Self-cinching adjustable loop suture construct

Abstract

The self-cinching adjustable loop suture construct includes a suture strand having a first end, a second end, and an adjustment loop. The end loop is disposed at the first end, and a continuous loop is disposed on the suture strand at the adjustment loop, the continuous loop being movable along the suture strand at the adjustment loop. A self-cinching section is disposed on the suture strand between the adjustment loop and the end loop. An anchor is disposed in the end loop. A shuttle suture is disposed in the continuous loop, and a threading suture is disposed in the end loop. The suture construct provides a self-cinching adjustable loop tensioning device for securely fastening tissue that can be securely fastened without the use of knots to maintain tension during ligament repair or reconstruction.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 446,836, filed February 18, 2023, entitled Self-Cinching Suture Devices and Methods, all of which are incorporated herein by reference in their entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to instruments and methods for orthopedic surgery, and more particularly to suture constructs for securely fastening ligaments and tissue. [Background technology]

[0003] Conventional suture constructs and related methods for securement of flexible suture material are difficult or ineffective for certain orthopedic surgical procedures. Conventional suture constructs for ligament fixation often rely on one or more strands of flexible suture material that are securely fastened to tissue, bone, anchors, or other suture constructs to tension one or more ligaments for repair or reconstruction. However, conventional suture constructs typically rely on knots to securely fasten tag ends of the suture material together or to secure the suture material to a structure. Such knots can loosen over time due to fatigue or cyclic loading of the joint. Additionally, conventional knots in suture material can become failure points and cause discomfort to the patient during the healing process.

[0004] Additionally, conventional rigid suture anchors, typically used with suture constructs for ligament fixation, can be difficult to insert through tissue or bone tunnels due to the anchor's physical geometry and size. Because some applications require the rigid anchor to be tunnel-penetrable, these limitations on rigid anchors constrain their useful size and shape for use in many orthopedic surgical procedures, particularly those utilizing transosseous tunnels drilled into bone. Rigid fixation anchors can also lead to discomfort after the surgical procedure. Summary of the Invention [Problem to be solved by the invention]

[0005] Thus, there is a need for improved suture constructs for tissue repair and reconstruction in orthopedic procedures. [Means for solving the problem]

[0006] The present disclosure provides improved self-cinching adjustable loop suture constructs and related methods for performing orthopedic surgical procedures.

[0007] In some embodiments, the present disclosure provides a suture construct device including a suture strand including a first end, a second end, and an adjustment loop. The end loop is disposed at the first end, and a continuous loop is disposed on the suture strand at the adjustment loop, the continuous loop being movable along the suture strand at the adjustment loop. A self-cinching section is disposed on the suture strand between the adjustment loop and the end loop. In some embodiments, an anchor is disposed in the end loop.

[0008] In some embodiments, a shuttle suture is disposed in the continuous loop and a threading suture is disposed in the end loop. The threading suture and / or shuttle suture can be used to pull the suture construct through tissue, a bone tunnel, an anchor, another suture construct, or other structure until the anchor is in a desired fixation position.

[0009] One object of the present disclosure is to provide a suture construct that maintains a low profile while the suture construct is being pulled through tissue, a bone tunnel, an anchor, another suture construct, or other structure, and includes an anchor that is configured to self-deploy upon exiting the structure at a desired location.

[0010] Another object of the present disclosure is to provide a self-cinching adjustable loop suture construct that can be fastened and maintained in tension without the use of knots.

[0011] It is yet another object of the present disclosure to provide a self-cinching adjustable loop suture construct that includes a compression anchor that can maintain a low profile during threading of the suture construct and expand to a larger profile upon tensioning of the suture construct after threading.

[0012] Another object of the present disclosure is to provide a self-cinching adjustable loop suture construct for use in anterior cruciate ligament (ACL) repair.

[0013] It is a further object of the present disclosure to provide a self-cinching adjustable loop suture construct for use during anterior cruciate ligament (ACL) reconstruction.

[0014] It is yet another object of the present disclosure to provide a self-cinching adjustable loop suture construct for use during meniscal root repair of the knee.

[0015] It is a further object of the present disclosure to provide a self-cinching adjustable loop suture construct that can be pulled in tissue in a first direction but self-deploys when tension is applied to the suture construct in the opposite direction.

