Self-drilling anchor inserter

Abstract

An anchor inserter includes an inserter tube extending along a longitudinal axis, the inserter tube having a proximal inserter end and a distal inserter end. The inserter further includes an inserter tip attached to and extending distally from the distal inserter end. The inserter tip has a proximal tip end and a distal tip end, with a suture anchor holding slot extending through the distal tip end. The inserter has one or more cutting edges extending at least partially along an outer perimeter edge of the distal tip end. The distal tip end has a first arm and a second arm. The first arm is substantially straight and the second arm is curved.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 781,246, filed December 18, 2018, and entitled “Self-Drilling Anchor Inserter,” the entire contents of which are incorporated herein by reference. This application is related to the priority and benefit of U.S. Provisional Patent Application No. 62 / 572369, filed October 13, 2017, U.S. Provisional Patent Application No. 62 / 618851, filed January 18, 2018, U.S. Provisional Patent Application No. 62 / 631034, filed February 15, 2018, U.S. Provisional Patent Application No. 62 / 543,516, filed August 10, 2017, and U.S. Provisional Patent Application No. 62 / 536208, filed July 24, 2017. TECHNICAL FIELD

[0003] The present invention relates to drills, anchor drivers, and drill guides for drilling a bone hole at a surgical repair site and inserting a suture anchor into the bone hole, and more particularly to a self-drilling all-suture anchor and inserter.

[0004] 2. Related Art

[0005] Many orthopedic surgical procedures and medical procedures require the fixation of one body to another body. Such bodies can include bone, soft tissue, and prosthetics. One body can be fixed in place relative to another body using connector devices such as screws and suture anchors (e.g., cannulated, non-knot type suture anchors and soft, all-suture anchors). For example, various orthopedic surgical procedures require the insertion and fixation of suture anchors within bone.

[0006] One example of a suture anchor is a soft suture anchor, such as Devices. See, e.g., U.S. 9826971. Because soft anchors are often made entirely of suture material, they are sometimes referred to as “all-suture” anchors, and generally include a fiber construct anchor body portion (or a fiber, braid, or woven fabric type structure, such as a flexible mesh, as described in U.S. Patent No. 9173652) and a suture or filament portion. In a traditional Y- knot device, the suture is pierced completely through the braided material multiple times, such that the suture passes through the “front” surface and the “back” surface. When a Y-knot anchor is constructed in the traditional manner, the suture segment on the back surface of the braid is in contact with the bone and can be abraded by the bone due to friction.

[0007] There are at least two general conventional methods for inserting a suture anchor into bone. In one method, a drill bit is used to create and prepare a bone hole. The drill bit is typically advanced through a drill guide to create the bone hole, and then a suture anchor is passed through or down the drill guide into the bone hole for deployment. If the drill guide is moved between the creation of the bone hole and the advancement of the suture anchor, the drill guide can be moved out of alignment with the bone hole. If the drill guide is no longer aligned with the bone hole, the suture anchor typically cannot be inserted and deployed. Thus, when the drill guide is moved out of alignment with the first bone hole, a second bone hole is typically created.

[0008] In a second method, the drilling step is eliminated in an attempt to avoid the misalignment problem described above. Self-penetrating suture anchors, such as Y- knot RC suture anchors, for example, are designed with an inserter that allows the anchor in the inserter to be positioned directly at a desired location on the bone. When the anchor in the inserter is positioned at the desired location, the inserter can be hammered, thereby forcing the anchor directly into the bone. However, hammering the anchor into the bone applies an impact force to the bone, which can be undesirable for some surgical site locations. For example, at glenoid bone or smaller bones, such as in the extremities, the impact force can be particularly undesirable. Additionally, the self-penetrating anchors are typically required to be larger in size. Thus, such anchors can not only be undesirable, but can also not be usable in smaller bones.

[0009] Accordingly, there is a need for a suture anchor inserter that can insert a small suture anchor into bone without the need to drill a bone hole or apply an impact force to the bone, and that is capable of achieving a minimum hole size created when the anchor does not cause hole enlargement.

[0010] Related Art Section Disclaimer of Description: To the extent that specific patents / publications / products are discussed in this Related Art Section and / or elsewhere in this disclosure, such discussion is intended only to illustrate the present technology and should not be taken as an admission that such was the prior art to the present technology. For example, any discussion of a patent / documents / product in this section should not be taken as an admission that such was the prior art to the technology described herein. To the extent that specific patents / publications / products are discussed in this Related Art Section and / or elsewhere in this disclosure, such discussion is intended only to illustrate the present technology and should not be taken as an admission that such was the prior art to the present technology. For example, any discussion of a patent / documents / product in this section should not be taken as an admission that such was the prior art to the technology described herein. To the extent that specific patents / publications / products are discussed in this Related Art Section and / or elsewhere in this disclosure, the description / disclosure of which is herein incorporated by reference in its entirety. SUMMARY

[0011] Embodiments of the present invention recognize that conventional methods for drilling a bone hole and inserting a suture anchor present potential problems and / or disadvantages (as discussed herein and above). For example, removing a drill bit from a drill guide and replacing the drill bit with a driver to insert a suture anchor increases the risk of misalignment of the drill guide with the bone hole, which requires additional surgical time and has the risk of causing trauma to surrounding tissue and bone. In another example, hammering an anchor into bone applies an impact force to the bone, which can be undesirable for some surgical site locations. Accordingly, there is a need for an easy-to-use suture anchor inserter that is capable of inserting a suture anchor into bone without the need to drill a bone hole or apply an impact force to the bone and that is capable of achieving a minimum hole size that results when the anchor does not cause hole enlargement. Various embodiments of the present invention can be advantageous in that they can address or reduce one or more of the potential problems and / or disadvantages discussed herein.

[0012] The present disclosure is directed to inventive configurations, structures, and resulting functionality of a self-drilling anchor inserter configured to insert a suture anchor into bone. According to one aspect, the invention is an anchor inserter. The anchor inserter includes an inserter tube extending along a longitudinal axis, the inserter tube having a proximal inserter end and a distal inserter end. The inserter further includes an inserter tip attached to and extending distally from the distal inserter end. The inserter tip has a proximal tip end and a distal tip end, with a suture anchor retention slot extending through the distal tip end. The inserter has one or more cutting edges extending at least partially along an outer perimeter edge of the distal tip end. The distal tip end has a first arm and a second arm. The first arm is substantially straight, and the second arm is curved.

[0013] According to another aspect, the invention is an anchor inserter including a hollow inserter tube extending along a longitudinal axis and having a proximal inserter end and a distal inserter end. The anchor inserter further includes a hollow suture tube extending through the hollow inserter tube. The hollow suture tube has a proximal suture end and a distal suture end. The anchor inserter further includes an inserter tip attached to and extending distally from the distal inserter end. The inserter tip has a proximal tip end and a distal tip end. One or more features on the proximal tip end are removably connected to one or more features on the distal inserter end.

[0014] According to yet another aspect, the present application is an anchor inserter system including a cannulated inserter tube extending along a longitudinal axis and having a proximal inserter end and a distal inserter end. The system further includes a cannulated suture tube extending through the cannulated inserter tube. The cannulated suture tube has a proximal suture end and a distal suture end. The system further includes an inserter tip attached to and extending distally from the distal inserter end. A suture anchor holding slot extends through the inserter tip, and an anchor extending through the suture anchor holding slot has a length of suture positioned therethrough. The length of suture extends proximally along the inserter tip.

[0015] Suture material or suture, as these terms are used and described herein, can include monofilament or multifilament suture and any other metallic or non-metallic wire-like or string-like material suitable for performing a suture function. Such materials can include bioabsorbable and non-absorbable materials.

[0016] Suture anchor, as this term is used herein, can include soft suture anchors and rigid suture anchors. Soft suture anchors are formed from filaments of suture material that are retained within a pre-formed bone hole by being deformable to increase their diameter to be larger than the size of the bone hole, thereby residing within cancellous bone and beneath the bone cortex. One such suture anchor is disclosed in U.S. Patent No. 9,826,971, assigned to the assignee hereof, which is incorporated by reference herein in its entirety. Because soft anchors are often made entirely of suture material, they are sometimes referred to as “all-suture” anchors, and generally include a fibrous construct anchor body portion (or a fiber, braid, or woven fabric type structure, such as a flexible mesh, as described in U.S. Patent No. 9,173,652) and a suture or filament portion. Methods and devices for inserting / deploying such all-suture anchors are known, examples of which are disclosed in U.S. Patent No. 9,173,652.

