Self-piercing all-suture anchor inserter, and self-piercing anchor inserter system

Abstract

To provide a self-drilling anchor inserter configured to insert suture anchors into bone.SOLUTION: The invention provides a self-drilling suture inserter 10 including a shaft 18 extending along a longitudinal axis having a proximal end 20 and a distal end 14, which is connected to a tubular portion 22. The inserter 10 also includes an inserter tip 16, which is attached to the shaft 18 and extends distally from the shaft 18. The inserter tip 16 comprises a suture anchor retention slot extending therethrough. The inserter tip 16 also comprises a distal end 14 with a drilling point. The tubular portion 22 can also include an outer tube having a first inner volume, and a suture tube having a second inner volume. The suture tube extends within the first inner volume of the outer tube.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] Cross - reference to related applications This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 572,369, filed Oct. 13, 2017; U.S. Provisional Patent Application No. 62 / 618,851, filed Jan. 18, 2018; U.S. Provisional Patent Application No. 62 / 631,034, filed Feb. 15, 2018; U.S. Provisional Patent Application No. 62 / 543,516, filed Aug. 10, 2017; and U.S. Provisional Patent Application No. 62 / 536,208, filed Jul. 24, 2017.

[0002] Technical field of the invention The present invention relates to a drill, an anchor driver, and a drill guide for drilling a bone hole in a surgical repair site and inserting a suture anchor into the bone hole, and more particularly to a self-perforating all-suture anchor and an inserter.

Background Art

[0003] Description of related art Many orthopedic and medical procedures require fixing one body part to another. Such body parts can include bone, soft tissue, and prosthetics. One body part can be fixed in position relative to another using a connector device such as screws and suture anchors (e.g., cannulated knotless suture anchors and soft all-suture anchors). For example, various orthopedic procedures require the insertion and fixation of suture anchors into bone.

[0004] An example of a suture anchor is a soft suture anchor such as the Y-Knot® device. See, for example, U.S. Patent No. 9,826,971. Soft anchors are typically made entirely of suture material and are sometimes referred to as "all-suture" anchors, and generally include an anchor body portion of a fibrous structure (or a fibrous, braided or woven fabric type structure such as a flexible web as described in U.S. Patent No. 9,173,652) and a suture or filament portion. In a conventional Y-Knot® device, the suture passes completely through the blade material and is stabbed multiple times, so the suture passes through the "front" and "back" surfaces. When a Y-Knot® anchor is constructed in a conventional manner, the suture segment on the back surface of the blade may contact the bone and be worn down by friction against the bone.

[0005] There are at least two conventional general 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 a bone hole, and then the suture anchor is inserted into the bone through or past the drill guide 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, if the drill guide becomes misaligned from the alignment of the first bone hole, it is often necessary to create a second bone hole.

[0006] In a second method, the drilling step is eliminated to avoid the aforementioned misalignment problem. Self-punching suture anchors, such as the Y-Knot® RC suture anchor, are designed, for example, with an inserter that allows the anchor of the inserter to be positioned directly at a desired location on the bone. Once the anchor of the inserter is positioned at the desired location, the inserter is driven in and the anchor can be pushed directly into the bone. However, driving the anchor into the bone applies an impact force to the bone , depending on the location of the surgical site, the impact force may not be desirable. For example, in joint socket bones or small bones such as the extremities, the impact force may not be particularly desirable. Furthermore, self-punching anchors generally require a larger size. Therefore, such anchors are not only undesirable but may not be usable in smaller bones.

[0007] Therefore, there is a need for a suture anchor inserter that can insert a small suture anchor into bone without the need to drill a bone hole or apply an impact force to the bone.

[0008] Explanation of the disclaimer in the related art section: As long as a particular patent / publication / use / product is discussed in this related art section or elsewhere in this disclosure, these discussions should not be taken as an admission that the patents / publications / products discussed are prior art for the purposes of patent law. For example, some or all of the patents / publications / products considered may not be early enough in time, may not reflect a subject that has developed early enough in time, and / or may not be sufficiently enabled to be prior art for the purposes of patent law. As long as a particular patent / publication / use / product is discussed in this related art section and / or throughout the application, the description / disclosure is hereby incorporated by reference in its entirety into this specification. Disclosure of prior art document information U.S. Patent Application Publication No. 2014 / 0257383 relates to the percutaneous insertion of a soft, non - rigid suture anchor structure pre - loaded in an inserter that is "self - punching". U.S. Patent Application Publication No. 2014 / 0257383 describes that a preferred embodiment of the soft suture anchor is a suture anchor that is entirely composed of filaments of a compressible, expandable, soft material such as commonly used suture materials, and the inserter is adapted to not only carry the entire suture anchor to the bone matrix but also be able to form a hole in the bone to receive the anchor in the same step.

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 (discussed above herein) and inserting suture anchors. For example, removing the drill bit from the drill guide and replacing it with a driver to insert the suture anchor increases the risk of misalignment between the bone hole and the drill guide, which requires additional surgical time and poses a risk of trauma to the surrounding tissue and bone. In another example, driving the anchor into the bone applies an impact force to the bone, which may not be desirable depending on the location of the surgical site. Accordingly, 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 apply an impact force to the bone. 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] This disclosure is directed to the construction, structure, and resulting function of an invention of a self-perforating anchor inserter configured to insert a suture anchor into bone. According to one aspect, the present invention is a suture anchor inserter. The suture anchor inserter includes a shaft extending along a longitudinal axis having a proximal end and a distal end, connected to a tubular portion. The inserter also includes an inserter tip attached to the shaft and extending distally from the shaft. The inserter tip includes a suture anchor retaining slot extending therethrough. The inserter tip also includes a distal end having a drill point. The tubular portion also includes, but is not limited to, an outer tube having a first internal volume and a suture tube having a second internal volume. The suture tube extends within the first internal volume of the outer tube.

[0011] According to another aspect, the invention is a self-trunching anchor inserter system further including an anchor having a length of suture positioned (or woven) therethrough, the anchor extending through the suture anchor retention slot such that a first end of the length of suture extends along a first side of the shaft and a second end of the length of suture extends along a second side of the shaft.

[0012] According to yet another aspect, a method for drilling a bone hole and inserting a suture anchor into the bone hole includes: (i) a shaft extending along a longitudinal axis having a proximal end and a distal end, the distal end being configured to receive a suture anchor; a shaft having a distal end connected to the tubular portion; and a catheter attached to the shaft and extending distally from the shaft. providing an inserter comprising an inserter tip extending through the inserter tip, a suture anchor retaining slot extending through the inserter tip, a drill point at a distal end of the inserter tip, an outer tube of a tubular portion having a first interior volume, and a suture tube of a tubular portion having a second interior volume, the suture tube extending into the first interior volume of the outer tube; (ii) inserting a suture anchor through the suture anchor retaining slot, the suture anchor having a length of suture to be positioned (or woven) therethrough; and (iii) inserting the length of suture on a first side of the shaft. (iv) tensioning a first end of the length of suture on a second side of the shaft and a second end of the length of suture on a second side of the shaft; (v) positioning the distal end of the guide tube relative to the bone; and (v) positioning the drill point at a desired bone hole location. The method includes, but is not limited to, (i) extending the inserter through the guide tube so that the inserter is on the surface of the bone; and (ii) drilling a bone hole into the bone with a drill point of the inserter.

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

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

[0015] The anchor body of such suture anchors can be formed of a biocompatible and / or bioabsorbable material. 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 inner and outer members include, but are not limited to, polyetheretherketone ("PEEK"), polylactic acid / β-tricalcium phosphate ("PLA / beta-TCP") composite materials, ultra-high molecular weight polyethylene ("UHMWPE"), and other metallic, non-metallic, polymeric materials. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The present invention will be more fully understood and evaluated by reading the following detailed description in conjunction with the accompanying drawings. The accompanying drawings show only typical embodiments of the disclosed subject matter, and thus the disclosed subject matter should not be regarded as limiting its scope as other equally effective embodiments may be recognized. Reference is now made briefly to the accompanying drawings.

[0017]

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[0018] An exemplary description of the structure and functionality of the self-piercing full suture anchor and inserter of embodiments of the present invention, and methods associated therewith, is set forth below. The advantages of the present invention are shown by the exemplary description set forth herein. However, the specific conditions and details should be construed as being widely applicable in the art and should not be construed as unduly limiting or restricting embodiments of the present invention.

