A bone anchor, a method of forming the bone anchor, an anchor assembly, and a method of use thereof

Abstract

A bone anchor comprising an elongated hollow length, wherein a first portion of the elongated hollow length extends through a second portion of the elongated hollow length.

Description

[0001] A BONE ANCHOR, A METHOD OF FORMING THE BONE ANCHOR, AN ANCHOR ASSEMBLY, AND A METHOD OF USE THEREOF

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 733,433 filed on December 12, 2024, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to adjustable knotless bone anchors having a desired thickness and devices and methods of forming such anchors and uses thereof. Specifically, the disclosure is directed to methods of continuously forming knotless bone anchors having customizable thickness, and the resulting anchors formed and uses thereof.

[0006] The present invention, in some embodiments thereof, also relates to systems and methods of attaching a soft tissue or a biocompatible material such as, for example, an arthroscopic patch, an allograft, or a bone plate, to a bone by forming at least one bore in the bone and inserting a bone anchor in each of the at least one bore, the bone anchor having an attached retaining anchor for attaching the soft tissue or biocompatible material to the bone.

[0007] BACKGROUND OF THE INVENTION

[0008] In many surgical procedures, bone anchors or similar fixation devices are used to secure sutures or other repair materials to bone, facilitating tissue repair at a target site. Common applications include securing soft tissue, such as ligaments and tendons, to bone, such as in rotator cuff repair or anterior cruciate ligament (ACL) reconstruction. These anchors are typically inserted after preparing the bone with tools like obturators or drills. Various medical specialties, including orthopedic, reconstructive, and trauma surgery, rely on these devices and methods for effective tissue repair. A primary goal in these surgeries is to enhance patient outcomes, which is closely related to procedural efficiency. When surgical systems and methods are straightforward, intuitive, require less insertions and placements (e.g., puncture wounds), and are easy to handle for a healthcare practitioner, surgical efficiency can be improved, directly contributing to better patient outcomes.

[0009] It is known in the art to attach or fixate one body to another where such bodies may include bone and soft tissue such as, for example tendons. Various orthopedic surgery procedures may be performed to fix one body relative to another using connector devices such as screws and anchors including sutures. Such anchors may be inserted into bone by drilling a bore in the bone using a bone borer or drill positioned in a drill guide, and then passing an anchor into the bore via the drill guide. In this type of procedure, the drill guide must be maintained in alignment with the bore in the bone so that after the drill is retracted the anchor may be inserted into the bore utilizing an anchor inserter or other insertion device. This type of procedure is often complicated by inadequate view of the bore / anchor insertion site such as, for example, when performing an arthroscopic procedure. Additionally, the size of the bore must correspond to the anchor / inserter in order to achieve a good result. Another method, which may avoid the misalignment issue, is utilizing a self-punching anchor with a suture, where an anchor is mounted on or in an inserter. This allows the anchor to be directly positioned at the insertion site when the inserter forms a bore in the bone, for example, by hammering, forcing the anchor directly into the bore formed in the bone.

[0010] Such procedures are disclosed in, for example, U.S. Patent Applications Publications Nos. 2023 / 0320723, 2023 / 0056585, 2018 / 0132841, 2017 / 0172561, and 2018 / 0296207; and U.S. Patents Nos. 11,723,646 and 11, 819,204.

[0011] During certain arthroscopic surgeries, particularly for procedures like rotator cuff repair, the use of anchors to attach tissue to bone can be critical. These anchors must be carefully selected and placed to ensure effective and lasting repair. The choice of anchor thickness and the impact of the bore in the bone are significant considerations that influence surgical outcomes.

[0012] For example, anchors that can be used in repair of labral tears to affix glenoid labrum to the bone, can be made from all-suture materials. Traditionally, these anchors have been made of metal, non-biodegradable, polymer materials, or biodegradable materials, raising potential safety concerns. For example, metal anchors can protrude and cause chondral damage, which can be difficult to revise or reposition, and may distort or prevent magnetic resonance imaging of the joint. Likewise, plastic anchors can also become prominent, brittle, and loose, and can toggle, break in the joint, or migrate. Furthermore, biodegradable anchors can loosen or break on insertion, and may lead to osteolysis, causing failure of labral healing, and potentially releasing products of degradation on cartilage.

[0013] All-soft suture anchors offer several advantages over solid suture anchors, including reduced bone loss and limited joint damage in case of anchor failure. Furthermore, the small diameter of these anchors may also be beneficial by allowing coupling on several points, thereby reducing the risk of recurrent instability, as well as minimizing the likelihood of glenoid rim fracture.

[0014] However, when compared with traditional solid suture anchors, typical all-soft suture anchors required less force for displacement, and lower load-to-failure (LTF) indicating potential micromotion, which, in turn, could lead to disrupted healing, bone damage and resorption, as well as surgical failure. Furthermore, there are a number of suture implant systems which claim to be “knotless,” that is, these implantable sutures do not require a surgeon to tie a knot during surgery. Many such systems control tension on tissue by the depth to which an anchor is driven into bone. U.S. Pat. Nos. 5,782,864 and 7,381,213 by Lizardi disclose certain types of suture anchors which capture a fixed- length loop of suture. Adjustable loop knotless anchor assemblies utilizing an anchor element inserted into a sleeve are described by Thai in U.S. Pat. Nos. 5,569,306 and 6,045,574 and in U.S. Patent No. 8,419,769.

[0015] SUMMARY OF THE INVENTION

[0016] According to an aspect of some embodiments, there is provided a bone anchor comprising an elongated hollow length, wherein a first portion of the elongated hollow length extends through a second portion of the elongated hollow length.

[0017] According to some embodiments, the first portion of the elongated hollow length extends at least one of: at least partially radially into an interior portion of the second portion of the elongated hollow length; and along an interior portion of the second portion of the elongated hollow length.

[0018] According to some embodiments, the first portion of the elongated hollow length extends through a hollow of the second portion of the elongated hollow length.

[0019] According to some embodiments, the elongated hollow length is formed of a braided material.

[0020] According to some embodiments, the braided material includes a plurality of strands and a proximal end, wherein the elongated hollow length includes a first opening along the elongated hollow length between strands of the braided material, at a distance from the proximal end, and wherein the first portion of the elongated hollow length is inserted via the first opening into the elongated hollow length.

[0021] According to some embodiments, the bone anchor defines a loop formed along the elongated hollow length at the first opening.

[0022] According to some embodiments, the bone anchor includes a portion having an adjustable length.

[0023] According to some embodiments, the portion having an adjustable length is adjustable by pulling on an end portion of the elongated hollow length.

[0024] According to some embodiments, the bone anchor is configured to be inserted into a bore in a bone and is configured to be retained in the bore by at least one of: friction between at least a portion of the bone anchor and the bone; and geometric constraints of at least one portion of the anchor relative to the bore in the bone, the geometric constraints caused by friction between at least two portions of the elongated hollow length.

[0025] According to some embodiments, the bone anchor is configured to be inserted into a bore in a bone and wherein the bone anchor does not require knotting to be retained within the bore.

[0026] According to some embodiments, a portion of the second portion of the elongated hollow length defines a thickened portion of the bone anchor.

[0027] According to some embodiments, the thickened portion is at least twice as thick as the first portion of the elongated hollow length.

[0028] According to some embodiments, the thickened portion is at least three times as thick as the first portion of the elongated hollow length.

[0029] According to some embodiments, the bone anchor includes first and second ends, at least one elongated portion extending from the first end and a loop extending from the second end, wherein the at least one elongated portion extends through the loop.

[0030] According to some embodiments, the loop is defined by a third portion of the elongated hollow length, wherein the third portion is adjacent to the first portion of the elongated hollow length.

[0031] According to some embodiments, the third portion of the elongated hollow length is adjacent to the second portion of the elongated hollow length.

[0032] According to some embodiments,, when the bone anchor has been inserted into a bore in a bone and tension is applied to the at least one elongated portion, a portion of the tension is applied to the loop.

[0033] According to some embodiments, the bone anchor includes a sleeve, wherein a portion of the bone anchor is positioned within a first portion of the sleeve.

[0034] According to some embodiments, the bone anchor consists essentially of the elongated hollow length and the sleeve.

[0035] According to some embodiments, the bone anchor has an unbent orientation wherein the sleeve extends in a straight line, and a bent orientation wherein the sleeve is one of bent and curved.

[0036] According to some embodiments, the sleeve has an outer surface configured to increase friction with an anchored surface.

[0037] According to some embodiments, the second portion of the elongated hollow length defines a thickened portion of the bone anchor, and wherein the thickened portion is positioned inside the sleeve. According to some embodiments, the sleeve includes a second portion adjacent the first portion of the sleeve, wherein the second portion of the sleeve is configured to be pulled to move the sleeve into position along the bone anchor.

[0038] According to some embodiments, at least the first portion of the elongated hollow length and the second portion of the elongated hollow length extend through the sleeve.

[0039] According to some embodiments, the bone anchor is flexible.

[0040] According to some embodiments, the bone anchor includes first and second ends and wherein the bone anchor is bendable into a structure in which the first and second ends face in a same direction.

[0041] According to some embodiments, the bone anchor is bendable into a closed shaped structure.

[0042] According to an aspect of some embodiments, there is provided a bone anchor comprising an elongated hollow length formed of a braided material, wherein the elongated hollow length includes an opening along the elongated hollow length between strands of the braided material, wherein a first portion of the elongated hollow length is inserted via the opening and extends through a second portion of the elongated hollow length.

[0043] According to some embodiments, there is provided a method of forming the bone anchor, wherein the elongated hollow length includes a second opening proximal to the first opening, the method including: positioning a pull wire within the elongated hollow length with a pull wire loop extending out of the first opening and at least one pull wire end extending out of the second opening; and proximal pulling of the at least one pull wire end to pull the first portion of the elongated hollow length into the second portion of the elongated hollow length.

[0044] According to some embodiments, the anchor assembly includes a second anchor, wherein the second anchor is attached to the bone anchor by the elongated hollow length.

[0045] According to some embodiments, the anchor assembly does not require the advancement of knots along a portion of the elongated hollow length.

[0046] According to some embodiments, the anchor assembly is knotless.

[0047] According to some embodiments, the bone anchor is configured to be inserted into a bore in a bone and the second anchor is configured to attach a tendon to the bone.

[0048] According to some embodiments, the second anchor includes a plurality of external loops.

[0049] According to some embodiments, the second anchor is attached to the bone anchor by threading of the elongated hollow length through at least a portion of the plurality of external loops.

[0050] According to some embodiments, a fourth portion of the elongated hollow length is threaded through a first portion of the plurality of external loops in a first direction and a fifth portion of the elongated hollow length is threaded through a second portion of the plurality of external loops in a second direction, and wherein the first direction is opposite to the second direction.

[0051] According to some embodiments, the second anchor is flexible.

[0052] According to some embodiments, the second anchor is bendable into a structure having one of a C-shape and a U-shape, wherein in the C-shape end portions of the second anchor are directed toward each other, and wherein in the U-shape end portions of the second anchor directed in a same direction.

[0053] According to some embodiments, the bone anchor and the second anchor are separated by a distance, and wherein the distance is reducible by pulling an end portion of the elongated hollow length.

[0054] According to some embodiments, when the bone anchor is in position in a bore in a bone, the second anchor is configured to attach a tendon to the bone.

