Continuous loop suture assembly and related surgical techniques

Abstract

The repair suture consists of strands of suture material formed into continuous loops. One end of the loop may be thicker than the other. The repair suture can be part of a suture assembly that includes the repair suture, a connecting suture having a looped end and a straight end, and a suture anchor. The suture anchor may have a suture bridge that divides the cross-sectional area inside the anchor into two unequal sections. The suture assembly can be used to create a tag form for repairing tissue or attaching tissue to bone. In a two-row method where the inner row is compressed, the loose suture ends from the inner row are inserted into an outer row anchor having a proximal anchor body, a distal tip, and an internal locking element for locking the distal tip to the proximal anchor body.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Patent Application Publication No. 17 / 736,006, filed on May 3, 2022, the entire content of which is incorporated herein by reference.

[0002] Background of the Invention 1. Field of the Invention The present disclosure generally relates to soft tissue repair surgery, and more particularly to suture and anchor systems for attaching soft tissue to bone.

Background Art

[0003] 2. Background Art Soft tissues such as ligaments and tendons can sometimes detach from their associated bone as a result of repeated stress, acute trauma, or degeneration due to aging. Partial detachment can often be managed by a combination of multiple treatments including physical therapy, rest, acetaminophen, anti - inflammatory drugs, and steroids. However, complete detachment usually requires surgery.

[0004] One common soft tissue - to - bone reattachment procedure is rotator cuff repair, which involves reattaching the rotator cuff tendon to the humeral head. Rotator cuff repair can be open, arthroscopic, or mini - open, and can be performed using knotted or knotless techniques. A typical knotted repair technique involves incorporating a suture strand with two free ends into a suture anchor, implanting the suture anchor into the bone under the torn rotator cuff tendon, passing the two free ends of the suture through the tendon from bottom to top, and then using the free ends to create a knot to fix the tendon to the bone. In knotless repair techniques, the two free ends of the suture are passed through the distal end of a second suture anchor instead of being tied, and this is then implanted into the bone, capturing the suture ends in an interference fit between the anchor and the bone.

[0005] Many surgeons prefer knotless repair techniques because they require less technical expertise and take less time than knotted repair techniques. Additionally, knots can be large and can cause impingement of the tendon on the bone. However, knotless techniques can be problematic because they also allow for relative movement between the tendon and the suture. Further, slippage of the suture can occur if the interference fit between the knotless suture anchor and the surrounding bone is not tight enough, as is often the case with patients whose bone density has decreased due to aging or disease. Another problem with both knotted and knotless repair techniques is anchor pullout, which can occur as a result of trauma or decreased bone density. Yet another problem is the formation of unwanted tissue strands or folds known as "suture end skin deformity" lesions between sutures or knots, which can lead to impingement and degrade the quality of the repair. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEMS

[0006] These and other problems are addressed by the present disclosure as summarized below.

[0007] SUMMARY OF THE INVENTION In one aspect of the present disclosure, a repair suture includes a strand of suture material formed in a continuous loop. In one example, the strand is a thin filament. In another example, the strand is a tape. In yet another example, the strand has a variable diameter.

[0008] The loop includes a first end, a second end, and two sides extending between the first end and the second end. In an example using a variable diameter strand, the thinnest portion of the strand is at the first end of the loop and the thickest portion of the strand is at the second end of the loop.

[0009] The method of repairing tissue according to the present disclosure includes: 1) folding a suture loop into a U-shape having a loop at a first end, a loop at a second end, and a central loop; 2) passing the loop at the first end through the tissue at a first location and passing the loop at the second end through the tissue at a second location; 3) forming a load-bearing form with the loops at the two ends; and 4) fixing the load-bearing form to the tissue with an auxiliary locking mechanism. Examples of auxiliary locking mechanisms that can be used include knots, interference fits between a part of the suture loop and an internal bridge in a rigid suture anchor, pressure exerted by the contact surface of a soft suture anchor against surrounding bone, or internal locking in an outer anchor.

[0010] In one example of the method, the load-bearing form is formed by passing the loop at the first end through the loop at the second end.

[0011] In an alternative example of the method, the load-bearing form is formed by cutting the loop at the first end to form separate limbs, and then extending one of the limbs through the loop at the second end. A locking knot is formed by tying the two limbs together.

[0012] In one aspect of the method, the loop includes a first end, a second end, and two sides extending between the first end and the second end, and the strand has a thickness that increases from a minimum thickness at the first end to a maximum thickness at the second end. When the loop is folded, the thickest part of the strand located at the loop of the second end provides interference locking with the internal anchor bridge when being load-bearing.