[0017] As described in U.S. Patent No. 8,409,252, for example, “non-soft,” “hard,” or “rigid” suture anchors generally include a “hard” anchor body portion (which can or can not include an inner member and an outer member) and a suture / filament portion. The anchor body of such suture anchors can be formed from biocompatible and / or bioabsorbable materials. These materials can have a composition such that they are reabsorbed by the body, for example, during the healing process of bone. Exemplary materials suitable for use in the inner member and the outer member include, but are not limited to, polyether ether ketone (“PEEK”), polylactic acid / beta-tricalcium phosphate (“PLA / β-TCP”) composite, ultra-high molecular weight polyethylene (“UHMWPE”), as well as other metallic, non-metallic, and polymeric materials. BRIEF DESCRIPTION OF DRAWINGS

[0018] The present application will be more fully understood and appreciated by reading the following detailed description in conjunction with the accompanying drawings. The drawings are provided solely for illustration of the disclosed subject matter and are not intended as a definition of the full range of equivalence, of which the disclosed subject matter should be given the full scope. Referring now to the drawing, in which:

[0019] FIG. 1 is a perspective schematic view of an inserter tip according to one embodiment;

[0020] FIG. 2 is a side schematic view of a distal tip end of an inserter tip according to one embodiment;

[0021] FIG. 3 is a side perspective schematic view of a distal tip end of an inserter tip according to one embodiment;

[0022] FIG. 4 is a close-up front schematic view of a distal tip end of an inserter tip according to one embodiment;

[0023] FIG. 5 is a close-up perspective schematic view of an anchor positioned within an anchor retention slot of an inserter tip according to one embodiment;

[0024] FIG. 6 is a perspective schematic view of an inserter tip connected to a suture tube according to one embodiment;

[0025] FIG. 7 is a perspective schematic view of a distal suture tube of a suture tube connected to an inserter tip according to one embodiment;

[0026] FIG. 8A is a close-up perspective schematic view of an inserter tip connected to a suture tube according to one embodiment;

[0027] FIG. 8B is a close-up perspective schematic view of an inserter tip connected to a suture tube according to an alternative embodiment;

[0028] FIG. 9 is a close-up perspective schematic view of a proximal suture tube of a suture tube according to one embodiment;

[0029] FIG. 10 is a close-up rear perspective schematic view of a proximal suture tube of a suture tube according to one embodiment;

[0030] FIG. 11 is a perspective schematic view of a self-drilling anchor inserter according to one embodiment;

[0031] FIG. 12 is a close-up perspective schematic view of a distal inserter end of an inserter tube connected to an inserter tip according to one embodiment;

[0032] FIG. 13 is a partially transparent perspective schematic of a portion of a distal inserter end of an inserter tube connected to an inserter tip according to one embodiment;

[0033] FIG. 14 is a close-up perspective schematic of a proximal inserter end of an inserter tube according to one embodiment;

[0034] FIG. 15 is a perspective schematic of a guide according to one embodiment;

[0035] FIG. 16 is a rear perspective schematic of a guide according to one embodiment;

[0036] FIG. 17 is a close-up perspective schematic of a guide tip according to one embodiment;

[0037] FIG. 18 is a close-up perspective schematic of a guide tip according to an alternative embodiment;

[0038] FIG. 19 is a close-up perspective schematic of a guide tip according to another embodiment;

[0039] FIG. 20 is a side perspective schematic of a self-drilling anchor inserter in a retracted position according to one embodiment;

[0040] FIG. 21A is a side perspective schematic of a distal tip end of a self-drilling anchor inserter in a retracted position according to one embodiment;

[0041] FIG. 21B is a close-up front perspective schematic of a distal tip end of an inserter tip within a guide tip according to one embodiment;

[0042] FIG. 22 is a side perspective schematic of a self-drilling anchor inserter in an extraction position according to one embodiment;

[0043] FIG. 23 is a side perspective schematic of a distal end of a self-drilling anchor inserter in an extraction position according to one embodiment;

[0044] FIG. 24A is a rear perspective schematic of a full suture anchor according to one embodiment;

[0045] FIG. 24B is a top perspective schematic of a full suture anchor of FIG. 24A ; and

[0046] FIG. 25Ais a back view schematic of a full suture anchor according to one embodiment;

[0047] FIG. 25B is FIG. 25A a top view schematic of a full suture anchor;

[0048] FIG. 26A is a top view schematic of a full suture anchor loaded onto an inserter tip according to one embodiment;

[0049] FIG. 26B is a side view schematic of a full suture anchor loaded onto an inserter tip of FIG. 26A

[0050] FIG. 27A is a top view schematic of a full suture anchor loaded onto an inserter tip according to one alternative embodiment;

[0051] FIG. 27B is a side view schematic of a full suture anchor loaded onto an inserter tip of FIG. 27A

[0052] FIG. 28A is a top view schematic of a full suture anchor according to one embodiment;

[0053] FIG. 28B is a side view schematic of a full suture anchor in FIG. 28A

[0054] FIG. 29A is a top view schematic of an anchor braid loaded with two segments of suture according to one embodiment;

[0055] FIG. 29B is a top view schematic of an anchor braid loaded with two segments of suture according to an alternative embodiment;

[0056] FIG. 30A is a top view schematic of a threader passing through an anchor braid according to one embodiment;

[0057] FIG. 30B is a top view schematic of an anchor braid of FIG. 30A with a first end loaded into a threader;

[0058] FIG. 30C is a top view schematic of an anchor braid of FIG. 30A with a central eyelet;

[0059] FIG. 31 is a top view schematic of an anchor braid of FIG. 30C with a segment of suture passing through a central eyelet;

[0060] FIG. 32A ​​​is a top view schematic of a folded and sutured anchor braid according to one embodiment;

[0061] FIG. 32B is a top view schematic of an anchor braid with an additional material covering according to one embodiment; FIG. 32A

[0062] FIG. 33 is a top view schematic of an inserter in an unloaded pre-deployment configuration according to one alternative embodiment;

[0063] FIG. 34 is a top view schematic of an inserter in an unloaded pre-deployment configuration according to one additional alternative embodiment;

[0064] FIG. 35 is a close-up perspective schematic of a distal end of an inserter according to one embodiment;

[0065] FIG. 36A is a side view schematic of an embodiment of a suture anchor in an undeployed state according to one embodiment;

[0066] FIG. 36B is a side view schematic of a suture anchor according to one embodiment; FIG. 36A

[0067] FIG. 37 is a side view schematic of a disposable handpiece according to one embodiment;

[0068] FIG. 38 is a perspective digital photograph of a soft all-suture anchor in a pre-deployment configuration, unloaded (not loaded onto a mounting device or inserter) according to one embodiment;

[0069] FIG. 39A is a side view schematic of an embodiment of an all-suture anchor in a pre-deployment configuration, connected to a mounting device or inserter according to one embodiment; FIG. 38

[0070] is a side view schematic of an embodiment of an all-suture anchor in a post-deployment configuration, positioned in a bone hole according to one embodiment; FIG. 39B FIG. 38 is a side view digital photograph of an embodiment of an all-suture anchor in a post-deployment configuration, positioned in a bone hole according to one embodiment;

[0071] FIG. 39C FIG. 38 is a side view digital photograph of an embodiment of an all-suture anchor in a post-deployment configuration, positioned in a bone hole according to one embodiment;

[0072] FIG. 40 ​​​​is a perspective view digital photograph of a soft all-suture anchor in an unloaded (not loaded onto a mounting device or inserter), pre-deployment configuration, according to one embodiment;

[0073] FIG. 41A is a side view schematic of an embodiment of the all-suture anchor of FIG. 40 in a post-deployment configuration, according to one embodiment, connected to a mounting device or inserter;

[0074] FIG. 41B is a side view schematic of an embodiment of the all-suture anchor of FIG. 40 in a post-deployment configuration, according to one embodiment, positioned in a bone hole;

[0075] FIG. 41C is a side view schematic of a portion of an alternative embodiment of the all-suture anchor, according to one embodiment;

[0076] FIG. 42 is a side view digital photograph of an embodiment of the all-suture anchor of FIG. 40 in a post-deployment configuration, according to one embodiment, after addition of an activator;

[0077] FIG. 43 is a side view schematic of an all-suture anchor inserter device, according to one alternative embodiment;

[0078] FIG. 44 is a perspective view schematic of an all-suture anchor inserter device in a pre-deployment configuration and position, according to one alternative embodiment; and

[0079] FIG. 45 is a perspective view schematic of an all-suture anchor inserter device in a pre-deployment configuration and position, according to one alternative embodiment. DETAILED DESCRIPTION

[0080] Reference is now made to the drawings in which like reference numerals refer to like parts throughout the several views, seeing a self-drilling anchor inserter 10 FIG. 11 and portions thereof. Inserter 10 includes an inserter tip 12, as shown in FIG. 1 . FIG. 1 is a perspective view schematic of inserter tip 12, according to one embodiment. Inserter tip 12 has a proximal tip end 14 and a distal tip end 16, with a shaft 18 extending therebetween. Shaft 18 extends along a central longitudinal y-y axis. In the depicted embodiment, shaft 18 is solid, although it can be hollow.

