Anchor inserter and anchor inserter system

Abstract

The present invention relates to an anchor inserter and an anchor inserter system, the anchor inserter comprising an inserter tube extending along a longitudinal axis, the inserter tube 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 an outer perimeter edge of the distal tip end. The distal tip end has a first arm and a second arm. The first arm is substantially straight and the second arm is curved.

Description

[0001] This application is a divisional application of the invention application with application date of December 18, 2019, application number 201980084695.7, and name “Self-drilling anchor inserter”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 781,246, filed on December 18, 2018, and entitled “Self-Drilling Anchor Inserter,” the entire contents of which are incorporated herein by reference. This application is related to U.S. Provisional Patent Application No. 62 / 572369, filed on October 13, 2017, U.S. Provisional Patent Application No. 62 / 618851, filed on January 18, 2018, U.S. Provisional Patent Application No. 62 / 631034, filed on February 15, 2018, U.S. Provisional Patent Application No. 62 / 543,516, filed on August 10, 2017, and U.S. Provisional Patent Application No. 62 / 536208, filed on July 24, 2017. Technical Field

[0004] The present invention relates to anchor inserters and anchor inserter systems, and more particularly to drills, anchor drivers and drill guides for drilling and inserting suture anchors into bone holes at surgical repair sites, and more particularly to self-drilling all-suture anchors and inserters. Background Art

[0005] Many plastic surgery procedures and medical procedures require fixing one subject to another subject. Such subjects may include bone, soft tissue, and prosthesis. One subject may be fixed in place relative to another subject using connector devices such as screws and suture anchors (e.g., hollow non-knotted suture anchors and soft full suture anchors). For example, various plastic surgery procedures require insertion and fixation of suture anchors within bones.

[0006] An example of a suture anchor is a soft suture anchor such as Devices. See, e.g., U.S. Pat. No. 9,826,971. Because soft anchors are often made entirely of suture material, they are sometimes referred to as "all-suture" anchors, and typically include a fiber-constructed anchor body portion (or a fiber, braided or woven fabric-type structure, such as a flexible mesh, 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 completely pierced through the braided material multiple times so that the suture passes through the "front" surface and the "back" surface. When a Y-knot anchor is constructed in a conventional manner, the suture segments on the back surface of the braid come into contact with the bone and may be worn by the bone due to friction.

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

[0008] In the second method, the drilling step is eliminated in an attempt to avoid the above-mentioned misalignment problem. Self-perforating suture anchors, such as Y-knot RC suture anchors, are designed with inserters, for example, which allow the anchor in the inserter to be positioned directly at the desired position on the bone. When the anchor in the inserter is positioned at the desired position, the inserter can be hammered, thereby forcing the anchor to enter the bone directly. However, hammering the anchor into the bone will apply impact force to the bone, which may be undesirable for some surgical sites. For example, at the glenoid bone or smaller bones, such as in the limbs, the impact force may be particularly undesirable. In addition, the size of the self-perforating anchor is generally required to be larger. Therefore, such anchors may not only be undesirable, but also unusable in smaller bones.

[0009] Therefore, there is a need for a suture anchor inserter that can insert a small suture anchor into bone without drilling a bone hole or applying impact forces to the bone and that can achieve a minimum hole size that is created without the anchor causing the hole to enlarge.

[0010] Related Art Section Disclaimer Description: With respect to specific patents / publications / products discussed above in the Related Art Section Description or elsewhere in this disclosure, such discussion should not be considered an admission that the discussed patents / publications / products are prior art for patent law purposes. For example, some or all of the discussed patents / publications / products may not be sufficiently early in time, may not reflect subject matter that was developed early enough in time, and / or may not be sufficient to achieve prior art equivalents for patent law purposes. With respect to specific patents / publications / products discussed above in the Related Art Section Description and / or throughout the application, their descriptions / disclosures are incorporated herein by reference in their respective entireties. Summary of the invention

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

[0012] The present disclosure relates to the inventive configuration, structure and resulting function of a self-drilling anchor inserter configured to insert a suture anchor into a bone. According to one aspect, the present invention is an anchor inserter. The anchor inserter includes an inserter tube extending along a longitudinal axis, the inserter tube having a proximal inserter end and a distal inserter end. The inserter 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, wherein a suture anchor retaining 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.

[0013] According to another aspect, the present invention is an anchor inserter comprising a hollow inserter tube extending along a longitudinal axis and having a proximal inserter end and a distal inserter end. The anchor inserter also comprises a hollow suture tube extending through the hollow inserter tube. The hollow suture tube has a proximal suture end and a distal suture end. The anchor inserter also comprises 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.

[0014] According to yet another aspect, the present invention is an anchor inserter system comprising a hollow inserter tube extending along a longitudinal axis and having a proximal inserter end and a distal inserter end. The system also comprises a hollow suture tube extending through the hollow inserter tube. The hollow suture tube has a proximal suture end and a distal suture end. The system also comprises an inserter tip attached to the distal inserter end and extending distally from the distal inserter end. A suture anchor retaining slot extends through the inserter tip, and an anchor through which a length of suture is positioned extends through the suture anchor retaining slot. The length of suture extends proximally along the inserter tip.

[0015] Suture material or suture, as these terms are used and described herein, may include monofilament or multifilament suture and any other metallic or non-metallic filamentary or thread-like material suitable for performing the function of a suture. Such materials may include bioabsorbable and nonabsorbable materials.

[0016] Suture anchor, when the term is used in this article, can include soft suture anchor and rigid suture anchor. Soft suture anchor is formed by the filament of suture material, and these filaments are retained in the bone hole due to deformability to increase its diameter to a size greater than the preformed bone hole, so as to reside in the cancellous bone and below the bone cortex. One such suture anchor is disclosed in U.S. Patent No. 9826971 assigned to the assignee of this article, and the entire text of this U.S. Patent is incorporated herein by reference. Because soft anchors are often made entirely of suture material, they are sometimes referred to as "full suture" anchors, and generally include a fiber structure anchor body portion (or fiber, braided or woven fabric type structure, such as a flexible mesh, as described in U.S. Patent No. 9173652) and a suture or filament portion. Methods and devices for inserting / deploying such full suture anchors are known, and examples thereof are disclosed in U.S. Patent No. 9173652.

