Suture release constructs and methods of tissue fixation

Reinforced surgical constructs and methods of tissue repairs. A surgical construct can offer both repair and shuttling capabilities to allow for a single pass to load multiple sutures at once. A surgical construct includes one or more repair sutures provided with one or more junctions (one or more releasable stitches), to allow the repair sutures to be joined and subsequently released. At least one of the one or more junctions (releasable stitches) can be formed by weaving back and forth another flexible strand (releasing suture) through the one or more repair sutures. When the flexible strand is pulled, it pulls out the one or more junctions (releasable stitches) from the repair sutures, freeing the repair sutures. The surgical construct may be part of a knotless or knotted construct.

BACKGROUND

The disclosure relates to surgical devices and, more specifically, to sutures and associated methods of tissue repairs.

SUMMARY

Surgical constructs with releasable junctions and methods of tissue repairs are disclosed. A surgical construct can offer both repair and reinforcement capability. A surgical construct can include one or more repair strands provided with one or more releasable junctions (one or more releasable stitches), to allow the repair strands to be joined and subsequently released. At least one of the one or more releasable junctions (releasable stitches) can be formed by passing back and forth another flexible strand (releasing suture) through the one or more repair strands to form a plurality of passes. When the another flexible strand is pulled, it pulls out the one or more releasable junctions (releasable stitches) from the repair strands, releasing the repair strands. The surgical construct may be part of a knotless or knotted construct.

Methods of forming a releasable, stitched junction capable of being released to allow repair strands to be disengaged/disjoined are also provided. One or more repair strands are provided with at least one or more releasable junctions (one or more releasable stitches) formed by another independent strand (releasing suture) which is passed/shuttled through the one or more repair strands, to form a releasable junction. The another independent strand (releasing suture) may be similar to or different from the one or more repair strands, and may have similar or different characteristics and properties as those of the repair strands. The one or more releasable junctions (releasable stitches) can be removed to allow release of the repair strands by pulling on the releasing suture.

Methods of tissue repair are also disclosed. A first tissue is approximated to a second tissue with a repair strand provided with at least one or more releasable junctions (one or more releasable stitches) formed by a releasing suture that is passed or weaved back and forth through at least a portion of the repair strand. When the releasing suture is pulled, it pulls out the releasable stitch from the repair suture, freeing up the repair suture. The releasable junction provides additional support, strength, and reinforcement of the tissue repair. In an embodiment, a repair strand with at least one releasable junction (releasable stitch) is attached to a first tissue and to a second tissue, to provide a reinforced tissue repair and assist in surgical procedures requiring repair sutures to be joined to each other, as well as released from each other at a certain time during the surgery.

DETAILED DESCRIPTION

The disclosure provides surgical constructs formed of flexible strands that are joined together and subsequently disengaged. The surgical constructs are suturing constructs.

The surgical constructs include a repair strand (flexible strand such as suture) provided with at least one releasable stitch formed by a releasing suture (another flexible strand such as suture) that is passed or weaved back and forth through at least a portion of the body of the repair strand to form a releasable stitch. When the releasing suture is pulled, the releasable stitch is removed (pulled out) from the repair strand.

The surgical constructs can be employed for passing or shuttling at least one length of flexible material, for example suture such as high strength suture, tape, wire, cable, or fabric. After the passing or shuttling of various lengths of flexible materials with the surgical constructs in a first configuration (having the releasable stitch), the surgical constructs can attain a second configuration different from the first configuration (without the releasable stitch). The surgical constructs may be knotless or knotted. The surgical constructs may be part of additional knotless or knotted construct(s) and/or may be employed in conjunction with knotless or knotted construct(s).

The surgical constructs permit passing and secure attachment of additional flexible strands through and with the repair strand, with increased strength and reinforcement capabilities. The ability to pass additional sutures through and with the repair strand would permit multiple suture strands to be loaded at a tissue repair site without the requirement of individually passing the suture through the tissue more than once. Surgical repairs with improved strands having reinforced junctions/suture releasable stitches such as the improved strands of the present disclosure (and as detailed below) provide multiple strands joined at a releasable junction point which provides increased strength and supporting capabilities at a repair site, with the benefit of releasing the repair strands as desired during the surgical procedure.

The surgical constructs include a repair strand that is joined into a predetermined configuration or bounded with other repair strands together by a releasing suture. The releasing suture forms a releasable stitch. The surgical constructs provide for improved methods of tissue repair and multiple suture strand loading techniques with a single suture needle passage.