[0081] Proximal tip end 14 of inserter tip 12 includes features FIG. 11 for connecting inserter tip 12 to the rest of self-drilling anchor inserter 10. In particular, as shown inFIG. 1 As shown in FIG. 1, the proximal tip end 14 includes a tip protrusion portion 20. In the depicted embodiment, the tip protrusion portion 20 is generally triangular in cross-section. In other words, the tip protrusion portion 20 is tapered such that its diameter or width increases in the proximal direction relative to the central longitudinal y-y axis (or shaft 18). The tip protrusion portion 20 includes one or more protrusions 22. In the depicted embodiment, the tip protrusion portion 20 includes two rectangular protrusions 22 that extend in the proximal direction and are spaced apart such that they are opposite.

[0082] Still referring to FIG. 1, FIG. 1 the tip protrusion portion 20 is connected to a hollow proximal tip tube 24. The proximal tip tube 24 includes one or more tip grooves 26 extending therethrough. In the depicted embodiment, the proximal tip tube 24 includes two tip grooves 26 that are spaced apart such that they are opposite. Also as FIG. 1 shown in FIG. 1, the protrusions 22 of the tip protrusion portion 20 are generally aligned with the grooves 26 of the proximal tip tube 24. The protrusions 22 and grooves 26 are connected to features on the rest of the self-drilling anchor inserter 10 FIG. 11 ) as described in detail below.

[0083] Turning now to FIG. 2 FIG. 2 shows a side view schematic of the distal tip end 16 of the inserter tip 12 according to one embodiment. The distal tip end 16 of the inserter tip 12 is generally bifurcated (i.e., forked) or hooked, having a total diameter or width that is greater than the total diameter or width of the shaft 18. As FIG. 1 and FIG. 2 shown in FIG. 2, the distal tip end 16 includes a first arm 28 that extends in the distal direction substantially parallel to the central longitudinal y-y axis. The first arm 28 is substantially straight, having a rounded first arm end 30.

[0084] The distal tip end 16 also includes a second arm 32. The second arm 32 is generally L-shaped, as FIG. 2 shown in FIG. 2. The second arm 32 includes a straight portion 34 that extends in the distal direction substantially parallel to the central longitudinal y-y axis and the first arm 28. The straight portion 34 of the second arm 32 is connected to a curved portion 36. The curved portion 36 includes an inner perimeter edge 38 that curves toward the central longitudinal y-y axis such that the inner perimeter edge extends at an angle relative to the central longitudinal y-y axis. In other words, the inner perimeter edge 38 of the second arm 32 curves toward the axis extending through a length of the first arm 28.

[0085] The configuration of the first arm 28 and the second arm 32 creates a suture anchor holding slot 40 therebetween. The suture anchor holding slot 40 further comprises a straight portion 42 connected to a curved portion 44 that extends at an angle. The suture anchor holding slot 40 is sized or otherwise configured to hold the anchor braid as well as a length of suture of a full suture anchor, allowing the full suture anchor to be pushed into a bone hole by the inserter tip 12.

[0086] Turning now to FIG. 3 , a side perspective schematic view of the distal tip end 16 of the inserter tip 12 is shown, according to one embodiment. The inner perimeter edge 38 of the second arm 32 of the distal tip end 16 extends to a sharp second arm end 46. As FIG. 1 shown, the second arm end 46 has an edge 46A that extends substantially perpendicular to the central longitudinal y-y axis. In FIG. 1 and FIG. 2 , the second arm end 46 extends through the first arm end 30 of the first arm 28 to ensure that the first arm end 30 does not have significant contact with the bone during drilling.

[0087] The second arm 32 further comprises an outer perimeter edge 48 that has an optimized geometry for drilling. As FIG. 3 shown in , the outer perimeter edge 48 of the second arm 32 has a straight portion 50 that extends substantially parallel to the central longitudinal y-y axis in the distal direction. The outer perimeter edge 48 further comprises a beveled portion 52. The beveled portion 52 extends at an angle relative to the straight portion 50 (and the central longitudinal y-y axis). Additionally, as shown, the beveled portion 52 extends at an angle relative to the transverse x-x axis that extends through the suture anchor holding slot 40 from the straight portion 50.

[0088] FIG. 3 The configuration of the beveled portion 52 is due to a recessed region 54 on the second arm 32. As shown, the beveled portion 52 extends to a first end portion 56 of the outer perimeter edge 48. In the depicted embodiment, the first end portion 56 is generally perpendicular relative to the straight portion 50. The first end portion 56 is connected to a second end portion 58 of the outer perimeter edge 48. The second end portion 58 extends along a z-z axis that is substantially perpendicular to the longitudinal y-y axis and / or the transverse x-x axis. The first end portion 56 and the second end portion 58 together partially extend around an end surface 60 of the second arm 32.

[0089] FIG. 1 and FIG. 3As shown in FIG. 2, the second arm 32 includes two recessed regions 54, which are corners of the second arm 32 that have been recessed to form a plurality of cutting edges 62 along the second arm 32. The geometry of the distal tip end 16 creates positive rake angles and clearance angles at the ramped portion 52, the first end portion 56, and the second end portion 58. Together, the ramped portion 52 and the first end portion 56 and the second end portion 58 of the outer perimeter edge 48 are the cutting edges 62 for effective cutting action. The straight portion 50 of the outer perimeter edge 48 is a reaming edge 64.

[0090] Turning now to FIG. 4 , a close-up front view schematic of the distal tip end 16 of the inserter tip 12 is shown, according to one embodiment. In particular, FIG. 4 the circumference c of the final hole formed by the reaming edge 64 FIG. 3 is shown. The size and configuration of the final hole is set to the smallest hole size that is created when the anchor (e.g., anchor braid) does not cause the hole to enlarge.

[0091] Referring now to FIG. 5 , a close-up perspective schematic of an anchor 100 positioned within the suture anchor holding slot 40 of the inserter tip 12 is shown, according to one embodiment. As FIG. 5 shown, the anchor 100 is positioned or otherwise wrapped within the suture anchor holding slot 40 such that the first end 114A of the anchor 100 and the second end 114B of the anchor 100 extend along opposite sides of the distal tip end 16 and the shaft 18. The anchor 100 is positioned relative to the cutting edges 62 such that all of the cutting edges 62 are distal relative to the anchor 100. Also as FIG. 5 shown, the suture 102 is attached to the first end 114A and the second end 114B of the anchor 100. The suture 102 also extends on opposite sides of the distal tip end 16 and the shaft 18.

[0092] Turning now to FIG. 6 , a perspective schematic of the inserter tip 12 connected to a hollow suture tube 66 is shown, according to one embodiment. As shown, the proximal tip end 14 of the inserter tip 12 is connected to the suture tube 66. As described in detail below, the suture tube 66 includes features that allow the suture 102 connected to the anchor 100 to pass through the inserter 10 FIG. 13 . The suture tube 66 includes a distal suture tube end 68 that is sized and configured to fit within the hollow proximal tip tube 24 of the inserter tip 12. In other words, the outer diameter of the distal suture tube end 68 is less than the inner diameter of the proximal tip tube 24.

[0093] In FIG. 8BIn the alternative embodiment shown, the suture tube 66 is comprised of two component parts: a first suture tube 66A and a second suture tube 66B. The first suture tube 66A and the second suture tube 66B are hollow, and the second suture tube 66B is sized and configured to fit around the first suture tube 66A. In other words, the first suture tube 66A fits within the second suture tube 66B. As FIG. 8B As shown, the second suture tube 66B connects the first suture tube 66A to the proximal tip end 14 of the inserter tip 12. Specifically, the distal suture tube end 68 (of the second suture tube 66B) extends into the hollow proximal tip tube 24 of the inserter tip 12. Thus, the first suture tube 66A functions as a tube, while the second suture tube 66B acts as a connector.

[0094] Reference is now made to FIG. 7 , which shows a perspective schematic view of the distal suture tube end 68 of the suture tube 66 connected to the inserter tip 12, according to one embodiment. As shown, the suture tube 66 is at least partially within the hollow proximal tip tube 24. The suture tube 66 does not extend completely into the proximal tip tube 24. The distal suture tube end 68 and the proximal tip tube 24 include a feature that prevents the suture tube 66 from moving further into the proximal tip tube 24. This is to prevent the distal suture tube end 68 from crushing, compressing, or otherwise interfering with the suture 102. As FIG. 7 and FIG. 8A shown, the suture 102 extends from the anchor 100 into the proximal tip tube 24 and into the distal suture tube end 68 of the hollow suture tube 66.

