Self-drilling anchor inserter

Abstract

To provide a drill, anchor driver, and a drill guide for drilling a bone hole at a surgical repair site and inserting a suture anchor in the bone hole.SOLUTION: An anchor inserter 10 includes an inserter tube 74 extending along a longitudinal axis and having a proximal inserter end 76 and a distal inserter end 78. The inserter also includes an inserter tip 12 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.SELECTED DRAWING: Figure 11

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 781,246, entitled "Self-Drilling Anchor Inserter," filed December 18, 2018, which is incorporated herein by reference in its entirety. This application is related to U.S. Provisional Patent Application No. 62 / 572,369, filed October 13, 2017, U.S. Provisional Patent Application No. 62 / 618,851, filed January 18, 2018, U.S. Provisional Patent Application No. 62 / 631,034, 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 / 536,208, filed July 24, 2017.

[0002] FIELD OF THEINVENTION The present invention relates to drills, anchor drivers, and drill guides for drilling bone holes and inserting suture anchors into bone holes at a surgical repair site, and more particularly to self-drilling total suture anchors and inserters. [Background technology]

[0003] 2. Description of Related Art Many orthopedic and medical procedures require the fixation of one body to another. Such bodies may include bones, soft tissue, and prosthetic limbs. One body may be fixed in position relative to another body using connector devices, such as screws and suture anchors (e.g., cannulated knotless suture anchors and soft all-suture anchors). For example, various orthopedic procedures require the insertion of suture anchors into and fixation with bone.

[0004] One example of a suture anchor is a soft suture anchor, such as the Y-Knot™ device. See, for example, U.S. Pat. No. 9,826,971. Because soft anchors are typically made entirely of suture material, they are sometimes referred to as "all suture" anchors, and generally include an anchor body portion of fibrous construction (or a fibrous, braided or woven type structure, such as a flexible web, as described in U.S. Pat. No. 9,173,652) and a suture or filament portion. In a conventional Y-Knot device, the suture is pierced completely through the braided material multiple times, so that the suture passes through a "front" surface and a "back" surface. When a Y-Knot anchor is constructed in a conventional manner, the suture segment on the back surface of the braid comes into contact with the bone and may wear down on the bone due to friction.

[0005] There are at least two conventional common methods for inserting a suture anchor into bone. In one method, a drill bit is used to create and prepare a bone hole. Typically, the drill bit is advanced through a drill guide to create the bone hole, and then the suture anchor is advanced through or past the drill guide into the bone for placement. If the drill guide is moved between creating the bone hole and advancing the suture anchor, it can become misaligned with the bone hole. If the drill guide is not aligned with the bone hole, it is often not possible to insert and place the suture anchor. Therefore, creation of a second bone hole is often required when the drill guide becomes misaligned with the first bone hole.

[0006] The second method eliminates the drilling step in an attempt to avoid the misalignment problem mentioned above. Self-punching suture anchors, such as the Y-Knot RC Suture Anchor, for example, allow the inserter to position the anchor directly at the desired location on the bone. Self-punching anchors are designed with an inserter that punches the bone. Once the inserter anchor is positioned in the desired location, the inserter can be driven to drive the anchor directly into the bone. However, driving the anchor into the bone subjects the bone to impact forces that may be undesirable depending on the location of the surgical site. For example, in glenoid bones or small bones such as extremities, impact forces may be particularly undesirable. Furthermore, self-punching anchors are generally required to be larger in size. Thus, such anchors may be undesirable or even impossible to use in smaller bones.

[0007] Therefore, 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 achieve the minimum hole size that occurs when the anchor is not contributing to the hole enlargement.

[0008] Related Art Section Disclaimer Description: To the extent that certain patents / publications / products are described in this Related Art Section Description or elsewhere in this disclosure, these descriptions should not be construed as an admission that the described patents / publications / products are prior art under patent law. For example, some or all of the described patents / publications / products may not be early enough in time, may not reflect subject matter developed early enough in time, and / or may not be sufficiently effective to amount to prior art for patent law purposes. To the extent that a particular patent / publication / product is discussed above in this Related Art Section Description and / or throughout the application, the description / disclosure is incorporated herein in its entirety by reference. BRIEF SUMMARY OF THE PRESENT DISCLOSURE

[0009] The embodiments of the present invention recognize that there are potential problems and / or shortcomings with conventional methods for drilling bone holes and inserting suture anchors (discussed herein above). For example, removing the drill bit from the drill guide and replacing it with a driver to insert the suture anchor increases the risk of misalignment of the bone hole with the drill guide, which requires additional surgical time and risks trauma to the surrounding tissue and bone. In another example, driving the anchor into the bone imposes an impact force on the bone, which may be undesirable depending on the location of the surgical site. Thus, there is a need for an easy-to-use suture anchor inserter that can insert a suture anchor into a bone without the need to drill a bone hole or impose an impact force on the bone, and achieve the minimum hole size that occurs when the anchor is not contributing to the enlargement of the hole. Various embodiments of the present invention may be advantageous in that they may solve or reduce one or more of the potential problems and / or shortcomings described herein.

[0010] The present disclosure is directed to the inventive composition, structure, and resulting function 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 and having a proximal inserter end and a distal inserter end. The inserter also includes an inserter tip attached to the distal inserter end 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 a circumferential 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.

[0011] According to another aspect, the present invention provides an anchor inserter including a cannulated inserter tube extending along a longitudinal axis and having a proximal inserter end and a distal inserter end. The anchor inserter also 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 anchor inserter further includes an inserter tip attached to the distal inserter end 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.

[0012] According to yet another aspect, the invention is an anchor inserter system further including a cannulated inserter tube extending along a longitudinal axis and having a proximal inserter end and a distal inserter end. The system also 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 the distal inserter end and extending distally from the distal inserter end. A suture anchor retention slot extends through the inserter tip and the anchor, and a length of suture positioned through the anchor extends through the suture anchor retention slot. A length of suture extends proximally along the inserter tip.

[0013] Suture material or suture, as the term is used and described herein, includes monofilament or multifilament sutures and any other metallic or nonmetallic filament or wire-like material suitable for performing the function of a suture, which may include both bioabsorbable and nonabsorbable materials.

[0014] Suture anchor, as used herein, can include soft suture anchors and hard suture anchors. Soft suture anchors are formed from filaments of suture material that are held in pre-formed bone holes by deforming to a diameter larger than the size of the bone hole, thereby residing in cancellous bone and subcortical bone. One such suture anchor is disclosed in U.S. Pat. No. 9,826,971, assigned to the assignee of the present application and incorporated herein by reference in its entirety. Since soft anchors are usually made entirely of suture material, they are sometimes referred to as "all-suture" anchors, and generally include an anchor body portion of a fibrous construction (or a fibrous, braided or woven type structure such as a flexible web, as described in U.S. Pat. No. 9,173,652) and a suture or filament portion. Methods and devices for inserting / positioning such all-suture anchors are known, examples of which are disclosed in U.S. Pat. No. 9,173,652. As described in U.S. Patent No. 8,409,252, for example, a "non-soft," "hard," or "rigid" suture anchor generally includes a "hard" anchor body portion (which may or may not include an inner member and an outer member) and a suture / filament portion.

