All-suture knotless tissue repair

Abstract

A knotless all-suture system with a preformed repair loop. The system includes an insertion instrument with a tension actuator, the instrument housing a knotless all-suture construct. The construct includes an all-suture anchor and a first repair suture. The first repair suture is formed in a preformed loop that extends proximally from the all-suture anchor and includes a locking passage that extends through the all-suture anchor. The preformed loop extends along and within a shaft of the insertion instrument and is coupled to the tension actuator, such that actuating the tension actuator sets the all-suture anchor via tension along the preformed loop.

Description

[0001] PT-6178-WO-PCT

[0002] ALL-SUTURE KNOTLESS TISSUE REPAIR

[0003] CROSS REFERENCE TO RELATED APPLICATIONS

[0004] This application claims the benefit to U.S. Provisional App. No. 63 / 691 ,354, filed September 6, 2024, titled “ALL-SUTURE KNOTLESS TISSUE REPAIR”, herein incorporated by reference, in its entirety. This application claims the benefit to U.S. Provisional App. No. 63 / 711 ,229, filed October 24, 2024, titled “SOFT ANCHOR REPAIR ASSEMBLY”, herein incorporated by reference, in its entirety.

[0005] FIELD

[0006] 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 be knotless and may repair soft tissue.

[0007] BACKGROUND

[0008] 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 include a small profile soft anchor and insertion system that may repair a soft tissue without the need to tie knots.

[0009] DEFINITIONS

[0010] Described herein are tissue repair systems, which use a soft anchor. The tissue repair systems of this disclosure may provide a high fixation strength connection between the soft anchor and bone. The tissue repair systems may include a locking passage, PT-6178-WO-PCT 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, or a combination of both, 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.

[0011] “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 more 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.

[0012] “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.

[0013] “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 at least this 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.

[0014] “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 PT-6178-WO-PCT 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.

[0015] “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, such as the repair suture.

[0016] “Repair Suture” is the suture (or equivalent as defined herein) coupled to the repair tissue and relied upon to affix the repair tissue to bone.

[0017] SUMMARY

[0018] Described herein are various improved methods and systems for tissue repair with a soft anchor, obtained with a preformed knotless loop. The preformed loop may extend proximally from the anchor, with an opening sized to receive an end of soft tissue therethrough before being reduced to fix the soft tissue in place and knotlessly lock the loop in its reduced state. The preformed loop acts as a cerclage and may knotlessly reattach a tendon or ligament with a free end to a bone, the free end being inserted through the preformed loop. The preformed loop may be coupled to a tensioning portion of an insertion instrument, and the anchor may be deployed by tension applied directly and bilaterally on portions of the preformed loop.

[0019] One example embodiment disclosed herein is an all-suture tissue repair system including an insertion instrument and a tissue repair construct. The insertion instrument may include a handle that includes a tension actuator. The instrument may house the construct therein and may be used to insert and deploy the tissue repair construct. The tissue repair construct may include a soft anchor, that may be a tubular body with a longitudinal axis, a distal end and a proximal end. The construct may also include a repair PT-6178-WO-PCT suture that extends through the soft anchor and includes a preformed loop that extends proximally from the soft anchor proximal end. The repair suture may also extend through itself to form a locking passage; the locking passage located within the soft anchor. A free limb of the repair suture may extend from a proximal end of the locking passage and proximally from the soft anchor. The preformed loop may extend along and within a shaft of the insertion instrument and is operatively coupled to the tension actuator.

[0020] In some optional embodiments, the first repair suture may have a first end fixed to the soft anchor distal end, and the repair suture may extend proximally from the fixed end while interweaving along and through the tubular body before extending both from the anchor proximal end and back into the anchor proximal end to form the preformed loop.

[0021] In some optional embodiments, the tension actuator may include a spool and cleat, and the preformed loop may be wrapped around the spool and cinched in the cleat to couple to the tension actuator. In some optional embodiments, the preformed loop may extend from the soft anchor proximal end defining a first limb of the preformed loop, along the insertion instrument shaft and then return back into the soft anchor proximal end defining a second limb of the preformed loop and wherein both the first and second limb of the preformed loop may be operatively coupled to the tension actuator so that tension is distributed evenly on both the first and second limbs of the preformed loop when the tension actuator is actuated. In some embodiments, the repair suture free limb may also be coupled to the tension actuator. The repair suture free limb may be wrapped around the spool and cinched in the cleat, together with the preformed loop.

