Systems, devices, and methods for abdominal wall closure
By combining a robotic system with self-locking ligatures and bioabsorbable wedges or ramp structures, the problems of complex ligature operations and significant tissue damage in laparoscopic surgery have been solved, achieving efficient and safe closure of abdominal wall hernia defects.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- TAS MEDICAL INC
- Filing Date
- 2024-09-18
- Publication Date
- 2026-05-29
AI Technical Summary
Existing techniques for closing abdominal wall hernia defects, especially in laparoscopic surgery, suffer from problems such as complex ligation procedures, significant tissue damage, and difficulty in effective closure.
Self-locking ligatures are used in intra-abdominal operations via a robotic system. The robot's end effector is used to position, pass through, and tighten the ligatures. Combined with bioabsorbable wedges or ramp structures, knotless tightening and tissue adhesion of the ligatures are achieved, reducing tissue damage.
This method achieves efficient closure of abdominal wall hernia defects, reduces tissue damage, improves surgical flexibility and safety, and lowers the risk of postoperative complications.
Smart Images

Figure CN122121807A_ABST
Abstract
Description
[0001] Cross-references to related applications
[0002] This application claims priority to each of U.S. Provisional Application No. 63 / 584233, filed September 21, 2023, and U.S. Provisional Application No. 63 / 584264, filed September 21, 2023, both of which are expressly incorporated herein by reference in their entirety for all purposes. Technical Field
[0003] This disclosure relates to surgically closing abdominal wall defects by placing one or more self-locking ligatures. Background Technology
[0004] Laparoscopic abdominal wall hernia repair using self-locking ligatures has been previously described. In this regard, see PCT / US2018 / 013764, filed July 12, 2019, entitled “Systems, Apparatus, and Methods for Closing Abdominal Wall Defects”; PCT / US2020 / 053148, filed September 20, 2020, entitled “Systems, Apparatus, and Methods for Tissue Fixation and Approximation of Tissue Defects”; and PCT / US2021 / 015033, filed January 26, 2021, entitled “Medical Systems, Apparatus, and Methods Suitable for Tissue Fixation and Approximation of Tissue Defects,” all of which are incorporated herein by reference in their entirety. The procedures described in the aforementioned applications involve manipulating surgical instruments both outside the patient's body and inside the abdominal cavity. Beginning with a tiny incision made through the skin transverse to one side of the abdominal wall defect, the distal end of a self-locking ligature can be inserted into the abdominal cavity. The distal end can be pulled out from the abdominal cavity on the opposite side of the tissue defect and then pulled back under the skin to the site of the first incision. The ligature is percutaneously tensioned in a locking head (also referred to as a lock-head or lock head in this text) at its proximal end, and excess ligature length is removed. Through this laparoscopic procedure, the locking head remains in a stationary position anterior to the rectus abdominis sheath and the anterior abdominal wall. Summary of the Invention
[0005] In one aspect, a method for closing an abdominal wall hernia defect includes: positioning a first self-locking ligature within the abdominal cavity of a patient adjacent to the abdominal wall hernia defect; approaching a first side of the defect with the proximal end of the first self-locking ligature, wherein the first self-locking ligature includes a lock located on or near the distal end of the first self-locking ligature; passing the proximal end of the first self-locking ligature through the first side of the defect from a first posterior position of the tissue adjacent to the abdominal wall hernia defect to a first anterior position of the tissue adjacent to the abdominal wall hernia defect; passing the proximal end of the first self-locking ligature through the second side of the defect from a second anterior position of the tissue adjacent to the abdominal wall hernia defect to a second posterior position of the tissue adjacent to the abdominal wall hernia defect; translating the proximal end of the first self-locking ligature through the lock; and tightening the first self-locking ligature to at least partially close the defect.
[0006] In some embodiments, a robotic system is used to perform the steps of approaching, passing through, and translating. In other embodiments, the method includes inserting one or more end effectors of the robotic system into the abdominal cavity through one or more cannulas. In still other embodiments, the one or more end effectors of the robotic system include one or both of a gripper and a needle holder. In still other embodiments, the one or more cannulas include at least one cannulas with a diameter of 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 mm or greater. In still other embodiments, the one or more cannulas include at least one cannulas with a diameter of 8 mm or greater.
[0007] In some embodiments, the method includes cutting at least a portion of the proximal end of the first self-locking ligature. In other embodiments, the cutting of the proximal portion is performed using a blade positioned within the locking mechanism of the first self-locking ligature. In still other embodiments, the cutting of the proximal portion is performed using a blade of a laparoscopic device. In yet another embodiment, the laparoscopic device includes surgical scissors, such as hook scissors. In some embodiments, the laparoscopic device is part of a robotic system.
[0008] In some embodiments, the first self-locking ligature includes a needle and a guide that connects the needle to the proximal end of the first self-locking ligature, and the method further includes: inserting the needle into a first side of the abdominal wall hernia defect; and inserting the needle into a second side of the abdominal wall hernia defect. In other embodiments, the method includes cutting the guide. In still other embodiments, a laparoscopic device (such as surgical scissors, e.g., hook scissors) is used to perform cutting the guide. In still other embodiments, the needle is a curved needle. In still other embodiments, the overlap between the guide and the ligature portion may include a transition section. The transition section can reduce kinking of the self-locking ligature. In such embodiments, the method may include pulling the transition section through the first side of the abdominal wall hernia defect and pulling the transition section through the second side of the abdominal wall hernia defect, wherein the transition section causes dilation of the opening in the tissue surrounding the abdominal wall hernia defect.
[0009] In some embodiments, the abdominal wall hernia defect is located within the rectus abdominis muscle or the linea alba. In some embodiments, during the steps of passing through and translating the first self-locking ligature, no part of the first self-locking ligature is percutaneously positioned. In some embodiments, during the tightening step, the self-locking ligature is percutaneously positioned. In some embodiments, the method includes rotating the tightened first self-locking ligature around the abdominal wall hernia defect such that the ligature head is repositioned outside the abdominal cavity. In some embodiments, the method includes passing the self-locking ligature through the posterior sheath of the rectus abdominis muscle. In some embodiments, the method includes passing the self-locking ligature through the anterior sheath of the rectus abdominis muscle.
[0010] In some embodiments, the method includes: positioning a plurality of self-locking ligatures within the abdominal cavity adjacent to an abdominal wall hernia defect; approaching a first side of the abdominal wall hernia defect with the proximal end of each of the plurality of self-locking ligatures; passing the proximal end of each of the plurality of self-locking ligatures from a posterior position within the tissue adjacent to the first side of the abdominal wall hernia defect to an anterior position within the tissue adjacent to the abdominal wall hernia defect, wherein each self-locking ligature is spaced apart from adjacent self-locking ligatures; passing the proximal end of each of the plurality of self-locking ligatures from an anterior position within the tissue adjacent to the abdominal wall hernia defect to a posterior position within the tissue adjacent to the abdominal wall hernia defect; translating the proximal end of each of the self-locking ligatures through a lock; and tightening each of the self-locking ligatures to at least partially close the abdominal wall hernia defect. In other embodiments, the method includes translating each of the tightened self-locking ligatures around the abdominal wall hernia defect such that each lock of each of the plurality of self-locking ligatures is no longer positioned within the abdominal cavity. In other embodiments, the method includes individually at least partially tightening each of a plurality of self-locking cable ties. In other embodiments, the method includes sequentially at least partially tightening each of a plurality of self-locking cable ties, the sequence including at least partially tightening a first self-locking cable tie, followed by at least partially tightening each of the remaining self-locking cable ties. In other embodiments, the method includes sequentially at least partially tightening each of a plurality of self-locking cable ties. In still other embodiments, the sequence includes at least partially tightening the first self-locking cable tie; and at least partially tightening the self-locking cable ties adjacent to the first self-locking cable tie. In some embodiments, the sequence includes at least partially tightening each of the plurality of cable ties in a straight line from a first end of the defect to a second end of the defect. In other embodiments, the sequence includes at least partially tightening each of the plurality of cable ties in a center-outward sequence from the middle of the abdominal wall hernia defect to the end of the abdominal wall hernia defect. In other embodiments, the sequence includes at least partially tightening each of a plurality of ties from the end of the abdominal wall hernia defect to the middle of the abdominal wall hernia defect in an outward-to-middle order.
[0011] In other embodiments, the method includes performing tightening more than once on each cable tie, wherein each cable tie is tightened progressively. In still other embodiments, the method includes setting a relaxation period between a first tightening and a second tightening on each cable tie. In other embodiments, the plurality of self-locking cable ties may be distributed substantially along the length of the abdominal wall hernia defect to account for the tightening forces generated during the tightening of the plurality of self-locking cable ties. In still other embodiments, the plurality of self-locking cable ties may prevent, mitigate, inhibit, or improve damage to the tissue engaged by each of the plurality of self-locking cable ties during the tightening of each cable tie.
[0012] In some embodiments, the locking head of the first self-locking ligature is a low-profile locking head, and wherein the ligature portion includes an inclined portion extending from the ligature portion to the low-profile locking head, wherein the inclined portion engages with the muscle tissue surrounding the abdominal wall hernia defect. In other embodiments, the first self-locking ligature includes a ramp or wedge adjacent to the proximal side of the locking head, wherein the ramp or wedge is configured to facilitate easy translation of the proximal end of the first self-locking ligature through the locking head. In still other embodiments, the ramp or wedge includes an inclined portion that engages with the muscle tissue surrounding the abdominal wall hernia defect.
[0013] In one aspect, a method for closing a soft tissue defect includes: fully positioning a first self-locking ligature within a body cavity of a patient adjacent to the soft tissue defect, the self-locking ligature including: a guide, a ligature portion, and a locking head positioned on the ligature portion, the locking head configured to tighten to the ligature portion; and tightening the first self-locking ligature around the soft tissue defect, wherein tightening causes the sides of the soft tissue defect to come into contact.
[0014] In some embodiments, a robotic system is used to perform the tightening step. In other embodiments, the method includes inserting one or more end effectors of the robotic system into a body cavity through one or more cannulas. In some embodiments, the method includes cutting at least a portion of the self-locking ligature using a laparoscopic device. In other embodiments, the laparoscopic device includes surgical scissors. In other embodiments, the laparoscopic device includes hook scissors. In some embodiments, the overlap between the guide and the ligature portion includes a transition section. The transition section can reduce kinking of the self-locking ligature. The method may include pulling the transition section through a first side of the abdominal wall hernia defect and pulling the transition section through a second side of the abdominal wall hernia defect, wherein the transition section causes dilation of the opening in the tissue surrounding the abdominal wall hernia defect. In some embodiments, the method includes rotating the tightened self-locking ligature around a soft tissue defect such that the lock head is repositioned outside the body cavity.
[0015] In one aspect, a kit for closing soft tissue defects includes: a plurality of self-locking ligatures, each of the self-locking ligatures including: a guide, a ligature portion, and a locking head positioned on the ligature portion and configured to tighten to the ligature portion; a ligature placement device configured to deploy at least one of the plurality of self-locking ligatures into a patient's body cavity; and a laparoscopic cutter.
[0016] In some embodiments, the laparoscopic cutter includes laparoscopic surgical scissors, an RF cutter, and / or an ultrasonic cutter. In other embodiments, the laparoscopic device includes hook scissors. In some embodiments, the locking head of the first self-locking ligature is a low-profile locking head, and the ligature portion includes an inclined portion extending from the ligature portion to the low-profile locking head. The inclined portion can engage muscle tissue surrounding the abdominal wall hernia defect. In some embodiments, the first self-locking ligature includes a ramp or wedge adjacent proximally to the locking head, and wherein the ramp or wedge includes an inclined portion configured to engage tissue near the soft tissue defect. In some embodiments, the width of the ligature portion is between 2 mm and 14 mm. In some embodiments, the overlap between the guide and the ligature portion includes a transition section configured to reduce kinking of the self-locking ligature, and wherein the transition section is configured to cause dilation of the pore in the tissue surrounding the soft tissue defect.
[0017] In one aspect, a method for robotically closing an abdominal wall hernia defect includes: providing a robotic system comprising one or more end effectors; positioning a first self-locking ligature within the abdominal cavity adjacent to the defect; approaching a first side of the defect with the proximal end of the first self-locking ligature using the robotic system, wherein the self-locking ligature includes a locking head at or near the distal end of the self-locking ligature; passing the proximal end of the first self-locking ligature through the first side of the defect using the robotic system; passing the proximal end of the first self-locking ligature through a second side of the defect using the robotic system; translating the proximal end of the first self-locking ligature through the locking head using the robotic system and tightening the first self-locking ligature to at least partially close the defect; and translating the tightened first self-locking ligature around the defect using the robotic system such that the locking head is no longer positioned within the abdominal cavity.