[0015] The anchor bodies of such suture anchors may be formed of biocompatible and / or bioabsorbable materials. These materials may be of such compositions that are resorbed by the body, for example, during the bone healing process. Exemplary materials suitable for use in the inner and outer members include, but are not limited to, polyetheretherketone ("PEEK"), polylactic acid / β-tricalcium phosphate ("PLA / beta-TCP") composites, ultra-high molecular weight polyethylene ("UHMWPE"), and other metallic, non-metallic, and polymeric materials. [Brief description of the drawings]

[0016] The present invention will be more fully understood and appreciated from a reading of the following detailed description in conjunction with the accompanying drawings, which illustrate only typical embodiments of the disclosed subject matter and are not intended to limit the scope of the disclosed subject matter but to illustrate other equally effective implementations. Reference will now be made briefly to the accompanying drawings, in which:

[0017] [Figure 1] 1 is a schematic diagram of a perspective view of an inserter tip, according to one embodiment. [Diagram 2] 1 is a schematic diagram of a side view of the distal tip end of the inserter tip, according to one embodiment. [Diagram 3] 1 is a schematic diagram of a side perspective view of the distal tip end of the inserter tip, according to one embodiment. [Figure 4] 1 is a schematic diagram of an enlarged front view of the distal tip end of the inserter tip, according to one embodiment. [Diagram 5] 1 is a schematic diagram of an enlarged perspective view of an anchor positioned in an anchor retention slot of an inserter tip, according to one embodiment. [Figure 6] 1 is a schematic diagram of a perspective view of an inserter tip connected to a suture tube, according to one embodiment. [Figure 7] 1 is a schematic diagram of a perspective view of a distal suture tube end of a suture tube connected to an inserter tip, according to one embodiment. [Figure 8A] 1 is a schematic diagram of an enlarged perspective view of an inserter tip connected to a suture tube, according to one embodiment. [Figure 8B] 13 is a schematic diagram of an enlarged perspective view of an inserter tip connected to a suture tube according to an alternative embodiment. [Figure 9] 1 is a schematic diagram of an enlarged perspective view of a proximal suture tube end of a suture tube, according to one embodiment. [Figure 10] 1 is a schematic diagram of an enlarged rear perspective view of a proximal suture tube end of a suture tube, according to one embodiment. [Figure 11] 1 is a schematic diagram of a perspective view of a self-drilling anchor inserter, according to one embodiment. [Figure 12]1 is a schematic diagram of an enlarged perspective view of a distal inserter end of an inserter tube connected to an inserter tip, according to one embodiment. [Figure 13] 1 is a schematic diagram of a partially transparent perspective view of a distal inserter end of an inserter tube connected to an inserter tip, according to one embodiment. [Figure 14] 1 is a schematic diagram of a close-up view of the proximal inserter end of the inserter tube, according to one embodiment. [Figure 15] 1 is a schematic diagram of a perspective view of a guide, according to one embodiment. [Figure 16] 1 is a schematic diagram of a rear perspective view of a guide, according to one embodiment. [Figure 17] 1 is a schematic diagram of an enlarged perspective view of a guide tip, according to one embodiment. [Figure 18] 13 is a schematic diagram of an enlarged perspective view of a guide tip according to an alternative embodiment. [Figure 19] 13 is a schematic diagram of an enlarged perspective view of a guide tip according to another embodiment. [Figure 20] 1 is a schematic diagram of a side perspective view of a self-drilling anchor inserter in a retracted position, according to one embodiment. [Figure 21A] 1 is a schematic diagram of a side perspective view of a distal tip end of a self-trilling anchor inserter in a retracted position, according to one embodiment. [Figure 21B] 1 is a schematic diagram of an enlarged front view of the distal tip end of the inserter tip within the guide tip, according to one embodiment. [Figure 22] 1 is a schematic diagram of a side perspective view of a self-drilling anchor inserter in an extracted position according to one embodiment. [Figure 23] 1 is a schematic diagram of a side perspective view of a distal end of a self-drilling anchor inserter in an extracted position, according to one embodiment. [Figure 24A] 1 is a schematic diagram of a rear view of a full suture anchor, according to one embodiment. [Figure 24B] 24B is a schematic diagram of a top view of the entire suture anchor of FIG. 24A. [Figure 25A] 1 is a schematic diagram of a rear view of a full suture anchor, according to one embodiment. [Figure 25B] 25B is a schematic diagram of a top view of the entire suture anchor of FIG. 25A. [Figure 26A] 1 is a schematic diagram of a top view of a full suture anchor loaded onto an inserter tip, according to one embodiment. [Figure 26B] FIG. 26B is a schematic diagram of a side view of the entire suture anchor loaded onto the inserter tip of FIG. 26A. [Figure 27A] 13 is a schematic diagram of a top view of a full suture anchor loaded onto an inserter tip according to an alternative embodiment. [Figure 27B] 27B is a schematic diagram of a side view of the entire suture anchor loaded onto the inserter tip of FIG. 27A. [Figure 28A] 1 is a schematic diagram of a top view of a full suture anchor, according to one embodiment. [Figure 28B] 28B is a schematic diagram of a side view of the entire suture anchor of FIG. 28A. [Figure 29A] 1 is a schematic diagram of a top view of an anchor braid loaded with two lengths of suture, according to one embodiment. [Figure 29B] 13 is a schematic diagram of a top view of an anchor braid loaded with two lengths of suture according to an alternative embodiment. [Figure 30A] 1 is a schematic diagram of a top view of a threader passing through an anchor braid, according to one embodiment. [Figure 30B] 30B is a schematic diagram of a top view of the anchor braid of FIG. 30A with a first end loaded into a threader. [Figure 30C] 30B is a schematic diagram of a top view of the anchor braid of FIG. 30A having a central eyelet. [Diagram 31] 30D is a schematic diagram of a top view of the anchor braid of FIG. 30C, with the length of suture passing through the central eyelet. [Figure 32A] 1 is a schematic diagram of a top view of a folded and stitched anchor braid according to one embodiment. [Figure 32B] 32B is a schematic diagram of a top view of the anchor braid of FIG. 32A having an additional material covering. [Diagram 33]13 is a schematic diagram of a top view of an inserter in an unloaded, pre-deployment configuration according to an alternative embodiment. [Diagram 34] 13 is a schematic diagram of a top view of an inserter in an unloaded, pre-deployment configuration according to a further alternative embodiment. [Diagram 35] 1 is a schematic diagram of an enlarged perspective view of a distal end of the inserter, according to one embodiment. [Figure 36A] 1 is a schematic diagram of a side view of an embodiment of a suture anchor in an undeployed state, according to one embodiment. [Figure 36B] 36B is a schematic diagram of a side view of the shortened and expanded suture anchor of FIG. 36A in a deployed state, according to one embodiment. [Figure 37] 1 is a schematic diagram of a side view of a disposable handpiece, according to one embodiment. [Figure 38] FIG. 1 is a digital photograph of a perspective view of a soft all-suture anchor in an unloaded (not loaded into an attachment device or inserter) pre-deployment configuration according to one embodiment. [Figure 39A] 39 is a schematic diagram of a side view of one embodiment of the entire suture anchor of FIG. 38 connected to a mounting device or inserter in a pre-deployment configuration, according to one embodiment. [Figure 39B] 39 is a schematic diagram of a side view of one embodiment of a full suture anchor of FIG. 38 in a post-deployment configuration positioned in a bone hole, according to one embodiment. [Figure 39C] 39 is a digital photograph of a side view of one embodiment of the entire suture anchor of FIG. 38 in a post-deployment configuration positioned in a bone hole, according to one embodiment. [Diagram 40] FIG. 1 is a digital photograph of a perspective view of a soft all-suture anchor in an unloaded (not loaded into an attachment device or inserter) pre-deployment configuration according to one embodiment. [Diagram 41] 41A is a schematic diagram of a side view of an embodiment of the entire suture anchor of FIG. 40 connected to a mounting device or inserter in a pre-deployment configuration and FIG. 41B is a schematic diagram of a side view of an embodiment of the entire suture anchor of FIG. 40 in a post-deployment configuration positioned in a bone hole, according to one embodiment. [Figure 41C] 1 is a schematic diagram of a side view of a portion of an alternative embodiment of a full suture anchor, according to one embodiment. [Diagram 42] 41 is a digital photograph of a side view of one embodiment of the entire suture anchor of FIG. 40 in a post-deployment configuration after an activator has been added, according to one embodiment. [Diagram 43] 13 is a schematic diagram of a side view of a full suture anchor insertion device according to an alternative embodiment. [Diagram 44] 1 is a schematic diagram of a perspective view of a full suture anchor insertion device in a pre-deployment configuration and position according to an alternative embodiment. [Diagram 45] 1 is a schematic diagram of a perspective view of a full suture anchor insertion device in a pre-deployment configuration and position according to an alternative embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Referring now to the drawings, in which like reference numerals refer to like parts throughout, there is seen a self-drilling anchor inserter 10 (FIG. 11) and its component parts. The inserter 10 shown in FIG. 1 comprises an inserter tip 12. FIG. 1 is a schematic illustration of a perspective view of the inserter tip 12, according to one embodiment. The inserter tip 12 has a proximal tip end 14 and a distal tip end 16, with a shaft 18 extending therebetween. The shaft 18 extends along a central longitudinal yy axis. In the depicted embodiment, the shaft 18 is solid, but may be cannulated.

