Device for tissue removal

Abstract

The present application relates to a device for tissue removal. The medical device comprises a rim, at least one wire and a sheath; the rim defines an annulus in a plane and defines a width measured perpendicular to the plane; and at least one wire coupled to a distal end of the rim and extending proximally from the distal end out of the plane to a proximal end of the rim, the at least one wire having a cross-sectional dimension measured perpendicular to a longitudinal axis of the at least one wire, the size of the cross section is smaller than the width of the edge; the sheath is configured to cover at least a portion of the rim and a portion of the at least one wire.

Description

This application is a divisional application of Chinese application No. 202080093323.3 entitled “Apparatus for Tissue Removal”. Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 62 / 939,296, filed November 22, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates in its entirety to the removal or retrieval of tissue or other body or foreign objects. More specifically, at least some embodiments of this disclosure relate to an apparatus for endoscopic removal of substances (such as necrotic tissue) from a body cavity, and related methods using that apparatus. Background Technology

[0003] Fluid and necrotic aggregates (e.g., tissue) can occur as complications of acute pancreatitis. It has been found that body cavities and infection (if present) are resolved more smoothly when necrotic tissue is removed. Stents are commonly used to perform transoral / transmural endoscopic drainage or debridement collection, where the stent is placed between the collection and the stomach to allow drainage into the stomach. Currently, endoscopic necrosis resection is performed by inserting an endoscope through the stent and into the cavity containing the collection. However, no tools specifically designed for this procedure exist. Commonly used standard tools present various problems that limit the efficiency of performing this procedure. Summary of the Invention

[0004] According to one example, the medical device may include an edge, at least one wire, and a sheath; the edge defines an annulus in a plane and defines a width measured perpendicular to the plane; the at least one wire is coupled to a distal end of the edge and extends proximally from the distal end away from the plane to a proximal end of the edge, the at least one wire having a cross-sectional dimension measured perpendicular to a longitudinal axis of the at least one wire, the cross-sectional dimension being smaller than the width of the edge; the sheath is configured to at least cover a portion of the edge and a portion of the at least one wire.

[0005] In another example, the edge may have a generally rectangular cross-section. At least one wire may have a rectangular cross-sectional dimension, and the width of at least one wire may be less than the width of the edge. The edge may define a thickness measured in a plane, and this thickness may be greater than the thickness of at least one wire. The edge includes at least one opening at its distal end, and the at least one wire may extend through at least one opening. The edge may include two openings at its distal end, through which at least one wire may extend, and a portion of at least one wire may be outside the loop and located distal to the edge.

[0006] In another example, the medical device may further include at least one actuator. The actuator may be coupled to a proximal end of an edge and / or a proximal end of at least one wire. The at least one actuator may be covered by a sheath. The at least one actuator may also be longitudinally movable relative to the sheath. The at least one actuator may be coupled to both the proximal end of the edge and the proximal end of at least one wire, such that the edge and at least one wire are simultaneously extended or retracted via longitudinal movement of the at least one actuator relative to the sheath. The at least one actuator may be a plurality of actuators, and each of the plurality of actuators may be configured to move longitudinally relative to the sheath, independent of the longitudinal movement of the other plurality of actuators.

[0007] In another example, the edge of the medical device may be a nitinol strip. The edge may be able to flex at least 90° relative to the sheath. The edge may be a continuous curve without a sharp point, and the inner surface of the edge may be rough. The edge may be serrated or fan-shaped, or sharp.

[0008] In another example, the distal end of the medical device is substantially composed of the edge and the at least one wire, the distal end extending from and retracting from the sheath, and the distal end of the medical device being rotatable relative to the sheath.

[0009] According to one example, the medical device may include an edge and at least one wire; the edge defines a ring in a plane, wherein the edge includes at least one opening within a distal end of the edge; the at least one wire is coupled to the distal end of the edge and extends away from the plane to a proximal end of the edge, wherein the at least one wire extends through the at least one opening. The medical device may also include a sheath configured to at least cover a portion of the edge and a portion of the at least one wire. The edge may have two openings within a distal end of the edge, wherein at least one wire extends through the two openings, and wherein a portion of the at least one wire is outside the ring, distal to the edge, and in the plane. The edge may have a generally rectangular cross-section, and the at least one wire may have a rectangular cross-section.

