Medical systems, devices and methods suitable for tissue fixation and approximation of tissue defects

Abstract

To provide an improved strap having one-way locking (knotless) characteristics suitable for gathering tissue, such as closing a hernia defect.SOLUTION: The device 1 includes a locking head 5 at a proximal end, a strap 3 extending from the locking head 5, and a leader 7 extending from the strap 3. The leader 7 may have a loop 9 or other protuberance at its distal end to facilitate grasping during a surgical procedure, or alternatively, the leader 7 may have a distal end without a grasping feature in some embodiments, as it may be easily grasped by some surgical tools even without an engagement feature at the end. In general, leader 7 may be grasped anywhere along its length by any common tool used to grasp sutures.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] [Inventor] Albert K. Chin, a United States citizen residing in Palo Alto, California; Thomas A. Kramer, a United States citizen residing in San Carlos, California; Gannon Borchers, a United States citizen residing in San Francisco, California; Peter Bugos, a United States citizen residing in Redwood City, California; [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to U.S. Provisional Patent Application No. 62 / 965,988, filed January 26, 2020, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to medical devices and methods, and more particularly to straps having one-way locking (knotless) properties suitable for approximating tissue, such as to close hernia defects. [Background technology]

[0003] Sutures are commonly used to reappose tissues and hold them in a desired configuration until they can heal together. Initially, sutures provide maximum strength for the repair, but as the tissue heals, they become largely redundant. Depending on the anatomical region where the suture is placed, natural forces may exist that pull the tissue apart, slowing or preventing healing. Traditional sutures provide a circular or single-point cross-sectional shape that does not effectively distribute force, concentrating the force like slicing cheese by threading a taut wire through a relatively soft cheese material. Such limitations of sutures are common to many surgical applications, but are particularly common in repairing large defects such as abdominal hernias or other repairs where significant forces are exerted on the suture.

[0004] A ventral hernia is an abdominal wall defect that typically occurs after failure of closure of a midline incision from a previous open surgery. Between 350,000 and 500,000 ventral hernias are repaired annually in the United States. In these cases, the defect may be greater than 10 cm wide, greater than 40 cm long, and extend below the xiphoid process of the sternum toward the pubic symphysis. They can be repaired using traditional "open" surgical procedures, which require a large incision, or laparoscopic procedures, which require a small abdominal incision. Ventral hernias can occur after a patient has undergone abdominal surgery. For example, upon completion of an open surgical procedure, full-thickness abdominal wall closure is performed. Interrupted sutures are placed through the anterior rectus sheath, rectus muscles, and posterior rectus sheath. Suture repair has a long-term failure rate of 41% to 52%, leading to ventral hernia formation. Poor tissue strength, combined with significant tension in the suture lines, leads to failure of abdominal closure, which requires hernia repair.

[0005] In traditional laparoscopic repair, multiple trocar ports are inserted and large patches of synthetic mesh are placed to cover the defect. This technique avoids large abdominal incisions and can result in significantly less postoperative pain compared to open procedures. However, abdominal defects are typically not closed; rather, large synthetic patches are applied to the inner surface of the abdominal wall to cover the defect. The placement of large prostheses increases the incidence of postoperative complications, such as seroma formation. Fluid pockets of seroma then increase the likelihood of infection of the laparoscopically placed mesh, necessitating antibiotic therapy in addition to its removal. Intestinal adhesions are also a potential complication of implanting large foreign body patches.

[0006] At the surgeon's discretion, it may be desirable to partially or completely close the abdominal defect using laparoscopic techniques, significantly reducing the size of the artificial mesh patch required to repair the ventral hernia or eliminating its use. U.S. Patent No. 9,055,940 (incorporated herein in its entirety) describes a system and technique that uses a capture device to puncture the abdominal wall on both sides of the hernia defect and grasp the ends of a suture delivered into the abdominal cavity. One end of the suture is withdrawn from the body, and a capture device is tunneled subcutaneously from the first end of the suture to grasp the opposite end of the suture and deliver it to the first puncture site. The suture is then tied at the first puncture site, and the knot is inserted through the skin to the level of the anterior rectus sheath, where tension can be applied to close the hernia defect. This technique is repeated for each interrupted suture placed during ventral hernia closure. Using a relatively narrow 2cm spacing between sutures to increase repair strength, 14 interrupted sutures are required to close a 30cm-long hernia defect. For larger defects, sequential tensioning of the sutures is necessary to gently reappose the edges, otherwise the sutures may tear the abdominal wall tissue. To allow for sequential tensioning of individual sutures, slipknots, including double knots, are typically used. Continuous tension must be maintained on all sutures during the tightening and closure process. This can be accomplished by applying surgical forceps immediately proximal to each slipknot after each sequential tensioning step. However, this results in an excessive number of surgical forceps in the surgical field.

[0007] The aforementioned hernia defect closure techniques are very laborious. The placement of each interrupted suture involves at least 12 surgical manipulation steps that must be performed for each of the 10 or more sutures placed in the patient.

[0008] It is desirable that laparoscopic techniques and instruments allow for the placement of multiple interrupted fixation devices on each side of the hernia defect, with sequential tightening of each device to reappose the edges of the defect. Additionally, it is desirable that the devices have a larger tissue contact area than traditional sutures, reducing or preventing the devices from dissecting, pulling, or tearing tissue. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] U.S. Patent No. 9,055,940 Summary of the Invention

[0010] A medical device for approximating and securing tissue without the need for knots includes a locking head, strap portions, distal ridges, and a leader portion. The device also includes a transition portion between the leader and strap portions and a reinforcing portion proximal to the ridges. The leader portion is used to pull the strap portions through small openings in tissue into the patient, and the transition portion provides a gradual transition in stiffness and size between the leader and strap portions. In some embodiments, multiple medical devices are provided, each including a transition portion between the leader and strap portions, a reinforcing portion, and a locking head for receiving a distal end of a strap, the locking head allowing translational movement therethrough in one direction but preventing translational movement of the strap through the locking head in the opposite direction. The multiple medical devices can be used to secure and approximate a soft tissue defect, with the multiple straps securing the soft tissue defect at spaced apart positions. In some embodiments, the resulting multiple straps can be fastened to close or approximate the soft tissue defect. In some embodiments, the multiple straps can be fastened sequentially and sequentially to achieve incremental approximation of the soft tissue defect.

[0011] Embodiments of medical devices, systems, and methods for approximating and securing tissue without the need for knots include a locking head, a strap portion, a distal ridge, and a leader portion. The device also includes a transition portion between the leader and strap portion and a reinforcing portion proximal to the ridge. The leader portion is used to pull the strap portion through a small opening in the tissue and into the body, and the transition portion provides a gradual transition in stiffness and size between the leader and strap portion. A tensioner and cutter are provided, as well as a threading tool configured to be slidably removed from the lumen of the tensioner and cutter. A blade is provided within the lumen of the tensioner and cutter for cutting off excess leader and / or strap when the procedure is complete.

[0012] The foregoing will be apparent from the following more particular description of exemplary embodiments of the invention, as illustrated in the accompanying drawings, in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments of the invention. [Brief explanation of the drawings]

[0013] [Figure 1] 1 illustrates one embodiment of a device for approximating tissue in accordance with embodiments of the present disclosure. [Figure 2A] 10A-10C illustrate segments of one embodiment of a locking feature for a strap. [Figure 2B] 10A-10C illustrate segments of one embodiment of a locking feature for a strap. [Figure 2C] 10A-10C illustrate segments of one embodiment of a locking feature for a strap. [Figure 2D] 10A-10C illustrate segments of one embodiment of a locking feature for a strap. [Figure 2E] 10A-10C illustrate segments of one embodiment of a locking feature for a strap. [Figure 2F] 10A-10C illustrate segments of one embodiment of a locking feature for a strap. [Figure 2G] 10A-10C illustrate segments of one embodiment of a locking feature for a strap. [Figure 3] FIG. 10 is a cross-sectional view of an embodiment of a locking head. [Figure 4] FIG. 10 is a cross-sectional view of another embodiment of a locking head. [Figure 5A] 1 is a perspective view of an embodiment of a locking head and strap; FIG. [Figure 5B] 10A is a side cross-sectional view of an embodiment of a lock head and strap. FIG. [Figure 6] FIG. 10 is a cross-sectional cutaway view of one embodiment of a locking head including a ball. [Figure 7A] FIG. 10 is a cross-sectional cutaway view of one embodiment of a low-profile, in-line lock head. [Figure 7B] FIG. 1 is a perspective cutaway view of one embodiment of a low-profile, in-line lock head. [Figure 8] 10A-10C illustrate an embodiment of an auto-locking strap embodiment. [Figure 9A] FIG. 1 is a diagram of the anatomical location of a ventral hernia. [Figure 9B] 1 is an anatomical cross-sectional view of a ventral hernia. [Figure 10] FIG. 10 is a cross-sectional cutaway view of one embodiment of a self-locking strap with distal strap retention features. [Figure 11A] FIG. 1 is a side cutaway view of one embodiment of a mesh leader. [Figure 11B] FIG. 1 is a side cutaway view of one embodiment of a mesh leader. [Figure 12A] FIG. 10 is a top cutaway view of one embodiment of a method for attaching a reader to a strap. [Figure 12B] FIG. 10 is a top cutaway view of one embodiment of a method for attaching a reader to a strap. [Figure 13A] 1A-1C are side and top cutaway views of one embodiment of a method for attaching a reader to a strap. [Figure 13B] 1A-1C are side and top cutaway views of one embodiment of a method for attaching a reader to a strap. [Figure 13C] 1A-1C are side and top cutaway views of one embodiment of a method for attaching a reader to a strap. [Figure 13D] 1A-1C are side and top cutaway views of one embodiment of a method for attaching a reader to a strap. [Figure 14] FIG. 10 is a top cross-sectional view of one embodiment of a leader having a reinforced zone. [Figure 15] FIG. 10 is a side cutaway view of one embodiment of a distal loop attached to a suture passer. [Figure 16] FIG. 10 is a side cutaway view of one embodiment of a double loop at the distal end of a leader. [Figure 17] FIG. 10 is a top view of an embodiment of a strap packaged in a rolled tube. [Figure 18A] FIG. 10 is a side view of one embodiment of a mesh strap with an attached needle and locking head. [Figure 18B] 19B is a side exploded view of one embodiment of a mesh strap with needles and a locking head of FIG. 19A. FIG. [Figure 18C] FIG. 10 is a side cutaway view of one embodiment of a mesh strap with attached needles and locking heads. [Figure 18D] 19D is a side exploded cutaway view of one embodiment of a mesh strap with needles and a locking head of FIG. 19C. [Figure 19A] FIG. 10 is a side cutaway view of one embodiment of a mesh strap attached to a lock head. [Figure 19B] FIG. 10 is a side cutaway view of one embodiment of a mesh strap attached to a lock head. [Figure 20A] 10A-10C illustrate an embodiment of an engagement arrangement for a locking head and a strap. [Figure 20B] 10A-10C illustrate an embodiment of an engagement arrangement for a locking head and a strap. [Figure 20C] 10A-10C illustrate an embodiment of an engagement arrangement for a locking head and a strap. [Figure 21]FIG. 10 is a cross-sectional cutaway view of one embodiment of a lock head having a cantilever beam. [Figure 22A] 10A-10C are side, cross-sectional and cutaway views of one embodiment of a locking head having a collar suitable for mesh or elastic straps. [Figure 22B] 10A-10C are side, cross-sectional and cutaway views of one embodiment of a locking head having a collar suitable for mesh or elastic straps. [Figure 23A] FIG. 13 is a perspective view of one embodiment of a non-attached locking head suitable for mesh or elastic straps. [Figure 23B] FIG. 10 is a side cross-sectional view of one embodiment of a non-attached locking head suitable for mesh or elastic straps. [Figure 24] FIG. 16 is a perspective cutaway view of one embodiment of a crimp-attachable locking head. [Figure 25] FIG. 12 is a perspective view of one embodiment of a locking head having a biased one-way lever. [Figure 26] FIG. 1 is a perspective cutaway view of one embodiment of a dual cam lock head. [Figure 27A] FIG. 1 is a perspective view of one embodiment of a single cam lock head. [Figure 27B] FIG. 1 is a perspective view of one embodiment of a single cam lock head. [Figure 28A] FIG. 13 is a perspective view of one embodiment of a locking head having teeth suitable for mesh or elastic straps. [Figure 28B] FIG. 10 is a side cross-sectional view of one embodiment of a locking head having teeth suitable for mesh or elastic straps. [Figure 29A] FIG. 1 is a perspective view of one embodiment of a locking head including a toothed buckle. [Figure 29B] FIG. 10 is a side cross-sectional view of one embodiment of a lock head including a toothed buckle. [Figure 30A] FIG. 10 is a perspective view of one embodiment of a strap received within a locking head. [Figure 30B] FIG. 30B illustrates the embodiment of FIG. 30A for circumferential fastening of tissue. [Figure 31A]10A-10C illustrate an embodiment of a device having a locking head with teeth for gripping a strap and allowing unidirectional movement of the strap through the locking head. [Figure 31B] FIG. 31B is a side view of the embodiment of FIG. 31A. [Figure 32] 1A-1D illustrate exemplary surgical systems, devices, and methods for ventral hernia approximation or closure. [Figure 33A] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 33B] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 33C] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 33D] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 33E] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 33F] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 33G] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 33H] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 34A] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 34B] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 34C] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 34D] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 34E] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 34F]1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 34G] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 35A] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 35B] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 35C] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 35D] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 35E] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 35F] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 35G] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 35H] 1A-1D illustrate exemplary condensation and fixation steps of a ventral hernia procedure. [Figure 36A] FIG. 2 is a side view of an exemplary tensioner and cutter of the present invention. [Figure 36B] FIG. 1 is a perspective cutaway view of the proximal end of an exemplary tensioner and cutter of the present invention. [Figure 36C] FIG. 1 is a perspective cutaway view of the distal end of an exemplary tensioner and cutter of the present invention. [Figure 37] FIG. 10 is a side cutaway view of an exemplary threading tool of the present invention disposed within an exemplary tensioner and cutter lumen. [Figure 38A] FIG. 1 illustrates an exemplary ratchet system prior to latching. [Figure 38B] FIG. 10 is a diagram showing the amount of backlash in a ratchet system. [Figure 38C] FIG. 10 shows the ratchet system with the teeth fully engaged and locked. [Figure 39A] 1 illustrates an exemplary tensioner and cutter of the present invention. [Figure 39B] 1 illustrates an exemplary tensioner and cutter of the present invention. [Figure 39C] 1 illustrates an exemplary tensioner and cutter of the present invention. [Figure 40] 10A-10C illustrate an exemplary sliding spring mechanism for providing a compliance gap for the tensioner and cutter. [Figure 41] 10A-10C illustrate an exemplary spring and foam mechanism for providing a compliance gap for the tensioner and cutter. DETAILED DESCRIPTION OF THE INVENTION

