TENSIONABLE CONSTRUCTS WITH MULTI-LIMB LOCKING MECHANISM THROUGH SINGLE SPLICE AND METHODS OF TISSUE REPAIR

Abstract

Systems and methods for soft tissue to bone repairs, without knot tying. Soft tissue repair systems include self-cinching constructs with a fixation device, a flexible strand with multiple flexible limbs, and a shuttle/pull device attached to the flexible strand to shuttle the multiple flexible limbs through the flexible strand and form a locking splice.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This is a divisional of U.S. application Ser. No. 14/831,511, filed on Aug. 20, 2015, the entire disclosure of which is incorporated by reference herein in its entirety.

BACKGROUND

The present invention relates to surgical devices and, in particular, to devices and methods for repair or fixation of soft tissue to bone without the need for knots.

SUMMARY

Surgical constructs, systems, and techniques for knotless soft tissue repair and fixation, such as fixation of soft tissue (ligament, tendon, graft, etc.) to bone are disclosed.

A surgical construct includes a tensionable construct in the form of a multi-limb locking construct formed through a single splice. A flexible strand is split into a plurality of limbs that are shuttled back through a flexible strand, to create a locking splice construct that is tensionable after insertion in bone. A surgical construct allows attached tissue to be brought proximate to bone and does not require tying of any knots. A flexible strand may be fixed to a fixation device and split into a plurality of limbs that are shuttled back through a flexible strand, to create a locking splice construct that is tensionable after insertion in bone.

In an embodiment, a surgical construct includes an anchor, a suture that is attached to the anchor and that splits into two or more limbs, and a suture shuttle with a looped end. A suture can be fixed within the anchor by a knot or similar construct. A suture shuttle is inserted into a center of a single suture with a plurality of suture limbs, to shuttle the suture limbs back through the suture, creating a multi-limb locking mechanism through a single locking splice.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a tensionable knotless construct according to an exemplary embodiment.

FIGS. 2 and 3 illustrate an exemplary method of tissue repair with the tensionable knotless construct of FIG. 1.

FIGS. 4 and 5 illustrate another exemplary method of tissue repair with the tensionable knotless construct of FIG. 1.

DETAILED DESCRIPTION

Surgical constructs, systems, and techniques for knotless soft tissue repair and fixation, such as fixation of soft tissue (ligament, tendon, graft, etc.) to bone are disclosed.

The surgical constructs comprise tensionable knotless anchors that are inserted into bone and are provided with a multi-limb suture locking mechanism through single splice (tensionable construct). The tensionable knotless anchor may be formed essentially of suture or suture-like material (i.e., a soft anchor without a solid body) or may be attached to a fixation device.

The multi-limb suture locking mechanism through single splice is formed of a flexible strand (a suture) and a shuttle/pull device (a suture passing instrument) attached to the flexible strand. A flexible strand includes an unsplit region or end (a single main limb of suture or main strand) and a plurality of limbs attached to the unsplit region (main strand). A shuttle/pull device attached to the unsplit region allows passing of the plurality of limbs through the tissue and then spliced back through the unsplit region. In this manner, multiple locking limbs with variable loop lengths are locked through just one splice. If a fixation device (such as a solid anchor, for example) is employed, a splice may be formed outside the body of the fixation device or inside the body of the fixation device. A multi-limb suture locking mechanism through single splice may be employed for tissue repairs.

In an embodiment, a flexible strand (for example, suture) is split into multiple strands or limbs. The strands are passed through the tissue and then spliced back through the single main limb of suture. The individual limbs can slide with variable tension and all could lock within the jacket.

In an embodiment, a surgical construct includes an anchor, a suture that is fixed to the anchor and that splits into two or more limbs, and a suture shuttle with a looped end. A suture can be fixed within the anchor by a knot at the end of the suture. A suture shuttle is inserted into a center of the single suture, and is designed to help shuttle the suture limbs back through the suture, creating a single locking splice. A locking splice may be formed outside an anchor body or inside an anchor body.