[0019] Referring now to the drawings, like reference numerals throughout refer to like parts, and FIG. 1 shows a schematic perspective view of an inserter 10 in an unloaded, pre - placement configuration, according to an embodiment. The inserter 10 is generally constructed of a metal such as stainless steel or nitinol, although other suitable materials having sufficient strength to handle the forces necessary to drill and insert the anchor may be used. (To be understood by those skilled in the art in conjunction with a review of the present disclosure). Further, various features of the inserter 10 may be constructed of various materials. For example, nitinol with a sufficiently small diameter is used for the length 12 of the inserter 10 to enable the inserter 10 to have the flexibility necessary to pass through a curved guide tube and operate to reach a desired insertion position. In another example, stainless steel with a sufficiently large diameter is used for the length 12 of the inserter 10 so that the inserter 10 can have the rigidity necessary to be placed at a desired insertion position and operate under its own support without using a guide tube.

[0020] As shown in FIG. 1, the inserter 10 includes a distal end 14 having an inserter tip 16 connected to a shaft 18, and the shaft 18 extends proximally along a central longitudinal y-y axis and connects to a tubular portion 22. The tubular portion 22 extends between the shaft 18 and the proximal end 20. However, in one embodiment, as shown in FIGS. 32-35, the shaft 18 extends the length of the inserter 10 without the tubular portion 22. In another embodiment shown in FIG. 31, the proximal end 20 of the inserter 10 is at the proximal end 24 of the tubular portion 22. In such embodiments, drilling (as described below) is performed by gripping and rotating the tubular portion 22 with a handpiece chuck. The tubular portion 22 may include a plane (e.g., plane 72) as shown in FIGS. 9A and 10, or other features that facilitate connection to the chuck. In embodiments where the shaft 18 extends the length of the inserter 10, the shaft 18 may also include a plane (e.g., plane 72 of FIGS. 9A and 10) at the proximal end 20 of the inserter 10 (i.e., the shaft 18) to similarly facilitate drilling. However, as shown in FIG. 1 and described herein, the tubular portion 22 may extend to a power handpiece interface, such as a quick-change connector 26, at the proximal end 20 of the inserter 10. The quick-change connector 26 generally refers to features that facilitate the use of a power attachment for drilling. Embodiments of the quick-change connector 26 are described in detail below.

[0021] Referring now to FIGS. 2 and 3, there are shown schematic top and cross-sectional views of an inserter 10 in an unloaded, pre-placement configuration according to an embodiment. As shown in FIGS. 2 and 3, the inserter tip 16 has a relatively thin profile as compared to the shaft 18, the tubular portion 22, and the quick-change connector 26. In the embodiment shown in FIG. 3, the tubular portion 22 can also include, but is not limited to, an outer tube 28 and an inner suture tube 30. As shown, the suture tube 30 is positioned or disposed within the outer tube 28. Thus, the diameter d3' of the outer tube 28 is larger than the diameter d3'' of the suture tube 30. Therefore, the suture tube 30 extends within the first inner channel 32 of the outer tube 28. Further, the suture tube 30 includes a second inner channel 34 that extends therethrough such that the first inner channel 32 of the outer tube 28 and the second inner channel 34 of the suture tube 30 communicate. It is important to note that the suture tube 30 need not be attached to or directly connected to the inserter tip 16 or the shaft 18 of the inserter 10.

[0022] In an alternative embodiment, the inserter 10 includes two or more suture tubes 30 for maintaining separation of the lengths of suture. Such multiple suture tubes 30 may be adjacent to, concentric with, or in any other configuration relative to each other within the outer tube 28. In yet another embodiment, instead of multiple suture tubes 30, a single suture tube 30 includes a single multi-lumen projection, with each lumen containing a length of suture for maintaining separation of the lengths of suture.

[0023] As also shown in FIG. 3, at least the proximal portion 36 of the outer tube 28 extends into the distal end 38 of the quick-change connector 26. Further, in the illustrated embodiment, at least the proximal end 40 of the shaft 18 extends into the tubular portion 22. Specifically, in the illustrated embodiment, the proximal end 40 of the shaft 18 extends into both the distal portion 42 of the outer tube 28 and the distal portion 44 of the suture tube 30. In the embodiment shown in FIG. 2, the shaft 18 includes a tapered portion 46. The tapered portion 46 extends from the distal end 48 of the tubular portion 22 to a position proximal to the proximal end 50 of the inserter tip 16, as shown in FIG. 2. The tapered portion 46 may include male threads (not shown) that firmly connect the shaft 18 to the outer tube 28. However, other connection methods such as interference fits or welding may be used.

[0024] Briefly referring to FIG. 32, a schematic top view of the unloaded, pre-placement configuration of the inserter 10 according to an embodiment is shown. In FIG. 32, the inserter 10 includes a threaded section 45 at the proximal end 20. In the illustrated embodiment, the tapered portion 46 extends distally to the contact surface 47 of the outer tube 28. Thus, the outer tube 28 (not shown) may be connected to the inserter 10 via male threads (not shown) of the threaded section 45. In the embodiment shown in FIG. 32, the suture tube 30 is configured to fit over and around the proximal end 20 of the inserter 10.

[0025] Further referring to FIG. 2, the inserter tip 16 includes a suture anchor retaining slot 52. The suture anchor retaining slot 52 is sized or configured to hold the length of the suture of the anchor blade and the entire suture anchor such that the entire suture anchor can be pushed into the bone holes created by drill points 54A and 54B (shown in FIG. 4) at the distal end 14 of the inserter 10 (and the inserter tip 16).

[0026] Referring now to FIGS. 4 and 5, there is shown a schematic of an enlarged top view and a top perspective view of the distal end 14 of the inserter 10 according to one embodiment. As shown in FIGS. 4 and 5, the distal end 14 (and the inserter tip 16) of the inserter 10 includes a suture anchor retaining slot 52 that extends through the distal anchor placement passage 56 to the drill points 54A, 54B. The anchor placement passage 56 allows the anchor to be removed from the inserter 10. The anchor placement passage 56 may be the same size as, narrower than, or wider than the suture anchor retaining slot 52. Further, the suture anchor retaining slot 52 may change size during its useful life. In another embodiment, the drill points 54A, 54B and the anchor placement passage 56 are configured such that the material of the inserter 10 flexes in response to a rotational or compressive force applied to the drill points 54A, 54B in a manner that closes or opens the anchor placement passage 56.

[0027] In the embodiment shown in FIGS. 4 and 5, the suture anchor retaining slot 52 is elongate and creates a pair of prongs 58A, 58B. Each prong 58A, 58B extends to the drilled ends 60A, 60B around the suture anchor retaining slot 52 and each has a respective drill point 54A, 54B. Thus, in the illustrated embodiment, there are a pair of drill points 54A, 54B, each extending from one of the pair of prongs 58A, 58B. The drill points 54A, 54B are configured to cut bone as they rotate. The rotation may be such that the inserter 10 rotates in a single direction multiple times, or the rotation may be such that the inserter 10 rotates and vibrates clockwise and counterclockwise, either fully or partially. The effective diameter of the drill points 54A, 54B may be larger or smaller than the diameter of the other material of the inserter 10. As shown in FIG. 5, the central longitudinal y-y axis extends through at least approximately the center of the suture anchor retaining slot 52 and the anchor placement passage 56. In the illustrated embodiment, the z-z axis extends perpendicular to the central longitudinal y-y axis.

