Systems, apparatus, and methods used for abdominal wall closure

Abstract

A system, apparatus, and method for closing a laparoscopic abdominal wall defect by placement of one or more self-locking straps. The strap may include teeth that can tighten the strap within the locking head of the strap. The strap may initially be positioned in an intraperitoneal location, which may be suitable for use with robotic surgical instruments. By passing the fully tensioned strap (or rotating the strap axially), the locking head can be moved from the abdominal cavity to a second position located intra-abdominal or anterior to the abdominal wall and outside the abdominal cavity, thereby avoiding complications such as increased bowel perforation, organ laceration, vascular damage, and adhesion formation caused by the presence of a locking head with a large profile in the abdominal cavity. When the locking head is in the second position, it may be embedded in the surrounding tissue to resist movement of the strap in the potential rotational direction over time.

Description

TECHNICAL FIELD

[0001] Cross-reference of related applications This application claims the benefit of priority to each of U.S. Provisional Application No. 63 / 584,233 filed on September 21, 2023 and U.S. Provisional Application No. 63 / 584,264 filed on September 21, 2023, the entire contents of which are expressly incorporated herein by reference for all purposes. BACKGROUND ART

[0002] The present disclosure relates to surgical closure of abdominal wall defects by the arrangement of one or more self-locking straps.

[0003] Laparoscopic ventral hernia repair using self-locking straps has already been described. For further information, see PCT / US2018 / 013764, filed July 12, 2019, entitled "SYSTEMS, DEVICES, AND METHODS FOR CLOSING AN ABDOMINAL WALL DEFECT," PCT / US2020 / 053148, filed September 20, 2020, entitled "SYSTEMS, DEVICES AND METHODS FOR TISSUE FIXATION AND APPROXIMATING TISSUE DEFECTS," and PCT / US2021 / 015033, filed January 26, 2021, entitled "MEDICAL SYSTEMS, DEVICES AND METHODS ADAPTED FOR TISSUE FIXATION AND APPROXIMATING TISSUE DEFECTS." All of these are incorporated herein by reference in their entirety. The procedure described in the above application involves the manipulation of surgical instruments both outside the body and inside the abdominal cavity of the individual. Starting from a small incision that penetrates the skin on one side located laterally to the abdominal wall defect, the distal end of a self-locking strap can be inserted into the abdominal cavity, and its distal end can be withdrawn from the abdominal cavity on the opposite side of the tissue defect, and then pulled back under the skin to the first incision site, where the strap is subjected to percutaneous tension within the locking head (hereinafter also called the lock head) at the proximal end of the strap and cut to remove the excess strap length. In this laparoscopic procedure, the locking head maintains a resting position anterior to the anterior sheath of the rectus abdominis muscle and the abdominal wall. [Overview of the project]

[0004] In one embodiment, a method for closing an abdominal wall hernia defect, the method comprising: positioning a first self-locking strap in the vicinity of an abdominal wall hernia defect within the abdominal cavity of an individual; accessing a first side of the defect using the proximal end of the first self-locking strap, wherein the first self-locking strap has a locking head located on or near the distal end of the first self-locking strap; inserting the proximal end of the first self-locking strap 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; inserting the proximal end of the first self-locking strap through a 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; moving the proximal end of the first self-locking strap through the locking head; and tightening the first self-locking strap to at least partially close the defect.

[0005] In some embodiments, the steps of access, insertion, and movement are performed using a robotic system. In further embodiments, the method includes inserting one or more end effectors of the robotic system into the abdominal cavity via one or more trocars. In even further embodiments, one or more end effectors of the robotic system include one or both of a grasping forceps and a needle holder. In some further embodiments, one or more trocars include at least one trocar having a diameter of 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 mm or more. In even further embodiments, one or more trocars include at least one trocar with a diameter of 8 mm or more.

[0006] In some embodiments, the method includes cutting at least a portion of the proximal end of a first self-locking strap. In further embodiments, the cutting of the portion of the proximal end is performed using a blade positioned within the locking head of the first self-locking strap. In yet another embodiment, the cutting of the portion of the proximal end 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.

[0007] In some embodiments, the first self-locking strap has a needle and a leader, the leader connecting the needle to the proximal end of the first self-locking strap, and the method 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 further embodiments, the method includes cutting the leader. In further embodiments, cutting the leader is performed using a laparoscopic device such as surgical scissors, for example, hook scissors. In some further embodiments, the needle is a curved needle. In some further embodiments, the overlap of the leader and strap portion may include a transition. The transition can reduce kinking of the self-locking strap. In such embodiments, the method may include pulling the transition through the first side of the abdominal wall hernia defect and pulling the transition through the second side of the abdominal wall hernia defect, the transition causing dilation of the hole in the tissue surrounding the abdominal wall hernia defect.

[0008] In some embodiments, the abdominal wall hernia defect is located within the rectus abdominis muscle or within the linea alba. In some embodiments, no portion of the first self-locking strap is positioned percutaneously during the insertion and movement steps of the first self-locking strap. In some embodiments, the self-locking strap is positioned percutaneously during the tightening step. In some embodiments, the method includes rotating the tightened first self-locking strap around the abdominal wall hernia defect so that the lock head is repositioned outside the abdominal cavity. In some embodiments, the method includes inserting the self-closing strap through the posterior sheath of the rectus abdominis muscle. In some embodiments, the method includes inserting the self-closing strap through the anterior sheath of the rectus abdominis muscle.

[0009] In some embodiments, the method includes: positioning a plurality of self-locking straps in the abdominal cavity near an abdominal wall hernia defect; accessing a first side of the abdominal wall hernia defect using the proximal end of each of the plurality of self-locking straps; inserting each proximal end of each of the plurality of self-locking straps through the first side of the abdominal wall hernia defect from a posterior to anterior position in the tissue adjacent to the abdominal wall hernia defect, with each self-locking strap spaced apart from adjacent self-locking straps; inserting each proximal end of each of the plurality of self-locking straps through a second side of the abdominal wall hernia defect from an anterior to posterior position in the tissue adjacent to the abdominal wall hernia defect; moving each proximal end of each self-locking strap through a lock head; and tightening each of the self-locking straps to at least partially close the abdominal wall hernia defect. In some further embodiments, the method includes moving each of the tightened self-locking straps around the abdominal wall hernia defect so that each of the lock heads of each of the plurality of self-locking straps is no longer located in the abdominal cavity. In some further embodiments, the method includes individually and at least partially tightening each of the plurality of self-locking straps. In some further embodiments, the method includes at least partially tightening each of the plurality of self-locking straps in a sequence that includes at least partially tightening a first self-locking strap, followed by at least partially tightening each of the remaining self-locking straps of the plurality of self-locking straps. In some further embodiments, the method includes at least partially tightening each of the straps of the plurality of self-locking straps in a predetermined sequence. In yet another further embodiment, the sequence includes at least partially tightening a first self-locking strap and at least partially tightening a self-locking strap adjacent to the first self-locking strap. In some embodiments, the sequence includes at least partially tightening each of the plurality of straps in a linear sequence from the first end of the defect to the second end of the defect.In other embodiments, the sequence includes tightening each of the multiple straps at least partially in a central-to-outer sequence from the center of the abdominal wall hernia defect toward the edges of the abdominal wall hernia defect. In yet another embodiment, the sequence includes tightening each of the multiple straps at least partially in an outward-to-central sequence from the edges of the abdominal wall hernia defect toward the center of the abdominal wall hernia defect.

[0010] In some further embodiments, the method includes tightening each strap two or more times, with each strap being tightened in stages. In further embodiments, the method includes providing a relaxation period between the first tightening of each strap and the second tightening of each strap. In some further embodiments, the multiple self-locking straps may distribute the tightening force generated when the multiple self-locking straps are tightened substantially along the longitudinal direction of the abdominal wall hernia defect. In some further embodiments, the multiple self-locking straps may prevent, reduce, suppress or mitigate damage to the tissue engaged by each of the multiple self-locking straps during the tightening of each strap.

[0011] In some embodiments, the locking head of the first self-locking strap is a low-profile locking head, and the strap portion includes a ramp-like portion extending from the strap portion to the low-profile locking head, the ramp-like portion engaging with the muscle tissue surrounding the abdominal wall hernia defect. In other embodiments, the first self-locking strap includes a ramp or wedge adjacent to the proximal side of the locking head, the ramp or wedge being configured to facilitate the movement of the proximal end of the first self-locking strap through the locking head. In some further embodiments, the ramp or wedge includes a sloping portion that engages with the muscle tissue surrounding the abdominal wall hernia defect.

[0012] In one embodiment, a method for closing a soft tissue defect, the method comprising: positioning a first self-locking strap, which includes a leader, a strap portion, and a lock head configured to be positioned on and fastened to the strap portion, near the soft tissue defect so as to fit entirely within the body cavity of an individual; and bringing the two sides of the soft tissue defect together by tightening the first self-locking strap around the soft tissue defect.

[0013] In some embodiments, the tightening step is performed using a robotic system. In some further embodiments, the method includes inserting one or more end effectors of the robotic system into the body cavity via one or more trocars. In some embodiments, the method includes cutting at least a portion of the self-locking strap using a laparoscopic device. In some further embodiments, the laparoscopic device has surgical scissors. In some further embodiments, the laparoscopic device has hook scissors. In some embodiments, the overlap of the leader and strap portion includes a transition portion, which can reduce kinking of the self-locking strap. The method may include pulling the transition portion through a first side of the abdominal wall hernia defect and pulling the transition portion through a second side of the abdominal wall hernia defect, the transition portion causing dilation of the hole in the tissue surrounding the abdominal wall hernia defect. In some embodiments, the method includes rotating the tightened self-locking strap around the soft tissue defect so that the lock head is repositioned outside the body cavity.

[0014] In one embodiment, a kit for closing a soft tissue defect, the kit comprising: a plurality of self-locking straps, each having a leader, a strap portion, and a locking head positioned on the strap portion and configured to fasten with the strap portion; a strap deployment device configured to deploy at least one of the plurality of self-locking straps into the body cavity of an individual; and a laparoscopic cutting instrument.

[0015] In some embodiments, the laparoscopic cutting instrument includes laparoscopic surgical scissors, a high-frequency cutter, and / or an ultrasonic cutter. In some further embodiments, the laparoscopic device includes hook-type scissors. In some embodiments, the locking head of the first self-locking strap is a low-profile locking head, and the strap portion includes a ramp-like portion extending from the strap portion to the low-profile locking head. The ramp-like portion may engage with the muscle tissue surrounding the abdominal wall hernia defect. In some embodiments, the first self-locking strap has a ramp or wedge adjacent to the proximal side of the locking head, and the ramp or wedge includes a sloping portion configured to engage with the tissue near the soft tissue defect. In some embodiments, the width of the strap portion is between 2 mm and 14 mm. In some embodiments, the overlap between the leader and the strap portion includes a transition portion, which is configured to reduce kinking of the self-locking strap, and which is configured to cause dilation of the hole in the tissue surrounding the soft tissue defect.

[0016] In one embodiment, a robotic method for closing an abdominal wall hernia defect includes providing a robotic system comprising one or more end effectors; positioning a first self-locking strap in the abdominal cavity near the defect; accessing a first side of the defect by the robotic system with the proximal end of the first self-locking strap, wherein the self-locking strap includes a lock head on or near its distal end; inserting the proximal end of the first self-locking strap through the first side of the defect by the robotic system; inserting the proximal end of the first self-locking strap through a second side of the defect by the robotic system; moving the proximal end of the first self-locking strap through the lock head by the robotic system to tighten the first self-locking strap and at least partially close the defect; and moving the tightened first self-locking strap around the defect by the robotic system so that the lock head is no longer located in the abdominal cavity.

[0017] In some embodiments, the method includes providing a plurality of self-locking straps, each of which is initially positioned in the abdominal cavity near the defect; accessing a first side of the defect with the proximal end of each of the plurality of self-locking straps; using a robotic system to insert the proximal end of each of the plurality of self-locking straps through the first side of the defect, with each self-locking strap spaced apart from adjacent self-locking straps; using the robotic system to insert the proximal end of each of the plurality of self-locking straps through a second side of the defect; using the robotic system to move the proximal end of each self-locking strap through a locking head, tightening each self-locking strap to at least partially close the defect; and using the robotic system to move each of the tightened first self-locking straps around the defect, such that each locking head of each of the plurality of straps is no longer located in the abdominal cavity. In some embodiments, one or more end effectors of the robotic system include one or both of a grasping forceps and a needle holder. In some embodiments, the method includes using a robotic system to move each of the tightened first self-locking straps around the defect so that each lock head is no longer located in the abdominal cavity. In some embodiments, the method includes using a robotic system to individually and at least partially tighten each of a plurality of straps. In some embodiments, the method includes using a robotic system to tighten each of a plurality of straps in a sequence, including at least partially tightening the first strap, and then using a robotic system to at least partially tighten each of the remaining straps. In some embodiments, the method includes sequentially tightening each of a plurality of straps to at least a partial degree. In some embodiments, the step includes using a robotic system to tighten the first strap so that at least partial tightening is achieved, and then tightening adjacent straps so that at least partial tightening is achieved.In some embodiments, the method includes tightening each strap two or more times with a robotic system, wherein each strap is tightened by a stepwise tightening. In some embodiments, the method includes providing a slack period between the first tightening of the strap and the second tightening of the strap.

