SUTURE CONSTRUCT AND METHOD OF TISSUE FIXATION

An adjustable fixation system for coupling a tissue or graft to bone is disclosed including a suture construct including a first limb, a second limb and a body therebetween. The body is continuously braided with the first and second limbs and has a longitudinal passage therethrough. The first and second limbs define a braided portion including a braided core. The suture construct is configured to form at least one adjustable loop formed by passing the first limb between braids of the suture construct, along the longitudinal passage and back out between braids of the adjustable suture construct. Tension on at least one of the first or second limbs reduces a diameter of the longitudinal passage around a length of the first limb and thereby the braided core disposed along the body longitudinal passage and knotlessly locks the adjustable loop.

FIELD

The present disclosure relates to methods and devices for tissue fixation in a surgical repair.

BACKGROUND

Soft tissue (such as ligaments and tendons) that has ruptured or torn may be repaired or replaced surgically. In some tissue repairs, an adjustable loop construct may be coupled to the tissue, the loop formed by threading the suture through itself along a longitudinal passage of the suture. Tensioning of the suture may cinch the longitudinal passage and knotlessly lock the suture loop so that it is no longer adjustable. This is similar to a Chinese finger trap. Sutures that form these suture loops are coreless along their entire length. During cyclic loading, typical during daily use of the joint or tissue, these coreless sutures may slowly elongate, and/or the locking passage may relax over time and the suture loop may extend, loosening the tissue repair. There is therefore a need for an adjustable loop construct that resists elongation or loosening over time.

SUMMARY

Described herein are various improvements in methods and devices for tissue fixation using an adjustable fixation loop that may be knotlessly locked. The adjustable fixation loop includes a braided suture that includes a braided core (a core that includes braids therein) that is briefly interrupted by a locking length that is defined by a longitudinal passage or void therealong. This adjustable fixation loop forms a knotless locking loop that provides improved elongation resistance during physiological loading. Adjustable fixation loop may form a portion of a graft suspension system or tissue repair system that may include an anchor. 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.

More specifically an example embodiment disclosed herein may include a tissue repair system including a suture construct with a first and second braided core segment and a locking length therebetween. The locking length is continuously braided with the first and second braided core segment, the locking length defining a locking passage therealong. The locking length is preferably short relative to the remaining suture construct. The suture construct forms at least one adjustable loop, formed by placing the first braided core segment into and along the locking length. Tension on at least one of the first or second braided core segments knotlessly locks the locking length around the first braided core segment disposed therein.

In some example embodiments, the suture construct includes at least two adjustable loops with the first and second braided core segment disposed within the locking length. In this example, tension on at least one of the first or second braided core segments knotlessly locks the locking length around both the first and second braided core segment disposed therein. In this example embodiment, the first and second braided core segments pass through the locking length in opposite directions.

In some example embodiments, the adjustable loop may be operatively coupled to an anchor. In some example embodiments, the adjustable fixation loop may provide a suspension means for suspending a ligament in a bone hole. In some example embodiments, the locking passage may define a cradle for operatively coupling with a ligament graft. In some example embodiments, the locking length has a first length and the first and second braided core segments in combination define a second length, the second length more than twice as long as the first length. In some other embodiments, the suture construct is trimmed after knotlessly locking the construct and in this trimmed configuration; the second length is more than three times as long as the first length.

In some example embodiments, all of the strands in the first and second braided core segment are disposed along the locking length also. In some example embodiments, the adjustable fixation construct may include a second adjustable loop formed by passing the second limb between braids of the adjustable suture construct, along the locking length of the body and back out between braids of the adjustable suture construct such that the locking passage includes a length of the first and second limbs including, by definition, the braided core of both the first and second core. In some example embodiments, the first and second limbs pass through the locking length in opposite directions.

