.

[0064] It should be noted that the methods described herein do not have to be performed in the order described, or in any particular order. Furthermore, various operations described with respect to the methods identified herein may be performed serially or in parallel.

[0065] Although specific embodiments have been illustrated and described herein, it is understood that any configurations calculated to accomplish the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of the various embodiments. It is understood that the above description has been made in an illustrative manner and is not limiting. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those skilled in the art upon reviewing the above description. Accordingly, the scope of the various embodiments includes any and all other applications in which the above compositions, structures, and methods are used.

[0066] Although the subject matter has been described in language specific to structural features and / or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claimed subject matter. The technical ideas included in the present disclosure are described below. (Appendix 1) 1. A tissue resection device for resecting tissue within a body lumen, comprising: a body extending along a given axis; a distal cap disposed distally of the body and coupled to a shaft extending along the axis, the body and the distal cap being movable relative to one another; an anchoring mechanism for engaging the body and the distal cap adjacent to the selected tissue to be excised within the body lumen; a tissue capturing device deployable from the tissue resection device such that the tissue selected to be resected can be captured by the tissue capturing device; a tissue resection apparatus for resecting the tissue selected to be resected. (Appendix 2) 10. The tissue resection device of claim 1, further comprising a tissue closure device. (Appendix 3) 3. The tissue resection device of claim 1 or 2, wherein the anchoring mechanism includes a first balloon disposed on the distal cap and a second balloon disposed on the body, the first and second balloons being expandable to engage the body lumen such that the selected tissue to be resected is between the first and second balloons. (Appendix 4) 4. The tissue resection device of any one of claims 1 to 3, wherein the tissue capture device includes one or more posts arranged circumferentially around a surface of the body and extendable from the body in a direction along the axis to secure the selected tissue to be resected relative to the distal cap. (Appendix 5) 5. The tissue resection device of any one of claims 2 to 4, wherein the tissue closure device includes a closure mechanism for joining portions of the body lumen. (Appendix 6) 6. The tissue excision device of any one of claims 1 to 5, wherein the tissue excision device includes a blade disposed circumferentially around a surface of the body and extendable from the body in a direction along the axis to excise the selected tissue to be excised. (Appendix 7) 6. The tissue resection device of any one of claims 1 to 5, wherein the tissue resection device includes a blade disposed circumferentially around a surface of the distal cap and extendable from the distal cap in a direction along the axis to resect the selected tissue to be resected. (Appendix 8) 8. The tissue excision device of claim 7, wherein the tissue excision device is disposed on an outer shaft, the distal cap is disposed on an inner shaft, and the tissue excision device is extendable from the distal cap in response to the inner shaft being movable relative to the outer shaft. (Appendix 9) 1. A tissue ablation system for ablating tissue within a body lumen, comprising: 1. A tissue ablation device comprising: a body extending along a given axis; a distal cap disposed distally of the body and coupled to a shaft extending along the axis, the body and the distal cap being movable relative to one another; a tissue resection device comprising an anchoring mechanism that engages the body and the distal cap adjacent selected tissue to be resected within the body lumen; a visualization device for visualizing the deployment of the tissue ablation device within a body lumen relative to the selected tissue to be ablated. (Appendix 10) a tissue capturing device deployable from the tissue resection device such that the tissue selected to be resected is captureable by the tissue capturing device; a tissue excision device for excising the selected tissue for ablation; 10. The system of claim 9, further comprising a tissue closure device. (Appendix 11) 11. The system of any of claims 9-10, wherein the anchoring mechanism includes a first balloon disposed on the distal cap and a second balloon disposed on the body, the first and second balloons being expandable to engage the body lumen such that the selected tissue to be excised is between the first and second balloons. (Appendix 12) 12. The system of any of claims 10-11, wherein the tissue capture device includes one or more posts circumferentially disposed about a surface of the body and extendable from the body in a direction along the axis to secure the selected tissue to be excised relative to the distal cap. (Appendix 13) 13. The system of any of claims 10-12, wherein the tissue resection device includes a blade disposed circumferentially around a surface of the body and extendable from the body in a direction along the axis to resect the selected tissue to be resected. (Appendix 14) 14. The system of any of claims 10-13, wherein the tissue resection device includes a blade disposed circumferentially around a surface of the distal cap and extendable from the distal cap in a direction along the axis to resect the selected tissue to be resected. (Appendix 15) 15. The system of claim 14, wherein the tissue excision device is disposed on an outer shaft, the distal cap is disposed on an inner shaft, and the tissue excision device is extendable from the distal cap in response to the inner shaft being movable relative to the outer shaft.

Claims

1. 1. A device for ablating tissue in a body lumen, comprising: a body extending along an axis; a distal cap disposed distally of the body and coupled to a shaft extending along the axis, the body and the distal cap being movable relative to one another; a tissue capture device deployable from the device such that tissue selected to be resected can be captured by the tissue capture device; a tissue resection device for resecting the selected tissue to be resected; the tissue capture device includes one or more posts circumferentially disposed about a surface of the body and extendable from the body in a direction along the axis to secure the selected tissue to be excised relative to the distal cap; The device, wherein the shaft is comprised of an inner shaft and an outer shaft, the tissue excision device is disposed on the outer shaft, the distal cap is disposed on the inner shaft, and the tissue excision device is extendable from the distal cap in response to the inner shaft being movable relative to the outer shaft.

2. The device of claim 1 , further comprising a tissue closure device.

3. The device of claim 2 , wherein the tissue closure device includes a closure mechanism for joining portions of the body lumen.

4. 10. The device of claim 1, wherein the tissue excision apparatus includes a blade disposed circumferentially around a surface of the body and extendable from the body in a direction along the axis to excise the selected tissue to be excised.

5. The device of any one of claims 1 to 4, wherein the tissue excision device is a blade, the blade being extendable from the distal cap in a direction along the axis to excise the tissue selected to be excised.

6. A device as described in claim 5, wherein the blades are arranged circumferentially around the surface of the distal cap and are extendable from the distal cap in response to the inner shaft being movable relative to the outer shaft.

7. 1. A system for ablating tissue within a body lumen, comprising:

1. A device for ablating tissue, comprising: a body extending along an axis; a device comprising: a distal cap disposed distally of the body and coupled to a shaft extending along the axis, the body and the distal cap being movable relative to one another; a visualization device for visualizing the deployment of the device within a body lumen relative to the tissue selected to be ablated; a tissue capture device; a tissue resection device for resecting the selected tissue to be resected; the tissue capture device includes one or more posts circumferentially disposed about a surface of the body and extendable from the body in a direction along the axis to secure the selected tissue to be excised relative to the distal cap; The system, wherein the shaft comprises an inner shaft and an outer shaft, the tissue excision device is disposed on the outer shaft, the distal cap is disposed on the inner shaft, and the tissue excision device is extendable from the distal cap in response to the inner shaft being movable relative to the outer shaft.

8. The system described in claim 7, further comprising a tissue closure device.

9. The system of claim 8 , wherein the tissue closure device includes a closure mechanism for joining portions of the body lumen.

10. 8. The system of claim 7, wherein the tissue excision device includes a blade disposed circumferentially around a surface of the body and extendable from the body in a direction along the axis to excise the selected tissue to be excised.

11. The system of any one of claims 7 to 10, wherein the tissue excision device is a blade, the blade being extendable from the distal cap in a direction along the axis to excise the selected tissue to be excised.

12. The system described in claim 11, wherein the blades are arranged circumferentially around the surface of the distal cap and are extendable from the distal cap in response to the inner shaft being movable relative to the outer shaft.

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