[0013] In one example, the suture loop is positioned within a suture anchor having a proximal end, a distal end, and a suture engagement feature disposed at the distal end. The central loop of the suture loop extends around the suture engagement feature, and the loops at the first end and the second end extend proximally through the proximal end of the suture anchor.

[0014] In another example, the suture loop extends through an all-suture anchor configured to expand radially outward and exert a contact force against surrounding bone when deployed.

[0015] In another aspect of the present disclosure, the suture assembly includes an inner anchor, a repair suture, and a connecting suture. The inner anchor has a first side, a second side, and a proximal end. The repair suture is formed as a continuous loop and folded back to form a loop at a first end, a loop at a second end, and a central loop, and is positioned within the inner anchor such that the loop at the first end extends from the proximal end of the inner anchor on its first side, and the loop at the second end extends from the proximal end of the inner anchor on its second side. The connecting suture has a looped end joined to a straight end by an intermediate portion and is folded back within the inner anchor such that the straight end extends from the proximal end of the inner anchor on its first side, and the looped end extends from the proximal end of the inner anchor on its second side.

[0016] In an example of the suture assembly, the loop is formed from a strand of suture material and includes a first end, a second end, and two sides extending between the first end and the second end. The strand has a thickness that increases from a minimum thickness at the first end along each side to a maximum thickness at the second end.

[0017] In one aspect of the present disclosure, the suture anchor has an open proximal end that communicates with an internal cannula. The suture engagement feature extends across the internal cannula and divides the cross-sectional area of the internal cannula into two sections, where the cross-sectional area of one section is equal to about 60% of the total cross-sectional area of the internal cannula at that location, and the cross-sectional area of the other section is equal to about 40% of the total cross-sectional area of the internal cannula at that location.

[0018] The two-row method of attaching tissue to bone according to the present disclosure involves implanting two suture assemblies, such as those described above, at two inner locations on the bone under the detached tissue, and creating a tag form using the loops of the ends of the repair sutures within the two suture assemblies before fixing the tissue to the bone at the two inner locations. The loop at one end of each tag form forms the base of the tag, and the loop at the other end is cut to divide it into two limb portions. The straight end of the connecting suture of the second suture assembly is inserted into the loop of the connecting suture of the first suture assembly, and the straight end of the first suture assembly is pulled to draw the connecting suture assembly into the tissue at the first location, creating an inner bar that connects the two tag forms. One of the limb portions cut from each tag form and the straight end of the connecting suture of the first suture assembly are inserted into a first outer anchor, which is then implanted in the bone at the first outer location, capturing the suture in an interference fit between the outer anchor and the bone. The other cut limb portion from each tag form and the looped end of the connecting suture are inserted into a second outer anchor, which is then implanted in the bone at the second outer location.

[0019] In one aspect of the two-row method, each repair suture is formed from a strand of suture material and includes a first end, a second end, and two sides extending between the first end and the second end. The strand has a thickness that increases from a minimum thickness at the first end to a maximum thickness at the second end. The maximum thickness of the strand is preferably located at the loop of the second end, and the second suture assembly is preferably positioned such that the straight end of the connecting suture of the second suture assembly faces the looped end of the connecting suture of the first suture assembly.

[0020] In another aspect of the two-column method, the first outer anchor includes a proximal anchor body, a distal tip, and an internal locking element configured to lock the distal tip to the proximal anchor body when the outer anchor is implanted into bone. The distal tip has a retention feature configured to receive the free end of the repair suture from the inner column and a suture engagement feature configured to engage a pair of support sutures. The distal tip may also include a pointed distal end configured to facilitate insertion into bone and a pair of spikes extending proximally and radially outwardly from the pointed distal end.

[0021] In one example of the method, the internal locking element of the first outer anchor may include mating threads formed on a distal portion of the internal cannula of the proximal anchor body and a proximal portion of the distal tip.

[0022] In another aspect of the present disclosure, the outer suture anchor includes a proximal anchor body having an open proximal body, a distal tip including an eyelet configured to receive an end of a repair suture, and an internal locking element configured to lock the distal tip to the proximal anchor body when the outer anchor is implanted into bone. At least one support suture extends proximally from a suture engagement feature at the distal tip and continues outwardly through the open proximal end of the anchor body.

[0023] In one example, the internal locking element of the outer suture anchor includes mating threads formed on a distal portion of the internal cannula of the proximal anchor body and a proximal portion of the distal tip.

[0024] In another example, the suture engagement feature includes an apertured tab extending proximally from a proximal end of the distal tip, and the support suture extends through the apertured tab.