[0095] Turning now to FIG. 9 and FIG. 10 , close-up perspective and close-up rear perspective views of the proximal suture tube end 70 of the suture tube 66 are shown, according to one embodiment. As FIG. 9 shown, after the suture 102 extends into the distal suture tube end 68, it passes through the suture tube 66 to the proximal suture tube end 70. As FIG. 10 shown, the suture 102 that protrudes from the proximal suture tube end 70 is pulled distally along the outer surface 72 of the suture tube 66.

[0096] Reference is now made to FIG. 11 , which shows a perspective schematic view of the self-drilling anchor inserter 10, according to one embodiment. To create the self-drilling anchor inserter 10, the suture tube 66 is FIG. 6 threaded through and placed within the hollow inserter tube 74. The inserter 74 has a proximal inserter end 76 and a distal inserter end 78. The distal inserter end 78 extends and connects to the proximal tip end 14 of the inserter tip 12.

[0097] Turning now to FIG. 12FIG. 6, a close-up perspective view of the distal inserter end 78 of the inserter tube 74 connected to the inserter tip 12 is shown, in accordance with one embodiment. The distal inserter end 78 includes features for connecting the inserter tube 74 to the inserter tip 12. In particular, as shown in FIG. 13 FIG. 6, the distal inserter end 78 includes one or more internal protrusions 79 extending from an inner surface 81 of the inserter tube 74. According to one embodiment, the internal protrusions 79 are formed by crimping the distal inserter end 78. Thus, crimping the inserter tube 74 forms a partial circumferential cavity 82 along the outer circumference of the inserter tube 74, while forming the internal protrusions 79 along the inner circumference of the inserter tube 74. In the depicted embodiment, the distal inserter end 78 includes two opposing internal protrusions 79 spaced apart such that a gap 83 is formed therebetween.

[0098] Still referring to FIG. 12 FIG. 6, the distal inserter end 78 additionally includes one or more inserter slots 84 extending at least partially through the inserter tube 74. In the depicted embodiment, the inserter tube 74 includes two opposing inserter slots 84 spaced apart such that a gap 85 is formed therebetween. The inserter slots 84 of the inserter tube 74 are sized and configured to receive the protrusions 22 of the inserter tip 12. Likewise, the grooves 26 of the inserter tip 12 are sized and configured to receive the internal protrusions 79 of the inserter tube 74.

[0099] The resulting snap or press connection between the inserter tube 74 and the inserter tip 12 is shown in FIG. 13 FIG. 7. In particular, FIG. 13 FIG. 7, a partially transparent perspective view of the distal tip end 78 of the inserter tube 74 connected to the inserter tip 12 is shown, in accordance with one embodiment. As shown, the connection between the inserter slots 84 of the inserter tube 74 and the protrusions 22 of the inserter tip 12 is a light press connection. The protrusions 22 fit into the inserter slots 84 to resist torsional and compressive loads. The internal protrusions 79 of the inserter tube 74 snap into the grooves 26 of the inserter tip 12 to interlock the inserter tube 74 and the inserter tip 12 to resist tensile loads.

[0100] In embodiments as in FIG. 13 FIG. 7, the distal inserter end 78 additionally includes a fine laser cut 86 extending along the outer surface 80 of the inserter tube 74 and into the same. The fine laser cut 86 allows the distal inserter end 78 to have some flexibility. Also as shown in FIG. 13 FIG. 7, when the suture tube 66 is locked within the inserter tube 74 via the connection of the inserter tube 74 to the inserter tip 12, the sutures 102 extend in an annular space between the inserter tube 74 and the suture tube 66. In FIG. 13In this embodiment, the free end 112 of the suture 102 is shown extending distally along the suture tube 66 between the suture tube 66 and the inserter tube 74.

[0101] Reference is now made to FIG. 14 which is a close-up schematic view of the proximal inserter end 76 of the inserter tube 74 according to one embodiment. The proximal inserter end 76 of the inserter tube 74 extends to a powered handpiece interface, such as a quick change connector 88. The quick change connector 88 generally refers to a feature that facilitates drilling with a powered accessory. As FIG. 11 shown, the inserter tip 16 has a relatively thin profile compared to the inserter tube 74 and the quick change connector 88.

[0102] Reference is again made to FIG. 14 shown, the quick change connector 88 is compatible with a traditional AO connection (as will be understood by one of ordinary skill in the art with review of the present disclosure). However, other connections can be used, such as a Trinkle or Hudson connection. In the depicted embodiment, the quick change connector 88 includes one or more flat surfaces 90 that extend along an axis that is parallel to the central longitudinal y-y axis. Specifically, the quick change connector 88 includes three flat surfaces 90 that have a triangular cross-section. The quick change connector 88 also includes three grooves 92 that extend into the quick change connector 88 at a location where two of the three flat surfaces 90 contact or otherwise converge. However, the three flat surfaces 90 allow the central longitudinal y-y axis of the self-drilling anchor inserter 10 to be collinear with the central longitudinal y-y axis that extends through the chuck (not shown).

[0103] The quick change connector 88 can be formed from a solid piece of metal or formed in the proximal inserter end 76 of the inserter tube 74 (as FIG. 14 shown). Forming the quick change connector 88 as a tube provides a number of advantages for use with the self-drilling anchor inserter 10. For example, the proximal inserter end 76 remains open to allow for better flow of ethylene oxide to sterilize the suture material housed within the tube, and can reduce the number of components required to assemble the self-drilling anchor inserter 10.

[0104] Still referring to FIG. 14 , the proximal inserter end 76 of the inserter tube 74 includes a hard stop feature 94. As shown in the depicted embodiment, the hard stop feature 94 is positioned or otherwise located along the proximal inserter end 76 of the inserter tube 74. The hard stop feature 94 is distal relative to the quick change connector 88 such that the hard stop feature 94 prevents the quick change connector 88 from entering or advancing through the guide 11 FIG. 22). In the depicted embodiment, the hard stop feature 94 is a ring that wraps around the outer surface 80 of the inserter tube 74. However, any other shape or configuration for the hard stop feature 94 can be used if sized large enough to be greater than the diameter of the guide 11.

[0105] Turning now to FIG. 15 and FIG. 16 , perspective and rear perspective views of a guide 11 are shown according to a person alternative embodiment. The guide 11 includes a proximal guide handle 13 connected to a hollow guide tube 15 with a central longitudinal y-y axis extending therethrough. As shown in FIG. 15 , the guide tube 15 extends distally from the guide handle 13 to a guide tip 17. The guide handle 13 can be ergonomically shaped with external ridges 21 for improved grip. As shown in FIG. 16 , the guide handle 13 is hollow such that a handle passage extending through the guide handle 13 is aligned with a tube passage extending through the guide tube 15.

[0106] In the embodiment shown in FIG. 15-16 , the handle passage is made up of a first passage portion 23A and a second passage portion 23B. The first passage portion 23A extends to a proximal handle end 25 of the guide handle 13, while the second passage portion 23B is connected to the guide tube 15. The first passage portion 23A and the second passage portion 23B are separated by a space 27 within the guide handle 13. Additionally, as shown in FIG. 16 , one or more openings 29 extend through the guide handle 13 and into the space 27. The space 27 and the openings 29 allow fluid to escape the guide 11 rather than out of the proximal handle end 25.

[0107] Reference is now made to FIG. 17-19 , a close-up perspective view of the guide tip 17 is shown according to an embodiment. In the embodiment shown in FIG. 15 and FIG. 17 , the guide tip 17 has a fishmouth shape. Specifically, the guide tip 17 is a guide tip tube 31 with two regions of reduced diameter 33. In other words, the length of the guide tip tube 31 is shorter in the two regions 33. These regions 33 are half-moon shaped, thereby forming the fishmouth shape of the guide tip 17. The fishmouth shape of the guide tip 17 allows it to compress the anchor 100 and provide stability during insertion.

[0108] In the embodiment shown in FIG. 18 , the inserter tip 17 has a crown shape. Specifically, the guide tip 17 has a protrusion 35 extending distally therefrom. In the depicted embodiment, the protrusion 35 is triangular and extends distally from the guide tip tube 31. In FIG. 19In the illustrated embodiment, the guide tip 17 is crown-shaped, but the guide tube 15 includes a distal curved portion 37. The distal curved portion 37 curves away from a central longitudinal y-y axis extending through the guide 11.