Another example embodiment disclosed herein includes a knotless tissue fixation system including a tissue anchor and a continuously braided suture operatively coupled to the tissue anchor, the braided suture having a braided core therealong, interrupted by a short coreless portion, defining a locking length. The locking length defines a predetermined limited length sufficient to both knotlessly and securely lock around a length of suture disposed within the locking length upon tension being applied to the continuously braided suture.

In some example embodiments, the braided suture including the braided core may be disposed along the locking length to form a knotless locking suture loop. In some example embodiments, the suture disposed along the locking length is a separate suture, independently formed from the braided suture. In some example embodiments, the tissue anchor may be an all-suture anchor that is deformable to selectively couple with a bone hole. In some example embodiments, the tissue anchor may be a rigid anchor. In some example embodiments, the braided suture has the same number of strands in the braided core segment as the locking length. In some example embodiments, the suture enters and exits the coreless portion and thereby the locking length between braids of the braided suture at opposing ends of the locking length. In some example embodiments, the locking length has a length that is limited to a minimum length sufficient to securely knotlessly lock around the suture. In some example embodiments, the locking length has a length that is substantially shorter than a length of suture with a braided core and tension on the suture preferentially elongates the locking length. In some example embodiments, the locking length is limited to a minimum length for locking around the suture while the braided core portion is maximized to minimize elongation or strain over time. The locking length may have a first length sufficient to lock around the suture disposed therein, and the entire continuously braided suture defines a second length, the second length being more than twice the first length.

An example method of coupling a first tissue to a second tissue is also disclosed herein, including coupling a suture to the first tissue, and coupling the suture to a second tissue, wherein the suture includes a locking length extending between first and second braided core segments of the suture. Both braided core segments and the locking length are continuously braided with each other and have equal number of strands to each other therealong. One of the braided core segments are placed into and along the locking length. A first tension is then applied to tension a first limb of the suture to draw the first tissue towards a target location; and a second tension is then applied to the suture, to knotlessly lock the locking length around the braided core segment disposed therein and thereby knotlessly fix the first tissue to the second tissue.

In some example methods, coupling the suture to the second tissue may include engaging an anchor with a second tissue, the anchor operatively coupled to the suture. In some example methods, another braided core segment of the suture is placed into and along the locking length before applying a second tension. In some example methods, another braided core segment of the suture may be placed into and along another locking length of the suture before applying a second tension.

An example method of knotlessly fixing a tissue or graft is also disclosed including: coupling a suture to the tissue or graft, wherein the suture includes a locking length extending between a first and second limb of the suture; wherein both limbs and the locking length are continuously braided with each other so as to have a uniform number of braids therealong; and wherein both limbs include braids disposed within and around a core of both limbs and wherein the locking length defines a longitudinal passage, and therefore absent braids along its core. The method also includes applying a first tension to the first limb to draw the tissue or graft towards a target location. The method also includes applying a second tension to the suture with the first limb disposed within the longitudinal passage, so as to contract the longitudinal passage around the first limb and knotlessly lock the loop and thereby the tissue or graft. The example method may also include coupling a suture to a tissue or graft by suspending a graft over the locking length. The example method may also include coupling a suture to a tissue or graft by threading a length of the suture through the tissue or graft. The example method may also include inserting an anchor into a tissue associated with the target location, the anchor operatively coupled to the suture and deploying the anchor to fix the anchor with the tissue associated with the target location such that applying the second tension knotlessly locks the tissue or graft with the anchor and thereby the target location. The anchor may be selected from a group consisting of an all-suture anchor; a rigid anchor and a button anchor. Deploying the anchor may be performed before applying the second tension. Deploying the anchor may be performed after applying the second tension.

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, 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.

