WO2025207348A1

WO2025207348A1 - Soft anchor tissue repair system

Info

Publication number: WO2025207348A1
Application number: PCT/US2025/020036
Authority: WO
Inventors: Mark E. Housman
Original assignee: Smith and Nephew Asia Pacific Pte Ltd; Smith and Nephew Inc
Current assignee: Smith and Nephew Asia Pacific Pte Ltd; Smith and Nephew Inc
Priority date: 2024-03-26
Filing date: 2025-03-14
Publication date: 2025-10-02
Anticipated expiration: 2026-09-26

Abstract

A tissue repair system including a soft anchoring construct with a repair suture and an insert member. The repair suture includes a lumen, and the insert member is located within this lumen for a length, this length defining an anchoring portion of the repair suture. The soft anchoring construct may be assembled to an insertion instrument that includes a tubular end effector with a lumen that slidingly received the repair suture. The anchoring portion is located distal to the tubular end effector and is prevented from entering the tubular end effector lumen. Tension on repair suture ends may deploy the anchoring portion to set it in bone.

Description

SOFT ANCHOR TISSUE REPAIR SYSTEM

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit to U.S. Provisional App. No. 63/569,865, filed March 26, 2024, titled “DOUBLE-LOADED ALL-SUTURE MICRO-ANCHOR”, herein incorporated by reference, in its entirety

FIELD

The present disclosure relates to constructs and associated methods for repairing soft tissue. More specifically, this disclosure relates to a soft anchor tissue repair system that may repair soft tissue.

BACKGROUND

Many orthopedic surgeries involve the use of anchors and suture constructs for repairing tissues. Preferably repairs are performed arthroscopically and preferably include anchors that are small, requiring less bone removal, while providing sufficient chronic fixation. More recently anchors that are formed predominantly of soft materials, such as braided suture material have become preferable. In addition, anchoring systems that do not require a knot to be tied (knotless) may be preferable. Disclosed herein are various soft anchor systems that includes a small profile soft anchor and insertion system that may repair a soft tissue without the need to tie knots.

DEFINITIONS

Described herein are tissue repair systems, which use a soft anchor. The tissue repair systems of this disclosure may provide a high fixation strength, fixing the soft anchor within bone. The tissue repair systems are may include a locking passage, avoiding the need for the surgeon to tie a knot. The tissue repair systems may include at least one suture. The term “suture” may include traditional sutures, that may be either hollow or may include braids along their core, unless were specified. The term “suture” may include equivalent flexible members, such as but not limited to suture tape or flattened suture and may in some cases be cable, ribbon or wire, where appropriate.

“Soft Anchor” is intended to mean a flexible and/or deformable anchor, where the anchor body is formed of soft, flexible suture-like material. The soft, flexible suture-like material of the anchor body changes to a more laterally and/or radially expanded configuration upon setting or deployment. A tensioning member that is operatively coupled through a portion of the soft anchor may be tensioned to laterally expand the soft anchor body. The term “soft anchor” does not preclude it from including supplemental portions that are somewhat rigid. In some embodiments, the soft anchor is formed entirely of braided strands. Some soft anchors deform to a deployed configuration that also includes a longitudinal contraction.

“Deploy” is intended to mean to change the shape of the body of the soft anchor so that it is set, fixed or anchored with/within a tissue. Deploying may increase an outer lateral dimension of the anchor body to secure it with a tissue. For example, this may fix the soft anchor within a bone hole. To deploy an anchor changes the anchor to a deployed configuration.

“Lock” or “locked configuration” with respect to a suture construct is intended to mean locking a suture such that the suture may no longer slide in at least one direction. Sliding in this at least one direction for example may loosen a repair tissue that is secured in place. The suture may form a loop including a tissue coupled thereto and the loop perimeter is prevented from sliding and increasing in perimeter size. With respect to an anchor body, a locked configuration is intended to mean locking the anchor body in a deployed configuration to inhibit the anchor body from relaxing/moving out of the deployed configuration.

