US20180296207A1 - Self-punching soft anchor - Google Patents

Abstract

A self-punching soft suture anchor insertable into bone without preforming a hole in bone. The soft suture anchor is formed entirely of suture and is mounted on an inserter with a sharp tip for forming a hole in bone without pre-drilling. The inserter, with the soft suture anchor mounted thereon, is advanced into the bone. As the inserter is withdrawn, the soft suture anchor is released and thereby remains in the bone.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This application is a continuation of U.S. patent application Ser. No. 15/242,331, filed Aug. 19, 2016, which is a continuation of U.S. patent application Ser. No. 13/624,321, filed Sep. 21, 2012, now U.S. Pat. No. 9,421,008, which claims the benefit of U.S. Provisional Application No. 61/538,163, filed Sep. 23, 2011, the disclosures of which are incorporated by reference in their entireties herein.
FIELD OF THE INVENTION
• The present invention relates to the field of surgery and, more particularly, to a joint or ligament reconstruction technique and associated fixation and reconstruction device.
BACKGROUND OF THE INVENTION
• When soft tissue such as a ligament or a tendon becomes detached from a bone, surgery is usually required to reattach or reconstruct the tissue. Often, a tissue graft is attached to the bone to facilitate regrowth and permanent attachment. Techniques and devices that have been developed generally involve tying the soft tissue with suture to an anchor or a hole provided the bone tissue. Knotless suture anchors, such as the two piece Arthrex PushLock® anchor, disclosed in U.S. Pat. No. 7,329,272, have been developed to facilitate tissue fixation to bone.
• It would be desirable to provide a suture construct which has a design that allows tensioning of the construct as necessary and upon insertion into bone. Also needed is a suture construct that may be knotless and that is formed essentially of a soft material such as suture (or suture-based materials or other soft materials and/or compositions) with the ability to be inserted into a bone socket and then tightened by simple traction on one of the suture strands.
SUMMARY OF THE INVENTION
• The present invention provides a suture construct for fixation of soft tissue to bone with the ability to tension/retension the suture construct. The suture construct may be a knotted or a knotless construct.
• The suture construct of the present invention is a soft, suture-based anchor which is self-cinching and has a specific, accordion-type configuration (i.e., with the ability to fold from a first, extended position to a second, folded or compressed position). The suture-based anchor may be formed essentially of a flexible material such as suture (for example, FiberWire® suture) or suture chain (such as FiberChain®) or suture tape (such as FiberTape®), to form a SutureLock™, ChainLock™ or TapeLock™ suture-based anchor, respectively.
• A suture (such as FiberWire®) may be employed to form a SutureLock™ anchor. Another suture (for example, a TigerWire® suture) is first passed through a length of the FiberWire® through multiple points such that the TigerWire® circles back to exit through the FiberWire® near the spot where it entered (in a suture-through-suture technique), creating a loop that penetrates the suture in a “sine-wave” configuration. Tensioning the two free ends of the TigerWire® tightens the loop and “accordionizes” the suture, creating expansion of the SutureLock™ anchor to create an interference fit. The SutureLock™ anchor is inserted into a bone socket/tunnel and the tails of the TigerWire® are tensioned to “accordionize” the FiberWire® (i.e., to fold or compress the FiberWire® to achieve an “accordion-like” shape). Additional sliding sutures may be added (threaded) through the soft anchor (SutureLock™ anchor) so that the soft anchor becomes double-loaded, triple-loaded, etc., i.e., multiple-loaded, as desired and depending on the specific characteristics of each surgical repair.
• A suture chain (such as FiberChain® or FiberLink®) may be employed to form a ChainLock™ anchor. A free end of the suture chain (FiberChain®) is first passed through the chain (for example, through every other link in the chain) so that, when the free end is tightened, it collapses the chain in an accordion-like fashion with laterally-projecting links to produce an interference fit. The loop is closed down by pulling tension on the tail and this collapses the link like an accordion, forming the ChainLock™ anchor (i.e., folding or compressing the FiberChain® to achieve an “accordion-like” shape). A flexible strand (for example, a FiberWire®) is threaded through a middle link of the accordion. This flexible strand acts as the sliding suture for tissue fixation after the anchor is placed into bone. Once the ChainLock™ anchor is inserted into the bone socket/tunnel, the sliding suture (FiberWire®) is tensioned so that the tail of the FiberChain is flush with the bone after tensioning. Additional sliding sutures may be added (threaded) through the soft anchor (ChainLock™ anchor) so that the soft anchor becomes double-loaded, triple-loaded, etc., i.e., multiple-loaded, as desired and depending on the specific characteristics of each surgical repair.
