WO2025141577A1

WO2025141577A1 - System and method for forming a bore in a bone and inserting at least one anchor

Info

Publication number: WO2025141577A1
Application number: PCT/IL2024/051227
Authority: WO
Inventors: Kirill DEDUL; Alexander BREYDBURG; Inbal HUVEN; Moshe Eshkol; Shay AZOULAY; Hagay BOTANSKY
Original assignee: TAG Medical Products Corp Ltd
Current assignee: TAG Medical Products Corp Ltd
Priority date: 2023-12-27
Filing date: 2024-12-27
Publication date: 2025-07-03
Anticipated expiration: 2026-06-27

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 is in communication with the distal exiting chamber; and an inserter positioned within the second passageway, wherein the inserter is deployable from the second passageway, through the distal exiting chamber.

Description

SYSTEM AND METHOD FOR FORMING A BORE IN A BONE AND INSERTING AT LEAST ONE ANCHOR

RELATED APPLICATIQN/S

This application claims the benefit of priority of U.S. Provisional Patent Application Nos. 63/615,001 filed on December 27, 2023; 63/619,449 filed on January 10, 2024; 63/717,904 filed on November 08, 2024, the contents of which are incorporated herein by reference in their entirety.

FIELD AND BACKGROUND OF THE INVENTION

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 forming at least one bore in a bone and inserting at least one anchor in each of the at least one bore.

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.

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.

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 selfpunching 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.

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.

SUMMARY OF THE INVENTION

The present invention, in some embodiments thereof, relates to a 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.

According to an aspect of some embodiments of the present invention there is provided an anchor delivery system for forming a bore in a bone and inserting at least one anchor.

According to some embodiments, the system comprises: 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 deployable from the second passageway, through the distal exiting chamber.

According to some embodiments, the anchor delivery system includes 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. According to some embodiments, the system includes 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.

According to some embodiments, 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.

According to some embodiments, the handle includes a main channel that communicates with the first passageway.

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

According to some embodiments, the inserter is bendable for passage through the exiting chamber.

According to some embodiments, the main channel of the handle and the first passageway are coaxial.

According to some embodiments, 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.

According to some embodiments, 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.

According to some embodiments, 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 portion of the inserter head is positioned in the handle recess and the second portion of the inserter head is positioned in the body recess. According to some embodiments, the handle is axially movable in a distal direction to convert the system from the priming state to the insertion state.

According to some embodiments, 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.

According to an aspect of some embodiments of the present invention 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.

According to some embodiments, 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.

According to some embodiments, 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.

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

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 the suture thread proximal end to bend the second flexible anchor, thereby securing the second flexible anchor to the soft tissue against the bone.

According to an aspect of some embodiments of the present invention there is provided an anchor delivery system comprising: a. a handle having a main channel extending therethrough and a recess arranged on a circumference of the handle; b. a sleeve having a through bore sized and shaped to at least partially receive the handle therethrough, the 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.

According to some embodiments, prior to the proximal 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.

According to some embodiments, following the 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.

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.

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.

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

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

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, and the inserted is configured for axial displacement c. a third operative orientation, wherein the inserter is axially displaced.

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

According to some embodiments, the second operative orientation is realized when the handle is retracted proximally relative to the sleeve. According to some embodiments, in the third operative orientation, the inserter is advanced distally after distal displacement of the handle relative to the sleeve.

According to some embodiments, 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.

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 extending axially, wherein the knob of the handle is slidably coupled to the track of the sleeve.

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 of the present invention 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, 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 at least one bone anchor.

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

According to some embodiments, the handle recess is located radially inward relative to the sleeve recess.

According to some embodiments, the inserter head is biased inwards towards the handle. According to some embodiments, the handle recess is configured both to accommodate a portion of the inserter head, and to urge distal axial displacement of the inserter.

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.

According to some embodiments, the distal end of the sheath has a selected one of a plurality of shapes, radii, and configurations to accommodate a selected surgical tool.

According to some embodiments, a material of the inserter is flexible and configured to be radially deflected upon change of pressure thereon in a radial direction.

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

According to some embodiments, the handle knob is slidably coupled with a longitudinally extending track within the sleeve through bore.

According to some embodiments, the at least one bone anchor includes first and second flexible bone anchors, wherein a distal end of the inserter is operably coupled to the first flexible bone anchor and the second flexible bone anchor, both the first and second flexible bone anchors threaded with suture thread, and both the first and second flexible bone anchors configured to bend upon tightening of the suture thread.

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

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

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.

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

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

According to an aspect of some embodiments of the present invention there is provided a system for inserting an anchor into a bore in a bone, the system including: a body having a longitudinal axis, a distal end configured for engaging the bone, and a first passageway extending along the body, wherein the first passageway is parallel to the longitudinal axis; and a first inserter configured to be inserted into the first passageway, the first inserter configured for forming the bore in the bone and for inserting a first anchor into the bore in the bone at a first insertion location.

According to some embodiments, the bore in the bone may be malleted by the first inserter.

According to some embodiments, the body includes a second passageway extending along the body, wherein the second passageway is parallel to the longitudinal axis; the system including a second inserter configured to be inserted into the second passageway, and configured for forming a bore in the bone and for inserting a second anchor into the bone at a second insertion location.

According to some embodiments, the system includes first and second anchors and a suture extending between the first and second anchors.

According to some embodiments, the first and second passageways are connected laterally to allow the suture to extend between the first and second anchors.

According to some embodiments, at least one of the first and second inserters is rigid.

According to some embodiments, the first inserter is structured for mounting a first anchor on an outer surface thereof.

According to some embodiments, the first inserter is configured for back and forth rotational movement to form the bore in the bone.

According to some embodiments, the back and forth rotational movement is limited to 180 degrees.

According to some embodiments, the back and forth rotational movement is limited to 270 degrees.

According to some embodiments, the first passageway has a first cross-sectional profile and wherein one of: the first passageway has a first cross-sectional profile and wherein the first inserter has a second cross-sectional profile which matches the first cross-sectional profile of the first passageway; and the first inserter has a second cross-sectional profile, wherein the first cross-sectional profile does not correspond to the second cross-sectional profile, and wherein the mismatched first and second cross-sectional profiles limit rotation of the first inserter in the first passageway.

According to some embodiments, the first inserter includes a tip having a plurality of projections extending distally for engaging the bone, the tip configured to be rotated about the longitudinal axis to form the bore in the bone. According to some embodiments, the first inserter includes an inserter head having an opening configured for insertion therethrough of the second inserter.

According to some embodiments, the first inserter includes an inserter head and wherein the inserter head is shaped to facilitate gripping of the first inserter for rotation of the first inserter.

According to some embodiments, the body has a longitudinal slit between the first and second passageways, the slit extending distally to the body distal end, the slit configured for passage of at least one suture therethrough between the first and second anchors.

According to some embodiments, the body includes: an outer portion, the outer portion having a distal portion for engaging the bone and aligning a drill with a drilling location on the bone; and an inner portion including the first passageway; wherein the inner portion is sized and shaped to be positioned inside the outer portion.

According to some embodiments, the body includes: an outer portion, the outer portion having a distal portion for engaging the bone and aligning a drill with a drilling location on the bone; and an inner portion including the first and second passageways; wherein the inner portion is sized and shaped to be positioned inside the outer portion.

According to some embodiments, the body includes: a bone engager, coaxial with the body longitudinal axis, for positioning the body relative to the bone; and a third passageway parallel to the longitudinal axis, the third passageway configured for insertion of a drill thereinto; wherein the first, second, and third passageways are disposed radially about the body longitudinal axis; wherein the body is configured to be selectably rotated to align a drilling location with one of the first and second insertion locations.

According to some embodiments, the body is configured to be selectably rotated in at least one of the following sequences: from a first position, in which the third passageway is aligned with a first insertion location for drilling of a first bore in the bone; to a second position, in which the first inserter is aligned with the first insertion location for insertion of the first anchor into the bone; and from a first position, in which the third passageway is aligned with a first insertion location for drilling of a first bore in the bone; to a second position, in which the second inserter is aligned with the first insertion location for insertion of the second anchor into the bone. According to some embodiments, the first, second, and third passageways are disposed at radially equidistant locations apart from each other, about the body longitudinal axis.

According to some embodiments, the body includes a fourth passageway, each of the first, second, third, and fourth passageways are disposed at radially equidistant locations apparat from each other, about the body longitudinal axis.

According to some embodiments, the third passageway has a lateral opening proximal to the body distal end, the third passageway configured for insertion thereinto of a flexible drill.

According to some embodiments, the system includes: a central rod having three stations positioned radially equidistantly around the central rod, the central rod rotatable with the body, wherein each of the stations corresponds to one of a first anchor insertion orientation, a second anchor insertion orientation, and a drilling orientation of the body; and an actuator configured to allow the selectable rotation of the body among the three stations, at which the first, second, and third passageways are aligned with a first insertion location, a second insertion location, and a drilling location, respectively.

According to some embodiments, the central rod includes a recess corresponding to each the station and wherein the actuator includes a lateral rod having a groove configured to mate with a recess on the central rod at each the station.

According to some embodiments, the central rod includes a groove corresponding to each the station and wherein the actuator includes a lateral rod having a recess configured to mate with a groove on the central rod at each the station.

According to some embodiments, the system includes an indicator, at a proximal portion of the body, for indicating which of the first, second, and third passageways is aligned with the bone.

According to some embodiments, the body includes a lateral opening sized and shaped for insertion thereinto of a tool to rotate the first inserters back and forth to form the bore in the bone at the first insertion location.

According to some embodiments, the body includes a lateral opening sized and shaped for insertion thereinto of a tool to rotate at least one of the first and second inserters back and forth to form, for each of the at least one of the first and second inserters, a bore in the bone at a respective one of the first and second insertion locations.

According to some embodiments, the lateral opening has a hexagonal cross-sectional profile configured for receiving a hexagonal- shaped tool. According to some embodiments, the lateral opening has a cross-sectional profile which allows back and forth rotation of the tool and which limits rotation of the tool to a preselected range of rotation.

According to some embodiments, the rotation of the first inserter back and forth to form the bore in the bone is limited by the limited rotation of the tool.

According to an aspect of some embodiments of the present invention there is provided 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.

According to some embodiments, 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.

According to some embodiments, the retaining anchor is at least one of flexible and compressible.

According to some embodiments, 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.

According to some embodiments, 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.

According to some embodiments, 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. According to some embodiments, 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.

According to an aspect of some embodiments of the present invention there is provided a method for inserting at least a first anchor into a bone, comprising: engaging the bone with a body having a longitudinal axis and a first passageway extending along the body, wherein the first passageway is parallel to the body longitudinal axis; and forming a first bore in the bone by engaging the bone with a first inserter extending through the first passageway, the first inserter having a first anchor mounted on a distal portion thereof, and inserting the first anchor into the first bore simultaneously with forming the first bore.