[0028] Referring further to FIG. 5, a pair of prongs 58A, 58B each include inner walls 62A, 62B that define suture anchor retaining slots 52. The inner walls 62A, 62B each extend along an axis parallel to the z-z axis. Similarly, the drill ends 60A, 60B of the prongs 58A, 58B each have drill surfaces 64A, 64B. The drill surfaces 64A, 64B face each other, and each drill surface 64A, 64B extends along an axis not parallel to the z-z axis. That is, since the drill surfaces 64A, 64B are inclined with respect to the z-z axis, they are inclined with respect to the inner walls 62A, 62B. The drill surfaces 64A, 64B of the prongs 58A, 58B limit the suture anchor retaining slot 52 from opening in the YZ plane, thereby locking the anchor placement passage 56 while the inserter tip 16 is inserted into the bone. Further, the angular relationship of the drill surfaces 64A, 64B with respect to the inner walls 62A, 62B prevents one of the prongs 58A, 58B from moving in a first direction along an axis parallel to the z-z axis, while the other of the prongs 58A, 58B moves in a second direction opposite to the first direction along an axis parallel to the z-z axis when a closing force is applied to the prongs 58A, 58B. Thus, the prongs 58A, 58B cannot move in opposite directions along an axis parallel to the z-z axis when a closing force is applied along the lateral x-x axis. As shown in FIG. 5, the lateral x-x axis is perpendicular to the central longitudinal y-y axis.

[0029] Briefly referring now to FIG. 35, a schematic of an enlarged perspective view of the distal end 14 of the inserter 10 according to one embodiment is shown. As shown in FIG. 35, the inserter tip 16 has a first face 57 having a length L1 and a second face 59 having a length L2. Specifically, L2 is greater than L1 in order to create an effective drill diameter d1 that is greater than the diameter d2 of the shaft 18. The difference in the diameters d1, d2 creates a clearance for the anchor, suture, and shaft 18 in the bone hole.

[0030] Referring now to FIGS. 33-34, a schematic top view of the inserter 10 in an unloaded, pre-arrangement configuration according to an alternative embodiment is shown. In the embodiment shown in FIG. 33, the inserter tip 16 is spade-shaped. With the spade-shaped inserter tip 16, the drill points 54A, 54B can drill a larger hole compared to the inserter tip 16 of FIGS. 4 and 5, and provide space for the anchor blade behind the drill points 54A, 54B. FIG. 34 shows an embodiment of the inserter tip 16 with an offset anchor placement passage 56 (offset with respect to the central longitudinal y-y axis). The offset anchor placement passage 56 allows for a true drill point 55 at the first drill point 54A.

[0031] Referring now to FIGS. 6A and 6B, schematic top and cross-sectional views of the inserter tip 16 according to an embodiment are shown. As shown in FIGS. 6A and 6B, the suture anchor retention slot 52 comprises a rounded proximal edge 66 and a sharp distal edge 68. The sharp distal edge 68 allows the inserter 10 to be easily withdrawn from the bone and securely release all suture anchors. In particular, the sharp distal edge 68 is used to cut the anchor blade (not the length of the suture) such that the inserter 10 can be removed without loosening or withdrawing all suture anchors. On the other hand, the rounded proximal edge 66 protects the anchor blade during insertion. The inserter tip 16 shown in FIGS. 6A and 6B comprises an anchor placement passage 56, while the inserter tip 16 of FIGS. 7A and 7B does not. In an alternative embodiment of the inserter tip 16 shown in FIGS. 7A and 7B, all suture anchors are loaded into the anchor retention slot 52 and advanced into the bone by the force of the rounded proximal edge 66. The all suture anchors are then cut into two pieces by the sharp distal edge 68 when the inserter 10 is retracted and removed.

[0032] Referring briefly to FIGS. 2-3, the quick change connector 26 includes an adapter 70 at its distal end 38, from which a rod 74 extends proximally to a proximal end 76. Referring now to FIGS. 8A-8C, various schematic views of the quick change connector 26 according to an embodiment are shown. As shown in FIGS. 8A-8C, the adapter 70 is compatible with a conventional AO connection (which should be understood by those skilled in the art in conjunction with the present disclosure). However, other connections such as Trinkle or Hudson connections may be used. The rod 74 includes a plane 72 extending along an axis parallel to the central longitudinal y-y axis, as shown in FIGS. 8A and 8B. In the illustrated embodiment, the rod 74 includes a groove 78. The groove 78 extends through the rod 74 from a first edge 80A of the plane 72 to a second edge 80B of the plane 72.

[0033] Referring now to FIGS. 9A-9D, various schematic views of the quick change connector 26 according to an alternative embodiment are shown. As shown in FIG. 9A, the rod 74 includes three planes 72 having a triangular cross-section (shown in FIG. 9D). The rod 74 also includes three grooves 78 extending through the rod 74 at a location where two of the three planes 72 converge or otherwise come together, as shown in FIGS. 9A and 9C. Also, as shown in FIGS. 9B and 9C, the adapter 70 is compatible with a conventional AO connection (other connections may be used). However, the three planes 72 allow the central longitudinal y-y axis of the inserter 10 to be collinear with the central longitudinal y-y axis extending through a glass grasping chuck (not shown). The quick change connector 26 may be formed from a solid piece of metal (FIGS. 9B, 9C, 9D) or may be formed at the end of a tube (FIG. 9A). Forming the quick change connector 26 in a tube provides many advantages when used in conjunction with the inserter 10. For example, the proximal end 76 can be opened to better flow ethylene oxide for sterilization of the suture material contained within the tube, and the number of components required for assembly of the inserter 10 can be reduced.

[0034] Referring now to FIG. 10, a detailed schematic view of a proximal hard stop mechanism 82 on the inserter 10 according to an embodiment is shown. As shown in the illustrated embodiment, the hard stop mechanism 82 is positioned or disposed along the proximal end 20 of the inserter 10. The hard stop mechanism 82 is distal from the quick change connector 26 so as to prevent the quick change connector 26 from entering or advancing through the guide. In the illustrated embodiment, the hard stop mechanism 82 is a ring wound around the outer surface 84 of the inserter 10. However, any other shape or configuration for the hard stop mechanism 82 may be used if it is sized sufficiently larger than the diameter of the guide.

[0035] Referring briefly to FIGS. 11A - 12B, schematic front and rear views of the full suture anchor 100 according to the embodiment are shown. FIG. 11A shows a rear view of the full suture anchor 100 and FIG. 11B shows a front view. As shown, the length of the suture 102 passing into and out of the anchor blade / fibrous structure 104 passes through only one (e.g., the "front") surface 106 of one of the anchor blades 104 (FIG. 11B). Similarly, FIGS. 12A and 12B show a rear view (FIG. 12B) and a front view (FIG. 12A) where the suture 102 passes through only one (e.g., the "front") surface 106 of one of the anchor blades 104 (FIG. 12B). When the full suture anchor 100 has a suture 102 that passes through only one (e.g., the "front") surface 106, the anchor blade 104 protects the suture 102 from wear on the opposite (e.g., the "back") surface 108 (FIGS. 11A and 12A) when loaded on the inserter (e.g., to be understood by one of ordinary skill in the art in combination with the considerations of the present disclosure). In FIGS. 11A - 12B, the suture 102 passes through the anchor blade 104 at a number of passing positions. The number of passing positions in FIGS. 13B and 14B is eight passing positions 110, and the number of passing positions for some alternative full suture anchors 100 is six passing positions 110. The number of passing positions 110 can vary depending on the composition and size of the suture 102 and / or the anchor blade 104. The number of passing positions 110 can be optimized by balancing input parameters such as anchor blade length, anchor blade width, anchor blade pick density, suture diameter, etc., to obtain output parameters such as manufacturability, anchor creep under load, and tensile strength, etc.

[0036] Referring briefly to FIGS. 36A and 36B, schematic top and side views of a full suture anchor 100 according to an alternative embodiment are shown. As shown in FIGS. 36A and 36B, the length of suture 102 passes through approximately the center 105 of anchor blade 104. In the illustrated embodiment, the length of suture 102 enters the anchor blade 104 through one (e.g., “front”) surface 106 and exits through the opposite (e.g., “back”) surface 108 of the anchor blade 104. As shown in FIG. 41, with the length of suture 102 positioned on both sides of the anchor blade 104, the anchor blade 104 can be positioned relative to the bone, while the length of suture 102 follows along the inserter 10, the anchor blade 104 can be loaded onto the inserter 10.

[0037] In another alternative embodiment, as shown in FIGS. 39A and 39B, the anchor blade 104 can be loaded with a plurality of lengths of sutures 102A, 102B. In the illustrated embodiment, the anchor blade 104 is loaded with two lengths of sutures 102A, 102B. The lengths of suture 102 can extend through the anchor blade 104 along its opposing edges 107A, 107B (FIG. 39B) through two off - center positions 109A, 109B (FIG. 39A), or in any conceivable combination (including extensions of the lengths of sutures 102A, 102B passing through approximately the center 105 of the anchor blade 104). Further, the lengths of sutures 102A, 102B can enter / exit the anchor blade 104 on the same surface (FIGS. 11A - 12B) or on opposing surfaces (FIGS. 36A - 36B).