[0018] In some embodiments, the multiple straps are configured to distribute the tightening force generated during the tightening of the multiple straps substantially along the entire length of the defect. In some embodiments, the multiple straps can prevent, reduce, suppress, or mitigate damage to the tissue engaged by each strap when each of the multiple straps is tightened.

[0019] In one embodiment, a robotic method for closing an abdominal wall hernia defect located within the rectus abdominis muscle tissue of an individual includes providing a robotic system comprising one or more end effectors; positioning a first self-locking strap in the abdominal cavity near the defect; accessing a first side of the defect by the robotic system at the proximal end of the first self-locking strap, wherein the self-locking strap includes a lock head on or near the distal end of the self-locking strap and a ramp or wedge adjacent to the proximal side of the lock head; inserting the proximal end of the first self-locking strap through the first side of the defect by the robotic system; inserting the proximal end of the first self-locking strap through a second side of the defect by the robotic system; moving the proximal end of the first self-locking strap through the lock head by the robotic system to tighten the first self-locking strap and at least partially close the defect; and moving the tightened first self-locking strap around the defect by the robotic system so that the lock head is no longer located in the abdominal cavity, wherein the ramp or wedge facilitates the movement of the strap including the lock head.

[0020] In some embodiments, the ramp or wedge includes an inclined portion that engages with the rectus abdominis muscle tissue. In some embodiments, the method comprises a plurality of self-locking straps, each of which is initially positioned near a defect in the abdominal cavity, and each of which includes a locking head and a wedge or ramp; accessing a first side of the defect at the proximal end of each of the plurality of self-locking straps; inserting the proximal end of each of the plurality of self-locking straps through the first side of the defect using a robotic system, such that each self-locking strap is spaced apart from adjacent self-locking straps; inserting the proximal end of each of the plurality of self-locking straps through a second side of the defect using a robotic system; moving the proximal end of each self-locking strap through the locking head using a robotic system; tightening each self-locking strap to at least partially close the defect; and moving each tightened first self-locking strap around the defect using a robotic system such that the locking head of each of the plurality of straps is no longer located in the abdominal cavity, the ramp or wedge facilitating the movement of each of the plurality of straps including the locking head. In some embodiments, each wedge or ramp is at least partially formed from a bioabsorbable or biodegradable material, and each wedge or ramp can be at least partially absorbed or decomposed. In some embodiments, a lock head that is no longer located in the abdominal cavity may be configured to secure the tightened strap. In some embodiments, one or more end effectors of the robotic system include one or both of a grasping forceps and a needle holder. In some embodiments, the method includes tightening each of a plurality of straps individually and at least partially by the robotic system. In some embodiments, the method includes a sequence in which the robotic system tightens each of a plurality of straps, the sequence including at least partially tightening a first strap, and then at least partially tightening each of the remaining straps by the robotic system.In some embodiments, the method includes using a robotic system to sequentially tighten each of a plurality of straps to at least a partial extent. In some embodiments, the method includes using the robotic system to tighten a first strap to at least a partial extent, and then tightening adjacent straps to at least a partial extent. In some embodiments, the method includes tightening each strap multiple times with the robotic system, with each strap being tightened in a stepwise manner. In some embodiments, the method includes providing a slackening period between tightening the strap for the first time and before tightening the strap for the second time.

[0021] In some embodiments, the multiple straps can distribute the tightening force generated while tightening the multiple straps using a robotic system substantially along the entire length of the defect. In some embodiments, the multiple straps can prevent, reduce, suppress, or mitigate damage to the tissue engaged by each strap when tightening each strap.

[0022] In one embodiment, a method for closing an abdominal wall hernia defect includes positioning a first self-locking strap in the abdominal cavity near the defect, accessing a first side of the defect with the proximal end of the first self-locking strap, wherein the self-locking strap includes a lock head on or near its distal end, inserting the proximal end of the first self-locking strap through the first side of the defect, inserting the proximal end of the first self-locking strap through a second side of the defect, moving the proximal end of the first self-locking strap through the lock head to tighten the first self-locking strap to at least partially close the defect, and moving the tightened first self-locking strap around the defect so that the lock head is no longer located in the abdominal cavity.

[0023] In some embodiments, the method provides a plurality of self-locking straps, each of which is initially positioned in the abdominal cavity near the defect; accessing a first side of the defect with the proximal end of each of the plurality of self-locking straps; inserting the proximal end of each of the plurality of self-locking straps through the first side of the defect, with each self-locking strap spaced apart from adjacent self-locking straps; inserting the proximal end of each of the plurality of self-locking straps through a second side of the defect; moving the proximal end of each self-locking strap through a locking head to tighten each self-locking strap to at least partially close the defect; and moving each of the tightened first self-locking straps around the defect so that each locking head of each of the plurality of straps is no longer located in the abdominal cavity. In some embodiments, the method includes performing one or more steps of the method using a robotic system including grasping forceps and a needle holder. In some embodiments, the method includes using a robotic system to move each of the tightened first self-locking straps around the defect so that each locking head is no longer located inside the abdominal cavity. In some embodiments, the method includes performing one or more steps manually.

[0024] In some embodiments, the method includes individually tightening each of a plurality of straps at least partially. In some embodiments, the method includes a sequence for tightening each of the plurality of straps, the sequence including tightening a first strap at least partially, and then tightening each of the remaining straps at least partially. In some embodiments, the method includes sequentially tightening each of the plurality of straps to at least a partial degree. In some embodiments, the method includes tightening a first strap to at least a partial degree, and then tightening adjacent straps to at least a partial degree. In some embodiments, the method includes a step of tightening each strap two or more times, with each strap being tightened in stages.

[0025] In some embodiments, the method includes providing a slackening period between a first tightening of a strap and a second tightening of a strap. In some embodiments, the multiple straps are configured to distribute the force generated while tightening the multiple straps substantially along the entire length of the defect. In some embodiments, the multiple straps can prevent, reduce, suppress or mitigate damage to the tissue engaged by each strap when each strap is tightened.

[0026] In one aspect, a method for closing an abdominal wall hernia defect within the rectus abdominis muscle tissue of an individual comprises disposing a first self-locking strap within the abdominal cavity in the vicinity of the defect, accessing a first side of the defect at the proximal end of the first self-locking strap, wherein the self-locking strap comprises a lock head on or near its distal end, and comprises a ramp or wedge adjacent to the proximal side of the lock head, threading the proximal end of the first self-locking strap through the first side of the defect, threading the proximal end of the first self-locking strap through the second side of the defect, moving the proximal end of the first self-locking strap through the lock head, tightening the first self-locking strap to at least partially close the defect, and moving the tightened first self-locking strap around the defect such that the lock head is no longer located within the abdominal cavity, wherein the ramp or wedge facilitates movement of the strap comprising the lock head.

[0027] In some embodiments, the ramp or wedge comprises an inclined portion that engages with the rectus abdominis muscle tissue. In some embodiments, the method comprises providing a plurality of self-locking straps, each of the plurality of self-locking straps being initially disposed in the vicinity of the defect within the abdominal cavity, and each of the plurality of self-locking straps comprising a lock head and a wedge or ramp, accessing the first side of the defect at the proximal end of each of the plurality of self-locking straps, threading the proximal end of each of the plurality of self-locking straps through the first side of the defect, wherein each self-locking strap is spaced apart from the adjacent self-locking strap, threading the proximal end of each of the plurality of self-locking straps through the second side of the defect, moving the proximal end of each self-locking strap through the lock head, tightening each self-locking strap to at least partially close the defect, and moving each tightened first self-locking strap around the defect such that the respective lock head of the plurality of straps is no longer located within the abdominal cavity, wherein the ramp or wedge facilitates movement of each of the plurality of straps comprising the lock head.

[0028] In some embodiments, each ramp or wedge is at least partially formed from a bioabsorbable or biodegradable material, and each ramp or wedge can be at least partially absorbed or decomposed. In some embodiments, a lock head that is no longer located in the abdominal cavity may be configured to secure the tightened strap. In some embodiments, the method includes performing one or more steps in the method using a robotic system including grasping forceps and a needle holder. In some embodiments, the method includes performing a step using the robotic system to move each of the tightened first self-locking straps around the defect so that each lock head is no longer located in the abdominal cavity. In some embodiments, the method includes performing one or more steps manually. In some embodiments, the method includes individually and at least partially tightening each of the plurality of straps. In some embodiments, the method includes a sequence for tightening each of the plurality of straps, the sequence including at least partially tightening the first strap, and then at least partially tightening each of the remaining straps. In some embodiments, the method includes sequentially tightening each of the plurality of straps to at least a partial extent. In some embodiments, the method includes tightening a first strap such that at least partial tightening is achieved, and tightening adjacent straps such that at least partial tightening is achieved.

[0029] In some embodiments, the method includes the step of tightening each strap two or more times, and each strap is tightened in stages. In some embodiments, the method includes providing a relaxation period between after the first tightening of the strap and before the second tightening of the strap. In some embodiments, the plurality of straps is configured to distribute the force generated during tightening of the plurality of straps substantially along the entire length of the defect. In some embodiments, the plurality of straps may prevent, reduce, inhibit or mitigate damage to the tissue engaged by each strap when tightening each strap.

[0030] In an aspect, the self-locking strap includes a distal end and a proximal end, a lock head located at or near the distal end of the self-locking strap and including a slot through the lock head, a wedge or ramp positioned adjacent to the proximal side of the lock head, wherein the wedge or ramp includes an inclined surface, and the slot through the lock head is configured to allow a portion of the self-locking strap to pass through the lock head in one direction and prevent the self-locking strap from passing through the lock head in the opposite direction.

[0031] 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 smaller than the height of the distal side of the inclined surface. In some embodiments, the ramp or wedge includes a slot that operatively associates with the slot of the lock head. In some embodiments, at least a portion of the ramp or wedge comprises a bioabsorbable or biodegradable material. In some embodiments, the lock head has a cuboid shape.

[0032] In some embodiments, a locking head device attached to or positioned near the distal end of a self-locking strap includes a housing defining a through-slot, the slot configured to receive the proximal end of the self-locking strap, the self-locking strap being permitted to pass through the slot in one direction and prevented from passing through the slot in a second, opposite direction, and a wedge or ramp adjacent to, attached to or mounted on either the proximal side of the housing, including a slot aligned with the slot in the housing, which allows the self-locking strap to pass through.