[0109] Turning now to FIG. 20 , a side view schematic of a self-drilling anchor inserter 10 in a retracted position is shown, according to one embodiment. In use, the self-drilling anchor inserter 10 is placed through the guide 11 (via the hollow guide handle 13 and the hollow guide tube 15). As shown in FIG. 20 , in the retracted position, the distal tip end 16 of the inserter tip 12 is located within the guide tip 17. As shown in FIG. 21A , the distal tip end 16 is located within the crown-shaped guide tip 17. The protrusion 35 of the guide tip 17 extends distally past the distal tip end 16. In the retracted position, the anchor 100 is held within the guide tube 15 prior to insertion. Also as shown in FIG. 21B , the guide tip 17 has a diameter dl that is approximately the same (or slightly larger) than a diameter d2 of the distal tip end 16. The similar diameters dl, d2 are designed for a minimal gap therebetween.

[0110] Referring now to FIG. 22 , a side view schematic of a self-drilling anchor inserter 10 in an extended position is shown, according to one embodiment. To move the self-drilling anchor inserter 10 from the retracted position to the extended position, the self-drilling anchor inserter 10 is extended in a distal direction through the guide 11. The self-drilling anchor inserter 10 can be extended through the guide 11 until its hard stop feature 94 contacts the proximal handle end 25 of the guide 11. As shown in FIG. 23 , the distal tip end 16 extends in a distal direction past the crown-shaped guide tip 17. The distal tip end 16 extends distally past the protrusion 35 of the guide tip 17. When the self-drilling anchor inserter 10 is in the extended position, the anchor 100 is inserted and can be deployed.

[0111] Referring briefly to FIG. 24A-24B , front and back view schematics of a full suture anchor 100 are shown, according to one embodiment. FIG. 24A a back view of the full suture anchor 100 is shown, while FIG. 24B a front view is shown. As shown, the stated length of suture 102 that passes through the anchor braid / fiber construct 104 passes through only one (e.g., the "front") surface 106 of the anchor braid 104 FIG. 24B . Similarly, FIG. 25A-25B back and front views are also shown, where the suture 102 passes through only one (e.g., the "front") surface 106 of the anchor braid 104 FIG. 25B FIG. 25A FIG. 25B ​​). When the full suture anchor 100 has suture 102 passing through only one (e.g., “front”) surface 106, the anchor braid 104 protects the suture 102 from abrasion on the opposite (e.g., “back”) surface 108 FIG. 24A and FIG. 25A ) when loaded onto an inserter (as will be appreciated by one of ordinary skill in the art in view of the present disclosure). In FIG. 24A-25B , the suture 102 passes through the anchor braid 104 at multiple pass locations. FIG. 26B and FIG. 27B The number of pass locations in some alternative full suture anchors 100 is six pass locations 110. The number of pass locations 110 can vary depending on the composition and dimensions of the suture 102 and / or the anchor braid 104. The number of pass locations 110 can be optimized by balancing input parameters such as anchor braid length, anchor braid width, anchor braid weft density, suture diameter, etc. to yield output parameters such as manufacturability, anchor creep under load, and pull-out strength.

[0112] Briefly turning to FIG. 28A-28B , top and side view illustrations of a full suture anchor 100 according to one alternative embodiment are shown. As FIG. 28A-28B indicated, the length of suture 102 passes through a general center 105 of the anchor braid 104. In the depicted embodiment, the length of suture 102 enters the anchor braid 104 through one (e.g., “front”) surface 106 and exits through an opposite (e.g., “back”) surface 108 of the anchor braid 104. As FIG. 11-13 indicated, with the length of suture 102 positioned on both sides of the anchor braid 104, the anchor braid 104 can be loaded onto an inserter 10 such that the anchor braid 104 can be positioned against a bone while the multiple lengths of suture 102 follow along the inserter 10.

[0113] In another alternative embodiment, as FIG. 29A-29B indicated, the anchor braid 104 can be loaded with multiple lengths of suture 102A, 102B. In the depicted embodiment, the anchor braid 104 is loaded with two lengths of suture 102A, 102B. The multiple lengths of suture 102 can extend through the anchor braid 104 along opposite edges 107A, 107B FIG. 29B ), through two off-center locations 109A, 109B FIG. 29A , or any conceivable combination thereof (including the length of suture 102A, 102B extending through a general center 105 of the anchor braid 104). Additionally, the multiple lengths of suture 102A, 102B can be on the same surface FIG. 24A-25B ) or on opposite surfaces FIG. 28A-28Binto / out of the anchor braid 104.

[0114] Referring now to FIG. 30A-31 , a top view schematic of an all-suture anchor 100 is shown, according to an additional alternative embodiment. FIG. 30A-30C A process for creating an inverted anchor braid 104 is depicted. As FIG. 30A illustrated, a threader 128 having a threader loop 130 is first threaded through the anchor braid 104. Then, in FIG. 30B , the end 114B of the anchor braid 104 is pulled through the threader loop 130. Finally, the threader loop 130 is pulled back through the anchor braid 104, thereby forming a central eyelet 132, as FIG. 30C illustrated. By threading a length of suture 102 through the anchor braid 104 (as described in any of the embodiments shown in connection with FIG. 24A-25B , FIG. 28A-28B and FIG. 29A-29B ), and through the central eyelet 132 (as FIG. 31 illustrated), the length of suture 102 can be loaded onto the inverted anchor braid 104.

[0115] Referring back to FIG. 24A-25B , from the illustrated unloaded pre-deployment configuration, the all-suture anchor 100 is loaded onto the inserter tip 16, as shown in the exemplary embodiment of the inserter tip 16 in FIG. 26A-26B . To load the inserter tip 16, the anchor braid 104 is fed through the suture anchor retention slot 40 such that the pair of ends 112A, 112B of the suture 102 and the pair of ends 114A, 114B of the anchor braid 104 are on opposite sides of the suture anchor retention slot 40 (and the inserter 10). Furthermore, in one embodiment, the all-suture anchor 100 is fed through the suture anchor retention slot 50 such that the four in the by location 110 are on opposite sides of the suture anchor retention slot 40 (and the inserter 10). The suture 102 is then tensioned along the shaft 18 of the inserter tip 16, which causes the pair of ends 112A, 112B of the suture 102 and the pair of ends 114A, 114B of the anchor braid 104 to extend along the inserter 10 (i.e., each along an axis that is generally parallel to the central longitudinal y-y axis).

[0116] Turning now to FIG. 27A-27B , top view schematics of an all-suture anchor in an unloaded pre-deployment configuration and a loaded pre-deployment configuration are shown, according to an alternative embodiment. FIG. 27A-27BThe full-stitch anchor 100 shown is a Y-knot stitch anchor. Certain structural and functional aspects of embodiments of the present invention are similar to embodiments of the soft stitch anchor described and illustrated in U.S. Patent 9,826,971. Those similarities should be understood by those skilled in the art in conjunction with a review of this disclosure and the accompanying drawings, in conjunction with the published applications, and will not be discussed further in detail herein. Certain differences in various inventive features including embodiments of the present invention are further briefly described herein and below with reference to the accompanying drawings. However, in embodiments where the full-stitch anchor 100 is a Y-knot stitch anchor, only the anchor braid 104 is loaded into the inserter tip 16. FIG. 27B As shown, when the anchor braid 104 is loaded into the stitch anchor holding slot 40, the central portion 116 of the stitch 102 is pulled away from the inserter tip 16 (i.e., pulled in the direction distal to the inserter tip). This prevents the stitch 102 from falling into the stitch anchor holding slot 40. Holding the stitch 102 outside the stitch anchor holding slot 40 avoids damage due to the arms 28, 32 of the inserter 10. FIG. 2-3 The heat generated during drilling into the bone could potentially damage the suture 102, or prevent it from being cut when the inserter 10 is removed.

[0117] Now go to FIG. 32A-32B The diagram shows a top view of an anchor braid 104 with additional material 120 according to one embodiment. Those skilled in the art will recognize and understand possible embodiments of a Y-knot anchor with additional material (such as a monofilament polymer) to increase strength. The additional material can be applied to the fully stitched anchor 104. FIG. 32A As shown, the anchor braid 104 is folded in half. Each (i.e., both) side edges 122A, 122B of the anchor braid 104 are sewn together using monofilaments 120 to form a closed area 124, wherein a certain length of stitch 102 is inside, as shown... FIG. 32B As shown. In addition to increasing strength, this will also prevent the anchor braid 104 from flipping itself during insertion and from exposing the stitches 102 to the bone, thus preventing wear. Furthermore, the described torsion of the anchor braid 104, combined with the denser material extending along the axis of the anchor braid 104, can produce a threaded, fully stitched anchor 100.

