System for repairing soft tissue tears

Abstract

To provide a system and method for repairing soft tissue tears such as meniscal tears.SOLUTION: An anchor system 100 has a first implant 102 connected to a length of a suture 106. The length of the suture 106 is folded such that a tension rim 123 extends from the first implant 102 and a lock rim 121 extends from the first implant 102. The anchor system 100 also includes: a second implant 104 fixed to the lock rim 121; and a length adjustment mechanism 108 of the suture 106 between the first and second implants 102, 104. The tension rim 123 is passed through the adjustment mechanism 108. This forms an adjustment loop 126 in the length of the suture 106 passing the first implant 102 and extending from the adjustment mechanism 108. The adjustment loop 126 is one-way adjustable loop for moving the first and second implants 102, 104 in relative position to each other.SELECTED DRAWING: Figure 6

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 738,551, filed September 28, 2018, entitled "System and Method for Repairing Soft Tissue Tears," U.S. Provisional Patent Application No. 62 / 791,127, filed March 1, 2019, entitled "System and Method for Repairing Soft Tissue Tears," and U.S. Provisional Patent Application No. 62 / 782,689, filed December 20, 2018, entitled "System and Method for Repairing Soft Tissue Tears."

[0002] The present invention relates generally to surgical tools and instruments, and more particularly to systems and methods for repairing soft tissue tears, such as meniscal tears. [Background technology]

[0003] 2. Description of Related Art The menisci are pieces of cartilage located within the knee joint between the top of the tibia and the bottom of the femur. They facilitate stable movement of the tibia and femur relative to each other and act as shock absorbers and load distributors. Menisci are frequently damaged as a result of injury and / or accidents (e.g., A damaged meniscus can prevent proper movement of the knee joint and cause pain, among other things. It may cause.

[0004] More specifically, the essential role of an intact meniscus and its importance for proper knee function is well documented and accepted by the general orthopedic community. An intact and functioning meniscus is essential for optimal distribution of weight-bearing forces moving through the knee joint while maintaining knee stability. The meniscus is also important for maintaining the articular cartilage surface of the knee. Loss of meniscal tissue is considered an important precursor to the development of knee osteoarthritis.

[0005] A major challenge in repairing a torn meniscus is the fact that the tissue itself is a fibrous structure that is not uniformly vascular. The vascular zone of the meniscus comprises approximately one-third of the meniscal tissue and is generally recognized as the "red-red" and "red-white" zones. The "red-red" zone (i.e., The most vascularized part of the meniscus) is where meniscus repair heals easily and along its periphery The "red-white" zone is the area where the meniscus is located. The "red-white" zone extends from the most vascularized area toward the medial side of the meniscus, eventually decreasing in blood supply to a non-vascularized tissue (sometimes referred to as the "white-white" zone). Proper surgical technique is considered critical for successful repair to be achieved in the "red-white" zone. It is generally accepted knowledge that approximately 15% of all meniscal tears occur in the "red-red" zone, another 15% occur in the "red-white" zone, and the remaining 70% occur in the "white-white" (or non-vascular) zone of the meniscus.

[0006] Another major challenge in repairing a torn meniscus is the difficulty of reducing and apposing the torn tissue due to the variable size and shape of the tear. Without proper apposition and stability, the torn meniscus tissue will not heal properly.

[0007] Techniques for repairing torn meniscus tissue were first developed and pioneered by surgeons focused on early sports medicine through the 1980s. The "inside-out" and "outside-in" suturing techniques became the so-called gold standard for meniscal tissue repair. Both of these techniques focused on passing small diameter sutures (size 2-0 or 3-0) through the meniscus to reduce and close the tear, then tying a suture knot above the knee capsule to stabilize the tear. These early all-suture repairs were characterized by the fact that the suture knots were located on the outside of the knee joint, leaving the meniscal surface relatively smooth, and the use of needles and sutures gave the surgeon a great deal of flexibility in appropriately reducing and stabilizing the tear.

[0008] Over time, these early surgeons began to use a combination of complementary techniques to promote vascular response in the less vascular areas of the meniscus. Methods such as rasp of the tear edges and meniscus, intermittent application of thrombus, drilling to create vascular channels, and covering with fascial sheaths or synovial flaps have been shown in several studies to be 150% more effective in healing meniscal tears compared with repairs that do not use such combination techniques.

[0009] Specific issues and challenges associated with the aforementioned all-suture inside-out and outside-in repair techniques primarily center around issues related to the "user interface" and "tethering" of the meniscus to the knee capsule. More specifically, "user interface" issues generally relate to the technical demands required in the operating room: the surgeon's skill and the number of assistants required to safely pass a needle and suture from the anterior to the posterior meniscus through the posterior meniscus from the posterior / medial side of the knee joint (i.e., the so-called "inside-out" technique); or, alternatively, passing a needle and suture from the lateral medial side of the knee into the knee joint, through the meniscus, retrieving and reinserting it into the meniscus, passing it through the capsule, and back to the medial side of the knee (the so-called "outside-in" technique). The aforementioned tethering issues are related to more recent concerns about securing sutures onto the knee capsule, thereby "tethering" the meniscus to the knee capsule, as evidence suggests that such tethering may interfere with the normal biomechanics of the meniscus (e.g., load and force distribution, etc.).

