WO2025150051A1

WO2025150051A1 - Device, system, and method for securing tissue to a bone

Info

Publication number: WO2025150051A1
Application number: PCT/IL2025/050032
Authority: WO
Inventors: Valeriya SHYLINGOV; Sapir DADON; Faraj SABAG; Inbal HUVEN; Moshe Eshkol; Alexander BREYDBURG; Hagay BOTANSKY
Original assignee: TAG Medical Products Corp Ltd
Current assignee: TAG Medical Products Corp Ltd
Priority date: 2024-01-10
Filing date: 2025-01-10
Publication date: 2025-07-17
Anticipated expiration: 2026-07-10

Abstract

A device for securing of a tissue to a bone, comprising: an anchor configured to be deployed into a bore in a bone, the anchor having a passageway therethrough; and a first suture moveably loaded in the passageway, the first suture including a first loop having first and second extensions that extend from the passageway; wherein the first extension is configured to be passed through the first loop; wherein a tissue securing portion of the first suture is configured to be wrapped around the tissue; and wherein at least one of the first and second extensions is configured to be pulled proximally to shorten the first loop and to secure the tissue to the bone.

Description

DEVICE, SYSTEM, AND METHOD FOR SECURING TISSUE TO A BONE

RELATED APPLICATIONS )

This application claims the benefit of priority of U.S. Provisional Patent Application No. 63/619,461, filed on January 10, 2024, the contents of which are incorporated herein by reference in their entirety.

This application is also related to U.S. Provisional Patent Application No. 63/423,480 filed on November 7, 2022, the contents of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to devices and methods for securing of a tissue to a bone, and more particularly to anchor systems.

BACKGROUND OF THE INVENTION

Various medical procedures require securing a soft tissue, such as tendons or other connective tissues, to a bone. Exemplary procedures are biceps tenodesis or a rotator cuff repair.

The known techniques using the tools known in the art for performing the fixation procedures often require knot tying, which is difficult to perform in an arthroscopic approach. These include techniques as discussed in, for example, US Patent No. 9,345,567.

SUMMARY OF THE INVENTION

The present invention seeks to provide an improved device, system, and method for securing of a tissue to a bone.

According to an aspect of some embodiments there is provided a device for securing of a tissue to a bone, comprising: an anchor configured to be deployed into a bore in a bone, the anchor having a passageway therethrough; and a first suture moveably loaded in the passageway, the first suture including a first loop having first and second extensions that extend from the passageway; wherein the first extension is configured to be passed through the first loop; wherein a tissue securing portion of the first suture is configured to be wrapped around the tissue; and wherein at least one of the first and second extensions is configured to be pulled proximally to shorten the first loop and to secure the tissue to the bone.

According to some embodiments, the anchor is deformable.

According to some embodiments, the tissue is a tendon.

According to some embodiments, at least a portion of the anchor is tubular and defines the passageway, and wherein the first suture is slidable through the passageway.

According to some embodiments, the passageway includes an inner lumen of a portion of the anchor.

According to some embodiments, a portion of the first loop extends through the passageway.

According to some embodiments, the anchor defines a geometric shape having an opening therein and wherein the first loop and the first and second extensions are defined by portions of the first suture that pass through the opening.

According to some embodiments, the first and second extensions are configured to be passed through the passageway in opposite directions.

According to some embodiments, the tissue securing portion is one of the first loop and the first extension.

According to some embodiments, the device includes a second suture movably loaded through the passageway, wherein the second suture configured to provide a frictional component to the first suture.

According to some embodiments, the second suture has a third extension; wherein the third extension is configured to be passed through the first loop,

According to some embodiments, the first suture includes a second loop; wherein the tissue securing portion is the second loop; wherein the first loop is configured to be passed through the second loop prior to passage of the first extension through the first loop; and wherein the second extension is configured to be passed through the first loop; and wherein both the first and second extensions are configured to be pulled proximally to shorten the first and second loops and to secure the tissue to the bone.

According to some embodiments, the first and second extensions of the first suture are configured to be passed through the passageway in a same direction.

According to some embodiments, the second extension is configured to be passed through the first loop.

According to some embodiments, the tissue securing portion is the first loop; the device including a second suture movably loaded through the passageway, the second suture having third and fourth extensions extending from the passageway; wherein the first and second extensions are configured to form at least one winding around at least one of the third and fourth extensions; wherein the at least one winding is configured to be tightened relative to the anchor.

According to some embodiments, the second suture is provided with a slider movable along the third and fourth extensions, the slider configured to be moved distally to tighten the at least one winding relative to the anchor.

According to some embodiments, the slider is a deforming slider.

According to some embodiments, the deforming slider is deformable.

According to some embodiments, the deforming slider has a first orientation, in which the deforming slider extends along a longitudinal axis, and a second orientation, in which the deforming slider has at least one of a bend and a curve.

According to some embodiments, when in the second orientation, the deforming slider has a shape selected from: a w-shape, an n-shape, and a spiral shape.

According to some embodiments, in the first orientation, the deforming slider has a first cross-sectional profile and wherein, in the second orientation, the deforming slider has a second cross-sectional profile and wherein the second cross-sectional profile is larger than the first cross-sectional profile.

According to some embodiments, the deforming slider is configured to increase friction between the second suture and the deforming slider.

According to some embodiments, the deforming slider is configured to prevent at least a first portion of one of the first and second sutures from moving relative to a second portion of the one of the first and second sutures.

According to some embodiments, one of the third and fourth extensions is configured to be pulled to move the slider distally along the third and fourth extensions.

According to some embodiments, one of the third and fourth extensions is provided with a knot to prevent the slider from becoming disengaged from the one of the third and fourth extensions.

According to some embodiments, the slider is tubular.

According to some embodiments, the first extension is configured to be positioned around the tissue and to be threaded through the passageway, thereby forming a second loop around the tissue, prior to passing of the first extension through the first loop. According to some embodiments, the anchor includes at least a second passageway therethrough, the first loop and the first and second extensions configured to be passed through the second passageway.

According to some embodiments, the at least a second passageway includes between one and four passageways.

According to some embodiments, at least a portion of the first suture is configured to extend at least partly alongside a portion of the anchor.

According to an aspect of some embodiments there is provided a device for securing of a tissue to a bone, comprising: an anchor configured to be deployed into a bore in a bone, the anchor having a passageway therethrough; and a first suture moveably loaded in the passageway, the first suture including first and second extensions that extend from the passageway, wherein the first and second extensions of the first suture are configured to be passed through the passageway in a same direction; wherein a tissue securing portion of the first suture is configured to be wrapped around the tissue; and wherein at least one of the first and second extensions is configured to be pulled proximally to secure the tissue to the bone; the device including a second suture movably loaded through the passageway, the second suture having third and fourth extensions extending from the passageway; wherein the second suture is provided with a deforming slider movable along one of the third and fourth extensions; wherein the deforming slider is deformable and wherein the deforming slider has a first orientation, in which the deforming slider extends along a longitudinal axis, and a second orientation, in which the deforming slider has at least one of a bend and a curve; and wherein the deforming slider is configured to increase friction between the second suture and the deforming slider.

According to some embodiments, the first and second extensions are configured to form at least one winding around at least one of the third and fourth extensions; wherein the at least one winding is configured to be tightened relative to the anchor; wherein the deforming slider is configured to be moved distally to tighten the at least one winding relative to the anchor.

According to some embodiments, when in the second orientation, the deforming slider has a shape selected from: a w-shape, an n-shape, and a spiral shape. According to some embodiments, in the first orientation, the deforming slider has a first cross-sectional profile and wherein, in the second orientation, the deforming slider has a second cross-sectional profile and wherein the second cross-sectional profile is larger than the first cross-sectional profile.

According to some embodiments, a system for securing of a tissue comprises the device and an inserter configured to retain the anchor and to insert the anchor into the bore in the bone.

According to some embodiments, the inserter includes a distal recess and a lateral recess configured to retain the anchor on the inserter prior to insertion of the anchor into the bore in the bone.

According to some embodiments, rein the inserter has a longitudinal axis and wherein the lateral recess is oriented perpendicularly relative to the inserter longitudinal axis.

According to some embodiments, the recess includes a first wall oriented at an oblique angle relative to the inserter longitudinal axis.

According to some embodiments, the recess has a second wall oriented at a perpendicular angle relative to the inserter longitudinal axis, the second wall proximal to the first wall.

According to an aspect of some embodiments there is provided a method for securing a tissue, including: inserting an anchor into a bore in a bone, the anchor having a passageway therethrough and a first suture movably loaded in the passageway; wherein the first suture includes a first loop having first and second extensions that extend from the passageway; manipulating a tissue securing portion of the first suture around the tissue; and passing at least one of the first and second extensions through the first loop; pulling at least one of the first and second extensions to shorten the first loop and to secure the tissue to the bone.

According to some embodiments, the pulling includes shortening the first loop.

According to some embodiments, the pulling includes forming a knot in the first suture.

According to some embodiments, a second suture is positioned in the passageway to provide a frictional component to the first suture. According to some embodiments, the second suture includes a third extension and wherein the method includes, before the pulling, passing the third extension through the first loop.

According to some embodiments, the manipulating includes wrapping one of the first loop and the first extension around the tissue.

According to some embodiments, the first suture includes a second loop; wherein the manipulating includes manipulating the second loop around the tissue; wherein the method includes, after the manipulating, passing the first loop through the second loop.

According to some embodiments, the manipulating includes manipulating the first loop around the tissue; wherein the device includes a second suture movably loaded in the passageway, the second suture having third and fourth extensions that extend from the passageway; wherein the method includes, after the passing, forming at least one winding of the first and second extensions around at least one of the third and fourth extensions; and wherein the pulling includes pulling the first and second extensions proximally to shorten the first loop and to secure the tissue to the bone.

According to some embodiments, the method includes, after the pulling, moving a slider distally along the first and second portions of the second suture, to tighten the at least one winding relative to the anchor.

According to some embodiments, the moving the slider includes pulling one of the first and second ends of the second suture.

According to some embodiments, the slider is a deforming slider.

According to some embodiments, the deforming slider increases friction between the second suture and the deforming slider.

According to some embodiments, the deforming slider prevents at least a first portion of one of the first and second sutures from moving relative to a second portion of the one of the first and second sutures.

According to some embodiments, the method includes, prior to the passing at least one of the first and second extensions through the first loop, passing the at least one of the first and second extensions through the passageway thereby forming a second loop; and wherein the second loop is the securing portion.