According to some embodiments, the body includes a second passageway extending along the body, wherein the second passageway is parallel to the body longitudinal axis; and forming a second bore in the bone by engaging the bone with a second inserter extending through the second passageway, the forming a second bore in the bone being performed simultaneously with forming the first bore in the bone; wherein the second inserter has a second anchor mounted on a distal portion thereof; and inserting the second anchor into the second bore simultaneously with forming the first and second bores.

According to some embodiments, the inserting includes inserting first and second anchors having a suture extending therebetween.

According to some embodiments, the forming includes applying pressure to the bone by one of hammering and torsion applied at a proximal portion of the first inserter.

According to some embodiments, the forming and inserting includes: aligning a drilling passageway with a first insertion location on the bone; forming the first bore in the bone at the first insertion location; aligning the first passageway with the first bore and inserting the first anchor into the first bore; aligning the drilling passageway with a second insertion location on the bone; forming a second bore in the bone at the second insertion location; and aligning the second passageway with the second bore and inserting the second anchor into the second bore.

According to some embodiments, the forming and inserting includes: aligning a drilling passageway with a first insertion location on the bone; forming a first bore in the bone at the first insertion location; aligning the first passageway with the first bore and inserting the first anchor into the first bore; aligning the drilling passageway with a second insertion location on the bone; forming a second bore in the bone at the second insertion location; and aligning the second passageway with the second bore and inserting the second anchor into the second bore.

According to some embodiments, the first and second passageways and the drilling passageway are disposed at radially equidistant locations apart from each other, about the body longitudinal axis.

According to some embodiments, each of the aligning a drilling passageway with a first insertion location on the bone, aligning the first passageway, aligning the drilling passageway with a second insertion location on the bone, and aligning the second passageway includes selectably rotating the body to an orientation at which one of the drilling passageway, the first passageway, and the second passageway is located at a position corresponding to one of the first insertion position and the second insertion position on the bone.

According to some embodiments, the forming of each of the first and second bores in the bone includes applying to a portion of the body a back and forth twisting motion in a plane parallel to the body longitudinal axis, the back and forth twisting motion convertible to a back and forth rotational motion of the first and second inserters to form the bores in the bone.

According to an aspect of some embodiments of the present invention there is provided 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.

According to some embodiments, there is provided a method, 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.

According to some embodiments, 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.

According to some embodiments, the biocompatible material is selected from an arthroscopic patch, an allograft, and a bone plate.

According to an aspect of some embodiments of the present invention there is provided a system for inserting an anchor into a bone, the system including: a body having a longitudinal axis and a first passageway for passage therethrough of one of a bone tool and an implant manipulation tool; wherein the first passageway extends along the body and is parallel to the longitudinal axis; and wherein the body includes a bone engager, coaxial with the body longitudinal axis, for positioning the body relative to the bone, wherein the body is configured to be selectably rotated about the bone engager to align the first passageway with one of at least first and second insertion locations.

According to some embodiments, the one of a bone tool and an implant manipulation tool includes one of: a drill for forming a bore in the bone; an obturator for forming a bore in the bone; and an inserter for forming a bore in the bone and for inserting at least one anchor into the bore.

According to some embodiments, the system includes at least a second passageway extending along the body, wherein each of the at least a second passageway is parallel to the longitudinal axis, and wherein each of the at least a second passageway is sized and shaped for insertion thereinto of a one of a bone tool and an implant manipulation tool.

According to some embodiments, the at least a second passageway includes second and third passageways; wherein the first, second, and third passageways are disposed at positions 120 degrees radially apart about the body longitudinal axis.

According to an aspect of some embodiments of the present invention there is provided a system for inserting a first anchor into a first bore in a bone, the system including: a body having a longitudinal axis, a distal end configured for engaging the bone, and a first passageway extending along the body, wherein the first passageway is parallel to the longitudinal axis; and a first inserter configured to be inserted into the first passageway, the first inserter configured for forming the first bore in the bone at a first insertion location and for inserting the first anchor into the first bore in the bone at the first insertion location; wherein the body includes a lateral opening sized and shaped for insertion thereinto of a tool to rotate the first inserter back and forth to form the first bore in the bone at the first insertion location.

According to some embodiments, the body includes a second passageway extending along the body, wherein the second passageway is parallel to the longitudinal axis; the system including a second inserter configured to be inserted into the second passageway, and configured for forming a second bore in the bone at a second insertion location and for inserting a second anchor into the bone at the second insertion location; wherein the system is configured such that the tool inserted into the lateral opening rotates the second inserter back and forth to form the second bore in the bone at the second insertion location, simultaneously with rotating the first inserter back and forth.

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.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) 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. In the drawings:

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

Figs. 3 A - 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;

Figs. 5 A - 5C are multiple views of an exemplary implementation of the sheath, where Fig. 5A illustrates a side perspective view, Fig. 5B illustrates 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;

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

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;

Figs. 8 A - 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. 8 A 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;

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; Figs. 10A - 1OD, 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. IOC 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. IOC, according to some embodiments;

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;

FIG. 12A is a perspective view of a system, according to some embodiments n;

FIG. 12B is a perspective view of a system, according to some embodiments;

FIG. 13 A is a cross-sectional view of the system of Fig. 1A, taken in the direction of arrows 13A-13A therein, according to some embodiments;

FIG. 13B is a perspective view of a distal end of the system of Fig. 12A, showing anchors therewithin, according to some embodiments;

FIG. 13C is a perspective view of the distal end of the system of Fig. 12A, wherein a needle has been extended, according to some embodiments;

FIG. 14 is a side view of a portion of an inserter having an anchor mounted thereon, according to some embodiments;

FIG. 15 is a perspective view of a system according to according to some embodiments;

FIGs. 16A-B are perspective view of inner and outer portions, respectively, of the system of Fig. 15, according to some embodiments;

FIG. 17 is a perspective view of the distal end of an inserter, according to some embodiments;

FIG. 18 is a perspective view of a system, according to some embodiments;

FIG. 19 is a perspective view of a distal portion of the system of Fig. 18, according to some embodiments;

FIG. 20A-B are schematic representations of a cross-section of the system of Fig. 18, taken in the direction of arrows 20AB-20AB therein, according to some embodiments;

FIG. 21 is a perspective view of a proximal portion of the system of Fig. 18, according to some embodiments;

FIG. 22A is a perspective view a portion of a system, according to some embodiments;

FIG. 22B is a cross-sectional view of the portion of the system of Fig. 22A, taken in the direction of arrows 22B-22B therein, according to some embodiments; FIG. 22C is an offset cross-sectional view of the portion of the system of Fig. 11 A, taken in the direction of arrows 22C-22C therein, according to some embodiments;

FIGs. 23A-B are cross-sectional views of anchors which have been implanted in tissue, using the system, according to some embodiments;

FIG. 23C is a perspective view of a shoulder joint after implantation of anchors, using the system, according to some embodiments;

FIG. 24 is a flow chart illustrating a method for forming at least one bore in a bone and inserting an anchor in each of the at least one bore, according to some embodiments;

Fig. 25 is a perspective view of an inserter on which there is mounted a device, according to some embodiments;

FIG. 26 is a side view of a device, according to some embodiments;

FIG. 27 is a schematic view of the device of Fig. 26 after deployment of the bone anchor portion thereof through a soft tissue and into a bone, according to some embodiments;

FIG. 28 is a flowchart illustrating a method of inserting at least one anchor using the device of Fig. 1, according to some embodiments; and

Fig. 29 is a flowchart illustrating a method of tissue repair by a sandwich technique, according to some embodiments.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

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 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.

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.

Definitions

The term “coupled,” and its various forms such as “operably coupling,” "coupling" or "couplable,” refers to and comprises any direct or indirect, structural coupling, connection or attachment, or 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 coupling through an intermediary member or adhesive, or abutting and otherwise resting against, whether frictionally or by separate means without any physical connection. “Operably coupled” refers to the joining of two members directly or indirectly to one another. Such joining may be stationary in nature or moveable in nature. Such joining may be achieved 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.

The term “moveably” coupled means that two components are attached to each other, perhaps via one or more other components, such that one or both of the two components may move. Additionally, the term “moveably coupled” refers 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 horizontally, vertically, slidably, translationally, rotatably, or any combination thereof. In yet other words, the term “moveably coupled” refers to a situation 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 here 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 items that are in direct physical contact with each other, although the items may (or may not) be attached, secured, fused, or welded together.

The term "system" shall also be taken to include any collection of systems or sub-systems that individually or jointly may execute a set, or multiple sets, of one or more functions. Also, the term "system" refers to 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.

“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 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.

"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 as the terms, "including,” "having,” “containing,” and their derivatives.

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

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 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.

A “target site” is a predefined location or area delineated by 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 the terms ‘anatomical site,’ ‘desired location,’ ‘predetermined location,’ ‘repair site,’ etc.

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 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 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.

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 e.g., soft bone anchors or hard bone anchors, composed of any combination of a plurality of materials such as metal, bioresorbable polymers, composite materials, suture, etc., and may comprise a plurality of designs, such as 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 a plurality of flexible filament or fiber material designed to securely attach soft tissue (such as 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 the intended surgical repair for a specific thickness, strength, and flexibility.

Overview

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.

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.

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. 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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

According to an aspect of some embodiments there is provided a system for forming at least one bore in a bone, each at a respective insertion location, and inserting at least one anchor into the bore in the bone at each insertion location, respectively. The system may include a generally elongate body having a longitudinal axis, and a distal end configured for engaging a bone. At least a first passageway is formed within the body and extends along the body, wherein the first passageway is parallel to the body longitudinal axis, according to some embodiments. A first inserter may be positioned in or may be inserted into the first passageway, and the first inserter is suitable for forming a bore in the bone and for inserting a first anchor into the bone at a first insertion location, according to some embodiments. Optionally, the bore in the bone may be malleted by the first inserter, according to some embodiments.

The system may include a second passageway extending along the body, the second passageway parallel to the longitudinal axis, and a second inserter configured to be inserted into the second passageway, for forming a bore in the bone and for inserting a second anchor into the bore in the bone, at a second insertion location, according to some embodiments.

The first and second anchors may be mounted on the first and second inserters, respectively, at respective distal ends thereof, according to some embodiments. Optionally, an inserter may include a groove or recess at its distal end for retaining a portion of an anchor. Optionally, an inserter may include a lateral groove extending generally proximally, for retaining a portion of an anchor and allowing the inserter to form a bore in the bone without the anchor interfering in formation of the bore.

A suture may extend between the first and second anchors, according to some embodiments. The first and second passageways may be connected laterally, for example, by a slit extending along the body to the body distal end, such that the body may be considered as having a passageway having a generally figure-8 shape, i.e., in cross-section two circular portions connected by a central bridge. The slit allows the suture to extend between the first and second anchors. In this manner, when the first and second anchors are inserted into the bores formed in the bone, the anchors are connected to each other by the suture. This allows, for example, soft tissue to be attached to the bone via anchors and suture, according to some embodiments. Optionally, there may be more than one suture interconnecting the anchors, for example, two sutures, three sutures or any other number of sutures.