[0010] According to one example, a method for tissue removal may include positioning a medical device (including an edge and at least one wire) such that the edge is adjacent to target tissue, and removing the target tissue from the adjacent tissue by capturing the target tissue with the edge of the edge. The edge may define an annulus in a plane and define a width measured perpendicular to the plane, and the edge may include at least one opening within a distal end of the edge. At least one wire may be coupled to the distal end of the edge and extend proximally from the distal end away from the plane to the proximal end of the edge. At least one wire may extend through at least one opening. At least one wire may have a cross-sectional dimension measured perpendicular to the longitudinal axis of at least one wire, and this cross-sectional dimension may be smaller than the width of the edge. Attached Figure Description

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments.

[0012] Figure 1A This is a front view of the distal end of the device according to an exemplary embodiment of the present disclosure.

[0013] Figure 1B for Figure 1A A top view of the distal end of the device.

[0014] Figure 1C for Figure 1A A close-up view of the distal end of the device.

[0015] Figure 1D This is a perspective view of a medical device according to an exemplary embodiment of the present disclosure.

[0016] Figure 1E This is a close-up view of the edge of a medical device according to an exemplary embodiment of the present disclosure.

[0017] Figure 2A for Figure 1A A perspective view of the device in an extended position outside the sheath, at the distal end of the device.

[0018] Figure 2B for Figure 1A Another perspective view of the device in a slightly retracted position within the sheath, at its distal end.

[0019] Figure 2C for Figure 1A Another perspective view of the device in its fully retracted position within the sheath, with the distal end of the device in this position.

[0020] Figure 2D for Figure 1A An orthographic view of the device in its fully retracted position within the sheath, at the distal end.

[0021] Figure 2E This is a perspective view of the distal end of the device according to an exemplary embodiment of the present disclosure, including a closer view of the sheath.

[0022] Figures 2F to 2G Perspective views of different mandrels according to exemplary embodiments of the present disclosure.

[0023] Figure 3A This is a perspective view of the distal end of a device according to another exemplary embodiment of the present disclosure.

[0024] Figure 3B for Figure 3A Another perspective view of the distal end of the device, where the edge is further recessed relative to the wire.

[0025] Figure 4A This is a perspective view of the distal end of a device according to an exemplary embodiment of the present disclosure.

[0026] Figure 4B for Figure 4A Another perspective view of the distal end of the device, in which the wire is further retracted relative to the edge.

[0027] Figure 5A This is a perspective view of the distal end of a device according to another exemplary embodiment of the present disclosure.

[0028] Figure 5B for Figure 5A Another perspective view of the distal end of the device. Detailed Implementation

[0029] Reference will now be made in detail to several aspects of this disclosure, examples of which are illustrated in the accompanying drawings. Where possible, the same or similar reference numerals will be used in the drawings to refer to the same or similar parts. When the device is introduced to a subject (e.g., a patient), the term "distal" refers to the part furthest from the user. In contrast, when the device is placed on a subject, the term "proximal" refers to the part closest to the user.

[0030] The foregoing general description and the following detailed description are exemplary and illustrative only, and do not limit the claimed features. As used herein, the terms “comprises,” “comprising,” “having,” “including,” or other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article of manufacture, or apparatus that includes a list of elements includes not only those elements, but may also include other elements not expressly listed or inherent to such process, method, article of manufacture, or apparatus. In this disclosure, relative terms, such as, for example, “about,” “generally,” “typically,” and “approximately,” are used to indicate possible variations of ±10% in a specified value or characteristic.

[0031] This disclosure addresses one or more limitations of the prior art. However, the scope of this disclosure is defined by the appended claims and is not intended to solve any specific problem. This disclosure relates to systems and apparatuses for removing medical tissue, as well as related methods, etc. It should be noted that various embodiments of the medical apparatus can also be used for removing food impaction, other bodily substances, or any foreign body. References Figures 1A to 1E The image shows the distal end 5 of a medical device 1 according to an exemplary embodiment. The medical device 1 includes an edge 10, a wire 20, and a sheath 30.

