Multi-span tensionable loop for knotless spanning of tissue between anchor points and tool for using the same

Abstract

The suture structure includes a single filament of suture that forms two closable loops from a separate finger trap configuration, with a fixed-length spanning portion extending between the fixed portions of the two finger traps. The tails of the suture extend from each finger trap and are slidably disposed therein to tighten the respective loops. The structure can include anchors slidably coupled to each of the first and second loops. An inserter for the structure includes first and second insertion devices, each having a proximal handle and a distal insertion shaft. The two handles are coupled to each other such that the insertion shafts are disposed side by side with respect to each other, with the first shaft passing through and extending beyond the second handle shaft. The first handle is coupled proximally to the second handle, such that the first device can be separated from the second device by removing it proximally, which withdraws the first shaft from the second handle.

Description

Technical Field

[0001] This application generally relates to devices and methods for fixing soft tissue (e.g., ligaments, tendons, grafts) to bone, and more specifically, to a suture structure for creating a tensionable link between at least two anchors inserted using the same inserter, and embodiments of such an inserter.

Background Art

[0002] Particularly common injuries among athletes and the elderly are the complete or partial detachment of tendons, ligaments, or other soft tissues from bone. A ligament is a fibrous tissue that connects bones to other bones in the body, and a tendon is a fibrous tissue that connects muscles to bones in the body. Tissue detachment can occur in many ways, for example, as a result of an accident such as a fall, excessive movement during work, during a sports competition, or excessive effort in any one of many other situations and / or activities. These types of injuries generally result from excessive stress or abnormal forces acting on the tissue. When a ligament is damaged, it does not regenerate on its own, so reconstructive surgery may be required. In the case of a partial detachment, commonly referred to as a "sprain," the injury often heals without medical intervention, and the patient is kept at rest and care is taken to ensure that the injury is not exposed to excessive activity during the healing process. However, when a ligament or tendon is completely detached from its attachment site on one or more of the associated bones, or when a ligament or tendon is cut as a result of a traumatic injury, surgical intervention may be required to fully restore function to the damaged joint. Currently available devices for tissue attachment include screws, staples, suture anchors, and tacks.

[0003] A repair structure made from one or more surgical filaments is typically used in soft tissue repair procedures, such as rotator cuff fixation, to fix tissue in a desired position. The repair structure is typically disposed 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 disposed within the bone to which the tissue approaches.

[0004] Soft tissue repair includes arthroscopic repair of rotator cuff tears. These types of repairs can be long and difficult procedures, including the formation of bone holes, finding any bone holes again after formation, placing an anchor within each bone hole, and managing multiple suture limbs. This operation of managing multiple suture limbs can include identifying the limbs, separating them from each other, and / or passing them through the tissue, for example, using a stitching path. Due to the complexity of this procedure, the time in the operating room can be overly long and / or the quality of the repair can be reduced, leading to various complications understood by those skilled in the art.

[0005] There are many surgical procedures for repairing the rotator cuff and, more generally, reattaching ligaments or other soft tissues to bone. However, existing devices and methods can be limited, at least because they do not always provide the desired strength or adjustability. Many existing devices and methods are configured to fix soft tissue to a single bone anchor that is inserted into the bone using a tool. In some examples, for instance, when multiple bone anchors are required, inserting multiple anchors into the bone requires multiple insertions of the insertion tool into the surgical site, each insertion involving placing the bone anchor and associated suture structure in a separate position. Furthermore, some existing devices and methods also use additional fixation devices, such as cortical buttons, and each suture structure needs to be used to facilitate the fixation of the soft tissue to the bone. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0006] Accordingly, there is a need for improved fixation devices and repair and reconstruction procedures that allow for multiple bone anchor positions. In particular, there is a need for an instrument that can be used with an anchor to enable a surgical technique that benefits from the continuous implantation of soft tissue anchors, without the need for instrument exchange, thereby saving surgical time, reducing trauma, and making such surgery easier.

Means for Solving the Problems

[0007] Examples of the present disclosure include systems, devices, and methods for performing surgical procedures involving suturing, such as rotator cuff repair, among other soft tissue repair procedures. More specifically, certain examples of the disclosed systems, devices, and methods enable 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] As a representative example, it crosses through an anchor and forms a loop including the anchor by passing itself through a self-locking mechanism such as a splice (e.g., finger trap), crosses through a second anchor, and forms a second loop including the second anchor by passing itself through another self-locking mechanism such as a splice (e.g., finger trap) at a certain distance from the first self-locking mechanism. As a result, when the end of the suture is pulled, the loop closes. Examples include a suture structure having a length of suture. The self-locking mechanism of the suture serves to allow the loop to contract but resist the expansion of the loop. The self-locking mechanism can be a splice (e.g., finger trap) or a knot, among other structures that achieve the purpose of allowing contraction while resisting expansion. In some examples, a single strand of suture is used to construct the suture structure, excluding the anchors. Each anchor can also include one or more sutures loaded onto each anchor to function as a means of pulling the anchor separately from any force applied to the length of suture that forms the contracting loop. These additional sutures can be used to "set" the anchor into the bone or at a position beyond the hole where the anchor was placed by "pushing up" the anchor into the bone (or through the hole) when a force is applied, thereby enabling the anchor to resist further application of a force that tends to remove the anchor from the bone (or return the anchor through the hole). The structures disclosed herein can be used in various surgical repair procedures in which soft tissue is disposed or brought into proximity to bone at a desired position.

