阅读说明：本技术 用于修复软组织撕裂的系统 (System for repairing soft tissue tears ) 是由 朱塞佩·隆巴迪 于 2019-09-30 设计创作，主要内容包括：用于修复软组织撕裂诸如半月板撕裂的系统和方法。锚定件系统具有连接至一定长度的缝合线的第一植入物。所述一定长度的缝合线被折叠成使得张紧分支从所述第一植入物延伸并且锁定分支从所述第一植入物延伸。所述锚定件系统还包括固定至所述锁定分支的第二植入物以及在所述第一植入物与所述第二植入物之间的所述一定长度的缝合线中的调节机构。所述张紧分支穿过所述调节机构。这在从所述调节机构延伸穿过所述第一植入物的所述一定长度的缝合线中形成了调节环。所述调节环是单向可调节环,用于使所述第一植入物和所述第二植入物彼此相对地移动。(Systems and methods for repairing soft tissue tears, such as meniscal tears. The anchor system has a first implant connected to a length of suture. The length of suture is folded such that a tensioning limb extends from the first implant and a locking limb extends from the first implant. The anchor system also includes a second implant secured to the locking branch and an adjustment mechanism in the length of suture between the first implant and the second implant. The tensioning branch passes through the adjusting mechanism. This forms an adjustment loop in the length of suture extending from the adjustment mechanism through the first implant. The adjustment ring is a unidirectional adjustable ring for moving the first and second implants relative to each other.)

1. An anchor system, comprising:

a first implant connected to a length of suture folded such that a tensioning limb extends from the first implant and a locking limb extends from the first implant;

a second implant secured to the locking branch;

an adjustment mechanism in the length of suture between the first implant and the second implant; and is

Wherein the tension limb passes through the adjustment mechanism.

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

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

4. The system of claim 2, wherein the eye joint is in the locking branch.

5. The system of claim 1, wherein the second implant is secured to the locking branch via a piercing plug in the locking branch.

6. The system of claim 5, wherein the piercing plug is formed by inserting an end of the locking branch through a hole in the locking branch.

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 holes in each of the first and second implants.

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

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

11. 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 hollow pusher rod extending distally from a pusher body and an actuator extending from the pusher body through the elongate body;

wherein the hollow pusher rod is slidable within the needle;

a locking mechanism on the elongated body, the locking mechanism movable between a locked position and an unlocked position; and is

Wherein the actuator is movable from a first configuration to a second configuration when the locking mechanism is in the locked position and 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 release region between the distal end of the pusher rod and the pusher rod body.

13. The device of claim 12, further comprising a slit extending from the release region into the pusher rod.

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

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

16. A meniscal repair method comprising:

providing a conveying device with: an elongate body having a needle extending distally therefrom; a pusher assembly within the elongate body, the pusher assembly comprising a hollow pusher rod extending distally from a pusher body and an actuator extending from the pusher body through the elongate body, wherein the hollow pusher rod is 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 having: a first implant connected to a length of suture folded such that a tensioning limb extends from the first implant and a locking limb extends from the first implant; a second implant secured to the locking branch; and an adjustment mechanism in the length of suture between the first implant and the second implant, wherein the tensioning limb passes through the adjustment mechanism;

positioning the needle at a first puncture location on a first side of tissue;

piercing the needle through the first piercing location to 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 a first side of the tissue;

positioning the needle at a second puncture location on a second side of the tissue;

piercing the needle through the first piercing location to a second side of the tissue;

moving the locking mechanism from the locked position to the unlocked position;

moving the actuator further distally deploys the second implant from the delivery device.

17. The method of claim 16, further comprising the step of pulling the tension branch.

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

19. The method of claim 17, further comprising the steps of: positioning the tensioning leg between the hollow pusher rod and the needle.

20. The method of claim 19, further comprising the steps of: moving the actuator proximally, severing the tensioning branch between the hollow pusher rod and the needle.

1.Technical Field

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.

2.Description of the related Art

The meniscus is a piece of cartilage located in the knee joint between the top of the tibia and the bottom of the femur. The meniscus is used to promote stable movement of the tibia and femur relative to each other, and to absorb shock and distribute loads. Due to injury and/or accident, the meniscus is often damaged (e.g., torn). Damaged menisci may interfere with normal knee movement and cause pain and the like.