[0018] In some embodiments, the method includes: providing a plurality of self-locking ligatures, each of the plurality of self-locking ligatures initially positioned intraperitoneally adjacent to a defect; approaching a first side of the defect with the proximal end of each of the plurality of self-locking ligatures; passing the proximal end of each of the plurality of self-locking ligatures through the first side of the defect using a robotic system, wherein each self-locking ligature is spaced apart from adjacent self-locking ligatures; passing the proximal end of each of the plurality of self-locking ligatures through a second side of the defect using the robotic system; translating the proximal end of each of the self-locking ligatures through a lock head using the robotic system; and tightening each of the self-locking ligatures to at least partially close the defect; and translating each of the tightened first self-locking ligatures around the defect using the robotic system such that each lock head of each of the plurality of ligatures is no longer positioned intraperitoneally. In some embodiments, one or more end effectors of the robotic system include one or both of a gripper and a needle holder. In some embodiments, the method includes using the robotic system to perform the step of translating each of the tightened first self-locking ligatures around the defect such that each lock head is no longer positioned intraperitoneally. In some embodiments, the method includes individually tightening each of a plurality of cable ties at least partially using a robotic system. In some embodiments, the method includes sequentially tightening each of a plurality of cable ties at least partially using a robotic system, the sequence including at least partially tightening a first cable tie, followed by at least partially tightening each of the remaining cable ties using the robotic system. In some embodiments, the method includes sequentially tightening each of a plurality of cable ties at least partially. In some embodiments, the method includes at least partially tightening a first cable tie using a robotic system; and at least partially tightening adjacent cable ties. In some embodiments, the method includes performing tightening more than once on each cable tie using a robotic system, wherein each cable tie is tightened progressively. In some embodiments, the method includes setting a relaxation period between a first tightening and a second tightening on a cable tie.
[0019] In some embodiments, the plurality of cable ties are configured to distribute the tightening force generated during tightening of the plurality of cable ties substantially along the length of the defect. In some embodiments, the plurality of cable ties are configured to prevent, mitigate, inhibit, or improve damage to the tissue joined by each of the plurality of cable ties during tightening of each cable ties.
[0020] In one aspect, a method for robotically closing an abdominal wall hernia defect within the rectus abdominis tissue of a patient includes: providing a robotic system comprising one or more end effectors; positioning a first self-locking ligature within the abdominal cavity adjacent to the defect; approaching a first side of the defect with the proximal end of the first self-locking ligature using the robotic system, wherein the self-locking ligature includes a lock at or near the distal end of the self-locking ligature and a ramp or wedge adjacent to the proximal side of the lock; passing the proximal end of the first self-locking ligature through the first side of the defect using the robotic system; passing the proximal end of the first self-locking ligature through a second side of the defect using the robotic system; translating the proximal end of the first self-locking ligature through the lock and tightening the first self-locking ligature to at least partially close the defect using the robotic system; and translating the tightened first self-locking ligature around the defect using the robotic system such that the lock is no longer positioned within the abdominal cavity, wherein the ramp or wedge facilitates easy translation of the ligature, including the lock.
[0021] In some embodiments, the ramp or wedge includes an inclined portion that engages with rectus abdominis tissue. In some embodiments, the method includes: providing a plurality of self-locking ligatures, each of the plurality of self-locking ligatures initially positioned intra-abdominally adjacent to the defect and wherein each of the plurality of self-locking ligatures includes a lock and a wedge or ramp; approaching a first side of the defect with the proximal end of each of the plurality of self-locking ligatures; passing the proximal end of each of the plurality of self-locking ligatures through the first side of the defect using a robotic system, wherein each self-locking ligature is spaced apart from adjacent self-locking ligatures; passing the proximal end of each of the plurality of self-locking ligatures through a second side of the defect using a robotic system; translating the proximal end of each of the self-locking ligatures through the lock using a robotic system; and tightening each of the self-locking ligatures to at least partially close the defect; and translating each of the tightened first self-locking ligatures around the defect using a robotic system such that each lock of each of the plurality of ligatures is no longer positioned intra-abdominally, wherein the ramp or wedge facilitates easy translation of each of the plurality of ligatures, including the lock. In some embodiments, each wedge or ramp is at least partially formed of a bioabsorbable or biodegradable material, and each wedge or ramp can be at least partially absorbed or degraded. In some embodiments, a lock no longer positioned within the abdominal cavity may be configured to anchor the tightened cable ties. In some embodiments, one or more end effectors of the robotic system include one or both of a gripper and a needle holder. In some embodiments, the method includes individually tightening each of a plurality of cable ties at least partially using the robotic system. In some embodiments, the method includes sequentially at least partially tightening each of a plurality of cable ties using the robotic system, the sequence including at least partially tightening a first cable ties, followed by at least partially tightening each of the remaining cable ties using the robotic system. In some embodiments, the method includes sequentially at least partially tightening each of a plurality of cable ties using the robotic system. In some embodiments, the method includes at least partially tightening a first cable ties using the robotic system; and at least partially tightening adjacent cable ties using the robotic system. In some embodiments, the method includes performing tightening more than once on each cable ties using the robotic system, wherein each cable ties are tightened progressively using the robotic system. In some embodiments, the method includes setting a relaxation period between a first tightening and a second tightening of the cable tie.
[0022] In some embodiments, the multiple cable ties may be distributed substantially along the length of the defect by the tightening force generated during the tightening of the multiple cable ties by a robotic system. In some embodiments, the multiple cable ties may prevent, mitigate, inhibit, or improve damage to the tissue joined by each of the multiple cable ties during the tightening of each cable ties.
[0023] In one aspect, a method for closing an abdominal wall hernia defect includes: positioning a first self-locking ligature within the abdominal cavity adjacent to the defect; approaching a first side of the defect with the proximal end of the first self-locking ligature, wherein the self-locking ligature includes a locking head at or near the distal end of the self-locking ligature; passing the proximal end of the first self-locking ligature through the first side of the defect; passing the proximal end of the first self-locking ligature through a second side of the defect; translating the proximal end of the first self-locking ligature through the locking head and tightening the first self-locking ligature to at least partially close the defect; and translating the tightened first self-locking ligature around the defect such that the locking head is no longer positioned within the abdominal cavity.
[0024] In some embodiments, the method includes: providing a plurality of self-locking ligatures, each of the plurality of self-locking ligatures initially positioned intraperitoneally adjacent to a defect; approaching a first side of the defect with the proximal end of each of the plurality of self-locking ligatures; passing the proximal end of each of the plurality of self-locking ligatures through the first side of the defect, wherein each self-locking ligature is spaced apart from an adjacent self-locking ligature; passing the proximal end of each of the plurality of self-locking ligatures through a second side of the defect; translating the proximal end of each of the self-locking ligatures through a lock head; and tightening each of the self-locking ligatures to at least partially close the defect; and translating each of the tightened first self-locking ligatures around the defect such that each lock head of each of the plurality of ligatures is no longer positioned intraperitoneally. In some embodiments, the method includes performing one or more of the steps using a robotic system including a gripper and a needle holder. In some embodiments, the method includes using the robotic system to perform the step including translating each of the tightened first self-locking ligatures around the defect such that each lock head is no longer positioned intraperitoneally. In some embodiments, the method includes manually performing one or more of the steps.
[0025] In some embodiments, the method includes individually tightening each of a plurality of cable ties at least partially. In some embodiments, the method includes sequentially tightening each of a plurality of cable ties at least partially, the sequence including at least partially tightening a first cable tie, followed by at least partially tightening each of the remaining cable ties. In some embodiments, the method includes sequentially tightening each of a plurality of cable ties at least partially. In some embodiments, the method includes at least partially tightening a first cable tie; and at least partially tightening adjacent cable ties. In some embodiments, the method includes performing tightening more than once on each cable tie, wherein each cable tie is tightened progressively.
[0026] In some embodiments, the method includes setting a relaxation period between a first tightening and a second tightening of the cable ties. In some embodiments, the plurality of cable ties are configured to distribute the tightening forces generated during the tightening of the plurality of cable ties substantially along the length of the defect. In some embodiments, the plurality of cable ties are configured to prevent, mitigate, inhibit, or improve damage to the tissue joined by each of the plurality of cable ties during tightening of each cable tie.
[0027] In one aspect, a method for closing an abdominal wall hernia defect within a rectus abdominis muscle block in a patient includes: positioning a first self-locking ligature within the abdominal cavity adjacent to the defect; approaching a first side of the defect with the proximal end of the first self-locking ligature, wherein the self-locking ligature includes a lock at or near the distal end of the self-locking ligature and a ramp or wedge adjacent to the proximal side of the lock; passing the proximal end of the first self-locking ligature through the first side of the defect; passing the proximal end of the first self-locking ligature through a second side of the defect; translating the proximal end of the first self-locking ligature through the lock and tightening the first self-locking ligature to at least partially close the defect; and translating the tightened first self-locking ligature around the defect such that the lock is no longer positioned within the abdominal cavity, wherein the ramp or wedge facilitates easy translation of the ligature, including the lock.
[0028] In some embodiments, the ramp or wedge includes an inclined portion that engages with rectus abdominis tissue. In some embodiments, the method includes: providing a plurality of self-locking ligatures, each of the plurality of self-locking ligatures initially positioned intra-abdominally adjacent to the defect and wherein each of the plurality of self-locking ligatures includes a lock and a wedge or ramp; approaching a first side of the defect with the proximal end of each of the plurality of self-locking ligatures; passing the proximal end of each of the plurality of self-locking ligatures through the first side of the defect, wherein each self-locking ligature is spaced apart from adjacent self-locking ligatures; passing the proximal end of each of the plurality of self-locking ligatures through a second side of the defect; translating the proximal end of each of the self-locking ligatures through the lock; and tightening each of the self-locking ligatures to at least partially close the defect; and translating each of the tightened first self-locking ligatures around the defect such that each lock of each of the plurality of ligatures is no longer positioned intra-abdominally, wherein the ramp or wedge facilitates easy translation of each of the plurality of ligatures, including the lock.
[0029] In some embodiments, each wedge or ramp is at least partially formed of a bioabsorbable or biodegradable material, wherein each wedge or ramp is at least partially absorbed or degraded. In some embodiments, the lock head no longer positioned within the abdominal cavity is configured to anchor the tightened ligature. In some embodiments, the method includes performing one or more of the steps using a robotic system including a gripper and a needle holder. In some embodiments, the method includes performing a step using a robotic system including translating each of the tightened first self-locking ligatures around the defect such that each lock head is no longer positioned within the abdominal cavity. In some embodiments, the method includes performing one or more of the steps manually. In some embodiments, the method includes individually tightening each of a plurality of ligatures at least partially. In some embodiments, the method includes sequentially tightening each of a plurality of ligatures at least partially, the sequence including at least partially tightening a first ligature, followed by at least partially tightening each of the remaining ligatures. In some embodiments, the method includes sequentially tightening each of a plurality of ligatures at least partially. In some embodiments, the method includes at least partially tightening a first cable tie; and at least partially tightening an adjacent cable tie.
[0030] In some embodiments, the method includes performing tightening more than once on each cable tie, wherein each cable tie is tightened progressively. In some embodiments, the method includes setting a relaxation period between a first tightening and a second tightening on the cable tie. In some embodiments, the plurality of cable ties are configured to distribute the tightening force generated during tightening of the plurality of cable ties substantially along the length of the defect. In some embodiments, the plurality of cable ties are configured to prevent, mitigate, inhibit, or improve damage to the tissue joined by each of the plurality of cable ties during tightening of each cable tie.
[0031] In one aspect, a self-locking cable tie includes: a distal end and a proximal end; a lock head located near or at the distal end of the self-locking cable tie and including a slot through the lock head; a wedge or ramp positioned adjacent to the proximal side of the lock head, the wedge or ramp including an inclined surface, wherein the slot through the lock head is configured to allow a portion of the self-locking cable tie to translate through the lock head in one direction and prevent the self-locking cable tie from translating through the lock head in the opposite direction.
[0032] In some embodiments, the distal side of the inclined surface comprises a height substantially the same as the height of the lock head, and the proximal side of the inclined surface comprises a height less than that of the distal side. In some embodiments, the wedge or ramp comprises a slot operatively communicating with a slot in the lock head. In some embodiments, at least a portion of the wedge or ramp comprises a bioabsorbable or biodegradable material. In some embodiments, the lock head comprises a cuboid shape.
[0033] In one aspect, a locking device attached to or near the distal end of a self-locking cable tie includes: a housing defining a slot therethrough, the slot being configured to receive the proximal end of the self-locking cable tie, wherein the self-locking cable tie is allowed to translate through the slot in one direction and prevented from translating through the slot in the opposite second direction; a wedge or ramp adjacent to, adhered to, or attached to one of the proximal sides of the housing, and including a slot aligned with the slot in the housing, and the slot of the wedge or ramp allowing the self-locking cable tie to translate through it.