[0017] As described in U.S. Pat. No. 8,409,252, for example, a "non-flexible," "hard," or "rigid" suture anchor typically includes a "hard" anchor body portion (which may or may not include an inner member and an outer member) and a suture / filament portion. The anchor body of such a suture anchor can be formed of a biocompatible and / or bioresorbable material. These materials can have a composition such that they are reabsorbed by the body, for example, during the healing process of a bone. Exemplary materials suitable for use in the inner member and the outer member include, but are not limited to, polyetheretherketone ("PEEK"), polylactic acid / β-tricalcium phosphate ("PLA / β-TCP") composites, ultra-high molecular weight polyethylene ("UHMWPE"), and other metallic, non-metallic, and polymeric materials. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The present invention will be more fully understood and appreciated by reading the following detailed description in conjunction with the accompanying drawings. The accompanying drawings illustrate only typical embodiments of the disclosed subject matter and are therefore not to be considered limiting of its scope, as the disclosed subject matter may admit of other equally effective embodiments. Reference is now made briefly to the accompanying drawings, in which:

[0019] Figure 1 is a perspective schematic diagram of an inserter tip according to one embodiment;

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

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

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

[0023] Figure 5 is a close-up perspective schematic illustration of an anchor positioned within an anchor retaining slot at the tip of an inserter according to one embodiment;

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[0045] Fig. 24B yes Fig.24A A top view schematic diagram of a full suture anchor;

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

[0047] Fig.25B yes Fig.25A A top view schematic diagram of a full suture anchor;

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

[0049] Fig.26B is loaded to Fig.26A A schematic side view of a full suture anchor on the inserter tip;

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

[0051] Fig.27B is loaded to Fig.27A A schematic side view of a full suture anchor on the inserter tip;

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

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

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

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

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

[0057] Fig. 30B yes Fig. 30A A top schematic view of an anchor braid of wherein the first end is loaded into a threader;

[0058] Fig. 30C With central hole Fig. 30A A top view schematic diagram of an anchor braid;

[0059] Fig.31 A suture with a central eyelet Fig. 30C A top view schematic diagram of an anchor braid;

[0060] Fig.32Ais a top schematic view of a folded and stitched anchor braid according to one embodiment;

[0061] Fig.32B Is covered with additional material Fig.32A A top view schematic diagram of an anchor braid;

[0062] Fig.33 is a top schematic view of an inserter in an unloaded, pre-deployed configuration according to an alternative embodiment;

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

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

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

[0066] Fig.36B According to an implementation scheme Fig.36A A schematic side view of the suture anchor in a deployed state showing shortening and expansion;

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

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

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

[0070] Fig.39B is a post-deployment configuration positioned in a bone hole according to one embodiment Fig.38 A schematic side view of an embodiment of a full suture anchor;

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

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

[0073] Fig.41A is a device connected to a mounting device or inserter in a pre-deployment configuration according to one embodiment. Fig.40 A schematic side view of an embodiment of a full suture anchor;

[0074] Fig.41B is a post-deployment configuration positioned in a bone hole according to one embodiment Fig.40 A side schematic diagram of an embodiment of a full suture anchor embodiment;

[0075] Fig.41C is a schematic side view of a portion of an alternative embodiment of a full suture anchor according to one embodiment;

[0076] Fig.42 is in a post-deployment configuration after adding an activating agent according to one embodiment Fig.40 A digital photograph of a side view of an embodiment of a full suture anchor;

[0077] Fig.43 is a schematic side view of a full suture anchor insertion device according to an alternative embodiment;

[0078] Fig.44 is a perspective schematic illustration of a full suture anchor insertion device in a pre-deployment configuration and position according to an alternative embodiment; and

[0079] Fig.45 is a perspective schematic illustration of a full suture anchor insertion device in a pre-deployment configuration and position according to an alternative embodiment. DETAILED DESCRIPTION

[0080] Referring now to the drawings, wherein like reference numerals refer to like parts throughout, a self-drilling anchor inserter 10 ( Fig.11 ) and its component parts. The inserter 10 includes an inserter tip 12, such as Figure 1 shown. Figure 1 1 is a perspective schematic diagram of an inserter tip 12 according to one embodiment. The inserter tip 12 has a proximal tip end 14 and a distal tip end 16 and a shaft 18 extending therebetween. The shaft 18 extends along a central longitudinal yy axis. In the depicted embodiment, the shaft 18 is solid, although it can be hollow.

[0081] 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, Figure 1 As shown in , the proximal tip end 14 includes a tip protrusion 20. In the depicted embodiment, the cross-section of the tip protrusion 20 is generally triangular. In other words, the tip protrusion 20 is tapered so that its diameter or width increases in the proximal direction relative to the central longitudinal yy axis (or axis 18). The tip protrusion 20 includes one or more protrusions 22. In the depicted embodiment, the tip protrusion 20 includes two rectangular protrusions 22, which extend in the proximal direction and are spaced apart so that they are opposite.

[0082] Still refer to Figure 1 , the tip protrusion 20 is connected to a hollow proximal tip tube 24. The proximal tip tube 24 includes one or more tip grooves 26 extending therethrough. In the depicted embodiment, the proximal tip tube 24 includes two tip grooves 26 spaced apart so that they are opposite. Figure 1 As shown in FIG. 1 , the protrusion 22 of the tip protrusion portion 20 is substantially aligned with the groove 26 of the proximal tip tube 24. The protrusion 22 and the groove 26 are connected to the self-drilling anchor inserter 10 ( Fig.11 ) on the remainder of the device, as described in detail below.

[0083] Now go to Figure 2 , shows a schematic side view of the distal tip end 16 of the inserter tip 12 according to one embodiment. The distal tip end 16 of the inserter tip 12 is generally forked (i.e., forked) or hook-shaped, and its overall diameter or width is greater than the overall diameter or width of the shaft 18. Figure 1 and Figure 2 As shown in , the distal tip end 16 comprises a first arm 28 extending in a distal direction substantially parallel to the central longitudinal yy axis. The first arm 28 is substantially straight with a rounded first arm end 30.

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

[0085] The configuration of the first arm 28 and the second arm 32 creates a suture anchor retaining slot 40 therebetween. The suture anchor retaining slot 40 also includes a straight portion 42 connected to a curved portion 44 that extends at an angle. The suture anchor retaining slot 40 is sized or otherwise configured to retain a length of suture of the anchor braid and a full suture anchor, thereby allowing the full suture anchor to be pushed into a bone hole through the inserter tip 12.

[0086] Now go to Figure 3 , shows a side perspective schematic diagram 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 the sharp second arm end 46. Figure 1 As shown, the second arm end 46 has an edge 46A extending substantially perpendicular to the central longitudinal axis yy. Figure 1 and Figure 2 In the embodiment shown in FIG. 1 , the second arm end 46 extends through the first arm end 30 of the first arm 28 to ensure that the first arm end 30 does not make significant contact with the bone during drilling.