More specifically, the basic role of an intact meniscus and its importance for proper knee function has been well documented and accepted by the general osteology community. A full and properly functioning meniscus is critical for optimal distribution of load bearing forces transmitted through the knee joint while maintaining knee joint stability. The meniscus is also important for protecting the articular cartilage surface of the knee. Loss of meniscal tissue is considered a key precursor to the development of knee osteoarthritis.

The main challenge in repairing meniscal tears lies in the fact that: the tissue itself is a heterogeneous fibrous structure of the blood vessel. The vascular zone of the meniscus occupies approximately one third of the meniscus tissue and is commonly referred to as the "red-red" and "red-white" zones. The "red-red" zone (i.e., the most highly vascularized portion of the meniscus) is the area known to heal easily and located at its periphery in meniscal repairs. The "red-white" region extends from the largest vascular area towards the interior of the meniscus, where the blood supply eventually drops to non-vascular tissue (sometimes referred to as the "white-white" region). It is believed that proper surgical technique is critical if successful repair is to be achieved in the "red-white" region. It is well known that about 15% of all meniscal tears occur in the "red-red" zone, another 15% of meniscal tears occur in the "red-white" zone, and the remaining 70% of meniscal tears occur in the "white-white" (or non-vascularized) zone of the meniscus.

Another significant challenge in repairing meniscal tears is that the size and shape of the tear varies, making repositioning and apposition of the torn tissue difficult. Without proper apposition and stability, torn meniscal tissue will not heal properly.

The technology for repairing torn meniscal tissue was first developed and initiated in the 1980 s by surgeons who concentrated on sports medicine early on. The earliest method used only sutures during the repair process. The "inside-out" and "outside-in" suturing techniques become the so-called "gold standard" for repairing meniscal tissue. Both of these techniques focus on passing a small diameter suture (2-0 or 3-0 in size) through the meniscus, reducing and closing the tear, and then tying the suture knot over the knee capsule to secure and stabilize the tear. These early total suture repairs were characterized by the meniscus surface remaining relatively smooth because the suture was tied outside of the knee joint, and the use of needles and sutures allowed the surgeon great flexibility in substantially reducing and stabilizing the tear.

Eventually, these early surgeons began to concomitantly use complementary techniques to promote vascular responses in more of the meniscal non-vascular regions. Various approaches such as tear margins and meniscal capsule polishing (meniscal rasping), the application of interstitial blood clots, the formation of vascular channels by trephine, and fascial sheath or synovial flap coverage have shown in many studies 150% greater healing efficacy for meniscal tear than repairs without such concomitant techniques.

The particular problems and challenges associated with the above-described full-stitch, inside-out and inside-out repair techniques are primarily focused on the problems associated with the "user interface" and the "tethering" of the meniscus to the knee capsule. More specifically, the "user interface" problem generally relates to the technical requirements required in the operating room: the skill and number of assistants of the surgeon required to safely pass the needle and suture from the anterior portion of the meniscus through the posterior portion of the meniscus and back out through the posterior/medial side of the knee (a so-called "inside-out" technique); or the skill and number of assistants of the surgeon required to thread a needle and suture into the knee joint from the outer medial side of the knee, through the meniscus, remove and reinsert back into the meniscus, and then back through the capsule to the medial side of the knee (a so-called "outside-in" technique). The aforementioned binding problems are related to recent problems related to securing sutures to the knee capsule to "bind" the meniscus to the knee capsule, as there is evidence that binding the meniscus to the knee capsule may interfere with the normal biomechanics of the meniscus (e.g., load and force distribution, etc.).

With the growing awareness of the importance of menisci in the late 1980 s, new meniscal repair methods were developed. These new methods focus on improving the execution of the program so that it is easier, simpler and faster to accomplish. The new gold standard method has become a so-called "all-in-one" technique. The total internal technique is intended to not impinge on the knee capsule or require any incision on the posterior/medial side of the knee (i.e., such as required by the inside-out and outside-in suturing techniques described above). With total internal techniques, the entire repair process, including approximation and fixation, can be performed within the joint.

The initial total internal repair device was a nail-like implant that was inserted through a standard arthroscopic door and then forcibly pushed through the meniscus, through the tear, to close and secure the tear without the use of sutures. These nail implants are made of a biomaterial, such as PLA, PLLA or PGA, which are expected to biodegrade over time. However, these materials are very stiff on initial insertion and in use have been found to degrade or bioabsorb much more slowly than expected. Clinical use and follow-up results indicate that there are inherent risks associated with the use of nail implants in the knee joint, as many published studies report device failure, possibly leading to tear reformation, implant loosening in the knee joint, and articular cartilage damage. Furthermore, it can be challenging for the surgeon to adequately address the various tear shapes and sizes using these nail implants.

