Multi-span tethered collar for knot-free spanning of tissue between anchor points and tools for use thereof

Abstract

A suture construct includes a single suture filament arranged from separate finger catchers to form two tethered loops, with a fixed length spanning portion extending between fixed portions of the two finger catchers. The tail of the suture extends from each finger trap and is slidably disposed therein to tighten the corresponding collar. The construct may include an anchor slidably coupled to each of the first collar and the second collar. An inserter for a construct includes a first insertion device and a second insertion device, each having a proximal handle and a distal insertion shaft. The two handles are coupled together to position the insertion shaft alongside each other, wherein the first shaft extends through and beyond the second handle shaft. The first handle is proximally coupled to the second handle such that the first device is disengageable from the second device by proximal removal, which withdraws the first shaft from the second handle.

Description

Technical Field

[0001] The present application generally relates to devices and methods for securing soft tissue (e.g., ligaments, tendons, grafts) to bone, and more specifically to suture constructs for creating a tensionable link between at least two anchors inserted using the same inserter, and embodiments of such inserters. Background Art

[0002] It is a common injury that a tendon, ligament or other soft tissue is completely or partially separated from a bone, especially common in athletes and the elderly. Ligaments are fibrous tissues that connect bones to other bones in the body, and tendons are fibrous tissues that connect muscles to bones in the body. Tissue detachment can occur in many ways, for example, in work-related activities, during sports events, or in any of many other situations and / or activities due to accidents (such as falls, overexertion). These types of injuries are usually caused by excessive stress or special forces applied to the tissue. When a ligament is damaged, surgical reconstruction may be necessary because the ligament may not be able to regenerate on its own. With regard to partial detachment (commonly referred to as the general term "sprain"), the injury usually heals without medical intervention, and the patient rests, and is careful not to subject the injury to excessively intense activities during the healing process. However, if the attachment site on the ligament or tendon and the associated one or more bones is completely detached, or if the ligament or tendon is broken due to a traumatic injury, it may be necessary to perform surgical intervention to restore the full function of the injured joint. Currently available devices for tissue attachment include screws, staples, suture anchors, and tacks.

[0003] Repair constructs made of one or more surgical filaments are often used in soft tissue repair procedures (such as rotator cuff fixation) to fix tissue in a desired position. The repair construct is often placed through one or more portions of the tissue to be repaired, which can cause trauma to the tissue, and is often coupled to an anchor placed in the bone to which the tissue is proximal.

[0004] Soft tissue repair includes arthroscopic repair of rotator cuff tears. These types of repairs can be long and difficult surgeries involving bone hole creation, finding any bone holes again after creation, placing anchors into each bone hole, and managing multiple suture branches. The act of managing multiple suture branches can include identifying the branches, isolating them from each other, and / or passing them through tissue, such as using suture tunnels. This surgical complexity can result in excessive operating room time and / or poor repair, which can result in a variety of complications as understood by those skilled in the art.

[0005] There are a variety of surgical procedures for rotator cuff repair, and more generally for reattaching ligaments or other soft tissues to bones. However, existing devices and methods may be limited, at least because they cannot always provide the desired strength or adjustability. Many existing devices and methods are configured to fix soft tissue to a single bone anchor, which is inserted into the bone using a tool. In some instances, for example, where multiple bone anchors are required, inserting multiple anchors into the bone requires inserting the insertion tool into the surgical site multiple times, wherein each insertion involves placing the bone anchor and the associated suture construct at separate locations. Further, some existing devices and methods also require the use of additional fixation devices, such as cortical buttons, wherein each suture construct is used to facilitate the fixation of soft tissue to the bone.

[0006] Therefore, there is a need for improved fixation devices and repair and reconstructive procedures that allow multiple bone anchor positions. Specifically, there is a need for an instrument that can be used with anchors that enables surgical techniques to benefit from sequential implantation of soft anchors without the need for instrument replacement, thereby saving surgical time, reducing trauma and making such procedures easier. Summary of the invention

[0007] Examples of the present disclosure include systems, devices, and methods for performing surgical procedures involving sutures, such as rotator cuff repair and other soft tissue repair procedures. More specifically, certain examples of the disclosed systems, devices, and methods allow a user to create a tensionable link between at least two anchors inserted using the same inserter, and embodiments of such inserters are disclosed herein.

[0008] Representative examples include suture constructs having a length of suture that crosses an anchor, forms a loop including the anchor by passing through a self-locking mechanism such as a joint (e.g., a finger-like catcher) in itself, crosses a second anchor, and forms a second loop including the second anchor by passing through another self-locking mechanism such as a joint (e.g., a finger-like catcher) in itself at a distance from the first self-locking mechanism, so that the end of the suture is pulled to close the loop. The self-locking mechanism of the suture is used to allow the contraction of the loop, but resist the expansion of the loop. The self-locking mechanism can be a joint (e.g., a finger-like catcher) or a knot, as well as other structures that achieve the purpose of allowing contraction while resisting expansion. In some examples, in addition to the anchor, a single strand of suture is used to construct the suture construct. The anchor may also include one or more sutures loaded into each of them to serve as a component that pulls the anchor separately from any force applied to the length of suture that forms the contraction loop. These additional sutures can be used to "set" the anchor into position in the bone or outside the hole in which the anchor is placed, causing the anchor to "shrink" within the bone (or outside the hole) when force is applied, thereby allowing the anchor to resist further applied forces tending to separate them from the bone (or cause them to return through the hole). The constructs disclosed herein can be used in a variety of surgical repair procedures in which soft tissue is to be set at or near a desired position relative to bone.

[0009] An example of the present disclosure is a suture construct formed by a first flexible member, the first flexible member including a first adjustment mechanism, a second adjustment mechanism, a first tail, a second tail, a spanning portion, a first anchor, and a second anchor. The first adjustment mechanism is formed in the first flexible member to create a first loop extending from the first adjustment mechanism, the first loop defining a first loop opening. The first tail of the first flexible member extends from the first adjustment mechanism, and the spanning portion of the first flexible member extends from the first adjustment mechanism. The second adjustment mechanism is also formed in the first flexible member, and in this way creates a second loop extending from the second adjustment mechanism. The second loop defines a second loop opening. The second tail of the first flexible member extends from the second adjustment mechanism, the first anchor is slidably coupled to the first portion of the suture of the first loop, and the second anchor is slidably coupled to the second portion of the suture of the second loop. In addition, the first tail is configured to slide relative to the first adjustment mechanism to reduce the size of the first loop opening, and thus reduce the first distance between the first anchor and the first adjustment mechanism, and the second tail is configured to slide relative to the second adjustment mechanism to reduce the size of the second loop opening, and thus reduce the second distance between the first anchor and the second adjustment mechanism. Further, the spanning portion of the first flexible member defines a fixed distance along the suture line between the first adjustment mechanism and the second adjustment mechanism.

[0010] At least one of the first adjustment mechanism or the second adjustment mechanism may include a self-locking knot. Likewise, at least one of the first adjustment mechanism or the second adjustment mechanism may include a finger-shaped catcher arrangement. In some embodiments, the first adjustment mechanism may include a first finger-shaped catcher, wherein the first tail passes through the first finger-shaped catcher, and the second adjustment mechanism may include a second finger-shaped catcher, wherein the second tail passes through the second finger-shaped catcher. In some such embodiments, the spanning portion may be defined by a fixed length of suture between the first finger-shaped catcher and the second finger-shaped catcher. The first finger-shaped catcher and the second finger-shaped catcher may each define a length along the first flexible member approximately in the range of about 1 mm to about 10 mm. The fixed length of the spanning portion may be approximately in the range of about 1 mm to about 10 mm. At least one of the first anchor or the second anchor may be a soft anchor constructed of a braided material. The first flexible member may be a single continuous flexible member.

[0011] The suture construct may further include a second flexible member extending through the first anchor such that the first anchor may also be slidably disposed on the second flexible member. The first flexible member and the second flexible member may extend through the same path through the first anchor. The suture construct may further include a third flexible member extending through the second anchor such that the second anchor may also be slidably disposed on the third flexible member. The second flexible member may be a flexible member of a loop of another suture construct.

[0012] Another example of the present disclosure is a method for preparing a surgical implant, the method comprising passing a first tail of a first flexible member through a first anchor, and after passing the first tail through the first anchor, creating a first loop in the first flexible member by forming a first adjustment mechanism. The first flexible member has the first tail extending from one side of the first adjustment mechanism and a first portion of the first flexible member and the first loop extending from an opposite side of the first adjustment mechanism, so that the first anchor is slidably disposed on the first flexible member of the first loop. The method also includes passing a second tail of the first flexible member through a second anchor, and after passing the second tail through the second anchor, creating a second loop in the first flexible member by forming a second adjustment mechanism. The first flexible member has the second tail extending from one side of the second adjustment mechanism and a second portion of the first flexible member and the second loop extending from an opposite side of the second adjustment mechanism, so that the second anchor is slidably disposed on the first flexible member of the second loop. The first portion of the first flexible member and the second portion of the first flexible member together define a spanning portion of the first flexible member, the spanning portion defining a fixed length of the first flexible member between the first adjustment mechanism and the second adjustment mechanism. Tension on the first tail tightens the first loop and reduces a maximum distance between the first anchor and the spanning portion, and tension on the second tail tightens the first loop and reduces a maximum distance between the second anchor and the spanning portion.

[0013] At least one of the first adjustment mechanism or the second adjustment mechanism may include a self-locking knot and / or at least one of the first adjustment mechanism or the second adjustment mechanism may include a finger catch arrangement. The method may include: the first adjustment mechanism includes a first finger catch, wherein the first tail passes through the first finger catch; the second adjustment mechanism includes a second finger catch, wherein the second tail passes through the second finger catch, and the span is defined by a fixed length of suture between the first finger catch and the second finger catch. The first flexible member may be a single continuous flexible member.

[0014] The method may further include passing the tail of the second flexible member through the first anchor so that the first anchor may also be slidably disposed on the second flexible member. The first flexible member and the second flexible member may extend through the same path through the first anchor. The method may further include passing the tail of a third suture filament through the second anchor so that the second anchor may also be slidably disposed on the third suture filament. The second suture filament may be a suture filament of a loop of another suture construct according to those described above or elsewhere in the present disclosure.

[0015] Yet another example of the present disclosure is a surgical instrument comprising a first insertion device and a second insertion device. The first insertion device comprises: a first inserter shaft having a first distal tip configured to hold an anchor and implant it into tissue; and a first handle disposed around the proximal end of the first inserter shaft. The second insertion device is configured to be coupled to the first insertion device and comprises: a second inserter shaft having a second distal tip configured to hold an anchor and implant it into tissue; and a second handle disposed around the proximal end of the second inserter shaft. The second handle has a hole passing through the second handle and is configured to allow the first inserter shaft to be disposed in the hole when the second insertion device is coupled to the first insertion device. The first handle is configured to be removably coupled to the distal end of the second handle so that the first insertion device can be disengaged from the second insertion device, for example, by withdrawing the first handle proximally from the second handle and thus withdrawing the first inserter shaft proximally from the hole of the second handle. In addition, when the first insertion device and the second insertion device are coupled, the first distal tip of the first inserter shaft extends distally beyond the second distal tip of the second inserter shaft.

[0016] The proximal tip of the first insertion shaft may extend proximally beyond the first handle. The proximal tip of the second insertion shaft may extend proximally beyond the second handle. When the first instrument is coupled to the second instrument, the first insertion shaft and the second insertion shaft may be adjacent and substantially parallel along their respective lengths. The first handle and the second handle, when coupled, may define a continuous single handle of the surgical instrument.

[0017] The first handle may include a latch configured to removably secure the connection of the first handle to the second handle, and the first handle may include a flexible portion for controlling the engagement of the latch with the second handle. The flexible portion may also enable a force applied to the flexible portion by a user to release the engagement of the latch with the second handle. The first handle may have a first mandrel configured to hold a length of suture extending from the first distal tip. The second handle may have a second mandrel configured to hold a length of suture extending from the second distal tip. The second handle may include a recess configured to receive a length of suture extending from the first distal tip to the first mandrel.