[0038] Referring now to FIGS. 37A - 38, a top view of the entire suture anchor 100 according to an additional alternative embodiment is shown. FIGS. 37A - 37C illustrate the process for creating the reverse anchor blade 104. As shown in FIG. 37A, the thread passer 128 having the thread passing loop 130 first passes through the anchor blade 104. Next, in FIG. 37B, the end 114B of the anchor blade 104 is drawn out through the thread passing loop 130. Finally, the thread passing loop 130 is drawn back through the anchor blade 104 as shown in FIG. 37C, creating the central eyelet 132. The length of the suture 102 can be loaded onto the reverse anchor blade 104 by passing the length of the suture 102 through the anchor blade 104 as described in connection with any of the embodiments shown in FIGS. 11A - 12B, FIGS. 36A - 36B, and FIGS. 39A - 39B, and by passing it through the central eyelet 132 as shown in FIG. 38.

[0039] Referring again to FIGS. 11A - 12B, from the unloaded, pre - placement configuration, the entire suture anchor 100 is loaded onto the inserter tip 16 as shown in FIGS. 13A and 13B. To load the inserter tip 16, the anchor blade 104 is fed through the suture anchor retention slot 52 such that a pair of ends 112A, 112B of the suture 102 and a pair of ends 114A, 114B of the anchor blade 104 are on the opposite side of the suture anchor retention slot 52 (and inserter 10). Further, in one embodiment, the entire suture anchor 100 is fed through the suture anchor retention slot 50 such that four of the passage positions 110 are on the opposite side of the suture anchor retention slot 52 (and inserter 10). The suture 102 is then pulled and tensioned along the shaft 18, thereby extending a pair of ends 112A, 112B of the suture 102 and a pair of ends 114A, 114B of the anchor blade 104 along the inserter 10 (i.e., along an axis generally parallel to the central longitudinal y - y axis).

[0040] Referring now to FIGS. 14A and 14B, schematic top views of a full suture anchor in an unloaded, pre-placement configuration, and in a loaded, pre-placement configuration, according to alternative embodiments, are shown. The full suture anchor 10 shown in FIGS. 14A and 14B is a Y-Knot® suture anchor. Certain structural and functional aspects of embodiments of the present invention are similar to those of the soft suture anchor embodiments described and illustrated in U.S. Patent Application Publication No. 9,826,971. These similarities, together with the published application, should be understood by those skilled in the art in conjunction with the present disclosure and the accompanying drawings, and are not described in detail herein. Certain differences, including various inventive features of embodiments of the present invention, are described more briefly herein with reference to the accompanying drawings. However, in embodiments where the full suture anchor 100 is a Y-Knot® suture anchor, only the anchor blade 104 is loaded into the inserter tip 16. As shown in FIG. 14B, when the anchor blade 104 is loaded into the suture anchor retaining slot 52, the central portion 116 of the suture 102 is pulled away from the inserter tip 16 (i.e., in a distal direction). This prevents the suture 102 from falling into the suture anchor retaining slot 52. By holding the suture 102 outside the suture anchor retaining slot 52, potential damage to the suture 102 due to heat generated in the prongs 58A, 58B (FIGS. 4-5) as it is drilled into the bone, or the suture 102 being cut during removal of the inserter 10, is avoided. In one embodiment, as shown in any of the embodiments of FIGS. 13A-14B, when the full suture anchor 100 is loaded onto the inserter tip 16, the anchor placement passage 56 can be moved to a closed position, as shown in FIG. 15, to create a closed suture anchor retaining slot 52. In one embodiment, the anchor placement passage 56 is moved to the closed position by bending the prongs 58A, 58B in a manner that completely closes the anchor placement passage 56.

[0041] Referring now to FIG. 16, there is shown a side view of all suture anchors 100 in a pre-placement configuration loaded onto inserter 10, according to an embodiment. As shown in FIG. 16, when all suture anchors 100 are loaded onto inserter tip 16, anchor blade 104 is twisted along inserter tip 16. When anchor blade 104 is loaded onto inserter tip 16 at tight twist portion 118, further twisting of anchor blade 104 is not generated when inserting anchor blade 104 into bone by rotating all suture anchors 100 in the direction of twist portion 118. That is, the twist portion 118 of anchor blade 104 when loaded onto inserter tip 16 prevents anchor blade 104 from twisting on itself as it is inserted into bone, and also prevents the length of suture 102 from twisting on itself as a result of anchor blade 104 being twisted. Therefore, suture 102 can exit the bone hole without a twist portion. In the illustrated embodiment, anchor blade 104 has a twist portion 18 of 1.5 rotations, which effectively prevents the length of suture 102 from being exposed at inserter tip 16.

[0042] Referring now to FIGS. 17A and 17B, a schematic top view of an anchor blade 104 having additional material 120 according to an embodiment is shown. Those skilled in the art should recognize and understand potential embodiments of the Y-Knot® anchor using additional materials, such as a single filament polymer, to increase strength. The additional material can be applied to the all-suture anchor 104. As shown in FIG. 17A, the anchor blade 104 is folded in half. A single filament 120 is used to stitch together each (i.e., two) side edge 122A, 122B of the anchor blade 104, as shown in FIG. 17B, to create a closed area 124 with the length of the suture 102 on the inside. In addition to improving strength, this will prevent the anchor blade 104 from rolling on itself during insertion, causing wear by exposing the suture 102 to the bone. Further, by twisting the anchor blade 104 as described, in combination with a higher density material running within the axis of the anchor blade 104, a threaded all-suture anchor 100 can be provided.

[0043] Referring briefly to FIG. 18, a schematic perspective view of an inserter 10 in a loaded, pre-placement configuration according to an embodiment is shown. In the illustrated embodiment, the anchor blade 104 is loaded onto the inserter tip 16 as described above. FIG. 19 shows a schematic side view of the inserter 10 in a loaded, pre-placement configuration according to an embodiment. In FIG. 19, the outer tube 28 and the quick-change connector 26 have been removed for clarity. As shown, the anchor blade 104 extends through the suture anchor holding slot 52 and has a twist portion 118 around the inserter tip 16. The first end 112A and the second end 112B of the suture extend to opposite sides of the shaft 18 within the suture tube 30. In the illustrated embodiment, the ends 112A, 112B are retracted or pulled distally within the suture tube 30. FIGS. 20-21 similarly show the ends 112A, 112B within the internal volume 34 of the suture tube 30. Figures 22-24 show schematic views of various top and cross-sectional views of the loaded inserter 10 in a pre-placement configuration according to an embodiment. Components such as the suture tube 30 and the ends 112A, 112B of the suture 102 are accommodated by the outer tube 28 such that they can rotate, twist, or rotate with the anchor blade 104 during insertion.

[0044] As shown in FIGS. 19, 21, and 23, the first end 112A and the second end 112B of the suture 102 extend inward from the anchor blade 104 along the shaft 18 into the suture tube 30. Once inside the suture tube 30, the first end 112A and the second end 112B of the suture 102 retreat toward the inserter tip 16 as shown. With the first end 112A and the second end 112B on opposite sides of the shaft 18 and inside the suture tube 30, the shaft 18 presses against the rims 112A, 112B to lock against the suture tube 30, thereby pulling on the length of the suture 102 and maintaining the position and configuration of the anchor blade 104. FIG. 41 also shows the suture tube 30 extending around the length of the suture 102 and the shaft 18. The suture tube 30 compresses the length of the suture 102 against the shaft 18. Although not shown in FIG. 41, the suture tube 30 extends the length of the suture 102.

[0045] Referring now to FIGS. 25-26, schematic views of various figures of the loaded inserter 10 in a pre-placement configuration according to an alternative embodiment are shown. As shown in FIG. 25, the shaft 18 includes a bend region 126. In the embodiment shown in FIG. 26, the bend region 126 extends within the tubular portion 22 of the inserter 10. Thus, the bend region 126 can extend along any portion of the length 12 (FIG. 1) of the inserter 10. The bend region 126 can be created, for example, by a series of small cuts, laser cuts, or etching as shown in FIG. 26. The bend region 126 increases the flexibility of the inserter 10 such that the inserter 10 can extend through a curved guide (to be understood by those skilled in the art in conjunction with the present disclosure).