• A suture tape (such as FiberTape®) may be employed to form a TapeLock™ anchor. A FiberWire® suture is first passed through a length of the FiberTape® such that the FiberWire® circles back to exit through the FiberTape® near the spot where it entered, creating a loop that penetrates the tape in a “sine-wave” configuration. Tensioning the two free ends of the FiberWire® tightens the loop and “accordionizes” the suture tape (i.e., folding or compressing the FiberTape® to achieve an “accordion-like” shape), creating expansion of the TapeLock™ anchor to create an interference fit. The TapeLock™ anchor is inserted into a bone socket/tunnel and the tails of the FiberWire® are tensioned to “accordionize” the FiberTape® (i.e., to fold or compress the FiberTape® to achieve an “accordion-like” shape). Additional sliding sutures may be added (threaded) through the soft anchor (TapeLock™ anchor) so that the soft anchor becomes double-loaded, triple-loaded, etc., i.e., multiple-loaded, as desired and depending on the specific characteristics of each surgical repair.
• These and other features and advantages of the invention will be more apparent from the following detailed description that is provided in connection with the accompanying drawings and illustrated exemplary embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates a suture-based anchor (SutureLock™ anchor) according to an exemplary embodiment of the present invention.
• FIG. 2 illustrates the suture-based anchor (SutureLock™ anchor) ofFIG. 1 secured in bone with a pusher (a ring-handed instrument).
• FIG. 3 illustrates the suture-based anchor (SutureLock™ anchor) ofFIG. 2 with at least one tail of the suture tensioned, to accordionize the suture-based anchor (SutureLock™ anchor), so that the suture is flush with the inner cortex of the bone after tensioning.
• FIG. 4 illustrates a suture-based anchor (ChainLock™ anchor) according to another exemplary embodiment of the present invention.
• FIG. 5 illustrates the suture-based anchor (ChainLock™ anchor) ofFIG. 4 with a FiberWire threaded through a middle link and with one tail of the suture chain tensioned.
• FIG. 6 illustrates the suture-based anchor (ChainLock™ anchor) ofFIG. 5 secured in bone with a pusher (a ring-handed instrument).
• FIG. 7 illustrates the suture-based anchor (ChainLock™ anchor) ofFIG. 6 with a tail of the suture chain tensioned, to accordionize the suture-based anchor (ChainLock™ anchor), so that the suture chain is flush with the inner cortex of the bone after tensioning.
• FIG. 8 is an enlarged view of the pusher (ring-handed instrument) ofFIG. 6.
• FIG. 9 illustrates a suture-based anchor (TapeLock™ anchor) according to yet another exemplary embodiment of the present invention (with a FiberWire® suture passed through the length of a suture tape).
• FIG. 10 illustrates the suture-based anchor (TapeLock™ anchor) ofFIG. 9 with the two free ends of the FiberWire® suture tightened to accordionize the suture tape.
• FIG. 11 illustrates the suture-based anchor (TapeLock™ anchor) ofFIG. 10 secured in bone with a pusher (a ring-handed instrument).
• FIG. 12 illustrates the suture-based anchor (TapeLock anchor) ofFIG. 11 with the tails of the FiberWire tensioned, to accordionize the suture-based anchor (TapeLock anchor) so that the suture tape is flush with the inner cortex of the bone after tensioning.
• FIGS. 13(a)-(d) illustrate subsequent steps of a method of self-reinforcing knotless fixation of soft tissue with a suture-based anchor of the present invention, and according to an exemplary method of knotless fixation of the present invention.
• FIGS. 14(a)-(e) illustrate subsequent steps of another method of self-reinforcing knotless fixation of soft tissue with a suture-based anchor of the present invention, and according to another exemplary method of knotless fixation of the present invention.
• FIG. 15 illustrates a folding tube suture anchor according to another exemplary embodiment of the present invention.
• FIG. 16 illustrates the folding tube suture anchor ofFIG. 15 tensioned.
• FIGS. 17-21 illustrate subsequent steps of folding the tube anchor ofFIG. 15.
• FIG. 22 illustrates a soft anchor implant for soft tissue repairs according to another embodiment of the present invention.
• FIGS. 23(a) and (b) illustrate a soft anchor implant for soft tissue repairs according to another embodiment of the present invention.
• FIG. 24 illustrates a soft anchor implant for soft tissue repairs according to another embodiment of the present invention.
• FIG. 25 illustrates a soft anchor implant for soft tissue repairs according to another embodiment of the present invention.
• FIGS. 26(a)-(c) illustrate subsequent steps of forming the soft anchor implant ofFIG. 22.
• FIG. 27 illustrates another view of the soft anchor implant ofFIG. 25.
• FIGS. 28-33(a) and33(b) illustrate methods of tissue fixation with a soft anchor implant of the present invention.
• FIGS. 34-41, 42(a),42(b), and43-45 illustrate other methods of tissue fixation with soft anchor implants of the present invention.
DETAILED DESCRIPTION OF THE EMBODIMENTS