[0014] While the invention is susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail herein. It is to be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, all modifications, equivalents, and alternatives are intended to fall within the spirit and scope of the invention.

[0015] Exemplary embodiments of the present invention are described below. Certain terminology is used in the following description for convenience and is not intended to be limiting. The words "proximal" and "distal" refer to directions toward and away from the surgeon using the surgical instrument or device, respectively. The words "anterior," "posterior," "superior," and "inferior" refer to location and orientation relative to the human body.

[0016] Devices and methods for manufacturing surgical straps (the present devices) are presented herein. At least a portion of the straps may be permanent implants that hold wounds in place within the body, or they may be temporary implants that, for example, hold skin together like sutures to allow healing. The disclosed embodiments can be used to bring any type of tissue together within the body where sutures, wires, staples, or straps are used. Applications include orthopedic bone joining, such as in sternotomy, hernia repair, and general wound closure. For illustrative purposes, the present disclosure describes devices and methods related to hernia repair, particularly ventral hernia repair. However, the disclosed devices and methods can be used in any surgical procedure to join tissue, close an opening or defect in tissue, or secure a device to or between two or more sections of tissue.

[0017] Referring to FIG. 1 , a first exemplary embodiment of a device 1 for closing a tissue opening is shown. The device includes a locking head 5 at its proximal end, a strap 3 extending from the locking head 5, and a leader 7 extending from the strap 3. The leader 7 may have a loop 9 or other ridge at its distal end to facilitate grasping during a surgical procedure. Alternatively, the leader 7 may have a distal end without a grasping feature in some embodiments, since it can be easily grasped by some surgical tools even without an engagement feature at the end. Generally, the leader 7 can be grasped anywhere along its length with any common tool used to grasp sutures, although depending on the procedure and available surgical tools, it may be easier, quicker, or more convenient to grasp a loop or other distinctive feature at the distal end. Because the leader 7 has a smaller cross-section and / or outer diameter than at least a portion of the strap 3, less force is generally required to pull the leader 7 through multiple layers of tissue.

[0018] 2A-2G illustrate embodiments of straps, commonly referred to as zip ties or cable ties, that have features along their length that engage with a locking head to allow movement in only one direction. Device 1 can be fastened around the tissue sections to be retracted, and the device will retain tension without the surgeon needing to hold the device or tie a knot. This is an important feature of certain embodiments of the invention described herein, as it allows the surgeon to at least partially fasten device 1 while engaging in other tasks. The surgeon can then return to the at least partially fastened device 1 and continue the fastening process and / or the remainder of the procedure. Accordingly, embodiments of the invention described may be considered "knotless," e.g., slipknot-free, and / or "clampless," i.e., not requiring clamping to achieve the above. As further described below, such a configuration allows for continuous tightening or fastening of device 1, which may be advantageous in several ways, including for the reasons described above. Furthermore, if two or more straps 3 are required, each associated device 1 and strap 3 may be fastened at least partially in series, allowing the surgeon great flexibility in the fastening or fastening technique.

[0019] In one embodiment, the strap 13 may have an opposing surface with angled teeth 11 on one side and a relatively smooth opposing surface, similar to a conventional cable tie, as shown in FIG. 2A.

[0020] In another embodiment, strap 15 may have teeth 17 and 18 on opposite sides, as shown in Figure 2B, which may be staggered (not shown) to avoid thinning the cross section of strap 15.

[0021] 2C shows one embodiment of a strap 19 having a hole 21 that engages a pawl or other feature of the locking head 5. This strap 19 may be easy to fabricate, with a relatively simple and low-cost injection mold, because the orientation of the hole 21 is perpendicular to the strap 19. The hole 21 may, in some embodiments, extend completely through the strap 19, or may not extend through the strap 19 but may comprise a pocket defined within the strap having a thickness less than that of the strap 19, as shown. In this embodiment, the locking head 5 would include a feature that forces a unidirectional fastening action or transition of the strap 19 through the locking head 5.

[0022] In some embodiments, the strap may lack a separate locking feature. FIG. 2D shows such a strap 23 having a substantially smooth surface on at least one of its opposing sides that can engage with a locking head having teeth, cams, tines, or other features that facilitate one-way locking by using friction to hook, grab, grip, or otherwise impinge on the strap to grip. Elastomeric straps may be smooth, for example, as shown in FIG. 2D. Some strap embodiments may be fully elastic or include elastic elements that can continue to provide pressure to tissue as it contracts or relaxes after surgery. Elastic straps may be made of rubber-like materials such as thermoplastic elastomers (TPEs) or silicone.

[0023] 2E shows another embodiment having side rails 28 on at least one opposing side of the strap 27 opposite the teeth 29. The side rails 28 add strength and rigidity to the strap 27. The side rails 28 may extend the length of the strap 27, or alternatively, may extend along a portion of the strap 27.

[0024] In some embodiments, the engagement features on the strap may have gaps. For example, Figure 2F shows a strap 31 having teeth 33 separated by gaps 37, which may be flats or voids or pockets as described above in connection with Figure 2C. The strap 31 may also include side rails 35 as described in connection with Figure 2E.

[0025] Other embodiments, including those disclosed above, may have multiple sets or portions of teeth 451, including one or more teeth 43 or other engagement features, longitudinally separated or spaced apart by gaps 41, as shown in FIG. 2G. This configuration allows the strap 39 to advance freely between the toothed portions 43 with little resistance between the spaced apart portions of teeth 45, allowing for easier fastening without added resistance when the strap is still loose against the anatomy. Additionally, the gaps 41 also serve to reduce the number of impacts that individual strap teeth 43 make with the locking mechanism of the lock head. For example, when an operator fastens a long strap, each tooth 43 of the strap 39 may contact a tooth in the lock head, subjecting the teeth to repeated stress and potential wear, potentially reducing the retention strength of the lock head. Therefore, the intermittent toothed portions 451 reduce the number of contacts between the teeth 43 in the lock head during fastening, resulting in less wear and greater strength. Finally, fewer teeth on the strap can reduce the cost and complexity of manufacturing in processes such as injection molding, as molding long, thin teeth, like those on long cable ties, can require expensive tooling.

[0026] In some embodiments, there may be teeth 451 with a longitudinal length, followed by a gap, followed by one or more portions of teeth 451 with additional longitudinal lengths. The lengths of the teeth 451 may be substantially equal or may vary, as would be understood by one skilled in the art. One exemplary length for the teeth 451 may include approximately 25 mm, but one skilled in the art would readily understand that other lengths may be implemented, each within the scope of the present invention. This configuration allows the surgeon to easily slide the strap 39 through the locking head and then release the device upon engagement with the teeth 451, allowing the device to remain in place while the surgeon applies another self-locking device to the wound. The surgeon can then further tighten the strap around the wound to engage the next set of teeth 451 spaced closer together (with a smaller circumference). The above approach is also possible with straps having engagement features substantially all along their length. However, having smaller engagement features or intermittent engagements may have manufacturing or cost advantages as the tooling required to make the features may be simpler.

[0027] The strap embodiments disclosed herein serve as examples, and one skilled in the art will recognize that there are many strap designs that, when combined with various locking head designs, provide one-way knotless and clampless locking capabilities, all of which are within the scope of the invention disclosed herein. Further, as one skilled in the art will recognize, various combinations of the foregoing embodiments are contemplated; for example, as shown in FIG. 2C, strap 19 having aperture 21 can also include side rails 28 similar to those in FIG. 2E.

[0028] Reference is now made to FIGS. 3-7B, which illustrate various examples of locking heads. FIG. 3 shows a cross-sectional view of a locking head 51 attached to the proximal end of a strap 52. The locking head 51 has a resilient hinge 53 such that, as the strap 52 (partially shown) passes through a channel 63 in the direction of arrow 61, a pawl 65 flexes to allow the strap to pass. When the strap 52 is pulled in the direction opposite to arrow 61, the teeth of the strap engage with the teeth 59 of the locking head 51, thus preventing the strap 52 from passing through. When the strap is held taut, the force of the strap 52 on the teeth 59 causes the pawl 65 to flex in the opposite direction about the apex 54. As a result, the teeth 59 tend to align with the strap 52 as it passes through the locking head 51, resulting in more of the teeth 59 engaging the teeth of the strap 52 (not shown) in the direction opposite to arrow 61. In yet another embodiment, as shown in FIG. 4, a locking head 71 has teeth 79 that are substantially parallel to the transverse direction 73 of the strap 72. Resilient hinge 75 allows pawl 77 to bend out of the way as strap 72 passes through channel 74 in the direction of arrow 73, and then bend back to the orientation shown so that teeth 79 are substantially parallel to the teeth of the strap, allowing the teeth to engage the strap (not shown).

[0029] 5A and 5B show cross-sectional views of one embodiment of a locking head 81 having a tab 83 that engages with a gap 87 in a strap 82. The tab 83 can be angled to allow the strap 82 to traverse through the channel 85 in the direction of arrow 89 while preventing rearward movement to achieve a one-way locking action. FIG. 5B shows another cross-sectional view of this embodiment with the tab 83 engaged with the gap 87 in the strap 82. This embodiment of a locking head 81 having one or more tabs 83 is generally suited to strap designs having holes, i.e., notches or partial cuts in the strap, as shown in FIG. 2C, although this type of locking head is also suited to toothed designs.

