Anchor delivery and an anchor configuration therefor, including methods of forming and use

Abstract

An anchor delivery system comprising: a first passageway having a first longitudinal axis and a distal exiting chamber having a portion coaxial with the first longitudinal axis, wherein the first passageway is sized and shaped for deployment of a surgical tool for forming a bore in a bone; a second passageway having a second longitudinal axis offset from the first longitudinal axis, wherein the second passageway has a distal portion in communication with the distal exiting chamber; and an inserter positioned within the second passageway, wherein the inserter is flexible all along its length, and wherein the inserter is deployable from the second passageway, through the distal exiting chamber.

Description

[0001] SYSTEM, DEVICE, AND METHOD FOR ANCHOR DELIVERY, AN ANCHOR CONFIGURATION FOR USE THEREIN, A METHOD OF FORMING THE ANCHOR CONFIGURATION, 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 / 717,904 filed on November 8, 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 systems and methods for forming a bore in a bone and inserting an anchor into the bore and, more particularly but not exclusively, to systems, devices, and methods for forming a bore in a bone and inserting an anchor in the bore.

[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. 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.

[0011] 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.

[0012] 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.

[0013] 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.

[0014] 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 an anchor delivery system comprising: a first passageway having a first longitudinal axis and a distal exiting chamber having a portion coaxial with said first longitudinal axis, wherein said first passageway is sized and shaped for deployment of a surgical tool for forming a bore in a bone; a second passageway having a second longitudinal axis offset from said first longitudinal axis, wherein said second passageway has a distal portion in communication with said distal exiting chamber; and an inserter positioned within said second passageway, wherein said inserter is flexible all along its length, and wherein said inserter is deployable from said second passageway, through said distal exiting chamber.

[0017] According to some embodiments, said inserter is headless.

[0018] According to some embodiments, the system includes: a body having a longitudinal axis, wherein said first and second passageways extending through said body and are parallel to said longitudinal axis; and a handle axially movable relative to said body; wherein said system has a retaining state, wherein said inserter is retained between said handle and said body, and an insertion state, wherein said inserter is movable through said second passageway in a distal direction by axial movement of said handle relative to said body in a distal direction.

[0019] According to some embodiments, the system includes a body, wherein said system includes only said first passageway and said second passageway extending through said body.

[0020] According to some embodiments, the system includes a handle axially movable relative to said second passageway, wherein a portion of said handle is couplable to said inserter and wherein displacement of said handle in a distal direction is operable to deploy said inserter from said second passageway.

[0021] According to some embodiments, the system includes: a body having a longitudinal axis, wherein said first and second passageways extending through said body and are parallel to said longitudinal axis; and a handle axially movable relative to said body; wherein said system has a retaining state, wherein said inserter is retained between said handle and said body, and an insertion state, wherein said inserter is movable through said second passageway in a distal direction by axial movement of said handle relative to said body in a distal direction.

[0022] According to some embodiments, the body includes: a sleeve having a through bore sized and shaped to at least partially receive said handle therethrough; and a sheath partially received in said sleeve and extending distally therefrom, wherein said sheath includes said first and second passageways.

[0023] According to some embodiments, said handle includes a main channel that communicates with said first passageway.

[0024] According to some embodiments, in said retaining state, said main channel and said first passageway are sized and shaped for advancement therethrough of the surgical tool.

[0025] According to some embodiments, said inserter is bendable for passage through said exiting chamber.

[0026] According to some embodiments, said main channel of said handle and said first passageway are coaxial.

[0027] According to some embodiments, said main channel of said handle and said first passageway are sized and shaped for insertion therethrough of one of a drill and an obturator.

[0028] According to some embodiments, said inserter has a proximal end including an inserter head having first and second portions, wherein said handle includes a handle recess sized and shaped for retaining the first portion of said inserter head, and wherein said body has a body recess sized and shaped for retaining the second portion of said inserter head; wherein, in said retaining state, said inserter head is positioned proximal to said handle recess and is positioned in said body recess.

[0029] According to some embodiments, said handle is axially movable in a proximal direction to convert said system from said retaining state to a priming state, in which said first portion of said inserter head is positioned in said handle recess and said second portion of said inserter head is positioned in said body recess.

[0030] According to some embodiments, said handle is axially movable in a distal direction to convert said system from said priming state to said insertion state.

[0031] According to some embodiments, said inserter is bendable and biased radially inward relative to said handle wherein, in said retaining state, at least a proximal portion of said inserter is stressed radially outward.

[0032] According to an aspect of some embodiments, there is provided an anchor delivery system comprising: a. a handle and a recess arranged on a circumference of the handle; b. a sleeve - sized and shaped to at least partially receive the handle therethrough, the sleeve having a through bore having a recess communicating with the through bore; c. a sheath being partially received into the sleeve and extending distally therefrom, the sheath having a first channel and a second channel, the first and second channels being parallel to each other, wherein the main channel of the handle communicates with the first channel of the sheath and the recess of the handle communicates with the second channel of the sheath; d. an inserter having an inserter head at a proximal end thereof, wherein the inserter is at least partially disposed radially between the sleeve and the handle and the inserter head is configured to be radially inwardly deflected upon proximal axial displacement of the handle relative to the sleeve.

[0033] According to an aspect of some embodiments, there is provided a method to deliver at least one bone anchor, implemented in a system comprising: a handle having a main channel extending therethrough and a recess arranged on a circumference of the handle; a sleeve having a through bore at least partially receiving the handle therethrough, the through bore having a recess arranged on a circumference thereof; a sheath being partially received into the sleeve and extending distally therefrom, the sheath having a first channel and a second channel, the first and second channels being parallel to each other, wherein the main channel communicates with the first channel and the handle recess and the sleeve recess communicates with the second channel; an inserter having an inserter head at a proximal end thereof and the at least one bone anchor at a distal end thereof, wherein the inserter is at least partially disposed radially between the sleeve and the handle and the inserter head is configured to be radially deflected upon distal axial displacement of the handle relative to the sleeve, comprising the actions of: a. distally advancing a surgical tool through the handle main channel until it at least partially extends distally from a distal end of the sheath; b. proximally retracting the handle relative to the sleeve, to allow the inserter head to deflect inwardly to the handle recess to couple the inserter head to the handle; and c. distally advancing the handle relative to the sleeve, to advance the inserter relative to the sheath, to deliver the at least one bone anchor.

[0034] According to an aspect of some embodiments, there is provided an inserter including: a proximal portion having an inserter head; a distal portion sized and shaped for retaining at least one anchor and for insertion of the anchor into a bone; and a bendable section between said proximal portion and said distal portion, wherein said bendable section is configured to bend upon application of force thereto; wherein said inserter is flexible all along its length.

[0035] According to some embodiments, said inserter is headless.

[0036] According to some embodiments, said inserter includes a longitudinal axis; wherein said inserter has an unstressed configuration, in which said inserter bendable section is unbent and said inserter head is positioned along said longitudinal axis; and wherein said inserter has a stressed configuration, in which said inserter bendable section is bent and said inserter head is not positioned along said longitudinal axis.

[0037] According to some embodiments, said inserter includes a longitudinal axis; wherein said inserter has an unstressed configuration, in which said inserter bendable section is bent and said inserter head is not positioned along said longitudinal axis; and wherein said inserter has a stressed configuration, in which said inserter bendable section is bent and said inserter head is positioned along said longitudinal axis.

[0038] According to an aspect of some embodiments, there is provided a sandwich configuration having first and second flexible bone anchors with an associated suture thread, wherein said 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 said 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 said 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 said at least two loops is positioned on each side of the center of the second tubular body, said at least one loop of said 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 said suture thread; wherein the length of thread extends from the distal loop through said internal passageway of said first flexible bone anchor; wherein the length of thread exiting the internal passageway passes through said distal loop; wherein the length of thread exiting the distal loop extends through a first end of said external passageway of said second flexible bone anchor; wherein the length of thread passes from a first end of said external passageway, through a first portion of said external passageway, toward a center of said 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 said external passageway, through a second portion of said external passageway, toward the center of the external passageway and exits the external passageway; wherein the length of thread extends from said 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 said distal loop; wherein the length of thread extending from the distal loop passes between the tubular body of said second flexible bone anchor and said external passageway thereof; and wherein the length of thread extends proximally.

[0039] According to 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 said suture thread proximal end to bend the second flexible anchor, thereby securing said second flexible anchor to the soft tissue against the bone.

[0040] According to an aspect of some embodiments, 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; ii. 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.

[0041] According to an aspect of some embodiments, there is provided a device for securing a soft tissue or a biocompatible material to a bone, said device including: a bone anchor; a suture, wherein said bone anchor is slidable relative to said suture; and a retaining anchor slidable along said suture toward said bone anchor.

[0042] According to some embodiments, one of: said bone anchor includes a passageway extending alongside or through at least a portion of said bone anchor, and said suture extends through said passageway; and said bone anchor is slidingly engaged with said suture. According to some embodiments, said retaining anchor is at least one of flexible and compressible.

[0043] According to some embodiments, said suture retaining anchor includes one of: a plurality of loops through which said suture is extendible; and a plurality of apertures through which said suture is threadable.

[0044] According to some embodiments, said bone anchor has a passageway extending therethrough; wherein said suture includes a loop having first and second extensions, said retaining anchor slidably mounted on said loop; wherein one of: said first and second extensions are each configured to extend through said passageway; and said first and second extensions are each configured to be engaged with said bone anchor; and wherein said first extension includes a portion having an aperture, wherein said loop extends through said aperture.

[0045] According to some embodiments, said retaining anchor is at least one of: thick enough to cushion the soft tissue or arthroscopic patch or allograft against a pressure applied by the suture to the soft tissue; and tough enough such that said soft tissue or arthroscopic patch or allograft is not damaged by said suture.

[0046] According to some embodiments, said bone anchor is configured to be inserted through a hole in the soft tissue or biocompatible material, said retaining anchor sized and / or shaped such that said retaining anchor cannot be passed through said hole.