As a result, attention has turned to suture-based repairs, a new focus being to perform suture-based repairs using all-in-one techniques. Several systems have recently emerged which attempt to achieve this goal. However, these systems have not been found to be entirely satisfactory.

Accordingly, there is a need for new and improved methods and devices for meniscal repair.

Description of disclaimers in the related art section: to the extent that specific patents/publications/products are discussed above in the related art section or elsewhere in this disclosure, such discussion is not to be taken as an admission that the discussed patents/publications/products are prior art for patent law purposes. For example, some or all of the discussed patents/publications/products may not be sufficiently early in time, may not reflect subject matter that has developed sufficiently early in time, and/or may not be sufficient to implement prior art techniques equivalent to the objectives of the patent laws. To the extent that the specific patents/publications/products described above in the related art section and/or discussed throughout the application, the descriptions/publications thereof are incorporated herein by reference in their respective entireties.

Background

Disclosure of Invention

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 has a first implant connected to a length of suture. The length of suture is folded such that a tensioning limb extends from the first implant and a locking limb extends from the first implant. The anchor system also includes a second implant secured to the locking branch and an adjustment mechanism in the length of suture between the first implant and the second implant. The tensioning branch passes through the adjusting mechanism.

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 hollow pusher rod extending distally from a pusher body and an actuator extending from the pusher body through the elongate body. The hollow pusher rod is slidable within the needle. The delivery device also includes a locking mechanism on the elongate body, the locking mechanism being 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.

According to another aspect, the invention is a method of meniscal repair. The method comprises the following steps: (i) providing a conveying device with: an elongate body having a needle extending distally therefrom; a pusher assembly within the elongate body, the pusher assembly comprising a hollow pusher rod extending distally from a pusher body and an actuator extending from the pusher body through the elongate body, wherein the hollow pusher rod is 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 an anchor system having: a first implant connected to a length of suture folded such that a tensioning limb extends from the first implant and a locking limb extends from the first implant; a second implant secured to the locking branch; and an adjustment mechanism in the length of suture between the first implant and the second implant, wherein the tensioning limb passes through the adjustment mechanism; (iii) positioning the needle at a first puncture location on a first side of tissue; (iv) piercing the needle through the first piercing location to a second side of the tissue; (v) moving the actuator distally to deploy the first implant from the delivery device; (vi) removing the needle from the first puncture location on a first side of the tissue; (vii) positioning the needle at a second puncture location on a second side of the tissue; (viii) piercing the needle through the first piercing location to a second side of the tissue; (ix) moving the locking mechanism from the locked position to the unlocked position; and (x) moving the actuator further distally to deploy the second implant from the delivery device.

These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

Drawings

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

fig. 1 is a side perspective schematic view of an anchor system according to an embodiment;

fig. 2 is a schematic perspective view of an implant of the anchor system according to an embodiment;

fig. 3A is a schematic perspective view of a first step in forming a piercing plug in a suture, according to an embodiment;

FIG. 3B is a perspective view of a second step of forming a piercing plug on a suture according to an embodiment;

FIG. 3C is a perspective view of a third step of forming a piercing plug on a suture, according to an embodiment;

fig. 3D is a perspective view of a final step of forming a piercing plug in a suture according to an embodiment;

fig. 4 is a schematic perspective view of the length of suture connected to a second implant, according to an embodiment;

fig. 5 is a perspective schematic view of an anchor system in a pre-deployment configuration, according to an embodiment;

fig. 6 is a perspective schematic view of an anchor system in a pre-deployment configuration, according to an embodiment;

fig. 7 is a side view schematic illustration of an anchor system according to an alternative embodiment;

FIG. 8 is a perspective view of the anchor system of FIG. 7;

FIG. 9 is another perspective view of the anchor system of FIG. 7;

fig. 10 is a perspective schematic view of an anchor system according to another alternative embodiment;

fig. 11 is a schematic perspective view of a delivery device according to an embodiment;

fig. 12 is a schematic perspective view of a pusher assembly of a delivery device according to an embodiment;

fig. 13 is a side schematic view of a delivery device in a first configuration, according to an embodiment;

fig. 14 is a side schematic view of a delivery device in a second configuration, according to an embodiment;

fig. 15 is a side view schematic illustration of a delivery device with a locking mechanism in an unlocked position, according to an embodiment;

fig. 16 is a side schematic view of a delivery device in a third configuration, according to an embodiment;

fig. 17 is a side schematic view of a delivery device in a fourth configuration, according to an embodiment;

