Devices, systems and methods for tissue resection

Abstract

Exemplary embodiments of the present disclosure relate to devices, systems, and methods for tissue resection in a patient's body cavity, and may include a body extending along an axis, and a distal cap positioned distal to the body and coupled to a shaft extending along the axis. The body and the distal cap are movable relative to each other. An anchoring mechanism may engage the body and the distal cap in the body cavity proximate to the selected tissue to be resected. A tissue capture device may be deployed from the tissue resection device so that the selected tissue to be resected may be fixed by the tissue capture device. The tissue resection device may further include a tissue resection instrument for resecting the selected tissue to be resected.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority under 35 U.S.C. 119 to U.S. Provisional Patent Application Serial No. 62 / 675,681, filed on May 23, 2018, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0003] The present disclosure relates generally to devices, systems and methods for performing endoscopic procedures; more specifically, to tissue resection devices for use in endoscopic mucosal resection (EMR) and / or endoscopic submucosal dissection (ESD), which procedures include such devices, systems and methods to achieve partial or full circumferential endoscopic full-thickness resection (eFTR), tissue closure and / or tissue apposition. Background Art

[0004] Endoscopic mucosal resection (EMR) and / or endoscopic submucosal dissection (ESD) can be used to remove benign or diseased tissue, such as lesions, cancerous tumors, and / or other abnormalities, from the gastrointestinal system of a patient. In some patients, a full-thickness resection (FTR, which may be partial or completely circumferential in a body cavity) may be necessary to ensure complete removal of diseased tissue, as opposed to removal of only the mucosal layer of the gastrointestinal system.

[0005] However, full-thickness resection (FTR) presents additional challenges, such as anatomical difficulties in removing tissue adjacent to vital internal organs and other sensitive structures, and the risk of postoperative leakage, potentially increasing the health risks to the patient undergoing a full-thickness resection.

[0006] Based on these and other considerations, improvements of the present invention may be useful. Summary of the invention

[0007] The purpose of this summary is to introduce a series of concepts in a simplified form, which are further described in the detailed description below. This summary is not necessarily intended to identify the key features or essential features of the claimed subject matter, nor is it intended to be used as an auxiliary means to determine the scope of the claimed subject matter.

[0008] According to an exemplary embodiment of the present disclosure, a device for tissue resection in a body cavity may include a main body extending along an axis, and a distal cap located at the distal side of the main body and connected to a shaft extending along the axis. The main body and the distal cap are movable relative to each other. The device for tissue resection may further include an anchoring mechanism capable of engaging the main body and the distal cap adjacent to the selected tissue to be resected in the body cavity. The device for tissue resection may further include a tissue capture device deployable from the tissue resection device, and the selected tissue to be resected may be fixed by the tissue capture device. The device for tissue resection may further include a tissue resection instrument for resecting the selected tissue to be resected.

[0009] In various aforementioned and other embodiments of the present disclosure, the tissue excision 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 main body. The first balloon and the second balloon may be expandable to engage with the body cavity so that the selected tissue to be excised is between the first balloon and the second balloon. The tissue capture device may include one or more rods that are circumferentially disposed on the surface of the main body and extend from the main body in the direction along the axis to abut against the distal cap to fix the selected tissue to be excised. The tissue closure device may include a closure mechanism for connecting different parts of the body cavity. The tissue excision device may include a blade that is circumferentially disposed on the surface of the main body and can extend from the main body in the direction along the axis for excising the selected tissue to be excised. The tissue excision device may include a blade that is circumferentially disposed on the surface of the distal cap and can extend from the distal cap in the direction along the axis for excising the selected tissue to be excised. The tissue excision device may be disposed on an outer shaft, and the distal cap may be disposed on an inner shaft. The tissue excision device may extend from the distal cap in response to an inner shaft that can move relative to the outer shaft.

[0010] According to an exemplary embodiment of the present disclosure, a system for tissue resection in a body cavity may include a tissue resection device. The tissue resection device may include a main body extending along an axis, and a distal cap located at the distal side of the main body and connected to a shaft extending along the axis. The main body and the distal cap may move relative to each other. The tissue resection device may include an anchoring mechanism that enables the main body and the distal cap to be matched in the body cavity adjacent to the selected tissue to be resected. The system may further include a visualization device for visualizing the positioning of the tissue resection device in the body cavity relative to the selected tissue to be resected.

[0011] In various foregoing and other embodiments of the present disclosure, the system may further include a tissue capture device that can be deployed from the tissue resection device so that the selected tissue to be resected can be fixed by the tissue capture device. The system may further include a tissue resection device for resecting the selected tissue to be resected, 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 balloon and the second balloon may be expandable so as to engage with the body cavity, so that the selected tissue to be resected may be between the first balloon and the second balloon. The tissue capture device may include one or more rods that are circumferentially disposed on the surface of the body and can extend from the body in the direction along the axis for fixing the selected tissue to be resected to abut the distal cap. The tissue resection device may include a blade that is circumferentially disposed near the surface of the body and can extend from the body in the direction along the axis for resecting the selected tissue to be resected. The tissue resection device may include a blade that is circumferentially disposed on the surface of the distal cap and can extend from the distal cap in the direction along the axis for resecting the selected tissue to be resected. The tissue removal device can be disposed on the outer shaft, and the distal cap can be disposed on the inner shaft. The tissue removal device can extend from the distal cap in response to movement of the inner shaft relative to the outer shaft.

[0012] According to an exemplary embodiment of the present disclosure, a method for resecting tissue in a body cavity may include delivering a tissue resection device to a position of a selected tissue for resection in the body cavity. The tissue resection device may include a main body extending along an axis. The tissue resection device may further include a distal cap, which is located at the distal side of the main body and is connected to a shaft extending along the axis. The main body and the distal cap are movable relative to each other. The tissue resection device may further include an anchoring mechanism for engaging the main body and the distal cap adjacent to the selected tissue to be resected. The anchoring mechanism may include a first balloon disposed on the distal cap, and a second balloon disposed on the main body. The method may further include expanding the first balloon so that the distal cap engages with the body cavity; extending the distal cap and the main body along the axis at a distance from each other and expanding the second balloon so that the main body engages with the body cavity.