• The present invention provides surgical systems and methods for knotted or knotless soft tissue (ligament, tendon, graft, etc.) repair and fixation, such as fixation of soft tissue to bone. The suture anchor of the present invention is a suture-based anchor with a body that consists essentially of a flexible material such as suture, high-strength suture such as FiberWire® suture (disclosed in U.S. Pat. No. 6,716,234), suture tape such as FiberTape® (disclosed in U.S. Pat. No. 7,892,256), suture chain such as FiberChain® (disclosed in U.S. Pat. No. 7,803,173), among others, or combination of these materials. The body of the flexible material forms a loop that closes down and collapses the loop like an accordion. Once the suture anchor is placed into a bone socket or tunnel, tails of the anchor are tensioned to allow the loop of flexible material to “accordionize” and to create an interference fit.
• Referring now to the drawings, where like elements are designated by like reference numerals,FIGS. 1-12 illustrate exemplary soft suture-basedanchors90,100,200 of the present invention that are provided with a specific, accordion-type configuration. The suture-basedanchors90,100,200 may be formed essentially of a flexible material such as suture (for example, FiberWire® suture) or suture chain (such as FiberChain®) or suture tape (such as FiberTape®), to form a SutureLock™, ChainLock™ or TapeLock™ suture-based anchor, respectively.
• FIG. 1 illustrates suture-based anchor90 (SutureLock™ anchor90) formed essentially of a flexible strand10 (for example, a suture such as a FiberWire® suture10). Another flexible strand11 (for example, another FiberWire® or TigerWire® suture11) is passed through the length of the FiberWire®10 (with a needle, for example) in a suture-through-suture technique. The flexible strand11 (TigerWire® suture11) is preferably a colored flexible strand or suture (or colored differently from the flexible strand10) to allow easy differentiation between the strands and to allow medical personnel (e.g., surgeon) to distinguish between the sutures. TheTigerWire®11 circles back to exit through theFiberWire®10 near the spot where it entered, creating aloop15 that penetrates the suture in a “sine-wave” configuration. The flexible strand11 (TigerWire® suture11) may be passed through thesuture10 at different locations and as desired, for example, at predetermined insertion points on the length of the suture10 (such as six locations, for example), which may be equally spaced from each other or from at least some of the remaining insertion points, or which may not be equally spaced relative to the other insertion points. The end of the TigerWire® suture11 is brought back to reenter theFiberWire10 near the spot where it first entered, to close theFiberWire®10 and form closedloop15.
• When the two free ends of flexible strand11 (TigerWire® suture11) are tightened (as shown inFIGS. 2 and 3), theFiberWire®10 is “accordionized” and theloop15 collapses in an accordion-like fashion with laterally-projecting links to produce an interference fit. Theloop15 is closed down by pulling tension on the tails and this tension collapses the suture like an accordion, forming theSutureLock™ anchor90.
• FIGS. 2 and 3 illustrate the insertion of theSutureLock™ anchor90 into a bone socket/tunnel30 employing a pusher50 (a ring-handed instrument) provided with aring52 and a forkedtip55. Details ofinstrument50 are shown inFIG. 8. Forkedtip55 of thepusher50 is employed for pushing theSutureLock™ anchor90 into the bone socket ortunnel30 formed within bone33 (i.e., pushing the FiberWire® suture10 at an insertion point where the TigerWire® suture11 entered the FiberWire® suture10).
• FIG. 3 illustrates the tails of the TigerWire® suture11 tensioned, to “accordionize” the FiberWire® and secure theSutureLock™ anchor90 withinbone33. The suture is flush with thebone33 after tensioning.
• FIG. 4 illustrates suture-based anchor100 (ChainLock™ anchor100) formed essentially of a suture chain110 (such as FiberChain® or FiberLink™110) comprising a plurality of links having similar or different diameters and lengths. Afree end111 of the FiberChain® suture110 is first passed through the chain to form a closedsuture chain loop115. In an exemplary embodiment only, thefree end111 is passed through every other link in the chain, with a graft preparation needle, for example. When thefree end111 is tightened (as shown inFIG. 5), theloop115 collapses in an accordion-like fashion with laterally-projecting links to produce an interference fit. Theloop115 is closed down by pulling tension on the tail and this collapses the link like an accordion, forming the ChainLock™ anchor.
• A flexible strand120 (for example, a slide suture such as a FiberWire® suture or TigerWire® suture) is threaded through a middle link of the accordion. Strand120 will act as the sliding suture for tissue fixation after the suture-basedanchor100 is placed into bone. Once theChainLock™ anchor100 is inserted into the bone socket/tunnel, the sliding suture120 (FiberWire® suture) is tensioned so that the tail of the FiberChain® suture is flush with the bone after tensioning.
• FIG. 5 illustrates the suture-based anchor100 (ChainLock™ anchor) with the sliding suture120 (FiberWire® suture120) threaded through a middle link and with onetail111 of thesuture chain110 tensioned.FIG. 6 illustrates the suture-based anchor100 (ChainLock™ anchor) inserted/pushed into bone socket ortunnel30 with a pusher (a ring-handed instrument)50 having aring52 and atip55. Details ofinstrument50 are shown inFIG. 8. Forkedtip55 of thepusher50 is employed for pushing the suture/FiberChain® into the bone socket ortunnel30 formed withinbone33.