[0032] Edge 10 is a wire, cable, or strip made of any suitable biocompatible flexible material (preferably nitinol), which provides excellent thermal shape memory and durability. Edge 10 defines a ring in a plane, perpendicular to a width 1001 measured in that plane. Figure 1C As shown), and the thickness 1002 measured in this plane ( Figure 1C(As shown). The shape of the ring is not particularly limited and can be, for example, circular, elliptical, teardrop-shaped, etc. For example, the edge 10 can be a single wire with two ends extending to the proximal end of the medical device, forming a ring at the distal end extending from the sheath 30. The edge 10 has a rectangular cross-section, but is not limited to this in other embodiments. The rectangular cross-section can provide lateral stiffness to the edge 10, which has the ability to exert lateral forces on tissue and help to enclose said tissue. The edge 10 includes an outer surface 10a of the ring and an inner surface 10b of the ring. The edge 10 also includes a first opening 11 and a second opening 12 at the distal end of the edge 10. In other embodiments, the edge 10 may include only one opening, multiple openings, or no opening at the distal end of the edge. One or more openings can be formed on the edge 10 by any suitable means, preferably by laser drilling. In other embodiments, the inner surface 10b of the edge 10 may also be sandblasted (overall or only at the distal end) to roughen the inner surface 10b and help prevent or minimize the edge 10 from slipping off or from harder or stronger tissues. In some other embodiments, the edge 10 may be laser-cut such that the bottom edge of the edge 10 (e.g., the edge of the backing wire 20) includes serrated edges 13” or fan-shaped edges 13’ (which may be sharp), thereby allowing the edge 10 to more easily scrape or remove harder or stronger tissues, such as… Figure 1E As shown. In some embodiments, the edge 10 may flex at least 90° relative to the sheath 30 in any direction (e.g., up / down / left / right), thereby allowing the edge 10 to contact and press against the tissue and scrape along the surface of the tissue.

[0033] The wire 20 can be a strip, wire, cable, etc., made of any suitable biocompatible flexible material (preferably nitinol). The wire 20 has a cross-sectional dimension measured perpendicular to its longitudinal axis, and this cross-sectional dimension is smaller than the width of the edge 10. Specifically, the wire 20 is flat and has a rectangular cross-sectional dimension. However, the wire 20 is not limited to this, and in other cases, it may have a generally circular cross-section. The width of the rectangular cross-section of the wire 20 is smaller than the width of the edge 10 measured perpendicular to the plane of the edge 10, but is not limited to this in other embodiments. In some embodiments, the thickness of the edge 10 (measured in the plane) may be greater than the width of the rectangular cross-section of the wire 20. For example, edge 10 may be about 0.5 mm to about 1 mm wide and about 0.05 mm to about 0.1 mm thick, or a more rigid edge 10 may be about 0.5 mm to about 1 mm wide and about 0.05 mm to about 0.15 mm thick; while wire 20 may have a width of about 0.1 mm to about 0.25 mm. The basket-like configuration of edge 10 and wire 20, further described below, may be about 30 mm to 35 mm long and about 20 mm to 25 mm wide, and about 5 mm to 10 mm deep (i.e., measured from the plane of edge 10 to the arched peak formed by the strands of wire 20). These dimensions are exemplary only and are not limiting.

[0034] The wire 20 is connected to the distal end of the edge 10 by extending through both the first opening 11 and the second opening 12, such that the portion of the wire 20 between the first opening 11 and the second opening 12 is outside the annulus on the distal side of the edge 10 (e.g., along the outer surface 10a) and lies in the plane of the annulus. For example, the end of the wire 20 may extend proximally in the device 1, wherein a single wire 20 forms at least two bends outside the plane of the annulus of the wire 20, thereby forming a basket-like structure. The wire 20 may pass through at least the first and second openings 20 as a connection point at the distal end of the edge 10. The single wire and the distal connection point can be advantageous in terms of reducing manufacturing costs. Furthermore, the flat wire 20 may be oriented relative to the edge 10 such that the wire 20 is flush with the distal end of the edge 10 via any suitable technique (e.g., thermoforming) to minimize any protrusion of the wire 20 outside the annulus on the distal side of the edge 10. Because of this connection method and the fact that the wire 20 is flat, and the edge 10 is a continuous or substantially continuous curve with a non-invasive distal tip, or in other words, without a sharp point, the pressure applied by the device 1 is very low as the edge 10 is pushed forward against the cavity wall. This is because such pressure or force is distributed over a large surface area, thus reducing the possibility of accidental penetration of the cavity wall (as with an edge having a sharp or other obvious point).