[0022] In some embodiments, the repair suture first end may include a knot and a through- punch, both located externally to the soft anchor, the through-punch disposed along a length of the repair suture that is located between the knot and the soft anchor. The repair suture first end may form a loop that extends through the soft anchor distal end, this loop located along a length of the repair suture that is located between the knot and the through- punch. The repair suture first end loop may extend through an entire diameter of the tubular body. The tubular body may include braided threads that are heat-sealed at the soft anchor distal end, and the repair suture first end loop may extend through the soft anchor distal end at a location slightly proximal of the heat-sealed braided threads. The through-punch may form a repair suture closed loop, the repair suture closed loop PT-6178-WO-PCT extending through the soft anchor distal end. The repair suture may form a second through-punch directly adjacent a distal end of the locking passage. A tail end of the repair suture, extending distally from the knot may extend through the repair suture repair loop, configured to tuck the knot into the soft anchor distal end, and reduce any catching of the tail end with the target tissue as the insertion instrument is inserted into and through tissue.

[0023] Some embodiments may include a second repair suture that extends through the soft anchor and includes its own preformed loop that extends from and back into the proximal end of the soft anchor, the second repair suture extending through itself to form a second locking passage located through the soft anchor, the second repair suture circumferentially offset through the tubular body from the first repair suture. The preformed loop of the second repair suture may extend along and within a shaft of the insertion instrument and may be operatively coupled to the tension actuator, such that tension on the second preformed loop via actuation of the tension actuator is configured to deploy the soft anchor and set the soft anchor in or with a target bone.

[0024] In some embodiments, the first repair suture has a first length portion with a first diameter and a second length portion with a larger diameter, and wherein the second length portion is externally and proximally located relative to the soft anchor during insertion and wherein tension on the repair suture free limb is configured to reduce the preformed loop and move the second length portion into the locking passage and thereby further set the soft anchor with the target tissue and also increase the knotless locking fixation.

[0025] A method of repair with the tissue repair system embodiments disclosed herein, is also disclosed. This method includes using the insertion instrument to insert the soft anchor into or through bone, with the preformed loop housed along an insertion instrument shaft. The tension actuator may then be actuated to apply tension to the preformed loop and thereby set the soft anchor with the bone. The preformed loop may then be released or removed from the insertion instrument after actuating. A free end of soft tissue may then be passed through the preformed loop and the free limb of the repair suture tensioned to reduce the preformed loop around the soft tissue. The free end of the repair suture may be further tensioned to knotlessly lock the locking passage and fix the soft tissue in place. PT-6178-WO-PCT

[0026] Another example embodiment is disclosed herein of a soft tissue repair system, including an insertion instrument and a knotlessly locking soft cerclage construct. The insertion instrument includes a handle with a tension actuator and houses the knotlessly locking soft cerclage construct, the construct including a soft anchor and a repair suture. The anchor may define a tubular body having a longitudinal axis, a distal end and a proximal end. The first repair suture may have a first end fixed to a distal end of the soft anchor, and extend proximally therefrom, interweaving along and through the tubular body before extending from and back into the anchor proximal end, forming a preformed cerclage loop. The repair suture may also extend through itself to form a locking passage, the locking passage interwoven through the soft anchor. The first repair suture may also include a free limb that extends proximally from a proximal end of the locking passage and proximally from the anchor proximal end. The preformed cerclage loop may extend along and within a shaft of the insertion instrument and couple directly to the tension actuator.

[0027] 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.

[0028] BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The disclosure will be more fully understood by reference to the detailed description, in conjunction with the following figures, wherein:

[0030] FIG. 1A schematically shows an example soft anchor repair construct, in an undeployed configuration, in accordance with this disclosure;

[0031] FIG. 1 B schematically shows an example soft anchor repair construct, in a deployed and repaired configuration, in accordance with this disclosure;

[0032] FIG. 2 schematically shows another example soft anchor repair construct, in an undeployed configuration, in accordance with this disclosure;

[0033] FIG. 3A schematically shows another example soft anchor repair construct, in an undeployed configuration, in accordance with this disclosure;

[0034] FIG. 3B schematically shows another example soft anchor repair construct, in a deployed and repairing configuration, in accordance with this disclosure; PT-6178-WO-PCT

[0035] FIGS. 4A-4K show a method of assembly of the soft anchor repair construct, in accordance with this disclosure;

[0036] FIG. 5A shows an example soft anchor repair construct housed in a distal end of an example insertion instrument, in accordance with this disclosure;

[0037] FIG. 5B shows an example soft anchor repair construct coupled to an example tension actuator of an example insertion instrument handle, in accordance with this disclosure;

[0038] FIG. 6 schematically shows another example soft anchor repair construct, in an undeployed configuration, in accordance with this disclosure; and

[0039] FIGs 7A-7C schematically show a proximal end of double repair suture soft repair constructs, representing arrangements of the two-repair suture construct, in accordance with this disclosure.