[0087] The second arm 32 also includes an outer peripheral edge 48 having an optimized geometry for drilling a hole. Figure 3 As shown in the figure, the outer peripheral edge 48 of the second arm 32 has a straight portion 50 extending substantially parallel to the central longitudinal yy axis in the distal direction. The outer peripheral edge 48 also includes an inclined portion 52. The inclined portion 52 extends at a certain angle relative to the straight portion 50 (and the central longitudinal yy axis). In addition, as shown in the figure, the inclined portion 52 extends from the straight portion 50 at a certain angle relative to the transverse xx axis extending through the suture anchor retaining slot 40.

[0088] The configuration of the inclined portion 52 is due to the recessed area 54 on the second arm 32. Figure 3 As shown, the inclined portion 52 extends to a first end portion 56 of the outer peripheral edge 48. In the depicted embodiment, the first end portion 56 is generally perpendicular relative to the straight portion 50. The first end portion 56 is connected to a second end portion 58 of the outer 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. The first end portion 56 and the second end portion 58 together extend partially around an end surface 60 of the second arm 32.

[0089] like Figure 1 and Figure 3, the second arm 32 includes two recessed areas 54, which are the corners of the second arm 32, which have been recessed to form a plurality of cutting edges 62 along the second arm 32. The geometry of the distal tip end 16 creates positive inclination and clearance angles at the inclined portion 52, the first end portion 56, and the second end portion 58. The inclined portion 52 and the first end portion 56 and the second end portion 58 of the outer peripheral edge 48 together are the cutting edges 62 for effective cutting action. The straight portion 50 of the outer peripheral edge 48 is a reaming edge 64.

[0090] Now go to Figure 4 , shows a close-up front schematic view of the distal tip end 16 of the inserter tip 12 according to one embodiment. In particular, Figure 4 The expanded edge 64 ( Figure 3 ) The circumference c of the final hole formed. The size and configuration of the final hole are set to the minimum hole size produced when the anchor (e.g., anchor braid) does not cause the hole to expand.

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

[0092] Now go to Figure 6 , shows a perspective schematic diagram of an inserter tip 12 connected to a hollow suture tube 66 according to one embodiment. As shown, the proximal tip end 14 of the inserter tip 12 is connected to the suture tube 66. As described in detail below, the suture tube 66 includes a suture 102 connected to an anchor 100 that allows the inserter 10 ( Fig.13 The suture tube 66 includes a distal suture tube end 68, the size and configuration of which are designed to fit within the hollow proximal tip tube 24 of the inserter tip 12. In other words, the outer diameter of the distal suture tube end 68 is smaller than the inner diameter of the proximal tip tube 24.

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

[0094] Reference now Figure 7 , shows a perspective schematic diagram of the distal suture tube end 68 of the suture tube 66 connected to the inserter tip 12 according to one embodiment. As shown, the suture tube 66 is at least partially located within the hollow proximal tip tube 24. The suture tube 66 does not extend completely into the proximal tip tube 24. The distal suture tube end 68 and the proximal tip tube 24 include features that 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 squeezing, compressing, or otherwise interfering with the suture 102. As shown in FIG. Figure 7 and Fig. 8A As shown, the suture 102 extends from the anchor 100 into the proximal tip tube 24 and into the distal suture tube end 68 of the hollow suture tube 66 .

[0095] Now turn to Fig. 9 and Fig.10 , showing a close-up perspective view and a close-up rear perspective view of the proximal suture tube end 70 of the suture tube 66 according to one embodiment. Fig. 9 As shown, after the suture 102 extends into the distal suture tube end 68, it passes through the suture tube 66 to the proximal suture tube end 70. Fig.10 As shown, the suture 102 extending from the proximal suture tube end 70 is pulled back distally along the outer surface 72 of the suture tube 66 .

[0096] Reference now Fig.11 , shows a perspective schematic diagram of a self-drilling anchor inserter 10 according to one embodiment. To produce the self-drilling anchor inserter 10, place the suture tube 66 ( Figure 6 ) passes through and is placed within a hollow inserter tube 74. The inserter 74 has a proximal inserter end 76 and a distal inserter end 78. The distal inserter end 78 extends and is connected to the proximal tip end 14 of the inserter tip 12.

[0097] Now go to Fig.12, shows a close-up perspective schematic diagram of the distal inserter end 78 of the inserter tube 74 connected to the inserter tip 12 according to one embodiment. The distal inserter end 78 includes features for connecting the inserter tube 74 to the inserter tip 12. In particular, as Fig.13 As shown, the distal inserter end 78 includes one or more internal protrusions 79 extending from the inner surface 81 of the inserter tube 74. According to one embodiment, the internal protrusions 79 are formed by curling the distal inserter end 78. Thus, curling the inserter tube 74 forms a partial circumferential cavity 82 along the outer circumference of the inserter tube 74 while forming the internal protrusions 79 along the inner circumference of the inserter tube 74. In the depicted embodiment, the distal inserter end 78 includes two internal protrusions 79 spaced apart so that they are opposed.

[0098] Still refer to Fig.12 , the distal inserter end 78 additionally includes one or more inserter slots 84 extending at least partially through the inserter tube 74. In the depicted embodiment, the inserter tube 74 includes two inserter slots 84 spaced apart so that they are opposed. 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.

[0099] The resulting snap or push connection between the inserter tube 74 and the inserter tip 12 is shown in FIG. Fig.13 In particular, Fig.13 A partially transparent perspective schematic diagram of the distal tip end 78 of the inserter tube 74 connected to the inserter tip 12 according to one embodiment is shown. 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 compression connection. The protrusion 22 fits into the inserter slot 84 to resist torsion and compression loads. The internal protrusion 79 of the inserter tube 74 snaps into the groove 26 of the inserter tip 12 to interlock the inserter tube 74 and the inserter tip 12 to resist tensile loads.

[0100] exist Fig.13 In the embodiment of the present invention, the distal inserter end 78 additionally includes a fine laser cut 86 extending along and into the outer surface 80 of the inserter tube 74. The fine laser cut 86 allows the distal inserter end 78 to have a certain flexibility. Fig.13 As shown, 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 in the annular space between the inserter tube 74 and the suture tube 66. Fig.13, the free end 112 of the suture 102 is shown extending distally along the suture tube 66 between the suture tube 66 and the inserter tube 74.