[0025] In one example, the support suture includes a looped end, a straight end, and an intermediate portion, and is folded such that the intermediate portion extends through the apertured tab and the looped end and the straight end extend proximally through the open proximal end of the proximal anchor body. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Brief Description of the Drawings

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Figure 11A

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DETAILED DESCRIPTION OF THE INVENTION

[0027] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT If necessary, detailed embodiments of the present invention are disclosed herein. However, it should be understood that the disclosed embodiments are merely exemplary of the invention, which may be provided in various alternative forms. The drawings are not necessarily to scale, and some features may be exaggerated or minimized to show details of particular components. Therefore, the specific structures and functional details disclosed herein are not limiting, but are to be construed as representative bases for teaching those skilled in the art how to use the invention in various ways.

[0028] Figures 1-3 show three examples of continuous loop sutures according to the present invention. Figure 1 shows a thin strand of suture wire 10 formed in a continuous loop 12 having a first end 14, a second end 16, and two sides 18, 20. The suture wire can be formed of any natural or synthetic suture material, such as silk, nylon, polyester, ultra-high molecular weight polyethylene (UHMWPE) or poly(ethylene terephthalate), or combinations thereof, and can be monofilament or multifilament, absorbent or non-absorbent, coated or uncoated, braided or unbraided, depending on the application and the preference of the surgeon. In rotator cuff repair, a #2 UHMWPE suture is recommended.

[0029] Figure 2 shows a strand of suture tape 110 formed in a continuous loop 112 having a first end 114, a second end 116, and two sides 118, 120. The suture tape 110 can be made of the same material as the suture wire 10, but is flat braided and can have a thickness of about 0.9 to about 2.0 mm.

[0030] Figure 3 shows a continuous suture loop 212 having a first end 214, a second end 216, and two sides 218, 220. The loop can be made of any of the suture materials listed above, and the thickness increases from a minimum at the first end 214 to a maximum at the second end 216 along both sides 218, 220. A laser marking 222 or other indicia can be provided at the second end 216 to facilitate the surgeon quickly finding the thickest part of the suture loop. In one example, the thin end 214 of the loop can have the thickness of a #2 suture, and the thick end 216 can have the thickness of a suture tape up to, for example, 1.5 - 2 mm.

[0031] Figure 4A is a schematic view showing a suture assembly 30 including a single suture loop 12 and a suture anchor 32. The suture anchor 32, which can be made of any conventional suture anchor material, such as titanium, poly-L-lactic acid (PLLA), or polyetheretherketone (PEEK), includes an anchor body 34 having an internal cannula 36, an open proximal end 38, a distal end 40, and a suture engagement feature 42 disposed near the distal end 40. The suture loop 12, which can be formed of a suture wire as in FIG. 1, a suture tape as in FIG. 2, or a variable-width strand as in FIG. 3, is folded to form a first end loop 44, a second end loop 46, and a central loop 48, and is positioned within the internal cannula 36 of the anchor 32 such that each of the end loops 44, 46 extends proximally through the open proximal end 38 of the anchor and the central loop 48 extends around the suture engagement feature 42 (which may also be referred to as a suture bridge). At some point, some surgical techniques may require cutting one or both of the end loops 44, 46 in order to separate the loop into separate strands, as briefly described below.

[0032] Figure 10b shows an alternative suture assembly 430 that includes a soft all-suture anchor 432 instead of the rigid anchor 32 of Figure 4A. A suture loop 412, which may have the same structure as loop 12 of Figure 1, loop 112 of Figure 2, or loop 212 of Figure 3, is woven or otherwise embedded in a woven, collapsible tube or sleeve 434 similar to the sleeves found in Bio-met Juggerknotless® and other commercially available all-suture knotless suture anchors. The sleeve 434, which may be made of the same material as and integrated with the suture loop 412, is bent into a U-shape having a first side 433, a second side 435, and two proximal openings 437, 439. The suture loop 412 is folded back to form a first end loop 444 and a second end loop 446, is embedded in the sleeve 434, and the first end loop 444 extends proximally through the first proximal opening 437 in the first side 433 and the second end loop 446 extends proximally through the second proximal opening 439 in the second side 435. When the all-suture anchor 432 is inserted into a pre-drilled hole in bone and the end loops 444, 446 are pulled, the sleeve 434 collapses longitudinally and expands radially, exerting a contact force on the walls of the pre-drilled hole. An advantage of the all-suture anchor 432 as shown in Figure 4B is that it requires a smaller hole diameter than is required for the conventional rigid anchor 32 of Figure 4A.