[0018] The surgical instrument may also include a breakaway sheath configured to be disposed around the first instrument axis and the second instrument axis and extending from the second handle to the first distal tip. The proximal end of the breakaway sheath may define a first section that may be configured to be removed from being disposed around the first instrument axis and the second instrument axis and, after being removed, may allow the breakaway sheath to translate proximally to expose the first distal tip while still covering the second distal tip. In addition, the breakaway sheath may include a second section that may be disposed distally of the first section and may be configured to be removed from being disposed around the first instrument axis and the second instrument axis. In addition, after being removed, the second section may allow the breakaway sheath to translate proximally to expose the second distal tip.

[0019] The surgical instrument may also include a suture construct connected to the surgical instrument according to the examples disclosed above or otherwise, wherein the first anchor is retained by the first distal tip, the second anchor is retained by the second distal tip, and the first tail and the second tail of the first flexible member are fixed to the second handle.

[0020] Yet another example of the present disclosure is a method of fixing soft tissue to bone, the method comprising guiding a first distal tip of a first insertion shaft of a first instrument carrying a first anchor through soft tissue at a first position, and inserting the first anchor into the bone at a second position. The anchor has a first tightenable collar of a suture construct coupled thereto. The method also comprises disposing the first anchor in the second position by withdrawing the first distal tip from the first position and the second position. The withdrawal comprises withdrawing the first insertion shaft proximally from a second handle of a second instrument. The second instrument has a second insertion shaft having a second distal tip carrying a second anchor, wherein the second anchor has a second tightenable collar of the suture construct coupled thereto. The method also comprises guiding the second distal tip of the second first insertion shaft through the soft tissue at a third position and inserting the anchor into the bone at a fourth position, and disposing the second anchor in the fourth position by withdrawing the second distal tip from the third position and the fourth position. The act of withdrawing includes positioning a spanning portion of the suture construct across the soft tissue, wherein the spanning portion fixedly couples the first adjustment mechanism of the first tieable loop to the second adjustment mechanism of the second tieable loop. The method also includes tensioning the spanning portion against the soft tissue by at least one of: (1) tensioning a first tail portion of the suture construct extending from the first adjustment mechanism, the tensioning cinching the first loop and pulling the first adjustment mechanism toward the first anchor; and (2) tensioning a second tail portion of the suture construct extending from the second adjustment mechanism, the tensioning cinching the second loop and withdrawing the second adjustment mechanism toward the second anchor.

[0021] The second anchor may include a third tieable loop of the second suture construct coupled thereto. The method may also include, after disposing the second anchor in the fourth position, guiding the distal tip of the insertion shaft carrying the third anchor through the soft tissue at the fifth position and inserting the third anchor into the bone at the sixth position. The third anchor may have a fourth tieable loop of the second suture construct coupled thereto. The method may also include disposing the third anchor in the sixth position by withdrawing the distal tip from the fifth position and the sixth position, wherein the withdrawal action includes disposing a second spanning portion of the second suture construct across the soft tissue. The second spanning portion may fixedly couple the third adjustment mechanism of the third tieable loop to the fourth adjustment mechanism of the fourth tieable loop. Further, the method may include tensioning the spanning portion against the soft tissue by at least one of: (1) tensioning a third tail portion of the second suture construct extending from the third adjustment mechanism, the tensioning cinch the third loop and pulling the third adjustment mechanism toward the second anchor; and (2) tensioning a fourth tail portion of the second suture construct extending from the fourth adjustment mechanism, the tensioning cinch the fourth loop and pulling the fourth adjustment mechanism toward the third anchor.

[0022] The suture construct can be formed by a single flexible member, and in at least some embodiments, can be connected to two bone anchors (e.g., full suture anchors, or toggle anchors, or other suitable anchors for anchoring in bone) for various soft tissue repair surgeries. A single flexible member can include two self-locking mechanisms, such as joints or knots formed therein, which are spaced apart at a substantially fixed distance, and each self-locking mechanism defines a loop portion. Each loop portion extends from a corresponding self-locking mechanism, and each loop portion is connected to an anchor such as a soft anchor. Example constructs can also be used with push-in hard anchors, wherein the anchor is placed and maintained in the bone by pushing the anchor axially into place. The sliding tail formed by the flexible member and extending from the self-locking mechanism can be operable to compress or otherwise make the corresponding loop portion smaller, which in turn pulls the corresponding anchor toward the self-locking mechanism.

[0023] In an exemplary embodiment, a suture construct formed by a flexible member includes a first finger catch formed in the flexible member, a first tail of the flexible member extending from the first finger catch, a spanning portion of the flexible member, a second finger catch formed in the flexible member, and a second tail of the flexible member extending from the second finger catch. The first finger catch creates a first loop extending from the first finger catch, wherein the first finger catch defines a first loop opening. The spanning portion extends from the first finger catch, connecting the first finger catch to the second finger catch. The second finger catch creates a second loop extending from the second finger catch, the second loop defining a second loop opening. The first tail is configured to slide relative to the first finger catch to reduce the size of the first loop opening, and thus reduce the size of the adjustable loop opening. Similarly, the second tail is configured to slide relative to the second finger catch to reduce the size of the second loop opening. The spanning portion is configured to prevent the loop opening from expanding when the suture is manipulated into a locked configuration. The spanning portion allows forces to be transmitted to the opposing finger catches, thereby preventing expansion of the loop opening when the suture is manipulated into a locked configuration, which forces might otherwise loosen the construct.

[0024] At least one of the adjustment mechanisms may be a knot, such as a self-locking knot. Non-limiting examples of such knots include a figure-8 lasso, an extended figure-8 lasso, or a Prussian knot. The flexible member may not be spliced ​​at the location of the first knot and the second knot. The fixed body may be coupled to the spanning portion of the flexible member. For example, the spanning portion may pass through a plurality of through holes provided in the fixed body.

[0025] The suture construct may also include an unlocking configuration. In some such embodiments, the suture may be configured to move between the locking configuration and the unlocking configuration by adjusting the relative load of the spanning portion and / or the tail portion (i.e., the first tail and / or the second tail). In an exemplary embodiment of a surgical implant, the implant includes a fixed body and a flexible member coupled to the fixed body. The fixed body has a longitudinal axis, a first side and a second side extending along it, and a first through hole and a second through hole. The flexible member includes a first part, which has a first tail, a first knot formed on the first part, and a first loop portion. The first tail extends through the first through hole, the first knot is arranged on the first side of the body, and the first loop portion extends away from the body from the first knot. The flexible member also includes a second part, which has a second tail, a second knot formed on the second part, and a second loop portion. The second tail extends through the second through hole, and the second loop portion extends away from the body from the second knot. The flexible member also includes a spanning portion that spans the fixed body and extends from the first knot to the second knot. The first knot and the second knot are further configured such that tension on the bridge portion prevents the adjustable loop from expanding.

[0026] At least one of the first knot or the second knot may be a self-locking knot. Non-limiting examples of such knots include a figure-8 lasso, an extended figure-8 lasso, or a Prussian knot. The flexible member may not be spliced ​​at the location of the first and second knots. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present disclosure will be more fully understood through the following detailed description taken in conjunction with the accompanying drawings, in which:

[0028] Figure 1 is a schematic side view of an exemplary embodiment of a multiple loop tensionable suture construct spanning between multiple suture anchors;

[0029] Figure 2 yes Figure 1 A schematic side view of a multi-loop tensionable suture construct;

[0030] Figure 3 is with Figure 1 A schematic side view of an exemplary soft anchor for use with a multi-loop tensionable suture construct;

[0031] Figure 4 is with Figure 1 A schematic side view of another exemplary soft anchor for use with a multi-loop tensionable suture construct;

[0032] Figure 5A and Figure 5B is a plurality of suture anchors (including Figure 3 The suture anchors span Figure 1 A schematic perspective view of a multi-loop tensionable suture construct;

[0033] Figure 6 is a multiple loop tensionable suture construct spanning a series of anchors (including Figure 1 A multi-loop tensionable suture construct and Figure 3 A schematic side view of an exemplary embodiment of a suture anchor of FIG.

[0034] Fig. 7A and Figure 7B is across the installed configuration Figure 6 A schematic perspective view of a portion of a plurality of multi-loop tensionable suture constructs having a series of anchors;

[0035] Figure 8 is a photograph providing a side view of an example of a multiple loop tensionable suture construct spanning between multiple suture anchors;

[0036] Fig. 9 Yes Figure 8 A photograph of a side view of a knotless loop arrangement of a multi-loop tensionable suture;

[0037] Fig. 10A is an isometric view of a dual insertion instrument for installing an embodiment of a multi-loop tensionable suture construct disclosed herein;

[0038] Fig. 10B yes Fig. 10A A top view of a dual insertion instrument assembly;

[0039] Fig. 10C It was intercepted along CC Fig. 10B A cross-sectional view of a dual insertion instrument assembly;

[0040] Fig.11A and Fig. 11B yes Fig. 10A an isometric view of a dual handle assembly of a dual insertion instrument assembly;

[0041] Fig. 11C yes Fig.11A and Fig. 11B A perspective side view of a dual handle assembly of the invention, wherein the handles are separated;

[0042] Fig. 12A yes Fig. 10A An isometric view of a two-handle assembly of a dual insertion instrument assembly, wherein the handles are partially separated;

[0043] Fig. 12B yes Fig. 12AA cross-sectional view of a dual insertion instrument assembly in an arrangement of;

[0044] Fig. 12C yes Fig. 10A An isometric view of a second insertion tool of a dual insertion instrument assembly;

[0045] Fig.13A is to provide something similar to Fig. 10A A photograph of a side view of a dual insertion instrument assembly of a dual insertion instrument assembly having Figure 8 A ready-to-use configuration of a multiple-loop tensionable suture construct and suture anchor;

[0046] Fig. 13B Yes Fig.13A a close-up photograph of a side view of a dual insertion instrument assembly and a distal end of a suture construct;

[0047] Fig. 13C Yes Fig.13A a close-up photograph of a side view of a dual insertion instrument assembly and a proximal end of a suture construct;

[0048] FIG. 14A to FIG. 14C Yes Fig.13A A photograph of a perspective view of a dual insertion instrument assembly and a suture construct illustrating the operation of separating the sheath prior to inserting a first anchor of the suture construct;

[0049] FIG. 14D to FIG. 14F are provided separately Fig.13A A photograph of a top view, a perspective view, and a perspective view of a dual insertion instrument assembly and a suture construct showing the operation of separating the sheath prior to inserting a second anchor of the suture construct;

[0050] FIG. 15A to FIG. 15C This is an example of using Fig.13A A perspective view of a dual insertion instrument assembly and a suture construct for inserting a first anchor of a suture construct;

[0051] Fig.15D is an example Fig.15A A perspective view of a dual insertion instrument assembly of FIG. 1 with a first insertion instrument separated from a second insertion instrument; and

[0052] FIG. 15E to FIG. 15G The second insertion instrument of the dual insertion instrument assembly is used to insert Fig.15A A perspective view of a second anchor of a suture construct. DETAILED DESCRIPTION

[0053] Certain exemplary embodiments will now be described to provide a comprehensive understanding of the principles of structure, function, manufacture and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. It will be understood by those skilled in the art that the devices and methods specifically described herein and shown in the accompanying drawings are non-limiting exemplary embodiments, and the scope of the present disclosure is limited only by the claims. The features illustrated or described in conjunction with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. In addition, in the present disclosure, similarly numbered components of the embodiments generally have similar features. In addition, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. It will be recognized by those skilled in the art that equivalent dimensions of such linear and circular dimensions can be easily determined for any geometric shape. The size and shape of the system and device and its components may depend at least on the anatomical structure of the subject in which the system and device will be used, the size and shape of the components with which the system and device will be used, and the method and surgery in which the system and device will be used.