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

[0102] Reference again Fig.14 As shown, the quick-change connector 88 is compatible with conventional AO connections (as will be understood by one of ordinary skill in the art in conjunction with a review of the present disclosure). However, other connections, such as Trinkle or Hudson connections, may be used. In the depicted embodiment, the quick-change connector 88 includes one or more flat surfaces 90 extending along an axis parallel to the central longitudinal yy axis. Specifically, the quick-change connector 88 includes three flat surfaces 90 having a triangular cross-section. The quick-change connector 88 also includes three grooves 92 extending into the quick-change connector 88 at locations where two of the three flat surfaces 90 contact or otherwise converge. However, the three flat surfaces 90 allow the central longitudinal yy axis of the self-drilling anchor inserter 10 to be colinear with the central longitudinal yy axis extending through the gripping chuck (not shown).

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

[0104] Still refer to Fig.14 , the proximal inserter end 76 of the inserter tube 74 includes a hard stop feature 94. As shown in the depicted embodiment, the hard stop feature 94 is positioned or otherwise located along the proximal inserter end 76 of the inserter tube 74. The hard stop feature 94 is distal relative to the quick-change connector 88 so that the hard stop feature 94 prevents the quick-change connector 88 from entering or advancing through the guide 11 ( Fig. 22). In the depicted embodiment, the hard stop feature 94 is a ring that wraps around the outer surface 80 of the inserter tube 74. However, any other shape or configuration for the hard stop feature 94 may be used if the size is designed to be sufficiently larger than the diameter of the guide 11.

[0105] Now go to Fig.15 and Fig.16 , shows a perspective view and a rear perspective view of a guide 11 according to an alternative embodiment of a person. The guide 11 includes a proximal guide handle 13 connected to a hollow guide tube 15, wherein a central longitudinal yy axis extends therethrough. Fig.15 As shown, the guide tube 15 extends distally from the guide handle 13 to the guide tip 17. The guide handle 13 can be ergonomically shaped with an external ridge 21 for improved grip. Fig.16 As shown, the guide handle 13 is hollow so that a handle passage extending through the guide handle 13 is aligned with a tube passage extending through the guide tube 15 .

[0106] exist Figure 15-16 In the embodiment shown, the handle channel is composed of a first channel portion 23A and a second channel portion 23B. The first channel portion 23A extends to the proximal handle end 25 of the guide handle 13, while the second channel portion 23B is connected to the guide tube 15. The first channel portion 23A and the second channel portion 23B are separated by a space 27 in the guide handle 13. In addition, as shown in FIG. Fig.16 As shown, 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 escape the guide 11 rather than out the proximal handle end 25.

[0107] Reference now Figure 17-Figure 19 , shows a close-up perspective schematic diagram of the guide tip 17 according to one embodiment. Fig.15 and Fig.17 In the embodiment shown, the guide tip 17 has a fish mouth shape. Specifically, the guide tip 17 is a guide tip tube 31 having two areas 33 of reduced diameter. In other words, the length of the guide tip tube 31 is shorter in the two areas 33. These areas 33 are half-moon shaped, thereby forming the fish mouth shape of the guide tip 17. The fish mouth shape of the guide tip 17 allows it to compress the anchor 100 and provide stability during insertion.

[0108] exist Fig.18 In the illustrated embodiment, the inserter tip 17 has a crown-like 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. Fig.19In the embodiment shown, 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.

[0109] Now go to Fig. 20 , shows a schematic side view of a self-drilling anchor inserter 10 in a retracted position according to one embodiment. In use, the self-drilling anchor inserter 10 is placed by the guide 11 (via the hollow guide handle 13 and the hollow guide tube 15). Fig. 20 As shown, in the retracted position, the distal tip end 16 of the inserter tip 12 is located within the guide tip 17. Fig.21A As shown in the embodiment of FIG. 1 , the distal tip end 16 is located within the crown-shaped guide end 17. The protrusion 35 of the guide tip 17 extends distally through the distal tip end 16. In the retracted position, the anchor 100 is retained within the guide tube 15 prior to insertion. Fig.21B As shown, the guide tip 17 has a diameter d1 that is substantially the same as (or slightly larger than) the diameter d2 of the distal tip end 16. The similar diameters d1, d2 are designed for minimal clearance therebetween.

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

[0111] Brief reference Figure 24A-24B , which show front and rear schematic views of a full suture anchor 100 according to one embodiment. Fig.24A A rear view of the full suture anchor 100 is shown, and Fig. 24B 1. As shown, the length of suture 102 entering and exiting the anchor braid / fiber construction 104 passes through only one (e.g., "front") surface 106 ( Fig. 24B ). Similarly, Figure 25A-25B A rear view is also shown ( Fig.25B ) and the front view ( Fig.25A ), wherein the suture 102 passes through only one (eg, "front") surface 106 of the anchor braid 104 ( Fig.25BWhen the full suture anchor 100 has the suture 102 passing through only one (e.g., "front") surface 106, the anchor braid 104 protects the suture 102 from being passed through the opposite (e.g., "back") surface 108 ( Fig.24A and Fig.25A ) on the wear (as will be understood by one of ordinary skill in the art in conjunction with a review of this disclosure). Figure 24A-Figure 25B In FIG. 1 , suture 102 is passed through anchor braid 104 at a plurality of pass-through locations. Fig.26B and Fig.27B The number of through locations in the embodiment of the present invention is eight through locations 110, while the number of through locations of some alternative full suture anchors 100 is six through locations 110. The number of through locations 110 may vary depending on the composition and size of the suture 102 and / or the anchor braid 104. The number of through locations 110 may be optimized by balancing input parameters (such as anchor braid length, anchor braid width, anchor braid pick density, suture diameter, etc.) to produce output parameters (such as manufacturability, anchor creep under load, and pull-out strength).

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

[0113] In another alternative embodiment, Figure 29A-29B As shown, the anchor braid 104 can be loaded with multiple sutures 102A, 102B. In the depicted embodiment, the anchor braid 104 is loaded with two sutures 102A, 102B. The multiple sutures 102 can be arranged along their opposite edges 107A, 107B ( Fig.29B ) extends through the anchor braid 104, passing through two eccentric locations 109A, 109B ( Fig.29A ), or any conceivable combination thereof (including the length of suture 102A, 102B extending through the approximate center 105 of the anchor braid 104). In addition, the plurality of sutures 102A, 102B may be on the same surface ( Figure 24A-Figure 25B ) or on the opposite surface ( Figure 28A-28B) enter / leave the anchor braid 104.