[0010] In the late 1980s, as awareness of the importance of the meniscus increased, new methods of meniscal repair were developed. These new methods focused on improving procedural execution to make it easier, simpler, and faster to accomplish. The new gold standard approach became the so-called "all-inside" technique. The all-inside technique is intended to avoid breaching the knee capsule and avoid incising the posterior / medial aspect of the knee (i.e., as required by the inside-out and outside-in suture techniques described above). With the all-inside technique, the entire repair, both approximation and fixation, is performed intra-articularly.

[0011] The first all-inside repair devices were tack-like implants inserted through a standard arthroscopic portal and then forced through the meniscus, thereby closing and securing the tear without the use of sutures. These tack-like implants were made from biomaterials such as PLA, PLLA, and PGA, and were expected to biodegrade over time. However, these materials were found to be very stiff when initially inserted and to degrade or bioabsorb much more slowly during use than expected. Clinical use and follow-up studies have demonstrated that there are inherent risks associated with the use of tack-like implants in the knee joint, as numerous published studies have reported device failures leading to tear reformation, implant loosening within the knee joint, and articular cartilage damage. Furthermore, it can be challenging for surgeons to adequately address various tear shapes and sizes using these tack-like implants.

[0012] As a result, there has been a return of attention to suture-based repairs and a renewed focus on performing suture-based repairs using all-inside techniques. There are several recent systems that attempt to achieve this goal. However, none of these systems are entirely satisfactory. We know that this is not the case.

[0013] Therefore, there is a need for new and improved methods and devices for meniscal repair.

[0014] Related Art Section Disclaimer Statement: To the extent that specific patents / publications / products are discussed in this Related Art Section Description or elsewhere in this disclosure, these discussions should not be construed as an admission that the discussed patents / publications / products are prior art under patent law. For example, some or all of the discussed patents / publications / products may not be early enough, may not reflect subject matter developed early enough, and / or may not be sufficiently effective to constitute prior art for purposes of patent law. To the extent that specific patents / publications / products are discussed above in this Related Art Section Description and / or throughout the application, the descriptions / disclosures thereof are incorporated herein by reference in their respective entireties. Summary of the Invention

[0015]

[0003] Embodiments of the present invention relate to systems and methods for repairing soft tissue tears, such as meniscal tears. According to one aspect, an anchor system includes a first implant connected to a length of suture. The length of suture is folded so that a tensioning rim extends from the first implant and a locking rim extends from the first implant. The anchor system also includes a second implant secured to the locking rim and an adjustment mechanism for the length of suture between the first and second implants. The tensioning rim passes through the adjustment mechanism.

[0016] According to another aspect, the present invention is a delivery device. The delivery device includes an elongate body having a needle extending distally therefrom and a pusher assembly within the elongate body. The pusher assembly has a cannulated pusher rod extending distally from the pusher body and an actuator extending from the pusher body through the elongate body. The cannulated pusher rod is slidable within the needle. The delivery device also includes a locking mechanism on the elongate body that is movable between a locked position and an unlocked position. The actuator is movable from a first configuration to a second configuration when the locking mechanism is in the locked position, and the actuator is movable from the second configuration to a third configuration when the locking mechanism is in the unlocked position.

[0017] According to yet another aspect, the present invention is a method of meniscus repair, the method comprising the steps of: (i) providing a delivery device including an elongate body having a needle extending distally therefrom, a pusher assembly within the elongate body, the pusher assembly including a cannulated pusher rod extending distally therefrom and an actuator extending from the pusher body through the elongate body, the cannulated pusher rod being slidable within the needle, and a locking mechanism on the elongate body, the locking mechanism being movable between a locked position and an unlocked position; (ii) providing a first implant connected to a length of suture, the length of suture being folded such that a tension rim extends from the first implant and a locking rim extends from the first implant; (iii) positioning a needle at a first puncture location on a first side of the tissue; (iv) inserting the needle into the second side of the tissue through the first puncture location; (v) moving the actuator distally to deploy the first implant from the delivery device; (vi) removing the needle from the first puncture location on the first side of the tissue; (vii) positioning the needle at a second puncture location on the second side of the tissue; (viii) inserting the needle into the second side of the tissue through the first puncture location; (ix) moving the locking mechanism from a locked position to an unlocked position; and (x) moving the actuator distally to deploy the second implant from the delivery device.

[0018] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiment(s) described hereinafter. [Brief explanation of the drawings]

[0019] One or more aspects of the invention are particularly pointed out and distinctly claimed as examples in the claims at the conclusion of this specification. The foregoing and other objects, features, and advantages of the invention will become apparent from the following description taken in conjunction with the accompanying drawings.