[0040] DETAILED DESCRIPTION

[0041] 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.

[0042] 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 PT-6178-WO-PCT 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.

[0043] FIG. 1 A schematically shows an example soft anchor construct 100 that may be inserted into and fixed 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. Construct 100 may fix with an external surface of bone or may be disposed within and fix within a bone. Construct 100 may repair a free end of a ligament or tendon, such as the proximal end of the bicep tendon or the lateral ligaments of the knee, for example.

[0044] FIG. 1A illustrates construct 100 in an undeployed configuration. Construct 100 may be obtained in a configuration that may be low profile for insertion into and through tissues and may be changed to a deployed or set 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.

[0045] In this embodiment, construct 100 may include a soft anchor 102, that may be similar to anchors disclosed in at least U.S. Patent 9,962,149, titled “Tissue Repair Assembly”; commonly owned and herein incorporated by reference in its entirety. Soft anchor 102 may be obtained operatively coupled with an insertion instrument that actively deploys anchor 102, producing a deployed anchor with a strong fixation strength within or with tissue when deployed. Active deployment is also disclosed in U.S. Patent 9,962,149, titled “Tissue Repair Assembly” and provides a back stop to hold the anchor 102 in place while deploying the anchor 102 via a high tensioning load on the deploying sutures, to produce high fixation within the target tissue when the anchor is deployed. Soft anchor 102 may define a tubular braided body, that may include heat-sealed braids at the anchor body distal end 112. The tubular body may therefore be formed of braided strands 110.

[0046] Construct 100 may include a repair suture 130 that may interweave repeatedly through walls of the anchor body 102. Repair suture 130 may extend along a first side of the longitudinal axis 106 of the anchor 102, around and external to the distal end 1 12 and return along and through a wall on an opposing side of the axis 106. Repair suture 130 may extend from and back into a proximal end 1 14 of anchor 102, defining a preformed PT-6178-WO-PCT loop 130a. Preformed loop 130a may also be called a cerclage loop 130a. Repair suture 130 may also include a free limb 130b that extends proximally from the anchor proximal end 1 14. Tension on the preformed loop 130a may deploy the anchor 102 into the deployed configuration and set the anchor 102 with the bone. Tension on the free limb 130b may also supplement anchor deployment.

[0047] Deploying the anchor 102 via tendon on the cerclage loop 130a provides an advantage, as it may act to pre-stretch or pre-yield the repair suture 130 before the soft tissue is repaired, and the repair suture is locked. This reduces any subsequent relaxing or stretching of the repair suture post-surgery, during normal use of the patient’s joint. This relaxation and stretching may allow the repair to loosen. The loop 130a defines two sides or limbs L1 , L2. While deploying, it is preferable that both sides L1 , L2 are tensioned equally, to deploy the anchor evenly and also avoid any inadvertent early locking of the locking passage 137. For example, when looking at FIG. 1 A, should the L2 side be tensioned more than side L1 , locking passage 137 may inadvertently cinch during deployment and lock during anchor deployment, potentially inhibiting subsequent reduction of the preformed loop 130a during the repair of the soft tissue. Therefore, the preformed loop 130a is preferably coupled to the insertion instrument tensioning actuator in a manner that applies tension to both sides L1 , L2 simultaneously and evenly.

[0048] Turning now to the anchor distal end 112, the repair suture distal end 130c may form a combination of knots, through-punches and loops to fix repair suture distal end 130c with the anchor distal end 1 12. This combination has been found to help reduce proximal migration of locking passage 137 both during the repair and post-surgery. Similar to through-punch disclosed in commonly assigned patent application WO2025 / 024687, titled “Soft Anchor System”, and filed July 25, 2024, and herein incorporated by reference in its entirety, a through-punch 153 may shield the locking passage entrance 137a from damage, induced by the application of high deployment loads via the cerclage loop 130a.

[0049] More specifically in this improved embodiment, distal end 130c may include a knot 151 , a through-punch 152 and a loop 154 that extends through the anchor 102. As explained herein, the repair suture 130 may deploy the anchor 102 via tension applied on the cerclage loop 130a, the higher this tension, the stronger the anchor fixation and less likely fixation will reduce over time and use. However, these high-tension loads may move PT-6178-WO-PCT the repair suture distal end and the locking passage 137 proximally, which may adjust the knotless locking fixation or cause surgeon concern when they can see locking passage 137 emerging from the anchor 102. This arrangement of knot 151 , loop 154 and punch 152 may help retain the repair suture distal end 130c and locking passage 137 within the anchor 102 after tensioning.