The term “locking length” defines a segment of a continuous length of a braided suture that includes a longitudinal passage (open space or void) along the suture. The locking length is defined in that both ends of the longitudinal passage terminate with a transition to a different segment of the continuous length of braided suture that includes braids disposed along the longitudinal passage in place of at least some of the opening space or void that defines the longitudinal passage. Therefore, this different or second segment does not include a longitudinal passage; or the longitudinal passage has become significantly smaller. This second segment may be called a “braided core” segment, as the core may include braids where they are absent in the locking length. The entire continuous length of the braided suture may be a length between 5-200 inches; however, locking length is preferably limited in length and may include a length up to a maximum of about 2 inches depending on the procedure and construct. Preferable ranges for many procedures and constructs may be between ¼ to 2 inches. Locking length is sufficiently long to provide a knotless lock around a length of suture disposed along the locking length upon tension being applied to the locking length.

In general, the entire length of braided suture that includes both at least one locking length and at least one braided core segment may be provided with an “initial length” and may be trimmed and altered during the procedure to a “final length”. For example, the length of suture may be supplied with an “initial length” that may include suture limbs that may be used to manipulate the length of suture. For example, these suture limbs may be used to apply tension to the lengths of suture and knotlessly lock the construct. During the procedure, the limbs may be trimmed and splices or knots may be formed. As such, the length of suture may be shortened to a “final length”, shorter than the initial length.

To exhibit enhanced resistance to elongation or strain over time, it is preferable that the total length of second segments (braided core segments) in the “final length” as defined above, be maximized. Relative to a suture with a hollow core along most or all of its length, a length of suture with a braided core exhibits a high resistance to elongation during cyclic loading post-surgery. It follows therefore that the length of the locking length should be minimized to maximize the braided core length, while the length of the locking length must be sufficiently long, to knotlessly lock the loop or repair construct. It is preferable that the total length of second segments be at least as long as the locking lengths. As way of an example, if a “final length” configuration includes a single “locking length” that is 1.5 inches, then the remaining length of suture in the “final length” construct including only a braided core length, is preferably at least 1.5 inches long. In some embodiments this remaining length may be significantly more than 1.5 inches, such as for example double loop constructs (discussed later herein), the remaining length may be at least 3 inches. Otherwise stated a ratio of locking length to braided core length is greater than 1:1, and more preferably greater than 1:2 and may be up to 1:100 depending on the application.

The term “knotlessly lock” defines a configuration of the suture construct with a locking length that prevents suture present within and along the longitudinal passage of the locking length from sliding along the locking length. The locking length, under tension is configured to elongate and narrow and forms a Chinese finger-trap style lock around a suture present within the locking length. This does not preclude a knot at other locations along the suture construct. For example, a knot may couple the suture to an anchor or couple the suture to a biological tissue and still meet the definition. Suture constructs that use Chinese finger-trap style knotless locking constructs typically include suture that have hollow cores along their entire length.

Referring now toFIG. 1A, a portion of a braided suture10is illustrated, and includes a locking length20disposed between two braided core lengths25aand25b.The braided suture10is continuously braided between the locking length20and braided core lengths25a,25b.The suture10is preferably formed with the same number of strands5between the locking length20and braided core lengths25a,25b.Each individual strand5may not change in the type and thickness as it extends along and between the locking length20and braided core lengths25a,25b,(beyond normal manufacturing tolerances). This does not preclude each individual strand from being different from other strands in material or thickness for example. A strand5preferably does not alter in material or thickness along its length, particularly as it relates to the transitions between the locking length20and braided core lengths25a,25b.

Referring to bothFIG. 1A and 1C, locking length20includes an outer wall22formed by strands5, defining the boundary of a core21, the core21absent braids therealong. Outer wall22may define a tubular shape. Outer wall22is formed of a plurality of strands5, braided around each other forming a continuous braided outer wall of the braided suture10along locking length20. As shown outer wall22includes a single layer or ring of strands5. Alternative configurations (not shown) may include a plurality of strand layers or concentric rings that may be intertwined with each other. Referring to bothFIG. 1A and 1B, braided core lengths25aand25binclude an outermost wall section26and a braided core23that includes strands,5. Outermost wall section26may include strands5that define a tubular shape.FIG. 1Bis a simplified representation of a single instantaneous cross section of this segment25a,and in reality there may be no distinct tubular shape formed that is separate from the strands in the core23, as such; all of the strands5shown inFIG. 1Bweave around each other in a pattern, such that the strands5continuously move between the outermost section26and core section23along the braided suture length. Outermost wall section26essentially represents an instantaneous outer-most layer of the segments25aand25b.