[0046] Referring briefly to FIGS. 40A and 40B, a schematic side view of the anti-slip component 134 according to an alternative embodiment of the inserter 10 is shown. In FIG. 40A, the inserter 10 includes a slidable anti-slip component 134. The shaft 18 passes through the anti-slip component 134 but is not attached thereto. The anti-slip component 134 includes a proximal end 136 and a distal end 138. In use, the length of the suture 102 is covered around the proximal end 136 and the distal end 138 to fix the length of the suture 102 in place. The anti-slip component 134 can be moved proximally (with a limit) or distally along the inserter 10 by sliding the anti-slip component 134 along the shaft 18. In another embodiment, as shown in FIG. 40B, the anti-slip component 134 includes a slot 140 for holding the length of the suture 102. Thus, the length of the suture 102 is covered around the proximal end 136 and the distal end 138 of the anti-slip component 134 and fixed within the slot 140. In use, after the inserter 10 drills a bone hole, the user can remove the length of the suture 102 from the slot 140, release the length of the suture 102 from the proximal end 136 and the distal end 138, and remove the inserter 10.

[0047] In another embodiment, as shown in FIG. 42, a sleeve 142, such as a rubber sleeve, is positioned over the shaft 18, the anti-slip component 134, and the length of the suture 102 to hold the length of the suture 102 in place. As briefly described above, the anti-slip component 134 (the length of the suture 102 and the sleeve 142) can slide distally along the shaft 18. However, the proximal movement of the anti-slip component 134 along the shaft 18 is restricted by the tension in the length of the suture 102. By the limited proximal movement, the distal face 144 of the sleeve 142 also serves as a hard stop for the inserter 10. Thus, in use, the inserter 10 is drilled into the bone until the hard stop (e.g., the distal face 144 of the sleeve 142) contacts the guide and the shaft 18. When the shaft 18 is removed from the bone, the lengths of the anchor blade 104 and the suture 102 remain within the bone, while the anti-slip component 134 and the sleeve 142 are attached to the length of the suture 102. Since the shaft 18 is no longer positioned through the anti-slip component 134, the length of the suture 102 can be released from the anti-slip component 134 and the sleeve 142.

[0048] Referring now to FIG. 27, a schematic side view of an inserter 10 in a loaded, pre-placement configuration at a bone hole location 86, according to an embodiment, is shown. As shown, the inserter 10 extends through the guide 88 at a selected bone hole location 86 such that the distal end 90 of the guide 88 is positioned against the surface 92 of the bone 94, while the quick-change connector 26 extends through and passes through the proximal end 96 of the guide 88. In the illustrated embodiment, the inserter tip 16, loaded with the anchor blade 104 at the distal end 90 of the guide 88, is positioned against the surface 92 of the bone 94. Once positioned, while the guide 88 is held stationary relative to the bone 94, the user rotates the inserter via the quick-change connector 26 using a handpiece, thereby rotating the drill ends 60A, 60B and the respective drill points 54A, 54B, and pushing the inserter 10 into the bone 94 until the anchor blade 104 is fully inserted into the bone 94. Features such as a hard stop function 82 (FIG. 10) limit the insertion depth by preventing the inserter 10 from further penetrating the guide 88.

[0049] Referring now to FIG. 28, a schematic side view of the inserter 10 in a loaded, pre - deployment configuration at the bone hole 98 is shown according to an embodiment. As shown, the drill ends 60A, 60B and respective drill points 54A, 54B form a hole 98 in the bone 94 as the inserter 10 advances within the guide 88. When the anchor blade 104 is inserted into the bone hole 98, the anchor blade 104 opens the anchor deployment passage 56, and the inserter 10 is removed leaving the anchor behind the bone hole. In another embodiment, the anchor deployment passage 56 can be forced open by an additional object such as a suture filament, wire, or rod that opens the anchor deployment passage 56 when the inserter 10 is independently removed or actuated. In another embodiment, the anchor deployment passage 56 may be blocked during insertion by an additional member such as a filament, wire, rod, a portion of the anchor, or other material to create a completely closed suture anchor retention slot 52. The blocking material exits the anchor deployment passage 56 when the inserter 10 is withdrawn or by an independent actuation. Finally, when the anchor deployment passage 56 is open, the inserter tip 16 is removed from the bone 94 and the inserter 10 can be retracted through the guide 88 such that the anchor blade 104 remains in the bone hole 98 and passes through the anchor deployment passage 56 as the inserter 10 is pulled out. The force holding the anchor blade 104 in the bone hole 98 can be provided by the interaction between the bone 94 and the anchor blade 104 or by the interaction between the anchor blade 104 and an anchor member introduced to hold the anchor blade 104 in place prior to the placement of the entire suture anchor 100.

[0050] Referring now to FIG. 29, a schematic side view of an inserter 10 in an unloaded, post-placement configuration, according to one embodiment, is shown. When the anchor blade 104 is fully inserted and the inserter 10 is removed, tension is applied to the suture 102 (ends 112A, 112B) by removal of the inserter 10, the user directly pulling on the suture 102 (ends 112A, 112B), or a combination of both means. The tension places and secures the anchor blade 104 in the post-placement configuration.

[0051] Referring now to FIGS. 30A and 30B, schematic side views of an embodiment of a full suture anchor 100 in pre-placement and post-placement configurations are shown. In the illustrated embodiment, the full suture anchor 100 is a soft suture anchor such as a Y-Knot® anchor 200. One such suture anchor is disclosed in U.S. Patent No. 9,826,971, assigned to the assignee of the present application, and incorporated herein by reference in its entirety.

[0052] Embodiments of the Y-Knot® anchor (or soft anchor or “fully sutured” anchor) 200 are illustrated in detail in FIGS. 30A-30B. As shown in FIGS. 30A-30B, the Y-Knot® anchor 200 includes at least two sections: at least one suture 202 that is the suture to be secured, and an anchor body 204 that forms a portion of the anchor 200 where a portion of the anchor body 204 has an increased width, thickness, and / or diameter and a decreased length as part of the arrangement. Looking at FIG. 30A shows the anchor body 204 in a pre-arrangement configuration, and looking at FIG. 30B shows the anchor body 204 that is “shortened” and “expanded” in a post-arrangement configuration, which is an addition to the increase by the pleats. This soft anchor embodiment also utilizes Poisson's ratio, which captures the cause-and-effect relationship as follows: when a material is compressed in a first direction, the material expands 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 when the material is stretched / pulled in the first direction, the material contracts in a direction perpendicular to the first direction. It is the anchor body 204 that has an increased width, thickness, and / or diameter during arrangement, but it should be understood that the suture 202 also plays a role in the placement of the anchor 200, even though the suture 202 (in some embodiments) slides freely with respect to the anchor body 204 and in other embodiments cannot slide (at least at certain positions or points). The suture 202 helps position, align, and support the anchor body 204 such that if the suture 202 is removed from the anchor body 204 after placement of the anchor 200, the anchor body 204 will freely overflow (i.e., release), the anchor body 204 will collapse and contract in size, and easy (and potentially undesirable) removal becomes possible.

[0053] That is, the anchor body 204 has two main functions. First, it serves as the base for the suture 202 that slides therein. Second, when compressed and / or pleated during placement, the anchor body 204 becomes more compact in one direction, thereby spreading outward and increasing its overall width, thickness, or diameter, creating a holding ability. This action of changing the shape of the anchor body 204 to increase its overall width, thickness, or diameter is a useful feature that can advantageously be used to secure the anchor 200 in the hole 98 or to the bone or soft tissue 94. For embodiments of the present invention, it is desirable for the anchor body 204 to be ideal for soft tissue reattachment to soft tissue where it is desired to pass a sliding knot to secure the reattachment of soft tissue to bone 94 or for repair. This is a combination of an expanding anchor body 204 that remains (in some embodiments and at least at certain positions or points during use, non - slidable in other embodiments) slidable with respect to the suture 202 that engages it.