[0019] The proximal tip end 14 of the inserter tip 12 includes features for connecting the inserter tip 12 to the remainder of the self-drilling anchor inserter 10 (FIG. 11). Specifically, as shown in FIG. 1, the proximal tip end 14 comprises a tip protruding portion 20. In the depicted embodiment, the cross section of the tip protruding portion 20 is substantially triangular. In other words, the tip protruding portion 20 is tapered such that its diameter or width increases in the proximal direction relative to the central longitudinal yy axis (or shaft 18). The tip protruding portion 20 comprises one or more protrusions 22. In the depicted embodiment, the tip protruding portion 20 comprises two rectangular protrusions 22 that extend proximally and are spaced apart so as to be opposed to one another.

[0020] 1, distal prong portion 20 is connected to a cannulated proximal tip tube 24. Proximal tip tube 24 includes one or more distal recesses 26 extending therethrough. In the depicted embodiment, proximal tip tube 24 includes two distal recesses 26 that are spaced opposite one another. As also shown in FIG. 1, prongs 22 of distal prong portion 20 are substantially aligned with recesses 26 of proximal tip tube 24. As described in more detail below, prongs 22 and recesses 26 connect to features on the remainder of self-drilling anchor inserter 10 (FIG. 11).

[0021] 2, there is shown a schematic diagram of a side view of the distal tip 16 of the inserter tip 12, according to one embodiment. The distal tip 16 of the inserter tip 12 is generally forked (i.e., pointed) or hook-shaped and has a larger overall diameter or width than that of the shaft 18. As shown in FIGS. 1 and 2, the distal tip 16 comprises a first arm 28 that extends distally substantially parallel to a central longitudinal yy-axis. The first arm 28 is substantially straight with a rounded first arm end 30.

[0022] The distal tip end 16 also includes a second arm 32. The second arm 32 is substantially L-shaped as shown in FIG. 2. The second arm 32 includes a straight portion 34 that extends distally substantially parallel to the central longitudinal yy 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 peripheral edge 38 that curves toward the central longitudinal yy axis such that the inner peripheral edge extends substantially at an angle relative to the central longitudinal yy axis. Stated another way, the inner peripheral edge 38 of the second arm 32 curves toward an axis that extends the length of the first arm 28.

[0023] The configuration of first arm 28 and second arm 32 creates a suture anchor retention slot 40 therebetween. Suture anchor retention slot 40 also includes a straight portion 42 connecting to a curved portion 44 extending at an angle therefrom. Suture anchor retention slot 40 is sized or otherwise configured to retain the anchor braid and the length of suture of the entire suture anchor, allowing the entire suture anchor to be driven into the bone hole by inserter tip 12.

[0024] 3, there is shown a schematic diagram of a side perspective view of the distal tip end 16 of the inserter tip 12, according to one embodiment. The inner peripheral edge 38 of the second arm 32 of the distal tip end 16 extends to a sharpened second arm end 46. As shown in FIG. 1, the second arm end 46 has an edge 46A that extends substantially perpendicular to the central longitudinal yy axis. In FIGS. 1 and 2, the second arm end 46 extends beyond the first arm end 30 of the first arm 28 to ensure that the first arm end 30 does not significantly contact bone during drilling.

[0025] The second arm 32 also includes a peripheral edge 48 having a geometry optimized for drilling. As shown in FIG. 3, the peripheral edge 48 of the second arm 32 has a straight portion 50 that extends distally substantially parallel to a central longitudinal yy-axis. The peripheral edge 48 also includes an angled portion 52. The angled portion 52 extends at an angle relative to the straight portion 50 (and the central longitudinal yy-axis). Additionally, as shown, the angled portion 52 extends from the straight portion 50 at an angle relative to a transverse xx-axis that extends through the suture anchor retention slot 40.

[0026] The configuration of the angled portion 52 is due to a recessed region 54 on the second arm 32. As shown in FIG. 3, the angled portion 52 extends to a first end portion 56 of the peripheral edge 48. In the depicted embodiment, the first end portion 56 is substantially perpendicular to the straight portion 50. The first end portion 56 connects to a second end portion 58 of the peripheral edge 48. The second end portion 58 extends along a zz-axis that is substantially perpendicular to the longitudinal yy-axis and / or the transverse xx-axis. Together, the first and second end portions 56, 58 extend partially around an end surface 60 of the second arm 32.

[0027] As shown in Figures 1 and 3, the second arm 32 includes two recessed regions 54, which are corners of the second arm 32 that are recessed to create a plurality of cutting edges 62 along the second arm 32. The geometry of the distal tip end 16 creates positive rank and relief angles at the angled portion 52, the first end portion 56, and the second end portion 58. Together, the angled portion 52 and the first and second end portions 56, 58 of the peripheral edge 48 are the cutting edge 62 for an effective cutting action. The straight portion 50 of the peripheral edge 48 is the reaming edge 64.

[0028] 4, there is shown a schematic diagram of a close-up front view of the distal tip end 16 of the inserter tip 12, according to one embodiment. In particular, FIG. 4 shows the circumference c of the final hole created by the reaming edge 64 (FIG. 3). The final hole is sized and configured to achieve the minimum hole size that would result when the anchor (e.g., the anchor braid) does not contribute to the hole enlargement.

[0029] 5, there is shown a schematic diagram of an enlarged perspective view of an anchor 100 positioned within a suture anchor retention slot 40 of the inserter tip 12, according to one embodiment. As shown in FIG. 5, the anchor 100 has a first end 114A of the anchor 100 and a second end 114B of the anchor 100 along either side of the distal tip end 16 and shaft 18. 5, the suture 102 is attached to first and second ends 114A, 114B of the anchor 100. The suture 102 also extends over both 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 to the anchor 100. As also shown in FIG. 5, the suture 102 is attached to first and second ends 114A, 114B of the anchor 100. The suture 102 also extends over both sides of the distal tip end 16 and the shaft 18.

[0030] 6, there is shown a schematic diagram of a perspective view of the inserter tip 12 connected to a cannulated suture tube 66, according to one embodiment. As shown, the proximal tip end 14 of the inserter tip 12 connects to the suture tube 66. As will be described in detail below, the suture tube 66 includes features that allow a suture 102 connected to an anchor 100 to be run 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 cannulated proximal tip tube 24 of the inserter tip 12. In other words, the outer diameter of the distal suture tube end 68 is smaller than the inner diameter of the proximal tip tube 24.

[0031] In an alternative embodiment shown in FIG. 8B, 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 cannulated, 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 shown in FIG. 8B, 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 cannulated proximal tip tube 24 of the inserter tip 12. Thus, the first suture tube 66A performs a tubing function and the second suture tube 66B functions as a connector.

[0032] 7, there is shown a schematic diagram of a perspective view of a distal suture tube end 68 of a 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 cannulated 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 features to prevent the suture tube 66 from moving further into the proximal tip tube 24. This is to prevent the distal suture tube end 68 from pinching, compressing, or otherwise interfering with the suture 102. As shown in FIG. 7 and FIG. 8A, the suture 102 extends from the anchor 100 into the proximal tip tube 24 and into the distal suture tube end 68 of the cannulated suture tube 66.

[0033] 9 and 10, there are shown schematic close-up perspective and rear perspective views of the proximal suture tube end 70 of the suture tube 66, according to one embodiment. As shown in FIG. 9, the suture 102 extends into the distal suture tube end 68, then passes through the suture end 66 to the proximal suture tube end 70. As shown in FIG. 10, the suture 102 extends out of the proximal suture tube end 70 and is pulled back distally below the outer surface 72 of the suture tube 66.