[0047] According to an aspect of some embodiments, there is provided a method for securing a soft tissue or a biocompatible material to a bone, said method including: inserting a bone anchor into a bore in the bone, wherein the bone anchor is slidable relative to a suture, and wherein a retaining anchor is slidable relative to the suture toward the bone anchor; pulling a portion of the suture to secure the soft tissue or biocompatible material relative to the bone.

[0048] According to some embodiments, the retaining anchor includes one of: a plurality of loops through which the suture is extendible; and a plurality of apertures through which the suture is threadable; wherein said pulling includes causing the suture to slide through the one of the plurality of loops and the plurality of apertures. According to some embodiments, the bone anchor includes a passageway extending therethrough; wherein the suture includes a loop having first and second extensions, and the retaining anchor is slidably mounted on said loop; wherein one of: the first and second extensions are each configured to extend through the passageway; and the first and second extensions are each configured to be engaged with the bone anchor; and wherein the first extension includes a portion having an aperture, wherein the loop extends through the aperture.

[0049] 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.

[0050] According to an aspect of some embodiments, there is provided an anchor delivery system comprising: a. a handle having a main channel extending therethrough and a recess arranged on a circumference thereof; b. a sleeve having a through bore at least partially receiving the handle therethrough, the through bore having a groove communicating with the through bore; c. a sheath being partially received into the sleeve and extending distally therefrom, the sheath has a first channel and a second channel, the first and second channels being partially parallel to each other, wherein the main channel of the handle communicates with the first channel of the sheath and the recess of the handle communicates with the second channel of the sheath; d. an inserter having an inserter head at a proximal end thereof, whereas the inserter is at least partially disposed radially between the sleeve and the handle and the inserter head is configured to be radially deflected upon axial displacement of the handle relative to the sleeve. According to some embodiments, prior to axial displacement of the handle relative to the sleeve, the system is in a first operative orientation, wherein the handle is partially enclosed within the sleeve and wherein the inserter head is selectively retained between the outer circumference of the handle and the inner circumference of the sleeve.

[0051] According to some embodiments, following proximal axial displacement of the handle relative to the sleeve, the system is in a second operative orientation, allowing the inserter head to radially deflect inwardly towards the recess of the handle, in order to be coupled to the handle.

[0052] According to some embodiments, the inserter head is supported within the recess of the handle following the proximal axial displacement of the handle relative to the sleeve.

[0053] According to some embodiments, the inserter is configured for distal displacement along with the handle when the inserter head is supported within the recess of the handle.

[0054] According to some embodiments, the groove of the sleeve is outwardly disposed radially relative to the handle recess.

[0055] According to some embodiments, the inserter head is biased towards inward deflection.

[0056] According to some embodiments, the system comprises at least three operative orientations: a. a first operative orientation, wherein the inserter head is supported between the handle and the sleeve, b. a second operative orientation, wherein the inserter head is configured to be radially deflected, c. a third operative orientation, wherein the inserter is configured for axial displacement.

[0057] According to some embodiments, a surgical tool is configured to advance distally through the main channel of the handle in the first operative orientation.

[0058] According to some embodiments, the second operative orientation is realized when the handle is retracted proximally relative to the sleeve.

[0059] According to some embodiments, in the third operative orientation, the inserter is configured to advance distally upon distal displacement of the handle relative to the sleeve.

[0060] According to some embodiments, wherein the sleeve through bore comprises at least two longitudinal gaps, a first gap in communication with the first channel and a second gap in communication with the second channel of the sheath.

[0061] According to some embodiments, the handle extends proximally from the sleeve and wherein the handle further comprises a knob and the sleeve inner circumference further comprises a track spanning axially, wherein the knob of the handle is slidably coupled to the track of the sleeve.

[0062] According to some embodiments, the length of the track of the sleeve modulates the axial displacement of the handle. According to an aspect of some embodiments, there is provided a method to deliver a bone anchor, implemented in a system comprising: a handle having a main channel extending therethrough and a recess arranged on a circumference thereof; a sleeve having a through bore at least partially receiving the handle therethrough, the through bore having a groove arranged on a circumference thereof; a sheath being partially received into the sleeve and extending distally therefrom, the sheath having a first channel and a second channel, the first and second channels being partially parallel to each other, wherein the main channel communicates with the first channel and the recess and groove communicates with the second channel; an inserter having an inserter head at a proximal end thereof, whereas the inserter is at least partially disposed radially between the sleeve and the handle and the inserter head is configured to be radially deflected upon axial displacement of the handle relative to the sleeve, comprising the actions of: a. distally advancing a surgical tool through the handle main channel until at least partially extending distally from a distal end of the sheath; b. proximally retracting the handle relative to the sleeve, thereby allowing the inserter head to deflect inwardly to the handle recess thereby coupling the inserter head to the handle; and c. distally advancing the handle relative to the sleeve, thereby advancing the inserter relative to the sheath, thereby delivering the bone anchor.

[0063] According to some embodiments, during surgical tool advancement, the inserter head is supported between the handle and the sleeve.

[0064] According to some embodiments, the handle recess is located inward to the sleeve groove.

[0065] According to some embodiments, the inserter head is biased inwards towards the handle.

[0066] According to some embodiments, the handle recess is configured both to accommodate the inserter head, and to urge axial displacement of the inserter.

[0067] According to some embodiments, the first channel and second channel of the sheath converge to a single exiting chamber at the distal end of the sheath.

[0068] According to some embodiments, the distal end of the sheath has a plurality of shapes, radii, and configurations to accommodate the desired surgical tool.

[0069] According to some embodiments, the inserter material is flexible and configured to be radially deflected upon change of pressure thereon.

[0070] According to some embodiments, the handle further comprises a knob configured to prevent further proximal retraction of the handle relative to the sleeve.

[0071] According to some embodiments, the handle knob is slidably coupled with a longitudinally extending track within the sleeve through bore. According to some embodiments, a distal end of the inserter is operably coupled to a first flexible bone anchor and a second flexible bone anchor, both threaded with suture thread, and both configured to bend upon tightening of suture thread.

[0072] According to some embodiments, upon distal advancement of handle, the first flexible bone anchor is delivered following by second flexible bone anchor.

[0073] According to some embodiments, the method further comprises the action of securing the first flexible bone anchor and the second flexible bone anchor by pulling at least one end of the suture thread.

[0074] According to some embodiments, the second flexible bone anchor comprises a passageway extending from a first end to a second end and configured to receive the suture thread from the first end till a center of the passageway, and to receive suture thread from the second end till the center of the passageway, and further configured to bend upon tightening of at least one end of the suture thread.

[0075] According to an aspect of some embodiments, there is provided a method of threading two flexible bone anchors with a suture thread in a system comprising: the suture thread with an external proximal end, a distal end, and one to a plurality of lengths extending between the proximal end and the distal end; a first flexible bone anchor with a tubular body and an internal passageway configured to receive at least one suture length extending from a first end to a second end; a second flexible bone anchor with a tubular body extending from a first end to a second end, a center between the first end and second end, and an external passageway comprised of two to a plurality of external loops external to the tubular body thereof, and with a plurality of external loops on each side of the center thereof, and configured to receive at least one suture length, comprising the actions of: i. tying a loop adjacent to the distal end of the suture thread; ii. extending the continuing length of thread from action (i) through the internal passageway of the first flexible bone anchor; iii. passing the continuing length of thread from action (ii) through the loop; iv. continuing to extend the length of thread from action (iii) through the first end of the external passageway of the second flexible bone anchor; v. exiting the length of thread from action (iv) from the external passageway before extending to the center of the second flexible bone anchor; vi. looping the length of thread from action (v) and extending it through the second end of the external passageway of the second flexible bone anchor; vii. exiting the continuing length of thread from action (vi) from the external passageway before reaching the center of the second flexible bone anchor; viii. repeating actions ii and iii with the continuing length of thread from action (vii); ix. further extending the length of thread from action (viii) between the tubular body of the second flexible bone anchor and the external passageway thereof; and x. extending the length of thread from action (ix) to the external proximal end.

[0076] 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 a bone; delivering the second flexible bone anchor; pulling the external proximal end to bend the second flexible suture anchor, thereby securing the second flexible anchor to the soft tissue which is then secured against the bone.

[0077] 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.

[0078] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0079] 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.

[0080] In the drawings:

[0081] Fig. 1 is a side perspective view of an exemplary implementation of the anchor delivery system, according to some embodiments;

[0082] Figs. 2A - 2C are exploded views of exemplary implementations of the anchor delivery system, where Fig. 2A is an exploded view of the anchor delivery system of Fig. 1, according to some embodiments, Fig. 2B illustrates an implementation with an obturator, Fig. 2C illustrates an implementation with a drill, according to some embodiments;

[0083] Figs. 3A - 3E illustrate multiple views of an exemplary implementation of the handle, where Fig. 3A illustrates a side perspective view, Fig. 3B illustrates a bottom perspective view, Fig. 3C illustrates a first plan side view, Fig. 3D illustrates a second plan side view, and Fig. 3E illustrates a sectional view, section being taken along lines E - E in Fig. 3D, according to some embodiments; Figs. 4A - 4F are multiple views of an exemplary implementation of the sleeve, where Fig. 4A is a side perspective view, Fig. 4B is a plan side view, Fig. 4C is a sectional view (the section taken along lines C - C in Fig. 4B), Fig. 4D is a plan top view, Fig. 4E is a plan bottom view, and Fig. 4F is a sectional view (the section being taken along lines F - F in Fig. 4E), according to some embodiments;

[0084] Figs. 5A - 5C are multiple views of an exemplary implementation of the sheath, where Fig. 5A illustrates a side perspective view, Fig. 5B is a plan top view and Fig. 5C illustrates a sectional view, section being taken along lines C - C in Fig. 5A , according to some embodiments;

[0085] Fig. 6 is a side view of an exemplary implementation of the inserter, according to some embodiments;