“Knotlessly locking” or a word stemming derivative therefrom such as knotless locking or knotlessly locked, for example, is intended to mean a lock in a surgical construct or anchor system formed without having the tie a knot. A system provided with a preformed knot may be defined as knotlessly locking. Knotlessly locking may be achieved by passing at least one suture along a tortuous route through small openings, or through a suture locking passage construct, which may also be called Chinese finger traps, finger cinches or locking splices for example. To knotlessly lock the system, some of the sutures may extend through the suture locking passage of either the same suture or another suture, to form a self-locking adjustable suture construct as described herein. Suture locking passage may be selectively elongated, by applying tension to the locking passage to cinch around the suture disposed therein, thereby locking a portion of the adjustable suture construct.

“Deploying suture” is intended to mean an elongate flexible member that may be a suture(s) (or equivalent as defined herein) that deploys the soft anchor body, usually upon tension being applied to the deploying member. In some embodiments, the deploying member may also provide other functions.

“Repair Suture” is the suture (or equivalent as defined herein) passed through the repair tissue and used to affix the repair tissue to bone.

SUMMARY

Described herein are various improved methods and systems for tissue repair with a soft anchor with an insert member that acts as a bulking element, all assembled to a low-profile inserter. Tissue repair may repair soft tissue around the shoulder or hip for example.

One example embodiment disclosed herein includes a tissue repair system for tissue repair, the system including a soft anchoring construct and an insertion instrument. The soft anchoring construct includes a repair suture folded to define a distal bight end region with two limbs extending proximally from the distal bight end region. The distal bight end region of the repair suture includes a lumen. The soft anchoring construct also includes an insert member that is formed or obtained separately from the repair suture and is an elongate and flexible member. The insert member is located within and along the lumen at the distal bight end region, and together, the insert and distal bight end region define an anchoring region of the soft anchoring construct. The insertion instrument has a tubular end effector with a lumen extending axially therealong. The repair suture limbs extend along the tubular end effector lumen and the anchoring region is disposed distal to the tubular end effector. The tubular end effector lumen is sized to allow the repair suture limbs to slide therealong while preventing the anchoring region from entering the lumen, such that tension on the two limbs draws the anchoring region against a distal end surface of the tubular end effector and deforms the anchoring region to an increased transverse dimension, thus setting the anchoring region in bone.

In some example embodiments, the entire insert member may be located within the distal bight end region lumen. The insert member may be sized to dilate the distal bight end region when inserted. The insert member may be a length of suture. The insertion instrument may also include two longitudinally extending prongs, the anchoring region coextensive with the longitudinally extending prongs. The two longitudinally extending prongs may include distal self-tapping ends. The two longitudinally extending prongs may be circumferentially spaced to define two longitudinally extending slots that are sized to allow passage for the anchoring region therethrough while deforming to the increased transverse dimension. The two longitudinally extending prongs may be circumferentially spaced to define two longitudinally extending slots and wherein when the anchoring region is deformed to an increased transverse dimension, the anchoring region move through the two longitudinally extending slots to engage adjacent bone. The construct may also include a snare construct that extends along and within the distal bight end lumen and may draw a suture through the distal bight end lumen. The snare construct may draw one of the limbs of the two repair suture limbs through the distal bight end lumen, forming a repair suture loop coupled to a repair tissue and tension on one of the two repair suture limbs may knotlessly lock the repair suture loop.

Another example embodiments disclosed herein may include a tissue repair system for soft tissue repair that includes a soft anchoring construct and an insertion instrument. The soft anchoring construct may include a repair suture defining a distal bight end region and two limbs extending proximally therefrom. The distal bight end region includes a lumen. The soft anchoring construct may include an insert member, formed separately from the repair suture. The insert member is an elongate and flexible member. The insert member is located within and along the distal bight end region lumen, defining an anchoring region of the soft anchoring construct. The insert member is sized to bulk up or dilate the lumen of the distal bight region relative to the two limb upon insertion. The insertion instrument includes a tubular end effector with a lumen that extends axially therealong. The repair suture limbs extend along the tubular end effector lumen and the anchoring region is located distal to the tubular end effector. The two limbs may slide along the tubular end effector lumen and the anchoring region is sized so that it is prevented from entering the tubular end effector lumen, upon tension being applied to the two limbs.