[0035] The wire 20 extends proximally from the distal end of the edge 10 across the plane of the edge 10 to the proximal end of the edge 10, wherein the sheath 30 covers at least the proximal portion of the edge 10 and the proximal portion of the wire 20. Thus, the two strands of the wire 20 (arched or bent away from the plane) form a basket-like support in which removed tissue can be retained. In some embodiments, due to the presence of the wire 20, the device 1 does not include any functionally similar mesh or weave or other material (e.g., grid, lining, web) attached to the edge 10 to help retain any removed tissue. In other words, there is no material between the strands of the wire 20 or the loops formed by the edge 10, and the spaces between them are not filled with any article. The wire 20 is connected to the edge 10 only at the proximal end (via the heat-shrink tube 31 and crimp 32), at the distal end of the edge 10, and not elsewhere. Therefore, device 1 avoids various limitations associated with mesh or other similar functional materials, including clogging, jamming, and / or tearing; and the retained tissue can be cleanly removed from the basket support via partial retraction of the edges 10 and wires 20 into the sheath 30. The geometry of the edges 10 and wires 20 (the disclosed manner in which the edges 10 and wires 20 are joined together), and the use of nitinol material, contribute to providing a basket configuration with the unique ability to perform numerous high strain cycles without yielding or breaking.

[0036] In other embodiments, wire 20 may be coupled to a distal end of an edge without an opening, or wire 20 may be coupled to a distal end of an edge having multiple openings (by extending through said openings), thereby causing multiple strands of wire 20 to extend proximally to form a basket-like shape. In some embodiments, wire 20 or its multiple strands extend only proximally from the distal end of the edge to the proximal end of the edge, and do not extend laterally (i.e., side-to-side of the edge). In some embodiments, edge 10 may not have wire 20.

[0037] Figure 1DA medical device 1 is shown, which includes a controller 100. In this embodiment, a sheath 30 covers at least a portion of a heat-shrinkable tube 31, a crimping portion 32, and an actuator 33. The heat-shrinkable tube 31 covers at least the proximal portion of an edge 10 and a proximal portion of a wire 20, which can be joined together within the heat-shrinkable tube 31. The proximal ends of the edge 10 and the wire 20 are also crimped and contained within the crimping portion 32, the proximal end of which is connected to the actuator 33. The crimping portion 32 (which is a tubular housing) may also accommodate the distal portion of the actuator 33, which can be connected to the joined and crimped proximal ends of the edge 10 and the wire 20. The crimping portion 32 may cover all, a portion, or none of the heat-shrinkable tube 31. Before and during the crimping process, the heat-shrinkable tube 31 helps protect the proximal ends of the edge 10 and the wire 20. The actuator 33 is a flexible wire, cable, or multiple (e.g., three) wires or cables placed adjacent to each other and longitudinally movable relative to the sheath 30.

[0038] The proximal end of the sheath 30 is connected to a connection point 103 on the distal end of the controller 100. The controller 100 also includes a handle 101 and an actuation control 102. The handle 101 includes a thumb ring 101a, and the actuation control 102 includes a first finger ring 102a and a second finger ring 102b. The actuator 33 is connected to the actuation control 102 and can be longitudinally actuated relative to the sheath 103 by longitudinal movement of the actuation control 102 relative to the handle 101 (on which the actuation control 102 is held). Therefore, actuator 33 can extend distally by pushing actuation control 102 toward the distal end of handle 101, thereby causing edge 10 and wire 20 to extend further out of sheath 30 simultaneously; or actuator 33 can retract proximally by pulling actuation control 102 toward the proximal end of handle 101, thereby causing edge 10 and wire 20 to retract further or completely into sheath 30 simultaneously. Thus, the annular size of edge 10 and the stiffness of said annularity can be controlled by the extent to which edge 10 and wire 20 extend out of sheath 30. This allows the user to fully extend edge 10 and wire 20 away from sheath 30 for soft tissue removal, or to partially retract edge 10 and wire 20 into sheath 30 for more aggressive removal. The basket-like configuration of edge 10 and wire 20 can also be rotated by rotation of actuator 33 via a mechanism or control (not shown) of controller 100. The simultaneous extension, retraction, or rotation of edge 10 and wire 20 via a single actuator (i.e., actuator 33) can be termed a “single action”.