[0033] In some embodiments, the distal side of the inclined surface includes a height substantially equal to the height of the lock head, and the proximal side of the inclined surface includes a height less than the height of the distal side of the inclined surface. In some embodiments, at least a portion of the ramp or wedge includes a bioabsorbable or biodegradable material. In some embodiments, the lock head has a rectangular parallelepiped shape. [Brief explanation of the drawing]

[0034] [Figure 1] Figure 1 illustrates the configuration of the components used in the above-described laparoscopic ventral hernia repair procedure. [Figure 2] Figure 2 shows the position of the strap lock head anterior to the abdominal wall in the laparoscopic ventral hernia repair described above. [Figure 3] Figure 3 shows the intraperitoneal position of the self-locking strap used for abdominal wall closure in robotic surgery. [Figure 4] Figure 4 shows the intraperitoneal position of the locking head of the self-locking strap after abdominal wall closure with the self-locking strap. [Figure 5A] Figure 5A illustrates a part of an embodiment of the locking function on the strap. [Figure 5B] Figure 5B illustrates a part of an embodiment of the locking function on the strap. [Figure 5C]Figure 5C illustrates a part of an embodiment of the locking function on the strap. [Figure 5D] Figure 5D illustrates a part of an embodiment of the locking function on the strap. [Figure 5E] Figure 5E illustrates a part of an embodiment of the locking function on the strap. [Figure 5F] Figure 5F illustrates a part of an embodiment of the locking function on the strap. [Figure 5G] Figure 5G illustrates a part of an embodiment of the locking function on the strap. [Figure 6] Figure 6 shows a cross-sectional view of an embodiment of the lock head. [Figure 7] Figure 7 shows a cross-sectional view of another embodiment of the lock head. [Figure 8A] Figure 8A shows various embodiments of a lock head having an integrated cutting blade. [Figure 8B] Figure 8B shows various embodiments of a lock head having an integrated cutting blade. [Figure 8C] Figure 8C shows various embodiments of a lock head having an integrated cutting blade. [Figure 8D] Figure 8D shows various embodiments of a lock head having an integrated cutting blade. [Figure 8E] Figure 8E shows various embodiments of a lock head having an integrated cutting blade. [Figure 8F] Figure 8F shows a partially cutaway cross-sectional view of an embodiment of a low-profile inline lock head. [Figure 8G] Figure 8G illustrates a partially broken perspective view of an embodiment of the low-profile inline lock head shown in Figure 8F. [Figure 8H] Figure 8H depicts a self-locking strap and locking head with orientation features. [Figure 8I] Figure 8I depicts a self-locking strap and locking head with orientation features. [Figure 8J]Figure 8J depicts a self-locking strap and locking head with orientation features. [Figure 9A] Figure 9A shows a side view of an embodiment of a mesh strap to which a needle and a locking head are attached. [Figure 9B] Figure 9B shows an exploded side view of an embodiment of a mesh strap equipped with a needle and a locking head. [Figure 9C] Figure 9C shows a partially cutaway side view of an embodiment of a mesh strap to which a needle and a locking head are attached. [Figure 9D] Figure 9D shows a side-exploded partial break view of an embodiment of a mesh strap equipped with a needle and a locking head. [Figure 10A] Figure 10A shows a perspective view of an embodiment of the lock head and strap. [Figure 10B] Figure 10B shows a side cross-sectional view of an embodiment of the lock head and strap. [Figure 11] Figure 11 shows a partially fractured cross-sectional view of an embodiment of a lock head including a ball. [Figure 12A] Figure 12A illustrates an example of a transition section. [Figure 12B] Figure 12B illustrates an example of a transition section. [Figure 13A] Figure 13A illustrates several diagrams of exemplary mesh leaders. [Figure 13B] Figure 13B illustrates several diagrams of an exemplary mesh leader. [Figure 14A] Figure 14A shows a top view of the leader attached to the strap. [Figure 14B] Figure 14B shows a top view of the leader attached to the strap. [Figure 15A] Figure 15A shows a partial side and top cross-section of an embodiment of a method for attaching the leader to the strap. [Figure 15B] Figure 15B shows partial side and top cross-sectional views of an embodiment of a method for attaching the leader to the strap. [Figure 15C] Figure 15C illustrates a side and top section of an embodiment of a method for attaching the leader to the strap. [Figure 15D] Figure 15D illustrates a side and top section of an embodiment of a method for attaching the leader to the strap. [Figure 16A] Figure 16A illustrates the configuration of the components included in a self-locking strap for robotic abdominal wall closure. [Figure 16B] Figure 16B illustrates the configuration of the components included in a self-locking strap for robotic abdominal wall closure. [Figure 17A] Figure 17A illustrates the bioabsorbable wedge and the configuration after the wedge has been inserted into the self-locking strap. [Figure 17B] Figure 17B illustrates the bioabsorbable wedge and the configuration after the wedge has been inserted into the self-locking strap. [Figure 17C] Figure 17C illustrates the bioabsorbable wedge and the configuration after the wedge has been inserted into the self-locking strap. [Figure 17D] Figure 17D illustrates the bioabsorbable wedge and the configuration after the wedge has been inserted into the self-locking strap. [Figure 17E] Figure 17E illustrates the bioabsorbable wedge and the configuration after the wedge has been inserted into the self-locking strap. [Figure 17F] Figure 17F illustrates the bioabsorbable wedge and the configuration after the wedge has been inserted into the self-locking strap. [Figure 18] Figure 18 illustrates a device for delivering a self-locking strap with a needle under laparoscopy. [Figure 19A] Figure 19A shows a tensioner and cutter with an opening for inserting a strap. [Figure 19B] Figure 19B shows a tensioner and cutter with an opening for inserting a strap. [Figure 19C]Figure 19C shows a tensioner and cutter with an opening for inserting a strap. [Figure 20A] Figure 20A shows another embodiment of a tensioner and cutter having an opening for strap insertion. [Figure 20B] Figure 20B shows another embodiment of a tensioner and cutter having an opening for strap insertion. [Figure 20C] Figure 20C shows another embodiment of a tensioner and cutter having an opening for strap insertion. [Figure 21A] Figure 21A illustrates the procedure for closing an abdominal wall defect using a self-locking strap. [Figure 21B] Figure 21B illustrates the procedure for closing an abdominal wall defect using a self-locking strap. [Figure 21C] Figure 21C illustrates the procedure for closing an abdominal wall defect using a self-locking strap. [Figure 21D] Figure 21D illustrates the procedure for closing an abdominal wall defect using a self-locking strap. [Figure 21E] Figure 21E illustrates the procedure for closing an abdominal wall defect using a self-locking strap. [Figure 21F] Figure 21F illustrates the procedure for closing an abdominal wall defect using a self-locking strap. [Figure 21G] Figure 21G illustrates the procedure for closing an abdominal wall defect using a self-locking strap. [Figure 21H] Figure 21H illustrates the procedure for closing an abdominal wall defect using a self-locking strap. [Figure 22] Figure 22 summarizes the steps applied in abdominal wall defect closure techniques using self-locking straps. [Figure 23] Figure 23 illustrates the positioning of the self-locking strap after it has been tightened and rotated. [Figure 24A] Figure 24A illustrates how to insert a self-locking strap using a robotic surgical approach. [Figure 24B] Figure 24B illustrates the method of inserting a self-locking strap using a robotic surgical approach. [Figure 24C] Figure 24C illustrates how to insert a self-locking strap using a robotic surgical approach. [Figure 24D] Figure 24D illustrates the method of inserting a self-locking strap using a robotic surgical approach. [Figure 24E] Figure 24E illustrates how to insert a self-locking strap using a robotic surgical approach. [Figure 24F] Figure 24F illustrates the method of inserting a self-locking strap using a robotic surgical approach. [Figure 24G] Figure 24G illustrates how to insert a self-locking strap using a robotic surgical approach. [Figure 24H] Figure 24H illustrates the method of inserting a self-locking strap using a robotic surgical approach. [Figure 24I] Figure 24I illustrates the method of inserting a self-locking strap using a robotic surgical approach. [Figure 24J] Figure 24J illustrates how to insert a self-locking strap using a robotic surgical approach. [Figure 24K] Figure 24K illustrates how to insert a self-locking strap using a robotic surgical approach. [Figure 24L] Figure 24L illustrates the method of inserting a self-locking strap using a robotic surgical approach. [Figure 24M] Figure 24M illustrates the method of inserting a self-locking strap using a robotic surgical approach. [Modes for carrying out the invention]

[0035] In robot-assisted laparoscopic abdominal defect closure, the surgeon primarily performs surgical operations within the abdominal cavity, in contrast to the combined external and internal operations performed in laparoscopic abdominal wall hernia closure. An externally operated tensioner / cutter can ultimately cut the strap for closing the tissue defect. Miniature robotic end-effectors, such as robotic needle holders and grasping forceps, can perform tissue dissection, needle placement, and strap management. Such operations involve guiding the self-locking strap from the abdominal cavity, through the surrounding tissue defect, and back into the abdominal cavity (for example, an "inside-out" route, in contrast to other procedures where the strap is introduced and manipulated along a percutaneous "outside-in" route). The distal end of the self-locking strap is attached to a leader, which may be a length of suture, and the suture can be attached to a curved needle. The self-locking strap is initially introduced entirely into the abdominal cavity by the robotic needle holder for placement. Since robot-assisted abdominal wall hernia closure is performed intraperitoneally, the strap's locking head is located within the abdominal cavity and can be repositioned after tensioning and cutting of excess strap to avoid postoperative complications. Compared to sutures, such self-locking straps can advantageously spread compressive force over a larger area of ​​tissue, thereby reducing the risk of tearing and penetrating tissue even when the strap is tightened.

[0036] Surgical manipulation of closure straps within the abdominal cavity may be particularly well-suited to robotic surgical methods. Typically, robotic surgical manipulation may involve two or more trocars for the robotic cutter and grasping forceps. In some cases, the robotic grasping forceps may be large enough that it is undesirable for them to penetrate muscles such as the rectus abdominis during the robotic surgical procedure. Therefore, accessing the abdominal cavity via trocars positioned so that the robotic grasping forceps are located posterior to the rectus abdominis may be preferable to forming an access opening in the skin tissue in the anterior region of the tissue defect. This disclosure relates to an apparatus and method for introducing a closure strap into the abdominal cavity before it undergoes further surgical manipulation.

[0037] Figure 1 illustrates the components of the laparoscopic ventral hernia repair procedure described above. Surface skin 110 is observed, and below it, the rectus abdominis muscle 111, surrounded by the surrounding rectus abdominis sheath 112, forms the majority of the abdominal wall. Penetrating the thin layer of peritoneum 113, the surgeon enters the abdominal cavity 114. Surgical instruments applied from outside the body of the individual include a delivery and grasping needle 118 and a subcutaneous dissection guide 119. Using these instruments, a suture 117 attached to a self-locking strap 115 is passed across the defect with the help of laparoscopic grasping forceps 120. The locking head 116 of the self-locking strap 115 remains outside the skin 110 of the individual.

[0038] Figure 2 illustrates the anatomical placement of the self-locking strap 115 after closure of the abdominal wall defect. The lock head 116 is located anterior to the anterior portion of the rectus abdominis sheath 112 and inferior to the skin 110. overview

[0039] The self-locking strap according to this disclosure can be used to close tissue defects, such as tissue defects in the abdominal wall. Figure 3 shows the initial position of a self-locking strap 300 according to this disclosure. The self-locking strap 300 may be initially positioned in the abdominal cavity 114, for example, in preparation for abdominal wall closure under robot-assisted laparoscopy. The self-locking strap 300 may include a curved needle 322 connected to a leader 317 attached to the distal end of the strap portion 321. An optionally included bioabsorbable wedge 323 may be positioned distal to the lock head 316 of the strap. Generally, the leader 317 may be more flexible (less rigid) than the strap portion 321. The leader 317 may have a smaller cross-sectional area than the strap portion 321. The leader 317 may have a different geometry or material than the strap portion 321. Thus, the leader 317 may be used to guide the strap portion 321 into a predetermined position while pulling it through multiple tissue interfaces. In this sense, when the self-locking strap 300 is inserted into tissue, it may have an expanding effect in that the small-diameter leader 317 is first pulled through the tissue, guiding the larger strap portion 321 along the same path. Tissue expansion requires a smaller hole and is less traumatic to the tissue. Thus, the leader 317 can be inserted through the tissue without significantly affecting it, similar to a suture (in some embodiments, the leader may be a suture), while the strap portion 321, once positioned, has a larger footprint (e.g., width or cross-sectional area) at the point where it is located within and in contact with the tissue, thereby reducing the local pressure applied to the tissue and the risk of cutting or penetrating the tissue compared to a suture. The larger cross-sectional area of ​​the strap portion 321 may allow the surgeon to apply more bonding force to the tissue using the strap portion 321 compared to a suture, since the suture is smaller in size and therefore more likely to cut the tissue.

[0040] Figure 4 shows the anatomical placement of the self-locking strap 321 within the abdominal cavity 114 after closure of the abdominal wall defect. The lock head 316 is located within the abdominal cavity 114. As discussed herein, the self-locking strap 321 can be rotated from the position shown in Figure 4 to move the portion distal to the lock head 316 outside the abdominal cavity. strap part

[0041] The self-locking straps according to this disclosure may have a strap portion capable of interacting with a locking head of the self-locking strap to lock and tighten the self-locking strap. Figures 5A-5G show an example of a strap portion having a feature along the length of the strap portion for engaging with the locking head to allow movement in only one direction (for example, a locking type commonly called a zip tie or cable tie). The strap can be tightened as it surrounds a portion of tissue to be brought into close proximity, and the strap maintains tension without the operator holding the device, without the need for any knots, and without the need for additional tools such as clamps to hold the strap in a taut state. Advantageously, the maintenance of tension without the operator holding the device or needing knots may allow the operator to at least partially tighten the strap while the operator is engaged in other work. The operator may then return to the strap which is at least partially tightened and continue with either or both of the tightening step and / or the remaining procedure. Therefore, the examples of straps described herein can be considered knotless (e.g., without slip knots) and / or clampless (i.e., no clamps are required to achieve the above). As will be further explained below, such a configuration allows the straps to be tightened or secured sequentially and may be advantageous in several respects, including for the reasons stated above. Furthermore, if multiple straps are used, each associated strap may be tightened sequentially, or at least partially, which gives the operator greater flexibility in the scinting or strap tightening procedure.