[0020] [Figure 1] FIG. 1 is a schematic side perspective view of an anchor according to an embodiment. [Figure 2] FIG. 1 is a schematic side perspective view of an implant of an anchor system, according to an embodiment. [Figure 3A] FIG. 1B is a perspective schematic view of a first step of forming a puncture hitch in a suture, according to one embodiment. [Figure 3B] FIG. 10 is a perspective schematic view of a second step of forming a puncture hitch in a suture, according to one embodiment. [Figure 3C] FIG. 10 is a perspective schematic view of a third step of forming a puncture hitch in a suture, according to one embodiment. [Figure 3D] FIG. 10 is a perspective schematic view of the final step of forming a puncture hitch in the suture, according to an embodiment. [Figure 4] FIG. 10 is a perspective schematic diagram of a length of suture connected to a second implant, according to an embodiment. [Figure 5] FIG. 1 is a perspective schematic diagram of an anchor system in a pre-deployment configuration, according to an embodiment. [Figure 6] FIG. 1 is a perspective schematic diagram of an anchor system in a pre-deployment configuration, according to an embodiment. [Figure 7] FIG. 10 is a side view schematic of an anchor system according to an alternative embodiment. [Figure 8] FIG. 8 is a perspective schematic diagram of the anchor system of FIG. 7. [Figure 9] FIG. 8 is another perspective schematic view of the anchor system of FIG. 7. [Figure 10] FIG. 10 is a perspective schematic diagram of an anchor system according to another alternative embodiment. [Figure 11] FIG. 1 is a schematic perspective view of a delivery device, according to an embodiment. [Figure 12] FIG. 1 is a perspective schematic view of a pusher assembly of a delivery device, according to an embodiment. [Figure 13] FIG. 1 is a schematic side view of a delivery device in a first configuration, according to an embodiment. [Figure 14] FIG. 1B is a schematic side view of a delivery device in a second configuration, according to an embodiment. [Figure 15] FIG. 1B is a schematic side view of a delivery device with a locking mechanism in an unlocked position, according to an embodiment. [Figure 16] FIG. 10 is a schematic side view of a delivery device in a third configuration, according to an embodiment. [Figure 17] FIG. 10 is a schematic side view of a delivery device in a fourth configuration, according to an embodiment. [Figure 18] FIG. 10 is a schematic top view of a delivery device according to an alternative embodiment. [Figure 19] FIG. 10 is a schematic side view of a delivery device according to an alternative embodiment. [Figure 20] FIG. 10 is a cross-sectional side view schematic of a delivery device according to an alternative embodiment. [Figure 21] FIG. 10 is a cross-sectional side view schematic of a delivery device in a first configuration according to an alternative embodiment. [Figure 22] FIG. 10 is a cross-sectional side view schematic of a delivery device in a second configuration according to an alternative embodiment. [Figure 23] FIG. 1 is a top view schematic of an anchor system in a deployed configuration, according to an embodiment. [Figure 24] FIG. 10 is a schematic diagram of a top perspective view of an anchoring system in a deployed configuration according to another embodiment. [Figure 25] FIG. 10 is a schematic top perspective view of an anchor system in a deployed configuration according to an alternative embodiment. [Figure 26] FIG. 1 is a schematic side perspective view of an anchor system in a deployed configuration, according to an embodiment. [Figure 27] FIG. 1 is a schematic diagram of a top perspective view of an anchor system in a deployed configuration, according to an embodiment. [Figure 28] FIG. 1 is a schematic diagram of a top perspective view of an anchor system in a deployed configuration, according to an embodiment. [Figure 29] FIG. 10 is a schematic top perspective view of a delivery device deploying an anchor system, according to an embodiment. [Figure 30] FIG. 10 is a schematic top perspective view of a delivery device deploying an anchor system, according to an embodiment. [Figure 31] FIG. 10 is a schematic top perspective view of a delivery device deploying an anchor system, according to an embodiment. [Figure 32] FIG. 10 is a schematic top perspective view of a delivery device deploying an anchor system, according to an embodiment. [Figure 33] FIG. 10 is a schematic top perspective view of a delivery device deploying an anchor system, according to an embodiment. [Figure 34] FIG. 10 is a schematic top perspective view of a delivery device deploying an anchor system, according to an embodiment. [Figure 35] FIG. 10 is a schematic top perspective view of a delivery device deploying an anchor system, according to an embodiment. [Figure 36] FIG. 1 is a schematic top perspective view of an anchor system in a deployed configuration, according to an embodiment. [Figure 37] FIG. 1 is a schematic diagram of a top perspective view of an anchor system in a deployed configuration, according to an embodiment. [Figure 38] FIG. 1 is a schematic diagram of a top perspective view of an anchor system in a deployed configuration, according to an embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0021] Aspects of the present invention and its specific features, advantages, and details are more fully described below with reference to non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures are omitted so as not to unnecessarily obscure the details of the invention. It should be understood, however, that the detailed description and specific non-limiting examples, while indicating aspects of the invention, are given by way of illustration only, and not by way of limitation. Various substitutions, modifications, additions, and / or arrangements within the spirit and / or scope of the underlying inventive concept will be apparent to those skilled in the art from this disclosure.