In some embodiments, the insert member is entirely disposed within and along the distal bight end region lumen. The insert member may be a length of suture. The insertion instrument may also include two longitudinally extending prongs, extending distally from the tubular end effector, the anchoring region coextensive with the longitudinally extending prongs. Tension on the two limbs may draw the anchoring region against a distal end surface of the tubular end effector and deploy the anchoring region, thus setting the anchoring region in bone. The two longitudinally extending prongs are circumferentially spaced to define two longitudinally extending slots configured to allow passage for the anchoring region therethough while deploying. The construct may also include a snare construct extending along the distal bight end region lumen and insert member, and the snare construct may draw a suture through the distal bight end region lumen. The snare construct may draw a limb of the two limbs through the distal bight end region lumen, forming a repair suture loop coupled to the soft tissue. Tension on a limb of the two limbs after being drawn through the distal bight end lumen may knotlessly lock the repair suture loop.

Another example embodiment of a tissue repair system for soft tissue repair is disclosed including a soft anchoring construct and an insertion instrument. The soft anchoring construct includes a repair suture defining a distal bight end region and two limbs extending proximally from the distal bight end region. The distal bight end region includes a lumen. The soft anchoring construct also includes an insert member, formed separately from the repair suture, the insert member being elongate and flexible and having a length with a first and second end. The insert member is disposed within the lumen at the distal bight end region and is configured to add bulk to the distal bight end region. The first and second ends of the insert member both define a proximal end of an anchoring region of the soft anchoring construct. The insertion instrument includes a tubular end effector with a lumen extending axially therealong. The two limbs extend within the tubular end effector lumen and the anchoring region is disposed distal to the tubular end effector. The tubular end effector lumen is configured to allow the repair suture limbs to slide therealong and prevent the anchoring region from entering. Tension on the two limbs is configured to draw the first and second ends of the insert member against a distal end surface of the tubular end effector and deform the anchoring region to an increased transverse dimension, thus setting the anchoring region in bone.

These and other features and advantages will be apparent from a reading of the following detailed description and a review of the associated drawings. It is to be understood that both the foregoing general description and the following detailed description are explanatory only and are not restrictive of aspects as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure will be more fully understood by reference to the detailed description, in conjunction with the following figures, wherein:

FIG. 1 schematically shows an example soft anchor repair construct, in accordance with this disclosure;

FIGS. 2A-2C shows an example insertion instrument distal end, in accordance with this disclosure;

FIG. 3A illustrates a soft anchor repair construct assembled to an insertion instrument distal end, in accordance with this disclosure;

FIG. 3B illustrates the soft anchor repair construct assembled to the insertion instrument, inserted into bone and from a different viewing direction than FIG. 3A, in accordance with this disclosure;

FIG. 30 illustrates the soft anchor repair construct assembled to the insertion instrument, inserted into bone, and deployed, in accordance with this disclosure;

FIG. 4A schematically shows a second example soft anchor repair construct, deconstructed, in accordance with this disclosure;

FIG. 4B schematically shows the second example soft anchor repair construct, assembled, in accordance with this disclosure; and FIG. 4C schematically shows the second example soft anchor repair construct, assembled, deployed and knotlessly locked with a repair tissue, in accordance with this disclosure.

DETAILED DESCRIPTION

In the description that follows, like components have been given the same reference numerals, regardless of whether they are shown in different examples. To illustrate example(s) in a clear and concise manner, the drawings may not necessarily be to scale and certain features may be shown in somewhat schematic form. Features that are described and/or illustrated with respect to one example may be used in the same way or in a similar way in one or more other examples and/or in combination with or instead of the features of the other examples.