[0118] See now FIG. 33FIG. 34 shows a side view schematic of the inserter 10 at the bone hole location 39 in a pre-deployment loaded configuration, according to one embodiment. As shown, the inserter 10 extends through the guide 11 at the selected bone hole location 39 such that the guide tip 17 is positioned at the surface 41 of the bone 43. In the depicted embodiment, the inserter tip 16, which has the anchor braid 104 loaded in the guide tip 17, is positioned at the surface 41 of the bone 43. Once positioned and while the guide 11 is held stationary relative to the bone 43, the user rotates the inserter using the handpiece via the quick change connector 88, which rotates the inserter tip 16, and pushes the inserter 10 into the bone 43 until the anchor braid 104 is fully inserted into the bone 43. Features such as hard stop features 94 FIG. 14 limit the insertion depth by not allowing the inserter 10 to pass further through the guide 11.

[0119] Turning now to FIG. 34, a side view schematic of the inserter 10 in a bone hole 45 in a pre-deployment loaded configuration, according to one embodiment, is shown. As shown, as the inserter 10 is advanced in the guide 11, the inserter tip 16 forms a hole 45 in the bone 43. Once the anchor braid 104 is inserted into the bone hole 45, the inserter 10 is removed, leaving the anchor braid 104 in the bone hole 45. The force that holds the anchor braid 104 in the bone hole 45 can be provided by the interaction between the bone 43 and the anchor braid 104 or by the interaction between the anchor braid 104 and another member that is introduced to hold the anchor braid 104 in place prior to the full suture anchor 100 being deployed.

[0120] Referring now to FIG. 35 , a side view schematic of the inserter 10 in an unloaded post-deployment configuration, according to one embodiment, is shown. Once the anchor braid 104 is fully inserted and the inserter 10 is removed, tension is applied to the suture 102 (ends 112A, 112B) by removing the inserter 10, the user pulling directly on the suture 102 (ends 112A, 112B), or a combination of the two. This tension causes the anchor braid 104 to deploy into a post-deployment configuration to provide fixation.

[0121] Turning now to FIG. 36A-36B , a side view schematic of an embodiment of a full suture anchor 100 in a pre-deployment and post-deployment configuration is shown. In the depicted embodiment, the full suture anchor 100 is a soft suture anchor, such as the anchor 200. One such suture anchor is disclosed in U.S. Patent No. 9826971, assigned to the assignee hereof, which is incorporated by reference herein in its entirety.

[0122] Embodiments of an anchor (or soft anchor or "full suture" anchor) 200 are shown in detail in FIG. 36A-36B FIGS. 1-3. As shown in FIG. 36A-36B FIG. 1, Anchor 200 includes at least two segments: at least one suture 202, which is the suture to be anchored; and an anchor body 204, which is to become part of anchor 200 as part of deployment, which can increase in width, thickness, and / or diameter, and can contract in length. See FIG. 36A FIG. 2, which shows anchor body 204 in a pre-deployment configuration; and FIG. 36B FIG. 3, which shows "shortened" and "expanded" anchor body 204 in a post-deployment configuration, which is an additional result of increased due to crimping. This soft anchor embodiment also utilizes the Poisson's ratio, which captures the following cause / effect relationship: compressing a material in a first direction causes the material to expand in a direction perpendicular to the first direction (i.e., if compressed in the x-direction, the material will expand in the y-direction and / or z-direction), and stretching / elongating a material in a first direction causes the material to contract in a direction perpendicular to the first direction. Although it is anchor body 204 that increases in width, thickness, and / or diameter upon deployment, it should be understood that suture 202 can also play a role in the deployment of anchor 200, even though suture 202 can remain free (in some embodiments) to slide, and in other embodiments, is not slidable relative to anchor body 204 at least at certain locations or points of use. Suture 202 helps to position, align, and support anchor body 204 so that if suture 202 were to be removed from anchor body 204 after deployment of anchor 200, anchor body 204 could freely unfurl (i.e., release), allowing anchor body 204 to collapse and contract in size, allowing for easy (and potentially undesired) removal.

[0123] In other words, anchor body 204 has two main functions. First, it becomes the basis for suture 202 to slide within. Second, when compressed and / or crimped during deployment, anchor body 204 becomes more compact in one direction, thereby expanding outward and increasing its overall width, thickness, or diameter to create a holding capacity. This action of causing anchor body 204 to change shape to increase its overall width, thickness, or diameter is a useful feature that can be advantageously used to secure anchor 200 in hole 45 or against bone or soft tissue 43. It is this combination of the expanded anchor body 204 coupled with suture 202 that remains slidable relative to anchor body 204 (in some embodiments; and in other embodiments, is not slidable relative to this anchor body at least at certain locations or points of use) that makes embodiments of the present invention ideal for soft tissue reattachment to bone 43 or soft tissue to soft tissue, in which case it is desirable to deliver a sliding knot to secure the repair.

[0124] The following discussion relates to alternative embodiments of a disposable handpiece that can be used in conjunction with or deployed by the embodiments of the anchor inserter described herein, alternative embodiments of a full suture anchor that can be used in conjunction with or deployed by the embodiments of the anchor inserter described herein, and alternative embodiments of an anchor installation device / inserter and drill.

[0125] Turning to FIG. 37 , a side view schematic of a disposable handpiece 300 according to an alternative embodiment is shown. The disposable handpiece can include, but is not limited to, a motor 301; a chuck 302; a disposable battery 303 configured to power the motor; and at least one switch 304 configured to be actuated by the user (rotationally, linearly, perpendicular to the longitudinal axis of the device (“push”)) to turn on the drill bit 302 and / or to set the desired speed of the drill bit 302. Alternatively, the motor can be actuated by the user via a predetermined force applied to the inserter by the handpiece 300 against the bone (sufficient to begin drilling a hole in the particular bone, which can vary depending on the type and hardness of the bone). The handpiece 300 can also include a disposable plastic housing 305 to make the device lightweight, relatively inexpensive, and disposable. The disposable plastic housing 305 can be made of any plastic or combination of plastics. The inserter can also be made disposable and provided as a kit pre-attached to the handpiece 300. As described herein, the quick-change connector 88 of the inserter 10 can be attached to the chuck 302 of the disposable handpiece 300. The disposable handpiece can be used to rotate the inserter tip 16 and cutting edge 62 and to push the inserter 10 into the bone 43 until the anchor braid 104 is fully inserted into the bone 43 (as described with respect to FIG. 33 .

[0126] Generally, the alternative full suture anchor designs described and illustrated below are configured to work with and be deployed by the anchor inserter described herein in the same manner as the other full suture anchors described above and illustrated herein. Like the other full suture anchors, the alternative embodiments of the full suture anchor can include a fiber-constructed anchor body portion (or fiber, braid, or woven fabric type structure, such as a flexible mesh) and a suture or filament portion having a first end and a second end. The suture can pass through the filament in a variety of ways (including woven, through post, pierced top and bottom, etc., as will be understood by one of ordinary skill in the art in view of a review of the present disclosure). The fiber construction can include a first state in which, when in a pre-deployment and deployment condition, the fiber construction is uncompressed and extends along the longitudinal axis of the filament; and a second state in which, in a deployed condition, the flat fiber construction is compressed and expanded in a direction perpendicular to the longitudinal axis of the filament (as discussed herein).

[0127] According to one embodiment, the fiber construct has an open elongated column / lumen extending from a first end to a second end, and the filament is threaded through and at least partially positioned in the open column. In embodiments, the filament is free to slide through the open column such that the filament can be removed from the open column from the first end of the fiber construct and the second end of the fiber construct. Embodiments of the fiber construct can be tubular in addition to having an open elongated column / lumen. The flat ribbon / fiber construct can be woven directly in situ onto the filament (e.g., round segment suture braid), or woven with an open column into which the round segment suture braid can be inserted afterwards. In particular, as shown in FIG. 38 FIG. 6, a perspective schematic view of a soft full suture anchor 400 in an unloaded (not loaded onto a mounting device or inserter), pre-deployment configuration according to one embodiment is shown. The full suture anchor 400 can include, but is not limited to, a flat fiber construct 4 having a first end 4A and a second end 4B, and an open elongated column / lumen 6 having a first end 6A and a second end 6B (each of the first end 6A and the second end 6B of the open elongated column / lumen 6 can extend between or beyond the first end 4A and the second end 4B of the flat fiber construct). The open elongated column / lumen 6 can be woven along an axis parallel to a central axis of the flat fiber construct 4, or along the central axis of the flat fiber construct, or can be woven along a path that is not parallel to the central axis. As shown in FIG. 38 FIG. 6, the open elongated column / lumen is woven along the central axis.