• FIG. 7 illustrates the suture-based anchor100 (ChainLock™ anchor) with the tail of thesuture chain110 tensioned, to accordionize the suture-based anchor100 (ChainLock™ anchor) and to tighten the circle/loop115, so that thesuture chain110 is flush with thebone33 after tensioning. The two tails of slidingsuture120 ensure tissue fixation after the suture-basedanchor100 is placed within the bone tunnel/socket30.
• FIGS. 9-12 illustrate a suture-based anchor (TapeLock™ anchor)200 according to another exemplary embodiment of the present invention. Suture-based anchor200 (TapeLock™ anchor200) is formed essentially of asuture tape210, such as, for example, a FiberTape®suture210.Suture tape210 has a first length L1, a width W and a thickness (now shown).
• As illustrated inFIG. 9, flexible strand220 (for example, a suture such as a FiberWire® or TigerWire® suture220) is passed through a length of the FiberTape®210 (with a needle, for example) such that theFiberWire®220 circles back to exit through theFiberTape®210 near the spot where it entered, creating aloop215 that penetrates the tape in a “sine-wave” configuration. The flexible strand220 (FiberWire® suture220) may be passed through thetape210 at different locations and as desired, for example, at predetermined insertion points on the length of the suture tape210 (such as four locations, for example), which may be equally spaced from each other or from at least some of the remaining insertion points, or which may not be equally spaced relative to the other insertion points. The end of the TigerWire® suture220 is brought back to reenter theFiberTape210 near the spot where it first entered, to close theFiberTape®210 and form closedloop215.
• FIG. 10 shows how the tensioning the two free ends of the FiberWire® suture220 tightens theloop215 and “accordionizes” the suture tape210 (to achieve a length L2 smaller than the length L1), creating expansion of theTapeLock anchor200 to create an interference fit (i.e., achieving expansion in a transversal orientation relative to the longitudinal axis of the bone tunnel/socket). TheTapeLock™ anchor200 is inserted into a bone socket/tunnel30 (as shown inFIG. 11) employing a pusher50 (a ring-handed instrument) provided with aring52 and a forkedtip55. Forkedtip55 of thepusher50 is employed for pushing theTapeLock™ anchor200 into the bone socket ortunnel30 formed within bone33 (i.e., pushing theFiberTape®210 at an insertion point where the TigerWire® suture220 entered the tape).
• FIG. 12 illustrates the tails of the FiberWire® suture220 tensioned, to “accordionize” the FiberTape® and secure theTapeLock™ anchor200 withinbone33. The suture tape is flush with thebone33 after tensioning. TheTapeLock™ anchor200 having the expanded/accordion shape (in the deployed or accordionized position) is captured below the cortical surface of the bone to achieve fixation within the bone socket/tunnel30.
• Although the suture-basedanchors90,100,200 have been described above with two free suture ends for tying knots, the suture-based anchors of the present invention could be also provided as knotless suture constructs. If a knotless suture construct is desired, a knotless embodiment may be created by splicing a coreless suture (for example, a coreless FiberWire® suture) on the end of the anchor. This coreless FiberWire® suture would have a mechanism similar to that of an Arthrex ACL Tightrope® (like a Chinese finger-trap). The coreless suture may be threaded back through, as detailed below with reference toFIGS. 13(a)-(d) andFIGS. 14(a)-(e), which depict subsequent steps of two methods of self-reinforcing knotless fixation of soft tissue with the soft anchors of the present invention (for example, the suture-based anchors) and according to two exemplary methods of knotless fixation of the present invention.
• FIGS. 13(a)-(d):Soft suture anchor90 is inserted into bone socket/tunnel30 by employingpusher50, for example.Suture anchor90 is also provided with two limbs,limb #1 andlimb #2, of which one limb (for example, limb #1) is passed throughsoft tissue88. A threader92 (for example, a flexible nitinol threader92) is employed tothread limb #1 through about the center oflimb #2 and for a predetermined length, for example, for about 5 mm (FIG. 13(a)). This will lock the suture by a finger-trap mechanism (FIG. 13(b)). The limb is pulled to tighten the loop (FIG. 13(c)). The suture is then cut close to the loop and the suturedtissue88.
• FIGS. 14(a)-(e): an alternative self-reinforcing knotless fixation with the suture-based anchors of the present invention. A suture is threaded through suture for about 4 mm, to form the double-looped construct with loop #1 (10a) and loop #2 (10b) shown inFIG. 14(a). Pull-cord #1 and pull-cord #2 extend between thesaddle15 of the loop assembly. The double-looped construct is similar to a finger-trap mechanism and is self-locking by pulling the two pull-cords.
• Loop #2 is shuttled throughsoft tissue88 as shown inFIG. 14(b). By pulling on pull-cords #1 and #2, thesaddle15 of theloop assembly10a,10bis pre-positioned within one loop of the soft anchor's accordion.
• Outside of the workingcannula85, separate sutures are used to tie loop #1 (10a) and loop #2 (10b) together, to create closed loop down to the pull-cords (FIG. 14(c)). Subsequently, the pull-cords are pulled to bring the loops down tightly over thesoft tissue88. The self-locking and self-reinforcing finger-trap mechanism occurs at point A ofFIG. 14(d). The construct is tightened by pulling on the pull-cords.FIG. 14(e) shows final knotless construct90awith the pull-cords cut flush withbone33.