As used in the specification and claims, for the purposes of describing and defining the invention, the terms “about” and “substantially” are used to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The terms “about” and “substantially” are also used herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. “Comprise,” “include,” and/or plural forms of each are open ended and include the listed parts and can include additional parts that are not listed. “And/or” is open-ended and includes one or more of the listed parts and combinations of the listed parts. Use of the terms “upper,” “lower,” “upwards,” and the like is intended only to help in the clear description of the present disclosure and are not intended to limit the structure, positioning and/or operation of the disclosure in any manner.

FIG. 1 schematically shows an example soft anchor construct 100 that may be inserted into and fix with bone to repair a soft tissue, in accordance with this disclosure. In other applications, construct 100 may fix with soft tissue, such as meniscus or labral tissue. FIG. 1 illustrates construct 100 in an undeployed configuration. Construct 100 may obtained in a configuration that may be low profile and may be changed to a deployed configuration (shown in later figures) that has a larger transverse dimension and a shorter axial dimension that may be characterized as a generally bunched up mass. In this embodiment, construct 100 may include a braided body 1 10 with two limbs 1 10a, 1 10b extending from a distal bight region 110c. Tension on at least one of the two limbs 110a, 1 10b may change the distal bight region 110c to a deployed configuration.

The braided body 1 10 may be a single continuously braided body along its length and may be braided to have a lumen or cannulation 1 1 1 along its entire length. Braided body 1 10 may be a length of suture and may be USP size No. 2 having an outer diameter as obtained that is approximately 0.6mm. In other embodiments, braided body 110 may be continuously braided along its entire length, but the braiding pattern, may change therealong to define different functions. For example, limbs 1 10A, 110 B may be absent a lumen or cannulation 1 1 1 providing smaller outer diameter limbs, while distal bight region 1 10c may preferably include a lumen 11 1. The braided body 110 may be continuously braided along its length, but the braiding pattern may change therealong. For example, the picks per inch (PPI) or total number of strands may change at a transition point between the distal bight region 1 10c and the two limbs 110A, 110B. In one example, the distal bight region 110c may be a loosely braided portion, braided at less than 50 PPI, while the two limbs 1 10a, 1 10b may by tightly braided at greater than 10Oppi. Tension on the limbs 110a, 110b may preferably allow the braid picks along the bight region 1 10C to rotate relative to each other and more readily deform during deployment. Having a higher PPI along the limbs 110a, 1 10b may limit any elongation, strain or change in shape to the limbs 110a, 110b. Braided body 1 10 may be continuously braided so that the distal bight region 1 10c has a larger outer diameter and/or larger cannulation than the two limbs 110a, 1 10b.

Limbs 1 10a, 110b may couple directly to a repair tissue, such as a tendon or labrum, and therefore limbs 110a, 1 10b may define repair suture limbs. Distal bight end region 1 10c may be formed as “II” and may include an insert 120 therealong, together defining an anchoring region 130. Anchoring region 130 may be entirely inserted within bone and under the bone cortical layer and may, as its name suggest, upon deployment, fix, anchor or set the construct 100 with or within the bone. In other applications, anchoring region 130 may be inserted into or through other tissues, such as tendon, ligament or meniscal tissue and may, upon deployment, fix, anchor or set the construct 100 with or within a soft tissue. Insert 120 is disposed at the distal bight end 1 10c. Insert 1 0 may be located in the cannulation 1 11 and has a length that may extend around and along the distal bight end 1 10c. Insert 120 is configured to add bulk to the distal bight end 1 10c. When assembled to an insertion instrument (discussed later herein) insert 120 may be sized, in cooperation with the distal bight end 1 10c to prevent the distal bight end 110c from being pulled into an instrument lumen. Insert 120 may reinforce the distal bight end 1 10c.

Insert 120 may be a short flexible tubular member. Insert 120 may be formed of a short length of soft, flexible suture-like material. Insert 120 may be separately fabricated relative to the braided body 110 and inserted into and along the distal bight end 110c. Insert 120 may be pre-formed or provided in a “LT shape. Inserting insert 120 may dilate distal bight end 110c, or in other embodiments distal bight end 1 10c may be pre-formed or dilated first, to receive insert 120. Insert 120 may be inserted between braids of the distal bight region 110c, and therefore braided body 1 10 may be preferably braided to easily allow insertion of insert 120. Insert 120 may be entirely disposed along the distal bight end 1 10c and together they define the anchoring region 130 of construct 100. In some embodiments, insert 120 may be resilient (a spring) or a flexible polymeric tube. Insert member 120 may be elastically or plastically deformable. In some embodiments, insert 120 may include a high friction surface, which may increase a locking strength of a knotlessly locked configuration (discussed in more detail hereinafter).