[0034] 11, a schematic diagram of a perspective view of a self-trunching anchor inserter 10 is shown, according to one embodiment. To create the self-trunching anchor inserter 10, a suture tube 66 (FIG. 6) is placed through and into a cannulated inserter tube 74. The inserter tube 74 has a proximal inserter end 76 and a distal inserter end 78. The distal inserter end 78 extends to and connects to the proximal tip end 14 of the inserter tip 12.

[0035] 12, there is shown a schematic diagram of an enlarged perspective view of a distal inserter end 78 of an inserter tube 74 connected to the inserter tip 12, according to one embodiment. The distal inserter end 78 comprises features for connecting the inserter tube 74 to the inserter tip 12. In particular, as shown in FIG. 13, 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 created by crimping the distal inserter end 78. Thus, crimping the inserter tube 74 creates a partially circumferential cavity 82 along the outer circumference of the inserter tube 74, while the internal protrusions 79 are created along the inner circumference of the inserter tube 74. In the depicted embodiment, the distal inserter end 78 comprises two internal protrusions 79, which are spaced apart and opposed to one another.

[0036] 12 , the distal inserter end 78 further includes one or more inserter slots 84 extending at least partially through the inserter tube 74. In the depicted embodiment, the proximal tip tube 74 includes two inserter slots 84 that are spaced opposite one another. The inserter slots 84 of the inserter tube 74 are sized and configured to receive the protrusions 22 of the inserter tip 12. Similarly, the recesses 26 of the inserter tip 12 are sized and configured to receive the internal protrusions 79 of the inserter tube 74.

[0037] The resulting snap or press connection between the inserter tube 74 and the inserter tip 12 is shown in FIG. 13. In particular, FIG. 13 illustrates a schematic, partially transparent perspective view of the distal inserter end 78 of the inserter tube 74 connected to the inserter tip 12, according to one embodiment. As shown, the connection between the inserter slot 84 of the inserter tube 74 and the protrusion 22 of the inserter tip 12 is a light press connection. The protrusion 22 fits into the inserter slot 84 to withstand torsional and compressive loads. The internal protrusion 79 of the inserter tube 74 snaps into the recess 26 of the inserter tip 12 to withstand tension loads, interlocking the inserter tube 74 and the inserter tip 12.

[0038] In the embodiment of FIG. 13, the distal inserter end 78 further includes fine laser cuts 86 extending therein along the outer surface 80 of the inserter tube 74. The fine laser cuts 86 allow the distal inserter end 78 to have some flexibility. As also shown in FIG. 13, 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 suture 102 extends within the annular space between the inserter tube 74 and the suture tube 66. In FIG. 13, a free end 112 of the suture 102 is shown extending distally along the suture tube 66 between the inserter tube 74 and the inserter tube 74.

[0039] 14, which is a schematic diagram of a close-up 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 power handpiece interface, such as a quick-change connector 88. The quick-change connector 88 generally refers to features that facilitate the use of a power attachment for drilling. As shown in FIG. 11, the inserter tip 16 has a relatively thin profile in comparison to the inserter tube 74 and the quick-change connector 88.

[0040] Referring again to FIG. 14 , the quick-change connector 88 is compatible with conventional AO connections (as should be understood by those skilled in the art in conjunction with the discussion of this disclosure). However, other connections, such as Trinkle or Hudson connections, may also be used. In the depicted embodiment, the quick-change connector 88 includes one or more flats 90 extending along an axis parallel to the central longitudinal yy axis. In particular, the quick-change connector 88 includes three flats 90 having 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 flats 90 meet or otherwise converge. However, the three flats 90 allow the central longitudinal yy axis of the self-drilling anchor inserter 10 to be collinear with the central longitudinal yy axis extending through the grasping chuck (not shown).

[0041] The quick-change connector 88 may be formed from a solid piece of metal or may be formed into the proximal inserter end 76 of the inserter tube 74 (shown in FIG. 14). Forming the quick-change connector 88 into the tube provides a number of advantages for use with the self-drilling anchor inserter 10. For example, the proximal inserter end 76 may be open to better allow for the flow of ethylene oxide for sterilization of the suture material contained within the tube and may reduce the number of components required to assemble the self-drilling anchor inserter 10.

[0042] 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 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 wrapped around the outer surface 80 of the inserter tube 74. However, any other shape or configuration can be used for the hard stop feature 94 if sized sufficiently larger than the diameter of the guide 11.

[0043] 15 and 16, there are shown schematic perspective and rear perspective views of a guide 11, according to one embodiment. The guide 11 comprises a proximal guide handle 13 connected to a cannulated guide tube 15 through which a central longitudinal yy axis extends. 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 may be ergonomically shaped with an external ridge 21 for improved grip. As shown in FIG. 16, the guide handle 13 is cannulated such that the handle channel extending through the guide handle 13 is aligned with the tube channel extending through the guide tube 15.

[0044] In the embodiment shown in Figures 15-16, the handle channel is comprised of first and second channel portions 23A, 23B. The first channel portion 23A extends to the proximal handle end 25 of the guide handle 13, and the second channel portion 23B connects to the guide tube 15. The first and second channel portions 23A, 23B are separated by a space 27 within the guide handle 13. Additionally, as shown in Figure 16, one or more openings 29 extend through the guide handle 13 and into the space 27. The space 27 and openings 29 allow fluid to bypass the guide 11 rather than flow out the proximal handle end 25.

[0045] 17-19, enlarged oblique views of guide tip 17 are shown in accordance with several embodiments. 15 and 17, a schematic diagram of a perspective view is shown. 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 33 of reduced diameter. In other words, the length of the guide tip tube 31 is shortened in the two regions 33. These regions 33 are half-moon shaped, creating the fishmouth shape of the guide tip 17. The fishmouth shape of the guide tip 17 can compress the anchor 100 and provide stability during insertion.

[0046] In the embodiment shown in FIG. 18, the guide tip 17 has a crown shape. Specifically, the guide tip 17 has a protrusion 35 extending distally therefrom. In the embodiment depicted, the protrusion 35 is triangular and extends distally from the guide tip tube 31. In the embodiment shown in FIG. 19, the guide tip 17 is crown shaped, but the guide tube 15 includes a distal curved portion 37. The distal curved portion 37 is curved away from a central longitudinal yy axis that extends through the guide 11.

[0047] 20, a schematic diagram of a side perspective view of the 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 cannulated guide handle 13 and the cannulated guide tube 15). As shown in FIG. 20, in the retracted position, the distal tip end 16 of the inserter tip 12 is within the guide tip 17. As shown in the embodiment of FIG. 21A, the distal tip end 16 is within the crown-shaped guide tip 17. The protrusion 35 of the guide tip 17 extends distally beyond the distal tip end 16. In the retracted position, the anchor 100 is maintained within the guide tube 15 prior to insertion. As also shown in FIG. 21B, the guide tip 17 has a diameter d1 approximately the same as (or slightly larger than) the diameter d2 of the distal tip end 16. The similar diameters d1, d2 are designed such that there is minimal clearance between them.

[0048] 22, a schematic diagram of a side perspective view of the 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 extends distally through the guide 11. The self-drilling anchor inserter 10 may extend through the guide 11 until its hard stop feature 94 contacts the proximal handle end 25 of the guide 11. As shown in the embodiment of FIG. 23, the distal tip end 16 extends distally beyond the crown-shaped guide tip 17. The distal tip end 16 extends distally beyond the protrusion 35 of the guide tip 17. When the self-drilling anchor inserter 10 is in the extended position, an anchor 100 may be inserted and positioned.