[0034] In some embodiments, the distal side of the inclined surface comprises a height substantially the same as the height of the lock head, and the proximal side of the inclined surface comprises a height less than that of the distal side. In some embodiments, at least a portion of the wedge or ramp comprises a bioabsorbable or biodegradable material. In some embodiments, the lock head comprises a cuboid shape. Attached Figure Description
[0035] Figure 1 The configuration of the components used in the previously described laparoscopic abdominal wall hernia repair is depicted.
[0036] Figure 2 The position of the ligature lockhead in front of the abdominal wall is shown during the previously described laparoscopic abdominal wall hernia repair.
[0037] Figure 3 The intra-abdominal position of the self-locking ligature used for abdominal wall closure in robotic surgery is shown.
[0038] Figure 4 The image shows the intra-abdominal position of the self-locking zip tie after the abdominal wall is closed with the zip tie.
[0039] Figures 5A to 5G A section illustrating an embodiment of a locking feature on a cable tie portion is shown.
[0040] Figure 6 A cross-sectional view of an embodiment of the lock head is shown.
[0041] Figure 7 A cross-sectional view of another embodiment of the lock head is shown.
[0042] Figures 8A to 8E Various embodiments of lock heads with integrated cutting blades are shown.
[0043] Figure 8F A cross-sectional view of an embodiment of a low-profile inline lock head is shown.
[0044] Figure 8G It shows Figure 8F A perspective sectional view of an embodiment of a low-profile inline lock head.
[0045] Figures 8H to 8JSelf-locking cable ties and locks with directional features are depicted.
[0046] Figure 9A A side view of an embodiment of a mesh cable tie with attached pins and locks is shown.
[0047] Figure 9B An exploded side view of an embodiment of a mesh cable tie with needles and locks is shown.
[0048] Figure 9C A side sectional view of an embodiment of a mesh cable tie with attached pins and locks is shown.
[0049] Figure 9D An exploded side view of an embodiment of a mesh cable tie with needles and locks is shown.
[0050] Figure 10A A perspective view of an embodiment of the lock and cable tie is shown.
[0051] Figure 10B A side cross-sectional view of an embodiment of the lock head and cable tie is shown.
[0052] Figure 11 A cross-sectional view of an embodiment of a lock head including a ball is shown.
[0053] Figures 12A to 12B An example transition section is shown.
[0054] Figures 13A to 13B A view of an exemplary mesh guide is shown.
[0055] Figures 14A to 14B A top view shows the guide attached to the cable tie section.
[0056] Figures 15A to 15D Side and top sectional views of an embodiment of a method for attaching a guide to a cable tie are shown.
[0057] Figures 16A to 16B The configuration of components contained in a self-locking zip tie for closure of the abdominal wall of a robot is depicted.
[0058] Figures 17A to 17F The bio-absorbable wedge and its configuration after being inserted into a self-locking zip tie are shown.
[0059] Figure 18 An apparatus for delivering a self-locking ligature with a needle under laparoscopic guidance is described.
[0060] Figures 19A to 19C A tensioner and cutter with an open side for cable ties are shown.
[0061] Figures 20A to 20CAnother embodiment is shown, featuring a tensioner and a cutter on the open side for cable ties to enter.
[0062] Figures 21A to 21H The procedure for closing abdominal wall defects using self-locking ligatures is described.
[0063] Figure 22 The steps involved in using self-locking ligatures to close abdominal wall defects are summarized.
[0064] Figure 23 The positioning of the self-locking cable tie is shown after tightening and rotation.
[0065] Figures 24A to 24M A method for inserting self-locking ligatures using a robotic surgical approach is shown. Detailed Implementation
[0066] In robotic laparoscopic abdominal defect closure, surgeons primarily perform procedures within the abdominal cavity, as opposed to the combined external and internal procedures in laparoscopic abdominal wall hernia closure. The final cutting of the ligature used to close the tissue defect can be performed using tensioners and cutters operated externally. Miniature robotic end effectors, such as robotic needle holders and grippers, can perform tissue dissection, needle placement, and ligature management. Such operations allow the self-locking ligature to meander through the tissue surrounding the defect from the abdominal cavity and back into the abdominal cavity (e.g., in an "inside-out" path, as opposed to other surgical procedures that percutaneously introduce and manipulate the ligature along an "outside-in" path). The distal end of the self-locking ligature is attached to a guide, which can be a suture of a certain length, and the guide can be attached to a curved needle. The self-locking ligature is first introduced into the abdominal cavity as a whole for placement with the robotic needle holder. Because robotic abdominal wall hernia closure is performed inside the abdomen, the ligature locking head is located within the abdominal cavity, and it can be repositioned after ligature tensioning and excessive ligature transverse cutting to avoid postoperative complications. Compared to sutures, such self-locking ligatures can advantageously distribute compressive forces over a larger area of tissue, thereby reducing the risk of tissue tearing even when the ligature is tightened.
[0067] Surgical procedures involving intraperitoneal closure ligation may be particularly suitable for robotic surgical approaches. Robotic surgical procedures can typically involve two or more cannulas used for robotic cutters and graspers. In some cases, the robotic grasper may be large, and penetration of muscles (such as the rectus abdominis) during robotic surgical procedures is undesirable. Therefore, positioning the cannulas behind the rectus abdominis to allow the robotic grasper to enter the abdominal cavity may be preferred to create an access hole in the skin tissue in the area anterior to the tissue defect. This disclosure relates to devices and methods for first introducing a closure ligation into the abdominal cavity before performing further surgical procedures.
[0068] Figure 1The components of the previously described laparoscopic abdominal wall hernia repair technique are depicted, with an observation of the overlying skin 110, in which the underlying rectus abdominis muscle 111 is surrounded by a rectus abdominis sheath 112, forming most of the abdominal wall. Once the thin layer of peritoneum 113 is passed through, the surgeon has access to the abdominal cavity 114. Surgical instruments applied from outside the patient's body include delivery and grasping needles 118 and a subcutaneous dissection guide 119. Using these instruments, sutures 117 attached to a self-locking ligature 115 are passed through the defect with the aid of a laparoscopic grasper 120. The locking head 116 of the self-locking ligature 115 remains outside the patient's skin 110.
[0069] Figure 2 The anatomical configuration of the self-locking ligature 115 after closure of the abdominal wall defect is shown. The lock head 116 is located anterior to the anterior part of the rectus abdominis sheath 112 below the skin 110.
[0070] Overview
[0071] The self-locking ligature according to this disclosure can be used to close tissue defects, such as tissue defects in the abdominal wall. Figure 3 The initial position of the self-locking zip ties 300 according to this disclosure is shown. The self-locking zip ties 300 can be initially positioned inside the abdominal cavity 114, for example, in preparation for robotic laparoscopic abdominal wall closure. The self-locking zip ties 300 may include a bent needle 322 connected to a guide 317 attached to the distal end of the zip ties portion 321. Optionally included, a bioresorbable wedge 323 may be located distal to the zip ties lock head 316. The guide 317 may generally be more flexible (less rigid) than the zip ties portion 321. The guide 317 may have a smaller cross-sectional area than the zip ties portion 321. The guide 317 may include a different geometry or material than the zip ties portion 321. Therefore, the guide 317 can be used to guide the zip ties portion 321 into place, thereby pulling the zip ties portion 321 through multiple tissue interfaces. In this sense, inserting the self-locking ligature 300 into the tissue can have an expansion effect because the smaller diameter guide 317 is first pulled through the tissue, thereby guiding the larger ligature portion 321 along the same path. Tissue expansion requires a smaller opening and causes less trauma to the tissue. Therefore, the guide 317 can pass through the tissue like a suture (in some embodiments, the guide can be a suture) without significantly affecting the tissue, while the ligature portion 321, once in place, has a larger footprint (e.g., width or cross-sectional area) where it lies within and against the tissue, thus reducing the local pressure applied to the tissue and the risk of cutting into or penetrating the tissue compared to a suture. The larger cross-section of the ligature portion 321 allows the surgeon to apply more tissue adhesion with the ligature portion 321 compared to a suture, as a suture might cut through the tissue due to its small size.
[0072] Figure 4 The anatomical configuration of a self-locking ligature 321 within the abdominal cavity 114 after closure of the abdominal wall defect is shown. The locking head 316 is located within the abdominal cavity 114. As discussed herein, the self-locking ligature 321 can be... Figure 4 Rotate to the position shown to remove the distal lock head 316 out of the abdominal cavity.
[0073] Cable tie section
[0074] According to this disclosure, a self-locking cable tie may have a cable tie portion capable of interacting with the locking head of the self-locking cable tie to lock and tighten. Figures 5A to 5G An example of a cable tie portion is shown, which has features along its length to engage with a lock to allow travel in only one direction (e.g., in a locking manner commonly referred to as a zipper tie or wire harness tie). The cable tie can be tightened as it wraps around a portion of the tissue to be sutured, and the cable tie will remain taut without the surgeon needing a holding device or any knots or additional tools such as clamps to maintain the cable tie tension. Advantageously, maintaining tension without the surgeon needing a holding device or knots allows the surgeon to at least partially tighten the cable tie while performing other tasks. The surgeon can then return to the at least partially tightened cable tie and continue the tightening process and / or the remaining surgical steps. Therefore, the examples of cable ties described herein can be considered “knotless,” e.g., without slip knots and / or “clampless,” i.e., without the need for clamping to achieve the above. As will be further described below, such an arrangement allows for the sequential application or tightening of the cable tie, which may be advantageous in several respects, including for the reasons stated above. Furthermore, when using more than one zip tie, each associated zip tie can be tightened at least partially and continuously, thus allowing surgeons great flexibility in tightening or loosening surgical procedures.
[0075] In some examples, part or all of the ligature portion may be bioresorbable. In some examples, the ligature may include internal structures that are not bioresorbable, or substantially not bioresorbable, while the outer portion of the ligature portion is bioresorbable. In some other examples, the internal structures may be bioresorbable at a slower rate than the outer portion. In such examples, the outer portion may be bioresorbable, thereby reducing the ligature's profile and / or volume as the patient recovers. Even when the outer portion is bioresorbed, the remaining internal structures can continue to provide mechanical support to the tissue surrounding the defect.
[0076] In one example, the tie portion 513 may include an opposite side having angled teeth 511 on one side, and a relatively smooth opposite side, similar to a conventional zipper tie, such as... Figure 5A As shown.
[0077] In another example, the cable tie portion 515 may include teeth 517 and teeth 518 on two opposite sides, such as Figure 5B As shown. Teeth 517 and 518 can be staggered relative to each other to avoid thin sections in the cable tie portion 515.
[0078] Figure 5C An example of a cable tie portion 519 according to the present disclosure having an opening 521 that engages with a pawl or other feature in a lock head is shown. Since the orientation of the opening 521 is orthogonal to the cable tie portion 519, injection molding is permitted, thus allowing this cable tie portion 519 to be readily manufactured. In some examples, the opening 521 may extend completely through the cable tie portion 519, or these openings 521 may include recesses defined in the cable tie that do not extend through the cable tie portion 519 but have a thickness less than that of the cable tie portion 519, as shown. In this example, the lock head may include one or more features that force a unidirectional tightening movement or translation of the cable tie portion 519 through the lock head.
[0079] In some examples, cable ties may not have discrete locking features. Figure 5D A cable tie portion 523 is shown, having a substantially smooth surface 525 on at least one of its opposite sides. This surface 525 can engage with a locking mechanism having teeth, cams, fangs, or other features that facilitate gripping, holding, or seizing the cable tie by friction or otherwise striking it to secure the cable tie in a one-way locking manner. The elastic cable tie can, for example, be smooth, such as... Figure 5D As shown. Some examples of cable ties can be fully elastic or contain elastic elements and can continue to apply pressure to the tissue as it contracts or otherwise relaxes after surgery. Elastic cable ties can be made of rubber-like materials, such as thermoplastic elastomers (TPEs) or silicone.
[0080] Figure 5E Another example is shown where side rails 528 are located on opposite sides of teeth 529 on at least one of the opposite sides of cable tie portion 527. Side rails 528 increase the strength and rigidity of cable tie portion 527. Side rails 528 may extend the length of cable tie portion 527, or alternatively, may extend along one or more sections of cable tie portion 527.
[0081] In some examples, the joining features on the cable tie can have gaps. For example, Figure 5F A cable tie portion 531 is shown having teeth 533 separated by a gap 537, which can be combined as described above. Figure 5C Flat sections, gaps, or recesses; may also include side rails 535 and, as combined Figure 5E As stated above.