[0055] According to some embodiments, the first anchor includes a first end, a second end, and a sleeve extending from the first end to the second end, wherein the sleeve has an internal passageway extending therethrough, the passageway sized and shaped to accommodate suture threads therein, and wherein the first anchor includes a loop extending from the first end; wherein the second anchor includes a body having third and fourth ends and a center portion between the third and fourth ends, wherein the body has an external passageway sized and shaped to accommodate suture threads therein; wherein a third portion of the elongated hollow length extends from the internal passageway away from the first anchor, passes through the loop, and extends towards the external passageway; wherein a fourth portion of the elongated hollow length extends from the third portion of the elongated hollow length and enters external passageway at the third end of the second anchor, and exits the external passageway at the center portion of the second anchor; wherein a fifth portion of the elongated hollow length extends from the fourth portion of the elongated hollow length at the center portion of the second anchor, loops around and changes direction, and enters the external passageway from the fourth end of the second anchor; wherein a sixth portion of the elongated hollow length extends from the fifth portion of the elongated hollow length and passes through the external passageway from the fourth end to the center portion of the second anchor; where a seventh portion of the elongated hollow length extends from the sixth portion of the elongated hollow length, exits the external passageway at the center portion, and extends toward the first end of the internal passageway of the first anchor; and wherein an eighth portion of the elongated hollow length extends from the seventh portion of the elongated hollow length and passes through the internal passageway, from the first end to the second end, passes through the loop, extends toward the center portion of the second anchor, passes between the body and the external passageway, at the center portion of the second anchor, and extends away from the second anchor.

[0056] According to some embodiments, the eighth portion of the elongated hollow length has a proximal end portion, and wherein a distance between the first and second anchors may be shortened by pulling the proximal end portion.

[0057] According to some embodiments, the second anchor is configured to attached a tendon to a bone.

[0058] According to some embodiments, the second anchor is bendable when the proximal end portion is pulled proximally.

[0059] According to some embodiments, at least one of the first anchor and second anchor is tubular.

[0060] According to some embodiments, the external passageway is defined by a plurality of loops positioned along the body of the second anchor.

[0061] According to some embodiments, the external passageway is defined by an even number of loops axially distributed and symmetric with respect to the center portion of the second anchor.

[0062] According to some embodiments, the second and fourth suture lengths extend along portions of the external passageway, on either side of the center portion, in opposing directions.

[0063] According to an aspect of some embodiments, there is provided a method of forming an adjustable thickness anchor from a braided hollow cable, wherein the braided hollow cable has a distal end and a proximal end, and a distal exit and a proximal exit located between the distal end and the proximal end; wherein a portion of a pull wire extends along the interior of the braided hollow cable, the pull wire having a slidable loop and a pair of proximal extensions, wherein the slidable loop extends outside the braided hollow cable via the distal exit and the pair of proximal extensions extend outside the braided hollow cable via the proximal exit; the method including: a) inserting the distal end of a braided hollow cable through the distal loop of the pull wire; b) pulling the pair of pull wire proximal extensions, to pull a distal end portion of the braided hollow cable into the interior of the braided hollow cable via the distal exit, and out of the proximal exit, to form at least a first cable loop extending distally adjacent the distal exit and at least a second cable loop extending proximally out of the proximal exit; c) cutting the at least one second cable loop extending out of the proximal exit; d) using a sleeve having a proximal end and a distal end with a predetermined diameter and a predetermined length, sheathing a proximal portion of the first cable loop and a portion of the braided hollow cable distal to the distal exit, wherein a distal portion of the first cable loop extends distally beyond the distal end of the sleeve; e) inserting the proximal end of the braided hollow cable through the first cable loop; and f) pulling the proximal end of the braided hollow cable, to cause the sleeve to form a closed shaped knotless anchor.

[0064] 50. The method of claim 49, including, after action (b), removing the pull wire from the braided hollow cable.

[0065] According to some embodiments, the braided hollow cable is formed of a predetermined number of strands, wherein the predetermined number of strands is proportional to the desired thickness of the adjustable knotless anchor.

[0066] According to some embodiments, prior to the pulling the pair of pull wire proximal extensions, repeating the action of inserting the distal end of the braided hollow cable through the distal loop of the pull wire a selected number of times, wherein the selected number of times is proportional to the desired thickness of the adjustable knotless anchor.

[0067] According to some embodiments, the sleeve has an outer surface configured to increase friction with an anchored surface.

[0068] According to some embodiments, there is provided an anchor, having a predetermined thickness, the anchor formed by the method.

[0069] According to an aspect of some embodiments, there is provided a method of forming a knotless bone anchor including: inserting an end of a first portion of an elongated hollow cable into a second portion of the elongated hollow cable, at an entrance point along the elongated hollow cable; advancing the first portion of the elongated hollow cable into the interior of the elongated hollow cable, through the entrance point, such that the first portion is positioned radially inside the second portion of the elongated hollow cable.

[0070] According to some embodiments, a loop is defined by a third portion of the elongated hollow cable, wherein the third portion is located along the elongated hollow cable between the first and second portions. According to some embodiments, the method includes inserting a second end of the elongated hollow cable through the loop to form a closed shaped anchor.

[0071] According to some embodiments, the method includes, prior to the inserting a second end, positioning a sleeve over a portion of the loop and a portion of the second portion of the elongated hollow cable.

[0072] According to some embodiments, there is provided an anchor, having a predetermined thickness, the anchor formed by the method.

[0073] According to an aspect of some embodiments, there is provided a method of implanting a knotless anchor in a bore in a bone, the method including: inserting a knotless anchor into the bore, wherein the anchor is formed of an elongated hollow cable; pulling an end of the elongated hollow cable proximally to at least one of: adjust the size of the knotless anchor; and tighten the knotless anchor relative to the bone.

[0074] According to an aspect of some embodiments of the present invention there is provided a sandwich configuration having first and second flexible bone anchors with an associated suture thread, wherein the suture thread includes a proximal end, a distal end, and at least one length of suture thread extending between the proximal end and the distal end; wherein the first flexible bone anchor has a first tubular body and an internal passageway configured to receive at least one suture length extending from a first end of the first tubular body to a second end of the first tubular body; wherein the second flexible bone anchor has a second tubular body extending from a first end of the second tubular body to a second end of the second tubular body, a center between the first end of the second tubular body and second end of the second tubular body, and an external passageway defined by at least two loops external to the second tubular body, wherein at least one loop of the at least two loops is positioned on each side of the center of the second tubular body, the at least one loop of the at least two loops configured to receive the at least one suture length; wherein a distal loop is tied adjacent to the distal end of the suture thread; wherein the length of thread extends from the distal loop through the internal passageway of the first flexible bone anchor; wherein the length of thread exiting the internal passageway passes through the distal loop; wherein the length of thread exiting the distal loop extends through a first end of the external passageway of the second flexible bone anchor; wherein the length of thread passes from a first end of the external passageway, through a first portion of the external passageway, toward a center of the external passageway and exits the external passageway; wherein the length of thread exiting the center of the external passageway loops, to pass from a second end of the external passageway, through a second portion of the external passageway, toward the center of the external passageway and exits the external passageway; wherein the length of thread extends from the external passageway, toward the first flexible bone anchor and extends through the internal passageway of the first flexible bone anchor; wherein the length of thread exiting the internal passageway passes through the distal loop; wherein the length of thread extending from the distal loop passes between the tubular body of the second flexible bone anchor and the external passageway thereof; and wherein the length of thread extends proximally.

[0075] According to an aspect of some embodiments, there is provided a method utilizing the sandwich configuration, the method including: repairing a target site by securing a soft tissue to a bone; delivering the first flexible suture anchor to a prepared hole in the bone; delivering the second flexible bone anchor; pulling the suture thread proximal end to bend the second flexible anchor, to secure the second flexible anchor to the soft tissue against the bone.

[0076] According to an aspect of some embodiments of the present invention there is provided a method of threading two flexible bone anchors with a suture thread in a system comprising: the suture thread with a proximal end, a distal end, and at least one length of suture thread extending between the proximal end and the distal end; a first flexible bone anchor with a first tubular body and an internal passageway configured to receive at least one suture length extending from a first end of the first tubular body to a second end of the first tubular body; a second flexible bone anchor with a second tubular body extending from a first end of the second tubular body to a second end of the second tubular body, a center between the first end of the second tubular body and second end of the second tubular body, and an external passageway defined by at least two loops external to the second tubular body, wherein at least one loop is positioned on each side of the center of the second tubular body, the at least one loop configured to receive at least one suture length, comprising: i. tying a loop adjacent to the distal end of the suture thread; ii. extending a length of thread from the loop through the internal passageway of the first flexible bone anchor; iii. passing the length of thread exiting the internal passageway through the loop; iv. continuing to extend the length of thread exiting the loop through the first end of the external passageway of the second flexible bone anchor; v. passing the length of thread through a first portion of the external passageway, toward a center of the external passageway and exiting the external passageway; vi. looping the length of thread exiting the center of the external passageway to extend through a second portion of the external passageway, toward the center of the external passageway of the second flexible bone anchor and exiting the external passageway; vii. extending the length of thread from the external passageway toward the first flexible bone anchor and extending the length of thread through the internal passageway of the first flexible bone anchor; viii. passing the length of thread exiting the internal passageway through the loop; ix. passing the length of thread extending from the loop between the tubular body of the second flexible bone anchor and the external passageway thereof; and x. extending the length of thread proximally.

[0077] According to some embodiments, the method further comprises repairing a target site by securing a soft tissue to a bone: delivering the first flexible suture anchor to a prepared hole in the bone; delivering the second flexible bone anchor; pulling the suture thread proximal end to bend the second flexible anchor, to secure the second flexible anchor to the soft tissue against the bone.

[0078] According to an aspect of some embodiments, there is provided a method of continuously forming an adjustable thickness cable configured for the formation of an adjustable thickness anchor, implemented in a loom system comprising: a braiding module having a braiding deck with a plurality of selectable strands configured to form a braided cable; and a pull wire, the method comprising: a. using the braiding deck selecting a predetermined number of strands; b. using the braiding module, braiding the predetermined number of strands at a braiding point forming a braided hollow cable having a predetermined length defining a distal end and a proximal end; c. simultaneously with the action of braiding, incorporating a first slidable loop of a pull wire in the braiding point, wherein the first slidable loop is configured to extend distally and proximally beyond the braided hollow cable surface, forming a distal exit and a proximal exit respectively; d. cutting the braided hollow cable at the predetermined length; e. cutting the first slidable loop of a pull wire at a proximal extension beyond the proximal exit, forming a slidable hairpin member with a distal pull wire loop and a pair of proximal pull wires extensions.

[0079] According to some embodiments, the method further comprises forming the adjustable thickness anchor by: a. inserting the distal end of the braided hollow cable to the distal loop of the pull wire, forming at least one second loop of the braided hollow cable, wherein the distal end of the braided hollow cable is configured to extend beyond the distal loop of the pull wire; b. pulling the pair of pull wire extension into the braided hollow cable, and out of the proximal exit, thereby forming a third braided hollow cable loop extending proximally from the proximal exit; c. removing the slidable hairpin member; d. cutting the third braided hollow cable loop, thereby forming a braided hollow cable having a distal eyelet and a thickened portion between the distal exit and the proximal exit; e. using a sleeve having a proximal end and a distal end with a predetermined diameter and a predetermined length, sheathing the distal eyelet and a portion of the braided hollow cable proximally to the distal exit, wherein a portion of the distal eyelet extends distally beyond the distal end of the sleeve, f. inserting the proximal of the braided hollow cable through the eyelet; and g. pulling the braided hollow cable, thereby causing the sleeve to form a C-shape knotless anchor.