[0054] The drawings provided herein are not necessarily drawn to scale. In addition, to the extent arrows are used to describe the direction of tensionable or pullable components, these arrows are exemplary and in no way limit the direction in which the various components can be tensioned or pulled. Those skilled in the art will recognize other ways and directions for generating desired tension or movement. Similarly, although in some embodiments, the movement of one component is described relative to another component, those skilled in the art will recognize that other movements are possible. In addition, many terms can be used interchangeably in this disclosure, but those skilled in the art will understand. As non-limiting examples, the terms "suture", "filament" and "suture filament" can be used interchangeably with each other and with "flexible member".

[0055] The present disclosure as a whole relates to methods and devices for fixing soft tissues (including but not limited to ligaments, tendons and grafts) to bones or other desired locations in the body of a subject (e.g., humans, animals). The surgical implants described herein generally include a suture construct formed by a flexible member, such as a suture (also referred to as a filament or suture filament) threaded through two suture anchors or otherwise associated with two suture anchors in a manner that each suture anchor is slidably disposed on an adjustable loop of the suture construct, wherein a spanning portion of a fixed length extends between the adjustment mechanisms (e.g., knots, joints, finger-like catchers) of each adjustable loop. It should be understood by those skilled in the art that the flexible member includes any component that is flexible for use in surgical procedures (such as those provided herein), including but not limited to sutures, filaments, suture filaments, braided sutures or filaments, monofilaments, and other materials used to form them and / or to form other "soft" components (e.g., soft anchors). The size of each adjustable loop can be adjusted by manipulating one or both of the interconnected loops of the suture using the end of the suture. Figures 1 to 9 Examples of surgical implants having a suture construct and two anchors and uses thereof are illustrated. The examples include using a plurality of suture constructs in series with a plurality of anchors to secure tissue across a plurality of consecutive points, wherein a spanning portion of each suture construct extends from each of the plurality of consecutive points across the tissue between the anchors.

[0056] Examples of the present disclosure also include a surgical instrument for using a suture construct, wherein the instrument has a separate first insertion shaft and a second insertion shaft, each insertion shaft carrying one of the two anchors, so that the instrument can be delivered to a surgical site to install the two anchors without removing the entire instrument. In some examples, the surgical instrument is an assembly of two separable insertion instruments, wherein the insertion point of one insertion instrument extends distally beyond the insertion point of the other insertion instrument, so that one of the anchors of the surgical implant can be installed with the distal-most end of the assembly, and after the first installation, the portion of the insertion instrument used to install the first anchor can be withdrawn or otherwise at least partially separated from the other insertion instrument (e.g., disengaging the assembly), leaving the insertion shaft of the remaining instrument to install the second anchor of the surgical implant.

[0057] Exemplary Suture Constructs and Implants

[0058] Figure 11 is a schematic diagram of an exemplary embodiment of a surgical implant 100 including a multi-loop tensionable suture construct 200 spanning between a plurality of suture anchors 300a, 300b. The suture construct 200 may include a first tail 230a extending through a first adjustment mechanism 220a to form a first loop 210a and a second tail 230b extending through a second adjustment mechanism 220b to form a second loop 210b. The suture construct 200 may be formed of a single flexible member or a plurality of flexible members. The first adjustment mechanism 220a and the second adjustment mechanism 220b may be a knot such as a self-locking knot, or a joint in a suture such as a finger-like catcher arrangement. In at least some cases, the adjustment mechanisms 220a, 220b can be self-locking, such that tension on the loop portions 210a, 210b (e.g., tensioning the tails 230a, 230b to tighten the respective loops 210a, 210b) prevents movement of the respective tails 230a, 230b through the adjustment mechanisms 220a, 220b back into the loop portions 210a, 210b (e.g., loosening or untightening the loops). The suture construct 200 can include a length of suture between the first adjustment mechanism 220a and the second adjustment mechanism 220b, which is at least sometimes referred to herein as a spanning portion 290, at least because in the installed configuration, it can be positioned to span a portion of the tissue between the locations where the loops 210a, 210b extend into the tissue. In at least some examples, the spanning portion 290 can define a fixed length of suture between the first adjustment mechanism 220a and the second adjustment mechanism 220b. The fixed length can be defined, for example, by the span of the suture extending between the proximal terminals 220at and 220bt of the adjustment mechanisms 220a, 220b, respectively. At least in some instances, it is advantageous to keep the length of the span portion 290 as small as possible, for example to allow the anchors between the two anchors to be placed as close as possible. In some non-limiting embodiments, the span portion can have a length approximately in the range of about 1mm to about 10mm, or approximately in the range of about 3mm to about 5mm. However, the one-way locking effectiveness of the adjustment mechanisms 220a and 220b can generally increase with the increase of the lengths 292a and 292b until the range of about 3mm to about 5mm, and the effectiveness of the construct in terms of locking the loop does not depend on the span length 291. Typically, a smaller span length 291 allows the anchors to be placed closer to each other in each loop. Including the size of the anchors, the depth at which the anchors are placed into the bone, and the thickness of the tissue spanned, a span length 291 approximately in the range of about 3 mm to about 5 mm allows the surgeon to place the anchors as close to each other as desired (without placing them on top of each other).Those skilled in the art will appreciate that other lengths are possible, depending at least in part on the type of procedure being performed, the patient's anatomy and / or the surgeon's preference, as well as other factors understood by those skilled in the art.

[0059] The surgical implant 100 also includes a first anchor 300a disposed on the first loop 210a of the suture construct 200 and a second anchor 300b disposed on the second loop 210b of the suture catheter 200. These anchors may include: a hard anchor, such as Healix Ti TM Anchors, Healix Advance TM Anchors, Helix Advance Knotless TM Anchors, Healix BR TM Anchors, Healix PEEK TM Anchors, Healix Transtend TM Anchors, Anchors, Anchors, Anchors, Anchors, Anchors, Minilok TM Anchors, Micro- Anchors and anchors, each of which is also commercially available from DePuy Synthes; and soft anchors, such as VERSALOOP TM Anchors, also commercially available from DePuySynthes. Some exemplary embodiments of other soft suture anchors that can be used in conjunction with the present disclosure include those described in U.S. Patent No. 9,345,567 to Sengun, the contents of which are incorporated herein by reference in their entirety. The anchors 300a, 300b in the illustrated embodiments are soft anchors that can be constructed of a braided material such as a suture material. In some examples, the anchors 300a, 300b can be slidably disposed on the respective loops 210a, 210b so that the sutures of the loops 210a, 210b can slide through the anchors 300a, 300b. This arrangement can allow, for example, the anchors 300a, 300b to be installed into tissue, such as bone, and then allow tension on the tails 230a, 230b of the respective loops 210a, 210b to tighten the loops by advancing the suture through the anchors 300a, 300b to pull the adjustment mechanisms of the loops closer to the anchors 300a, 300b.

[0060] As shown, surgical implant 100 may also include sutures 499a, 499b extending to and passing through additional lengths of each anchor 300a, 300b. In some examples, one or two of these additional lengths of sutures 499a, 499b may be setting sutures for helping to guide corresponding anchors 300a, 300b to a desired or specified position, such as by pulling setting sutures 499a, 499b to actuate or otherwise set corresponding anchors 300a, 300b to a locking configuration at a desired or specified position and / or to move corresponding anchors 300a, 300b to a desired or specified position at a surgical site, and / or to actuate or otherwise set corresponding anchors 300a, 300b to a locking configuration at a desired or specified position. Setting the anchors 300a, 300b to a locked configuration may also or alternatively involve applying tension to the respective anchors 300a, 300b to adjust the anchors from their initial configuration, in which the anchors may have a lower profile, width, and / or diameter to allow them to more easily pass through small incisions and / or openings to reach the surgical site, to a locked configuration, in which the anchors may have a larger width or diameter than the initial configuration (e.g., in a "bundled" or "compacted" configuration) to help prevent the anchors from separating or otherwise moving from their desired or designated positions when force is applied. Additional lengths of suture 499a, 499b may be threaded through the respective anchors 300a, 300b in a manner similar to the sutures of the loops 210a, 210b, which may include, for example, passing through the same path as the sutures of the loops 210a, 210b on which the anchors 300a, 300b are disposed. In other examples, the additional length of suture threaded through the anchor is a loop of another suture construct 200, such as Figure 6 is shown in more detail in .

[0061] Figure 2 There is no anchor Figure 1Schematic diagram of a multi-loop tensionable suture construct 200. The length of the spanning portion 290 is indicated as (e.g., region 291) the length of the suture between the first adjustment mechanism 220a and the second adjustment mechanism 220b, and more specifically the length between the proximal terminals 220at, 220bt of the adjustment mechanisms 220a, 220b. The length of each first adjustment mechanism and the second adjustment mechanism is also indicated as (e.g., region 292a, 292b) the length of the suture between the spanning portion 290 and the entrance of the tail 230a, 230b into the corresponding adjustment mechanism 220a, 220b on one side of the adjustment mechanism forming the loop. In some non-limiting embodiments, the adjustment mechanisms 220a, 220b may have a length approximately in the range of about 1 mm to about 10 mm or approximately in the range of about 3 mm to about 5 mm (e.g., a finger-like trap configuration in which the trap is elongated to provide additional strength and locking). Those skilled in the art will appreciate that other lengths are possible, depending at least in part on the type of surgery being performed, the patient's anatomy, and / or the surgeon's preference, as well as other factors understood by those skilled in the art. The spanning portion may include visible indicia, such as a different color and / or pattern (e.g., stripes) to distinguish the center of the suture construct 200 during tightening of the loops in a constrained surgical environment, and to enable a user to center the spanning portion between openings in the tissue into which the loops 210a, 210b (and, in some instances, some or all of the adjustment mechanisms 220a, 220b) extend.

[0062] Figure 3 Illustrated with Figure 1 An exemplary soft anchor 300a for use with a multi-loop tensionable suture construct 200. The soft anchor 300a may have a generally circular and / or annular material arrangement with one or more channels, such as the three channels 301, 302, 303 shown, through which sutures may be passed through the anchor. In the illustrated embodiment, the first channel 301 and the third channel 303 are arranged on either side of the channel 302. The first channel 301 and the third channel 303 may be arranged to allow the suture to pass from the outer surface (e.g., away from the anchor 300a) to the inner surface (e.g., inward toward another inner surface portion of the anchor 300a). The second channel 302 may be arranged as a tunnel extending between one inner surface location and another inner surface location, functionally reversing the direction of the suture disposed therein. In operation, and as shown Figure 3As shown in FIG. 1 , the suture of the first loop 210a of the suture construct 200 extends through the first channel 301 (e.g., portion 211) into the anchor 300a, then crosses the inner portion of the anchor (e.g., portion 212) and enters the second channel 302 (e.g., portion 213), where the suture again exits and crosses the inner portion (e.g., portion 214) to pass through the third channel 303 (e.g., portion 215) and back out of the anchor 300a. Alternatively, and as shown in FIG. Figure 3 As shown, the first additional length of suture 499a can be coupled to the first anchor 300a via the same channels 301, 302, 303 as the flexible member of the first loop 210a. The channels 301, 302, 303 can slide the suture through so that the anchor 300a can move along the suture and / or the suture can move through the anchor 300a.