[0050] More specifically, repair suture fixed end 130c may include knot 151 that may be external to anchor 102. The repair suture may also form a closed loop 154, closed via through-punch 152, where the repair suture passes or punches through itself entirely. The repair suture 130 may extend through the entire suture thickness, transverse the suture longitudinal axis, to form through-punch 152. Closed loop 154 may also extend through the anchor distal end, at a location that is preferably proximal to the heat-sealed braided ends at the distal end of the anchor 102. The closed loop may pass through the entire width or diameter of the anchor 102 and then extend across and external to the anchor distal end 1 12.

[0051] Repair suture 130 may extend along both sides of the anchor 102 and interweave through the anchor walls. Repair suture 130 may extend only partially through walls of the tubular body anchor 102, interweaving through the wall and turning, short of reaching the lumen 105 for at least one of the passes or weaves through the anchor body tubular wall. Having the repair suture 130 remain within the wall of the anchor 102 and preferably absent from the lumen 105 has been found to increase friction in the construct’s final, locked and deployed configuration. After surgery, the repair may be cyclically loaded as the patient moves, which may loosen a knotlessly locked configuration. The additional friction incurred by weaving the suture 130 mostly within the body sidewall, may help to counteract loosening.

[0052] Immediately distal to locking passage 137, repair suture 130 may extend across and externally to the anchor distal end 1 12 again and then punch through itself again to form punch 153 before entering (137a) a lumen of repair suture 130 to define locking passage 137. Having repair suture 130 extend across and external to the anchor distal end 112 provides a bearing surface for the repair suture 130. Without this bearing surface (distal end edge of anchor 102), the high tension loads along the suture 130 during anchor deployment may tear the cannulation entrance 137a and punch 153, and lead to a PT-6178-WO-PCT damaged construct and reduced locking passage length. Therefore, the inventors have found that this additional bearing surface helps to mitigate damage to the construct 100, while still permitting high tension loads; high tension loads providing a strong anchor fixation within the target tissue.

[0053] Repair suture 130 may be a variable cross section suture 130. In some embodiments the repair suture 130 may have a first diameter or cross-sectional width that is a first diameter, identified as D1 in FIG. 1A and 1 B. Repair suture 130 may have a length portion that has a larger cross-sectional width D2. As obtained and during insertion of the construct 100, length portion D2 is preferably entirely external to the anchor 102, keeping the anchor profile minimal while within the instrument as a larger diameter suture within the anchor adds bulk to the anchor 102. This allows the instrument shaft that houses the anchor 102 to be as small as possible. Length portion D2 may be housed within the instrument shaft or handle. Length portion may be substantially shorter than the remaining repair suture 130. Length portion D2 may be a length that is less than 20% of the entire repair suture length. Length portion D2 may be a length that is less than 5% of the entire repair suture length. Length portion D2 may be a length that is less than double the length of the locking passage 137 and may be disposed along the repair suture 130 at a location that, upon reducing the preformed loop 130a to repair tissue and lock the locking passage, places at least a portion of the length portion D2 within and along the repair suture lumen at the locking passage 137, as shown in FIG. 1 B. Having the length portion D2 within the anchor when in the final locked and repaired configuration, may further deploy the anchor 102 and set it in location, and also further increases the locking passage locking.

[0054] FIG. 1 B shows construct 100 in a final repaired and locked configuration. As shown Anchor 102 is deployed and is therefore laterally expanded relative to the anchor configuration in FIG. 1A. Anchor 102 has been deployed by tensioning both L1 and L2 of preformed loop, evenly, via actuation of an inserter (disclosed in more detail in FIG 5A and 5B). A tissue end 51 has been passed through cerclage loop 130a and repair limb 130b has been tensioned to reduce cerclage loop 130a and locate and fix the tissue 50 in the repaired location. (As shown, the repair is some separated / exploded for clarity of understanding.) Reducing the preformed loop 130a has also located length portion D2 with the larger cross section in the anchor 102 and along locking passage 137. PT-6178-WO-PCT