According to some embodiments, the anchor includes at least one additional passageway, the method including: prior to the passing at least one of the first and second extensions through the first loop, passing each of the first and second extensions and portions of the first loop through the at least one additional passageway; and wherein the pulling includes compressing or deforming the anchor by the suture portions passed through the passageway and the at least one additional passageway.

According to an aspect of some embodiments there is provided a method for securing a tissue, including: inserting an anchor into a bore in a bone, the anchor having a passageway therethrough and a first suture movably loaded in the passageway; wherein the first suture includes first and second extensions that extend from the passageway; manipulating a tissue securing portion of the first suture around the tissue; and pulling at least one of the first and second extensions to secure the tissue to the bone; wherein the device includes a second suture movably loaded in the passageway, the second suture having third and fourth extensions that extend from the passageway; wherein the pulling includes pulling the first and second extensions proximally to shorten the first loop and to secure the tissue to the bone; wherein the device includes a second suture movably loaded in the passageway, the second suture having third and fourth extensions that extend from the passageway; wherein the pulling includes pulling the first and second extensions proximally to secure the tissue to the bone; wherein the method includes, after the pulling, moving a deforming slider distally along the first and second portions of the second suture; and wherein the deforming slider increases friction between the second suture and the deforming slider.

According to some embodiments, the method includes, after the manipulating, forming at least one winding of the first and second extensions around at least one of the third and fourth extensions, wherein the moving the deforming slider distally tightens the at least one winding relative to the anchor.

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 DRAWINGS

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:

FIGs. 1A-F are simplified schematic illustrations of stages of securing and/or retaining of a tissue to a bone, optionally a soft tissue, using a device, in accordance with some embodiments;

FIGs. 2A-F are simplified schematic illustrations of stages of securing of a tissue to a bone using a device, in accordance with some embodiments;

FIGs. 3A-E are simplified schematic illustrations of stages of securing of a tissue to a bone using a device, in accordance with some embodiments;

FIGs. 4A-H are simplified schematic illustrations of stages of securing of a tissue to a bone using a device, in accordance with some embodiments, following performance of the manipulation illustrated in Figs. 3A-E;

FIGs. 5A-I are simplified schematic illustrations of stages of securing of a tissue to a bone using a device, in accordance with some embodiments;

FIGs. 6A-D are simplified schematic illustrations of stages of securing of a tissue to a bone using a device, in accordance with some embodiments.

FIGs. 7A-L are simplified schematic illustrations of stages of securing of a tissue to a bone using a device, in accordance with some embodiments;

FIGs. 7M-0 are simplified schematic illustrations of a deforming slider that may be used in a device for securing a tissue to a bone, the deforming slider having one of a plurality of threading configurations, in accordance with some embodiments;

FIGs. 7P-R are simplified schematic illustrations detailing the plurality of threading configurations for the deforming slider of Figs. M-O, in accordance with some embodiments; FIGs. 7S-U are simplified schematic illustrations, each of a final position of a tendon secured relative to a bone, using the deforming slider of Figs. 7M-O, respectively, in accordance with some embodiments;

FIG. 8A is a side view of device for inserting an anchor into a bone, in accordance with some embodiments;

FIG. 8B is a perspective view of a portion of the device of Fig. 8A, in accordance with some embodiments;

FIG. 8C is an enlarged side view of a portion of the device of Fig. 8A, in accordance with some embodiments;

FIG. 8D is a side view of portions of devices for inserting an anchor into a bone, each having an anchor mounted thereon, in accordance with some embodiments; and

FIGs. 9A-I are simplified schematic illustrations of stages of securing of a tissue to a bone using a device, in accordance with some embodiments.

DETAILED DESCRIPTION OF EMBODIMENTS

Overview

An aspect of some embodiments relates to a device and/or system for securing a tissue such as, for example, a soft tissue such as, for example, a tendon, to a bone. According to some embodiments, the device includes an anchor having a passageway therethrough such as, for example, a lumen extending through at least a portion of the anchor or loops positioned along a portion of the anchor or any other suitable passageway connected to or integrally formed with the anchor. At least one suture may be slidingly threaded through the anchor passageway, for example, via openings in the anchor outer surface, such that the at least one suture may move through the lumen. When a suture moves through the lumen, minimal friction is created between the suture and the inner surface of the lumen or between adjacent sutures within the lumen. The device may be prethreaded and be prepackaged in sterile packaging.

According to some embodiments, the anchor is configured as a closed geometric shape such as, for example, a circle or an oval having an opening through which a suture may be slidingly threaded.

The prethreaded device may include a suture having a loop passing through the passageway and extending out of the lumen, the loop having two extensions which extend out of the anchor.

The device may be inserted into a bore in a bone by using an inserter or an anchor deployment device. Once the device has been inserted, with a portion of the loop and the loop extensions extending out of the bore, a tendon may be secured by wrapping the loop or one of the extensions around the tendon, the extension may be passed through the loop and pulled, thereby shortening the loop and securing the tendon to the bone.

A feature of some embodiments is that friction between overlapping portions of suture within the anchor lumen and/or friction between one or both suture portions and an inner surface of the lumen and/or friction between a suture portion and the loop and/or friction among any of the suture portions and an inner surface of the bore may prevent movement of the suture and thereby prevent the tendon from being released from the secured configuration.

Optionally, at least one additional suture may be threaded through the lumen, thereby further increasing friction among components of the device, thereby preventing movement of the suture relative to the lumen, after securing of the tendon to the bone.

One or both ends of the suture may be pulled to further compress or deform the anchor to prevent it from being released from the bore in the bone. When compressed or deformed, the anchor may assume a c-shaped or a u-shaped configuration of a configuration having a plurality of undulations.

According to some embodiments, the device may be suitable for use in an arthroscopic procedure and, optionally, a knot may be created within the arthroscopic surgical site.

An aspect of some embodiments relates to a device including an anchor having a passageway such as, for example, a lumen, extending through a portion thereof, as discussed herein, and a suture that is slidingly received within the passageway. The suture includes a loop having first and second extensions which extend out of the passageway. At least one additional suture is slidingly threaded in the passageway, thereby increasing the volume of the device, to prevent the anchor from becoming dislodged from the bore in the bone and/or increasing friction among elements of the device, as discussed herein. Any suitable number of additional sutures may be slidingly passed through the passageway, depending on a diameter of the bore in the bone and the width of the anchor being utilized in the procedure.

After insertion of the anchor into a bore in a bone, the loop or a loop extension may be positioned about a tendon to be secured to the bone, and ends of both sutures may be threaded through the loop. An end of the loop extension may be pulled, thereby shortening the loop and securing the tendon to the bone. The loop extensions and additional suture may form a twisted mass of suture material and/or a knot of suture material, optionally within the bore in the bone.

Friction among portions of the sutures within the lumen and/or friction between one or more suture portions and an inner surface of the lumen; and/or friction among suture portions and the loop; and/or friction among any of the suture portions and an inner surface of bore may prevent the tendon from being released from the secured configuration, according to some embodiments.

It is a particular feature of an embodiment that the action of pulling of at least one of the loop extensions may compress or deform the anchor, thereby preventing the anchor from being pulled out of the bore in the bone.

An aspect of some embodiments relates to a device including an anchor having a suture threaded through a passageway thereof such that two suture portions extend out of the passageway, according to some embodiments. The suture may be manipulated by passing ends of the two suture portions through a passageway formed in the anchor, optionally through a passageway defined by a geometric shape of the anchor, to form two loops. A first loop may be wrapped around a soft tissue such as, for example, a tendon, and the second loop may be passed through the first loop. The suture ends may then be passed through the second loop and pulled, thereby causing the loops to shorten and to move the tendon closer to the anchor. Further pulling of the suture ends causes the loops to move into the bore in the bone and to form a twisted mass of suture material and/or a knot between the anchor and the tendon, optionally in the bore, thereby securing the tendon to the bone.

An aspect of some embodiments relates to a device for securing a tissue such as, for example, a tendon, to a bone. The device includes an anchor having a passageway and first and second sutures threaded through the passageway such the first suture forms a loop and two loop extensions which extend out of the passageway. The second suture includes two portions extending out of the passageway, and a slider is positioned on the two portions of the second suture, the slider configured to slide along the two portions of the second suture.

After the device has been inserted into a bore in a bone, the loop and two extensions of the first suture and the two suture portions of the second suture may extend out of the bore. The loop may be positioned around a tissue or other soft tissue to be secured to the bone, and the two portions of the second suture may be threaded through the loop. Pulling on at least one of the portions of the first suture may shorten the loop, thereby urging the tendon closer to the anchor.

The suture portions of the first suture may be wound around at least one of the suture portions of the second suture. Pulling on an end of the second suture, while holding the ends of the first suture, may cause the slider to move toward the anchor, and may also cause the windings to tighten around the suture portion (s) of the second suture, while shortening the loop positioned around the tendon, thereby causing it to be urged closer to the anchor. As the loop shortens and the windings get tighter, this will form a mass of twisted suture portions, optionally within the bore, thereby securing the tendon to the bone. An aspect of some embodiments relates to a device for securing a tissue such as, for example, a tendon, to a bone. The device includes an anchor having a passageway and first and second sutures threaded through the passageway such the first suture forms a loop and two loop extensions which extend out of the passageway. The second suture includes two portions extending out of the passageway, and a slider is positioned on the two portions of the second suture, the slider configured to slide along the two portions of the second suture.

After the device has been inserted into a bore in a bone, the loop and two extensions of the first suture and the two suture portions of the second suture may extend out of the bore. The loop may be positioned around a tissue or other soft tissue to be secured to the bone, and one portion of the second suture may be threaded through the loop. Pulling on at least one of the portions of the first suture may shorten the loop, thereby urging the tendon closer to the anchor.

The suture portions of the first suture may be wound around one of the suture portions of the second suture. Pulling on an end of the second suture, while holding the ends of the first suture, may cause the slider to move toward the anchor, and may also cause the windings to tighten around the suture portion (s) of the second suture, while shortening the loop positioned around the tendon, thereby causing it to be urged closer to the anchor. As the loop shortens and the windings get tighter, this will form a mass of twisted suture portions, optionally within the bore, thereby securing the tendon to the bone.

