Repositionable tissue capture device

Abstract

A device includes a capture assembly, a hollow member, a tube, and a control member. The assembly includes a capture cannula received on a distal end of an insertion device, and a flange mounted on the insertion device proximal to the cannula. The hollow member, the tube, and the control member each have a proximal end accessible by a user. When the tube is advanced distally through the hollow member, the tube urges the cannula distally away from the insertion device. The control member includes a distal end forming a loop coupled around a circumference of the distal opening of the cannula. The ring moves between a contracted configuration in which at least a portion of the ring is pulled proximally into the tube and an open configuration in which the ring extends distally from the tube to open the ring and the distal opening of the cannula.

Description

Inventors: Deepak Kumar SHARMA, Sharath Kumar G, and Barry WEITZNER Priority Statement

[0001] This invention claims priority to U.S. Provisional Patent Application Serial No. 63 / 531,713, filed August 9, 2023, the disclosure of which is incorporated herein by reference. Technical Field

[0002] The present invention relates to endoscopic devices and particularly to a device for capturing tissue for removal from a living organism. Background Technology

[0003] Full-thickness resection (e.g., removing a portion of a digestive system organ, such as the colon, including the entire wall of the organ) is often used as a treatment for cancer. These procedures carry certain risks, including intra-abdominal hypertension, gas leakage at the resection site, and the possibility that the surgery may lead to the implantation of cancer cells in new areas. Furthermore, for various reasons, some lesion removal procedures that do not involve full-thickness resection often fail to remove the entire target portion of the tissue (e.g., a tumor). Summary of the Invention

[0004] This invention relates to a device for treating tissue. The device includes a tissue-capturing assembly removably attached to an insertion device configured for insertion into a target site within a living body. The tissue-capturing assembly includes a tissue-capturing cannula and a flange, wherein, in an initial configuration, the tissue-capturing cannula is removably received at the distal end of the insertion device, and when the tissue-capturing cannula is in the initial configuration, the flange is removably mounted on the insertion device located proximal to the tissue-capturing cannula. A first hollow member extends from a proximal end, accessible to the user and held outside the body during use, to a distal end coupled to the flange.

[0005] Additionally, the device includes a first tube slidably received within a first hollow member and extending distally beyond a flange to a distal end of the first tube, accessible to the user and held outside the body during use. The first tube is configured to push a cannula distally away from the insertion device when the first tube is advanced distally through the first hollow member. Furthermore, the device includes a first control member slidably received within the first tube and extending distally from a proximal end accessible to the user and held outside the body during use, the distal end forming a circumferentially connected first ring around a distal opening of a tissue capture cannula. The first ring is configured to move between a contracted state and an open state, in which at least a portion of the first ring is pulled proximally into the first tube, and in an open state, the first ring extends distally from the first tube to open the distal opening of the first ring and the tissue capture cannula.

[0006] In one embodiment, the device further includes a handle, the handle including a handle body and a first actuator coupled to the proximal end of the first tube, wherein the first hollow member is coupled to the handle body and the first actuator is movably coupled to the handle body such that movement of the first actuator relative to the handle body causes the first tube to move proximally and distally within the first hollow member.

[0007] In one embodiment, the apparatus further includes a second actuator coupled to a proximal end of the first control member. The second actuator is coupled to the first actuator such that movement of the second actuator relative to the first actuator causes the first control member to move proximally and distally within the first tube.

[0008] In one embodiment, the tissue capture cannula includes a circumferentially connected elastomeric ring around its proximal opening, the elastomeric ring being biased toward a closed configuration such that when the tissue capture cannula is pushed distally away from the insertion device, the elastomeric ring pulls the proximal opening of the tissue capture cannula closed.

[0009] In one embodiment, the device further includes a second hollow member extending from a proximal end accessible to the user and held outside the body during use to a distal end coupled to a flange; and a second tube slidably received within the second hollow member and extending distally beyond the flange to a distal end of the second tube. The second tube is configured to cooperate with the first tube to push a tissue capture cannula distally away from the insertion device when the second tube is advanced distally through the second hollow member.

[0010] The device also includes a second control member slidably received within the second tube and extending from a proximal end accessible to the user and held outside the body during use to a distal end, the distal end forming a circumferentially connected second ring surrounding a proximal opening of the tissue capture cannula. The second ring is configured to move between a contracted mode and an open mode, in which at least a portion of the second ring is pulled proximally into the second tube, and in an open mode, the second ring extends distally from the second tube to open the proximal opening of the second ring and the tissue capture cannula.

[0011] In one embodiment, the handle further includes a third actuator coupled to the proximal end of the second tube. The second hollow member is coupled to the handle body, and the third actuator is movably coupled to the handle body such that movement of the third actuator relative to the handle body causes the second tube to move proximally and distally within the second hollow member.

[0012] In one embodiment, the device further includes a fourth actuator coupled to the proximal end of the second control member. The fourth actuator is coupled to the third actuator such that movement of the fourth actuator relative to the third actuator causes the second control member to move proximally and distally within the second tube.

[0013] In one embodiment, the tissue capture sleeve is formed of either silicone or a biocompatible plastic.

[0014] In one embodiment, the tissue capture cannula is formed from either Tyvek or Mylar.

[0015] In one embodiment, the first ring is formed of a shape memory material configured such that when the first ring extends from the first tube, the first ring takes on an open-loop shape to pull the distal opening of the tissue capture cannula into an open state.

[0016] In one embodiment, the first ring is formed of a biocompatible metal biased such that as the first ring extends from the first tube, it takes on an open-loop shape to pull the distal opening of the tissue capture cannula into an open position.

[0017] In one embodiment, the first ring includes a plurality of radially inward-facing tissue cutting features.