[0030] Straps may also be locked using balls and wedges, much like a clutch that can lock the strap with significant force and little or no backlash when transitioning from sliding to holding. FIG. 6 shows a locking head 91 with a ball 95 locked between an inclined surface 93 and a strap 100. When the strap 100 is pulled in a fastening direction 99, the ball 95 displaces in the same direction 97, away from the inclined surface 93, allowing the strap 100 to move freely. When the strap 100 is released by the operator, the ball 95 abuts the inclined surface 93, pressing it against the strap 100, preventing movement in the opposite direction and clamping the strap 100 between the ball 95 and a bottom wall 98 of the locking head 91. The ball 95 may alternatively be cylindrical in some embodiments to apply a line load to the strap 100 rather than a point load, and it 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 fabric, woven, or textile strap materials that do not have sufficient distinct features for locking on. Additionally, features to improve friction can be added to the strap 100 or the locking head 91 that contacts the strap 100, including, but not limited to, the exemplary straps shown in Figures 2C, 2D, 2F, 2G, and 11B. Such features include, but are not limited to, surface roughness, texture, knurling, grating, bumps, or gradient bumps.

[0031] One embodiment with a low-profile, in-line locking head is shown in FIGS. 7A-7B. The locking head 101 has a channel 103 that is substantially parallel to the proximal portion of the strap 109, such that as the strap 109 passes through the locking head 101 in the direction of arrow 107, the distal strap (not shown) is substantially adjacent (e.g., parallel) to the proximal strap 109 (similar to the configuration shown in FIG. 20B). In this configuration, the teeth 105 are relatively aligned with the proximal end of the strap 109, so that after the strap is inserted and cut, the remaining strap protruding through the channel 103 is flush. As shown in the cross-sectional view of FIG. 7B, the locking head 101 can have a low profile, which can reduce internal trauma and residual pressure on adjacent tissue. For example, it can reduce skin blistering when the device is near the skin.

[0032] The embodiments of the medical devices disclosed herein can be composed of different sections with disparate mechanical properties suited to various aspects of surgical procedures. For example, referring to FIG. 8, device 1 is shown having different sections. Strap 3 is the section that transmits tissue condensation forces and remains in the body, holding the tissue indefinitely. Accordingly, strap 3 has a size (diameter or width / thickness) and material composition that can provide sufficient tensile and bending strength to withstand the required insertion, condensation, and long-term retention loads. Leader 7 is long, flexible, and small in diameter and is used to introduce the device into the body and pull strap 3 along its path through the tissue. Accordingly, leader 7 may be smoother, more flexible, or smaller in size than strap 3, and can act as a dilator to atraumatically pull the larger strap 3 through tissue without excessive resistance or damage to the tissue as it travels through the tissue opening. Device 1 also has a transition section 2 between leader 7 and strap 3, allowing for a gradual transition in stiffness and size between the two sections of device 1. The transition section 2 acts as a strain relief, reducing the stress concentrations inherent in connecting a relatively small member (the leader 7) to a relatively large member (the strap 3). The transition section 2 also reduces stress on tissue as the strap 3 is pulled within the body, preventing the device 1 from kinking as the leader 7 pulls the strap 3 through a tortuous path within the body through small anatomical passages. This can also reduce the force required to move the leader 7 in and out of the body, as the transition section 2 tends to prevent the device 1 from binding when maneuvering around sharp corners. The distal end of the leader 7 has a loop 9, which can facilitate grasping of the device 1 either inside or outside the body. As described further below in this disclosure, the loop 9 can be reinforced to maintain an open shape during the procedure. In some embodiments, the leader 7 can have a reinforcement section 10 proximal to the loop 9, which may or may not be reinforced in these embodiments. The reinforcement section 10 is sufficiently stiff to maintain a relatively rigid shape once inside the body cavity to facilitate grasping from within the body.

[0033] To illustrate some surgical features, one embodiment of the device is shown in the context of a ventral hernia procedure. The embodiments disclosed herein can be used in other surgical procedures requiring tissue approximation, such as approximation of muscle, fascia, skin, bone, and combinations thereof. Figures 9A-9B show a schematic representation of the anatomy of a ventral hernia. Figure 9A shows a cross-section of the torso across the abdomen, as shown in Figure 9B, and will be used throughout this disclosure. The simplified anatomy in Figure 9B shows skin 40, right rectus abdominis muscle 46, left rectus abdominis muscle 47, and abdominal defect 45 located between rectus abdominis muscles 46 and 47. Other regions of the body, including body cavity 48, exterior body 40, and subcutaneous region 42, are also labeled for clarity. For clarity, other types of tissue, such as muscle, connective tissue, and fat, are not shown in the figure, although various tissue layers and anatomical features exist between skin 44 and body cavity 48. A portion of a ventral hernia surgical procedure is shown herein to highlight the design and functionality of the device. A more complete description of a ventral hernia procedure is described in commonly owned U.S. patent application Ser. No. 16 / 477,674, filed July 12, 2019, which is incorporated herein by reference in its entirety. Additionally, devices, systems, and methods related to approximation, fixation, and closure of soft tissue defects are described in U.S. Provisional Application No. 62 / 907,577, filed September 28, 2019, entitled "SYSTEMS, DEVICE AND METHODS FOR TISSUE FIXATION AND APPROXIMATING TISSUE DEFECTS," and related International Publication No. US 2020 / 53148, filed September 28, 2020, entitled "SYSTEMS, DEVICE AND METHODS FOR TISSUE FIXATION AND APPROXIMATING TISSUE DEFECTS," both of which are commonly owned by the present applicant, and both applications are also incorporated herein by reference in their entirety.

[0034] The leader 7 is not necessarily circular, but may have a small diameter, less than about 1 mm, and must have very low or negligible bending stiffness to withstand the tensile force required to pull the strap through a tortuous path in tissue. As shown in FIGS. 11A-11B, in some embodiments, the leader 110 may be a mesh structure, such as a woven, braided, knit, or nonwoven sheet. The leader may be tubular, such as a tubular weave as shown in FIG. 11A, or a flat ribbon as shown in FIG. 11B. The leader may also be stretchable so that it can be necked to a small size when under tension. Furthermore, the tubular leader 113 may be flexible enough to flatten or generally reduce in diameter under tension, depending on the porosity and layup of the mesh. The leader 113 may have an open end 117 that can be attached to the distal end of the securing strap, as described further in this disclosure. In some embodiments, the leader can be a tubular braid made of Dacron™, a common thermoplastic polyester (polyethylene terephthalate), with a diameter of approximately 0.7 mm. Alternatively, the leader can be a monofilament or suture attached to the strap, or it can be an integral extension of the strap with a smaller cross-sectional area for easier threading through tissue.

[0035] The leader portion may be made of a different material than the strap, or may be made of the same material but with a different geometric configuration, such as a mesh or a solid structure having a different cross-sectional shape than the strap. For example, the leader may be a wire or strip made from a metal such as stainless steel or nitinol. However, it should be understood that the leader may be made from other materials, such as polyetheretherketone (PEEK) or polyethylene, or from suture materials, such as those described further below in the Materials section. The leader may have any desired length depending on the anatomy and surgical technique. For example, the leader may be relatively long enough to reach through tortuous paths in ventral hernia surgical procedures, as described below, especially in obese patients, who may require relatively long leaders and straps. For the entire device, a length of approximately 50 cm or more may be appropriate for some patients, while the device may need to be approximately 1200 cm or more, or even approximately 2400 cm or more in length for some patients. The length of the leader can be a portion of the device length, e.g., 50% or so, so that the leader and strap are approximately the same length, or, for example, the leader can be as long as 75% of the device length, or as long as about 25% of the device length. The length of the leader can be selected to facilitate grasping and control while pulling the strap through various layers of tissue. Because the leader is cut after the strap is in place, any excess length is simply discarded, but excessively long leaders can interfere with the procedure, increase material and manufacturing (component or tooling) costs, and be cumbersome to handle. Similarly, the strap is ultimately cut to leave only a small portion of its distal end outside the locking head after full tissue approximation.

[0036] Some or all of the length of the leader can have a size in its major cross-sectional dimension of about 0.35 mm to about 2 mm, or even larger in some applications. Thus, the entire length of the leader, or at least the majority of its length, is about 0.3 mm. 2 ~approx. 13mm2 However, it should be understood that the leader may have a cross-sectional area where the ratio falls outside the stated range. For example, the leader may be a small wire or suture having a diameter of 0.1 mm to 0.35 mm.

[0037] The proximal end of the leader 7 may be coupled to the distal end of the strap 3 after or during molding, e.g., as an overmolded or insert molded part, or the entire device may be molded as a single piece. The proximal end of the leader 7 may be overmolded onto the distal end of the strap 3 when the strap 3 is formed by injection molding; in these embodiments, the leader 7 may be of the same material as the strap 3, and the device 1 may be fabricated as a single, continuous piece with an integral locking head. Alternatively, the distal end of the strap 3 may include a metal insert, and the proximal end of the leader 7 may be coupled to the metal insert. However, it should be understood that the leader 7 may be coupled to the strap 3 by other connections, such as by a knot tied around the strap 3 or by looping and tying through a hole in the strap 3. Regardless of the structural and geometric properties of the transition section 2, the cross-sectional size of the transition section 2 should be comparable in size to or smaller than the strap 3 to pass through tissue layers with minimal resistance and tissue tearing. While the device may be cut at any point during the procedure to remove the leader and any excess strap, in some embodiments, the transition section 2 may be detachable. That is, the device may have reliefs, cutouts, insertion / locking joints, or similar features that weaken the leader 7 relative to the rest of the device, allowing it to be pulled apart by hand. That is, the leader 7 can be separated from the strap 3 by pulling with a force greater than that required to pull the strap through the body, thereby preventing it from inadvertently separating, but less than that which would break the strap. For example, if 1 lb of pulling force is required to pull the leader and strap through the body and the strap has a tensile strength of 7.5 lb, a separation force of approximately 1 lb to 7.5 lb is desired. In some embodiments, the leader can also be quickly released by the operator twisting or tearing it away from the strap.

[0038] In embodiments where the leader 7 is tubular or made of a mesh or other porous structure, it may tend to decrease in diameter when pulled under tension. In such a design, the leader can grip the strap 3 at the transition section, forming a low-profile joint. The strap 121 may have a reduced diameter at its distal end at the transition section 123 to accommodate the relatively small leader 127, as shown in FIG. 12A , which shows the proximal end 125 of the leader 127 before it is slid onto the transition section 123 during manufacturing. The transition section 123 may have features, such as one or more large-diameter bulges, to hold the leader 127 in place when it is not under tension, such as during manufacturing. However, when it is pulled under tension, such as when passing it through tissue, it tends to decrease in diameter, thus becoming gripped by the transition section of the strap. The leader 127 may be tapered at the transition section 123 or have a reduced cross-sectional dimension to match the cross-sectional dimension of the distal end of the strap 121. Alternatively, if leader 127 is of a smaller diameter or cross-sectional dimension than strap 121, leader 127 can be made larger in diameter or stretched to a larger diameter at transition portion 123. For strap designs such as that shown in FIG. 12A, which have a non-circular shape, "diameter" refers to the largest cross-sectional dimension.

[0039] 12B shows leader 127 advanced over strap 121 with a small amount of adhesive 129 applied to proximal end 125 of leader 127 to adhere leader 127 to strap 121. Adhesive 129 provides an end restraint such that when leader 127 is pulled taut and held by the adhesive bond, leader 127 reduces in diameter, or necks down, and clamps to strap 121 (FIG. 12B). Thus, adhesive 129 cooperates with the fastening action to form a strong bond between leader 127 and strap 121 whose strength increases with tension. The bond can be further strengthened by adding an adhesive layer substantially over the entire transition section 123 where leader 127 overlaps and grips strap 121.