FIG. 18 is a schematic top view of a delivery device according to an alternative embodiment;

FIG. 19 is a side schematic view of a delivery device according to an alternative embodiment;

FIG. 20 is a side cross-sectional schematic view of a delivery device according to an alternative embodiment;

fig. 21 is a side cross-sectional schematic view of a delivery device in a first configuration, according to an alternative embodiment;

fig. 22 is a side cross-sectional schematic view of a delivery device in a second configuration, according to an alternative embodiment;

fig. 23 is a top schematic view of an anchor system in a deployed configuration, according to an embodiment;

fig. 24 is a top perspective view of an anchor system in a deployed configuration according to another embodiment;

fig. 25 is a top perspective schematic view of an anchor system in a deployed configuration according to an alternative embodiment;

fig. 26 is a side perspective schematic view of an anchor system in a deployed configuration, according to an embodiment;

fig. 27 is a top perspective view of an anchor system in a deployed configuration, according to an embodiment;

fig. 28 is a top perspective view of the anchor system in a deployed configuration, according to an embodiment;

fig. 29 is a top perspective view of a delivery device deploying an anchor system, according to an embodiment;

fig. 30 is a top perspective view of a delivery device deploying an anchor system, according to an embodiment;

fig. 31 is a top perspective view of a delivery device deploying an anchor system, according to an embodiment;

fig. 32 is a top perspective view of a delivery device deploying an anchor system, according to an embodiment;

fig. 33 is a top perspective view of a delivery device deploying an anchor system, according to an embodiment;

fig. 34 is a top perspective view of a delivery device deploying an anchor system, according to an embodiment;

fig. 35 is a top perspective view of a delivery device deploying an anchor system, according to an embodiment;

fig. 36 is a top perspective view schematic diagram of an anchor system in a deployed configuration, according to an embodiment;

fig. 37 is a top perspective view schematic diagram of an anchor system in a deployed configuration, according to an embodiment; and

fig. 38 is a top perspective schematic view of an anchor system in a deployed configuration, under an embodiment.

Detailed Description

Aspects of the invention and certain features, advantages and details thereof are explained more fully hereinafter with reference to the non-limiting examples that are illustrated in the accompanying drawings. Descriptions of well-known structures are omitted so as to not unnecessarily obscure the present invention in detail. It should be understood, however, that the detailed description and the specific non-limiting examples, while indicating aspects of the present 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 basic inventive concept will be apparent to those skilled in the art in light of this disclosure.

Referring now to the drawings, wherein like reference numbers refer to like parts throughout, fig. 1 shows a side perspective view of an anchor system 100 according to an 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 (and/or vice versa) by forming a one-way adjustable loop via the adjustment mechanism 108 and the locking mechanism 116. In some embodiments, the adjustment mechanism 108 is an eye joint (i.e., a finger trap), while in other embodiments, the adjustment mechanism 108 is a sliding knot. The adjustment mechanism 108 may be any one-way adjustable locking configuration. In an embodiment, the locking mechanism 116 is a piercing pin. However, the locking mechanism 116 may be any fixed locking configuration, such as a knot.

As shown in fig. 2, the first implant 102 and the second implant 104 are rectangular so they lie flat against the damaged tissue. However, the implants 102, 104 may have any other geometric configuration. The first implant 102 and the second implant 104 may be constructed of 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 holes 110. In the depicted embodiment, the pair of adjacent spaced apart holes 110 extend through a first side 112 of the implant 102, 104 to a second side 114 of the implant 102, 104. The implants 102, 104 have a rounded saddle 112 between the holes 110 to maintain the suture 106 across the rounded saddle when the anchor system 100 is in the deployed configuration.

