Repositionable tissue capture device

Abstract

The device includes a capture assembly, a hollow member, a tube, and a control member. The assembly includes a capture sleeve received on the distal end of the insertion device and a flange mounted on the insertion device proximal to the sleeve. The hollow member, tube, and control member each have a proximal end accessible to the user. The tube pushes the sleeve distally away from the insertion device as the tube advances distally through the hollow member. The control member includes a distal end that forms a connected loop around the distal opening of the sleeve. The loop moves between a tightening configuration in which at least a portion of the loop is pulled proximal into the tube and an opening configuration in which the loop extends distally from the tube, opening the loop and the distal opening of the sleeve.

Description

Technical Field

[0001] The present disclosure relates to an endoscopic device, and more particularly to a device for capturing tissue for removal from a living body.

Background Art

[0002] Full-thickness resection (e.g., removal of a portion of a digestive organ (e.g., the colon) including the full thickness of the organ wall) is often used as a treatment for cancer. These procedures carry certain risks including intra-abdominal hypertension, loss of insufflation at the site of full-thickness resection, and the potential for seeding of cancer cells to new sites by the procedure. Further, certain procedures for lesion removal without full-thickness resection often cannot remove the entire targeted portion of tissue (e.g., a tumor) for various reasons.

Summary of the Invention

[0003] The present disclosure relates to a device for treating tissue. The device includes a tissue capture assembly removably attachable to an insertion device configured to be inserted into a target site within a living body. The tissue capture assembly includes, in an initial configuration, a tissue capture sleeve removably received on a distal end of the insertion device and a flange removably mounted on the insertion device proximal to the tissue capture sleeve when the tissue capture sleeve is in the initial configuration. A first hollow member extends from a proximal end, which remains outside the body and accessible to a user during use, to a distal end connected to the flange.

[0004] Furthermore, the device includes a first tube slidably housed within a first hollow member and, during use, extending from a proximal end that remains outside the body accessible to the user, beyond a flange, to the distal end of the first tube. The first tube is configured to push the tissue capture sleeve distally from the insertion device as the first tube is advanced distally through the first hollow member. Furthermore, the device includes a first control member slidably housed within the first tube and, during use, extending from a proximal end that remains outside the body accessible to the user, to a distal end that forms a first loop connected along the circumference of the distal opening of the tissue capture sleeve. The first loop is configured to move between a tightening configuration in which at least a portion of the first loop is retracted proximally into the first tube, and an opening configuration in which the first loop extends distally from the first tube, opening the first loop and the distal opening of the tissue capture sleeve.

[0005] In one embodiment, the device further includes a handle having a handle body and a first actuator connected to the proximal end of a first tube, wherein a first hollow member is connected to the handle body, and the first actuator is movably connected to the handle body, and the movement of the first actuator relative to the handle body causes the first tube to move proximal and distal within the first hollow member.

[0006] In one embodiment, the device further includes a second actuator connected to the proximal end of a first control member. The second actuator is connected to the first actuator, and the movement of the second actuator relative to the first actuator causes the first control member to move proximal and distal within the first tube.

[0007] In one embodiment, the tissue capture sleeve includes an elastomer loop connected along the circumference of the proximal opening of the tissue capture sleeve, the elastomer loop being biased into a closed configuration, and as the tissue capture sleeve is pushed distally from the insertion device, the elastomer loop pulls to close the proximal opening of the tissue capture sleeve.

[0008] In one embodiment, the device further includes a second hollow member extending from a proximal end that remains outside the body accessible to the user during use to a distal end connected to a flange, and a second tube slidably housed within the second hollow member and extending from a proximal end that remains outside the body accessible to the user during use beyond the flange to a distal end of the second tube. The second tube is configured to cooperate with the first tube to push the tissue capture sleeve distally out of the insertion device as the second tube is advanced distally through the second hollow member.

[0009] The device also includes a second control member slidably housed within a second tube and extending from a proximal end that remains outside the body accessible to the user during use to a distal end that forms a second loop connected along the circumference of the proximal opening of the tissue capture sleeve. The second loop is configured to move between a tightening configuration in which at least a portion of the second loop is retracted proximal into the second tube and an opening configuration in which the second loop extends distally from the second tube, opening the second loop and the proximal opening of the tissue capture sleeve.

[0010] In one embodiment, the handle further comprises a third actuator connected to the proximal end of a second tube. The second hollow member is connected to the handle body, and the third actuator is movably connected to the handle body, so that the movement of the third actuator relative to the handle body causes the second tube to move proximal and distal within the second hollow member.

[0011] In one embodiment, the device further includes a fourth actuator connected to the proximal end of the second control member. The fourth actuator is connected to the third actuator, and the movement of the fourth actuator relative to the third actuator causes the second control member to move proximal and distal within the second tube.

[0012] In one embodiment, the tissue capture sleeve is formed from one of silicone and biocompatible plastic. In one embodiment, the tissue capture sleeve is formed from one of Tyvek® and Mylar®.

[0013] In one embodiment, the first loop is formed from a shape memory material configured such that when the first loop extends from the first tube, the first loop takes on an open-loop shape, pulling the distal opening of the tissue-capturing sleeve into an open state.

[0014] In one embodiment, the first loop is formed from a biocompatible metal that, when the first loop extends from the first tube, is biased to take on an open-loop shape, pulling the distal opening of the tissue-trapping sleeve into an open configuration.

[0015] In one embodiment, the first loop includes a plurality of radially inwardly oriented tissue section features. Furthermore, this disclosure relates to a device for treating tissue. The device includes a catheter having a tissue capture assembly mounted on its distal portion. In its initial form, the tissue capture assembly includes a tissue capture sleeve removably received at the distal end of the catheter, and a flange extending radially outward from the outer surface of the catheter proximal to the tissue capture sleeve when the tissue capture sleeve is in its initial form.