While represented as a circular cross section, other cross section configurations may be formed, such as an oblong cross section, having a width larger than height. Different cross sections may be formed during braiding, or during a secondary manufacturing process that flattens or re-shapes the suture cross sections. As shown, the cross sections are shown in a simplified form. In reality, suture and the flexible strands that form the suture may naturally deform and relax to form a different cross section of a different shape (non-circular configuration) which is not precluded from this disclosure. Stated alternatively, this three-dimensional structure preferably defines a cross section shape and includes a predefined inner space or resident volume along the locking length20. The resident volume is a volume that may be formed by the three-dimensional structure in its manufactured state, but when the sides of the structure are compressed or relaxed, the resident volume may become smaller or disappear altogether. The cross section may also become non-circular. The term and shapes shown herein do not preclude the structure folding or collapsing in on itself, to temporarily obscure the presence of the resident volume and temporarily alter the cross section shape. The relaxed configuration of a shape as manufactured is not considered different from this disclosure. In addition, the locking length may deform (be dilated) in order to receive a length of suture therethrough, and knotlessly lock the construct. This deformation also does not preclude a cross section shape.

Locking length20transitions of braided core segment25a,25bat transitions35aand35b.There is no substantial interruption in the strands5as braided, at transitions35aand35b.Preferably, the transition is free of any splicing, gluing, or other fastening between segments25a,25band locking length20. Preferably, the braiding is continuous between all the segments along the suture10and the number of strands5is uniform such that the outer wall section26includes less strands5than tubular section22, as some of the strands5from outer wall22are braided to move centrally and form the braided core23along the braided core segment25aand25b.A maximum outer diameter of the locking length20may be larger than a corresponding outer diameter of the braided core segment25aand25b.This may be due to the radial shifting of strands5in outer wall section22relative to outer wall section26. In addition, the braiding pattern or tension on the braiding machine may be altered to weave the strands5more loosely, (lower pick count) to form a reduced strand count per length of the suture. This may aid in readily forming entrance and exit points for a suture at or adjacent to transition points35aand35b,discussed in more detail in another portion of this application. The core21may also preferably be increased with this lower pick count for at least one length suture to be placed along the core21, also discussed in more detail later. Strands5are preferably consistent in material and dimensions along suture.

Returning toFIGS. 1A, 1B and 1C, and as an example, the braided suture10may be formed of fourteen strands integrated in a pattern as described herein. This is exemplary and up to sixty-four strands are considered. Along braided core segment25a, at any instant cross section as represented inFIG. 1B, ten strands may form the outermost wall section26while four strands extend along the core23. As described earlier, these strands5are not limited to the tubular section26and core portion23along the length of braided core segment25a. In practice, these strands5move around each other according to a braiding pattern and location of braiding spools, and weave in and out of the core portion23and outermost wall section26continuously. At transition point35athe braiding pattern changes to move all strands5to or towards the outer wall section22to form locking length20with a longitudinal passage21therealong. All fourteen strands5, continuing with the example, are now braided round the core21that preferable free of strands5. The fourteen strands5continue to weave around each other to form a braided outer wall section22defining the longitudinal or locking passage. At transition point35b,the braiding pattern may return to the braiding pattern as described for braided core segment25a.