In another embodiment, a surgical construct comprises (i) a suture or suture-like material that has at least two regions: a first region or unsplit region; and a second region or split region that splits into two or more limbs; and (ii) a suture shuttle with a looped end. A suture shuttle can be pre-assembled to the first region of the suture or suture-like material. A suture shuttle may be inserted into a center of the first region (unsplit region) of the suture or suture-like material. A suture shuttle shuttles the suture limbs back through the suture or suture-like material, creating a single locking splice in the first region (unsplit region) and a plurality of multiple adjustable closed loops. Multiple adjustable closed loops may have adjustable perimeters, and the perimeters may be all similar or different, or at least one perimeter of one loop different than a perimeter of another loop. A surgical construct may consist essentially of (i) a suture or suture-like material that has at least two regions: a first region or unsplit region; and a second region or split region that splits into two or more limbs; and (ii) a suture shuttle with a looped end.

In another embodiment, a surgical construct includes (i) an anchor; (ii) a suture that is fixed to the anchor and that has at least two regions: a first region or unsplit region; and a second region or split region that splits into two or more limbs; and (iii) a suture shuttle with a looped end. A suture can be fixed within the anchor by a knot at the end of the suture. A suture shuttle can be pre-assembled to the first region of the suture. A suture shuttle may be inserted into a center of the first region (unsplit region) of the suture. A suture shuttle shuttles the suture limbs back through the suture, creating a single locking splice in the first region (unsplit region).

In an embodiment, a surgical system for tissue repairs includes a fixation device comprising a body, a longitudinal axis, a proximal end, and a distal end; and a tensionable construct pre-loaded on the fixation device. A tensionable construct may include a flexible strand with a plurality of limbs, and a shuttling device attached to the flexible strand. A flexible strand may have one end which terminates in a knot, and another end which is split into multiple flexible limbs.

Methods of soft tissue repair which do not require tying of knots and allow adjustment of both the tension of the suture and the location of the tissue with respect to the bone are also disclosed. An exemplary method of tissue repair comprises (i) installing a fixation device in bone, the fixation device comprising a body, a flexible strand split into a plurality of multiple flexible limbs, the flexible strand extending through at least a portion of the body of the fixation device, and a passing device attached to the flexible strand; and (ii) forming, with the multiple flexible limbs of the flexible strand and with the passing device, multiple knotless closed loops having adjustable perimeters, after the step of installing the fixation device in bone.

In one embodiment, two or more suture limbs extending from the split suture are passed through soft tissue. The limbs are then inserted into the suture shuttle loop. The tail of the suture shuttle is pulled, advancing the shuttle loop and two or more suture limbs through the locking splice. The ends of each of the two or more suture limbs are then independently advanced until the desired tension is achieved, creating simple stitches along the soft tissue.

In another embodiment, two or more suture limbs, as well as the suture shuttle loop and tail, are all passed through soft tissue. The limbs are then inserted into the suture shuttle loop. The suture shuttle loop and the two or more suture limbs loaded onto it are advanced through the locking splice by pulling the suture shuttle tail. The two or more suture limbs are then independently advanced until the desired tension is achieved, creating a mattress stitch on the soft tissue.

Another exemplary method of soft tissue repair comprises inter alia: (i) inserting a fixation device of a surgical construct into bone, the surgical construct comprising a fixation device (for example, an anchor) with a flexible strand (for example, suture) that is attached to the fixation device and that is split into multiple strands/limbs, and with a shuttle/pull device (a suture passing instrument) attached to the flexible strand; (ii) passing the multiple strands/limbs around or through tissue to be fixated (or reattached) to bone, and then through an eyelet/loop of the shuttle/pull device; and (iii) subsequently, pulling on the shuttle/pull device to allow the multiple strands/limbs to pass through the flexible strand and to form a locking splice. In an embodiment, individual multiple strands/limbs are each advanced until desired tension is achieved creating simple stitches along the tissue. In an embodiment, individual multiple strands/limbs may be sequentially advanced through the flexible strand.