A potential advantage associated with the system according to the invention, in some embodiments thereof, is that the inserters may be utilized both to form the bores in the bone and to insert the anchors into the bores, optionally in a single action for each inserter/anchor.

The inserter may be rigid, according to some embodiments, thereby facilitating application of force to a proximal end thereof. Such proximal force may be applied, for example, by hammering at a proximal end of the inserter such as, for example, at a head of the inserter. Alternatively, torsion forces may be applied to the bone by twisting the inserter back and forth to form a bore in the bone, according to some embodiments. According to some embodiments, a circular bore may be formed by the back and forth twisting motion.

An inserter may include a tip having a plurality of projections extending distally for engaging a bone, according to some embodiments. The tip may be rotated about a longitudinal axis of the inserter to form a bore in the bone. Optionally, the inserter may include a tip having a pair of projections, and a portion of an anchor may be retained in a groove or recess formed between the pair of projections, according to some embodiments.

First and second inserters may be positioned within longitudinally-oriented passageways within the body, and each inserter may include a head to facilitate insertion of the anchors into the bores in the bone, according to some embodiments. The inserter head may have any suitable shape such as, for example, oval, which may facilitate back and forth movement of the inserters for forming the bores in the bone. Alternatively, each of the inserter heads may be hammered to form a bore in the bone and, in the same action, to insert an anchor into the bore, according to some embodiments.

Optionally, a second inserter head has an opening sized and shaped for passage therethrough of a first inserter, according to some embodiments, such that the first inserter head is positioned proximal to the second inserter head. After formation of a bore in the bone and insertion of a first anchor by the first inserter, the first inserter may be removed. Then a second bore in the bone may be formed by the second inserter and a second anchor may be inserted into the second bore, according to some embodiments.

The back and forth twisting motion/torsion applied to each inserter ensures that each inserter is not rotated more than a certain radial amount about its axis, according to some embodiments. Since each inserter may have an anchor mounted thereon and the anchors are connected by at least a single suture, as discussed herein, the back and forth motion/torsion has the potential advantage that the degree of rotation of each anchor may be limited, according to some embodiments. Limiting the amount of rotation may ensure that the sutures between the anchors does not tear and does not get wound around the anchor and/or the inserter, according to some embodiments.

According to some embodiments, the degree of rotation of each inserter during the back and forth motion/torsion may be limited. This may be achieved by providing each inserter with an inserter head which is to be grasped by a user and turned back and forth. By grasping the inserter head, the degrees by which a user may turn the inserter back and forth may be limited, due to the degree by which his wrist can turn while holding the inserter head, according to some embodiments. Also, in the configuration where an inserter head is oval in shape, it is not easy to turn the head more than a certain amount while grasping the head. This may further ensure that the degree of rotation of the inserter will be limited and will therefore not cause the suture between anchors to tear or to get wound around the anchor and/or inserter, according to some embodiments.

Yet another feature which may limit the degree of rotation of each inserter is geometric interference between a portion of an inserter/inserter head and a portion of a passageway. For example, an inserter/inserter head may be provided with a first cross-sectional profile and a passageway may be provided with an inner second cross-sectional profile along at least a proximal portion of its length, where the portion of the inserter/inserter head with the first cross-sectional profile is positioned within the portion of the passageway with the second cross-sectional profile, according to some embodiments. Such a configuration may allow each inserter to be turned back and forth a limited amount before further turning is not possible due to the mismatched cross- sectional profiles, which may cause geometric interference between the inserter/inserter head and the passageway. For example, an inserter head may have a first cross-sectional profile which mates with a socket or socket-like proximal portion of the passageway, the socket or socket-like portion having a second cross-sectional profile, where the first and second cross-sectional profiles are mismatched, according to some embodiments.

According to some embodiments, the system may include at least one needle or toothed or textured surface which may extend distally from the body distal end. The at least one needle or toothed or textured surface may engage the bone to retain the body in position on the bone, according to some embodiments. In embodiments with a needle which may extend distally from the body distal end, there may also be provided a retraction system to retract the needle inside the body, such that the body distal end may be allowed to pass through soft tissue without the needle interfering therewith.

Optionally, the system may include a single inserter utilized to form a bore in a bone and to insert a single anchor into the bore in the bone, as discussed herein. Optionally, a single passageway may be utilized to form a first bore in a bone and to insert a first anchor into the first bore in the bone, and the same single passageway may be utilized to form a second bore in the bone and to insert a second anchor into the second bore in the bone.

According to an aspect of some embodiments the system may include an outer portion to guide drilling of a bore at an anchor insertion site and an inner portion for insertion of the anchor into the bore. The outer and inner portions may be sized and shaped such that the inner portion may nest within the outer portion. The outer portion may have a distal portion for engaging a bone and aligning a drill with a drilling location on the bone. The inner portion may include first and second passageways such that, a bore may be drilled in the bone using the outer portion as a drill guide and then the inner portion may be used for insertion of anchors utilizing inserters inserted into or positioned in the passageways, as discussed herein, according to some embodiments.

According to an aspect of some embodiments there is provided a system for aligning at least one drilling location with at least one respective insertion location. The body of the system may be selectably rotated about a longitudinal axis of the body, to align a drilling location with one of the first and second insertion locations, according to some embodiments. The body may include a bone engager, coaxial with the body longitudinal axis, for positioning the body relative to the bone. A third passageway is formed in the body, parallel to the longitudinal axis, the third passageway configured for insertion of a drill thereinto. The first, second, and third passageways may be disposed radially about the body longitudinal axis, optionally at radially equidistant locations about a central rod coaxial with the body longitudinal axis.

For example, according to some embodiments, the body may be selectably rotated according to the following sequence: First the body may be rotated from a first position, in which the third passageway is aligned with a first insertion location for drilling of a first bore in the bone, to a second position, in which the first inserter is aligned with the first insertion location for insertion of the first anchor into the bone.

Alternatively, according to some embodiments, the body may be selectably rotated according to the following sequence: First, the body may be rotated from a first position, in which the third passageway is aligned with a first insertion location for drilling of a first bore in the bone; to a second position, in which the second inserter is aligned with the first insertion location for insertion of the second anchor into the bone.

Optionally, the body of the system includes a fourth passageway, and each of the first, second, third, and fourth passageways are disposed at radially equidistant locations apparat from each other, about the body longitudinal axis, according to some embodiments.

The third passageway may have a lateral opening proximal to the body distal end, the third passageway intended for insertion thereinto of a flexible drill, according to some embodiments.

According to some embodiments, the system includes a mechanism including a central rod having three stations positioned radially equidistantly around the central rod, and the central rod is rotatable with the body. Each of the stations may correspond to one of a first anchor insertion orientation, a second anchor insertion orientation, and a drilling orientation of the body. An actuator may be provided to allow the selectable rotation of the body among the three stations, at which the first, second, and third passageways are aligned with a first insertion location, a second insertion location, and a drilling location, respectively, according to some embodiments.

The central rod may include a recess corresponding to each station, and the actuator includes a lateral rod having a groove configured to mate with a recess on the central rod at each station, according to some embodiments. Alternatively, the central rod includes a groove corresponding to each station and the actuator may include a lateral rod having a recess configured to mate with a groove on the central rod at each station, according to some embodiments.

The system may include an indicator, at a proximal portion of the body, for indicating which of the first, second, and third passageways is aligned with the bone, according to some embodiments.

According to an aspect of some embodiments, there is provided a system wherein inserters may be rotated back and forth to form respective bores in a bone. The system includes a body having a longitudinal axis, wherein inserters extend parallel to the body longitudinal axis. The body includes a lateral opening sized and shaped for insertion thereinto of a tool for rotating the inserters back and forth to form bores in the bone, for example, as discussed herein, at respective first and second insertion locations. The lateral opening may have a hexagonal cross-sectional profile configured for receiving a hexagonal- shaped tool, according to some embodiments.

The first and second passageways may each have a first cross-sectional profile and each of the first and second inserters may have a second cross-sectional profile which matches the first cross-sectional profile of the respective first and second passageways, according to some embodiments.

According to an aspect of some embodiments, there is provided a method for forming at least one bore in a bone and inserting an anchor into each of the at least one bore in the bone. According to the method, the bone may be engaged with a body having a longitudinal axis and a first passageway extending along the body, wherein the first passageway is parallel to the body longitudinal axis. A first bore may be formed in the bone by engaging the bone with a first inserter extending through the first passageway, according to some embodiments. The first inserter may have a first anchor mounted on a distal portion thereof. The first anchor may be inserted into the first bore, simultaneously with forming the first bore. The anchor may have a suture extending therebetween, according to some embodiments.

The bore may be formed by the inserter by applying pressure to the bone, for example, by hammering or by applying torsion at a proximal portion of the inserter, according to some embodiments.

According to some embodiments of the method, the body may have a second passageway extending therealong, parallel to the body longitudinal axis, and a second bore may be formed in the bone by engaging the bone with a second inserter extending through the second passageway, the second inserter having a second anchor mounted on a distal portion thereof, and the second anchor may be inserted into the second bore simultaneously with forming the second bore.

According to some embodiments, the forming and inserting may include aligning a drilling passageway with a first insertion location on the bone, forming a first bore in the bone at the first insertion location, aligning the first passageway with the first bore, and inserting the first anchor into the first bore. The forming and inserting may additionally include aligning the drilling passageway with a second insertion location on the bone, forming a second bore in the bone at the second insertion location, and aligning the second passageway with the second bore and inserting the second anchor into the second bore, according to some embodiments.

According to some embodiments of the method, the first and second passageways and the drilling passageway may be disposed at radially equidistant locations apart from each other, about the body longitudinal axis.

According to some embodiments of the method, each alignment of a drilling passageway with a first insertion location on the bone, alignment of the first passageway, alignment of the drilling passageway with a second insertion location on the bone, and alignment of the second passageway may include selectably rotating the body to an orientation at which one of the drilling passageway, the first passageway, and the second passageway may be located at a position corresponding to one of the first insertion position and the second insertion position on the bone.

According to some embodiments of the method, the forming of each of the first and second bores in the bone includes applying to a portion of the body a back and forth twisting motion in a plane parallel to the body longitudinal axis. This back and forth twisting motion may be converted to a back and forth rotational motion of the first and second inserters to form the bores in the bone, as discussed herein, according to some embodiments.