[0049] 24A-B, there are shown schematic diagrams of front and back views of a full suture anchor 100, according to one embodiment. FIG. 24A shows a back view of the full suture anchor 100, and FIG. 24B shows a front view. As shown, the length of suture 102 passing into and out of the anchor braid / fibrous construct 104 passes through only one (e.g., "front") surface 106 of the anchor braid 104 (FIG. 24B). Similarly, FIGS. 25A-B also show a back view (FIG. 25B) and a front view (FIG. 25A) in which the suture 102 passes through only one (e.g., "front") surface 106 of the anchor braid 104 (FIG. 25B). When a 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 opposing (e.g., "back") surface 108 (FIGS. 24A and 25A) when loaded onto an inserter (e.g., as should be understood by one of ordinary skill in the art in conjunction with a discussion of this disclosure). In FIGS. 24A-25B, the suture 102 passes through the anchor braid 104 at numerous pass locations. The number of pass locations in FIGS. 26B and 27B is eight pass locations 110, while the number of pass locations for some alternative full suture anchors 100 is There are six pass locations 110. The number of pass locations 110 can vary depending on the composition and size of the suture 102 and / or 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 pick density, suture diameter, etc., to obtain output parameters such as manufacturability, anchor creep under load, and tensile strength.

[0050] 28A-B, there are shown schematic top and side views of an entire suture anchor 100 according to an alternative embodiment. As shown in FIGS. 28A-B, a length of suture 102 passes through approximately the center 105 of the anchor braid 104. In the illustrated embodiment, the length of suture 102 enters the anchor braid 104 through one (e.g., "front") face 106 and exits through an opposing (e.g., "back") face 108 of the anchor braid 104. As shown in FIGS. 11-13, with a length of suture 102 positioned on either side of the anchor braid 104, the anchor braid 104 may be positioned against the bone while the anchor braid 104 may be loaded onto the inserter 10 such that the length of suture 102 is aligned with the inserter 10.

[0051] In another alternative embodiment, as shown in Figures 29A-29B, the anchor braid 104 may be loaded with multiple lengths of suture 102A, 102B. In the illustrated embodiment, the anchor braid 104 is loaded with two lengths of suture 102A, 102B. The length of suture 102 may extend through the anchor braid 104 along its opposing edges 107A, 107B (Figure 29B), through two off-center locations 109A, 109B (Figure 29A), or any possible combination thereof (including an extension of the length of suture 102A, 102B through approximately the center 105 of the anchor braid 104). Additionally, the lengths of suture 102A, 102B may enter / exit the anchor braid 104 on the same plane (Figures 24A-25B) or on opposing planes (Figures 28A and 28B).

[0052] 30A-31, there are shown schematic top views of a full suture anchor 100 according to an additional alternative embodiment. FIGS. 30A-30C depict a process for creating an inverted anchor braid 104. As shown in FIG. 30A, a threader 128 having a threader loop 130 is first passed through the anchor braid 104. Then, in FIG. 30B, an end 114B of the anchor braid 104 is pulled through the threader loop 130. Finally, as shown in FIG. 30C, the threader loop 130 is pulled back through the anchor braid 104 to create a central eyelet 132. A length of suture 102 can be loaded onto the reverse anchor braid 104 by passing the length of suture 102 through the anchor braid 104 and passing it through the central eyelet 132 as shown in FIG. 31, as described in connection with any of the embodiments shown in FIGS. 24A-25B, 28A-28B, and 29A-29B.

[0053] 24A-25B, from the unloaded, pre-deployed configuration shown, the entire suture anchor 100 is loaded onto the inserter tip 16, as shown in the exemplary embodiment of the inserter tip 16 in FIGS. 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). Additionally, in one embodiment, the entire suture anchor 100 is fed through the suture anchor retention slot 50 such that four of the pass locations 110 are on opposite sides of the suture anchor retention slot 40 (and the inserter 10). The suture 102 is then pulled taut along the shaft 18 of the inserter tip 16, thereby tensioning the pair of ends 112A, 112B of the suture 102 and the pair of ends 112A, 112B of the anchor braid 104. Ends 114A, 114B extend along the inserter 10 (ie, each along an axis generally parallel to the central longitudinal yy axis).

[0054] 27A-27B, there are shown schematic top views of a full suture anchor according to an alternative embodiment in an unloaded, pre-deployed configuration and a loaded, pre-deployed configuration. The full suture anchor 100 shown in FIGS. 27A-27B is a Y-Knot suture anchor. Certain structural and functional aspects of the embodiment of the present invention are similar to the embodiment of the soft suture anchor described and illustrated in U.S. Patent Application Publication No. 9,826,971. These similarities should be understood by those skilled in the art in conjunction with a consideration of this disclosure and the accompanying drawings, together with the published application, and are not described in detail herein. Certain differences, including various inventive features of the embodiment of the present invention, will be more briefly described herein with reference to the accompanying drawings. However, in the embodiment in which the full suture anchor 100 is a Y-Knot suture anchor, only the anchor braid 104 is loaded into the inserter tip 16. 27B, when the anchor braid 104 is loaded into the suture anchor retention slot 40, the central portion 116 of the suture 102 is pulled away from the inserter tip 16 (i.e., in a distal direction), thereby preventing the suture 102 from falling into the suture anchor retention slot 40. Retaining the suture 102 out of the suture anchor retention slot 40 avoids potential damage to the suture 102 from heat generated in the arms 28, 32 (FIGS. 2-3) as it is drilled into the bone, or severing the suture 102 when the inserter 10 is removed.

[0055] 32A-32B, a schematic diagram of a top view of an anchor braid 104 with additional material 120 is shown, according to one embodiment. One skilled in the art should recognize and understand potential embodiments of a Y-Knot anchor with additional material for added strength, such as a monofilament polymer. The additional material can be applied to the entire suture anchor 104. As shown in FIG. 32A, the anchor braid 104 is folded in half. The monofilament 120 is used to stitch together each (i.e., two) side edges 122A, 122B of the anchor braid 104, creating a closed region 124 with the length of suture 102 inside, as shown in FIG. 32B. In addition to improving strength, this will prevent the anchor braid 104 from rolling on itself during insertion, causing wear by exposing the suture 102 to the bone. Additionally, twisting the anchor braid 104 as described, in combination with a denser material running within the shaft of the anchor braid 104, can result in a fully threaded suture anchor 100.

[0056] 33, there is shown a schematic diagram of a side view of the inserter 10 in a loaded, pre-deployment configuration at a bone hole location 39, 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 on the surface 41 of the bone 43. In the depicted embodiment, the inserter tip 16 loaded with the anchor braid 104 within the guide tip 17 is positioned on the surface 41 of the bone 43. Once positioned, while the guide 11 is held stationary relative to the bone 43, the user uses the handpiece to rotate the inserter via the quick-change connector 88, thereby rotating the inserter tip 16 and pushing the inserter 10 into the bone 43 until the anchor braid 104 is fully inserted into the bone 43. A feature such as a hard stop feature 94 (FIG. 14) limits the insertion depth by preventing the inserter 10 from proceeding further through the guide 11.

[0057] 34, there is shown a schematic diagram of a side view of the inserter 10 in a pre-deployment configuration, loaded in a bone hole 45, according to one embodiment. As shown, the inserter The inserter tip 16 forms a hole 45 in the bone 43 as the inserter 10 advances within the guide 11. Once the anchor braid 104 is inserted into the bone hole 45, the inserter 10 is removed leaving the anchor braid 104 behind in the bone hole 45. The force holding the anchor braid 104 in the bone hole 45 can be provided by interaction between the bone 43 and the anchor braid 104, or by interaction between the anchor braid 104 and another member introduced to hold the anchor braid 104 in place before the entire suture anchor 100 is deployed.

[0058] 35, a schematic diagram of a side view of the inserter 10 in an unloaded, post-deployment configuration is shown, according to one embodiment. 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, by a user directly pulling on the suture 102 (ends 112A, 112B), or by a combination of both means. The tension positions and secures the anchor braid 104 in the post-deployment configuration.

[0059] 36A-B, there is shown a schematic diagram of a side view of one embodiment of a full suture anchor 100 in pre-deployed and post-deployed configurations. In the illustrated embodiment, the full suture anchor 100 is a soft suture anchor, such as a Y-Knot® anchor 200. One such suture anchor is disclosed in U.S. Patent No. 9,826,971, assigned to the assignee of the present application and incorporated herein by reference in its entirety.