The surgical construct in the predetermined configuration can be employed as a passing/shuttling loop, through which the same suture strand and/or another independent strands (sutures) may be passed in a single pass step, for improved tissue repair constructs. The surgical construct provides a site where additional sutures or strands or flexible materials may be passed/threaded through loops formed by the releasable stitch. The repair strands can be disengaged by pulling on the releasing suture to remove the releasable stitch and release the repair strands.

Referring now to the drawings, where like elements are designated by like reference numerals,FIGS.1-6illustrate various views of surgical constructs100,200,300,400(suture releasable stitch constructs100,200,300,400; suturing constructs100,200,300,400; constructs100,200,300,400; assemblies100,200,300,400) of the present disclosure.

Repair suture10ofFIG.1can include a middle region12with two tail regions11,13(tails11,13; ends11,13) and one exemplary releasing suture20being provided extending through the middle region12and along a longitudinal axis12aof the middle region12and out of tail13. The middle region12can be a suture or tape, for example a round suture or flat suture tape. The middle region can have a constant diameter/dimensions or a gradual taper. The two tail regions11,13can be formed of round suture, with same or different diameter.

Middle region12can have cross-sections of various forms and geometries, including round, elliptical, rectangular or flat, among others, or combination of such forms and geometries. In an exemplary embodiment only, middle region12can be provided as a braided round suture that can be coreless. The diameter of middle region12may be constant or may vary. The middle region12can be any suture strand or suture tape, for example, Arthrex FiberWire® suture (disclosed in U.S. Pat. No. 6,716,234, the entire disclosure of which is incorporated herein by reference). However, the surgical constructs100,200,300,400can be used with any type of flexible material or suture known in the art. The tail regions11,13may have similar or different diameters and/or widths. As illustrated inFIG.1, each of the widths/diameters of the tail regions11,13is about similar to the width/diameter of the middle region12. Tail regions11,13may have similar or different lengths. One or both of the tail regions11,13may have a very fine end that is coated, impregnated, or stiffened with a material such as plastic, for example. One or both of the tail regions11,13may include a tapered end that terminated in a very fine end.

For simplicity,FIGS.1-6illustrate repair suture10with only one exemplary releasable stitch50; however, the disclosure contemplates strands and flexible materials with any number of releasable stitches50, depending on the desired number of working strands and the particulars of each surgical repair. In addition, any number of repair sutures10may be employed with any number of releasing sutures20and releasable stitches50.

Releasable stitch50may be formed by passing releasing suture20at least once, preferably multiple times, through at least two separate regions/portions of the repair suture10, as shown inFIG.1, for example. Releasing suture20is provided inside the repair suture10, by for example, being fed inside the repair suture10. Releasable stitch50can be formed by passing back and forth the releasing suture20at different, spaced location and through bodies of portions/lengths/regions a, b of the repair suture10. Releasable stitch50can include a plurality of passes51(for example, five passes51, as illustrated inFIG.1) but it must be understood that the disclosure contemplates releasable stitch50with any number of passes51formed through the repair suture10. Additional passes through the repair suture10would typically provide a stronger overall stitch50.

FIG.1shows an “inside releasing suture” embodiment, i.e., releasing suture20is being fed inside of the repair suture10with the releasing suture20exiting an open end of the repair suture20, for example, a most distal end20b. The releasable stitch is provided adjacent tail11to form continuous, uninterrupted, flexible, knotless loop55. The “inside releasing suture” embodiment confers a clean appearance to the overall construct100and it is easier to manage. The repair suture10is in a first configuration (a “loop configuration”).

The releasable stitch50is formed of plurality of passes51by sewing back-and-forth strand20through the repair suture10. The more passes through the repair suture the stronger the overall stitch becomes. At least one of the plurality of passes51is provided within the body and end tail/region11of the repair suture10and along the lengths a, b of the repair suture10to permit for the passing/shuttling of the same repair suture10and/or other additional repair strands (flexible strands or similar elements such as suture, suture tapes, etc.) through the loop55. This aspect allows for additional sutures or tapes or any flexible material to pass through the reinforced loop to increase the strength of the repair.

One or more stitches50may be provided extending through and along the body of regions a and b of repair suture10, to attach/join/connect the regions a and b together, in a secured yet non-permanent manner, and to form a suture loop55(flexible, closed loop with a fixed perimeter). The suture loop55can allow passing of another strand(s) through the loop to aid in various tissue repairs. If multiple releasable stitches50are employed, the releasable stitches may have similar or different geometries and shapes and may be formed by similar or different releasing sutures.