[0018] Additionally, the present invention relates to a device for treating tissue. The device includes a catheter having a tissue-capturing assembly mounted on its distal portion. The tissue-capturing assembly includes a tissue-capturing cannula and a flange, wherein, in an initial configuration, the tissue-capturing cannula is removably received at the distal end of the catheter, and when the tissue-capturing cannula is in the initial configuration, the flange extends radially outward from the outside of the catheter located proximal to the tissue-capturing cannula.

[0019] The device also includes a first hollow member extending from a proximal end accessible to the user and held outside the living body during use to a distal end coupled to a flange.

[0020] The device also includes a first tube slidably received within a first hollow member and extending distally beyond a flange to a distal end of the first tube, accessible to the user and held outside the body during use. Furthermore, the device includes a first control member slidably received within the first tube and extending distally from a proximal end accessible to the user and held outside the body during use, the distal end forming a circumferentially connected first ring surrounding a distal opening of a tissue capture cannula. The first ring is configured to move between a contracted configuration and an open configuration, in which at least a portion of the first ring is pulled proximally into the first tube, and in an open configuration, the first ring extends distally from the first tube to open the distal opening of the first ring and the tissue capture cannula.

[0021] In one embodiment, the catheter is sized and shaped to be inserted into a blood vessel and the tissue to be targeted is a thrombus.

[0022] In one embodiment, the catheter is a braided catheter.

[0023] Additionally, the present invention relates to a method for capturing tissue. The method includes inserting a tissue capturing assembly into a living body to a target site adjacent to tissue to be treated, the tissue capturing assembly being removably attached to an insertion device, wherein the tissue capturing assembly includes a tissue capturing cannula removably received at a distal end of the insertion device and a flange removably mounted on the insertion device proximal to the tissue capturing cannula, wherein the tissue capturing cannula is coupled to a first control member slidably received within a first tube, a first ring at the distal end of the first control member being coupled around a distal opening of the tissue capturing cannula; pulling a target portion of the tissue toward the distal end of the insertion device; moving the first tube distally to push the tissue capturing cannula distally away from the insertion device such that the target portion of the tissue is received within the tissue capturing cannula; pulling the first control member proximally into the first tube to tighten and close the first ring on a portion of the tissue adjacent to the target portion of the tissue until the first ring closes the distal opening of the tissue capturing cannula; and when the user determines that a portion of the tissue captured within the tissue capturing cannula has been captured as desired, further pulling the first control member proximally into the first tube to sever the target portion of the tissue from a peripheral portion of the tissue.

[0024] In one embodiment, a tissue capture cannula is coupled to a second control member slidably received within a second tube, wherein a second ring at the distal end of the second control member is coupled around a proximal opening of the tissue capture cannula, the method further comprising pulling the second control member proximally into the second tube to tighten and close the second ring to close the proximal opening of the tissue capture cannula.

[0025] In one embodiment, the method further includes maintaining the proximal and distal openings of the tissue capture cannula closed while withdrawing the insertion device from the body.

[0026] In one embodiment, a first tube is coupled to a first actuator on a handle, and a first control member is coupled to a second actuator on the handle such that actuation of the first actuator moves the first tube proximally and distally relative to the insertion device, and the movement of the second actuator moves the first control member proximally and distally relative to the first tube.

[0027] In one embodiment, the method further includes, after the tissue capture cannula has been deployed on a target portion of the tissue, observing the tissue within the tissue capture cannula to determine whether the target portion of the tissue has been captured as needed; when it is determined that the target portion of the tissue has not been captured as needed, pushing a first control member distally out of a first tube to reopen the distal opening of the tissue capture cannula; after reopening the distal opening of the tissue capture cannula, withdrawing the previously captured tissue from the tissue capture cannula; repositioning the insertion device; pulling a subsequent target portion of the tissue toward the distal end of the insertion device; moving the first tube distally to push the tissue capture cannula distally away from the insertion device such that a subsequent target portion of the tissue is received within the tissue capture cannula; and pulling the first control member proximally into the first tube to tighten and close a first ring on a subsequent target portion of the tissue adjacent to the target portion of the tissue until the first ring closes the distal opening of the tissue capture device. Attached Figure Description

[0028] Figure 1 A cross-section of a segment of the colon wall is shown, illustrating different stages of tumor growth and spread.

[0029] Figure 2 A perspective view of a system for tissue removal according to an exemplary embodiment is shown.

[0030] Figure 3A It shows Figure 2 A 3D view of the system's handle.

[0031] Figure 3B It shows Figure 3A A detailed perspective view of the first part of the handle.

[0032] Figure 3C It shows Figure 3A A detailed perspective view of the second part of the handle.

[0033] Figure 3D It shows Figure 3A A three-dimensional view of the handle, with its thumb ring relative to... Figure 3A Rotate.

[0034] Figure 4 It shows Figure 2 A side view of the system's far-side components.

[0035] Figure 5 It shows Figure 4 A three-dimensional view of the distal end of the distal component.

[0036] Figure 6 It shows Figure 3A A three-dimensional view of the handle, in which the handle's spools are in the first interlaced configuration.

[0037] Figure 7 It shows Figure 4 A three-dimensional view of the distal component, in which the tissue covering sleeve is initially deployed on the target tissue.

[0038] Figure 8 It shows Figure 3A A perspective view of the handle, in which the first knob of the handle is in the first position.

[0039] Figure 9 It shows Figure 4 A three-dimensional view of the distal component, in which a tissue covering cannula is initially deployed on the target tissue, and the proximal end of the tissue covering cannula is tightened and closed.

[0040] Figure 10 It shows Figure 3A A perspective view of the handle, in which the second knob of the handle is in the first position.

[0041] Figure 11 It shows Figure 4 A three-dimensional view of the distal component, in which tissue captured within the tissue-covering cannula is severed from the surrounding tissue.

[0042] Figure 12A A perspective view of a tissue covering sleeve according to another embodiment, received on a target tissue, is shown.