[0086] Figs. 7A - 7C illustrate an exemplary implementation of the anchor delivery system shown in a first operative orientation, with an obturator extending out of the distal end thereof, where Fig. 7A illustrates a side perspective view, Fig. 7B illustrates a side plan view, and Fig. 7C illustrates a sectional view, section being taken along lines C - C in Fig. 7B, according to some embodiments;

[0087] Figs. 8A - 8C, illustrate an exemplary implementation of the anchor delivery system shown in the first operative orientation with a drill extending out of the distal end thereof, where Fig. 8A illustrates a side perspective view, Fig. 8B illustrates a plan side view, and Fig. 8C illustrates a sectional view, section being taken along lines C - C in Fig. 8B, according to some embodiments;

[0088] Figs. 9A - 9D, illustrate an exemplary implementation of the anchor delivery system shown in a second operative orientation where Fig. 9A illustrates a side perspective view, Fig. 9B illustrates a plan side view, Fig. 9C illustrates a sectional view taken along lines C - C in Fig. 9B, and Fig. 9D is an enlargement of a portion of the anchor delivery system shown in Fig. 9C, according to some embodiments;

[0089] Figs. 10A - 10D, illustrate an exemplary implementation of the anchor delivery system shown in a third operative orientation where Fig. 10A is a side perspective view, Fig. 10B is a plan side view, Fig. 10C is a sectional view taken along lines C - C in Fig. 10B, and Fig. 10D is an enlargement of a portion of the anchor delivery system shown in Fig. 10C, according to some embodiments;

[0090] Fig. 11 illustrates an exemplary implementation of a method of threading two flexible bone anchors that may be delivered using the anchor delivery system of Figs. 1 - 10D, according to some embodiments;

[0091] FIG. 12 is a flowchart illustrating a method of inserting at least one anchor using the device of Fig. 1, according to some embodiments; and

[0092] Fig. 13 is a flowchart illustrating a method of tissue repair by a sandwich technique, according to some embodiments. DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0093] The present relates to systems and methods for forming a bore in a bone and inserting an anchor into the bore and, more particularly but not exclusively, to forming at least one bore in a bone and inserting an anchor in each of the at least one bore. The bore in the bone may be predrilled or malleted by the inserter. The present invention, in some embodiments thereof, also relates to methods of forming bone anchors having a desired thickness. Specifically, the disclosure is directed to methods of continuously forming knotless bone anchors having customizable thickness, and the resulting anchors formed.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] 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.

[0100] Overview

[0101] According to some embodiments there are provided exemplary implementations of systems and methods to deliver a bone anchor. In certain exemplary implementations, the disclosed anchor delivery system provides increased ease of use for medical practitioners and thereby better patient outcomes. Additionally, in these and other exemplary implementations and methods thereof, the disclosed system provides increased procedure speed, increased accuracy, minimal tissue puncturing, and or intuitive use. The anchor delivery system may also allow for delivery of surgical tools such as obturators or drills, or other surgical tools to optionally prepare the target site, according to some embodiments.

[0102] According to an aspect of some embodiments, the system includes a first passageway having a first longitudinal axis and a distal end portion coaxial with the first longitudinal axis, for deployment of a surgical tool for forming a bore in a bone; a second passageway having a second longitudinal axis offset from the first longitudinal axis, the second passageway being in communication with the distal end portion of the first passageway; and an inserter positioned within the second passageway, the inserter being deployable from the second passageway, according to some embodiments. According to some embodiments, the system includes only the first and second passageways extending through a body of the system. In exemplary implementations, the system comprises a handle, a sleeve, a sheath, and an inserter. The present disclosure has applications for inserter distal advancement and thereby bone anchor delivery. The inserter may be flexible all along its length, according to some embodiments. Additionally, the inserter is configured to be supported by the handle and sleeve, and upon axial displacement of the handle in a proximal direction, the inserter proximal end is allowed to be deflected radially inwardly and thereby coupled to the handle. Thereafter, axial displacement of the handle in a distal direction causes axial displacement of the inserter in the distal direction. In exemplary implementations, a bone anchor or similar fixation device is coupled to the distal end of the inserter such that delivery of the inserter is synonymous with delivery of the bone anchor. For example, a bone anchor may be frictionally coupled to the distal end of the inserter while the inserter head is supported between the sleeve and the handle prior to and / or during axial movement of the handle.

[0103] In exemplary implementations, in the bone anchor delivery system, the inserter’s proximal end is retained between the sleeve and handle and disposed in a proximal position relative to the sleeve. A second operative orientation is defined by the inserter’s proximal end being allowed to deflect radially inwardly and still be disposed in the proximal position relative to the sleeve. Lastly, a third operative orientation is defined by the inserter being displaced distally relative to the sleeve for anchor delivery.

[0104] According to some embodiments, the inserter does not have an inserter head, and a proximal end of the inserter is retained between the sleeve and handle in the first operative orientation. In the second operative orientation, the inserter proximal end is allowed to deflect radially inwardly and still be disposed in the proximal position relative to the sleeve, according to some embodiments.

[0105] According to an aspect of some embodiments there is provided an inserter including: a proximal portion having an inserter head; a distal portion sized and shaped for retaining at least one anchor and for insertion of the anchor into a bone; and a bendable section between the proximal portion and the distal portion, wherein the bendable section is configured to bend upon application of force thereto. The inserter is flexible all along its length, between the inserter head and a distal end of the inserter, according to some embodiments. The inserter may be configured without an inserter head, according to some embodiments.

[0106] The inserter may have an unstressed configuration, in which the inserter bendable section is unbent and the inserter head is positioned along the longitudinal axis; and wherein the inserter has a stressed configuration, in which the inserter bendable section is bent and the inserter head is not positioned along the longitudinal axis, according to some embodiments.

[0107] The inserter may have an unstressed configuration, in which the inserter bendable section is bent and the inserter head is not positioned along the longitudinal axis; and wherein the inserter has a stressed configuration, in which the inserter bendable section is bent and the inserter head is positioned along the longitudinal axis, according to some embodiments.

[0108] According to an aspect of some embodiments there are provided systems and / or methods for delivery of one (or more) anchors connected by one or more threads for treatment of tissue, for example, securing soft tissue (e.g., tendon) to bone via threads passed through anchor(s) secured into bone.

[0109] The anchor(s) preconnected by sutures, and coupled to the inserter, delivered using implementations described herein may be used, for example, for performing a PASTA repair, a SANDWICH repair and / or a patch repair, for reconnecting a tendon to bone, for example, for rotator cuff repair or in repair of other tissue and / or other locations in the body. At least some implementations described herein address the technical problem of reducing surgical time, and / or improving the technical field of medical devices by providing a device that enables completing the medical procedure (or most of the medical procedure) by a single insertion of the medical device in the body. Such a procedure may include exposing an insertion location on a bone, a single insertion of the tool, utilizing the tool to insert an anchor, and then removing the surgical tool, according to some embodiments. One or more anchors, e.g., hard bone anchor(s), soft bone anchor(s), or combinations thereof, preconnected by sutures may be inserted (e.g., by drilling and / or punching) into tissue (e.g., bone) by the single insertion of the anchor delivery system into the body. The suture, which is prethreaded through the anchor(s) is then pulled to treat tissue, e.g., a suture which is prethreaded through an anchor drilled into bone is pulled to secure a tendon in place against the bone. In implementations with an additional soft anchor, the anchor is, for example, inserted into the bone, and then the at least one soft anchor may be secured against the soft tissue, e.g., ligament(s) or tendon(s), by pulling and or tying suture ends.

[0110] According to an aspect of the present disclosure, there is provided a method of operating the anchor delivery system for deployment of at least one anchor with at least one attached suture thread, and / or a method of treating a subject by deployment of at least one anchor with at least one attached suture thread. A hole is initially prepared at a target site, i.e., a predetermined anatomical location, for example, by use of a surgical tool such as an obturator and / or a drill inserted through the anchor delivery system. Then a bone anchor or similar fixation device coupled to the inserter may be deployed in the hole. The at least one anchor may have, for example, at least one thread end exiting the body of the subject. The thread end outside the body of the subject may be pulled, securing the soft tissue in place against the bone. Alternatively, additional bone anchors may be delivered and secured in a similar fashion, according to some embodiments. For example, an additional soft anchor may be secured against the soft tissue. The soft tissue, which is held in place by the suture thread and or anchor(s), may then repair, e.g., re-attach itself to the bone, according to some embodiments.

[0111] 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 the inserter prior to anchor delivery. Both prethreaded flexible anchors may be sized and shaped to be deployed from the anchor delivery device. 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.

[0112] Accordingly, in an exemplary implementation, provided herein is an anchor delivery system comprising: a handle having a main channel extending therethrough and a recess arranged on a circumference thereof; a sleeve having a through bore at least partially receiving the handle therethrough, the through bore having a groove communicating with the through bore; a sheath being partially received into the sleeve and extending distally therefrom, the sheath having a first channel and a second channel, the first and second channels being partially parallel to each other, wherein the main channel of the handle communicates with the first channel of the sheath and the recess of the handle communicates with the second channel of the sheath; an inserter having an inserter head at a proximal end thereof, wherein the inserter is at least partially disposed radially between the sleeve and the handle, and the inserter head is configured to be radially deflected upon axial displacement of the handle, in a proximal direction, relative to the sleeve. According to some embodiments of the anchor delivery system, (i) prior to axial displacement of the handle relative to the sleeve in the proximal direction, the system is in a first operative orientation, wherein the handle is partially enclosed within the sleeve and wherein the inserter head is selectively retained between the outer circumference of the handle and the inner circumference of the sleeve, wherein (ii) following axial displacement of the handle, in a proximal direction, relative to the sleeve, the system is in a second operative orientation, wherein the second operative orientation allows the inserter head to radially deflect towards the recess of the handle, wherein (iii) the inserter head is supported within the recess of the handle following the second operative orientation, wherein (iv) the inserter is configured for distal displacement following the second operative orientation, wherein (v) the sleeve recess is outwardly disposed radially relative to the handle recess, wherein (vi) the inserter head is biased towards inward deflection, wherein (vii) the system comprises at least three operative orientations: a first operative orientation, wherein the inserter head is supported by the handle and sleeve; a second operative orientation, wherein the inserter head is configured to be radially deflected; a third operative orientation, wherein the inserter is configured for axial displacement, wherein (viii) a surgical tool is configured to advance distally in the first operative orientation, wherein (ix) the second operative orientation is realized when the handle is retracted proximally relative to the sleeve, wherein (x) the third operative orientation is realized when the inserter is configured to advance distally upon distal displacement of the handle relative to the sleeve, wherein (xi) the sleeve through bore comprises at least two longitudinal gaps, a first gap in communication with the first channel and a second gap in communication with the second channel of the sheath, wherein (xii) the handle extends proximally from the sleeve and wherein the handle further comprises a knob and the sleeve inner circumference further comprising an track extending axially, wherein the knob of the handle is slidably coupled to the track of the sleeve, and (xiii) wherein the length of the track of the sleeve determines the length of axial displacement of the handle.