[0039] Figures 2A to 2D The distal end 5 of a medical device 1 is shown. The medical device 1 has an edge 10 that extends or retracts to varying degrees via a single action, and a wire 20. Figure 2AIn this configuration, as a result of the actuator 33 extending fully distally via the actuation control 102 (not shown), the edge 10 and the wire 20 are in a fully open position, thus extending the sheath 30 completely, as described above. Figure 2B In the middle, edge 10 and wire 20 are in a partially retracted position, with the actuation control 102 (not shown) of controller 100 (not shown) approximately at the midpoint of handle 101 (not shown). Figure 2B In the partially retracted position shown, the basket-like support formed by the edge 10 and the wire 20 can be closed around the held tissue for better clamping. The tissue can be dispensed or removed from the patient's body by completely pulling the distal end 5 of the medical device 1 out of the body, or more commonly, by completely retracting the basket-like structure of the edge 10 and the wire 20 and expelling the tissue as the basket retracts. Figures 2C to 2D As a result of the actuator 33 extending fully proximally via the actuation control 102 (not shown), the edge 10 and wire 20 are in a fully closed position, completely retracted into the sheath 30, as described above. After being fully retracted into the sheath 30, the edge 10 and wire 20 can cut through the held tissue and cleanly push the tissue into the stomach (the tissue will pass through the stomach) without having to shake off the tissue or remove it by another means. In some embodiments, the cross-sectional dimensions of the edge 10 can be selected relative to the diameter of the sheath 30 such that, in the retracted state (e.g., partially or fully retracted), the minimum bending radius and internal stress at the distal end of the edge 10 are set for multiple use cycles.

[0040] Figure 2E It shows something similar to Figures 2A to 2D The medical device shown has a sheath 30' that differs from the sheath 30. Specifically, the distal opening of the sheath 30' is octagonal, unlike the circular opening of the sheath 30. Figures 2A to 2D (As shown). Furthermore, at least a portion of the inner surface of the sheath (defining its lumen and extending proximally from the distal opening) has the same octagonal shape. The radius of the circumscribed circle of the distal opening of the octagon (defined by half the distance between the diagonals of the octagon) may be a distance greater than the width of the edge 10. The length of each side of the octagon may be the same as or approximately the same as the width of the edge 10. It should be noted that the distal opening of the sheath is not limited to the aforementioned shape, and in other embodiments, openings with different polygonal shapes (e.g., hexagons) may be present, as long as the sides of the polygon have a length that is the same as or approximately the same as the width of the edge 10.

[0041] The octagonal distal opening of the sheath 30' helps stabilize the basket-like support formed by the edge 10 and the wire 20, particularly during tissue capture. For example, in some embodiments, the distal end 5 can rotate freely before capturing the target tissue, allowing it to be oriented as needed. After orientation, the distal end 5 can retract into the sheath to capture the tissue within the basket-like support. However, in some cases, the distal end 5 may continue to rotate undesirably relative to the sheath, resulting in loss or failure to capture the target tissue. In contrast, the retraction of the distal end 5 into the octagonal distal opening of the sheath 30' suppresses undesirable rotation due to the polygonal shape of the distal opening and the dimensions of its sides (the width of its matching edge 10). Because of these dimensions, when retracted into the sheath 30', the edge 10 can capture or engage the parallel inner surface of the distal opening, thus suppressing or at least significantly limiting rotation. Therefore, when the edge 10 retracts into the sheath 30', the sheath 30' effectively supports the edge 10, thereby minimizing unwanted rotation. It should be noted that rotation is not suppressed when the distal end 5 extends because the tubular heat-shrinkable portion 31 engages the distal opening of the sheath 30'. Due to its tubular shape, the heat-shrinkable portion 31 is not supported within the octagonal distal opening of the sheath 30' and can rotate freely.