An aspect of some embodiments relates to a deforming slider which may be included in a device for securing a tissue such as, for example, a tendon, to a bone. A suture threaded through the deforming slider may be pulled, thereby deforming the deforming slider from a straight configuration to a deformed configuration in which the deforming slider is bent and/or curved and has one of a plurality of shapes such as, for example, a w-shape, an n-shape, and a spiral shape. The deforming slider, in the deformed configuration has a larger cross-sectional profile than when in the straight configuration, according to some embodiments. The deforming slider, when in the deformed configuration, may potentially function to increase friction between at least one suture portion and the deforming slider, according to some embodiments. Additionally, when in its deformed configuration, due to the larger cross-sectional profile of deforming slider, as compared with its cross-sectional profile in the straight configuration, the deforming slider may apply pressure to suture portions in the bore in the bone, thereby potentially preventing the suture portions in the bore from moving relative to each other, according to some embodiments. The deforming slider, when in the deformed configuration, may potentially be more resistant to backsliding along the suture and may be locked in place within the bore in the bore, according to some embodiments. An aspect of some embodiments relates to an anchor insertion device having an elongate body and proximal and distal ends. At the distal end a distal recess may be formed between distally extending projections, the distal recess sized and shaped for receiving a portion of an anchor such as, for example, a soft anchor having a circular or oval configuration, according to some embodiments. The inserter also includes a lateral recess sized and shaped for receiving apportion of the anchor, the lateral recess including a distal wall at an angle to the body and a proximal wall disposed approximately at a 90 degree angle to the body.

An anchor such as, any of those discussed herein, may be mounted on the inserter by positioning a portion of the anchor between the distal projections of the distal recess and then inserting a portion of the anchor into the lateral recess, according to some embodiments.

Once securely mounted on the inserter, the inserter may be moved distally into a bore in a bone to insert the anchor into the bore. Withdrawal of the inserter from the bore will allow the anchor portion within the lateral recess to slide over the distal wall, due to its angular orientation relative to the body, thereby being released from the lateral recess, and to be released from the distal recess, such that the anchor will remain within the bore in the bone, according to some embodiments.

An aspect of some embodiments relates to a device for securing a tissue such as, for example, a tendon, to a bone. The device includes an anchor having At least one passageway such as, for example, an inner lumen, and openings into the at least one passageway. Optionally, the anchor includes an additional passageway having openings thereinto. First and second sutures threaded through the at least one passageway such the first suture forms a first loop and two loop extensions which extend out of the passageway. A portion of one of the two loop extensions may be passed through the additional passageway such that it extends along a portion of an outer surface of the anchor The second suture includes first and second portions extending out of the passageway, and the first portions of the second suture includes a terminal loop.

After the device has been inserted into a bore in a bone, the first loop and two extensions of the first suture and the two suture portions of the second suture may extend out of the bore. A portion of the first suture may be positioned around a tissue or other soft tissue to be secured to the bone, and threaded through the terminal loop on the first portion of the second suture. Pulling on the second portion of the second suture may cause the second suture, with the first suture portion threaded through the terminal loop, to be passed through the passageway, thereby forming a securing loop around the tendon. Then the first suture portion may be removed from the terminal loop of the second suture, and the second suture may be discarded. Pulling the first loop and/or the first loop extensions may cause the securing loop to shorten, thereby causing the tendon to be urged toward the anchor. One of the first loop extensions may be threaded through the first loop and then pulled, thereby causing the first loop to shorten, while the same first loop extension forms an additional loop, optionally positioned between the anchor and the tendon. Finally, pulling the first loop extensions proximally may tighten the suture relative to the anchor, as suture portions slide through the lumen and alongside the outer surface of the anchor. This will also cause the tendon to be urged closer to the bone by securing loop.

The provision of multiple suture portions that extend through the anchor passageway(s) and/or along the outside surface of the anchor allow the device to secure the tendon to the bone. A particular feature of some embodiments is that the tendon may be secured in positioned relative to the bone by friction between adjacent suture portions within the lumen, between each suture portion within the lumen and the inner surface of the lumen, and between the loop extension of the first suture and the outer surface of the anchor.

Additionally, the anchor may be compressed or deformed due to the provision of multiple loops or portions of material of the anchor through which suture portions may extend at multiple locations along the anchor. Such compression or deformation of the anchor may potentially increase the amount of force applied by the anchor to inner surfaces of the bore in the bone, thereby potentially better retaining the anchor within the bore in the bone, and potentially better securing the tendon to the bone.

Optionally, any of the anchors discussed herein may be provided with a plurality of lumens through which at least one suture portion may be passed. Alternatively, any of the anchors discussed herein may be provided with, for example, loops or portions of the anchor material or any suitable passageway connected to or integrally formed with the anchor through which at least one of suture portions and first loop may be passed. For example, the first loop extensions may not enter into a lumen of the anchor but instead may pass through a loop or portion of the material or other passageway of the anchor at a location along the anchor, according to some embodiments. . It is to be understood by persons skilled in the art that, similarly, any of the embodiments discussed herein may include one or more passageways formed, for example, of loops or material of the anchor, for example, connected to or integrally formed with the anchor, through which one or more suture portions may slidingly extend, as discussed herein.

It is a further particular feature of some embodiments that any of the devices shown or discussed herein may be used in an arthroscopic procedure and a knot as discussed herein with reference to any of the embodiments shown or discussed herein may be created within the arthroscopic surgical site.

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

Device Having a Single Suture Extending Through an Anchor Lumen

Reference is now made to Fig. 1A, which is a simplified schematic illustration of a device 100 for securing of a tissue to a bone, constructed and operative in accordance with some embodiments. . Device 100 includes an anchor 102 having at least one suture 104 threaded through a portion thereof, as will be discussed further hereinbelow. Device 100 may be sterile and prepackaged, with the at least one suture prethreaded through the portion of the anchor 102, as discussed herein.

Anchor 102 may be deformable, i.e., formed of a material that may be bent, compressed, or otherwise deformed, to allow the anchor to be passed through or inserted, optionally under pressure, into a bore in a bone (not shown). For example, anchor 102 may be formed of any suitable biocompatible material such as, for example silicon or any suitable material covered in or coated with silicon. Suture 104 may be formed of any suitable biocompatible material such as, for example, polyester having a silicon coating or any of the following materials: Versaloop ® 1^st sutures Clinifibre size 2

Trucors size 2

Versaloop® 2^nd sutures:

Dynacord ® #2

PERM AT APE ® 1.3

DYNEEMA® SIZE 2-0

Anchor 102 may be at least partly tubular, having an inner lumen 106 having openings 108 and 110 into lumen 106. Lumen 104 and openings 108 and 110 are sized and shaped to allow suture 104 to slidingly move through lumen 104 of anchor 102, according to some embodiments. Optionally, at least lumen 104 of anchor 102 is formed such that minimal friction may be created when suture 104 slides through lumen 104 and openings 108 and 110. The importance of reduced friction will be discussed further below.

Suture 104 may be prethreaded through lumen 106, such that it extends out of lumen 106 via openings 108 and 110, according to some embodiments. Suture 104 includes a first portion 116 having an end 112 and a second portion 118 having an end 114. Suture 104 may be slidably positioned within lumen 104 such that portion 116 may slide toward opening 108 by pulling on end 114, or portion 118 may slide toward opening 110 by pulling on end 112.. Alternatively, anchor 102 may be provided with loops (or other means) through which suture 104 may be threaded, which allow the suture to be slidingly received in the loops, according to some embodiments. Alternatively, anchor 102 may have a closed geometric shape such as, for example, round or oval, having an opening, through which suture 104 may be slidingly threaded, according to some embodiments. This will be discussed further in detail, with regard to the embodiment of Figs. 3A-E. According to some embodiments, a loop 122 may be performed in device 100, as shown in Fig. IB. Alternatively loop 122 may be formed by threading suture end 114, as indicated by arrows 120a-h (Fig. 1A), first into opening 108, then through lumen 106, and then out of opening 110. Alternatively, loop 122 may be formed by threading suture end 112 first into opening 110; then through lumen 106, in a direction opposite that shown by arrows 120d-f; and then out of opening 108. It may be noted that, once loop 122 is formed in device 100, two overlapping portions of suture extend through lumen 106, namely, suture portions 142 and 144, which will be discussed further herein.

Device 100 may be inserted into a bore 130 in a bone 132 (Fig. IF) by using an inserter, for example, as discussed below with reference to Figs. 8A-D or an anchor deployment device (not shown), as discussed further herein. When inserted, the anchor will be deformed, optionally assuming an oval shape such as, for example, illustrated in Fig. 1A.

Once the anchor 102 has been inserted into the bore 130, loop 122 and suture portions 116 and 118 which extend out of anchor 102 may extend out of the bore. For the sake of simplicity, however, in the embodiment shown in Figs. 1A-E, the device is illustrated with anchor 102 in a noncompressed state, and the bore 130 and bone 132 are not shown. It is to be understood, however, that once the anchor 102 has been inserted into the bore 130 in bone 132 it will be in a compressed state, as shown in Fig. IF.

Suture end 114 of suture 104 may be threaded through loop 122, as shown by arrows 124 (Fig. 1C), to its position shown in Fig. ID.

A tendon 140, or other soft tissue to be secured or retained, may be positioned between portion 118 and loop 122, as shown in Fig. ID. Optionally, suture portion 118 may be threaded in such a way as to encompass the tendon 140 before loop 122 is formed, such that when the loop is formed tendon 140 is already positioned between suture portion 118 and loop 122. Alternatively, tendon 140 may be positioned between loop 122 and anchor 102, as shown in Fig. IE. By pulling on suture end 114, suture 104 will slide through lumen 106 (in the direction of from opening 108 to opening 110), thereby shortening loop 122 and lengthening portion 118, as shown in Fig. IE. This action, whether tendon 140 has been positioned between portion 118 and loop 122 (Fig. ID) or whether the tendon has been positioned between loop 122 and anchor 102 (Fig. IE), may cause the tendon to be moved closer to anchor 102, as loop 122 is shortened. Further pulling of suture portion 118 will cause loop 122 to shorten further until a twisted mass or knot 126 of suture material is formed in suture 104, optionally in bore 130, as seen in Fig. IF, thereby securing the tendon 140 to the bone 132. Optionally, suture portions 116 and 118 which extend out of bore 130 may be severed. Fig. IF shows a final position of the tendon 140 relative to the bore 130 in the bone 132, after severing of suture portions 116 and 118.

It may be noted that friction between overlapping portions 142 and 144 within lumen 106, and/or friction between one or both of portions 142 and 144 and an inner surface of lumen 106, and/or friction between portion 116 and loop 122, and/or friction between portion 118 and loop 122, and/or friction among any of the suture portions and an inner surface 133 of the bore 130 may prevent the tendon from being released from the configuration of suture portions shown in Fig. IF, according to some embodiments.

It may be noted that, while the actions described with regard to Figs. 1A-E include pulling on suture end 114 to shorten loop 122, alternatively, the loop may be shortened by pulling on suture end 112, which similarly will cause the suture 104 to slide through lumen 106 in anchor 102 (in a direction from opening 110 to opening 108).

