Self-drilling anchor inserter

Abstract

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 therefrom. The inserter tip has a proximal tip end and a distal tip end, and a suture anchor retention slot extends through the distal tip end. The inserter has one or more cutting edges extending at least partially along the outer peripheral 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

[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 THE INVENTION 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 part to another. Such bodies may include bones, soft tissues, and prosthetic limbs. One body part can be fixed in position relative to another body part using connector devices, such as screws and suture anchors (e.g., cannulated knotless suture anchors and soft all-suture anchors). For example, various orthopedic surgical 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, e.g., 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 conventional Y-Knot devices, the suture is threaded multiple times completely through the braided material, so that the suture passes through a "top" and a "bottom" surface. When Y-Knot anchors are constructed using conventional methods, the suture segment on the bottom of the braid comes into contact with the bone and can be worn down by friction.

[0005] There are at least two common conventional 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, the drill guide may 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, creating a second bone hole is often necessary 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 aforementioned misalignment problem. Self-punching suture anchors, such as the Y-Knot RC suture anchor, are designed with an inserter that allows the inserter to directly position the anchor at the desired location on the bone. Once the inserter anchor is positioned at the desired location, the inserter can be driven to drive the anchor directly into the bone. However, 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. For example, impact forces may be particularly undesirable in glenoid bones or small bones, such as those in the extremities. Furthermore, self-punching anchors generally require a larger size. Therefore, such anchors may not only be undesirable but may also be impossible to use in smaller bones.

[0007] Therefore, there is a need for a suture anchor inserter that can insert small suture anchors into bone without the need to drill a bone hole or apply impact forces to the bone, and that can achieve the smallest hole size that occurs when the anchor is not contributing to the hole enlargement.

[0008] Related Art Section Disclaimer Statement: 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 purposes of patent law. 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 by reference in its entirety. BRIEF SUMMARY OF THE INVENTION

[0009] Embodiments of the present invention recognize that there are potential problems and / or drawbacks with conventional methods for drilling bone holes and inserting suture anchors (discussed herein above). For example, removing a drill bit from a drill guide and replacing it with a driver to insert a 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 an anchor into bone subjects the bone to impact forces, which may be undesirable depending on the location of the surgical site. Therefore, there is a need for an easy-to-use suture anchor inserter that can insert a suture anchor into bone without the need to drill a bone hole or subject the bone to impact forces, and that can achieve the minimum hole size that occurs when the anchor is not contributing to the hole enlargement. 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 drawbacks described herein.

[0010] The present disclosure is directed to the inventive design, 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 therefrom. 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 the outer peripheral 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 is 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. The 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 non-metallic filament or wire-like material suitable for performing the function of a suture, which may include both bioabsorbable and nonabsorbable materials.