[0042] In some cases, part or all of the strap portion may be bioabsorbable. In some cases, the strap may contain internal structures that are not bioabsorbable, or substantially not bioabsorbable, while the outer portion of the strap portion is bioabsorbable. In some other cases, the bioabsorbable internal structure may be absorbed at a slower rate than the bioabsorption rate of the outer portion. In such cases, the outer portion may be bioabsorbable. This reduces the profile and / or volume of the strap as the individual heals. The remaining internal structure can continue to provide mechanical support to the tissue surrounding the defect, even while the outer portion is being bioabsorbed.

[0043] In one example, as shown in Figure 5A, the strap portion 513 may include opposing sides, similar to a conventional zip tie, and have teeth 511 with an inclination on one side, while having a relatively smooth opposing side.

[0044] In another example, as shown in Figure 5B, the strap portion 515 may include teeth 517 and 518 on opposite sides. The teeth 517 and 518 may be arranged in a staggered pattern relative to each other to avoid thinning of the strap portion 515.

[0045] Figure 5C illustrates an example of a strap portion 519 having an opening 521 that engages with a claw or other feature in a lock head according to the present disclosure. The direction of the opening 521 of the strap portion 519 is perpendicular to the strap portion 519, which may make it easy to manufacture as it can be injection molded. In some examples, the opening 521 may completely penetrate the strap portion 519, or it may include pockets defined in the strap that do not penetrate the strap portion 519, and as shown, the thickness of these pockets is less than the thickness of the strap portion 519. In this example, the lock head may include one or more features that force a unidirectional tightening movement or unidirectional movement of the strap portion 519 through the lock head.

[0046] In some examples, the strap may not have discrete locking parts. Figure 5D illustrates such a strap portion 523 having a substantially smooth surface 525 on at least one of the opposing sides that can engage with a lock head having teeth, cams, tines, or other features that facilitate one-way locking by using friction to hook, grasp, or grip the strap, or by otherwise biting into the strap for gripping. Elastomer straps may be smooth, for example, as shown in Figure 5D. Some examples of straps may be fully elastic or may contain elastic elements and may continue to apply pressure to the tissue as the tissue contracts or otherwise relaxes after surgery. Elastic straps may be made of a thermoplastic elastomer (TPE) or a rubber-like material such as silicone.

[0047] Figure 5E shows another example in which teeth 529 are provided on at least one of the opposing sides of the strap portion 527, and side rails 528 are provided on both sides of the teeth 529. The side rails 528 provide strength and rigidity to the strap portion 527. The side rails 528 may extend along the length of the strap portion 527, or alternatively, they may extend along one or more sections of the strap portion 527.

[0048] In some examples, the engagement features on the strap may have gaps. For example, Figure 5F shows a strap portion 531 having teeth 533 separated by a gap 537. As described above in relation to Figure 5C, the gap 537 may be a flat portion, a void, or a pocket. Furthermore, as described in relation to Figure 5E, a side rail 535 may also be included.

[0049] Other examples, including those disclosed above, may have multiple sets or sections of teeth 545, each containing one or more teeth 543, or other engaging features, as shown in Figure 5G, which may be longitudinally separated or longitudinally spaced by gaps 541. This configuration allows the strap portion 539 to move freely between the toothed sections 543, and because there is little resistance between the spaced sections of teeth 545, the strap can be easily tightened without adding resistance when the strap is still loose over the anatomical site. Furthermore, the gaps 541 also contribute to reducing the number of collisions that occur when the teeth 543 of individual straps come into contact with the locking mechanism in the lock head. For example, when an operator tightens a long strap, each tooth 543 on the strap portion 539 comes into contact with a tooth in the lock head, which can cause repeated stress and potential wear on the teeth in the lock head, potentially reducing the holding strength of the lock head. Therefore, the intermittent teeth 545 reduce the number of contacts with the teeth 543 in the lock head that occur during tightening, potentially resulting in less wear and increased strength. Finally, reducing the number of teeth on the strap can reduce manufacturing costs and complexity in steps such as injection molding, as molding elongated toothed sections, such as those on long cable ties, can require expensive molds.

[0050] In some examples, there may be a section of teeth 545 having a longitudinal length, followed by a gap, and then one or more sections of teeth 545 also having a longitudinal length. The lengths of the sections of teeth 545 may be substantially equivalent or may differ as will be understood by those skilled in the art. An example of the length of each section of teeth 545 may be about 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 configuration allows the surgeon to easily slide the strap portion 539 through the locking head and then release the device during surgery when the device engages with a section of teeth 545, thereby keeping the device in place while the surgeon applies another self-locking device to the wound. The surgeon may then further tighten the strap to engage with the next set of teeth 545 spaced apart from each other in a tighter proximity (i.e., smaller circumference) of the strap around the tissue defect. The above approach is also possible with straps having the engagement feature over substantially the entire length of their length. However, having smaller or intermittent engagement features may offer manufacturing or cost advantages, as it may require less complex manufacturing tools to form the features.

[0051] In some embodiments, the strap portion may include a functional region containing teeth and a non-functional region not containing teeth. Because the non-functional region does not contain teeth that can interact with the lock head, the operator may be able to move the lock head of the self-locking strap quickly across the non-functional region. The movement of the lock head across the functional region may be slower and / or require greater force because the teeth of the functional region may interact with the teeth of the lock head. In some examples, the ratio of the length of the functional region to the length of the non-functional region along the longitudinal direction of the strap 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 above ratios. However, other ratios may be suitable in some examples. 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 it may be a length within the range defined by any two of the above values.

[0052] In some cases, the width of the strap portion may be approximately 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14 mm, or within the range defined by any of the above values. To prevent tearing, it may be desirable to select a strap portion that is wide enough to distribute the force of the strap over a sufficiently large surface area of ​​the tissue, but narrow enough not to cause a substantial increase in the risk of causing a second tissue defect where the strap portion penetrates the tissue.

[0053] The strap sections disclosed herein are examples, and those skilled in the art will recognize that there are numerous strap designs that, when combined with various lock head designs, provide a one-way, knot-free, clamp-free locking function. All of these are within the scope of this disclosure. Furthermore, as those skilled in the art will understand, various combinations of the above examples are conceivable, and for example, a strap section 519 having an opening 521 as shown in Figure 5C may also include a side rail 528 similar to that in Figure 5E. Rockhead

[0054] Figures 6 to 8E illustrate various examples of lock heads. Figure 6 shows a cross-sectional view of a lock head 651 attached to the proximal end of a strap portion 652. The lock head 651 has an elastic hinge 653 such that when the strap portion 652 (partially shown) is inserted through the channel 663 in the direction of arrow 661, the claws 665 bend, allowing the strap to be inserted. When the strap portion 652 is pulled in the opposite direction to arrow 661, the teeth on the strap engage with the teeth 659 on the lock head 651, thereby preventing the strap portion 652 from being inserted. When the strap is held under tension, the force exerted by the strap portion 652 on the teeth 659 causes the claws 665 to bend in opposite directions around the apex 654, resulting in a tendency for the teeth 659 to align with the strap portion 652 as the strap portion 652 passes through the lock head 651. This causes more teeth 659 to engage with the teeth on the strap portion 652 in the direction opposite to arrow 661.

[0055] As another example, as shown in Figure 7, the lock head 771 has teeth 779 substantially parallel to the direction 773 through which the strap portion 772 passes. The elastic hinge 775 allows the claw 777 to flex so that it retracts when the strap portion 772 is inserted through the channel 774 in the direction of arrow 773, and then the claw 777 flexes back to the illustrated position so that the teeth 779 become substantially parallel to the teeth on the strap, allowing multiple teeth to engage with the strap.

[0056] In some examples, a self-locking strap may have a cutting blade integrated within the locking head for cutting the self-locking strap. Depending on the position of the cutting blade within the locking head, the cut end of the strap may be flush or recessed within the locking head. Figure 8A shows an example of a locking head 802 in which a strap portion 810 has a cutting blade 804 within a channel 808 through which the locking head 802 is inserted. In the example in Figure 8A, the blade 804 is opposite the ratchet teeth 806. Figure 8B shows another example of a locking head 812 in which a strap portion 810 has a cutting blade 804 within a channel 808 through which the locking head 812 is inserted. In the example in Figure 8B, the cutting blade 804 is located on the same side of the channel 808 as the ratchet teeth 806. Other arrangements, such as the example shown in Figure 8C, are also within the scope of this disclosure, in which the locking head 814 includes a cutting blade 804 embedded within a strap portion 810 adjacent to the locking head 814, with the teeth 806 located on the opposite side of the channel 808. In some examples, the lock head may have cutters on both sides of the channel. Thus, the examples in Figures 8A and 8B are combined. Figure 8D shows an end view of an example of a lock head 816 having a cutting blade 804 located at the rounded end 818 of the lock head 816 and opposite the teeth 806. The cutting blade 804 is mounted within the lock head 816 or, in other embodiments, embedded within the lock head 816. In some examples, the cutting blade 804 may be molded together with the lock head 816 (e.g., insert molded), or the cutting blade 804 may be bonded in place.

[0057] Refer to Figure 8E, which shows an end view of an example of a lock head 820 having a cutting blade 822. The cutting blade 822 includes a metal sheet having an opening 824 aligned with a channel 808 of the lock head 820. The opening 824 is dimensioned to allow a strap to pass through with clearance and to cut the strap when the strap is rotated. The metal sheet of the cutting blade 822 can be attached to the lock head 820 by any method for attaching a thin metal sheet or metal 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 by melting a plastic tab or boss that penetrates or goes over the edge of the metal sheet. The metal sheet of the cutting blade 822 may be made by punching, forming, laser cutting, or a combination thereof. In some examples, the metal sheet of the cutting blade 822 may not have an opening but may include a simple metal sheet with a sharp edge that overlaps the exit of the channel from which the strap exits.

[0058] An example with a low-profile inline lock head is shown in Figures 8F-8G. The lock head 801 may include a channel 803 substantially parallel to the proximal portion of the strap portion 809, such that the distal strap is substantially adjacent (e.g., parallel) to the proximal portion of the strap portion 809 when the strap portion 809 is inserted through the lock head 801 in the direction of arrow 807. In this configuration, the teeth 1205 are substantially collinear with the proximal end of the strap portion 809, so that after inserting and cutting the strap, the remaining strap protruding through the channel 803 is flush. As shown in the cross-sectional view in Figure 8G, the lock head 801 may have a low profile, which can reduce internal injury and reduce residual pressure on adjacent tissues by reducing skin bulging, for example, if the device is located near skin or other organs. The strap may include a ramp-like portion 811 extending from the strap portion 809 to the lock head 801. The ramp-shaped portion 811 can advantageously ensure a gradual transition from the strap portion 809 to the locking head 801. In some exemplary methods of rotating a self-locking strap after it has been tightened, the ramp-shaped portion 811 may help reduce, minimize, or prevent damage to the tissue into which the channel 803 rotates.

[0059] In other examples, a pair of geometric features that enforce the correct orientation may prevent the strap from being inserted into the lock head in the wrong orientation. Figures 8H–8J illustrate an example in which the strap 832 has a projection 834 on one side that engages with a corresponding shape (e.g., a slot 840) in the lock head 836. The projection may be a rail extending along a portion of the strap 832, as shown in Figure 8H (side view) and Figure 8I (top view). In some examples, the projection 834 may be located on the distal end side of the strap 832. In some examples, the projection 834 may extend along the entire length of the strap. As shown in Figure 8J, the projection 834 can engage with a corresponding shape (e.g., a slot 840) in the lock head 836. The slot 840 may be continuous with a channel 838 in the lock head 836. In some examples, the slot 840 is located opposite the teeth 842 of the lock head 836. The engagement of the projection 834 with the slot 840 can prevent the lock head 836 from engaging with the strap 832 in an inverted orientation. leader

[0060] The leader of a self-locking strap may have a smaller cross-section than the other parts of the self-locking strap. The smaller cross-section allows the leader to pass more easily through the tissue, thereby providing a path for the larger strap portion to pass through. The leader can connect the strap portion to a needle. The leader may include a woven fabric, braid, knit, or nonwoven sheet, which may be tubular in shape or a flat, two-dimensional shape such as a ribbon. Furthermore, the leader may include other mesh-like structures that connect the strap portion directly to the needle (or to the leader between the strap and the needle). Figure 9A shows a side view of such a device 900. The device 900 may include a leader 902, a needle 980, a strap portion 977, and a locking head 979.