[0060] One embodiment of a Y-Knot® anchor (or soft anchor or "all suture" anchor) 200 is shown in detail in Figures 36A-36B. As shown in Figures 36A-36B, the Y-Knot® anchor 200 includes at least two sections: at least one suture 202, which is the suture to be secured; and an anchor body 204, which forms a portion of the anchor 200, which may increase in width, thickness, and / or diameter and decrease in length as part of the deployment. Looking to Figure 36A, the anchor body 204 is shown in a pre-deployment configuration, and looking to Figure 36B, the anchor body 204 is shown in a "shortened" and "expanded" post-deployment configuration, which is in addition to the increase due to the pleats. This soft anchor embodiment also utilizes Poisson's ratio, which captures the following cause and effect relationship: That is, 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 expands in the y and / or z directions), and stretching / stretching a material in a first direction causes the material to contract in a direction perpendicular to the first direction. It should be understood that while it is the anchor body 204 that increases in width, thickness, and / or diameter upon deployment, the suture 202 also plays a role in the deployment of the anchor 200, even though (in some embodiments) the suture 202 is free to slide relative to the anchor body 204 and in other embodiments is unable to slide (at least at certain locations or points). The suture 202 helps position, align, and support the anchor body 204 such that when the suture 202 is removed from the anchor body 204 after deployment of the anchor 200, the anchor body 204 is free to spill (i.e., release) and the anchor body 204 collapses and shrinks in size, allowing for easy (and potentially undesirable) removal.

[0061] That is, anchor body 204 has two primary functions. First, it provides a base for suture 202 to slide within. Second, when compressed and / or pleated during deployment, anchor body 204 becomes more compact in one direction, thereby expanding outward, increasing overall width, thickness or diameter and creating retention capacity. This effect of causing anchor body 204 to change in shape to increase overall width, thickness or diameter is a useful property that may be advantageously used to secure anchor 200 in hole 45 or relative to bone or soft tissue 43. When threading a sliding knot is desired to secure a repair, embodiments of the present invention may be used to facilitate reattachment of soft tissue to bone 43 or soft tissue to soft tissue. It is this combination of an expanding anchor body 204 coupled with a suture 202 that remains slidable (in some embodiments, and at least at certain locations or points during use, and in other embodiments non-slidable) relative to the anchor body 204 that makes it ideal for reattachment to the tissue.

[0062] The following discussion relates to alternative embodiments of disposable hand pieces, alternative embodiments of total suture anchors that may be used in conjunction with or deployed by the anchor inserter embodiments described herein, and alternative embodiments of anchor insertion devices / inserters and drills.

[0063] 37, a schematic diagram of a side view of a disposable handpiece 300 is shown, according to an alternative embodiment. The disposable handpiece may 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 (rotationally, linearly, perpendicular to the longitudinal axis of the device ("pushed")) by a user to turn on the drill bit 302 and / or set a desired speed for the drill bit 302. Alternatively, the motor may be activated by a predetermined force applied by the user through the handpiece 300 to the inserter against the bone (sufficient to begin drilling a hole in a particular bone, which may vary depending on the hardness and type of bone). The disposable handpiece 300 allows the device to be easily and quickly moved around. 33 , may also include a disposable plastic housing 305 to make it less expensive and disposable. The disposable plastic housing 305 may be made from any plastic or combination of plastics. The inserter may be disposable or may be provided pre-attached to the handpiece 300 as a kit. The quick-change connector 88 of the inserter 10 described herein may be attached to the chuck 302 of the disposable handpiece 300. The disposable handpiece may be used to rotate the inserter tip 16 and cutting edge 62 and drive the inserter 10 into the bone 43 until the anchor braid 104 is fully inserted into the bone 43 (as described in connection with FIG. 33 ).

[0064] In general, the alternative all suture anchor designs described and illustrated below are configured to work with and be deployed by the anchor inserters described herein in the same manner as the other all suture anchors described above and illustrated herein. As with the other all suture anchors, the alternative all suture anchor embodiments may include an anchor body portion of a fibrous construct (or a fibrous, braided or woven type structure such as a flexible web) and a suture or filament portion having a first end and a second end. The suture may pass through the filament in numerous ways (woven, passing through the struts, penetrating the top and bottom, etc., as should be understood by those skilled in the art in conjunction with a review of this disclosure). The fibrous construct may include a first state in which the fibrous construct is uncompressed and extends along the longitudinal axis of the filament when in an unfolded, pre-deployed state, and a second state in which the flat fiber construct is compressed and expanded in a direction perpendicular to the longitudinal axis of the filament when deployed.

[0065] According to one embodiment, the fibrous construct has open elongated struts / lumens extending from a first end to a second end, and the filaments pass at least partially through and are positioned in the open struts. In one embodiment, the filaments slide freely through the open struts so that the filaments can be removed from the first end of the fibrous construct and from the second end of the fibrous construct. Fibrous construct embodiments can also be tubular in addition to having open elongated struts / lumens. Flat tapes / fibrous constructs can be woven in situ directly onto the filaments (e.g., rounded section suture braids) or woven with open struts into which rounded section suture braids can be inserted later. In particular, as shown in FIG. 38, a perspective view of a soft all-suture anchor 400 in an unloaded (not loaded into an attachment device or inserter) pre-deployment configuration according to one embodiment is shown. The all-suture anchor 400 has, but is not limited to, a flat fibrous construct 4 having a first end 4A and a second end 4B, and an open elongated strut / lumen 6 having a first end 6A and a second end 6B (the first end 6A and the second end 6B of the open elongated strut / lumen 6 may extend between or behind the first end 4A and the second end 4B of the flat fibrous construct, respectively). The open elongated strut / lumen 6 may be woven along or along an axis parallel to the central axis of the flat fibrous construct 4, or may be woven along a path that is not parallel to the central axis. As shown in FIG. 38, the open elongated strut / lumen is woven along the central axis.

[0066] 38, a filament 2 having a first end 2A and a second end 2B is shown passing through and at least partially positioned within an open strut 6. In one embodiment, the filament 2 freely slides through the open strut 6 such that the filament 2 is removed from the first end 2A of the fibrous construct 2 and / or the second end 2B of the fibrous construct 2 and from the open strut 6. According to an alternative embodiment, the filament is locked and not slidable through the open strut 6.

[0067] 39A and 39B, there is shown a schematic diagram of a side view of one embodiment of a full suture anchor 400 in a pre-deployed and post-deployed configuration. As mentioned above, the full suture anchor 400 includes at least two sections, at least one suture 2 having a first end 2A and a second end 2B, and an anchor body / fiber construct 4 having a first end 4A and a second end 4B, with an open elongate strut / lumen 6 extending to a first end 6A and a second end 6B, which forms a portion of the anchor 400 that can increase in width, thickness, and / or diameter and can decrease in length as part of deployment.

[0068] As shown in FIG. 39A, an attachment device (or inserter 10 as described herein) is provided in a pre-deployment configuration. The entire suture anchor 400 is shown connected to a distal deployment end 804 of the attachment device 800, which may be an inserter of an embodiment described herein, also including a handle 802. The distal deployment end 804 and entire suture anchor 100 are shown positioned within a bone hole 900 in cancellous bone 904 beneath the bone cortex 902. To deploy the entire suture anchor 400 (which may be connected to other tissue that needs to be brought into apposition to the bone, as should be understood by those skilled in the art in conjunction with the discussion of this disclosure), the first end 2A and / or the second end 2B are pulled away from the bone hole 400 under tension. The first end 2A and the second end 2B can be pulled and drawn in a direction away from the bone hole 900 with or without the insertion device 800 in place within the bone hole 900 (when the insertion device 800 is in place within the bone hole 900, it acts as a counter force to the pulling force from the hole 900 to assist in placement of the entire suture anchor 400).