[0128] Still referring to FIG. 38 FIG. 6, a filament 2 is shown having a first end 2A and a second end 2B, and threaded through and at least partially positioned in the open column 6. In embodiments, the filament 2 is free to slide through the open column 6 such that the filament 2 can be removed from the open column 6 from the first end 2A of the fiber construct 2 and the second end 2B of the fiber construct 2. According to alternative embodiments, the filament is locked and cannot slide through the open column 6.

[0129] Turning now to FIG. 39A and FIG. 39B FIGS. 7 and 8, side schematic views of embodiments of the full suture anchor 400 in pre-deployment and post-deployment configurations are shown. As described above, the full suture anchor 400 comprises at least two segments: at least one suture 2 having a first end 2A and a second end 2B; an anchor body / fiber construct 4 having a first end 4A and a second end 4B, which is to form part of the anchor 400 as part of deployment, which can increase in width, thickness, and / or diameter, and can contract in length; and an open elongated column / lumen 6 extending from a first end 6A to a second end 6B.

[0130] As shown in FIG. 39AAs shown, an installation device (or inserter 10 as described above) in a pre-deployment configuration is provided. A full suture anchor 400 is shown attached to a distal deployment end 804 of an installation device 800 (which may be an inserter in the embodiments described herein), which also includes a handle 802. The distal deployment end 804 and the full suture anchor 100 are shown positioned within a bone hole 900 in cancellous bone 904 beneath the cortical bone 902. To deploy the full suture anchor 400 (which may be attached to other tissues that need to be juxtaposed with bone, as should be understood by one of ordinary skill in the art in conjunction with a review of this disclosure), a first end 2A and / or a second end 2B are pulled / tensioned in a direction away from the bone hole 400. Regardless of whether the mounting device 800 is properly positioned in the bone hole 900, the first end 2A and the second end 2B can be pulled / tensioned in a direction away from the bone hole 900 (if the mounting device 800 is properly positioned in the bone hole 900, it can be used as a reaction force against the tension pulled out of the hole 900 to assist in the deployment of the full suture anchor 400).

[0131] like FIG. 39B As shown, the anchor body / fiber structure 4 is depicted as "shortened" and "expanded" in the deployed configuration and locked within the bone hole 900, an additional result of the increased wrinkles formed by the fiber structure 4 (which may also be part of the fiber structure 4). See also FIG. 39C The fully stitched anchor 400, and particularly the fiber construction 4, utilizes Poisson's ratio (as described above relative to other anchors) that captures the cause / effect relationship: compression of the material in a first direction causes the material to expand in a direction perpendicular to the first direction (i.e., if compressed in the x-direction, the material will expand in the y-direction and / or z-direction), and stretching / elongating the material in the first direction causes the material to contract in a direction perpendicular to the first direction. Although the width, thickness, and / or diameter of the anchor body / fiber construction 4 increases upon deployment, it should be understood that the stitch 2 also plays a role in the deployment of the anchor 400, even though the stitch 2 may remain free to slide in some embodiments and is not slippery relative to the anchor body 4 in other embodiments (at least at a particular location or point of use). The stitch 2 helps to position, align, and support the anchor body 4 (as those skilled in the art should understand from this review of the disclosure).

[0132] In other words, the anchor body / fiber construct 4 has two main functions. First, it becomes the basis for the suture 2 to slide within (within the post / lumen 6). Second, when compressed and / or pleated during deployment, the anchor body 4 becomes more compact in one direction, thereby expanding outward and increasing its overall width, thickness, or diameter to create a retention capability. This action of causing the anchor body 4 to change shape to increase its overall width, thickness, or diameter is a useful feature that can be advantageously used to secure the anchor 400 in the hole 900 or against bone or soft tissue. It is this combination of the expanding anchor body 4 coupled with the suture 2 that remains slidable relative to the anchor body 4 (in some embodiments; and in other embodiments, at least at particular locations or points in use) that makes embodiments of the present invention ideal for soft tissue reattachment to bone or soft tissue to soft tissue, in which case it is desirable to deliver a sliding knot to secure the repair.

[0133] In one embodiment, there is provided inventive configurations, structures, and resulting functionality of soft all-suture anchors utilizing a hybrid combination of soft implantable materials. The hybrid soft all-suture anchors of the embodiments have superior pull-out strength characteristics compared to conventional soft all-suture anchors. Embodiments of the present invention provide for better soft all-suture anchors in hard bone, in part due to the hybrid expanding component portion. These embodiments are also suitable for use in soft cancellous bone where there is a very thin or weak cortical layer. The hybrid all-suture anchors can include, but are not limited to, an expandable member / portion configured to increase in size from a first pre-deployment condition to a second deployed condition upon application of an activating agent; and a filament having a first filament end and a second filament end and positioned in contact relationship with the expandable member in the second deployed condition. The anchor can also include a planar fiber construct having a first end and a second end, and wherein the filament passes through the fiber construct. The planar fiber construct includes a first state in which when in an unfolded and pre-deployment condition, the planar fiber construct is uncompressed and extends along a longitudinal axis of the filament; and a second state in which in the deployed condition, the planar fiber construct is compressed and expanded in a direction perpendicular to the longitudinal axis of the filament. The structure, configuration, and functionality of the expandable member, as well as the fiber construct, when part of the embodiments, contribute to the setting and retention of the anchor in a bone hole in the post-deployment condition. The expandable portion / member can be part of a hybrid all-suture anchor used with only any filament portion (as described herein). The expandable portion / member can also be part of a hybrid all-suture anchor used with any filament portion and any fiber construct portion (as described herein).

[0134] For example, see FIG. 40, showing a perspective view of hybrid soft full suture anchor 500 in a pre-deployment configuration, according to one embodiment. Hybrid full suture anchor 500 can include, but is not limited to, a planar fiber construct 4 having a first end 4A and a second end 4B. Filament 2 is shown as having a first end 2A and a second end 2B, and is woven, threaded, or otherwise passed through fiber construct 4 at a pass-through location. For further description of structural aspects of the filament and fiber construct, see US 9826971, which is part of this example of the invention (as will be understood by those of ordinary skill in the art in review of this disclosure).

[0135] In embodiments, filament 2 is free to slide through fiber construct 4 (and expandable portion 3 when attached thereto), such that filament 2 can be removed from fiber construct 4 from first end 4A of fiber construct 4 and / or second end 4B of fiber construct 4. According to alternative embodiments, the filament is locked and not slidable through fiber construct 4 and / or expandable portion 3 (when attached to expandable portion 3).

[0136] Turning now to FIG. 41A and FIG. 41B , showing a side view schematic of an embodiment of full suture anchor 500 in pre-deployment and post-deployment configurations. As described above, full suture anchor 500 includes at least two sections: at least one suture 2 having a first end 2A and a second end 2B; an anchor body / fiber construct 4 having a first end 4A and a second end 4B, configured to form a portion of anchor 500 that can increase in width, thickness, and / or diameter, and can contract in length as part of deployment. Full suture anchor 500 also includes an expandable portion 3, configured to form a portion of anchor 500 that can increase in size in a post-deployment configuration in response to an activating agent (as will be understood by those of ordinary skill in the art in review of this disclosure).

[0137] As FIG. 41AAs shown, a mounting device (or inserter 10 as described above) is provided in a pre-deployment configuration. The all-suture anchor 500 is shown connected to a distal deployment end 804 of a mounting device 800 (which can be an inserter as described above) that also includes a handle 802. The distal deployment end 804 and the all-suture anchor 500 are shown positioned in a bone hole 900 in cancellous bone 904 beneath cortical bone 902. To deploy the all-suture anchor 500 (which can be connected to other tissue that needs to be co-located with the bone, as will be appreciated by those of ordinary skill in the art in view of a review of the present disclosure), the first end 2A and / or the second end 2B are pulled / tensioned in a direction away from the bone hole 400. The first end 2A and the second end 2B can be pulled / tensioned in a direction away from the bone hole 900 regardless of whether the mounting device 800 is in place in the bone hole 900 (if the mounting device 800 is in place in the bone hole 900, it can act as a counterforce to the tension being pulled out of the hole 900 to assist in the deployment of the all-suture anchor 500). Additionally, an activating agent can be added to the anchor to cause the expandable portion to expand to a second size that is larger than the first pre-deployment size. In one embodiment, the activating agent is water.