[0033] Figures 5A - D illustrate knotless fixation techniques that can be performed using the suture assembly 30 of Figure 4A. First, the suture anchor 32 is implanted into a bone 50, such as the humerus, and the underlying tissue 52, such as the rotator cuff tendon, and the end loops 44, 46 are passed upward through the tendon 52 as shown in Figure 5A. Next, the loop 44 at the first end of the suture loop 12 is passed through the loop 46 at the second end to create a tag form as shown in Figure 5B. The loop 44 at the first end is pulled upward until the loop 46 at the second end lies flat against the tendon 52, pressing the tendon against the bone 50 as shown in Figure 5C. The surgeon can optionally cut the loop 44 at the first end and separate it into two separate limbs 54, 56. Thereafter, the two limbs 54, 56, whether separated or not, are inserted into the distal end of a second suture anchor 60, and then the suture anchor is implanted into the bone 50 as shown in Figure 5D. This captures the limbs 54, 56 in an interference fit between the anchor 60 and the bone 50, securely holding the tendon 52 in place against the bone 50.

[0034] In an alternative technique, as shown in Figure 6A, after the loops 44, 46 at the two ends are inserted at two locations in the tendon 52, the surgeon cuts the loop 44 at the first end and separates it into two separate limbs 43, 45, and inserts one of the limbs 45 into the loop 46 at the second end as shown in Figure 6B. The limbs 43, 45 are pulled until the loop 46 at the second end lies flat against the tendon 52, pressing the tendon against the bone 50. Finally, as shown in Figure 6C, the limbs 43, 45 are tied, using a single knot or the like, to form a knot 58. At this point, the limbs 43, 45 can either be cut off or, if additional security is desired, inserted into a knotless anchor as shown in Figure 5D.

[0035] The techniques shown in FIGS. 5A - D and FIGS. 6A - C can be performed using any of the suture loops shown in FIGS. 1 - 3. When the variable - width loop 212 of FIG. 3 is used, since it causes a greater interference with the anchor, the loop 44 at the first end should include the thin end 214 of the loop 212, and the loop 46 at the second end should include the thick end 216 of the loop 212. Thus, the thick end 216 forms a strong and reliable base for the load - bearing, and the thin end 214 has the simple operability desired for tying the thread.

[0036] Furthermore, the suture assembly 430 of FIG. 4B can serve as an alternative to the suture assembly of FIG. 4A in the techniques of FIGS. 5A - D and 6A - C. The use of all suture anchors 432 can eliminate the need for steps 5D and 6C in these techniques, since the contact force exerted by the collapsed sleeve on the hole wall provides the same auxiliary locking function as the interference fit between the second suture anchor 60 and the bone 50 in FIG. 5D or the knot in FIG. 6C.

[0037] The techniques shown in FIGS. 5A - D and FIGS. 6A - C can also be combined with other known techniques to provide a wide range of options for the surgeon. For example, multiple sutures can be incorporated into the suture anchor to create a load - bearing form at multiple attachment points between the bone and the tendon, and multiple anchors can be used to create a double - row suture bridge.

[0038] In some examples, the second anchor 60 of FIG. 5D can be any type of commercially available knotless suture anchor, such as the HEALIX ADVANCE™ knotless anchor by Depuy Synthes or the PushLock™ and SwiveLock™ anchors by Arthrex. However, the fixation technique described above in relation to FIG. 5D holds the tendon more securely in place than the conventional knotless techniques commonly used with these anchors, since the load - bearing form formed at the intersection of the limb portions 54, 56 of the loop 46 at the second end and the loop 44 at the first end functions as a stop to prevent the tendon 46 from slipping relative to the suture. The knot 58 as shown in FIG. 6C further enhances the safety.

[0039] FIG. 7 shows an example of a suture anchor 32 including an anchor body 34, an internal insertion tube portion 36, an open proximal end portion 38, and a blunt distal end portion 40. The anchor body 34 is a double-thread, with the proximal portion 62 having a relatively small pitch and a small thread diameter to core diameter ratio to engage well within cortical bone, and the distal portion 64 having a large pitch and a large thread diameter to core diameter ratio to engage well within cancellous bone. A single hole 66 in the anchor body 34 allows bone marrow and associated stem cells to access the tendon or other soft tissue being repaired, promoting better healing. A suture bridge 42 extends across the internal insertion tube portion and divides the cross-sectional area of the internal insertion tube portion into two equal-sized sections 36A, 36B as shown in FIG. 8A.

[0040] In an alternative example, as shown in FIG. 8B, the suture bridge 142 can be located off-center and divides the internal insertion tube portion into a larger portion 136A and a smaller portion 136B. The cross-sectional area of the smaller portion 136B can be, for example, about 40% of the cross-sectional area of the entire internal insertion tube portion, and the cross-sectional area of the larger portion 136A can be about 60% of the cross-sectional area of the entire internal insertion tube portion. This off-center position of the suture bridge can reduce suture slippage because the narrow space of the smaller portion can increase the frictional force between the suture bridge 142, the suture, and the inner wall 168 of the anchor body 134. A particularly strong interference fit is achieved when the wide end portion of the variable-width loop suture of FIG. 3 is present in the smaller portion 136B of the internal insertion tube portion of the suture anchor.