An aspect of some embodiments relates to a tissue attachment device for implanting a bone anchor and a retaining anchor, for securing a soft tissue or a biocompatible material such as, for example, an arthroscopic patch or an allograft or a bone plate, to a bone. While the description may relate to securing of a soft tissue to a bone, it should be understood that, alternatively, any suitable biocompatible material may be secured to the bone, as discussed herein. The device includes a bone anchor having a suture threaded therethrough or engaged therewith and a retaining anchor slidably mounted on the suture. The bone anchor may be inserted into a bore in a bone and the retaining anchor may be positioned between the suture and the soft tissue to secure the soft tissue against or relative to the bone anchor. The device may be formed of biocompatible materials.

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.

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.

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.

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, and the retaining anchor may thereby be tightened against the proximal side of tissue as suture extension is pulled proximally. Thereafter, the suture may be tied off or knotted and excess suture material from extension may be removed.

The retaining anchor may be thick enough to cushion soft tissue relative to pressure applied by the suture to the soft tissue when tightened. The retaining anchor may also be tough enough or sturdy enough such that it will not be cut or damaged by the suture.

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.

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, thereby, 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.

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.

According to an aspect of some embodiments, there may be provided a system for forming at least a first bore in a bone and inserting a first anchor into the first bore in the bone. The system includes: a body having a longitudinal axis, a distal end configured for engaging the bone, and a first passageway extending along the body, wherein the first passageway is parallel to the longitudinal axis; and a first inserter configured to be inserted into the first passageway, the first inserter configured for forming the first bore in the bone at a first insertion location and for inserting the first anchor into the first bore in the bone at the first insertion location; wherein the body includes a lateral opening sized and shaped for insertion thereinto of a tool to rotate the first inserter back and forth to form the first bore in the bone at the first insertion location.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways.

System Having a Flexible Inserter

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.

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, thereby 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.

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.

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.

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. 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.

Referencing now Figs. 4 A - 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. 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.

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.

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. 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.

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.

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.

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.

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.

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. 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.

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.

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. 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.

In the exemplary implementations, of Figs. 7A-7C and Figs. 8 A-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.

Turning now to the exemplary implementation of Figs. 7 A - 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.

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.

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, thereby limiting 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, thereby limiting 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. 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.

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.

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. 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.

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.

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.

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.

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.

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.

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.

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.

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 thereby causing distal displacement of inserter 115 and thereby allowing 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, thereby coupling 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.

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.

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.

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.

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.

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. Threading Method for Flexible Bone Anchors

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.

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

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. 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 towards external passageway 410 at the first end 406 of second flexible anchor 40, and length 510 enters 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.

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 bonne 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.

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 from opposing ends until near the center 402, therefore extending in opposing directions; an exiting length of suture extending between external passageway 410 and body 403 of second flexible anchor 40, thereby 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 or 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.

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 that 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.

In some other exemplary orientations, the fact that there are two lengths of opposing sutures entering external passageway 410 from opposing ends causes radial tilting of the second anchor 40 when the proximal end 524 of the suture 50 is tightened, thereby facilitating 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.

Referring now to Figure 28 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.

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. 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.

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.

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.

At 3006, in the third operative orientation, the handle 100 may be displaced distally relative to sleeve 125 thereby causing distal displacement of inserter 115 and thereby allowing 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.

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.

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.

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.

Fig. 29 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.

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.

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.

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.

At 4008, a proximal end of the suture, attached to the first and second anchors, is pulled proximally, thereby tightening 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.

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, thereby facilitating 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.

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.

System Having Two Inserters

Referring now to the drawings, Figure 12A illustrates a system 60 according to some embodiments of the invention. System 60 includes an elongate body 12 having a proximal end 14 and a distal end 16, and extending generally along a longitudinal axis 18. Body 12 may be formed of any suitable material such as, for example, plastic, steel, aluminum, or titanium. The body may be from about 50-150 mm in length and from about 12-40 mm in diameter, according to some embodiments.

A pair of passageways 21 and 22 are formed in body 12, each passageway extending along the body parallel to axis 18. Optionally, body 12 may be formed of metal, for example, such as illustrated in Fig. 13B. It will be appreciated by persons skilled in the art that, optionally, any of the embodiments of the invention shown herein may include a body formed at least partly of plastic and/or metal, as discussed herein.

System includes a pair of generally elongate inserters, namely a first inserter 31 and a second inserter 32, each having a proximal end 24 and 26, respectively, and a distal end (not shown) within passageways 21 and 22, respectively. Inserters 31 and 32 may be formed of any suitable material such as, for example, stainless steel, nickel-titanium (nitinol), or titanium. Inserters 31 and 32 have respective generally flat heads 34 and 36, respectively, and head 34 is provided with an opening 38 sized and shaped to allow inserter 32 to pass therethrough and to enter passageway 22. While inserter heads 34 and 36 are each shown as having an oval shape, this is exemplary only, and it will be appreciated by persons skilled in the art that the inserter heads may have any desired shape such as, for example, round, as shown in Fig. 12B. In Fig. 12A, heads 34 and 36 as shown are oval, which may facilitate applying torsion forces to the bone via the inserters such as, for example, by rotating of the inserters in a back and forth motion, as discussed further herein. Each of heads 34 and 36 may be provided with a groove 35 for facilitating wrapping of at least one suture (for example, suture 54 shown in Fig. 14) which extends proximally from an anchor (for example, anchor 52 shown in Fig. 14) around the head.

It may be noted that, in the embodiment of Fig. 12B, inserters 31 and 32 extend distally, out of passageways 21 and 22, respectively. According to the embodiment of Fig. 12B, only a proximal portion of the inserters 31 and 32 may be guided by passageways 21 and 22. In contrast, in the embodiment of Fig. 12 A, the body 12 includes a wider proximal portion 12a and a narrower distal portion 12b, and passageways 21 and 22 extend distally through narrower distal portion 12b. According to the embodiment of Fig. 12A, the inserters 31 and 32 may be guided along passageways 21 and 22 to positions adjacent a bone.

With reference to Fig. 13A there is shown a cross-sectional view of system 60, wherein it can be seen that within body 12 passageways 21 and 22 are connected along their length by a slit 28, which will be discussed further herein. Slit 28 may be similar in structure and function to the elongated slit described in U.S.S.N. 63/424,114, the disclosure of which is incorporated herein by reference.

Referring now to Figs. 13B-C there is shown the distal end 16 of body 12, which includes openings 41 and 42 at the ends of passageways 21 and 22, respectively, according to some embodiments. In Fig. 2B it can be seen that anchors 51 and 52 are mounted on respective inserters 31 and 32 (Fig. 1A), within passageways 21 and 22, respectively.

With additional reference to Fig. 13C, system 60 may be provided with at least one needle 46 (one of which is shown in Fig. 13C), which may be extended from a needle aperture 44, according to some embodiments. Needle 46 may be provided to allow the body to be retained in a particular position relative to a bone, thereby facilitating insertion of the anchors without movement of the body 12 and, thereby, the inserters, relative to the bone. Alternatively, instead of the needle, the system may be provided with teeth or a textured surface at the body distal end 16, the teeth of textured surface provided to prevent movement of the body 12 relative to the bone.

Referring now to Fig. 14 there is shown a portion of an inserter 32, according to some embodiments. Inserter 32 is provided with a fork-shaped distal end 60 having projections 62 which may extend, for example, approximately 2 mm distally, and a groove 58 extending proximally along one or both sides 56 of the inserter 32, according to some embodiments. An anchor 52 may be mounted on inserter 32 such that it is retained at the fork-shaped distal end 60 of the inserter. A portion of the anchor 52 and suture 54 may rest within groove 58, thereby facilitating insertion and movement of the inserter 32 within passageway 21 (Fig. 13A), according to some embodiments.

It should be noted that anchor 52 (Fig. 14) may have at least one attached suture 54 which may extend from anchor 51 to anchor 52 located in passageway 22 (Fig. 13B), via slit 28 (Fig. 13A), according to some embodiments. The provision of slit 28 may allow anchors 51 and 52, which are connected by at least one suture 54, to be mounted on respective inserters 31 and 32, within respective passageways 21 and 22, and to be inserted into tissue, as discussed herein, according to some embodiments.

According to some embodiments, the system 60 may be preloaded with anchors 51 and 52 being mounted on inserters 31 and 32, respectively, with the inserters positioned within passageways 21 and 22, for example, as shown in Fig. 12A. In this configuration, suture 54 (Fig. 14) between the anchors 51 and 52 extends via slit 28 (Fig. 13A) between passageways 21 and 22.

According to some embodiments, the system according to the invention may allow the forming of a bore in a bone and, at in the same action, the insertion of an anchor into the bore in the bone. Such simultaneous formation of a bore and insertion of the anchor into the bore may obviate the need for aligning an inserter with a bore that has been previously formed in the bone. Such alignment may be difficult to achieve, especially when performing an arthroscopic procedure. It may be noted that simultaneous formation of a bore and insertion of the anchor into the bore may be performed in accordance with any of the embodiments discussed herein.

It may be noted that the bore in the bone may be predrilled or malleted by the inserter.

Optionally, a single inserter such as, for example, inserter 31 or 32, may be utilized to form a bore in a bone and to insert a single anchor into the bore in the bone, as discussed herein, according to some embodiments.

A potential benefit of forming a bore in a bone by applying a back and forth twisting motion/torsion to each inserter is that this may ensure that each inserter is not rotated more than a certain radial amount about its axis, as discussed herein, according to some embodiments. Since the anchors mounted on the inserters may be connected by a suture, according to some embodiments, the back and forth motion/torsion has the potential advantage that the degree of rotation of each anchor may be limited, according to some embodiments. The degree of rotation may be limited to a selected amount in each direction such as, for example, 90 degrees or 135 degrees, i.e., to a total of 180 degrees or 270 degrees. Limiting the amount of rotation may ensure that the sutures between the anchors does not tear and/or does not get wound around the anchor and/or the inserter, according to some embodiments. Another feature which may limit the degree of rotation of the inserters during the back and forth motion/torsion is the inserter head which is to be grasped by a user and turned back and forth. By grasping the inserter head, the degrees by which a user may turn the inserter back and forth may be limited, due to the degree by which his wrist can turn while holding the inserter head. Also, in the case where an inserter head is oval in shape, such as, for example, in the embodiment of Fig. 12A, it is not easy to turn the head more than a certain amount while grasping the head. This may further ensure that the degree of rotation of the inserter will be limited and will therefore not cause the suture between anchors to tear or to get wound around the anchor and/or inserter, according to some embodiments.

Yet another feature which may limit the degree of rotation of each inserter is geometric interference between a portion of an inserter/inserter head and a proximal portion of a passageway. For example, an inserter/inserter head may be provided with a first cross-sectional profile and a passageway may be provided with an inner second cross-sectional profile along at least a portion proximal of its length, optionally at a socket or socket-like proximal portion of the passageway, where the portion with the first cross-sectional profile is positioned within the portion with the second cross-sectional profile, according to some embodiments. For example, an inserter/inserter head may be provided with a hexagonal cross-sectional profile and the respective passageway may be provided with a rectangular inner cross-sectional profile, thereby limiting rotation of inserter/inserter head within the passageway. Other cross-sectional profiles of inserters/inserter heads and respective passageways, according to some embodiments, will be apparent to persons skilled in the art. Such a configuration is discussed further with regard to Figs. 22A-C. Such a configuration may allow each inserter to be turned back and forth a limited radial amount before further turning is not possible due to geometric interference caused by the mismatched cross- sectional profiles.