[0013] In various foregoing and other embodiments of the present disclosure, the method may further include closing the distal cap and the body so as to fold the selected tissue to be excised between the first balloon and the second balloon. The method may further include moving the folded selected tissue to be excised inwardly toward the axis of the tissue excision device. The method may further include fixing the folded selected tissue to be excised using a tissue capture device, wherein the fixing includes extending one or more rods circumferentially disposed on the surface of the body in a direction along the axis. The method may further include connecting the parts of the body cavity using a tissue closure device, wherein the tissue closure device includes a closure mechanism. The method may further include excising the selected tissue to be excised using a tissue excision device. The tissue excision device may include a blade circumferentially disposed on the surface of the body, and the excision may include extending the blade from the body in a direction along the axis. The tissue excision device may further include a blade circumferentially disposed on the surface of the distal cap. Excision may include extending the blade from the distal cap in a direction along the axis. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Various non-limiting embodiments of the present disclosure are described below by way of example and 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 illustrated is generally represented by a single numeral. For purposes of clarity, not every component is labeled in each of the drawings, nor is every component of each embodiment labeled, wherein illustration is not necessary to allow those skilled in the art to understand the present disclosure. In the drawings:

[0015] Figure 1 The patient's body cavity is shown;

[0016] Figure 2 An exemplary embodiment of a tissue resection device according to the present disclosure is shown;

[0017] Figure 3 An exemplary embodiment of a tissue resection device according to the present disclosure is shown;

[0018] Figure 4A-4B shows exemplary embodiments of tissue resection devices and visualization devices according to the present disclosure;

[0019] Figure 5A-5C An exemplary embodiment of an anchoring mechanism according to the present disclosure is shown;

[0020] Figure 6A-6B An exemplary embodiment of a tissue resection device according to the present disclosure is shown;

[0021] Figure 7A-7C An exemplary embodiment of a tissue resection device according to the present disclosure is shown;

[0022] Figure 8A-8J An exemplary process of removing tissue using a tissue removal device according to the present disclosure is shown;

[0023] Figure 9A-9B An exemplary tissue resection device according to the present disclosure is shown;

[0024] Figures 10A-10E An exemplary process of resecting tissue using a tissue resection device according to the present disclosure is shown.

[0025] Figures 11A-11C An exemplary tissue resection device and process for resecting tissue according to the present disclosure is shown;

[0026] Figure 12A-12C An exemplary tissue resection device and process for resecting tissue according to the present disclosure is shown;

[0027] Figure 13A-13B Exemplary tissue resection devices and procedures for resecting tissue according to the present disclosure are shown. DETAILED DESCRIPTION

[0028] The present disclosure is not limited to the specific embodiments described herein. The terms used herein are only for the purpose of describing specific embodiments and are not intended to be restrictive in the case of exceeding the scope of the appended claims. Unless otherwise specified, all technical terms used herein have the same meanings as those commonly understood by those skilled in the art to which the present disclosure belongs.

[0029] The singular forms "a", "an" and "the" used herein are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be further understood that the terms "include" and / or "have" and / or "comprise" when used herein specify the presence of stated features, regions, steps, elements and / or parts, but do not exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, parts and / or groups thereof.

[0030] It will be appreciated that references to "proximal" may be defined as the end of the systems and devices closest to the patient's point of entry, and "distal" may be defined as the end of the systems and devices closest to their intended location in the patient (e.g., the patient's gastrointestinal system).

[0031] As mentioned above, patients with lesions or other tissue in the gastrointestinal system may require resection. Figure 1, various sizes of lesions are shown in the body cavity of the patient (e.g., gastrointestinal system). As shown, the lesion tissue in the early stage may not extend through all layers of the body cavity, which may allow the excision of only the affected tissue layer. However, when the lesion tissue develops to the later stage, the excision of the entire tissue portion (e.g., full-thickness excision) may be required in order to completely excise the lesion tissue from the patient. Exemplary embodiments of the device, system and method for partial or full-thickness tissue excision according to the present disclosure may allow the selected tissue portion to contain the lesion tissue to be contained and excised from the surrounding tissue, and then the surrounding tissue is connected together so that the gap formed by the excision of the selected tissue is closed. In some embodiments, tissue excision may be full circumferential, such as extending 360° around the body cavity. In other embodiments, tissue excision may be partially circumferential, such as extending less than 360° near the body cavity. Although "excision" is used throughout the present disclosure, exemplary embodiments of the present disclosure may include excision, dissection, removal, ablation, cutting gasification, freezing, etc., and may be full thickness, partial thickness, and in the case of surgery in the body cavity, may be partially and / or completely circumferential.

[0032] Now refer to Figure 2 , shows an exemplary embodiment of a resection device 200 (e.g., an endoluminal resection device) according to the present disclosure. The device 200 can be delivered to a site in a patient for resection of a selected portion of tissue. In some embodiments, the selected tissue may be in a body cavity (such as the small intestine, colon, and / or other gastrointestinal system). The resection device 200 can be used for full-thickness resection of the large intestine, although it is conceivable that the resection device 200 can also be used for other anatomical resections. The device 200 may include a body 205 extending along an axis 202 and having a proximal end 205a and a distal end 205b. In some embodiments, the body 205 can be a lumen or a hollow tube. A handle (not shown) can be coupled to the proximal end 205a so that the distal end 205b can be driven by a medical professional. Although the body cavity is described with respect to the gastrointestinal system (including but not limited to the small intestine, colon, duodenum, and / or other gastrointestinal system), it should be understood that the devices, systems, and methods of the exemplary embodiments of the present disclosure may also be applicable to any body cavity in a patient.

[0033] The body 205 may include a shaft 210 that extends along the axis 202 coaxially with the body 205. In various embodiments, the shaft 210 can move relative to the body 205 along the axis 202. An anchoring mechanism 215 can be coupled to the body 205, for example, to fix the device 200 to the inner surface of a body cavity. In various embodiments, a portion of the anchoring mechanism 215 can be coupled to a distal end 210b of the shaft 210 as a distal cap 217 that extends distal to the distal end 205b of the body 205. For example, when the shaft 210 moves along the axis 202, a portion of the anchoring mechanism 215 coupled to the shaft 210 (e.g., the distal cap 217) can move relative to another portion of the anchoring mechanism 215 (e.g., coupled to the body 205).

[0034] In some embodiments, the anchoring mechanism 215 can be one or more expandable balloons 220a, 220b, ... 220n. Figure 2 205 , the first balloon 220a and the second balloon 220b are shown, but it is understood that any number "n" of balloons can be applied to the anchoring mechanism. The first balloon 220a can be disposed at a proximal portion of the distal end 205b of the body 205, for example, coupled to the body 205. The second balloon 220b can be disposed at a distal portion of the distal end 205b, for example, coupled to the shaft 210 on the distal cap 217, and distal to the first balloon 220a. The first balloon 220a and the second balloon 220b can be positioned along the axis 202, for example, using 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.

[0035] As described below, the anchoring mechanism (e.g., the first balloon 220a and the second balloon 220b) can surround and / or encapsulate the selected tissue portion site. For example, the first balloon 220a and the second balloon 220b can be engaged with the body 205 and the distal cap 217 adjacent to the selected tissue to be removed in the body cavity. The first balloon 220a and the second balloon 220b can be positioned to be spaced apart from each other by a distance "d". When the first balloon 220a and the second balloon 220b are in the desired site or position, these balloons can be radially expanded relative to the axis 202 to fill the body cavity and contact the inner surface of the body cavity. The balloon can be maintained to abut the inner surface of the body cavity by friction, and the movement of the shaft 210 and / or the body when the balloons 220a, 220b are in the expanded configuration causes the selected diseased tissue to fold or form wrinkles and isolate the selected tissue. In some embodiments, the balloons 220a, 220b can be made of a material that maximizes friction contact with the body cavity. It is contemplated that the first balloon and / or the second balloon may be constructed of the same or similar materials, and in some embodiments may be constructed of different materials. It should be understood that the balloons 505a, 505b, 510a, 510b, 515a, 515b may be constructed of any combination of materials. Figure 5A As shown in FIG, the first balloon 505a and / or the second balloon 505b may be made of a material 520 having a smooth elastic surface. Figure 5B A first balloon 510a and / or a second balloon 510b constructed of a material 525 having a textured elastic surface is shown. Figure 5C A first balloon 515a and / or a second balloon 515b are shown having a mesh covering surface 530. The mesh covering surface 530 may be an integrally formed material of the balloons 515a, 515b, and in other embodiments may be a separate covering over balloons 515a, 515b constructed of a different material.