[0063] Figure 4 Illustrated with Figure 1 Another exemplary soft anchor 300a' for use with the multi-loop tensionable suture construct 200 of the present invention. The soft anchor 300a' includes a single channel 304 that extends between two exterior locations of the soft anchor 300a' and, as shown, can extend through a majority of the soft anchor 300a' such that the channel 304 enables the suture to be reversed to enter and exit the soft anchor 300a' from substantially the same side (e.g., upper, relative to the figure) and extend through the opposite side (e.g., lower, relative to the figure) to secure the soft anchor 300a' to the suture. Figure 3 In the same manner as the soft anchor 300a, Figure 4 The soft anchor 300a' may have a first additional length of suture 499a extending through the channel 304. Figure 3 and Figure 4 Two possible arrangements are illustrated, but other arrangements (such as, but not limited to, a loop for suture 200 and a suture path that sets suture 499 both across, within and around anchor 300 at multiple locations) are possible and are included herein.

[0064] exist Figure 3 and Figure 4In the example of an anchor of the embodiment of the present invention, the anchors 300a, 300a' can be coupled to one or more sutures during the manufacture of the anchors 300a, 300a', and / or the sutures can be threaded through the channels 301 to 304 before use. In addition, those skilled in the art will appreciate various other configurations and techniques that can be used to associate the construct 200 or other constructs provided herein or otherwise derivable from the present disclosure with many different types of anchors. The construct 200 and the sutures 499a, 499b can enter and exit any number of channels formed in the anchor or otherwise provided as part of the anchor.

[0065] Figure 5A and Figure 5B is an illustration of a multi-loop tensionable suture construct 200 spanning between a plurality of suture anchors 300a, 300b in an installed configuration. Anchor 300b may have similar properties as suture anchor 300a, although they may be of different configurations or entirely different anchor types (e.g., one may be a soft anchor and the other may be a hard anchor). Figure 5A , a surgical implant 500 including a suture construct 200 and a first anchor 300a and a second anchor 300b is installed in tissues 50, 60. As shown, the soft tissue 50 is above the second tissue 60 (which may be bone), and the first anchor 300a and the second anchor 300b are each disposed in respective separate locations in the second tissue 60. Figure 5A The tissue 50, 60 is shown as semi-transparent to allow the anchors 300a, 300b and the loops 210a, 210b to be illustrated, and Figure 5B The tissues 50, 60 are shown as opaque to better illustrate the placement of the construct 200 over the soft tissue 50 in practice. Figure 5A , from each anchor 300a, 300b, a loop portion 210a, 210b may extend through the soft tissue 500. More specifically, the first loop portion 210a may extend through the first location 51a, and the second loop portion 210b may extend through the second location 51b. The span portion 290 may extend across the face of the soft tissue 50 and may connect the loop portions 210a, 210b. In operation, each anchor 300a, 300b and the corresponding loop portion 210a, 210b of the suture construct 200 coupled thereto may pass through the soft tissue 50 and enter the second tissue 60. Thereafter, the tails 230a, 230b may be pulled simultaneously or sequentially to tighten the loops 210a, 210b and pull the span portion 290 against the face of the soft tissue 50. Figure 5BIn the embodiment of the present invention, the position of the adjustment mechanism 220a, 220b is more easily seen as adjacent to or substantially adjacent to or even into the corresponding position 51a, 51b, where the loop portion 210a, 210b extends through the soft tissue 50 and connects to the anchor 300a, 300b. Also included herein are examples that include placing and securing the anchor within a single tissue layer (such as 50), through and beyond two tissue layers (such as 50 and 60), and / or into or through and beyond a third tissue layer or a fourth tissue layer or subsequent tissue layers.

[0066] Now in Figure 5A Exemplary techniques for using surgical implants 100, 500 and other implants provided herein or otherwise derived from the present disclosure are described in the context of FIG. 15A to FIG. 15G Related disclosures are further provided that focus more on insertion instruments rather than implants. First, the soft tissue 50 to be repaired can be pierced by passing the sharp tip of the insertion instrument through the soft tissue 50. Next, a location in the second tissue 60 (e.g., a bone) can be located at the location where the first anchor 300a will be implanted. A hole can then be formed in the second tissue 60 at the desired location for the first anchor 300 (e.g., by hammering the insertion tool to the appropriate depth in the bone). Next, the central sharpened core of the insertion tool can be removed (depending on the type of instrument and / or anchor used), thereby leaving the outer portion of the insertion tool in the hole in the second tissue 60, after which the first anchor 300a can be loaded onto the insertion tool and advanced into the hole in the second tissue 60. The insertion tool is then removed, leaving the first anchor 300a in the hole. This process is repeated for the second anchor 300b at a different location, after which the spanning portion can be tensioned against the soft tissue 50 by pulling on the tails 230a, 230b to tighten the loops 210a, 210b. Figures 6 to 7B , this process can be repeated multiple times, with additional anchors and suture constructs used to connect chains across all implanted anchors, with the spanning portion bridging across the soft tissue 50 between each anchor location. Also included herein are examples for creating holes through and / or into tissue using the anchors themselves at the end of an insertion tool and / or using an insertion tool with the anchors retained thereon, after which removal of the tool leaves the anchors in place (without requiring a separate step to first create the holes, and / or without requiring any portion of the insertion tool to temporarily remain in the tissue prior to placing the anchors, and without requiring a subsequent step to place the anchors).

[0067] Figure 6 is a schematic side view of an exemplary embodiment of a plurality of multi-loop tensionable suture constructs 600 connected to a series of anchors in an overlapping series. Figure 6In, the plurality of multi-loop tensionable suture constructs 600 include a first implant 601, which includes a first suture construct 200 and a first anchor 300a and a second anchor 300b. The plurality of multi-loop tensionable suture constructs also include a second implant 601 and a third implant 602, until the Nth implant (e.g., 60N), each implant having a loop portion 210a', 210a" coupled to the second anchor of the previous implant and a loop portion 210b', 210b" coupled to the first anchor of the next implant. Therefore, the first anchor 300a of the first implant 601 is only coupled to a single construct 200, as is the second anchor 300n+1 of the final implant 60N, wherein all intermediate implants are coupled to one anchor of each adjacent implant. Examples also include using a plurality of multi-loop constructs (such as a plurality of multi-loop tensionable suture constructs 600) to allow the first implant and the final implant to utilize a loop similar to Figure 6 The multiple loops of other adjacent pairs of anchors in the construct 600 can be connected to each other, and / or additional anchors or multiple anchors similar to multiple multiple loops of tensionable suture constructs 600 can be connected to one or more anchors in the anchors in the multiple multiple loops of constructs via the multiple loops of tensionable suture constructs. In this way, in order to produce the different multiple loops of constructs described, one or more given anchors in such constructs can have more than two multiple loops of tensionable suture loops associated therewith. Each construct 200 may include a first adjustment mechanism 220a and a second adjustment mechanism 220b, as described herein. Anchors are individually marked (e.g., 300a-d, 300n, 300n+1), but their association with the corresponding implants can be but not necessarily established before insertion. For example, before the second anchor 300b of the first implant 601 is inserted, the first loop 210a' can be connected to the first anchor 300a. Thus, for each subsequent suture construct, after the first suture construct, only a single "second" anchor and a loop portion configured to couple with the second anchor of an adjacent implant may be pre-installed. Alternatively, the entire plurality of multi-loop tensionable suture constructs 600 may be manufactured together and provided as a set with a predetermined number of implants, with each connection between the loop and the anchor already established. Furthermore, alternatively, an implant may be coupled to an already implanted anchor to form at least a portion of the plurality of multi-loop tensionable suture constructs 600.

[0068] Fig. 7A and Figure 7Bis an illustration of installing multiple implants 601, 602, 603, each implant having a multi-loop tensionable suture construct 200, 200', 200" arranged to span a series of anchors 300a, 300b, 300c, 300d, the anchors 300a, 300b, 300c, 300d being disposed in a second tissue 60, and the constructs 200, 200', 200" spanning the soft tissue 50 above the second tissue 60. The anchors 300c, 300d may have similar properties to the suture anchors 300a, 300b, although they may be different configurations or entirely different anchor types (e.g., one or more anchors may be soft anchors and one or more other anchors may be hard anchors). In some embodiments, the anchors may be all suture anchors, toggle anchors, or other suitable anchors for anchoring tissue to bone. Similar to Figure 5A ,exist Fig. 7A In the embodiment, the first tissue 50 and the second tissue 60 are semi-transparent to show the anchors 300a, 300b, 300c, 300d in the second tissue. Each construct 200, 200', 200" can be arranged with respect to two of the anchors 300a, 300b, 300c, 300d in the same manner as described above with respect to Figure 5A and Figure 5B Arrange in the same manner as described above. Fig. 7A In the embodiment, each construct 200, 200', 200" can pierce the soft tissue 50 at two unique locations, which is optional because the loops of adjacent constructs can also pierce the soft tissue at the same location, such as Figure 7B In the illustrated embodiment, suture constructs 601, 602, 603 together define a tieable construct having three spans and four anchor points.

[0069] Now in Fig. 7AAn exemplary technique for using surgical implants 601, 602, 603 is described in the context of. First, anchors 300a-d having attached sutures or suture loops spanning between multiple pairs of anchors are sequentially passed through soft tissue 50 and into bone 60. After placing the first anchor in this manner, the second anchor can be placed in this manner, at which point the associated suture end 200 can be tensioned to tighten the span between the first two anchors. Alternatively, the suture end 200 can remain untensioned until a later time. After placing the third anchor in the same manner as the placement of the first and second anchors, the suture end 200' can be tensioned, or remain untensioned until a later time. Subsequent anchors can be placed as needed, with the suture end 200' etc. being tensioned after each subsequent anchor is placed, or remain untensioned. After all anchors are placed in the plurality of multi-loop constructs, any suture ends that were not tensioned may be tensioned as needed to tighten the span between the respective pairs of anchors that were placed.

[0070] Figure 8 FIG. 8 is a photograph of an exemplary implant 80 having a multiple loop tensionable suture construct 800 spanning between multiple soft suture anchors 83a, 83b. The suture construct 800 is made of a single length of suture 801 formed into two separate loop sections 810a, 810b by passing each tail 830a, 830b of the suture 801 through a finger-like catcher 820a, 820b. The finger-like catchers 820a, 820b are formed in adjacent areas of the suture 801 with a spanning portion 890 extending therebetween. Each soft anchor 83a, 83b is formed as shown in FIG. Figure 3 The described method can be slidably disposed on a corresponding one of the loops 810a, 810b. Additional lengths of suture 999a, 999b are also threaded through each soft anchor 83a, 83b along the corresponding loop portion 810a, 810b. The additional lengths of suture 999a, 999b can be performed similar to Figure 1 The function of the additional length of suture 499a, 499b. Fig. 9 The finger catcher adjustment mechanism 820a, 820b is shown in more detail. Each finger catcher 820a, 820b can include a substantially stationary trap formed in the suture portion 812a, 812b on the side of the spanning portion 890. The stationary trap is the area through which the moving portion 811a, 811b of the suture passes, and extending from the trap, a length of suture opposite the loop portion 810a, 810b, is a tensionable tail 830a, 830b that can be pulled to tighten the loop 810a, 810b.

[0071] Alternatively, knots can be used to construct the loops 810a, 810b of construct 800, which enables non-spliced ​​sutures to be used to manufacture constructs 200, 800. Even if sutures are spliced, the construct 800 configuration can also be made without using joints at least relative to the position where the adjustment mechanism 820a, 820b is located. In at least some instances, the use of knots opposite to joints can provide enhanced safety and greater flexibility for manufacturing one-way contraction loops, at least because it allows the use of sutures and other benefits that are incompatible with alternative locking mechanisms (such as joints). Therefore, the examples of knots provided herein can be described as non-spliced, because these knots do not include joints as previously used in medical applications. Adjustment mechanisms 820a, 820b can generally include a variety of mechanisms, including self-locking mechanisms, and self-locking mechanisms can include, for example, joints, finger-shaped catchers, knots, and other arrangements known to those skilled in the art.