It should be noted that any of the above-discussed features/configurations which may limit rotation of an inserter may be applied to any of the embodiments discussed herein.

With additional reference to Figs. 23A-B, when it is desired to insert the anchors 51 and 52, the body distal end 16 is positioned on a bone 53 adjacent a location at which the anchors may be inserted, with the openings 41 and 42 of passageways 21 and 22 aligned with the anchor insertion locations, according to some embodiments. Optionally, at least one needle 46 (Fig. 13C) may be extended to retain the body distal end 16 adjacent the insertion locations.

According to some embodiments, head 36 of inserter 32 may be hammered in order to force the inserter distal end 60 against the bone 53, thereby forming a bore 57 in the bone, and thus forcing anchor 52 into the bore. Optionally, if hammering does not form a bore in the bone, such as, for example, if the cortex of the bone 53 is very hard, the inserter 32 may be rotated back and forth by manually turning head 36 back and forth to thereby form the bore 57 in the bone, for example, if necessary, and then the inserter head 36 may be hammered to force the inserter 32 with the anchor 52 mounted thereon into the bore 53. Once the anchor 52 has been forced into the bore 57 that has been formed in the bone, the inserter 32 may be retracted and the anchor 52 will remain within the bore, according to some embodiments.

It may be noted that, since the inserter 32 has a fork-shaped distal end 60 having a pair of projections 62, rotating of the inserter back and forth about its axis will result in a generally circular bore formed in the bone. Optionally, the inserter may have a distal end including any number of projections which are spaced radially around a longitudinal axis of the inserter, thereby resulting in a circular bore being formed in the bone.

After retraction and removal of inserter 32, inserter 31 may be similarly hammered and/or rotated back and forth to form a second bore 59 in the bone 53 for insertion of anchor 51 in a similar manner, according to some embodiments.

It should be noted that suture 54 which extends between anchors 51 and 52 may include free ends 48a and 48b which extend proximally after insertion of the anchors 51 and 52, as shown in Fig. 23A. Pulling of the suture free ends 48a and 48b may allow tissue such as, for example, a tendon 55, to be tightened against the bone 53 as shown in Fig. 23B, according to some embodiments.

Optionally, a third anchor may be inserted into the bone such as, for example, in the shoulder shown in Fig. 23C. The insertion points may define a triangle or any other suitable shape, according to some embodiments. This configuration of three anchors with at least one suture connecting therebetween may better hold a ligament against the bone and may prevent tearing of the ligament, according to some embodiments.

It may be noted that, while Figs. 23A-C may show embodiments having PEEK (polyether ether ketone) anchors, it will be understood by persons skilled in the art that, alternatively, soft anchors may be inserted into bone in a similar configuration, according to some embodiments.

Additionally, it may be noted that a bore may be formed in a bone in a similar manner, using an inserter according to any of the embodiments discussed and/or shown herein, the bore having a depth of from 5-30 mm, according to some embodiments. Considering that bone cortex is generally about 2 mm thick, this will allow the bore to be formed in the bone below the level of the cortex, according to some embodiments. System Having an Outer Shell

With reference to Figs. 15-16B there is shown a system 2100 according to some embodiments of the invention. System 2100 includes an outer shell 2102 having a proximal end 2105 with a proximal opening 2105, a distal end 2107 having distal openings 2106a and 2106b, and a longitudinal axis 2118. Outer shell 2102 may be formed of any suitable material such as, for example, plastic, steel, aluminum, and titanium. Within outer shell 2102 there is an inner body 2112 which is sized and shaped to fit within outer shell 2102. Inner body 2112 may be formed of any suitable material such as, for example, plastic, steel, aluminum, and titanium. Inner body 2112 may be provided with at least one ridge 2134 and outer shell 2102 may be provided with at least one corresponding slit such that, when inner body 2112 is positioned within outer shell 102, passageways 2120 and 2122 are aligned with distal openings 2106a and 2106b of outer shell 2102, according to some embodiments.

Inner body 2112 is provided with passageways 2120 and 2122 extending therealong in which are positioned inserters 2130 and 2132, according to some embodiments. Inserters 2130 and 2132 may be formed of any suitable material such as, for example, steel, nickel-titanium (nitinol), and titanium. Inserters 2130 and 2132 are similar in structure and function to inserters 31 and 32 (Fig. 12A) and similar components thereof will not be discussed again herein. It may be noted that the distal end of system 2100 may be similar in structure and function to the distal end of system 60 (Fig. 13B), having similar components as discussed herein, except that in system 60 inserters 31 and 232 may be housed in body 12 which may be formed of plastic, steel, aluminum, or titanium (Fig. 13B), while in system 2100 the distal ends of the inserters 2130 and 2132 may be housed within a distal portion of the outer shell 2102, which may be formed of plastic, as discussed herein.

Outer shell 2102 may be used as a guide to drill a pair of bores in a bone, according to some embodiments. For example, outer shell distal end 2107 may be positioned on a bone, adjacent a position at which anchors are to be inserted into the bone. A drill (not shown) may be inserted via proximal opening 2104, distally through outer shell 2102, and exit outer shell at distal opening 2106a to drill a first bore in a bone. After the first bore has been drilled, a second bore may be drilled via distal opening 2106b. Then the inner body 2112 may be inserted into outer shell 2102, and anchors mounted on inserters 2130 and 2132 may be inserted into the bores in a manner similar to that discussed herein with regard to system 60 of Fig. 12A, according to some embodiments.

According to some embodiments, a system having an outer shell and an inner body as described herein may allow drilling of a bore in a bone, using the outer shell as a drill guide, and the subsequent insertion of an anchor into the bore, wherein the insertion location, defined by the inner body, may be easily aligned with the bore that was drilled while using the outer shell as a drill guide.

With reference to Fig. 17 there is shown a distal portion of an inserter 2132, according to some embodiments. Inserter 2132 may be rigid and may be provided with a fork-shaped distal end 2160 having projections 2162 which are narrowest at their distal ends 2164. A groove 2158 extending proximally along one or both sides 56 of the inserter 2132 may be provided to facilitate mounting of an anchor thereon such as, for example, that shown in Fig. 14, according to some embodiments. As discussed herein with regard to Fig. 14, an anchor may be mounted on inserter 2132 such that it is retained at the fork-shaped distal end 2160 of the inserter. A portion of the anchor and suture may rest within groove, thereby facilitating insertion and movement of the inserter 2132 within passageway 2120 or 2122 (Fig. 15), according to some embodiments.

A particular feature of some embodiments is that the inserter projections 2162 may be formed with at least one curved portion 2166 between the projections 2162 and a thickened portion 2168 at a proximal end of the projections, opposite the at least one curved portion on the projection. It may be noted that the at least one curved portion 2166 may be located at a location on the inserter 2162 at which the most stress is applied when the inserter is hammered or twisted back and forth against a bone. In contrast to prior art inserters wherein this stress may cause the inserter to break, for example, at the location of the at least one curved portion, the present invention, in some embodiments thereof, may have a potential advantage in that the thickened portion 2168 provided on the projections 2162, opposite the at least one curved portion 2166, may prevent breaking of the inserter due to stress applied to the inserter when it is inserted into bone.

Another feature of some embodiments is that the inserter 2132 may be easily manufactured by machining, as not much material needs to be removed for the groove(s) and narrowing of the projections 2162.

Referring again to Fig. 13A, it should be noted that anchor 52 (Fig. 14) may have at least one attached suture 54 which may extend from anchor 51 to anchor 52 located in passageway 22 (Fig. 13B), via slit 28 (Fig. 13A), according to some embodiments. The provision of slit 28 may allow anchors 51 and 52, which are connected by at least one suture 54, to be mounted on respective inserters 31 and 32, within respective passageways 21 and 22, and to be inserted into tissue, as discussed herein. It may also be noted that the body of any of the embodiments discussed herein may similarly include a slit for allowing anchors to be connected by at least one suture. System Having a Rotatable Body

With reference to Figs. 18-21 there is shown a system 200 according to some embodiments of the invention. System 200 includes body 212 having a proximal end 202; a distal end 204 having distal openings 206a, 206b, and 206c; and a longitudinal axis 218. Body 212 may be formed of any suitable material such as, for example, plastic, steel, aluminum, and titanium.

Body 212 is provided with passageways 220 and 222 extending therealong, parallel to longitudinal axis 218, to respective openings 206a and 206b, and inserters 230 and 232 having respective heads 234 and 236 are positioned in passageways 220 and 222, respectively, according to some embodiments. Inserters 230 and 232 may be formed of any suitable material such as, for example, stainless steel, nickel-titanium (nitinol), or titanium. Inserters 230 and 232 are similar in structure and function to inserters 31 and 32 (Fig. 12A) and similar components thereof will not be discussed again herein.

Body 212 is also provided with a drill passageway 214 having a lateral opening 216 proximal to the body distal end 204, optionally, adjacent the body proximal end 202, the drill passageway extending distally from the body distal end 204, generally parallel to longitudinal axis 218, and terminating at distal opening 206c, according to some embodiments. Optionally, passageway 214 may extend generally parallel to the body longitudinal axis 218 for a portion or most of the length of body 212 and bend radially outwardly so as to terminate at opening 216. Alternatively, passageway 214 may be angled radially outward from body distal end 204 to opening 216. It may be noted that a center point of each of passageways 220 and 220 and drill passageway 214 are located within body 212 at positions approximately 120 degrees radially apart, according to some embodiments, as seen most clearly in Fig. 19.

According to some embodiments, at the distal end 204 of body 212 there is a two-pronged fork 208 which extends distally from a central rod 228, out of the body distal end 204. Fork 208 may include any number of projections such as, for example, two projections (as shown in Fig. 19), and may be utilized to retain the body adjacent an insertion location on a bone, optionally by providing a gripping action at the bone surface. An optional drill 210 may be provided, to be inserted via opening 216, to extend via passageway 214, and to exit passageway 214 via distal opening 206c. When the body 212 is located adjacent the insertion location on the bone, a bore may be drilled by drill 210, according to some embodiments, after which the body 212 may be rotated around axis 218, thereby aligning one of distal opening 206a and 206b with the bore that was drilled, as discussed hereinbelow.