[0016] Numerous other objects, advantages and features of the present disclosure will become readily apparent to those skilled in the art upon review of the drawings and description set forth below. [Brief explanation of the drawings]

[0017] [Figure 1] 1 shows an embodiment of a self-cinching adjustable loop suture construct. [Figure 2] 2 shows a detailed view of an embodiment of the self-cinching adjustable loop suture construct of FIG. 1. [Figure 3] 13A-13C show an alternative embodiment of a self-cinching adjustable loop suture construct comprising a threading suture and a shuttle suture. [Figure 4] 4 shows a detailed view of the embodiment of the self-cinching adjustable loop suture construct of FIG. 3. [Figure 5]10A-10C show detailed views of an embodiment of a self-cinching adjustable loop suture construct including anchors disposed in the end loops. [Figure 6] 10A-10C show alternative views of an embodiment of a self-cinching adjustable loop suture construct including anchors disposed in the end loops. [Figure 7] 10 illustrates an embodiment of a self-cinching section of a self-cinching adjustable loop suture construct. [Figure 8] 13A-13C show an alternative embodiment of the self-cinching section of the self-cinching adjustable loop suture construct. [Figure 9] 13A-13C show an alternative embodiment of the self-cinching section of the self-cinching adjustable loop suture construct. [Figure 10] 13A-13C show an alternative embodiment of the self-cinching section of the self-cinching adjustable loop suture construct. [Figure 11] 13A-13C show an alternative embodiment of the self-cinching section of the self-cinching adjustable loop suture construct. [Figure 12] 13A-13C show an alternative embodiment of the self-cinching section of the self-cinching adjustable loop suture construct. [Figure 13] 13A-13C show an alternative embodiment of the self-cinching section of the self-cinching adjustable loop suture construct. DETAILED DESCRIPTION OF THE INVENTION

[0018] The present disclosure provides various embodiments of an improved self-cinching adjustable loop suture construct for use during orthopedic surgical procedures.

[0019] Referring to FIG. 1 , an embodiment of a self-cinching adjustable loop suture construct 10 includes a suture strand 12 made of any suitable orthopedic flexible suture material, such as, but not limited to, a hollow core suture, a braided suture, a flat suture tape, or other suitable suture materials known in the art. The suture strand 12 includes a first end 14 and a second end 16. The first end 14 has an end loop 20 formed therein, and the second end 16 includes a free tag end that can be pulled to tension the construct. The second end 16 initially extends a distance away from the end loop 20 and then turns 180 degrees back toward the end loop 20 to form an adjustment loop 18, which is threaded onto the suture strand 12 itself to form a self-cinching section 30. The second end 16 exits the self-cinching section 30 in a direction away from the adjustment loop 18, terminating in a tag end.

[0020] The self-cinching section 30, in some embodiments, is formed by threading the second end 16 axially through the suture strand 12 for a short length, through the hollow core of the suture strand 12, and out of the suture strand 12 between the self-cinching section 30 and the end loop 20. Thus, when the second end 16 is pulled, the adjustment loop 18 can be tightened. During tightening, the suture material slides over the self-cinching section 30, which can shorten the adjustment loop 18 and apply tension to the suture construct. The self-cinching section 30 provides a locking mechanism that maintains tension on the suture construct 10 during tightening.

[0021] 1 , in some embodiments, the adjustment loop 18 has a free continuous loop 22 disposed therein. The free continuous loop 22 forms a ring of suture material. The continuous loop 22 may comprise any suitable suture material that can be formed into a continuous ring, such as a hollow core suture, a braided suture, a flat suture tape, or any other suture material. In some embodiments, the continuous loop 22 is formed by joining the suture material into a continuous ring. When the adjustment loop 18 is fastened, the suture strand 12 is free to slide within the continuous loop 22, and the continuous loop may move along the suture strand 12 inside the adjustment loop 18.

[0022] A shuttle suture 24 is disposed within the continuous loop 22. The shuttle suture 24 may be configured to be threaded through a suture construct in an anchor, tissue, ligament, bone, another suture construct, or other structure associated with the performance of an orthopedic surgical procedure. In some embodiments, the shuttle suture 24 is a sacrificial suture and is intended to be cut and removed from the suture construct 10 after implantation of the suture construct 10. In some embodiments, the shuttle suture 24 includes a shuttle suture loop 26. The shuttle suture loop 26 passes through the continuous loop 22, thereby securely securing the shuttle suture 24 to the continuous loop 22. The shuttle suture 24 may comprise any suitable flexible suture material, such as, but not limited to, a hollow core suture, a braided suture, a flat suture tape, or other suture material. In some embodiments, the shuttle suture loop 26 may be formed by joining the shuttle suture 24 to itself.