[0040] Additionally or alternatively, a heat shrink fitting can be placed over the strap and leader so that when heated, the heat shrink element presses down on the transition section, holding the leader onto the strap at the transition section to further strengthen the joint. In other embodiments, the leader can simply be glued to the strap, or it can narrow at the transition section to prevent the strap from thickening. Similarly, if the leader is a piece of material rather than a tubular structure, the leader can be glued to one side of the strap, or it can be heat staked or ultrasonically welded onto the strap.

[0041] Any combination of techniques disclosed herein or known to those skilled in the art can be used to connect the two elongate members. In some embodiments, crimps can be placed around both the leader and the strap so that they can be deformed to hold the two components together. Additionally, in some embodiments, a mesh can be woven through or around the strap, or the leader can be looped and tied to the strap.

[0042] As yet another example, the leader may be a prefabricated suture that is tied to the end of the strap via a feature such as a hole, notch, shoulder, or other feature for receiving the suture. Similarly, the leader may be a metal wire or two-dimensional strip with low bending stiffness so that it can be manipulated in relatively tight spaces within the body. The wire or strip may be overmolded with or otherwise attached to the strap using methods described herein or other methods known to those skilled in the art.

[0043] As noted above and shown in FIG. 12B, in some embodiments, when the tubular leader is retrained to transition away from the end of the strap, the leader tends to collapse radially when pulled, like a finger trap, gripping the strap and thus increasing the strength of the joint when pulled. While the embodiment of FIG. 12B uses adhesive to constrain (or glue) the leader end, FIGS. 13A-13D show an alternative means of constraining the leader by looping it through a hole in the strap. Device 255 shown in FIG. 13A has a hole 258 through a portion of strap 253 near its distal end, where strap 253 is placed on or near a smaller-sized transition section 252. A portion of the proximal end 259 of the leader 257 may be fed through the hole 258, as shown in Figures 13B and 13C, and then fed through the lumen of the leader 257 so that the proximal end 259 is inside the leader 257, and the excess length of the leader's proximal end 259 may be pulled out the side of the leader 257 and cut off. Figure 13D shows the final configuration after the leader 257 has been pulled forcefully away from the hole 258, which forces the leader 257 down onto the strap 253 of the transition section 252, resulting in a smooth, tapered section with a size and stiffness gradient from the stiffer strap 253 to the leader 257, which may have negligible bending stiffness.

[0044] In other embodiments, the leader can be fabricated as a continuous component with the strap; i.e., the leader, strap, and even the locking head can be molded as a single component, allowing the leader to have a shape that provides lower bending stiffness than the strap. For example, the device may be extruded or molded with a variable cross-section, such that the cross-sectional shape of the strap differs from that of the leader. Alternatively, the leader may be attached to the strap after both components are fabricated. Such applicable joining techniques include, but are not limited to, adhesive bonding, ultrasonic welding, heat staking, or, in the case of metals, welding or crimping. Alternatively, the leader may be a mesh or fabric overmolded (or otherwise bonded) with a soft plastic or elastomer. The overmolded portion provides flexibility, a surface area for distributing loads on the tissue, and mitigates the cheese-wire effect of sutures. A continuously integrated leader provides the tensile strength necessary to maintain closure of the tissue defect.

[0045] The device can be a color that contrasts with the tissue within the body cavity when viewed through a laparoscopic camera, or can use a color not normally seen in the human body, so that the surgeon can easily identify the device within the tissue or within the body. For example, the device may be yellow, blue, green, or orange, or a bright or fluorescent shade of each. Furthermore, the leader or loop (or other protrusion) can be a different color from the strap so that the leader can be easily identified within the body, since the surgeon may need to see the leader first to operate the device. In one embodiment, the permanently implantable strap can be a natural molded plastic color, i.e., with little or no coloring dye to enhance long-term biocompatibility; such plastics may appear white, or somewhat translucent, or off-white to yellow, for example, in straps comprising PEEK. The leader may be blue or orange to contrast with both the strap and the body tissue.

[0046] In some embodiments, it may be desirable to visualize the device or particular portions of the device, such as the leader, loop, locking head, or strap, by intracorporeal x-ray (or fluoroscopy). One or more of these portions can be made of a radiopaque material, such as a metal like stainless steel or nitinol, or a mixture of radiopaque materials, such as barium sulfate, bismuth compounds, or metals like tungsten or steel, or a radiopaque die plastic. Those skilled in the art will recognize that there are many compounds and formulations that result in radiopaque polymers.

[0047] In some embodiments, the loop may have or define an overlapping portion where the leader is joined to itself at or near the proximal end of the loop. The overlapping portion may have slightly higher rigidity than the remainder of the leader due to the doubling of material and the addition of an adhesive or crimping element. This increases the resistance to deformation as the loop resides within the body. That is, the added rigidity provides resistance to prevent the loop from separating when it comes into contact with a tool, such as a suture grasping instrument or snare. This may facilitate easier grasping because the loop is less likely to fall off the tool when the tool engages the loop. Those skilled in the art will recognize that there are many features that can be placed at or near the distal tip of the leader to enable grasping, such as one or more ridges, such as a ball, or a notch, zigzag tip, or "J"-shaped tip. Such embodiments provide a feature that can be easily grasped while still being small enough to pass through a small skin incision or small tissue hole.

[0048] In some leader embodiments having a tubular shape, loops can derive additional stiffness, forming a monofilament core that runs through the lumen of the loop. Additionally, the monofilament can extend back into the leader, providing layered stiffness along the leader. Referring now to FIG. 14 , the distal end of leader 67 is shown having loop 69 and a reinforcing element 66 around loop 69 inside the lumen. Reinforcing element 66 can be a monofilament made of a high polymer material, such as polypropylene, nylon, or polyethylene. However, those skilled in the art will recognize that there are many flexible thin filaments that can be used to reinforce the distal end of leader 67. Reinforcing element 66 begins at a first end 68 located proximal to loop 69, passes around loop 69, and ends at a second end 62 just proximal to loop 69. This configuration results in several regions along leader 67 with different stiffnesses. As shown by zone 70, the majority of leader 67 does not have a reinforcing element and therefore has the baseline flexibility of an unmodified leader. Zone 64 has one reinforcing element 66 passing through the lumen and therefore has greater stiffness than zone 70. Zone 63 has even greater stiffness due to the overlapping reinforcing elements 66 in the relatively short zone 63. Loop 69 has a similar stiffness to zone 64 because it has a single reinforcing element 66 passing through the lumen. The stiffness gradient along leader 67 can be tailored to produce a desired effect or behavior while the leader is in the body. In some embodiments, the added stiffness can make the distal leader less likely to relax, thereby tending to prevent it from adhering to tissue in the moist environment of a body cavity. Stiffness can also make loop 69 easier to grasp, as it tends to have a greater reaction force against any surgical grasping instrument encountered by loop 69; i.e., it tends not to simply separate when pushed.

[0049] In some embodiments, the stiffest portion, zone 63, may have a length ranging from about 5 mm to about 80 mm, and zone 64 may be from about 50 mm to about 200 mm long. In one embodiment, zone 63 is about 50 mm long and zone 64 is about 100 mm long.

[0050] As described elsewhere herein, reinforcement zones 63 and 64 and loop 69 may comprise a shape memory material, e.g., a shape memory metal, a shape memory alloy such as Nitinol, and / or a shape memory polymer, adapted to maintain a desired undeformed shape. In the case of loop 69, the shape memory material may be adapted to hold loop 69 in an open configuration using superelastic (or pseudo-superelastic) properties to generate the desired undeformed shape, as will be readily understood by those skilled in the art in the subject matter context.

[0051] In addition to providing a gripping feature for accessing the leader from within the body, the loop can also facilitate insertion of the leader through tissue. FIG. 15 shows a leader 140 having a loop 139 attached to an alternative embodiment of a suture passer 131. The suture passer 131 has a beveled tip 133 for penetrating tissue and a notch 137 (or hook) for retaining the loop 139. During operation, the leader 140 is pulled under tension along the length of the suture passer 131, as indicated by arrow 134, to pull the loop tip 132 against the notch 137, thereby allowing the loop 139 to remain attached to the suture passer 131 as it is driven through the layers of tissue. In other embodiments, such as the alternative embodiment shown as suture passer 49 in FIGS. 33A-35H, the suture passer may have a hook or clasp mechanism near the tip to securely hold the loop; in that case, the leader may not need to be held in tension because the loop is locked. The suture passer 131 may have a second notch 135 for capturing the loop 139 from within the body and withdrawing the leader 140 from the body. Each of the suture passer embodiments 131 and 49, as well as the other embodiments described herein, can be used in the various procedures described herein unless otherwise specified.

[0052] Referring now to FIG. 16 , one embodiment of a two-loop leader is shown, in which the leader 155 has a distal loop 151 and a proximal loop 153. The distal loop 151 can be used to pull the leader 155 into the body as described above, i.e., via a suture passer (not shown, but see FIG. 16 ). Once the distal loop 151 is inside the body cavity, it can be held by the suture passer to hold the leader 155 in place without wandering, and the proximal loop 153 is then held stable while a surgical grasper or other grasping tool is used to grasp the proximal loop 153. This handoff can be performed blindly within the body, i.e., by feel, or, more commonly, by visualization using a laparoscope. Furthermore, a two-loop leader design can eliminate the need for a laparoscopic grasper, thereby eliminating the need for a separate incision site. This is because the suture passer used to introduce the leader into the body cavity can remain engaged with one of the loops, e.g., distal loop 151, while it resides within the body. With the leader locked, another suture passer or similar device can be introduced through a second incision, and both devices can be angled together so that the second suture passer can grasp proximal loop 153.

[0053] The device (straps and / or leaders and / or transition sections) may be pre-curved so that all or part of the structure has some curvature when the surgeon removes the device from the package. See, for example, FIG. 8, where strap 3 is curved. In the most preferred embodiment, the leader is relaxed, i.e., has no significant bending stiffness, although some embodiments may include a pre-curved section that can provide a small amount of bending stiffness in the pre-curved section. The pre-curved section on strap 3 first ensures that the teeth of the strap are on the inner diameter of the loop and second allows the device to follow its natural path as it is inserted into the body cavity across the wound defect to be treated. The curve may be small (e.g., a 3-inch radius), large (e.g., a 10-inch radius), or any radius in between, as any curvature will tend to bias the device toward the opposite side of the wound, facilitating easier grasping, manipulation, and threading of the incision. However, a device that is too curved may provide too much resistance when passing through tissue. The device may be molded into a curved shape or packaged so that the material is formed, for example, by the material deforming within the package. FIG. 17 shows one embodiment of such a package, in which a device 161 is placed in a tube 163 wound into a circle. In addition to this tube package, many configurations for packaging a device in a curved configuration are within the scope of the present invention, such as constraining the device in a cardboard cutout package or placing the device in a thermoformed plastic tray shaped to curve all or a portion of the device. Alternatively, shape memory or superelastic materials, such as, but not limited to, Nitinol, can be employed to achieve an undeformed, pre-curved or pre-bent shape.

[0054] In other embodiments, the strap portion (permanent implant) of the device may be a mesh structure similar to the leader embodiment described above, for example, as shown in FIG. 12A. The strap may be constructed from a woven, braided, knitted, or nonwoven sheet, and may be tubular or have a flat, two-dimensional shape such as a ribbon or other mesh-like structure. FIG. 18A shows a side view of such a device 171, showing the strap 173 in either a tubular form or a mesh structure with a flat cross-section, both of which tend to lay flat on tissue and generally form a larger contact area than sutures, thus exerting less pressure on the tissue and reducing the tendency to injure it. The device 171 may have a needle 180 at its distal end and a bevel 178 at the tip of the needle for puncturing tissue. The needle 180 may be straight or curved, as shown, to facilitate suturing tissue defects such as abdominal hernias. Alternatively, device 171 may not have a needle at its distal end, but instead have nothing, a thin distal tip, a leader, or one or more loops, as disclosed above in various leader embodiments.