[0041] In another example shown in FIG. 9, the suture anchor 232 includes a double-thread anchor body 234 having an internal insertion tube portion 236 and an open proximal end 238, similar to the suture anchor 32 in FIG. 7, but with a tapered distal tip 240 and three holes 266A, B, C. The tapered tip 240 facilitates penetration into the bone, and the additional holes 266A, B, C allow more bone marrow and stem cells to access the tendon, promoting better healing. The suture anchor 232 also includes an internal suture bridge, which can be either centered as in the example of FIG. 8A or offset to one side as in the example of FIG. 8B.

[0042] FIG. 10A shows an example of a suture assembly 230 including the suture anchor 232 of FIG. 9, the variable-width suture loop 212 of FIG. 3, and a connecting suture 270 including a looped end 272 and a straight end 274. The suture loop 212 is folded to form a first-end loop 244, a second-end loop 246, and a central loop 248, and is positioned within the internal insertion tube portion 236 of the anchor 232 such that each of the end loops 244, 246 extends proximally through the open proximal end 238 of the anchor, and the central loop 248 extends around the suture bridge 242. The connecting suture 270 is also folded and positioned within the internal insertion tube portion such that its looped end 272 extends proximally through the open proximal end of the anchor 232 on the same side as the narrow second-end loop 246 of the suture loop 212 and the anchor bridge 242, and its straight end 274 extends proximally through the open proximal end of the anchor 232 on the same side as the wide first-end loop 244 of the suture loop 212 and the anchor bridge 242.

[0043] In other examples of the suture assembly, the variable-width suture loop 212 can be replaced with either the narrow suture loop 12 of FIG. 1 or the suture tape loop 112 of FIG. 2. Further, the connecting suture 270 can be replaced with any of the suture loops 12, 112, or 212.

[0044] FIG. 10B shows the full suture version of the suture assembly 530, and the variable-width suture loop 512 and the connecting suture 570 are embedded in a collapsible tube or sleeve 534 similar to the sleeve illustrated and described in connection with FIG. 4B. The loop 544 at the first end of the suture loop 512 extends proximally through the first opening 537 in the first side 533 of the sleeve 534, and the loop 546 at the second end of the suture loop 512 extends proximally through the second opening 539 in the second side 535 of the sleeve 534. The straight end 574 of the connecting suture 570 extends through the first opening 537 together with the loop 5442 at the first end of the suture loop 512, and the loop-shaped end 57 of the connecting suture 270 extends through the second opening 539 together with the loop 546 at the second end of the suture loop 512.

[0045] Figures 11A - E illustrate a two - row suture technique using two suture assemblies 230A, B. First, as shown in Figure 11A, the anchor 232A of the first suture assembly 230A is implanted in the bone 50, such as the upper arm, at a first location L1, and the anchor 232B of the second suture assembly 230B is implanted in the bone 50 at a second location L2 that defines the inner row together with the first location L1. Since the second suture assembly 230B is implanted in the same orientation as the first suture assembly 230, the straight end 274B of the connecting suture 270B of the second suture assembly 230B faces the looped end 272A of the connecting suture 270A of the first suture assembly 230A. The loop 244A of the first thick end of the suture loop 212A of the first suture assembly 230A and the straight end 274A of the connecting suture 270A of the first suture assembly 230 pass above a first location M1 of the tissue 52, such as the rotator cuff tendon, on the bone 50. The loop 246A of the second thin end of the suture loop 212A of the first suture assembly 230A and the looped end 272A of the connecting suture 270A of the first suture assembly 230 pass above a second location M2 in the tissue 52. The loop 244B of the first thick end of the suture loop 212B of the second suture assembly 230B and the straight end 274B of the connecting suture 270B of the second suture assembly 230B pass above a third location M3 in the tissue 52. The loop 244B of the second thin end of the suture loop 212B of the second suture assembly 230B and the looped end 272B of the connecting suture 270B of the second suture assembly 230B pass above a fourth location M4 in the tissue 52.

[0046] Next, as shown in Figure 11B, the loop 246A of the second end of the suture loop 212A of the first suture assembly 230A is pulled through the loop 244A of the first end of the suture loop 212A of the first suture assembly 230A to form a first packet configuration 280A, and the loop 246B of the second end of the suture loop 212B of the second suture assembly 230B is pulled through the loop 244B of the first end of the suture loop 212B of the second suture assembly 230B to form a second packet configuration 280B.