According to another embodiment, a method of soft tissue repair comprises inter alia: (i) inserting a fixation device of a surgical construct into bone, the surgical construct comprising a fixation device (for example, an anchor) with a flexible strand (for example, suture) that is attached to the fixation device and that is split into multiple strands/limbs, and with a shuttle/pull device (a suture passing instrument) attached to the flexible strand; (ii) passing the multiple strands/limbs together with the shuttle/pull device around or through tissue to be fixated (or reattached) to bone; (iii) subsequently, passing the multiple strands/limbs through an eyelet/loop of the shuttle/pull device; and (iv) subsequently, pulling on the shuttle/pull device to allow the multiple strands/limbs to pass through the flexible strand and to form a locking splice. In an embodiment, individual multiple strands/limbs are each advanced until the desired tension is achieved creating a mattress stitch on the tissue. In an embodiment, individual multiple strands/limbs may be sequentially advanced through the flexible strand.

Referring now to the drawings, where like elements are designated by like reference numerals, FIGS. 1-5 illustrate device 100 (surgical construct, integrated system, surgical system, or assembly 100) which includes fixation device 10 assembled with construct 99 (tensionable construct 99) formed of flexible strand or flexible material 30 and shuttle/pull device 40 (suture passing instrument 40) attached to the flexible strand 30. Tensionable construct 99 may be pre-loaded on the fixation device 10. Although the embodiments below will be described with reference to construct 99 (tensionable construct 99) attached to at least a part of fixation device 10, the disclosure is not limited to these exemplary embodiments and contemplates embodiments wherein construct 99 (tensionable construct 99) acts as a soft anchor, i.e., without being attached to any fixation device such as fixation device 10.

In an exemplary embodiment, fixation device 10 is a tensionable knotless anchor having a solid anchor body 11 provided with a longitudinal axis 11a, a proximal end 13, a distal end 12, and a plurality of ribs or ridges 15 extending circumferentially around body 11. Cannulation 11b extends along the body 11 to allow passage of flexible strand 30 and of a suture passing device, as detailed below. Proximal end 13 of the anchor 10 may contain a socket 19 (FIG. 1) configured to securely engage a tip of a driver.

In an exemplary embodiment, fixation device 10 is an anchor 10 which may be a screw-in anchor or a push-in style anchor. Anchor 10 may be formed of metal, biocompatible plastic such as PEEK, or a bioabsorbable PLLA material. Socket 19 at the distal end 13 of the anchor 10 may have any shape adapted to receive a driver tip for pushing tap-in or screw-in style anchors. Anchor 10 may be made of one or more pieces (a multi-piece construct), or may be provided as an integrated device (a unitary device). Anchor 10 may have various sizes (various diameters and/or lengths) and may be formed of biocompatible materials such as PEEK, biocomposite materials, metals and/or metal alloys, or combination of such materials, among others.

In an embodiment, construct 99 (tensionable construct 99) may be formed of flexible strand 30 (flexible material, suture, or tie down suture 30) and shuttle/pull device 40 (suture passing instrument such as FiberLink™ 40, wire loop 40, or nitinol loop 40) attached to the flexible strand 30. In an exemplary embodiment, the flexible strand 30 is a suture strand 30 and the shuttle/pull device 40 is a suture passing device 40. The flexible strand 30 includes an end 32 (unsplit end, unsplit region, or unsplit suture 32) which terminates in knot 31, and another end which is split into multiple limbs 33a, 33b . . . 33n (where “n” may be any number greater than 2). For simplicity, FIGS. 1-5 illustrate flexible strand 30 split into two limbs 33a, 33b; however, the constructs detailed below encompass any number of multiple limbs (suture limbs). Knot 31 may be a static knot 31 which prevents suture 30 from passing through distal blind hole 12a.

Suture 30, which is typically braided or multi-filament or tape, may be preloaded onto the anchor by tying static knot 31 which prevents suture 30 from passing through distal blind hole 12a. The suture may also be preloaded by insert molding or by any other means known in the art. Suture 30 passes through cannulation 11b and terminates in limbs 33a, 33b exiting proximal end 13 of body 11. Tensionable knotless anchor 10 is loaded onto a driver (not shown in FIGS. 1-5), and suture 30 is secured to the driver (for example, wrapped around a cleft of the driver) to fasten tensionable knotless anchor 10 securely to the driver.