[0113] In another exemplary implementation, provided herein is a method to deliver a bone anchor, implemented in a system comprising: a handle having a main channel extending therethrough and a recess arranged on a circumference thereof; a sleeve having a through bore at least partially receiving the handle therethrough, the through bore having a recess arranged on a circumference thereof; a sheath being partially received into the sleeve and extending distally therefrom, the sheath having a first channel and a second channel, the first and second channels being partially parallel to each other, wherein the main channel communicates with the first channel and the recess and recess of the groove communicates with the second channel; an inserter having an inserter head at a proximal end thereof, wherein the inserter is at least partially disposed radially between the sleeve and the handle and the inserter head is configured to be radially deflected upon axial displacement of the handle, in a proximal direction, relative to the sleeve, comprising: distally advancing a surgical tool through the handle main channel until at least partially extending distally from a distal end of the sheath; proximally retracting the handle thereby allowing the inserter head to deflect inwardly to the handle recess thereby coupling the inserter head to the handle; and distally advancing the handle, thereby advancing the inserter, thereby delivering the anchor.

[0114] According to some embodiments of the method of anchor delivery, (xiv) during surgical tool advancement, the inserter head is supported between the handle and the sleeve, wherein (xv) the handle recess is located radially inward relative to the sleeve recess, wherein (xvi) the inserter head is biased towards the longitudinal axis of the distal portion of the inserter, wherein (xvii) the inserter head is biased inwardly, wherein (xviii) the handle recess is configured both to accommodate the inserter head, and to urge axial displacement of the inserter, wherein (xix) the first channel and second channel of the sheath converges to a single exiting chamber at the distal end of the sheath, wherein (xx) the distal end of the sheath has a plurality of shapes, radii, and configurations to accommodate the desired surgical tool, wherein (xxi) the inserter material is flexible and biasing upon deflection, wherein (xxii) the handle further comprises a knob configured to halt further proximal retraction of the handle relative to the sleeve, and wherein (xxiii) the handle knob is slidably coupled with a longitudinally extending track within the sleeve through bore.

[0115] According to some embodiments there is provided a system for inserting at least one anchor into a bone. According to some embodiments, the system may be used for forming a bore through a soft tissue such as, for example, a tendon, and a bone, and inserting an anchor through the tendon and into the bore in the bone.

[0116] 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.

[0117] 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. 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.

[0118] 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.

[0119] 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.

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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 and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0125] Anchor Delivery System Having a Flexible Inserter

[0126] Turning now to Fig. 1, there is shown an exemplary implementation of anchor delivery system 10, according to some embodiments. Anchor delivery system 10 includes, from the proximal to distal end, a handle 100, a sleeve 125, and a sheath 150, according to some embodiments. Anchor delivery system 10 extends along a longitudinal axis 11, i.e., handle 100, sleeve 125, and sheath 150 each extends longitudinally along axis 11. Each of the handle 100, sleeve 125, and sheath 150 may be formed of any suitable for such as, for example, any medical grade metal and / or plastic, or any combination thereof, according to some embodiments.

[0127] Fig. 2A is an exploded view of system 10, where an exemplary implementation of an inserter 115 is illustrated along with handle 100, sleeve 125, and sheath 150, according to some embodiments. It is to be understood in the present disclosure that inserter 115 may refer to an inserter precoupled to a bone anchor, according to some embodiments. Inserter delivery or distal advancement necessarily implies bone anchor delivery, according to some embodiments. The term bone anchor should also be understood broadly in the present disclosure to apply to a plurality of types of fixation devices that allow for coupling (e.g., frictionally) to inserter 115, and reference to the distal end of inserter 115 may be synonymous with reference to the at least one coupled bone anchor. Fig. 2B is an exploded view of an exemplary implementation where an obturator 102 is configured to be utilized with anchor delivery system 10, and Fig. 2C illustrates anchor delivery system 10 where a drill 104 is configured to be utilized with anchor delivery system 10, according to some embodiments.

[0128] It is seen in Figs. 1 - 2C that sleeve 125 has a proximal end 1251 and a distal end 1253 and sheath 150 is typically fixedly attached to sleeve 125, according to some embodiments. Sheath 150 has a proximal end 1502 and a distal end 1504, the proximal end 1502 of the sheath 150 is at least partially inserted into the distal end 1253 of the sleeve 125, according to some embodiments. It is also seen in Figs. 1 - 2C that handle 100 is configured to be at least partially received into sleeve 125 through the proximal end 1251 thereof, according to some embodiments. The inserter 115 is configured to be disposed between the handle 100 and the sleeve 125, according to some embodiments.

[0129] Referencing now Figs. 3A - 3E there is illustrated an exemplary implementation of the handle 100, according to some embodiments. Handle 100 extends along longitudinal axis 11 with a handle head 1002 located proximally and a handle body 1004 extending distally to a handle distal end 1003, according to some embodiments. In exemplary implementations, handle head 1002 generally has a greater circumference than handle body 1004. The handle head 1002 may be used as a finger grip, according to some embodiments. In additional implementations, handle 100 may have an intermediate handle neck 10022 between handle body 1004 and handle head 1002, also with a greater circumference than handle body 1004.

[0130] Handle 100 is further defined by a main channel 1010 which extends through the entire length of handle 100 along longitudinal axis 11 of handle 100, according to some embodiments, as seen in Figs. 3B and 3E. Main channel 1010 is configured to receive a surgical tool such as obturator 102 or drill 104, or another surgical tool, according to some embodiments. It may be noted that, according to some embodiments, main channel 1010 may have a diameter suitable for passage therethrough of an obturator 102 or a drill 104, or another surgical tool, according to some embodiments. The diameter of main channel 1010 may be in a range of from 0.8-8.0 mm such as, for example, from w, from 1.2- 1.6mm, from 1.6-2.0mm, from 2-4mm, from 4-6mm, or from 6-8mm, according to some embodiments.

[0131] On an outer circumference of the handle 100 there is a recess such as, for example, recess 1008, according to some embodiments. The recess 1008 extends radially inwardly from the outer circumference of the handle 100 and is generally disposed adjacent the distal end 1003 of handle 100, according to some embodiments. In additional implementations, axially extending from recess 1008, in the proximal direction is a groove 1006, and in the distal direction is a groove 1012. Groove 1006 and groove 1012 extend axially along handle body 1004, in parallel to the longitudinal axis 11 of handle 100, according to some embodiments. In exemplary implementations, groove 1012 and groove 1006 are shallower, i.e., extend less radially inward from the handle 100 outer circumference than recess 1008. Fig. 3E illustrates an exemplary implementation of main channel 1010 and recess 1008, according to some embodiments. Handle head 1002 may have any one of a plurality of shapes and sizes, according to some embodiments. Furthermore, according to some embodiments, at least one of recess 1008, groove 1006, and groove 1012 may be shaped and sized in a plurality of configurations corresponding to the shape and size of various implementations of inserter 115, for example, as described further below. Further illustrated is an exemplary implementation of a knob 1014 located generally adjacent to distal end 1003 of handle 100 and extending radially outwardly from the outer circumference of handle 100. In exemplary implementations knob 1014 may be located diametrically opposite groove 1012, while in other implementations it may, for example, be disposed diametrically opposite recess 1008. The knob 1014 may be disposed in other locations on the outer circumference of handle 100 in further implementations.

[0132] Referencing now Figs. 4A - 4F, there is shown an exemplary implementation of a sleeve 125 having a generally cylindrical configuration extending along longitudinal axis 11. Sleeve 125 includes a sleeve body 1252 having a proximal end 1251 and a distal end 1253, and a through bore 1255 extending distally from a proximal end 1251 to a distal end 1253 of the sleeve 125, according to some embodiments. The through bore 1255, from proximal end 1251 to distal end 1253, is comprised of: a bore 1254, configured to slidably and at least partially accommodate handle 100; two longitudinally extending gaps such as a central gap 1260 and an inserter gap 1262, both of which extend distally; and a bore 1256 at the distal end 1253 of sleeve 125, according to some embodiments. From sleeve 125 proximal end 1251 to distal end 1252, bore 1254 converges into central gap 1260 and inserter gap 1262, and central gap 1260 and inserter gap 1262 distally converge into one bore at the proximal end 1251 of sleeve 125, i.e., bore 1256, according to some embodiments. Bore 1256 is configured to at least partially accommodate sheath 150, according to some embodiments.