[0061] In some examples, the leader 902 may include a mesh structure having a tubular or flat cross-section. The leader 902 tends to lie flat on the tissue and generally form a larger contact area than that of a suture, thereby applying less pressure to the tissue and reducing the tendency to cut the tissue. The self-locking strap 900 may include a needle 980 at its distal end and a bevel 978 at the tip of the needle for puncturing the tissue. The needle 980 may be straight or curved, as shown in the figure, to facilitate suturing of tissue defects such as abdominal wall hernias. Alternatively, the device 900 may not have a needle at its distal end, and instead the distal end may have nothing, a narrowed distal tip, a leader, or one or more loops as disclosed and described in each of the examples of leaders above.

[0062] The proximal end of the device 900 may have a locking head 979 that allows only unidirectional movement of the leader 902 when the leader 902 passes through the locking head 979. The leader 902 can be attached to the locking head 979 in the same manner as described herein for connecting the strap portion 977 to the leader 902 (see, for example, Figures 14A-14B and 15A-15D). For example, as shown in Figures 9A and 9B, the leader 902 may have an opening at the proximal end 974 surrounding the strap portion 977 (not drawn to scale) extending from the locking head 979. The strap portion 977 may taper as it extends toward the leader 902. The leader 902 may include one or more projections or bulges through which the leader 902 passes, which can secure the leader 902 and prevent it from slipping off the strap portion 977. Figure 9B shows an isometric exploded view of the device 900, which includes a leader 902 that is a flexible mesh structure, the leader 902 having an aperture lumen extending through its interior, or at least partially extending through its interior, and further having a distal end 972. The lock head 979 has an opening 975 that can receive the leader 902 and restricts the movement of the leader 902 in one direction.

[0063] In some examples, the needle 980 may be left on the leader 902 so that the needle 980 guides the leader 902 into the lock head 979, after which the needle 980 may be cut from the leader 902. Alternatively, the needle 980 may be cut from the leader 902 before passing it through the lock head 979. As shown in Figures 9C and 9D, the distal end 972 of the leader 902 may have a leader section 176 at its end near the needle 980. As shown in Figure 9C, the distal end 972 of the leader 902 has a distal portion 976 having a smaller cross-sectional shape near the attachment point to the needle 980. In some examples, the distal portion 976 may be a smaller diameter section with a denser braid, or it may be bonded, or otherwise formed into a smaller shape, or melted to a smaller size so that the fibers do not loosen or loosen after cutting. The distal section 976 may be more rigid than the leader 902 or the remainder of the leader 902, making it easier to push the distal section 976 through the lock head without bending or buckling. This is because the distal section 976 may have higher column strength than the leader 902. Alternative interaction between the strap and the lock head

[0064] Other examples of this disclosure describe tooth-tooth interaction between the locking head and the strap portion, but other mechanisms may be suitable. As an alternative, Figures 10A and 10B illustrate cross-sectional views of an example of a locking head 1081 having a tab 1083 that engages with a gap 1087 in the strap portion 1082. The tab 1083 may be angled to prevent retraction and achieve a one-way locking action, while allowing the strap portion 1082 to pass through the channel 1085 in the direction indicated by arrow 1089. Figure 10B shows another cross-sectional view of this example with the tab 1083 engaged with the gap 1087 in the strap portion 1082. This example of a locking head 1081 having one or more tabs 1083 is generally compatible with strap designs having an opening (i.e., a notch or partial notch in the strap) as shown in Figure 5C, but this type of locking head is also compatible with designs having teeth.

[0065] The strap may be locked using a ball and wedge, which is very similar to a clutch that can lock the strap with considerable force and little or no backlash during the transition from sliding to holding. Figure 11 illustrates a lock head 1191 having a ball 1195 sandwiched between an inclined surface 1193 and the strap portion 1100. When the strap 100 is pulled in the tightening direction 1199, the ball 1195 is displaced in the same direction 1197 and away from the inclined surface 1193, allowing the strap portion 1100 to pass freely. When the strap portion 1100 is released by the operator, the ball 1195 comes into contact with the inclined surface 1193, preventing it from moving in the opposite direction. As a result, the ball 1195 is pressed against the strap portion 1100, and the strap portion 1100 is clamped between the ball 1195 and the bottom wall 1198 of the lock head 1191. The ball 1195 may be cylindrical in some examples to apply a line load rather than a point load to the strap portion 1100, and the strap portion 1100 may be smooth or textured, resulting in a relatively simple and low-cost strap. In fact, this type of configuration can also be used with cloth, woven, or textile strap materials that lack discrete features for locking. Furthermore, features to improve friction may be added to the strap portion 1100 or the lock head 1191 at the point of contact with the strap portion 1100, including, but not limited to, the exemplary strap portions shown in Figures 5A-5G. Such features include, but are not limited to, surface roughness, texture, knurling, grids, protrusions, or inclined protrusions.

[0066] Some examples of the devices described herein include configurations in which the strap portion is perpendicular to the locking head. Transition section

[0067] In some examples, a self-locking strap ("device") may have a transition area at the distal end of the strap portion where it connects to the proximal end of the leader. That is, the transition area is a region having a transition in size, shape, and / or material. The transition area helps guide the strap portion through the tissue, particularly around corners, when the strap portion is pulled by the leader. The transition area can provide a gradual transition in size and / or stiffness between a relatively narrow and flexible leader and a relatively wide and stiff strap. Having a gradual transition in stiffness can reduce kinking between the leader and the strap portion, which may occur when the self-locking strap is pulled around corners, such as at entry or exit points in the tissue. Furthermore, the transition area can provide an expansion effect between a relatively narrow leader and a relatively wide strap portion, which may allow for a gradual increase in the lateral force exerted by the self-locking strap on the tissue as the strap portion is pulled through the tissue by the leader.

[0068] For example, Figure 12A shows a device having a transition section 1202 that includes a rounded end between the strap section 1204 and the leader 1206. The rounded end may be a full round or a fillet of the corners at the end of the strap section closest to the leader 1206. In other examples, the transition section may include a longer, more gradual reduction in dimension, as shown in Figure 12B. Figure 12B shows a transition section 1208 that tapers from the width of the strap section 1204 to the width of the leader 1206. The length of the transition section 1208 may be described as several times the width of the strap section. For example, as shown in Figure 12B, the transition section 1208 may be about 1.5 times the width of the strap section 1204, or it may be longer, for example, 2, 3, 4, or 5 times or more the width of the strap section 1204. In some embodiments, the transition section 1208 may have a maximum width of 2.5 mm and the leader has a diameter of 0.6 mm. The transition section may taper gradually, but not necessarily monotonically, over its length from the strap size to the leader size, in terms of diameter and / or width, to provide a gentle slope. The length of the transition section may be as small as about 2 mm, or it may be, for example, 5 mm or more (15 mm or more in some examples). Attaching the leader to the strap

[0069] The leader may have a diameter and / or width less than 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 approximately less than 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, or 0.5 mm, or any two of these values, although other values ​​may be suitable in some cases. The leader does not have to be circular. The leader may have low or negligible bending stiffness and be able to withstand the tensile force caused by pulling the strap through a path in the tissue (e.g., a curved path in the tissue). In some examples, as shown in Figures 13A and 13B, the leader 1300 or 1310 may be a mesh structure such as a woven fabric, braid, knitted fabric, or nonwoven sheet. The leader may be tubular in shape, such as a hollow weave, as shown in Figure 13A, or a flat ribbon, as shown in Figure 13B. The leader may be stretchable so as to constrict to a smaller size when under tension. Furthermore, the tubular leader 1300 may be sufficiently flexible and flatten under tension, or its diameter may generally decrease due to the porosity and arrangement of the mesh 1302. The leader 1300 may have an open end 1304 that can be fitted over the distal end of a strap that is fixed as further described herein. In some examples, the leader may be a tubular braid made of Dacron®, which is a common thermoplastic polyester (polyethylene terephthalate), and the diameter of the tubular braid may be about 0.7 mm. Alternatively, the leader may be a monofilament or suture attached to the strap, and in other embodiments, the leader may be an integrally molded extension of the strap with a smaller cross-sectional area to facilitate passage through tissue.

[0070] In some cases, the leader may be made from a different material than the strap. In some cases, the leader may be made from the same material as the strap, but may have a different geometric configuration, such as a solid structure with a different cross-sectional shape than the mesh or strap. For example, the leader may be a wire or strip made of a metal such as stainless steel or nitinol. In some cases, the leader may be made from other materials, such as polyetheretherketone (PEEK) or polyethylene, or, for example, sutures. This will be further described in the Materials section below. The leader may have any length as desired. It may be desirable to select a leader length that depends on the anatomical structure and surgical procedure. For example, the leader may be long enough to reach through the curved path in the abdominal wall hernia surgical procedure described below, and obese individuals in particular may require longer leaders and straps compared to non-obese individuals. In some examples, the entire strap (for example, from the lock head to the needle) may be 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 longer, or 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 longer, or within the range defined by any two of these values, although other values ​​may be appropriate in some cases. The length of the leader may be a percentage of the length of the device (e.g., 50%), in which case the leader and the strap may be approximately the same length. Alternatively, for example, the length of the leader may be up to 75% of the length of the device, or it may be as small as about 25% of the length of the device. The length of the leader may be selected to make it easy to grasp and control while pulling the strap through various layers of tissue. After the strap is in place, the leader can be cut, and any excess length is simply discarded.However, if the leader is excessively long, it can become cumbersome, potentially hindering the surgery or excessively increasing material or manufacturing (parts or tools) costs. Similarly, after bringing the tissue into close proximity, the strap can be cut, leaving only a small portion of the distal end outside the lock head.

[0071] In part or all of the leader's length, its main cross-sectional width or diameter may be approximately 0.35 mm to approximately 2 mm, and may be larger in some applications. The leader has a width of approximately 0.3 mm over its entire length, the majority of its length, or part of its length. 2 and approximately 13mm 2 It may have a cross-sectional area between [the specified values]. However, it should be understood that the leader may have a cross-sectional area such that the ratio falls outside the range. For example, the leader may be a small diameter wire or suture with a diameter between 0.1 mm and 0.35 mm.

[0072] The proximal end of the leader may be connected to the distal end of the strap either after or during the molding of the strap portion, for example, by overmolding or by insert molding of the proximal end of the leader into the mold, or the entire device may be molded as a single unit. In the case of the strap portion, the proximal end of the leader may be overmolded onto the distal end of the strap portion. In some examples, the leader may be made of the same material as the strap portion. In some examples, the distal end of the strap portion may include an inserted metal member, and the proximal end of the leader may be connected to the inserted metal member. In some embodiments, the leader may be connected to the strap by other connections, such as tying a knot around the strap portion, or tying the leader through a hole in the strap portion, or both. The transition area may include the region where the strap and the leader connect. It may include the overlap between the leader and the strap portion. In some embodiments, the cross-sectional dimensions of the transition area may be similar to or smaller than those of the strap portion to allow insertion through layers of tissue and minimize resistance and tissue tearing. During the process of removing the leader and excess strap portion, the device may be cut at any point, while in some examples, the transition section may allow the leader to be separated from the strap portion. In such examples, the distal end of the strap portion may have a relief, notch, insertable joint or constraining joint, or similar feature that allows it to be pulled away by hand with less strength compared to the rest of the strap portion. That is, the leader can be separated from the strap portion by pulling it with a force greater than the force required to pull the strap through the body. For example, if a tensile force of x lb is required to pull the leader and strap through the body, and the tensile strength of the strap is 7.5 lb, a breaking force between approximately x lb and 7.5 lb may be desirable. Also, in some embodiments, the leader can be quickly released by the operator twisting or tearing it to separate it from the strap portion.

[0073] In examples where the leader is tubular or made of a mesh or other porous structure, applying a tensile load to the leader may cause its diameter to decrease. In such examples, the leader may grip the strap at the transition, thereby forming a low-profile joint. Referring to Figures 14A and 14B, as shown in Figure 14A, the strap portion 1421 may have a smaller diameter at its distal end in the transition 1423 to accommodate a relatively small leader 1427. In some examples, as shown in Figures 14A and 14B, the proximal end 1425 of the leader 1427 is opened during manufacturing before the leader 1427 is slid onto the transition 1423. The transition 1423 may have features such as one or more larger diameter bulges to hold the leader 1427 in place when the leader 1427 is not under tension, for example during manufacturing. When pulled under tension (for example, when it is passed through tissue), the leader may tend to decrease in diameter, thereby gripping the transition section 1423 of the strap. The leader 1427 may be tapered at the transition section 1423 to match the cross-sectional dimensions of the distal end of the strap section 1421, or the cross-sectional dimensions of the leader 1427 may be reduced. Alternatively, even if the leader 1427 has a smaller diameter or cross-sectional dimensions than the strap section 1421 during manufacturing, the leader 1427 may have a larger diameter at the transition section 1423, or the leader 1427 may be stretched to have a larger diameter. In strap designs such as those having a non-circular shape as shown in Figure 14A, “diameter” refers to the maximum cross-sectional dimension.