[0016] The device also includes a first hollow member that, during use, extends from a proximal end that remains outside the body accessible to the user to a distal end connected to a flange. The device also includes a first tube slidably housed within a first hollow member and, during use, extending from a proximal end that remains outside the body accessible to the user, beyond a flange, to the distal end of the first tube. Furthermore, the device includes a first control member slidably housed within the first tube and, during use, extending from a proximal end that remains outside the body accessible to the user, to a distal end that forms a first loop connected along the circumference of the distal opening of the tissue capture sleeve. The first loop is configured to move between a tightening configuration in which at least a portion of the first loop is retracted proximally into the first tube, and an opening configuration in which the first loop extends distally from the first tube, opening the first loop and the distal opening of the tissue capture sleeve.

[0017] In one embodiment, the catheter is of a size and shape suitable for insertion into a blood vessel, and the target tissue is a thrombus. In one embodiment, the catheter is a braided catheter.

[0018] Furthermore, this disclosure relates to a method for capturing tissue. The method comprises the steps of inserting a tissue capture assembly, which is removably attached to an insertion device, into a living body to a target site adjacent to the tissue to be treated, wherein the tissue capture assembly comprises a tissue capture sleeve removably received at the distal end of the insertion device and a flange removably mounted on the insertion device proximal to the tissue capture sleeve, the tissue capture sleeve being connected to a first control member slidably housed in a first tube, and a first loop at the distal end of the first control member being connected around the distal opening of the tissue capture sleeve, and guiding the target portion of the tissue toward the distal end of the insertion device. The procedure includes the steps of: first drawing in; moving the first tube distally to push the tissue capture sleeve distally from the insertion device to accommodate the target portion of the tissue within the tissue capture sleeve; secondly drawing in the first control member proximal to the first tube and tightening the first loop to close over a portion of the tissue adjacent to the target portion of the tissue until the first loop closes the distal opening of the tissue capture sleeve; and, if the user determines that the portion of the tissue captured within the tissue capture sleeve has been captured as desired, further drawing in the first control member proximal to cut the target portion of the tissue from the surrounding tissue.

[0019] In one embodiment, the tissue capture sleeve is connected to a second control member slidably housed within a second tube, and the second control member is pulled proximal into the second tube, with a second loop at the distal end of the second control member connected along the periphery of the proximal opening of the tissue capture sleeve, thereby tightening the second loop and closing the proximal opening of the tissue capture sleeve.

[0020] In one embodiment, the method further includes the step of keeping the proximal and distal openings of the tissue capture sleeve closed when the insertion device is withdrawn from the body. In one embodiment, a first tube is connected to a first actuator on a handle, and a first control member is connected to a second actuator on a handle. The operation of the first actuator causes the first tube to move proximal and distal to the insertion device, and the movement of the second actuator causes the first control member to move proximal and distal to the first tube.

[0021] In one embodiment, the method further includes the steps of: observing the tissue within the tissue capture sleeve after the tissue capture sleeve has been deployed over a target portion of tissue to determine whether the target portion of tissue has been captured as desired; if it is determined that the target portion of tissue has not been captured as desired, advancing a first control member distally from the first tube to reopen the distal opening of the tissue capture sleeve; after the distal opening of the tissue capture sleeve has been reopened, withdrawing the tissue capture sleeve from the previously captured tissue; pulling the next target portion of tissue toward the distal end of the insertion device; moving the first tube distally to push the tissue capture sleeve distally from the insertion device so that the next target portion of tissue is accommodated within the tissue capture sleeve; and retracting the first control member proximal into the first tube to tighten the first loop over the next target portion of tissue adjacent to the target portion of tissue until the first loop closes the distal opening of the tissue capture sleeve. [Brief explanation of the drawing]

[0022] [Figure 1] This figure shows cross-sections of colon wall sections illustrating the growth stages and diffusion of a tumor. [Figure 2] This is a perspective view of a system for tissue removal according to an exemplary embodiment. [Figure 3A] Figure 2 is a perspective view of the system's handle. [Figure 3B] Figure 3A is a detailed perspective view of the first part of the handle. [Figure 3C] Figure 3A is a detailed perspective view of the second part of the handle. [Figure 3D] In the handle of FIG. 3A, it is a perspective view showing the state in which the sampling ring is rotated with respect to FIG. 3A. [Figure 4] It is a side view of the distal assembly of the system of FIG. 2. [Figure 5] It is a perspective view of the distal end of the distal assembly of FIG. 4. [Figure 6] In the handle of FIG. 3A, it is a perspective view showing the state in which the spool of the handle is in the first stepped form. [Figure 7] In the distal assembly of FIG. 4, it is a perspective view showing the state in which the tissue covering sleeve is preliminarily deployed over the target tissue. [Figure 8] In the handle of FIG. 3A, it is a perspective view showing the state in which the first knob of the handle is in the first form. [Figure 9] In the distal assembly of FIG. 4, it is a perspective view showing the state in which the tissue covering sleeve is preliminarily deployed over the target tissue and the proximal end of the tissue covering sleeve is tightened and closed. [Figure 10] In the handle of FIG. 3A, it is a perspective view showing the state in which the second knob of the handle is in the first form. [Figure 11] In the distal assembly of FIG. 4, it is a perspective view showing the state in which the tissue captured within the tissue covering sleeve is cut off from the surrounding tissue. [Figure 12A] It is a perspective view showing the state in which the tissue covering sleeve according to a further embodiment is disposed over the target tissue. <00001{09}>In the tissue covering sleeve of FIG. <{12A}>, it is a perspective view showing the state in which the distal end of the tissue covering sleeve is tightened and closed. [Figure 13] It is a diagram showing a system according to another exemplary embodiment of the present disclosure. [Figure 14] It is a diagram showing a system according to another exemplary embodiment of the present disclosure. [Figure 15] It is a diagram showing a system according to another exemplary embodiment of the present disclosure. [Figure 16] It is a diagram showing the distal portion of the system shown in FIGS. 13 to 15. [Figure 17] Figures 13 to 15 show the distal portion of the system. [Figure 18A] This figure shows a system according to yet another exemplary embodiment of the present disclosure. [Figure 18B] This figure shows a system according to yet another exemplary embodiment of the present disclosure. [Figure 19] This figure shows a system according to a further exemplary embodiment of the present disclosure. [Figure 20] This figure shows a system according to yet another exemplary embodiment of the present disclosure. [Figure 21] This figure shows a system according to yet another exemplary embodiment of the present disclosure. [Figure 22] This figure shows a sleeve containing the wire braid of the system shown in Figures 20 and 21. [Figure 23] This figure shows a system according to yet another exemplary embodiment of the present disclosure. [Modes for carrying out the invention]