With particular reference to Figs. 20A-B, there is shown a cross-section of the system of Fig. 18, in first and second operative orientations, according to some embodiments. Body 212 may be rotatable for aligning one of three openings 206a-c with a particular site on a bone such as, for example, an anchor insertion site. A mechanism 224 for allowing selective rotation of the body 212 is provided, the mechanism including a lateral rod 242 having a groove 246 near end 248 of lateral rod 242, according to some embodiments. The groove 246 is sized and shaped to mate with one of three recesses 244a-c on central rod 228, as discussed further herein, according to some embodiments.

When in the first operative orientation, shown in Fig. 20A, groove 246 on lateral rod 242 is not engaged with any of recesses 244a-c. In this operative orientation, body 212 is prevented from rotating about central rod 228 due to interference and/or friction between the lateral rod 242 and central rod 228.

An actuator 254, which may be, for example, a button located at a side of the body 212, optionally at the body proximal end 202, may be pressed in the direction indicated by arrow 256. Pressing on actuator 254 causes lateral rod 242 to move downward (in the sense of Fig. 20 A), to the position shown in Fig. 20B, whereat groove 246 on lateral rod 242 mates with one of recesses 244a-c, in this case, recess 244a. In this second operative orientation (Fig. 20B), the body 212 may be rotated about central rod 228 to align one of three openings 206a-c with a particular site on a bone such as, for example, an anchor insertion site. Optionally, the actuator 254 may be spring- loaded, thereby returning the lateral rod 242 to its position in Fig. 20A, so that the body 212 will not rotate, but will remain in the selected position relative to the insertion site, with the selected opening 206a-c aligned with the particular site on the bone.

At the body proximal end 202 there is an indicator button 250 which may, for example, be marked with an arrow, which may be oriented in one of three stations 252a-c, according to some embodiments. When the groove 246 mates with one of the recesses 244a-c, the body 212 may be rotated such that one of the inserter passageways 220 and 222 and drill passageway 204 is positioned over the insertion site, as noted above.

When body 212 has been rotated such that groove 246 on lateral rod 242 mates with recess 244a, as shown in Fig. 20B, the arrow on indicator button 250 may point to one of the stations, for example, station 252a, indicating that the drill passageway 204 is aligned with the insertion site on the bone. When in this orientation, the drill 210 may be operated to drill a bore in the bone at the insertion site, according to some embodiments.

While the system 200 is shown and described hereinabove as having a groove 246 on lateral rod 242 that mates with one of recesses 244a-c, at one of the stations, according to an alternative embodiment, the lateral rod may be provided with a recess that mates with grooves on the central rod, according to some embodiments, thereby allowing alignment of the drill passageway 204 with an insertion site on the bone.

After a bore has been drilled in the bone, and it is desired to rotate the body 212 so that one of the passageways, for example, passageway 220, is aligned with the insertion site, actuator 254, may be pushed, which causes lateral rod 242 to move downward (from its position seen in Fig. 20A to its position seen in Fig. 20B), according to some embodiments. When lateral rod 242 is moved downward, groove 246 on lateral rod 242 again mates with recess 244a, thereby allowing body 212 to be rotated on central rod 228, for example, until the indicator button 250 points to station 252b, for example, indicating that passageway 220 is aligned with the insertion site on the bone, according to some embodiments. Optionally, as noted above, the actuator 254 may be spring- loaded, thereby returning the lateral rod 242 to its position in Fig. 20A, so that the body 212 will not rotate, but will remain in this selected position relative to the insertion site, with the selected opening 206a-c aligned with the particular site on the bone.

In this orientation, inserter 230 may be hammered (or rotated back and forth, as discussed herein) to insert an anchor into the bore in the bone. Drill passageway 204 may then be aligned with a second insertion site and a second bore may be formed in the bone. Passageway 222 may thereafter be aligned with the second insertion site in a similar manner, according to some embodiments.

It may be noted that, in the embodiment of the invention discussed herein with regard to Figs. 18-21, the mechanism described has three stations, each positioned 120 degrees radially apart from the others. However, if desired, system 200 may be provided with a central rod having four equidistantly- spaced recesses and the mechanism may allow for four stations, each positioned 90 degrees radially apart from an adjacent station, according to some embodiments. This may allow a drill and three inserters to be aligned, in turn, with an insertion site, according to some embodiments.

According to some embodiments, the system of the claimed invention, such as that having a mechanism as described herein, allows for selectable positioning of insertion passageways and a drill passageway in alignment with anchor insertion locations, according to some embodiments. This may allow drilling of at least one bore in a bone, using a drill in the drill passageway, and the subsequent insertion of an anchor into each of at least one bore in the bone, wherein the insertion location or locations are automatically aligned with the drilling location or locations. Such a mechanism may be applied to any of the other embodiments discussed herein. System Having Rotatable Hexagonal Inserters

With reference to Figs. 22A-C there is shown a portion of a system 2300 according to some embodiments of the invention. System 2300 includes a body 2312 having a longitudinal axis 2318 and passageways 2320 and 2322 extending therethrough, parallel to the longitudinal axis. Passageways 2320 and 2322 are each formed within a rotatable tube or tubular portion 2340 and 2342, respectively, the tubes each having a first inner cross-sectional profile, according to some embodiments.

A pair of inserters 2330 and 2332 are disposed within passageways 2320 and 2322, respectively. Inserters 2330 and 2332 may be similar in function to inserters 31 and 32 (Fig. 12A) and similar components thereof will not be discussed again herein. It may be noted, however, that inserters 31 and 32 may each have a cross-sectional profile which corresponds to the cross-sectional inner profile of passageways 21 and 22 (Fig. 12A). For example, in Figs. 22A-C, inserters 2330 and 2332 may each have a hexagonal cross-sectional profile, at least at the portion thereof that pass through gears 2350 and 2352 (discussed below) and passageways 2320 and 2322 each have a corresponding inner hexagonal profile, at least at the portions of the gears 2350 and 2352 through which the hexagonal portions of the inserters pass, according to some embodiments. Alternatively, in some embodiments, inserters 2330 and 2332 may each have a first cross-sectional profile and passageways 2320 and 2322 may each have an inner second cross-sectional profile that does not correspond to the cross-sectional profile of inserters 2330 and 2332, , according to some embodiments, as will be discussed further herein.

In the embodiment shown, most clearly seen in Fig. 22B, tubes 2340 and 2342 each have an inner hexagonal cross-sectional profile which corresponds to the hexagonal cross-sectional profile of inserters 2330 and 2332. It will be appreciated by persons skilled in the art that, if desired, any other corresponding cross-sectional profiles such as, for example, rectangular, may be provided to the tubes and inserters of system 2300.

System 2300 may be provided with a mechanism 2310 to facilitate forming a bore in a bone by rotating inserters 2330 and 2332 back and forth, according to some embodiments, as discussed herein. In particular, mechanism 2310 may include gears 2350 and 2352 which are defined on, connected to, or otherwise operationally associated with respective tubes 2340 and 2342, according to some embodiments. Gears 2350 and 2352 may be provided with respective first sets of teeth 2360 and 2362 on outer portions of respective gears 2350 and 2352, the teeth facing outwardly away from respective passageways 2320 and 2322. A second set of teeth 2316 is defined on, connected to, or otherwise operationally associated with a plate 2320 attached to body 2312, teeth 2316 facing toward the gears 2350 and 2352. Teeth 2316 are sized and shaped to engage with teeth 2360 and 2362 between the inserters (2330 and 2332) and plate 2320, according to some embodiments. Gears 2350 and 2352 may be defined on, connected to, or otherwise operationally associated with respective tubes 2340 and 2342, the teeth 2360 and 2362 of respective gears being positioned at locations relative to tubes 2340 and 2342, respectively, such that the gears do not interfere with each other, according to some embodiments. For example, in the embodiment shown, teeth 2360 of tube 2340 are located more distally than teeth 2362 of tube 2342, thereby preventing interference between gears 2350 and 2352. It can be seen, however, that both sets of teeth 2360 and 2362 are positioned so as to engage teeth 2316 on plate 2320, as seen most clearly in Fig. 121B.

On an outer surface of plate 2320 there is an opening 2324 for a tool (not shown) which is configured to be inserted into opening 2324 and rotated about its axis to move teeth 2316 back and forth relative to body 2312, for example, to the right and to the left in the sense of Fig. 121B, according to some embodiments. Optionally, opening 2324 has a hex-shaped cross-sectional profile and a hex-shaped tool (not shown) may be used to move teeth 2316 back and forth, according to some embodiments. When teeth 2316 are moved back and forth, the engagement of teeth 2316 with teeth 2360 and 2362 on gears 2350 and 2352, respectively, causes tubes 2340 and 2342 to be rotated back and forth, in the directions indicated by arrow 2326, according to some embodiments. The back and forth movement of tubes, and consequently inserters 2330 and 2332, will limit the radial extent to which the inserters may be rotated about their respective axes, as discussed herein, according to some embodiments.

Alternatively, according to some embodiments, opening 2324 and the tool (not shown) may have different cross-sectional profiles, such that the tool is prevented from turning within the opening 2324 by more than a predetermined radial amount by geometric interference between the tool and the opening 2324. This may limit rotation of each of inserters 2330 and 2332 by a preselected amount such as, for example, 270 degrees, according to some embodiments. This geometric interference between opening 2324 and the tool which may be inserted thereinto is similar to the geometric interference between inserters and passageways, discussed herein with regard to the embodiment of Fig. 12 A, which may limit the radial degree of rotation of the inserters, according to some embodiments. For example, a tool having a rectangular cross-sectional profile may be inserted into an opening 2324 having a hexagonal inner cross-sectional profile, thereby limiting rotation of tool within the opening 2324. Other combinations of cross-sectional profiles of a tool and opening 2324 will be apparent to persons skilled in the art.

Mechanism 2310 effectively allows application of the back and forth twisting motion in a plane parallel to the body longitudinal axis 2318, and conversion of the back and forth twisting motion to a back and forth rotational motion (in a plane perpendicular to the body longitudinal axis) of the first and second inserters to form the bores in the bone, according to some embodiments.

In order to form a bore in a bone, one of the inserters, for example, inserter 2330, may be pushed down against the bone, and at the same time a tool may be used to move teeth 2316 back and forth, thereby moving teeth 2360 and 2362 on respective gears 2350 and 2352, to rotate inserters 2330 and 2332 back and forth such that the distal ends (not shown) of the inserters 2330 and 2332 form bores in the bone, according to some embodiments, and first and second anchors (not shown in Figs. 22A-C) may be inserted using respective inserters 2330 and 2332, in a manner similar to that discussed with regard to the embodiment of Fig. 12A. Alternatively, a first inserter 2330 only may be utilized to form a first bore in the bone and a first anchor may be inserted using inserter 2330 in passageway 2320, after which inserter 2330 may be removed from passageway 2320. Optionally, a second bore may be formed in the bone in a similar manner, utilizing inserter 2332, either via the first passageway 2320 or via a second passageway 2322, and a second anchor may be inserted into the second bore, according to some embodiments.