[0069] As shown in FIG. 39B, the anchor body / fibrous construct 4 is shown "shortened" and "expanded" in a deployed configuration and locked in the bone hole 900, which may be in addition to the increase due to pleats formed by the fibrous construct 4 (which may be part of the fibrous construct 4). See also FIG. 39C. The entire suture anchor 400, and in particular the fibrous construct 4, also utilizes Poisson's ratio (as described above for the other anchors), which captures the following cause and 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 expands in the y and / or z directions), and stretching / stretching the material in a first direction causes the material to contract in a direction perpendicular to the first direction. It is the anchor body / fibrous construct 4 that increases in width, thickness, and / or diameter upon deployment, while the suture 2 is free (in some embodiments) to slide and in other embodiments cannot slide (at least at certain locations or points) relative to the anchor body 4. Regardless, it should be understood that the suture 2 also plays a role in the placement of the anchor 400. The suture 2 helps to position, align, and support the anchor body 4 (as should be understood by one of ordinary skill in the art in conjunction with a discussion of this disclosure).

[0070] Thus, the anchor body / fibrous construct 4 has two primary functions. First, it provides a base for the suture 2 to slide within (within the strut / lumen 6). Second, when compressed and / or pleated during deployment, the anchor body 4 becomes more compact in one direction, thereby expanding outward, increasing its overall width, thickness or diameter and creating retention capabilities. This effect of changing the shape of the anchor body 4 to increase its overall width, thickness or diameter is a useful property that may be advantageously used to secure the anchor 400 within the hole 900 or against bone or soft tissue. It is this combination of an expanding anchor body 4 coupled with a suture 2 that remains slidable (in some embodiments, and at least at certain locations or points during use, in other embodiments non-slidable) relative to the anchor body 4 that makes embodiments of the present invention ideal for reattachment of soft tissue to bone, or soft tissue to soft tissue, when threading a sliding knot is desired to secure the repair.

[0071] In one embodiment, an inventive composition, structure, and resulting function of a soft all-suture anchor utilizing a hybrid combination of soft implantable materials is provided. The hybrid soft all-suture anchor of one embodiment includes superior pull-out strength properties compared to conventional soft all-suture anchors. The present invention provides a better soft all-suture anchor for use 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 anchor may include, but is not limited to, an expanding member / portion configured to increase in size from a first pre-deployed state to a second deployed state upon application of an activator, and a filament having a first filament and a second filament, positioned in contact with the expandable member in the second deployed state. The anchor may also include a flat fibrous construct having a first end and a second end, with the filament passing through the fibrous construct. The flat fibrous construct includes a first state in which the flat fibrous construct is uncompressed and extends along the longitudinal axis of the filaments when the flat fibrous construct is in an unfolded, pre-deployed state, and a second state in which the flat fibrous construct is compressed and expanded in a direction perpendicular to the longitudinal axis of the filaments when the flat fibrous construct is in a deployed state. The expandable member and the structure, configuration, and functionality (as part of the embodiment) of the fibrous construct help to set and retain the anchor in the bone hole in the post-deployed state. 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 fibrous construct portion (as described herein).

[0072] For example, referring to FIG. 40, a perspective view of a hybrid soft all suture anchor 500 in a pre-deployed configuration is shown, according to one embodiment. The hybrid all suture anchor 500 may include, but is not limited to, a flat fibrous construct 4 having a first end 4A and a second end 4B. A filament 2 is shown having a first end 2A and a second end 2B and woven, threaded, or otherwise passing through the fibrous construct 4 at a pass-through position. For further description of the structural aspects of the filaments and fibrous constructs that are part of this embodiment of the invention (and should be understood by those skilled in the art in conjunction with the discussion of this disclosure), see U.S. Pat. No. 9,826,971.

[0073] In one embodiment, the filament 2 is attached to the first end 4A of the fibrous construct 4 and / or the second end 4B of the fibrous construct 4 so that the filament 2 can be removed from the fibrous construct 4. The filaments 2 slide freely through the fibrous construct 4 (and, when attached thereto, the expandable portion 3). According to an alternative embodiment, the filaments are locked and not slidable through the fibrous construct 4 and / or the expandable portion 3 (when attached thereto).

[0074] 41A and 41B, there is shown a schematic diagram of a side view of one embodiment of a full suture anchor 500 in a pre-deployed and post-deployed configuration. As mentioned above, the full suture anchor 500 includes at least two sections, at least one suture 2 having a first end 2A and a second end 2B, and an anchor body / fibrous construct 4 having a first end 4A and a second end 4B, configured to form a portion of the anchor 500 that can increase in width, thickness, and / or diameter and can decrease in length as part of deployment. The full suture anchor 500 also includes an expandable portion 3 configured to respond to an activator to form a portion of the anchor 500 that can increase in size in the post-deployed configuration (as should be understood by one of ordinary skill in the art in conjunction with the discussion of this disclosure).

[0075] As shown in FIG. 41A, an attachment device (or inserter 10 as described herein) is provided in a pre-deployment configuration. A full suture anchor 500 is shown connected to a distal deployment end 804 of an attachment device 800, which may be an inserter as described herein above, also including a handle 802. The distal deployment end 804 and full suture anchor 500 are shown positioned within a bone hole 900 in cancellous bone 904 beneath the bone cortex 902. To deploy the full suture anchor 500 (which may be connected to other tissue that needs to be brought into apposition to the bone, as should be understood by those skilled in the art in conjunction with the discussion of this disclosure), the first end 2A and / or the second end 2B are pulled away from the bone hole 400 under tension. The first and second ends 2A, 2B can be pulled and drawn away from the bone hole 900 with or without the insertion device 800 in place within the bone hole 900 (when the insertion device 800 is in place within the bone hole 900, it acts as a counteracting force to the pulling force from the hole 900 to aid in the placement of the entire suture anchor 500). Additionally, an activator can be added to the anchor to cause the expandable portion to expand to a second size that is greater than the first pre-deployment size. In one embodiment, the activator is water.

[0076] As shown in FIG. 41B, the anchor body / fiber construct 4 is shown "shortening" and "expanding" in a deployed configuration and locked in the bone hole 900, which may be in addition to the augmentation due to pleats formed by the fibrous construct 4 (which may be part of the fibrous construct 4). The entire suture anchor 500, and in particular the fibrous construct 4, also utilizes Poisson's ratio (as also described above) which captures the following cause and 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 and / or z directions), and stretching / stretching the material in the first direction causes the material to contract in a direction perpendicular to the first direction. It should be understood that while it is the anchor body / fibrous construct 4 that increases in width, thickness, and / or diameter upon deployment, the sutures 2 also play a role in the deployment of the anchor 500, albeit with the sutures 2 freely sliding (in some embodiments) and not being able to slide (at least in certain locations or points) relative to the anchor body 4. The sutures 2 help to position, align, and support the anchor body 4 (as should be understood by one of ordinary skill in the art in conjunction with a discussion of this disclosure).

[0077] That is, the anchor body / fibrous construct 4 has two primary functions. First, it provides a base for the suture 2 to slide within (within the struts / lumens 6). Second, when compressed and / or pleated during deployment, the anchor body 4 becomes more compact in one direction, thereby expanding outward, increasing its overall width, thickness or diameter and creating retention capabilities. This action of changing the shape of the anchor body 4 and increasing its overall width, thickness or diameter is what causes the anchor body 4 to expand outward. This is a useful property that may be advantageously used to secure anchor 500 within hole 900 or relative to bone or soft tissue. It is this combination of an expanding anchor body 4 coupled with a suture 2 that remains slidable (in some embodiments, and at least at certain locations or points during use, in other embodiments non-slidable) relative to anchor body 804 that makes embodiments of the present invention ideal for reattachment of soft tissue to bone, or soft tissue to soft tissue, when threading a sliding knot is desired to secure a repair.