Optionally, at least one additional suture may be threaded through lumen 106, for example, as shown in Fig. 2A. While the additional suture(s) does not form part of the knot 126 (Fig. IF), it may increase friction among components of device 100, specifically between suture 104 and an inner surface of lumen 106 and/or between the additional suture(s) and suture 104, thereby preventing movement of the suture relative to the lumen, after the tendon 140 has been secured. This will be discussed further herein. While openings 108 and 110 and lumen 106 are sized and shaped to allow at least suture 104 to slidingly move through anchor 102, as discussed herein, optionally, at least lumen 104 of anchor 102 is formed such that minimal friction may be created when at least suture 104 slides through lumen 104 and openings 108 and 110. The importance of reduced friction will be discussed further below. It should be noted that, although device 100 may include at least one additional suture which may extend proximally from anchor

102, this should not interfere with formation of knot 126.

It is a particular feature of some embodiments that the action of pulling of first suture end 112 or of second suture end 114 is configured to further compress or deform the anchor 102, thereby preventing the anchor 102 from being released from the bore in the bone. Optionally, the anchor 102 may be deformed, assuming a c-shaped or a u-shaped configuration such as, for example, shown in Fig. IF, or assuming a configuration having a plurality of undulations. It is to be noted that such configurations of anchor 102 may be achieved in accordance with any of the embodiments discussed herein.

It is a further particular feature of some embodiments that the device for securing of a tissue to a bone, according to any of the embodiments shown or discussed herein, may be used in an arthroscopic procedure and a knot as discussed herein may be created within the arthroscopic surgical site.

Device Having Two Sutures Extending Through an Anchor Lumen

Reference is now made to Figs. 2A-F which illustrate a device 200 for securing a portion of soft tissue to a bone in accordance with some embodiments. Some components of device 200 may be similar in structure and function to those of device 100 (Fig. 1A) and may not be discussed again in detail. For example, as illustrated in Fig. 2A, loop 122 may be formed in a manner similar to that shown in Figs. 1A-B. Additionally, some actions for manipulating sutures in device 200 may be similar to those discussed with regard to device 100 (Figs. 1A-F) and may not be discussed again in detail.

Device 200 includes at least one additional suture 204 (as compared with device 100 having a single suture), suture 204 having a first end 212 and a second end 214. Lumen 104 and openings 108 and 110 in anchor 102 are sized and shaped to allow sutures 104 and 204 to slidingly move through lumen 104 of anchor 102, according to some embodiments.

The at least one additional suture 204 may be used to increase volume of the device 200 to prevent the anchor from becoming dislodged from bore 130 in bone 132, and/or increase friction among elements of device 200 to prevent the anchor from becoming dislodged from bore 130, as discussed herein. The at least one additional suture 204 may be positioned as shown in Fig. 2A by threading it in a manner similar to that of suture 104, discussed herein. Optionally, more than one additional suture may be provided in device 200, further increasing friction among components of device 200. The number of sutures threaded through the anchor may be selected depending on a diameter of bore 130 and the width of the anchor being utilized in the procedure. As discussed above with regard to Fig. 1A, each of sutures 104 and 204 may be prethreaded through lumen 106, such that they extend out of lumen 106 via openings 108 and 110, according to some embodiments. Suture 104 includes a first portion 116 having an end 112 and a second portion 118 having an end 114. Suture 204 includes a first portion 216 having an end 212 and a second portion 218 having an end 214. Suture 104 may be slidably positioned within lumen 104, as discussed herein, such that portion 116 may slide toward opening 108 by pulling on end 114, or portion 118 may slide toward opening 110 by pulling on end 112.. Alternatively, anchor 102 may be provided with loops (or other means) through which suture 104 may be threaded, according to some embodiments, as discussed herein. Alternatively, anchor 102 may have a closed geometric shape through which suture 104 may be slidingly threaded, according to some embodiments, as discussed herein.

According to some embodiments, a loop 122 may be preformed in device 200, as shown in Fig. 2B. Alternatively loop 122 may be formed as discussed herein with regard to Figs. 1A-B.

According to some embodiments, device 200 may be inserted into a bore 130 in a bone 132 (Fig. 2F), as discussed herein. Once the anchor 102 has been inserted into the bore 130, loop 122, suture portions 116 and 118 of suture 104, and suture portions 216 and 218 of suture 204 which extend out of anchor 102 may extend out of the bore 130. For the sake of simplicity, however, in the embodiment shown in Figs. 2A-E, the device is illustrated with anchor 102 in a noncompressed state, and the bore 130 and bone 132 are not shown. It is to be understood, however, that once the anchor 102 has been inserted into the bore 130 in bone 132 it will be in a compressed state, as shown in Fig. 2F.

As illustrated in Fig. 2C, suture end 114 of suture 104 may be threaded through loop 122, as shown by arrows 124 (Fig. 2C), to its position shown in Fig. ID. Additionally, suture end 214 of suture 204 may be threaded through loop 122, as shown by arrows 224. It may be noted that suture end 114 of suture 104 and suture end 214 of suture 204 may be threaded through loop 122 either sequentially, with either of ends 114 and 214 being threaded first through loop 122, or simultaneously.

A tendon 140, or other soft tissue to be secured or retained, may be positioned between portion 118 of suture 104 and loop 122, as shown in Fig. 2D. Alternatively, tendon 140 may be positioned between loop 122 and anchor 102, as shown in Fig. 2E. By pulling on suture end 114 of suture 104, suture 104 will slide through lumen 106 (in the direction of from opening 108 to opening 110), thereby shortening loop 122 and lengthening portion 118, as shown in Fig. 2E. This action, whether tendon 140 has been positioned between portion 118 and loop 122 (Fig. 2D) or whether the tendon has been positioned between loop 122 and anchor 102 (Fig. 2E), may cause the tendon to be moved closer to anchor 102, as loop 122 is shortened. Further pulling of suture portion 118 of suture 104 will cause loop 122 to shorten further until a twisted mass or a knot 226 of suture material is formed by sutures 104 and 204 , as seen in Fig. 2F, thereby securing the tendon 140 to the bone 132.

Optionally, suture portions 116 and 118 of suture 104 and suture portions 216 and 218 of suture 204, which extend out of bore 130 may be severed. Fig. 2F shows a final position of the tendon 140 relative to the bore 130 in the bone 132, after severing of suture portions 116, 118, 216, and 218.

It may be noted that friction among overlapping portions 142 and 144 and a portion 146 of suture 204 within lumen 106; and/or friction between one or more of portions 142, 144, and 204 and an inner surface of lumen 106; and/or friction among portion 116, portion 216, and loop 122; and/or friction among portion 118, portion 218, and loop 122; and/or friction among any of the suture portions and an inner surface 133 of bore 130 may prevent the tendon from being released from the configuration of suture portions shown in Fig. 2F, according to some embodiments.

It may be noted that, while the actions described with regard to Figs. 2A-E include pulling on suture end 114 to shorten loop 122, alternatively, the loop may be shortened by pulling on suture end 112, which similarly will cause the suture 104 to slide through lumen 106 in anchor 102 (in the direction of from opening 110 to opening 108).

It is a particular feature of an embodiment that the action of pulling of first suture end 112 or of second suture end 114 is configured to further compress or deform the anchor 102, thereby preventing the anchor 102 from being pulled out of the bore 130 within the bone 132. Optionally, all of suture portions 116, 118, 216, and 218 may be pulled so as to deform the anchor 102.

Device Having Two Loops

Reference is now made to Fig. 3A, which is a simplified schematic illustration of a device 300 for securing of a tissue to a bone, constructed and operative in accordance with some embodiments. . Device 300 includes an anchor 102 having a first suture 104 and a second suture 204 threaded through a portion thereof, as discussed herein with regard to Fig. 2A. Some components of device 300 may be similar in structure and function to those of device 200 (Fig. 2A) and may not be discussed again in detail. Additionally, some actions for manipulating sutures in device 300 may be similar to those discussed with regard to device 200 (Figs. 2A-F and may not be discussed again in detail. As discussed above with regard to Fig. 2A, each of sutures 104 and 204 may be prethreaded through lumen 106, such that it extends out of lumen 106 via openings 108 and 110 as discussed herein, according to some embodiments. Since anchor 102 has a closed geometric shape having an opening 310, a first loop 302 may be formed by threading suture end 212 of suture 204, in the direction of arrows 304, through opening 310, as shown in Figs. 3B-C, according to some embodiments, as discussed herein. A second loop 306 may be formed by threading suture end 214 of suture 204, in the direction of arrows 308, through opening 310, as shown in Figs. 3D-E.

Device 300 may be inserted into a bore 130 in a bone 132 (Fig. 4H) by using an inserter, for example, as discussed herein with reference to Figs. 8A-D or an anchor deployment device (not shown), as discussed further herein. Once the anchor 102 has been inserted into the bore 130, loops 203 and 306 and suture portions 216 and 218 which extend out of anchor 102 may extend out of the bore. For the sake of simplicity, however, in the embodiment shown in Figs. 4A-G, the device is illustrated with anchor 102 in a noncompressed state, and the bore 130 and bone 132 are not shown. It is to be understood, however, that once the anchor 102 has been inserted into the bore 130 in bone 132 it will be in a compressed state, as shown in Fig. 4H.

With additional reference to Figs. 4A-H, loop 306 may be positioned such that it extends partly around tendon 140, or other soft tissue to be secured or retained, with two portions of suture 204, namely suture portions 312 and 314 extending around approximately one third to one half of tendon 140, as shown in Fig. 4B.

Loop 302 is passed in the direction of arrows 316 through loop 306, as shown in Figs. 4C-D. Suture ends 212 and 214 of suture 204 are then both threaded in the direction of arrows 320 through loop 302, as shown in Figs. 4E-F.

Suture portions 216 and 218 may be pulled proximally, in the direction of arrows 322 shown in Fig. 4G, thereby causing suture portions 216 and 218 to slide through opening 310 in anchor 102, thereby shortening loops 302 and 306, respectively and lengthening portions 216 and 218, as shown in Fig. 4H. Shortening of loops 302 and 306 may cause the tendon to be moved closer to anchor 102, according to some embodiments. Further pulling of suture portions 216 and 218 may cause loops 302 and 306 to shorten further until a twisted mass or a knot 324 of suture material is formed in suture 104, as seen in Fig. 4H, thereby securing the tendon 140 to the bone 132. Optionally, suture portions 216 and 218 which extend out of bore 130 may be severed. Fig. 4H shows a final position of the tendon 140 relative to the bone 132, after severing of suture portions 216 and 218. Optionally, at least one additional suture 104 may be threaded through lumen 106, for example, as shown in Fig. 3A. While the additional suture(s) may not form part of knot 324 (Fig. 4H), it may increase friction among components of device 300, specifically between suture 204 and an inner surface of lumen 106 and/or between the additional suture(s) 104 and suture 204, thereby preventing movement of the suture 204 relative to the lumen, after the tendon 140 has been secured.