• The flexible strands employed for the formation of the suture-basedanchors90,100,200,90amay be high-strength sutures, such as the high strength suture sold by Arthrex, Inc. of Naples, Fla. under the registered tradename TigerWire® or FiberWire®, which is disclosed and claimed in U.S. Pat. No. 6,716,234, the entire disclosure of which is incorporated herein by reference. FiberWire® suture is formed of an advanced, high-strength fiber material, namely ultrahigh molecular weight polyethylene (UHMWPE), sold under the tradenames Spectra (Honeywell) and Dyneema (DSM) fibers, braided with at least one other fiber, natural or synthetic, to form lengths of suture material. The preferred FiberWire® suture includes a core within a hollow braided construct, the core being a twisted yarn of UHMWPE.
• The suture tape employed for the formation ofsuture anchor200 may be a FiberTape® as disclosed in U.S. Pat. No. 7,892,256, the disclosure of which is herein incorporated by reference. The suture tapes may have the same, uniform width or may have different widths, and may comprise the same or different materials.
• Although the terms “chain,” “suture chain” and FiberChain® have been used interchangeably in this application, it must be understood that the term “chain” is not limited to only “suture chain” or FiberChain®; rather, the term “chain” encompasses a plurality of loops of any material and of any dimension (i.e., loops of similar or different diameters), as long as the loops are interconnected to each other. An exemplary suture chain that may be used in the present application is described in U.S. Pat. No. 7,803,173 and/or in U.S. Patent Appl. Publ. No. 2007/0135843, the disclosures of both of which are incorporated by reference in their entirety herewith.
• The flexible material forming the suture anchors90,100,200,90amay be also formed of suture tape or a combination of suture and tape, a stiff material, or combination of stiff and flexible materials, depending on the intended application.
• FIGS. 15-21 illustrate another exemplary embodiment of asoft anchor300 of the present invention.Anchor300 is a folding tube suture anchor which may be formed of textile or homogenous material (no sheath) and which does not have any “hard” surfaces. As shown inFIGS. 15 and 16, foldingtube suture anchor300 is formed of a tube (cylinder)310 provided with apertures/holes311 to allow aflexible strand320 to pass therethrough. When the tube is inserted into a bone tunnel/socket and when tension is applied, thetube310 folds and lodges into the bone tunnel/socket. The distance between two adjacent apertures/holes311 may be the same or different.
• FIGS. 17-21 illustrate subsequent steps of folding thetube anchor300 ofFIG. 15.
• FIG. 17: Inserter350 (pulling here just to be out of the way) and blue FiberWire® suture320 in loaded position using TigerWire® suture360 keep assembly tight and loaded, adjacent bone tunnel/socket30 inbone33.
• FIG. 18:Inserter350 “pushes” theassembly300 into the pilot hole (but only as deep as desired ending position).
• FIG. 19: The TigerWire® suture360 is removed and theanchor300 is ready to be deployed (inserter350 is still “pushing” the anchor into the pilot hole).
• FIG. 20: The blue FiberWire® suture320 is pulled (will slide just like a normal anchor) to create a “folding” effect (theinserter350 is still “pushing” theanchor300 into the pilot hole).
• FIG. 21: Once theanchor300 is folded, theinserter350 is removed as theanchor300 is fixed into place in bone tunnel/socket30.
• FIGS. 22-40 illustratesoft anchor implants400a,400b,400c(accordion anchors400a,400b,400c) for tissue repairs (for example, soft tissue repairs such as PASTA repairs (Partial Articular-Sided Tendon Avulsion repairs)) according to yet additional embodiments of the present invention. As detailed below, these soft anchor implants are smaller than the conventional bone anchors (which are relatively large) and are formed of a soft (suture-based) material (in contrast to the conventional anchors which are typically formed of hard materials such as PEEK, PLLA, bTCP, metal, PGA, biomaterials, etc.). Thesoft anchor implants400a,400b,400cdetailed below may be employed in percutaneous insertions by simple surgical techniques, with multiple additional indications, to provide biomechanically strong constructs.
• FIGS. 22-24 illustrate exemplarysoft anchor implants400a(implant A),400b(implant B),400c(implant C), respectively, of the present invention.Soft anchor400aofFIG. 22 is a suture tape/core suture construct.Soft anchor400bofFIG. 23 is a two anchor construct.Soft anchor400cofFIG. 24 is a loop anchor construct.
• FIG. 25 illustratessoft anchor implant400a(implant A) formed of a suture tape410 (for example, a FiberTape®) which has a length of flexible strand420 (for example, a suture core such as a #2 FiberWire® core) incorporated therein (i.e., extending within the body of the suture tape or on the outside of the suture tape). Asmall knot421 is tied at one end of the flexible strand420 (and of the end of the tape410) so that, when the suture core (FiberWire® core)420 is pulled at the other end, thesuture tape410 bunches up (folds up) similarly to the bellows of an accordion. The bunched-upsuture tape410 becomes thesoft anchor400aof the present invention.