An example method of construction of construct 100 may include obtaining a repair suture 1 10, that may be a size No. 2 suture and may include a lumen therealong. The repair suture 110 may be folded to form a “LT or a distal bight end region 1 10c. An insert member 120 may also be obtained, the insert member having a diameter or cross- sectional width that is at least an inner lumen diameter of the repair suture 110. The insert member as obtained may be sized to at least fill the inner lumen 1 11. Insert member 120 may have a diameter or cross-sectional width that is greater than an outside diameter of the repair suture 1 10. The insert member may be a size No. 5 suture, that has an outside diameter between 0.7-0.8mm. The insert member may then be inserted into the lumen 1 11 along the distal bight end region 110c. While being inserted, the braided body at the distal bight end region 110c may radially expand (dilate) to fit the insert member 120 therein. In some example methods of construction, a dilating tool may first be used to prepare the distal bight region 1 10c. Once inserted, the outer diameter of braided body along distal bight regionl 10c may be dilated to be double its original size. Stated another way, the outer diameter of braided body along distal bight regionl 10c may be double a corresponding outer diameter of limbs 1 10a, 100b due to assembly with the insert member 120.

FIG. 2A-2C schematically shows various views of an insertion instrument shaft distal end 200. Distal end 200 may be tubular with a lumen 205 therealong. Insertion instrument may include a proximal handle end (not shown), with insertion instrument tubular shaft extending distally therefrom. Distal end 200 may include a tubular portion 208 defining a 360-degree bounded lumen 205 (FIG. 2B), with two prongs 220a, 220b extending distally therefrom. Prongs 220a, 220b may be diametrically opposed from each other. Prongs 220a, 220b may extend circumferentially (best seen in FIG. 2C) and be continuous with an outer circumferential surface of tubular portion 208. Circumferentially between both prongs 220a, 220b are two circumferential slots 210a, 210b. Slots 210a, 210b may have a circumferential width configured to allow passage of the anchoring portion 130 therethrough during deployment. Slots 210a, 210b may have a circumferential width that is at least as wide as a diameter “D” of the anchoring portion 130 to receive the anchoring portion therethrough during deployment.

Slots 210a, 210b extend up to and including a distal most edge end of the distal end 200. Prongs 220a, 220b may each have a distal sharp edge 221 , configured to pierce bone. This may provide a self-tapping function and avoid the need for a separate procedure to prepare the bone first. Insertion instrument distal end 200 is generally configured to be inserted through a small opening through the patient’s skin to access a joint and may be inserted through a prepared arthroscopic port. Insertion instrument may be termed an arthroscopic instrument.

FIG. 3A schematically shows construct 100 assembled with insertion instrument distal end 200. This may be the configuration as obtained. Anchoring region 130 extends along prongs 220a, 220b and may be at least partially contained within a boundary defined by inner lumen surfaces of prongs 220a, 220b. Anchoring region 130 may have a thickness or diameter (D) equal to or smaller than a corresponding circumferential width of slots 210a, 210b, as during deployment, anchoring region 130 moves laterally through these slots 210a, 210b. Anchoring region 130 may have an axial length that is equal to or less than a corresponding axial length of prongs 220a, 220b, such that the anchoring region 130 is proximally recessed relative to distal edge ends 221 of prongs 220a, 220b. This may allow prongs distal edge ends 221 to prepare a bone hole for the anchoring portion 130 to be housed in. Insertion instrument distal end 200 may be tubular such that limbs 110a, 110b may extend proximally along lumen 205. More specifically, insertion instrument distal end lumen 205 may be sized to slidingly receive limbs 1 10a, 1 10b, while also sized to prevent anchoring portion 130 from entering. In use, limbs 1 10a, 110b may be coupled to a tensioning actuation system in a proximal handle (not shown). Tensioning handle may be similar to instruments disclosed in at least US patent 9,962,149, titled “Tissue Repair Assembly”; commonly owned and herein incorporated by reference in its entirety.