[0023] This disclosure can be further understood by referring to the following description and accompanying drawings, where identical components are referred to by the same reference numerals. This disclosure relates to a device for excising and extracting tissue from a living organism in combination with an endoscope or other insertion device. The device is suitable for use in combination with a flexible device that is inserted into a target site in the body through a natural body lumen to separate a target portion of tissue from surrounding tissue and safely remove the separated tissue from the body.

[0024] In this application, the terms distal and proximal mean the direction away from the user of the device (distal) and the direction towards the user (proximal). Accordingly, with respect to the device according to the described embodiment, used in combination with an endoscopic device or other insertion device, the proximal end of the device is generally located outside the body accessible to the user, and the distal end is attached to the distal end of the endoscope and inserted into the body to a position adjacent to the target tissue to be treated.

[0025] Those skilled in the art will understand that, although devices according to various embodiments have been described in relation to the excision and removal of targeted tissue, these devices can also be used for the capture and removal of virtually any part of the body. For example, devices according to these embodiments can be used for the capture and removal of stones (e.g., kidney stones or gallstones), foreign bodies in the body (e.g., aspirated foreign bodies or foreign bodies remaining in the body due to medical procedures (e.g., parts detached from medical devices)). Furthermore, although these embodiments have been described in combination with flexible insertion devices such as flexible endoscopes, these embodiments can also be used in combination with rigid insertion devices such as lithoscopes for the removal of lesions in the bladder. These embodiments may also be useful for the capture and removal of thrombi or plaques in blood vessels.

[0026] As shown in Figure 1 and as will be understood by those skilled in the art, the stages of progression of malignant tumors in organs such as the colon are classified, in part, based on their location (e.g., intra-lymph node or extra-lymph node) and the depth to which the tumor has invaded the tissue forming the organ wall. Furthermore, the depth of tumor invasion into the organ wall will alter the plan for treating the lesion, and if the tumor has deeply invaded the wall, it may be necessary to remove the entire thickness of the organ wall. In any case, it is important that this tissue removal minimizes the risk of malignant cells disseminating to areas where malignant tumors were not previously present.

[0027] Figures 2 to 11 show a system 100 for tissue removal according to an exemplary embodiment of the present disclosure, including a handle 102 and an insertion section 104. In this embodiment, the insertion section 104 includes first and second flexible members 106a, 106b extending to a distal tissue capture device 108. The tissue capture device 108 is configured to be mounted on the distal end of a flexible insertion device (e.g., a flexible endoscope 110). The tissue capture device 108 includes a flange 109 configured to be fixed to the distal end of the insertion device (e.g., configured to friction fit at a fixed position on the distal end of the endoscope 110), and in this embodiment, a flexible tissue capture member 112 formed as a bag or sleeve 113 made of a flexible material (e.g., rubber, silicone, biocompatible plastic such as Tyvek® or Mylar®).

[0028] As those skilled in the art will understand, the sleeve 113 may be made of a transparent material so that the user can observe the tissue captured within the sleeve 113. Alternatively, the sleeve 113 may be formed from a wire mesh or other support structure housed in transparent plastic. As those skilled in the art will understand, the mesh or other support structure may be configured to hold the sleeve 113 in a desired shape when the sleeve 113 is not subjected to external force (i.e., the sleeve 113 is configured to take a desired shape when moved distally away from the endoscope 110). Furthermore, the sleeve 113 may optionally include a first marker 115 at the distal end of the sleeve 113 and / or a marker 117 at the proximal end to facilitate observation of the extent of the sleeve 113 relative to the tissue to be captured.

[0029] Alternatively, the snare itself may form a marker if it is visible through the sleeve 113 (for example, if the sleeve 113 is transparent). Furthermore, as those skilled in the art will understand, the sleeve 113 may be flexible, for example, the biasing force of the first loop 124a and the second loop 124b as they open stretches and opens the sleeve, and this flexibility may help to keep the proximal opening 114 and distal opening 116 of the sleeve 113 closed after tissue has been trapped inside the sleeve. As those skilled in the art will understand, this configuration may help to keep the trapped tissue inside the sleeve 113 and minimize the risk of cancer cells or other lesion cells being seeded into currently healthy areas.

[0030] The sleeve 113 is configured to be initially mounted on the distal end of the endoscope 110 (for example, wrapped around the distal end of the endoscope 110 distal to the flange 109), as will be described in more detail below. The sleeve 113 in this embodiment includes a proximal opening 114 and a distal opening 116. As will be 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 slidably housed inside each of the first and second flexible tubes 120a, 120b. Each of the first and second tubes 120a, 120b is hollow and slidably houses inside each of the first and second control members 122a, 122b (e.g., flexible wires).