[0043] Figure 12B It shows Figure 12A A three-dimensional view of a tissue covering cannula, wherein the distal end of the tissue covering cannula is tightly closed.

[0044] Figures 13 to 15 A system according to another exemplary embodiment of the present invention is shown.

[0045] Figure 16 and Figure 17 It shows Figures 13 to 15 The distal portion of the system shown.

[0046] Figure 18A and Figure 18B A system according to yet another exemplary embodiment of the present invention is shown.

[0047] Figure 19 A system according to another exemplary embodiment of the present invention is shown.

[0048] Figure 20 and Figure 21 A system according to another exemplary embodiment of the present invention is shown.

[0049] Figure 22 It shows including Figure 20 and Figure 21 The system shown has a sleeve for the braided wire.

[0050] Figure 23 A system according to yet another exemplary embodiment of the present invention is shown. Detailed Implementation

[0051] The invention can be further understood with reference to the following description and accompanying drawings, wherein like elements are designated by like reference numerals. The present invention relates to an apparatus for the removal and extraction of tissue from a living body in conjunction with an endoscope or other insertive device. The apparatus is adapted for use with a flexible device inserted into a target site within the body via a natural body cavity to separate a target portion of the tissue from surrounding tissue and to safely remove the separated tissue from the body.

[0052] In this application, the terms "distal" and "proximal" refer to the direction away from (distal) and towards (proximal) the user of the device. Thus, for a device used in conjunction with an endoscope or other insertion device according to the described embodiments, the proximal end of the device is typically held externally and accessible to the user, while the distal end is attached to the distal end of the endoscope and inserted into the body at a location adjacent to the target tissue to be treated.

[0053] Those skilled in the art will understand that although the devices according to various embodiments are described with regard to the removal of target portions of tissue, these devices can also be used to capture and remove virtually any object from the body. For example, devices according to these embodiments can be used to capture and remove stones (e.g., kidney stones or gallstones), foreign bodies in the body (e.g., swallowed foreign bodies or foreign bodies left in the body due to medical procedures (e.g., detached portions of medical devices)). Furthermore, although these embodiments are described in conjunction with flexible insertion devices, such as flexible endoscopes, these embodiments can also be used with rigid insertion devices, such as bladder stone endoscopes for, for example, removing lesions within the bladder. These embodiments can also be used to capture and remove thrombi or plaques within blood vessels.

[0054] like Figure 1 As shown and as those skilled in the art will understand, malignant growths in organs (such as the colon) are staged in part based on the location (e.g., at a lymph node or externally) and depth of the tissue that has penetrated into and formed the organ wall. Furthermore, the depth of the growth's penetration into the organ wall will alter the treatment plan for the lesion, and in cases where the growth has penetrated deeply into the wall, it may be necessary to remove a portion of the full-thickness organ wall. In all these cases, it is important to minimize the risk that removing the tissue will result in the implantation of malignant cells into areas previously free of malignant growths.

[0055] Figures 2 to 11A system 100 for removing tissue according to an exemplary embodiment of the present invention is shown, comprising a handle 102 and an insertion segment 104. In this embodiment, the insertion segment 104 includes first and second flexible members 106a, 106b extending to a distal tissue capturing device 108. The tissue capturing device 108 is configured to be mounted on the distal end of a flexible insertion device (e.g., a flexible endoscope 110). The tissue capturing device 108 includes a flange 109 and a flexible tissue capturing member 112, the flange 109 being configured to be secured to the distal end of the insertion device (e.g., configured to frictionally engage at a fixed position on the distal end of the endoscope 110), and in this embodiment, the flexible tissue capturing member 112 is formed as a bag or cannula 113 made of a flexible material, such as rubber, silicone, or biocompatible plastics, such as Tyvek or Mylar.

[0056] As those skilled in the art will understand, the cannula 113 may be made of a transparent material, allowing the user to observe the tissue captured within the cannula 113. Alternatively, the cannula 113 may be formed of a mesh or other upper structure enclosed in a transparent plastic. Those skilled in the art will understand that the mesh or other upper structure may be configured to hold the cannula 113 in a desired shape when the cannula is not subjected to external force (i.e., such that the cannula 113 will present the desired shape when it is moved distally away from the endoscope 110). Furthermore, the cannula 113 may optionally include a first mark 115 at the distal end and / or a mark 117 at the proximal end of the cannula 113 to facilitate observation of the cannula 113's restriction relative to the tissue to be captured.

[0057] Alternatively, the snare itself may be marked, as it is visible through the cannula 113 (e.g., if the cannula 113 is transparent). Furthermore, those skilled in the art will understand that the cannula 113 may be flexible, such that, for example, when the first and second rings 124a, 124b are opened, the cannula is stretched open by the bias of the first and second rings 124a, 124b, and such flexibility may help retain the proximal and distal openings 114, 116 of the cannula 113, respectively, after tissue has been captured therein. As those skilled in the art will understand, this may help retain the captured tissue within the cannula 113 to minimize the risk of implanting cancer cells or other diseased cells into the currently healthy area.

[0058] As will be described in more detail below, the cannula 113 is configured to be received in its initial configuration on the distal end of the endoscope 110 (e.g., wrapped around the distal end of the endoscope 110 located distal to the flange 109). The cannula 113 of this embodiment includes a proximal opening 114 and a distal opening 116. As described below, each of the first and second flexible members 106a, 106b may be formed as a hollow member (e.g., a flexible coil), and each of the first and second flexible tubes 120a, 120b is slidably received within the hollow member. Each of the first and second tubes 120a, 120b is hollow and slidably receives each of the first and second control members 122a, 122b (e.g., a flexible wire).