[0022] Referring now to the drawings, wherein like reference numerals refer to like parts throughout, FIG. 1 shows a side perspective schematic illustration of a suture anchor system 100, according to one embodiment. The anchor system 100 includes a first implant 102 and a second implant 104 interconnected by a length of suture 106. The length of suture 106 terminates in a first end 120 and a second end 122. The length of suture 106 is used to adjust the position of the first implant 102 relative to the second implant 104 by creating a unidirectionally adjustable loop via an adjustment mechanism 108 and a locking mechanism 116. and / or vice versa). In some embodiments, the adjustment mechanism 108 is an eye splice (i.e., a finger trap), and in other embodiments, the adjustment mechanism 108 is a sliding knot. The adjustment mechanism 108 can be any one-way adjustable locking construct. In certain embodiments, the locking mechanism 116 is a puncture hitch. However, the locking mechanism 116 may be any fixed locking construct, such as a knot.

[0023] As shown in FIG. 2, the first and second implants 102, 104 are rectangular so that they lie flat against the damaged tissue. However, the implants 102, 104 may have any other geometric configuration. The first and second implants 102, 104 may be constructed from suture material, plastic, or any other suitable surgical material. As shown in FIG. 2, each implant 102, 104 has a pair of adjacent, spaced-apart openings 110. In the illustrated embodiment, the pair of adjacent, spaced-apart openings 110 extends through a first side 112 of the implants 102, 104 to a second side 114 of the implants 102, 104. The implants 102, 104 have rounded saddles 112 between the openings 110 to retain the sutures 106 when the anchor system 100 is in the deployed configuration.

[0024] 3A-3D, perspective schematic illustrations of a method for forming a locking mechanism 116 on a length of suture 106 are shown, according to one embodiment. In the embodiment shown in FIGS. 3A-3D, the locking mechanism 116 is a puncture hitch. To form the puncture hitch 116, a hole 118 is formed in the length of suture 106 between a first end 120 and a second end 122. As shown in FIG. 3A, a threader 124 or another similar device is placed through the hole 118 in the length of suture 106. The first end 120 of the suture 106 is then threaded or woven through the threader 124, as shown in FIG. 3B. The threader 124 is then drawn through the hole 118 on the length of suture 106, forming a loop 125 in the suture 106, as can be seen in FIG. 3C. To minimize the loop 125, tension is applied to the first end 120 of the suture 106, thereby forming the puncture hitch 116 shown in FIG. 3D.

[0025] 4, a perspective schematic diagram of a length of suture 106 connected to a second implant 104 is shown, according to one embodiment. In the illustrated embodiment, the second implant 104 includes a pair of adjacent, spaced-apart openings 110. A second end 122 of the length of suture 106 first passes from a first side 112 of the implant 104 through one of the adjacent, spaced-apart openings 110. The second end 122 of the length of suture 106 then passes from a second side 114 of the implant 104 through the other adjacent, spaced-apart opening 110 (over a rounded saddle 112) such that an intermediate portion 128B of the suture 106 extends between the adjacent, spaced-apart openings 110 on the second side 114 of the implant 104. Finally, as shown in Figure 4, the second end 122 of the length of suture 106 is threaded through puncture hitch 116, resulting in a "puncture hitch tail" 121 extending to the first end 120 of suture 106 and a "tension rim" 123 extending to the second end 122 of suture 106. Puncture hitch 116 acts as a noose that self-folds around puncture hitch tail 121 and is stationary relative to the position of adjustment mechanism 108 (Figure 1).

[0026] 5, a perspective schematic diagram of an anchor system 100 is shown, according to one embodiment. From the configuration shown in FIG. 4, a first implant 102 is connected to a length of suture 106. A second end 122 of the length of suture 106 passes from a second side 114 of the implant 102 through one of a pair of adjacent, spaced-apart openings 110. The second end 122 of the length of suture 106 (i.e., tension rim 123) is then attached to the implant 102 such that an intermediate portion 128A ( FIG. 6 ) of the suture 106 extends between the adjacent, spaced-apart openings 110 on the first side 112 of the implant 102 (over the rounded saddle 112). The length of suture 106 passes through the other of the adjacently spaced openings 110 from the first side 112 of the suture 102. Finally, the second end 122 of the length of suture 106 (i.e., tensioning rim 123) passes through the adjustment mechanism 108. The tensioning rim 123 is slidable relative to the puncture hitch tail 121 (as the puncture hitch tail 121 does not slide).

[0027] 6, a perspective schematic diagram of an anchor system 100 is shown, according to one embodiment. As shown in the illustrated embodiment, the adjustment mechanism 108 is an eye splice. The eye splice 108 is formed in a length of suture 106, and a second end 122 (i.e., tension limb 123) of the length of suture 106 passes through the eye splice 108, forming an adjustment loop 126 in the suture 106 between the first implant 102 and the eye splice 108. Thus, in the pre-deployment configuration, an intermediate portion 128A extends between the openings 110 in the first side 112 of the first implant 102, and an intermediate portion 128B extends between the openings 110 in the second side 114 of the second implant 104, with the eye splice 108 and the puncture hitch 116 sandwiched therebetween. To adjust the adjustment loop 126 (ie, change its diameter), the second end 122 of the suture 106 is pulled, causing the first implant 102 and the second implant 104 to move closer together.