Prior to the fastening of the anchor 10 to the driver, suture passing device 40 (for example, a FiberLink™, a wire loop, or a nitinol loop) is threaded through suture 30 (i.e., attached to a center of the suture 30 through splice region 39 of unsplit end or region 32), as shown in FIG. 1. Suture passing device 40 includes closed eyelet/loop 44 for passing suture, and tail 42. Suture passing device 40 passes through an aperture 32a of suture 30, within the body of suture 30 and within the tensionable knotless anchor 10, and then exits an aperture 32b of suture 30. A distance between apertures 32a, 32b of suture 30 corresponds to splice or splice region 39. Tensionable knotless anchor 10 loaded with tensionable construct 99 (formed of suture 30 attached to the suture passing device 40) is then secured into bone 80 (for example, into a hole/socket/tunnel formed in bone 80) by using a driver.

FIGS. 2 and 3 depict exemplary repair 200 with tensionable knotless anchor 10 of construct 100 after it has been inserted into a drilled hole in bone 80, the suture released from the driver, and the driver removed. Suture limbs 33a, 33b are passed through (or around) tissue 50 which is to be moved to a desired location (for example, brought into proximity of a drilled hole or socket in bone 80, to be reattached, for example, to bone 80). Suture limbs 33a, 33b are subsequently passed through eyelet/loop 44 of the suture passing device 40. Tail 42 of suture passing device 40 is then pulled, thereby pulling suture limbs 33a, 33b towards tensionable knotless anchor 10, so that each of the suture limbs 33a, 33b is passed/advanced through locking splice 39 (splice region 39) of suture 30, i.e., each of the suture limbs 33a, 33b doubles on itself within suture 30 and inside tensionable knotless anchor 10, to form multiple adjustable tensionable loops 88a, 88b, . . . 88n (where “n” has any value greater than 2). For simplicity, FIGS. 2 and 3 show only two multiple adjustable loops 88a, 88b corresponding to respective multiple limbs 33a, 33b; however, the constructs disclosed herein contemplate any number of multiple adjustable tensionable loops (corresponding to the number of multiple limbs). The suture passing device 40 has also been further pulled through the splice region 39 of suture 30.

FIG. 3 illustrates surgical construct 100 with limbs 33a, 33b after the limbs have been pulled through themselves, creating locking splice 39 and tensionable loops 88a, 88b. The suture passing device (not visible) helps create single locking splice 39 within tensionable knotless anchor 10 by facilitating suture limbs 33a, 33b of suture 30 to pass through (shuttle back through) the unsplit end or unslpit suture 32. Locking splice 39 may be formed within body 11 of fixation device 10, or outside body 11 of fixation device 10. In an embodiment, locking splice 39 may be formed outside body 11 of fixation device 10 and within a bone tunnel formed within bone 80 (wherein construct 100 is inserted).

Once limbs 33a, 33b have been fully passed through suture 30, each of the limbs 33a, 33b may be pulled to reduce the perimeter of loops 88a, 88b and until tissue 50 has been moved to the desired location, such as near a drilled hole in bone 80. Once the desired tension and location is achieved, ends of limbs 33a, 33b may be clipped off to complete the soft tissue repair or fixation 200.

FIGS. 4 and 5 illustrate another exemplary method of soft tissue repair 300 which does not require tying of knots and allows adjustment of both tension of the suture limbs and the location of the tissue with respect to the bone. According to this embodiment, two or more suture limbs 33a, 33b, as well as the suture shuttle loop 44 and tail 42, are all passed through tissue 50. The limbs 33a, 33b are then inserted into the suture shuttle loop 44. The suture shuttle loop 44, together with the two or more suture limbs 33a, 33b loaded onto the suture shuttle loop 44, are advanced through the locking splice 39 by pulling the suture shuttle tail 42, to form adjustable tensionable loops 88a, 88b, as shown in FIG. 5. As in the previously-described embodiment, loops 88a, 88b are multiple adjustable tensionable loops 88a, 88b, each corresponding to a respective one of multiple limbs 33a, 33b. Loops 88a, 88b have an adjustable perimeter and are self-locking, tensionable constructs formed of a splice (spliced region) and a continuous adjustable closed loop attached to the splice. The two or more suture limbs 33a, 33b may be then independently advanced until the desired tension is achieved, creating a mattress stitch on the tissue 50 and completing repair 300. In an embodiment, the two or more suture limbs 33a, 33b may be sequentially or simultaneously advanced, and then independently tensioned so that desired tension is achieved and final repair completed.