FIG. 3B schematically represents construct 100 assembled with insertion instrument 200 from a perpendicular direction relative to FIG. 3A. Figure 3B shows the insertion instrument distal end 200 inserted but not yet deployed within bone, 50. Preferably anchoring region 130 is inserted below cortical layer 52. Distal edge ends 221 may have formed the bone hole while inserting the distal end 200. The legs of the “U” shaped anchoring region 130 may at least partially rest though slots 210a, 210b during insertion.

Tension on limbs 1 10a, 110b (see arrows) may deploy anchoring region 130 to the configuration shown in FIG. 3C. During actuation, anchoring region 130, including insert member 120 may be drawn proximally, however, the anchoring region 130 is sized so that it is prevented from entering insertion instrument lumen 205. Stated another way, lumen 205 is sized to prevent the anchoring region 130 from entering it and provide a back stop. While this may be achieved though instrument lumen size, other means are contemplated, such as a projecting member traversing the lumen 205 or at least partially narrowing of the lumen 205 at the lumen entrance. Anchoring region 130 therefore bunches up against a surface adjacent the proximal end edge of slots 210a, 210b, causing the anchoring region 130 to bunch up and deploy to a laterally increased width. This may set, embed or anchor the anchoring region 130 within the cancellous bone 50 and under the harder cortical bone 52, as shown in FIG. 3C. Slots 210a, 210b are sized to allow passage of the anchoring portion 130 therethrough in a radial direction, to deploy, engage and set within the cancellous bone 50. The anchoring portion 130 is deployed with the insertion instrument remaining stationary and remaining inserted in the target bone. Advantageously, this insertion instrument distal end 200 is a single stationary tube that both houses anchoring region 130 and provides a backstop surface for deploying an anchoring region 130. No additional mechanism, tubing, push rods etc may be needed, meaning the system may be smaller in profile, requiring smaller ports and bone holes.

Insertion instrument may then be removed and repair suture limbs 1 10a, 1 10b may then be coupled to a repair tissue. In some example methods, the two repair suture limbs 1 10a, 1 10b may be tied together in a knot to couple the repair tissue. In other example method, at least one of the limbs 110a, 110b may be coupled to another anchor (not shown). In other example method, at least one of the limbs 1 10a, 110b may be coupled to a snare and snared through the anchoring portion 130 as is disclosed hereinafter.

FIG. 4A illustrates components of an example construct 200 that includes snaring members for drawing a suture through the construct. Construct 400 may be similar to the construct 100, with the addition of at least one transfer suture or snaring member, 410a. A second optional transfer suture 410b is also shown. Transfers suture(s) 410a (and 410b) may be threaded through the braided walls of braided body 110 adjacent to insert member 120, as shown in FIG. 4B. Transfers suture(s) 410a (and 410b) may be threaded through the braided walls of braided body 110 and located along an external surface of the insert member 120 and an inner lumen surface of distal bight region 110c, as shown in FIG. 4B. Transfer sutures 410a, 410b may include a looped end configured to couple to a separate suture and then draw the separate suture into and along the anchoring region 130. In some embodiments, transfer suture(s) 410a (and 410b) may couple to repair limbs 1 10a, 1 10b and draw the limbs 1 10a, 1 10b back through itself (along distal bight region 1 10c). FIG. 4C illustrates an example repair with the anchoring portion 130 in a deployed configuration. Construct 400 may be deployed in a similar manner as described for construct 100. Limb 1 10a may be coupled to a repair tissue 40 and then drawn through the distal bight region 1 10c, via one of the transfer sutures, in this example it is snared and transferred via transfer suture 410b. More specifically, limb 110a may be coupled to a loop end 454 of transfer suture 410b and then the opposite end of the transfer suture 410b may be withdrawn to transfer the end 110a through the lumen 11 1 of distal bight end 110c, including along an external surface of insert member 120. This forms a repair loop 440a that is unilateral in that it is on a single side of the construct longitudinal axis. Alternatively, the repair loop 440a may extend across the longitudinal axis of the construct 400, by snaring the end 110a with the transfer suture 410a. A similar repair loop may be formed, in a mirror image form with limb 1 10b and one of transfer suture 410a, or 410b to form another repair loop similar to loop 440a. Tension on at least one of limb 110a or 1 10b before or after the repair loop(s) is/are formed may cinch the lumen 111 of distal bight end 1 10c around any suture disposed therein and knotlessly lock the repair.