[0074] Figure 14B shows the leader 1427 advanced onto the strap portion 1421. In some examples, a small amount of adhesive 1429 can be applied to the proximal end 1425 of the leader 1427 to temporarily fasten it to the strap portion 1421. The adhesive 1429 can provide a constraint such that when the leader 1427 is pulled under tension and held by the adhesive bond, the diameter of the leader 1427 decreases or necks down to clamp the strap portion 1421. Thus, the adhesive 1429 works in cooperation with the tightening action to form a strong bond between the leader 1427 and the strap portion 1421, with the strength increasing with tension. The joint can be further strengthened by adding an adhesive layer that overlaps the leader 1427 with the strap portion 1421 and covers substantially the entire transition portion 1423 that is gripping it.

[0075] Furthermore, or alternatively, to further reinforce the joint, a heat-shrink fitting may be placed over the strap and leader, so that when heated, the heat-shrink fitting presses against the transition and holds the leader on the strap at the transition. In other examples, the leader may simply be joined to the strap, and the strap may be narrowed at the transition so as not to increase the thickness. Similarly, if the leader is a strip of material rather than a tubular structure, it may be joined to one side of the strap, heat-stake, thermally bonded, and / or ultrasonically welded to the strap. Other approaches for attaching the leader to the strap may also be suitable.

[0076] Any combination of methods for joining two elongated members, disclosed herein or known to those skilled in the art, can be used. In some examples, the crimp may be positioned around both the leader and the strap and be deformable to hold the two components together. Furthermore, in some examples, the mesh may be woven through or around the strap, or the leader may be looped and tied to the strap.

[0077] As yet another example, the leader may be a commercially available suture tied to the end of the strap via features such as holes, notches, steps, or other features for receiving sutures. Similarly, the leader may be a metal wire or 2D strip with low bending stiffness so that it can be manipulated in relatively confined spaces within the body. The wire or strip may be overmolded with the strap or otherwise attached to the strap using the method described herein or other methods well known to those skilled in the art.

[0078] As described above and as shown in Figure 14B, in some examples, when a tubular leader is prevented from moving away from the end of the strap, the leader tends to buckle radially like a finger trap when pulled, gripping the strap, and as a result, the strength of the joint increases as it is pulled. In the example in Figure 14B, adhesive is used to restrain (or temporarily fasten) the end of the leader, but Figures 15A-15D illustrate another means of restraining the leader by passing it through a hole in the strap and looping it. The device 1555 shown in Figure 15A has a hole 1558 that penetrates a portion near the distal end of the strap portion 1553 located on or near the transition portion 1552, where the strap portion 1553 has a reduced size. A portion of the proximal end 1559 of leader 1557 can be inserted through the hole 1558, as shown in Figures 15B and 15C, and then through the lumen of leader 1557, thereby positioning the proximal end 1559 inside leader 1557. The excess length of the proximal end 1559 of leader may be pulled out from the side of leader 1557 and the excess length cut off. Figure 15D illustrates the final configuration after leader 1557 is strongly pulled away from hole 1558, thereby tightening leader 1557 against strap portion 1553 at transition portion 1552, resulting in a smooth tapered portion with a dimensional and stiffness gradient from the stiffer strap portion 1553 towards leader 1557. Leader 1557 may have negligible and / or low bending stiffness.

[0079] In other examples, the leader may be fabricated as a continuous component with the strap. That is, the leader, strap, and even the lock head may be molded as a single component, so that the leader has a shape that results in lower bending stiffness than the strap. For example, the device may be extruded or molded so that the cross-sectional shape of the strap differs from that of the leader, thus having a variable cross-sectional shape. Alternatively, the leader may be attached to the strap after both components have been fabricated. Applicable joining techniques for such a method include, but are not limited to, adhesive bonding, ultrasonic welding, thermal scribing (thermal bonding), or welding or scribing in the case of metals. In some examples, the leader may be a mesh or fabric overmolded (or otherwise combined with) a soft plastic or elastomer. The overmolded portion may maintain flexibility and provide additional surface area to distribute the load over the tissue, which may help reduce the effect of the suture cutting through the tissue like a "cheese wire". A continuous, integrated leader provides the tensile strength necessary to maintain closure of the tissue defect.

[0080] The strap or its auxiliary components may have one or more colors and / or patterns that contrast with or are not typically seen in the human body, thereby allowing the operator 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 shade of each color. Furthermore, the leader or loop (or other protrusion) may be colored differently from the strap so that it can be easily identified within the body, as the operator may need to see the leader first in order to operate the device. As an example, a permanently implantable strap may be the natural color of the molded plastic, i.e., it may contain little to no coloring dyes to enhance long-term biocompatibility. Such plastics may appear white, slightly translucent, or off-white to yellow, for example, in a strap containing PEEK. The leader may be blue or orange to contrast with both the strap and the tissue within the body.

[0081] In some cases, it may be desirable to visualize a device or specific parts of a device, such as a reader, loop, lock head, or strap, within the body using X-ray (or fluoroscopy). One or more of these sections may be formed from radiopaque materials, such as metals like stainless steel or nitinol, or from radiopaque molds or plastics containing blends of radiopaque materials (such as barium sulfate, bismuth compounds, or metals like tungsten or steel). Those skilled in the art will recognize that there are numerous compounds and formulations that result in radiopaque polymers.

[0082] Self-locking straps may have a preferred orientation. For example, it may be desirable for the teeth of a self-locking strap to be positioned so that they abut the adjacent muscle, with the smooth side of the strap facing the abdominal cavity. This orientation provides a smooth interface to the sensitive intestinal tissue on the outside, while also providing a toothed surface that abuts the rectus abdominis muscle and rectus sheath, which can help hold the strap in place. Due to issues of image resolution, contrast, and glare, it may be difficult for the surgeon to visually determine the orientation of a surgical strap through a laparoscope. Therefore, a visible identifier on one side of the strap may help the surgeon identify each side of the strap. The identifier may include molded or colored letters, or a colored strip, provided on one side of the strap.

[0083] In some examples, the loop may have, or define, an overlap at or near its proximal end where the leader is joined to itself. The overlap may have slightly higher rigidity than the rest of the leader due to the doubling of the material and any additional adhesive or crimping elements. This gives the loop greater resistance to deformation when implanted in the body. That is, the added rigidity provides resistance to preventing the loop from moving away when a tool, such as a suture gripping forceps or snare, comes into contact with the loop. This can make gripping easier because the loop is less likely to detach from the tool when the tool engages with it. Those skilled in the art will recognize that many features that can enable gripping, such as one or more projections (e.g., balls), or notches, or zigzag tips, or "J" shaped tips, can be placed at or near the distal end of the leader. Such examples provide easily grippable features and still have a small size that allows insertion through small skin incisions or small holes in tissue. Multiple straps including a lamp

[0084] Figure 16A is a side view of the self-locking strap 1600, showing the position of the wedge 1623 (also referred to herein as the ramp) immediately adjacent to the lock head 1616. The self-locking strap 1600 may be suitable for robotic surgical procedures. The wedge 1623 is inclined downward from the level of the lock head 1616 toward the surface of the strap portion 1621. A leader 1617 can be attached to the distal end of the strap portion 1621. A needle 1622 can be attached to the distal end of the leader 1617. The needle 1622 may be a curved needle. Figure 16B is a bottom view of the self-locking strap 1600, showing the teeth 1624 exposed on the underside of the strap portion 1621.

[0085] Figures 17A-17C show enlarged views of the wedge 1623, indicating the location of the slot 1725 extending along the entire length of the lower aspect of the wedge 1623. Figure 17A shows a top view of the wedge 1623. Figure 17B shows an end view of the wedge 1623. Figure 17C shows a side view of the wedge 1623. The wedge 1626 may include the slot 1725. The dimensions of the slot 1725 can be set to interferentially fit with the strap portion 1621. Figure 17D shows that the distal end of the strap portion 1621 can be inserted into the slot 1725 of the wedge 1623. Figure 17E is a side view of the strap portion 1621 with the wedge 1623 located immediately distal to the strap's lock head 1616. Figure 17F is a bottom view showing the strap portion 1621 with the wedge 1723 in place.

[0086] In some examples, the ramp or wedge may be bioabsorbable. In such examples, when the self-locking strap is rotated to move the lock head away from the body cavity, the bioabsorbability of either the ramp or wedge may allow the lock head to act as a tissue anchor, thereby preventing further rotation of the self-locking ramp. A device for deploying a self-locking strap into a body cavity.

[0087] Refer to Figure 18, which depicts an apparatus 1800 according to this disclosure for delivering a self-locking strap. The apparatus 1800 may include a sheath 1802 and a push tube 1804. The sheath 1802 may be sized to accommodate a needle 1808. The needle 1808 may be a curved needle. The apparatus 1800 can be inserted into a robotic trocar, cannula, or trocar sleeve (hereinafter referred to as the "port"). To protect the needle 1808 from abrasion while it passes through the port, the needle 1808 may be positioned within the sheath 1802. The strap portion may be positioned within the cavity of the push tube 1804. The sheath 1802 may include an overhang portion 1812 located at the distal end of the push tube 1804. The needle 1808 can be accommodated within the overhang portion 1812. The illustrated assembly (e.g., needle 1808, leader 1810, sheath 1802, strap portion 1806, and push tube 1804) can be inserted into a laparoscopic access port or trocar. The port or trocar may 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 values. However, other values ​​may be suitable in some cases. In some examples, the port may have a size or diameter conventionally used for accessing the intraperitoneal space. Once in the intraperitoneal space, the needle 1808 can be pushed out into the body cavity from the overhang portion 1812 using the push tube 1804. Once inside the body cavity, the needle 1808 can be grasped and manipulated, for example, by a robotic surgical manipulator. The leader 1810 and strap portion 1806 can be drawn into the body cavity by pulling any portion of the leader 1810 that extends into the body cavity from the needle and / or device 1800.

[0088] In some examples, the needle 1808 may be made of a superelastic material, and therefore elastically deformable, so that it can return to its original shape (or a shape close to 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 include a thin-walled PTFE tube. Tensioner and cutter tool for cutting self-locking straps

[0089] For example, around an abdominal wall hernia defect, a self-locking strap must be attached and tightened, after which the excess strap must be removed. Conventional laparoscopic and robotic cutting instruments may not be able to effectively cut the strap. For example, high-frequency cutters are ineffective against plastic straps because the strap is non-conductive, and scissor-type cutters may not be strong enough to cut the strap because the strap may be made of metal or tough plastic material. Furthermore, it is preferable to maintain tension on the strap while cutting it. This is to facilitate cutting the strap and to ensure that the cut end of the strap is flush with the lock head or rather retracted so as not to protrude into the tissue. This tension can be achieved mechanically and / or physically by the operator applying a proximal force to the strap.

[0090] In some laparoscopic methods, the excess strap is passed through the lumen of a tensioner / cutter so that the tensioner / cutter contacts the lock head and provides a reaction force against it, and while the strap is being pulled through the tensioner / cutter to apply tension, the strap can be tightened and cut. When the excess strap is under tension, a cutting device at the distal end of the tensioner / cutter can cut the strap via a cam-operated blade or via a blade that cuts the strap as it rotates. In such a method, the surgeon can, for example, use grasping forceps to pull the excess strap, pass the excess strap through the lumen of the tensioner / cutter, and cut the excess strap while twisting the tensioner / cutter.

[0091] In robot-assisted surgery, the entire strap may be positioned within the body cavity and manipulated there by surgical robotic tools (e.g., grasping forceps). Self-locking straps may not be cut, resulting in a relatively long excess length of the strap, making it impractical or impossible to position the self-locking strap within the lumen of the tensioner / cutter.

[0092] Figures 19A-19C illustrate an example of a tensioner / cutter 1902 that can engage with a strap from within a body cavity. The tensioner / cutter 1902 may include an opening 1904 having a slot that allows a self-locking strap to be inserted into the tensioner / cutter 1902 from the side, and allows the end of the tensioner / cutter 1902 to slide along the self-locking strap and engage with the locking head of the self-locking strap. As shown in Figure 19C, the tensioner / cutter 1902 may include one or more blades 1906 at its distal end that can contact the strap when the tensioner / cutter 1902 is rotated relative to the self-locking strap, thereby cutting the strap at the locking head. The blades 1906 may be attached in a plastic device by welding, bonding, or molding (e.g., insert molding of the blades 1906). In some examples, the tensioner and cutter 1902 may further include a slot that allows the needle, leader, and / or strap portion to exit the 1902 and be grasped by a gripping forceps (e.g., a gripping forceps).