Turning now to fig. 3A-3D, schematic perspective views of a method for forming a locking mechanism 116 in the length of suture 106 are shown, according to an embodiment. In the embodiment shown in fig. 3A-3D, the locking mechanism 116 is a piercing plug. To form the piercing pin 116, an aperture 118 is formed in the length of suture 106 between the first end 120 and the second end 122. As shown in FIG. 3A, a threader 124 or another similar device is placed through the aperture 118 in the length of suture 106. Thereafter, as shown in fig. 3B, first end 120 of suture 106 is threaded or braided through threader 124. A threader 124 is then pulled through the aperture 118 in the length of suture 106, as shown in fig. 3C, thereby forming a loop 125 in the suture 106. To minimize the loop 125 and thereby create the piercing pin 116 shown in fig. 3D, the first end 120 of the suture 106 is tensioned.

Referring now to fig. 4, a perspective view of the length of suture 106 connected to the second implant 104 is shown, according to an embodiment. In the depicted embodiment, the second implant 104 includes pairs of adjacent spaced apart holes 110. The second end 122 of the length of suture 106 is first passed from the first side 112 of the implant 104 through one of the adjacent spaced apart holes 110. The second end 122 of the length of suture 106 is then passed from the second side 114 of the implant 104 through another of the adjacent spaced apart holes 110 such that the intermediate portion 128B of the suture 106 extends between the adjacent spaced apart holes 110 (on the rounded saddle 112) on the second side 114 of the implant 104. Finally, the second end 122 of the length of suture 106 is passed through the piercing pin 116, as shown in fig. 4, resulting in a "piercing pin tail" 121 extending to the first end 120 of the suture 106 and a "tensioning leg" 123 extending to the second end 122 of the suture 106. The piercing pin 116 acts as a self-collapsing noose around the piercing pin tail 121 and is fixed in position relative to the adjustment mechanism 108 (fig. 1).

Turning now to fig. 5, a perspective schematic view of an anchor system 100 is shown, according to an embodiment. According to the configuration shown in fig. 4, the first implant 102 is connected to the length of suture 106. The second end 122 of the length of suture 106 passes through one of the pair of adjacent spaced apart holes 110 from the second side 114 of the implant 102. The second end 122 of the length of suture 106 (i.e., the tensioning branch 123) is then passed from the first side 112 of the implant 102 through the other of the adjacent spaced apart holes 110 such that an intermediate portion 128A (fig. 6) of the suture 106 extends between the adjacent spaced apart holes 110 (on the rounded saddle 112) on the first side 112 of the implant 102. Finally, the second end 122 of the length of suture 106 (i.e., the tensioning leg 123) is passed through the adjustment mechanism 108. Tensioning branch 123 can slide relative to piercing pin tail 121 (because piercing pin tail 121 does not slide).

Referring now to fig. 6, a perspective schematic view of an anchor system 100 is shown, according to an embodiment. As shown in the depicted embodiment, the adjustment mechanism 108 is an eye joint. An eye joint 108 is formed in the length of suture 106, and a second end 122 (i.e., a tensioning limb 123) of the length of suture 106 is passed through the eye joint 108, thereby forming an adjustment loop 126 in the suture 106 between the first implant 102 and the eye joint 108. Thus, in the pre-deployment configuration, with the eyejoint 108 and the piercing pin 116 therebetween, the middle portion 128A extends between the holes 110 on the first side 112 of the first implant 102 and the middle portion 128B extends between the holes 110 on the second side 114 of the second implant 104. To adjust the adjustment ring 126 (i.e., change its diameter), the second end 122 of the suture 106 is pulled, thereby moving the first and second implants 102, 104 closer together.

Turning now to fig. 7-10, various schematic views of an anchor system 100 are shown, according to an alternative embodiment. Fig. 7 shows a side view of the anchor system 100 according to an alternative embodiment, wherein the first implant 102 and the second implant 104 are hollow anchors (or any other tubular configuration). The hollow anchors 102, 104 are constructed of a soft material, such as a suture material. In the depicted embodiment, the length of suture 106 is doubled over to form a sliding limb 123 and a non-sliding limb 121 (i.e., a tensioning limb 123 and a piercing peg tail 121).

Still referring to fig. 7, the length of suture 106 is threaded through the first and second hollow anchors 102, 104. Knot 116 is used to secure second hollow anchor 104 to non-sliding branch 121. An eye joint 108 is formed in the non-slip branch 121 between the first and second hollow anchors 102, 104. The first hollow anchor 102 is slidably connected to the suture 106 (sliding branch 123). The sliding branch 123 is then passed through the eye joint 108, thereby forming the adjusting ring 126, as shown in fig. 7.