FIG. 2Arepresents an example adjustable suture loop construct100formed with suture10, according to the present teachings. As shown two loops,40aand40bare shown. In alternative embodiments, a single loop may suffice. Shown is a length of suture such as braided suture10having a first braided core segment25aand a second braided core segment25b.First and second braided core segments25a,25bextend up to and include first and second limbs125a,125b.The suture10is braided and has a locking length20limited as described herein. First and second braided core segments25aand25binclude braided cores23as described herein. First and second apertures32and34are defined in the braided suture10at first and second locations that are preferably adjacent transition areas35aand35b.First and second apertures32and34may be formed when constructing the loops40aand40b,by inserting a limb between strands of the braided wall. Apertures32and34may also be partially formed during the braiding process as looser portions between pairs of strands5of the suture10.

A first limb end125aof the suture10may be passed through the first aperture32and through longitudinal passage (core21) of locking length20and out the second aperture34. The second limb end125bmay be passed through the second aperture34, through and along the locking length core21and out the first aperture32. In alternative embodiments, the loops may be formed at ends of the locking length, such that first limb end125aof the suture10may be passed through the second aperture34and through core21of locking length20and out the first aperture32. The second limb end125bmay be passed through the first aperture32, through and along the locking length core21and out the second aperture34. In further alternative embodiments, the second limb125bmay have its own discrete entrance apertures and exit apertures (as shown) slightly spaced away from apertures32and34. As shown inFIG. 2A, each loop is formed with the limbs125aand125bcrossing over each other in opposite directions through core21. In further alternative embodiments, limbs125aand125bmay form loops by entering the same side of the locking length20, through entrance32for example, and extending along core21in the same direction.

Adjustable suture construct100may be coupled to a biological tissue and tension on at least one of the limbs125aor125bmay reduce the corresponding loop length and draw the biological tissue in apposition with a target area or tissue. For example, limb125amay be coupled to a first and a second side of a tear through tissue before forming the loop construct, such as loop construct100, and thereby before threading limb125athrough and along the locking length20. Once at least one adjustable loop is formed, similar to construct100, tension on limb125amay draw the first and second side of a tear together. Further tension on limb125a,may reduce a diameter of the core21of the locking length20around the suture limbs disposed therealong and knotlessly lock the two tissue sides together. This example may be duplicated with both limbs125a,125bcoupling to tissue, and thereby using a double loop. The locking length20is configured to cinch around a suture disposed along the locking length core. Similar to a Chinese finger trap, the locking length20secures or cinches around the suture disposed along the locking length core and prevents this suture from sliding along the locking length core. The locking length20preferably cinches around a length of the braided core25a,25b,and not a length of the suture10that is includes a longitudinal passage such as a locking length20. The locking length may have a first length, and the entire adjustable suture construct100in a final length configuration, as defined herein may have a second length including the first length. The ratio of the first length to the second length is less than 1:1. The ratio of the first length to the second length is preferable less than 1:2 and may be up to 1:100 depending on the application. The first length is preferable significantly less than the second length.

FIG. 2Billustrates another example of an adjustable suture loop150with two discrete locking lengths20a,20balong the loop150.FIG. 2Cillustrates another example of an adjustable suture loop170with at least one locking length along the loop170. In this example a separate suture or flexible strand,175that may be coupled to a tissue (not shown) and may extend along the locking length20.

FIG. 3Aillustrates an example graft suspension construct300including an adjustable suture loop construct310formed from suture construct10. Suture loop construct310may be similar to the loop construct100, with the addition of cortical button316, which is a form of tissue anchor. Cortical buttons316have a first configuration for inserting the button316into and along a bone-tunnel and are then deployed or flipped to engage a cortical surface of the bone. In this configuration, locking length20may form a cradle, and a graft may be wrapped over the locking length20. Construct300is described in detail in commonly owned U.S. Pat. No. 10,383,617, herein incorporated by reference, in its entirety. The graft suspension construct300comprises a suture construct310having a first loop312and a second loop314(together, the suspension loop324) suspended from anchor316. The suture construct310includes a locking length20with two limbs325aand325bextending therefrom. A length of the suture310may be about 46 inches. The cortical button316may be of conventional construction for securement to the outside of a bone, such as a cortical button. The graft suspension device300locking length20defines a cradle and may be located substantially midway along the length of the suture310.