Also shown in FIG. 4C is a suture 460, separately formed and obtained, that may be coupled to another portion of the tissue 40, another tissue, and/or to tissue anchor. Suture 460 may be transferred through anchoring portion 130 via a transfer suture (410a shown) so as to be disposed within the lumen 1 11 and may be coextensive with and external to the insert member 120. Tension on at least one of limb 110a or 110b thereafter may cinch the inner lumen 111 of distal bight end 1 10c around this separate suture disposed therein and knotlessly lock the separate suture 460 with the construct 400.

In some embodiments transfer suture(s) 410a, 410b may punch through an entire diameter of body 1 10 first, and then enter a lumen of braided body 1 10 adjacent insert member 120, which may improve control of tension and locations of any formed locking passages. In some embodiments a transfer suture(s) 410a, (410b) may interweave pr punch through the insert member 120 as it extends along the lumen 1 1 1 , which may improve increase a fixation strength of any formed locking passages.

Transfer suture(s) 410a, 410b may be a separately formed suture, that may be absent a lumen. Transfer suture(s) 410a, 410b may define a smaller diameter suture than any portion of the braided body 1 10. In some embodiments transfer suture(s) 410a, 410b may be a flexible member such as a cable or a wire. Transfer suture(s) 410a, 410b may include a looped end 454 for receiving the repair suture limb. Looped end 454 may be a fixed loop in that it does not reduce with tension. In other embodiments, looped end 454 may include a reducing loop, that reduces and cinches around the repair suture end with tension. One skilled in the art will realize the disclosure may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing examples are therefore to be considered in all respects illustrative rather than limiting of the disclosure described herein. Scope of the disclosure is thus indicated by the appended claims, rather than by the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

Claims

What is claimed is: Claims

1 . A tissue repair system for soft tissue repair comprising; a soft anchoring construct including; a repair suture defining a distal bight end region and two limbs extending proximally from the distal bight end region, the distal bight end region having a lumen; and an insert member having a length, the insert member located within and along the distal bight end region lumen, wherein the insert member length and distal bight region together define an anchoring region of the soft anchoring construct; and an insertion instrument comprising a tubular end effector having a lumen extending axially therealong, the repair suture limbs extending along the tubular end effector lumen and the anchoring region located distally from the tubular end effector, wherein the tubular end effector lumen is configured to prevent entry by the anchoring region, such that tension on the two limbs is configured to draw the anchoring region against a distal end surface of the tubular end effector and deform the anchoring region to an increased transverse dimension, thus setting the anchoring region in bone.

2. The tissue repair system for soft tissue repair of claim 1 wherein the entire insert member is located within the distal bight end region lumen.

3. The tissue repair system for soft tissue repair of claim 1 wherein the insert member is configured to dilate the distal bight region.

4. The tissue repair system for soft tissue repair of claim 1 wherein the insert member is a length of suture having a diameter configured to radially deform the repair suture along the distal bight end region.

5. The tissue repair system for soft tissue repair of claim 1 wherein the insertion instrument further comprises two longitudinally extending prongs extending from the tubular distal end, the anchoring region coextensive with the two longitudinally extending prongs.

6. The tissue repair system for soft tissue repair of claim 5 wherein the two longitudinally extending prongs include distal ends configured to self-tap through bone.