[0133] The central gap 1260 is at least partially parallel to the inserter gap 1262, according to some embodiments. In exemplary implementations, central gap 1260 and inserter gap 1262 may be centrally to near distally located in sleeve 125 and extend from about 10% to about 50% of the length of sleeve 125. In further exemplary implementations, the curvature of each of central gap 1260 and inserter gap 1262 may range from fully defining a separate channel (such as illustrated in the top view of Fig. 4D of central gap 1260 and inserter gap 1262), to partially defining a longitudinally curved gap, e.g., partially open, such that central gap 1260 and inserter gap 1262 may slidably accommodate a surgical tool, such as obturator 102 or drill 104, and inserter 115, respectively. Furthermore, according to some embodiments, bore 1256, at distal end 1253 of sleeve 125, may extend to any one of a plurality of lengths such as, for example, from about 10% of the length of sleeve 125 to about 35% of the length of sleeve 125, wherein bore 1256 is configured to at least partially receive sheath 150. According to some embodiments, bore 1254, at proximal end 1251 of sleeve 125, may have a length ranging from about 40% to about 70% of the length of sleeve 125, wherein bore 1254 is configured to at least partially receive handle body 1004 and accommodate inserter 115. As illustrated in Fig. 4C, sleeve 125 may also include a handle track 1264 on an inner circumference of sleeve 125, wherein the handle track 1264 may extend in parallel to the longitudinal axis 11 such as, for example, extending partially along bore 1254, according to some embodiments.

[0134] In further exemplary implementations, sleeve 125 may contain a recess, such as recess 1258, disposed radially outward from bore 1254. Through bore 1255 may additionally include a recess such as recess 1258 disposed on an outer circumference of through bore 1255, according to some embodiments. In exemplary implementations, recess 1258 may slope or decrease in radial distance, for example, from a recess proximal end 12581, to a distal end of recess 1258. In other implementations, recess 1258 may include, adjacent its proximal end 12581, a recess brink such as, for example, brink 12582, extending generally and slightly inwardly from an outer circumference of recess 1258. In other implementations, distally from brink 12582, recess 1258 may inwardly slope till it joins bore 1254, inserter gap 1262, or generally through bore 1255. In still further implementations, the proximal side of recess 1258, located proximally to brink 12582, may extend at an equal to lesser inward slope than the distal end of recess 1258 located distal to rim 12582. In further implementations, the radial outward distance (depth) of recess 1258 may generally be greatest on its proximal end 12581. Furthermore, brink 12582 may be generally or approximately diametrically opposite a proximal end of handle track 1264, according to some embodiments. In alternative implementations, the proximal end of handle track 1264 may be generally or approximately opposite recess 1258. In still additional implementations, the proximal end 12581 of recess 1258 may extend radially outward by about 5-30% of the diameter of bore 1254. Moreover, brink 12582 may have a length of from about 0-50% of the length of proximal end 12581 of recess 1258, according to some embodiments.

[0135] Turning now to Figs. 5A - 5C, there is illustrated an exemplary implementation of the sheath 150. The sheath 150 is a generally tubular element extending along the longitudinal axis 11 and having a proximal end 1502 and a distal end 1504, according to some embodiments. The sheath 150 has a first channel 1506 and a second channel 1508, both extending in parallel to longitudinal axis 11 thereof, according to some embodiments. Optionally, sheath 150 has only first channel 1506 and second channel 1508 extending therethrough, according to some embodiments. First channel 1506 and second channel 1508 may be at least partially parallel to each other and may converge, at the distal end of sheath 150, to one channel such as, for example, exiting chamber 1510, according to some embodiments, wherefrom a surgical device may exit the sheath past distal end 1504.

[0136] It may be noted that sheath first channel 1506 may be coaxial with an aperture 1505 at sheath distal end 1504, while sheath second channel 1508 may not be coaxial with aperture 1505, according to some embodiments. Rather, sheath second channel 1508, while parallel with first channel 1506, may be offset from aperture 1505, according to some embodiments.

[0137] According to some embodiments, first and second sheath channels 1506 and 1508 may each be configured in any one of a variety of longitudinally extending shapes such as, for example, circular, semicircular, crescent, or varying curvatures that are configured to slidably accommodate inserter 115 for second sheath channel 1508 and obturator 102, drill 104, or another surgical tool for first channel 1506. Moreover, prior to delivery, surgical tools and inserter 115 with a bone anchor coupled to the inserter may advance distally through exiting chamber 1510 (see Fig. 5C) before exiting sheath distal end 1504, according to some embodiments.

[0138] It may be noted that first channel 1506 may have a diameter in a range of from l-8mm such as, for example, from l-2mm, from 2-3mm, from 3-4mm, from 4-5mm, from 5-6mm, from 6-7mm, or from 7-8mm, suitable for passage therethrough of an obturator 102 or a drill 104, or another surgical tool, according to some embodiments. It may also be noted that second channel 1508 may have a diameter in a range of froml-4mm such as, for example, from l-2mm, from 2-3mm, or from 3-4mm, suitable for passage therethrough of an inserter 115 and at least one anchor, according to some embodiments.

[0139] Moreover, distal end 1504 may have a jagged circumference configured to stabilize sheath 150 at a specific target site / anatomical location or to support a surgical tool being delivered to the location, according to some embodiments. For example, in exemplary implementations, the circumference of distal end 1504 may be lined with at least two jagged teeth or edges of specified lengths at specified intervals, the teeth may be curved or with a sharp apex, or alternatively, distal end 1504 may be round but sharp-edged or with a serrated edge.

[0140] Turning now to Fig. 6 there is illustrated an exemplary implementation of inserter 115, according to some embodiments. The inserter may be formed of any suitable material such as, for example, any medical grade metal or plastic, according to some embodiments. The inserter may include an inserter head 1152 at a proximal end thereof, an inserter body 1154, and an inserter distal end 1156, to which at least one bone anchor or similar fixation device may be operably coupled, according to some embodiments. According to some embodiments, there inserter 115 does not include an inserter head. Inserter head 1152 may be implemented in a plurality of shapes and sizes, in addition to cylindrical, square, spherical, etc., according to some embodiments. The inserter body 1154 may have a thickness or diameter in a range of from l-4mm such as, for example, from l-2mm, from 2-3mm, or from 3-4mm, according to some embodiments.

[0141] The inserter 115 may be formed of any suitable material such as, for example, medical grade metal or plastic, nitinol, or 302 stainless steel. Optionally, the inserter head 1152 may be integral with the inserter body 1154, according to some embodiments. Optionally, the inserter head 1152 may not be integral with the inserter body 1154, and each of these components may be formed of a different material or of the same material, according to embodiments.

[0142] In exemplary implementations, the inserter 115 is made of a flexible material, such as nitinol, for example, and upon exertion of pressure thereon, the inserter 115 is biased towards its unstressed configuration. Inserter 115 may be flexible along its entire length, according to some embodiments. It is noted that, in the unstressed configuration, inserter 115 may generally extend along a longitudinal axis 12, or in its unstressed configuration inserter head may be disposed slightly off longitudinal axis 12 e.g., radially inwardly, for example, towards longitudinal axis 11, according to some embodiments. In additional exemplary implementations, inserter body 1154 may comprise a distal portion 11544 extending generally axially along axis 12, and a proximal portion 11542 adjacent inserter head 1152 and biased to be deflected radially inwardly in an unstressed configuration. In other words, proximal portion 11542 of inserter body 1154 may be disposed radially inwardly from longitudinal axis 12 in an unstressed configuration and, upon displacement from the unstressed configuration, i.e., for example, transition to the stressed configuration, proximal portion 11542 may be displaced to longitudinal axis 12 or may be displaced radially outwardly beyond longitudinal axis 12, according to some embodiments. Proximal portion 11542 is biased to be deflected radially inwardly, according to some embodiments. Additional implementations may have alternative inserter 115 stressed and unstressed configurations, e.g., biased towards alternative axis, without deviating from the scope of the present disclosure. It is noted that, for the purposes of this description, when inserter 115 is disposed away from its unstressed configuration, it assumes a stressed configuration and is biased towards the unstressed configuration thereof, according to some embodiments.

[0143] In the exemplary implementations, of Figs. 7A-7C and Figs. 8A-8C anchor delivery system 10 is arranged in the first operative orientation; in the exemplary implementations of Figs. 9A-9D anchor delivery system 10 is arranged in the second operative orientation; and in the exemplary implementation of Figs. 10A-10D anchor delivery system 10 is arranged in the third operative orientation.

[0144] Turning now to the exemplary implementation of Figs. 7A - 7C, anchor delivery system 10 is arranged in the first operative orientation and delivery of a surgical tool is enabled while inserter 115 is in a stressed form and distal advancement of inserter 115 relative to the sheath 150 is prevented.

[0145] In Fig. 7C it is seen that inserter head 1152 is supported between handle 100 and sleeve 125, according to some embodiments. For example, inserter head 1152 is partially supported by sleeve recess 1258 and an outer circumference of handle body 1004, according to some embodiments. Inserter head 1152 may, for example, partially abut the perimeter of recess 1258, for example, at rim 12582, recess proximal end 12581, etc., and on an inward side of inserter head 1152 may abut and be biased towards handle 100, according to some embodiments. The portion of handle body 1004 supporting inserter head 1152 may be a portion proximal to handle groove 1006, according to some embodiments. Generally, while inserter head 1152 is supported between handle 100 and sleeve 125 in the first operative orientation, at least one surgical tool such as obturator 102 (Fig. 7A), drill 104 (Fig. 8A), etc., or combinations thereof may be delivered through main channel 1010 of the handle 100, first channel 1506 of the sheath 150 and into the specific target site, according to some embodiments.

[0146] Turning back now to Fig. 7A-7C, a distal end 1024 of obturator 102 extends past distal end of sheath 150 and an obturator head 1022 extends proximally past handle head 1002, according to some embodiments. In some implementations, handle neck 10022 is not received into sleeve 125 since it has a greater circumference than inner circumference of bore 1254 of the sleeve 125, according to some embodiments. This limits axial displacement of handle 100 relative to the sleeve 125. In other implementations, handle head 1002 has a greater circumference than inner circumference of bore 1254 of the sleeve 125, according to some embodiments. This limits axial displacement of the handle 100 relative to the sleeve 125. In still further implementations, only handle body 1004 of handle 100 is configured to be slidably received into bore 1254 of the sleeve 125. In yet further implementations, handle head 1002 and handle neck 10022 may be configured for a user to grip and hold during the surgical procedure.

