Knotless lip repair technology and related devices

Abstract

Suture Anchor Without Knot for Fixing Soft Fibers to Bone The suture anchor used in the first technique includes a proximal anchor body and a distal tip having a small hole configured to receive the end of the repair suture. Internal locking elements on the distal tip and the proximal anchor body are provided to lock the tip and the anchor body together when the suture anchor is implanted into the bone. The suture assembly used in the alternative knotless technique includes a suture anchor, a repair suture, and a shuttle suture. Both the repair suture and the shuttle suture are looped at one end and straight at the other end. In the alternative technique, the loop and tail of the repair suture are manipulated to form a tag configuration that extends around the tissue, and the shuttle suture is used to firmly fix the tag configuration and the tissue to the bone.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 17 / 736,015, filed May 3, 2022, the disclosure of which is incorporated herein by reference for all purposes.

[0002] This disclosure generally relates to soft tissue repair surgery, and more particularly to surgical methods and devices for glenoid labrum repair.

Background Art

[0003] Labral tears can occur as a result of sports injuries and other types of trauma, and can also be caused by aging as the labrum becomes brittle over time. Minor tears can be treated with medication, physical therapy, and rest, but more severe injuries require surgery.

[0004] Labral surgery can be an open surgery or an arthroscopic surgery and can be performed by using a suturing technique with knots or without knots. A typical suturing - with - knots repair technique involves loading a suture with two free ends into a suture anchor and implanting the suture anchor into the glenoid fossa bone at a location on one side of the damaged labrum. After one end of the suture is passed between the labrum and the glenoid fossa, both ends are tied together to create a knot that fixes the labrum to the bone. In a knotless repair technique, the suture is first passed through the labrum, and then both ends are fed to the distal tip of the suture anchor before the suture anchor is implanted into the bone. After the suture anchor is implanted, both ends of the suture are held in place by interference fit between the suture anchor and the bone.

[0005] Knotless labral repair techniques are generally preferred over knot - tying techniques but can be problematic because they allow relative movement between the labrum and the suture. In addition, suture slippage can occur if the interference fit between the knotless suture anchor and the surrounding bone is not tight enough (as is often the case in patients with reduced bone density due to age or disease).

[0006] These problems and other problems are addressed by the present disclosure summarized below. SUMMARY OF THE INVENTION

[0007] In one aspect of the present disclosure, a suture anchor used in a knotless suture technique for fixing soft tissue to bone includes a distal tip having a small hole configured to receive the end of a repair suture. The distal tip is removably fixed to the distal tip of a driver shaft, and a proximal anchor body is attached for longitudinal movement in the direction of the distal tip. An internal locking element on the distal tip and the proximal anchor body are provided to lock the tip and the anchor body together when the suture anchor is implanted into bone.

[0008] In one aspect of the present disclosure, the internal locking element includes a mating portion of a spring lock. The spring lock includes an annular groove or annular bead on the distal portion of the anchor body, and an annular groove configured to receive the annular bead, or an annular bead configured to protrude into the annular groove.

[0009] In another aspect of the present disclosure, the proximal anchor body may include an outer wall including a plurality of annular ribs separated by annular channels.

[0010] In yet another aspect of the present disclosure, the driver shaft includes an inner shaft and an outer shaft attached for sliding movement relative to each other. The distal tip is configured to be removably fixed to the inner shaft, and the proximal anchor body is configured to be removably fixed to the outer shaft and slidable with the outer shaft.

[0011] In yet another aspect of the present disclosure, the proximal anchor body may include a distal tip defining a notch configured to align with a small hole in the distal tip when the proximal anchor body is in a fully deployed position. The notch has a proximal end that prevents proximal movement of the repair suture through the small hole when a semi-circular notch aligns with the small hole.

[0012] A suture assembly used in an alternative technique for fixing soft tissue to bone includes a suture anchor, a repair suture, and a shuttle suture. The suture anchor has a first side, a second side, and a proximal end. The repair suture has a looped end and a tail, is doubled over on itself, and is disposed within the suture anchor such that its looped end extends from the proximal end of the suture anchor on its first side and its tail extends from the proximal end of the suture anchor on its second side. The shuttle suture has a looped end and a tail, is doubled over on itself, and is disposed within the suture anchor such that its looped end extends from the proximal end of the suture anchor on its second side and its tail extends from the proximal end of the suture anchor on its second side.

[0013] In another aspect of the present disclosure, the loop of the repair suture is larger than the loop of the shuttle suture.