7. The tissue repair system for soft tissue repair of claim 5 wherein the two longitudinally extending prongs are circumferentially spaced to define two longitudinally extending slots configured to allow passage for the anchoring region therethough while deforming to the increased transverse dimension.

8. The tissue repair system for soft tissue repair of claim 5 wherein the two longitudinally extending prongs are circumferentially spaced to define two longitudinally extending slots and therein when the anchoring region is deformed to an increased transverse dimension, the anchoring region extends through the two longitudinally extending slots to engage adjacent bone.

9. The tissue repair system for soft tissue repair of claim 1 further comprising a snare construct extending within the distal bight end lumen, configured to draw a suture through the distal bight end lumen.

10. The tissue repair system for soft tissue repair of claim 9 wherein the snare construct is configured to draw a limb of the two limbs through the distal bight end lumen, forming a repair suture loop.

1 1 . The tissue repair system for soft tissue repair of claim 10 wherein tension on one of the two limbs after a limb of the two limbs has been drawn through the distal bight end lumen knotlessly locks the repair suture loop.

12. A tissue repair system for soft tissue repair comprising; a soft anchoring construct including; a repair suture defining a distal bight end region and two limbs extending proximally from the distal bight end region, the distal bight end region having a lumen; and an insert member that is elongate and flexible, located entirely within and along the distal bight end region lumen, defining an anchoring region of the soft anchoring construct; and an insertion instrument comprising a tubular end effector having a lumen extending axially therealong, the repair suture limbs extending along the tubular end effector lumen and the anchoring region located distally to the tubular end effector, wherein the two limbs are configured to slide along the tubular end effect lumen and the insert member is configured to dilate the distal bight region such that the anchoring region is prevented from entering the tubular end effector lumen, upon tension being applied to the two limbs.

13. The tissue repair system for soft tissue repair of claim 12 wherein the insert member is configured to dilate the distal bight region such that the anchoring region has an outside diameter that is at least double a corresponding diameter of a limb of the repair suture limb.

14. The tissue repair system for soft tissue repair of claim 12 wherein the insert member is a length of suture.

15. The tissue repair system for soft tissue repair of claim 12 wherein the insertion instrument further comprises two longitudinally extending prongs, the anchoring region coextensive with the longitudinally extending prongs.

16. The tissue repair system for soft tissue repair of claim 15 wherein tension on the two limbs is configured to draw the anchoring region against a distal end surface of the tubular end effector and deform the anchoring region to an increased transverse dimension, thus setting the anchoring region in bone and wherein the two longitudinally extending prongs are circumferentially spaced to define two longitudinally extending slots configured to allow passage for the anchoring region therethough while changing to the increased transverse dimension.

17. The tissue repair system for soft tissue repair of claim 12 further comprising a snare construct extending along the distal bight end region lumen and insert member and configured to draw a suture through the distal bight end lumen.

18. The tissue repair system for soft tissue repair of claim 17 wherein the snare construct is configured to draw a limb of the two limbs through the distal bight end lumen, forming a repair suture loop coupled to the soft tissue.

19. The tissue repair system for soft tissue repair of claim 18 wherein tension on another limb of the two limbs after being drawn through the distal bight end lumen knotlessly locks the repair suture loop.

20. A tissue repair system for soft tissue repair comprising; a soft anchoring construct including; a repair suture defining a distal bight end region and two limbs extending proximally from the distal bight end region, the distal bight end region having a lumen; and an insert member having a length with a first and second end, the insert member located within the repair suture lumen and configured to add bulk to the distal bight end region, and wherein the first and second ends of the insert member define a proximal end of an anchoring region of the soft anchoring construct; and an insertion instrument comprising a tubular end effector having a lumen extending axially therealong, the two limbs extending within the tubular end effector lumen and the anchoring region disposed distal to the tubular end effector, wherein the tubular end effector lumen is configured to allow the repair suture limbs to slide therealong and prevent the anchoring region from entering, and wherein tension on the two limbs is configured to draw the first and second ends of the insert member against a distal end surface of the tubular end effector and deform the anchoring region to an increased transverse dimension, thus setting the anchoring region in bone.