[0054] The following considerations relate to alternative embodiments of the disposable handpiece, alternative embodiments of all suture anchors that can be used in combination with or disposed by the embodiments of the anchor inserter described herein, and alternative embodiments of the anchor insertion device / inserter and drill.

[0055] Referring to FIG. 43, it is a schematic side view of a disposable handpiece 300 according to an alternative embodiment. The disposable handpiece can include, but is not limited to, a motor 301, a chuck 302, a disposable battery 303 configured to supply power to the motor, and at least one switch 304 configured to operate (rotationally, linearly, perpendicular to the longitudinal axis of the device ( "pushed")) by the user turning on the drill bit 302 and / or setting the desired speed of the drill bit 302. Alternatively, the motor can be configured to cause the inserter to the bone and the handpiece 300 to the user via the Thus, it can be activated by a given predetermined force (a force sufficient to start drilling a hole in a particular bone, which may vary depending on the hardness and type of bone). The disposable handpiece 300 may also include a disposable plastic housing 305 to make the device lightweight, less expensive, and disposable. The disposable plastic housing 305 can be made from any plastic or combination of plastics. The inserter may be made to be disposable and may be provided pre-attached to the handpiece 300 as a kit. The proximal end of the anchor inserter described herein can be attached to the chuck 302 of the disposable handpiece 300. Using the disposable handpiece, the drill ends 60A, 60B and respective drill points 54A, 54B can be rotated and the inserter 10 can be pushed into the bone 94 until the anchor blade 104 is fully inserted into the bone 94 (as described in connection with FIG. 27).

[0056] Generally, the alternative all-suture anchor designs described and illustrated below are configured to operate with and thereby be disposed by the anchor inserter described herein in the same manner as the other all-suture anchors described and illustrated herein. Similar to the other all-suture anchors, alternative embodiments of the all-suture anchor may include an anchor body portion of a fibrous construct (or a fibrous, braided or woven fabric type structure such as a flexible web), and a suture or filament portion having a first end and a second end. The suture can pass through the filaments in a number of ways (as would be understood by one of ordinary skill in the art in review of the present disclosure, woven, passing through struts, passing through the top and bottom, etc.). The fibrous construct can include a first state in which the fibrous construct is not folded and the fibrous construct is not compressed when in the pre-placement state and extends along the longitudinal axis of the filament, and a second state in which the flat fibrous construct is compressed and expanded in a direction perpendicular to the longitudinal axis of the filament when the fibrous construct is disposed.

[0057] According to one embodiment, the fibrous structure has an open elongated strut / lumen extending from a first end to a second end, and the filament passes through and is positioned at least partially within the open strut. In one embodiment, the filament is slidable through the open strut such that the filament can be removed from the open strut from the first end and the second end of the fibrous structure. Embodiments of the fibrous structure may also be tubular in addition to having an open elongated strut / lumen. The flat tape / fibrous structure may be woven in situ directly onto the filament (e.g., a round-section suture blade), or may be woven with an open strut into which a round-section suture blade may be inserted later. In particular, as shown in FIG. 44, it is a schematic perspective view of an all-suture anchor 400 in a pre-deployment configuration, not loaded (not loaded into an insertion device or inserter). The all-suture anchor 400 includes, but is not limited to, a flat fibrous structure 4 having a first end 4A and a second end 4B, and an open elongated strut / lumen 6 having a first end 6A and a second end 6B (the first end 6A and the second end 6B of the open elongated strut / lumen 6 may extend between or behind the first end 4A and the second end 4B of the flat fibrous structure, respectively). The open elongated strut / lumen 6 may be woven along or along an axis parallel to the central axis of the flat fibrous structure 4, or may be woven along a path not parallel to the central axis. As shown in FIG. 44, the open elongated strut / lumen is woven along the central axis.

[0058] Referring further to FIG. 44, a filament 2 is shown having a first end 2A and a second end 2B, passing through an open strut 6, and being positioned at least partially therein. In one embodiment, the filament 2 is slidable through the open strut 6 such that the filament 2 can be removed from the open strut 6 from the first end 2A and / or the second end 2B of the fibrous structure 2. According to an alternative embodiment, the filament is locked and not slidable through the open strut 6.

[0059] Referring now to FIGS. 45A and 45B, schematic side views of embodiments of a full suture anchor 400 in a pre-implant and post-implant configuration are shown. As described above, the full suture anchor 400 includes at least two sections of at least one suture 2 having a first end 2A and a second end 2B, and an anchor body / fiber construct 4 having a first end 4A and a second end 4B, with an open elongated strut / lumen 6 extending to a first end 6A and a second end 6B, which forms a portion of the anchor 400 that can increase in width, thickness, and / or diameter and can be shortened in length as part of the placement.

[0060] As shown in FIG. 45A, a mounting device (or inserter as described herein) in a pre-implant configuration is provided. The full suture anchor 400 is shown connected to the distal end 804 of the mounting device 800, which may be the inserter of the embodiments described herein, and also includes a handle 802. The distal end 804 and the full suture anchor 100 are shown positioned within the bone cavity 900 of the cancellous bone 904 under the cortical bone 902. To place the full suture anchor 400 (which can be connected to other tissues that need to be juxtaposed to the bone, as should be understood by those skilled in the art in conjunction with the present disclosure), the first end 2A and / or the second end 2B are pulled away from the bone cavity 400 to receive tension. The first end 2A and the second end 2B are pulled away from the bone cavity 900, with or without the insertion device 800, in a direction away from the bone cavity 900 and can be pulled (when the insertion device 800 is in a predetermined position within the bone cavity 900, it acts as a reaction force against the tensile force from the hole 900 to assist in the placement of the full suture anchor 400).

[0061] As shown in FIG. 45B, the anchor body / fiber construct 4 is shown “shortened” and “expanded” in the post-placement configuration and locked in the bone hole 900, and can be an addition to the increase due to the pleats formed by the fibrous construct 4 (which may be part of the fibrous construct 4). See also FIG. 45C. The all-suture anchor 400, and in particular the fibrous construct 4, also utilizes the Poisson's ratio that captures the cause-and-effect relationship (as described above for other anchors). That is, when the material is compressed in a first direction, the material expands 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 by stretching / elongating the material in the first direction, the material contracts in a direction perpendicular to the first direction. It is the anchor body / fibrous construct 4 that increases in width, thickness, and / or diameter during placement, but it should be understood that the suture 2 also plays a role in the placement of the anchor 400, even though the suture 2 slides freely (in some embodiments) with respect to the anchor body 4 and cannot slide (at least at certain positions or points) in other embodiments. The suture 2 serves to assist in positioning, aligning, and supporting the anchor body 4 (to be understood by those skilled in the art in conjunction with the teachings of the present disclosure).

[0062] That is, the anchor body / fibrous structure 4 has two main functions. First, it serves as the base for the suture 2 that slides within (the strut / lumen 6). Second, when compressed and / or pleated during placement, the anchor body 4 becomes more compact in one direction, thereby spreading outward and increasing the overall width, thickness, or diameter, resulting in a holding capacity. This action of changing the shape of the anchor body 4 to increase its overall width, thickness, or diameter is a useful feature that can be advantageously used to secure the anchor 400 within the hole 900 or to bone or soft tissue. To ensure repair, if it is desirable to pass a sliding knot, embodiments of the present invention are ideally suited for reattachment of soft tissue to bone or reattachment of soft tissue to soft tissue by this combination of an expanding anchor body 4 that remains slidable (in some embodiments and at least at certain positions or points during use, non-slidable in other embodiments) and is coupled to the suture 2.

[0063] In one embodiment, the configuration, structure, and resulting functions of a soft all-suture anchor that utilizes a hybrid combination of soft implantable materials are provided. One The hybrid soft total suture anchor of the embodiment includes excellent pull-out strength characteristics as compared with the conventional soft total suture anchor. Embodiments of the present invention provide a better soft total suture anchor for use in cortical bone, in part, due to the hybrid type expansion component portion. These embodiments are also suitable for use in soft cancellous bone having a very thin or weak cortical layer. The hybrid type total suture anchor can include, but is not limited to, an expansion member / portion configured to increase in size from a first pre-placement state to a second placement state when an activator is applied, and a filament having a first filament and a second filament, and is positioned in contact with the expandable member in the second placement state. The anchor can also include a flat fibrous construct having a first end and a second end, and the filament passes through the fibrous construct. The flat fibrous construct includes a first state in which the flat fibrous construct is not compressed and extends along the longitudinal axis of the filament when in the non-folded, pre-placement 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 filament in the state where the flat fibrous construct is placed. The structure, configuration, and functionality of the expandable member and the fibrous construct (as part of the embodiment) help to set and hold the anchor in the bone hole in the post-placement state. The expandable portion / member can be part of a hybrid type total suture anchor used only with any filament portion (as described herein). The expandable portion / member can also be part of a hybrid type total suture anchor used with any filament portion and any fibrous construct portion (as described herein).