[0036] In some embodiments, the anchoring mechanism 215 may include a tracking device to ensure accurate positioning in the body cavity. For example, the device 300 may include one or more markings 305 on the anchoring mechanism 215. Figure 3 As shown in the figure, the first balloon 220a may include a first marker 305a, and the second balloon 220b may include a second marker 305b. It should be understood that any number "n" of markers 305a, 305b, ... 305n may be used in conjunction 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 so that when the shaft 210 and the distal cap 217 are extended from the body 205, the second markers 305b disposed on the second balloon 220b are spaced apart by a distance "d".

[0037] In various embodiments, one or more markers 305 can be radiopaque markers and / or echogenic markers. A medical professional can guide the device 200, 300 to a desired location in a patient's body cavity using direct visualization, fluoroscopic imaging, and / or ultrasound guidance through one or more markers 305. It is advantageous to use one or more markers 305 to ensure precise positioning in the patient. A medical professional may wish to remove diseased tissue as well as a portion of healthy tissue surrounding the diseased tissue to ensure complete removal of any cancer cells. Precise positioning of the device 200, 300, such as selecting a precise distance "d", can allow a medical professional to minimize the amount of healthy tissue required to be removed.

[0038] Refer again Figure 2 In some embodiments, the device 200 may further include one or more working channels 225 for extending additional auxiliary components 230 to the site. For example, a visualization device (such as a camera, fiber optic cable, and / or other imaging device, or endoscope) may be delivered to the desired location, although any other auxiliary components used during the procedure (including but not limited to lighting devices, grasping tools, fluid delivery devices, suction devices, etc.) may utilize the working channel 225. The auxiliary components may be controlled and / or driven by the medical professional at the proximal end 205a of the device 200. In some embodiments, the auxiliary components may be locked to the handle to maintain a selected position, while the medical professional is free to manipulate other auxiliary components and / or adjust the device 200 to ensure that the diseased tissue is selected for resection.

[0039] In some embodiments, the auxiliary components can be delivered through the device 200 in various ways. Figure 4A As shown in , the device 400 may include a working channel 410 extending along the interior of a shaft (not shown). An auxiliary member 415 may then extend along this central working channel 410 and extend from a distal cap 420. This may be advantageous so that when the distal cap 420 is retracted, an auxiliary member, such as a visualization aid (such as an endoscope or other visualization device) can be applied. For example, the visualization aid may be manipulable when the shaft is not extended so that there is no gap or distance "d" between the first balloon and the second balloon. In the example shown in FIG. Figure 4BIn other embodiments shown in, an auxiliary member 425 (e.g., an endoscope or other visualization device) may be attached to the outer surface 430 of the device 405. For example, a mechanical fastener (e.g., a ring 435) may be coupled to the outer surface 430 of the device 405 for coupling the auxiliary member 425. This configuration may be advantageous because the auxiliary member may be applied when the distal cap 440 is in an extended and / or retracted position. For example, when positioning the device 405 in a body cavity, and when positioning the distal cap 440 relative to a selected tissue to be removed, a medical professional may apply a visualization auxiliary member. It should be understood that the selected tissue to be removed may be an area of ​​diseased tissue, such as a portion of healthy tissue including a tumor and / or a lesion, and adjacent to the diseased tissue. In some embodiments, the selected tissue to be removed may include a benign cyst or lesion. A portion of healthy tissue may be removed to minimize the risk of incompletely capturing the diseased tissue and / or moving the diseased tissue cells to potentially contaminate another tissue area.

[0040] Refer again Figure 2 In some embodiments, the device 200 may further include a tissue capture device 235. In some embodiments, the tissue capture device can be a suction device, a mechanical grasping tool, and / or other component for capturing tissue. For example, suction can be applied to grasp tissue, and / or can be used in conjunction with an auxiliary member 230 (such as a mechanical grasping tool) so that tissue (e.g., a diseased tissue portion) can be engaged and held inwardly toward the center of the body 205 (e.g., grasped and / or suctioned). When the selected tissue is grasped and held between the balloons 220a and 220b, the tissue capture device 235 can be extended to hold the tissue in place. In some embodiments, one or more rods can be extended from the body (see Figure 8G ) to capture tissue. The rods may extend from the body 205 in a manner parallel to the axis 202. The rods may be arranged around the body 205 in a circumferential pattern and may be individually actuated so that tissue can be captured between the rods and the distal cap 217.

[0041] In some embodiments, the device 200 may further include one or more tissue closure devices 240 for closing the body cavity together before the diseased tissue is removed. In various embodiments, the tissue closure device 240 can be a stapler, although other types of closure systems are also conceivable. In some embodiments, the tissue closure device 240 can be part of the tissue capture device 235. For example, when these rods extend toward the distal cap 217 to capture tissue, nails can be deployed from the distal cap 217 and / or other parts of the tissue capture device 235 or the body, such as a portion of the perimeter of the capture line of the capture device or other parts of the body, such as a portion of the perimeter of the capture line of the capture device and the outside of the resection line (e.g., the cutting line in the case of a blade) of the resection device. Using force against the tissue capture device 235 and / or the distal cap 217, the nails can be conformed to a closed shape so that the selected tissue is fixed.

[0042] The device 200 may further include one or more tissue removal devices 245 for separating diseased tissue. Figures 6A-7C ), the tissue excision device 245 can be one or more blades, knives, cutting tools, cauterization tools, etc., and can be configured to extend from the body 205 once the device 200 is in place and the selected tissue is positioned for excision. For example, in various embodiments, one or more blades can extend in a direction parallel to the axis 202, such as from the proximal portion of the distal end 205b of the body 205 toward the distal portion of the distal end 205b of the body 205. The blade can be moved circumferentially around the body 205, such as to excise the selected tissue inside the stapled portion, or can be a punch or biscuit cutter configuration that excises the entire circumference in one movement. It is advantageous to excise the selected tissue after the nail is deployed to fix the selected tissue to prevent undesirable tissue separation. It is also conceivable that in other embodiments, the tissue excision device 245 can excise the tissue before the tissue closure device 240 fixes the tissue.