[0031] The first tube 120a is connected to the distal opening 116 of the sleeve 113, and the second tube 120b is connected to the proximal opening 114 of the sleeve 113. The first and second tubes 120a and 120b are each independently movable distally and proximal within their corresponding first and second flexible members 106a and 106b. Therefore, when the first and second tubes 120a and 120b are moved simultaneously, the sleeve 113 can be moved proximal and distal relative to the distal end of the endoscope 110, and when the first tube 120a is moved, for example, relative to the second tube 120b, the distal opening 116 of the sleeve 113 moves relative to the proximal opening 114 of the sleeve 113.

[0032] Furthermore, the first control member 122a housed in the first tube 120a is connected to the distal opening 116 and forms a first loop 124a that defines the distal opening 116, and the second control member 122b housed in the second tube 120b is connected to the proximal opening 114 and forms a second loop 124b that defines the proximal opening 114. That is, the circumferential portion of the first loop 124a is connected to the sleeve 113 along a path extending along the circumference of the distal opening 116, and the distal opening 116 of the sleeve 113 is opened and closed by opening and closing the first loop 124a. Similarly, the circumferential portion of the second loop 124b is connected to the sleeve 113 along a path extending along the circumference of the proximal opening 114, and the proximal opening 114 of the sleeve 113 is opened and closed by opening and closing the second loop 124b.

[0033] As those skilled in the art will understand, the first and second loops 124a, 124b may be formed from a material configured to open forcefully when not constrained (for example, by the corresponding one of the first and second tubes 120a, 120b). Thus, as those skilled in the art will understand, either or both of the first and second loops 124a, 124b and the corresponding proximal opening 114 and distal opening 116 of the sleeve 113 may be opened and closed independently of each other by retracting the first and second control members 122a, 122b proximal into the respective first or second tubes 120a, 120b, or by extending the first and second control members 122a, 122b distally.

[0034] Figure 3A shows a first control member 122a connected to a first knob 132 that extends through the body 130 of the handle 102 and is 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 the 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, the second control member 122b extends through the body 130 of the handle 102 and is connected to a second knob 136 which is slidably connected to the body 130; the second spool 138 is connected to a second tube 120b and is slidably mounted on the body 130 of the handle 102; and the proximal end of the second flexible member 106b is fixed to the body 130.

[0035] The distal end of the second flexible member 106b is fixed to the flange 109. Therefore, when the first spool 134 is moved distally relative to the main body 130, the first tube 120a moves distally within the first flexible member 106a, and the first tube 120a moves distally from the distal end of the first flexible member 106a, causing the distal end of the sleeve 113 to extend distally from the endoscope 110. When the second spool 138 is moved distally relative to the main body 130, the second tube 120b moves distally within the second flexible member 106b, and the second tube 120b moves distally from the distal end of the second flexible member 106b, causing the proximal end of the sleeve 113 to extend distally from the endoscope 110. As a person skilled in the art will understand, when the first and second spools 134 and 138 are moved distally simultaneously, the sleeve 113 moves distally from the endoscope 110 without changing the distance between the proximal opening 114 and the distal opening 116.

[0036] Alternatively, by moving one of the first spool 134 and the second spool 138 relative to the other, the distance between the proximal opening 114 and the distal opening 116 can be shortened or lengthened as desired. Furthermore, as those skilled in the art will understand, either the first and second spools 134, 138 or the first and second knobs 132, 136 may include a locking mechanism that can be operated by a user to hold the member locked in its current position, thereby allowing the user to use their hand or fingers for other purposes without worrying about changes in the position of the member controlled by various actuators on the handle 102.

[0037] As described above, the first loop 124a may be formed of a biocompatible metal such as stainless steel biased to face an open shape, or of a shape memory material (e.g., nitinol, an alloy of nitinol and cobalt, PEEK, and plastics such as polycarbonate) configured to constrict the first loop 124a and, consequently, the distal opening 116 (i.e., reduce the diameter of the distal opening 116) when the first loop 124a is in a first position where a portion of the first loop 124a is housed within the first tube 120a. Due to the bias or shape memory properties of the first loop 124a, when the first control member 122a is advanced distally relative to the first tube 120a, the larger portion of the first loop 124a moves distally outside the first tube 120a, causing the first loop 124a to expand and further open the distal opening 116.

[0038] Similarly, the second loop 124b may be formed of a biased material or shape memory material configured to constrict the second loop 124b and, consequently, the proximal opening 114 (i.e., reduce the diameter of the proximal opening 114) when the second loop 124b is in a first position where a portion of the second loop 124b is housed within the second tube 120b. Due to the bias or shape memory properties of the second loop 124b, when the second control member 122b is advanced distally relative to the second tube 120b, the larger portion of the second loop 124b moves distally outward from the second tube 120b, causing the second loop 124b to expand and further open the proximal opening 114.

[0039] As those skilled in the art will understand, the handle 102 of this embodiment includes an optional thumb ring 140 fixed to the body 130, and the first and second spools 134, 138 each include optional first and second finger loops 135, 137, respectively, which assist in moving the first and second spools 134, 138 relative to the body 130. Furthermore, as those skilled in the art will understand, either or both of the first loop 124a and the second loop 124b may be connected to a source of RF energy or other energy to assist in the excision of target tissue and / or to cauterize the resulting wound, which is likely to be useful with respect to the first loop 124a.