Releasable stitch50can be formed by passing/sewing/weaving the releasing suture20through repair strand10at different locations and in at least two different directions, a first, longitudinal direction A about parallel to longitudinal axis12aof repair suture10and a second direction B about orthogonal to longitudinal axis12aof repair suture10. Releasing suture20may be any flexible strand, for example, suture strands, suture tapes, nitinol strands, FiberWire® suture, TigerWire® suture, or FiberLink™ among many others. One or more releasing sutures20may pass through repair suture10. When the releasing suture20is pulled, it pulls out the releasable stitch50from the repair suture10and opens up the loop55.

FIG.2illustrates surgical construct200which is similar in part to construct100detailed above (the “inside releasing suture” embodiment with a releasable suture loop) but differs in that construct200includes releasing suture20(a separate, independent strand20) which exits the repair suture10at a location “L” situated along the middle region12or tail13, and not at a most distal end20bof the tail13, as in the first embodiment. The embodiment ofFIG.2is an “outside releasing suture” construct with a releasable suture loop, wherein the releasing suture20is fed outside of the repair suture10. Depending on how the stitch50is used and upon the complexity of the surgical activity, the releasing suture20may provide additional benefits if fed outside the repair suture.

FIGS.3and4illustrate subsequent steps of removing the releasable stitch50of exemplary construct100ofFIG.1. Pulling on the releasing suture20in direction “P” along the length of suture20and away from the repair suture10, allows the releasing suture20to remove the releasable stitch50and to confer the repair suture10a second configuration. The repair suture loop55is free to open.FIG.4illustrates repair suture10in the second configuration (non-loop configuration), with releasing suture20completely removed and loop55completely opened (no loop).

FIG.5illustrates surgical construct300which is similar in part to constructs100,200detailed above, but differs in that construct300includes releasing suture20which extends longitudinally through the middle region12or one of the tails11,13and the other one of the tails11,13of the repair suture10, i.e., without a loop formation. Releasing suture20also passes through a plurality of regions of the repair suture10(for example, four or more separate regions, as shown inFIG.5) to form releasable stitch150in the form of a releasable suture bunch/knot. When releasing suture20is pulled in direction “P” to pull out of the repair suture10, the stitch150is removed and the repair suture10becomes unbunched/unknotted, i.e., repair suture10changes from first to second configuration to become a flexible, free strand without any joined or connected sections.

FIG.6illustrates surgical construct400which is similar in part to constructs100,200,300detailed above, but differs in that construct400includes releasing suture20which forms releasable stitch250joining two or more repair sutures10,110and extending longitudinally only through one of the repair sutures10,110, without a loop formation. When the releasing suture20is pulled, it pulls out the releasable stitch250from the repair sutures10,110and frees the repair sutures10,110(a “releasable sutures” embodiment).

Typically, sutures can be spliced (fixed spliced sutures) or tied together or joined permanently in different manners but they cannot be disengaged (set free subsequent to the splicing or joining other than being cut to open the joined region). The present disclosure provides a solution to join a suture in a predetermined configuration or to bind multiple sutures together, while also providing a simple method to release these sutures. The formed loop can be released by removing/uncoupling the suture release stitch from the repair suture of the surgical construct. After the stitch has been removed, the suture(s) attains and returns to the initial form/state.

A surgical construct100,200,300,400includes one or more repair sutures10,110provided with one or more junctions50,150,250(one or more releasable stitches50,150,250), to allow the repair sutures10,110to be joined and subsequently released. At least one of the one or more junctions50,150,250(releasable stitches) can be formed by passing or weaving back and forth another flexible strand20(releasing suture20) through the one or more repair strands10,110. When the releasing suture20is pulled, it pulls out the one or more junctions50,150,250(one or more releasable stitches50,150,250) from the repair sutures10,110, releasing the repair sutures10,110and opening up loop55. The surgical construct100,200,300,400may be a knotless or knotted construct, or may be part of a knotless or knotted construct.

Methods of forming a reinforced or stitched junction50,150,250(one or more releasable stitches50,150,250) capable of being released to allow repair strands to be disengaged/disjoined are also provided. One or more repair sutures10,110are provided with at least one or more junctions50,150,250(one or more releasable stitches50,150,250) formed by another independent strand20(releasing suture20) which is passed/shuttled through the one or more repair sutures10,110, to form a junction. The another independent strand (releasing suture) may be similar to or different from the one or more repair sutures, and may have similar or different characteristics and properties as those of the repair strands. The one or more junctions50,150,250(one or more releasable stitches50,150,250) can be removed to allow release of the repair strands by pulling on the releasing suture.