[0078] 41B, the expandable portion 3 is shown at an expanded second size, larger than the first smaller pre-deployment size, after being exposed to an activator. The expandable portion expands in volume upon exposure to the activator and wedges in the bone hole 900, locking the anchor 500 in place. According to an embodiment, the filament 2 may be freely slid back and forth through the fibrous construct 4 and the expandable portion 3 (as may be required when connected to the expandable portion 3) to tension the filament 2 and reattach the soft tissue (not shown). In certain circumstances where the fibrous construct 4 is not present, the slidable filament 2 may be cut through the expandable portion 3, resulting in a less than optimal placement of the entire suture anchor 500. As such, in some embodiments of the full suture anchor 500 with or without the fibrous construct 4, the short second length of suture 2-1 is wrapped or looped around the filament 2 (see FIG. 41C ) to prevent the filament 2 from sewing / cutting through the expandable portion 3 when it contacts the expandable portion 3.

[0079] 42, there is shown a digital photographic side view of the embodiment of the entire suture anchor of FIG. 40 in a deployed configuration after the addition of an activator, according to an embodiment. As shown, the expandable portion 3 has increased in size to a second deployed configuration state (bone hole not shown to illustrate the extent of expansion of the expandable portion 3) and the filament 2 is positioned through and / or otherwise contacting the expandable portion 3.

[0080] Similarly with respect to the filament 2 and fibrous construct 4 described above and the embodiments shown in Figures 41A-41C, the expandable portion 3 may be a portion of any full suture anchor described herein or may include a full suture anchor as shown and described in U.S. Patent Application No. 16 / 033,616. The same structure and function of the expandable portion 3 described above and shown in Figures 41A-41C are applicable to these embodiments of full suture anchors (with or without a filamentous construct).

[0081] According to an alternative embodiment of the present invention, a full suture anchor insertion device 600 is provided, as shown in FIGS. 43-45. The full suture anchor insertion device 600 is configured to drill a bone hole at a desired anchor placement location and place a full suture anchor (which may include any full suture anchor discussed, referenced, described, and / or illustrated herein) in the bone hole in one motion with one device. In many procedures involving quadruple soft tissue fixation, it is a common problem that the surgeon loses the location of the hole to be drilled in the bone for anchor placement after removing the drill and guide. Furthermore, during typical anchor insertion, the drill guide must be held in one hand while the other hand is used to drill the pilot hole and insert the anchor. The full suture anchor insertion device 600 allows the procedure to be performed one-handed by incorporating the guide in the anchor. The full suture anchor insertion device 600 also reduces the time required to install the anchor by combining the drilling and anchor insertion steps into one. The uniqueness of the entire suture anchor insertion device 600 relates, in part, to the use of the anchor driver rod 601 to drill a bone tunnel by oscillating the anchor driver rod 601 on a drill. The oscillating motion of the drill rotates the anchor driver rod 601 back and forth. As the driver rod 601 oscillates, the distal end of the device The tip of the prong 603-1 at the end acts as a drill bit to create a hole as the surgeon user drives it into the bone. Once the rod and anchor (located at the distal end of the device, not shown) are inserted, the vibration is stopped and the driver rod 601 is withdrawn. The entire suture anchor is then set by pulling on the suture tails of the anchor and / or adding an activator (as discussed herein).

[0082] Briefly, as shown in Figures 43-45, a full suture anchor insertion device 600 includes, but is not limited to, an anchor driver rod 601, a guide 602 with a handle and suture cleat, a sliding guide tip 603, a metal guide tube 604, and a single loaded full suture anchor (not shown, preferably positioned on the distal end near bifurcation 603-1). The sliding guide tip 603 can be used to position the full suture anchor before beginning to oscillate the device and to protect the surrounding tissue while the anchor is oscillated and inserted.

[0083] A preferred feature of the entire suture anchor insertion device 600 is that its method of use allows for anchor insertion with minimal steps from the surgeon. Briefly, the surgeon can connect a powered handpiece (not shown, e.g., as described above or as would be understood by one of ordinary skill in the art in conjunction with a discussion of this disclosure) having an equivalent vibration mode to the rear end of the inserter rod 601. Then, holding the guide handle 602 and the powered handpiece, the surgeon can position the sliding guide tip 603 at the location and angle of the bone where the surgeon wishes to attach the anchor. Further, the surgeon can turn on the vibration mode of the handpiece and drive the inserter rod 601 into the bone (not shown). When the metal guide tube 604 is 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 suture (not shown) is removed from the cleat and the device is removed. The anchor can then be set by pulling the suture tail and / or an actuator is added (as described herein and above).

[0084] Suture material, suture or filament, as that term is used and described herein, includes monofilament or multifilament sutures and any other metallic or nonmetallic filament or wire-like material suitable for performing the function of a suture, which may include both bioabsorbable and nonabsorbable materials and may be rounded, flat or braided.

[0085] Although embodiments of the present invention have been particularly shown and described with reference to certain exemplary embodiments, it will be understood by those skilled in the art that various changes in details may be made therein without departing from the spirit and scope of the invention as defined by the claims, which may be supported by the written description and drawings. Moreover, when an exemplary embodiment is described with reference to a particular number of elements, it will be understood that the exemplary embodiment may be implemented utilizing any of the particular number of elements or less.

Claims

1. an inserter tube extending along a longitudinal axis and having a proximal inserter end and a distal inserter end; an inserter tip attached to and extending distally from the distal inserter end, the inserter tip having a proximal tip and a distal tip; a suture anchor retention slot extending through the distal tip end; one or more cutting edges extending at least partially along a peripheral edge of the distal tip; An anchor inserter comprising:

2. The anchor inserter of claim 1 , wherein the distal tip end comprises a first arm and a second arm.

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

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

5. 5. The anchor inserter of claim 4, wherein the second arm includes a second arm end, the second arm end being substantially aligned with the first arm or extending beyond the first arm.

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

7. The anchor inserter of claim 1 , further comprising a proximal tip tube at the proximal tip end.

8. The anchor inserter of claim 7 , wherein the proximal tip end is tapered and increases in width toward the proximal tip tube.

9. a cannulated inserter tube extending along a longitudinal axis and having a proximal inserter end and a distal inserter end; a cannulated suture tube extending through the cannulated inserter tube, the cannulated suture tube having a proximal suture tube and a distal suture tube end; an inserter tip attached to and extending distally from the distal inserter end, the inserter tip having a proximal tip end and a distal tip end; one or more features on the proximal tip end removably connected to one or more features on the distal inserter end; An anchor inserter comprising:

10. The anchor inserter of claim 9 , wherein the proximal tip end comprises a proximal tip tube, the distal suture tube end extending at least partially within the proximal tip tube.

11. The anchor inserter of claim 9 , wherein the one or more features on the proximal tip end are protrusions and the one or more features on the distal inserter end are slots.

12. The anchor inserter of claim 9 , wherein the cannulated suture tube is substantially collinear with the longitudinal axis.

13. The anchor inserter of claim 9 , further comprising a quick-change connector attached to and extending proximally from the proximal inserter end.

14. The anchor inserter of claim 13 , wherein the quick change connector is an AO compatible quick change connector.

15. a cannulated inserter tube extending along a longitudinal axis and having a proximal inserter end and a distal inserter end; a cannulated suture tube extending through the cannulated inserter tube, the cannulated suture tube having a proximal suture tube end and a distal suture tube end; an inserter tip attached to and extending distally from the distal inserter end; a suture anchor retention slot extending through the inserter tip; Anchor and Equipped with The length of suture positioned through the anchor extends through the suture anchor retention slot, such that the length of suture extends proximally along the inserter tip.

16. The system of claim 15 , wherein the anchor is an anchor braid and the length of suture is positioned through one surface of the anchor braid.

17. The system of claim 15, further comprising a plurality of pass locations along the anchor, the length of suture being woven through the anchor at the plurality of pass locations.

18. The system of claim 15 , wherein the length of suture extends within the distal suture tube of the cannulated suture tube.

19. The system of claim 15, wherein the length of suture extends out of the cannulated suture tube at the proximal suture tube end and extends distally along an outer surface of the cannulated suture tube.

20. The system of claim 19, wherein the length of suture extends within an annular space between the cannulated suture tube and the cannulated inserter tube.

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