[0080] According to some embodiments, the predetermined number of strands is proportional to the sought thickness of the adjustable anchor thickness.

[0081] According to some embodiments, prior to the action of pulling the pair of pull wire extension, the method includes repeating the action of inserting the distal end of the braided hollow cable to the distal loop of the pull wire for a number of times proportional to the sought thickness of the adjustable anchor thickness.

[0082] According to some embodiments, the sleeve further comprises an outer surface configured to increase friction with an anchored surface.

[0083] According to some embodiments, there is provided a spool of the adjustable thickness cable configured for the formation of the adjustable thickness anchor formed by claim 1, comprising a plurality of the slidable hairpin members disposed along the braided hollow cable at predetermined intervals. According to some embodiments, there is provided an anchor, having a predetermined thickness formed by the method.

[0084] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0085] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0086] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0087] In the drawings:

[0088] FIG. 1 is a schematic illustration of the weaving and braiding deck, according to some embodiments;

[0089] FIG. 2 illustrates the effect of the number of strands selected on the hollow braided cable formed, according to some embodiments;

[0090] FIGs. 3A-F, illustrate a method of forming the first part of the adjustable-thickness anchor, according to some embodiments;

[0091] FIGs. 4A-C illustrate a method of forming the second part of the adjustable-thickness anchor, according to some embodiments;

[0092] FIG. 5 is a schematic illustrating the placement of the adjustable thickness anchor within a drilled bone bore, according to some embodiments;

[0093] FIG. 6 is an illustration of an exemplary anchor assembly, according to some embodiments;

[0094] FIG. 7 is a flowchart illustrating actions performed in producing an adjustable knotless anchor, according to some embodiments; and

[0095] Fig. 8 is a schematic illustration of a method of threading the anchor assembly of Fig. 6, according to some embodiments.

[0096] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0097] The present invention, in some embodiments thereof, relates to adjustable knotless bone anchors having a desired thickness and devices and methods of forming such anchors and uses thereof. Specifically, the disclosure is directed to methods of continuously forming knotless bone anchors having customizable thickness, and the resulting anchors formed and uses thereof. It may be noted that the present invention, in some embodiments thereof, may be utilized in various surgical procedures including, for example, arthroscopic surgery or keyhole surgery.

[0098] In arthroscopic surgery, for example, for procedures like rotator cuff repair, the use of anchors to attach tissue to bone is important. These anchors must be carefully selected and placed to ensure effective and lasting repair. The choice of anchor thickness and the impact of the bore in the bone are some of the considerations that influence surgical outcomes. The thickness of the anchor affects both the mechanical stability and the biological integration of the repair. Larger diameter anchors generally provide greater pullout strength, which helps maintaining tissue fixation during the healing process, and increasing the diameter of suture anchors can generally enhance load-to-failure (LTF) rates, suggesting that larger anchors may reduce the risk of failure during, for example, rotator cuff repairs.

[0099] However, using larger anchors can also mean creating a larger bore in the bone, which can lead to more significant bone loss and potential complications if not managed correctly, as well as certain angle and space constraints. The effect can be that the bore size in the bone must be balanced between providing sufficient anchor strength and minimizing bone damage. In patients with compromised bone quality, such as those with osteoporosis, under-tapping techniques (using a tap one size smaller than the intended anchor) have been explored to increase fixation strength without excessively enlarging the bore. However, this approach does not always result in increased LTF for all types of anchors, indicating that careful anchor customization based on specific anchor materials, anchor thickness and patient bone quality is necessary.

[0100] Anchor material also affects surgical outcomes. As indicated, metal anchors can cause complications such as chondral damage or migration, whereas biodegradable anchors can lead to osteolysis or incomplete resorption. Conversely, all-suture anchors, which are smaller in diameter and cause less bone loss, offer several advantages, including reduced joint damage in case of failure and minimal impact on imaging.

[0101] However, these all- suture anchors may be associated with weaker initial fixation and LTF compared to solid anchors. The choice of anchor also depends on specific surgical needs and patient factors. For example, in cases where bone quality is poor or where revision surgery might be necessary, non-degradable materials like polyether ether ketone (PEEK) may be preferred due to their stability and compatibility with imaging. Surgeons must also consider factors such as insertion depth and angle, as these can significantly affect anchor pullout strength and overall repair integrity.

[0102] A more complete understanding of the methods of producing continuous forming knotless bone anchors having customizable thickness can be obtained by reference to the accompanying drawings. These figures (also referred to herein as “FIGs.”) are merely schematic representations based on convenience and the ease of demonstrating the present disclosure, and are, therefore, not intended to indicate relative size, scale and dimensions of the devices or components thereof, and / or to define or limit the scope of the exemplary implementations. Although specific terms are used in the following description for the sake of clarity, these terms are intended to refer only to the particular structure of the exemplary implementations selected for illustration in the drawings, and are not intended to define or limit the scope of the disclosure. In the drawings and the following description, it is to be understood that like numeric designations refer to components of like function and / or structure.

[0103] Overview

[0104] According to some embodiments there are provided exemplary implementations of a bone anchor and an assembly including a bone anchor and a soft tissue anchor such as, for example, a tendon anchor.

[0105] In exemplary implementations, the anchor delivery system of the present disclosure may deliver two prethreaded flexible anchors. Both prethreaded flexible anchors may be operably coupled to the distal end of an inserter prior to anchor delivery. Optionally, prior to delivery, a first prethreaded flexible anchor such as, for example, a bone anchor, may be operably coupled to the distal end of an inserter, and a second prethreaded flexible anchor such as, for example, a soft tissue anchor, may be operably coupled to a portion of inserter proximal to the inserter distal end, according to some embodiments.

[0106] Both prethreaded flexible anchors may be sized and shaped to be deployed from the anchor delivery device, according to some embodiments. Both prethreaded flexible anchors may have elongate bodies extending from a first end to a second end, the bodies configured to transition from an unbent orientation wherein the first end and second end are maximally extended, to a bent orientation wherein first and second ends are closer to each other than in the unbent orientation, according to some embodiments. According to some embodiments, each prethreaded flexible anchor has a passageway extending along its body, the passageway sized and shaped for threading at least one length of suture therethrough. In further exemplary implementations of methods of anchor delivery, the two prethreaded flexible anchors may comprise a first anchor to be delivered first by the anchor delivery system in the bent orientation into the hole, and then a second anchor, to be delivered second and secured against soft tissue. In exemplary implementations of threading methods, the second anchor is prethreaded such that from the first end to a center of the second anchor a suture thread length is directed in one direction, and from the center to the second end a suture thread length is directed in an opposing, second direction. This threading method is potentially beneficial in enabling transition of the second anchor from an unbent to a bent orientation, preventing passage of the second anchor into the hole, and shortening the span of any one length of suture thread which may prevent knotting, tangling, or any other issues that may affect the mobility, functionality, tightening capability, or ease of use of the suture thread.

[0107] According to an aspect of some embodiments there is provided a bone anchor which is slidingly engaged with a suture for attachment to a bone. At least a portion of the bone anchor may be tubular or may include a passageway or inner lumen extending along at least a portion of the bone anchor, according to some embodiments. Access to passageway or lumen may be obtained via either of two openings which are sized and shaped for passage of at least one suture therethrough. Optionally, the passageway or a portion thereof may be at least partly external to the bone anchor, the passageway formed of any suitable material connected to or integrally formed with bone anchor such as, for example, loops. Alternatively, instead of providing the bone anchor with a passageway through which the suture may pass, the bone anchor may be slidingly engaged with the suture, according to some embodiments.

[0108] A suture may extend through the passageway, the suture forming a loop having first and second extensions, the first extension formed with an aperture sized and shaped for having a portion of suture pass therethrough.

[0109] According to some embodiments, the device also includes a retaining anchor having a patch, optionally formed of a flexible material, and at least one loop or connector for allowing the retaining anchor to be slidingly mounted on the suture. Alternatively, the retaining anchor may include a plurality of apertures through which the suture may be threaded, such that the retaining anchor is slidingly mounted on the suture. The patch is optionally formed of a flexible material, and is optionally formed of a compressible material.

[0110] The bone anchor may be deployed, by any of the systems discussed herein or by any suitable deployment device, through an opening in a soft tissue and into a bore in a bone, as discussed herein. When the bone anchor is deployed through the tissue and into the bore in the bone, the suture loop may extend from the bone anchor, out of the bore, and through the opening in the tissue.

[0111] After the bone anchor has been deployed, the suture extension may be pulled proximally to shorten the loop, as the loop slides through passageway. As the loop is shortened, it may slide through the loops of the retaining anchor as the retaining anchor moves toward the proximal side of the tissue, according to some embodiments. This may tighten the retaining anchor against the proximal side of tissue as suture extension is pulled proximally. Thereafter, the suture may be tied off or knotted and excess suture material from extension may be removed. The retaining anchor may be thick enough to cushion soft tissue relative to pressure applied by the suture to the soft tissue when tightened. The retaining anchor may also be tough enough or sturdy enough such that it will not be cut or damaged by the suture.

[0112] As the bone anchor is configured to be inserted through an opening in the soft tissue (or arthroscopic patch or allograft or bone plate or other biocompatible material), the retaining anchor is sized and / or shaped such that the retaining anchor cannot be passed through the opening in the soft tissue.

[0113] It should be noted that that provision of a device having a bone anchor and retaining anchor, both of which are slidable relative to suture may provide an improved device for securing a soft tissue to a bone which may facilitate attaching a soft tissue or an arthroscopic patch or an allograft or bone plate or other biocompatible material to a bone. The device may potentially reduce pressure on the soft tissue and, according to some embodiments. This may allow better healing of the tissue and / or may prevent damage caused by excess pressure to the soft tissue, as compared with a suture alone which may force a soft tissue against a bone.

[0114] Additionally, the retaining anchor may potentially provide a cushioning component to the device, whereby force applied to the tissue proximal side may be distributed across the area of the retaining anchor. This may potentially reduce pressure and / or stress to the tissue, as compared with a bone anchor which does not include a retaining anchor and which retains the tissue relative to the bone by means of the suture pulled against the tissue on the tissue proximal side. Depending on the size of the retaining anchor, i.e., the area of the retaining anchor that contacts and is forced against the tissue, this may potentially significantly reduce pressure and / or stress applied to the tissue, and may potentially prevent damage to tissue.

[0115] An aspect of some embodiments relates to knotless bone anchors formed from at least one cable, suture thread, or wire (hereinafter “cable”), whereby the anchor may be inserted into a bore in a bone and retained therein without any knotting of the cable. In particular, no knot moves outside the bone, according to some embodiments. Additionally, there is no knot at all required outside the bone, and there is no knot at all, so there is no need to tighten or move a knot outside the bone, according to some embodiments. This provides a potential advantage of allowing for easier and / or faster anchoring of tissue to the bone, with no foreign bumps to interact with tissue, according to some embodiments.