Fig. 8 and 9 show perspective views of the anchor system 100 of fig. 7. In fig. 8, the first hollow anchor 102 is slidably attached to the suture 106 by passing the adjustment ring 126 through a slit 130 (or another type of section) in the first hollow anchor 102. Specifically, as shown in fig. 8, the adjustable ring section 102 passes through a slit 130 in the first hollow anchor 102 and exits from a side 132 of the anchor 102. The adjustable loop segment 126 is then threaded over the distal end 134 of the first hollow anchor 102, thereby ligating it, as shown in FIG. 9.

Fig. 10 shows a perspective schematic view of an anchor system 100 according to another alternative embodiment. The implants 102, 104 in fig. 10 are also hollow anchors (or any other tubular configuration). In the depicted embodiment, the hollow anchors 102, 104 are constructed of a braided material. The length of suture 106 adjustably connects the first hollow anchor 102 and the second hollow anchor 104. In an embodiment, the length of suture 106 is a 2-0 suture, however other types of sutures may be used. The length of suture 106 is doubled over so that the two ends 120, 122 terminate on the same side, while the other end forms a "U" shape (also shown in fig. 7). The second hollow anchor 104 is secured to the suture 106 via a knot 116 in the length of suture 106. As with the previous embodiments of the anchor system 100, an ocular joint 108 is formed in a locking branch 121 (also referred to herein as a non-sliding branch or piercing plug tail) of the length of suture 106. The other branch, tensioning branch 123, passes through eye joint 108, forming adjustment ring 126. Similar to the anchor system 100 shown in fig. 8 and 9, the adjustment ring 126 extends around the distal end 134 of the first hollow anchor 102.

Turning now to fig. 11-17, various schematic views of a delivery device 200 according to embodiments 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 elongated body 202 having a proximal end 204 and a distal end 206. The delivery device 200 includes an adjustable introducer sleeve 210 and a stopper (not shown) having a positive lock 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 located entirely within the needle 212 of the delivery device 200. Hollow pusher rod 208 extends within lumen 232 of needle 212 of delivery device 200. The purpose of hollow pusher rod 208 is to push anchor system 100 from delivery device 200, as described in detail below. The elongate body 202 also includes an actuator 214 and a locking mechanism 216.

Turning now to fig. 12, a perspective schematic view 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 with a hollow pusher rod 208 extending distally therefrom. The pusher body 218 includes an actuator 214. In the depicted embodiment, the actuator 214 is a thumb slide. The hollow pusher rod 208 includes a release region 222 between a distal end 224 of the pusher assembly 220 and the pusher body 218. The release region 222 is where a portion of the hollow pusher rod 208 has been removed. The relief areas 222 allow corners or bends formed in the needle 212 to be easily rounded.

Still referring to fig. 12, the hollow pusher rod 208 also includes a slot 226 at the distal end 224 of the pusher rod assembly 220. As shown, a slit 226 extends from the release region 222 into the distal end 224 of the hollow pusher rod 208. This allows the ends 120, 122 of the suture 106 to be positioned within the slot 226. The hollow pusher rod 208 may then be pulled proximally toward the opening 228 (fig. 17) of the needle 212, thereby forming a pinch point 230 between the hollow pusher rod 208 and the lumen 232 of the needle 212 and severing the ends 120, 122 of the suture 106.

Turning now to fig. 13-17, side-view schematic diagrams of a delivery device 200 in various configurations are shown, according to an embodiment. In the first configuration, the actuator 214 is a first distance from the distal end 206 of the elongate body 202, as shown in fig. 13. In the first configuration, the delivery device 200 is prepared to deploy the anchor system 100. In the second configuration, the actuator 214 is a second distance from the distal end 206 of the elongate body 202, as shown in fig. 14. In an embodiment, the first distance is greater than the second distance. When moved from the first configuration to the second configuration, the first implant 102 is deployed. Thus, by moving the actuator 214 (e.g., thumb slide) distally along the elongate body 202, the first implant 102 is deployed.

In both the first and second configurations, as shown in fig. 13 and 14, the locking mechanism 216 is in a locked position. In the depicted embodiment, the locking mechanism 216 is a locking switch. The lock switch 216 may slide or otherwise move between a locked position and an unlocked position. In the locked position, as shown in fig. 13 and 14, the actuator 214 cannot be distally advanced from the second configuration of fig. 14. The actuator 214 cannot travel distally along the elongate body 202 past the lockout switch 216. The lock switch 216 may be depressed and moved to an unlocked position as shown in fig. 15.