[0055] The proximal end of device 171 may have a locking head 179 that allows only one-way movement of strap 173 as it passes through the locking head 179. Strap 173 may be attached to locking head 179 by the same means described herein for connecting strap 3 to leader 7 (see, e.g., FIGS. 12A-12B and 13A-13D). For example, as shown in FIGS. 18A and 18B, strap 173 may have an opening at its proximal end 174 that encloses tab 177 extending from locking head 179. Tab 177 may be similar to transition portion 123 shown in FIGS. 12A-12B and 13A-13D and may have a tapered or straight profile and may have one or more bumps or bulges through which strap 173 passes. 18B shows an isometric exploded view of device 171, which includes strap 173, a flexible mesh structure having an open lumen extending therethrough, or at least partially therethrough, and distal end 172. Locking head 179 has aperture 175 capable of receiving strap 173 and restricting movement of strap 173 in one direction.

[0056] In some embodiments, the needle 180 can remain on the strap 173 so that the needle 180 guides the strap 173 into the locking head 179, after which the needle 180 can be severed from the strap 173. Alternatively, the needle 180 can be severed from the strap 173 before threading it through the locking head 179. Depending on the mesh layup, the distal end of the strap 173 may fray where it is severed, making it difficult to thread through at least most types of locking heads that have holes. The distal end 172 of the strap 173 may have a leader portion 176 at its distal end near the needle 180, as illustrated in FIGS. 18C-18D. As shown in FIG. 18C, the distal end 172 of the strap 173 has a leader 176 that has a smaller cross-sectional shape near the attachment to the needle 180. The leader 176 may be a section with a tighter weave and a smaller diameter, or may be glued or otherwise formed into a smaller shape or melted to a smaller size to prevent it from being lost or unraveling after the fibers are cut. These manufacturing processes may make the leader 176 stiffer than the strap 173 or the rest of the strap 173, and as a result, it may have higher column strength than the strap 173, making it easier to push through the lock head without bending or buckling.

[0057] In some embodiments, the strap 184 can be attached directly to the lock head using any common technique for joining two polymeric materials, such as gluing, heat staking, ultrasonic welding, or overmolding, as shown in FIGS. 19A-19B. As shown in FIG. 19A, for example, a lock head 182 containing a hole 183 therein has a tab 186 that provides a larger surface area for the strap 184 to attach to. That is, in this embodiment, the strap 184 is attached to the tab 186 at the base of the lock head 182 via a relatively large attachment joint 185. FIG. 19B shows a lock head 188 containing a hole 189 therein, which lacks a tab but has a potentially smaller attachment joint 190 with a smaller overall size. Those skilled in the art will recognize many means for attaching a flexible mesh to a small lock head. For example, the mesh can be looped through a hole or hook-like feature in the lock head and tied into a knot or crimped, or it can be passed through a looped feature in the lock head and then crimped or glued back on itself to prevent it from rolling back.

[0058] 20A-20C, cross-sectional views of different configurations of straps encircling a tissue section 190 are shown. Depending on the nature of the surgical procedure, different strap and locking head configurations may have particular advantages depending on the surgical procedure (internal vs. external, open vs. closed, laparoscopic, etc.) and the surgical tools used. In FIG. 20A, a locking head 193 has a strap 194 attached to its base, which encircles the tissue 190 such that a distal end 192 of the strap 194 exits in substantially the same direction as a proximal end 191 of the strap 194. Alternatively, FIG. 20B shows a configuration in which a proximal end 198 of a strap 199 attached to a locking head 196 faces in the opposite direction from a proximal end 195 of the strap 199 as the strap encircles the tissue 190. Finally, as shown in FIG. 20C, in this embodiment, neither end of the strap 203 is attached to the outside of the locking head 200; instead, the distal end 201 and proximal end 202 pass through the locking head 200 via a one-way locking mechanism. Alternatively, one or both ends of the strap 203 may be crimped to the locking head 200. Note that the sketches of the locking heads shown in the figures are for illustrative purposes and are intended to show the main features and functionality. Therefore, they are shown in simplified form. However, they can be shaped to have an extremely low profile, streamlined, and atraumatic shape. Furthermore, the strap embodiment shown in FIGS. 20A-20B may alternatively be a one-piece plastic injection-molded unit with a typical strap-engagement configuration as shown, although the strap is integrally attached to the locking head.

[0059] The locking head may include a hole through which the strap passes or moves parallel to the locking head, locking passage in one direction or moving relative to the locking head in the opposite direction. To achieve this locking action, the hole may have teeth therein that bite into the mesh. The teeth may be metal teeth inserted into the plastic head, punched into the metal locking head, or formed by other means. Alternatively, the teeth may be molded integrally into the plastic locking head. Similarly, the locking head may contain barbs or similar one-way gripping features designed to hook onto the mesh, thereby providing one-way restriction. An example is shown in FIG. 21, which shows a cross-section of a locking head 204 with angled tines 205 (e.g., beams or arms) at the hole 221 through which the strap 208 passes. The strap can pass in the direction of the arrow 207 but is restricted in the opposite direction. The gaps 206 between the tines 205 (beams or prongs) can be the same thickness as the strap in its extended form, i.e., the thickness when pulled through the hole under tension, i.e., when the strap is flat. This reduces the resistance when pulling in the direction of arrow 207. In designs where the gaps 206 are reduced, the locking resistance increases, as does the pull-out resistance in the direction of arrow 207 perceived by the operator during use. In some embodiments, there can be no gap, i.e., the gaps 206 are zero, such that the tines 205 contact the body of the locking head 204. Thus, when the strap 208 is pulled in the direction of arrow 207, the tines 205 can flex to allow the strap 208 to pass, but due to their orientation, the tines have significant stiffness when forced in the opposite direction, thus locking the strap 208 against movement in the direction opposite to arrow 207.

[0060] Another type of locking mechanism is shown in FIGS. 22A-23B. FIG. 22A is a cross-sectional view of a locking head 209 having a bore that tapers from a wide opening 212 to a narrow outlet 210 with a gap 211. The gap 211 can be sized in a similar manner to that described above in FIG. 21, except that the outlet 210 must be flexible enough to deform sufficiently to allow the strap 208 to pass through it when the gap 211 is zero. Generally, the outlet 210 can be round, such as annular, or rectangular, as the strap 208, which is a flexible mesh structure, compresses or conforms as it passes through the locking head 209 in the direction of arrow 213. After the strap 208 is tensioned around an object, the strap 208 is subjected to tension in the opposite direction, indicated by arrow 214. Because the locking head 209 tapers in the opposite direction at the outlet 210, the strap 208 tends to bunch, creating a bulge 215 in the strap 208 at the outlet 210 and increasing resistance to movement in the reverse direction. This behavior can also occur when the strap is elastic, such as made of a rubber-like material that necks under tension, i.e., an incompressible or nearly incompressible elastic material such as rubber, elastomers, and thermoplastic elastomers. In some embodiments, the strap may be an elastic member, while in other embodiments, the elastic member resides inside a tubular mesh strap, where the strap is elastic along its length but can be reinforced by an outer mesh. In such embodiments, the locking head may not need to be tapered, as the elastic member will neck into a sufficient annular shape when pulled under tension through the locking head. A loop smaller than the undeformed diameter of the strap tends to prevent loosening. A smaller loop generally provides higher retention but is more difficult for the operator to fasten.

[0061] Elastic straps tend to continue to apply force to the tissue even if the tissue within the strap contracts (reduced in volume), whereas rigid straps, such as thermoplastic straps, tend to relax when the encapsulating tissue contracts after surgery.

[0062] In other embodiments, the strap need not be permanently attached to the locking head at either end, as both ends can be clamped through the locking head either during or before use. Figures 23A-23B show a locking head 217 having a wide opening 218 and a narrow exit 220, and an oppositely oriented bore with a wide opening 219 and a narrow exit 216 disposed in opposite directions. Generally, in the embodiments disclosed herein, the locking head may be separated from the strap when provided to the operator; in these embodiments, both the distal and proximal ends of the strap can pass through the same or separate one-way locking features of the locking head.

[0063] In yet another embodiment, as shown in FIG. 24 , the straps can be crimped with malleable locking heads 235 that can be crushed around the straps 224. One end of the straps 224 can be pre-attached or crimped to the first channel 222, while the opposite end of the strap is placed through the second channel 223, which is then crushed during the procedure. The second channel 223 can be sized so that the straps 224 slide with an interference fit so that the locking heads 235 remain in place during the procedure even before crushing the locking heads 235. This allows for gentle wound closure by adding multiple straps fastened sequentially along the defect.

[0064] In some embodiments, the strap can be secured by a cam mechanism using either a bending cam element or a hinged cam element. FIG. 25 shows a locking head 228 having a hinged lever 225 such that when the strap enters through an entrance 227 in the locking head, the lever 225 is forced open, allowing the strap to pass in the direction of arrow 226. The cam is biased to compress the strap. The bending cam arm is essentially the same as the embodiment shown in FIG. 21 , described above. Another type of locking head embodiment having two cam elements is shown in FIG. 26, in which a strap 229 passes between two opposing cam heads 230 and 231 and is biased to compress the strap between the cam heads. Finally, a locking head 233 having a single cam element 232 is shown in FIGS. 27A-27B. This cam element 232 has a pivot 234, allowing the cam 232 to pinch the strap against the body of the locking head; the cam 232 may have teeth, as shown, to facilitate gripping the strap. The teeth capture the strap when it is under tension in the direction of arrow 236, and thus can self-lock in that direction. If the size of the orifice through which the strap passes is small enough to ensure engagement with the teeth, a biasing spring may not be necessary. The strap is generally free to move in the direction indicated by arrow 237.

[0065] Referring now to FIG. 28A, a locking head 238 is shown having adjacent holes 241 and 239 through which the strap passes. In addition to the strap embodiments previously described, the strap may alternatively include a length of fabric, mesh, or wire mesh extending at least partially along the length of the strap. Furthermore, the leader may be a mesh or fabric overmolded (or combined with other means) with a soft plastic or elastomer extending from both ends of the overmolded portion. These extensions can be introduced from opposite directions to form a unidirectional constraint opposite the direction of tension. The overmolded portion provides flexibility, surface area for distributing loads on the tissue, and mitigates the cheese-wire effect of the suture. The continuously integrated leader provides the tensile strength necessary to maintain closure of the tissue defect. Teeth penetrate and retain the mesh or fabric.

[0066] Hole 239 has teeth 240 angled in the direction of arrow 244, the direction a strap, including any of the strap embodiments described herein, passes through during fastening. This restricts strap passage in the opposite direction because the teeth bite into the strap. Similarly, in the opposite hole 241, teeth 242 face in the opposite direction 246, allowing the strap to pass through in that direction. Teeth 240 and 242 may be molded into the head, stamped or punched into a metal locking head, or implemented in a polymer locking head with a metal gripping portion. FIG. 28B shows a cross-section of an embodiment with teeth on both sides of each hole; for example, hole 249 has teeth 245 on the upper side and teeth 247 on the lower side. Both sets are angled in the direction of arrow 251 to allow strap passage in that direction while locking displacement in the opposite direction. Similarly, lower hole 256 has teeth 250 on the upper side and teeth 260 on the lower side. Both sets are angled in the direction of arrow 254 to allow passage of the strap in that direction while locking displacement in the opposite direction. In each of these embodiments, the teeth may overlap, i.e., be staggered on each side of the locking head to reduce the effective size of the holes, thereby providing a stronger engagement. Furthermore, if the teeth are bent enough to allow the strap to pass through each hole, the teeth may be long enough to contact the opposite side of the hole. The holes may be oriented to allow passage of the strap in the same direction, or there may be only one hole if the opposite end of the strap is permanently attached to the locking head.