[0059] A first tube 120a is connected to the distal opening 116 of the cannula 113, and a second tube 120b is connected to the proximal opening 114 of the cannula 113. The first and second tubes 120a and 120b are respectively movable distally and proximally within their respective first and second flexible members 106a and 106b. Thus, if the first and second tubes 120a and 120b move in unison, the cannula 113 can move proximally and distally relative to the distal end of the endoscope 110, and if the first tube 120a, for example, moves relative to the second tube 120b, the distal opening 116 of the cannula 113 will move relative to the proximal opening 114 of the cannula 113.

[0060] Furthermore, a first control member 122a received within the first tube 120a forms a first ring 124a that is connected to and defines the distal opening 116, while a second control member 122b received within the second tube 120b forms a second ring 124b that is connected to and defines the proximal opening 114. That is, the circumference of the first ring 124a is connected to the sleeve 113 along a path extending around the circumference of the distal opening 116, such that opening and closing the first ring 124a opens and closes the distal opening 116 of the sleeve 113. Similarly, the circumference of the second ring 124b is connected to the sleeve 113 along a path extending around the circumference of the proximal opening 114, such that opening and closing the second ring 124b opens and closes the proximal opening 114 of the sleeve 113.

[0061] Those skilled in the art will understand that the first and second rings 124a, 124b can be formed of a material configured to spring open when unconstrained (e.g., not constrained by a corresponding one of the first and second tubes 120a, 120b). Therefore, as those skilled in the art will understand, either or both of the first and second rings 124a, 124b, and the corresponding proximal and distal openings 114, 116 of the sleeve 113, can be opened and closed independently of each other by pulling the first and second control members 122a, 122b proximally into the corresponding tube of the first or second tube 120a, 120b or by extending the first and second control members 122a, 122b distally from the corresponding tube of the first or second tube 120a, 120b.

[0062] Figure 3A A first control member 122a is shown, extending through the body 130 of the handle 102 to connect to a first knob 132 slidably connected to the body 130 of the handle 102. Furthermore, a first spool 134 is connected to a first tube 120a and slidably mounted on the body 130 of the handle 102, with the proximal end of a first flexible member 106a fixed to the body 130. The distal end of the first flexible member 106a is fixed to a flange 109. Similarly, a second control member 122b extends through the body 130 of the handle 102 to connect to a second knob 136 slidably connected to the body 130, and a second spool 138 is connected to a second tube 120b and slidably mounted on the body 130 of the handle 102, while the proximal end of the second flexible member 106b is fixed to the body 130.

[0063] The distal end of the second flexible member 106b is fixed to the flange 109. Therefore, the distal movement of the first spool 134 relative to the body 130 causes the first tube 120a to move distally within the first flexible member 106a, so that the first tube 120a moves distally from the distal end of the first flexible member 106a, so that the distal end of the cannula 113 extends distally from the endoscope 110, and the distal movement of the second spool 138 relative to the body 130 causes the second tube 120b to move distally within the second flexible member 106b, so that the second tube 120b moves distally from the distal end of the second flexible member 106b, so that the proximal end of the cannula 113 is pushed distally from the endoscope 110. As those skilled in the art will understand, if the first and second spools 134, 138 move distally in sync, the cannula 113 will move distally away from the endoscope 110 without changing the distance between the proximal opening 114 and the distal opening 116.

[0064] Alternatively, if one of the first and second spools 134, 138 moves relative to the other, the distance between the proximal and distal openings 114, 116 can be shortened or lengthened as needed. Those skilled in the art will also understand that any of the first and second spools 134, 138 or the first and second knobs 132, 136 may include a lock that can be actuated by the user to hold the locking component in its current position, allowing the user to use their hand or fingers for other purposes without worrying about any changes in the position of the components controlled by the various actuators on the handle 102.

[0065] As noted above, the first ring 124a may be formed of a biocompatible metal, such as stainless steel, having a shape bias toward opening; or it may be formed of a shape memory material (e.g., nitinol, alloys of nitinol and cobalt, plastics such as PEEK and polycarbonate, etc.) configured such that when the first ring 124a is in a first position, in which a portion of the first ring 124a is received within the first tube 120a, the first ring 124a, and thus the distal opening 116, contracts (i.e., the diameter of the distal opening 116 decreases). Due to the bias or shape memory nature of the first ring 124a, if the first control member 122a is advanced distally relative to the first tube 120a, a larger portion of the first ring 124a will move distally outside the first tube 120a, causing the first ring 124a to expand and further open the distal opening 116.

[0066] Similarly, the second ring 124b may be biased or made of a shape memory material configured such that when the second ring 124b is in a first position, in which a portion of the second ring 124b is received within the second tube 120b, the second ring 124b, and thus the proximal opening 114, contracts (i.e., the diameter of the proximal opening 114 decreases). The biased or shape memory properties of the second ring 124b function such that when the second control member 122b is advanced distally relative to the second tube 120b, a larger portion of the second ring 124b will move distally outside the second tube 120b, causing the second ring 124b to expand and further open the proximal opening 114.

[0067] As those skilled in the art will understand, the handle 102 of this embodiment includes an optional thumb loop 140 fixed to the body 130, and the first and second spools 134, 138 also include optional first and second finger loops 135, 137, respectively, to facilitate movement of the first and second spools 134, 138 relative to the body 130. Furthermore, those skilled in the art will understand that either or both of the first and second loops 124a, 124b can be coupled to an RF source or other energy source to facilitate the removal of target tissue and / or cauterization of any resulting wounds, but this is more likely to apply to the first loop 124a.