[0116] An exemplary knotless bone anchor includes a continuous cable forming a structure which is to be inserted into a bore in a bone, according to some embodiments. Instead of knotting, the knotless bone anchor is held in position in the bore in the bone by portions of the cable that are positioned in a constrained space which causes the cable portions to rub against each other and / or against the bone, which prevents movement of the cable portions relative to each other and relative to the bone, due to a coefficient of friction between the portions of the cable and / or at least one portion of the cable and the bone, according to some embodiments. This prevents pullback of the cable portions relative to the bone, according to some embodiments. This also keeps the anchor in position in the bore in the bone, according to some embodiments.

[0117] A knotless bone anchor may be selectively tightened by pulling on one part of the cable, according to some embodiments. Further pulling of the cable moves multiple portions of the cable, according to some embodiments. This causes more friction relative to portions of the cable and the bone, according to some embodiments. This friction replaces some or all of the functions of a knot, according to some embodiments.

[0118] The use of a knotless bone anchor, according to some embodiments, provides a potential advantage in that it avoids having knots which may cause irritation or damage to tissue at the surgical site. Additionally, after implantation of a knotless bone anchor, bone is allowed to grow over the anchor and cables inside the bore in the bone, according to some embodiments. This potentially locks the cables in place to prevent movement of the anchor relative to the bone, according to some embodiments.

[0119] According to some embodiments, the size of a knotless bone anchor or the length of cable extending from the knotless bone anchor is adjustable, for example, by pulling on an end portion of the cable. This adjustability is allowed even absent repositioning of the anchor or leaving the anchor at a fixed location or after the anchor is at a final depth, according to some embodiments. Adjusting the anchor allows shortening of the cable such that, for example, when used in conjunction with a second anchor, for example, for attaching a tendon to the bone, the second anchor may be wrapped around the tendon and the tendon may be pulled closer to the bone by pulling on the cable end portion, according to some embodiments. Adjusting the size of the knotless anchor potentially allows the anchor to better fit a larger bore in a bone, according to some embodiments. The cable length can be adjusted to accommodate larger tendons, according to some embodiments. Additionally, the cable length can be adjusted depending on the distance selected between the tendon and the bone, according to some embodiments.

[0120] According to some embodiments, the knotless anchor has two ends, a loop extending from a first end, and at least one cable portion extending from a second end. The at least one cable portion extends through the loop, according to some embodiments. The size of the anchor may be adjusted by moving the at least one cable through the loop, according to some embodiments.

[0121] The knotless anchor is insertable into a bore in a bone, for example, in a tendon repair procedure, such as, for example, a tenodesis procedure, according to some embodiments. Once the knotless anchor is positioned inside the bore, the cable end portion may be pulled, for example, to tighten the anchor such as, for example, then the knotless anchor is attached to a second anchor for example, for attaching a tendon to the bone, according to some embodiments. Tension on the at least one cable portion extending through the loop relieves a portion of the strain on the at least one cable, according to some embodiments. This potentially prevents breakage of the at least one cable, according to some embodiments.

[0122] The adjustable knotless bone anchor is defined by a closed shape, according to some embodiments. The closed shape is formed of a plurality of portions of the cable extending along the length of the anchor, according to some embodiments. This may potentially provide the anchor with increased strength, for example, for being retained in a bore in a bone, according to some embodiments. This may also potentially provide the anchor with increased strength, for example, for attachment of a tendon to the bone, optionally using a second anchor wrapped around the tendon, according to some embodiments.

[0123] The adjustable knotless bone anchor may be formed of a single strand of cable and an outer sleeve, wherein portions of the cable overlap within the sleeve, according to some embodiments. This potentially results in a potential advantage of the anchor having increased strength, according to some embodiments.

[0124] The adjustable knotless bone anchor may include a sleeve, positioned over at least a portion of the anchor, according to some embodiments. The sleeve may be positioned on the anchor during formation of the anchor, according to some embodiments. The sleeve may have an outer surface configured to rub against an anchored surface such as, for example, the edges of a bore in a bone, according to some embodiments. Movement between the sleeve and the bone is limited by a coefficient of friction between the sleeve outer surface and the bone, according to some embodiments. The outer surface may include, for example, protrusions, optionally directed proximally such that, once the adjustable knotless bone anchor is inserted into a bore in a bone, the protrusions will further resist pull and increase the LTF of the anchor, according to some embodiments.

[0125] Additionally, the sleeve may have an inner surface configured to rub against portions of the cable located within the sleeve, according to some embodiments. Movement between the sleeve and the portions of the cable located within the sleeve is limited by a coefficient of friction between the sleeve inner surface and the portions of cable located within the sleeve, according to some embodiments.

[0126] The adjustable knotless bone anchor may be used in an assembly including the adjustable knotless anchor in combination with a second anchor such as, for example, an anchor to be attached to a tendon by a components such as, for example, a suture, a wire, or a cable (hereinafter “cable”), according to some embodiments. The adjustable knotless anchor may be inserted into a bore in a bone, according to some embodiments. The second anchor may have radially extending loops through which the cable extend, according to some embodiments. Tightening of the cable causes the second anchor to bend and wrap around the tendon to hold the tendon in place relative to the bone, according to some embodiments.

[0127] Specifically, an end portion of the cable may be inserted through the loops of the tendon anchor, according to some embodiments. This attaches the bone anchor to the tendon anchor, according to some embodiments. The cable may be first passed through loops on a first side of the tendon anchor, starting at a center portion of the tendon anchor and ending at the end of the first side of the tendon anchor, and then passed through loops on the second side of the tendon anchor, starting at the center portion of the tendon anchor and ending at the end of the second side of the tendon anchor, according to some embodiments. This results in two portions of the cable being positioned within loops on opposite sides of the second anchor, wherein the two portions of the cable have been passed through loops in opposite directions, according to some embodiments. When the cable is tightened between the bone anchor and the second anchor, friction between the two portions of the cable within the loops prevents movement of the cable relative to the second anchor, according to some embodiments. This causes the second anchor to be retained in position relative to the bone anchor, according to some embodiments. This results in the tendon, which is held by the second anchor, to be retained in positioned relative to the bone, in which the bone anchor has been inserted, according to some embodiments.

[0128] An aspect of some embodiments relates to a bone anchor formed of a cable having an elongated hollow length, wherein a first portion of the elongated hollow length extends at least partially radially into and / or along an interior portion of a second portion of the elongated hollow length, according to some embodiments. According to some embodiments, the braided material includes a plurality of strands and a proximal end, and the elongated hollow length includes a first opening along the elongated hollow length between strands of the braided material, at a distance from the proximal end, and the first portion of the elongated hollow length is inserted via the first opening into the elongated hollow length. According to some embodiments, the bone anchor defines a loop formed along the elongated hollow length at the first opening. For example, the cable may be formed of a plurality of braided strands, according to some embodiments. The first portion of the elongated hollow length is inserted into the second portion of the elongated hollow length, between strands of the cable, at a first location along the second portion of the elongated hollow length, according to some embodiments. The first portion of the elongated hollow length may exit the second portion of the elongated hollow length at a second location along the second portion of the elongated hollow length, according to some embodiments.

[0129] An additional strand such as, for example, a pull wire, may be positioned partly within the elongated hollow length, according to some embodiments. The additional strand may include a loop extending out of the second portion of the elongated hollow length and at least one end portion extending out of the second portion of the elongated hollow length, according to some embodiments. The first portion of the elongated hollow length may be passed through the loop of the additional strand and then pulled into the interior of the elongated hollow length, according to some embodiments.

[0130] An aspect of some embodiments relates to a method of forming an adjustable knotless bone anchor. The adjustable knotless bone anchor may be formed by forcing an end portion of a cable, such as, for example, a braided cable, into or pulling an end portion of a cable into a first exit point along the cable and through an interior portion of the cable to a second exit point along the cable, according to some embodiments. This forms a thickened portion of cable between the first and second exits points, with a looped portion of the cable extending from one end of the cable, out of one end of the thickened portion, at the first exit point, according to some embodiments. A second end of the cable is inserted through the looped portion, according to some embodiments. This causes a knotless anchor to be formed, the knotless anchor having a closed shape, according to some embodiments. Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0131] Braiding Module for Forming a Braided Hollow Cable

[0132] Accordingly and in an exemplary implementation, provided herein is a method of continuously forming an adjustable thickness cable configured for the formation of an adjustable thickness anchor, implemented in a loom system illustrated schematically in FIG. 1, comprising: a braiding module 5000 having braiding deck 5011 with a plurality of selectable strands lOOOi configured to form a braided hollow cable 5100; and a pull wire 5200, according to some embodiments. The method comprises: using the braiding deck 5011, selecting a predetermined number of strands lOOOi; then using the braiding module 5000, braiding the predetermined number of strands lOOOi at braiding point 1100 forming a braided hollow cable 5100 having a predetermined length defining a distal end 5101 and a proximal end 5102 (see e.g., FIG. 3A). Prior to commencing the braiding, the number of strands lOOOi is selected. With reference to Fig. 2, it should be noted that the number of strands lOOOi selected will determined the thickness of the resulting braided hollow cable 5100 or the density of strands in the resulting braided hollow cable 5100, according to some embodiments. Additionally, the number of strands selected will determine the spacing between adjacent strands in the resulting cable 5100 and / or the rigidity of the resulting cable 5100, according to some embodiments. Simultaneously with the action of braiding, a first slidable loop of a pull wire is incorporated in the braiding, between strands lOOOi, wherein portions of the first slidable loop extend distally and proximally outside the surface of braided hollow cable 5100, through a distal exit 1031 and a proximal exit 1032, respectively, of cable 5100 (see e.g., Fig. 3 A). It may be noted that distal exit 1031 and proximal exit 1032 are located between strands 1000 of cable 5101, according to some embodiments.

[0133] The braided hollow cable 5100 is cut to a predetermined length, according to some embodiments. The proximal extensions 5201 are cut beyond the proximal exit 1032, forming a slidable hairpin member or pull wire 5200 having a distal pull wire loop 5210 and the proximal pull wire extensions 5201, according to some embodiments.

[0134] In another exemplary implementation, the action of cutting the braided hollow cable is omitted and the braiding can proceed to form a braided hollow cable 5100 where pull wires 5200 can be continuously incorporated into the braided hollow cable 5100, with distal pull wire loops 5210 and proximal pull wire extensions 5201 of the pull wires 5200, according to some embodiments. This forms a hollow braided cable 5100 having an extended length, with a plurality hairpin members or pull wires 5200 (see e.g., FIG. 1) disposed therein at predetermined intervals. It is noted that the intervals may be equal or unequal, according to some embodiments. The cable 5100 can then be cut as needed and used for forming the adjustable thickness anchor 5010, according to some embodiments.