It may be noted that friction between portions of sutures 104 and 204 within lumen 106; and/or friction between one or more of portions 104 and 204 and an inner surface of lumen 106; and/or and/or friction among any of the suture portions and an inner surface 133 of bore 130 may prevent the tendon from being released from the configuration of suture portions shown in Fig. 4H, according to some embodiments.

It may be noted that, although device 300 may include at least one additional suture 104 which may extend proximally from anchor 102, this should not interfere with formation of knot 324. Optionally, ends 112 and 114 of additional suture 104 may threaded through loop 302, either together with ends 212 and 214 of suture 204 or in any sequence relative to ends 212 and 214, such that they may form part of a knot.

It is a particular feature of some embodiments that the action of pulling of suture ends 212 and 214 is configured to further compress or deform the anchor 102, thereby preventing the anchor 102 from being pulled out of the bore 130 in bone 132.

Device Having Two Sutures and a Slider - First Embodiment

Reference is now made to Fig. 5A, which is a simplified schematic illustration of a device 500 for securing of a tissue to a bone, constructed and operative in accordance with some embodiments. . Some components of device 500 any be similar in structure and function to those of device 200 (Fig. 2A) and may not be discussed again in detail. Additionally, some actions for manipulating sutures in device 500 may be similar to those discussed with regard to any of the devices discussed herein such as, for example, device 200 (Figs. 2A-F), and may not be discussed again in detail.

Device 500 includes an anchor 102 having an inner lumen 106 having openings 108 and 110 which may be similar in structure and function to that discussed herein with regard to anchor 102, and may not be discussed again here in detail. A first suture 504 may be threaded through lumen 106, as discussed herein with regard to suture 104 (Fig. 2A). Suture 504 includes portions 516 and 518 having respective ends 512 and 514. Device 500 is provided with a slider 510 having a through hole 508. Slider 510 may be any suitable component having a through hole, such as, for example, a tubular component, where the through hole is sized and shaped for allowing at least suture portions 516 and 518 to slide therethrough with little resistance End 514 of suture 504 is provided with a knot 520 or other widened portion, which will be discussed further herein. Knot 520 prevents slider 510 from being released from suture portion 518.

A second suture 604 may be threaded through lumen 106 such that suture portions 616 and 618 extend out of lumen opening 110 and a loop 620 extends out of lumen opening 108. It may be noted that three lengths of suture extend through lumen 106, namely one length of suture 504 and two lengths of suture 604.

Device 500 may be inserted into a bore 130 in a bone 132 (Fig. 51) by using an inserter, for example, as discussed herein with reference to Figs. 8A-D or an anchor deployment device (not shown). Once the anchor 102 has been inserted into the bore 130, loop 620 and suture portions 616, 618, 516, and 518 which extend from anchor 102 may extend out of the bore. For the sake of simplicity, however, in the embodiment shown in Figs. 5A-H, the device is illustrated with anchor 102 in a noncompressed state, and the bore 130 and bone 132 are not shown. It is to be understood, however, that once the anchor 102 has been inserted into the bore 130 in bone 132 it will be in a compressed state, as shown in Fig. 51.

With additional reference to Figs. 5C-D, loop 620 may be positioned such that it extends partly around tendon 140, or other soft tissue to be secured or retained, with two portions of suture 604, namely suture portions 622 and 624 extending around approximately one third to one half of tendon 140, as shown in Fig. 5D.

Suture ends 606 and 608 are passed in the direction of arrows 522 through loop 620, as shown in Fig. 5C. Suture ends 606 and 608 of suture 604 then may be pulled proximally, in the direction of arrows 524 shown in Fig. 5D, thereby causing suture portions 616 and 618 to slide through anchor lumen 106, thereby shortening loop 620 and lengthening portions 616 and 618. Shortening of loop 620 may cause the tendon to be moved closer to anchor 102, as loop portions 622 and 624 are shortened, according to some embodiments, as seen by the position of tendon 140 relative to anchor 102 in Fig. 5D as compared with the position of the tendon relative to the anchor in Fig. 5C.

Suture portions 616 and 618 of suture 604 may be wound around suture portions 516 and 518 of suture 504, at least once and optionally two or more times, thereby forming a winding or windings 610 around suture portions 516 and 518, as shown in Fig. 5E. Suture portions 616 and 618 may then be held or pulled proximally, thereby causing loop 620 to shorten and causing windings 610 to tighten around suture portions 516 and 518, as shown in Figs. 5F-H. As loop 620 shortens, tendon 140 is moved closer to anchor 102. Additionally, windings 610 may be forced distally, toward anchor 102, by moving slider 510 distally along suture portions 516 and 518 or by pulling on suture end 512, thereby causing slider to be forced distally toward anchor 102 by knot 520 as suture 504 slides through lumen 106 (in a direction from opening 110 to opening 108), until windings 610; loop 620; and suture portions 516, 518, 616, and 618 form a twisted mass or a knot 630 of suture material, optionally in bore 130, as shown in Fig. 51. Optionally, slider will have been moved into bore 130. The tendon 140 will thereby be secured to the bone 132.

Optionally, suture portions 516, 616, and 618 which extend out of bore 130 may be severed. Fig. 51 shows a final position of the tendon 140 relative to the bone 132, after severing of suture portions 516, 616, and 618.

It may be noted that friction among loop portions 622 and 624 and a portion of suture 204 within lumen 106; and/or friction among one or more of portions 622, 624, and 204 and an inner surface of lumen 106; and/or friction among any of the suture portions within the bore; and/or friction among any of the suture portions within the bore and an inner surface 133 of bore 130 may prevent the tendon from being released from the configuration of suture portions shown in Fig. 51, according to some embodiments.

It is a particular feature of some embodiments that the action of pulling of suture portions 616 and 618 is configured to further compress or deform the anchor 102, optionally into a u- shaped configuration or a configuration having a plurality of undulations, for example, as shown in Fig. 51, thereby preventing the anchor 102 from being pulled out of the borel30 in bone 132.

Device Having Two Sutures and a Slider - Second Embodiment

According to some embodiments, instead of winding suture portions 616 and 618 of suture 604 around suture portions 516 and 518 of suture 504, as shown in Fig. 5E, suture portions 516 and 518 may be wound at least once and optionally two or more times around suture portion 518 only, thereby forming a winding or windings 612 around suture portion 518, as shown in Fig. 6A. Suture portions 616 and 618 may then be pulled proximally, thereby causing loop 620 to shorten and causing windings 612 to tighten around suture portion 518, as shown in Figs. 6B-D. As loop 620 shortens, tendon 140 is moved closer to anchor 102, in a similar manner as illustrated in Figs. 5E-H. Additionally, windings 610 may be forced distally, toward anchor 102, by moving slider 510 distally along suture portions 516 and 518 or by pulling on suture end 512, thereby causing slider to be forced distally toward anchor 102 by knot 520 as suture 504 slides through lumen 106 (in a direction from opening 110 to opening 108), until windings 612; loop 620; and suture portions 516, 518, 616, and 618 form a twisted mass or a knot 614 of suture material, optionally in bore 130, similar to knot 630 (Fig. 51). The tendon 140 will thereby be secured to the bone 132. Optionally, suture portions 516, 616, and 618 which extend out of bore 130 may be severed.

It is a particular feature of some embodiments that the action of pulling of suture portions 616 and 618 is configured to further compress or deform the anchor 102, thereby preventing the anchor 102 from being pulled out of the bore 130 in bone 132.

Device Having Two Sutures and a Slider - Third Embodiment

Reference is now made to Fig. 7A, which is a simplified schematic illustration of a device 700 for securing of a tissue to a bone, constructed and operative in accordance with some embodiments. . Some components of device 700 (Fig. 7A-B) may be similar in structure and function to those of device 500 (Fig. 5A-B) and may not be discussed again in detail. Additionally, some actions for manipulating components in device 700 may be similar to those discussed with regard to device 500 (Figs. 5A-6D) and may not be discussed again in detail.

Device includes first suture 504 threaded through lumen 106 and has slider positioned thereon and second suture is threaded through lumen 106, as shown in Figs. 7A-B and discussed herein. It may be noted that three lengths of suture extend through lumen 106, namely one length of suture 504 and two lengths of suture 604, similar to the suture lengths discussed above with regard to Fig. 5A.

Device 700 may be inserted into a bore 130 in a bone 132 (Fig. 7L) by using an inserter, for example, as discussed herein with reference to Figs. 8A-D or an anchor deployment device (not shown). Once the anchor 102 has been inserted into the bore 130, loop 620 and suture portions 616, 618, 516, and 518 which extend from anchor 102 may extend out of the bore. For the sake of simplicity, however, in the embodiment shown in Figs. 7A-K, the device is illustrated with anchor 102 in a noncompressed state, and the bore 130 and bone 132 are not shown. It is to be understood, however, that once the anchor 102 has been inserted into the bore 130 in bone 132 it will be in a compressed state, as shown in Fig. 7L. .

With additional reference to Figs. 7C-D, loop 620 may be positioned such that it extends partly around tendon 140, or other soft tissue to be secured or retained, with two portions of suture 604, namely suture portions 622 and 624 extending around approximately one third to one half of tendon 140, as shown in Fig. 7D.

Suture end 608 is passed in the direction of arrow 626 through loop 620, as shown in Fig. 7C. Suture end 608 of suture 604 then may be pulled proximally, in the direction of arrow 628 shown in Fig. 7D, thereby causing suture portion 616 to slide through anchor lumen 106, thereby shortening loop 620 and lengthening portion 616. Shortening of loop 620 may cause the tendon to be moved closer to anchor 102, as loop portion 624 is shortened, according to some embodiments, as seen by the position of tendon 140 relative to anchor 102 in Fig. 7D as compared with the position of the tendon relative to the anchor in Fig. 7C.

Suture portion 618 may then be pulled proximally, in the direction of arrow 632, as shown in Fig. 7E, thereby causing loop 620 to pull on suture portion 616 such that suture portion 616 is folded over at a portion thereof that extends through loop 620, and end 616 moves in the direction of arrow 638, i.e., distally, toward anchor 102, as illustrated in Figs. 7E-F. Due to this folding of suture portion 616, two lengths of suture, namely suture portions 634 and 636 of suture portion 616 may be positioned partly around tendon 140 such as, for example, from a third to half way around tendon 140, in addition to portions 622 and 624 of loop 620, as illustrated in Figs. 7F-G.