[0043] like Figure 6A-6BAs shown in , the excision device 600 may include a tissue excision instrument 645 extending from the body 605 in a direction parallel to the axis 602. In various embodiments, the tissue excision instrument 645 may be circumferentially disposed on the body 605 so that the selected tissue to be excised can be excised when positioned between the anchoring mechanisms 615. For example, the anchoring mechanisms may engage with tissue proximate to the selected tissue to be excised. In various embodiments, the tissue excision instrument 645 may be in a retracted position, as shown at reference numeral 650. In the retracted position, the tissue excision instrument 645 may be completely retracted within the body 605 (e.g., below the surface 655) so that no tissue can be excised. In the extended position (as shown at reference numeral 660), the tissue excision instrument 645 may 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 selected tissue to be excised against the distal cap 617. Once the tissue is secured by the tissue capture device, the tissue excision instrument 645 may be extended to excise the selected tissue to be excised. In some embodiments, tissue removal instrument 645 can be a single blade disposed circumferentially in body 605 that can be actuated in a single motion. In other embodiments, multiple tissue devices that are individually disposed around body 605 and can be driven can be applied.

[0044] Additionally, it is contemplated that the tissue removal device may extend from the body 605, 705 (e.g., Fig. 6A - Figure 6 and Fig. 7A ), and / or extending from distal caps 617, 717 (as shown in Figure 7B-Figure 7C ). The tissue removal instrument 645, 745, 745' may be a Figure 2 In the embodiment where the tissue removal device 245, 645, 745, 745' is a blade, the blade can be formed in any shape, including but not limited to a straight blade edge, a tapered blade edge, a crenelated shape, and / or a serrated shape. For example, the tissue removal device 745 can extend from the body 705 in the direction indicated by the arrow 750.

[0045] The tissue removal device 745 can be extended and / or retracted in a direction parallel to the axis 702. In other embodiments, the tissue removal device 745' can be disposed in the distal cap 717'. The tissue removal device 745' can be extended and / or retracted using an outer shaft 755 and an inner shaft 760, wherein the tissue removal device 745' is coupled to the shaft 760 and the inner shaft 760 is coupled to the distal cap 717'. In the retracted position, the tissue removal device 745' can be nested in a gap 770 in the distal cap 717'. To expose the tissue removal device 745', the inner shaft 760 can be moved in a distal direction, such as indicated by arrow 765, while the outer shaft 755 and the tissue removal device 745' remain in a stationary state. In some embodiments, the inner shaft 760 can remain in a stationary state while the outer shaft 755 and the tissue removal device 745' move in a proximal direction toward the body 705. In other embodiments, the inner shaft 760 can be moved in a distal direction and the outer shaft 755 and tissue resection device 745' can be moved in a proximal direction.

[0046] Figure 7C Shown in Figure 7A-7B . For example, device 700" may include a tissue resection device 745 disposed in the body 705, and a tissue resection device 745' disposed in the distal cap 717'. The tissue resection devices 745, 745' may be able to resect the selected tissue to be resected from two directions, for example, the tissue resection device 745 may extend from the body 705 in the distal direction, and the tissue resection device 745' may extend from the distal cap 717' in the proximal direction. In embodiments in which the 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 fit together.

[0047] Now refer to Figure 8A-8J , showing the process of tissue removal using an exemplary embodiment of a tissue removal device 800 according to the present disclosure. It should be understood that in Figure 2-7CAny features described in the exemplary embodiments shown in the figure may also be incorporated into the device 800. In step 805a, a scope (e.g., an endoscope, a gastroscope, a colonoscope, a duodenoscope, etc.) may be inserted into a patient and delivered to a body cavity 815 having tissue to be removed. In some embodiments, a visualization device 810, such as an auxiliary piece (such as a camera, an optical fiber, or other device) may be used to visualize the tissue to be removed. The device 810 may extend in the body cavity 815 in the direction of the axis 802. As described above, the tissue may have a tumor, a lesion, and / or may be pathological. A medical professional may mark the tissue to be removed (e.g., the portion indicated by arrow 820). The tissue may be marked with ink, a radiopaque contrast agent, an echogenic contrast agent, or other known techniques. In some embodiments, a medical professional may apply fluoroscopic imaging and / or ultrasound-guided guidance techniques to visualize the selected tissue. The tissue to be removed may be marked as two circumferential bands (e.g., 825a, 825b) to limit the area of ​​the tissue to be removed. It should be understood that when tissue is removed from the body cavity 815, the tissue may be completely removed, thereby separating the body cavity into two parts. To prevent the edges of the body cavity 815 (e.g., at the margins of the markings 825a, 825b) from separating, the edges of the body cavity 815 may be connected using a tissue closure device (such as staples and / or adhesives). This may minimize and / or prevent contamination of the body cavity 815 by surrounding body fluids.

[0048] In step 805b, as in Figure 8B As shown in , the device 810 can be removed from the patient, and the tissue removal device 800 having a proximal end 800a and a distal end 800b and consisting of a body 813 can be inserted and delivered to a body cavity 815 to reach the marked tissue to be removed. The distal end 800b of the device 800 can have a distal cap 817 and can be positioned distal to the marked tissue to be removed (the second marking band 825b). It is understood that the proximal end 800a of the device 800 can be outside the patient, and the distal end 800b of the device 800 can be located at the site where the tissue is to be removed. In step 805c, as in Figure 8C As shown in , an anchoring mechanism (such as balloon 819b) can be expanded to secure the device 800 to the body cavity 815. The balloon 819b can be disposed on the distal cap 817 and in contact with the inner surface 821 of the body cavity 815, for example, in an area distal to the tissue marked by the markers 825a, 825b to be resected. The balloon 819b can be expanded in a radial direction relative to the axis 802.

[0049] In step 805d, as in Fig.8DAs shown in , the device 800 can be extended so that the anchoring mechanism surrounds the tissue to be removed limited by the markers 825a, 825b. For example, the anchoring mechanism can be engaged with the tissue adjacent to the selected tissue for removal in the body cavity. As described above, the shaft 823 can be connected to the distal cap 817 and can be moved relative to the body 813 along the axis 802. In some embodiments, the body 813 can be moved relative to the shaft 823 and / or the distal cap 817. For example, when the balloon 819b is expanded so that the distal cap 817 is fixed to the inner surface 821 of the body cavity 815, the body 813 can be moved away from the distal cap 817 in the proximal direction to expose the shaft 823. The body 813 can be positioned to the area in the body cavity outside the boundary of the tissue marked with markers 825a, 825b (for example, on its proximal side). The balloon 819a can be expanded so that the device 800 is fixed to the body cavity 815. The body 813 and the distal cap 817 can be separated along the axis 802 by a distance "d2", which can correspond to the selected tissue to be resected, such as between the markings 825a and 825b.