[0147] Fig. 7C further illustrates obturator 102 being delivered through the anchor delivery system 10, according to some embodiments, where obturator head 1022 of obturator 102 extends proximally past handle head 1002; and the body of obturator 102 extends distally through handle main channel 1010, via sleeve bore 1254 and central gap 1260, and through sheath first channel 1506 and extends past sheath distal end 1504. Notably, obturator 102 is inserted through the anchor delivery system 10, that is, it may slide, rotate, or otherwise move with respect to anchor delivery system 10, according to some embodiments. Concurrent to obturator 102 insertion, sliding, delivery, and any other intermediate actions to deploy the obturator to the desired anatomical site, it is specifically seen in Fig. 7C that the inserter head 1152 is supported between sleeve 125 and handle 100, with inserter body 1154 extending distally from sleeve recess 1258, through handle groove 1006, handle recess 1008, handle groove 1012, sleeve inserter gap 1262, sheath inserter channel 1508, till inserter distal end 1156 and / or coupled bone anchor ends in sheath inserter channel 1508, according to some embodiments. In further implementations, inserter 115 may be partially supported by at least one of the previously mentioned (at least partial) enclosures it passed through. In yet further implementations, the obturator may be pushed, twisted, slid, or otherwise inserted through anchor delivery system 10 to prepare an anatomical site for bone anchor delivery, while concurrently handle 100 may remain stationary relative to sleeve 125 and at least partially enclosed within sleeve 125.

[0148] More specifically, in the first operative orientation of the anchor delivery system 10, handle knob 1014 may be engaged with handle track 1264 of sleeve 125 at the distal-most end of handle track 1264, according to some embodiments. Alternatively, according to some embodiments, the distal end 1003 of handle 100 is generally received into and abuts a distal end of bore 1254 of sleeve 125 in this first operative orientation of anchor delivery system 10.

[0149] Upon longitudinal axial movement in a proximal direction of handle 100 relative to sleeve 125, anchor delivery system 10 may transition from the first operative orientation to the second operative orientation, according to some embodiments. In certain implementations, the extent of axial movement of handle 100 with respect to sleeve 125 may correspond to the longitudinal length of handle track 1264 of sleeve 125. Furthermore, in place of a knob and track mechanism, the axial motion of handle 100 relative to sleeve 125 may alternatively be modulated by a comparable complementary physical stop, such as retaining grooves, rings, slots, flanges, etc., either on handle 100 or sleeve 125, respectively, according to some embodiments. In exemplary implementations, knob 1014 of handle 100 enables slidable coupling of sleeve 125 to handle 100 and may modulate the extent of possible proximal retraction and / or distal advancement of handle 100 relative to sleeve 125.

[0150] As illustrated in Fig. 7C, bore 1254 of sleeve 125 at least partially and slidably accommodates the handle body 1004, while simultaneously accommodating and or supporting inserter 115 in recess 1258, according to some embodiments. Sleeve recess 1258 may be shaped and configured to allow sleeve 125 to releasably support and accommodate at least the proximal end of inserter 115, e.g., proximal portion 11542 and inserter head 1152, according to some embodiments. While in the first operative orientation, inserter head 1152 is disposed in its stressed configuration, wherein the inserter head 1152 is deflected radially outwardly and prevented from inward radial deflection by the outer circumference of handle body 1004 of handle 100, which is disposed adjacent to handle groove 1006, according to some embodiments.

[0151] Sheath proximal end 1502 is configured to be at least partially received into bore 1256 of sleeve 125, according to some embodiments. Thus, according to some embodiments, main channel 1010 of handle 100 is in communication with central gap 1260 of sleeve 125 and first channel 1506 of sheath 150, and sleeve recess 1258 is in communication with handle recess 1008, inserter gap 1262, and sheath second channel 1508. Generally, according to some embodiments, handle body 1004 is partially to fully received in sleeve 125 in this first operative orientation, e.g., handle body 1004 is partially to fully accommodated in bore 1254 in this first operative orientation. Specifically, the distal end 1003 of handle 100 generally abuts a distal end of bore 1254 of sleeve 125 in this first operative orientation of anchor delivery system 10, according to some embodiments.

[0152] It may be noted that, in the embodiment shown, system 10 includes sheath 150 which is at least partially received into sleeve 125 (see, for example, Figs. 7A-C). It should be appreciated by persons skilled in the art that, alternatively, the sheath and sleeve may be formed as a single integral component, and handle body 1004 may be received in a bore in the single integral component (similar to bore 1254 in sleeve 125 shown, for example, in Figs. 4A-C), according to some embodiments.

[0153] Referencing now Fig. 8A-8C which illustrates another exemplary implementation of anchor delivery system 10 in the first operative orientation where drill 104 is inserted through the anchor delivery system 10. In exemplary implementations, drill proximal end 1042 extends proximally past handle 100, and upon delivery drill distal end 1044 extends past sheath distal end 1504. As in the above-mentioned implementations with obturator 102, drill 104 may be pushed, twisted, drilled, punched, etc., according to some embodiments, to facilitate preparation of the anatomical site for inserter 115 and bone anchor delivery. Drill 104 extends through and may be moveable relative to the main channel 1010 of handle 100, sleeve through bore 1255 and central gap 1260, and through sheath first channel 1506, according to some embodiments. Thus, in the first orientation, obturator 102, drill 104, or another surgical tool may be delivered without requiring axial movement of handle 100 relative to sleeve 125, sheath 150, or inserter 115, according to some embodiments.

[0154] Moving now to Fig. 9A-9D, there is illustrated anchor delivery system 10 arranged in the second operative orientation, according to some embodiments, where inserter 115 is allowed to transition from stressed to unstressed configuration, i.e., where inserter head 1152 may radially deflect inwardly. The second operative orientation is achieved, according to some embodiments, by proximally displacing handle 100 relative to sleeve 125 so that inserter head 1152 may now deflect radially inwardly and become coupled with handle 100.

[0155] As illustrated in the cross section of Fig. 9C and Fig. 9D, when sleeve recess 1258 is aligned with handle recess 1008, inserter head 1152 is permitted to deflect radially inward, according to some embodiments. Since inserter 115 is biased towards its unstressed configuration, and in the first operative orientation it is prevented from inward deflection by an outer circumference of handle 100, when sleeve recess 1258 is aligned with handle recess 1008 the inserter head 1152 is free to deflect inwardly into handle recess 1008, according to some embodiments. Handle recess 1008 is located inward relative to sleeve recess 1258, the two recesses reaching alignment and communication after sufficient axial proximal displacement of handle 100 relative to the rest of anchor delivery system 10, e.g., sleeve 125 and inserter 115, according to some embodiments. In other words, upon proximal axial displacement of handle 100, such that handle recess 1008 is arranged to be on an inner circumference of sleeve recess 1258, inserter head 1152 may deflect inwardly and be inserted into the handle recess 1008, according to some embodiments.

[0156] In the exemplary arrangement of the second operative orientation shown in Figs. 9A - 9D, handle 100 is extended proximally relative to sleeve 125. In some implementations, the movement e.g., proximal extension of handle 100 may be modulated by a collet lock, friction, track and knob mechanism such as handle knob 1014 and track 1264, or a combinations thereof. In this exemplary implementation, the proximal end of track 1264 prevents further proximal motion of handle knob 1014. In other implementations, the proximal extension of handle 100 may be modulated frictionally, with snaps, twisting, or other means such that handle 100 can be guided to the configuration that allows inserter head 1152 to radially deflect. In exemplary implementations, inserter head 1152 is biased to be inwardly deflected such that when sleeve recess 1258 is aligned with handle recess 1008 on an inward circumference, inserter head 1152 may deflect from sleeve recess 1258 towards handle recess 1008. Inserter head 1152 is urged inwardly such that when it is allowed to deflect it is supported by handle recess 1008, wherein handle recess 1008 is shaped to support inserter head 1152, according to some embodiments.

[0157] It is noted that in this operative orientation, after inserter head 152 deflects inward into handle recess 1008 and is disposed in its unstressed configuration, inserter 115 is coupled to handle 100 and is configured to be moveable along with the handle 100, according to some embodiments. That is, handle recess 1008 is configured to receive and couple to inserter head 1152, according to some embodiments. Thus, sufficient proximal axial displacement of the handle 100 relative to the sleeve 125 causes handle 100 and inserter 115 to be coupled, according to some embodiments. It is also noted that to align sleeve recess 1258 and handle recess 1008, handle 100 is in a proximal extended configuration, from which handle 100 may be moved distally thereafter, according to some embodiments.

[0158] Referencing now Figs. 10A-10D, there is illustrated an exemplary implementation of anchor delivery system 10 in the third operative orientation, where inserter head 1152 coupled to handle 100 is configured for distal axial displacement. Generally, in the third operative orientation handle 100 is displaced distally relative to sleeve 125, according to some embodiments. This causes distal displacement of inserter 115, according to some embodiments. This allows for anchor delivery, according to some embodiments. Inserter head 1152 is supported by handle recess 1008 and may be displaced distally relative to sleeve 150, according to some embodiments. Inserter head 1152 is secured in handle recess 1008, according to some embodiments. This couples inserter 115 and the bone anchor thereof to handle 100, according to some embodiments. Thus, axial movement of handle 100 distally causes inserter 115 to move distally as well, according to some embodiments. For example, inserter head 1152 may be secured by at least one abutting wall of handle recess 1008, according to some embodiments. Handle recess 1008 may be one of a plurality of shapes, sizes, and depths, complementary to a plurality of shapes, sizes, and depths of inserter head 115, to support and distally advance inserter head 115, according to some embodiments.