[0072] The adjustment mechanisms 820a, 820b can be formed on the filament 801 in many different ways. Fig. 9 In the illustrated embodiment shown in detail in , the adjustment mechanism 820a, 820b is a finger-shaped catcher. More generally, the adjustment mechanism 820a, 820b can also be a knot, such as a slip knot and / or a single-strand single-loop slipknot. When arranged in a construct similar to construct 800, these adjustment mechanisms 820a, 820b can exhibit self-locking behavior, which is due to, for example, when the loops 810a, 810b are tensioned and tied, the tension on the spanning portion 890 pulls the two sleeve portions of the finger-shaped catcher. The illustrated embodiment in no way limits the type and / or number of the adjustment mechanism 820a, 820b, which can be used as a knot with the suture constructs provided herein (e.g., constructs 200, 800) to achieve the desired function of the construct. Fig. 9 The finger catches and knots shown in are some non-limiting examples of self-locking adjustment mechanisms and self-locking mechanisms, and more generally, adjustment mechanisms can be used in place of the finger catches and knots described herein. In view of the present disclosure, one skilled in the art will recognize other adjustment mechanisms 820a, 820b (such as, for example, tooth and pawl arrangements) suitable for use in conjunction with the constructs and implants of the present disclosure, which can be advantageously used with monofilament flexible members (e.g., sutures) where splicing may not be possible due to the monofilament nature of the flexible member.

[0073] The manipulation of a single flexible member can be achieved in various ways to form each of tails 830a, 830b, loop portions 810a, 810b, adjustment mechanisms 820a, 820b, and spanning portions 890. The order in which the various features of construct 800 (e.g., tail, loop portions, adjustment mechanisms, spanning portions, etc.) are formed is generally not critical. As generally shown, a single flexible member includes two ends, which are ultimately tails 830a, 830b. In an exemplary embodiment, the flexible member extends from a first tail 830a, formed into a first loop 810a by returning through a first adjustment mechanism 820a formed into a suture. Alternatively, a second tail is formed into a second loop 810b by returning through a second adjustment mechanism 820b formed into a suture.

[0074] Although Figure 8 The example of the adjustment mechanism 820a, 820b is illustrated as a finger-shaped catcher arrangement, but other configurations are possible. One such example is to use an 8-shaped lasso knot or an extended 8-shaped lasso knot to form a loop portion. In operation, the tail is freely pulled through the 8-shaped lasso knot to shrink the loop portion. By applying tension to the shrinking tail (for example, forming a suture across the portion), the suture construct can be placed in a locked configuration. Another exemplary construct includes a suture knotted with a Prussian knot to form a loop portion, a shrinking tail forming a spanning portion, and a sliding tail providing a tightening of the loop. For example, a Prussian knot can be produced by piercing the end of the suture through the center portion of the suture. In operation, the sliding tail is freely pulled through the Prussian knot to shrink the loop portion. By applying tension on the shrinking tail (for example, applying tension on the spanning portion by tightening two loops), the suture construct can be placed in a locked configuration. The use of knots allows for greater flexibility in the manufacturability of the unidirectional contracting loop construct 400 by enabling the use of sutures 500 that are incompatible with alternative locking mechanisms (e.g., connectors). One such example is a suture with a solid core, such as the DePuySynthes Dynacord available from DePuy Synthes Sports Medicine (Mitek) of Raynham, MA, USA. TM Suture. Dynacord TM The suture is constructed with a solid core that is configured to shrink when hydrated. Additional information about such suture configurations is provided at least in U.S. Pat. No. 8,870,915 to Mayer et al., the contents of which are incorporated herein by reference in their entirety. The shrinkage behavior of the constructs provided herein (e.g., implant 100 and / or constructs 200, 800) can be similar to that of Dynacord. TMTechniques are used in combination to resist repair loss due to creep, reapproximation of tissue between which a gap has formed, and / or maintaining compressive forces on the approximated tissue.The presence of a solid core and its typical intimacy with the suture braid may provide an attractive locking mechanism such as a knot external to the suture core.

[0075] exist Figure 8 In the illustrated embodiment, the surgical construct 800 is formed by a single flexible member. However, it should be understood by those skilled in the art that the disclosure provided herein may be suitable for forming using multiple flexible members. For example, in some instances, a bridging portion similar to the spanning portion 890 may be formed by tying together or otherwise connecting two separate flexible members, each flexible member having a knot, a portion of a loop and a sliding tail, similar to the adjustment mechanism 820a, 820b, the portion 810a, 810b of the loop and the sliding tail 830a, 830b formed therein. The bridging portion may be a third flexible member or a terminal of one of the first flexible member and the second flexible member forming the portion 810a of the first loop and the portion 810b of the second loop. The use of a single flexible member may provide benefits in terms of convenience, strength and reliability of manufacturing and / or formation. The use of a variety of flexible member types may provide benefits in terms of the adaptability of the construct 800, so as to more easily have different performance characteristics at different positions along the construct.

[0076] The surgical constructs and implants provided herein can be used in a variety of surgeries to secure soft tissue grafts to bone.One common surgery is to repair a torn or ruptured rotator muscle in a patient's shoulder.

[0077] Examples of the present disclosure also include suture constructs contained in sterile packaging in a ready-to-use configuration. This includes options such as having a multi-loop tensionable construct assembled with multiple anchors, each anchor on its own inserter shaft, and having those shafts assembled together into the insertion instrument. The instrument, inserter shaft, construct, and anchor can be clean and sterile, and can be kept in a thermoformed or other such tray, and further, can be contained in a single bag or multiple bags and kept in a box to be used as a barrier to keep the ready-to-use complete assembly clean and sterile, and easy to handle between final packaging at the company's manufacturing site. The packaging can then be opened and used for a single treatment situation in an operating room or surgical center operating room, after which the unimplanted components can be appropriately discarded and / or decomposed for recycling. Another option includes packaging one or more multi-loop tensionable constructs, inserter shafts, insertion instruments or implants, and other subcomponents of the instrument components separately from other components or subcomponents. In the first described option, all components can be transported together and presented to the surgeon in a single package without the need for assembly. In the second described option, some parts, such as inserter shaft or insertion instrument, can be packaged in a non-sterile manner, and provided for cleaning and sterilization in a hospital or surgical center. In this scenario in the second option, after each treatment case is used, or otherwise, as required, reusable instrument parts can be cleaned again and sterilized again for subsequent reuse. In addition, in this second option, for example, after opening the packaging that may be separated and before using instrument and implant in the treatment situation, some assembly (such as implant may be assembled on the inserter shaft) may be required. In this second option as well, parts can be transported in different packaging, and for specific treatment cases, the surgeon can decide what instrument and implant parts may be needed, and can indicate that only those parts are prepared and brought to the position of the treatment case.

[0078] As discussed herein, at least some portions of the constructs and instruments disclosed herein may be designed to be discarded after a single use, and / or at least some portions of the constructs and instruments may be designed to be used multiple times. However, in either case, the instrument may be reconditioned and reused after at least one use. Repair may include any combination of steps of disassembling the instrument, cleaning or replacing specific parts, and subsequent reassembly. Specifically, the instrument may be removable, and any number of specific parts or components of the instrument may be selectively replaced or removed in any combination. After cleaning and / or replacing specific components, the instrument may be reassembled for subsequent use at a repair facility or by a surgical team just prior to a surgical operation. Those skilled in the art will appreciate that repair instruments may utilize various techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting repair instruments are within the scope of the present application.

[0079] Preferably, the present invention described herein is processed prior to a surgical procedure. First, new or used instruments and / or constructs are obtained and cleaned as needed. The instruments and / or constructs can then be sterilized. In one sterilization technique, the instruments and / or constructs are placed in a closed and sealed container (such as a plastic or TYVEK bag). The container and instruments and / or constructs are then placed in a radiation field (such as gamma radiation, X-rays, or high-energy electrons) that can penetrate the container. The radiation kills bacteria on the instruments and / or constructs and in the container. The sterilized instruments and / or constructs can then be stored in a sterile container. The sealed container keeps the instruments and / or constructs sterile until they are opened in a medical facility.

[0080] The device and / or construct is preferably sterilized. This can be accomplished by any of a variety of means known to those skilled in the art, including beta or gamma radiation, ethylene oxide, steam, and liquid baths (eg, cold soaks).

[0081] Exemplary Insertion Devices

[0082] FIG. 10A to FIG. 15G Exemplary surgical instruments for installing suture implants disclosed herein or otherwise derivable from the present disclosure, such as implants 80, 100, 500, 600, are presented. Fig. 10A 1 is an isometric view of a dual insertion instrument 1000 for installing an embodiment of a multi-loop tensionable suture construct disclosed herein. The instrument 1000 is referred to as a dual insertion instrument because the instrument 1000 can be an assembly of a first insertion device 1100 and a second insertion device 1200, wherein the first and second refer to their arrangement for providing insertion of a first anchor with the first device 1100 and then for subsequent insertion of a second anchor via the second insertion device 1200 as discussed below. In some examples, each of the first insertion device 1100 and the second insertion device 1200 can be a separate subassembly of a surgical instrument assembly including both a first subassembly and a second subassembly, wherein each subassembly has, for example, a handle and a shaft component. The first insertion device 1100 may include a first proximal handle 1120 and a first insertion shaft 1110 extending distally. The second insertion device 1200 may include a second proximal handle 1220 and a second insertion shaft 1210 extending distally. Fig. 10AThe first insertion device 1100 and the second insertion device 1200 coupled together are illustrated, wherein the first handle 1120 and the second handle 1220 are combined to form a single handle arrangement. Two insertion shafts 1110, 1210 can extend together from the combined handles 1120, 1220, wherein the first distal tip 1111 of the first insertion shaft 1111 extends beyond the second distal tip 1211 of the second insertion shaft 1210, so that the first distal tip 1110 can be used while the first device 1100 and the second device 1200 are combined without being interfered by the second distal tip 1211. The first distal tip 1111 and the second distal tip 1112 can be configured to hold and insert the anchor into the tissue. The first insertion shaft 1110 and the second insertion shaft 1210 can be arranged to be substantially parallel to each other and extend together along their overlapping portion (e.g., between the handle and the second distal tip 1211).

[0083] Fig. 10B 1 is a top view of the dual insertion instrument assembly 1000 and shows a second mandrel 1229 having a circumferential channel 1228 on the second proximal handle 1220 that can be used to manage sutures extending from an anchor held by the second distal tip 1211. Also shown is an example of a latch mechanism formed by the flexible portion 1121 of the first proximal handle 1120 that can be used to control the fixation of the handles 1120, 1220 together, as shown in FIG. Fig. 10C shown. Fig. 10C 1 is a cross-sectional view of the dual insertion instrument assembly 1000 and more clearly illustrates the arrangement of the insertion shafts 1110, 1210 and the coupling of the handles 1120, 1220. From the handle, the first proximal handle 1120 can hold the proximal end of the first insertion shaft 1110, wherein the proximal terminal end 1115 of the first insertion shaft 1110 extends proximally from the proximal end 1125 of the first proximal handle 1120. This arrangement can allow the insertion shaft 1110 to be struck with a hammer or other tool to facilitate the insertion of the first distal tip 1111 into hard tissue such as bone. The first proximal handle 1120 can also include a first mandrel 1129 having a circumferential channel for managing sutures extending from an anchor held by the first distal tip 1111.