Further pulling of suture end 608 may cause folded suture lengths 634 and 636 to extend further around tendon 140, and loop 620 may be pulled further toward anchor 102, optionally sliding into lumen 106, as shown in Fig. 7H.

Suture portions 616 and 618 of suture 604 may be passed between suture portions 516 and 518 of suture 504, as shown by arrows 640 in Fig. 71. While keeping proximally-directed tension on suture portions 516 and 518, as indicated by arrows 526, suture portion 516 may then be pulled proximally, in the direction of arrow 528, which may cause slider 510 to slide distally along suture portions 516, toward anchor 102, optionally moving slider into bore 130 (Fig. 7L).

Suture portions 516, 518, 616, and 618 form a twisted mass or a knot 602 of suture material, optionally in bore 130, as shown in Fig. 7L. The tendon 140 will thereby be secured to the bone 132. Optionally, suture portions 516, 616, and 618 which extend out of bore 130 may be severed. Fig. 7L shows a final position of the tendon 140 relative to the bone 132, after severing of suture portions 516, 616, and 618.

Friction among loop 620 and suture portions 634 and 636 within lumen 106, and/or friction among slider 510 and the twisted mass or knot 630 adjacent to or within bore may prevent the tendon from being released from the configuration of suture portions formed, according to some embodiments.

It may be noted that friction among overlapping portions of loop 620 and a portion 504 within lumen 106; and/or friction between one or more of portions of sutures 504 and 604 and an inner surface 133 of bore 130 may prevent the tendon from being released from the configuration of suture portions shown in Fig. 7L, according to some embodiments. It is a particular feature of some embodiments that the action of pulling of suture portions 616 and 618 is configured to further compress or deform the anchor 102, thereby preventing the anchor 102 from being pulled out of the bore 130 in bone 132.

Device for Securing a Tendon to a Bone Using A Deforming Slider, According to Some Embodiments

Figs. 7M-0 are simplified schematic illustrations of a deforming slider 530 that may be used in device 700 for securing a tissue to a bone, according to some embodiments. Various components in Figs. 7M-0 are similar in structure and function to corresponding components in Figs. 7A-L, and will not be discussed again herein in detail.

In the embodiments shown in Figs. 7M-O, the deforming slider 530 may be a solid anchor (i.e., not tubular), formed of any suitable material such as, for example, UHMWPE (ultra- high-molecular- weight polyethylene) or PET (polyethylene terephthalate), and may contain small amounts of PA (polyamide), according to some embodiments. Deforming slider 530 may have a length in a range of from 10-18mm such as, for example, from 10-12mm, from 12-14mm, from 14-16mm, or from 16-18mm, according to some embodiments. Deforming slider 530 may have a diameter of from 1-2.5mm such, as for example, from 1-1.3mm, from 1.3-1.6mm, from 1.6-1.9mm, from 1.9-2.2mm, or from 2.2-2.5mm, according to some embodiments.

Deforming slider 530 may be manipulated to be converted from a straight orientation to a bent or curved orientation, for example, as discussed herein, according to some embodiments. Deforming slider 530 may have a stiffness in a range of from 2000-7000N/m such as, for example, from 2000-3000N7m, from 3000-4000N/m, from 4000-5000N/m, from 5000-6000N/m, or from 6000-7000N/m, according to some embodiments.

Deforming slider 530 may be attached to first suture 504 (hereinafter also referred to as “suture 504”), in place of slider 510 (Figs. 7A-L). As discussed previously, suture 504 includes a suture portion 516 having an end 512, and a suture portion 518 having an end 514 with a knot 520 adjacent end 514, according to some embodiments.

As shown in each of Figs. 7M-O, suture portion 518 is threaded multiple times, back and forth, through deforming slider 530, according to one of a plurality of threading configurations, for example, as discussed in further detail with regard to Figs. 7P-R, according to some embodiments. It will be appreciated by persons skilled in the art that, while a variety of threading configurations are possible, three threading configurations in particular are illustrated and discussed herein, according to some embodiments. As will be discussed further with regard to Figs. 7S-U, after pulling of suture end 512, these threading configurations will result in a bending of deforming slider 530, to form a w-shape, an n-shape, or a spiral shape, for example, as discussed herein, according to some embodiments.

With additional reference to Figs. 7P-R there are shown a plurality of threading configurations for deforming slider 530, in accordance with some embodiments. Each of the threading configurations shown, after tightening of the suture threaded through deforming slider 530, will result in a particular bent and/or curved anchor configuration, for example, as discussed in detail herein, according to some embodiments.

With particular reference to Fig. 7P, it is seen that suture portion 518 of suture 504 has been threaded through deforming slider 530 multiple times, in the direction of arrows 548. Specifically, the threading configuration includes passing suture portion 518 into deforming slider 530 at point 532 and out of deforming slider 530 at point 534, passing suture portion 518 into deforming slider 530 at point 536 and out of deforming slider 530 at point 538, passing suture portion 518 into deforming slider 530 at point 540 and out of deforming slider 530 at point 542, and passing suture portion 518 into deforming slider 530 at point 544 and out of deforming slider 530 at point 546, according to some embodiments. This results in a suture loop 552, between points 534 and 536; a suture loop 554, between points 538 and 540; and a suture loop 556, between points 542 and 546, according to some embodiments.

After suture 504 has been passed through lumen 106 of anchor 102 (see, for example, Fig. 7E), portion 516 of suture 504 is optionally passed through loop 554, according to some embodiments. Alternatively, after suture 504 has been passed through lumen 106 of anchor 102 (see, for example, Fig. 7B), portion 516 of suture 504 is optionally passed through at least one of loops 552 and 556, according to some embodiments.

When end 512 of suture portion 516 is pulled, for example, in the direction of arrow 558, this will shorten the length of suture portion 516 extending through deforming slider 530, thereby causing deforming slider 530 to bend at portions 586 and 588 of deforming slider 530, according to some embodiments. Bending of deforming slider 530 at portions 586 and 588 will result in deforming slider 530 being converted from a straight orientation (Fig. 7M) to a w- shaped orientation, for example, as shown in the lower portion of Fig. 7P, according to some embodiments. It should be noted that, in the bent orientation, the deforming slider 530 in the w- shaped orientation has a larger cross-sectional profile than when in the straight orientation, according to some embodiments.

With particular reference to Fig. 7Q, it is seen that suture portion 518 has been threaded through deforming slider 530 multiple times, in the direction of arrows 548. Specifically, the threading configuration includes passing suture portion 518 into deforming slider 530 at point 568 and out of deforming slider 530 at point 570, passing suture portion 518 into deforming slider 530 at point 572 and out of deforming slider 530 at point 574, and passing suture portion 518 into deforming slider 530 at point 576 and out of deforming slider 530 at point 578, according to some embodiments. This results in a suture loop 582, between points 5570 and 572; and a suture loop 584, between points 574 and 576, according to some embodiments.

After suture 504 has been passed through lumen 106 of anchor 102 (see, for example, Fig. 7E), portion 516 of suture 504 is optionally passed through loop 584, according to some embodiments. Alternatively, after suture 504 has been passed through lumen 106 of anchor 102 (see, for example, Fig. 7B), portion 516 of suture 504 is optionally passed through loop 548, according to some embodiments.

When end 512 of suture portion 516 is pulled, for example, in the direction of arrow 558, this will shorten the length of suture portion 516 extending through deforming slider 530, thereby causing deforming slider 530 to bend at portions 562, 564, and 566 of deforming slider 530, according to some embodiments. Bending of deforming slider 530 at portions 562, 564, and 566 will result in deforming slider 530 being converted from a straight orientation (Fig. 7N) to an n-shaped orientation, for example, as shown in the lower portion of Fig. 7Q, according to some embodiments. It should be noted that, in the bent orientation, the deforming slider 530 in the n-shaped orientation has a larger cross-sectional profile than when in the straight orientation, according to some embodiments.

With particular reference to Fig. 7R, it is seen that suture portion 518 has been threaded through deforming slider 530 multiple times, in the direction of arrows 548. Specifically, the threading configuration includes passing suture portion 518 into deforming slider 530 at point 642 and out of deforming slider 530 at point 644, passing suture portion 518 into deforming slider 530 at point 646 and out of deforming slider 530 at point 648, passing suture portion 518 into deforming slider 530 at point 650 and out of deforming slider 530 at point 652, passing suture portion 518 into deforming slider 530 at point 654 and out of deforming slider 530 at point 656, passing suture portion 518 into deforming slider 530 at point 658 and out of deforming slider 530 at point 660, and passing suture portion 518 into deforming slider 530 at point 662 and out of deforming slider 530 at point 664, according to some embodiments. This results in a suture loop 666, between points 644 and 646; a suture loop 668, between points 648 and 650; a suture loop 670, between points 652 and 654; a suture loop 672, between points 656 and 658; and a suture loop 674, between points 660 and 662, according to some embodiments.

After suture 504 has been passed through lumen 106 of anchor 102 (see, for example, Fig. 7E), portion 516 of suture 504 is optionally passed through at least one of loops 672 and 668, according to some embodiments. Alternatively, after suture 504 has been passed through lumen 106 of anchor 102 (see, for example, Fig. 7B), portion 516 of suture 504 is optionally passed through at least one of loops 674, 670, and 666, according to some embodiments.

When end 512 of suture portion 516 is pulled, for example, in the direction of arrow 558, this will shorten the length of suture portion 516 extending through deforming slider 530, thereby causing deforming slider 530 to bend/curve at all portions between points 642 and 664, according to some embodiments. Bending/curving of deforming slider 530 at all of these anchor portions will result in deforming slider 530 being converted from a straight orientation (Fig. 70) to a spiral orientation, for example, as shown in the lower portion of Fig. 7R, according to some embodiments. It may be noted that, in the lower portion of Fig. 7R, deforming slider 530 is shown in the spiral orientation, in a side view and a plan view, according to some embodiments. It should be noted that, in the bent/curved orientation, the deforming slider 530 in the spiralshaped orientation has a larger cross-sectional profile than when in the straight orientation, according to some embodiments.