[0082] Other examples, including those disclosed above, may have multiple sets or segments of teeth 545, including one or more teeth 543, or other engagement features, wherein the multiple sets or segments of teeth 545 are longitudinally separated or spaced by gaps 541, such as Figure 5G As shown. This configuration allows the cable tie portion 539 to move freely between the toothed segments 543 with minimal resistance between the spaced segments of the teeth 545, making it easy to tighten without increasing resistance when the cable tie is still loose at the anatomical location. Furthermore, the gaps 541 also serve to reduce the number of impacts from individual cable tie teeth 543 contacting the locking mechanism in the lock head. For example, when an operator tightens a long cable tie, each tooth 543 on the cable tie portion 539 contacts a tooth in the lock head, resulting in repetitive stress and potential wear on the teeth in the lock head, which can reduce the lock head's retaining strength. Therefore, the discontinuous toothed segments 545 reduce the number of contacts with the teeth 543 in the lock head during tightening, potentially leading to less wear and higher strength. Finally, reducing the number of teeth on the strip can reduce manufacturing costs and complexity in processes such as injection molding, where molding long and narrow toothed segments (such as in long zipper straps) may require expensive tools.
[0083] In some examples, there may be tooth segments 545 with a longitudinal length, followed by gaps, and then one or more tooth segments 545 also having a longitudinal length. As those skilled in the art will understand, the lengths of the tooth segments 545 may be substantially equal, or they may vary. An exemplary length of the tooth segment 545 may include approximately 25 mm, but those skilled in the art will readily understand that other lengths may be implemented, each of which is within the scope of this disclosure. This arrangement allows the surgeon to easily slide the ligature portion 539 through the lock and then release the device when it interlocks the tooth segment 545 during surgical manipulation, such that the device remains in place when the surgeon applies other self-locking devices to the wound. Next, the surgeon may further tighten the ligature to engage the next set of spaced teeth 545 at a tighter fit (i.e., a smaller circumference) of the ligature around the tissue defect. The above method is also possible for ligatures with engagement features substantially along their entire length. However, segments with smaller engagement features or intermittent engagement segments may have manufacturing or cost advantages, as the tools used to manufacture the features may be less complex.
[0084] In some examples, the zip tie portion may include a toothed functional area and a toothless non-functional area. Because the non-functional area does not contain teeth that can interact with the lock head, the surgeon can move the self-locking zip tie lock head rapidly over the non-functional area. Because the teeth in the functional area can interact with the teeth of the lock head, the movement of the lock head over the functional area may be slower and / or require greater force. In some examples, the ratio of the length of the functional area to the length of the non-functional area along the length of the zip tie portion may be 1:10, 1:5, 1:4, 1:3, 1:2, 3:1, 4:1, 5:1, or 10:1, or any ratio within the range defined by any two of the foregoing ratios, although other ratios may be appropriate in some cases. In some examples, the length of the functional area may be approximately 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, or 50 cm, or a length within the range defined by any two of the foregoing values.
[0085] In some examples, the width of the zip tie portion can be approximately 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14 mm, or a width within the range defined by any of the foregoing values. It may be desirable to choose a zip tie portion that is wide enough to apply force across a sufficiently large surface area of the tissue to prevent tearing, but also narrow enough not to substantially increase the risk of causing a second tissue defect where the zip tie portion extends through the tissue.
[0086] The cable tie portion disclosed herein is provided as an example, and those skilled in the art will recognize that numerous cable tie designs exist that provide one-way knotless and clamp-free locking capabilities when coupled with various lock head designs, all within the scope of this disclosure. Furthermore, as those skilled in the art will now recognize, various combinations of the above examples can be envisioned, for example, such as... Figure 5C The cable tie portion 519 shown with opening 521 may also include side rails 528, similar to... Figure 5E Those in it.
[0087] lock
[0088] Figures 6 to 8E Various examples of locks are shown. Figure 6A cross-sectional view of a lock head 651 attached to the proximal end of a cable tie portion 652 is shown. The lock head 651 has a resilient hinge 653 such that when the cable tie portion 652 (partially shown) passes through the channel 663 in the direction of arrow 661, a pawl 665 deflects to allow the cable tie to pass through. When the cable tie portion 652 is pulled in the direction opposite to arrow 661, the teeth on the cable tie engage with the teeth 659 on the lock head 651, thereby preventing the cable tie portion 652 from passing through. When the cable tie is taut, the force on the teeth 659 of the cable tie portion 652 causes the pawl 665 to flex in the opposite direction around the apex 654, causing the teeth 659 to tend to align with the cable tie portion as it passes through the lock head 651, resulting in more teeth 659 engaging with the teeth on the cable tie portion in the direction opposite to arrow 661.
[0089] In another example, such as Figure 7 As shown, the lock head 771 has teeth 779 that are substantially parallel to the direction 773 through which the cable tie portion 772 passes. As the cable tie portion 772 passes through the channel 774 in the direction of arrow 773, the resilient hinge 775 allows the pawl 777 to flex away and then flex back to the orientation shown, such that the teeth 779 are substantially parallel to the teeth on the cable tie, thereby allowing multiple teeth to engage with the cable tie.
[0090] In some examples, self-locking cable ties may have an integrated cutting blade within the lock head to cut the cable tie. Depending on the position of the cutting blade within the lock head, the cut end of the cable tie may be flush with or recessed into the lock head. Figure 8A An example of a lock head 802 is shown, which has a cutting blade 804 within a channel 808, through which a cable tie portion 810 passes. Figure 8A In the example, blade 804 is opposite to ratchet 806. Figure 8B An example of a lock head 812 is shown, which has a cutting blade 804 within a channel 808, through which a cable tie portion 810 passes. Figure 8B In the example, the cutting blade 804 is positioned on the same side of the channel 808 as the ratchet tooth 806. Other arrangements are within the scope of this disclosure, such as Figure 8C The example shown includes a lock head 814 comprising a cutting blade 804 embedded in a cable tie portion 810 adjacent to the lock head 814, wherein teeth 806 are on opposite sides of the channel 808. In some examples, the lock head may have cutters on both sides of the channel, thus combining... Figure 8A and Figure 8B Examples. Figure 8DAn end view of an example lock head 816 is shown, the lock head 816 having a cutting blade 804 located in a circular end 818 of the lock head 816 and opposite a locking tooth 806. The cutting blade 804 is attached to or otherwise embedded in the lock head 816. In some examples, the cutting blade 804 may be molded together with the lock head 816 (e.g., insert molding), or the cutting blade 804 may be bonded in place.
[0091] Now refer to Figure 8E The image shows an end view of an example lock head 820 with a cutting blade 822. The cutting blade 822 comprises a metal sheet having an aperture 824 aligned with a channel 808 of the lock head 820. The aperture 824 is sized to allow cable ties to pass through while providing a gap, and to cut the cable ties as they rotate. The metal sheet of the cutting blade 822 can be attached to the lock head 820 by any method used for attaching a thin-walled metal sheet or plate to a plastic material. For example, the cutting blade 822 can be attached to the lock head 820 by bonding, insert molding, ultrasonic welding, or melting a plastic sheet or boss that passes through or across the edge of the metal sheet. The metal sheet of the cutting blade 822 can be made by stamping, forming, laser cutting, or a combination thereof. In some examples, the metal sheet of the cutting blade 822 may not have an aperture, but may comprise a simple metal sheet with a sharp edge overlapping the exit of the channel from which the cable tie exits.
[0092] exist Figures 8F to 8G An example of a low-profile, straight-line lock head is shown. The lock head 801 may include a channel 803 substantially parallel to the proximal portion of the cable tie portion 809, such that when the cable tie portion 809 passes through the lock head 801 in the direction of arrow 807, the distal cable tie will be substantially adjacent to (e.g., parallel to) the proximal cable tie portion 809. In this configuration, the teeth 1205 are aligned with the proximal end of the cable tie portion 809, such that after the cable tie is inserted and cut, the remaining cable tie protruding through the channel 803 will be flush. Figure 8G As shown in the cross-sectional view, the locking head 801 can be low-profile, which can reduce trauma to the body and can reduce residual pressure on adjacent tissues, for example, by reducing skin swelling when the device is located near the skin or other organs. The cable tie may include a sloping portion 811 extending from the cable tie portion 809 to the locking head 801. The sloping portion 811 can advantageously ensure that the transition from the cable tie portion 809 to the locking head 801 is gradual. In some exemplary methods of rotating the self-locking cable tie after tightening, the sloping portion 811 can be used to reduce, minimize, or prevent damage to the tissue into which the channel 803 rotates.
[0093] In other examples, the correct orientation of the geometric feature pairs prevents the cable ties from passing through the lock in the wrong orientation. Figures 8H to 8JAn example is shown in which the cable tie 832 has a protrusion 834 on one side that engages with a matching shape (e.g., a slot 840) in the lock head 836. Figure 8H (Side view) and Figure 8I As shown in the top view, the protrusion may be a track extending along a portion of the cable tie 832. In some examples, the protrusion 834 may be present toward the distal end of the cable tie 832. In some examples, the protrusion 834 may extend along the entire length of the cable tie. The protrusion 834 may engage with a matching shape (e.g., slot 840) in the lock head 836, such as... Figure 8J As shown. The slot 840 may abut against the channel 838 of the lock head 836. In some examples, the slot 840 is opposite to the teeth 842 of the lock head 836. The engagement of the protrusion 834 with the slot 840 prevents the lock head 836 from engaging the cable tie 832 in an inverted orientation.
[0094] Guide
[0095] The guide of a self-locking cable tie may have a smaller cross-section than the rest of the self-locking cable tie. The smaller cross-section allows the guide to pass more easily through the tissue, thus providing a path that the larger portion of the cable tie can traverse. The guide connects the cable tie portion to the needle. The guide may include a braid, braid, knitted fabric, or nonwoven sheet, which may be tubular or have a flat 2D shape, such as a cable tie or other mesh structure that connects the cable tie portion directly to the needle (or a guide connecting the cable tie and the needle). Figure 9A A side view of such a device 900 is shown. The device 900 may include a guide 902, a needle 980, a cable tie portion 977, and a lock head 979.
[0096] In some examples, guide 902 may include a mesh structure having a tubular form or a flat cross-section. Guide 902 may tend to lie flat on the tissue and form a contact area that is generally larger than that of the suture, thus providing less pressure on the tissue and reducing the tendency to cut into the tissue. Self-locking ligature 900 may include a needle 980 at its distal end and a bevel 978 at the tip of the needle for piercing the tissue. As shown, needle 980 may be straight or curved to facilitate suturing tissue defects such as abdominal wall hernias. Alternatively, device 900 may not have a needle at its distal end, but may have a structureless, constricted distal tip, guide, or one or more loops, as disclosed above in various guide examples.
[0097] The proximal end of the device 900 may have a locking head 979, which allows only unidirectional movement of the guide 902 as it passes through the locking head 979. The guide 902 may be attached to the locking head 979 in the same manner as described in this disclosure for attaching the cable tie portion 977 to the guide 902 (e.g., see [reference]). Figures 14A to 14B and Figures 15A to 15D For example, such as Figure 9A and Figure 9B As shown, guide 902 may have an opening at its proximal end 974 that surrounds a cable tie portion 977 (not drawn to scale) extending from lock head 979. Cable tie portion 977 may taper as it extends into guide 902. Guide 902 may include one or more bumps or protrusions thereon, which may secure guide 902 and prevent guide 902 from slipping off cable tie portion 977. Figure 9B An isometric exploded view of device 900 is shown. Device 900 includes a guide 902 and a distal end 972. The guide 902 is a flexible mesh structure having an open cavity passing through it or at least partially passing through it. Lock head 979 has an aperture 975 that can receive the guide 902 and restrict the movement of the guide 902 in one direction.
[0098] In some examples, needle 980 may remain on guide 902, such that needle 980 guides guide 902 into lock head 979, after which needle 980 may be cut off from guide 902. In other methods, needle 980 may be cut off from guide 902 before passing through lock head 979. The distal end 972 of guide 902 may have a guide segment 176 at its distal end near needle 980, as... Figures 9C to 9D As shown. Figure 9C As shown, the distal end 972 of guide 902 has a distal segment 976 that has a smaller cross-sectional shape near its attachment to needle 980. In some examples, the distal segment 976 may be a segment with a tighter weave and a smaller diameter, or it may be bonded or otherwise shaped into a smaller shape or melted into a smaller size, such that the fibers do not loosen or come undone after being cut. The distal segment 976 may be stiffer than guide 902 or the rest of guide 902, making it easier to push through the lock without folding or buckling, because it may have greater pin strength than guide 902.