[0042] Figures 2F to 2G A mandrel 200s is shown, which can be used to form a polygonal (e.g., octagonal) distal opening of a sheath 30'. The mandrel 200 includes a shank 201, a flange 202, distal ends 204, 204' of the shank 201, and an insertion shaft 205. The shaft 205 includes a tapered portion 203 leading to a point. The shank 201 is not particularly limited and can be any suitable shank shape for gripping. The flange 202 projects radially outward from the shank 201 and is present on the distal portion of the shank 201. The diameter of the flange 202 is not particularly limited, as long as the flange 202 serves as a barrier between the shank 201 and the remaining proximal portion of the shaft 205. The distal ends 204, 204' of the shank 201 can be flat or shaped surfaces. For example, the distal end 204 is a flat surface end (…). Figure 2F As shown), while the distal end 204' is a fan-shaped surface (as shown). Figure 2G (As shown). However, the distal end is not limited to this and may have a surface of any suitable shape. The shaft 205 projects longitudinally from the distal ends 204, 204' and is centered about the longitudinal axis of the shank 201. The shaft 205 has a diameter smaller than that of the shank 201. More specifically, the shaft 205 may have a diameter approximately the diameter of the distal opening of the sheath 30'. Figure 2E As shown. Axis 205 is multifaceted and can be polygonal in shape, such as an octagon. The length of axis 205 is not particularly limited. The distal end of axis 205 tapers downward to a point.

[0043] To form the polygonal distal opening of the sheath 30', the shaft 205 of the mandrel 200 can be heated and then inserted into the distal opening of the sheath 30'. This causes the distal opening to be molded to fit the shape of the shaft 205, which can be polygonal. The sheath 30' (with the shaft 205 inserted therein) can then be cooled to set the molded shape of the distal opening of the shaft 30'. Note that the distal end of the sheath 30' can also be molded by inserting the shaft 205 into the sheath 30' to a certain extent, such that the distal ends 204, 204' can abut against the distal end of the sheath 30'. For example, such insertion of the shaft 205 (such that the distal ends 204' contact the distal end of the sheath 30') will result in the sheath 30' having a fan-shaped distal end that conforms to the surface of the distal ends 204'.

[0044] In other embodiments, the edge 10 and the wire 20 can be extended or retracted independently of each other via the use of multiple actuators, each actuator configured to move longitudinally relative to the sheath, independent of the movement of other actuators. This can be referred to as "dual-action". (See reference...) Figures 3A to 3B and Figures 4A to 4B Another embodiment of the medical device 1' is shown, the medical device 1' having an edge 10 that extends or retracts to different degrees via a dual action and a wire 20. The device 1' includes the edge 10, the wire 20, and the sheath 30, as shown in Figures 1 to 14. Figure 2C The embodiment is described below. The sheath 30 covers at least a portion of the edge crimp portion 32a and the wire crimp portion 32b, with their proximal ends connected to the edge actuator 33a and the wire actuator 33b, respectively. The edge crimp portion 32a and the wire crimp portion 32b may respectively cover and crimp a portion of the proximal ends of the edge 10 and the wire 20. Furthermore, the edge crimp portion 32a and the wire crimp portion 32b are independently movable relative to the sheath 30 and also independently movable relative to each other. The proximal ends of the edge actuator 33a and the wire actuator 33b may be connected to any suitable controller via one or more connection points of the controller. For example, each actuator 33a, 33b may be connected to a corresponding actuation control. As another example, such an actuation control may be like control 102, however, divided into two parts, each part translating along the handle 101.

[0045] exist Figure 3A In the middle, edge 10 retracts towards sheath 30 because edge actuator 33a retracts proximally; while wire 20 neither retracts nor extends. Therefore, edge 32a is partially proximally to wire crimp portion 32b. Figure 3BIn this configuration, edge 10 retracts further toward sheath 30 because edge actuator 33a retracts further proximally; while wire 20 neither retracts nor extends. Therefore, edge 32a is entirely proximal to the wire crimp portion 32b. Due to this dual effect, the arching or curvature of the strands of wire 20 becomes more pronounced, and the strands of wire 20 become increasingly spaced, thereby allowing for easy removal of the removed tissue without having to completely retract both edge 10 and wire 20 into sheath 30.