[0114] See now Figure 30A-Figure 31 , shows a top schematic view of a full suture anchor 100 according to an additional alternative embodiment. Figure 30A-Figure 30C A process for producing an inverted anchor braid 104 is depicted. Fig. 30A As shown, the threader 128 having the threader loop 130 is first passed through the anchor braid 104. Then, Fig. 30B In the embodiment, the end 114B of the anchor braid 104 is pulled through the threader loop 130. Finally, the threader loop 130 is pulled back through the anchor braid 104 to form a central eyelet 132, as shown in FIG. Fig. 30C By passing a length of suture 102 through the anchor braid 104 (such as a combination Figure 24A-Figure 25B , Figure 28A-28B and Figure 29A-29B 132 (as described in any of the embodiments shown in FIG. Fig.31 As shown), the length of suture 102 may be loaded onto the inverted anchor braid 104.

[0115] Return to see Figure 24A-Figure 25B , from the unloaded pre-deployment configuration shown, the full suture anchor 100 is loaded onto the inserter tip 16, as shown. Figure 26A-26B 16. To load the inserter tip 16, the anchor braid 104 is fed through the suture anchor retaining slot 40 so that a pair of ends 112A, 112B of the suture 102 and a pair of ends 114A, 114B of the anchor braid 104 are on opposite sides of the suture anchor retaining slot 40 (and the inserter 10). In addition, in one embodiment, the full suture anchor 100 is fed through the suture anchor retaining slot 50 so that four of the pass positions 110 are on opposite sides of the suture anchor retaining slot 40 (and the inserter 10). The suture 102 is then tensioned along the axis 18 of the inserter tip 16, which causes the pair of ends 112A, 112B of the suture 102 and the pair of ends 114A, 114B of the anchor braid 104 to extend along the inserter 10 (i.e., each along an axis substantially parallel to the central longitudinal yy axis).

[0116] Now go to Figure 27A-27B , showing a top schematic view of a full suture anchor in an unloaded pre-deployment configuration and a loaded pre-deployment configuration according to an alternative embodiment. Figure 27A-27BThe full suture anchor 100 shown in is a Y-knot suture anchor. Certain structural and functional aspects of the embodiments of the present invention are similar to the embodiments of the soft suture anchor described and shown in U.S. 9,826,971. Those similarities should be understood by one of ordinary skill in the art in conjunction with a review of the present disclosure and the accompanying drawings, in conjunction with the published applications, and will not be discussed in further detail herein. Certain differences in the various inventive features comprising the embodiments of the present invention are further briefly described herein and below with reference to the accompanying drawings. However, in the embodiment where the full suture anchor 100 is a Y-knot suture anchor, only the anchor braid 104 is loaded into the inserter tip 16. As Fig.27B As shown, when the anchor braid 104 is loaded into the suture anchor retaining slot 40, the central portion 116 of the suture 102 is pulled away from the inserter tip 16 (i.e., pulled in a direction distal to the inserter tip). This prevents the suture 102 from falling into the suture anchor retaining slot 40. Keeping the suture 102 out of the suture anchor retaining slot 40 avoids the suture 102 from being pulled out of the suture anchor retaining slot 40 by the arms 28, 32 ( Figure 2-Figure 3 ) to prevent potential damage to the suture 102 due to the heat generated when drilling into the bone, or to avoid being cut when removing the inserter 10.

[0117] Now go to Figure 32A-32B , shows a top view schematic diagram of an anchor braid 104 with additional material 120 according to one embodiment. One of ordinary skill in the art will recognize and understand possible embodiments of a Y-knot anchor having additional material (such as a monofilament polymer) for added strength. Additional material may be applied to a full suture anchor 104. Fig.32A As shown, the anchor braid 104 is folded in half. Each (i.e., two) side edges 122A, 122B of the anchor braid 104 are sutured together using monofilament 120 to form a closed area 124, wherein the length of suture 102 is inside, such as Fig.32B In addition to increasing strength, this will prevent the anchor braid 104 from turning over on itself during insertion and exposing the suture 102 to the bone, thereby causing wear. Additionally, the described twisting of the anchor braid 104 combined with the denser material extending in the axis of the anchor braid 104 can produce a threaded, fully suture anchor 100.

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

[0119] Turning now to 34, a schematic side view of the inserter 10 in a loaded pre-deployment configuration in accordance with one embodiment is shown in a bone hole 45. As shown, as the inserter 10 is advanced in the guide 11, the inserter tip 16 forms a hole 45 in the bone 43. Once the anchor braid 104 is inserted into the bone hole 45, the inserter 10 is removed, leaving the anchor braid 104 in the bone hole 45. The force 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 full suture anchor 100 is deployed.

[0120] See now Fig.35 , shows a schematic side view of the inserter 10 in an unloaded post-deployment configuration 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, the user pulling directly on the suture 102 (ends 112A, 112B), or a combination of both means. The tension deploys the anchor braid 104 into the post-deployment configuration to provide fixation.

[0121] Now go to Figure 36A-36B , shows a schematic side view of an embodiment of a full suture anchor 100 in a pre-deployment and post-deployment configuration. In the depicted embodiment, the full suture anchor 100 is a soft suture anchor, such as Anchor 200. One such suture anchor is disclosed in US Pat. No. 9,826,971, assigned to the assignee herein, which is incorporated herein by reference in its entirety.

[0122] An embodiment of the anchor (or soft anchor or "full suture" anchor) 200 is Figure 36A-36B As shown in detail in Figure 36A-36B As shown, Anchor 200 comprises at least two sections: at least one suture 202, which is the suture to be anchored, and an anchor body 204, which will form a portion of anchor 200 that can increase in width, thickness and / or diameter, and can shrink in length, as part of deployment. Fig.36A , showing the anchor body 204 in a pre-deployment configuration; and Fig.36B , showing the "shortened" and "expanded" anchor body 204 in a post-deployment configuration, which is an additional result of the increase caused by the wrinkles. This soft anchor embodiment also takes advantage of Poisson's ratio, which captures the following cause / effect relationship: compressing a material in a first direction causes the material to expand in a direction perpendicular to the first direction (i.e., if compressed in the x-direction, the material will expand in the y-direction and / or z-direction), and stretching / stretching the material in the first direction causes the material to contract in a direction perpendicular to the first direction. Although it is the anchor body 204 that increases in width, thickness, and / or diameter upon deployment, it should be understood that the suture 202 may also play a role in the deployment of the anchor 200, even though the suture 202 may remain free to slide (in some embodiments), and in other embodiments (at least at a specific location or specific point in use) relative to the anchor body 204. The suture 202 helps to position, align and support the anchor body 204 so that if the suture 202 is to be removed from the anchor body 204 after the anchor 200 is deployed, the anchor body 204 can freely unwind (i.e., release), thereby allowing the anchor body 204 to collapse and shrink in size, thereby allowing easy (and potentially undesirable) removal.