[0099] The alternating interaction between the cable ties and the lock head
[0100] Other examples in this disclosure discuss tooth-to-tooth interaction between the lock head and the cable tie section, but other mechanisms may also be suitable. As an alternative example, Figure 10A and Figure 10BA cross-sectional view is shown of an example of a lock head 1081 having a tab 1083 that engages with a gap 1087 in the cable tie portion 1082. The tab 1083 may be angled such that it allows the cable tie portion 1082 to pass through the channel 1085 in the direction of arrow 1089, while preventing backward movement to achieve a one-way locking action. Figure 10B Another cross-sectional view of this example is shown, in which the tab 1083 engages in the gap 1087 in the cable tie portion 1082. This example of a lock head 1081 having one or more tabs 1083 is typically associated with locks having, for example, tabs 1083. Figure 5C The hole shown (i.e., the cut or partial cut in the cable tie) is compatible with cable tie designs, although this type of lock head is also compatible with toothed designs.
[0101] Cable ties can be locked using balls and wedges, much like a clutch, which can lock the cable ties with considerable force and with little or no backlash when transitioning from slipping to holding them in place. Figure 11 A lock head 1191 is shown with a ball 1195 confined between an inclined surface 1193 and a cable tie portion 1100. When the cable tie 100 is pulled in the tightening direction 1199, the ball 1195 displaces in the same direction 1197 and away from the inclined surface 1193, thereby allowing the cable tie portion 1100 to translate freely. When the operator releases the cable tie portion 1100, it is prevented from traveling in the opposite direction because the ball 1195 impacts the inclined surface 1193, which forces the ball 1195 against the cable tie portion 1100, thereby clamping the cable tie portion 1100 between the ball 1195 and the bottom wall 1198 of the lock head 1191. In some examples, the sphere 1195 can instead be a cylinder to apply a linear load rather than a point load on the cable tie portion 1100, which can be smooth or textured, resulting in a relatively simple, low-cost cable tie. In practice, this type of configuration can also be used with fabric, woven, or textile cable tie materials that lack lockable discrete features. Additionally, features that improve friction can be added to the location where the lock head 1191 contacts the cable tie portion 1100, and include, but are not limited to, features that improve friction. Figures 5A to 5G The exemplary cable tie portion shown is illustrated. Such features include, but are not limited to, surface roughness, texture, knurling, grids, bumps, or beveled bumps.
[0102] Some examples of the various devices described in this article include configurations where the cable tie section is orthogonal to the lock head.
[0103] transition section
[0104] In some examples, the self-locking cable tie (“device”) may have a transition section at the distal end of the tie portion where the self-locking cable tie engages proximal to the guide; that is, the transition section is a section where a transition occurs in size, shape, and / or material. The transition section facilitates guiding the tie portion through the tissue, and particularly through corners as the tie portion is pulled by the guide. The transition section can provide a gradual transition in size and / or stiffness between the relatively narrow and flexible guide and the relatively wide and stiffer tie. A gradual transition with stiffness can reduce kinking between the guide and the tie portion, which can occur when the self-locking cable tie is pulled around corners (such as entry or exit points in the tissue). Furthermore, the transition section can provide an expansion effect between the relatively narrow guide and the relatively wide tie portion, thereby allowing a gradual increase in the lateral force exerted on the tissue by the self-locking cable tie as the tie portion is pulled through the tissue by the guide.
[0105] For example, Figure 12A An apparatus with a transition section 1202 is shown, which includes a rounded end between the cable tie portion 1204 and the guide 1206. The rounded end can be a full rounded corner or a chamfered corner at the corner of the cable tie portion closest to the guide 1206. In other examples, the transition section can include a longer, more progressively smaller dimension, such as... Figure 12B As shown in the image. Figure 12B A transition section 1208 is shown that tapers gradually from the width of the cable tie portion 1204 to the width of the guide 1206. The length of the transition section 1208 can be described as being the same as the width of the cable tie portion. For example, the transition section 1208 can be approximately 1.5 times the width of the cable tie portion 1204, such as... Figure 12B As shown, it can be longer, for example, 2, 3, 4, or 5 times or more the width of the cable tie portion 1204. In some embodiments, the transition section 1208 may have a maximum width of 2.5 mm, while the guide has a diameter of 0.6 mm; the transition section may gradually, but not necessarily monotonically, taper in diameter and / or width from the cable tie size to the guide size over a certain length to provide a gradual gradient. The length of the transition section can be as small as 2 mm or, for example, 5 mm or longer, such as 15 mm or more in some examples.
[0106] Attachment of guides and cable ties
[0107] The guide may have a diameter and / or width less than or less than about 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, or 0.5 mm, or within the range defined by any two of the foregoing values, but in some cases, other values may also be suitable. The guide need not be circular. The guide may have low or negligible bending stiffness and be able to withstand tension from pulling the cable tie through a path in the tissue (e.g., a tortuous path in the tissue). Figure 13A and Figure 13B As shown, in some examples, guides 1300 or 1310 can be mesh structures, such as woven fabric, braids, knitted fabric, or nonwoven fabric sheets. The shape of the guide can be tubular, such as... Figure 13A The hollow woven fabric shown, or as Figure 13B The flat strip shown is an example. The guide can be extendable, such that it necks to a smaller size when under tension. Furthermore, the tubular guide 1300 can be sufficiently flexible to flatten under tension, or its diameter can generally be reduced due to the porosity and layout of the mesh 1302. The guide 1300 can have an open end 1304 capable of fitting over the distal end of the cable tie to be secured, as further described in this disclosure. In some examples, the guide can be made of Dacron. TM The guide is a tubular braid made of a common thermoplastic polyester (polyethylene terephthalate) with a diameter of approximately 0.7 mm. Alternatively, the guide can be a monofilament or suture attached to the cable tie, and in other embodiments, the guide can be an integral molded extension of the cable tie with a smaller cross-sectional area for easier passage through tissue.
[0108] In some examples, the guide may be made of a different material than the ligature portion. In some examples, the guide may be made of the same material as the ligature portion but with a different geometry, such as a mesh or solid structure with a different cross-sectional shape than the ligature. For example, the guide may be a wire or strip of metal made of a metal such as stainless steel or nitinol. In some examples, the guide may be made of other materials, such as polyetheretherketone (PEEK) or polyethylene, or, for example, suture material, as further described below in the Materials section. The guide can have any desired length. It may be desirable to choose a guide length that depends on the anatomical location and surgical technique. For example, the guide may be long enough to be reached through the tortuous path of the surgical procedure for abdominal wall hernia surgery as described below, particularly for obese patients who may require longer guides and ligatures compared to non-obese patients. In some examples, the length of the entire cable tie (e.g., from the lock to the needle) can be greater than or equal to approximately 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, or 240 cm, or within the range defined by any two of the foregoing values, although in some cases other values may also be suitable. The guide length can be a portion of the device length, for example, 50%, such that the guide and the cable tie portion have approximately the same length, or, for example, the guide can be as long as 75% of the device length or as short as approximately 25% of the device length. The guide length can be selected such that the guide is easy to grasp and control when the cable tie is pulled through the various layers of tissue. Since the guide can be cut after the zip ties are in place, any excess length is simply discarded; however, if the guide is too long, it can be problematic, as it may interfere with the procedure or increase the cost of materials or manufacturing (parts or tools). Similarly, after complete closure of the tissue, the zip ties can be cut to leave only a small portion of the distal end outside the zip ties.
[0109] Some or all of the length of the guide may have a width or diameter ranging from approximately 0.35 mm to approximately 2 mm in its main cross-sectional dimension, or even larger in some applications. The entire length, most of the length, or a portion of the length of the guide may have a width between approximately 0.3 mm. 2 With approximately 13 mm 2 The cross-sectional area between [the specified values]. However, it should be recognized that the guide can have a cross-sectional area such that the ratio falls outside the range. For example, the guide can be a fine thread or stitch with a diameter between 0.1 mm and 0.35 mm.
[0110] The proximal end of the guide can be coupled to the distal end of the cable tie either after or during the molding of the cable tie portion, for example, as an overlay molding or insert molding, or the entire device can be molded as a single component. When the cable tie portion is molded, the proximal end of the guide can be overlaid onto the distal end of the cable tie portion. In some examples, the guide can be made of the same material as the cable tie portion. In some examples, the distal end of the cable tie portion can include a metal insert, and the proximal end of the guide can be coupled to the metal insert. In some examples, the guide can be coupled to the cable tie by other connection methods, such as by knotting around the cable tie portion, looping and knotting through a hole in the cable tie portion, or both. A transition section can include the area where the cable tie and guide connect. This area can include the overlap between the guide and the cable tie portion. In some examples, the cross-sectional dimensions of the transition section can be comparable to or smaller than the cable tie portion to allow passage through tissue layers, thereby minimizing resistance and tissue tearing. While the device can be cut at any location during the surgical procedure to remove the guide and any excess cable ties, in some examples, a transition section may allow the guide to detach from the cable tie portion. In such examples, a release element, incision, insertion / binding connector, or similar feature may be present at the distal end of the cable tie portion, making the distal end of the cable tie portion weaker than the rest of the cable tie portion, allowing it to be pulled apart by hand; that is, the guide can be separated from the cable tie portion by pulling the guide with a force greater than required to pull the cable tie through the body. For example, if a tension of x lb is required to pull the guide and cable tie through the body, and the cable tie has a tensile strength of 7.5 lb, a release force between approximately x lb and 7.5 lb may be required. In some examples, the guide can also be quickly released by the operator twisting or tearing to separate the guide from the cable tie portion.
[0111] In examples where the guide is tubular or made of mesh or other porous structures, stretching it may tend to reduce its diameter. In such examples, the guide can be clamped onto a cable tie in the transition section, thereby forming a low-profile joint. (See reference...) Figure 14A and Figure 14B The cable tie portion 1421 may have a reduced diameter at its distal end in the transition section 1423 to accommodate a relatively small guide 1427, such as Figure 14A As shown. In some examples, such as Figure 14A and Figure 14BAs shown, during manufacturing, the proximal end 1425 of the guide 1427 is opened before sliding over the transition section 1423. The transition section 1423 may have features such as one or more large-diameter protrusions to hold the guide 1427 in place when the guide is not under tension (e.g., during manufacturing). When the guide is stretched (e.g., when the guide passes through tissue), the diameter of the guide may tend to decrease, thereby clamping onto the transition section 1423 of the cable tie. The guide 1427 may be tapered or have a reduced cross-sectional dimension in the transition section 1423 to match the cross-sectional dimension of the distal end of the cable tie portion 1421. Alternatively, during manufacturing, even if the diameter or cross-sectional dimension of the guide 1427 is smaller than that of the cable tie portion 1421, the diameter of the guide 1427 in the transition section 1423 may be larger, or stretched to a larger diameter. For cable tie designs, such as Figure 14A The cable tie design shown has a non-circular shape; the "diameter" refers to the largest cross-sectional dimension.
[0112] Figure 14B A guide 1427 is shown that is advanced onto the cable tie portion 1421. In some examples, a small amount of adhesive 1429 may be added to the proximal end 1425 of the guide 1427 to bond the guide 1427 to the cable tie portion 1421. The adhesive 1429 can provide a constraint such that when the guide 1427 is stretched and held by the adhesive bond, the diameter of the guide 1427 decreases or necks and clamps onto the cable tie portion 1421. Thus, the adhesive 1429 can act in conjunction with a tightening action to create a strong joint between the guide 1427 and the cable tie portion 1421 with increasing strength as tension increases. The joint can be further strengthened by adding an adhesive layer that substantially covers the entire transition section 1423, where the guide 1427 overlaps and grips the cable tie portion 1421.
[0113] Additionally or alternatively, heat-shrinkable fittings can be placed on top of the cable ties and guides to further reinforce the joint, such that when heated, the heat-shrinkable element presses down onto the transition section and holds the guide on the cable tie within the transition section. In other examples, the guide can be simply bonded to the cable tie, and the cable tie can be narrowed in the transition section so as not to increase thickness. Similarly, if the guide is a strip of material rather than a tubular structure, it can be bonded to one side of the cable tie, heat-fused, thermally bonded, and / or ultrasonically welded to the cable tie. Other methods of attaching the guide to the cable tie may also be suitable.
[0114] Any combination of methods disclosed herein or known to those skilled in the art for joining two elongated members may be employed. In some examples, a crimping member may be placed around both the guide and the cable tie, such that the crimping member can deform to hold the two parts together. Furthermore, in some examples, a mesh may be threaded through or woven around the cable tie, or the guide may be bent into a loop and tied to the cable tie.
[0115] As yet another example, the guide can be an off-the-shelf suture, attached to one end of the cable tie via features such as holes, notches, shoulders, or other features for receiving the suture. Similarly, the guide can be a metal wire or a two-dimensional strip with low bending stiffness, allowing the guide to be manipulated within a relatively compact space within the body. The wire or strip can be overmolded with the cable tie, or otherwise attached to the cable tie using the methods described herein or other methods known to those skilled in the art.