[0055] In some other embodiments, construct 100 may include a second repair suture construct, formed with a second separately formed suture that is separately routed through the same anchor 102. This second repair suture may be routed in the same way as repair suture 130 and may be circumferentially offset from the first repair construct 130, forming a double cerclage loop construct in the same anchor 102. As schematically shown in FIGs 7A-7C, several embodiments of double cerclage loop construct arrangements are disclosed. For example, in FIG. 7A, a representation of the proximal end of the anchor 102 is shown, with the first cerclage loop 130a extending from one side to the diametrically opposite side of anchor 102, similar to the arrangement shown in FIG 1 A and 1 B. A second repair suture cerclage loop 150a may extend from circumferentially offset locations, orienting the second cerclage loop 150a perpendicular to the first cerclage loop 130a, in this view. This might be termed a perpendicular arrangement of the double cerclage loop construct. Another example is shown in FIG. 7B, showing a parallel arrangement, wherein the first cerclage loop 130a may extend from and back into the anchor proximal end 114 at circumferentially offset locations but on the same side of axis 106 relative to the second cerclage loop 150a. This might be termed a parallel arrangement of the double cerclage loop construct. Another example is shown in FIG. 7C, wherein the first cerclage loop 130a may extend from and back into the anchor proximal end 114 directly adjacent each other and on diametrically opposite side of axis 106 relative to the second cerclage loop 150a. The second repair suture may be entirely diametrically opposite the first repair suture. This may be similar to the embodiment shown in FIG. 2. Another example is shown in FIG. 7D, wherein both cerclage loops 130a, 150a (330A, 330B) may extend from and back into the anchor proximal end 114 on diametrically opposite sides of the axis 106 relative to each other. This may be similar to the embodiment shown in Figs 3A, 3B.

[0056] FIG. 2 shows a double cerclage loop embodiment that may be formed with one or two repair sutures. As shown, a single repair suture 230 is shown, with a single knot 151 . Like elements / components to construct 100 are given the same identifier and key differences between constructs 100 and 200 are discussed herein. Repair suture 230 may have two free limbs 232a, 232b extending from a proximal end of anchor 102. Repair suture 230 may define two cerclage loops 230a, 230b extending from the anchor proximal end, each cerclage loop extending from and into its same side of the anchor axis 106 PT-6178-WO-PCT

[0057] (similar to FIG. 7C). Both cerclage loops 230a, 230b are assembled to an inserter actuation assembly, such that actuation places tension on both cerclage loops 230a, 230b to deploy the anchor 102. If formed with two separate sutures, there may be two separate knots (not shown) and each end may form through-punches and loops at the distal end similar to embodiments 100. The two separate repair sutures may be independently actuated to reduce their respective loops 230a, 230b.

[0058] FIG. 3A shows a double cerclage loop embodiment 300 that may also be formed with one or two repair sutures. As shown, a single repair suture 330 is shown. Like elements / components to construct 100 are given the same identifier and key differences between constructs 100 and 300 are discussed herein. Repair suture 330 may have two free limbs 332a, 332b extending from a proximal end of anchor 102. Repair suture 330 may define two cerclage loops 330a, 330b extending from the anchor proximal end, each cerclage loop extending from and into opposite sides of the anchor axis 106, similar to FIG 7D. Both cerclage loops 330a, 330b are assembled to an inserter actuation assembly, such that actuation places tension on both cerclage loops 330a, 330b to deploy the anchor 102. Suture may include a knot 151 at its midpoint, to limit slipping of the locking passages 337a, 337b asymmetrically along the anchor 102.

[0059] Remaining with FIG. 3A, there may be an advantage to placing two repair constructs including two longitudinal passages (one each) on opposing sides of the anchor 102. Any construct with a single locking passage on a single side of an anchor 102 may be prone to asymmetrical loading, and inherently susceptible to repair loop loosening due to asymmetric loop loading. The added security and back up, provided by this double locking passage construct may be particularly advantageous in repair scenarios involving high degrees of expected tissue motion. This is best explained when viewing FIG. 3B, illustrating a repaired configuration of construct 300 with the cerclage loops 330a, 330b repairing tissue 50 and the anchor in a deployed configuration 102’. Should the tissue 50 be rotated counterclockwise (see Arrow CC) the locking passage 337b is placed under more tension due to the friction between the tissue 50 and suture 330. Conversely, locking passage 337a is unloaded due to the friction between the tissue 50 and suture 330. However, because the suture 330 in this embodiment is continuous or coupled together, the suture loop remains stationary as locking passage 337b remains actuated / under PT-6178-WO-PCT tension. Stated another way, counterclockwise tension (CC) from tissue motion tightens locking passage 337b and prevents loosening of the repair loop as a whole.

[0060] To ensure the cerclage loops 330a, 330b (or 230a, 230b) remain co-located during clinical use, an optional proximal sheath 340 may be added to constrain the position of the suture loops. This sheath 340 may prevent spatial separation of the loops 330a, 330b that may otherwise compromise the dual trap engagement mechanism by inducing differing friction / loading states on each individual loop. A sheath such as a hollow braided tube, may be incorporated into any of the multi loop constructs to facilitate the spatial co-location of the at least two cerclage loops when they are engaging the repair tissue 50. In some embodiments the construct may engage a cortical button and may repair or reduce for bone-to-bone reduction.