Fig. 7S-U are simplified schematic illustrations, each of a final position of a tendon secured relative to a bone, using the additional anchor of Figs. 7M-O, respectively, in accordance with some embodiments. As seen in these drawings, deforming slider 530, in its bent and/or curved orientation (w-shaped in Fig. 7S, n-shaped in Fig. 7T, or spiral in Fig. 7U) has been forced distally, toward anchor 102, until the sutures form a twisted mass or a knot of suture material, for example, as discussed wherein with regard to Fig. 7L, according to some embodiments. It should be noted that deforming slider 530, when in its deformed orientation (any of Figs. 7S-U) functions to increase friction between suture portion 516 and the deforming slider, according to some embodiments. Additionally, when in its deformed orientation (any of Figs. S-U), due to the larger cross-sectional profile of deforming slider 530, as compared with its cross-sectional profile prior to being deformed (Figs. 7M-O), deforming slider 530 may apply pressure to suture portions in bore 130, thereby preventing the suture portions in the bore from moving relative to each other, according to some embodiments.

Anchor Inserters According to Some Embodiments

With reference to Figs. 8A-C there is shown an anchor inserter 800 which includes an elongate body 802 having a longitudinal axis 820, a proximal end 804, and a distal end 806. Inserter 800 may be formed of any suitable material. A handle 808 may be provided at proximal end 804. Distal end 806 has a recess 810 formed of a pair of distally extending projections 812. Recess 810 is sized and shaped for receiving a portion of an anchor 830 (Fig. 8D) such as, for example, a soft anchor having a circular or oval configuration, and recess 810 may extend proximally from 5-10 mm from a distal tip 814 of each projection 812.

Inserter 800 also includes a lateral recess 816 sized and shaped for receiving an anchor 830 therein. Recess 816 includes a distal wall 818 disposed at an angle to longitudinal axis 820 and a proximal wall 822 disposed approximately at a 90 degree angle to longitudinal axis 820. Lateral recess may extend approximately one quarter to one half of the distance into a side of inserter 800. An anchor such as an anchor 830 including at least one suture 818 threaded therethrough, in accordance with any of the embodiments discussed herein, may be inserted into recess 810, with a portion 822 of the anchor positioned between projections 812, and then a portion 824 of the anchor may be retained within lateral recess 816, as illustrated, for example, in Fig. 8D, such that anchor 830 will be securely mounted on inserter 800.

Once securely mounted on inserter 800, the inserter may be moved distally into a bore 130 in a bone 132 to insert anchor 830 into the bore, for example, as discussed with regard to the embodiment of Fig. 2F. Withdrawal of the inserter 800 from the bore 130 will allow anchor portion 824 to slide over distal wall 818, due to its angular orientation relative to body longitudinal axis 820, and anchor 830 will remain within the bore 130, as discussed herein.

Device Having Two Sutures, One of Which Includes a Terminal Loop

Reference is now made to Fig. 9A, which is a simplified schematic illustration of a device 900 for securing of a tissue to a bone, constructed and operative in accordance with some embodiments. . Some components of device 900 may be similar in structure and function to those of any of the devices discussed herein such as, for example, device 200 (Fig. 2A), and may not be discussed again in detail. Additionally, some actions for manipulating sutures in device 500 may be similar to those discussed with regard to any of the devices discussed herein such as, for example, device 200 (Figs. 2A-F), and may not be discussed again in detail.

Device 900 includes an anchor 902 having an inner lumen 906 provided with openings 908 and 910 which may be similar in structure and function to openings 108 and 110 of device 500 (Fig. 5A), and may not be discussed again here in detail. Additionally, anchor 902 is provided with openings 912 and 914; wherein all of openings 908, 910, 912, and 914 are sized and shaped for allowing a plurality of sutures to extend therethrough. Optionally, openings 906 and 908 may be located on a portion of anchor 902 that is radially inward with regard to lumen 906 and the geometric shape of anchor 902 which, in the embodiment shown, may be circular or oval, while openings 912 and 914 may be located on a portion of anchor 902 that is radially outward with regard to lumen 906 and the geometric shape of anchor 902. Device 900 may include at least one first suture 920 which may be passed through opening 908, through lumen 906 toward opening 910, and extends out of opening 910, such that portions 916 and 918 extend out of respective openings 908 and 910. Portions 916 and 918 have respective ends 924 and 922, and suture end 924 is provided with a terminal loop 926.

Device 900 is also provided with a second suture 930 which includes a loop 940 having extensions 941 and 943 which extend via opening 908 into lumen. Extension 941 extends along lumen 906, from opening 908 to opening 914, passes out of opening 914, extends along an outer surface of anchor 902, passes back into lumen 906 via opening 912, passes out of lumen 906 via opening 910, and then has a portion 934 that extends outside anchor 902. Extension 943 extends along lumen 906, from opening 908 to opening 910, and then has a portion 932 that extends outside anchor 902. Portions 932 and 934 have respective ends 936 and 938.

Loop 940 includes suture portions 946 and 948 which may extend out of lumen 906 via opening 908, and suture portions 946 and 948 pass through a loop (not shown) or portion of material (not shown) of anchor 902 at respective locations 952 and 954. Similarly, suture portions 932 and 934 extend out of lumen 906 via opening 910 and pass through a loop (not shown) or portion of material (not shown) of anchor 902 at respective locations 956 and 958.

Device 900 may be inserted into a bore in a bone (not shown) by using an inserter, for example, as discussed herein with reference to Figs. 8A-D or an anchor deployment device (not shown). Once the anchor 902 has been inserted into the bore, loop 940 and suture portions 916, 918, 932, and 934 which extend from anchor lumen 906 may extend out of the bore. For the sake of simplicity, however, in the embodiment shown in Figs. 9A-I, the device is illustrated with anchor 902 in a noncompressed state, and the bore and bone are not shown. It is to be understood, however, that once the anchor 902 has been inserted into the bore in the bone it will be in a compressed state, for example, as shown with regard to embodiments discussed herein. .

With additional reference to Figs. 9B-D, a tendon 140 of other soft tissue to be secured or retained may be positioned such that it is adjacent suture portion 932. Suture portion 932 may be positioned around tendon 140, and suture end 936 may be threaded through loop 926, as shown by arrow 942 (Fig. 9B). Then suture portion 918 may be pulled as indicated by arrow 944 (Fig. 9C). This will cause tendon 140 to be moved closer to anchor 902 by suture portion 932. Since suture 920 extends through lumen 906 (at the stage of Fig. 9B), and suture portion 932 is passed through loop 926, pulling on suture portion 918 will cause suture portion 932 to pass into lumen 906 via opening 908, thereby forming a securing loop 950, to be threaded through lumen 906, and to exit the lumen via opening 910. Once loop 926 has been passed through lumen 906 and exits opening 910, it will have pulled suture portion 932 along with the loop 926 such that suture portion passes via opening 908 through lumen 906 and out of opening 910. Suture portion 932 may be pulled proximally by suture 920, as indicated by arrow 946, for example, until suture portion 932 extends proximally alongside suture portion 934, as shown in Fig. 9D. Suture portion 932 may then be removed from loop 926, and suture 20 may be discarded.

Pulling on at least suture portion 932, and optionally also on suture portions 934, 946, and 948, in the direction of arrow 941, may cause tendon 140 to be moved in the direction of arrow 943, closer to anchor 902, as shown in Fig. 9E.

With reference to Figs. 9F-H, suture end 936 may be passed through loop 940, as indicated by arrow 945 (Fig. 9F). Thereafter, suture portion 934 may be pulled in the direction indicated by arrow 947 (Fig. 9G), which will cause loop 940 to shorten (Fig. 9H), while suture portion 932 forms a loop 960 (Figs. 9H-I). Suture portions 932 and 934 may be pulled proximally, as indicated by arrows 949 (Fig. 91) which will tighten the suture 930 relative to anchor, as portions of suture 930 slide through lumen 906 and alongside the outer surface of anchor 902, i.e., between openings 912 and 914. This will also cause tendon 140 to be moved closer to the bone (not shown), by securing loop 950. After tightening the suture 930 relative to anchor 902, suture portions 932 and 934 which extend out of the bore (not shown) in the bone (not shown) may be severed.

It may be noted that, due to the multiple suture portions that extend through lumen 906 and/or along the outside surface of anchor 902, the device may secure the tendon 140 to the bone due to friction between adjacent suture portions within the lumen 906, between each suture portion within the lumen 906 and the inner surface of the lumen 906, and between the suture portion 941 and the outer surface of the anchor.

Further, due to the provision of loops (not shown) or portions of material (not shown) of the anchor through which portions of the may suture extend at locations 952, 954, 956, and 958, when suture portions 932 and 934 are pulled in the direction of arrows 949, the anchor 902 may be compressed or deformed into a c-shaped or a u-shaped configuration or into a configuration having a plurality of undulations, as discussed herein. Such compression or deformation of the anchor may cause the anchor 902 to apply more force to inner surfaces of the bore in the bone, thereby better retaining the anchor within the bore in the bone, and better securing the tendon 140 to the bone.

While anchor 902 is described as having a single lumen 906 extending through a portion thereof, with openings 908, 910, 912, and 914 provided into lumen 906, this an exemplary embodiment. Alternatively, anchor 902, or any of the anchors discussed herein, may be provided with a plurality of lumens through which at least one suture portion may be passed. Alternatively, anchor 902 may be provided with, for example, loops (not shown) or portions of the material (not shown) of anchor 902 or any suitable passageway connected to or integrally formed with the anchor through which at least one of suture portions 916, 918, 932, and 934 and loop 940 may pass. For example, suture portion 934 may not enter into a lumen of anchor 902 but instead may pass through a loop or portion of the material or other passageway of anchor 902 at a location 904, according to some embodiments. . It is to be understood by persons skilled in the art that, similarly, any of the embodiments discussed herein may include one or more passageways formed, for example, of loops or material of the anchor, for example, connected to or integrally formed with the anchor, through which one or more suture portions may slidingly extend, as discussed herein.

It is appreciated by a person skilled in the art that the device for securing of a tissue to a bone is preferably intended for use in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. It is noted that the device is preferably indicated for use in foot, ankle, knee, hip, hand, wrist, elbow and shoulder.

It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove, rather the scope of the present invention includes both combinations and subcombinations of various features described hereinabove as well as variations and modifications thereof which are not in the prior art.

It is expected that during the life of a patent maturing from this application many relevant anchors will be developed and the scope of the term anchor 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, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure. 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. 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.

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.

It is appreciated that certain features of the invention, 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, 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. A device for securing of a tissue to a bone, comprising: an anchor configured to be deployed into a bore in a bone, said anchor having a passageway therethrough; and a first suture moveably loaded in said passageway, said first suture including a first loop having first and second extensions that extend from said passageway; wherein said first extension is configured to be passed through said first loop; wherein a tissue securing portion of said first suture is configured to be wrapped around the tissue; and wherein at least one of said first and second extensions is configured to be pulled proximally to shorten said first loop and to secure the tissue to the bone.