When the lock switch 216 is in the unlocked position, as shown in fig. 15, the actuator 214 may 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 moved from the second configuration to the third configuration, the pusher rod 208 extends out of the needle 212, thereby deploying the second implant 104. As shown, in the third configuration, the release region 222 is exposed between the pusher rod 208 and the needle 212.

In the third configuration, the suture 106 may move into the release region 222 between the pusher rod 208 and the needle 212. With one or more ends 120, 122 of the suture 106 extending through the release region 222, the delivery device 200 can be moved from the third configuration to the fourth configuration. To move the delivery device 200 from the third configuration to the fourth configuration, the actuator 214 is pulled in a proximal direction. When the delivery device 200 is moved from the third configuration to the fourth configuration (fig. 17), the hollow pusher rod 208 is pulled back into the needle 212, allowing one or more ends 120, 122 of the suture 106 to be cut against the needle 212.

Referring now to fig. 18-22, various schematic views of a delivery device 200 are shown, according to an alternative embodiment. Fig. 18 and 19 illustrate an alternative latch slide 219 and tensioning wheel 221 of the elongated body 202 of the delivery device 200. The delivery device 200 also includes an actuator 214 on an opposite side of the elongate body 202 relative to the latch slide 219. As shown in fig. 20, a rack 234 within the elongated body 202 is connected to the hollow pusher rod 208 and moves the hollow pusher rod 208 in and out of the needle 212.

Still referring to fig. 20, the actuator 214 includes a ratchet mechanism for selectively advancing the hollow pusher rod 208. When actuator 214 is pulled in a proximal direction, rack 234 moves distally, thereby driving hollow pusher rod 208 in a distal direction. The actuator 214 may have a spring return such that the actuator 214 returns to its first (or starting) configuration when released. The tensioning wheel 221 extends partially through the elongated body 202 such that the suture 106 extending within the needle 212 can be wrapped around the tensioning wheel 221. The tensioning wheel 221 provides traction on the suture 106 as the implants 102, 104 are deployed. In the depicted embodiment, tensioning wheel 221 includes teeth 223 for grasping suture 106. The latch slide 219 is optional and may be used to selectively lock the tension wheel 221 against rotation.

In a first configuration, as shown in fig. 19 and 22, the hollow pusher rod 208 extends within the needle 212. The delivery device 200 may then be moved from the first configuration to the second configuration, as shown in fig. 21. To move the delivery device 200 from the first configuration to the second configuration, the actuator 214 is squeezed or pulled in a proximal direction. Moving actuator 214 proximally drives rack 234 distally and, thus, pushes hollow pusher rod 208 distally out of needle 212, thereby expelling first implant 102 from needle 212. The actuator 214 may be released and then pulled proximally again as the second implant 104 is expelled and deployed. The actuator 214 may also be maintained in the second configuration (fig. 21) by holding the actuator 214 proximally, thereby exposing the release region 222. With the relief area 222 exposed, the ends 120, 122 of the suture 106 may extend into the relief area 222. One or more ends 120, 122 of the suture 106 are then cut against the needle 212 when the actuator 214 is released (fig. 22).

Referring now to fig. 23-25, various schematic views of the anchor system 100 in various stages between a pre-deployment configuration and a deployed configuration are shown, according to an alternative embodiment. As described above, the anchor system 100 (fig. 6) is located entirely within the needle 212 of the delivery device 200. For example, the first implant 102 is loaded distally in the needle 212 relative to the second implant 104, with the piercing pin tail 121 and tensioning leg 123 extending proximally therefrom within the delivery device 200. (Note that it is contemplated that multiple anchor systems 100 may be loaded into the delivery device 200, with the first implant 102 of the additional anchor system 100 located behind the second implant 104 of the primary anchor system 100).

In an embodiment, the piercing bolt tail 121 is releasably connected to the delivery device 200 and functions as a tether for controlling the delivery of the second implant 104 and applying a traction force to the first implant 102. To deploy the anchor system 100, the delivery device 200 is placed on a first side 302 of the tissue 300 or other object. As shown in fig. 23, the tissue 300 includes a tear 304 (or cut or other tissue injury). In the first configuration, the delivery device 200 is placed on the tissue 300 and the first side 302 of the tear 304. Needle 212 travels through tissue 300 and tear 304 at first puncture location 308 and out a second, opposite side 306 of tissue 300 (fig. 29).