[0116] As described above and in Figure 14B As shown, in some examples, when the tubular guide is restricted from translating away from one end of the cable tie, the guide tends to collapse radially when pulled, much like a snare toy, thus gripping the cable tie tightly and therefore increasing the strength of the joint when pulled. Although Figure 14B The example in the image uses adhesive to constrain (or secure) one end of the guide, but Figures 15A to 15D This demonstrates another means of securing the guide by wrapping around a hole in the cable tie. Figure 15A The device 1555 shown has a hole 1558 passing through a portion near the distal end of the cable tie portion 1553, located on or near the transition section 1552, where the cable tie portion 1553 has a reduced size. A portion of the proximal end 1559 of the guide 1557 can pass through and through the hole 1558, as shown. Figure 15B and Figure 15C As shown, it is then inserted into and passes through the inner cavity of guide 1557, such that proximal end 1559 is located inside guide 1557. Excess length of proximal end 1559 of guide can be pulled out and cut off from the side of guide 1557. Figure 15D The final configuration is shown: after the guide 1557 is tightened away from the hole 1558, the guide 1557 is pressed downward against the cable tie portion 1553 in the transition section 1552, thereby creating a smooth tapered section with a dimensional and stiffness gradient from the stiffer cable tie portion 1553 toward the guide 1557, the guide 1557 may have negligible and / or low bending stiffness.
[0117] In other examples, the guide can be made as a continuous component with the cable tie; that is, the guide, cable tie, or even the locking mechanism can be molded as a single component, allowing the guide to have a shape that provides lower bending stiffness than the cable tie. For example, the device can be extruded or molded to have a variable cross-section, such that the cross-sectional shape of the cable tie differs from that of the guide. Alternatively, the guide can be attached to the cable tie after both parts have been made; suitable joining techniques include, but are not limited to, bonding, ultrasonic welding, thermoforming (thermal bonding), or, in the case of metals, welding or crimping. In some examples, the guide can be a mesh or fabric overlaid with a soft plastic or elastomer (or otherwise combined). Overlaid molding sections can remain flexible and can provide additional surface areas to distribute the load over the tissue, which can be used to mitigate the "cheese-cutting" effect of sutures. Continuously integrated guides provide the tensile strength necessary to maintain the closure of tissue defects.
[0118] The ligature or its sub-components may have one or more colors and / or patterns that contrast with the tissue in the body cavity as seen through a laparoscopic camera, or use colors typically not visible in the human body, allowing the surgeon to easily identify the device in the tissue or within the body cavity. For example, the device may be yellow, blue, green, or orange, or a bright or fluorescent hue of each. Furthermore, the guide or loop (or other protrusion) may be colored differently from the ligature, making the guide easily identifiable within the body, as the surgeon may initially need to see the guide to manipulate the device. In one example, a permanently implantable ligature may be the color of a natural molded plastic, i.e., with little or no coloring dye to enhance long-term biocompatibility; for example, for ligatures including PEEK, such plastic may be white, or slightly translucent, or off-white to yellow. The guide may be blue or orange, contrasting with both the ligature and the tissue in the body.
[0119] In some examples, it may be desirable to visualize a device or parts thereof, such as guides, rings, locks, or cable ties, inside the body using X-rays (or fluorescence fluoroscopy). One or more of these segments may be made of radiopaque materials, such as metals (e.g., stainless steel or nitinol), or plastics having radiopaque masterbatches or blends of radiopaque materials, such as barium sulfate, bismuth compounds, or metals (e.g., tungsten or steel). Those skilled in the art will recognize that many compounds and formulations exist that produce radiopaque polymers.
[0120] There may be a preferred orientation for self-locking ligatures. For example, it may be desirable to position the ligature with its teeth against the muscle to be ligated, such that the smooth side of the ligature faces the abdominal cavity. This orientation provides a smooth interface to the sensitive external intestinal tissue while providing a serrated surface against the rectus abdominis muscle and its sheath, which can help hold the ligature in place. Due to issues with image resolution, contrast, and glare, surgeons may have difficulty visually observing the orientation of surgical ligatures laparoscopically. Therefore, visible identifiers on one side of the ligature can help surgeons identify each side of the ligature. Identifiers may include molded or colored writing or colored stripes on one side of the ligature.
[0121] In some examples, the loop may have or define an overlapping section, where the guide is attached to itself proximal to the loop or adjacent to the proximal end of the loop. Due to the doubling of material and any added adhesive or crimping elements, the overlapping section can have slightly higher stiffness than the rest of the guide; this gives the loop greater resistance to deformation while it remains in the body. That is, the increased stiffness provides resistance to prevent the loop from slipping away when it is contacted by a tool, such as a suture gripper or snare. This facilitates easier gripping because the loop is less likely to detach from the tool when it engages with it. Those skilled in the art will appreciate that there are many features that enable gripping, such as one or more protrusions like a ball, or notches, serrated tips, or "J"-shaped tips, which can be located at or near the distal tip of the guide. Such examples provide features that allow for easy gripping while still being small enough to pass through small skin incisions or small openings in tissue.
[0122] Including the cable ties of the slope
[0123] Figure 16A This is a side view of the self-locking cable tie 1600, showing the location of the wedge 1623 (also referred to herein as a ramp) immediately adjacent to the locking head 1616. The self-locking cable tie 1600 can be used for surgical procedures in robotic surgery. The wedge 1623 slopes downwards from the level of the locking head 1616 onto the surface of the cable tie portion 1621. A guide 1617 can be attached to the distal end of the cable tie portion 1621. A needle 1622 can be attached to the distal end of the guide 1617. The needle 1622 can be a curved needle. Figure 16B The bottom view of the self-locking cable tie 1600 shows the teeth 1624 exposed on the underside of the cable tie portion 1621.
[0124] Figures 17A to 17C An enlarged view of the wedge 1623 is shown, indicating the location of the slot 1725 extending along the entire length of the lower surface of the wedge 1623. Figure 17A A top view of wedge 1623 is shown. Figure 17B An end view of wedge 1623 is shown. Figure 17CA side view of wedge 1623 is shown. Wedge 1626 may include slot 1725. The slot 1725 may be sized to interfere with the cable tie portion 1621. Figure 17D The distal end of the cable tie portion 1621 is shown to be able to be inserted into the slot 1725 of the wedge 1623. Figure 17E This is a side view of the cable tie portion 1621, where the wedge block 1623 is located immediately adjacent to the cable tie lock head 1616 on the far side. Figure 17F A bottom view of the cable tie portion 1621 is shown, with the wedge 1723 in place.
[0125] In some instances, the wedge or ramp can be bioresorbable. In examples where a self-locking zip tie rotates to move the locking head away from the body cavity, the bioresorption of the wedge or ramp can allow the locking head to act as a tissue anchor, thereby preventing further rotation of the self-locking ramp.
[0126] Device for inserting self-locking straps into body cavities
[0127] Now refer to Figure 18This document describes a device 1800 for delivering self-locking cable ties according to the present disclosure. The device 1800 may include a sheath 1802 and a push tube 1804. The sheath 1802 may be sized to surround a needle 1808. The needle 1808 may be a bent needle. The device 1800 may be inserted into a robotic cannula, cannula, or cannula sleeve (referred to herein as a “port”). To protect the needle 1808 from friction during movement through the port, the needle 1808 may be placed within the sheath 1802. A cable tie portion may be positioned within a cavity of the push tube 1804. The sheath 1802 may include a dangling portion 1812 located at the distal end of the push tube 1804. The needle 1808 may be fitted within the dangling portion 1812. The entire assembly shown (such as needle 1808, guide 1810, sheath 1802, ligature portion 1806, and push tube 1804) can be inserted into a laparoscopic access port or cannula. The port or cannula can have a diameter of 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, or 35 mm, or a value within the range defined by any two of the preceding values; however, in some cases, other values may also be suitable. In some examples, the port may have a size or diameter conventionally used for accessing the intra-abdominal space. Once in the intra-abdominal space, the needle 1808 can be pushed out of the pendant portion 1812 and into the body cavity using the push tube 1804. Once in the body cavity, the needle 1808 can be grasped and manipulated, for example, by a robotic surgical arm. The guide 1810 and the ligature portion 1806 can be pulled into the body cavity by pulling any part of the needle and / or the guide 1810 extending from the device 1800 into the body cavity.
[0128] In some examples, the needle 1808 may be made of a material with superelastic properties, allowing it to deform elastically and return to its original shape (or near its original shape) after being removed from the sheath 1802. The sheath 1802 and the push tube 1804 may be made of metal or polymer; for example, the sheath 1802 may comprise a thin-walled PTFE tube.
[0129] Tensioners and cutters for cutting self-locking cable ties
[0130] After a self-locking ligature is installed and tightened, such as around an abdominal wall hernia defect, excess length of the ligature must be removed. Conventional laparoscopic and robotic cutting tools may not be effective at cutting the ligature. For example, an RF cutter will have no effect on plastic ligatures because they are non-conductive, and a scissor-type cutter may not be strong enough to cut the ligature because it may be metal or made of a tough plastic material. Furthermore, it is preferable to maintain tension on the ligature during cutting to make cutting easier and ensure that the cutting tip of the ligature is flush with or even recessed into the lock head so as not to protrude into the tissue. This tension can be achieved mechanically and / or physically by the surgeon applying a proximal force to the ligature.
[0131] In some laparoscopic methods, excess ligatures can be tightened and cut by passing them through the lumen of a tensioner and cutter, causing the tensioner and cutter to abut against a locking mechanism, thus providing a reaction force against the locking mechanism, while the ligature is pulled through the tensioner and cutter to provide tension. Once the excess ligature is under tension, a cutting device at the distal end of the tensioner and cutter can cut the ligature either by a cam-driven blade or by a blade that cuts the ligature while rotating. In such methods, the surgeon can pull the excess ligature, for example using a grasper, and pass it through the lumen of the tensioner and cutter while twisting the tensioner and cutter to cut the excess ligature.
[0132] In robotic surgery, the entire ligature can be placed inside the body cavity and manipulated by surgical robotic tools (e.g., a robotic gripper). Self-locking ligatures can be uncut, resulting in a relatively long excess length that makes placing the ligature into the lumen of the tensioner and cutter impractical or impossible.
[0133] Figures 19A to 19C An example of a tensioner and cutter 1902 that can engage with a cable tie from within a body cavity is shown. The tensioner and cutter 1902 may include a slotted opening 1904 that allows the self-locking cable tie to be placed laterally into the tensioner and cutter 1902, such that one end of the tensioner and cutter 1902 can slide downward along the self-locking cable tie to engage with the locking head of the self-locking cable tie. Figure 19C As shown, the tensioner and cutter 1902 may include one or more blades 1906 at its distal end, which may strike the cable ties as the tensioner and cutter 1902 rotates relative to the self-locking cable tie, thereby cutting the cable tie at the lock head. The blades 1906 may be attached by welding, bonding, or molding (e.g., insert molding) for plastic devices. In some examples, the tensioner and cutter 1902 may additionally include a slot that allows needles, guides, and / or cable tie portions to protrude from 1902 and be gripped by a gripper (e.g., a laparoscopic gripper).
[0134] The slot does not have to span the entire length of the tensioner and cutter. Figures 20A to 20C An example of a tensioner and cutter 2002 with an open side 2010 is shown, wherein the slot 2004 is located only at the distal end of the cutter 2002. The tensioner and cutter 2002 (in...) Figure 20A (As shown in the image) This allows surgeons to place ties into the tensioner and cutter 2002 using a robotic gripper. Figure 20B An end view of a tensioner and cutter 2002 with blade 2006 is shown, the blade 2006 being at the distal end and configured to cut self-locking cable ties upon rotation. Figure 20C The same view of the tensioner and cutter 2002 is shown, wherein the cable tie portion 2008 is located inside the tensioner and cutter 2002 and adjacent to the blade 2006. The slot 2004 in the tensioner and cutter 2002 can be sized such that the slot 2004 tends to hold the self-locking cable tie without requiring excessive force to insert the cable tie into the tensioner and cutter; that is, the slot 2004 can have a slight interference fit, or a line-to-line fit, relative to the thickness of the cable tie, or be slightly oversized relative to the cable tie to allow the cable tie to be aligned to a certain extent for entry and exit from the slot.
[0135] In such an example, there is an integrated cutting blade, with Figures 19A to 19C and Figures 20A to 20C The tensioner shown is similar to a tensioner (without a cutting blade) that can be used to secure and twist cable ties while stretching them to cleanly cut them near the lock.
[0136] In other examples, surgical scissors, particularly hook scissors (which may be referred to herein as ligature cutters), may be suitably used to cut ligature portions or guides. In some examples, laparoscopic hook scissors may be suitably used to cut ligature portions or guides. Advantageously, the hook scissors can prevent or inhibit the slippage of the ligature portion or guide during cutting. It should be understood that other devices for cutting ligatures (and / or guides) may be suitably implemented. For example, RF or ultrasonic cutters may be used to cut ligatures and / or guides.