[0084] like Fig. 10CAs shown in , the proximal extension 1230 of the second proximal handle 1220 can extend into the distal opening cavity 1126 of the first proximal handle 1120 to more completely engage (e.g., rotationally and otherwise lock) the two handles when coupled, and improve the user's feel for the handles as a single handle. The flexible portion 1121 of the first proximal handle 1120 can control the engagement of the latch 1122 extending into the proximal opening recess 1222 of the second proximal handle 1220, and when latched can hold the assembled configuration of the first handle 1120 and the second handle 1220 together. Pressing the flexible portion 1121 toward the central axis of the first handle 1120 can disengage the latch 1122 and allow the first insertion device 1100 to be disengaged and withdrawn from the second insertion device 1200, as shown in FIG. Fig. 12A and Fig. 12B Continuing to refer to Fig. 10C , the first insertion shaft 1110 may extend through the second handle 1220 to extend distally beside (and beyond) the second insertion shaft 1210. The distal tip 1111, 1211 of each insertion shaft 1110, 1210 may include a terminal notch 1112, 1212 configured to hold an anchor (such as the soft anchor shown herein), and the shaft may also include, for example, a notch 1113, 1213 proximal to the terminal notch 1112, 1212, which may be used as a portion of the anchor when carried by the insertion shaft before and during insertion. The distal tips 1111 and 1211 may also be configured to allow piercing of tissue (e.g., by terminating at a tip). This may enable insertion and placement of anchors such as those in assembly 80 to be performed directly into and / or through soft tissue and into and / or through bone tissue without the need for pre-preparation or creation of holes.

[0085] Fig.11A and Fig. 11B 1 and 2. The first proximal handle 1120 and the second proximal handle 1220 are shown coupled together and viewed from two different angles. Fig.11A As shown, channel 1227 extends distally from channel 1228 of second mandrel 1229 of second handle 1220, thereby providing a path in which sutures from an anchor such as assembly 80 retained on insertion shaft 1210 (not shown) can be placed and managed along the path on second mandrel 1229 to extend to insertion shaft 1120 (not shown). On the other side, as shown Fig. 11BAs shown, another channel 1226 may extend along the entire second handle 1220 to connect the channel 1128 of the first spindle 1129 of the first handle 1220 to the proximal end of the second handle 1120 and thereby provide a passageway into which additional sutures from anchors of an assembly such as 80 retained on the insertion shaft 1110 (not shown) may be placed and managed along the path and thereby on the first spindle 1129. The arrangement of the sutures in this manner may be used to securely retain them to prevent accidental premature separation from the inserter assembly 1000, such as might occur if the sutures were contacted by the hand of a user retaining the assembly 1000. Fig. 11B Also visible are two passages 1232, 1231 (e.g., holes) through which the first insertion shaft 1110 and the second insertion shaft 1210 can extend and extend distally out of the second handle 1220. The first insertion shaft 1110 can extend out of the first hole 1231, and the second insertion shaft 1210 can extend out of the second hole 1232. Return to Fig.11A , showing the hole 1131 of the first handle 1120, which can be used to retain the first insertion shaft and allow the proximal end to extend proximally from the first handle 1120.

[0086] Depressing the flexible portion 1121 of the first handle 1220 may cause the teeth 1122 to separate from the corresponding features 1223 disposed in the recess 1222 of the second handle 1120, thereby allowing the first handle to be disengaged and separated from the second handle 1220, as shown in FIG. Fig. 11C As shown, and as follows about Fig. 12A and Tu 12B for more details. Fig. 11C , shows a flat portion 1235 of the proximal extension 1230 of the second handle, which, when engaged with a corresponding flat section of the cavity 1126 of the first handle 1120, can provide a rotational lock of the first handle 1120 and the second handle 1220 when coupled. In operation, with the first insertion shaft 1110 extending through the hole in the second proximal handle 1220, disengagement of the first handle 1120 can be achieved by proximally translating the first handle 1120 away from the second handle 1220 until the first insertion shaft 1110 is fully withdrawn from the second handle 1220. Fig. 12A and Fig. 12BThe removal (or insertion) of the first insertion device 1100 from the second insertion device 1200 is illustrated, wherein the first insertion shaft 1110 is not completely withdrawn from the second handle 1220. It can be seen that the proximal terminal 1215 of the second insertion shaft 1210 extends proximally beyond the proximal end of the second handle 1220. This arrangement allows the second insertion shaft 1210 to be struck with a hammer or other tool to facilitate the insertion of the second distal tip 1211 into hard tissue such as bone. After the first insertion device 1100 is used to perform a first insertion, the first insertion device can be completely removed from the second insertion device 1200 at the surgical repair site before the second insertion device is used to perform a second insertion operation. Fig. 12C The second insertion device is shown with the first insertion device disengaged and completely removed. Fig. 12C In this configuration, the second insertion device 1200 can be used independently to place and insert an anchor after the placement and insertion of a previous anchor.

[0087] Examples of the present dual insertion instrument may also include the use of a breakaway sheath. The breakaway sheath may be, for example, a cannula having a frangible and / or bendable section and longitudinal perforations or other features to enable selective radial removal of a portion from the shaft. The breakaway sheath may be configured to surround the two insertion shafts 1110, 1210 and the surgical implant (e.g., Figure 1 Surgical implants 100, Figure 8 Implant 80, such as Fig.13A 1301, 1302, 1303 (see FIG. 1302, 1303). Fig. 13C and Fig.14D ), the proximal segment can be frangible, bendable, and / or otherwise separable from the proximal portion of the insertion shaft 1110, 1210 without separating the remainder of the breakaway sheath. In this manner, removing one or more proximal segments from the insertion shaft 1110, 1211 allows the remainder of the breakaway sheath to be advanced proximally to, for example, expose the first distal tip 1111 for use. Subsequent removal of one or more additional proximal segments can enable the second distal tip 1211 to be exposed for use. Thus, the examples of breakaway sheaths disclosed herein provide modular protection and can be partially retained over certain areas to protect those areas (e.g., a second anchor during insertion of a first anchor) until they need to be exposed for use.

[0088] Fig.13A Is has Figure 8The implant 80 and the separation sheath 1300 disposed around the implant 80 and the insertion shafts 1110, 1210 are in a ready-to-use configuration. Fig. 10A 1000. The suture tail of the suture construct 800 is wrapped around the second mandrel 1229 along with the additional suture 499b coupled to the second anchor, and the additional suture 499a coupled to the first anchor is wrapped around the first mandrel 1129. Fig. 13B is a close-up photograph of the distal end of the dual insertion instrument assembly 1000. The first anchor 83a of the construct 800 is retained in the distal tip 1111 of the first insertion shaft 1110, and the second anchor 83b is retained in the distal tip 1211 of the second insertion shaft 1210, with the tails 820a, 820b and additional sutures 499a, 499b extending proximally along the shafts 1110, 1210 and within the separation sheath 1300. Fig. 13B , the separation sheath 1300 extends beyond the distal tip 1111 to completely cover the implant 80. Fig. 13C The proximal end of the breakaway sheath 1300 is shown where it meets the handle of the dual insertion instrument 1000. The breakaway portion 1301 is shown after it has been removed from the shafts 1110, 1210 and the breakaway sheath 1300 has been translated proximally. Fig. 13C Also shown are tails 830a, 830b wrapped around the second mandrel 1229 and the second additional suture 999b and the first additional suture 999a wrapped around the first mandrel 1129. As explained below, the first separation portion 1301 can be used to help the user separate the additional separation portions, and with the first separation portion 1301 removed, the distal-most end of the instrument 1000 can still be covered.

[0089] FIG. 14A to FIG. 14C is a photograph of the dual insertion instrument assembly 1000 and the suture construct 80, which shows the operation of separating the sheath 1300 before inserting the first anchor 83a of the suture construct 80. It is noted that the first and second anchors of the implant 80 (and the associated additional sutures) can be reversible, and as shown in FIG. FIG. 14A to FIG. 14F As shown in FIG. , the first anchor can be Figure 8 The designation that the first anchor is installed first is maintained even though the color-indicating anchors of the additional sutures 999a, 999b are installed in the reverse order as indicated by the naming convention used above. FIG. 13A to FIG. 13C The first step of removing the second separation portion 1302 of the sheath 1300 is Fig.14A14, wherein arrow 1401 indicates the movement of the second separation portion 1302 from the shaft 11100, 1210. With the second portion 1302 removed, the separation sheath 1300 may be moved proximally, such as Fig. 14B As shown by arrow 1402 in the figure, the distal end 1310 of the detachment sheath 1300 is retracted to expose the first distal tip 1111 and the first anchor 83b. Fig. 14C In this position, a first insertion operation can be performed using the instrument 1000 to install the first anchor 83a in the tissue.

[0090] FIG. 14D to FIG. 14F is a photograph of the dual insertion instrument assembly 1000 and the suture construct 80, which illustrates the operation of separating the sheath 1300 before inserting the second anchor 83b of the suture construct 80. Fig. 14C With the first insertion operation completed, the first additional suture can be unwound from the first mandrel 1129, and the first insertion device 1100 can be removed from the second insertion device 1200. However, this operation is not illustrated as having been FIG. 14D to FIG. 14F and it can therefore be assumed, although not shown, that the first shaft and the first handle are no longer present in the subsequent steps. Fig.14D , the third separation portion 1303 of the separation sheath 1300 can be removed from the second insertion shaft, as shown by arrow 1403. Then, as shown in FIG. Fig.14E As shown, the detachment sheath 1300 can be translated proximally (as shown by arrow 1404) to expose the second distal tip 1211 and the second anchor 83b, which is also Fig.14F According to Fig.14E and Fig.14F In this configuration, the second insertion device 1200 can be used to perform a second insertion operation to install the second anchor 83b. FIG. 15A to FIG. 15G An exemplary installation operation illustrating separation of the dual insertion instrument 1000 is provided in FIG.

[0091] exist Fig.15A , the dual insertion instrument 1000 assembly is shown in an initial state, wherein the first handle and the second handle are coupled together. The surgical implants 80, 100 are not shown, but are assumed to be present, for example FIG. 13A to FIG. 13C In a configuration of , in which soft anchors (e.g., anchors 83a, 83b) are preloaded for implantation on each of the two axes, and the associated sutures are retained on the handles 1120, 1220. As described above, in FIG. 13A to FIG. 13C and Fig.15AIn the assembled configuration of , a longer first insertion shaft 1110 attached to the more proximal side of the handle presents a first anchor for implantation through soft tissue and into the bone, such as by striking the proximal end of the assembly with a mallet 1520 or other impact tool after positioning the tip of the first shaft on the tissue. Thus, in a first step, as Fig.15A As shown, the instrument 1000 can be brought to the surgical repair site and the first distal tip 1111 can be guided (as shown by arrow 1501) to the desired first location of the soft tissue. Fig. 15B As shown, the first anchor can be implanted into the second tissue at the second location by striking the proximal end of the first shaft with a hammer 1520 (as shown by arrow 1521) to drive the first distal tip 1111 into the second tissue at the second location. With the first anchor installed, a first additional suture (e.g., Figure 8 999a) can be unwound from the first proximal handle (as shown by arrow 1502). When the suture leaves the first proximal handle, the flexible portion can be pressed, for example, Fig. 10C The flexible portion 1121 of the first shaft 1110 (as indicated by arrow 1503) is moved to release the first proximal handle 1120 from the second proximal handle 1220, after which the first proximal handle can be withdrawn proximally (as indicated by arrow 1504) until the first shaft 1110 is disengaged from the second proximal handle 1220. Fig.15E As shown in , the second anchor on the second shaft is left attached to the second handle. The second distal tip 1211 can then be navigated (as shown by arrow 1505) to a third location, for example, a location on the soft tissue that is different from the first location. Fig.15F As shown, implantation of the second anchor can be accomplished by striking the proximal end of the second handle with a hammer 1520 or other impact tool to place the second anchor into or through the soft tissue and at a fourth location (e.g., a location in the second tissue that is different from the second implantation location of the first anchor) into or through the second tissue. With the second anchor installed, the tail of the suture construct and the second additional suture can be unwound from the second mandrel (as indicated by arrow 1506), at which point the second insertion device 1200 can be removed. The spanning portion of the construct between the two anchors can then be tensioned via the tail to complete the repair, thereby producing, for example, Figure 5A and Figure 5B Installation arrangement.