[0047] The loops 246A, B of the second end are pulled as shown in FIG. 11C until the loops 244A, B of the first end lie flat against the tissue 52. Thereafter, the straight end 274B of the connecting suture of the second suture assembly 230B is inserted into the looped end 272A of the connecting suture of the first suture assembly 230A, the straight end 274A of the connecting suture of the first suture assembly 230 is pulled upward, and the straight end 274B of the connecting suture of the second suture assembly 230B is pulled downward through the tendon 52 to create an inner bar 282 that joins the two tags 280A, 280B as shown in FIG. 8D. Thereafter, the apexes of each of the second suture loops 246A, B are cut, and the second suture loop 246A of the first suture assembly 230A is divided into two free limbs 284A, 286A, and the second suture loop 246B of the second suture assembly 230B is divided into two free limbs 284B, 286B.

[0048] In the final step shown in FIG. 11E, the straight end 274A of the connecting suture 270A of the first suture assembly, one free limb 284A of the suture loop of the first suture assembly, and one free limb 284B of the suture loop of the second suture assembly are inserted into or through the distal end of the first outer anchor 300A, which is then implanted at the first outer location L3 in the bone 50, holding the ends 274A, 284A, and 284B in an interference fit between the outer surface of the anchor 300A and the bone 50. The looped end 272B of the second suture assembly, the remaining free limb 286A of the suture loop of the second suture assembly, and the remaining free limb 286B of the suture loop of the first suture assembly are inserted into or through the distal end of the second outer anchor 300B, which is then implanted at the second outer location L4 in the bone 50, holding the ends 272B, 286A, and 286B in an interference fit between the outer surface of the anchor 300B and the bone 50.

[0049] The variable-width suture loops 212A, B used in the methods of FIGS. 11A-E can be replaced by wire suture loops of the type shown in FIG. 1 or suture tape loops shown in FIG. 2. Alternatively, the methods of FIGS. 11A-E can be performed using the full suture anchor assembly 530 of FIG. 10B instead of the rigid suture anchor assembly 230 of FIG. 10A.

[0050] FIGS. 12-16 show an outer anchor 300 that can be used in the methods of FIGS. 5A-D and FIGS. 6A-C and the methods of FIGS. 11A-E. The outer anchor 300 includes a proximal anchor body 302 and a distal tip 304. The proximal anchor body 302 includes an internal insertion tube portion 306 and is adapted to slide along a tubular cylinder driver 308 having a closed proximal end 310 and an open distal end 312. The distal portion 313 of the internal insertion tube portion 306 is female threaded. The proximal portion of the internal insertion tube portion 306 is hexagonal and receives the distal portion of a ball-end hex driver 314.

[0051] The distal tip 304 includes a pointed distal end 316 to facilitate insertion into bone and a pair of proximal spikes 318A, B that extend proximally radially outward from the pointed distal end 316 to reduce the likelihood of anchor pullout. The proximally extending neck portion 320 is positioned radially inward of the spikes 318A, B. The distal portion 322 of the neck portion 320 is threaded, and the thin proximal portion 324 extends into the open distal end 312 of the cylinder driver 308. An eyelet 326 provided in the threaded distal portion 322 of the neck portion 320 receives the free ends of the repair sutures 328, 330 from the inner row. An apertured tab 332 is provided at the proximal end of the neck portion 324 to receive the first and second support sutures 334A, B, and these support sutures extend through the concentric interiors of the anchor body 302, the cylinder driver 308, and the hex driver 314. For purposes of illustration, the support sutures 334A, B are shown in FIG. 14 as extending freely from the proximal end of the cylinder driver shaft 308, but in actuality, as shown in FIG. 12, they are tied above the ball-shaped proximal end 336 of the ball-end hex driver 314 and hold the distal tip 304 in place until implantation is complete.

[0052] After the repair sutures 328, 330 are inserted through the eyelet 326 into the distal tip 304, the surgeon taps or strikes lightly the closed proximal end 310 of the cylinder driver 308 to penetrate the pointed distal end 316 of the distal tip into the bone. When the distal threads of the proximal anchor body 302 engage the bone 50, as shown in FIG. 15, the surgeon rotates the hex driver 314 to screw the proximal anchor body 302 deeper into the bone.

[0053] By continuously rotating the hexagonal driver, the female threaded distal portion 313 of the inner cannula 306 of the proximal anchor body 302 is caused to reach and engage with the male threaded proximal portion 322 of the distal tip 304, locking the proximal anchor body 302 and the distal tip 304 together. At this point, the ends of the support sutures 328, 330 are released, and both the ball-end hexagonal driver and the cylinder driver are withdrawn from the anchor 300, as shown in FIG. 16. Here, the repair sutures 328, 330 are trapped between the bone 50 and the anchor 300 and between the distal end 338 of the proximal anchor body 302 and the distal end 340 of the eyelet 326 at the distal tip 304. The support sutures 34A, B can be used, if desired, after the outer anchor 300 is placed, to increase the strength of the repair and prevent or reduce suture-end skin deformity lesions that can interfere with healing and cause stabilization.