[0014] As used herein, the term "suture anchor" can include both soft and hard suture anchors. Soft suture anchors are formed from filaments of suture material that are retained within a pre-formed bone hole by deforming the filament so that its diameter exceeds the size of the hole, thereby residing within the cancellous bone and subcortically. One such suture anchor is disclosed in U.S. Pat. No. 9,826,971, which is assigned to the assignee of the present application and is incorporated herein by reference in its entirety. 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. Methods and devices for inserting / deploying such all-suture anchors are known, examples of which are disclosed in U.S. Pat. No. 9,173,652. As described in U.S. Pat. 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 can be formed of biocompatible and / or bioabsorbable materials. These materials can 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 / beta-tricalcium phosphate ("PLA / beta-TCP") composites, ultra-high molecular weight polyethylene ("UHMWPE"), and other metallic, non-metallic, and polymeric materials. [Brief explanation 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, to which other equally effective embodiments may be admitted. 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. [Figure 2] 1 is a schematic diagram of a side view of the distal tip end of an inserter tip, according to one embodiment. [Figure 3] 1 is a schematic diagram of a side perspective view of the distal tip end of an 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. [Figure 5] FIG. 10 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] 10 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]FIG. 1 is a schematic diagram of an enlarged perspective view of the distal inserter end of the inserter tube connected to the inserter tip, according to one embodiment. [Figure 13] 1 is a schematic diagram of a partially transparent perspective view of the distal inserter end of the inserter tube connected to the 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] 10 is a schematic diagram of an enlarged perspective view of a guide tip according to an alternative embodiment. [Figure 19] 10 is a schematic diagram of an enlarged perspective view of a guide tip according to another embodiment. [Figure 20] FIG. 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] FIG. 10 is a schematic diagram of a side perspective view of the distal tip end of a self-trilling anchor inserter in a retracted position, according to one embodiment. [Figure 21B] 10 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] FIG. 10 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] FIG. 10 is a schematic diagram of a side perspective view of the distal end of a self-trilling anchor inserter in the extracted position, according to one embodiment. [Figure 24A] 1 is a schematic diagram of a rear view of an entire 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 an entire 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 an entire suture anchor loaded onto an inserter tip, according to one embodiment. [Figure 26B] 26B is a schematic diagram of a side view of the entire suture anchor loaded onto the inserter tip of FIG. 26A. [Figure 27A] 10 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 an entire suture anchor, according to one embodiment. [Figure 28B] 28B is a schematic 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] 10 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] 10 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 with a central eyelet. [Figure 31] 30D is a schematic diagram of a top view of the anchor braid of FIG. 30C, with a 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 with an additional material covering. [Figure 33]10 is a schematic diagram of a top view of an inserter in an unloaded, pre-deployment configuration according to an alternative embodiment. [Figure 34] 10 is a schematic diagram of a top view of an inserter in an unloaded, pre-deployment configuration according to a further alternative embodiment. [Figure 35] 1 is a schematic diagram of an enlarged perspective view of the 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 an attachment 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 the entire 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 deployed configuration positioned in a bone hole, according to one embodiment. [Figure 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. [Figure 41] 41A and 41B are schematic side views of an embodiment of the entire suture anchor of FIG. 40 connected to an attachment device or inserter in a pre-deployment configuration and 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. [Figure 42] 41 is a digital photograph of a side view of one embodiment of the entire suture anchor of FIG. 40 in a deployed configuration after an activator has been added, according to one embodiment. [Figure 43] 10 is a schematic diagram of a side view of a full suture anchor insertion device according to an alternative embodiment. [Figure 44] 10 is a schematic diagram of a perspective view of an entire suture anchor insertion device in a pre-deployment configuration and position according to an alternative embodiment. [Figure 45] 10 is a schematic diagram of a perspective view of an entire suture anchor insertion device in a pre-deployment configuration and position according to an alternative embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0018] Referring now to the drawings, wherein 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 y-axis. In the depicted embodiment, the shaft 18 is solid, but may also 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 includes 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 tapers such that its diameter or width increases in the proximal direction relative to the central longitudinal y-axis (or shaft 18). The tip protruding portion 20 includes one or more protrusions 22. In the depicted embodiment, the tip protruding portion 20 includes two rectangular protrusions 22 that extend proximally and are spaced apart so as to face each other.

[0020] 1 , distal protrusion 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, which are spaced apart and opposite one another. As also shown in FIG. 1 , protrusions 22 of distal protrusion portion 20 are substantially aligned with recesses 26 of proximal tip tube 24. As described in detail below, protrusions 22 and recesses 26 connect to features on the remainder of self-drilling anchor inserter 10 ( FIG. 11 ).

[0021] Referring now to Figure 2, a schematic side view of the distal tip 16 of the inserter tip 12 is shown, 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 Figures 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 extending 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] Referring now to FIG. 3, a schematic diagram of a side perspective view of the distal tip end 16 of the inserter tip 12 is shown, 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 the central longitudinal y-y 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 y-y axis). Additionally, as shown, the angled portion 52 extends from the straight portion 50 at an angle relative to the transverse x-x 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 FIGS. 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 multiple 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, first end portion 56, and 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 edges 62 for effective cutting action. The straight portion 50 of the peripheral edge 48 is the reaming edge 64.

[0028] Referring now to Figure 4, there is shown a schematic diagram of an enlarged front view of the distal tip end 16 of the inserter tip 12, according to one embodiment. In particular, Figure 4 shows the circumference c of the final hole created by the reaming edge 64 (Figure 3). The final hole is sized and configured to achieve the minimum hole size that would result if the anchor (e.g., anchor braid) were not contributing to the hole enlargement.