[0046] exist Figure 4A In the middle, the wire 20 retracts towards the sheath 30 because the wire actuator 33b retracts proximally; while the edge 10 neither retracts nor extends. Therefore, the wire crimp portion 32b is located near the edge crimp portion 32a. Figure 4B In this process, wire 20 retracts further toward sheath 30 because wire actuator 33b retracts further proximally; while edge 10 neither retracts nor extends. Therefore, wire crimp 32b is entirely proximal to edge crimp 32a. Due to this dual effect, edge 10 increasingly takes on a bean-like shape. In other words, wire 20 is pulled proximally at the distal end of edge 10 (to which wire 20 is attached), causing the distal end of the annular shape of edge 10 to become increasingly concave toward the center of the annular shape. Furthermore, the lateral ends of the annular shape of edge 10 also bend radially outwards. Therefore, Figure 4B The dual effect shown results in the edge 10 forming a bean-shaped form, which also allows for easy drainage of the removed tissue without having to fully retract both the edge 10 and the wire 20 into the sheath 30. It should be noted that in some other embodiments, a third actuator may also be included to individually actuate the rotation of the edge 10 and / or the wire 20.

[0047] refer to Figures 5A to 5B Figure 1 illustrates another embodiment of a medical device 1, which includes an edge 10, a first wire 20a and a second wire 20b, and a sheath 30. The first wire 20a and the second wire 20b are coupled to the distal end of the edge 10 by extending both the first opening 11 and the second opening 12 through the edge 10, wherein portions of both the first wire 20a and the second wire 20b are located outside the annulus on the distal side of the edge 10, as shown in Figures 1 to 2010. Figure 2C The wire 20 in the embodiment. Alternatively, the first wire 20a and the second wire 20b may extend through a separate pair of openings in the edge 10. The first wire 20a and the second wire 20b extend from the distal end of the edge 10 toward the proximal end of the edge 10 away from the plane of the edge 10, wherein the sheath 30 at least covers a portion of the heat shrink tube 31, the crimp portion 32, and the actuator 33, as also shown in Figures 1 to 20. Figure 2CIn this embodiment, the heat-shrinkable tube 31 covers at least the proximal portion of the edge 10, as well as the proximal portions of the first wire 20a and the second wire 20b. The proximal ends of the edge 10 and the first wire 20a and the second wire 20b are crimped and contained in a crimping portion 32, the proximal end of which is connected to the actuator 33. Thus, in this embodiment, the two strands of the first wire 20a and the two additional strands of the second wire 20b (arched or bent away from the plane of the edge 10) form a basket-like support in which tissue can be held. Due to the additional strands, greater support can be provided to the device 1”.

[0048] The following discussion further illustrates an example of a method for removing tissue using any of the embodiments of the removal devices shown in the figures. The user may deliver the medical device 1,1',1” into the body of a subject, for example, via natural cavities (such as the mouth or anus) and through the subject's tortuous natural body cavities (such as the esophagus, stomach, colon, etc.). The device may be delivered by any suitable means, such as through the working lumen of an endoscope. The user may guide the medical device 1,1',1” to the intended target site by various means, including imaging. Once the target area is reached, the user can position the device 1,1',1" (including edge 10 and wire 20) such that edge 10 is in contact with / facing the tissue intended for removal. In other instances, device 1,1',1" can also be used in an inverted position such that wire 20 faces the target tissue to break up larger tissue clumps or to help anchor device 1,1',1" in place. The user can obtain the target tissue by scraping it with edge 10, allowing the target tissue to be broken up, moved, or removed and held within the basket-like support formed by edge 10 and wire 20. Edge 10 can flex at least 90° relative to sheath 30 in any direction (e.g., up / down / left / right), allowing edge 10 to press against and scrape along the surface of the tissue in this manner.

[0049] The user can also deliver fluid (e.g., saline) through the sheath 30 of the device 1,1',1" via a connection to an additional port (not shown) at the distal end of the handle 101. After obtaining the target tissue, the user can guide the device 1,1',1" to the appropriate site for dispensing the tissue (e.g., the stomach) and dispense the tissue. In some instances, the tissue can be dispensed by retracting the edge 10 and the wire 20 into the sheath 30 via a single or double action, such that the edge 10 and the wire 20 can cut through and expel the held tissue. In other instances, the tissue can be dispensed by retracting only the edge 10 (without the wire 20) via a double action, such that the arch or curve of the strands of the wire 20 becomes more pronounced and the strands of the wire 20 become more spaced, thereby allowing the discharge of the removed tissue. In other instances, the tissue can be dispensed by retracting only the wire 20 (without the edge 10) via a double action, such that the edge 10 becomes increasingly heart-shaped, which allows the discharge of the removed tissue. In other instances, tissue can be dispensed by rotating the device 1,1',1” and allowing the tissue to fall off the edge 10 simply by gravity. In other instances, tissue can be held within the basket-like support of the distal end 5 of the device 1, and the distal end 5 can be completely pulled away from the patient's body to remove the tissue. In other instances, tissue can be removed via suction applied through the endoscope's passage. Thus, the user (e.g., a physician) can be able to orient the device 1,1',1”, securely grasp large amounts of tissue, cleanly remove the tissue by any method or mechanism (including those described above), and repeat this sequence without the device 1,1',1” being blocked, deformed, or broken during the procedure.