[0137] Methods for repairing tissue defects
[0138] Figures 21A to 21G The steps for repairing tissue defects from the perspective of the abdominal cavity are shown. Figure 21A The image shows a laparoscopic view of the abdominal wall defect 2127 and the soft tissue margin 2128 surrounding the defect 2127 when the robotic needle holder 2126 inserts the curved needle 1622 onto one side of the defect 2127. A ligature 1600 is first introduced into the abdominal cavity, as per [reference to...]. Figure 3The self-locking cable tie 300 is depicted in the image. At this time, the guide 1617 and the cable tie portion 1621 are located within the abdominal cavity. Figure 21B The image shows a curved needle 1622 performing suturing in tissue 2128 on the opposite surface of the defect 2127. Figure 21C This shows the position where the ties 1621 has been pulled into the tissue 2128 from both sides of the tissue defect 2127. Figure 21D A bent pin 1622 is shown inserted through a lock head 1616. The bent pin 1622 and guide 1617 are pulled through an opening in the lock head 1616 until the toothed portion of the cable tie portion 1621 engages with the lock head 1616. In an alternative example, the guide may be cut before the distal end of the cable tie portion 1621 is inserted through the lock head 1616. Figure 21E The tension applied to the cable tie portion 1621 is shown to cause the self-locking cable tie to at least partially close the edge of the defect 2127. As discussed herein, once the cable tie 1600 is fully tightened, the portion of the cable tie portion 1621 that is overhanging the lock head 1616 and the guide 1617 can be cut from the cable tie 1600.
[0139] Multiple cable ties 1600 can be inserted along the defect 2127, and the cable ties 1600 can be tensioned continuously and / or progressively to allow complete closure of the defect 2127. Using multiple spaced-apart cable ties can distribute the force applied by the cable ties 1600 across or along the defect 2127 and associated tissue 2128, reducing the likelihood of the cable ties 1600 damaging the joined tissue 2128. Furthermore, the incremental and / or continuous tensioning of the cable ties 1600 allows the joined tissue 2128 to relax and / or adapt to the new tension position or force provided by the cable ties 1600. The relaxation period can prevent, mitigate, inhibit, or improve tissue damage or tearing. When a continuous tensioning process of multiple cable ties 1600 is performed over a period of time (e.g., 10-15 minutes), the relaxation period allows the stress in the surrounding soft tissue 2128 to gradually decrease, thereby preventing cracking or tearing of the tissue 2128 by the cable tie portion 1621. Figure 21F The final complete closure of the abdominal wall defect 2127 is shown after multiple self-locking ligatures 1600 are tightened in succession. Figure 21G Multiple locking heads 1616 are shown remaining exposed in the abdominal cavity. A robotic needle holder 2126 can be used to rotate each ligature 1600 approximately 180 degrees in the direction of the locking heads 1616 to position each locking head 1616 in front of the abdominal wall (e.g., away from the abdominal cavity). Figure 21H A wedge 1623 is shown, which facilitates access to an opening 2129 in the soft tissue so that the cuboid lock head 1616 can be rotated into the soft tissue 2128 with reduced force.
[0140] Figure 22The illustration depicts a method 2200 for surgical steps used in abdominal wall defect closure using self-locking ligatures. The steps of method 2200 can be performed using a robotic system. The steps include the progressive, sequential tensioning of multiple ligatures to mitigate excessive tissue tension during the closure of large defects, and the rotation of the ligatures to remove the locking mechanism from the abdominal cavity, thereby avoiding postoperative damage to the intestines and intra-abdominal organs and blood vessels. While method 2200 is discussed with reference to transperitoneal repair of abdominal wall defects, it should be understood that this disclosure provides for repairing other tissue defects through other body cavities via an inside-out approach.
[0141] In step 2201, a self-locking ligature is inserted into the abdominal cavity. For example, the insertion device according to this disclosure can be used to perform the insertion of the self-locking ligature into the abdomen.
[0142] In step 2202, the needle of the self-locking ligature is inserted through tissue on both sides of the abdominal wall defect. Step 2202 can be performed using a robotic needle holder. The needle can be curved.
[0143] In step 2204, the needle and guide are pulled to center the self-locking ligature across the abdominal wall defect.
[0144] In step 2206, the needle may be inserted through the lock head of the cable tie, or if the needle has been cut off, the guide may be inserted into the lock head, or if the guide has been cut off, the cable tie may be inserted into the lock head.
[0145] In step 2208, the cable tie is pulled through the lock head to activate the cable tie lock. In some examples, the guide may be cut before step 2208.
[0146] At step 2210, additional self-locking cable ties are placed along the length of the defect according to steps 2201 to 2208.
[0147] In step 2212, each band is tightened sequentially and / or progressively to close the defect. Each band may be tightened sequentially and / or progressively such that the force exerted by any single band on the tissue surrounding the defect is not excessive compared to the other bands. In some examples, the bands may be tightened from the first end of the defect to the second end (e.g., in a linear sequence, first tightening the first band adjacent to the first end of the defect, then tightening the next band adjacent to the first band, until the last band adjacent to the second end of the defect is tightened). In some examples, the bands may be tightened from the middle of the defect toward the first and second ends of the defect (e.g., in a middle-outward sequence, first tightening the first band adjacent to the middle of the defect, then tightening the next band adjacent to the first band, until the last band adjacent to the first and second ends of the defect is tightened). In some examples, the cable ties can be tightened from the first end and the second end toward the middle (e.g., in an outside-in order, first tighten the first cable tie adjacent to the first end and the second end of the defect, then tighten the next cable tie adjacent to the first cable tie, until the last cable tie adjacent to the middle of the defect is tightened).
[0148] In step 2214, excess cable ties are cut at the exit of each of the lock heads. Cutting excess cable ties can advantageously reduce the profile of the cable ties extending into the patient's body cavity.
[0149] In step 2216, each cable tie may optionally be rotated to orient each lock head forward. Rotation of each cable tie can be performed by gripping each cable tie with a robotic needle holder.
[0150] Figure 23 An exemplary final position of the self-locking ligature 1616 in the anterior abdominal wall is shown after the ligature 1600 is rotated to move the locking head 1616 away from the abdominal cavity 114. The self-locking ligature 1600 may traverse the peritoneum 113.
[0151] Various examples disclosed herein provide a self-locking ligature for closing tissue defects such as abdominal wall hernias. The examples disclosed herein are not limited to application in closing abdominal wall hernia defects, but can be applied to fixation and / or juxtaposition of soft tissue or bone defects or other tissue and / or bone defects.
[0152] In some examples, as discussed, the surgical procedure can be performed with the assistance of a robotic system. In other examples, also as discussed, the surgical procedure can be performed manually, i.e., a manual laparoscopic surgical procedure performed inside the abdomen.
[0153] In some examples, the surgical procedure can be performed using self-locking zip ties that include the aforementioned wedges or ramps.
[0154] In other examples, the surgical procedure can be performed using self-locking zip ties that do not include wedges or ramps.
[0155] In some cases, the surgical procedure results in the lockhead being located inside the abdomen after the self-locking ligature (or multiple ligatures) has been tightened. The tightened ligatures are translated to rotate or translate the lockhead away from or out of the abdominal cavity, moving the lockhead to an anterior position. As mentioned above, this translation can be facilitated or alleviated by wedges or ramps, but may also include ligatures without wedges or ramps.
[0156] In some examples, the wedge or ramp can be bioabsorbable or biodegradable, such that the wedge or ramp is absorbed or degraded after the lock with the wedge or ramp is repositioned to the forward position.
[0157] In some examples, the wedge or ramp may not be bioabsorbable or biodegradable, such that the wedge or ramp is neither absorbed nor degraded after the lock with the wedge or ramp is repositioned to the forward position.
[0158] In some examples, a repositioned lock head, positioned at the front, provides an anchor for the cable tie, ensuring that the tightened cable tie does not move or translate in either direction over time. In examples that include wedges or ramps, the absorption or degradation of the wedges or ramps allows the lock head to perform a bidirectional anchoring function.
[0159] Various aspects and / or examples of this disclosure may be combined with various aspects and / or examples of PCT / US2021 / 015033 and / or PCT / US2020 / 053148.
[0160] Example
[0161] Example surgical method
[0162] To illustrate some characteristics of self-locking ligatures in the context of surgical procedures, Figures 24A to 24MAn example of the device is illustrated in the context of abdominal wall hernia surgery. The method can be performed via manual laparoscopic surgery, robotic surgery, or a combination of both. During some of these methods, no portion of the self-locking ligature is percutaneously positioned when manipulating the tissue defect. The examples disclosed herein can be used in other surgical procedures requiring tissue apposition, such as apposition of muscles, fascia, skin, bone, and combinations thereof. The overall port or cannula used in such example methods can have a diameter of 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, or 35 mm, or a value within the range defined by any two of the preceding values, although other values may be suitable in some cases. In particular, cannulas with a diameter of 8 mm or greater can be adapted for use with a robotic gripper.
[0163] Figure 24A A self-locking zip tie 2402 is shown in preparation for robotic laparoscopic abdominal wall closure. The self-locking zip tie 2402 may include a bent needle attached to a guide, which in turn is attached to the distal end of the zip tie portion. The zip tie is shown being gripped by a gripper 2404 for insertion into the laparoscopic port. Although the gripper 2404 is a manual gripper, it should be understood that this method can be performed alternatively using a robotic gripper.
[0164] Figure 24B A self-locking ligature 2402 inside the abdominal cavity is shown as depicted on a monitor, accompanied by live video from a laparoscopic camera after the self-locking ligature 2402 has been inserted through the laparoscopic port. Figure 24B In the middle, the self-locking cable tie 2402 is held by the gripper 2404.
[0165] Figure 24C A first robotic gripper 2410 is shown piercing a self-locking ligature 2402 through a first hole in the posterior rectus sheath 2414 on the first side of the defect 2408. A second robotic gripper 2412 holds the tissue around the defect 2408.
[0166] Figure 24D A robotic gripper 2410 is shown placing a needle into the middle portion of defect 2408, indicating a "double bite" surgical procedure. In other examples, and depending on the needle curvature, a single suture can be performed to reduce the risk of abdominal wall hernia.
[0167] Figure 24E The image shows a robotic gripper pulling needle 2406 out of a hole on the opposite side of defect 2408. A second robotic gripper 2412 helps stabilize needle 2406 as it leaves the tissue.
[0168] Figure 24F The diagram shows a first robotic gripper 2410 pulling the guide 2416 out of the opposite hole in the rectus abdominis sheath 2414 after the needle has been withdrawn from the hole. The ligature portion 2418 is located in the abdominal cavity.
[0169] Figure 24G The diagram shows the cable tie portion 2418 being pulled across the front of the defect 2408; that is, the cable tie portion 2418 is shown being pulled out from the opposite hole in the posterior sheath 2414 of the rectus abdominis muscle as the cable tie portion 2418 passes through the first hole. The cable tie portion 2418 may be pre-bent along its length to indicate the correct orientation for wrapping around the defect. In some examples, the cable tie portion 2418 may be stored in the package in a curved or rounded shape, which tends to shape the polymer material 2418 of the cable tie portion into a curved shape.
[0170] Figure 24H The diagram shows the robotic gripper 2410 placing the distal end of the cable tie 2418 through the lock head 2420 when the cable tie portion 2418 has been almost completely pulled through the defect 2408.
[0171] Figure 24I A substantially tightened cable ties 2402 is shown, spaced apart from the cable tie portion 2418 surrounding the defect, and engaging with a lock head 2420 when tightened by a pair of grippers 2410 and 2412. Additionally, markings 2422 (e.g., black stripes) indicating the orientation of the band are shown on the cable tie. A pair of markings may be located on the cable tie portion 2418 and the lock head 2420 to indicate to the surgeon the correct orientation for inserting the cable tie portion 2418 into the lock head. For example, as shown, markings may be placed on the lock head 2420 to indicate to the surgeon that the markings on the cable tie should align with the markings on the lock head to ensure proper alignment. In some examples, and as... Figure 24I As shown, the teeth of the zip tie portion 2418 are located on the side of the rectus abdominis muscle, such that the smooth side of the zip tie faces the abdominal cavity. As discussed herein, other markings or geometric features may be included on the zip tie and lockhead to ensure proper orientation.
[0172] Figure 24J A robotic cutting tool 2424 is shown for cutting off excess length of cable ties that extend beyond the lock head 2420. As shown above, in other examples, a tensioner and a cutter may be used, or the lock head 2420 may have an integrated cutting blade.