[0040] During use, the tissue capture device 108 is mounted on the distal end of the endoscope 110 by moving the flange 109 over the distal end of the endoscope 110 until the flange 109 is in a desired position on the endoscope 110. Simultaneously, the sleeve 113 is placed over the distal end of the endoscope 110 by moving the endoscope 110 through the proximal opening 114 and the distal opening 116, so that the sleeve 113 is wrapped around the distal end of the endoscope 110. In this configuration, in this embodiment, the first and second flexible members 106a and 106b are pre-connected to the flange 109 and the body 130 of the handle 102, and the first and second tubes 120a and 120b extend through the flange 109. At this point, the first and second control members 122a and 122b extend distally from the distal ends of the first and second tubes 120a and 120b, respectively, and the first and second loops 124a and 124b are connected to the distal opening 116 and proximal opening 114 of the sleeve 113, respectively.

[0041] In this configuration, the endoscope 110 and tissue capture device 108 are inserted into the patient's body (e.g., into a body lumen accessed through a natural body orifice) and guided through the body to a position adjacent to the target portion of the tissue T to be treated. The user may observe the target tissue, for example, using the visual system of the endoscope 110 (e.g., through a lens mounted on the distal surface of the endoscope 110). The user then grasps the target tissue or, otherwise, pulls it to a desired position relative to the distal end of the endoscope 110. For example, polyps or other lesions protruding from the wall of a target organ may be pulled toward the distal surface of the endoscope 110 by using a grasping device or by applying suction through the working channel of the endoscope 110 (e.g., a working channel opening on the distal surface of the endoscope 110), thereby controlling the tissue being drawn toward the opening of the working channel.

[0042] As those skilled in the art will understand, certain lesions (e.g., sessile polyps) may be flattened along the surface of the target organ wall. In such cases, the user may inject fluid beneath the target lesion to lift it away from the rest of the organ wall surface, or otherwise treat the tissue to make it easier to lift and excise from the surrounding tissue. In either case, the user moves the target tissue until it is positioned as desired (e.g., when the sleeve 113 is moved distally away from the endoscope 110, the target tissue passes through the distal opening 116 and enters the sleeve 113). Specifically, as described above, the sleeve 113 is held open when it is wrapped around or stretched out of the distal end of the endoscope 110.

[0043] Next, the user advances the first knob 132 distally to keep the distal opening 116 open, and simultaneously advances the first and second spools 134 and 138 distally to advance the sleeve 113 distally from the endoscope 110 so that the target tissue T passes through the distal opening 116 and enters the sleeve 113. When the distal end of the sleeve 113 reaches the desired location (for example, when the first loop 124a and distal opening 116 are positioned around a portion of the tissue, leaving a desired margin around the target lesion), the user holds the first spool 134 in that position and pulls the first knob 132 proximal to pull the first control member 122a and the first loop 124a back into the first tube 120a, tightening the first loop 124a and the distal opening 116 of the sleeve 113 around the tissue that constitutes the margin around the target tissue T within the sleeve 113 (the entire target tissue T and the tissue forming the margin) (see, for example, Figure 7). At the same time, the user may pull the second knob 136 proximal to close the proximal opening 114 of the sleeve 113 so that the proximal end of the target tissue T is closed within the sleeve 113 (see, for example, Figure 9).

[0044] Next, the user can observe the tissue within the sleeve 113 and the surrounding tissue to determine whether the target tissue T and the desired margin tissue surrounding the tissue T have been captured within the sleeve 113. If the user determines that the tissue T and margin tissue have not been captured as desired, the user can reopen the proximal opening 114 and the distal opening 116 by advancing the first and second knobs 132 and 136 distally relative to the body 130 of the handle 102, and then pull the first and second spools 134 and 138 proximally relative to the body 130 to pull the sleeve 113 proximal to the previously captured tissue and pull the sleeve 113 back onto the distal end of the endoscope 110. The user can observe the target tissue, reposition the endoscope 110 as desired, and repeat these steps to capture a new tissue portion within the sleeve 113.

[0045] After the user confirms that a portion of the desired tissue T, along with healthy, desired margin tissue, is captured within the sleeve 113 and that the proximal opening 114 and distal opening 116 are closed over the tissue, the user may cut the captured tissue from the surrounding tissue by pulling the first knob 132 proximal until the first loop 124a is tightly constricted around the base of the captured tissue to sufficiently cut the tissue from the surrounding tissue (see, for example, Figure 11). As those skilled in the art will understand, the user may apply RF energy or other energy (in a unipolar or bipolar configuration as desired) to facilitate the cutting of the tissue and / or to help seal the wound (e.g., cauterize).

[0046] Subsequently, the user may hold the first and second knobs 132 and 136, respectively, in their fully retracted positions, effectively sealing the proximal opening 114 and distal opening 116 of the sleeve 113, so that the captured tissue T is sealed within the sleeve 113 during removal from the body. As described above, one or both of the first and second knobs 132 and 136 may include a locking mechanism that holds the knob in its most proximal position (i.e., with the proximal opening 114 and distal opening 116 closed) until the endoscope 110 and tissue capture device 108 are removed from the body. Thus, the captured tissue is kept within the sleeve 113 without contact with other tissues or bodily fluids, minimizing the risk of disease cell seeding from the captured tissue.

[0047] As those skilled in the art will further understand, the sleeve 113 (and / or any support structure or other structure that holds the sleeve 113 in a desired shape) can take on a variety of shapes. For example, as shown in Figures 12A and 12B, a device according to a further embodiment may include a first loop 224a that opens and closes the distal opening 216 of the sleeve 213 with respect to the first loop 224a in the same manner as described above with respect to the distal opening 116 of the sleeve 113. However, the first loop 224a includes a plurality of tissue cutting teeth 215 that extend radially from the first loop 224a. As those skilled in the art will understand, the teeth 215 are configured to cut tissue when the first loop 224a is firmly drawn around the captured tissue.