[0135] Method of Forming an Adjustable Thickness Anchor

[0136] Turning now to FIGs. 3A-C, the methods disclosed for forming the adjustable thickness anchor are described, according to some embodiments. One such method comprises: inserting the distal end 5101 of the braided hollow cable 5100 into the distal loop 5210 of the pull wire, forming a first loop or eyelet 1013 of the braided hollow cable 5100, wherein the distal end 5101 of the braided hollow cable 5100 is configured to extend distally, beyond the distal loop 5210 of the pull wire 5200, according to some embodiments. As illustrated in FIGs. 3 A and 3B, braided hollow cable 5100 has a thickened section 5103 where slidable hairpin member 5200 extends through braided hollow cable 5100, wherein distal loop 5210 of the pull wire 5200 extends distally beyond the distal exit 1031 defined in the surface braided hollow cable 5100, at a distal end of the thickened section 5103 (see e.g., FIG. 3A). It should be noted that the length of the cable 5100 that is passed through distal pull wire loop 5210 should be approximately twice the length of the thickened section 5103, according to some embodiments.

[0137] Turning now to FIG. 3B in particular, 3C, by pulling the pair of pull wire extensions 5201, the pull wire 5200 is pulled through the thickened section 5103 of the braided hollow cable 5100, according to some embodiments. This forms a first loop or eyelet 1013, according to some embodiments. As pull wire 5200 is pulled proximally, the distal end 5101 of cable 5100 is also pulled into thickened section 5103, and a looped portion of the cable is pulled out of the proximal exit 1032, effectively forming a second cable loop 1011 extending proximally from the proximal exit 1032, according to some embodiments. Then, for example, by pulling on just one strand of the pair of pull wire extensions 5201, the slidable hairpin member 5200 is removed, according to some embodiments. The second braided hollow cable loop 1011 is then cut (see e.g., location 1016 in FIG. 3D), according to some embodiments. As illustrated in FIG. 3E, the distal end 5101 of the braided hollow cable 5100, is now disposed within thickened portion 5103, according to some embodiments. This forms a separate strand 5105 having distal end 5101 and a proximal end 1052, according to some embodiments. Braided hollow cable 5100 now has a new “distal” end 1051, and both new distal end 1051 and proximal end 1052 may be moved into thickened portion 5103 by pulling on one end of eyelet 1013 and manipulating the thickened portion, according to some embodiments. The new distal end 1051 and the separate strand 5105 will then both be accommodated inside thickened portion 5103, resulting in first cable loop 1013 defining an eyelet disposed distally, according to some embodiments.

[0138] With reference to Fig. 4A, there is shown a sleeve 5300 having length L5300 between a proximal end 5303 and a distal end 5301, according to some embodiments. Sleeve 5300 has an extension 3003 having proximal end 5302 extending proximally from sleeve proximal end 5303, according to some embodiments. Sleeve 5300 has a predetermined diameter, associated with the desired thickness of the adjustable anchor, and a predetermined length, according to some embodiments. The distal eyelet 1013 of cable 5100 and a portion of the braided hollow cable 5100 are inserted into sleeve 5300, via sleeve proximal end 5303, and a distal portion of distal eyelet 1013 extends out of sleeve distal portion 3001, such that the sleeve 5300 distal portion 3001 covers a proximal portion of the distal eyelet 1013 and a proximal portion 3005 of sleeve 5300 covers a portion of the braided hollow cable 5100 proximal to the distal exit 1031, according to some embodiments. Sleeve extension 3003 may be used to move sleeve 5300 into position over eyelet 1013 and a portion of cable 5100 proximal to eyelet 1013, according to some embodiments. It may also be noted that the provision of thickened portion 5103, which is shown proximal to sleeve 5300 in Figs. 4A-C, may prevent sleeve 5300 from moving proximally, out of position, along cable 5100, according to some embodiments.

[0139] As illustrated, a portion of the distal eyelet 1013 extends distally beyond the distal end 5301 of the sleeve. As illustrated in FIG. 4B , the proximal end 5102 of the braided hollow cable 5100 is inserted through the distal eyelet 1013 extending beyond the distal end 5301 of the sleeve 5300, according to some embodiments. The proximal end 5102 of the braided hollow cable 5100 is then pulled, according to some embodiments. This causes the anchor to be formed into a structure having a closed shape, with sleeve 5300 forming a C-shape portion of the knotless anchor, according to some embodiments. It is noted that the sleeve may be formed into another shape such as, for example, a U- shape, according to some embodiments, such as, for example, shown by the embodiments of Figs. 5 and 6.

[0140] It may be noted that thickened portion 5103 may create friction with sleeve 5300, according to some embodiments. This holds sleeve 5300 in position once pulled over the thickened portion 5130, according to some embodiments.

[0141] In certain exemplary implementations, and as illustrated, for example, in FIG. 2, the predetermined number of strands lOOOi is proportional to the desired thickness of the adjustable anchor, according to some embodiments. Additionally or alternatively, prior to the action of pulling the pair of pull wire extensions 5201 on the slidable hairpin member 5200 (Fig. 3B), the distal end 5101 of the braided hollow cable 5100 may be inserted through the distal loop 5210 of the pull wire 5200 a number of times, such that, when the pull wire extensions 5201 are pulled proximally, a plurality of distal eyelets will be formed, according to some embodiments. The number of times the cable 5100 is inserted through the pull wire distal loop 5210 will be proportional to the desired thickness of the adjustable anchor, such that eyelet 1013 will be comprised of several cable loops 1017j, according to some embodiments.

[0142] Moreover, the sleeve 5300 may have an outer surface configured to increase friction with an anchored surface, according to some embodiments. This outer surface can include, for example, protrusions (not shown) directed proximally, such that, once inserted into a bore in a bone, the protrusions will further resist pull and increase the LTF of the anchor, according to some embodiments. (See e.g., sleeve 5012 positioned in bore 5710 in bone 5700, in FIG. 5, wherein the sleeve may have protrusions for preventing movement of the bone anchor relative to the bone, according to some embodiments.)

[0143] Optionally, sleeve 5300 may be similar in structure and / or function to sleeve 5303 shown in any of Figs. 4A-C and 6, according to some embodiments. For example, the sleeve may include an extension proximal end 5302, according to some embodiments. It is noted that the anchor (Fig. 4C) includes a cable end 5102 which extends proximally therefrom, according to some embodiments. The cable end 5102 may be used to attach the anchor to a tendon anchor such as, for example, anchor 6040 (Fig. 6), according to some embodiments. This creates an assembly including a bone anchor and a tendon anchor, according to some embodiments. Cable 5100 may be attached to a tendon anchor such as, for example, shown in Fig. 5 and, for example, according to the method described herein with regard to Fig. 8, according to some embodiments.

[0144] Exemplary Method of Forming an Adjustable Knotless Anchor

[0145] With reference to Fig. 7 there is shown a flowchart illustrating actions performed in producing an adjustable knotless anchor, according to some embodiments. As discussed herein with regard to Figs. 1-2, a braided hollow cable such as, for example, cable 5100, is formed with a selected number of strands lOOOi, according to some embodiments. Additionally as noted above with regard to Figs. 1-2, a pull wire is incorporated into the braiding, with a slidable loop of the pull wire exiting the cable, between cable strands, at a distal exit along the cable, and with a pair of proximal pull wire extensions extend out of the cable via a proximal exit along the cable, according to some embodiments.

[0146] At 702, a length of the braided hollow cable (hereinafter, “cable”) is selected and the cable is cut to the selected length, according to some embodiments. It is noted that the selected length includes the distal and proximal exits, according to some embodiments. The cable may be formed of PET (polyethylene terephthalate) or UHMWPE (ultra-high molecular weight polyethylene), according to some embodiments.

[0147] At 704, the distal end of the cable is inserted into the distal loop of the pull wire (for example, loop 5210 in Fig. 3 A), according to some embodiments. This forms a first loop or eyelet (for example, eyelet 1013 in Fig. 3B) at a distal end of the cable, according to some embodiments. The pull wire extensions are pulled, at 706, to pull a distal portion of the cable including the cable distal end (for example, cable distal end 5101 in Fig. 3B) into the interior of the cable, alongside the portion of the pull wire inside the cable, for example, as shown in Figs. 3B-C, according to some embodiments. The pull wire extensions are pulled out of the cable proximal exit (for example, proximal exit 5201 in Figs. 3B-C), such that a second loop portion of the cable (for example, second loop 1011 in Fig. 3C) is also pulled out of the proximal exit, for example, as shown in Fig. 3C, according to some embodiments.

[0148] At 708, one strand of the pair of pull wire extensions is pulled, to remove the pull wire from the cable, according to some embodiments. The second cable loop extending out of the proximal exit is cut, at 710, for example, as shown in Fig. 3A, according to some embodiments. This forms a new strand (for example, separate strand 5105) and creates a new cable distal end (for example, distal end 1051), according to some embodiments.

[0149] At 712, the separate strand and the new cable distal end may be moved into the thickened portion 5103 of the cable by pulling on one end of eyelet 1013 and manipulating the thickened portion, according to some embodiments. The new distal end 1051 and the separate strand 5105 will then both be accommodated inside thickened portion 5103, with the first cable loop 1013 defining an eyelet disposed distally, for example, as shown in Fig. 3F, according to some embodiments.

[0150] The eyelet of the cable is inserted into a sleeve (for example, sleeve 5300 shown in Fig. 4A), at 714, such that the sleeve covers a proximal portion of the eyelet and a distal portion of the eyelet extends out of the sleeve, according to some embodiments. Sleeve 5300 may have an extension having proximal end 5302 (for example, proximal end 5302 of sleeve extension 3003 in Fig. 4A) extending proximally from the sleeve proximal end, according to some embodiments. The sleeve extension may be used to positioned the sleeve on the cable, with the eyelet extending partly out of the sleeve, according to some embodiments. The sleeve has a predetermined diameter, associated with a desired thickness of the adjustable anchor, and a predetermined length, according to some embodiments.

[0151] At 716, the cable proximal end (for example, cable proximal end 5102 in Fig. 4B) is inserted through the eyelet, for example, as shown in Fig. 4B, and the cable proximal end 5102 is then pulled, according to some embodiments. This causes the sleeve 5300 to form a knotless anchor wherein at least the sleeve 5300 defines a C-shape, for example, as shown in Fig. 4C, according to some embodiments. This may be similar to C-shaped sleeve 5012 in Fig. 5, according to some embodiments.

[0152] Anchor Assembly Including a Flexible Bone Anchor and a Flexible Tendon Anchor

[0153] Turning now towards Fig. 6, there is shown an exemplary implementation of an anchor assembly 6000, according to some embodiments. Anchor assembly 6000 includes two flexible anchors such as, for example, a bone anchor 6030 and a soft tissue anchor such as, for example, a tendon anchor 6040, according to some embodiments. This allows for the two flexible bone anchors to concurrently be operable coupled and, for example, be selectively accommodated by an inserter of a bone anchor delivery system (not shown), according to some embodiments. In additional implementations, the two flexible bone anchors have been deployed, the two flexible bone anchors may be secured so that tissue repair at a target site may be facilitated. Anchors 6030 and 6040 may also be used in conjunction with alternative bone anchor delivery systems, inserter ends, and delivery methods, according to some embodiments. Furthermore, according to some embodiments, this may facilitate the bending and placement of the two flexible anchors such as, for example, two flexible bone anchors, or a flexible bone anchor and a flexible tendon anchor. In further implementations, the configuration shown may help prevent knotting, tangling, or other issues that might affect the mobility, functionality, or tightening capability of the suture thread (or cable or wire or other fastening material).