[0173] While the preceding diagrams illustrate the application of a single self-locking ligature, abdominal wall hernia repair can involve multiple ligatures to progressively reduce the defect. Multiple ligatures can be tightened sequentially along the defect in a manner similar to the single ligature described above. In the example, where...
[0174] In some examples, instead of using a robotic cutter, such as Figure 24J As shown, a hybrid approach can be adopted, where an additional laparoscopic access port (or hole) is used to introduce the tensioner / cutter, allowing them to operate in conjunction with the surgical robot. For example, Figure 24K A tensioner and cutter 2426 are shown, positioned substantially laterally into the abdominal cavity via a laparoscopic port 2428. The tensioner and cutter 2426 allow the surgeon to pull the guide and / or ligature portion to tension the self-locking ligature. As shown, a portion of the guide and ligature portion can be percutaneously positioned to allow the surgeon to grasp the guide and / or ligature portion. Figure 24L The diagram shows a first tensioner and cutter 2426 inserted into the abdominal cavity between two robotic surgical ports 2430. A ligature (and guide) can be positioned within the tensioner and cutter 2426 from within the body, particularly when using a slotted tensioner and cutter, allowing the ligature to enter laterally as described above. In some examples, the self-locking ligature can be delivered into the abdominal cavity using both robotic surgical ports 2430.
[0175] Figure 24M The tensioner and cutter 2426 is shown in its proper position above and adjacent to the lock head 2402 of the self-locking cable ties 2402. The tensioner and cutter 2426 can be positioned over an excessive length of the cable tie portion of the self-locking cable ties 2402 by manipulating the tensioner and cutter 2426 from outside the body and manipulating the cable tie from inside the body using a gripper (e.g., robotic gripper 2410 and / or 2412). The tensioner and cutter 2426 may have surgeon-visible markings or other features on its outer surface to indicate correct orientation relative to alignment features on the cable ties 2402 and / or lock head 2420. Once the tensioner and cutter 2426 is in place, as shown by the cable tie portion passing through its lumen, the cable tie can be tightened from outside the body while the tensioner and cutter rotate, thereby cutting the cable tie. Tension helps to cut the cable tie more cleanly, requiring a lower angle of twist before breakage compared to twisting without tension.
[0176] In some examples, the surgical procedure results in the lock head being located inside the abdomen after the self-locking ligature (or multiple ligatures) has been tightened. In other examples, the tightened ligature can be rotated or translated, causing the lock head to move away from or out of the abdominal cavity. In some examples, the hole-tightened ligature can be rotated or translated to move the lock head to an anterior position. This translation or rotation can be facilitated by a surgical gripper or by manipulating the ligature with a tensioner and cutter before it is cut.
Claims
1. A method for closing an abdominal wall hernia defect, the method comprising: Position the first self-locking ligature inside the patient's abdominal cavity adjacent to the abdominal wall hernia defect; Approach the first side of the defect with the proximal end of the first self-locking cable tie, wherein the first self-locking cable tie includes a lock head positioned on or near the distal end of the first self-locking cable tie; The proximal end of the first self-locking ligature passes through the first side of the defect from a first posterior position adjacent to the abdominal wall hernia defect, and reaches a first anterior position adjacent to the abdominal wall hernia defect. The proximal end of the first self-locking ligature passes through the second side of the defect from a second anterior position adjacent to the abdominal wall hernia defect, and reaches a second posterior position adjacent to the abdominal wall hernia defect. The proximal end of the first self-locking cable tie is translated through the lock head; and Tighten the first self-locking cable tie to at least partially close the defect.
2. The method according to claim 1, wherein, A robotic system is used to perform the approach, crossing, and translation steps.
3. The method of claim 2, comprising inserting one or more end effectors of the robotic system into the abdominal cavity via one or more cannulas.
4. The method according to claim 3, wherein, One or more end effectors of the robot system include one or both of a gripper and a needle holder.
5. The method according to claim 3 or 4, wherein, The one or more cannulas include at least one cannulas with a diameter of 8 mm or greater.
6. The method according to any one of claims 1 to 5, comprising cutting at least a portion of the proximal end of the first self-locking cable tie.
7. The method according to claim 6, wherein, The cutting of the proximal portion is performed using a blade positioned within the locking head of the first self-locking cable tie.
8. The method according to claim 6, wherein, The proximal portion is cut using the blade of a laparoscopic device.
9. The method according to claim 8, wherein, The laparoscopic device includes a laparoscopic cutter.
10. The method according to claim 9, wherein, The laparoscopic device includes hook scissors.
11. The method according to any one of claims 1 to 10, wherein, The first self-locking cable tie includes a needle and a guide, the guide connecting the needle to the proximal end of the first self-locking cable tie, and wherein the method further includes: The needle is inserted into the first side of the abdominal wall hernia defect; and The needle is inserted into the second side of the abdominal wall hernia defect.
12. The method of claim 11, further comprising cutting the guide.
13. The method according to claim 12, wherein, The step of cutting the guide is performed using a laparoscopic cutter.
14. The method according to any one of claims 11 to 13, wherein, The needle is a curved needle.
15. The method according to any one of claims 11 to 14, wherein, The overlap between the guide and the zip tie includes a transition section configured to reduce kinking of the self-locking zip tie, and wherein the method includes pulling the transition section through a first side of the abdominal wall hernia defect and pulling the transition section through a second side of the abdominal wall hernia defect, wherein the transition section causes dilation of a hole in the tissue surrounding the abdominal wall hernia defect.
16. The method according to any one of claims 1 to 15, wherein, The abdominal wall hernia defect is located within the rectus abdominis muscle or the linea alba.
17. The method according to any one of claims 1 to 16, wherein, During the steps of passing through and translating the first self-locking cable tie, no part of the first self-locking cable tie is percutaneously positioned.
18. The method according to any one of claims 1 to 16, wherein, During the tightening step, the self-locking cable ties are percutaneously positioned.
19. The method according to any one of claims 1 to 17, further comprising rotating a tightened first self-locking ligature around the abdominal wall hernia defect such that the locking head is repositioned outside the abdominal cavity.
20. The method according to any one of claims 1 to 19, comprising passing the self-locking ligature through the posterior sheath of the rectus abdominis muscle.
21. The method according to any one of claims 1 to 20, comprising passing the self-locking ligature through the anterior rectus abdominis sheath.
22. The method according to any one of claims 1 to 21, further comprising: Multiple self-locking ligatures are positioned within the abdominal cavity adjacent to the abdominal wall hernia defect; Approach the first side of the abdominal wall hernia defect with the proximal end of each of the plurality of self-locking ligatures; The proximal end of each of the plurality of self-locking ligatures is passed from a posterior position in the tissue adjacent to the abdominal wall hernia defect through a first side of the abdominal wall hernia defect to an anterior position in the tissue adjacent to the abdominal wall hernia defect, wherein each self-locking ligature is spaced apart from adjacent self-locking ligatures. The proximal end of each of the plurality of self-locking ligatures is passed from an anterior position in the tissue near the abdominal wall hernia defect through the second side of the abdominal wall hernia defect to a posterior position in the tissue near the abdominal wall hernia defect. Translate the proximal end of each of the self-locking cable ties through the lock head; and Tighten each of the self-locking ligatures to at least partially close the abdominal wall hernia defect.
23. The method of claim 22, further comprising translating each of the tightened self-locking bands around the abdominal wall hernia defect such that each lock of each of the plurality of self-locking bands is no longer positioned within the abdominal cavity.
24. The method of claim 22 or 23, comprising individually tightening each of the plurality of self-locking cable ties at least partially.
25. The method according to any one of claims 22 to 24, comprising sequentially tightening each of the plurality of self-locking cable ties at least partially, the sequence comprising at least partially tightening the first self-locking cable tie, and then at least partially tightening each of the remaining self-locking cable ties of the plurality of self-locking cable ties.
26. The method according to any one of claims 22-25, comprising sequentially tightening each of the plurality of self-locking cable ties at least partially.
27. The method according to claim 26, wherein, The sequence includes: at least partially tightening the first self-locking cable tie; and at least partially tightening the self-locking cable ties adjacent to the first self-locking cable tie.
28. The method according to claim 26, wherein, The sequence includes tightening each of the plurality of cable ties at least partially in a straight line from the first end of the defect to the second end of the defect.
29. The method according to claim 26, wherein, The sequence includes at least partially tightening each of the plurality of ligatures from the middle of the abdominal wall hernia defect to the end of the abdominal wall hernia defect in a middle-outward sequence.
30. The method according to claim 26, wherein, The sequence includes at least partially tightening each of the plurality of ligatures from the end of the abdominal wall hernia defect to the middle of the abdominal wall hernia defect in an outward-to-inward order.
31. The method according to any one of claims 22 to 30, comprising performing a tightening more than once on each cable tie, wherein, Each cable tie is tightened gradually.
32. The method of one or more of claims 31, further comprising setting a relaxation time period between the first tightening on each cable tie and the second tightening on each cable tie.
33. The method according to any one of claims 22 to 32, wherein, The plurality of self-locking ligatures are configured to distribute the tightening force generated during tightening of the plurality of self-locking ligatures substantially along the length of the abdominal wall hernia defect.
34. The method according to any one of claims 22 to 33, wherein, The plurality of self-locking cable ties are configured to prevent, mitigate, inhibit, or improve damage to the tissue engaged by each of the plurality of self-locking cable ties during the tightening of each cable ties.
35. The method according to any one of claims 1 to 34, wherein, The first self-locking cable tie has a low-profile locking head, and wherein the cable tie portion includes an inclined portion extending from the cable tie portion to the low-profile locking head, wherein the inclined portion engages with the muscle tissue surrounding the abdominal wall hernia defect.
36. The method according to any one of claims 1 to 34, wherein, The first self-locking ligature includes a ramp or wedge adjacent to the proximal side of the lock head, wherein the ramp or wedge includes an inclined portion that engages with the muscle tissue surrounding the abdominal wall hernia defect.
37. A method for closing soft tissue defects, comprising: A first self-locking ligature is fully positioned within the patient's body cavity adjacent to the soft tissue defect. The self-locking ligature includes: a guide, a ligature portion, and a locking head positioned on the ligature portion, the locking head being configured to tighten onto the ligature portion; and The first self-locking ligature is tightened around the soft tissue defect, wherein the tightening causes the two sides of the soft tissue defect to come into contact.
38. The method according to claim 37, wherein, The tightening step is performed using a robotic system.
39. The method of claim 38, further comprising inserting one or more end effectors of the robotic system into the body cavity via one or more cannulas.
40. The method according to any one of claims 37 to 39, comprising cutting at least a portion of the self-locking ligature using a laparoscopic device.
41. The method according to claim 40, wherein, The laparoscopic device includes surgical scissors.
42. The method according to claim 41, wherein, The laparoscopic device includes hook scissors.
43. The method according to any one of claims 37 to 42, wherein, The overlap between the guide and the zip tie includes a transition section configured to reduce kinking of the self-locking zip tie, and wherein the method includes pulling the transition section through a first side of the abdominal wall hernia defect and pulling the transition section through a second side of the abdominal wall hernia defect, wherein the transition section causes dilation of a hole in the tissue surrounding the abdominal wall hernia defect.
44. The method according to any one of claims 37 to 43, further comprising rotating a tightened first self-locking ligature around the soft tissue defect such that the locking head is repositioned outside the body cavity.
45. A kit for closing soft tissue defects, the kit comprising: A plurality of self-locking cable ties, each of which includes: Guide component, Cable ties, and A locking head, the locking head being positioned on the cable tie portion, the locking head being configured to tighten to the cable tie portion; A cable ties insertion device configured to insert at least one of the plurality of self-locking cable ties into a patient's body cavity; and Laparoscopic cutter.
46. The kit according to claim 45, wherein, The laparoscopic cutter includes surgical scissors.
47. The kit of claim 46, wherein, The laparoscopic device includes hook scissors.
48. The kit according to any one of claims 45 to 47, wherein, The first self-locking zip tie has a low-profile zip tie, and the zip tie portion includes an inclined portion extending from the zip tie portion to the low-profile zip tie, wherein the inclined portion is configured to engage the muscle tissue surrounding the abdominal wall hernia defect.
49. The kit according to any one of claims 45 to 47, wherein, The first self-locking zip tie includes a ramp or wedge proximal to the lock head, wherein the ramp or wedge includes an inclined portion configured to engage with tissue adjacent to the soft tissue defect.
50. The kit according to any one of claims 45 to 49, wherein, The width of the cable tie portion is between 2 mm and 14 mm.
51. The kit according to any one of claims 45 to 50, wherein, The overlap between the guide and the cable tie portion includes a transition section configured to reduce kinking of the self-locking cable tie, and wherein the transition section is configured to cause dilation of pores in the tissue surrounding the soft tissue defect.