[0061] FIGS. 4A-4K illustrate a method of constructing construct 100. A repair suture 130 may first be prepared. Preparation includes obtaining a repair suture 130 that includes at least a portion with a hollow core (for cannulation 137). Repair suture 130 may be obtained with a length portion with a larger cross section D1 (shown in FIG. 1 ). A stopping knot 151 may be formed close to the first terminal end 134. Forming the stopping knot 151 may include forming a first half hitch and then forming a second half hitch that axially overlaps the first half hitch. Suture 130 may then be passed through the entire anchor 102 at a location adjacent the anchor distal end 112. Suture 130 may be passed through the entire anchor 102 in a direction transverse a longitudinal axis 106 of anchor 102. Suture 130 may be passed through the entire anchor 102 at a location slightly proximal from any heat- sealed ends of the braids in the anchor 102. Suture end 135 may then be passed through itself, using a needle 420 forming loop 154 and a punch 152 directly adjacent knot 151 (FIG. 4B and 4G). Punch 152 may be located through a length of the repair suture that extends directly between the anchor 102 to the knot 151. Punch 152 forms a loop 154 which is then reduced via tension on end 135 (FIG. 4D).

[0062] A shuttle suture 140 may then by passed through a lumen of the repair suture cannulation 137 (FIG. 4E), located along end 135, for a determined length that defines a length of the locking passage137 and then the shuttle suture 140 at the cannulation entrance end 137a may be punched through the repair suture 130 at a location between the punch 152 and entrance 137a (FIG. 4F). End 135 and shuttle suture first end 140a are PT-6178-WO-PCT then passed, through and along the anchor 102 from the anchor distal end 112 to the anchor proximal end 114 defining a first pass and the shuttle suture second end 140b may be passed through and along the anchor 102 from the distal end 112 to the proximal and 1 14 defining a second pass, located circumferentially offset from the first pass (FIG. 4G). The first and second passes may be an opposing side of the anchor axis 105. As shown in FIG. 4H, the first and second passes are circumferentially offset approximately between 55-100 angular degrees from each other, to form an arrangement similar to that shown in FIG. 7B. Repair suture end 130b may then be coupled to shuttle suture second end 140b, and tension on first end 140a may draw the shuttle suture along the anchor 102, so as to remove the shuttle suture and draw the repair suture end 130b to form the cerclage loop 130a and then into and along the anchor 102, to form construct 100. Optionally repair suture end 134 may be passed through loop 154 to tuck this end into the anchor, as shown in FIG. 4I.

[0063] This process may be repeated (FIGs 4A-4I) with a second repair suture (150) and a second shuttle suture, the difference being that in Steps 4G and 4H, the second repair suture and second shuttle may be passed through portions of the anchor 102 that are circumferentially offset from the first repair suture to form arrangements as shown in FIG. 7B for example.

[0064] Construct 100 (or 200, or 300) may then be assembled to the insertion instrument 500, as shown in FIG. 5A and 5B. Any of the constructs (100, 200, 300) may be assembled to insertion instrument 500. Anchor 102 may be located within an outer tube 505 at inserter distal end 500a. Cerclage loop 130a (or 230a, 230b, 330a, 330b) may extend through anchor 102 (FIG. 5A), along bore 560 (FIG. 5A, 5B) through handle 556 (FIG. 5B) and may be wrapped around hub 557 (FIG. 5B). FIG. 5B is a cross section of the handle end 500b of an insertion instrument 500 that may have an internally threaded shaft tensioning mechanism. A rotatable knob 557 is mounted on the back or proximal end of the handle 556. Rotation of knob 557 interacts with an internally threaded cavity of the handle 556 and retracts a block 559 and applies tension on suture construct (100, 200 or 300), including tension on cerclage loop 130a, 230a, 230b, 330a, 330b to deploy the anchor 102. PT-6178-WO-PCT

[0065] Returning now to FIGs 4J and 4K, in order to evenly deploy the anchor 102, on both sides of the anchor axis 106, it is preferable that the cerclage loop (130a, 230a, 230b, 330a, 330b) is tensioned evenly on both limbs or sides (L1 , L2) of the cerclage loop. Shown in FIG. 4J, both limbs or sides L1 , L2 of the cerclage loop are first evenly lightly tensioned to remove any slack on the loop limbs L1 , L2 and then wrapped around rotatable knob 557 in a first direction, such as a clockwise direction before being cinched in the cleat 560 (FIG. 4K). If there are two repair suture constructs, the second repair suture (150) is assembled in the same manner and wrapped in the same first direction around the knob 557. A clockwise turning on the knob 557 may be operable to apply tension evenly to both sides L1 , L2 of each preformed cerclage loop (130a, 150a) and evenly deploy the anchor 102, without inadvertently actuating the locking passage 137.