[0067] 29A-29B show a buckle-style locking head 264 with a first loop 265 that may be offset from a second loop 262, although the locking head can operate similarly when the loops are flush. Each loop has teeth 266 and 261 that penetrate and restrain the strap when the strap is pulled in the opposite direction. For example, as shown in FIG. 30B, lower strap 268 can be displaced in the direction of arrow 271 but is restricted in the opposite direction by abutting against tooth 266. Lower strap 268 is restrained by center shaft 263 to ensure abutment against tooth 266. This is more specifically shown for strap 267, which has a curved portion 279 when forced between tooth 261 and center shaft 263. Additionally, teeth 261 and 266 can be angled downward as shown to provide greater interference with straps 267 and 268, respectively. As noted in other embodiments, other versions of this embodiment may have only one strap locking loop, while the other end of the strap may be permanently attached to the locking head.

[0068] Although the foregoing locking head embodiments have been described with respect to attaching mesh straps, those skilled in the art will recognize that these designs are also applicable to non-mesh straps, such as smooth plastic or metal straps or elastic straps.

[0069] In all of the foregoing mesh strap embodiments, the leader can be made of the same material as the strap as a continuous structure and can be thinned to facilitate passage through small orifices in the body. The small size can be achieved by weaving, braiding, or other manufacturing techniques, or the leader can be heat-set in a smaller dimension, or conversely, the strap portion can be heat-set or expanded to a larger size. Alternatively, the leader can be a separate component from the strap and attached to the distal end of the strap by methods described herein or other methods for attaching a narrow leader to a relatively wide strap. In some embodiments, the leader can be a wire, suture, plastic strip, or mesh attached to the distal end of the mesh strap.

[0070] All of the embodiments disclosed herein may have a needle attached to the distal end. The needle may be attached to the distal end of a strap or leader and serve to guide the device through tissue, similar to a suture with an attached needle. The leader or strap can be attached to the needle by any of the methods previously described for joining a leader to a strap or a strap to a locking head, but the method of needle attachment is not limited to these techniques. Once the needle has passed through the desired tissue, the excess length of the strap or leader is cut, thereby removing the needle, and the strap can be placed through the locking head and fastened.

[0071] material

[0072] The device embodiments described herein can be made from any material capable of withstanding the forces exerted when pulling the device through the body, and the permanent implant (strap) must be able to hold tissue together without breaking or bending significantly. Furthermore, because the strap is a permanent implant, it must be made from a material with long-term biocompatibility. Depending on the configuration of the embodiments described herein, the material may be the same; for example, the locking head, strap, and leader can be made from the same material, whether they are a continuous structure or separate elements joined during the manufacturing process. Conversely, the device may be made from separate materials. For example, the leader and loop may be made from one material (e.g., Dacron) and the strap from another material (e.g., nylon). Candidate materials include polymers or metals. Non-limiting examples include Dacron, PEEK, PEKK, nylon, polypropylene, polyethylene, polyethylene terephthalate, polyolefin, polyester (PET), or any other common suture material. Non-limiting examples of metals include stainless steel and nitinol. For example, the leader can be made of a nitinol wire attached to a PEEK strap. Additionally, in some embodiments, at least a portion of the devices described herein can include a bioabsorbable material.

[0073] Pre-bent or pre-curved portions of the leader 7, transition section 2 and / or strap 3 (if present) may be achieved through the use of superelastic or shaped materials as described above.

[0074] Additionally, loop 9 may include a shape memory material biased to remain in the open loop configuration as shown, helping to ensure that loop 9 tends to remain open during the surgical procedure.

[0075] 30A and 30B show an embodiment of a strap having a locking head that is substantially perpendicular to the strap. The device 301 is shown in a locked configuration in FIG. 30A, with the teeth 306 oriented toward the inside of the loop, i.e., near the surrounding tissue. The locking head 305 is disposed so that the proximal end 306 of the strap 303 is substantially perpendicular to the distal end 304 of the strap.

[0076] 30B shows an embodiment of this device 301 disposed around a cross-section of tissue 347. As device 301 is fastened around tissue 347, strap 303 must curve to accommodate the orthogonal locking heads while fastening. For example, proximal end 306 and distal end 304 of strap 303 curve at bends 309 and 310, respectively, to allow distal end 304 to pass through locking head 305. Bends 309 and 310 generally become sharper (smaller radii) as device 301 is fastened to tissue 347, resulting in larger bends and, particularly, localized increases in tensile stresses that can reduce the holding strength of device 301.

[0077] In some procedures, however, device 301 may be placed in the anatomy such that the orthogonal locking head configuration does not necessarily create a bend near the locking head. For example, referring to FIG. 30C, device 301 is disposed around the side of tissue 347 such that locking head 305 resides near the side of tissue 347, rather than in the central portion of tissue 347 as previously shown in FIG. 30B. Thus, proximal end 306 and distal end 304 of strap 303 meet at a nearly orthogonal angle that is receptive to locking head 305, which has an orthogonal hole for receiving distal end 304 of strap 303.

[0078] 31A and 31B show one embodiment of a device 311 that allows movement in only one direction and has a locking head 315 with teeth 316 for gripping a strap 313. In this embodiment, the distal end 314 of the strap 313 is substantially parallel to the proximal end 313 of the strap as the distal end 314 of the strap 313 passes through the locking head 315. The tension, as indicated by arrow "T," is substantially aligned throughout the force path through the locking head 315, thereby applying minimal bending stress to the tension in the device 311.

[0079] Once the straps are engaged with the locking head, the self-locking straps remain in place hands-free, allowing the surgeon to focus on other tasks, such as fastening other straps. This allows for continuous tensioning without the need for knots or clamps. For example, FIG. 32 illustrates a ventral hernia procedure using four self-locking straps during continuous tensioning. The right rectus abdominis muscle 346 is separated from the left rectus abdominis muscle 347 by a defect 45. In this scenario, the surgeon closes the defect in stages by fastening each strap 321, 323, 325, and 327 in the desired order. As shown in FIG. 32, straps 321, 323, 325, and 327 are locked into place. Notably, the top end of defect 45 has a gap "A" that is smaller than the gap "B" that exists throughout the remainder of defect 45. This is because, in this example, the surgeon fastened strap 321 incrementally more than the others, locally reducing defect 45. This technique of gradually reducing the defect 45 tends to reduce intraoperative forces on the tissue, thereby preventing localized tears or excessive strap subsidence. The surgeon can proceed with tensioning the straps sequentially, i.e., from 321 to 323, 325, 327, or in any order based on the surgeon's preference. For example, the surgeon may skip straps when tightening in stages, or if the defect is larger in the center, tighten the central (323 and 325) straps more tightly than the end straps (321 and 327). Any number of straps can be used, depending on the length of the defect 45 and the degree of separation between the muscle tissues. In some embodiments, the surgeon can space the sequentially tightened straps approximately 1 cm apart along the defect, such that a 10 cm defect would have 8 to 10 straps depending on the starting and ending points along the defect.

[0080] size

[0081] The devices disclosed herein do not need to be radially symmetric. That is, they may be flat or rectangular in shape to increase the contact area with the tissue and reduce stress on the tissue, for example, compared to a small-diameter suture that can cut muscle tissue. In some embodiments, the strap may include a cross-sectional shape (e.g., flat, oval, etc.) that reduces tension on the tissue at the puncture site and reduces the likelihood of tissue tearing. In some embodiments, the strap may reduce stress concentrations where it contacts the tissue. In some embodiments, the first cross-sectional dimension of the strap is larger than the orthogonal cross-sectional dimension, and the leader may be smaller than the largest dimension of the strap and smaller than the smaller dimension of the strap. For example, the cross-sectional dimension of the strap may be 2.5 mm x 1.2 mm. The leader may be a suture, such as a 0.35 mm diameter prolene suture, or may be a suture of another size, for example, between 0.35 and 0.6 mm diameter. In other embodiments, the leader may be a tubular structure, such as a woven Dacron braid with a diameter of approximately 0.7 mm.

[0082] In some embodiments, the straps of the present invention offer various improvements over conventional sutures. In some embodiments, the straps provide reduced suture pullout potential, increased closure strength, fewer straps required for closure, faster healing times, or reduced closure failure compared to traditional sutures. Additionally, the devices disclosed herein offer knotless, self-locking capabilities for easy, incremental closure. That is, numerous self-locking strap devices can be positioned along a hernia defect and incrementally cinched, as the one-way locking mechanism holds tissue in place hands-free and without the need for knots or clamps in the surgical field.

[0083] In some embodiments, the edges of the straps can be configured to contact or apply pressure against the tissue to distribute the force evenly across the contact area. For example, the shape of the straps can be convex to distribute the force more evenly along a segment of tissue rather than concentrating the force at a single point.

[0084] The systems and devices described herein can be implemented to approximate and fixate soft tissue defects.

[0085] 9A and 9B, one embodiment of the system, device, and method is shown as an exemplary ventral hernia procedure to illustrate some of the features related to the surgical procedure. The embodiments disclosed herein can be used in other surgical procedures requiring tissue approximation, such as approximation of muscle, fascia, skin, bone, and combinations thereof.

[0086] 33A, leader 7 is positioned inside the body through a first hole 200 in the patient's skin 40 and grasped by grasping tip 41 of suture passer or grasping needle (hereinafter referred to as suture passer) 49, and through a first hole in left rectus abdominis muscle 47 (on a first side of the soft tissue defect) so that loop 9 and reinforcement portion 10 are within body cavity 48. Next, in FIG. 33B, cross guide 300, including handle 302, shaft 304 and distal eyelet 306, is passed through first hole 200 in the patient's skin and advanced subcutaneously so that eyelet 306 is positioned adjacent to second hole 202 in the patient's skin 44.

[0087] As shown in Figure 33C, the suture passer 49 is passed through the second hole 202 in the patient's skin, the eyelet 306 in the cross guide 300, and the right rectus abdominis muscle 46 (on the second side of the soft tissue defect), and the grasping tip 41 is actuated to grasp the leader 7, preferably the loop 9. The suture passer 49 is then withdrawn through the eyelet 306 in the cross guide 300 and through the second hole 202, directing the leader 7 through the eyelet 306 and the second hole 202, as also shown in Figure 33D.

[0088] FIG. 33E illustrates the cross guide 300 being guided together with the leader 7 captured in the eyelet 306 and pulled through the first hole 200 in the patient's skin 44. FIG. 33F illustrates the leader 7 being threaded through the locking head 5 and then captured by the distal end of the threading tool 500. The distal end of the threading tool 500 may include a hook, loop, eyelet, or other means for attaching the leader 7 thereto. The threading tool 500 includes a shaft slidably and removably disposed within the lumen of the tensioner and cutter 400. As shown in FIG. 33F, the threading tool 500 resides within the lumen of the tensioner and cutter 400.

[0089] As shown in FIG. 33G, the threading tool 500 is removed from the lumen of the tensioner and cutter 400, tightening the straps 3 around the two sides 47, 46 of the soft tissue defect 45. Continued tensioning of the threading tool 500 and / or leader 7 results in gradual, sequential tightening of the straps 3 and approximation / closure of the soft tissue defect.

[0090] Finally, once the defect has been converged and secured as in FIG. 33H, excess leader 7 and strap 3 can be cut by a blade within the lumen of tensioner and cutter 400, for example, by rotating tensioner and cutter 400 so that leader 7 is in cutting contact with the blade, as described in more detail below.

[0091] The tensioner and cutter 400 and threading tool 500 will now be described with reference to Figures 36A-36C and 37. The tensioner and cutter 400 includes a proximal handle without an actuatable element connected to a shaft defining a lumen extending axially therethrough. The lumen also extends through the proximal handle, as shown in Figure 36B. A cutting element or blade is provided at or near the distal end of the shaft and is configured to sever the leader 7 and / or strap 3 when the procedure is complete.

[0092] The threading tool 500 includes a proximal handle (shown as a circle, but which can be any grippable shape) and a shaft sized to fit within the lumen of the tensioner and cutter 400 and configured to be removed therefrom when pulled proximally. The distal end of the threading tool 500 may include a connector, such as a hook, loop, or eyelet, or other mechanism, that allows connection with the leader 7. The distal end of the threading tool 500 is sized to extend beyond the distal end of the tensioner and cutter 400 and pass through the locking head 5 located at the distal portion of the threading tool 500. When the leader 7 is connected to the distal end of the threading tool 500, pulling the threading tool handle proximally removes the shaft from the lumen of the tensioner and cutter 400 and pulls the leader 7 proximally therethrough. Finally, as the leader and strap move or slide through the locking head 5 mechanism, the strap 3 begins to shorten and tighten. Once sufficient tightening is determined, the tensioner and the leader of the strap in the area of ​​the cutting element or blade of cutter 400 are severed.