Cortical button316may include a plurality of apertures330, which may be eight apertures, extending therethrough and configured for the passage of the suture310therethrough. More specifically the cortical button316receives the limbs325aand325btherethrough. In this embodiment, cortical button316does not receive the locking length20therethrough. Similar to construct shown inFIG. 2A, limbs325aand325bof the suture310are braided core segments and are threaded through the locking length20to complete the suspension loop324. Limbs325aand325bmay be joined together to form a single tail334, described in detail in commonly owned U.S. Pat. No. 10,383,617, herein incorporated by reference, in its entirety. Single tail334may therefore also include a locking length20. Routing the suture construct310through the plurality of apertures330as shown keeps the various strands of suture limbs325aand325bseparated, making them less likely to bunch or tangle. Other cortical buttons known in the art may include fewer apertures therethough, and a plurality of lengths of suture may extend through the same apertures, while not departing from the invention. The single tail334may be further adapted to form a finger loop336to provide a means whereby the surgeon can adjust the distance of the locking length20from the anchor316, and/or shortening the length of the suspension loop324, either before or during the surgical operation. Advantageously, the finger loop336may be used with just one hand.

Loops312and314are formed by passing limbs325aand325bthrough gaps between adjacent strands of the suture310. A length of the locking length20is selected to be sufficiently long enough to accommodate a ligament fixation graft suspended thereover, but short enough to facilitate efficient adjustment of the suspension loop324while in a bone tunnel. As described herein, having a shorter locking length20allows for a maximum length of the loop construct310to include braids along the core. Locking length20may be sufficiently long to cradle the graft (not shown). The graft suspension device may be configured to fix an ACL ligament graft within the knee and as such is expected to undergo considerable physiological cyclic loading as the patient articulates his or her knee. In alternative embodiments, adjustable construct100or310may include a second anchor, operatively coupled to the constructs. This construct may be used to repair a knee meniscus tear, or stabilize a shoulder joint, or tibia and fibia bones close to the ankle syndesmosis. Having a maximum length of braided core is preferential to resist strain or elongation during this physiological loading. Suture elongate may reduce tension on the graft and tissue or graft stabilization over time.

FIG. 3Bis a representation of a cross section through locking length20ofFIG. 3A. The strands are not shown to scale, for simplicity. The strands5are all preferably the same size between the outer rim22and the two braided core portions extending therethrough.

FIG. 4Ashows an alternative configuration of an adjustable suture loop construct415operatively coupled to a cortical button410that may be used to fix a graft for ACL reconstruction procedures or other tissue of graft stabilization. This embodiment includes two locking lengths420aand420b,along the construct415, which may be disposed through or directly adjacent cortical button410. The cortical button410or anchor may provide cortical bone fixation of the graft or tissue and may be similar to other cortical buttons known in the art. Cortical buttons have a first configuration for inserting the button into and along a bone tunnel and are then deployed or flipped to engage a cortical surface of the bone. Similar to previously described embodiments, adjustable loop construct415has an adjustable length that is configured to form a knotless locking loop. Construct415includes two discrete locking lengths420aand420balong the adjustable loop415that are separated by a braided core length. Pulling on the free limbs401aand401b,reduces the loop length first and then upon further tension each locking length420aand420bmay constrict, and knotlessly lock the adjustable loop construct415. Free limbs401a,401bmay then be trimmed, to form a final length, as defined herein. Locking length420a,420blocks around a braided core length. Locking length is sufficiently long to knotlessly lock the adjustable construct415, but is still substantially shorter than the final length.