[0064] For example, referring to FIG. 46, a perspective view of a hybrid soft all-suture anchor 500 in a pre-placement configuration according to an embodiment is shown. The hybrid all-suture anchor 500 can include, but is not limited to, a flat fibrous structure 4 having a first end 4A and a second end 4B. The filament 2 has a first end 2A and a second end 2B and is shown passing through the fibrous structure 4 at passage positions 25, 27 and 25, 28 by being woven, threaded, or otherwise passed through the fibrous structure 4. For further explanation of the structural aspects of the filament and the fibrous structure, which are part of this example of the present invention (and should be understood by those skilled in the art in conjunction with the present disclosure), reference is made to U.S. Patent No. 9,826,971.

[0065] In one embodiment, the filament 2 is slidably passed through the fibrous structure 4 (and the expandable portion 3 when attached thereto) such that the filament 2 can be removed from the fibrous structure 4 at the first end 4A of the fibrous structure 4 and / or the second end 4B of the fibrous structure 4. According to an alternative embodiment, the filament is locked and not slidable through the fibrous structure 4 and / or the expandable portion 3 (when attached to the expandable portion 3).

[0066] Referring now to FIGS. 47A and 47B, schematic side views of an embodiment of the all-suture anchor 500 in pre-placement and post-placement configurations are shown. As described above, the all-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 structure 4 having a first end 4A and a second end 4B, and is 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 the placement. The all-suture anchor 500 also includes an expandable portion 3 configured to form a portion of the anchor 500 that can increase in size in the post-placement configuration in response to an activator (and should be understood by those skilled in the art in conjunction with the present disclosure).

[0067] As shown in FIG. 47A, an attachment device (or the inserter described herein) in a pre-configuration is provided. The entire suture anchor 500 is shown connected to the distal end 804 of the attachment device 800, (which may be an inserter as described above herein), and also includes a handle 802. The distal end 804 and the entire suture anchor 500 are shown positioned within the bone cavity 900 of the cancellous bone 904 under the bone cortex 902. To place the entire suture anchor 500 (which can be connected to other tissues that need to be juxtaposed to the bone, as should be understood by those skilled in the art in conjunction with the present disclosure), the first end 2A and / or the second end 2B are pulled away from the bone cavity 400 and subjected to tension. The first end 2A and the second end 2B are pulled away from the bone cavity 900 with or without the insertion device 800 to a predetermined position within the bone cavity 900 and can be pulled (when the insertion device 800 is in a predetermined position within the bone cavity 900, it acts as a reaction force against the tensile force from the cavity 900 to assist in the placement of the entire suture anchor 500). Further, an activator can be added to the anchor to expand the expandable portion to a second size larger than the first pre-configuration size. In one embodiment, the activator is water.

[0068] As shown in FIG. 47B, the anchor body / fiber construct 4 is shown “shortened” and “inflated” in the post-placement configuration and locked in the bone hole 900, and can be an addition to the increase by the pleats formed by the fibrous construct 4 (which may be part of the fibrous construct 4). The full suture anchor 500, and in particular the fibrous construct 4, also utilizes the Poisson's ratio that captures the cause-and-effect relationship (similarly as described above). That is, when the material is compressed in the first direction, the material expands 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 when the material is stretched / elongated in the first direction, the material contracts in a direction perpendicular to the first direction. It is the anchor body / fibrous construct 4 that increases in width, thickness, and / or diameter during placement, but it should be understood that the suture 2 also plays a role in the placement of the anchor 500, even though the suture 2 slides freely (in some embodiments) with respect to the anchor body 4 and cannot slide (at least at certain positions or points) in other embodiments. The suture 2 serves to assist in positioning, aligning, and supporting the anchor body 4 (which should be understood by those skilled in the art in conjunction with the teachings of the present disclosure).

[0069] That is, the anchor body / fibrous structure 4 has two main functions. First, it serves as the base for the suture 2 that slides within (in the strut / lumen 6). Second, when compressed and / or pleated during placement, the anchor body 4 becomes more compact in one direction, thereby spreading outward and increasing the overall width, thickness, or diameter, resulting in a holding capacity. This action of changing the shape of the anchor body 4 to increase its overall width, thickness, or diameter is a useful feature that can be advantageously used to fix the anchor 500 within the hole 900 or to bone or soft tissue. To ensure repair, if it is desirable to pass a sliding knot, an embodiment of the present invention is ideal for reattachment of soft tissue to bone or reattachment of soft tissue to soft tissue, which is this combination of an expandable anchor body 4 that remains slidable (in some embodiments and at least at certain positions or points during use, non-slidable in other embodiments) and is coupled to the suture 2.

[0070] Referring further to FIG. 47B, the expandable portion 3 is shown in an expanded second size that is larger than the first, smaller pre-placement size after being exposed to the activator. The expandable portion expands greatly in volume when exposed to the activator and is wedged in the bone hole 900 to lock the anchor 500 in place. According to an embodiment, to tension the filament 2 to reattach soft tissue (not shown), the filament 2 can slide freely back and forth through the fibrous structure 4 and the expandable portion 3 (which may be required when connected to the expandable portion 3). In certain situations where the fibrous structure 4 is absent, the slidable filament 2 may be cut through the expandable portion 3, thereby reducing the optimality of the placement of the entire suture anchor 500. Therefore, in some embodiments of the entire suture anchor 500 with or without the fibrous structure 4, the short second length of the suture 2-1 is wrapped around or looped around the filament 2 (see FIG. 47C) and touches the expandable portion 3. When touched, it prevents sewing / cutting through the expandable portion 3 by the filament 2.

[0071] Referring to FIG. 48, a side view of a digital photograph of an embodiment of the full suture anchor of FIG. 46 in a post-placement configuration after addition of the actuator, according to the embodiment, is shown. As shown, the expandable portion 3 has increased in size to the second placement configuration state (the bone hole is not shown illustrating the degree of expansion of the expandable portion 3), and the filament 2 is positioned through and / or otherwise in contact with the expandable portion 3.

[0072] Similarly, with respect to the above-described filament 2 and fibrous construct 4 and the embodiments shown in FIGS. 47A-47C, the expandable portion 3 may be part of any of the full suture anchors described herein, or may include the full suture anchors shown and described in U.S. Patent Application No. 16 / 033616. The same structure and function of the expandable portion 3 described above and shown in FIGS. 47A-47C are applicable to these embodiments of the full suture anchor (with or without a fibrous construct).

[0073] According to an alternative embodiment of the present invention, as shown in FIGS. 49-51, a full suture anchor insertion device 600 is provided. 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 contemplated, referenced, described, and / or illustrated herein) in the bone hole in one operation with one device. In many procedures involving fixation to quadruple soft tissue, it is a common problem that after the surgeon removes the drill and guide, the surgeon loses the location of the hole drilled in the bone for anchor placement. Further, during normal anchor insertion, the drill guide must be held in one hand, and the other hand is used to drill the pilot hole and insert the anchor. The full suture anchor insertion device 600 enables the procedure to be performed with one hand by incorporating a guide into the anchor. The full suture anchor insertion device 600 also shortens the time required to attach the anchor by combining the drilling step and the anchor insertion step into one. The uniqueness of the full suture anchor insertion device 600 relates in part to the use of an anchor driver rod 601 for drilling a bone tunnel by vibrating the anchor driver rod 601 on the drill. The oscillatory motion of the drill rotates the anchor driver rod 601 back and forth. As the driver rod 601 vibrates, the tip of the bifurcation 603-1 at the distal end of the device acts as a drill bit to create a hole as the surgeon-user presses it into the bone. Once the rod and the anchor (positioned at the distal end of the device and not shown) are inserted, the vibration is stopped and the driver rod 601 is withdrawn. Next, the full suture anchor is set by pulling on the suture tail of the anchor and / or by adding an activator (as contemplated herein).