[0050] In step 805e, as in Fig. 8E As shown in , the distal cap 817 and / or the body 813 can be pulled together to compress the selected tissue to be removed between the marker 825a and the marker 825b. For example, the distal cap 817 can be moved in the proximal direction (toward the proximal direction) while the body 813 remains stationary, the body 813 can be moved in the distal direction while the distal cap 817 is stationary, or both the body 813 and the distal cap 817 can be moved. It should be understood that when the balloons 819a, 819b are in an expanded state so that the distal cap 817 and / or the body 813 move together, the friction between each balloon 819a, 819b and the inner surface 821 of the body cavity 815 can be minimized and / or the slippage of the balloons 819a, 819b can be prevented, so that the selected tissue to be removed can be turned into a wrinkled (folded) state, as indicated at 827 in the figure, and the distance "d3" between the body 813 and the distal cap 817 is smaller than the distance "d2", as shown in FIG. Fig.8D as shown in .

[0051] In step 805f, as in Figure 8F As shown in , the folded tissue 827 (e.g., tissue to be excised) can be pulled radially inward toward the axis 823. In some embodiments, an auxiliary member 829 (such as a suction device or a mechanical grasper tool) can be used as a tissue capture device. The auxiliary member can be moved in a circumferential direction so as to rotate about the axis 802, thereby pulling the selected tissue to be excised inward until the entire circumferential portion is pulled inward. As described above, this process can be advantageous for full-thickness excision (e.g., excision of all tissue layers from a portion of a body cavity). In step 805g (see Figure 8G), one or more tissue capture devices 831 can extend from the body 813 in the distal direction to capture and abut the inner surface 833 of the distal cap 817 to hold the selected tissue to be removed, as indicated at reference numeral 830. The tissue capture devices 831 can be arranged circumferentially around the device 800 relative to the axis 802. In various embodiments, when multiple portions of the circumference of the tissue are pulled in or the entire circumference of the tissue is pulled in before the capture device is actuated, the tissue pulled by the auxiliary member can be captured in the tissue capture device. In various embodiments, the tissue capture devices 831 can be rods, for example, having a blunt distal end so as to hold the tissue in place without damaging the tissue.

[0052] In some embodiments, when the rod is extended to the distal cap 817, the tissue closure device can close or seal the tissue limited by the markers 825a, 825b. For example, the staples 840 can be delivered circumferentially to the abutment rod to fix the tissue, for example, using the markers 825a, 825b (see Figure 8J ) limited tissue to be removed (see Figure 8J ). In other embodiments, the tissue may be fixed using an adhesive or other closure mechanism. In some embodiments, the nail may be preloaded in the body 813, and the distal cap 817 may include or contain a forming anvil. When the body 813 and the cap 817 are closed, the force applied to the nail when the nail is pressed into the anvil may close the nail around the tissue. In various embodiments, a plurality of nails may be stapled together simultaneously using an axially translating clamping mechanism or a nail driving mechanism, for example, when the body 813 and the distal cap 817 are moved together along the axis 802. In other embodiments, a plurality of nails may be stapled together sequentially, for example, using a rotating wedge clamping mechanism or a nail driving mechanism, whereby one nail is formed at a time when the wedge mechanism is rotated around the circumference of the body 813 and the wedge sequentially contacts, drives, and forms each nail. Such a mechanism may require a smaller nail forming force than other forming mechanisms and techniques. In some embodiments, the nail can be preloaded in the distal cap 817, with the body 813 acting as a forming anvil, and the nail can be spring-loaded, or hydraulically driven, or a combination thereof. Alternatively, a simultaneous or sequential (e.g., wedge) drive mechanism can be applied. Before stapling, the tissue capture device 831 (e.g., rod) can temporarily hold the tissue. Medical professionals will be able to confirm with tissue markings before stapling and / or excision that the selected tissue to be excised includes all the desired tissue to be excised, and can be adjusted according to demand. The tissue capture device 831 (e.g., rod) may include a tissue closure device 240, which may be a forming anvil. When the nail is deployed, the nail can be formed by the force acting on the forming anvil so that the selected tissue to be excised is closed with the nail.

[0053] When the tissue is secured using the tissue capture device 831 and / or the tissue closure device, in step 805h and as Figure 8H As shown in , the tissue removal device 835 can be extended from the body 813 and / or the distal cap 817. Figure 2 and Figures 6A-7C As described, the tissue resection device can be disposed circumferentially around the axis 802 around the body 813 and / or the distal cap 817. In various embodiments, the tissue resection device 835 can be located radially inward of the tissue capture device 831 and / or the tissue closure device, so that when the tissue is resected, the staples of the tissue capture device 831 and / or the tissue closure device are used to hold the fixed tissue. In this way, the resected portion of the interbody cavity 815 can be prevented from separating during surgery. In the embodiment shown in FIG. Figure 8I As shown in step 805i, distal cap 817 and body 813 may be pulled together as tissue is excised or cut. Tissue capture device 831 and / or tissue closure device may be retracted. Excised tissue may be removed from the patient through a working channel (see Figure 2 ) by, for example, using a mechanical gripper or other retrieval device.

[0054] In such Figure 8J 805j, when the procedure is complete, the balloons 819a, 819b may be deflated so that the device 800 is no longer secured to the inner surface 821 of the body cavity 815. The device 800 may then be removed from the patient, for example, retracted proximally from the body cavity 815. A staple 840 or other closure mechanism (such as suture and / or adhesive) may secure the ends of the body cavity 815 from the tissue limited by the markers 825a, 825b. In various embodiments, the closure mechanism may be comprised of bioabsorbable and / or biodegradable materials. The closure mechanism may naturally degrade as tissue regeneration occurs. In some embodiments, the closure mechanism may be removed from the patient.

[0055] Now refer to Figure 9A-9B , shows another exemplary embodiment of a tissue resection device 900 according to the present disclosure. Fig. 9A , the device 900 is shown in an extended position 905, and Fig. 9B Device 900 is shown in a retracted position 910 .

[0056] Device 900 may include a body portion 915 and a distal cap portion 920. Body 915 may be tubular in shape, extending along axis 902, and distal cap 920 may be coupled to shaft 925 that is movable along axis 902. Shaft 925 may be coaxial with body 915 along axis 902. In various embodiments, distal cap 920 may be at least partially spherical, such as dome-shaped, and coaxial with body 915 and shaft 925. Shaft 925 may be movable relative to body 915, so distal cap 920 and body 915 may be shaped to be spaced apart from each other by a distance "d4" to accommodate tissue to be resected, such as in Figure 2-8J The implementation scheme described in .

[0057] The device 900 may be configured to extend along the outer surface of a scope 930 (e.g., an endoscope, a colonoscope, a gastroscope, and / or a duodenoscope). For example, the distal end 930b of the scope 930 may first be positioned at a desired position in a body cavity, while the proximal end 930a is outside the patient. The device 900 may then be delivered to the distal end 930b. In various embodiments, the scope 930 may be inside the shaft 925 of the device 900. In various embodiments, the scope 930 may have a visualization device 955 (e.g., a camera, a fiber optic cable, etc.). In various embodiments, the visualization device 955 may be disposed on the distal end of the scope 930, although it is conceivable that the visualization device 955 may be disposed on the side of the scope 930. In some embodiments, a visualization device independent of the scope 930 may be used to visualize the positioning of the device 900.