[0093] The slot may not extend along the entire length of the tensioner / cutter. Figures 20A-20C illustrate an example of a tensioner / cutter 2002 having an open side 2010 and a slot 2004 located only at the distal end of the tensioner / cutter 2002. The tensioner / cutter 2002 shown in Figure 20A allows the operator to insert the strap into the tensioner / cutter 2002 via a robotic grasping forceps. Figure 20B shows an end view of a tensioner / cutter 2002 having a blade 2006 at the distal end and configured to cut a self-locking strap by rotation. Figure 20C shows the same view of the tensioner / cutter 2002, with the strap portion 2008 located inside the tensioner / cutter 2002 and adjacent to the blade 2006. The slot 2004 in the tensioner / cutter 2002 may be dimensioned to have a tendency to hold the self-locking strap without requiring excessive force when inserting the self-locking strap into the tensioner / cutter. That is, the slot 2004 may have a slight interference fit with respect to the thickness of the self-locking strap, or a line-to-line fit, or be slightly oversized compared to the self-locking strap, so that the self-locking strap is aligned to some extent to enter and exit the slot.

[0094] In such examples with an integrated cutting blade, a tensioner without a cutting blade, similar to those shown in Figures 19A-19C and 20A-20C, can be used to secure the strap and twist the strap while it is being pulled under tension, thereby cleanly cutting the strap near the locking head.

[0095] In other examples, surgical scissors, particularly hook scissors (which may be referred to herein as strap clippers), may be appropriately used to cut the strap or leader. In some examples, laparoscopic hook scissors may be appropriately used to cut the strap or leader. Advantageously, hook scissors may prevent or restrain the strap or leader from slipping away during cutting. It should be understood that other devices for cutting the strap (and / or leader) may be appropriately implemented. For example, an RF cutter or an ultrasonic cutter may be used to cut the strap and / or leader. Methods for repairing tissue defects

[0096] Figures 21A–21G illustrate the steps for repairing a tissue defect from a view of the abdominal cavity. Figure 21A shows a laparoscopic view of the abdominal wall defect 2127 and the soft tissue margin 2128 surrounding the defect 2127 as the robotic needle holder 2126 inserts the curved needle 1622 into one side of the defect 2127. The strap 1600 is first introduced into the abdominal cavity, as shown in Figure 3 with respect to the self-locking strap 300. The leader 1617 and strap portion 1621 are positioned in the abdominal cavity at this point. Figure 21B shows the curved needle 1622 performing a stitch in the tissue 2128 on the contralateral aspect of the defect 2127. Figure 21C shows the strap portion 1621 being pulled into position in the tissue 2128 on both sides of the tissue defect 2127. Figure 21D shows the curved needle 1622 inserted through the lock head 1616. The curved needle 1622 and leader 1617 are pulled through the opening of the lock head 1616 until the toothed portion of the strap portion 1621 engages with the lock head 1616. In an alternative example, the leader may be cut before inserting the distal end of the strap portion 1621 through the lock head 1616. Figure 21E shows that the tension applied to the strap portion 1621 causes the self-locking strap to at least partially close the edge of the defect 2127. As described herein, the portion of the strap portion 1621 that protrudes from the lock head 1616 and leader 1617 can be cut from the strap 1600 after the strap 1600 has been fully tightened.

[0097] Multiple straps 1600 can be inserted along the defect 2127, and tension may be applied sequentially and / or stepwise to the straps 1600 to enable complete closure of the defect 2127. By using multiple straps spaced apart from each other, the force applied by the straps 1600 can be distributed across or along the defect 2127 and associated tissue 2128, reducing the likelihood of the straps 1600 damaging the engaged tissue 2128. Furthermore, the stepwise and / or sequential tensioning of the straps 1600 allows the engaged tissue 2128 to relax and / or adapt to the new tension applied by the straps 1600 at the new position or force. The relaxation period can prevent, reduce, inhibit, or mitigate tissue damage or tearing. When the process of sequentially applying tension to the multiple straps 1600 is carried out over a period of, for example, 10 to 15 minutes, the relaxation period allows the stress in the surrounding soft tissue 2128 to gradually relieve, preventing separation or tearing of the tissue 2128 by the strap portions 1621. Figure 21F illustrates the complete closure of the abdominal wall defect 2127 obtained following the sequential application of tension to the multiple self-locking straps 1600. Figure 21G shows that the multiple lock heads 1616 remain exposed in the abdominal cavity. The robotic needle holder 2126 may be used to rotate each strap 1600 about 180 degrees toward the lock head 1616, positioning each lock head 1616 in an anterior aspect of the abdominal wall (e.g., the side away from the abdominal cavity). Figure 21H illustrates a wedge 1623 that facilitates entry into an opening 2129 within the soft tissue, enabling the rectangular lock head 1616 to be rotated into the soft tissue 2128 with reduced force.

[0098] Figure 22 illustrates Method 2200, which consists of surgical steps used to close an abdominal wall defect using self-locking straps. The steps of Method 2200 can be performed using a robotic system. The steps include the stepwise sequential tensioning of multiple straps to reduce excess tissue tension during the closure of a large defect, and the rotation of the straps to remove the lock head from the abdominal cavity, thereby avoiding postoperative damage to the intestines and intra-abdominal organs and intra-abdominal blood vessels. Although Method 2200 is described in relation to the repair of an abdominal wall defect via the abdomen, it should be understood that this disclosure may also enable the repair of other tissue defects via other body cavities through a medial-to-lateral approach.

[0099] In step 2201, the self-locking strap is inserted into the abdominal cavity. Insertion of the self-locking strap into the abdominal cavity can be performed, for example, by the deployment device according to this disclosure.

[0100] In step 2202, the self-locking strap needle is inserted through the tissue on both sides of the abdominal wall defect. Step 2202 can be performed using a robotic needle holder. The needle is bendable.

[0101] In step 2204, the needle and leader are pulled so that the self-locking strap is centrally positioned across the abdominal wall defect.

[0102] In step 2206, optionally, insert the needle through the lock head of the strap, or if the needle is cut, insert the leader into the lock head, or if the leader is cut, insert the strap into the lock head.

[0103] In step 2208, pull the strap through the locking head to begin locking the strap. In some examples, the leader may be cut before step 2208.

[0104] In step 2210, an additional self-locking strap is positioned along the length of the missing portion, in accordance with steps 2201-2208.

[0105] In step 2212, each strap is tightened sequentially and / or stepwise to close the defect. Each strap may be tightened sequentially and / or stepwise so that no single strap exerts a greater force on the tissue surrounding the defect compared to the other straps. In some examples, the straps can be tightened from the first end of the defect toward the second end of the defect (for example, in a linear order, first tightening the first strap closest to the first end of the defect, then the next strap closest to the first strap, and so on, until the last strap closest to the second end of the defect). In some examples, the straps can be tightened from the center of the defect toward the first and second ends of the defect (for example, in a central-outward order, first tightening the first strap near the center of the defect, then the next strap near that first strap, and finally the last strap near the first and second ends of the defect). In some cases, the straps can be tightened from the first and second ends of the defect toward the center of the defect (for example, in an outward-to-center order, first tightening the first strap near the first and second ends of the defect, then tightening the next strap near the first strap, and finally tightening the last strap near the center of the defect).

[0106] In step 2214, the excess strap is cut at the point where it emerges from each lock head. Cutting the excess strap can advantageously reduce the profile of the strap extending into the body cavity of the individual.

[0107] In step 2216, optionally rotate each strap so that each lock head is facing forward. Each strap can be rotated by gripping it with the robotic needle holder.

[0108] Figure 23 shows an example of the final position of the strap's lock head 1616 in the anterior abdominal wall, following the rotation of the strap 1600 to move the lock head 1616 away from the abdominal cavity 114. The self-locking strap 1600 can penetrate the peritoneum 113.

[0109] Various examples of this disclosure provide, for example, self-locking straps for closing tissue defects such as abdominal wall hernias. The examples disclosed herein are not limited to applications to closing abdominal wall hernia defects, but may also be applied to fixation and / or abutment of soft tissue or bone defects, or other tissue and / or bone defects.

[0110] In some cases, as described above, the procedure may be performed with the assistance of a robotic system. In other cases, as described above, the procedure may be performed manually, i.e., as a manual laparoscopic procedure within the abdominal cavity.

[0111] In some cases, the procedure may be carried out using a self-locking strap including the ramp or wedge described above.

[0112] In other examples, the procedure may be performed using a self-locking strap that does not include either a ramp or a wedge.

[0113] In some cases, the procedure results in the lock head being in an intra-abdominal position after tightening a self-locking strap (or multiple self-locking straps). The lock head is moved forward by rotating or passing the tightened strap so that the lock head is away from or outside the abdominal cavity. As described above, this movement may be facilitated or facilitated by a ramp or wedge, but may also include a strap that does not include either a ramp or wedge.

[0114] In some cases, the ramp or wedge may be bioabsorbable or biodegradable, so that the ramp or wedge is absorbed or decomposed after the lock head, which includes the ramp or wedge, is repositioned to a forward position.

[0115] In some cases, the ramp or wedge does not need to be bioabsorbable or biodegradable, and as a result, the ramp or wedge is neither absorbed nor decomposed after the lock head equipped with the ramp or wedge is repositioned to a forward position.

[0116] In some examples, a repositioned lock head provides an anchor for the strap, ensuring that the tightened strap does not move or displace in either direction over time. In examples involving a wedge or ramp, the absorption or degradation of the wedge or ramp allows the lock head to have a bidirectional anchoring function.

[0117] 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. [Examples]

[0118] Exemplary surgical methods To illustrate some of the features of the self-locking strap in a surgical context, an example of the device in an abdominal wall hernia repair procedure is illustrated in Figures 24A–24M. This method may be performed by manual laparoscopic, robotic, or a combination of both approaches. In some of these methods, no part of the self-locking strap is positioned percutaneously even when the self-locking strap is manipulated around the tissue defect. The examples disclosed herein can be used in other surgical procedures requiring the proximity of tissues, such as muscles, fascia, skin, bone, and combinations thereof. The port or trocar may 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 values. However, other values ​​may be suitable in some cases. In particular, trocars with a diameter of 8 mm or more may be suitable for use with robotic grasping forceps.

[0119] Figure 24A shows a self-locking strap 2402 in preparation for robot-assisted laparoscopic abdominal wall closure. The self-locking strap 2402 may include a curved needle connected to a leader, which is further attached to the distal end of the strap. The strap is shown being grasped by a grasping forceps 2404 for insertion into the laparoscopic port. The grasping forceps 2404 are manual grasping forceps, but it should be understood that the procedure can also be performed using robotic grasping forceps as an alternative.

[0120] Figure 24B shows the self-locking strap 2402 in the abdominal cavity as displayed on a monitor showing live footage from a laparoscopic camera, after it has been inserted through the laparoscopic port. In Figure 24B, the self-locking strap 2402 is being grasped by a grasping forceps 2404.

[0121] Figure 24C shows the first robotic grasping forceps 2410 piercing the needle 2406 of the self-locking strap 2402 through the first opening in the posterior sheath 2414 of the rectus abdominis muscle on the first side of the defect 2408. The second robotic grasping forceps 2412 grasps the tissue surrounding the defect 2408.

[0122] Figure 24D shows the robotic grasping forceps 2410 inserting a needle into the middle of the defect 2408, illustrating the “double bite” technique. In other cases, depending on the curvature of the needle, reduction of the abdominal wall hernia may be performed with a single suture insertion.

[0123] Figure 24E shows the robot's grasping forceps withdrawing needle 2406 from the hole opposite the defect 2408. The second 2412 helps stabilize needle 2406 as it moves out of the tissue.

[0124] Figure 24F shows the first robotic grasping forceps 2410 pulling out the leader 2416 through the contralateral opening of the rectus abdominis sheath 2414 after the needle has emerged from the opening. The strap portion 2418 is located in the abdominal cavity.

[0125] Figure 24G shows that the strap portion 2418 is being pulled over the anterior portion of the defect 2408, i.e., that the strap portion 2418 is being pulled out from the opposite hole in the posterior sheath of the rectus abdominis muscle 2414 while the strap portion 2418 is being inserted through the first hole. The strap portion 2418 may be pre-curved along its longitudinal direction to indicate the appropriate orientation for looping around the defect. In some examples, the strap portion 2418 may be housed in a curved or circular shape that tends to shape the polymer material of the strap portion 2418 into a curved shape.