Surgical construct 100 with the knotless anchor 10 and tensionable construct 99 may be employed in following exemplary repairs:

1) Used in subscapularis repair for simple partial tears: place anchor 10, pass sutures, shuttle using FiberLoop® (Arthrex, Inc., Naples, Fla.), and tighten.

2) Full rotator cuff (RC) tears (subscapularis, supraspinatus, infraspinatus).

• • a. Same technique for single row fixation: this will allow for simple repairs passing only one limb of each suture separately through the RC, then shuttle with FiberLink® (Arthrex, Inc., Naples, Fla.), tighten.
  • b. Single row fixation with horizontal mattress: pass sutures separately, pass FiberLink® through RC as well, shuttle sutures, tighten.
  • c. Double row fixation with one anchor 10: pass sutures separately, pass FiberLink® through RC, shuttle sutures, tighten, and bring sutures to lateral row anchor(s).
  • d. Double row fixation with multiple anchors 10:
    • i. Pass sutures/FiberLink® up through RC either as unit or separately as desired; shuttle sutures into opposing anchor with opposing FiberLink® for interconnection medially.
    • ii. Since multiple limbs are available, may also shuttle one suture into same anchor for individual anchor fixation. This would be a suture from same anchor/FiberLink® that was passed through RC separately from FiberLink®. This allows for SutureBridge™ fixation without knots.
      • 1. All passes may be passed through the RC with both anchors done before shuttling sutures.
      • 2. The technique could feature only two sutures per anchor with two anchors medially and two vented SwiveLock® (Arthrex, Inc., Naples, Fla.) anchors laterally.

3) Partial Articular-sided Supraspinatus Tendon Avulsion (PASTA) Repair:

• • a. Pass anchor 10 through slit in RC or create a sheath to come through the RC easily, then fixate anchor into bone through tendon
  • b. Pass sutures separately via Lasso or BirdBeak® (Arthrex, Inc., Naples, Fla.)
  • c. Shuttle sutures back into FiberLink®, or if hole too big, shuttle FiberLink® through RC as well into a different, smaller hole
  • d. Tighten

4) A tape such as FiberTape® could be incorporated into anchor 10:

• • a. This would allow for SpeedBridge™ plus repairs as above to get better fixation and take away that doctors want to “tie” sutures medially to “help with fixation.” By interconnecting anchors 10 and passing a suture through the medial tissue, fixing it to its same anchor, surgeons get individual anchor fixation and construct fixation together.
  • b. This would also decrease potential for suture cut-through.

5) InternalBrace™—preferably employed with tape. InternalBrace™ may be employed with anchor 10 and interlock anchors across a joint. This would allow a surgeon to “dial in” how much tension to place on the construct. Instead of trying to fix the tension with the initial fixation with the proper length of the FiberTape® (Arthrex, Inc., Naples, Fla.), this technique would allow a surgeon to tighten sequentially. Any external ligament reconstruction or repair like medial collateral ligament (MCL), medial patella-femoral ligament (MPFL), lateral collateral ligament (LCL), anterior cruciate (AC), ankle, etc. would be appropriate. Any internal reconstruction or repair like anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) could potentially be internally braced with this anchor as well.

6) Any use of a SwiveLock® would be appropriate usage of anchor 10 in lieu of a free suture and vented SwiveLock® (VSL).

• • a. This would include ankle or elbow or hip.
  • b. SCR would be included in this list as a replacement for VSL.
  • c. These could replace the VSL anchors In the SpeedBridge™ kit once the tapes were applied.

Although tensionable knotless anchor 10 has been depicted above having ridges 15, and thus designed to be pushed into bone 80, it could instead be fabricated with threads and thereby designed to be twisted or screwed into bone.

Surgical system 100 of FIGS. 1-5 (with knotless tensionable anchor 10, suture 30 with suture limbs 33a, 33b, and suture passing device 40 attached to suture 30) may be employed in exemplary methods of tissue repair such as a Bankart or SLAP repair, wherein the knotless suture anchor 10 (i.e., a modified knotless SutureTak™ with suture limbs) simplifies arthroscopic glenohumeral joint instability repair by combining a proven and reproducible suture anchor insertion procedure with knotless soft tissue fixation.