[0066] During the procedure, after anchor deployment, the repair suture 130, 150, 230a, 230b, 330a, 330b) including the cerclage loop may be disconnected from knob 557 and a tissue end 50 may be passed through the cerclage loop. Tension on repair suture end (232a, 232b, 332a, 332b, 130b) may then reduce the cerclage loop length, draw the tissue 50 towards the anchor 102 and cinch the locking passage (137, 237a, 237b, 337a, 337b) knotlessly lock the locking passage.

[0067] A method of use may therefore include inserting the construct (100, 200, 300) into a target tissue with insertion instrument 500 and then actuating the tension actuator to deploy the anchor 102. Deploying may include applying tension to both sides L1 and L2 of all cerclage loops, evenly. Deploying may include applying tension to a free limb of all repair sutures in addition to the cerclage loop sides L1 , L2. Once the anchor 102 is deployed within the target tissue, the repair suture free ends (130b, 232a, 232b, 332a, 332b) and cerclage loop(s) (130a, 230a, 230b, 330a, 330b) may be removed from the insertion instrument 500. The first preformed cerclage loop 130a, 230a, 330a may be coupled to a first repair tissue. The first repair tissue free end 51 is inserted through the first cerclage loop 130a, 230a, 330a. If present, the second preformed cerclage loop 150a, 230b, 330b may be coupled to a first repair tissue. The first repair tissue free end 51 is inserted through the second cerclage loop 150a, 230b, 330b. Alternatively, the second preformed cerclage loop 150a, 230b, 330b may be coupled to a different repair tissue. PT-6178-WO-PCT

[0068] Once coupled to a corresponding target tissue, a free limb (130b, 232a, 232b, 332a, 332b) may be tensioned to reduce a corresponding cerclage loop 130a, 230a, 230b, 330a, 330b and fix the target tissue in place. Reducing the cerclage loop may draw a larger diameter portion D2 of the repair suture into the corresponding locking passage. Subsequent tensioning in the free limb may then cinch the locking passage 137, 237a, 237b, 337a, 337b and knotlessly lock the corresponding cerclage loop.

[0069] Some embodiments may include a separate extra repair suture, configured to be knotted during the repair. This repair suture may be a suture tape and may be slidingly coupled the anchor 102, similar to the sutures disclosed in at least U.S. Patent 9,962,149, titled “Tissue Repair Assembly”; commonly owned and herein incorporated by reference in its entirety. In some embodiments the separate repair suture may be fixedly coupled so that it may not slide. An example embodiment is shown in FIG. 6. To limit movement, repair suture 130 punches through suture 630. This punch 610 may be disposed along the repair suture 130 at a location between knot 151 and punch 152. Separate repair suture 630 may remain external to the anchor 102, as shown, or may interweave along the anchor 102 similar to the repair suture 130, at a circumferentially offset location to the repair suture 130.

[0070] 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 illustrative in all respects rather than limiting of the disclosure described herein. The 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

PT-6178-WO-PCTWhat is claimed is:Claims1 . An all-suture tissue repair system, comprising; an insertion instrument including a handle with a tension actuator, the insertion instrument housing a tissue repair construct including; a soft anchor, defining a tubular body having a longitudinal axis, a distal end and a proximal end; and a first repair suture that extends through the soft anchor and includes a preformed loop that extends proximally from the soft anchor proximal end, the repair suture extending through itself to form a locking passage located within the soft anchor; and a free limb of the repair suture extends proximally from a proximal end of the locking passage and also proximally from the soft anchor; wherein the preformed loop extends along and within a shaft of the insertion instrument and is operatively coupled to the tension actuator.

2. The soft tissue repair system of claim 1 wherein the first repair suture has a first end fixed to a distal end of the soft anchor, and wherein the repair suture extends proximally from the fixed end while interweaving along and through the tubular body before extending both from the anchor proximal end and back into the anchor proximal end to form the preformed loop.

3. The soft tissue repair system of claim 1 wherein the tension actuator includes a spool and cleat and wherein the preformed loop is wrapped around the spool and cinched in the cleat to couple to the tension actuator.

4. The soft tissue repair system of claim 1 wherein the preformed loop extends from the proximal end of the soft anchor proximal end defining a first limb of the preformed cerclage loop, and also returns back into the proximal end of the soft anchor defining a second limb of the preformed cerclage loop and wherein both the first and second limb of the preformed cerclage loop are operatively coupled to the tension actuator so that tension is distributed evenly on both the first and second limbs of the preformed cerclage loop when the tension actuator is actuated.PT-6178-WO-PCT5. The soft tissue repair system of claim 1 wherein the repair suture free limb is coupled to the tension actuator.