[0023] In some embodiments, an anchor 40 is disposed in the end loop 20 at the first end 14 of the suture strand 12. The anchor 40 may comprise any suitable anchor for securely securing the suture construct 10 under tension to a structure, such as, but not limited to, suture tape, suture material, plastic, PEEK, a button, a screw, an implant, a plate, a graft, or an orthopedic device, such as, but not limited to, a needle, a bioabsorbable anchor, an implant, a button, or a screw. In some embodiments, as shown in FIG. 1 , the anchor 40 comprises a soft anchor formed from a flexible suture tape material. As such, the anchor 40 is a compressible material that may deform while the suture construct is being pulled through tissue, a bone tunnel, or other structure. The compressible and resilient nature of the anchor 40 material in some embodiments allows the anchor 40 to self-expand to a larger profile and size upon exiting the structure at the desired fixation location. Anchor 40, which includes a soft, flexible material, may also conform better than a rigid suture button to the surface of the bone or structure to which it is attached. For example, the bone surface adjacent to the bone tunnel may be irregular, curved, uneven, and generally non-planar. By providing anchor 40 in the form of a soft, deformable anchor material, the anchor may have a compact profile that, when deployed and tensioned, mates with the irregular bone surface, allowing anchor 40 to enhance fixation by conforming to the bone's irregular surface geometry and texture.

[0024] 2, in some embodiments, anchors 40 are formed by securely fastening anchors 40 to a suture strand that passes the suture material of end loop 20 across the suture tape material of anchor 40 multiple times to form end loop 20. End loop 20 may be formed by bonding the suture material of the suture strand to itself, thereby forming a secure loop after the suture strand is passed across the suture tape material of anchor 40.

[0025] Referring to FIG. 3, an alternative embodiment of the suture construct 10 includes the structure already described with respect to FIG. 1 and also includes a threading suture 50 disposed in the end loop 20 in addition to the anchor 40. The threading suture 50 may comprise any suitable flexible suture material, such as, but not limited to, a hollow core suture, a braided suture, a flat suture tape, or other suture material. The threading suture 50 may be configured to be threaded through the suture construct in an anchor, tissue, a ligament, bone, another suture construct, or other structure associated with the performance of an orthopedic surgical procedure. The threading suture 50 in some embodiments is a sacrificial suture and is intended to be cut and removed from the suture construct 10 after implantation of the suture construct 10. The threading suture 50, in some embodiments, includes a threading suture loop 52. The threading suture loop 52 is threaded through the end loop 20 to securely secure the threading suture 50 to the end loop 20. The threading suture loop 52 may be formed by bonding the suture material of the threading suture 50 to itself.

[0026] The free tag end of the second end 16 may be removably inserted into a threading suture sleeve 54 defined in the threading suture 50 to temporarily conceal the tag end of the second end 16 as the suture construct is threaded through tissue, bone, ligament, anchor, or other structure during a procedure. By inserting the tag end of the second end 16 into the threading suture sleeve 54, the suture construct 10 may be more easily pulled without the tag end becoming caught or inadvertently displaced or damaged. Once the threading suture 50 has been pulled to a desired position, the tag end of the second end 16 may be removed from the threading suture sleeve 54 by pulling the tag end free. In some embodiments, the tag end of the second end 16 is inserted axially into the hollow core of suture material of the threading suture 50 that forms the threading suture sleeve 54.

[0027] 4 and 6, in some embodiments, the threading suture loop 52 of the threading suture 50 extends around both the end loop 20 and the anchor 40. Thus, a portion of the anchor 40 is disposed between the suture material of the threading suture loop 52 and the end loop 20.

[0028] Referring to FIG. 5 , in some embodiments, anchor 40 comprises a substantially flat, flexible material disposed on end loop 20. Anchor 40 may comprise a flexible, flat suture tape material in some embodiments. The suture strands forming end loop 20 are threaded transversely through the body of anchor 40 several times to secure anchor 40 to end loop 20. As shown in FIG. 5 , anchor 40 includes first threading portion 46 a, second threading portion 46 b, third threading portion 46 c, fourth threading portion 46 d, fifth threading portion 46 e, and sixth threading portion 46 f. Each threading portion includes an anchor hole through which the suture strands of end loop 20 are threaded transversely through the material of anchor 40.

[0029] When the suture strands of the end loop 20 are threaded through the anchor 40, multiple anchor loops are formed in the anchor 40. A first anchor loop 42a is formed in the anchor 40 between the first and second threading portions 46a, 46b. In some embodiments, the first anchor loop 42a is oriented radially inward relative to the end loop 20 such that the first anchor end 44a protrudes radially from the end loop 20. As such, the first anchor end 44a is configured to enhance the fit of the anchor 40 with the structure when the suture construct is deployed and tensioned.