[0048] Furthermore, the sleeve has a conical shape, and the proximal opening 214 is biased to close on its own as soon as it is removed from the distal end of the endoscope 210 (for example, by including a flexible band loop 217 around the proximal opening 214). In this case, the system can omit the connection to the proximal end of the sleeve 213, because the proximal end of the sleeve 213 closes immediately after the sleeve 213 moves distally away from the distal end of the endoscope 210, and there is no need to open or close the sleeve 213 after it has been deployed from the distal end of the endoscope 210.

[0049] As those skilled in the art will understand, in Figure 12A, the proximal opening 214 of the sleeve 213 is still stretched around the distal end of the endoscope 210, and as shown in Figure 12B, after the sleeve 213 has been completely withdrawn from the endoscope 210, the proximal opening 214 is closed by the band loop 217. As those skilled in the art will recognize, the teeth 215 may be employed with the sleeve 213 and the first loop 214a, or alternatively, the sleeve 213 may be employed with the first loop 224a without the teeth 215, in the same manner as shown with respect to the first loop 124a.

[0050] Figures 13 to 15 show a system 250 that operates in substantially the same manner as the above-described embodiment with respect to the sleeve 213. However, in this system 250, the cap 252 is slidably received around the distal end of the endoscope 254. The system 250 includes a handle similar to the handle 102, which includes flexible members 256a and 256b extending from the handle to a flange 258 mounted around the distal portion of the endoscope 254 in a manner similar to the flange 109 described above.

[0051] The flexible members 256a and 256b slidably house the first and second tubes 260a and 260b, respectively. The first and second tubes 260a and 260b slidably house the first and second control members 262a and 262b, respectively, which extend distally from the distal ends of the first and second tubes 260a and 260b, and the first and second loops 264a and 264b are connected to the distal opening 266 and proximal opening 268 of the sleeve 270, respectively. In the initial configuration, the proximal end of the sleeve 270 and the second loop 264b are received around the distal end of the cap 252. In the initial configuration, the cap 252 is retracted over the distal end of the endoscope 254, and the proximal end of the sleeve 270 is stretched and open around the cap 252. At this point, the distal end of the sleeve 270 is stretched and open over the distal end of the endoscope 254, and the tissue can be drawn towards the distal end of the endoscope 254 as described above.

[0052] In this embodiment, the user can extend the cap 252 distally by advancing the second tube 260b connected to the cap 252. The distal end of the sleeve 270 then moves away from the distal end of the endoscope 254, and the distal end of the sleeve 270 constricts around the captured tissue in the same manner as described above with respect to the sleeve 213. The user can then determine whether the desired portion of tissue has been captured in the sleeve 270 as desired. If the user determines that the target portion of tissue has not been captured as desired, the user can retract the cap 252 proximal by retracting the second tube 260b until the cap 252 returns to the distal end of the endoscope 254, and the distal end of the sleeve 270 is then released again so as to be stretched over the distal end of the endoscope 254. This releases the previously captured tissue.

[0053] Next, the user may observe the target tissue and reposition the endoscope 254 until it is positioned in the desired location relative to the target tissue to be captured. Then, the user redeploys the sleeve 270 in the same manner as described above, and if the user determines that the tissue has been captured as desired, the user may, while holding the cap 252 stationary, advance the first tube 260a further until the proximal end of the sleeve 270 is pulled away from the cap 252 and the proximal end of the sleeve 270 contracts to close the proximal opening of the sleeve 270. Subsequently, the user may operate the first loop 264a until the captured tissue is excised from the surrounding tissue and the sleeve 270 containing the captured tissue, along with the remainder of the endoscope 254 and system 250, is safely removed from the body.

[0054] Figures 16 and 17 show a distal portion 302 of the system 300 according to a further embodiment, which is substantially similar in structure and operation to the above-described embodiment, except as specifically described below. The system 300 includes a handle similar to the handle 102 described above and an insertion section including first and second flexible members 306a, 306b that extend 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).

[0055] The tissue capture device 308 includes a flange 309 configured to be fixed to the distal end of the insertion device (for example, configured to friction-fit at a fixed position on the distal end of the endoscope 310), and a flexible tissue capture member 312 formed as a bag or sleeve 113 made of a stretchable flexible material (for example, rubber, silicone, biocompatible plastic such as Tyvek® or Mylar®). The sleeve 313 in this embodiment is substantially cylindrical, with the proximal end 313a folded over a portion of the sleeve 313 to form a pocket at the proximal end 313a for accommodating a first loop 324a, and the distal end 313b also folded over a portion of the sleeve 313 to form a pocket at the distal end 313b for accommodating a second loop 324b.

[0056] The sleeve 313 is configured to be initially mounted on the distal end of the endoscope 310 (for example, wrapped around the distal end of the endoscope 310 distal to the flange 309). The sleeve 313 in this embodiment 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 housed inside. Each of the first and second tubes 320a, 320b is hollow and slidably houses each of the first and second control members 322a, 322b (for example, flexible wires) inside.

[0057] As shown in Figure 17, when the sleeve 313 is closed (when the first and second control members 322a, 322b and the first and second loops 324a, 324b are retracted into the first and second tubes 320a, 320b, respectively), the tissue T trapped within the sleeve 313 is surrounded by the first and second closing loops 324a, 324b without putting the material of the sleeve 313 under tension.

[0058] Figures 18A and 18B show a system 400 according to an exemplary embodiment of the present disclosure, which is substantially similar in structure and operation to the above-described exemplary embodiment, except as specifically described below. The system 400 includes a handle similar to the handle 102 described above and an insertion section which includes first and second flexible members 406a, 406b that extend 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).