[0123] In other words, the anchor body 204 has two main functions. First, it becomes the basis for the suture 202 to slide therein. Second, when compressed and / or pleated during deployment, the anchor body 204 becomes more compact in one direction, thereby expanding outward and increasing its overall width, thickness, or diameter to create retention capabilities. This action of causing the anchor body 204 to change shape to increase its overall width, thickness, or diameter is a useful feature that can be advantageously used to secure the anchor 200 in the hole 45 or against bone tissue or soft tissue 43. It is this combination of expanding the anchor body 204 coupled to the suture 202 that remains slidable relative to the anchor body 204 (in some embodiments; and in other embodiments, non-slidable relative to the anchor body at least at a specific location or specific point in use) that makes embodiments of the present invention ideal for soft tissue reattachment to bone 43 or soft tissue reattachment to soft tissue, where it is desired to deliver a sliding knot to secure the repair.

[0124] The following discussion relates to alternative embodiments of disposable handpieces, alternative embodiments of full suture anchors that may be used in conjunction with or deployed by embodiments of anchor inserters described herein, and alternative embodiments of anchor installation devices / inserters and drills.

[0125] Go to Fig.37 , shows a schematic side view of a disposable handpiece 300 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 by a user (rotationally, linearly, perpendicular to the longitudinal axis of the device ("push")) to turn on the drill 302 and / or set a desired speed of the drill 302. Alternatively, the motor may be actuated by a user applying a predetermined force to the inserter against the bone via the handpiece 300 (sufficient to begin drilling a hole in a particular bone, which may vary depending on the type and hardness of the bone). The handpiece 300 may also include a disposable plastic housing 305 to make the device lightweight, relatively inexpensive, and disposable. The disposable plastic housing 305 may be made of any plastic or combination of plastics. The inserter may also be made disposable and provided as a kit pre-attached to the handpiece 300. As described herein, the quick-change connector 88 of the inserter 10 can be attached to the chuck 302 of the disposable handpiece 300. The disposable handpiece can be used to rotate the inserter tip 16 and the cutting edge 62 and push the inserter 10 into the bone 43 until the anchor braid 104 is fully inserted into the bone 43 (e.g., relative to the Fig.33 described above).

[0126] In general, the alternative full suture anchor designs described and shown below are configured to work with and be deployed by the anchor inserter described herein in the same manner as other full suture anchors described above and shown herein. As with other full suture anchors, alternative embodiments of full suture anchors may include a fiber structure anchor body portion (or fiber, braided or woven fabric type structure, such as a flexible mesh) and a suture or filament portion having a first end and a second end. Sutures can be passed through the filaments in a variety of ways (including weaving, passing through a post, piercing the top and bottom, etc., as those of ordinary skill in the art should understand in conjunction with a review of this disclosure). The fiber structure may include a first state, wherein the fiber structure is uncompressed and extends along the longitudinal axis of the filament when in a pre-deployment and deployment state; and a second state, wherein in a deployed state, the flat fiber structure is compressed and expanded in a direction perpendicular to the longitudinal axis of the filament (as discussed herein).

[0127] According to one embodiment, the fiber construction has an open elongated column / lumen extending from a first end to a second end, and the filament passes through the open column and is at least partially positioned in the open column. In an embodiment, the filament slides freely through the open column so that the filament can be removed from the open column from the first end of the fiber construction and the second end of the fiber construction. In addition to having an open elongated column / lumen, embodiments of the fiber construction can also be tubular. The flat band / fiber construction can be woven directly in situ onto the filament (e.g., a circular segment suture braid), or woven with an open column, after which the circular segment suture braid can be inserted into the open column. In particular, as Fig.38 As shown in , a perspective schematic diagram of a soft, full suture anchor 400 in an unloaded (not loaded onto a mounting device or inserter), pre-deployment configuration according to one embodiment is shown. The full suture anchor 400 may include, but is not limited to, a flat fiber structure 4 having a first end 4A, a second end 4B, and an open elongated column / lumen 6 having a first end 6A and a second end 6B (each of the first end 6A and the second end 6B of the open elongated column / lumen 6 may extend between or beyond the first end 4A and the second end 4B of the flat fiber structure). The open elongated column / lumen 6 may be woven along an axis parallel to the central axis of the flat fiber structure 4, or along the central axis of the flat fiber structure, or may be woven along a path that is not parallel to the central axis. As shown in FIG. Fig.38 As shown, the open elongated columns / lumens are woven along a central axis.

[0128] Still see Fig.38 , a filament 2 is shown having a first end 2A and a second end 2B, and passing through and at least partially positioned in an open column 6. In an embodiment, the filament 2 slides freely through the open column 6, so that the filament 2 can be removed from the open column 6 from the first end 2A of the fiber construction 2 and the second end 2B of the fiber construction 2. According to an alternative embodiment, the filament is locked and cannot slide through the open column 6.

[0129] Now go to Fig.39A and Fig.39B , shows a schematic side view of an embodiment of a full suture anchor 400 in a pre-deployment and post-deployment configuration. As described above, the full suture anchor 400 comprises at least two sections: at least one suture 2 having a first end 2A and a second end 2B; an anchor body / fiber construction 4 having a first end 4A and a second end 4B, and an open elongated column / lumen 6 extending from a first end 6A to a second end 6B, the anchor body / fiber construction to form a portion of the anchor 400 that can increase in width, thickness, and / or diameter, and can contract in length, as part of deployment.

[0130] like Fig.39A8, a mounting device (or inserter 10 as described above) is provided in a pre-deployment configuration. The full suture anchor 400 is shown connected to a distal deployment end 804 of a mounting device 800 (which may be an inserter of the embodiments described herein), which also includes a handle 802. The distal deployment end 804 and the full suture anchor 100 are shown positioned in a bone hole 900 in a cancellous bone 904 beneath a cortical bone 902. To deploy the full suture anchor 400 (which may be connected to other tissues that need to be apposed to the bone, as will be understood by one of ordinary skill in the art in conjunction with a review of this disclosure), the first end 2A and / or the second end 2B are pulled / tensioned in a direction away from the bone hole 400. Regardless of whether the mounting device 800 is in place in the bone hole 900, the first end 2A and the second end 2B can be pulled / tensioned in a direction away from the bone hole 900 (if the mounting device 800 is in place in the bone hole 900, it can serve as a counterforce to the tension pulled from the hole 900 to assist in the deployment of the full suture anchor 400).