[0092] Those skilled in the art will understand the further features and advantages of the present disclosure based on the description and embodiments provided. Therefore, the present invention is not limited by the contents specifically shown and described. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

[0093] Examples of the above embodiments may include the following:

[0094] 1. A suture construct formed from a first flexible member, comprising:

[0095] a first adjustment mechanism formed in the first flexible member to create a first loop extending from the first adjustment mechanism, the first loop defining a first loop opening;

[0096] a first tail portion of the first flexible member, the first tail portion of the first flexible member extending from the first adjustment mechanism;

[0097] a spanning portion of the first flexible member, the spanning portion of the first flexible member extending from the first adjustment mechanism;

[0098] a second adjustment mechanism formed in the first flexible member to create a second loop extending from the second adjustment mechanism, the second loop defining a second loop opening;

[0099] a second tail portion of the first flexible member, the second tail portion of the first flexible member extending from the second adjustment mechanism;

[0100] a first anchor slidably coupled to a first portion of the suture of the first loop; and

[0101] a second anchor slidably coupled to a second portion of the suture of the second loop,

[0102] wherein the first tail portion is configured to slide relative to the first adjustment mechanism to reduce the size of the first collar opening and thereby reduce a first distance between the first anchor and the first adjustment mechanism,

[0103] wherein the second tail portion is configured to slide relative to the second adjustment mechanism to reduce the size of the second loop opening and thereby reduce a second distance between the first anchor and the second adjustment mechanism, and

[0104] Wherein the spanning portion of the first flexible member defines a fixed distance along a suture line between the first adjustment mechanism and the second adjustment mechanism.

[0105] 2. The suture construct of Example 1, wherein at least one of the first adjustment mechanism or the second adjustment mechanism comprises a self-locking knot.

[0106] 3. The suture construct of Examples 1 or 2, wherein at least one of the first adjustment mechanism or the second adjustment mechanism comprises a finger catcher arrangement.

[0107] 4. The suture construct according to any one of Examples 1 to 3,

[0108] Wherein, the first adjustment mechanism comprises a first finger-shaped catcher, and the first tail portion passes through the first finger-shaped catcher,

[0109] wherein the second adjustment mechanism comprises a second finger-shaped catcher, the second tail portion passes through the second finger-shaped catcher, and

[0110] The spanning portion is defined by a fixed length of stitching between the first finger catcher and the second finger catcher.

[0111] 5. The suture construct of Example 4, wherein the first finger catcher and the second finger catcher each define a length along the first flexible member approximately in the range of about 2 mm to about 10 mm.

[0112] 6. The suture construct of any one of Examples 1 to 5, wherein the fixed length of the spanning portion is approximately in the range of about 2 mm to about 10 mm.

[0113] 7. A suture construct according to any one of Examples 1 to 6, wherein at least one of the first anchor or the second anchor is a soft anchor constructed of a braided material.

[0114] 8. The suture construct of any one of Examples 1 to 7, wherein the first flexible member is a single continuous flexible member.

[0115] 9. According to any one of Examples 1 to 8, the suture construct further includes a second flexible member, which extends through the first anchor so that the first anchor can also be slidably disposed on the second flexible member.

[0116] 10. The suture construct of Example 9 wherein the first flexible member and the second flexible member extend through the same path through the first anchor.

[0117] 11. The suture construct according to Example 9 or 10 further comprises a third flexible member extending through the second anchor so that the second anchor can also be slidably disposed on the third flexible member.

[0118] 12. The suture construct of any one of Examples 9 to 11, wherein the second flexible member is a flexible member of a loop of another suture construct of claim 1.

[0119] 13. A method for preparing a surgical implant, comprising:

[0120] Passing the first tail portion of the first flexible member through the first anchor;

[0121] after passing the first tail through the first anchor, creating a first loop in the first flexible member by forming a first adjustment mechanism, the first flexible member having a first tail extending from one side of the first adjustment mechanism and a first portion of the first flexible member and a first loop extending from an opposite side of the first adjustment mechanism, such that the first anchor is slidably disposed on the first flexible member of the first loop;

[0122] passing the second tail portion of the first flexible member through a second anchor; and

[0123] After passing the second tail through the second anchor, creating a second loop in the first flexible member by forming a second adjustment mechanism, the first flexible member having a second tail extending from one side of the second adjustment mechanism and a second portion of the first flexible member and a second loop extending from an opposite side of the second adjustment mechanism, such that the second anchor is slidably disposed on the first flexible member of the second loop,

[0124] wherein the first portion of the first flexible member and the second portion of the first flexible member together define a spanning portion of the first flexible member, and the spanning portion defines a fixed length of the first flexible member between the first adjustment mechanism and the second adjustment mechanism,

[0125] wherein the tension on the first tail tightens the first loop and reduces the maximum distance between the first anchor and the spanning portion, and

[0126] wherein tension on the second tail tightens the first loop and reduces a maximum distance between the second anchor and the spanning portion.

[0127] 14. The method of example 13, wherein at least one of the first adjustment mechanism or the second adjustment mechanism comprises a self-locking knot.

[0128] 15. The method of example 13 or 14, wherein at least one of the first adjustment mechanism or the second adjustment mechanism comprises a finger catcher arrangement.

[0129] 16. The method according to any one of Examples 13 to 15,

[0130] Wherein, the first adjustment mechanism comprises a first finger-shaped catcher, and the first tail portion passes through the first finger-shaped catcher,

[0131] wherein the second adjustment mechanism comprises a second finger-shaped catcher, the second tail portion passes through the second finger-shaped catcher, and

[0132] The spanning portion is defined by a fixed length of stitching between the first finger catcher and the second finger catcher.

[0133] 17. A method according to any one of Examples 13 to 16, wherein the first flexible member is a single continuous flexible member.

[0134] 18. According to the method described in any one of Examples 13 to 17, the method also includes passing the tail of the second flexible member through the first anchor member so that the first anchor member can also be slidably disposed on the second flexible member.

[0135] 19. The method of Example 18, wherein the first flexible member and the second flexible member extend through the same path through the first anchor.

[0136] 20. The method of example 18 or 19 further comprising passing a tail of a third suture filament through the second anchor such that the second anchor can also be slidably disposed on the third suture filament.

[0137] 21. The method of any one of Examples 18 to 20, wherein the second suture filament is a suture filament of a loop of another suture construct according to claim 1.

[0138] 22. A surgical instrument comprising:

[0139] A first insertion device, the first insertion device comprising:

[0140] a first introducer shaft having a first distal tip configured to retain an anchor and implant it into tissue; and

[0141] a first handle disposed about a proximal end of the first inserter shaft; and

[0142] a second insertion device, the second insertion device being configured to be inserted into the first insertion device

[0143] The second insertion device comprises:

[0144] a second introducer shaft having a second distal tip configured to retain the anchor and implant it into tissue; and

[0145] a second handle disposed about a proximal end of the second inserter shaft, the second handle having a bore extending therethrough and configured to cause the first inserter shaft to be disposed therein when the second insertion device is coupled to the first insertion device,

[0146] wherein the first handle is configured to be removably coupled to a distal end of the second handle such that the first insertion device can be disengaged from the second insertion device by proximally withdrawing the first handle from the second handle and thereby proximally withdrawing the first inserter shaft from the aperture of the second handle, and

[0147] Wherein, when the first insertion device and the second insertion device are coupled, the first distal tip of the first inserter shaft extends distally beyond the second distal tip of the second inserter shaft.

[0148] 23. A surgical instrument as described in Example 22, wherein the proximal tip of the first insertion shaft extends proximally beyond the first handle.

[0149] 24. The surgical instrument of Examples 22 or 23, wherein the proximal tip of the second insertion shaft extends proximally beyond the second handle.

[0150] 25. A surgical instrument according to any one of Examples 22 to 24, wherein, when the first instrument is coupled to the second instrument, the first insertion axis and the second insertion axis are adjacent and substantially parallel along their respective lengths.

[0151] 26. The surgical instrument of any one of Examples 22 to 25,

[0152] wherein the first handle comprises a latch configured to removably secure the coupling of the first handle to the second handle, and

[0153] Wherein, the first handle includes a flexible portion, the flexible portion is used to control the engagement of the latch with the second handle, and enables a force applied to the flexible portion by a user to release the engagement of the latch with the second handle.

[0154] 27. A surgical instrument according to any one of Examples 22 to 26, wherein the first handle has a first mandrel configured to hold a certain length of suture extending from the first distal tip.

[0155] 28. The surgical instrument of Example 27, wherein the second handle has a second mandrel configured to hold a length of suture extending from the second distal tip.

[0156] 29. The surgical instrument of Example 28, wherein the second handle portion includes a recess configured to receive a length of suture extending from the first distal tip to the first spindle.

[0157] 30. The surgical instrument of any one of Examples 22 to 29, further comprising:

[0158] a breakaway sheath configured to be disposed about the first instrument shaft and the second instrument shaft and extending from the second handle to the first distal tip, the proximal end of the breakaway sheath defining a first segment configured to be removed from being disposed about the first instrument shaft and the second instrument shaft, and

[0159] The breakaway sheath is permitted to translate proximally after being removed to expose the first distal tip while still covering the second distal tip.

[0160] 31. The surgical instrument of example 30, wherein the breakaway sheath further comprises:

[0161] a second section, the second section being arranged distally of the first section, and

[0162] The sheath is configured to be removed from being disposed about the first instrument shaft and the second instrument shaft and, after being removed, to allow the breakaway sheath to translate proximally to expose the second distal tip.

[0163] 32. The surgical instrument of any one of Examples 22 to 31, further comprising:

[0164] The suture construct of claim 1 coupled to the surgical instrument, wherein the first anchor is retained by the first distal tip, the second anchor is retained by the second distal tip, and the first and second tails of the first flexible member are secured to the second handle.

[0165] 33. A surgical instrument as described in any of Examples 22 to 32, wherein the first handle and the second handle define a continuous single handle of the surgical instrument when connected.

[0166] 34. A method of fixing soft tissue to bone, comprising:

[0167] directing a first distal tip of a first insertion shaft of a first instrument carrying a first anchor through soft tissue at a first location and inserting the first anchor into bone at a second location, the anchor having a first tieable loop of a suture construct coupled thereto;

[0168] disposing the first anchor in the second position by withdrawing the first distal tip from the first position and the second position, the withdrawal comprising proximally withdrawing the first insertion shaft from a second handle of a second instrument, the second instrument having a second insertion shaft having a second distal tip carrying a second anchor having a second tieable loop of a suture construct coupled thereto;

[0169] directing a second distal tip of the second first insertion shaft through the soft tissue at a third location and inserting the anchor into the bone at a fourth location;

[0170] disposing the second anchor in the fourth position by withdrawing the second distal tip from the third position and the fourth position, the withdrawing comprising disposing a spanning portion of the suture construct across the soft tissue, the spanning portion fixedly coupling the first adjustment mechanism of the first cinchable loop to the second adjustment mechanism of the second cinchable loop; and

[0171] Tensioning the spanning portion against the soft tissue by at least one of:

[0172] tensioning a first tail portion of the suture construct extending from the first adjustment mechanism, the tensioning tightening the first loop and withdrawing the first adjustment mechanism toward the first anchor; and

[0173] The second tail of the suture construct extending from the second adjustment mechanism is tensioned, the tensioning tightening the second loop and withdrawing the second adjustment mechanism toward the second anchor.

[0174] 35. The method of example 34, wherein the second anchor comprises a third tieable loop of a second suture construct coupled thereto, the method further comprising:

[0175] after disposing the second anchor in the fourth position, directing the distal tip of an insertion shaft carrying a third anchor through the soft tissue at a fifth position and inserting the third anchor into the bone at a sixth position, the third anchor having a fourth tieable loop of a second suture construct coupled thereto,

[0176] disposing the third anchor in the sixth position by withdrawing the distal tip from the fifth position and the sixth position, the withdrawing comprising disposing a second spanning portion of the second suture construct across the soft tissue, the second spanning portion fixedly coupling a third adjustment mechanism of the third cinchable loop to a fourth adjustment mechanism of the fourth cinchable loop; and

[0177] Tensioning the spanning portion against the soft tissue by at least one of:

[0178] tensioning the third tail of the second suture construct extending from the third adjustment mechanism, the tensioning tightening the third loop and withdrawing the third adjustment mechanism toward the second anchor; and

[0179] A fourth tail portion of the second suture construct extending from the fourth adjustment mechanism is tensioned, the tensioning tightening the fourth loop and withdrawing the fourth adjustment mechanism toward the third anchor.