[0154] The configuration shown includes first flexible anchor such as, for example, knotless adjustable bone anchor 6030, a second flexible anchor such as, for example, tendon anchor 6040, which are attached by a cable (or wire or suture or other fastening material, hereinafter referred to as “suture thread 6050), suture thread 6050 being threaded such that a proximal end 524 may be tightened to secure anchor 6030 and anchor 6040 to facilitate tissue repair at a target site, according to some embodiments. Anchor 6030 has a first end 6302a, a second end 6302b, and a body 6304 extending from first end 6302a to second end 6302b with a passageway 6306 to accommodate suture thread(s) therein, according to some embodiments. In exemplary implementations, the body 6304 of first bone anchor 6030 may be tubular such that a passageway 6306 extends through body 6304 from first end 6302a to second end 6302b.

[0155] Anchor 6030 may be in an unbent orientation when passageway 6306 extends in a straight line, and in a bent orientation when passageway 6306 is bent (as shown in Fig. 6) and first end 6302a and second end 6302b are closer to each other than in the unbent orientation, according to some embodiments.

[0156] Body 6304 may include a sleeve, according to some embodiments. Body 6304, according to some embodiments, may be similar in structure and / or function to sleeve 5300 (Figs. 4A-C), and will not be discussed again herein in detail. Body 6304 may have an outer surface configured to increase friction with an anchored surface, according to some embodiments. This outer surface can include, for example, protrusions (not shown) directed proximally, such that, once inserted into a bore in a bone , the protrusions will further resist pull and increase the LTF of the anchor, according to some embodiments.

[0157] Anchor 6040 extends from first end 6406 to second end 6404 with a center 6402, according to some embodiments. Anchor 6040 may also have a body 6403 that is tubular, and may also have a passageway to accommodate length(s) of suture thread 6050, according to some embodiments. In exemplary implementations, the passageway may be external to the tubular body of second flexible bone anchor 6040, such as, for example, illustrated by external passageway 6410 which is comprised of two to a plurality of loops 6408i on the outer surface of the body 6403 of anchor 6040. For example, external passageway 6410 may be comprised of an even number of loops 6408i axially distributed and symmetric with respect to center 6402, according to some embodiments.

[0158] According to the configuration shown, suture thread 6050 has a loop 6503 that extends from a thickened portion 6103 of suture thread 6050 , the thickened portion 6103 positioned inside anchor body 6304, according to some embodiments. Thickened portion 6103 extends within and along a length of passageway 6306, according to some embodiments.

[0159] A first length 6508 of suture thread extending from thickened portion 6103 exits passageway 6306 , according to some embodiments. Length 6508 passes through loop 6503 and extends towards external passageway 6410 of anchor 6040, according to some embodiments. Length 6508 of suture thread 6050 extends away from anchor 6030 to become suture length 6510 which enters external passageway 6410 at first end 6406 of anchor 6040, and then exits passageway 6410 before about center 6402 of anchor 6040, according to some embodiments. Length 6510 exits external passageway 6410 near center 6402, extending into length 6512 which loops and changes direction at bend 6514 before entering external passageway 6410 of anchor 6040 from second end 6404 and extending into length 6516 which extends through external passageway 6410 from second end 6404 to the center 6402 of anchor 6040, according to some embodiments. In other words, length 6510 extends from the first end 6406 to near center 6402 and length 6516 extends from the second end 6404 to near center 6402 of external passageway 6410 of second flexible bone anchor 6040, according to some embodiments. Generally, external passageway 6410, above and below center 6402 receives lengths of sutures extending in opposing directions, according to some embodiments.

[0160] Length 6516 exits external passageway 6410 before about the center 6402 and extends into length 6518 which approaches the first end 6302a of passageway 6306 of anchor 6030, according to some embodiments. Length 6518 extends into length 6520 which passes through passageway 6306 from first end 6302a to second end 6302b of anchor 6030, according to some embodiments. Length 6520 exits passageway 6306 at second end 6302b of first flexible bone anchor 6030 and passes through loop 6503 and extends as length 6522 towards the center 6402 of anchor 6040, according to some embodiments. Length 6522 extends between body 6403 and external passageway 6410 near the center 6402 of anchor 6040, according to some embodiments. Therefore, length 6522 crosses also between length 6510 and length 6516 of suture 6050 before extending and exiting as proximal end 6524, according to some embodiments.

[0161] Generally, according to some embodiments, it is noted that exemplary implementations of the anchor assembly 6000 shown in Fig. 6 may comprise a plurality of lengths of sutures passing through anchor 6030 and passing through loop 6503; two lengths of opposing sutures entering external passageway 6410 of anchor 6040 from opposing ends until near the center 6402 of anchor 6040, therefore extending in opposing directions; an exiting length of suture extending between external passageway 6410 and body 6403 of anchor 6040, thereby also extending between the two lengths of opposing sutures and body 6403 of anchor 6040 before exiting as proximal end 6524 of suture 6050; and a proximal end 6524 that may be pulled to secure anchor 6030, anchor 6040, and / or suture 6050 at desired target locations, and that may also transition at least one flexible anchor to a bent orientation thereof.

[0162] In exemplary implementations, methods may include: using a bone anchor delivery system (not shown) to optionally prepare the target site by drilling a hole within a bone; and advancing an inserter (not shown) of the delivery system, the inserter configured such that anchor 6030 may be operably coupled to the inserter in the bent orientation and anchor 6040 can be accommodated between anchor 6030 and a distal end of the inserter in its unbent orientation, wherein the anchors are threaded, for example, as described in method 20 discussed below with reference to Fig. 8; delivering anchor 6030 into the drilled hole; pulling proximal end 6524 of suture 6050 so that anchor 6040 is in its bent orientation and is prevented from passage into the drilled hole; securing the suture so that the anchors secure soft tissue to bone at a select target site; and, optionally, other intermediate and additional actions.

[0163] In some other exemplary orientations, the fact that there are two lengths of opposing sutures entering external passageway 6410 of anchor 6040 from opposing ends causes radial tilting of the anchor 6040 when the proximal end 6524 of the suture 6050 is tightened, according to some embodiments. This facilitates bending of anchor 6040 and prevents the vertical passage of the anchor 6040 into the pre-drilled bore within the bone, according to some embodiments. Additionally, the fact that there are two lengths of opposing sutures entering external passageway 6410 from opposing ends of anchor 6040 potentially prevents tangling of the thread, as it shortens the span of the thread that goes longitudinally through the loops, according to some embodiments.

[0164] Threading Method for Flexible Bone Anchors

[0165] Turning now towards Fig. 8, there is shown an exemplary implementation of threading method 20 where two flexible bone anchors are threaded. Threading method 20 also allows for the two flexible bone anchors to concurrently be operably coupled and selectively accommodated by, for example, an inserter of a bone anchor delivery system (not shown), according to some embodiments. In additional implementations, after the two flexible bone anchors have been deployed, threading method 20 allows the two flexible bone anchors to be secured so that tissue repair at a target site may be facilitated. Threading method 20 may also be used in conjunction with any of a variety of bone anchor delivery systems, inserter ends, and delivery methods, according to some embodiments. Furthermore, according to some embodiments, threading method 20 may facilitate the bending and placement of the two flexible bone anchors. In further implementations, method 20 may help prevent knotting, tangling, or other issues that might affect the mobility, functionality, or tightening capability of the suture thread. It is noted that the threading method 20 may be utilized for a bone anchor 6030 (Fig. 6) and a soft tissue anchor 6040 (Fig. 6) such as, for example, a tendon anchor, according to some embodiments.

[0166] Threading method 20 comprises a first flexible bone anchor 30, a second flexible bone anchor 40, and suture thread 50, suture thread 50 being threaded such that a proximal end 524 may be tightened to secure first flexible bone anchor and second flexible bone anchor to facilitate tissue repair at a target site, according to some embodiments. First flexible bone anchor 30 has a first end 302a, a second end 302b, and a body 304 extending from first end 302a to second end 302b with a passageway to accommodate suture thread(s) therein, according to some embodiments. In exemplary implementations, the body 304 of first bone anchor 30 may be tubular such that a passageway 306 extends through body 304 from first end 302a to second end 302b. First flexible bone anchor 30 may be in an unbent orientation when passageway 306 extends in a straight line, and in a bent orientation (as shown in Fig. 8) when passageway 306 is bent and first end 302a and second end 302b are closer to each other than in the unbent orientation, according to some embodiments.

[0167] Similarly, second flexible bone anchor 40 extends from first end 406 to second end 404 with a center 402, according to some embodiments. Second flexible bone anchor 40 may also have a body 403 that is tubular, and may also have a passageway to accommodate length(s) of suture thread 50, according to some embodiments. In exemplary implementations, the passageway may be external to the tubular body of second flexible bone anchor 40, such as, for example, illustrated by external passageway 410 which is comprised of two to a plurality of loops 408i on the outer surface of the body 403 of second flexible bone anchor 40. For example, external passageway 410 may be comprised of an even number of loops 408i axially distributed and symmetric with respect to center 402, according to some embodiments.

[0168] Threading method 20 comprises suture thread 50 having a distal end 502 with an adjacent loop 503 that extends into length 504 which extends between loop 503 and the first end 302a of flexible anchor 30, according to some embodiments. Length 504 of suture 50 further extends into length 506 which enters passageway 306 and extends through passageway 306 from first end 302a to second end 302b, exiting passageway 306 and extending into length 508, according to some embodiments. Length 508 passes through loop 503 and extends towards external passageway 410 of second flexible anchor 40, according to some embodiments. Length 508 of suture thread 50 extends away from flexible anchor 30 and towards external passageway 410 at the first end 406 of second flexible anchor 40, and length 510 enters external passageway 410 at first end 406, and then exits passageway 410 before about center 402 of second flexible anchor 40, according to some embodiments. Length 510 exits external passageway 410 near center 402, extending into length 512 which loops and changes direction at bend 514 before entering external passageway 410 of second flexible anchor 40 from second end 404 and extending into length 516 which extends through external passageway 410 from second end 404 to the center 402 of second flexible anchor 40, according to some embodiments. In other words, length 510 extends from the first end 406 to near center 402 and length 516 extends from the second end 404 to near center 402 of external passageway 410 of second flexible bone anchor 40, according to some embodiments. Generally, external passageway 410, above and below center 402 receives lengths of sutures extending in opposing directions, according to some embodiments.

[0169] Length 516 exits external passageway 410 before about the center 402 and extends into length 518 which approaches the first end 302a of passageway 306 of first flexible anchor 30, according to some embodiments. Length 518 extends into length 520 which passes through passageway 306 from first end 302a to second end 302b of first flexible anchor 30, according to some embodiments. Length 520 exits passageway 306 at second end 302b of first flexible bone anchor 30 and passes through loop 503 and extends as length 522 towards the center 402 of second flexible anchor 40, according to some embodiments. Length 522 extends between body 403 and external passageway 410 near the center 402 of second flexible bone anchor 40, according to some embodiments. Therefore, length 522 crosses also between length 510 and length 516 of suture 50 before extending and exiting as proximal end 524, according to some embodiments.