[0028] 7-10, various schematic views of an anchor system 100 according to an alternative embodiment are shown. FIG. 7 shows a side view of an anchor system 100 according to an alternative embodiment in which the first and second implants 102, 104 are cannulated anchors (or any other tubular constructs). The cannulated anchors 102, 104 are constructed from a soft material, such as suture material. In the illustrated embodiment, the length of the suture 106 is folded in half to form a sliding rim 123 and a non-sliding rim 121 (i.e., a tension rim 123 and a puncture hitch tail 121).

[0029] 7, a length of suture 106 passes through first and second cannulated anchors 102, 104. A knot 116 is used to attach second cannulated anchor 104 to non-sliding rim 121. An eye splice 108 is formed in non-sliding rim 121 between first cannulated anchor 102 and second cannulated anchor 104. First cannulated anchor 102 is slidably connected to suture 106 (sliding rim 123). Sliding rim 123 then passes through eye splice 108, forming adjustment loop 126, as shown in FIG. 7.

[0030] Figures 8 and 9 show perspective schematic diagrams of the anchor system 100 of Figure 7. In Figure 8, a first cannulated anchor 102 is slidably attached to a suture 106 by threading an adjustment loop 126 through a slit 130 (or another type of segment) in the first cannulated anchor 102. Specifically, as shown in Figure 8, the adjustment loop segment 102 passes through the slit 130 in the first cannulated anchor 102 and exits from a side 132 of the anchor 102. The adjustable loop segment 126 then passes through a distal end 134 of the first cannulated anchor 102, thereby lassoing it, as shown in Figure 9.

[0031] 10 is a perspective schematic diagram of an anchor system 100 according to another alternative embodiment. The implants 102, 104 of FIG. 10 are cannulated anchors (or any other tubular In the illustrated embodiment, the cannulated anchors 102, 104 are made of braided material. The length of suture 106 adjustably connects the first cannulated anchor 102 and the second cannulated anchor 104. In one embodiment, the length of suture 106 is 2-0 suture, although other types of sutures can be used. The length of suture 106 is folded in half so that both ends 120, 122 terminate on the same side and the other end forms a "U" shape (also shown in FIG. 7). The second cannulated anchor 10 4 is secured to the suture 106 via a knot 116 in the length of suture 106. As with the previous embodiment of anchor system 100, an eye splice 108 is formed in a locking rim 121 (also referred to herein as a non-sliding rim or puncture hitch tail) of the length of suture 106. Another rim, a tension rim 123, passes through eye splice 108 and forms an adjustment loop 126. As with anchor system 100 shown in FIGS. 8 and 9, adjustment loop 126 extends around a distal end 134 of first cannulated anchor 102.

[0032] 11-17, various schematic diagrams of a delivery device 200 according to one embodiment are shown. The delivery device 200 is configured to store one or more anchor systems 100 therein for deployment. FIG. 11 shows a perspective view of the delivery device 200. The delivery device 200 includes an elongate body 202 having a proximal end 204 and a distal end 206. The delivery device 200 includes an adjustable introducer sleeve 210 and a stop (not shown) having a positive locking mechanism (not shown) extending from the distal end 206 of the elongate body 102. A needle 212 extends distally from within the introducer sleeve 210. The anchor system 100 (FIG. 6) is fully disposed within the needle 212 of the delivery device 200. A cannulated pusher rod 208 extends within a lumen 232 of the needle 212 of the delivery device 200. The purpose of cannulated pusher rod 208 is to push anchor system 100 from delivery device 200, as described in detail below. Elongate body 202 further includes an actuator 214 and a locking mechanism 216.

[0033] 12 , a perspective schematic diagram of a pusher assembly 220 of a delivery device 200 is shown, according to an embodiment. The pusher assembly 220 includes a pusher body 218 having a cannulated pusher rod 208 extending distally therefrom. The pusher body 218 includes an actuator 214. In the illustrated embodiment, the actuator 214 is a thumb slide. The cannulated pusher rod 208 includes a relief area 222 between a distal end 224 of the pusher assembly 220 and the pusher body 218. The relief area 222 is where a portion of the cannulated pusher rod 208 has been removed. The relief area 222 facilitates rounding any corners or bends formed in the needle 212.

[0034] 12 , cannulated pusher rod 208 also includes a slit 226 at the distal end 224 of pusher assembly 220. As shown, slit 226 extends from relief area 222 into distal end 224 of cannulated pusher rod 208. This allows ends 120, 122 of suture 106 to be positioned within slit 226. Cannulated pusher rod 208 can then be withdrawn proximally toward opening 228 ( FIG. 17 ) in needle 212, forming a pinch point 230 between cannulated pusher rod 208 and lumen 232 of needle 212, allowing ends 120, 122 of suture 106 to be severed.