[0131] like Fig.39B As shown, the anchor body / fiber construct 4 is shown as being "shortened" and "expanded" and locked in the bone hole 900 in the post-deployment configuration, which is an additional result of the increase caused by the wrinkles formed by the fiber construct 4 (which may also be a part of the fiber construct 4). See also Fig.39C The full suture anchor 400, and in particular the fiber construct 4, utilizes Poisson's ratio (as described above with respect to other anchors) which captures the following cause / effect relationship: compressing a material in a first direction causes the material to expand in a direction perpendicular to the first direction (i.e., if compressed in the x-direction, the material will expand in the y-direction and / or z-direction), and stretching / elongating the material in the first direction causes the material to contract in a direction perpendicular to the first direction. Although it is the anchor body / fiber construct 4 that increases in width, thickness, and / or diameter upon deployment, it should be understood that the suture 2 may also play a role in the deployment of the anchor 400, even though the suture 2 may remain free to slide in some embodiments and may be non-slidable relative to the anchor body 4 in other embodiments (at least at a particular location or point in use). The suture 2 helps position, align, and support the anchor body 4 (as will be appreciated by one of ordinary skill in the art in conjunction with a review of this disclosure).

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

[0133] In one embodiment, an inventive configuration, 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 the embodiment has superior pull-out strength characteristics compared to conventional soft, all-suture anchors. Embodiments of the present invention provide a better soft, all-suture anchor for use in hard bone, in part due to the hybrid expansion component portion. These embodiments are also applicable to soft cancellous bones where a very thin or weak cortical layer is present. 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-deployment condition to a second deployment condition after application of an activator; and a filament having a first filament end and a second filament end, and positioned in contact with the expandable member in the second deployment condition. The anchor may also include a flat fiber structure having a first end and a second end, and wherein the filament passes through the fiber structure. The flat fiber structure includes a first state, wherein when in the unfolding and pre-deployment state, the flat fiber structure is uncompressed and extends along the longitudinal axis of the filament; and a second state, wherein in the deployed state, the flat fiber structure is compressed and expanded in a direction perpendicular to the longitudinal axis of the filament. The structure, configuration and function of the expandable member and the fiber structure (when as part of the embodiment) help to set and maintain the anchor in the bone hole in the post-deployment state. The expandable portion / member can be a part of a hybrid full suture anchor used only with any filament portion (as described herein). The expandable portion / member can also be a part of a hybrid full suture anchor used with any filament portion and any fiber structure portion (as described herein).

[0134] For example, see Fig.40, showing a perspective view of a hybrid soft all-suture anchor 500 in a pre-deployment configuration according to one embodiment. The hybrid all-suture anchor 500 may include, but is not limited to, a flat fiber construction 4 having a first end 4A, a second end 4B. The filament 2 is shown having a first end 2A and a second end 2B, and is woven, threaded, or otherwise passed through the fiber construction 4 at a passing location. For further description of structural aspects of the filament and fiber construction, see U.S. 9826971, which is part of this example of the invention (as one of ordinary skill in the art would understand in conjunction with a review of this disclosure).

[0135] In an embodiment, the filament 2 slides freely through the fiber construction 4 (and the expandable portion 3 when attached thereto) so that the filament 2 can be removed from the fiber construction 4 from the first end 4A of the fiber construction 4 and / or the second end 4B of the fiber construction 4. According to an alternative embodiment, the filament is locked and cannot slide through the fiber construction 4 and / or the expandable portion 3 (when attached to the expandable portion 3).

[0136] Now go to Fig.41A and Fig.41B , a side schematic view of an embodiment of a full suture anchor 500 is shown in a pre-deployment and post-deployment configuration. As described 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; an anchor body / fiber construction 4 having a first end 4A and a second end 4B, the anchor body / fiber construction being configured to form a portion of the anchor 500 that can increase in width, thickness, and / or diameter, and can contract in length, as part of deployment. The full suture anchor 500 also includes an expandable portion 3 that is configured to form a portion of the anchor 500 that can increase in size in a post-deployment configuration in response to an activating agent (as will be understood by one of ordinary skill in the art in conjunction with a review of this disclosure).

[0137] like Fig.41A8, a mounting device (or inserter 10 as described above) is provided in a pre-deployment configuration. The full suture anchor 500 is shown connected to a distal deployment end 804 of a mounting device 800 (which may be an inserter as described above), which also includes a handle 802. The distal deployment end 804 and the full suture anchor 500 are shown positioned in a bone hole 900 in a cancellous bone 904 beneath a cortical bone 902. To deploy the full suture anchor 500 (which may be connected to other tissues that need to be apposed to the bone, as will be understood by one of ordinary skill in the art in conjunction with a review of this disclosure), the first end 2A and / or the second end 2B are pulled / tensioned in a direction away from the bone hole 400. Regardless of whether the mounting device 800 is in place in the bone hole 900, the first end 2A and the second end 2B can be pulled / tensioned in a direction away from the bone hole 900 (if the mounting device 800 is in place in the bone hole 900, it can act as a counterforce to the tension pulled from the hole 900 to assist in the deployment of the full suture anchor 500). In addition, 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.

[0138] like Fig.41B As shown, the anchor body / fiber construct 4 is shown as "shortened" and "expanded" and locked in the bone hole 900 in the post-deployment configuration, which is an additional result of the increase caused by the wrinkles formed by the fiber construct 4 (which may also be a part of the fiber construct 4). The full suture anchor 500, and in particular the fiber construct 4, utilizes Poisson's ratio (similarly, as described above), which captures the following cause / effect relationship: compressing the material in a first direction causes the material to expand in a direction perpendicular to the first direction (i.e., if compressed in the x-direction, the material will expand in the y-direction and / or z-direction), and stretching / stretching the material in the first direction causes the material to contract in a direction perpendicular to the first direction. Although it is the anchor body / fiber construct 4 that increases in width, thickness, and / or diameter upon deployment, it should be understood that the suture 2 may also play a role in the deployment of the anchor 500, even though the suture 2 may remain free to slide in some embodiments and may not slide relative to the anchor body 4 in other embodiments (at least at a specific location or specific point in use). The suture 2 helps position, align and support the anchor body 4 (as will be appreciated by one of ordinary skill in the art in conjunction with a review of this disclosure).

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

[0140] Still see Fig.41B , after exposure to the activating agent, the expandable portion 3 is shown expanded to a second size that is larger than the first, smaller, pre-deployment size. When exposed to the activating agent, the volume of the expandable portion expands greatly, causing it to wedge into the bone hole 900 and lock the anchor 500 in place. According to one embodiment, in order to tension the filament 2 to reattach soft tissue (not shown), the filament 2 can slide freely forward and backward through the fiber construct 4 and through the expandable portion 3 (as may be required when connected to the expandable portion 3). In some cases where the fiber construct 4 is not present, the freely sliding filament 2 may cut through the expandable portion 3, resulting in less than optimal deployment of the full suture anchor 500. Therefore, in some embodiments of the full suture anchor 500 with or without the fiber construct 4, the second short segment of suture 2-1 can be wrapped around the filament 2 (see Fig.41C ) is wrapped or encircled to prevent the filament 2 from sawing / cutting through the expandable portion 3 when in contact with the expandable portion 3.