[0030] A second anchor loop 42b is formed in the anchor 40 between the second threading portion 46b and the third threading portion 46c. In some embodiments, the second anchor loop 42b is oriented radially outward from the end loop 20. A third anchor loop 42c is formed in the anchor 40 between the third threading portion 46c and the fourth threading portion 46d. In some embodiments, the third anchor loop 42c is oriented radially inward from the end loop 20. A fourth anchor loop 42d is formed in the anchor 40 between the fourth threading portion 46d and the fifth threading portion 46e. In some embodiments, the fourth anchor loop 42d is oriented radially outward from the end loop 20. A fifth anchor loop 42e is formed in the anchor 40 between the fifth threading portion 46e and the sixth threading portion 46f. In some embodiments, the fifth anchor loop 42e is oriented radially inward relative to the end loop 20 such that the second anchor end 44b projects radially from the end loop 20 opposite the first anchor end 44a. The second anchor end 44b is therefore configured to enhance the fit of the anchor 40 with the structure when the suture construct is tensioned.

[0031] 5, in some embodiments, the threading suture 50 includes a threading suture loop 52 that is also threaded through the anchor 40. The strand of material forming the threading suture loop 52 is threaded around the end loop 20 and through a first hole 56a formed in the anchor 40 between the third and fourth threading portions 46c, 46d, across the surface of the anchor 40 that forms the bridge 47 on the side of the anchor 40 facing the end loop 20, and out a second hole 56b in the anchor 40 and back to the threading suture 50. The connection of the threading suture 50 to both the anchor 40 and the end loop 20 prevents the anchor 40 from shifting to an undesired position when the suture construct is being pulled through a tissue, ligament, or bone tunnel.

[0032] When the suture construct 10 is being pulled through a structure (such as a tissue or bone tunnel) via the passing suture 50, the first and second anchor ends 44 a, 44 b of the anchor 40 may extend loosely along the suture strand in a linear direction toward the adjustment loop 18 with a low profile. However, when the suture construct is threaded to the other side of the structure through which it is being pulled via the passing suture 50 (such as in a bone tunnel), and tension is applied to the suture construct by pulling on the second end 16, the anchor 40 may be deployed. In some applications, upon threading through a bone tunnel, the first and second anchor ends 44 a, 44 b resiliently self-deploy and project radially outward from the end loop 20 along the surface of the anatomical structure, such as the femoral cortex during ACL repair or reconstruction. When tension is applied to the suture construct, the anchor 40 grips the femoral cortex and contracts away from the adjustment loop 18 as the first and second anchor ends 44a, 44b move toward each other along the end loop 20, thereby forming a closure against the adjacent tissue or bone that prevents re-slip of the anchor in the tunnel. During use, as the suture construct 10 is tensioned, the multiple anchor loops of the anchor 40 fold toward the third anchor loop 42c, which is generally midline of the anchor 40, thereby expanding the profile of the anchor 40 and providing a fixation point against which tension can be further applied to the suture construct 10.

[0033] Various embodiments of the self-cinching section 30 are disclosed for providing the self-cinching features described herein. In a first embodiment, a single-pass axial self-cinching sleeve is formed by axially threading a suture strand through a hollow core suture material to form a locking mechanism, as shown in FIGS. 2 and 4. In another embodiment, referring to FIG. 7, the suture material is joined in a fully interwoven configuration, and the suture strand is transversely threaded through the suture material using a needle to form the self-cinching section 30. Multiple transverse threads may be provided to achieve the desired locking effect, with more transverse threads generally resulting in a greater locking effect when the suture construct is tensioned. This configuration may be used with hollow core or tape suture materials. Referring to FIG. 8, in another embodiment, the suture material may be joined in a single-thread-weave configuration, where the weave portion includes suture material that is transversely threaded through the body of the suture material at a first self-cinching section 30a, and the single-thread includes axially threading the suture material through a hollow core of the suture material adjacent the weave portion to form a second self-cinching section 30b, which together form a self-cinching section 30 along the axial length of the suture strand.

[0034] Referring to FIG. 9, in another embodiment, the suture material may be joined in a weave-and-single-pass configuration, which is the inverse of the configuration shown in FIG. 8, where the first self-cinching section 30a is an axial single-pass through a hollow core of suture material forming a sleeve, and the second self-cinching section 30b includes multiple transverse passes of the suture strand through itself.