Methods of tissue repair are also disclosed. A first tissue is approximated to a second tissue with a repair suture10,110provided with at least one or more junctions50,150,250(one or more releasable stitches50,150,250) formed by a releasing suture20that is passed back and forth through at least two different locations of the repair suture10,110. When the releasing suture20is pulled, it pulls out the releasable stitch50,150,250from the repair suture10,110, freeing up the repair suture10,110. The junction50,150,250(one or more releasable stitches50,150,250) provides additional support, strength, and reinforcement of the tissue repair as well as of the repair suture10,110. In an embodiment, a repair suture10,110with at least one reinforced junction50,150,250(one or more releasable stitches50,150,250) is attached to a first tissue and to a second tissue, to provide a reinforced tissue repair and assist in multiple surgical procedure requiring repair sutures to be joined to each other, as well as released from each other to go back to their initial shape/configuration/state.

A repair suture10,110includes a releasable stitch50,150,250. The releasable stitch50,150,250includes a plurality of passes51formed by passing at least another strand20multiple times through two regions a, b of the repair suture10,110. When the another strand20is pulled out of the suture10,110, the releasable stitch50,150,250is removed from the repair suture.

A surgical construct100,200,300,400comprises a repair suture10,110with at least one releasable stitch50,150,250formed of a plurality of passes51which extend in between two separate regions a, b of the repair suture10,110and which are formed by a strand20passing back and forth through the two separate regions a, b of the repair suture10,110to form the releasable stitch50,150,250. The strand20is passed at an angle relative to a longitudinal axis12aof the repair suture10,110to connect the two separate regions a, b or the two separate repair sutures10,110and form a loop55. The repair suture10,110has a middle region12and two tail regions11,13adjacent the middle region12. The releasable stitch50,150,250is removable when the strand20is pulled out of the repair suture10,110.

A surgical construct100,200,300,400comprises a suture10,110with a middle region12and two end tails11,13; and a strand20passed multiple times through the middle region12and through one of the end tails11,13to form a closed, flexible, continuous end loop55with a fixed perimeter and a releasable junction50,150,250, and to connect the one end of the tails11,13to the middle region12. The strand20passes through other of the two end tails11,23.

A method of suturing comprises (i) passing a suture construct100,200,300,400through or around tissue, the suture construct comprising a first flexible strand10,110with a closed, flexible, continuous end loop55with a fixed perimeter and a releasable stitch50,150,250, and a second flexible strand20passed through and in between at least two separate longitudinal lengths a, b of the first flexible strand10,110to form the releasable stitch50,150,250and the closed, flexible, continuous end loop55with a fixed perimeter; and (ii) pulling on the second flexible strand20to remove the releasable stitch50,150,250and to open the closed, flexible, continuous end loop55with a fixed perimeter. The method further comprises threading at least another flexible strand through the closed, flexible, continuous end loop55with a fixed perimeter; and passing the another flexible strand through or around tissue together with the suture construct100,200,300,400. The first flexible strand10,110, the second flexible strand20, and the another flexible strand can be passed simultaneously through the tissue, in a single pass step. The suture construct100,200,300,400(with or without any additional strands) can be attached to a fixation device. The fixation device can be knotless or knotted. A knotless fixation device can be a swivel anchor or a pushlock anchor.

The surgical construct100,200,300,400can be a shuttling/suture passer. The surgical construct100,200,300,400can be a repair suture. The surgical construct100,200,300,400can be a suturing construct. The suture may be a round suture or a suture tape, or combination thereof. The suture may be high strength suture, tape, suture tape, combination of suture and tape, wire, cable, or fabric, among many others.

Methods of tissue repair are also disclosed. In an embodiment, additional flexible strands can be passed simultaneously with a suture construct100,200,300,400by conducting a single pass through tissue to be repaired (ligament, tendon, graft, etc.). The suture construct (repair suture10,110and releasing suture20) and any additional flexible strands passed and secured through the loop55may be passed and/or shuttled simultaneously with or without a surgical instrument such as a suture passer. The suture construct and the additional flexible strands may be passed or shuttled simultaneously without loading a separate shuttling stitch or wire, and without passing each strand independently. One or more additional flexible strands may pass through one or more loops55(with a needle or a suture passer).