According to some embodiments, the system of the claimed invention, such as that discussed herein, wherein torsion applied in one plane may be converted to torsion applied in another plane to inserters, may facilitate forming of bores in a bone. Such a mechanism may be applied to any of the other embodiments discussed herein, according to some embodiments.

Method of Forming at Least One Bore in a Bone and Inserting an Anchor in Each of the at Least One Bore in the Bone

Fig. 24 illustrates a method (2400) for forming a bore in at least one bone and inserting an anchor in each of the at least one bore, according to some embodiments. According to the method, a system, according to any of the embodiments disclosed herein, may be positioned on a bone adjacent a first insertion site (2402). The system may include at least a first inserter having an anchor mounted thereon, as discussed herein. A first bore may be formed in the bone and a first anchor which was mounted on the first inserter may be inserted into the first bore by advancing the first inserter (2404) and twisting the first inserter back and forth to both form the first bore in the bone and insert the first anchor (2406). Alternatively, a first bore may be formed in the bone and a first anchor may be inserted into the first bore by optionally advancing the first inserter until it contacts the bone (2408), and then by hammering the first inserter to both form the first bore in the bone and to insert the first anchor (2410), as discussed herein. Optionally, instead of actions (2404 and 2406) and instead of actions (2408 and 2410), a first bore may be drilled in the bone, such as, for example, if the cortex is thick, as discussed herein, after which a first anchor may be inserted into the first bore using a first inserter, as discussed herein, according to some embodiments.

After the first anchor has been inserted in the first bore, the first inserter may be retracted (2412). If it is desired to form a second bore in the bone and to insert a second anchor into the second bore, the system may, optionally, be repositioned adjacent a second insertion site, according to some embodiments. Alternatively, a second inserter having a second anchor mounted thereon may be positioned/repositioned adjacent a second insertion site, according to some embodiments.

A second bore may be formed in the bone and a second anchor may be inserted into the second bore by advancing the second inserter (2414) and twisting the second inserter back and forth to both form the second bore in the bone and insert the second anchor (2416). Alternatively, a second bore may be formed in the bone and a second anchor may be inserted into the second bore by optionally advancing the second inserter until it contacts the bone (2418), and then by hammering the second inserter to both form the second bore in the bone and to insert the second anchor (2420), as discussed herein. Optionally, instead of actions (2414 and 2416) and instead of actions (2418 and 2420), a second bore may be drilled in the bone, such as, for example, if the cortex is thick, as discussed herein, after which a second anchor may be inserted into the second bore using a second inserter, as discussed herein, according to some embodiments.

It should be noted that, according to some embodiments, the first and second anchors may be attached by a suture, as discussed herein, and that action (2406) or (2410) together with action (2416) or (2420) allows the anchors to be inserted into the bores without the interconnecting suture interfering with formation of the bores and/or insertion of the anchors, as discussed herein.

After the second anchor has been inserted into the second bore, the system, including the second inserter, may be retracted (2422).

Anchor Device Including a Retaining Anchor

With reference to Fig. 25 there is shown an inserter 2502 which may be, for example, similar in structure and function to any of the inserters discussed herein. A device 2500 may be mounted on inserter 2502, as discussed herein, according to some embodiments. Device 2500 may be utilized for securing a soft tissue or a biocompatible material such as, for example, an arthroscopic patch or an allograft or a bone plate, to a bone. Device 2500 may be formed of biocompatible materials and may include an bone anchor 2510 having a suture 2504 threaded through a passageway thereof and a retaining anchor 2530, which may optionally be a buffer, slidingly mounted on the suture 2504, as will be discussed in detail with regard to Figs. 26-27, according to some embodiments. Referring now to Fig. 26, there is shown bone anchor 2510 which may be formed of any biocompatible material, as discussed herein. At least a portion of bone anchor 2510 may be tubular or includes a passageway or inner lumen 2506 extending along at least a portion of the bone anchor, according to some embodiments. Access to passageway or lumen 2506 may be obtained via either of openings 2512 and 2514 which are sized and shaped for passage of at least one suture therethrough, according to some embodiments. Alternatively, instead of the bone anchor 2510 having a passageway 2506 through which the at least one suture may pass, the bone anchor may be slidingly engaged with the suture.

While in the embodiment shown passageway 2506 is shown as a lumen extending within bone anchor 2510, alternatively, the passageway or a portion thereof may be at least partly external to bone anchor 2510, the passageway formed of any suitable material connected to or integrally formed with bone anchor 2510, according to some embodiments. For example, the passageway may be formed by a plurality of loops extending along the outer surface of bone anchor 2510.

According to some embodiments, suture 2504 may extend through passageway 2506, the suture forming a loop 2508 having extensions 2516 and 2518. Extension 2516 may be formed with an aperture 2520 sized and shaped for having a portion of suture 2504 pass therethrough, according to some embodiments.

Device 2500 may also include a retaining anchor 2530 having a patch 2522 and at least one loop or connector 2524 for allowing the retaining anchor 2530 to be slidingly mounted on suture 2504, according to some embodiments. Patch 2522 is optionally formed of a flexible material, and is optionally formed of a compressible material, according to some embodiments. While retaining anchor 2530 is shown as having a pair of loops 2524, alternatively, retaining anchor 530 may be provided with any suitable number of loops or connectors that allow it to slide along suture 2504, according to some embodiments. Alternatively, retaining anchor 2530 may include a plurality of apertures (not shown) through which suture 2504 may slidingly be threaded, allowing retaining anchor 2530 to be slidingly mounted on the suture 2504.

With further reference to Fig. 27, bone anchor 2510 may be deployed, by any of the systems discussed herein or by any suitable deployment device, through an opening 2532 in a soft tissue 2540 and into a bore 2526 in a bone 2528. When bone anchor 2510 is deployed through tissue 2540 and into bore 2526 in the bone 2528, suture loop 2508 may extend from bone anchor 2510, out of bore 2526, and through opening 2532. in tissue 2540, according to some embodiments. Alternatively, tissue 2540 may be secured to bone 2528 by wrapping a portion of suture 2504 around the tissue 2540. According to some embodiments, after the bone anchor 2510 has been deployed and is properly positioned, the suture extension 2518 may be pulled proximally to shorten loop 2508, as the loop slides through passageway 2506. As loop 2508 is shortened, loop 2508 may slide through loops 2524 of retaining anchor 2530 as retaining anchor 2530 moves toward the proximal side 2536 of tissue 2540, and retaining anchor 2530 may thereby be tightened against the proximal side 2536 of tissue 2540 as suture extension 2518 may be pulled proximally, according to some embodiments. Thereafter, the suture 2504 may be tied off or knotted and excess suture material from extension 2518 may be removed, according to some embodiments.

While in the embodiment shown in Figs. 26-27 the suture 2504 is slidable through passageway 2506, alternatively, device 2500 may include a bone anchor which engages a suture, the suture positioned outside the bone anchor, the device configured to tighten the retaining anchor against the tissue as the suture loop is shortened.

The retaining anchor 2530 may be thick enough to cushion soft tissue relative to pressure applied by the suture 2504 when tightened. Retaining anchor 2530 may also be tough enough or sturdy enough such that it will not be cut by the suture 2504.

As the bone anchor 2510 is configured to be inserted through an opening 2532 in the soft tissue 2540 ( or biocompatible material), the retaining anchor 2530 is sized and/or shaped such that the retaining anchor cannot be passed through the opening in the soft tissue.

It should be noted that that provision a device 2500 having bone anchor 2510 and retaining anchor 2530, both of which are slidable relative to suture 2504 may provide an improved device for securing a soft tissue 2540 to a bone 2528 which may potentially reduce pressure on the soft tissue and, thereby, 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.

Additionally, retaining anchor 2530 may potentially provide a cushioning component to the device, whereby force applied to the tissue proximal side 2536 may be distributed across the area of the retaining anchor 2530, according to some embodiments. This may 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 2540 on the tissue proximal side 2536. Depending on the size of the retaining anchor, i.e., the area of the retaining anchor that contacts and may be forced against the tissue, this may significantly reduce pressure and/or stress applied to the tissue, and may potentially prevent damage to tissue, according to some embodiments. While the embodiment described with regard to Figs. 25-27 relates to a retaining anchor 2530 for attaching a soft tissue 2540 to a bone 2528, alternatively, device 2500 may be utilized for attaching an arthroscopic patch or an allograft (not shown) to the bone.

It should be noted that the anchor(s) of any of Figs. 11 and 25-27 may be utilized in any of the systems described herein, according to some embodiments. For example, according to some embodiments, the pair of anchors 30/40 (Fig. 11) or the pair of anchors 2510/2530 (Fig. 26) may be implanted using any of system 10 (Fig. 1), system 60 (Fig. 12A), system 2100 (Fig. 15), system 200 (Fig. 18), or system 2300 (Fig. 22A).

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.

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

The term “consisting of’ means “including and limited to.’

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.

As used herein, the singular form "a,” "an" and "the" include plural references unless the context clearly dictates otherwise.

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.

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. 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.

As used herein, the term “treating” includes 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.

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.

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 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 deployable from said second passageway, through said distal exiting chamber.

2. The anchor delivery system according to claim 1, including 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.

3. The anchor delivery system according to claim 1, including: 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.

4. The system according to claim 3, wherein said 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.

5. The system according to claim 4, wherein said handle includes a main channel that communicates with said first passageway.

6. The system according to claim 5 wherein, in said retaining state, said main channel and said first passageway are sized and shaped for advancement therethrough of the surgical tool.

7. The system according to claim 5, wherein said inserter is bendable for passage through said exiting chamber.

8. The system according to claim 5, wherein said main channel of said handle and said first passageway are coaxial.

9. The system according to claim 8, wherein 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.

10. The system according to claim 3, wherein 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.

11. The system according to claim 10, wherein 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.

12. The system according to claim 11, wherein said handle is axially movable in a distal direction to convert said system from said priming state to said insertion state.

13. The system of claim 3, wherein 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.

14. 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.

15. The inserter according to claim 14, wherein 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.

16. The inserter according to claim 14, wherein 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.

17. 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.

18. A method utilizing the sandwich configuration of claim 17, 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.

19. A system for inserting an anchor into a bore in a bone, said system including: a body having a longitudinal axis, a distal end configured for engaging the bone, and a first passageway extending along said body, wherein said first passageway is parallel to said longitudinal axis; and a first inserter configured to be inserted into said first passageway, said first inserter configured for forming the bore in the bone and for inserting a first anchor into the bore in the bone at a first insertion location.

20. A system according to claim 19, wherein the bore in the bone may be malleted by said first inserter.

21. The system according to claim 19, wherein said body includes a second passageway extending along said body, wherein said second passageway is parallel to said longitudinal axis; said system including a second inserter configured to be inserted into said second passageway, and configured for forming a bore in the bone and for inserting a second anchor into the bone at a second insertion location.