[0093] In some embodiments, it is preferable to maintain tension on the portion of the leader 7 and / or strap 3 that extends through the lumen of the tensioner and cutter 400. This tension can be achieved mechanically and / or physically by the surgeon applying a proximal force to the leader 7 and / or strap 3.

[0094] In general, backlash in a ratchet system, such as that including the locking head 5, can be defined as the longest possible distance between successive adjacent engagement teeth 451. Backlash is felt or apparent when one ratchet reverses its drive direction or is released. If tension can be slowly released during the tensioning process, the teeth 451 can remain stationary in their engaged state. The ratchet, backlash, and engagement sequence is shown in Figures 38A-38C.

[0095] Preventing backlash of the self-locking strap 3 prior to the cutting step can be designed into the tensioner and cutter 400. Providing a compliance gap, as shown in FIGS. 39A-39C, can prevent the possibility of backlash of the strap 3 when it is fastened around the soft tissue defect 45. The compliance gap can be achieved by a defined spacing, as in FIGS. 39A-39B, or by other means, such as a foam pad or spring, as described below. FIG. 39B shows the tensioner and cutter 400 with the strap 3 in place, prior to cutting the excess remainder of the strap 3.

[0096] 39A-39C, an alternative embodiment of a tensioner and cutter 400 for eliminating backlash is shown. The tensioner and cutter 400 thus includes an additional locking head 5' disposed within the lumen and / or handle of the tensioner-cutter 400. There are two locking heads 5, 5' in this device 400. The locking head 5, as previously described, is used to maintain tension around the soft tissue defect 45, while the locking head 5' is disposed within the tensioner and cutter 400 to reduce and / or eliminate backlash, maintaining tension in the system until the surgeon decides to cut off the remaining excess strap 3.

[0097] As shown in Figure 39B, the applied tension T is substantially equal across the entire strap 3. When tension is applied to the locking head 5', allowing the surgeon to release the strap 3 and cut the remnant, the compliance gap is absorbed as in Figure 39C, and the tension T in the remnant becomes less than the tension T in the fastened strap 3 around the soft tissue defect 45.

[0098] Thus, when the remainder of the strap is severed from the lock head 5, the tension is immediately released. Any gap (backlash) between the mating teeth 451 of the lock head 5 is immediately absorbed, thereby applying an instantaneous force between those teeth 451. This impact force on the teeth 451 is significantly greater than the normal retention force and can strain the engaged teeth 451, shortening their useful life and potentially causing immediate failure.

[0099] If tension on the remainder of the strap 3 is slowly released before cutting, the locking head teeth 451 can engage while maintaining the intended tissue-holding force. It has been demonstrated that the untensioned strap remainder can be cut with a maximum of one rotation of the tensioner and cutter 400, but when some tension is applied, it can be cut in less than a half-turn. Since fewer rotations to cut is a desirable feature for users, ideally the tension in the tensioner would be slightly less than the tension in the tissue-holding loop, as shown in FIG. 39C.

[0100] Thus, in some embodiments, the toothed portion of the strap 3 can be pulled from the proximal face of the handle through the shaft of the tensioner and cutter 400, and an additional locking head 5' can be provided on the shaft and / or proximal end of the handle to lock the strap 3 at the degree of tension applied by the surgeon when tensioning the strap 3. In alternative embodiments, the surgeon applies physical tension to the strap 3 to achieve a similar result. In both cases, the surgeon applies sufficient tension to close the soft tissue defect 45 without applying excessive tension that could cut the abdominal wall tissue. The tensioner and cutter 400 rotates with the strap 3 under tension, achieving severance of the excess strap length without backlash in the strap 3. When severance of the excess strap 3 is performed without tension on the excess length of the strap 3, rotation of the blade near the distal end of the shaft pulls and twists the strap 3 at the location of the locking head 5' that contacts the abdominal wall tissue. This movement of the strap 3 during the cutting process could inadvertently sever or damage one of the locking teeth 451 on the strap 3, preventing the strap 3 from holding proper tension. Maintaining tension on the strap 3 with an additional locking head 5' on the proximal end of the tensioner and cutter 400 ensures that a clean cut of the strap 3 is achieved in the proper position without damaging the locking mechanism. Tension can be maintained on the strap 3 during the cutting process by the additional locking head 5' located proximally on or in the handle of the tensioner and cutter 400 and / or by the surgeon tensioning the strap 3.

[0101] The lock head 5' may be structurally and functionally the same as the lock head 5, and the lock head 5' provides at least the following additional functions.

[0102] 1. Ensure that the tensioner tip can be maintained near the strap head 5' before cutting off the excess remaining portion of the strap 3; and

[0103] 2. Maintaining tension on the remainder of the strap 3 to facilitate cutting (e.g., less than a half turn of the tensioner and cutter 400).

[0104] The cutting edge of the tensioner and cutter 400 may be recessed approximately the distance between two or three ratchet teeth 451. This can ensure that at least two ratchet teeth 451 are present for engagement on the outside of the lock head 5'.

[0105] The tension in the remainder of the strap 3 directly correlates to the amount of rotation of the tensioner and cutter 400 required to sever the remainder of the strap 3, which has been demonstrated to be 1 / 4 turn with high tension and 1 turn with no tension. High tension is desirable from a user's perspective because a half turn can be achieved with one hand movement, while a full turn requires two hand movements. High tension has a secondary user effect: the higher the tension, the greater the tactile feedback provided to the user in the form of a "pop" sensation that indicates the strap remainder has been severed. With no tension, there is little to no tactile feedback.

[0106] Figures 40 and 41 show exemplary mechanisms for providing such a compliance gap. Figure 40 illustrates a spring member, while Figure 41 shows a foam and spring mechanism.

[0107] In all described embodiments of the various systems, devices and methods discussed herein, the following general principles may be applied.

[0108] Increasing the stiffness of the loop 9 relative to the leader 7 provides some resistance to movement and deformation, thereby making the loop easier to grasp. In a moist surgical environment, an unreinforced, or relaxed, loop 9 may collapse and / or close. Reinforcement serves to keep the loop 9 open and accessible to the surgeon. The grasping needle or suture passer 49 may be angled to reach the loop directly, or a separate surgical grasping instrument, such as a laparoscopic grasping instrument, may be introduced into the body cavity to connect the loop 9 to the grasping needle 49.

[0109] The reinforced portion 10 of the leader 7 can also aid in grasping the loop 9. The reinforced portion 10 has at least some bending stiffness and can resist deformation upon contact so that a grasping tool does not push the leader 7 excessively. Thus, the resistance of the reinforced portion 10 tends to keep the loop in place rather than dangling within the body cavity. Also, in a moist surgical environment, an unreinforced, or relaxed, leader 7 may adhere to nearby features, such as the wall of the body cavity 48. Thus, the reinforced portion 10 serves to keep the leader 7 and loop 9 present and accessible to the surgeon. Furthermore, at least a portion of the reinforced portion 10 can be pre-bent or pre-curved relative to the leader 7 to lie toward the body midline for easier grasping. At least a portion of the leader 7 may also be pre-curved, as can at least a portion of the strap 3.

[0110] The leader 7 may generally be more flexible (less stiff) than the strap 3 by having a smaller cross-sectional area and / or by including a different geometry or material. In some embodiments, the bending stiffness of the leader is zero or negligible, since it may be a pure tension member. The leader 7 passes through one or more layers of tissue, providing a smaller, more flexible lead-in or pilot, allowing the surgeon to thread the strap into position around the defect. The leader 7 can therefore be used to guide the strap 3 into position while pulling it through multiple tissue interfaces. In this sense, inserting the device 1 may have a dilating effect, pulling the smaller diameter leader 7 through the tissue first and guiding the larger strap 3 along the same path. Dilating the tissue requires a smaller hole and is less traumatic to the tissue. Thus, the leader 7 can be fed through tissue like a suture (in some embodiments, the leader can be a suture) without significantly impacting the tissue, while the strap 3, once in position, has a larger footprint (width) where it resides within the tissue, thus reducing the pressure applied to the tissue and reducing the risk of dissecting or piercing the tissue.

[0111] A sharp connection between the leader 7 and the strap 3 can create excessive resistance and may tear the tissue or cause the connection between the leader 7 and the strap 3 to break.

[0112] In some embodiments, device 1 may have a transition section 2 at the distal end of strap 3 where it joins the proximal end of leader 7, where leader 7 and strap 3 overlap, attach, or transition in size, shape, or material. Transition section 2 can assist in guiding strap 3 through tissue, particularly around corners, as it follows leader 7 by providing a gradual transition in size and / or stiffness between relatively relaxed leader 7 and stiffer strap 3. For example, strap 3 may have a maximum diameter of 2.5 mm, while leader 7 may have a diameter of 0.6 mm. Transition section 2 tapers gradually (though not necessarily monotonically) to provide a gradual gradient in diameter over its length from the size of strap 3 to the size of leader 7. The length of transition section 2 may be as little as 2 mm, or may be, for example, 5 mm or more, and in some embodiments, 15 mm or more.

[0113] To ensure proper positioning of the strap 3, a temporary attachment feature can be added to the distal end of the strap at its proximal end near the locking head 5. One embodiment of a strap 31 having such a feature is shown in FIG. 10. This temporary locking feature can include a post 38 that fits snugly with a cavity 39 on the strap 31 near the distal end 32 of the strap 31 near the locking head 35. When the leader 37 is advanced outside the patient until a short length of the strap 31 protrudes, the position of the distal end 32 of the strap 31 is temporarily maintained. One skilled in the art will recognize other ways of temporarily locking the two members together, such as hooks, recesses, or hook-and-loop type fasteners (e.g., without limitation, Velcro®). These are merely exemplary, and one skilled in the art will recognize that other methods of temporarily aligning the ends of the strap are within the scope of this disclosure.

[0114] Generally, preferred embodiments of the various devices described herein include a configuration in which the strap is perpendicular to the locking head.

[0115] Thus, with reference to Figures 33A-33H, the following steps can be performed:

[0116] 1. Creation of holes 200, 202 through the patient's skin 44 adjacent two sides 47, 46 of the soft tissue defect (hole creation not shown but known to those skilled in the art).

[0117] 2. Grasp the leader 7 with a grasping needle or suture passer 49 and push the grasped leader 7 and loop 9 through a first hole 202 in the patient's skin and into a first side 47 of the soft tissue defect (FIG. 33A).

[0118] 3. Pass the eyelet 306 of the cross guide 300 through the first hole 200 in the patient's skin 44 and position the eyelet 306 subcutaneously adjacent to the second hole 202 in the patient's skin 44 (FIG. 33B).

[0119] 4. Grasping the leader 7 with the tip 41 of the suture passer 49, pass the leader 7 through the second side 46 of the soft tissue defect, through the eyelet 306 of the cross guide 300, and out the second hole 202 in the patient's skin, where the suture passer 49 first passes the leader 7 through the eyelet 306 of the cross guide before grasping it (FIG. 33C).

[0120] 5. Disconnect the suture passer 49 from the leader 7 (Figure 33D).

[0121] 5. Pull the cross guide eyelet 36 and cross guide 300 through the first hole 200 in the patient's skin, thereby pulling the leader 7 through the second hole 202 in the patient's skin to a subcutaneous position and pulling the leader 7 out of the first hole 200 in the patient's skin (FIG. 33E).

[0122] 6. Connect the leader 7 and strap 3 to the threading tool 500 and pull the leader 7 through the locking head 5 (the locking head 5 is temporarily attached to the protruding portion of the threading tool 500), thereby pulling the leader 7 and strap 3 through the lumen of the tensioner and cutter 400 and achieving a fastening configuration that closes the soft tissue defect (FIGS. 33F and 33G).