[0170] Generally, according to some embodiments, it is noted that exemplary implementations of threading method 20 may comprise two lengths of sutures passing through first flexible anchor 30 and passing through loop 503 adjacent to distal end 502 of suture 50; two lengths of opposing sutures entering external passageway 410 of anchor 40 from opposing ends until near the center 402 of anchor 40, therefore extending in opposing directions; an exiting length of suture extending between external passageway 410 and body 403 of second flexible anchor 40, according to some embodiments. The existing length of suture also extending between the two lengths of opposing sutures and body 403 of second flexible anchor 40 before exiting as proximal end 524 of suture 50; and a proximal end 524 that may be pulled to secure first flexible anchor 30, second flexible anchor 40, and or suture 50 at desired target locations, and that may also transition at least one flexible anchor to a bent orientation thereof.

[0171] Optionally, body 304 may include a sleeve such as, for example, sleeve 5303 shown in any of Figs. 4A-C and 36, according to some embodiments. The sleeve may be similar in structure and / or function to that described with regard to any of Figs. 4A-C and 6, and may include an extension proximal end 5302, according to some embodiments.

[0172] In exemplary implementations, methods may also include: using a bone anchor delivery system to optionally prepare the target site by drilling a hole within a bone; and advancing an inserter configured such that first flexible anchor 30 may be operably coupled onto the inserter in the bent orientation and second flexible anchor 40 can be accommodated between first flexible anchor 30 and a distal end of the inserter in its unbent orientation, wherein the flexible anchors are threaded as described in method 20; delivering first flexible bone anchor 30 into the drilled hole; pulling proximal end 524 of suture 50 so that second flexible anchor 40 is in its bent orientation and is prevented from passage into the drilled hole; securing the suture so that the flexible bone anchors secure soft tissue to bone at a select target site; and, optionally, other intermediate and additional actions.

[0173] In some other exemplary orientations, the fact that there are two lengths of opposing sutures entering external passageway 410 of anchor 40 from opposing ends causes radial tilting of the second anchor 40 when the proximal end 524 of the suture 50 is tightened, according to some embodiments. This facilitates its bending of anchor 40 and prevents the vertical passage of the second anchor 40 into the pre-drilled bore within the bone, according to some embodiments. Additionally, the fact that there are two lengths of opposing sutures entering external passageway 410 from opposing ends of anchor 40 potentially prevents tangling of the thread, as it shortens the span of the thread that goes longitudinally through the loops, according to some embodiments.

[0174] It is expected that during the life of a patent maturing from this application many relevant drilling and / or insertion systems and devices will be developed and the scope of the term drilling and insertion system and / or device is intended to include all such new technologies a priori.

[0175] The terms "comprises,” "comprising,” "includes,” "including,” “having,” and their conjugates mean "including but not limited to.”

[0176] The term “consisting of’ means “including and limited to.”

[0177] The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, actions and / or parts, but only if the additional ingredients, actions and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0178] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention, in some embodiments thereof. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0179] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number “and” a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0180] For the purposes of the present disclosure, directional or positional terms such as, for example, “proximal,” “distal,” "top,” "bottom,” "upper," "lower," "side," "front," "frontal," "forward," "rear," "rearward," "back," "trailing," "above," "below," "left," "right," "radial," "vertical," "upward," "downward," "outer," "inner," "exterior," "interior," "intermediate,” “apical,” “basal,” etc., are merely used for convenience in describing the various exemplary implementations of the present disclosure.

[0181] The terms “first,” “second,” and the like, herein do not denote any order, quantity, or importance, but rather are used to denote one element from another. The terms “a,” “an” and “the” herein do not denote a limitation of quantity, and are to be understood to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The suffix “(s)” as used herein is intended to include both the singular and the plural of the term that it modifies, thereby including one or more of that term.

[0182] Reference throughout the specification to “one exemplary implementation,” “another exemplary implementation,” “an exemplary implementation,” and so forth, means that a particular element (e.g., action, feature, structure, and / or characteristic) described in connection with the exemplary implementation is included in at least one exemplary implementation described herein, and may or may not be present in other exemplary implementations. In addition, it is to be understood that the described elements may be combined in any suitable manner in the various exemplary implementations.

[0183] In the context of the disclosure, the term “C-shape” refers to any single structure (e.g., sleeve 5300) that terminates in two portions, the majority of which extend in a same general direction. Transition of the single structure between such portions may be, for example, curved, an acute angle, or an obtuse right angle.

[0184] In the context of the disclosure, the term “hairpin member” refers to, for example, a pull wire 5200 that has two elongated portions that are generally parallel and form a double- stranded region with the two elongated portions being connected by a single- stranded loop. Likewise the term "slidable" as described and used herein, refers to, for example, any interaction between the hairpin member and the braided hollow cable, which provides non-destructive slippage between the hairpin member and the braided hollow cable.

[0185] The term “coupled,” and its various forms such as “operably coupling,” "coupling" or "couplable,” refers to and comprises, for example, any direct or indirect, structural coupling, connection or attachment. It may also refer, for example, to an adaptation or capability for such a direct or indirect structural or operational coupling, connection, or attachment, as well as integrally formed components and components which are coupled via or through another component or by the forming process. Indirect coupling may involve, for example, coupling through an intermediary member or adhesive, or abutting and otherwise resting against, whether, for example, frictionally or by separate means without any physical connection.

[0186] “Operably coupled” refers to the joining of two members directly or indirectly to one another. Such joining may be, for example, stationary in nature or moveable in nature. Such joining may be achieved, for example, with the two members (or the two members and any additional intermediate) being integrally formed as a single unitary body with one another or with the two members or the two members and any additional members being attached to one another. Such joining may be permanent in nature or may be removable or releasable in nature.

[0187] The term “moveably” coupled means that two components are attached to each other, perhaps via one or more other components, for example, such that one or both of the two components may move. Additionally, the term “moveably coupled” refers, for example, to a situation where one element is coupled to another element in a fixed spatial relation but is free to move with respect to the other element, in a plurality of directions that include, for example, horizontally, vertically, slidably, translationally, rotatably, or any combination thereof. In yet other words, the term “moveably coupled” refers to a situation, for example, where the movement of the one element does not necessarily result in a movement of the other element and vice versa. The one element may be supported with respect to or mounted to the other element in a way that permits movement.

[0188] The term “accommodate” used herein need only mean that at least a portion of something is inside the interior space, and there is not necessarily a requirement for all portions to be inside the interior space. The term “abut” refers to, for example, items that are in direct physical contact with each other, although the items may (or may not) be, for example, attached, secured, fused, or welded together.

[0189] The term "system" shall also be taken to include any collection of systems or sub-systems that individually or jointly may, for example, execute a set, or multiple sets, of one or more functions. Also, the term "system" refers to, for example, a logical assembly arrangement of multiple devices, elements, objects, or components, and is not restricted to an arrangement wherein all of the component devices are in the same housing.

[0190] “Communicate" (and its derivatives e.g., a first component "communicates with" or "is in communication with" a second component) and grammatical variations thereof are used to indicate, for example, a structural, functional, mechanical, electrical, optical, or fluidic relationship, or any combination thereof, between two or more components or elements. As such, the fact that one component is said to communicate with a second component is not intended to exclude the possibility that additional components can be present between, and / or operatively associated or engaged with, the first and second components.

[0191] "Comprising" and its derivatives, as used herein, are intended to be open ended terms that specify the presence of the stated features, elements, components, groups, integers, and / or actions, but do not exclude the presence of other unstated features, elements, components, groups, integers and / or actions. The foregoing also applies to words having similar meanings such, for example, as the terms, "including,” "having,” “containing,” and their derivatives.

[0192] “Typically” or “usually” shall be understood to infer as in most cases, instances, embodiments, or implementations.

[0193] The term "about" as well as “approximate” means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but may be approximate and / or larger or smaller, as desired, reflecting, for example, tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art. In general, an amount, size, formulation, parameter or other quantity or characteristic is "about" or "approximate" whether or not expressly stated to be such.

[0194] A “target site” is a predefined location or area delineated by, for example, specific borders or boundaries, with the objective of reaching or accessing this precise area for a particular purpose. In the present disclosure the target site also refers to the target for the drill, obturator, inserter, or bone anchor to approach and perform a function, in other words the desired goal, target area, or anatomical location on which the function is to be performed. The foregoing also broadly applies to words having similar meanings in this disclosure such as, for example, the terms “anatomical site,” “desired location,” “predetermined location,” “repair site,” etc.

[0195] The terms “proximal” and “distal” are relative terms where the proximal end refers to an end nearer or towards the user / medical practitioner / surgeon implementing and using the system, and the distal end refers to an end nearer or towards the subject / patient and an anatomical site or target site thereof. Additionally, "delivery" refers to the controlled movement or advancement of, for example, a selected surgical tool or component through the bone anchor delivery device, extending from a proximal position within the device to a position beyond the distal end of the device. This movement, for example, enables the tool to engage with the target anatomical site, facilitating the placement, preparation, insertion, or deployment of a bone anchor or other surgical elements into or near the target site.

[0196] Furthermore, the terms “anchor” and “bone anchor” in the context of the present disclosure shall be understood broadly to comprise a plurality of fixation devices of any of a plurality of types such as, e.g., soft bone anchors or hard bone anchors, composed of any combination of a plurality of materials such as, for example, metal, bioresorbable polymers, composite materials, suture, etc., and may comprise a plurality of designs, such as, for example, screws, hooks, barbs, retractable designs, expanding designs, etc., to optimize stability and fixation in hard or soft tissue at a specified target site. Similarly, the terms “suture” or “thread” shall be broadly understood to encompass, for example, a plurality of flexible filament or fiber material designed to securely attach soft tissue (such as, for example, tendons, ligaments, or muscles) to bone or other tissues. The suture or thread may be comprised of at least one of a plurality of materials, such as synthetic polymers, natural fibers, or bioresorbable material, for example. The suture or thread type may be selected based on, for example, the intended surgical repair for a specific thickness, strength, and flexibility.

[0197] As used herein the term "method" refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts, for example.

[0198] As used herein, the term “treating” includes, for example, abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0199] It is appreciated that certain features of the invention, in some embodiments thereof, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, in some embodiments thereof, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0200] While in the foregoing specification the methods of producing continuous forming knotless bone anchors having, for example, adjustable sizes and / or attached suture lengths and / or customizable thickness have been described in relation to certain exemplary implementations, and many details are set forth for the purpose of illustration, it will be apparent to those skilled in the art that the alignment methods, implementable using the systems disclosed herein, are susceptible to additional implementations, and that certain of the details described in this specification and as are more fully delineated in the following claims can be varied considerably without departing from the basic principles disclosed herein.

[0201] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0202] It is the intent of the Applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A bone anchor comprising an elongated hollow length, wherein a first portion of said elongated hollow length extends through a second portion of said elongated hollow length.

2. A bone anchor according to claim 1, wherein said first portion of said elongated hollow length extends at least one of: at least partially radially into an interior portion of said second portion of said elongated hollow length; and along an interior portion of said second portion of said elongated hollow length.

3. A bone anchor according to claim 1, wherein said first portion of said elongated hollow length extends through a hollow of said second portion of said elongated hollow length.

4. A bone anchor according to claim 1, wherein said elongated hollow length is formed of a braided material.

5. A bone anchor according to claim 4, wherein said braided material includes a plurality of strands and a proximal end, wherein said elongated hollow length includes a first opening along said elongated hollow length between strands of said braided material, at a distance from said proximal end, and wherein said first portion of said elongated hollow length is inserted via said first opening into said elongated hollow length.