[0180] Based on the embodiments described above, those skilled in the art will appreciate the additional features and advantages of the present disclosure. Therefore, the present invention should not be limited to what has been specifically shown and described, unless otherwise indicated in the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Claims

1. A suture construct formed from a first flexible member, comprising: a first adjustment mechanism formed in the first flexible member to create a first loop extending from the first adjustment mechanism, the first loop defining a first loop opening; a first tail portion of the first flexible member, the first tail portion of the first flexible member extending from the first adjustment mechanism; a spanning portion of the first flexible member, the spanning portion of the first flexible member extending from the first adjustment mechanism; a second adjustment mechanism formed in the first flexible member to create a second loop extending from the second adjustment mechanism, the second loop defining a second loop opening; a second tail portion of the first flexible member, the second tail portion of the first flexible member extending from the second adjustment mechanism; a first anchor slidably coupled to a first portion of the suture of the first loop; as well as a second anchor slidably coupled to a second portion of the suture of the second loop, wherein the first tail portion is configured to slide relative to the first adjustment mechanism to reduce the size of the first collar opening and thereby reduce a first distance between the first anchor and the first adjustment mechanism, wherein the second tail portion is configured to slide relative to the second adjustment mechanism to reduce the size of the second loop opening and thereby reduce a second distance between the first anchor and the second adjustment mechanism, and Wherein the spanning portion of the first flexible member defines a fixed distance along a suture line between the first adjustment mechanism and the second adjustment mechanism.

2. The suture construct according to claim 1, wherein: At least one of the first adjustment mechanism or the second adjustment mechanism includes a self-locking knot.

3. The suture construct according to claim 1 or claim 2, wherein: At least one of the first adjustment mechanism or the second adjustment mechanism includes a finger catcher arrangement.

4. The suture construct according to claim 1, in, The first adjustment mechanism includes a first finger-shaped catcher, the first tail portion passes through the first finger-shaped catcher, wherein the second adjustment mechanism comprises a second finger-shaped catcher, the second tail portion passes through the second finger-shaped catcher, and The spanning portion is defined by a fixed length of stitching between the first finger catcher and the second finger catcher.

5. The suture construct according to claim 4, wherein: The first finger catch and the second finger catch each define a length along the first flexible member approximately in a range of about 2 mm to about 10 mm.

6. The suture construct of any preceding claim, wherein: The fixed length of the spanning portion is approximately in the range of about 2 mm to about 10 mm.

7. The suture construct of any preceding claim, wherein: At least one of the first anchor or the second anchor is a soft anchor constructed of a braided material.

8. The suture construct of any preceding claim, wherein: The first flexible member is a single continuous flexible member.

9. The suture construct of any preceding claim, further comprising a second flexible member extending through the first anchor such that the first anchor is also slidably disposed on the second flexible member.

10. The suture construct of claim 9, wherein: The first flexible member and the second flexible member extend through the same path through the first anchor.

11. The suture construct of claim 9 or claim 10, further comprising a third flexible member extending through the second anchor such that the second anchor is also slidably disposed on the third flexible member.

12. The suture construct according to any one of claims 9 to 11, wherein: The second flexible member is another The flexible member of the loop of the suture construct of claim 1.

13. A method for preparing a surgical implant, comprising: Passing the first tail portion of the first flexible member through the first anchor; after passing the first tail through the first anchor, creating a first loop in the first flexible member by forming a first adjustment mechanism, the first flexible member having a first tail extending from one side of the first adjustment mechanism and a first portion of the first flexible member and a first loop extending from an opposite side of the first adjustment mechanism, such that the first anchor is slidably disposed on the first flexible member of the first loop; Passing the second tail portion of the first flexible member through the second anchor; as well as After passing the second tail through the second anchor, creating a second loop in the first flexible member by forming a second adjustment mechanism, the first flexible member having a second tail extending from one side of the second adjustment mechanism and a second portion of the first flexible member and a second loop extending from an opposite side of the second adjustment mechanism, such that the second anchor is slidably disposed on the first flexible member of the second loop, wherein the first portion of the first flexible member and the second portion of the first flexible member together define a spanning portion of the first flexible member, the spanning portion defining a fixed length of the first flexible member between the first adjustment mechanism and the second adjustment mechanism, wherein the tension on the first tail tightens the first loop and reduces the maximum distance between the first anchor and the spanning portion, and wherein tension on the second tail tightens the first loop and reduces a maximum distance between the second anchor and the spanning portion.

14. The method according to claim 13, wherein: At least one of the first adjustment mechanism or the second adjustment mechanism includes a self-locking knot.

15. The method according to claim 13 or claim 14, wherein: At least one of the first adjustment mechanism or the second adjustment mechanism includes a finger catcher arrangement.

16. The method according to any one of claims 13 to 15, in, The first adjustment mechanism includes a first finger-shaped catcher, the first tail portion passes through the first finger-shaped catcher, wherein the second adjustment mechanism comprises a second finger-shaped catcher, the second tail portion passes through the second finger-shaped catcher, and The spanning portion is defined by a fixed length of stitching between the first finger catcher and the second finger catcher.

17. The method according to any one of claims 13 to 16, wherein: The first flexible member is a single continuous flexible member.

18. The method of any one of claims 13 to 17, further comprising passing a tail portion of a second flexible member through the first anchor such that the first anchor is also slidably disposed on the second flexible member.

19. The method according to claim 18, wherein: The first flexible member and the second flexible member extend through the same path through the first anchor.

20. The method of claim 18 or claim 19, further comprising passing a tail of a third suture filament through the second anchor such that the second anchor is also slidably disposed on the third suture filament.

21. The method according to any one of claims 18 to 20, wherein: The second suture filament is another A suture filament of a loop of the suture construct according to claim 1.

22. A surgical instrument comprising: A first insertion device, the first insertion device comprising: a first inserter shaft having a first distal tip, the The first distal tip is configured to retain the anchor and implant it into tissue; and a first handle disposed about a proximal end of the first inserter shaft; and A second insertion device, the second insertion device is configured to be coupled to the first insertion device, the second insertion device comprising: a second inserter shaft having a second distal tip, the The second distal tip is configured to retain the anchor and implant it into tissue; and a second handle disposed about a proximal end of the second inserter shaft, the second handle having a bore extending therethrough and configured to cause the first inserter shaft to be disposed therein when the second insertion device is coupled to the first insertion device, wherein the first handle is configured to be removably coupled to a distal end of the second handle such that the first insertion device can be disengaged from the second insertion device by proximally withdrawing the first handle from the second handle and thereby proximally withdrawing the first inserter shaft from the aperture of the second handle, and Wherein, when the first insertion device and the second insertion device are coupled, the first distal tip of the first inserter shaft extends distally beyond the second distal tip of the second inserter shaft.

23. The surgical instrument of claim 22, wherein: The proximal tip of the first insertion shaft extends proximally beyond the first handle.

24. A surgical instrument according to claim 22 or claim 23, wherein: The proximal tip of the second insertion shaft extends proximally beyond the second handle.

25. The surgical instrument according to any one of claims 22 to 24, wherein: When the first instrument is coupled to the second instrument, the first insertion axis and the second insertion axis are adjacent and substantially parallel along their respective lengths.

26. A surgical instrument according to any one of claims 22 to 25, in, The first handle includes a latch configured to removably secure the coupling of the first handle to the second handle, and Wherein, the first handle includes a flexible portion, the flexible portion is used to control the engagement of the latch with the second handle, and enables a force applied to the flexible portion by a user to release the engagement of the latch with the second handle.

27. The surgical instrument according to any one of claims 22 to 26, wherein: The first handle has a first mandrel configured to retain a length of suture extending from the first distal tip.

28. The surgical instrument of claim 27, wherein: The second handle has a second mandrel configured to retain a length of suture extending from the second distal tip.

29. The surgical instrument of claim 28, wherein: The second handle includes a recess configured to receive a length of suture extending from the first distal tip to the first mandrel.

30. The surgical instrument according to any one of claims 22 to 29, further comprising: A breakaway sheath configured to be disposed about first and second instrument axes and extending from the second handle to the first distal tip, the proximal end of the breakaway sheath defining a first segment configured to be removed from being disposed about the first and second instrument axes and, after being removed, allowing the breakaway sheath to translate proximally to expose the first distal tip while still covering the second distal tip.

31. The surgical instrument of claim 30, wherein: The separation sheath further comprises: A second segment is disposed distally of the first segment and is configured to be removed from being disposed about the first instrument shaft and the second instrument shaft and, after being removed, allow the breakaway sheath to translate proximally to expose the second distal tip.

32. The surgical instrument according to any one of claims 22 to 31, further comprising: The suture construct of claim 1 coupled to the surgical instrument, wherein the first anchor is retained by the first distal tip, the second anchor is retained by the second distal tip, and the first and second tails of the first flexible member are secured to the second handle.

33. A surgical instrument according to any one of claims 22 to 32, wherein: The first handle and the second handle, when coupled, define a continuous single handle of the surgical instrument.

34. A method of fixing soft tissue to bone, comprising: directing a first distal tip of a first insertion shaft of a first instrument carrying a first anchor through soft tissue at a first location and inserting the first anchor into bone at a second location, the anchor having a first tieable loop of a suture construct coupled thereto; disposing the first anchor in the second position by withdrawing the first distal tip from the first position and the second position, the withdrawal comprising proximally withdrawing the first insertion shaft from a second handle of a second instrument, the second instrument having a second insertion shaft having a second distal tip carrying a second anchor having a second tieable loop of the suture construct coupled thereto; directing a second distal tip of the second first insertion shaft through the soft tissue at a third location and inserting the anchor into the bone at a fourth location; disposing the second anchor in the fourth position by withdrawing the second distal tip from the third position and the fourth position, the withdrawing comprising disposing a spanning portion of the suture construct across the soft tissue, the spanning portion fixedly coupling a first adjustment mechanism of the first cinchable loop to a second adjustment mechanism of the second cinchable loop; as well as Tensioning the spanning portion against the soft tissue by at least one of: tensioning a first tail portion of the suture construct extending from the first adjustment mechanism, the tensioning tightening the first loop and withdrawing the first adjustment mechanism toward the first anchor; as well as The second tail of the suture construct extending from the second adjustment mechanism is tensioned, the tensioning tightening the second loop and withdrawing the second adjustment mechanism toward the second anchor.

35. The method of claim 34, wherein: The second anchor comprises a third tieable loop of a second suture construct coupled thereto, the method further comprising: after disposing the second anchor in the fourth position, directing a distal tip of an insertion shaft carrying a third anchor through the soft tissue at a fifth position and inserting the third anchor into the bone at a sixth position, the third anchor having a fourth tieable loop of the second suture construct coupled thereto, disposing the third anchor in the sixth position by withdrawing the distal tip from the fifth position and the sixth position, the withdrawing comprising disposing a second spanning portion of the second suture construct across the soft tissue, the second spanning portion fixedly coupling a third adjustment mechanism of the third cinchable loop to a fourth adjustment mechanism of the fourth cinchable loop; and Tensioning the spanning portion against the soft tissue by at least one of: tensioning the third tail of the second suture construct extending from the third adjustment mechanism, the tensioning tightening the third loop and withdrawing the third adjustment mechanism toward the second anchor; and A fourth tail portion of the second suture construct extending from the fourth adjustment mechanism is tensioned, the tensioning tightening the fourth loop and withdrawing the fourth adjustment mechanism toward the third anchor.

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