[0159] In the second operative orientation, according to some embodiments, after inserter head 1152 deflects inwardly away from sleeve recess 1258, sleeve recess 1258 is empty. Sleeve recess 1258 and groove 1006 remain empty in the third operative orientation, according to some embodiments. The third operative orientation allows for anchor delivery via axial displacement of inserter 115 coupled to handle 100 and generally does not allow for inserter 115 to be uncoupled from handle 100, according to some embodiments.

[0160] Cross-section 10C illustrates inserter head 1152 supported in handle recess 1008, according to some embodiments. Detailed view Fig. 10D illustrates an exemplary implementation of inserter head 1152 supported by recess 1008. When inserter 115 is displaced distally, the proximal wall of recess 1008 abuts inserter head 1152 and advances inserter 115 distally upon handle 100 distal advancement, according to some embodiments. Handle 100 may be advanced distally until knob 1014 is prevented from advancement by the distal end of track 1264, according to some embodiments. In further implementations, the distal advancement of handle 100, which is partially received into bore 1254 of sleeve 125 may be prevented at the distal end of bore 1254, or alternatively by the distal end of handle head 1002 which may not be received into bore 1254. Since handle recess 1008 supports inserter head 1152 in the third operative orientation, and knob 1015 is about diametrically opposite handle recess 1008, according to some embodiments, and the distal advancement of knob 1258 corresponds to the advancement of inserter 115.

[0161] To displace the inserter 115 distally out of sheath distal end 1504, handle 100 is advanced distally following the proximal extended configuration of handle 100, to align handle recess 1008 with sleeve recess 1258 in the second operative orientation, according to some embodiments. As handle 100 is advanced distally, distal end 1156 of inserter 115, or coupled bone anchor, may advance distally through the second channel 1508 of the sheath 150, past sheath exiting chamber 1510, and may advance past sheath distal end 1504, according to some embodiments.

[0162] Distal end 1156 of inserter 115 may have one of a plurality of shapes and sizes to accommodate and operably couple to any one of a plurality of bone anchor(s) types, according to some embodiments. For example, distal end 1156 may be forked, pronged, slotted, tapered, clawed, threaded, magnetized, or otherwise shaped or configured to selectively accommodate and operably couple to at least one bone anchor or fixation device, according to some embodiments. In the exemplary implementation illustrated in Fig. 10A, distal end 1156 of inserter 115 has forked end 1156a configured, for example, to selectively accommodate and operably couple to two flexible anchors. Illustrative exemplary implementation methods of delivering two flexible anchors are described further below.

[0163] When handle 100 and inserter 115 are advanced distally, inserter end 1156 extends past sheath distal end 1504 and the operably coupled bone anchor(s) or similar fixation device(s) may be delivered to a desired anatomical site, according to some embodiments. Any sutures exiting the bone anchor may also be tightened after anchor delivery to facilitate tissue repair, according to some embodiments. In additional implementations, more than one bone anchor e.g., hard, soft, or combinations thereof, or similar fixation device(s), may be delivered, for example if more than one bone anchor or similar fixation device is operably coupled to inserter 115. After anchor delivery, inserter 115 may be retracted proximally as handle 100 is retracted proximally since inserter head 1152 remains supported in handle recess 1152, thus handle 100 and inserter 115 remain coupled, according to some embodiments.

[0164] Threading Method for Flexible Bone Anchors

[0165] Turning now towards Fig. 11, 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 operable coupled and selectively accommodated by forked end 1156a of inserter 115 of bone anchor delivery system 10 in the first, second, and third operative orientations, according to some embodiments. In additional implementations, after bone anchor delivery system 10 delivers the two flexible bone anchors, 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 alternative 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.

[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 306 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. 11) 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, according to some embodiments.

[0172] In exemplary implementations, methods may also include: using bone anchor delivery system 10 to optionally prepare the target site by drilling a hole within a bone; and advancing inserter 115 with a flat fork distal end configured such that first flexible anchor 30 may be operably coupled onto the flat fork in the bent orientation and second flexible anchor 40 can be accommodated between first flexible anchor 30 and distal end 1156 of inserter 115 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] Referring now to Figure 12 there is shown a flowchart illustrating a method 3000 of inserting at least one anchor using the device 10 of Fig. 1, according to some embodiments.

[0175] According to method 3000, in a first operative orientation, at 3002, a surgical tool may be deployed to form a bore in a bone, for example, via device 10, including handle 100, sleeve 125, and sheath 150, according to some embodiments. The surgical tool may be, for example, an obturator (such as, for example, obturator 102 shown in Fig. 7C) or a drill (for example, drill 104 shown in Fig. 8C), according to some embodiments. A bore is formed in the bone, for example, by pushing, twisting, drilling, punching, sliding, rotating, or otherwise moving the surgical tool relative to system 10, according to some embodiments. For example, the surgical tool may be deployed through main channel 1010 of handle 100, central gap 1260 of sleeve 125, and first channel 1506 of sheath 150, according to some embodiments.

[0176] While the surgical tool is deployed, an inserter (such as, for example, inserter 115, shown in Fig. 7C or 8C) may be retained in a stressed form in device 10, and distal advancement of inserter 115 relative to the sheath 150 is prevented, according to some embodiments, for example, as discussed herein with regard to Figs. 7C and 8C. The inserter 115 may be partially supported within portions of device 10, according to some embodiments.

[0177] Device 10 may be converted from the first operative orientation to the second operative orientation, for example, by longitudinal axial movement in a proximal direction of handle 100 relative to sleeve 125, according to some embodiments.

[0178] At 3004, in the second operative orientation, inserter 115 is allowed to transition from a stressed to an unstressed configuration, for example, such that inserter head 1152 may radially deflect inwardly and become coupled with handle 100, according to some embodiments. This may be achieved, for example, by aligning sleeve recess 1258 with handle recess 1008, such that inserter head 1152 is deflected radially inward, according to some embodiments. Since inserter 115 is biased towards its unstressed configuration, and in the first operative orientation (for example, as shown in Figs. 7C and 8C), inserter 115 may be prevented from inward deflection, for example, by an outer circumference of handle 100, when sleeve recess 1258 is aligned with handle recess 1008 the inserter head 1152 is free to deflect inwardly into handle recess 1008, according to some embodiments. In other words, for example, upon proximal axial displacement of handle 100, such that handle recess 1008 is arranged to be on an inner circumference of sleeve recess 1258, inserter head 1152 may deflect inwardly and be inserted into the handle recess 1008, according to some embodiments. Once the inserter head 1152 has been inserted into the handle recess 1008, the inserter 115 is effectively coupled to handle 100 and is configured to be moveable along with the handle 100, and handle 100 may be moved distally thereafter, according to some embodiments.

[0179] At 3006, in the third operative orientation, the handle 100 may be displaced distally relative to sleeve 125, according to some embodiments. This causes distal displacement of inserter 115, according to some embodiments. This This allows for delivery of the at least one anchor associated with the inserter 115, according to some embodiments such as, for example, shown in Fig. 10C-D.

[0180] When inserter 115 is displaced distally, the proximal wall of recess 1008 abuts inserter head 1152 and advances inserter 115 distally upon handle 100 distal advancement, according to some embodiments. As handle 100 is advanced distally, distal end 1156 of inserter 115, together with at least one coupled anchor, may advance distally through the second channel 1508 of the sheath 150, past sheath exiting chamber 1510, and may advance past sheath distal end 1504, and be deployed out of aperture 1505, together with it associated at least one anchor or fixation device, according to some embodiments.

[0181] At 3008, after delivery of the at least one anchor, suture(s) attached to the anchor(s) may be pulled or otherwise tightened to facilitate tissue repair, according to some embodiments.

[0182] After anchor delivery, inserter 115 may be retracted proximally, for example, either by retracting device 10 proximally, or by retracting handle 100 proximally, since inserter head 1152 remains supported in handle recess 1152, thus handle 100 and inserter 115 remain coupled, according to some embodiments.

[0183] Fig. 13 is a flowchart illustrating a method 4000 of tissue repair by a sandwich technique, according to some embodiments. Method 4000 may be facilitated, for example, by device 10 or any other suitable anchor insertion device, and may be performed, for example, utilizing first anchor 30 and second anchor 40 (Fig. 11), or bone anchor 2510 and retaining anchor 2530 (Fig. 26), or any other suitable pair of anchors, according to some embodiments.

[0184] According to method 4000, at 4002, a target site may be prepared by forming a bore within a bone, according to some embodiments. The bore may be formed, for example, using device, for example, by pushing, twisting, drilling, punching, sliding, rotating, or otherwise moving a surgical tool such as, for example, an obturator 102 (for example, as shown in Fig. 7C) or a drill 104 (for example, as shown in Fig. 8C) relative to system 10, according to some embodiments.

[0185] At 4004, an inserter, such as, for example, inserter 115 (Fig. 6), may be advanced into the bore in the bone, the inserter having a first anchor operably coupled to a distal end of the inserter, according to some embodiments. The first anchor is inserted into the bone by the advancement of the inserter, according to some embodiments. At least one suture is attached to the first anchor, and to a second anchor is attached to the at least one suture, at a location proximal to the first anchor, according to some embodiments.

[0186] At 4006, the inserter is removed from the surgical site, according to some embodiments. This may be accomplished, for example, by withdrawing device 10 proximally, or by moving handle 100 proximally to move coupled inserter 115 proximally relative to the surgical site, according to some embodiments.

[0187] At 4008, a proximal end of the suture, attached to the first and second anchors, is pulled proximally, according to some embodiments. This tightens the first and second anchors against the bone / tissue, according to some embodiments. According to some embodiments, the second anchor may be converted to a bent orientation, such as, for example, shown in Fig. 27, whereby it is prevented from passage into the drilled hole. For a surgical procedure in which the first and second anchors are flexible bone anchors, soft tissue and / or an artificial material may be secured to bone at a select target site, according to some embodiments.

[0188] In some other exemplary embodiments, such as, for example, in the embodiment of Fig. 11, in which there are two lengths of opposing sutures entering external passageway 410 from opposing ends, this configuration of sutures 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 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 potentially prevents from the thread to be tangled, as it shortens the span of the thread that goes longitudinally through the loops, according to some embodiments.