In this example embodiment, each limb401aand401bforms an eyesplice loop, loop405aand405b,that is linked422during construct assembly. Stated in another way limb401aextends from locking length420aat point402a,forms a loop405aand then enters locking length420aat point402aand exits at point403a.Similarly, limb401bextends from locking length420band at point402b,forms a loop405band then enters locking length420bat point402band exits at point403b. Points402a402b,403aand403bdefine ends of the locking lengths or suture transition points, similar to transition points35aand35bas described in FIG.1. In some embodiments, link422may operatively couple to a second anchor.

Represented inFIG. 4Bis a tissue repair assembly450including an adjustable suture construct470including a locking length20and braided core length25a,25b. Suture construct470is operatively coupled440to both a first anchor such as cortical anchor316,410and also operatively coupled440to a second anchor430. The two anchors may be coupled to opposite ends of the construct470. Operatively coupling may include threading the suture through the anchors316,410,430, or tying knots for example. Second anchor430may be a cortical anchor that is the same or different from anchor316,410. Second anchor430may be a soft anchor, formed of a soft flexible material such as braided suture. Second anchor may be a cylindrical anchor that is inserted into a prepared hole within a tissue. It is preferable that the entire length of the suture470includes a braided suture with a braided core (25a,25b), except for the locking length(s)20. Construct470may include a single locking length20or a plurality thereof spaced apart along the construct470. Further examples of adjustable suture constructs for graft or tissue suspension or stabilization are also disclosed in commonly assigned provisional application 62/862,807 filed on Jun. 18, 2019 and titled “Methods and Devices for Tissue Graft Fixation”; herein incorporated in its entirety by reference.

FIG. 4Cis a representation of a cross section through locking length420aofFIG. 4A. The strands5are not shown to scale, for simplicity. The strands5are all preferably the same size between the outer rim22and the braided core portion extending therethrough.

FIG. 5A and 5Billustrates an exemplary soft anchor500operatively coupled to braided suture construct10. Soft anchor500is represented as a tubular body formed of suture braids and may be similar to an all-suture anchor disclosed in commonly owned U.S. Pat. No. 9,962,149 herein incorporated by reference in its entirety. Soft anchors however come in many forms known in the art; generally including predominantly soft, flexible and/or braided material having a first configuration for inserting into biological tissue such as a bone tunnel. Soft anchors also include a second or deployed configuration, that is oftentimes deployed by placing tension on a flexible strand or suture that extends along and is operative coupled to a length of the soft anchor. This suture or flexible strand may be defined as the “deploying suture”. A deployed soft anchor has a different shape from the first configuration in that it is both laterally deformed and longitudinally deformed. It is generally laterally expanded and longitudinally compressed compared to the first configuration. Soft anchors may come in other forms than a longitudinal tubular shape as shown, including flat tape that deforms into a series of S-beds, tubes in a U-bend shape, or tubes in a W-bend shape for example. Soft anchors are not precluded from including at least a portion including material that is rigid.

Suture10is shown operatively coupled to the soft suture anchor, and may be interwoven repeatedly through a portion of the anchor500. Suture10may be the “deploying suture”. Alternatively, suture10may be operatively coupled to the anchor500and a repair tissue505and therefore be defined as the “repair suture”. Suture may be threaded through a portion of the anchor500to form an adjustable loop similar to loop construct100. Suture10may thread through a portion of the anchor500and form a single adjustable loop only, as illustrated inFIG. 5B. In some embodiments, suture construct10may act as both the deploying suture and repair suture. As such, this disclosure includes a suture such as a suture10, operatively coupled to a soft anchor500coupling the repair tissue505with the anchor500.