[0014] In yet another aspect of the present disclosure, the repair suture is thicker than the shuttle suture.

[0015] In yet another aspect of the present disclosure, the repair suture has a thickness that varies from a maximum within the loop to a minimum within the tail.

[0016] A method of fixing soft tissue to bone by using the suture assembly disclosed above includes: inserting the suture assembly into bone under separated tissue and to one side of the separated tissue; passing the tail of the repair suture between the separated tissue and the bone; and passing the tail of the repair suture back over the separated tissue and through the loop of the repair suture to create a luggage tag configuration.

[0017] In one aspect of the present disclosure, the method further includes locking the luggage tag configuration in place relative to the tissue by capturing the tail of the repair suture in an interference fit between a suture engagement feature and the inner wall of the suture anchor.

[0018] In one aspect of the present disclosure, the method further includes passing a loop of shuttle suture between the separated tissue and bone; pulling the tail of the repair suture through the loop of the shuttle suture after the load-bearing configuration is created; and pulling the tail of the shuttle suture to pull the tail of the repair suture down through the second side of the suture anchor, up through the first side, and out through the proximal end of the first side, thereby tightly securing the load-bearing configuration to the tissue.

[0019] In another aspect of the present disclosure, the separated tissue is a damaged glenoid labrum and the bone is the glenoid bone.

[0020] In another aspect of the present disclosure, the method includes implanting a suture anchor into the bone under the tissue on one side of the tissue, the suture anchor being pre-loaded with a repair suture having a looped end and a tail; passing the tail of the repair suture between the separated tissue and bone; and returning the tail of the repair suture over the separated tissue and through the loop of the repair suture to create a load-bearing structure; and locking the load-bearing configuration in place against the tissue.

[0021] In yet another aspect of the method, the suture anchor includes an inner wall defining a cannulation and a suture engagement feature extending throughout the cannulation, and locking the load-bearing configuration in place against the tissue includes capturing the tail of the repair suture in an interference fit between the suture engagement feature and the inner wall.

[0022] In an alternative method, the suture anchor assembly includes a full suture anchor, and the repair suture and shuttle suture are embedded within a tube or sleeve configured and arranged to apply a contact force against the surrounding bone when configured to fold longitudinally and expand radially, and locking the load-bearing configuration in place against the tissue includes deploying the full suture anchor to apply the contact force against the surrounding bone.

Brief Description of the Drawings

[0023]

Figure 1A

Figure 1B

Figure 1C

Figure 1D

Figure 1E

Figure 2A

Figure 2B

Figure 3

Figure 4A

Figure 4B

Figure 5

Figure 6A

Figure 6B

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Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

[0024] If desired, detailed embodiments of the invention are disclosed herein; it should be understood, however, that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various and alternative forms. The drawings are not necessarily to scale; that is, some features may be exaggerated or minimized to show details of particular components. Accordingly, the specific structural and functional details disclosed herein are not to be construed as limiting, but merely as a representative basis for one skilled in the art to employ the invention in various ways.

[0025] FIGS. 1A-E show a prior art knotless suture first technique for fixing a damaged glenoid labrum 10 to the glenoid bone 12. In FIG. 1A, the distal tip of a conventional straight suture 14 is passed between the labrum 10 and the bone 12 by using a suture passer device 16 that has been passed through a posterior cannula 18. After the suture 14 has been fed into the joint, the suture passer device 16 is withdrawn and a grasping instrument 20 is passed through the posterior cannula 18 to grasp the suture 14 as shown in FIG. 1B. Next, the distal tip of the suture 14 is drawn into the posterior cannula 18 as shown in FIG. 1C. Next, a socket 22 is formed in the bone 12 by using a drill 24 or similar tool that passes through the posterior cannula 18 as shown in FIG. 1D. Finally, the distal tip of the suture 14 is fed through the distal tip 26 of a suture anchor 28 and then inserted into the bone socket 22 as shown in FIG. 1E. Typically, this procedure is repeated two more times so that the labrum 10 is fixed to the bone 12 at three locations.

[0026] Figures 2A and 2B show a suture anchor 30 or other conventional knotless suture first soft fiber / bone reattachment method that can be used in the present method of FIGS. 1A-E. The suture anchor 30 includes a distal tip 32 that is removably fixed to the distal end of an inner driver shaft 34 that penetrates the interior of a proximal anchor body 36. An outer driver shaft 37 is attached for sliding movement relative to the inner driver shaft 34. The proximal anchor body 36 is removably fixed to the distal end of the outer driver shaft 37 and is slidable therewith.