[0029] Referring now to FIG. 5 , there is shown a schematic illustration of an enlarged perspective view of an anchor 100 positioned within the suture anchor retention slot 40 of the inserter tip 12, according to one embodiment. As shown in FIG. 5 , the anchor 100 is positioned or otherwise wound within the suture anchor retention slot 40 such that a first end 114A of the anchor 100 and a second end 114B of the anchor 100 extend along opposite sides of the distal tip end 16 and shaft 18. The anchor 100 is positioned relative to the cutting edge 62 such that all of the cutting edges 62 are distal to the anchor 100. Also shown in FIG. 5 , a suture 102 is attached to the first and second ends 114A, 114B of the anchor 100. The suture 102 also extends along opposite sides of the distal tip end 16 and shaft 18.

[0030] 6, a schematic diagram of a perspective view of an inserter tip 12 connected to a cannulated suture tube 66 is shown, 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 explained 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, with the second suture tube 66B 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 the tubing function and the second suture tube 66B functions as a connector.

[0032] 7, a schematic diagram of a perspective view of the distal suture tube end 68 of a suture tube 66 connected to the inserter tip 12 is shown, 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 FIGS. 7 and 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 illustrations of an enlarged perspective view and an enlarged rear perspective view 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 beneath the outer surface 72 of the suture tube 66.

[0034] 11 , a schematic diagram of a perspective view of a self-tapping anchor inserter 10 is shown, according to one embodiment. To create the self-tapping 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 , a schematic diagram of an enlarged perspective view of the distal inserter end 78 of the inserter tube 74 connected to the inserter tip 12 is shown, 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 includes two internal protrusions 79, which are spaced apart and opposite 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, which are spaced apart and 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 shows 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 along and into the outer surface 80 of the inserter tube 74. The fine laser cuts 86 allow the distal inserter end 78 to have some flexibility. Also shown in FIG. 13 , when the suture tube 66 is locked within the inserter tube 74 via the inserter tube 74's connection to the inserter tip 12, the suture 102 extends within the annular space between the inserter tube 74 and the suture tube 66. FIG. 13 shows a free end 112 of the suture 102 extending distally along the suture tube 66 between the inserter tube 74 and the inserter tube 74.

[0039] 14, a schematic illustration of a close-up view of the proximal inserter end 76 of the inserter tube 74 is shown, 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 a feature that facilitates the use of a power attachment for drilling. As shown in FIG. 11, the inserter tip 16 has a relatively thin profile compared 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 a 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 triangular cross-sections. The quick-change connector 88 also includes three grooves 92 extending within the quick-change connector 88 at locations 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 within the proximal inserter end 76 of the inserter tube 74 (shown in FIG. 14). Forming the quick-change connector 88 into the tube offers many 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, schematic perspective and rear perspective views of a guide 11 are shown, according to one embodiment. The guide 11 includes a proximal guide handle 13 connected to a cannulated guide tube 15 through which a central longitudinal y-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 external ridges 21 for improved grip. As shown in FIG. 16, the guide handle 13 is cannulated so 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. First channel portion 23A extends to the proximal handle end 25 of the guide handle 13, and 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 exiting the proximal handle end 25.

[0045] 17-19, schematic diagrams of enlarged perspective views of guide tip 17 are shown, according to several embodiments. In the embodiment shown in FIGS. 15 and 17, guide tip 17 has a fishmouth shape. Specifically, guide tip 17 is a guide tip tube 31 with two regions 33 of reduced diameter. In other words, the length of guide tip tube 31 is shortened in the two regions 33. These regions 33 are half-moon shaped, creating the fishmouth shape of guide tip 17. The fishmouth shape of guide tip 17 allows for compression of anchor 100 and provides 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 depicted embodiment, 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 curves away from a central longitudinal yy axis extending through the guide 11.

[0047] Referring now to FIG. 20 , a schematic 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 that is approximately the same as (or slightly larger than) the diameter d2 of the distal tip end 16. The similar diameters d1 and d2 are designed to minimize clearance between them.

[0048] Referring now to FIG. 22 , a schematic side perspective view of the self-drilling anchor inserter 10 in the 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 deployed.