[0123] 7. When the strap 3 has achieved a sufficient fastening configuration such that the soft tissue defect has been approximated, secured, and closed, the luminal blade of the tensioner and cutter 400 is used to cut off the excess elongated body from the strap 3, for example, by rotating the tensioner and cutter 400 (FIG. 33H).

[0124] 34A-34G, in light of the above discussion, an alternative set of steps can be performed to approximate, fixate, and close the soft tissue defect.

[0125] 1. Creation of holes 200, 202 through the patient's skin 44 adjacent two sides 47, 46 of the soft tissue defect (not shown, but known to those skilled in the art).

[0126] 2. Grasp the leader 7 with the tip 41 of the suture passer 49 and push the grasped leader 7 through the first hole 200 in the patient's skin 44 and into the first hole in the first side 47 of the soft tissue defect 45 (Figure 34A).

[0127] 3. Pass the eyelet 306 of the cross guide 300 through the second hole 202 in the patient's skin 44 and position the eyelet 306 subcutaneously adjacent to the first hole 200 in the patient's skin 44 (FIG. 34B).

[0128] 4. Attach the locking head 5 to the cross guide 300 and pull the locking head 5 subcutaneously to a position adjacent the second hole 202 in the patient's skin 44, as also shown in FIG. 34B.

[0129] 5. Withdraw the cross guide eyelet 306 and cross guide 300 through the second hole 202 in the patient's skin, leaving the locking head 5 in position adjacent to the second hole 202 in the patient's skin (FIG. 34C).

[0130] 6. The suture passer 49 is passed through the second hole 202 in the patient's skin, through the locking head 5, and through the second side 46 of the soft tissue defect 45, as also shown in FIG. 34C.

[0131] 7. As also shown in FIG. 34C, grasp the distal end of the leader 7, e.g., loop 9, with the tip 41 of the suture passer.

[0132] 8. Pass the leader 7 and strap 3 through the locking head 5 and pull it through the second hole 202 in the patient's skin 44 (FIG. 34D).

[0133] 9. Attach the leader 7 to the distal end of the threading tool 500 and pull the leader 7 and strap 3 through the lumen of the tensioner and cutter 400 to achieve a fastening configuration in which the soft tissue defect 45 is closed (FIGS. 34E and 34F).

[0134] 10. Once the soft tissue defect has been approximated, secured and closed, the tensioner and luminal blade of cutter 400 is used to cut the excess elongate body from the strap 3 of the fastening configuration (FIG. 34G).

[0135] 35A-35H, in light of the above discussion, another alternative set of steps can be performed to approximate, fixate, and close the soft tissue defect.

[0136] 1. Form first and second holes 200, 202 through the patient's skin 44, as not shown but known to those skilled in the art.

[0137] 2. Hook or connect the leader 7 to the eyelet 306 of the cross guide 306, insert the eyelet 306 of the cross guide through the first hole 200 in the patient's skin, and pass the hooked or connected leader 7 to a position adjacent to the second hole 202 in the patient's skin, thereby positioning the locking head 5 also adjacent to the first hole 200 in the patient's skin (FIG. 35A).

[0138] 3. Unhook or detach the leader 7 from the eyelet 306 of the cross guide 300 and pull the cross guide 300 out of the first hole 200 in the patient's skin (FIG. 35A).

[0139] 4. Grasp the distal end of the leader 7, e.g., loop 9, with the tip 41 of the suture passer 49, pass the leader 7 through the second hole 202 in the patient's skin and into the second hole in the second side 46 of the soft tissue defect 45, and withdraw the suture passer 49 through the second hole 202 in the patient's skin (FIG. 35B). The locking head 5 is pulled proximate to the first hole 200 through the first hole 200 in the patient's skin 44, as shown in FIG. 35C.

[0140] 5. Insert the suture passer 49 into the first hole 200 in the patient's skin through the locking head 5 and grasp the distal end of the leader 7, e.g., loop 9 (FIG. 35D).

[0141] 6. Using the suture passer 49, pull the distal end of the leader 7 through the first hole in the first side 47 of the soft tissue defect, through the locking head 5, and up through the first hole 200 in the patient's skin 44, removing the suture passer 49 therefrom. The locking head 5 is now in a subcutaneous position adjacent to the first hole 200 in the patient's skin 44 (FIG. 35E).

[0142] 7. Attach the distal end of the leader 7, e.g., loop 9, to the distal end of the threading tool 500 and pull the leader 7 and strap 3 through the lumen of the tensioner and cutter 400 to achieve a fastening configuration in which the soft tissue defect 45 is progressively closed (Figures 35F and 35G).

[0143] 8. When the soft tissue defect 45 is sufficiently approximated, secured and closed, the tensioner and luminal blade of the cutter 400 is used to cut the excess elongate body from the fastening configuration strap 3 (FIG. 35H).

[0144] The descriptions of the embodiments and their applications set forth herein should be construed as illustrative and are not intended to limit the scope of the present disclosure. Features of various embodiments may be combined with features of other embodiments and / or their combinations within the scope of the present disclosure. Variations and modifications of the embodiments disclosed herein are possible, and practical alternatives and equivalents to the various elements of the embodiments will be understood and apparent to those skilled in the art upon review of the present disclosure. Such variations and modifications of the embodiments disclosed herein can be made without departing from the scope and spirit of the present invention. Accordingly, all alternatives, variations, modifications, etc., possible to those skilled in the art are deemed to be within the scope of the present disclosure.

Claims

1. 1. A system for sequentially fastening straps to close a tissue defect, said system comprising: a first surgical strap; a second surgical strap; and a first tensioner and a second tensioner, each of the first tensioner and the second tensioner comprising: a lumen passing through the first tensioner and the second tensioner; a one-way locking means disposed within the lumen, the one-way locking means engaging at least a portion of the first surgical strap or the second surgical strap; the first surgical strap and the second surgical strap are configured to be positioned about the tissue defect in a spaced apart arrangement; the first strap is configured to be transitioned through the one-way locking means of the first tensioner, thereby at least partially closing the tissue defect; The system is configured such that the second strap is transitioned through the one-way locking means of the second tensioner, thereby further at least partially closing the tissue defect.

2. 2. The system of claim 1, wherein the first and second surgical straps each further include a leader at a distal end, an elongate body at a proximal end, and a transition portion between the elongate body and the leader, the leader having a lower bending stiffness than the elongate body.

3. The system of claim 2 , wherein the reader comprises a mesh.

4. The system of claim 2 , wherein the leader is a suture.

5. The system of claim 2 , wherein the first surgical strap and the second surgical strap each comprise a single molded part.

6. The system of claim 2 , wherein the first surgical strap and the second surgical strap each comprise at least one of the group consisting of a woven construction, a nonwoven construction, a braided construction, and a knit construction.

7. 2. The system of claim 1, wherein said one-way locking means comprises a locking head.

8. 10. The system of claim 1, further comprising at least one suture passer including a proximal handle, a shaft, and a grasping tip at a distal end of the shaft, and an actuation knob on the proximal handle in operable communication with the grasping tip and configured to open and close the grasping tip.

9. The system of claim 8 , further comprising a cross guide including a proximal handle, a shaft extending therefrom, and an eyelet at a distal end of the shaft.

10. 1. A method of closing an opening by sequentially gathering a series of spaced straps to provide a gentle force to close the opening, said method comprising: providing a first system for sequentially tightening straps, the first system having a first tensioner including a first one-way locking means and a first strap having a locking head; routing a distal end of the first strap through the locking head of the first strap, the first strap being disposed around the opening; grasping the distal end of the first strap; pulling the distal end of the first strap through a lumen of the first tensioner and the first one-way locking means of the first tensioner to apply at least some tension to the first strap, wherein the first strap is held under tension within the first tensioner and the first one-way locking means is positioned within the lumen of the first tensioner; providing a second system for sequentially tightening straps, said second system including a second tensioner including a second one-way locking means and a second strap; routing a distal end of the second strap through a locking head of the second strap, the second strap being disposed around the opening; grasping the distal end of the second strap; pulling the distal end of the second strap through a lumen of the second tensioner and the second one-way locking means of the second tensioner to apply at least some tension to the second strap, wherein the second strap is held under tension within the second tensioner and the second one-way locking means is positioned within the first tensioner; adding a strap, the first strap and the second strap being spaced apart from each other when positioned around the opening; and sequentially commencing to converge the openings by transitioning the first strap through the first locking head of the first tensioner and then transitioning the second strap through the second one-way locking means of the second tensioner.

11. 11. The method of claim 10, further comprising the step of transitioning the first strap through the first one-way locking means of the first tensioner and then transitioning the second strap through the second one-way locking means of the second tensioner.

12. 12. The method of claim 11, further comprising cutting off an excess length of the first strap and cutting off an excess length of the second strap.

13. closing the opening by transitioning the second strap through the second one-way locking means of the second tensioner and then transitioning the first strap through the first one-way locking means of the first tensioner. The method of claim 10 further comprising:

14. 14. The method of claim 13, further comprising cutting off an excess length of the first strap and cutting off an excess length of the second strap.

15. providing a third system for sequentially tightening straps, the third system including a third tensioner including a third one-way locking means and a third strap having a locking head; routing a distal end of the third strap through the locking head of the third strap, the third strap being disposed around the opening; grasping the distal end of the third strap; pulling the distal end of the third strap through a lumen of the third tensioner and the third one-way locking means of the third tensioner to apply at least some tension to the third strap, wherein the third strap is held under tension within the third tensioner; adding a strap, the first strap, the second strap, and the third strap spaced apart from one another when positioned around the opening; sequentially commencing to converge the openings by transitioning the first strap through the first one-way locking means of the first tensioner, then transitioning the second strap through the second one-way locking means of the second tensioner, and then transitioning the third strap through the third one-way locking means of the third tensioner; The method of claim 10 further comprising:

16. 16. The method of claim 15, further comprising the step of closing the opening by transitioning the first strap through the first one-way locking means of the first tensioner, then transitioning the second strap through the second one-way locking means of the second tensioner, and then transitioning the third strap through the third one-way locking means of the third tensioner.

17. 17. The method of claim 16, further comprising the steps of cutting off an excess length of the first strap, cutting off an excess length of the second strap, and cutting off an excess length of the third strap.

18. closing the opening by sequentially transitioning the third strap through the third one-way locking means of the third tensioner, transitioning the second strap through the second one-way locking means of the second tensioner, and then transitioning the first strap through the first one-way locking means of the first tensioner.

16. The method of claim 15, further comprising:

19. 20. The method of claim 18, further comprising the steps of cutting off an excess length of the first strap, cutting off an excess length of the second strap, and cutting off an excess length of the third strap.

20. 1. A method for sequentially fastening a series of spaced straps to close an opening, said method comprising: providing a first system for sequentially fastening straps, the first system having a first strap, the first strap including a leader at a distal end, an elongated body at a proximal end, and a transition portion between the elongated body and the leader, the leader having a lower bending stiffness than the elongated body, and the elongated body including a locking head; grasping the leader of the first strap; pulling the leader of the first strap through the locking head of the first strap, the first strap being disposed around the opening; applying at least some tension to the first strap; providing a second system for sequentially fastening straps, the second system having a second strap, the first strap including a leader at a distal end, an elongate body at a proximal end, and a transition portion between the elongate body and the leader, the leader having a lower bending stiffness than the elongate body, the leader being a mesh or a suture, and the elongate body including a locking head; grasping the leader of the second strap; pulling the leader of the second strap through the locking head of the second strap, the second strap being disposed around the opening; applying at least some tension to the second strap; adding a strap, the first strap and the second strap being spaced apart from each other when positioned around the opening; and sequentially beginning to converge the openings by transitioning the first strap through the locking head of the first strap and then transitioning the second strap through the locking head of the second strap.

21. 21. The method of claim 20, further comprising the step of transitioning the first strap through the locking head of the first strap and then transitioning the second strap through the locking head of the second strap.

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