6. A bone anchor according to claim 4, wherein said bone anchor defines a loop formed along said elongated hollow length at said first opening.

7. A bone anchor according to claim 1, wherein said bone anchor includes a portion having an adjustable length.

8. A bone anchor according to claim 7, wherein said portion having an adjustable length is adjustable by pulling on an end portion of said elongated hollow length.

9. A bone anchor according to claim 1, wherein said bone anchor is configured to be inserted into a bore in a bone and is configured to be retained in the bore by at least one of:friction between at least a portion of said bone anchor and the bone; and geometric constraints of at least one portion of said anchor relative to the bore in the bone, said geometric constraints caused by friction between at least two portions of said elongated hollow length.

10. A bone anchor according to claim 1, wherein said bone anchor is configured to be inserted into a bore in a bone and wherein said bone anchor does not require knotting to be retained within the bore.

11. A bone anchor according to claim 1, wherein a portion of said second portion of said elongated hollow length defines a thickened portion of said bone anchor.

12. A bone anchor according to claim 11, wherein said thickened portion is at least twice as thick as said first portion of said elongated hollow length.

13. A bone anchor according to claim 11, wherein said thickened portion is at least three times as thick as said first portion of said elongated hollow length.

14. A bone anchor according to claim 1, wherein said bone anchor includes first and second ends, at least one elongated portion extending from said first end and a loop extending from said second end, wherein said at least one elongated portion extends through said loop.

15. A bone anchor according to claim 14, wherein said loop is defined by a third portion of said elongated hollow length, wherein said third portion is adjacent to said first portion of said elongated hollow length.

16. A bone anchor according to claim 15, wherein said third portion of said elongated hollow length is adjacent to said second portion of said elongated hollow length.

17. A bone anchor according to claim 14 wherein, when said bone anchor has been inserted into a bore in a bone and tension is applied to said at least one elongated portion, a portion of the tension is applied to said loop.

18. A bone anchor according to claim 1, including a sleeve, wherein a portion of said bone anchor is positioned within a first portion of said sleeve.

19. A bone anchor according to claim 18, wherein said bone anchor consists essentially of said elongated hollow length and said sleeve.

20. The bone anchor according to claim 18, wherein said bone anchor has an unbent orientation wherein said sleeve extends in a straight line, and a bent orientation wherein said sleeve is one of bent and curved.

21. The bone anchor according to claim 18, wherein said sleeve has an outer surface configured to increase friction with an anchored surface.

22. The bone anchor according to claim 18, wherein said second portion of said elongated hollow length defines a thickened portion of said bone anchor, and wherein said thickened portion is positioned inside said sleeve.

23. A bone anchor according to claim 18, wherein said sleeve includes a second portion adjacent said first portion of said sleeve, wherein said second portion of said sleeve is configured to be pulled to move said sleeve into position along said bone anchor.

24. A bone anchor according to claim 18, wherein at least said first portion of said elongated hollow length and said second portion of said elongated hollow length extend through said sleeve.

25. A bone anchor according to claim 1, wherein said bone anchor is flexible.

26. A bone anchor according to claim 25, wherein said bone anchor includes first and second ends and wherein said bone anchor is bendable into a structure in which said first and second ends face in a same direction.

27. A bone anchor according to claim 25, wherein said bone anchor is bendable into a closed shaped structure.

28. A bone anchor comprising an elongated hollow length formed of a braided material, wherein said elongated hollow length includes an opening along said elongated hollow length between strands of said braided material, wherein a first portion of said elongated hollow length is inserted via said opening and extends through a second portion of said elongated hollow length.

29. A method of forming the bone anchor according to claim 4, wherein said elongated hollow length includes a second opening proximal to said first opening, said method including: positioning a pull wire within said elongated hollow length with a pull wire loop extending out of said first opening and at least one pull wire end extending out of said second opening; and proximal pulling of the pull wire end to pull said first portion of said elongated hollow length into said second portion of said elongated hollow length.

30. An anchor assembly including the bone anchor according to claim 1 and a second anchor, wherein said second anchor is attached to said bone anchor by said elongated hollow length.

31. An anchor assembly according to claim 30, wherein said anchor assembly does not require the advancement of knots along a portion of said elongated hollow length.

32. An anchor assembly according to claim 30, wherein said anchor assembly is knotless.

33. An anchor assembly according to claim 30, wherein said bone anchor is configured to be inserted into a bore in a bone and said second anchor is configured to attach a tendon to the bone.

34. An anchor assembly according to claim 30, wherein said second anchor includes a plurality of external loops.

35. An anchor assembly according to claim 34, wherein said second anchor is attached to said bone anchor by threading of said elongated hollow length through at least a portion of said plurality of external loops.

36. An anchor assembly according to claim 35, wherein a fourth portion of said elongated hollow length is threaded through a first portion of said plurality of external loops in a first direction and a fifth portion of said elongated hollow length is threaded through a second portion of saidplurality of external loops in a second direction, and wherein said first direction is opposite to said second direction.

37. An anchor assembly according to claim 30, wherein said second anchor is flexible.

38. An anchor assembly according to claim 37, wherein said second anchor is bendable into a structure having one of a C-shape and a U-shape, wherein in end portions of said C-shape of said second anchor are directed toward each other, and wherein in end portions of said U-shape of said second anchor directed in a same direction.

39. An anchor assembly according to claim 30, wherein said bone anchor and said second anchor are separated by a distance, and wherein said distance is reducible by pulling an end portion of said elongated hollow length.

40. An anchor assembly according to claim 30 wherein, when said bone anchor is in position in a bore in a bone, said second anchor is configured to attach a tendon to the bone.

41. An anchor assembly according to claim 30, wherein the first anchor includes a first end, a second end, and a sleeve extending from said first end to said second end, wherein said sleeve has an internal passageway extending therethrough, said passageway sized and shaped to accommodate suture threads therein, and wherein said first anchor includes a loop extending from said first end; wherein said second anchor includes a body having third and fourth ends and a center portion between said third and fourth ends, wherein said body has an external passageway sized and shaped to accommodate suture threads therein; wherein a third portion of said elongated hollow length extends from said internal passageway away from said first anchor, passes through said loop, and extends towards said external passageway; wherein a fourth portion of said elongated hollow length extends from said third portion of said elongated hollow length and enters external passageway at said third end of said second anchor, and exits said external passageway at said center portion of said second anchor; wherein a fifth portion of said elongated hollow length extends from said fourth portion of said elongated hollow length at said center portion of said second anchor, loops around and changes direction, and enters said external passageway from said fourth end of said second anchor;wherein a sixth portion of said elongated hollow length extends from said fifth portion of said elongated hollow length and passes through said external passageway from said fourth end to the center portion of said second anchor; where a seventh portion of said elongated hollow length extends from said sixth portion of said elongated hollow length, exits said external passageway at said center portion, and extends toward said first end of said internal passageway of said first anchor; and wherein an eighth portion of said elongated hollow length extends from said seventh portion of said elongated hollow length and passes through said internal passageway, from said first end to said second end, passes through said loop, extends toward said center portion of said second anchor, passes between said body and said external passageway, at said center portion of said second anchor, and extends away from said second anchor.

42. The anchor assembly according to claim 41, wherein said eighth portion of said elongated hollow length has a proximal end portion, and wherein a distance between said first and second anchors may be shortened by pulling said proximal end portion.

43. The anchor assembly according to claim 41, wherein said second anchor is configured to attached a tendon to a bone.

44. The anchor assembly according to claim 41, wherein said second anchor is bendable when a proximal end portion of said elongated hollow length is pulled proximally.

45. The anchor assembly according to claim 30, wherein at least one of said first anchor and second anchor is tubular.

46. The anchor assembly according to claim 41, wherein said external passageway is defined by a plurality of loops positioned along said body of said second anchor.

47. The anchor assembly according to claim 41, wherein said external passageway is defined by an even number of loops axially distributed and symmetric with respect to said center portion of said second anchor.

48. The anchor assembly according to claim 41, wherein said second and fourth portions of said elongated hollow length extend along portions of said external passageway, on either side of said center portion, in opposing directions.

49. A method of forming an adjustable thickness anchor from a braided hollow cable, wherein the braided hollow cable has a distal end and a proximal end, and a distal exit and a proximal exit located between the distal end and the proximal end; wherein a portion of a pull wire extends along the interior of the braided hollow cable, the pull wire having a slidable loop and a pair of proximal extensions, wherein the slidable loop extends outside the braided hollow cable via the distal exit and the pair of proximal extensions extend outside the braided hollow cable via the proximal exit; said method including: a) inserting the distal end of a braided hollow cable through the distal loop of the pull wire; b) pulling the pair of pull wire proximal extensions, to pull a distal end portion of the braided hollow cable into the interior of the braided hollow cable via the distal exit, and out of the proximal exit, to form at least a first cable loop extending distally adjacent the distal exit and at least one second cable loop extending proximally out of the proximal exit; c) cutting the at least one second cable loop extending out of the proximal exit; d) using a sleeve having a proximal end and a distal end with a predetermined diameter and a predetermined length, sheathing a proximal portion of the first cable loop and a portion of the braided hollow cable distal to the distal exit, wherein a distal portion of the first cable loop extends distally beyond the distal end of the sleeve; e) inserting the proximal end of the braided hollow cable through the first cable loop; and f) pulling the proximal end of the braided hollow cable, to cause the sleeve to form a closed shaped knotless anchor.

50. The method of claim 49, including, after action (b), removing the pull wire from the braided hollow cable.

51. The method of claim 49, wherein the braided hollow cable is formed of a predetermined number of strands, wherein the predetermined number of strands is proportional to the desired thickness of the adjustable knotless anchor.

52. The method of claim 49, wherein, prior to said pulling the pair of pull wire proximal extensions, repeating the action of inserting the distal end of the braided hollow cable through the distal loop of the pull wire a selected number of times, wherein the selected number of times is proportional to the desired thickness of the adjustable knotless anchor.

53. The method of claim 49, wherein the sleeve has an outer surface configured to increase friction with an anchored surface.

54. An anchor, having a predetermined thickness, the anchor formed by the method of claim 49.

55. A method of forming a knotless bone anchor including: inserting an end of a first portion of an elongated hollow cable into a second portion of the elongated hollow cable, at an entrance point along the elongated hollow cable; advancing the first portion of the elongated hollow cable into the interior of the elongated hollow cable, through the entrance point, such that the first portion is positioned radially inside the second portion of the elongated hollow cable.

56. The method according to claim 55, wherein a loop is defined by a third portion of the elongated hollow cable, wherein said third portion is located along the elongated hollow cable between the first and second portions.

57. The method according to claim 56, including inserting a second end of the elongated hollow cable through the loop to form a closed shaped anchor.

58. The method according to claim 57 including, prior to said inserting a second end, positioning a sleeve over a portion of the loop and a portion of the second portion of the elongated hollow cable.

59. An anchor, having a predetermined thickness, the anchor formed by the method of claim 55.

60. A method of implanting a knotless anchor in a bore in a bone, said method including:inserting a knotless anchor into the bore, wherein the anchor is formed of an elongated hollow cable; pulling an end of the elongated hollow cable proximally to at least one of: adjust the size of the knotless anchor; and tighten the knotless anchor relative to the bone.

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