[0058] In various embodiments, when the device 900 is delivered to a patient's body cavity, the device 900 can be fixed to the inner surface of the body cavity by suction (for example, using an anchoring mechanism 935). The anchoring mechanism 935 can be in the body 915 and / or the distal cap 920 for engaging with the body cavity tissue. In some embodiments, the anchoring mechanism 935 can be configured to have a plurality of suction channels 940 extending around the periphery 945 of the body 915 and / or the distal cap 920. By pulling in the tissue and holding it at the body 915 and / or the distal cap 920 as a tissue capture device, the vacuum can activate the suction (see Fig. 10C ). It should also be understood that other attachment mechanisms may be used as anchoring mechanisms 935 to engage the distal cap 920 and / or body 915 to the inner surface of a body cavity. For example, mechanical fasteners (such as hooks, needles (e.g., J-shaped needles), sutures, and / or T-shaped tags) may be configured to extend radially from an opening on the outer circumference 945 of the distal cap 920 and / or the body 915 to secure the device 900. The mechanical fasteners may extend circumferentially to engage with the body cavity.

[0059] Now refer to Figures 10A-10E, shows a process of removing tissue using an exemplary embodiment of a tissue removal device 1000 according to the present disclosure. It should be understood that in Figure 2-9B Any features described in may be included in device 1000. Fig. 10A In step 1005a shown in FIG. 1 , endoscope 1010 may be delivered to body cavity 1015 having a tissue portion to be removed. As described above, by circumferentially removing selected tissue of body cavity 1015, a full-thickness tissue portion may be removed. When endoscope 1010 is in a desired position, e.g., a medical professional has visually determined the tissue to be removed using endoscope 1010, device 1000 may be extended to an open position. As in FIG. Fig. 10B As shown at step 1005b in FIG. 1 , the distal cap 1020 and / or the body 1030 may be extended using the shaft 1025 so that the distal cap 1020 is spaced apart from the body 1030 by a distance “d5”. The distance “d5” may cover tissue of the selected body cavity 1015 to be resected.

[0060] When the device 1000 is positioned as desired, suction may be initiated using the suction device 1035 in the body 1030 and / or the distal cap 1020 as a tissue capture device. The inner surface 1040 of the body cavity 1015 may be pulled toward and engaged with the suction device 1035. In some embodiments, a plurality of suction channels 1037 may be engaged with the inner surface 1040 of the body cavity 1015, thereby engaging the entire circumferential portion of the body cavity with the device 1000. In various embodiments, the suction device 1035 may be disposed in both the distal cap 1020 and the body 1030, thereby enabling the selected tissue to be resected to be defined by the distal portion of the tissue engaged with the distal cap 1020 and the proximal portion of the tissue engaged with the body 1030. When the device 1000 is engaged with the distal cap 1020 and the body 1030, the device 1000 may be engaged with or secured to the body cavity 1015.

[0061] As in Figure 10D-10E At step 1005d shown in FIG. 1 , the distal cap 1020 and the body 1030 may be pulled together to collect the body cavity tissue confined by the distal and proximal engaged tissue portions, as shown at reference numeral 1045. Figure 8F As described in , an auxiliary member (such as a mechanical grasper tool or an additional suction device) can be used to pull the tissue radially inward. When the selected tissue to be resected is positioned between the body 1030 and the distal cap 1020, the distal cap 1020 can be removed as described above. Figure 8G-8JThe use of a tissue closure device 1050 and / or a tissue resection device 1055 is described. For example, the tissue closure device 1050 can be a ring, for example with blunt edges, disposed on the distal cap 1020 and / or the body 1030. When the distal cap 1020 and / or the body 1030 are pulled together, the tissue closure device can be used to hold the selected tissue to be resected so as to clamp the tissue closure device against the tissue.

[0062] When the selected tissue to be resected is clamped between the distal cap 1020 and the body 1030, the tissue resection device 1055 can be applied 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) can extend from the distal cap 1020 and / or the body 1030. The tissue resection device 1055 can be moved circumferentially around the distal cap 1020 and / or the body 1030 around the axis 1002. For example, the tissue resection device 1055 can start tissue resection at 0° and end tissue resection at 360° to completely resect a portion of the body cavity 1015. In various embodiments, the blade can be similar to a punch, as described above.

[0063] In some embodiments, tissue closure device 1060 can be used to connect the edges of body cavity 1015 from the portion to be removed. For example, tissue closure device 1060 can include staples, sutures, clamps, and / or adhesives as closure mechanisms. These closure mechanisms can be preloaded in device 1000 for deployment. Figure 8G-8J , the tissue closure device 1060 is circumferentially deployed near the tissue. It should be understood that the tissue closure device 1060 can insert a nail or other closure mechanism before the tissue is removed using the tissue removal device 1055. Sealing the body cavity before removing the selected portion of tissue can minimize and / or prevent the body cavity from being contaminated by surrounding body fluids and / or surrounding areas surrounding body fluids from the body cavity. When the selected tissue to be removed has been removed, the device 1000 can be separated from the inner surface 1040 of the body cavity 1015, for example by stopping the vacuum. Then, the device 1000 can be removed from the patient by retracting in the proximal direction.

[0064] Now refer to Figures 11A-11C , Figure 12A-12C and Figure 13A-13B, another embodiment of a tissue removal device 1100, 1200 and a process for removing tissue are shown. The device 1100, 1200 may include a body portion 1110 extending along an axis 1102. The body portion 1110 may be generally rod-shaped and in various embodiments may be a hollow tube, for example, for receiving a portion of a body cavity 1120. A distal cap 1115 may be disposed distally of the body 1110 along the axis 1102 and may be generally circular, rod-shaped, or any other shape configured to couple with the body 1110. In some embodiments, the distal cap 1115 may be coupled to a sheath or lumen 1117 that may extend along the axis 1102a and may be manipulated proximally (e.g., outside of a patient) to be positioned 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 side of the 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 constructed of a material for containing a selected tissue to be resected, such as steel, nitinol, plastic, an expandable balloon, and / or any other material. In some embodiments, the proximal end 1110a of the body 1110 may have an opening 1220 that may be used for delivery of other tools and / or devices, including but not limited to a resection device (such as a knife), an attachment tool (such as a t-shaped marker), or other components of the tissue resection device 1100, 1200. For example, a scope (such as an endoscope, a gastroscope, a colonoscope, a duodenoscope, etc.) may be received in the opening 1220, which may include one or more tools for tissue resection and one or more working channels.

[0065] In various embodiments, the body 1110 and the distal cap 1115 can be delivered to the body cavity 1120 in a coupled configuration, and then the distal cap 1115 can be separated from the body 1110 to a position for tissue excision. For example, in steps 1105a, 1205a, the distal cap 1115 can be positioned distal to the selected tissue 1125 to be excised in the body cavity 1120, and the body 1110 can be positioned proximal to the selected tissue 1125 to be excised in the body cavity 1120, so that the body 1110 is separated from the distal cap 1115 by a distance "d6". In some embodiments, the medical professional can mark the tissue to be excised, such as using ink, radiopaque contrast agent, echogenic contrast agent, or other known techniques, as described above, and / or apply fluoroscopic imaging and / or ultrasound-guided guidance techniques for visualizing the selected tissue for excision. Additionally, the medical professional may be able to visualize the positioning of the devices 1100, 1200 using a visualization device, such as a camera, fiber optic cable, and / or other imaging device that may be delivered to the desired location.