• As detailed below,implants400band400care similar to theimplant400ain that they are also formed essentially of a suture tape (a FiberTape®)410 with a flexible strand (a FiberWire® core)420 incorporated through the suture tape (i.e., extending throughout the length of the suture tape and within the body of the suture tape, or secured on the outside of the suture tape).
• FIGS. 26(a)-(c) depict the formation ofsoft anchor implant400a(implant A). The implant is passed through an exemplary piece of cardboard. Thecore suture420 of the implant is then pulled so that theknot421 at the end of thetape410 helps thesuture tape410 bunch up down to the cardboard. The tape will completely bunch up underneath the cardboard.
• FIGS. 27-33(a) and (b) illustrate additional views of thesoft anchor implant400a(implant A) and methods of tissue fixation.
• FIG. 27:Soft anchor implant400a(implant A) consists essentially of a continuous piece (strand) of suture tape410 (FiberTape®410) with a length of approximately 5 cm, of which about 2 cm will be buried into bone on either side of the suture tape. About 1 cm of the suture tape (i.e., the remaining length located in between the 2 cm sides that are buried into bone) acts as a “bridge” over the tissue to be repaired (for example, a torn rotator cuff). The Fiberwire® core420 (preferably a #2 Fiberwire® suture) is pulled out the middle of thesuture tape410. Asmall knot421 is tied in the end of eachcore suture420.
• FIG. 28: Each tape end is loaded onto an inserter device450 (described in more details inFIGS. 40-42) and punched through the tissue (the rotator cuff) and into thebone33 to a depth of about 2 cm. Eachcore420 is then pulled causing thesuture tape410 to become “bunched up” inside the bone, thus securing theimplant400ainside the bone.
• FIG. 29: A marking pen may be employed to mark the 2 cm intermedullaryportions415 of thesuture tape410 of theimplant400a.
• FIG. 30: The implant punctures the tissue (exemplary cardboard) and the 2 cm intermedullaryportions415 of thesuture tape410 are inserted through the tissue (exemplary cardboard).
• FIG. 31: Pull on the core sutures420 to deploy theimplant400a.
• FIG. 32: The implant is seen from the top—the bridge ofsuture tape410 extends across the tissue (i.e., the rotator cuff or the exemplary cardboard).
• FIGS. 33(a) and (b): The core sutures420 are tied to one another to secure the bridge ofsuture tape410 on top of the tissue (i.e., on top of the rotator cuff or the exemplary cardboard). The anchors are deployed underneath the bridge and the tissue, and the bridge is seen on top of the tissue.
• FIGS. 34 and 35 illustrateimplant400aof the present invention employed in an exemplary tissue repair, i.e., a PASTA repair (Partial Articular-Sided Tendon Avulsion repair), which is typically considered to be a challenging trans-tendon rotator cuff repair that requires passing sutures through the rotator cuff and large implants of about 4.5 to about 5.5 mmFIG. 35 depicts a PASTA repair with twoanchors400aof the present invention, for large legions (only one anchor may be used for small lesions).
• FIG. 35 illustrates afirst anchor400ainserted percutaneously through the rotator cuff and down into the bone. Moving over into the subacromial (SA) space, asecond anchor400ais inserted into the bone by first penetrating the rotator cuff. The second anchor is secured into the bone by pulling on the core suture to deploy the anchor (i.e., to bunch up the suture tape within the tunnel/socket in the bone). The core sutures420 from the twoanchors400aare then tied together over the repair and on top of the cuff (to compress the PASTA lesion to the prepared bone bed).
• FIGS. 36-38 illustrateimplant400bof the present invention employed in another exemplary tissue repair according to the present invention.Implant400bconsists of two separate soft anchors (FiberTape® anchors). Each anchor consists essentially of a length of suture tape (a FiberTape®)410 of about 2 cm with a suture core (a #2 FiberWire® core)420 extending therethrough. When the anchor is deployed, the 2 cm FiberTape® will be buried into bone together with the knot421 (formed as inimplant400a). Thesuture core420 is used for the repair.
• FIGS. 37 and 38 illustrate both anchors ofimplant400bpierced through exemplary tissue (i.e., cardboard and clover leaf). By pulling on the core sutures420, each of the anchors is deployed into the bone. The core sutures420 are then tied together on top of the tissue, to secure the construct.
• FIG. 39 illustratesimplant400cwhich is a modified FiberTape® anchor that consists essentially of a length of suture tape (FiberTape®)410 of about 2 cm with a suture core420 (for example, #2 FiberWire® core420) extending therethrough and forming aloop422 within the body of the suture tape410 (or securely attached to the outside of the body of the suture tape).Implant400cis about similar toimplant400bbut differ in that thecore suture420 is looped into the FiberTape® anchor. Eachimplant400c(anchor400c) may be about 2 cm in length. When the #2 FiberWire® core suture is pulled, the FiberTape® anchor bunches up (i.e., deploys or accordionizes). Since no knot is present, the looped core suture can slide within theimplant400c. The core sutures420 are used for repair.
• The accordion anchors400a,400b,400cdetailed above have increased pull-out strength (dramatically stronger compared to the strength of current suture anchors known in the art), and offer the following advantages:
• No permanent solid anchor is present;
• If implant gets loose, there is no hard abrasive surface to do damage to the surrounding structures;
• No bone/anchor cyst reaction;
• Easy revision if necessary;
• Provides broad area of issue compression via the suture tape;
• Allows for scans/MRI—no scatter;
• Diminishes the permanent stress riser;
• Porous nature of thesoft anchors400a,400b,400callows for vigorous bone ingrowth into the FiberTape® anchor pores—the FiberTape® may be coated with collagen and/or other tissue growth-promoting compositions and materials such as hyaluronic acid, for example; and
• Bone marrow contents can easily seep up through the soft anchor into the repair site thus enhancing healing.
• FIGS. 40-42 (a) and (b) illustrate details of anexemplary insertion device450 which may be used to secure soft suture implants (such as, for example, thesoft suture implants90,100,200,90a,400a,400b,400cof the present invention). Theinsertion device450 may be provided preloaded with an accordion anchor (such asanchor400a, for example) or with multiple accordion anchors. Theinsertion device450 may have the configuration of a sharp spear with a sharp tip that creates the bone tunnel/socket for anchor insertion. Theinsertion device450 may have the shape of a small needle (for example, an 18 gauge needle, or about 1.6 mm) provided with agroove456 at the neck where theanchor knot421 fits. In an exemplary embodiment, and as shown inFIG. 40, the anchor wraps circumferentially around the shaft of theinserter450.
• As shown inFIG. 40, spikes466 on the inserter may point down (i.e., in a direction from top to bottom relative to a longitudinal axis of the device) to push the FiberTape® into bone (but without catching and pulling the FiberTape® out when the inserter is removed).Core suture knot421 rests (fits into) thegroove456 in the inserter. Thesharp spear tip460 creates the bone tunnel for anchor insertion. The inserter may be provided with at least one markingline480 to indicate how far to insert the FiberTape®. Red markings on the FiberTape® may be used to ensure that an appropriate length of the FiberTape® has been inserted.
• FIGS. 41 and 42 illustrate theinsertion device450 without a preloaded anchor and showing the plurality of downward projectingspikes466 provided on the inserter body, to allow griping of the suture tape (FiberTape®) of the soft implant during insertion. As theinserter450 is pulled out, thespikes466 “let go” of thesoft anchor400a. Preferably, thespikes466 are very shallow to avoid creating undo friction during anchor insertion. The design of the spikes mimics how a rasp creates friction in one direction with minimal friction in the opposite direction.
• FIGS. 42(a) and (b) illustrate how each anchor could be loaded on a separate insertion spear to obtain anchor/insertion device assembly500. If multiple insertion devices/spears450 are used, thespears450 could be loaded into a gun-type device such as, for example, the Arthrex “Meniscal Cinch” device. For example,FIGS. 43 and 44 illustrate aspear451 from a meniscal cinch assembly that pushes implant B (anchor400b) into the bone.
• The accordion anchors400a,400b,400cdetailed above may be also employed with a self cinching suture mechanism that could be incorporated into the implant/anchor. Once the anchor is deployed, the surgeon would simply pull on the self-cinching suture strands to firmly secure the device and compress the tissue (for example, the rotator cuff). The accordion anchors400a,400b,400ccould be utilized for multiple additional indications such as, for example, AC joint reconstruction (as shown inFIG. 45, wherein the #2 FiberWire® core sutures are passed through the coracoid and clavicle and then tied over a button having a dog-bone configuration), syndesmosis reconstruction, quad/patellar tendon rupture repair, hallux-valgus repair, and any other tendon repair to bone.
• As shown inFIG. 45, theaccordion anchor400a(the FiberTape® anchor) is employed in an exemplary AC joint reconstruction method with a fixation device503 (button503) having a specific “dog-bone-shape” configuration, as detailed and described in U.S. Patent Application Publication No. 2012/0150203, the disclosure of which is incorporated by reference in its entirety herewith. The #2 FiberWire® core sutures420 are passed throughtunnels515,525 in the coracoid511 and clavicle522 (for example, small 2 mm tunnels), and then tied over the dog-bone button503, to accordionize the tape and form the accordion anchor at the base of the coracoid.
• The accordion anchors400a,400b,400cdetailed above may be also employed in conjunction with additional various knotted and/or knotless fixation devices (or combination of such knotted and knotless fixation devices), such as PushLock® anchors and/or SwiveLock® anchors to secure, for example, a medial row on rotator cuff repairs.
• While the present invention is described herein with reference to illustrative embodiments for particular applications, it should be understood that the invention is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, embodiments and substitution of equivalents all fall within the scope of the invention. Accordingly, the invention is to be limited not by the specific disclosure herein, but only by the appended claims.