[0049] 24A-24B, there are shown schematic front and back views of an entire suture anchor 100, according to one embodiment. FIG. 24A shows a back view of the entire 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-25B 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 the entire suture anchor 100 has sutures 102 passing through only one (e.g., "front") surface 106, the anchor braid 104 protects the sutures 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 the discussion of this disclosure). In FIGS. 24A-25B, the sutures 102 pass through the anchor braid 104 at numerous pass positions. The number of pass positions in FIGS. 26B and 27B is eight pass positions 110, while the number of pass positions in some alternative entire suture anchors 100 is six pass positions 110. The number of pass positions 110 can vary depending on the composition and size of the sutures 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-28B, schematic top and side views of an entire suture anchor 100 according to an alternative embodiment are shown. As shown in FIGS. 28A-28B, 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") surface 106 and exits through the opposing (e.g., "back") surface 108 of the anchor braid 104. With lengths of suture 102 positioned on either side of the anchor braid 104, the anchor braid 104 can be positioned against the bone while the anchor braid 104 can be loaded onto the inserter 10 such that the length of suture 102 is aligned with the inserter 10, as shown in FIGS. 11-13.

[0051] In another alternative embodiment, as shown in FIGS. 29A-29B, the anchor braid 104 can 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 can extend through the anchor braid 104 along its opposing edges 107A, 107B (FIG. 29B), through two off-center locations 109A, 109B (FIG. 29A), or any conceivable combination thereof (including an extension of the length of suture 102A, 102B through approximately the center 105 of the anchor braid 104). Furthermore, the lengths of suture 102A, 102B can enter / exit the anchor braid 104 on the same plane (FIGS. 24A-25B) or on opposing planes (FIGS. 28A and 28B).

[0052] 30A-31 , schematic top views of a full suture anchor 100 are shown, 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, creating 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 so 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). Further, in one embodiment, the entire suture anchor 100 is fed through the suture anchor retention slot 50 so 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 causing 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 approximately 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 embodiments of the present invention are similar to the soft suture anchor embodiments 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, along with that published application, and are not described in detail herein. Certain differences, including various inventive features of embodiments of the present invention, will be more briefly described herein with reference to the accompanying drawings. However, in embodiments 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., distally), thereby preventing the suture 102 from falling into the suture anchor retention slot 40. Retaining the suture 102 outside the suture anchor retention slot 40 avoids potential damage to the suture 102 from heat generated within 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 having additional material 120 is shown, according to one embodiment. Those skilled in the art should recognize and understand potential embodiments of a Y-knot anchor using additional material for increased 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. A 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 prevents the anchor braid 104 from rolling on itself during insertion, exposing the suture 102 to bone and causing wear. 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 , a schematic side view of the inserter 10 in a pre-deployment configuration loaded at a bone hole location 39 is shown, 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 the hard stop feature 94 ( FIG. 14 ) limits the insertion depth by preventing the inserter 10 from advancing further through the guide 11.

[0057] 34 , there is shown a schematic side view of the inserter 10 in a loaded, pre-deployment configuration in a bone hole 45, according to one embodiment. As shown, the inserter tip 16 forms the 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 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. The tension positions and secures the anchor braid 104 in the post-deployment configuration.

[0059] 36A-36B, there is shown a schematic side view of one embodiment of a whole suture anchor 100 in pre-deployed and post-deployed configurations. In the illustrated embodiment, the whole suture anchor 100 is a soft suture anchor such as a Y-Knot® anchor 200. 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.

[0060] One embodiment of a Y-Knot® anchor (or soft anchor or “all-suture” anchor) 200 is illustrated in detail in FIGS. 36A-36B. As shown in FIGS. 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 that may increase in width, thickness, and / or diameter and decrease in length as part of deployment. Looking at FIG. 36A, the anchor body 204 is shown in a pre-deployment configuration, while looking at FIG. 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 it to expand in a direction perpendicular to the first direction (i.e., when 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, albeit with the suture 202 being free to slide (in some embodiments) and not (at least at certain locations or points) relative to the anchor body 204 in other embodiments. 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), allowing the anchor body 204 to collapse and shrink in size, allowing for easy (and potentially undesirable) removal.

[0061] Thus, anchor body 204 has two primary functions. First, it provides a base 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, increasing its overall width, thickness, or diameter and creating holding capacity. This effect of causing anchor body 204 to change in shape to increase its overall width, thickness, or diameter is a useful property that can be advantageously used to secure anchor 200 in hole 45 or relative to bone or soft tissue 43. 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, in other embodiments non-slidable) relative to anchor body 204 that makes embodiments of the present invention ideal for reattaching soft tissue to bone 43 or soft tissue to soft tissue when threading a sliding knot is desired to secure the repair.