[0068] In use, the tissue capture device 108 is mounted on the distal end of the endoscope 110 by moving the flange 109 on the distal end of the endoscope 110 until the flange is in the desired position on the endoscope 110. Simultaneously, by moving the endoscope 110 through the proximal opening 114 and the distal opening 116, the cannula 113 is pulled on the distal end of the endoscope 110, causing the cannula 113 to wrap around the distal end of the endoscope 110. In this configuration, in this embodiment, the first and second flexible members 106a, 106b are pre-attached to the body 130, which is connected to the flange 109 and the handle 102, and wherein the first and second tubes 120a, 120b extend through the flange 109. At this time, the first and second control components 122a and 122b extend distally from the distal ends of the first and second tubes 120a and 120b, respectively, wherein the first and second rings 124a and 124b are respectively connected to the distal opening 116 and the proximal opening 114 of the sleeve 113.

[0069] In this configuration, the endoscope 110 and tissue capture device 108 are inserted into the patient's body (e.g., into a body cavity via a natural body orifice) and guided through the body to a target portion adjacent to the tissue T to be treated. The user can, for example, observe the target tissue using the visual system of the endoscope 110 (e.g., via a lens mounted on the distal end face of the endoscope 110). The user then grasps the target tissue or otherwise pulls it into the desired position relative to the distal end of the endoscope 110. For example, a gripper or suction applied through the working channel of the endoscope 110 (e.g., the working channel leading to the distal end face of the endoscope 110) can be used to control polyps or other lesions protruding from the wall of the target organ, such that the tissue is pulled against the distal end face of the endoscope 110 toward the opening of the working channel.

[0070] As those skilled in the art will understand, some lesions (e.g., sessile polyps) may be flattened along the surface of the target organ's wall. In such cases, the user may inject fluid beneath the target lesion to lift the lesion from the surface of another part of the organ's wall, or otherwise treat the tissue to make it easier to lift and remove from surrounding tissue. In any case, the user moves the target tissue until it is positioned as needed (e.g., such that the target tissue passes through the distal opening 116 into the cannula 113 as the cannula 113 is moved distally away from the endoscope 110). Specifically, as noted above, the cannula 113 remains open when it is wrapped around or spread around the distal end of the endoscope 110.

[0071] The user then advances the first knob 132 distally to keep the distal opening 116 open and simultaneously advances the first and second spools 134, 138 distally to advance the cannula 113 distally away from the endoscope 110, with the target tissue T passing through the distal opening 116 into the cannula 113. When the distal end of the cannula 113 reaches the desired position (e.g., when the first ring 124a and the distal opening 116 are positioned around a portion of the tissue, leaving a desired edge beyond the target lesion), the user holds the first spool 134 in place and pulls the first knob 132 proximally to retract the first control member 122a and the first ring 124a into the first tube 120a to contract the first ring 124a and the distal opening 116 of the cannula 113 within the cannula 113 around the edge forming the target tissue T (the entire target tissue T and the tissue forming the edge) (e.g., see...). Figure 7 Simultaneously, the user can retract the second knob 136 proximally to close the proximal opening 114 of the cannula 113, thereby closing the proximal end of the target tissue T within the cannula 113 (see, for example, see...). Figure 9 ).

[0072] The user can then observe the tissue within and around the cannula 113 to determine if the target tissue T and the desired edges of the tissue surrounding T have been captured within the cannula 113. If the user determines that the tissue T and the edge tissue have not been captured as desired, the user can reopen the proximal and distal openings 114 and 116 by pushing the first and second knobs 132, 136 distally relative to the body 130 of the handle 102, and subsequently pull the first and second spools 134, 138 proximally relative to the body 130 to pull the cannula 113 proximally away from the previously captured tissue and pull the cannula 113 back onto the distal end of the endoscope 110. The user can observe the target tissue, reposition the endoscope 110 as needed, and repeat these steps to capture new portions of the tissue within the cannula 113.

[0073] When the user is satisfied that the desired portion of tissue T and the desired edge of healthy tissue have been captured within the cannula 113 and the proximal and distal openings 114, 116 have been closed on the tissue, the user can cut the captured tissue from the surrounding tissue by retracting the first knob 132 proximally until the first ring 124a is sufficiently tightened around the base of the captured tissue to cut the tissue from the surrounding tissue (e.g., see...). Figure 11 Those skilled in the art will understand that users may also apply RF or other energy (in monopolar or bipolar arrangements as needed) to facilitate cutting the tissue and / or help seal (e.g., burn) the wound.

[0074] The user can then hold the first and second knobs 132, 136 in their fully retracted positions to effectively seal the proximal and distal openings 114, 116 of the cannula 113, ensuring that the captured tissue T is sealed within the cannula 113 during removal from the body. As noted above, either or both of the first and second knobs 132, 136 may include a locking mechanism that holds the knob in its proximal position (i.e., with the proximal and distal openings 114, 116 closed) until the endoscope 110 and the tissue capture device 108 are removed from the body. Thus, the captured tissue remains within the cannula 113, preventing contact with other tissues or fluids and minimizing the risk of implanting diseased cells from the captured tissue.

[0075] Those skilled in the art will also understand that the sleeve 113 (and / or any upper structure or other structure that holds the sleeve 113 in the desired shape) can take any of a variety of shapes. For example, as Figure 12A and Figure 12B As shown, the device according to another embodiment may include a first ring 224a that opens and closes the distal opening 216 of the sleeve 213 in the same manner as described above for the distal opening 116 of the sleeve 113. However, the first ring 224a includes a plurality of tissue-cutting teeth 215 extending radially inward from the first ring 224a. As those skilled in the art will understand, the teeth 215 are configured to cut tissue when the first ring 224a is tightened around the captured tissue.

[0076] Furthermore, the cannula has a conical shape, wherein the proximal opening 214 is biased to close automatically once it is disengaged from the distal end of the endoscope 210 (e.g., via a flexible band 217 surrounding the proximal opening 214). In this configuration, the system can eliminate any connection to the proximal end of the cannula 213, as it closes immediately once the proximal end of the cannula 213 is moved distally away from the endoscope 210, and no opening and closing is required after the cannula 213 has been deployed from the distal end of the endoscope 210.