[0141] Go to Fig.42 , showing a deployed configuration after adding an activating agent according to one embodiment Fig.40 1. A side view digital photograph of an embodiment of a full suture anchor of FIG. As shown, the size of the expandable portion 3 is increased to a second deployment configuration (bone holes are not shown to illustrate the extent of expansion of the expandable portion 3), and the filament 2 is positioned to pass through the expandable portion 3 and / or otherwise be in contact with the expandable portion.

[0142] With respect to the above-mentioned filament 2 and fiber structure 4 and Fig.41ASimilarly, the expandable portion 3 may be a portion of any full suture anchor described herein, or otherwise include a full suture anchor as shown and described in U.S. Patent Application No. 16 / 033616. Fig.41A - The same structure and function of the expandable portion 3 shown in C can be applied to these embodiments of the full suture anchor (with and without fiber construction).

[0143] According to an alternative embodiment of the present invention, a full suture anchor insertion device 600 is provided, such as Figure 43-Figure 45 As shown. The full suture anchor insertion device 600 is configured to drill a bone hole in a desired anchor deployment location and deploy a full suture anchor (which may include any full suture anchor as discussed, referenced, described and / or shown herein) in the bone hole with one device in one action. In many surgeries involving the fixation of soft tissue in the limbs, a common problem is that surgeons lose the location of the hole they drilled in the bone for anchor deployment after removing the drill and guide. In addition, during a typical anchor insertion, the drilling guide must be held with one hand while the other hand is used to drill the guide hole and insert the anchor. The full suture anchor insertion device 600 incorporates a guide into the anchor, which allows the surgery to be completed with one hand. The full suture anchor insertion device 600 also reduces the time required to install the anchor by combining the drilling step and the anchor insertion step into one step. The uniqueness of the full suture anchor insertion device 600 partially involves the use of an anchor driver rod 601 to drill a bone tunnel by oscillating it on the drill. The oscillating motion of the drill causes the anchor driver rod 601 to rotate back and forth. As the driver rod 601 oscillates, the tip of the fork 603-1 at the distal end of the device acts as a drill to form a hole as the surgeon user pushes it into the bone. When the rod and anchor (located at the distal end of the device, not shown) have been inserted, the oscillation stops and the driver rod 601 is pulled out. The full suture anchor is then set by pulling on the suture tail of the anchor and / or adding an activator (as discussed herein).

[0144] In short, Figure 43-Figure 45 As shown, the 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 wedge, 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 the fork 603-1). The sliding guide tip 603 can be used to position the full suture anchor before starting to oscillate the device and protect any surrounding tissue while the anchor is oscillating and being inserted.

[0145] The preferred function of the full suture anchor insertion device 600 is to allow the insertion of the anchor with a minimum number of steps in the method in which the surgeon uses it. In short, the surgeon can connect a powered handpiece (not shown, such as described above, or otherwise understood by a person of ordinary skill in the art in conjunction with a review of the present disclosure) with an equal oscillation 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 a certain location in the bone and at the angle at which they want to install the anchor. The surgeon can then turn on the oscillation mode of the handpiece and push the inserter rod 601 into the bone (not shown). When the metal guide tube 604 becomes flush with the bone surface (and the distal end of the sliding guide tip 603 is flush with the distal end of the metal guide tube), the oscillation can be stopped, the suture (not shown) removed from the wedge, and the device removed. The anchor can then be set by pulling on the suture tail and / or adding an activator (as described here and above).

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

[0147] Although embodiments of the present invention have been specifically shown and described with reference to certain exemplary embodiments, it will be understood by those skilled in the art that various changes in detail may be made therein without departing from the spirit and scope of the present invention as defined by the claims supported by the written description and the accompanying drawings. In addition, where exemplary embodiments are described with reference to a certain number of elements, it will be understood that the exemplary embodiments may be practiced with less than or greater than the certain number of elements.

Claims

1. An anchor inserter, comprising: a hollow introducer tube extending along a longitudinal axis, the hollow introducer tube having a proximal introducer end and a distal introducer end; a hollow suture tube extending through the hollow introducer tube, the hollow 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, the inserter tip having a proximal tip end and a distal tip end; a suture anchor retaining slot extending through the distal tip end, wherein the suture anchor retaining slot includes a straight portion connected to a curved portion extending at an angle from the straight portion; and One or more features on the proximal tip end, the one or more features on the proximal tip end being removably connected to one or more features on the distal inserter end.

2. The anchor inserter of claim 1, wherein: The proximal tip end includes a proximal tip tube, and the distal suture tube end extends at least partially into the proximal tip tube.

3. The anchor inserter of claim 1, 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.

4. The anchor inserter of claim 1, wherein: The hollow suture tube is substantially co-linear with the longitudinal axis.

5. The anchor inserter of claim 1, further comprising: A quick change connector is attached to and extends proximally from the proximal inserter end.

6. The anchor inserter of claim 5, wherein: The quick change connector is an AO-compatible quick change connector.

7. An anchor inserter system comprising: a hollow introducer tube extending along a longitudinal axis, the hollow introducer tube having a proximal introducer end and a distal introducer end; a hollow suture tube extending through the hollow introducer tube, the hollow suture tube having a proximal suture tube end and a distal suture tube end; an inserter tip attached to and extending distally from the proximal inserter end; a suture anchor retaining slot extending through the inserter tip, wherein the suture anchor retaining slot includes a straight portion connected to a curved portion extending at an angle from the straight portion; and An anchor having a length of suture positioned therethrough, the suture extending through the suture anchor retaining slot such that the length of suture extends proximally along the inserter tip.

8. The system of claim 7, wherein: The anchor is an anchor braid, wherein the length of suture is positioned through a surface of the anchor braid.

9. The system of claim 7, further comprising: A plurality of pass-through locations along the anchor, wherein the length of suture is woven through the anchor at the plurality of pass-through locations.

10. The system of claim 7, wherein: The length of suture extends into the distal suture tube end of the hollow suture tube.

11. The system of claim 7, wherein: The length of suture extends outwardly from the hollow suture tube at the proximal suture tube end and extends distally along an outer surface of the hollow suture tube.

12. The system of claim 11, wherein: The length of suture extends within the annular space between the hollow suture tube and the hollow introducer tube.

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