6. The soft tissue repair system of claim 2 wherein the repair suture first end includes a knot and a through-punch, both disposed externally to the soft anchor, the through- punch disposed along a length of the repair suture that is located between the knot and the soft anchor.

7. The soft tissue repair system of claim 6 wherein the repair suture forms a loop that extends through the soft anchor distal end, the loop located along the repair suture between the knot and the through-punch.

8. The soft tissue repair system of claim 7 wherein the repair suture loop extends through an entire diameter of the tubular body.

9. The soft tissue repair system of claim 8 wherein the tubular body includes braided threads that are heat-sealed at the soft anchor distal end, and therein the repair suture loops extends through the soft anchor distal end at a location proximally spaced from the heat-sealed braided threads.

10. The soft tissue repair system of claim 7 wherein the through-punch forms a repair suture closed loop, the repair suture closed loop extending through the soft anchor distal end.1 1. The soft tissue repair system of claim 7 wherein the repair suture forms another through-punch adjacent to a distal end of the locking passage.

12. The soft tissue repair system of claim 7 wherein the knot has a free limb tail extending therefrom, the free limb tail extending between the repair suture loop and a distal-most edge of the soft anchor to tuck the knot against the soft anchor.

13. The soft tissue repair system of claim 1 further comprising a second repair suture, separately formed from the first repair suture, the second repair suture extending through the soft anchor and includes a preformed loop that extends from and back into the proximal end of the soft anchor proximal end, the second repair suture extending through itself to form a second locking passage that extends through the soft anchor,PT-6178-WO-PCT the second repair suture construct circumferentially offset through the tubular body from the first repair suture construct.

14. The soft tissue repair system of claim 13 wherein the first and second repair sutures are arranged in a parallel arrangement relative to each other, on opposing sides of the anchor axis from each other.

15. The soft tissue repair system of claim 13 wherein the preformed loop of the second repair suture extends along and within a shaft of the insertion instrument and is operatively coupled to the tension actuator, such that tension on the preformed loop via actuation of the tension actuator is configured to deploy the soft anchor and set the soft anchor in or with a bone.

16. The soft tissue repair system of claim 1 wherein the repair suture has a first length portion with a first diameter and a second length portion with a larger diameter than the first diameter portion, and wherein the second length portion is located externally to the soft anchor and wherein tension on the repair suture free limb is configured to reduce the preformed loop and move the second length portion into the locking passage.

17. A method of repair with the tissue repair system of claim 1 comprising: using the insertion instrument to insert the anchor in bone, with the preformed cerclage loop housed along an insertion instrument shaft; actuating the tension actuator to apply tension to the preformed cerclage loop and therefore setting the soft anchor with the bone; releasing the preformed cerclage loop from the insertion instrument after actuating; threading a free end of soft tissue through the preformed cerclage loop; tensioning the free end of the repair suture to reduce the preformed cerclage loop; and tensioning the free end of the repair suture to knotlessly lock the locking passage and fix the soft tissue in place.

18. A tissue repair system, comprising;PT-6178-WO-PCT an insertion instrument, the insertion instrument including a handle with a tension actuator, the instrument housing a knotlessly locking loop construct, the construct including; an soft anchor, defining a tubular body having a longitudinal axis, a distal end and a proximal end; and a first repair suture having a first end fixed to a distal end of the soft anchor, the first repair suture extending proximally from the fixed end while interweaving along and through the tubular body before extending from the anchor proximal end, forming a preformed cerclage loop that extends from and back into the anchor proximal end and wherein the first repair suture also extends through itself to form a locking passage, the locking passage interwoven through the soft anchor, a free limb of the first repair suture extending from a proximal end of the locking passage and anchor proximal end; and a second repair suture having a first end fixed to a distal end of the soft anchor, the second repair suture extending proximally from the fixed end while interweaving along and through the tubular body before extending from the anchor proximal end, forming a preformed cerclage loop that extends from and back into the anchor proximal end and wherein the second repair suture also extends through itself to form a locking passage interwoven through the soft anchor, a free limb of the second repair suture extending from a proximal end of the locking passage and anchor proximal end; wherein the first and second repair suture extend through the soft anchor in a parallel arrangement to each other on opposing sides of the soft anchor, and wherein the cerclage loops both extends along and within a shaft of the insertion instrument and are coupled to the tension actuator.

19. The soft tissue repair system of claim 18 wherein both the first and second repair suture first ends includes a knot and a through-punch disposed externally to the soft anchor.

20. The soft tissue repair system of claim 19 wherein the repair sutures both include a loop at the soft anchor distal end that extend through the soft anchor distal end.

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