[0062] The following discussion relates to alternative embodiments of disposable handpieces, 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 the particular bone, which may vary depending on the hardness and type of bone). The disposable handpiece 300 allows the device to be lightweight and easy to use. , may also include a disposable plastic housing 305 to make it less expensive and more 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] Generally, the alternative suture anchor designs described and illustrated below are configured to operate with and be deployed by the anchor inserters described herein in the same manner as the other suture anchors described above and illustrated herein. Similar to the other suture anchors, alternative embodiments of the suture anchor 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 be threaded through the filament in numerous ways (woven, passing through struts, penetrating 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 have 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 flattened fibrous 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 the first end to the second end, with the filament at least partially passing through and positioned within the open struts. In one embodiment, the filament slides freely through the open struts, allowing the filament to be removed from the first end of the fibrous construct and the second end of the fibrous construct. In addition to having open elongated struts / lumens, the fibrous construct embodiment may also be tubular. A flat tape / fibrous construct may be woven in situ directly onto the filament (e.g., a rounded section suture braid) or may be woven with open struts into which a rounded section suture braid may 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-deployed configuration, according to one embodiment, is shown. The entire suture anchor 400 includes, but is not limited to, a flat fibrous construct 4 having a first end 4A and a second end 4B, and open elongated struts / lumens 6 having a first end 6A and a second end 6B (the first and second ends 6A and 6B of the open elongated struts / lumens 6 may extend between or behind the first and second ends 4A and 4B of the flat fibrous construct, respectively). The open elongated struts / lumens 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 struts / lumens are 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 slides freely through the open strut 6 such that the filament 2 can be 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 are shown schematic side views of one embodiment of a whole suture anchor 400 in pre-deployment and post-deployment configurations. As discussed above, the whole suture anchor 400 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; and an open elongate strut / lumen 6 extending to the first end 6A and the second end 6B, which form 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 an attachment device 800, which may be an inserter 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 below 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 counteracting force to the pulling force from the hole 900 to assist in the placement of the entire suture anchor 400).

[0069] As shown in FIG. 39B, the anchor body / fiber construct 4 "shortens" and "expands" in its deployed configuration and is shown 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). 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 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 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 suture 2 also plays a role in the deployment of the anchor 400, albeit with the suture 2 sliding freely (in some embodiments) and not (at least at certain locations or points) in other embodiments relative to the anchor body 4. 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 holding capacity. This effect of changing the shape of the anchor body 4 and increasing its overall width, thickness, or diameter is a useful property that can be advantageously used to secure the anchor 400 within the 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 the anchor body 4 that makes embodiments of the present invention ideal for soft tissue to bone reattachment or soft tissue to soft tissue reattachment when threading a sliding knot is desired to secure the repair.

[0071] In one embodiment, the inventive design, structure, and resulting functionality 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 pullout strength characteristics compared to conventional soft all-suture anchors. Embodiments of the present invention provide a soft all-suture anchor that is better suited for use in hard bone, in part due to the hybrid expandable component portion. These embodiments are also suitable for use in soft, cancellous bone with a very thin or weak cortical layer. The hybrid all-suture anchor may include, but is not limited to, an expandable 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 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 in a deployed state. The expandable member and the structure, configuration, and functionality (as some embodiments) of the fibrous construct aid in setting and retaining 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 filament construct portion (as described herein).

[0072] For example, referring to Figure 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 has a first end 2A and a second end 2B and is shown woven, threaded, or otherwise passing through the fibrous construct 4 at a pass-through position. For a 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 a discussion of this disclosure), see U.S. Patent No. 9,826,971.

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

[0074] 41A and 41B, there are shown schematic side views of one embodiment of a whole suture anchor 500 in a pre-deployed and a post-deployed configuration. As discussed above, the whole 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 whole suture anchor 500 also includes an expandable portion 3 (as should be understood by one of ordinary skill in the art in conjunction with a discussion of this disclosure) configured to respond to an activator to form a portion of the anchor 500 that can increase in size in the post-deployed configuration.

[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 above herein), which also includes 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 below 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. First end 2A and second end 2B can be pulled or drawn away from bone hole 900, with or without insertion device 800 in place within bone hole 900 (when insertion device 800 is in place within bone hole 900, it acts as a counter force to the pulling force from hole 900 to assist in placement of the entire suture anchor 500). Additionally, an activator can be added to the anchor to expand the expandable portion to a second size that is larger 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 "shortens" and "expands" in a deployed configuration, shown 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 (also as 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 suture 2 also plays a role in the deployment of the anchor 500, albeit with the suture 2 sliding freely (in some embodiments) and not (at least at certain locations or points) in other embodiments relative to the anchor body 4. 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).