[0059] The tissue capture device 408 includes a flange 409 configured to be fixed to the distal end of the insertion device (for example, configured to friction-fit at a fixed position on the distal end of the endoscope 410), and in this embodiment, a flexible tissue capture member 412 formed as a bag or sleeve 413 made of a stretchable flexible material (for example, rubber, silicone, biocompatible plastic such as Tyvek® or Mylar®). The sleeve 413 in this embodiment is substantially cylindrical and includes first and second tubes 420a, 420b connected to the proximal end 413a and distal end 413b, respectively, with a plurality of first tubes 420a distributed around the circumference of the proximal opening 414, and a plurality of second tubes 420b distributed around the circumference of the distal opening 416. Since the first and second tubes 420a and 420b have a gap 415 between them, when the first and second loops 424a and 424b are tightened, respectively, to close the bag (in the same manner as described above), the first and second tubes 420a and 420b are pulled together to close the proximal opening 414 and the distal opening 416, and the tissue can be sealed inside the sleeve 413.

[0060] The sleeve 413 is configured to be initially mounted on the distal end of the endoscope 410 (for example, wrapped around the distal end of the endoscope 410 distal to the flange 409). Similar to the embodiments described above, each of the first and second flexible members 406a, 406b is formed as a hollow member that slidably houses each of the first and second tubes 420a, 420b. Each of the first and second tubes 420a, 420b is hollow and slidably houses each of the first and second control members 422a, 422b (for example, flexible wires). When the distal opening 416 is fully tightened and closed as in the previous embodiments, the radially inward force applied to the tissue within the distal opening 416 severs this tissue from the surrounding tissue, and the target tissue is captured within the sleeve 413.

[0061] Figure 19 shows a system 500 according to an exemplary embodiment of the present disclosure, which is substantially similar in structure and operation to the embodiments described above, except as specifically described below. In its initial form, the system 500 includes a sleeve 513 that is received around the distal end of an endoscope 510. In this embodiment, the sleeve 513 is received in a bellows-like manner on the distal end of the endoscope 510 in its initial form, so that the length of the sleeve 513 along its longitudinal axis L may be longer than the length of the portion P of the endoscope that receives the sleeve 513.

[0062] The sleeve 513 is folded into an accordion-like fold 515, and when the sleeve 513 is unfolded away from the endoscope 510, the sleeve 513 is stretched and smoothed (for example, by advancing tube 520a distal to tube 520b). In this embodiment, the fold 515 is formed so that the top of the fold 515 does not extend radially outward beyond the outer diameter of the flange 509. Thus, the external shape of the system 500 does not increase beyond the external shape of the flange 509.

[0063] Figures 20 and 21 show a system 600 according to an exemplary embodiment of the present disclosure, which is substantially similar in structure and operation to the embodiments described above, except as specifically described below. 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. System 600 differs from the embodiments described above in that a sleeve 613 includes a plurality of wires 615 embedded within the elastomer material of the sleeve 613.

[0064] In this embodiment, the wire 615 is configured to bias the sleeve 613 into an open state in which the proximal opening 614 and the distal opening 616 are held open by the wire 615. For example, the wire 615 may be formed from nitinol having a memory shape corresponding to the open state. The sleeve 613 is closed by drawing the control wires 622a and 622b into the first and second tubes 620a and 620b, as described above.

[0065] Alternatively, the wire 615 can be biased into a closed configuration with the proximal opening 614 and distal opening 616 closed. In such an embodiment, the sleeve 613 is held open by being stretched around the distal end of the endoscope 610 and automatically closes (due to the biasing of the wire 615) immediately after the sleeve 613 is separated from the endoscope. The user then excises the tissue trapped within the sleeve 613 by tightening the wire loop as described above.

[0066] Figure 22 shows a sleeve 713, which includes a wire braid 715 of wire that can be configured to bias the sleeve 713 into an open or closed state in a manner similar to that described with respect to the wire 615 above. In this embodiment, the wire braid 715 may also be formed from nitinol having a stored shape that is biased or configured to hold the sleeve 713 in an open or closed state. Furthermore, in this embodiment, the wire braid 715 is covered with an elastic coating to minimize trauma when the outer surface of the sleeve 713 comes into contact with tissue (for example, during insertion of the endoscope 710 into a target site in the body).

[0067] Figure 23 shows System 800 according to an exemplary embodiment of the present disclosure, which is structurally similar to the embodiments described above, except that this system is not designed for use with an endoscope or similar insertion device. In contrast, System 800 is a catheter-based system for capturing thrombi and removing them from blood vessels. System 800 includes a catheter 802 having a sleeve 813 mounted on the distal end of the catheter 802 in a manner similar to how the sleeve of the embodiments described above is attached to an endoscope. As those skilled in the art will understand, in this embodiment, the catheter 802 may be a braided catheter in order to increase the kink resistance and buckling strength of the catheter 802 (for example, to increase its ability to advance the catheter 802 into a target site in the body).

[0068] System 800 includes a similar arrangement of first and second flexible members 806a and 806b extending from a handle similar to the handle 102 that remains outside the body to a flange 809 mounted on the distal portion of the catheter 802, and first and second tubes 820a and 820b. In this embodiment, each of the control wires 822a and 822b extends through their respective corresponding first and second tubes 820a and 820b to control the operation of each of the first and second loops 824a and 824b in substantially the same manner as described in the above embodiments. In this embodiment, the catheter 802 has a diameter of 1 mm to 15 mm and can be introduced into a blood vessel and through the blood vessel to the site of the thrombus. The user then captures the thrombus in the same manner as described above, for example, with respect to polyp excision and capture.

[0069] In this case, the thrombus can be captured by applying aspiration, by introducing a mechanical grasping device through the catheter 802, or by any other known means. The sleeve 813 is then pushed out over the thrombus from the distal end of the catheter 802, and the distal opening 816 is closed in a manner similar to that described with respect to any of the embodiments described above. The catheter 802 can then be removed from the body together with the sleeve 813 and the thrombus held inside it.