The knotless suture constructs and systems detailed above may be used in conjunction with any knotless fixation devices which can allow a flexible strand and attached suture passing device to form a single locking splice with attached multiple adjustable loops formed by multiple suture limbs. The knotless suture constructs and systems detailed above may be used in conjunction with any additional fixation devices (which may be similar to or different from construct 100) depending on the characteristics of the repair site.

A flexible strand may be a suture strand, a tape such as suture tape, or any suture-like material known in the art that could pass through tissue. A flexible strand may include a high-strength suture, such as an ultrahigh molecular weight polyethylene (UHMWPE) suture. High strength suture may be a FiberWire® suture (Arthrex). FiberWire® suture is formed of an advanced, high-strength fiber material, namely ultrahigh molecular weight polyethylene (UHMWPE), sold under the tradenames Spectra® (Honeywell International Inc., Colonial Heights, Va.) and Dyneema® (DSM N.V., Heerlen, the Netherlands), braided with at least one other fiber, natural or synthetic, to form lengths of suture material.

A flexible strand may be also formed of TigerWire® suture, or suture chain (such as FiberChain® disclosed in U.S. Pat. No. 7,803,173), or suture tape (such as FiberTape® disclosed in U.S. Pat. No. 7,892,256), the disclosures of which are all incorporated in their entireties herein.

At least one of a flexible strand and a shuttle/pull device may be made of any known suture material, such as UHMWPE material or the FiberWire® suture. The UHWMPE suture may be without a core to permit ease of splicing. The shuttle/pull device may be a shuttle/pull suture device such as a FiberLink™ or a Nitinol loop.

The limbs may also be formed of a flexible material, a stiff material, or combination of stiff and flexible materials, depending on the intended application. Both the limbs and the splice region may be also coated and/or provided in different colors. The knotless anchors of the present invention can be used with any type of flexible material or suture that forms a splice and a loop.

Claims

1. A surgical construct for tissue repairs, comprising:

a tensionable construct comprising a flexible strand with a plurality of limbs, and a shuttling device attached to the flexible strand,

wherein the shuttling device allows the plurality of limbs of the flexible strand to pass through the flexible strand and form a locking splice and multiple adjustable closed loops.

2. The surgical construct of claim 1, wherein the tensionable construct consists of the flexible strand with the plurality of limbs and the shuttling device attached to the flexible strand.

3. The surgical construct of claim 1, wherein the flexible strand is a suture or suture tape with an end region split into the plurality of limbs.

4. The surgical construct of claim 1, wherein the flexible strand is formed of ultrahigh molecular weight polyethylene.

5. The surgical construct of claim 1, wherein the shuttling device is a suture passing instrument or a wire loop.

6. A surgical system for tissue repairs, comprising:

a fixation device comprising a body, a longitudinal axis, a proximal end, and a distal end; and

a tensionable construct pre-loaded on the fixation device, the tensionable construct consisting of a flexible strand and a shuttling device attached to the flexible strand, wherein the flexible strand has one end which terminates in a knot and another end which is split into multiple limbs.

7. The surgical system of claim 6, wherein the flexible strand is affixed to the body of the fixation device by passing the flexible strand through an opening at a distal end of the body and tying the knot.

8. The surgical system of claim 6, wherein the shuttling device is configured to be pulled out of the body of the fixation device to allow the multiple limbs of the flexible strand to pass through the flexible strand and form a locking splice.

9. The surgical system of claim 8, wherein the locking splice is formed outside the body of the fixation device.

10. The surgical system of claim 8, wherein the locking splice is formed inside the body of the fixation device.

11. The surgical system of claim 6, wherein at least a portion of the body is cannulated and the tensionable construct extends through the body.

12. The surgical system of claim 6, wherein the flexible strand is fixed to the body of the fixation device, or to a part of the body of the fixation device.

13. The surgical system of claim 6, wherein the body has an opening at a most proximal end configured to receive a driver head for driving the fixation device, and an opening at a most distal end configured to receive and house the knot of the flexible strand.

14. The surgical system of claim 6, wherein the fixation device is an anchor with an anchor body provided with a plurality of circumferential ribs or ridges extending from an outer surface of the anchor body.