[0054] Embodiments of the invention have been shown and described, but these embodiments are not intended to show and describe all possible forms of the invention. Rather, the terms used herein are terms of explanation, not limitation, and it should be understood that various modifications can be made without departing from the spirit and scope of the invention.

Claims

1. A strand of suture material formed in a continuous loop, said loop including a first end, a second end, and two sides extending between said first end and said second end, said strand having a thickness that increases from a minimum thickness at said first end to a maximum thickness at said second end. A repair suture comprising.

2. A method of repairing tissue, comprising: Obtaining a suture loop including a continuous curve of suture material having no free ends; Folding said suture loop into a U-shape having a loop at a first end, a loop at a second end, and a loop at the center; Passing said loop at the first end through the tissue at a first location; Passing said second loop through the tissue at a second location; Forming a packet configuration by passing said loop at the first end through said loop at the second end; Securing said packet configuration to the tissue with an auxiliary locking mechanism. A method comprising.

3. Said suture loop is positioned within a suture anchor including: A proximal end; A distal end; A suture engagement feature; Said central loop of said suture loop extends around said suture engagement feature, and said first loop and said second loop extend proximally through said proximal end of said suture anchor. Said auxiliary locking mechanism includes an interference fit between said suture loop and said suture engagement feature. The method according to claim 2.

4. Said suture loop is formed from a strand of suture material and includes a first end, a second end, and two sides extending between said first end and said second end. Said strand has a thickness that varies from a minimum thickness at said first end to a maximum thickness at said second end, and Said auxiliary locking mechanism includes an interference fit between said suture engagement feature and said maximum thickness of said suture loop. The method according to claim 3.

5. Said suture loop extends through a full suture anchor configured to expand radially outwardly and exert a contact force against surrounding bone upon deployment, and Said contact force of said suture anchor against said bone functions as said auxiliary locking mechanism. The method according to claim 2.

6. Securing said packet configuration to the tissue with an auxiliary locking mechanism comprises: Inserting a portion of said loop at the first end of said suture loop into the distal tip of an outer row anchor having an internal locking element; Implanting said outer anchor into bone. ​ The method according to claim 2, comprising a suture loop fixed by the interference between the internal locking element in the outer anchor and the bone and the outer anchor.

7. The outer anchor comprises a distal tip, a proximal anchor body mounted to move longitudinally toward the distal tip and, the internal locking element includes cooperating elements that engage with each other at the distal tip and the proximal anchor body to form a secure connection, the method according to claim 6.

8. The cooperating elements include mating threads coupled to a distal portion of the proximal anchor body and a proximal portion of the distal tip, the method according to claim 7.

9. An inner anchor having a first side, a second side and a proximal end, a repair suture formed as a continuous loop, folded back to form a loop at a first end, a loop at a second end and a central loop, and positioned within the inner anchor, whereby the loop at the first end extends from the proximal end of the inner anchor on its first side, and the loop at the second end extends from the proximal end of the inner anchor on its second side, the repair suture, a connecting suture having a looped end joined to a straight end by an intermediate portion, folded back and positioned within the inner anchor, whereby the straight end extends from the proximal end of the inner anchor on its first side, and the looped end extends from the proximal end of the inner anchor on its second side, the connecting suture comprising a suture assembly.

10. The repair suture is formed from strands of suture material and includes a first end, a second end and two sides extending between the first end and the second end, and the strands have a thickness that increases from a minimum thickness at the first end to a maximum thickness at the second end, the suture assembly according to claim 9.

11. The proximal end of the inner anchor is open and communicates with an internal cannula, the inner anchor further includes suture engagement features extending across the internal cannula at a predetermined location, the internal cannula has a predetermined first cross-sectional area at the predetermined location, and The internal suture engaging feature portion divides the internal insertion tube portion into a first portion having a second cross-sectional area and a second portion having a third cross-sectional area, wherein the second cross-sectional area is about 60% of the first cross-sectional area, and the third cross-sectional area is about 40% of the first cross-sectional area, The suture loop is locked to the suture anchor by an interference fit between the maximum thickness of the strand and the third portion of the internal insertion portion at the predetermined location. The suture assembly according to claim 10.

12. The repair suture and the connecting suture extend through an all-suture anchor having a first opening located on the first side, a second opening located on the second side, and a central ring, The loop of the first end of the repair suture extends proximally through the first opening in the all-suture anchor, The loop of the second end of the repair suture extends proximally through the second opening in the all-suture anchor, The straight end of the connecting suture extends through the first opening in the all-suture anchor, and The looped end of the connecting suture extends through the second opening in the all-suture anchor. The suture anchor according to claim 10.