[0070] It will be apparent to those skilled in the art that various modifications can be made to this disclosure without departing from the scope of this disclosure. Furthermore, those skilled in the art will understand that any feature of any of the various embodiments can be combined in any way that does not contradict the description and / or function of the embodiments.

Claims

1. A device for treating tissue, A tissue capture assembly that is removablely attachable to an insertion device configured to be inserted into a target site in a living organism, wherein the tissue capture assembly, in its initial form, includes a tissue capture sleeve that is removablely received on the distal end of the insertion device, and a flange that is removablely mounted on the insertion device proximal to the tissue capture sleeve when the tissue capture sleeve is in its initial form, A first hollow member extending from a proximal end that remains outside the body accessible to the user during use to a distal end connected to the flange, A first tube slidably housed within the first hollow member and, during use, extending from a proximal end that remains outside the body accessible to the user, beyond the flange, to the distal end of the first tube, wherein the first tube is configured to push the tissue capture sleeve distally from the insertion device when the first tube is advanced distally through the first hollow member, A device comprising: a first control member slidably housed within the first tube and extending from a proximal end that remains outside the body accessible to the user during use to a distal end that forms a first loop connected along the circumference of the distal opening of the tissue capture sleeve, wherein the first loop is configured to move between a tightening configuration in which at least a portion of the first loop is retracted proximally into the first tube and an open configuration in which the first loop extends distally from the first tube, opening the first loop and the distal opening of the tissue capture sleeve.

2. The device according to claim 1, further comprising a handle including a handle body and a first actuator connected to the proximal end of the first tube, wherein the first hollow member is connected to the handle body, the first actuator is movably connected to the handle body, and the movement of the first actuator relative to the handle body causes the first tube to move proximal and distal within the first hollow member.

3. The device according to claim 2, further comprising a second actuator connected to the proximal end of the first control member, wherein the second actuator is connected to the first actuator, and the movement of the second actuator relative to the first actuator causes the first control member to move proximal and distal within the first tube.

4. The device according to any one of claims 1 to 3, wherein the tissue capture sleeve includes an elastomer loop connected along the circumference of the proximal opening of the tissue capture sleeve, the elastomer loop is biased to a closed configuration, and when the tissue capture sleeve is pushed distally from the insertion device, the elastomer loop pulls to close the proximal opening of the tissue capture sleeve.

5. A second hollow member extending from a proximal end that remains outside the body accessible to the user during use to a distal end connected to the flange, A second tube slidably housed within the second hollow member and, during use, extending distally beyond the flange to the distal end of the second tube from a proximal end that remains outside the body accessible to the user, the second tube is configured to cooperate with the first tube to push the tissue capture sleeve distally from the insertion device as the second tube is advanced distally through the second hollow member, The device according to claim 2, further comprising: a second control member slidably housed within the second tube and extending, during use, from a proximal end that remains outside the body accessible to the user, to a distal end that forms a second loop connected along the circumference of the proximal opening of the tissue capture sleeve, wherein the second loop is configured to move between a tightening configuration in which at least a portion of the second loop is retracted proximal into the second tube, and an open configuration in which the second loop extends distally from the second tube, opening the second loop and the proximal opening of the tissue capture sleeve.

6. The device according to claim 5, wherein the handle further comprises a third actuator connected to the proximal end of the second tube, the second hollow member is connected to the handle body, the third actuator is movably connected to the handle body, and the movement of the third actuator relative to the handle body causes the second tube to move proximal and distal within the second hollow member.

7. The device according to claim 6, further comprising a fourth actuator connected to the proximal end of the second control member, wherein the fourth actuator is connected to the third actuator, and the movement of the fourth actuator relative to the third actuator causes the second control member to move proximal and distal within the second tube.

8. The device according to any one of claims 1 to 7, wherein the tissue capture sleeve is formed from one of silicon and biocompatible plastic.

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

10. The device according to any one of claims 1 to 9, wherein the first loop is formed of a shape memory material configured such that when the first loop extends from the first tube, the first loop takes an open-loop shape, pulling the distal opening of the tissue capture sleeve into the open form.

11. The device according to any one of claims 1 to 10, wherein the first loop is formed of a biocompatible metal that, when the first loop extends from the first tube, takes on an open loop shape and is biased to pull the distal opening of the tissue capture sleeve into the open form.

12. The device according to any one of claims 1 to 11, wherein the first loop includes a plurality of radially inwardly oriented tissue section features.

13. A device for treating tissue, A catheter comprising a tissue capture assembly mounted on the distal portion, wherein the tissue capture assembly, in its initial configuration, comprises a tissue capture sleeve removably received at the distal end of the catheter, and a flange extending radially outward from the outer surface of the catheter proximal to the tissue capture sleeve when the tissue capture sleeve is in its initial configuration, A first hollow member extending from a proximal end that remains on the outside of the body accessible to the user during use to a distal end connected to the flange, A first tube is slidably housed within the first hollow member and, during use, extends from a proximal end that remains outside the body accessible to the user, beyond the flange, to the distal end of the first tube, A device comprising: a first control member slidably housed within the first tube and extending from a proximal end that remains outside the body accessible to the user during use to a distal end that forms a first loop connected along the circumference of the distal opening of the tissue capture sleeve, wherein the first loop is configured to move between a tightening configuration in which at least a portion of the first loop is retracted proximally into the first tube and an open configuration in which the first loop extends distally from the first tube, opening the first loop and the distal opening of the tissue capture sleeve.

14. The device according to claim 13, wherein the catheter is of a size and shape suitable for insertion into a blood vessel, and the target tissue is a thrombus.

15. The device according to claim 13 or 14, wherein the catheter is a braided catheter.

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