[0027] The distal tip 32 includes an enlarged rounded distal portion 39 and a proximal extension neck 40. An elongated aperture 41 formed within the neck 40 is configured to receive the ends of the sutures 14A, B. An annular bead 42 extends around the exterior of the proximal end 44 of the neck 38.

[0028] The proximal anchor body 36 is tubular in configuration and includes a distal end 52 having an outer wall 46, an inner wall 48, a proximal end 50, and a semi-circular notch 53. The outer wall 46 includes a plurality of rounded annular ribs 54 separated by a rounded annular channel 56. An annular groove 58 is formed within the inner wall 48 at the proximal end 50.

[0029] To secure the sutures 14A and 14B within the bone 50, the surgeon inserts the distal tip 38 of the suture anchor 30 into the pre-drilled bone socket 22, pushes it down onto the outer driver shaft 37, and moves the outer driver shaft 37 and the proximal anchor body 36 together in the direction of the distal tip 38 (as shown in FIG. 3). The downward movement of the outer driver shaft 37 and the proximal anchor body 36 continues until the annular groove 58 at the proximal end 50 of the proximal anchor body 36 fits over the annular bead 42 on the neck 40 of the distal tip 36, locking the proximal anchor body 36 and the distal tip 36 together (as shown in FIGS. 4A and 4B). At this point, the outer driver shaft 34 and the inner driver shafts 34, 37 are withdrawn, the anchor 30 remains within the bone 50, and the sutures 14A, B are trapped not only between the ribs 54 of the proximal anchor body 37 and the wall of the bone socket 22 but also between the distal end 60 of the aperture 40 and the proximal end of the semi-circular notch 53.

[0030] FIG. 5 shows a repair suture 114 that can be used in an alternative method for securing damaged soft tissue, such as a rotator cuff, to bone, such as glenoid bone. The suture 114 has a straight end 116, a loop end 118, and a maximum T at the loop end 118 MAX to a minimum T at the straight end 116 MIN including a thickness that varies therebetween. In the illustrated embodiment, the thickness tapers gradually from the apex 119 of the loop end 118 to the tip 120 of the straight end 116. However, in another example, the entire loop end 118 may have a constant thickness T MAX and the entire straight end 116 (i.e., the entire length of the portion extending from the base of the loop 118 to the tip 120) may have a constant thickness T MIN thereof.

[0031] FIG. 6A shows a suture assembly 200 that includes a suture anchor 270, a repair suture 214 that is structurally similar to the repair suture 114 of FIG. 5, and a shuttle suture 280. The suture anchor 270 includes an inner wall 271 that defines a cannulation 272, an open proximal end 274 that communicates with the cannulation 272, and suture engagement features such as a rod or suture bridge 276 that extends across the cannulation and divides the cannulation into a first side 277 and a second side 278.

[0032] The repair suture 214 is doubled over itself and positioned within the cannulation 272 such that its tail 216 extends proximally along the second side 278 of the cannulation 272 and out through the open proximal end 274, and its loop end 218 extends proximally along the first side 277 of the cannulation 272 and out through the open proximal end 274.

[0033] The shuttle suture 280 has a looped end 282 and a tail 284, and the looped end 282 extends outwardly through the proximally open proximal end 274 along the second side 278 of the cannulation 272, and the tail 284 extends outwardly through the proximally open proximal end 274 along the first side 277 of the cannulation 272, doubled over itself and disposed within the cannulation 272. The looped end 282 of the shuttle suture 280 is smaller than the looped end 218 of the repair suture 214. Additionally, the shuttle suture 280 is thinner than the repair suture 214 over all or most of its length.

[0034] Figure 6B shows an alternative suture assembly 300 that includes a softer full suture anchor 370 rather than the rigid anchor 270 of Figure 6A. The repair suture 314 and the shuttle suture 380 can be woven or embedded within a foldable tube or sleeve 286 made of the same material as and integratable with the repair suture 314 and the shuttle suture 380. The sleeve 386 is bent into a U-shape having a first side 377, a second side 378, and two proximal openings 301, 303. The looped end 318 of the repair suture 314 passes through the first side 377 of the U-shaped sleeve 386 and out of the first proximal opening 301, and the straight end 316 of the repair suture 314 passes through the second side 378 of the U-shaped sleeve and out of the second proximal opening 303. The looped end 382 of the repair suture 380 passes through the second side 378 of the U-shaped sleeve 386 and out of the second proximal opening 303, and the tail 384 of the repair suture 380 passes through the first side 377 of the U-shaped sleeve 386 and out of the first proximal opening 301.