Claims (18)

What is claimed is:

1. A self-punching soft, suture based anchor assembly, comprising:

an insertion device for forming a hole in bone; and

a soft suture anchor mounted on the insertion device, the soft suture anchor being formed entirely of a flexible material.

2. The self-punching soft, suture based anchor assembly ofclaim 1, wherein the flexible material is suture.

3. The self-punching soft, suture based anchor assembly ofclaim 2, wherein the suture is a high-strength suture.

4. The self-punching soft, suture based anchor assembly ofclaim 1, wherein the insertion device comprises a shaft in the form of a spear with a sharp tip at a distal end of the shaft for forming the hole in bone.

5. The self-punching soft, suture based anchor assembly ofclaim 4, wherein the soft suture anchor is wrapped around the shaft.

6. The self-punching soft, suture based anchor assembly ofclaim 4, wherein the soft suture anchor fits into a groove on the shaft of the insertion device.

7. The self-punching soft, suture based anchor assembly ofclaim 4, wherein the shaft of the insertion device comprises a plurality of spikes to grip the soft suture anchor.

8. The self-punching soft, suture based anchor assembly ofclaim 1, mounted on a gun-type device.

9. A method of inserting a soft suture anchor into bone without preforming a hole in the bone using a self-punching soft, suture based anchor assembly comprising an insertion device and a soft suture anchor mounted on the insertion device, the method comprising the steps of:

a. forming a hole in the bone by advancing the insertion device with the soft suture anchor mounted thereon into the bone, the insertion device comprising a shaft in the form of a spear with a sharp tip at the distal end of the shaft for forming the hole in bone; and

b. withdrawing the insertion device from the hole in the bone, leaving the soft suture anchor in the hole.

10. The method ofclaim 9, wherein the soft suture anchor is released from the shaft of the insertion device as the insertion device is withdrawn from the hole in bone.

11. The method ofclaim 9, wherein the soft suture anchor is formed of a flexible material.

12. The method ofclaim 11, wherein the flexible material comprises suture.

13. The method ofclaim 12, wherein the suture is a high-strength suture.

14. The method ofclaim 9, comprising an initial step of mounting at least one said self-punching soft, suture based anchor assembly on a gun-type device, and using the gun-type device to insert the soft anchor into the hole in bone without preforming the hole.

15. A soft, suture based anchor assembly, comprising:

an insertion device for a soft, suture based anchor, the insertion device comprising an elongated member configured for insertion in a hole in bone; and

a soft suture anchor mounted on the insertion device, the soft suture anchor being formed entirely of a flexible material.

16. The soft, suture based anchor assembly ofclaim 15, wherein the flexible material is suture.

17. The soft, suture based anchor assembly ofclaim 16, wherein the suture is a high-strength suture.

18. The soft, suture based anchor assembly ofclaim 1, wherein the insertion device comprises a shaft with a forked tip at a distal end of the shaft for receiving and engaging the soft, suture based anchor.

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