[0035] 13-17, side view schematics of the delivery device 200 are shown in multiple configurations, according to certain embodiments. In a first configuration, as shown in FIG. 13, the actuator 214 is a first distance from the distal end 206 of the elongate body 202. In the first configuration, the delivery device 200 is prepared to deploy the anchor system 100. In a second configuration, as shown in FIG. 14, the actuator 214 is a second distance from the distal end 206 of the elongate body 202. In certain embodiments, the first distance is greater than the second distance. When moving from the first configuration to the second configuration, the first implant 102 is deployed. Thus, by moving the actuator 214 (e.g., a thumb slide) distally along the elongate body 202, the first implant 102 is deployed.

[0036] In both the first and second configurations, the locking mechanism 216 is in a locked position in FIGS. 13 and 14 . In the illustrated embodiment, the locking mechanism 216 is a lockout switch. The lockout switch 216 is slidable or otherwise movable between a locked position and an unlocked position. In the locked position, as shown in FIGS. 13 and 14 , the actuator 214 cannot be advanced distally from the second configuration of FIG. 14 . The actuator 214 cannot be advanced distally along the elongate body 202 past the locking switch 216. The lockout switch 216 can be depressed and moved to the unlocked position, as shown in FIG. 15 .

[0037] When the lockout switch 216 is in the unlocked position, as shown in FIG. 15 , the actuator 214 can be moved distally a third distance from the distal end 206 of the elongate body 202 to achieve the third configuration, shown in FIG. 16 . When moving from the second configuration to the third configuration, the pusher rod 208 is extended out of the needle 212, deploying the second implant 104. In the third configuration, a relief area 222 is exposed between the pusher rod 208 and the needle 212, as shown.

[0038] In the third configuration, the suture 106 can move into a relief area 222 between the pusher rod 208 and the needle 212. With the end(s) 120, 122 of the suture 106 extending through the relief area 222, the delivery device 200 can be moved from the third configuration to a fourth configuration. To move the delivery device 200 from the third configuration to the fourth configuration, the actuator 214 is retracted proximally. As the delivery device 200 moves from the third configuration to the fourth configuration ( FIG. 17 ), the cannulated pusher rod 208 can be retracted into the needle 212, severing the end(s) 120, 122 of the suture 106 relative to the needle 212.

[0039] 18-22, schematic diagrams of various views of a delivery device 200 are shown, according to an alternative embodiment. FIGS. 18 and 19 show an optional latch slide 219 and tension wheel 221 on the elongated body 202 of the delivery device 200. The delivery device 200 also includes an actuator 214 on the opposite side of the elongated body 202 from the latch slide 219. As shown in FIG. 20, a rack 234 within the elongated body 202 is connected to the cannulated pusher rod 208 and moves the cannulated pusher rod 208 in and out of the needle 212.

[0040] 20 , the actuator 214 includes a ratchet mechanism for selectively advancing the cannulated pusher rod 208. When the actuator 214 is retracted proximally, the rack 234 moves distally, driving the cannulated pusher rod 208 distally. The actuator 214 may have a spring return such that, when released, the actuator 214 returns to its first (or starting) configuration. The tension wheel 221 extends partially through the elongated body 202 so that the suture 106 extending within the needle 212 can wrap around the tension wheel 221. The tension wheel 221 provides traction to the suture 106 as the implants 102, 104 are deployed. In the illustrated embodiment, the tension wheel 221 includes teeth 223 for gripping the suture 106. The latch slide 219 is optional and can be used to selectively lock the tension wheel 221 against rotation.

[0041] In the first configuration, as shown in Figures 19 and 22, the cannulated pusher rod 208 extends into the needle 212. The delivery device 200 can then be moved from the first configuration to the second configuration, as shown in Figure 21. To move the delivery device 200 from the first configuration to the second configuration, the actuator 214 is pushed or retracted proximally. Moving the actuator 214 proximally moves the rack 234 distally. The actuator 214 can be actuated to push the cannulated pusher rod 208 distally from the needle 212, ejecting the first implant 102 from the needle 212. The actuator 214 can be released to eject and deploy the second implant 104 and then retracted proximally again. The actuator 214 can also be maintained in a second configuration ( FIG. 21 ) by holding the actuator 214 proximally and exposing the relief area 222. With the relief area 222 exposed, the ends 120, 122 of the suture 106 can extend into the relief area 222. The actuator 214 is then released ( FIG. 22 ), causing the end(s) 120, 122 of the suture 106 to sever relative to the needle 212.

[0042] 23-25, schematic illustrations of various views of anchor system 100 at various stages between a pre-deployed configuration and a deployed configuration are shown, according to an alternative embodiment. As described above, anchor system 100 (FIG. 6) is fully disposed within needle 212 of delivery device 200. For example, a first implant 102 is loaded distally within needle 212 relative to a second implant 104 having a puncture hitch tail 121 and a tensioning rim 123 extending proximally therefrom within delivery device 200. (Note that it is contemplated that multiple anchor systems 100 can be loaded into delivery device 200, with the first implant 102 of an additional anchor system 100 positioned behind the second implant 104 of the first anchor system 100.)