22. The system according to claim 21, including first and second anchors and a suture extending between said first and second anchors.

23. The system according to claim 22, wherein said first and second passageways are connected laterally to allow said suture to extend between said first and second anchors.

24. The system according to claim 21, wherein at least one of said first and second inserters is rigid.

25. The system according to claim 19, wherein said first inserter is structured for mounting a first anchor on an outer surface thereof.

26. The system according to claim 19, wherein said first inserter is configured for back and forth rotational movement to form the bore in the bone.

27. The system according to claim 26, wherein said back and forth rotational movement is limited to 180 degrees.

28. The system according to claim 27, wherein said back and forth rotational movement is limited to 270 degrees.

29. The system according to claim 19, wherein said first passageway has a first cross-sectional profile and wherein one of: said first passageway has a first cross-sectional profile and wherein said first inserter has a second cross-sectional profile which matches said first cross-sectional profile of said first passageway; and said first inserter has a second cross-sectional profile, wherein said first cross-sectional profile does not correspond to said second cross-sectional profile, and wherein said mismatched first and second cross-sectional profiles limit rotation of said first inserter in said first passageway.

30. The system according to claim 19, wherein said first inserter includes a tip having a plurality of projections extending distally for engaging the bone, said tip configured to be rotated about said longitudinal axis to form the bore in the bone.

31. The system according to claim 21, wherein said first inserter includes an inserter head having an opening configured for insertion therethrough of said second inserter.

32. The system according to claim 19, wherein said first inserter includes an inserter head and wherein said inserter head is shaped to facilitate gripping of said first inserter for rotation of said first inserter.

33. The system according to claim 21, wherein said body has a longitudinal slit between said first and second passageways, said slit extending distally to said body distal end, said slit configured for passage of at least one suture therethrough between said first and second anchors.

34. The system according to claim 19, wherein said body includes: an outer portion, said outer portion having a distal portion for engaging the bone and aligning a drill with a drilling location on the bone; and an inner portion including said first passageway; wherein said inner portion is sized and shaped to be positioned inside said outer portion.

35. The system according to claim 21, wherein said body includes: an outer portion, said outer portion having a distal portion for engaging the bone and aligning a drill with a drilling location on the bone; and an inner portion including said first and second passageways; wherein said inner portion is sized and shaped to be positioned inside said outer portion.

36. The system according to claim 21, wherein said body includes: a bone engager, coaxial with said body longitudinal axis, for positioning said body relative to the bone; and a third passageway parallel to said longitudinal axis, said third passageway configured for insertion of a drill thereinto; wherein said first, second, and third passageways are disposed radially about said body longitudinal axis; wherein said body is configured to be selectably rotated to align a drilling location with one of said first and second insertion locations.

37. The system according to claim 36, wherein said body is configured to be selectably rotated in at least one of the following sequences: from a first position, in which said third passageway is aligned with a first insertion location for drilling of a first bore in the bone; to a second position, in which said first inserter is aligned with said first insertion location for insertion of the first anchor into the bone; and from a first position, in which said third passageway is aligned with a first insertion location for drilling of a first bore in the bone; to a second position, in which said second inserter is aligned with said first insertion location for insertion of the second anchor into the bone.

38. The system according to claim 36, wherein said first, second, and third passageways are disposed at radially equidistant locations apart from each other, about said body longitudinal axis.

39. The system according to claim 36, wherein said body includes a fourth passageway, each of said first, second, third, and fourth passageways are disposed at radially equidistant locations apparat from each other, about said body longitudinal axis.

40. The system according to claim 36, wherein said third passageway has a lateral opening proximal to said body distal end, said third passageway configured for insertion thereinto of a flexible drill.

41. The system according to claim 36, wherein said system includes: a central rod having three stations positioned radially equidistantly around said central rod, said central rod rotatable with said body, wherein each of said stations corresponds to one of a first anchor insertion orientation, a second anchor insertion orientation, and a drilling orientation of said body; and an actuator configured to allow said selectable rotation of said body among said three stations, at which said first, second, and third passageways are aligned with a first insertion location, a second insertion location, and a drilling location, respectively.

42. The system according to claim 41 , wherein said central rod includes a recess corresponding to each said station and wherein said actuator includes a lateral rod having a groove configured to mate with a recess on said central rod at each said station.

43. The system according to claim 41, wherein said central rod includes a groove corresponding to each said station and wherein said actuator includes a lateral rod having a recess configured to mate with a groove on said central rod at each said station.

44. The system according to claim 41 , said system including an indicator, at a proximal portion of said body, for indicating which of said first, second, and third passageways is aligned with the bone.

45. The system according to claim 19, wherein said body includes a lateral opening sized and shaped for insertion thereinto of a tool to rotate said first inserters back and forth to form the bore in the bone at said first insertion location.

46. The system according to claim 21, wherein said body includes a lateral opening sized and shaped for insertion thereinto of a tool to rotate at least one of said first and second inserters back and forth to form, for each of said at least one of said first and second inserters, a bore in the bone at a respective one of said first and second insertion locations.

47. The system according to claim 46, wherein said lateral opening has a hexagonal cross- sectional profile configured for receiving a hexagonal-shaped tool.

48. The system according to claim 46, wherein said lateral opening has a cross-sectional profile which allows back and forth rotation of the tool and which limits rotation of the tool to a preselected range of rotation.

49. The system according to claim 48, wherein said rotation of said first inserter back and forth to form the bore in the bone is limited by the limited rotation of the tool.

50. 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.

51. A device according to claim 50, wherein 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.

52. A device according to claim 50, wherein said retaining anchor is at least one of flexible and compressible.

53. A device according to claim 50, wherein 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.

54. A device according to claim 50, 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.

55. A device according to claim 50, wherein 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.

56. The device according to claim 50, wherein 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.

57. A method for inserting at least a first anchor into a bone, comprising: engaging the bone with a body having a longitudinal axis and a first passageway extending along the body, wherein the first passageway is parallel to the body longitudinal axis; and forming a first bore in the bone by engaging the bone with a first inserter extending through the first passageway, the first inserter having a first anchor mounted on a distal portion thereof, and inserting the first anchor into the first bore simultaneously with forming the first bore.

58. The method of Claim 57, wherein the body includes a second passageway extending along the body, wherein the second passageway is parallel to the body longitudinal axis; and forming a second bore in the bone by engaging the bone with a second inserter extending through the second passageway, said forming a second bore in the bone being performed simultaneously with forming the first bore in the bone; wherein the second inserter has a second anchor mounted on a distal portion thereof; and inserting the second anchor into the second bore simultaneously with forming the first and second bores.

59. The method according to claim 58, wherein said inserting includes inserting first and second anchors having a suture extending therebetween.

60. The method according to claim 57, wherein said forming includes applying pressure to the bone by one of hammering and torsion applied at a proximal portion of the first inserter.

61. The method according to claim 57, wherein said forming and inserting includes: aligning a drilling passageway with a first insertion location on the bone; forming the first bore in the bone at the first insertion location; aligning the first passageway with the first bore and inserting the first anchor into the first bore; aligning the drilling passageway with a second insertion location on the bone; forming a second bore in the bone at the second insertion location; and aligning the second passageway with the second bore and inserting the second anchor into the second bore.

62. The method according to claim 58, wherein said forming and inserting includes: aligning a drilling passageway with a first insertion location on the bone; forming a first bore in the bone at the first insertion location; aligning the first passageway with the first bore and inserting the first anchor into the first bore; aligning the drilling passageway with a second insertion location on the bone; forming a second bore in the bone at the second insertion location; and aligning the second passageway with the second bore and inserting the second anchor into the second bore.

63. The method according to claim 62, wherein said first and second passageways and the drilling passageway are disposed at radially equidistant locations apart from each other, about the body longitudinal axis.

64. The method according to claim 62, wherein each of said aligning a drilling passageway with a first insertion location on the bone, aligning the first passageway, aligning the drilling passageway with a second insertion location on the bone, and aligning the second passageway includes selectably rotating the body to an orientation at which one of the drilling passageway, the first passageway, and the second passageway is located at a position corresponding to one of the first insertion position and the second insertion position on the bone.

65. The method according to claim 58, wherein said forming of each of the first and second bores in the bone includes applying to a portion of the body a back and forth twisting motion in a plane parallel to the body longitudinal axis, said back and forth twisting motion convertible to a back and forth rotational motion of the first and second inserters to form the bores in the bone.

66. 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.

67. A method according to claim 66, 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 said pulling includes causing the suture to slide through the one of the plurality of loops and the plurality of apertures.

68. A method according to claim 66, 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.

69. A device according to claim 42, wherein said biocompatible material is selected from an arthroscopic patch, an allograft, and a bone plate.

70. A system for inserting an anchor into a bone, said system including: a body having a longitudinal axis and a first passageway for passage therethrough of one of a bone tool and an implant manipulation tool; wherein said first passageway extends along said body and is parallel to said longitudinal axis; and wherein said body includes a bone engager, coaxial with said body longitudinal axis, for positioning said body relative to the bone, wherein said body is configured to be selectably rotated about said bone engager to align the first passageway with one of at least first and second insertion locations.

71. The system according to claim 70, wherein said one of a bone tool and an implant manipulation tool includes one of: a drill for forming a bore in the bone; an obturator for forming a bore in the bone; and an inserter for forming a bore in the bone and for inserting at least one anchor into the bore.

72. The system according to claim 70, including at least a second passageway extending along said body, wherein each of said at least a second passageway is parallel to said longitudinal axis, and wherein each of said at least a second passageway is sized and shaped for insertion thereinto of a one of a bone tool and an implant manipulation tool.

73. The system according to claim 72, wherein said at least a second passageway includes second and third passageways; wherein said first, second, and third passageways are disposed at positions 120 degrees radially apart about said body longitudinal axis.

74. A system for inserting a first anchor into a first bore in a bone, said system including: a body having a longitudinal axis, a distal end configured for engaging the bone, and a first passageway extending along said body, wherein said first passageway is parallel to said longitudinal axis; and a first inserter configured to be inserted into said first passageway, said first inserter configured for forming the first bore in the bone at a first insertion location and for inserting the first anchor into the first bore in the bone at the first insertion location; wherein said body includes a lateral opening sized and shaped for insertion thereinto of a tool to rotate said first inserter back and forth to form the first bore in the bone at the first insertion location.

75. The system according to claim 74, wherein said body includes a second passageway extending along said body, wherein said second passageway is parallel to said longitudinal axis; said system including a second inserter configured to be inserted into said second passageway, and configured for forming a second bore in the bone at a second insertion location and for inserting a second anchor into the bone at the second insertion location; wherein the system is configured such that the tool inserted into said lateral opening rotates said second inserter back and forth to form the second bore in the bone at the second insertion location, simultaneously with rotating said first inserter back and forth.