With the needle 212 on the second side 306 of the tissue 300, the actuator 214 is engaged, e.g., the thumb slide 214 travels in a distal direction along the elongate body 202, driving the hollow pusher rod 208 distally to achieve the second configuration. In the second configuration, the hollow pusher rod 208 pushes the first implant 102 out of the delivery device 200 and the first implant is deployed on the second side 306 of the tissue 300, as shown in fig. 23. Needle 212 is then withdrawn from first puncture location 308 on first side 302 of tissue 300 (fig. 30 and 31). In the embodiment of the delivery device 200 shown in fig. 18-22, the suture 106 may be drawn by the tensioning wheel 221 as the needle 212 is withdrawn. Needle 212 is then moved to a second puncture location 310 (adjacent to first puncture location 308) on tissue 300 and first side 302 of tear 304 (fig. 32).

Needle 212 is then advanced through first side 302, tear 304, and second side 306 of tissue 300 at second puncture location 310 (fig. 33-35). With the needle 212 on the second side 306 of the tissue 300, the delivery device 200 moves to the third and fourth configurations. From the second configuration, the lockout switch 216 is depressed or otherwise engaged to allow additional distal movement of the actuator 114. With the lock switch 216 in the unlocked position, the actuator 114 is moved distally to the third configuration, again driving the hollow pusher rod 208 distally. In a third configuration, the hollow pusher rod 208 pushes the second implant 104 out of the delivery device 200 and the second implant is deployed, as shown in fig. 23.

The piercing plug tail 121 may be released (i.e., the cinching and pulling force released) at any time after the second implant 104 is deployed, thereby allowing the delivery device 200 to be removed, i.e., the needle 212 to be pulled back through the second piercing location 310 to 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 so, the adjustable loop 126 is cinched (i.e., the diameter of the adjustable loop 126 is reduced) or collapsed by pulling/tensioning the second end 122 (or tensioning limb 123) of the suture 106 (fig. 36-38). Tensioning the second end 122 may pull both implants 102, 104 toward the second side 306 of the tissue 300, thereby reducing the length of the suture 106 therebetween. In fig. 23, two anchor systems 100 are shown, each having a different adjustment mechanism 108. The anchor system 100 on the left includes a slip knot 108A and the anchor system 100 on the right includes an ocular joint 108B. The eye joint 108B (and sliding knot 108A) locks the first implant 102 in position relative to the second implant 104. The piercing pegs 116 maintain the position of the second implant 104 along the suture 106.

After the desired compression is achieved (between first implant 102 and second implant 104) and with delivery device 200 still in the third configuration, release region 122 is exposed between hollow pusher rod 208 and needle 212. The delivery device 200 may be rotated or otherwise manipulated to receive the excess tensioning fingers 123 in the release area 122. The actuator 114 can then be engaged again, for example, by sliding the thumb slide 114 back in the proximal direction (toward the proximal end 204 of the elongate body 202). Moving the actuator 214 proximally may draw the hollow pusher rod 208 proximally into the needle 212, allowing the excess tensioning leg 123 to be cut and removed against the needle 212. This process can be repeated (or performed simultaneously) while leaving any excess piercing plug tail 121. The resulting deployed configuration of the anchor system 100 is shown in fig. 26-28. Fig. 24 and 25 show an alternative embodiment in which the implants 102, 104 are hollow anchors.

All definitions, as defined and used herein, should be understood to take precedence over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

While various embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications 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 meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/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. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the embodiments may be practiced otherwise than as specifically described and claimed. Embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure.

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 indicates otherwise. It should also be understood that the terms "comprises" (and any form of "comprising", such as "comprises" and "comprising)", "has" (and "has)", such as "has" and "has)", "contains" (and any form of "containing", such as "comprises" and "containing)", and "contains" (and "contains" and any form of "containing", such as "contains" and "contains" are open-ended verbs. Thus, a method or apparatus that "comprises," "has," "includes" or "contains" one or more steps or elements. Likewise, a step of a method or an element of a device 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. Further, a device or structure that is constructed in a certain manner is constructed in at least that manner, but may also be constructed in ways that are not listed.

The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below, if any, are intended to include any structure, material, or act for performing the function in combination with other claimed elements as 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 limited to the invention in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the invention. The embodiments were chosen and described in order to best explain the principles of one or more aspects of the invention and the practical application, and to enable others of ordinary skill in the art to understand one or more aspects of the invention for various embodiments with various modifications as are suited to the particular use contemplated.