[0043] In one embodiment, the puncture hitch tail 121 is releasably connected to the delivery device 200 and functions as a tether used to control the delivery of the second implant 104 and to apply traction to the first implant 102. To deploy the anchor system 100, the delivery device 200 is positioned against a first side 302 of tissue 300 or other object. As shown in FIG. 23, tissue 300 includes a tear 304 (or cut or other tissue injury). Delivery device 200 in a first configuration is positioned on a first side 302 of tissue 300 and tear 304. Needle 212 is advanced through tissue 300 and tear 304 at a first puncture location 308 and exits a second, opposite side 306 of tissue 300 (FIG. 29).

[0044] With the needle 212 on the second side 306 of the tissue 300, the actuator 214 can be engaged, e.g., the thumb slide 214 can be advanced distally along the elongate body 202 to drive the cannulated pusher rod 208 distally to achieve the second configuration. In the second configuration, the cannulated pusher rod 208 pushes the first implant 102 out of the delivery device 200, where it is deployed on the second side 306 of the tissue 300, as shown in FIG. 23 . The needle 212 is then withdrawn from the first puncture location 308 on the first side 302 of the tissue 300 ( FIGS. 30 and 31 ). In the embodiment of the delivery device 200 shown in FIGS. 18-22 , the suture 106 can be pulled by the tension wheel 221 as the needle 212 is withdrawn. Needle 212 then moves to a second puncture location 310 (adjacent to first puncture location 308) on the first side 302 of tissue 300 and tear 304 (FIG. 32).

[0045] The needle 212 is then advanced through the first side 302, the tear 304, and the second side 306 of the tissue 300 at the second puncture location 310 (FIGS. 33-35). With the needle 212 at the second side 306 of the tissue 300, the delivery device 200 is moved to a third configuration and a fourth configuration. From the second configuration, the lockout switch 216 is pressed or otherwise engaged to allow additional distal movement of the actuator 114. With the lockout switch 216 in the unlocked position, the actuator 114 is moved distally to the third configuration, again driving the cannulated pusher rod 208 distally. In the third configuration, also shown in FIG. 23, a cannulated pusher rod 208 pushes the second implant 104 out of the delivery device 200, where it is deployed. .

[0046] At any time after the second implant 104 has been deployed, the puncture hitch tail 121 can be released (i.e., releasing the tether and traction), allowing the delivery device 200 to be removed, i.e., the needle 212 to be pulled back through the second puncture location 310 and into the first side 302 of the tissue 300. With the anchor system 100 deployed, the anchor system 100 can be used to move the first side 302 of the tissue 300 and the second side 306 of the tissue 300 together to close the tear 304. To do this, the adjustable loop 126 is tightened (i.e., the diameter of the adjustable loop 126 is reduced) or otherwise collapsed by pulling / tensioning the second end 122 (or tensioning limb 123) of the suture 106 ( FIGS. 36-38 ). Applying tension to the second end 122 pulls both implants 102, 104 toward the second side 306 of the tissue 300, decreasing the length of the suture 106 between them. In FIG. 23 , two anchor systems 100 are shown, each with a different adjustment mechanism 108. The anchor system 100 on the left includes a slide knot 108A, and the anchor system 100 on the right includes an eye splice 108B. The eye splice 108B (and slide knot 108A) lock the first implant 102 in position relative to the second implant 104. The puncture hitch 116 maintains the position of the second implant 104 along the suture 106.

[0047] After the desired compression is achieved (between the first implant 102 and the second implant 104), with the delivery device 200 still in the third configuration, a relief area 122 is exposed between the cannulated pusher rod 208 and the needle 212. The delivery device 200 can be rotated or otherwise manipulated to receive the excess tension rim 123 within the relief area 122. The actuator 114 can then be re-engaged, for example, by sliding the thumb slide 114 back proximally (toward the proximal end 204 of the elongated body 202). Moving the actuator 214 proximally retracts the cannulated pusher rod 208 proximally into the needle 212, allowing the excess tension rim 123 to be severed from and removed from the needle 212. The same process can be repeated (or occur simultaneously) with any excess puncture hitch tail 121 remaining. The resulting deployed configuration of anchor system 100 is shown in Figures 26-28. Figures 24 and 25 show an alternative embodiment in which implants 102, 104 are cannulated anchors.

[0048] All definitions defined and used herein should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0049] While various embodiments have been described and illustrated herein, those skilled in the art will readily envision various other means and / or structures for performing the functions and / or obtaining the results and / or one or more advantages described herein, and each such variation and / or modification is deemed to be within the scope of the embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application(s) for which the teachings are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. Accordingly, the foregoing embodiments are presented by way of example only, and it should be understood that within the scope of the appended claims and their equivalents, embodiments may be practiced otherwise than as specifically described and claimed. The embodiments of the present disclosure are: This disclosure relates to individual features, systems, articles, materials, kits, and / or methods described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits, and / or methods is within the scope of the present disclosure, provided that such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent.