[0138] As FIG. 41B shown, the anchor body / fiber construct 4 is shown "shortened" and "expanded" in a post-deployment configuration and locked in the bone hole 900 as a result of the added consequence of the pleats formed by the fiber construct 4 (which can also be a portion of the fiber construct 4). The all-suture anchor 500, and in particular the fiber construct 4, utilizes a Poisson's ratio (similarly, as described above) that captures the following cause / effect relationship: compressing a material in a first direction causes the material to expand in a direction perpendicular to the first direction (i.e., if compressed in the x-direction, the material will expand in the y-direction and / or z-direction), and stretching / elongating a material in a first direction causes the material to contract in a direction perpendicular to the first direction. While it is the anchor body / fiber construct 4 that increases in width, thickness, and / or diameter upon deployment, it will be appreciated that the suture 2 can also play a role in the deployment of the anchor 500, even though the suture 2 can remain free to slide in some embodiments, and in other embodiments (at least at particular locations or particular points in use) is not slidable relative to the anchor body 4. The suture 2 helps to position, align, and support the anchor body 4 (as will be appreciated by those of ordinary skill in the art in view of a review of the present disclosure).

[0139] In other words, the anchor body / fiber construct 4 has two main functions. First, it becomes the basis for the suture 2 to slide within (within the post / lumen 6). Second, when compressed and / or crimped during deployment, the anchor body 4 becomes more compact in one direction, thereby expanding outward and increasing its overall width, thickness, or diameter to create a retention capability. This action of causing the anchor body 4 to change shape to increase its overall width, thickness, or diameter is a useful feature that can be advantageously used to secure the anchor 500 in the hole 900 or against bone or soft tissue. It is this combination of the expanding anchor body 4 coupled with the suture 2 that remains slidable relative to the anchor body 804 (in some embodiments; and in other embodiments, at least at particular locations or points in use) that makes embodiments of the present application ideal for soft tissue reattachment to bone or soft tissue to soft tissue, in which case it is desirable to deliver a sliding knot to secure the repair.

[0140] Still referring to FIG. 41B , after exposure to the activating agent, the expandable portion 3 is shown expanded to a second, larger size than the first, smaller pre-deployment size. Upon exposure to the activating agent, the volume of the expandable portion expands greatly, thereby causing it to wedge into the bone hole 900 and lock the anchor 500 in place. According to one embodiment, to tension the filament 2 to reattach soft tissue (not shown), the filament 2 can be freely slid forward and backward through the fiber construct 4 and through the expandable portion 3 (as can be required when connected to the expandable portion 3). In certain cases where the fiber construct 4 is not present, the free-sliding filament 2 can saw / cut through the expandable portion 3, resulting in less than optimal deployment of the all-suture anchor 500. Thus, in some embodiments of the all-suture anchor 500 with or without the fiber construct 4, a second, short length of suture 2-1 can be wrapped or looped around the filament 2 (see FIG. 41C ) to prevent sawing / cutting through the expandable portion 3 by the filament 2 when in contact with the expandable portion 3.

[0141] Turning to FIG. 42 , a side-view digital photograph of an embodiment of the all-suture anchor of FIG. 40 is shown in a post-deployment configuration after addition of an activating agent according to one embodiment. As shown, the expandable portion 3 has increased in size to a second, deployed configuration (the bone hole is not shown to illustrate the extent of expansion of the expandable portion 3), and the filament 2 is positioned through and / or otherwise in contact with the expandable portion 3.

[0142] With respect to the filament 2 and fiber construct 4 described above, and FIG. 41AIn the embodiments shown as -C, similarly, expandable portion 3 can be part of any all-suture anchor described herein, or otherwise include an all-suture anchor shown and described in U.S. Patent Application No. 16 / 033,616. The above and FIG. 41A The same structure and function of expandable portion 3 shown as -C can apply to these embodiments of all-suture anchors (with and without fiber construction).

[0143] According to alternative embodiments of the present application, an all-suture anchor insertion device 600 is provided, as shown in FIG. 43-45 The all-suture anchor insertion device 600 is configured to drill a bone hole in a desired anchor deployment location, and deploy an all-suture anchor (which can include any all-suture anchor as discussed, referenced, described, and / or shown herein) in the bone hole with one device in one motion. In many procedures involving fixation of soft tissue in a limb, a common problem is that surgeons lose the location of the hole they drilled in the bone for anchor deployment after they remove the drill and guide. Additionally, during a typical anchor insertion, the drill hole guide must be held with one hand, while the other hand is used to drill the guide hole and insert the anchor. The all-suture anchor insertion device 600 combines the guide into the anchor, which allows for single-handed completion of the procedure. The all-suture anchor insertion device 600 also reduces the time required to install the anchor by combining the drill step and anchor insertion step into one step. The uniqueness of the all-suture anchor insertion device 600 involves, in part, the use of an anchor driver rod 601 to drill the bone tunnel by oscillating it on the drill. The oscillating motion of the drill causes the anchor driver rod 601 to spin back and forth. When the driver rod 601 is oscillating, the tips of the prongs 603-1 at the distal end of the device act as a drill bit to form a hole as the surgeon user pushes it into the bone. When the rod and anchor (positioned at the distal end of the device, not shown) have been inserted, the oscillation stops, and the driver rod 601 is pulled out. The all-suture anchor (as discussed herein) is then set by pulling on the suture tails of the anchor and / or adding an activating agent.

[0144] In short, as shown in FIG. 43-45 The all-suture anchor insertion device 600 includes, but is not limited to, an anchor driver rod 601, a guide 602 with a handle and suture wedge, a sliding guide tip 603, a metal guide tube 604, and a single loaded all-suture anchor (not shown, preferably positioned on the distal end near the prongs 603-1). The sliding guide tip 603 can be used to position the all-suture anchor before starting the oscillation of the device, and to protect any surrounding tissue while the anchor is oscillating and being inserted.

[0145] The preferred function of the full suture anchor insertion device 600 is to allow for insertion of an anchor in the method used by the surgeon with the fewest steps. In brief, the surgeon can connect a powered handpiece (not shown, e.g., as described above, or otherwise understood by one of ordinary skill in the art in view of the review of the present disclosure) having an equal oscillation pattern to the rear end of the inserter shaft 601. Holding the guide handle 602 and the powered handpiece, the surgeon can position the sliding guide tip 603 at a certain location in the bone and at the angle at which they want to install the anchor. The surgeon can then turn on the oscillation pattern of the handpiece and push the inserter shaft 601 into the bone (not shown). When the metal guide tube 604 becomes flush with the bone surface (and the distal end of the sliding guide tip 603 is flush with the distal end of the metal guide tube), the oscillation can be stopped, the suture (not shown) removed from the wedge, and the device removed. The anchor can then be set by pulling on the suture tail and / or adding an activator (as described herein and above).

[0146] Suture material, suture, or filament, as these terms are used and described herein can include monofilament or multifilament suture and any other metallic or non-metallic filamentary or thread-like material suitable for performing the function of a suture. The material can include bioabsorbable and non-absorbable materials and can be round, flat, or braided.

[0147] While embodiments of the application have been particularly shown and described with reference to certain illustrative embodiments, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the spirit and scope of the application as defined by the following claims supported by the written description and drawings. In addition, while example embodiments have been described with reference to a certain number of elements, it will be understood that fewer or greater than the certain number of elements can be utilized to practice the example embodiments.

Claims

1. An anchor inserter, comprising: An inserter tube extending along a central longitudinal axis, the inserter tube having a proximal inserter end and a distal inserter end; An inserter tip, the inserter tip being attached to and extending distally from the distal inserter end, the inserter tip having a proximal tip end and a distal tip end; A suture anchor retaining slot extends through the distal tip end; as well as One or more cutting edges, said one or more cutting edges extending at least partially along the outer peripheral edge of the distal tip end, The distal tip has a first arm and a second arm, and The second arm includes two recessed areas, which are corners of the second arm, and are recessed to form multiple cutting edges along the second arm. The proximal tip includes a tip projection portion with one or more protrusions, and the anchor inserter further includes a proximal tip tube located at the proximal tip. The tip projection portion is connected to the proximal tip tube, which includes two tip grooves spaced apart such that they are opposite each other. The protrusions of the tip projection portion are substantially aligned with the grooves of the proximal tip tube. The suture anchor retaining slot includes a straight portion connected to the curved portion, the curved portion extending from the straight portion at an angle.

2. The anchor inserter of claim 1, wherein the first arm is substantially straight and the second arm is curved.

3. The anchor inserter of claim 2, wherein the inner peripheral edge of the second arm extends at an angle relative to the longitudinal axis.

4. The anchor inserter of claim 3, wherein the second arm includes a second arm end that is substantially aligned with or extends beyond the first arm.

5. The anchor inserter of claim 1, further comprising a reamed edge extending at least partially along the outer peripheral edge of the distal tip end, the reamed edge being connected to one of the one or more cutting edges.

6. The anchor inserter of claim 1, wherein the proximal tip end is tapered, and its width increases toward the proximal tip tube.

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