Soft anchors500that are knotlessly locked have been described in at least commonly owned U.S. Pat. No. 9,962,150, herein incorporated by reference in its entirety. Soft anchor500may be operatively coupled to suture10as shown inFIG. 5A, with locking length20adjacent anchor500. Locking length20may be at a distal end510of anchor as shown, or may be along a length of the anchor500or across a top or proximal end of anchor500. Locking length20may be proximally spaced from anchor500. Locking length20may have a length approximately equal to or greater than lateral width or diameter of soft anchor500. Suture10may form two adjustable loops similar to that described inFIG. 2B, with at least a portion threaded between braids of the anchor500to operatively couple the suture10with anchor500. Tension on at least one limb25a,25bmay deploy anchor500, which may laterally and longitudinally deform anchor500, represented inFIG. 5B. Limbs25aand25bmay be coupled to tissue505and a first tension on at least one limb25aor25bmay draw the tissue505towards the anchor500. Further tension may knotlessly lock the tissue505with the anchor500and may lock the anchor500in the second, deployed configuration. Alternative configurations may include a plurality of locking lengths20. For example, a first locking length20may extend along a first length of the anchor500on a first side, and a second locking length may extend along the anchor500on a second different side of the anchor500, or proximally spaced from anchor500.

FIG. 6shows an example of a knotless suture construct operatively coupled to a rigid anchor600. Rigid anchor600may be sized to form an interference fit within a tissue such as a bone hole, or may have a deployable portion to laterally expand and lock with the target tissue. For example, a plug may be axially slid into an opening of the rigid anchor to laterally deform an outer portion of the anchor, which may include wings or barbs. Rigid anchor600is operatively coupled to a suture loop construct formed of suture10and may include a single loop (shown inFIG. 6) or a double loop construct shown inFIGS. 2a,2B. Suture10may be operatively coupled using a knot610to the anchor. In the particular exemplary embodiment illustrated inFIG. 6, rigid anchor600may include a plurality of barbs615extending circumferentially around it. Alternative embodiments may include external threads or flexible wings, and anchor600may be a screw-in anchor or a push-in style anchor. Transverse openings/channels616and617allow suture10and/or suture passing device(s) to pass around bar620. Cannulation611extends along the anchor600to allow passage of suture10and or passing devices. In alternative embodiments suture10may have an alternative routing around anchor600, eliminating the bar620. For example suture10may extend along a length of cannulation611and around a distal-most end630of anchor and along an outer wall of anchor (not shown) back to a proximal end635. Outer wall may include elongate slots to receive the length of the suture therealong and provide space between a bone tunnel wall and the suture10. An example embodiment may include anchors with elongate slots as shown in commonly owned U.S. Pat. No. 8,758,367 incorporated by reference in its entirety.

Returning to the example embodiment inFIG. 6, suture10, as previously described may be preloaded within or along anchor600and may be operatively coupled by tying static knot610. Alternatively suture10may be coupled using insert molding, adhesive, welding or by any other means known in the art. Suture10is shown directly coupled at a distal-most end of anchor600, but may alternatively be directly coupled along a length of the suture10that lies along a portion of the anchor600, proximally disposed therefrom. As shown, suture10may pass round bar620, which is large enough to allow suture10to take gradual turns instead of sharp turns. Suture10then passes through anchor cannulation611.

Anchor may be provided with a suture passer such as a snare or wire (not shown) threaded through locking length20to provide a means of easily threading a limb (25b) though the locking length20. Suture passer may include a loop to snare suture limb25band may enter and exit locking length20at apertures32and34, similar to those described inFIG. 2A. Locking length20may be approximately shorter than anchor length from distal most630end to proximal most end635. Preferably, suture loop construct may include a braided core segment (limb25aand25b) that forms a substantial portion of the suture construct. Preferably, a ratio of the length with a braided core to a locking length is greater than 1:1 to provide reduced elongation due to physiological cyclic loading.

Once anchor600is inserted into bone, using an inserter device (not shown), suture limb25bmay be coupled to tissue650and then drawn through locking length20using suture passer (not shown). A first tension may then draw tissue650towards the anchor600proximal end635and therefore the bone. Further tension may activate the locking length20so as to knotlessly lock the suture loop and thereby the tissue650with anchor600.

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.