[0035] Referring to FIG. 10, an embodiment of a self-cinching section includes a weave-single-thread-weave configuration including first and second weave sections and a single-thread axial sleeve disposed between the weave sections, where the first self-cinching section 30a includes a weave section with multiple transverse threads, the second self-cinching section 30b includes a single axial thread with a hollow core of suture material forming the sleeve, and the third self-cinching section 30c includes a weave section with multiple transverse threads.

[0036] 11, an embodiment of a self-cinching section includes a single-thread-weave-single-thread configuration including first and second axial sleeves and a weave section between the first and second sleeves. In this embodiment, the first self-cinching section 30a includes a single axial thread through a hollow core of suture material, the second self-cinching section 30b includes a weave section with multiple transverse threads of suture material through itself, and the third self-cinching section includes a single axial thread through a hollow core of suture material.

[0037] 12, an embodiment of the self-cinching sections includes a single-thread-weave-single-thread-weave configuration, in which the first and third self-cinching sections 30a, 30c each include a weave section with multiple transverse threads of suture material through it, and the second and fourth self-cinching sections 30b, 30d each include a single axial thread through a hollow core of suture material.

[0038] 13, an embodiment of a self-cinching section includes multiple axial single-thread sections of suture material that are threaded through their own hollow core at first, second, and third self-cinching sections 30 a, 30 b, 30 c. Numerous other combinations of single-thread, interwoven, or single-thread and interwoven can be combined to form self-cinching sections in a suture construct.

[0039] Thus, although specific embodiments of the present invention for novel and useful self-cinching adjustable loop suture constructs and methods have been described, such references to specific embodiments are not intended to be construed as limitations on the scope of the invention. [Explanation of symbols]

[0040] 10. Suture Construct 12 Suture Twist 14 First end 16 Second end 18 Regulatory Loop 20 End Loop 22 Continuous Loop 24 Shuttle suture 26 Shuttle Suture Loop 30 Self-cinching division 30a First self-cinching section 30b Second self-cinching section 30c 3rd self-cinching section 30d 4th self-cinching section 40 Anka 42a First Anchor Loop 42b 2nd anchor loop 42c 3rd Anchor Loop 42d 4th anchor loop 42e 5th Anchor Loop 44a First anchor end 44b Second anchor end 46a First insertion part 46b Second insertion part 46c Third insertion part 46d Fourth insertion part 46e 5th insertion part 46f 6th insertion part 47 Bridge 50 Inserting suture 52 Insertion suture loop 54 Insertable suture sleeve 56a 1st hole 56b 2nd hole

Claims

1. 1. A suture construct device comprising: a suture strand including a first end, a second end, and an adjustment loop; an end loop disposed at the first end; a continuous loop disposed on the suture strand at the adjustment loop, the continuous loop being movable along the suture strand at the adjustment loop; a self-cinching section disposed on the suture strand between the adjustment loop and the end loop; an anchor disposed in the end loop; a shuttle suture disposed in the continuous loop; a threaded suture disposed in the end loop; A suture construct device comprising:

2. a threading suture loop disposed on the threading suture, the threading suture loop extending to the end loop; The apparatus of claim 1 further comprising:

3. The device of claim 2 , wherein the threading suture loop mates with the anchor inside the end loop.

4. a shuttle suture loop disposed on the shuttle suture; The apparatus of claim 3 further comprising:

5. The device of claim 4 , wherein the shuttle suture loop is disposed around the continuous loop.

6. The device of claim 5 , wherein the anchor is substantially flat.

7. The device of claim 6 , wherein the anchor is flexible.

8. The device of claim 7 , wherein the anchor comprises a flexible flat suture tape.

9. The device of claim 8 , wherein the anchor includes first and second anchor ends extending radially from the end loop.

10. 10. The device of claim 9, wherein the anchor comprises first, second, third, fourth, and fifth anchor loops each extending from the end loop.

11. The device of claim 10 , wherein the end loop is threaded transversely through the anchor between the first, second, third, fourth, and fifth loops.

12. The device of claim 11 , wherein the threading suture extends around the anchor inside the end loop.

13. The device of claim 11 , wherein the threading suture extends transversely to the anchor inside the end loop.

14. The device of claim 5 , wherein the self-cinching section comprises a suture strand extending axially therethrough.

15. The device of claim 5 , wherein the self-cinching section comprises the suture strand extending transversely to the suture strand itself.

16. The device of claim 5 , wherein the self-cinching section comprises a suture strand extending axially and transversely to the suture strand itself.

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