[0189] Optionally, at 4010, the suture may be secured, for example, by knotting, according to some embodiments. Optionally, excess suture length may be removed such as, for example, by cutting, according to some embodiments.

[0190] 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.

[0191] The terms "comprises,” "comprising,” "includes,” "including,” “having,” and their conjugates mean "including but not limited to.”

[0192] The term “consisting of’ means “including and limited to.”

[0193] 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.

[0194] 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.

[0195] 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.

[0196] 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.

[0197] 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.

[0198] 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. 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.

[0199] 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.

[0200] 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.

[0201] 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.

[0202] “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.

[0203] 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. 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.

[0204] 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.

[0205] “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.

[0206] "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.

[0207] “Typically” or “usually” shall be understood to infer as in most cases, instances, embodiments, or implementations.

[0208] 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.

[0209] 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.

[0210] 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.

[0211] 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.

[0212] 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.

[0213] 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. 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.

[0214] 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.

[0215] 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.

[0216] 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. An anchor delivery system comprising: a first passageway having a first longitudinal axis and a distal exiting chamber having a portion coaxial with the first longitudinal axis, wherein the first passageway is sized and shaped for deployment of a surgical tool for forming a bore in a bone; a second passageway having a second longitudinal axis offset from the first longitudinal axis, wherein the second passageway has a distal portion in communication with the distal exiting chamber; and an inserter positioned within the second passageway, wherein the inserter is flexible all along its length, and wherein the inserter is deployable from the second passageway, through the distal exiting chamber.

2. The anchor delivery system according to claim 1, wherein the inserter is headless.

3. The anchor delivery system according to claim 1, including: a body having a longitudinal axis, wherein the first and second passageways extending through the body and are parallel to the longitudinal axis; and a handle axially movable relative to the body; wherein the system has a retaining state, wherein the inserter is retained between the handle and the body, and an insertion state, wherein the inserter is movable through the second passageway in a distal direction by axial movement of the handle relative to the body in a distal direction.

4. The anchor delivery system according to claim 1 including a body, wherein the system includes only the first passageway and the second passageway extending through the body.

5. The anchor delivery system according to claim 1, including a handle axially movable relative to the second passageway, wherein a portion of the handle is couplable to the inserter and wherein displacement of the handle in a distal direction is operable to deploy the inserter from the second passageway.

6. The anchor delivery system according to claim 1, including: a body having a longitudinal axis, wherein the first and second passageways extending through the body and are parallel to the longitudinal axis; and a handle axially movable relative to the body;wherein the system has a retaining state, wherein the inserter is retained between the handle and the body, and an insertion state, wherein the inserter is movable through the second passageway in a distal direction by axial movement of the handle relative to the body in a distal direction.

7. The system according to claim 6, wherein the body includes: a sleeve having a through bore sized and shaped to at least partially receive the handle therethrough; and a sheath partially received in the sleeve and extending distally therefrom, wherein the sheath includes the first and second passageways.

8. The system according to claim 7, wherein the handle includes a main channel that communicates with the first passageway.

9. The system according to claim 8 wherein, in the retaining state, the main channel and the first passageway are sized and shaped for advancement therethrough of the surgical tool.

10. The system according to claim 8, wherein the inserter is bendable for passage through the exiting chamber.

11. The system according to claim 8, wherein the main channel of the handle and the first passageway are coaxial.

12. The system according to claim 11, wherein the main channel of the handle and the first passageway are sized and shaped for insertion therethrough of one of a drill and an obturator.

13. The system according to claim 6, wherein the inserter has a proximal end including an inserter head having first and second portions, wherein the handle includes a handle recess sized and shaped for retaining the first portion of the inserter head, and wherein the body has a body recess sized and shaped for retaining the second portion of the inserter head; wherein, in the retaining state, the inserter head is positioned proximal to the handle recess and is positioned in the body recess.

14. The system according to claim 13, wherein the handle is axially movable in a proximal direction to convert the system from the retaining state to a priming state, in which the first portionof the inserter head is positioned in the handle recess and the second portion of the inserter head is positioned in the body recess.

15. The system according to claim 14, wherein the handle is axially movable in a distal direction to convert the system from the priming state to the insertion state.

16. The system of claim 6, wherein the inserter is bendable and biased radially inward relative to the handle wherein, in the retaining state, at least a proximal portion of the inserter is stressed radially outward.

17. An anchor delivery system comprising: a. a handle and a recess arranged on a circumference of the handle; b. a sleeve - sized and shaped to at least partially receive the handle therethrough, the sleeve having a through bore having a recess communicating with the through bore; c. a sheath being partially received into the sleeve and extending distally therefrom, the sheath having a first channel and a second channel, the first and second channels being parallel to each other, wherein the main channel of the handle communicates with the first channel of the sheath and the recess of the handle communicates with the second channel of the sheath; d. an inserter having an inserter head at a proximal end thereof, wherein the inserter is at least partially disposed radially between the sleeve and the handle and the inserter head is configured to be radially inwardly deflected upon proximal axial displacement of the handle relative to the sleeve.

18. A method to deliver at least one bone anchor, implemented in a system comprising: a handle having a main channel extending therethrough and a recess arranged on a circumference of the handle; a sleeve having a through bore at least partially receiving the handle therethrough, the through bore having a recess arranged on a circumference thereof; a sheath being partially received into the sleeve and extending distally therefrom, the sheath having a first channel and a second channel, the first and second channels being parallel to each other, wherein the main channel communicates with the first channel and the handle recess and the sleeve recess communicates with the second channel; an inserter having an inserter head at a proximal end thereof and the at least one bone anchor at a distal end thereof, wherein the inserter is at least partially disposed radially between the sleeve and the handle and the inserter head is configured to be radially deflected upon distal axial displacement of the handle relative to the sleeve, comprising the actions of:a. distally advancing a surgical tool through the handle main channel until it at least partially extends distally from a distal end of the sheath; b. proximally retracting the handle relative to the sleeve, to allow the inserter head to deflect inwardly to the handle recess to couple the inserter head to the handle; and c. distally advancing the handle relative to the sleeve, to advance the inserter relative to the sheath, to deliver the at least one bone anchor.

19. An inserter including: a proximal portion having an inserter head; a distal portion sized and shaped for retaining at least one anchor and for insertion of the anchor into a bone; and a bendable section between the proximal portion and the distal portion, wherein the bendable section is configured to bend upon application of force thereto; wherein the inserter is flexible all along its length.

20. The inserter according to claim 19, wherein the inserter is headless.

21. The inserter according to claim 19, wherein the inserter includes a longitudinal axis; wherein the inserter has an unstressed configuration, in which the inserter bendable section is unbent and the inserter head is positioned along the longitudinal axis; and wherein the inserter has a stressed configuration, in which the inserter bendable section is bent and the inserter head is not positioned along the longitudinal axis.

22. The inserter according to claim 19, wherein the inserter includes a longitudinal axis; wherein the inserter has an unstressed configuration, in which the inserter bendable section is bent and the inserter head is not positioned along the longitudinal axis; and wherein the inserter has a stressed configuration, in which the inserter bendable section is bent and the inserter head is positioned along the longitudinal axis.

23. 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.

24. A method utilizing the sandwich configuration of claim 23, 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, thereby securing the second flexible anchor to the soft tissue against the bone.

25. 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; ii. 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.

26. A device for securing a soft tissue or a biocompatible material to a bone, the device including: a bone anchor;a suture, wherein the bone anchor is slidable relative to the suture; and a retaining anchor slidable along the suture toward the bone anchor.

27. A device according to claim 26, wherein one of: the bone anchor includes a passageway extending alongside or through at least a portion of the bone anchor, and the suture extends through the passageway; and the bone anchor is slidingly engaged with the suture.

28. A device according to claim 26, wherein the retaining anchor is at least one of flexible and compressible.

29. A device according to claim 26, wherein the suture retaining anchor includes one of: a plurality of loops through which the suture is extendible; and a plurality of apertures through which the suture is threadable.

30. A device according to claim 26, wherein the bone anchor has a passageway extending therethrough; wherein the suture includes a loop having first and second extensions, the retaining anchor slidably mounted on the loop; wherein one of: the first and second extensions are each configured to extend through the passageway; and the first and second extensions are each configured to be engaged with the bone anchor; and wherein the first extension includes a portion having an aperture, wherein the loop extends through the aperture.

31. A device according to claim 26, wherein the retaining anchor is at least one of: thick enough to cushion the soft tissue or arthroscopic patch or allograft against a pressure applied by the suture to the soft tissue; and tough enough such that the soft tissue or arthroscopic patch or allograft is not damaged by the suture.

32. The device according to claim 26, wherein the bone anchor is configured to be inserted through a hole in the soft tissue or biocompatible material, the retaining anchor sized and / or shaped such that the retaining anchor cannot be passed through the hole.

33. A method for securing a soft tissue or a biocompatible material to a bone, the method including: inserting a bone anchor into a bore in the bone, wherein the bone anchor is slidable relative to a suture, and wherein a retaining anchor is slidable relative to the suture toward the bone anchor; pulling a portion of the suture to secure the soft tissue or biocompatible material relative to the bone.

34. A method according to claim 33, wherein the retaining anchor includes one of: a plurality of loops through which the suture is extendible; and a plurality of apertures through which the suture is threadable; wherein the pulling includes causing the suture to slide through the one of the plurality of loops and the plurality of apertures.

35. A method according to claim 33, wherein the bone anchor includes a passageway extending therethrough; wherein the suture includes a loop having first and second extensions, and the retaining anchor is slidably mounted on the loop; wherein one of: the first and second extensions are each configured to extend through the passageway; and the first and second extensions are each configured to be engaged with the bone anchor; and wherein the first extension includes a portion having an aperture, wherein the loop extends through the aperture.

36. 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.

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