[0077] Those skilled in the art should understand that, Figure 12A In the middle, the proximal opening 214 of the cannula 213 still extends around the distal end of the endoscope 210, and as... Figure 12B As shown, after the cannula 213 has been fully pulled away from the endoscope 210, the proximal opening 214 has been closed by the band 217. Those skilled in the art will recognize that the teeth 215 can be used with the cannula 213 and the first band 214a, and alternatively, the cannula 213 can be used with the first band 224a excluding the teeth 215, in the same manner as shown for the first band 124a.

[0078] Figures 13 to 15 System 250 is shown, which operates in a manner substantially similar to that described above with respect to cannula 213. However, in system 250, cap 252 is slidably received around the distal end of endoscope 254. System 250 includes a handle similar to handle 102, which includes flexible members 256a and 256b extending from the handle to flange 258, which is mounted around the distal portion of endoscope 254 in a manner similar to flange 109 described above.

[0079] Flexible members 256a and 256b slidably receive first and second tubes 260a and 260b therein. First and second tubes 260a and 260b slidably receive first and second control members 262a and 262b therein, extending distally from the distal ends of the first and second tubes 260a and 260b, respectively, wherein first and second rings 264a and 264b are respectively connected to the distal opening 266 and proximal opening 268 of the cannula 270. In the initial configuration, the proximal end of the cannula 270 and the second ring 264b are received around the distal end of the cap 252. In the initial configuration, the cap 252 is retracted at the distal end of the endoscope 254, and the proximal end of the cannula 270 is opened around the cap 252. At this time, the distal end of the cannula 270 is opened at the distal end of the endoscope 254, allowing tissue to be pulled against the distal end of the endoscope 254 as described above.

[0080] The user can extend the cap 252 distally by advancing the second tube 260b, which in this embodiment is coupled to the cap 252. The distal end of the cannula 270 then moves away from the distal end of the endoscope 254, and the distal end of the cannula 270 retracts around the captured tissue in the same manner as described above with respect to cannula 213. The user can then determine that the desired portion of the tissue has been captured within the cannula 270 as needed. If the user determines that the desired portion of the tissue has not been captured as needed, the user can retract the cap 252 proximally by retracting the second tube 260b until the cap 252 moves back onto the distal end of the endoscope 254, and then reopen the distal end of the cannula 270 as it expands onto the distal end of the endoscope 254. This releases the previously captured tissue.

[0081] The user can then observe the target tissue and reposition the endoscope 254 until it is positioned relative to the target tissue to be captured as needed. The user then redeploys the cannula 70 in the same manner as described above, and if the user determines that tissue has been captured as needed, the user can also advance the first tube 260a while keeping the cap 252 stationary until the proximal end of the cannula 270 is pulled away from the cap 252 and the proximal end of the cannula 270 contracts to close the proximal opening of the cannula 270. The user can then manipulate the first ring 264a until the captured tissue is removed from the surrounding tissue, and the cannula 270, including the captured tissue, can be safely removed from the body along with the endoscope 254 and the rest of the system 250.

[0082] Figure 16 and Figure 17 The distal portion 302 of a system 300 according to another embodiment is shown. Except as specifically pointed out below, the system 300 is structurally and operationally substantially similar to the previously described embodiments. The system 300 includes a handle similar to the handle 102 described above and an insertion portion, in this embodiment, the insertion portion including first and second flexible members 306a, 306b extending to a distal tissue capture device 308 configured to be mounted on the distal end of a flexible insertion device (e.g., a flexible endoscope 310).

[0083] The tissue capture device 308 includes a flange 309 and a flexible tissue capture member 312. The flange 309 is configured to be secured to the distal end of the insertion device (e.g., configured to frictionally engage at a fixed position on the distal end of the endoscope 310). In this embodiment, the flexible tissue capture member 312 is formed as a bag or cannula 113 made of a stretchable flexible material, such as rubber, silicone, or biocompatible plastics, such as Tyvek or Mylar. The cannula 313 in this embodiment is substantially cylindrical, with its proximal end 313a folded back on a portion of the cannula 313 to form a pouch at the proximal end 313a, in which a first ring 324a is received. The distal end 313b is also folded back on a portion of the cannula 313 to form a pouch at the distal end 313b, in which a second ring 324b is received.

[0084] The cannula 313 is configured to be received in its initial configuration on the distal end of the endoscope 310 (e.g., wrapped around the distal end of the endoscope 310 located distal to the flange 309). In this embodiment, the cannula 313 includes a proximal opening 314 and a distal opening 316. Each of the first and second flexible members 306a, 306b may be formed as a hollow member, and each of the first and second flexible tubes 320a, 320b is slidably received within the hollow member. Each of the first and second tubes 320a, 320b is hollow and slidably receives each of the first and second control members 322a, 322b (e.g., flexible wires) therein.

[0085] like Figure 17 As shown, when the sleeve 313 is closed (when the first and second control members 322a, 322b and the first and second rings 324a, 324b are pulled into the first and second tubes 320a, 320b respectively), the tissue T trapped in the sleeve 313 is enclosed by the first and second closing rings 324a, 324b without placing the material of the sleeve 313 under tension.

[0086] Figure 18A and Figure 18B A system 400 according to an exemplary embodiment of the present invention is shown, which, except as specifically pointed out below, is substantially similar in structure and operation to the previously described exemplary embodiments. System 400 includes a handle similar to the handle 102 described above and an insertion portion, in this embodiment including first and second flexible members 406a, 406b extending to a distal tissue capture device 408 configured to be mounted on the distal end of a flexible insertion device (e.g., a flexible endoscope 410).