[0050] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus without departing from the scope of this disclosure. Other embodiments of this disclosure will be apparent to those skilled in the art in light of the specification and practice of the invention disclosed herein. It is contemplated that the specification and examples should be considered exemplary only, wherein the true scope and spirit of the invention are indicated by the following claims.

Claims

1. A medical device comprising: The edge defines the annulus and has two openings at its distal end; as well as A wire, the wire being connected to the distal end of the edge and extending from the distal end of the edge toward the proximal end of the edge, wherein the wire extends through the two openings.

2. The medical device of claim 1, wherein the edge comprises a nickel-titanium alloy.

3. The medical device according to any of the preceding claims, wherein the wire is coupled to the proximal end of the edge.

4. The medical device according to any of the preceding claims, wherein the inner surface of the edge is rough.

5. The medical device according to any of the preceding claims, wherein the edge of the edge comprises a sawtooth or fan shape.

6. The medical device according to any of the preceding claims, wherein the edge has a continuous curve and a non-invasive distal tip at the distal end of the edge.

7. The medical device according to any of the preceding claims further includes a sheath configured to receive at least a portion of the edge and at least a portion of the wire, wherein the distal opening of the sheath is octagonal.

8. The medical device according to any of the preceding claims, wherein a first portion of the wire is located proximal to the distal end of the edge, and a second portion of the wire is located distal to the distal end of the edge.

9. The medical device of claim 8, wherein a first portion of the wire extends radially outward relative to the longitudinal axis of the edge, wherein the edge has a curved outer surface, and a second portion of the wire extends along and contacts the curved outer surface of the edge.

10. The medical device of claim 8, wherein the first portion of the wire includes a first bend extending proximally from a first opening of the two openings, and the first portion of the wire also includes a second bend extending proximally from a second opening of the two openings, both the first bend and the second bend extending radially outward relative to the longitudinal axis of the edge.

11. A medical device comprising: The edge defines the annulus and has a first opening and a second opening at its distal end; as well as A wire, the wire being connected to the distal end of the edge and extending from the distal end toward the proximal end of the edge, wherein a first bend in the wire extends toward the proximal end from the first opening and a second bend in the wire extends toward the proximal end from the second opening.

12. The medical device of claim 11, further comprising a shaft configured to cover a portion of the edge and a portion of the wire.

13. A medical device comprising: An edge that defines an annulus and has a first opening and a second opening at its distal end, wherein the edge has a first side and an opposing second side relative to its longitudinal axis; as well as A wire, the wire being coupled to the distal end of the edge and extending from the distal end toward the proximal end of the edge, wherein a first portion of the edge extends to the proximal side of the first opening or the second opening and bends radially outward from the first side, wherein a second portion is located distal to the distal end of the edge and extends along the curved outer surface of the edge between the first opening and the second opening.

14. A medical device comprising: An edge that defines a ring in a plane and defines a width that is perpendicular to the plane; At least one wire, the at least one wire being connected to the distal end of the edge and extending from the distal end toward the proximal end of the plane to the proximal end of the edge, the at least one wire having a cross-sectional dimension measured perpendicular to the longitudinal axis of the at least one wire, the cross-sectional dimension being smaller than the width of the edge; A sheath, the sheath being configured to cover at least a portion of the edge and a portion of the at least one wire; as well as A plurality of actuators, wherein the plurality of actuators are coupled to the proximal end of the edge and / or the proximal end of the at least one wire.

15. The medical device of claim 14, wherein the plurality of actuators are covered by the sheath, wherein each of the plurality of actuators is configured to move longitudinally relative to the sheath and is independent of the longitudinal movement of the other actuators.

Images