[0035] Figures 7-12 illustrate a technique for fixing soft tissue 10 such as a damaged glenoid labrum to bone 12 such as glenoid bone by using the suture assembly 200 of FIG. 6A. Initially, suture anchor 270 is inserted into a pre-drilled socket 222 in bone 12 at a location on one side of tissue 10, and suture passer device 215 is used to pass the tail 216 of repair suture 214 and the loop 282 of shuttle suture 280 from between tissue 10 and bone 12 to the side of tissue 10 opposite the suture anchor 270 (as shown in FIGS. 7 and 8). Next, the tail 216 of repair suture 214 is passed back through the looped end 218 of the repair suture over tissue 10 to form a bight configuration 290 (as shown in FIG. 9). Next, the tail 216 of repair suture 214 is doubled over itself and pulled out through the looped end 282 of shuttle suture 280 (as shown in FIG. 10). Next, the tail 284 of shuttle suture 280 is pulled proximally to draw the tail 216 of repair suture 214 down into the second side 278 of the cannulation 272 of the suture anchor (as shown in FIG. 11). Continued pulling of shuttle suture 280 finally draws the tail 216 of repair suture 214 upward through the first side 277 of cannulation 272 and out through the open proximal end 274 of suture anchor 270, thus tightly cinching the bight configuration 290 against tissue 19 (as shown in FIG. 12). At this point, shuttle suture 280 can be removed.

[0036] In the configuration shown in FIG. 12, the tail 216 of repair suture 214 can be considered to include the following four segments: a first segment 292 extending between the base 217 of loop 218 and the distal end of suture bridge 276; a second segment 294 extending between the distal end of suture bridge 276 and the apex 219 of loop 218 on the second side 278 of suture bridge 276; a third segment 296 extending between the apex 219 of loop 218 and the distal end of suture bridge 276 on the first side 277 of suture bridge 276; and a fourth segment 298 extending between the distal end of suture bridge 276 and the looped end 282 of shuttle suture 280.

[0037] The suture anchor assembly 290 is locked to the tissue 10 at a predetermined location by trapping segments 292, 294, 296, 298 of the tail 216 of the repair suture 214 in an interference fit between the suture bridge 276 and the inner wall 271 of the suture anchor 289. To create this interference fit, the sum of the thicknesses of the first segment 292 and the fourth segment 298 and / or the sum of the thicknesses of the second segment 294 and the third segment 296 should be slightly greater than the distance D between the suture bridge 296 and the inner wall 271 of the suture anchor 279. In the case where the suture tail 216 has a uniform thickness T MIN over its entire length and the suture bridge 276 is precisely centered within the cannulation 272, this would mean that D should be slightly less than 2T MIN by a small amount.

[0038] In addition to the shoulder labral repair described above, the methods and devices disclosed herein can be used to repair suture-end skin deformations and / or small ruptures within the tendon sheath and various other types of injuries within tendons and other soft fibers.

[0039] The method of FIGS. 7-12 can also be performed by using the all-suture anchor of FIG. 6B rather than the rigid suture anchor of FIG. 6A. In this case, the suture anchor assembly is locked in place with respect to the tissue by the contact force applied by the all-suture anchor on the surrounding bone when the anchor is deployed, rather than by an interference fit between the suture and the internal suture bridge.

[0040] Although embodiments of the invention have been shown and described, it is not intended that these embodiments represent and describe all possible forms of the invention. Rather, the terms used herein are terms of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention.

Claims

1. A suture anchor, comprising: A distal tip configured to be removably fixed to the distal end of a driver shaft, the distal tip including a small hole configured to receive the end of a repair suture; A proximal anchor body attached for longitudinal movement in the direction of the distal tip; and An internal locking element configured to lock the distal tip to the proximal anchor body when the suture anchor is implanted in bone. The suture anchor comprising the above.

2. The suture anchor according to claim 1, wherein the internal locking element includes a fitting portion of a spring lock.

3. The fitting portion of the spring lock includes: A first element formed on the distal portion of the proximal anchor body; and A second element formed on the proximal portion of the distal tip. The suture anchor according to claim 2.