A method of tissue repair (for example, soft tissue to soft tissue, or soft tissue to bone fixation) includes passing a suturing construct100,200,300,400through tissue and securing the tissue with the suturing construct. The suturing construct100,200,300,400may be passed through or around tissue by loading the construct onto a suture passer and simultaneously passing a repair suture together with the releasing suture and any additional repair strands. Additional repair strands are passed through the closed loop55of the suturing construct and passed/shuttled through or around tissue without the need to pass each additional repair strand individually. A single pass loads multiple repair strands at once. The tissue repairs may employ at least one knotless and/or knotted fixation device. The knotless fixation devices may be knotless anchors, for example, swivel and/or screw-in suture anchors and/or push-in anchors (such as an Arthrex SwiveLock® anchor or a PushLock® Anchor). In an exemplary embodiment only, the fixation device is a knotless suture anchor such as the two-piece Arthrex PushLock® anchor, disclosed in U.S. Pat. No. 7,329,272, or an Arthrex SwiveLock® anchor, disclosed in U.S. Pat. No. 8,012,174 issued Sep. 6, 2011, and U.S. Pat. No. 9,005,246 issued Apr. 14, 2015, the disclosures of all of which are fully incorporated by reference in their entirety herein.

The surgical constructs100,200,300,400described above may be formed of strands of a high strength suture material with surgically-useful qualities, including knot tie down characteristics and handling, such as Arthrex fiberWire® suture disclosed in U.S. Pat. No. 6,716,234 the entire disclosure of which is incorporated herein by reference. The surgical constructs may be formed of optional colored strands (preferably black) to assist surgeons in distinguishing between suture lengths with the trace and suture lengths without the trace.

Strands10,100,20may be made of any known suture construct, such as multifilament, braided, knitted, woven suture, or including fibers of ultrahigh molecular weight polyethylene (UHMWPE). Flexible strands10,110,20can consist of, or consist essentially of, suture. Flexible strands10,110,20can be formed of any suture, tape, weave, fabric, ribbon, textile, web, or mesh, or any combinations of these materials. Flexible strands10,110,20can be formed of a high strength suture material such as FiberWire® suture, sold by Arthrex, Inc. of Naples, Fla., and described in U.S. Pat. No. 6,716,234, the disclosure of which is incorporated by reference herein. 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. Flexible strands10,110,20can be braided or multi-filament suture such as FiberTape® suture tape (as disclosed in U.S. Pat. No. 7,892,256, the disclosure of which is incorporated in its entirety herewith) or collagen tape, or wide “tape like” material, or combinations thereof.

Flexible strands10,110,20can consist essentially of suture or suture material, or combination of suture and other materials such as long chain synthetic polymers like polyester and nylon, or materials such as PET, silk nylon or absorbable polymers, or coating materials (such as wax, silk, or silicone products), among many others. Flexible strands10,110,20can consist of strands with cross-sections of various forms and geometries, including round, oval, rectangular, or flat, among others, or combinations of such forms and geometries. In an embodiment, at least one of flexible strands10,110,20can be provided as a suture which is braided, knitted or woven.

Flexible strands10,110,20can be also formed of a stiff material, or combination of stiff and flexible materials, depending on the intended application. Flexible strands10,110,20can be also coated and/or provided in different colors. In an embodiment, parts (or all) of suturing construct100,200,300,400can be coated (partially or totally) with wax (beeswax, petroleum wax, polyethylene wax, or others), silicone (Dow Corning silicone fluid 202A or others), silicone rubbers (Nusil Med 2245, Nusil Med 2174 with a bonding catalyst, or others) PTFE (Teflon, Hostaflon, or others), PBA (polybutylate acid), ethyl cellulose (Filodel) or other coatings, to improve lubricity of the suture and/or tape, pliability, handleability or abrasion resistance, for example.

Flexible strands10,110,20can be also provided with tinted tracing strands, or otherwise contrast visually with other parts of the construct, which remain a plain, solid color, or displays a different tracing pattern, for example. Various structural elements of surgical construct100,200,300,400may be visually coded, making identification and handling of the suture legs simpler. Easy identification of suture in situ is advantageous in surgical procedures.

The term “high strength suture” is defined as any elongated flexible member, the choice of material and size being dependent upon the particular application. For the purposes of illustration and without limitation, the term “suture” as used herein may be a cable, filament, thread, wire, fabric, or any other flexible member suitable for tissue fixation in the body.