[0050] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. Additionally, the terms "comprise" (and any form of comprise, such as "comprises" and "comprising"), "have" (and any form of have, such as "has" and "having"), "include" (and any form of include, such as "includes" and "including"), and "contain" (any form of contain, such as "contains" and "containing") will be understood to be open-ended linking verbs. Consequently, a method or device "comprises," "has," "includes," or "contains" one or more steps or elements. Similarly, a method step or device element that "comprises," "has," "includes," or "contains" one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a particular way is configured in at least that way, but may also be configured in ways not listed.

[0051] The corresponding structure, materials, acts, and equivalents of all means or steps plus functional elements in the following claims are intended to include any structure, material, or acts for performing a function, if any, in combination with the elements of other claims that are specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or to limit the invention to the form disclosed. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the invention. The embodiments were chosen and described to best explain the principles and practical application of one or more aspects of the invention and to enable others skilled in the art to appreciate one or more aspects of the invention in various embodiments with various modifications suitable for the particular uses contemplated.

Claims

1. a first implant connected to a length of suture, the length of suture being folded such that a tensioning rim extends from the first implant and a locking rim extends from the first implant; a second implant secured to the locking rim; an adjustment mechanism for the length of the suture between the first implant and the second implant; The tensioning limb passes through the adjustment mechanism.

2. The system of claim 1 , further comprising an adjustment loop within the length of the suture extending from the adjustment mechanism through the first implant.

3. The system of claim 1 , wherein the adjustment mechanism is an eye splice.

4. The system of claim 2 , wherein the eye splice is within the lock rim.

5. The system of claim 1 , wherein the second implant is secured to the locking rim via a puncture hitch in the locking rim.

6. The system of claim 5 , wherein the puncture hitch is formed by inserting an end of the locking rim through a hole in the locking rim.

7. The system of claim 1 , wherein the first implant and the second implant are rectangular.

8. The system of claim 1 , further comprising a pair of spaced-apart adjacent openings in each of the first and second implants.

9. The system of claim 8 , further comprising a rounded saddle between each opening of the pair of spaced adjacent openings.

10. The system of claim 8 , wherein the length of the suture extends through the pair of spaced-apart adjacent openings in each of the first and second implants.

11. an elongate body having a needle extending distally therefrom; a pusher assembly within the elongate body, the pusher assembly including a cannulated pusher rod extending distally from the pusher body and an actuator extending from the pusher body through the elongate body; a pusher assembly, the cannulated pusher rod being slidable within the needle; a locking mechanism on the elongate body, the locking mechanism being movable between a locked position and an unlocked position; a delivery device, wherein the actuator is movable from a first configuration to a second configuration when the locking mechanism is in the locked position, and wherein the actuator is movable from the second configuration to a third configuration when the locking mechanism is in the unlocked position.

12. The device of claim 11 , further comprising a relief area between the distal end of the pusher rod and the pusher body.

13. The device of claim 12 further comprising a slit extending from the relief area into the pusher rod.

14. The device of claim 11 , further comprising a pinch point between the cannulated pusher rod and the needle lumen.

15. The device of claim 11 , wherein the actuator is a thumb slide.

16. 1. A method of meniscus repair comprising: providing a delivery device comprising: an elongate body having a needle extending distally therefrom; a pusher assembly within the elongate body, the pusher assembly including a cannulated pusher rod extending distally therefrom and an actuator extending from the pusher body through the elongate body, the cannulated pusher rod being slidable within the needle; and a locking mechanism on the elongate body, the locking mechanism being movable between a locked position and an unlocked position; providing an anchor system comprising: a first implant connected to a length of suture, the length of suture being folded so that a tensioning rim extends from the first implant and a locking rim extends from the first implant; a second implant secured to the locking rim; and an adjustment mechanism for the length of suture between the first implant and the second implant, the tensioning rim passing through the adjustment mechanism; positioning the needle at a first puncture location on a first side of tissue; inserting the needle through the first puncture location into a second side of the tissue; moving the actuator distally to deploy the first implant from the delivery device; removing the needle from the first puncture location on the first side of the tissue; positioning the needle at a second puncture location on a second side of the tissue; inserting the needle through the first puncture location into a second side of the tissue; moving the locking mechanism from the locked position to the unlocked position; and moving the actuator distally to deploy the second implant from the delivery device.

17. The method of claim 16 further comprising the step of pulling the tensioning rim.

18. 18. The method of claim 17, wherein the step of pulling the tensioning limbs pulls the first and second implants toward the second side of the tissue.

19. 18. The method of claim 17, further comprising positioning the tensioning rim between the cannulated pusher rod and the needle.

20. 20. The method of claim 19, further comprising moving the actuator proximally to sever the tension limb between the cannulated pusher rod and the needle.

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