4. The first element includes an annular bead or an annular groove; The second element includes an annular groove configured to receive the annular bead or an annular bead configured to project into the annular groove. The suture anchor according to claim 3.

5. The suture anchor according to claim 1, further comprising a plurality of annular ribs separated by an annular channel formed on the outer wall of the proximal anchor body.

6. The driver shaft includes an inner shaft and an outer shaft attached for sliding movement relative to each other; The distal tip is configured to be removably fixed to the inner shaft; The proximal anchor body is configured to be removably fixed to the outer shaft and to be slidable together with the outer shaft.

7. The proximal anchor body includes a distal tip defining a notch configured to align with the small hole in the distal tip when the proximal anchor body is in a fully deployed position, the notch having a proximal end that prevents proximal movement of a repair suture passing through the small hole when the notch aligns with the small hole.

8. A suture anchor having a first side, a second side, and a proximal end; A repair suture having a looped end and a tail, the repair suture being doubled over itself and disposed within the suture anchor such that the looped end of the repair suture extends from the proximal end of the suture anchor on the first side thereof and the tail of the repair suture extends from the proximal end of the suture anchor on the second side thereof. A shuttle suture having a looped end and a tail, wherein the shuttle suture is doubled over itself and its looped end extends from the proximal end of the suture anchor on the second side thereof, and its tail extends from the proximal end of the suture anchor on the second side thereof, and is disposed within the suture anchor, the shuttle suture A suture assembly comprising. **Claim 9** The suture assembly according to claim 8, wherein the loop of the repair suture is larger than the loop of the shuttle suture. **Claim 10** The suture assembly according to claim 8, wherein the repair suture is thicker than the shuttle suture. **Claim 11** The suture assembly according to claim 8, wherein the repair suture has a thickness that varies from a maximum within the loop to a minimum within the tail. **Claim 12** A method of attaching tissue to bone, Inserting the suture assembly according to claim 8 into the bone under the separated tissue and to one side of the separated tissue; Passing the tail of the repair suture between the separated tissue and the bone; and Returning the tail of the repair suture over the separated tissue and passing it through the loop of the repair suture to create a cinch configuration, A method comprising. **Claim 13** The method according to claim 12, further comprising locking the cinch configuration in place relative to the tissue. **Claim 14** The suture anchor includes an inner wall defining a cannulation and a suture engagement feature extending throughout the cannulation, Locking the cinch configuration in place relative to the tissue includes capturing the tail of the repair suture in an interference fit between the suture engagement feature and the inner wall, the method according to claim 13. **Claim 15** The suture anchor is a full suture anchor configured to expand radially outwardly when deployed and apply a contact force to the surrounding bone; Locking the cinch configuration in place relative to the tissue includes deploying the full suture anchor to apply the contact force to the surrounding bone, the method according to claim 13. **Claim 16** Passing the loop of the shuttle suture between the separated tissue and the bone; After the cinch configuration is created, pulling the tail of the suture through the loop of the shuttle suture; and The method of claim 12, further comprising pulling the tail of the shuttle suture to draw the tail of the repair suture downward through the second side of the suture anchor, upward through the first side, and out through the open proximal end, thereby tightly securing the configuration to the tissue.

17. The method of claim 12, wherein the separated tissue is a damaged glenoid labrum and the bone is a glenoid fossa bone.

18. A method of attaching tissue to bone, comprising: implanting a suture anchor into bone under the tissue on one side of the tissue, the suture anchor being pre-loaded with a repair suture having a loop end and a tail; passing the tail of the repair suture between the separated tissue and the bone; returning the tail of the repair suture over the separated tissue and passing the loop of the repair suture to create a bight configuration; and securing the bight configuration in place against the tissue. A method comprising.

19. The suture anchor includes an inner wall defining a cannulation and a suture engagement feature extending throughout the cannulation, The method of claim 18, wherein securing the bight configuration in place against the tissue includes capturing the tail of the repair suture within an interference fit between the suture engagement feature and the inner wall.

20. The suture anchor is a full suture anchor configured to expand radially outwardly when deployed and apply a contact force to the surrounding bone; The method of claim 18, wherein securing the bight configuration in place against the tissue includes deploying the full suture anchor to apply the contact force to the surrounding bone.

21. The method of claim 18, wherein the loop of the repair suture is larger than the loop of the shuttle suture.

22. The method of claim 18, wherein the separated tissue is a damaged glenoid labrum and the bone is a glenoid fossa bone.

23. The method of claim 18, wherein the separated tissue is a damaged tendon plate.

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