[0074] Briefly stated, as shown in FIGS. 49 - 51, the full suture anchor insertion device 600 includes, but is not limited to, an anchor driver rod 601, a guide 602 having a handle and a suture slip stop portion, 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 branch portion 603 - 1). The sliding guide tip 603 can be used to position the full suture anchor before the device begins to vibrate and to protect the surrounding tissue while the anchor vibrates and is inserted.

[0075] A preferred function of the full suture anchor insertion device 600 is to enable anchor insertion with a minimum number of steps from the surgeon in its method of use. Briefly stated, the surgeon can connect an electric handpiece (not shown, having, for example, an equal vibration mode as described above or understood by one of ordinary skill in the art in combination with the present disclosure) to the rear end of the inserter rod 601. Next, while holding the guide handle 602 and the power handpiece, the surgeon can position the sliding guide tip 603 at the position and angle of the bone where the anchor is to be attached. Further, the surgeon can turn on the vibration mode of the handpiece and push the inserter rod 601 into the bone (not shown). When the metal guide tube 604 is in the same plane as the bone surface (and when the distal end of the sliding guide tip 603 is in the same plane as the distal end of the metal guide tube), the suture (not shown) is removed from the slip stop portion and the device is removed. Next, the anchor can be set by pulling the suture tail and / or an actuator is added (as described herein and above).

[0076] When the term suture material, suture thread or filament is used and described herein, it includes single filaments or multifilament sutures as well as any other metallic or non-metallic filamentous or wire-like materials suitable for performing the function of sutures. This material may include both bioabsorbable and non-absorbable materials and may be round, flat or braided.

[0077] Embodiments of the invention have been particularly shown and described with reference to specific exemplary embodiments, but it will be understood by those skilled in the art that various changes in detail may be made without departing from the spirit and scope of the invention as defined by the claims that can be supported by the description and drawings provided. Further, if an exemplary embodiment is described with reference to a specific number of elements, it will be understood that the exemplary embodiment may be practiced using any number of elements less than the specific number.

Claims

1. An anchor inserter, comprising a shaft having a proximal end and a distal end and extending along a y - y axis which is a central longitudinal axis, an inserter tip attached to the shaft and extending distally from the shaft, a first drill point which is an outer peripheral surface of a distal end of the inserter tip and is a first drill tip, a suture anchor holding slot extending through the inserter tip and enabling an anchor having a suture to be pushed into a bone hole created by the first drill point, the suture anchor holding slot having a pair of opposing inner walls, an anchor placement passage extending from the suture anchor holding slot to an outer distal surface of the inserter tip and enabling the anchor to be removed from the inserter tip, and comprising, the anchor placement passage having a pair of opposing drill surfaces, the pair of inner walls extending in a direction parallel to both the y - y axis and a z - z axis perpendicular to the y - y axis, the pair of drill surfaces extending in a direction parallel to the y - y axis, and a first virtual plane parallel to and equidistant from the pair of drill surfaces and a second virtual plane parallel to and equidistant from the pair of inner walls are displaced from each other in a direction along an x - x axis perpendicular to both the y - y axis and the z - z axis. An anchor inserter.

2. The anchor inserter according to claim 1, further comprising a second drill point which is an outer peripheral surface of a distal end of the inserter tip.

3. The anchor inserter according to claim 2, wherein the first drill point is disposed distally with respect to the second drill point.

4. The anchor inserter according to claim 1, wherein the pair of opposing drill surfaces are closer to each other than the pair of inner walls.

5. The anchor inserter according to claim 1, wherein the pair of inner walls are at an angle offset from the pair of drill surfaces.

6. The anchor inserter according to claim 1, further comprising a quick-change connector attached to the shaft and extending proximally from the shaft.

7. The anchor inserter according to claim 6, wherein the quick-change connector comprises a distal adapter and a rod extending proximally therefrom.

8. The anchor inserter according to claim 7, wherein the rod comprises at least one plane.

9. Further comprising a tubular portion connected to the proximal end of the shaft, wherein the tubular portion, an outer tube of the tubular portion having a first internal volume, and a suture tube of the tubular portion having a second internal volume, the suture tube extending into the first internal volume of the outer tube, the suture tube and the outer tube. The anchor inserter according to claim 1.

10. The anchor inserter according to claim 9, wherein the shaft extends at least to a distal portion of the outer tube and at least to a distal portion of the suture tube, and at least a proximal portion of the outer tube extends into the quick-change connector.

11. A self-perforating anchor inserter system, a tubular portion, a shaft having a proximal end and a distal end and extending along a y-y axis which is a central longitudinal axis, the shaft being connected to the tubular portion, an inserter tip attached to the shaft and extending distally from the shaft, a first drill point which is a distal end peripheral surface of the inserter tip and is a first drill tip, An anchor having a suture anchor holding slot that extends through the inserter tip, has a pair of opposing inner walls, and allows the anchor having the suture to be pushed into a bone hole generated by the first drill point. An anchor blade and the anchor having the suture positioned through the anchor blade, the suture extending through the suture anchor holding slot so that a first end of the suture extends along a first side surface of the shaft and a second end of the suture extends along a second side surface of the shaft. An anchor placement passage that extends from the suture anchor holding slot to an outer distal surface of the inserter tip and allows the anchor to be removed from the inserter tip. Comprising: The anchor placement passage has a pair of opposing drill surfaces. The pair of inner walls extend in a direction parallel to both the y - y axis and the z - z axis perpendicular to the y - y axis. The pair of drill surfaces extend in a direction parallel to the y - y axis, and A self - piercing anchor inserter system in which a first virtual plane parallel to and equidistant from the pair of drill surfaces is displaced along the x - x axis perpendicular to both the y - y axis and the z - z axis with respect to a second virtual plane parallel to and equidistant from the pair of inner walls.

12. The self - piercing anchor inserter system according to claim 11, further comprising a second drill point which is an outer peripheral surface of a second drill tip at a distal end of the inserter tip.

13. The self - piercing anchor inserter system according to claim 12, wherein the first drill point is disposed distally with respect to the second drill point.

14. The inserter tip comprises a pair of prongs, each prong extending along a side surface of the suture anchor holding slot and the anchor placement passage. The self-perforating anchor inserter system according to claim 11, wherein the pair of prongs are closer to each other within the anchor placement passage than within the suture anchor holding slot.

15. The self-perforating anchor inserter system according to claim 11, wherein the suture is positioned through one surface of the anchor blade.

16. The self-perforating anchor inserter system according to claim 11, wherein, in a previous configuration arranged at a predetermined position within the bone and loaded at the tip of the inserter, the anchor blade is twisted around at least a part of the tip of the inserter.

17. The self-perforating anchor inserter system according to claim 11, wherein the suture anchor holding slot has a rounded proximal edge and a sharp distal edge.

18. The self-perforating anchor inserter system according to claim 11, further comprising a plurality of passing positions along the anchor blade, and the suture is woven through the anchor blade at the plurality of passing positions.

19. The tubular portion an outer tube of the tubular portion having a first internal volume, a suture tube of the tubular portion having a second internal volume, the suture tube extending into the first internal volume of the outer tube, the self-perforating anchor inserter system according to claim 11, comprising the suture tube.

20. Before being arranged at a predetermined position within the bone and loaded at the tip of the inserter, the first end of the suture is between the first side surface of the shaft and the suture tube, and the second end of the suture is between the second side surface of the shaft and the suture tube, the self-perforating anchor inserter system according to claim 19. Claim 21. The pair of inner walls are at an angle offset from the pair of drill surfaces, whereby each of the pair of prongs having the pair of drill surfaces is configured not to be able to move in a direction approaching the other prong facing in a direction perpendicular to the y-y axis, which is the central longitudinal axis, and parallel to the z-z axis along the pair of inner walls. The self-piercing anchor inserter system according to claim 14. Claim 22 The self-piercing anchor inserter system according to claim 11, further comprising an AO-compatible quick-change connector attached to the tubular portion and extending proximally from the tubular portion.

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