2. The device according to claim 1, wherein said anchor is deformable.

3. The device according to claim 1, wherein the tissue is a tendon.

4. The device according to claim 1, wherein at least a portion of said anchor is tubular and defines said passageway, and wherein said first suture is slidable through said passageway.

5. The device according to claim 1, wherein said passageway includes an inner lumen of a portion of said anchor.

6. The device according to claim 1, wherein a portion of said first loop extends through said passageway.

7. The device according to claim 1, wherein said anchor defines a geometric shape having an opening therein and wherein said first loop and said first and second extensions are defined by portions of said first suture that pass through said opening.

8. The device according to claim 1, wherein said first and second extensions are configured to be passed through said passageway in opposite directions.

9. The device according to claim 1, wherein said tissue securing portion is one of said first loop and said first extension.

10. The device according to claim 1, including a second suture movably loaded through said passageway, wherein said second suture is configured to provide a frictional component to said first suture.

11. The device according to claim 10, said second suture having a third extension; wherein said third extension is configured to be passed through said first loop.

12. The device according to claim 1, wherein said first suture includes a second loop; wherein said tissue securing portion is said second loop; wherein said first loop is configured to be passed through said second loop prior to passage of said first extension through said first loop; and wherein said second extension is configured to be passed through said first loop; and wherein both said first and second extensions are configured to be pulled proximally to shorten said first and second loops and to secure the tissue to the bone.

13. The device according to claim 1, wherein said first and second extensions of said first suture are configured to be passed through said passageway in a same direction.

14. The device according to claim 13, wherein said second extension is configured to be passed through said first loop.

15. The device according to claim 13, wherein said tissue securing portion is said first loop; said device including a second suture movably loaded through said passageway, said second suture having third and fourth extensions extending from said passageway; wherein said first and second extensions are configured to form at least one winding around at least one of said third and fourth extensions; wherein said at least one winding is configured to be tightened relative to said anchor.

16. The device according to claim 15, wherein said second suture is provided with a slider movable along said third and fourth extensions, said slider configured to be moved distally to tighten said at least one winding relative to said anchor.

17. The device according to claim 16, wherein said slider is a deforming slider.

18. The device according to claim 17, wherein said deforming slider is deformable.

19. The device according to claim 18, wherein said deforming slider has a first orientation, in which said deforming slider extends along a longitudinal axis, and a second orientation, in which said deforming slider has at least one of a bend and a curve.

20. The device according to claim 18 wherein, when in said second orientation, said deforming slider has a shape selected from: a w-shape, an n-shape, and a spiral shape.

21. The device according to claim 18 wherein, in said first orientation, said deforming slider has a first cross-sectional profile and wherein, in said second orientation, said deforming slider has a second cross-sectional profile and wherein said second cross-sectional profile is larger than said first cross-sectional profile.

22. The device according to claim 17, wherein said deforming slider is configured to increase friction between said second suture and said deforming slider.

23.The device according to claim 17, wherein said deforming slider is configured to prevent at least a first portion of one of said first and second sutures from moving relative to a second portion of said one of said first and second sutures.

24. The device according to claim 16, wherein one of said third and fourth extensions is configured to be pulled to move said slider distally along said third and fourth extensions.

25. The device according to claim 16, wherein one of said third and fourth extensions is provided with a knot to prevent said slider from becoming disengaged from said one of said third and fourth extensions.

26. The device according to claim 16, wherein said slider is tubular.

27. The device according to claim 1, wherein said first extension is configured to be positioned around the tissue and to be threaded through said passageway, thereby forming a second loop around the tissue, prior to passing of said first extension through said first loop.

28. The device according to claim 27, wherein said anchor includes at least a second passageway therethrough, said first loop and said first and second extensions configured to be passed through said second passageway.

29. The device according to claim 28, wherein said at least a second passageway includes between one and four passageways.

30. The device according to claim 26, wherein at least a portion of said first suture is configured to extend at least partly alongside a portion of said anchor.

31. A device for securing of a tissue to a bone, comprising: an anchor configured to be deployed into a bore in a bone, said anchor having a passageway therethrough; and a first suture moveably loaded in said passageway, said first suture including first and second extensions that extend from said passageway, wherein said first and second extensions of said first suture are configured to be passed through said passageway in a same direction; wherein a tissue securing portion of said first suture is configured to be wrapped around the tissue; and wherein at least one of said first and second extensions is configured to be pulled proximally to secure the tissue to the bone; said device including a second suture movably loaded through said passageway, said second suture having third and fourth extensions extending from said passageway; wherein said second suture is provided with a deforming slider movable along one of said third and fourth extensions; wherein said deforming slider is deformable and wherein said deforming slider has a first orientation, in which said deforming slider extends along a longitudinal axis, and a second orientation, in which said deforming slider has at least one of a bend and a curve; and wherein said deforming slider is configured to increase friction between said second suture and said deforming slider.

32. The device according to claim 31, wherein said first and second extensions are configured to form at least one winding around at least one of said third and fourth extensions; wherein said at least one winding is configured to be tightened relative to said anchor; wherein said deforming slider is configured to be moved distally to tighten said at least one winding relative to said anchor.

33. The device according to claim 31, wherein, when in said second orientation, said deforming slider has a shape selected from: a w-shape, an n-shape, and a spiral shape.

34.The device according to claim 31 wherein, in said first orientation, said deforming slider has a first cross-sectional profile and wherein, in said second orientation, said deforming slider has a second cross-sectional profile and wherein said second cross-sectional profile is larger than said first cross-sectional profile.

35.The device according to claim 31, wherein said deforming slider is configured to prevent at least a first portion of one of said first and second sutures from moving relative to a second portion of said one of said first and second sutures.

36. A system for securing of a tissue, comprising the device of claim 1 and an inserter configured to retain said anchor and to insert said anchor into the bore in the bone.

37. The system according to claim 36, wherein said inserter includes a distal recess and a lateral recess configured to retain said anchor on said inserter prior to insertion of said anchor into the bore in the bone.

38. The system according to claim 36, wherein said inserter has a longitudinal axis and wherein said lateral recess is oriented perpendicularly relative to said inserter longitudinal axis.

39. The system according to claim 38, wherein said recess includes a first wall oriented at an oblique angle relative to said inserter longitudinal axis.

40. The system according to claim 39, wherein said recess has a second wall oriented at a perpendicular angle relative to said inserter longitudinal axis, said second wall proximal to said first wall.

41. A method for securing a tissue, including: inserting an anchor into a bore in a bone, said anchor having a passageway therethrough and a first suture movably loaded in the passageway; wherein the first suture includes a first loop having first and second extensions that extend from the passageway; manipulating a tissue securing portion of the first suture around the tissue; passing at least one of the first and second extensions through the first loop; and pulling at least one of the first and second extensions to shorten the first loop and to secure the tissue to the bone.

42. The method according to claim 41, wherein said pulling includes shortening said first loop.

43. The method according to claim 41, wherein said pulling includes forming a knot in the first suture.

44. The method of claim 41, wherein a second suture is positioned in the passageway to provide a frictional component to said first suture.

45. The method according to claim 44, wherein said second suture includes a third extension and wherein said method includes, before said pulling, passing the third extension through the first loop.

46. The method according to claim 41, wherein said manipulating includes wrapping one of the first loop and the first extension around the tissue.

47. The method according to claim 41, wherein the first suture includes a second loop; wherein said manipulating includes manipulating the second loop around the tissue; wherein said method includes, after said manipulating, passing the first loop through the second loop.

48. The method according to claim 41, wherein said manipulating includes manipulating the first loop around the tissue; wherein said device includes a second suture movably loaded in said passageway, said second suture having third and fourth extensions that extend from the passageway; wherein said method includes, after said passing, forming at least one winding of said first and second extensions around at least one of said third and fourth extensions; and wherein said pulling includes pulling the first and second extensions proximally to shorten the first loop and to secure the tissue to the bone.

49. The method according to claim 48 including, after said pulling, moving a slider distally along said first and second portions of said second suture, to tighten said at least one winding relative to said anchor.

50. The method according to claim 49, wherein said moving the slider includes pulling one of said first and second ends of said second suture.

51. The method of claim 49, wherein said slider is a deforming slider.

52. The method of claim 51, wherein said deforming slider increases friction between said second suture and said deforming slider.

53. The method of claim 51, wherein said deforming slider prevents at least a first portion of one of said first and second sutures from moving relative to a second portion of said one of said first and second sutures.

54. The method according to claim 41, wherein said method includes, prior to said passing at least one of the first and second extensions through the first loop, passing said at least one of the first and second extensions through said passageway thereby forming a second loop; and wherein said second loop is said securing portion.

55. The method according to claim 50, wherein said anchor includes at least one additional passageway, said method including: prior to said passing at least one of the first and second extensions through the first loop, passing each of said first and second extensions and portions of said first loop through said at least one additional passageway; and wherein said pulling includes compressing or deforming the anchor by said suture portions passed through said passageway and said at least one additional passageway.

56. A method for securing a tissue, including: inserting an anchor into a bore in a bone, said anchor having a passageway therethrough and a first suture movably loaded in the passageway; wherein the first suture includes first and second extensions that extend from the passageway; manipulating a tissue securing portion of the first suture around the tissue; and pulling at least one of the first and second extensions to secure the tissue to the bone; wherein said device includes a second suture movably loaded in said passageway, said second suture having third and fourth extensions that extend from the passageway; wherein said pulling includes pulling the first and second extensions proximally to shorten the first loop and to secure the tissue to the bone; wherein said device includes a second suture movably loaded in said passageway, said second suture having third and fourth extensions that extend from the passageway; wherein said pulling includes pulling the first and second extensions proximally to secure the tissue to the bone; wherein said method includes, after said pulling, moving a deforming slider distally along said first and second portions of said second suture; and wherein said deforming slider increases friction between said second suture and said deforming slider.

57.The method of claim 56, wherein said method includes, after said manipulating, forming at least one winding of said first and second extensions around at least one of said third and fourth extensions, wherein said moving the deforming slider distally tightens said at least one winding relative to the anchor.

58. The method of claim 56, wherein said deforming slider prevents at least a first portion of one of said first and second sutures from moving relative to a second portion of said one of said first and second sutures.

PCT/IL2025/050032

18 February 2025

14/22

SUBSTITUTE SHEET (RULE 26) 20/22 18 February 2025 21/22 18 February 2025 22/22 18 February 2025