[0066] As described above, in some embodiments, the devices 1100, 1200 can be delivered over the endoscope 1240, and a visualization device can be used by delivering to the treatment site through the working channel of the endoscope. For example, the endoscope 1240 can extend along the axis 1102a and be received in the opening 1220. Fig. 12C As shown in , endoscope 1240 may include one or more working channels for conveying lumen 1117, resection device (such as knife), and / or mechanical fastener 1225, such as t-tag. In some embodiments, device 1100, 1200 can be an independent auxiliary part of endoscope. In other embodiments, main body 1110 and distal cap 1115 can be conveyed to treatment site through the working channel of endoscope, and can be extended to match the inner diameter of body cavity. Lumen 1117 (which can be guide wire or other rigid or semi-rigid propulsion tool in some embodiments) can allow medical professionals to connect main body 1110 and / or distal cap 1115. In some embodiments, main body 1110 and / or cap 1115 can be conveyed to treatment site by advancing along on imaging device (such as endoscope). In this way, the endoscope can act as a guidewire for enabling the medical professional to position the body 1110 and cap 1115 as desired, and the endoscope can include one or more working channels that can be used to deliver other instruments / accessories to the treatment site. In some embodiments, the cap 1115 can be manipulated by the medical professional from the proximal end (e.g., outside the patient) using forceps or other accessories inserted into the working channel of the endoscope. In some embodiments, the devices and / or accessories can be manipulated by percutaneously inserting into the target tissue through an external entry point laparoscopically.

[0067] The body 1110 and / or the distal cap 1115 may include an anchoring mechanism 1130 for engaging with the inner surface 1120a of the body cavity 1120. The anchoring mechanism 1130 may be disposed along the outer circumferential surface 1135, 1140 of each body 1110 and / or distal cap 1115. The anchoring mechanism 1130 may be embedded so as to fix and stabilize the body 1110 and / or distal cap 1115 in the inner surface 1120a of the body cavity 1120 but not perforate, e.g., extend beyond the outer surface 1120b of the body cavity 1120. It should be understood that the body 1110 and / or the distal cap 1115 may engage with the healthy tissue portion in the body cavity 1120, so that all diseased tissue may be positioned in the selected tissue to be resected 1125 (so that the body 1110 and the distal cap 1115 are positioned adjacent to the selected tissue to be resected to be spaced apart from each other by a distance "d6") and removed with the device 1100.

[0068] The anchoring mechanism 1130 may be one or more mechanical fasteners, including but not limited to clamps, clips, hollow shafts, barbs. In some embodiments, the anchoring mechanism 1130 may be a suture or other device for fixing the body 1110 and / or the distal cap 1115 to the inner surface 1120a of the body cavity 1120. In some embodiments, the anchoring mechanism 1130 may be a hollow shaft disposed in one direction so that the body 1110 and / or the distal cap 1115 may be rotated around the axis 1102 in a first direction indicated by arrow 1145, thereby embedding or locking the hollow shaft into the inner surface 1120a of the body cavity 1120. If the body 1110 and / or the distal cap 1115 need to be readjusted, the body 1110 and / or the distal cap 1115 may be rotated around the axis 1102 in a second direction opposite to the first direction (arrow 1145) so as to release the hollow shaft from the inner surface 1120a of the body cavity 1120.

[0069] When the body 1110 and the distal cap 1115 are positioned in the body cavity 1120 along the axis 1102 and fixed to the inner surface 1120a of the body cavity 1120, in addition to the above Figure 2 , Figure 8F , Figure 9A-9B and Figures 10A-10E In addition to and / or in addition to the mechanical grasping method described above, the selected tissue to be resected 1125 can be pulled inwardly into the body 1110 by suction. In some embodiments, the grasping tool can grasp the inner surface 1120a of the selected tissue to be resected 1125 and pull the tissue radially inwardly from the body cavity 1120, such as in Fig. 11B 1105b in FIG. 1106. For example, as described above, in some embodiments, a grasping tool may be delivered to a treatment site through a working channel of the endoscope. The endoscope may allow engagement of the grasping tool within a distance "d6" between the distal cap 1115 and the body 1110. The medical professional may engage the grasping tool to grasp the selected tissue and pull the tool inwardly into the body 1110.

[0070] In some embodiments, one or more fasteners (such as hooks, barbs, etc.) can be disposed on the inner circumferential surface 1150 to secure the selected tissue 1125 to be removed (see FIG. Fig. 11C ). In some embodiments, a suction device as a tissue capture device can be engaged with the body 1110 and activated to pull the selected tissue to be resected 1125 radially inward into the body 1110. For example, a suction force can be applied to pull the selected tissue to be resected 1125 in a proximal direction along the axis 1102, as indicated by arrow 1155.

[0071] In some embodiments, the expandable ring 1305 (see Figures 13A-13B) is deployed (expanded) to the selected tissue 1125 to be removed. The ring 1305 can be attached to the inner surface 1120a of the tissue, for example using hooks, loops, or other mechanical fasteners. The ring 1305 can have a variable diameter, for example, made of a flexible material, so that the ring 1305 can be collapsible and expandable. The ring 1305 can be attached to the selected tissue for removal (see Fig. 13B ) and can be pulled into the body 1110. In some embodiments, a grasping tool 1310 can be used, for example, with a proximal end external to the patient, for engagement by a medical professional to pull the selected tissue inward. The grasping tool 1310 can extend along the axis 1102 and be pulled in the proximal direction so that the ring can radially contract to be pulled into the body 1110, thereby pulling the selected tissue into the body 1110 (see Fig. 13B ).

[0072] In some embodiments, one or more balloons may be used to pull selected tissue 1125 to be resected into body 1110. Referring now to Figures 12A-12C , the balloon 1210 can be expanded in the body cavity 1120 and engaged with the selected tissue to be resected 1125. The balloon 1210 may include an anchoring mechanism 1215 for engaging with the inner surface 1120a of the body cavity at the selected tissue to be resected 1125, for example, using one or more mechanical fasteners, clamps, clips, barbs, hooks, etc. When the balloon 1210 is engaged with the selected tissue to be resected 1125, the balloon 1210 may be in a deflated state or a super-deflated state (for example, for completely emptying the vacuum of the balloon), (see Fig. 12B Step 1205b) The balloon 1210 may thus have a webbing effect. Figure 12B-Figure 12C As shown in , the balloon in a deflated state, which is indicated by reference numeral 1210 ′ and still engaged with the inner surface 1120a of the body cavity at the selected tissue 1125 to be resected, can then be retracted in the proximal direction to pull the tissue into the body 1110 .