[0126] Figure 24H shows that the robotic grasping forceps 2410 has the distal end of the strap portion 2418 through the lock head 2420, with the strap portion 2418 pulled until it almost completely crosses the defect 2408.

[0127] Figure 24I shows that while the strap 2402 is being tightened by a pair of forceps 2410 and 2412, the substantially tightened strap 2402 is separated from the strap portion 2418, which is looped around the defect and engaged with the lock head 2420. Furthermore, a marking 2422 (e.g., a black stripe) indicating the orientation of the strap is illustrated on the strap. A pair of marks may be present on the strap portion 2418 and the lock head 2420 to indicate to the surgeon the correct orientation for inserting the strap portion 2418 into the lock head. For example, as illustrated, a mark may be provided on the lock head 2420 to instruct the surgeon that the mark on the strap should be aligned with the mark on the lock head to ensure proper alignment. In some examples, and also as shown in Figure 24I, the teeth of the strap portion 2418 are positioned on the side of the rectus abdominis muscle, and the smooth side of the strap faces the abdominal cavity. As described herein, other markings or geometric features may be provided on the strap and lock head to ensure proper orientation.

[0128] Figure 24J shows a robotic cutting tool 2424 for cutting off the excess length of the strap portion that extends beyond the lock head 2420. As described above, in other examples, a tensioner and cutter may be used, or a cutting blade may be integrated into the lock head 2420.

[0129] The diagram illustrates the application of a single self-locking strap; however, in ventral hernia repair, multiple straps may be used to gradually reduce the defect. Sequentially tightening multiple straps along the defect can be done in the relevant cases in the same manner as described for the single strap illustrated above.

[0130] In some cases, as shown in Figure 24J, a hybrid approach may be employed in which tensioners / cutters are introduced using additional laparoscopic access ports (or holes) instead of robotic cutters, and they can be operated in coordination with a surgical robot. For example, Figure 24K shows a tensioner / cutter 2426 being positioned into the abdominal cavity substantially laterally via a laparoscopic port 2428. The tensioner / cutter 2426 may allow the surgeon to pull on the leader and / or strap portion to apply tension to a self-locking strap. As shown, a portion of the leader and strap portion may be positioned percutaneously so that the surgeon can grasp the leader and / or strap portion. Figure 24L shows a first tensioner / cutter 2426 being inserted into the abdominal cavity between two robotic surgical ports 2430. The strap (and leader) can be positioned inside the tensioner / cutter 2426 from within the main body, especially when using a tensioner / cutter with a slot (which allows for lateral insertion of the strap as described above). In some examples, a self-locking strap can be introduced into the abdominal cavity using two robotic surgical ports 2430.

[0131] Figure 24M shows the tensioner / cutter 2426 in place on the self-locking strap 2402 and in contact with the lock head 2402. The tensioner / cutter 2426 may be positioned over the excess length of the strap portion of the self-locking strap 2402 by a combination of operating the tensioner / cutter 2426 from outside the body and operating the strap from inside the body using grasping forceps (e.g., robotic grasping forceps 2410 and / or 2412). The tensioner / cutter 2426 may have marks or other features visible to the operator on its outer surface to indicate the correct orientation to the alignment feature on the strap 2402 and / or lock head 2420. As shown, once the tensioner / cutter 2426 is in place with the strap portion passing through its lumen, the strap can be pulled with tension from outside the body while the tensioner / cutter is rotated, thereby cutting the strap. Tension can help the strap cut more cleanly, requiring a smaller twist angle before breakage compared to twisting without tension.

[0132] In some cases, the procedure results in the lock head being in an intra-abdominal position after tightening a self-locking strap (or multiple self-locking straps). In some other cases, the tightened strap can be rotated or passed through so that the lock head moves away from or outside the abdominal cavity. In some cases, the tightened strap can be rotated or passed through to move the lock head to an anterior position. This movement or rotation can be facilitated by manipulating the strap with grasping forceps or with a tensioner / cutter before cutting the strap.

Claims

1. Position the first self-locking strap near the abdominal wall hernia defect within the individual's abdominal cavity, Accessing the first side of the defect using the proximal end of the first self-locking strap having a locking head located on or near the distal end of the first self-locking strap, The proximal end of the first self-locking strap is inserted 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, The proximal end of the first self-locking strap is inserted 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, Moving the proximal end of the first self-locking strap through the locking head, To at least partially close the defect, the first self-locking strap is tightened, Methods for closing abdominal wall hernia defects, including those mentioned above.

2. The method according to claim 1, wherein the access, insertion, and movement steps are performed using a robotic system.

3. The method according to claim 2, comprising inserting one or more end effectors of the robotic system into the abdominal cavity via one or more trocars.

4. The method according to claim 3, wherein one or more end effectors of the robot system have either a grasping forceps or a needle holder or both.

5. The method according to claim 3 or 4, wherein the one or more trocars have at least one trocar with a diameter of 8 mm or more.

6. The method according to any one of claims 1 to 5, comprising cutting off at least a portion of the proximal end of the first self-locking strap.

7. The method according to claim 6, wherein the cutting of the portion of the proximal end is performed using a blade positioned within the locking head of the first self-locking strap.

8. The method according to claim 6, wherein the cutting of the portion of the proximal end is performed using a blade of a laparoscopic device.

9. The method according to claim 8, wherein the laparoscopic device comprises a laparoscopic cutting instrument.

10. The laparoscopic device according to claim 9, wherein the device has a hook-shaped scissors.

11. The first self-locking strap has a needle and a leader, the leader connecting the needle to the proximal end of the first self-locking strap, Inserting the needle into the first side of the abdominal wall hernia defect, Inserting the needle into the second side of the abdominal wall hernia defect, The method according to any one of claims 1 to 10, further comprising:

12. The method according to claim 11, further comprising cutting the leader.

13. The method according to claim 12, wherein the step of cutting the leader is performed using a laparoscopic cutting instrument.

14. The method according to any one of claims 11 to 13, wherein the needle is a curved needle.

15. The overlap between the leader and the strap portion includes a transition section, which is configured to reduce kinking of the self-locking strap. This includes traction of the transitional portion through the first side of the abdominal wall hernia defect and traction of the transitional portion through the second side of the abdominal wall hernia defect, The method according to any one of claims 11 to 14, wherein the transition portion causes dilation of the 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 within the linea alba.

17. The method according to any one of claims 1 to 16, wherein no portion of the first self-locking strap is positioned percutaneously during the insertion and movement steps of the first self-locking strap.

18. The method according to any one of claims 1 to 16, wherein the self-locking strap is positioned transcutaneously during the tightening step.

19. The method according to any one of claims 1 to 17, further comprising rotating the tightened first self-locking strap around the abdominal wall hernia defect so that the locking head is repositioned to a location other than within the abdominal cavity.

20. The method according to any one of claims 1 to 19, comprising inserting the self-closing strap through the posterior sheath of the rectus abdominis muscle.

21. The method according to any one of claims 1 to 20, comprising inserting the self-closing strap through the anterior sheath of the rectus abdominis muscle.

22. Placing multiple self-locking straps in the abdominal cavity near the abdominal wall hernia defect, Using the proximal end of each of the aforementioned self-locking straps, access is made to the first side of the abdominal wall hernia defect. The proximal end of each of the plurality of self-locking straps is inserted through the first side of the abdominal wall hernia defect, from a posterior position to an anterior position within the tissue adjacent to the abdominal wall hernia defect, wherein each self-locking strap is spaced apart from adjacent self-locking straps. Inserting the proximal end of each of the multiple self-locking straps from an anterior position to a posterior position within the tissue adjacent to the abdominal wall hernia defect, through the second side of the abdominal wall hernia defect, Moving each of the proximal ends of the self-locking straps through the locking head, To at least partially close the abdominal wall hernia defect, each of the self-locking straps is tightened, The method according to any one of claims 1 to 21, further comprising:

23. The method according to claim 22, further comprising moving each of the tightened self-locking straps around the abdominal wall hernia defect so that each of the locking heads of each of the plurality of self-locking straps is no longer located in the abdominal cavity.

24. The method according to claim 22 or 23, comprising individually and at least partially tightening each of the plurality of self-locking straps.

25. The method according to any one of claims 22 to 24, comprising: at least partially tightening each of the plurality of self-locking straps in a sequence including at least partially tightening the first self-locking strap; and then at least partially tightening each of the remaining self-locking straps of the plurality of self-locking straps.

26. The method according to any one of claims 22 to 25, comprising tightening at least partially each of the self-locking straps in a predetermined order.

27. The method according to claim 26, wherein the sequence includes at least partially tightening the first self-locking strap and at least partially tightening a self-locking strap adjacent to the first self-locking strap.

28. The method according to claim 26, wherein the sequence includes tightening each of the plurality of straps at least partially in a linear sequence 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 straps in a central-to-outer sequence from the center of the abdominal wall hernia defect toward the edges of the abdominal wall hernia defect.

30. The method according to claim 26, wherein the sequence includes tightening each of the plurality of straps at least partially in an outward-to-center order from the end of the abdominal wall hernia defect toward the center of the abdominal wall hernia defect.

31. The method according to any one of claims 22 to 30, comprising tightening each strap two or more times, wherein each strap is tightened in stages.

32. The method according to one or more claims of 31, further comprising providing a relaxation period between the first tightening of each strap and the second tightening of each strap.

33. The method according to any one of claims 22 to 32, wherein the plurality of self-locking straps are configured to distribute the tightening force generated when the plurality of self-locking straps are tightened substantially along the longitudinal direction of the abdominal wall hernia defect.

34. The method according to any one of claims 22 to 33, wherein the plurality of self-locking straps are configured to prevent, reduce, suppress, or improve damage to the tissue engaged by each of the plurality of self-locking straps during the tightening of each strap.

35. The method according to any one of claims 1 to 34, wherein the locking head of the first self-locking strap is a low-profile locking head, the strap portion includes a ramp-shaped portion extending from the strap portion to the low-profile locking head, and the ramp-shaped 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 strap includes a ramp or wedge adjacent to the proximal side of the locking head, the ramp or wedge having an inclined portion that engages with the muscle tissue surrounding the abdominal wall hernia defect.

37. Position a first self-locking strap, including a leader, a strap portion, and a locking head configured to be positioned on the strap portion and fastened to the strap portion, near a soft tissue defect so that it fits completely within the body cavity of the individual. By tightening the first self-locking strap around the soft tissue defect, the two sides of the soft tissue defect are brought together. A method for closing soft tissue defects, including [specific method / technique].

38. The method according to claim 37, wherein the tightening step is performed using a robotic system.

39. The method according to claim 38, comprising inserting one or more end effectors of the robot system into the body cavity via one or more trocars.

40. The method according to any one of claims 37 to 39, comprising cutting at least a portion of the self-locking strap using a laparoscopic device.

41. The method according to claim 40, wherein the laparoscopic device has surgical scissors.

42. The method according to claim 41, wherein the laparoscopic device has hook-shaped scissors.

43. The overlap between the leader and the strap portion has a transition section, and the transition section is configured to reduce kinking of the self-locking strap. The transition area is pulled through the first side of the abdominal wall hernia defect, This includes traction of the transitional portion through the second side of the abdominal wall hernia defect, The method according to any one of claims 37 to 42, wherein the transition portion causes dilation of the 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 the tightened self-locking strap around the soft tissue defect so that the locking head is repositioned to a location other than within the body cavity.

45. Multiple self-locking straps, each of the self-locking straps is The leader, The strap part, A device having a lock head positioned on the strap portion and configured to be fastened with the strap portion, A strap deployment device configured to deploy at least one of the plurality of self-locking straps into the body cavity of an individual, Laparoscopic cutting instruments, A kit for closing soft tissue defects, equipped with [specific components / features].

46. The kit according to claim 45, wherein the laparoscopic cutting instrument comprises surgical scissors.

47. The kit according to claim 46, wherein the laparoscopic device has hook-shaped scissors.

48. The kit according to any one of claims 45 to 47, wherein the locking head of the first self-locking strap is a low-profile locking head, and the strap portion has a ramp-shaped portion extending from the strap portion to the low-profile locking head, the ramp-shaped portion being configured to engage with 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 strap has a ramp or wedge adjacent to the proximal side of the locking head, the ramp or wedge having an inclined portion configured to engage with the tissue near the soft tissue defect.

50. The kit according to any one of claims 45 to 49, wherein the width of the strap 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 leader and the strap portion has a transition portion, the transition portion is configured to reduce kinking of the self-locking strap, and the transition portion is configured to cause expansion of a hole in the tissue surrounding the soft tissue defect.

Images