[0087] The tissue capture device 408 includes a flange 409 and a flexible tissue capture member 412. The flange 409 is configured to be secured to the distal end of the insertion device (e.g., configured to frictionally engage at a fixed position on the distal end of the endoscope 410). In this embodiment, the flexible tissue capture member 412 is formed as a bag or cannula 413 made of a stretchable flexible material, such as rubber, silicone, or biocompatible plastics, such as Tyvek or Mylar. The cannula 413 in this embodiment is substantially cylindrical and includes first and second tubes 420a, 420b respectively connected to a proximal end 413a and a distal end 413b, wherein the first tube 420a is distributed around the circumference of a proximal opening 414, and the second tube 420b is distributed around the circumference of a distal opening 416. The first and second tubes 420a and 420b are separated from each other by a gap 415, such that when the first and second rings 424a and 424b are tightened to close the bag (in the same manner as described above), the first and second tubes 420a and 420b can be pulled together to close the proximal and distal openings 414 and 416 to seal the tissue within the sleeve 413.

[0088] The cannula 413 is configured to be received in its initial configuration on the distal end of the endoscope 410 (e.g., wrapped around the distal end of the endoscope 410 located distal to the flange 409). Similar to the embodiments described above, each of the first and second flexible members 406a, 406b may be formed as a hollow member, and each of the first and second tubes 420a, 420b is slidably received within the hollow member. Each of the first and second tubes 420a, 420b is hollow and slidably receives each of the first and second control members 422a, 422b (e.g., flexible wires). When the distal opening 416 is fully tightened and closed as in the previous embodiments, a radially inward force applied to the tissue in the distal opening 416 cuts the tissue from the surrounding tissue, thereby leaving the target tissue captured within the cannula 413.

[0089] Figure 19 A system 500 according to an exemplary embodiment of the present invention is shown, which, except as specifically pointed out below, is substantially similar in structure and operation to the previously described embodiments. System 500 includes a cannula 513 received in an initial configuration around the distal end of an endoscope 510. In this embodiment, the cannula 513 received on the distal end of the endoscope 510 has a corrugated tubular shape in its initial configuration, which allows the length of the cannula 513 along the longitudinal axis L to be longer than the length of a portion P of the endoscope around which the cannula 513 is received.

[0090] The cannula 513 is folded with accordion-like pleats 515, which flatten out as the cannula 513 is deployed from the endoscope 510, as the cannula 513 is elongated (e.g., by advancing the tube 520a distally relative to the tube 520b). In this embodiment, the pleats 515 are formed such that the peaks of the pleats 515 do not extend radially outward beyond the outer diameter of the flange 509. Therefore, the outer profile of the system 500 does not increase beyond the outer profile of the flange 509.

[0091] Figure 20 and Figure 21 A system 600 according to an exemplary embodiment of the present invention is shown, which, except as specifically pointed out below, is substantially similar in structure and operation to the previously described embodiments. System 600 includes a flange 609, first and second flexible members 606a and 606b, first and second tubes 620a and 620b, and a handle similar to the handle 102 described above. The difference between system 600 and the previously described embodiments is that the sleeve 613 includes a plurality of wires 615 embedded within an elastomeric material of the sleeve 613.

[0092] In this embodiment, wire 615 is configured to bias sleeve 613 into an open configuration, in which the proximal opening 614 and the distal opening 616 are held open by wire 615. For example, wire 615 may be formed of nitinol, which has a memory shape corresponding to the open configuration. Sleeve 613 can then be closed by pulling control wires 622a and 622b into the first and second tubes 620a and 620b, as described above.

[0093] Alternatively, the suture 615 may be biased toward a closed configuration, in which the proximal opening 614 and the distal opening 616 are closed. In such an embodiment, the cannula 613 will remain open by being spread around the distal end of the endoscope 610, and will automatically close once the cannula 613 is moved away from the endoscope (due to the bias of the suture 615). The user will then retract the suture loop, as described above, to remove tissue trapped within the cannula 613.

[0094] Figure 22A cannula 713 is shown comprising a wire braid 715, which can be configured to bias the cannula 713 open or closed in a manner similar to that described above with respect to wire 615. In this embodiment, the wire braid 715 may also be formed of biased or shape-memory nitinol, the shape being configured to hold the cannula 713 in an open or closed configuration. Furthermore, in this embodiment, the wire braid 715 is coated with an elastic coating to minimize trauma to tissue that may come into contact with the outer surface of the cannula 713 (e.g., during insertion of the endoscope 710 into a target site within the body).

[0095] Figure 23 A system 800 according to an exemplary embodiment of the present invention is illustrated, which is similar in construction to the embodiments described above, except that the system is not designed for use with an endoscope or similar insertable instrument. Instead, system 800 is a catheter-based system for capturing and removing thrombi from blood vessels. System 800 includes a catheter 802 having a cannula 813 mounted on the distal end of catheter 802 in a manner similar to the cannula mounting on an endoscope in earlier embodiments. As those skilled in the art will understand, in this embodiment, catheter 802 may be a braided catheter to enhance kink resistance and column strength (e.g., to enhance the ability to advance catheter 802 to a target site within the body).

[0096] System 800 includes a similar arrangement of first and second flexible members 806a and 806b and first and second tubes 820a and 820b, which extend from a handle-like structure 102 held externally to a flange 809 mounted on a distal portion of catheter 802. In this embodiment, each of control lines 822a and 822b extends through a corresponding one of the first and second tubes 820a, 820b to control the operation of first and second rings 824a, 824b in substantially the same manner as described for the previous embodiment. In this embodiment, the diameter of catheter 802 is between 1 mm and 15 mm, allowing the catheter to be inserted and passed through a blood vessel to the thrombus site. The user then captures the thrombus in a manner similar to that described above for the removal and capture of, for example, polyps.