[0073] In such Fig. 11C At step 1105c shown in FIG. 1 , the distal cap 1115 may be moved in a proximal direction toward the body 1110 to secure the selected tissue 1125 to be resected within the body 1110. In some embodiments, the distal cap 1115 may be coupled to the body 1110. For example, a mechanical fastener 1160 such as a clamp, a rivet (e.g., The distal cap 1115 and the main body 1110 can be connected together by rivets, snaps, etc. In some embodiments, T-shaped marks, barbs and / or hooks can connect the distal cap 1115 to the main body 1110.

[0074] As in Fig. 12CAt step 1205c in the embodiment, the distal cap 1115 can be moved in a proximal direction toward the body 1110 to secure the selected tissue to be resected 1125 within the body 1110. In some embodiments, mechanical fasteners 1225 (e.g., t-shaped markers) for closure inside the body 1110 and the cap 1115 can be used to capture tissue. The mechanical fasteners 1225 can be delivered through at least one cavity 1235 in the body 1110. In some embodiments, the mechanical fasteners 1225 can be delivered endoscopy as an auxiliary, as described above with respect to other auxiliary components (such as tissue resection devices, tissue grasping tools, etc.).

[0075] In various embodiments, the tissue resection device can be deployed to resect the selected tissue 1125 to be resected in the body 1110. Figure 6A-6B , Figures 7A-7C , Figure 8H , Figure 9A-9B ,and Figures 10A-10E As described, the tissue removal device may be a blade, an electrocautery device, and / or a radially expandable wire that may extend from the distal cap 1115 and may similarly operate to remove selected tissue 1125 from the body cavity 1120. As described above, the tissue removal device may be delivered to the treatment site via the working channel of the endoscope.

[0076] Many specific details have been set forth herein to provide a detailed understanding of the various embodiments. However, it will be appreciated by those skilled in the art that the various embodiments may be implemented without these specific details. In other cases, well-known operations, components, and circuits have not been described in detail so as not to obscure the various embodiments. It is understood that the specific structural and functional details disclosed herein may be representative and may not necessarily limit the scope of the various embodiments.

[0077] Some embodiments may be described using the words "coupled" and "connected" along with their derivatives. These terms are not intended to be used 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" may also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other.

[0078] It should be noted that the methods described herein do not have to be executed in the order described or in any particular order. In addition, various activities described with respect to the methods identified herein can be executed in a serial or parallel manner.

[0079] Although specific embodiments are illustrated and described herein, it should be understood that any arrangement calculated to achieve the same purpose can replace the disclosed specific embodiments. The present disclosure is intended to cover any and all adjustments or modifications of various embodiments. It should be understood that the above description is completed in an illustrative manner rather than a restrictive manner. The combination of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art when reviewing the above description. Therefore, the scope of the various embodiments includes any other purposes in which the above-mentioned compositions, structures, and methods are adopted.

[0080] Although the subject matter has been described in language specific to structural features and / or methods, it should 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 exemplary forms of implementing the claimed subject matter.

Claims

1. A tissue resection device for tissue resection in a body cavity, comprising: a main body extending along an axis; a distal cap positioned distal to the body and coupled to an inner shaft extending along the axis, the body and the distal cap being movable relative to each other; an anchoring mechanism capable of engaging said body and said distal cap in a body cavity proximate to a selected tissue to be resected; a tissue capture device deployable from the tissue resection device such that the selected tissue to be resected can be secured by the tissue capture device; and a tissue cutting device for cutting the selected tissue to be cut off, The tissue cutting device is disposed on an outer shaft extending along the axis, and the distal cap is disposed on the inner shaft, wherein the tissue cutting device can be extended from the distal cap in response to movement of the inner shaft relative to the outer shaft.

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

3. A tissue resection device according to any one of claims 1 to 2, wherein the anchoring mechanism includes a first balloon arranged on the distal cap and a second balloon arranged on the main body, the first balloon and the second balloon being expandable to engage with the body cavity so that the selected tissue to be resected is between the first balloon and the second balloon.

4. A tissue resection device according to any one of claims 1 to 2, wherein the tissue capture device comprises one or more rods which are circumferentially arranged along the surface of the body and can extend from the body in a direction along the axis to fix the selected tissue to be resected against the distal cap.

5. The tissue resection device of claim 2, wherein the tissue closure device comprises a closure mechanism for connecting portions of the body cavity.

6. The tissue resection device according to any one of claims 1 to 2, further comprising a second tissue cutting device, the second tissue cutting device comprising a blade, the blade being circumferentially arranged along the surface of the body and being extendable from the body in a direction along the axis to resect the selected tissue to be resected.

7. The tissue resection device according to any one of claims 1 to 2, wherein the tissue cutting device comprises a blade, which is circumferentially arranged along the surface of the distal cap and can extend from the distal cap in the direction along the axis to resect the selected tissue to be resected.

8. The tissue resection device according to claim 6, wherein the tissue cutting device comprises a blade, which is circumferentially arranged along the surface of the distal cap and can extend from the distal cap in the direction along the axis to resect the selected tissue to be resected.

9. A system for tissue removal in a body cavity, comprising: Tissue removal device, including A body extending along an axis; a distal cap positioned distal to the body and coupled to an inner shaft extending along the axis, the body and the distal cap being movable relative to each other; an anchoring mechanism capable of engaging said body and said distal cap in a body cavity proximate to a selected tissue to be resected; a tissue capture device deployable from the tissue resection device such that the selected tissue to be resected can be secured by the tissue capture device; and a tissue cutting device for cutting the selected tissue to be cut, wherein the tissue cutting device is disposed on an outer shaft extending along the axis, and the distal cap is disposed on the inner shaft, and the tissue cutting device can extend from the distal cap in response to movement of the inner shaft relative to the outer shaft; and A visualization device is used to visualize the position of the tissue resection device in the body cavity relative to the selected tissue to be resected.

10. The system according to claim 9, further comprising: Tissue closure devices.

11. A system according to any one of claims 9 to 10, wherein the anchoring mechanism includes a first balloon disposed on the distal cap and a second balloon disposed on the main body, the first balloon and the second balloon being capable of expanding to engage with the body cavity so that the selected tissue to be resected is between the first balloon and the second balloon.

12. A system according to claim 9 or 10, wherein the tissue capture device includes one or more rods, which are arranged circumferentially along the surface of the body and can extend from the body in the direction along the axis to fix the selected tissue to be resected against the distal cap.

13. The system according to any one of claims 9 to 10 further comprises a second tissue cutting device, the second tissue cutting device comprising a blade, the blade being circumferentially arranged along the surface of the body and being extendable from the body in a direction along the axis to cut the selected tissue to be cut.

14. The system according to any one of claims 9 to 10, wherein the tissue cutting device comprises a blade, which is circumferentially arranged along the surface of the distal cap and can extend from the distal cap in the direction along the axis to resect the selected tissue to be resected.

15. The system of claim 13, wherein the tissue cutting device comprises a blade disposed circumferentially along 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.

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