[0077] 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 holding capacity. This effect of changing the shape of the anchor body 4 and increasing its overall width, thickness, or diameter is a useful property that can be advantageously used to secure the anchor 500 within the hole 900 or 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 the anchor body 804 that makes embodiments of the present invention ideal for soft tissue to bone reattachment or soft tissue to soft tissue reattachment when threading a sliding knot is desired to secure the 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 to a larger volume upon exposure to the activator and wedges in the bone hole 900, locking the anchor 500 in place. According to embodiments, the filament 2 can freely slide back and forth through the fibrous construct 4 and expandable portion 3 (as may be required when connected to the expandable portion 3) to tension the filament 2 and reattach soft tissue (not shown). In certain situations 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 deployment of the entire suture anchor 500. Therefore, in some embodiments of the entire 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 entire suture anchor embodiment 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 (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 contacting the expandable portion 3.

[0080] Similarly with respect to the filament 2 and fibrous construct 4 described above and the embodiment shown in Figures 41A-41C, the expandable portion 3 may be part of any of the full suture anchors described herein or may include the full suture anchor 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 is applicable to these embodiments of the full suture anchor (with or without the fibrous 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 a single motion with one device. In many procedures involving quadruple soft tissue fixation, a common problem is that surgeons lose the location of the hole drilled into the bone for anchor placement after removing the drill and guide. Furthermore, during typical anchor insertion, the drill guide must be held with one hand while the other hand is used to drill the pilot hole and insert the anchor. The full suture anchor insertion device 600 incorporates a guide into the anchor, allowing the procedure to be performed one-handed. 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 tip of the prong 603-1 at the distal end of the device acts as a drill bit, creating a hole as the surgeon user drives it into the bone. Once the rod and anchor (positioned at the distal end of the device, not shown) are inserted, the oscillation is stopped and the driver rod 601 is withdrawn. The entire suture anchor is then set by pulling the suture tail of the anchor and / or adding an activator (as discussed herein).

[0082] 43-45, whole suture anchor insertion device 600 includes, but is not limited to, anchor driver rod 601, guide 602 with handle and suture cleat portion, sliding guide tip 603, metal guide tube 604, and single loaded whole suture anchor (not shown, preferably positioned on the distal end near bifurcation 603-1). Sliding guide tip 603 can be used to position the whole suture anchor before starting to vibrate the device and to protect the surrounding tissue while the anchor is vibrated 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 light of this disclosure) having an equivalent vibration mode to the rear end of the inserter rod 601. Next, holding the guide handle 602 and the powered handpiece, the surgeon can position the sliding guide tip 603 at the bone position and angle where they wish to attach the anchor. The surgeon can then 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 non-metallic 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] While 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 detail can 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. Furthermore, 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 y-y 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 end and a distal tip end, the distal tip end including a first arm and a second arm; a suture anchor retention slot created between the first arm and the second arm and extending through the distal tip end; a plurality of cutting edges extending at least partially along the circumferential edge of the second arm of the distal tip; Equipped with the suture anchor retention slot comprises a curved portion and a straight portion connected to the curved portion, the curved portion extending obliquely at an angle from the straight portion; the first arm being substantially straight and the second arm being curved; an inner peripheral edge of the curved portion of the second arm extends obliquely at an angle relative to the longitudinal y-y axis; an x-x axis is perpendicular to the longitudinal y-y axis and parallel to a direction passing through the suture anchor retention slot; a zz axis is parallel to a direction perpendicular to the longitudinal y-y axis and the x-x axis, and distal and proximal lie on a line parallel to the longitudinal y-y axis; The plurality of cutting edges include: an angled portion extending obliquely at an angle relative to the longitudinal y-y axis and the xx axis, and extending from the lateral side to the medial side in a direction parallel to the xx axis as it moves from the proximal side to the distal side; a first end portion connecting to a distal side of the angled portion and extending along the xx axis; a second end portion connected to the first end portion and extending along the zz axis.

2. 2. The anchor inserter of claim 1, wherein the second arm comprises a second arm end that is co-located with the first arm along the zz axis or extends more distally than the first arm.

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

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

5. The anchor inserter of claim 4 , wherein the proximal tip end is tapered and increases in width toward the proximal tip tube.

Images