13. A method of attaching tissue to bone, implanting the first suture assembly according to claim 9 into a first inner location of the bone under the detached tissue, implanting the second suture assembly according to claim 9 into a second inner location of the bone, wherein the looped end of the connecting suture of the second suture assembly faces the straight end of the connecting suture of the first suture assembly, passing the loop of the first end of the repair suture of the first suture assembly and the straight end of the connecting suture of the first suture assembly through a first location of the tissue, passing the loop of the second end of the repair suture of the first suture assembly and the looped end of the first suture assembly through a second location of the tissue, passing the loop of the first end of the repair suture of the second suture assembly and the straight end of the connecting suture of the second suture assembly through a third location of the tissue, Passing the loop at the second end of the repair suture of the second suture assembly and the looped end of the second suture assembly through a fourth location of the tissue, Passing the loop at the first end of the repair suture of the first suture assembly through the loop at the second end of the repair suture of the first suture assembly to form a first packet configuration, Passing the loop at the first end of the repair suture of the second suture assembly through the second loop of the repair suture of the second suture assembly to form a first packet configuration, Passing the straight end of the connecting suture of the second suture assembly through the looped end of the first suture assembly, Pulling the straight end of the connecting suture of the first suture assembly and drawing the straight end of the connecting suture of the second suture assembly through the tissue at the second location and creating an inner bar connecting the second and third locations, Cutting the loop at the first end of the first packet configuration to create a first limb end and a second free limb, Cutting the loop at the first end of the second packet configuration to create a third free limb and a fourth free limb, Inserting the straight end of the connecting suture of the first suture assembly, the first free limb, and the third free limb into a retaining feature at a first outer anchor, Inserting the looped end of the connecting suture of the second suture assembly, the second free limb, and the fourth free limb into a retaining feature at a second outer anchor, Implanting the first outer anchor at a first outer location of the bone, Implanting the second outer anchor at a second outer location of the bone A method comprising.

14. Each repair suture is formed from a strand of suture material and includes a first end, a second end, and two sides extending between the first end and the second end, and The strand has a thickness that increases from a minimum thickness at the first end to a maximum thickness at the second end, the method according to claim 13.

15. The maximum thickness of the strand is located at the loop of the first end, the method according to claim 13.

16. The method according to claim 13, wherein the second suture assembly is positioned such that the free end of the connecting suture of the second suture assembly faces the looped end of the connecting suture of the first suture assembly. **Claim 17** The first outer anchor is a proximal anchor body having an internal insertion tube portion, an open proximal end, an open distal end and a distal tip having a holding feature configured to receive the straight end, the first free end, and the third free end of the connecting suture of the first suture assembly, a suture engagement feature configured to engage a pair of support sutures and an internal locking element configured to lock the distal tip to the proximal anchor body when the outer anchor is implanted in bone. The method according to claim 13. **Claim 18** The distal tip includes a pointed distal end configured to facilitate insertion into bone, and a pair of spikes extending proximally and radially outwardly from the pointed distal end. The method according to claim 17. **Claim 19** The internal locking element includes mating threads formed on a distal portion of the internal insertion tube portion of the proximal anchor body and a proximal portion of the distal tip. The method according to claim 17. **Claim 20** A proximal anchor body having an internal insertion tube portion, an open proximal end, an open distal end and a distal tip having an eyelet configured to receive an end of a repair suture, a suture engagement feature extending proximally from the distal tip, and at least one pre - incorporated support suture extending proximally from the suture engagement feature and exiting through the open proximal end of the proximal anchor body. An outer suture anchor including the distal tip. **Claim 21** The outer suture anchor according to claim 20, further including an internal locking element configured to lock the distal tip to the proximal anchor body when the outer anchor is implanted in bone. **Claim 22** The internal locking element includes mating threads formed on a distal portion of the internal insertion tube portion of the proximal anchor body and a proximal portion of the distal tip. The outer suture anchor according to claim 21. **Claim 23** The suture engagement feature includes an apertured tab extending proximally from a proximal end of the distal tip, and ​ ​ The support suture is the outer suture anchor according to claim 20, extending through the tab with an opening.

24. The support suture includes a looped end portion, a straight end portion, and an intermediate portion, and is folded back such that the intermediate portion extends through the tab with an opening, and the looped end portion and the straight end portion extend proximally through the open proximal end of the proximal anchor body. The outer suture anchor according to claim 23.

25. The distal tip includes a pointed distal end configured to facilitate insertion into bone, and a pair of spikes extending proximally and radially outwardly from the pointed distal end. The outer suture anchor according to claim 20.

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