[0097] In this situation, the thrombus can be captured by applying suction through catheter 802, introducing a mechanical grasping device, or by any other known method. The distal end of cannula 813 is then pushed away from catheter 802 to cover the thrombus, and the distal opening 816 is closed in a manner similar to that described in any of the above embodiments. Catheter 802, together with cannula 813 and the thrombus held therein, can then be removed from the body.

[0098] It will be apparent to those skilled in the art that various modifications can be made to this invention without departing from its scope. Furthermore, those skilled in the art should understand that features of any of the various embodiments can be combined in any manner inconsistent with the description and / or functionality of the embodiments.

Claims

1. A device for treating tissue, comprising: a tissue capture assembly removably attached to an insertion device configured to be inserted to a target site within a living body, the tissue capture assembly including a tissue capture sleeve removably received on a distal end of the insertion device in an initial configuration and a flange removably mounted on the insertion device proximal of the tissue capture sleeve when the tissue capture sleeve is in the initial configuration; a first hollow member extending from a proximal end that remains accessible to a user outside of the body during use to a distal end coupled to the flange; a first tube slidably received within the first hollow member and extending distally beyond the flange from a proximal end accessible to the user that remains outside of the body during use to a first tube distal end, the first tube configured to push the tissue capture sleeve distally off the insertion device as it is advanced distally through the first hollow member; and a first control member slidably received within the first tube and extending from a proximal end accessible to the user that remains outside of the body during use to a distal end forming a first ring circumferentially coupled around a distal opening of the tissue capture sleeve, the first ring configured to move between a collapsed configuration in which at least a portion of the first ring is pulled proximally into the first tube and an open configuration in which the first ring extends distally from the first tube to open the first ring and the distal opening of the tissue capture sleeve.

2. The device of claim 1, further comprising: a handle including a handle body and a first actuator coupled to the proximal end of the first tube, wherein the first hollow member is coupled to the handle body and the first actuator is movably coupled to the handle body such that movement of the first actuator relative to the handle body moves the first tube proximally and distally within the first hollow member.

3. The device of claim 2, further comprising: a second actuator coupled to the proximal end of the first control member, wherein the second actuator is coupled to the first actuator such that movement of the second actuator relative to the first actuator moves the first control member proximally and distally within the first tube.

4. The device of any of claims 1-3, wherein the tissue capture sleeve includes an elastomeric ring circumferentially coupled around a proximal opening thereof, the elastomeric ring biased toward a closed configuration such that the elastomeric ring pulls the proximal opening of the tissue capture sleeve closed as the tissue capture sleeve is pushed distally off the insertion device.

5. The device of claim 2, further comprising: a second hollow member extending from a proximal end accessible to the user that remains outside of the body during use to a distal end coupled to the flange; a second tube slidably received within the second hollow member and extending distally beyond the flange to a second tube distal end from a proximal end that is user-accessible and remains outside the body during use, the second tube configured to cooperate with the first tube to push the tissue capture sleeve distally away from the insertion device as the second tube is advanced distally through the second hollow member; and a second control member slidably received within the second tube and extending from a proximal end that is user-accessible and remains outside the body during use to a distal end that forms a second ring circumferentially coupled around a proximal opening of the tissue capture sleeve, the second ring configured to move between a retracted configuration in which at least a portion of the second ring is pulled proximally into the second tube and an open configuration in which the second ring extends distally from the second tube to open the proximal opening of the tissue capture sleeve and the second ring.

6. The device of claim 5, wherein the handle further comprises a third actuator coupled to the proximal end of the second tube, wherein the second hollow member is coupled to the handle body and the third actuator is movably coupled to the handle body such that movement of the third actuator relative to the handle body moves the second tube proximally and distally within the second hollow member.

7. The device of claim 6, further comprising: a fourth actuator coupled to the proximal end of the second control member, wherein the fourth actuator is coupled to the third actuator such that movement of the fourth actuator relative to the third actuator moves the second control member proximally and distally within the second tube.

8. The device of any one of claims 1-7, wherein the tissue capture sleeve is formed of one of silicone and biocompatible plastic.

9. The device of claim 8, wherein the tissue capture sleeve is formed of one of Tyvek and Mylar.

10. The device of any one of claims 1-9, wherein the first ring is formed of a shape memory material configured such that when the first ring is extended from the first tube, the first ring assumes an open ring shape to pull the distal opening of the tissue capture sleeve to the open configuration.

11. The device of any one of claims 1-10, wherein the first ring is formed of a biocompatible metal biased such that when the first ring is extended from the first tube, the first ring assumes an open ring shape to pull the distal opening of the tissue capture sleeve to the open configuration.

12. The device of any one of claims 1-11, wherein the first ring comprises a plurality of radially inward facing tissue cutting features.

13. A device for treating tissue, comprising: a catheter comprising a tissue capture assembly mounted on a distal portion thereof, the tissue capture assembly comprising a tissue capture sleeve and a flange, the tissue capture sleeve removably received on a distal end of the catheter in an initial configuration, and the flange extending radially outward from an exterior of the catheter proximal of the tissue capture sleeve when the tissue capture sleeve is in the initial configuration; a first hollow member extending from a proximal end accessible to a user that remains outside a living body during use to a distal end coupled to the flange; a first tube slidably received within the first hollow member and extending distally beyond the flange from the proximal end accessible to the user during use to a first tube distal end; and a first control member slidably received within the first tube and extending from the proximal end accessible to the user during use to a distal end forming a first ring coupled around a circumference of a distal opening of the tissue capture sleeve, the first ring configured to move between a collapsed configuration in which at least a portion of the first ring is drawn proximally into the first tube and an open configuration in which the first ring extends distally from the first tube to open the first ring and the distal opening of the tissue capture sleeve.

14. The device of claim 13, wherein the catheter is sized and shaped to be inserted into a blood vessel and wherein the tissue to be targeted is a thrombus.

15. The device of any one of claims 13-14, wherein the catheter is a braided catheter.

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