[0009] An example of the present disclosure is a suture structure formed from a first flexible member including a first adjustment mechanism, a second adjustment mechanism, a first tail portion, a second tail portion, a spanning portion, a first anchor, and a second anchor. The first adjustment mechanism is formed within 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 portion 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 within the first flexible member and is configured to create a second loop extending from the second adjustment mechanism, the second loop defining a second loop opening. The second tail portion of the first flexible member extends from the second adjustment mechanism, the first anchor is slidably coupled to a first portion of the suture of the first loop, and the second anchor is slidably coupled to a second portion of the suture of the second loop. Further, the first tail portion is configured to slide relative to the first adjustment mechanism to reduce the size of the first loop opening and thus reduce a first distance between the first anchor and the first adjustment mechanism, and the second tail portion is configured to slide relative to the second adjustment mechanism to reduce the size of the second loop opening and thus reduce a second distance between the first anchor and the second adjustment mechanism. Still further, the spanning portion of the first flexible member defines a fixed distance along the suture between the first adjustment mechanism and the second adjustment mechanism.

[0010] At least one of the first adjustment mechanism or the second adjustment mechanism can include a self-locking knot. Similarly, at least one of the first adjustment mechanism or the second adjustment mechanism can include a finger trap configuration. In some embodiments, the first adjustment mechanism can be a first finger trap that includes a first finger trap through which a first tail passes, and the second adjustment mechanism can be a second finger trap that includes a second finger trap through which a second tail passes. In some such embodiments, the spanning portion can be defined by a fixed-length suture between the first finger trap and the second finger trap. Each of the first and second finger traps can define a length within the range of about 1 mm to about 10 mm along the first flexible member. The fixed length of the spanning portion can be in the range of approximately about 1 mm to about 10 mm. At least one of the first anchor or the second anchor can be a soft anchor constructed from a woven material. The first flexible member can be a single continuous flexible member.

[0011] The suture structure further comprises a second flexible member, and the second flexible member can extend through the first anchor such that the first anchor is also slidably disposed on the second flexible member. The first flexible member and the second flexible member can extend through the same path passing through the first anchor. The suture structure further comprises a third flexible member, and the third flexible member can extend through the second anchor such that the second anchor is also slidably disposed on the third flexible member. The second flexible member can be a flexible member of a loop of another suture structure.

[0012] Another example of the present disclosure is a method for preparing a surgical implant, the method including passing a first tail of a first flexible member through a first anchor and creating a first loop in the first flexible member by forming a first adjustment mechanism after passing the first tail through the first anchor. The first flexible member with the first tail and a first portion of the first flexible member extends from one side of the first adjustment mechanism, and the first loop extends from the opposite side of the first adjustment mechanism. Thus, the first anchor is slidably disposed on the first flexible member of the first loop. The method further includes passing a second tail of the first flexible member through a second anchor and creating a second loop in the first flexible member by forming a second adjustment mechanism after passing the second tail through the second anchor. The first flexible member with the second tail and a second portion of the first flexible member extends from one side of the second adjustment mechanism, and the second loop extends from the opposite side of the second adjustment mechanism. Thus, 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 that defines 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 the maximum distance between the first anchor and the spanning portion, and tension on the second tail tightens the first loop and reduces the maximum distance between the second anchor and the spanning portion.

[0013] At least one of the first adjustment mechanism or the second adjustment mechanism can include a self-locking knot, and / or at least one of the first adjustment mechanism or the second adjustment mechanism can include a finger trap configuration. The method can include a first adjustment mechanism including a first finger trap through which the first tail passes, a second adjustment mechanism including a second finger trap through which the second tail passes, and a spanning portion defined by a suture of a fixed length between the first finger trap and the second finger trap. The first flexible member can be a single continuous flexible member.

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

[0015] Yet another example of the present disclosure is a surgical instrument including a first insertion device and a second insertion device. The first insertion device includes a first insertion machine shaft having a first distal tip configured to hold an anchor and embed it in tissue, and a first handle disposed around a proximal end of the first insertion machine shaft. The second insertion device includes a second insertion machine shaft having a second distal tip configured to be coupled to the first insertion device and hold an anchor and embed it in tissue, and a second handle disposed around a proximal end of the second insertion machine shaft. The second handle has a bore therethrough and is configured to have the first insertion machine shaft disposed therein when the second insertion device is coupled to the first insertion device. The first handle is configured to be removably coupled to a distal end of the second handle, whereby, for example, the first insertion device can be separated from the second insertion device by pulling the first handle proximally from the second handle, thereby pulling the first insertion machine shaft proximally out of the bore of the second handle. Further, the first distal tip of the first insertion machine shaft extends distally beyond the second distal tip of the second insertion machine shaft when the first and second insertion devices are coupled.

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

[0017] The first handle can include a latch configured to removably secure the coupling of the first handle to the second handle. The first handle can include a flexible portion that can be for controlling the engagement of the latch with the second handle. The flexible portion can 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 can have a first spindle configured to hold a length of suture extending from the first distal tip. The second handle can have a second spindle configured to hold a length of suture extending from the second distal tip. The second handle can have a recess configured to receive a length of suture extending from the first distal tip to the first spindle.

[0018] The surgical instrument can further include a release sheath disposed around the first instrument shaft and the second instrument shaft and configured to extend from the second handle to the first distal tip. The proximal end of the release sheath can define a first section that is removed from being disposed around the first instrument shaft and the second instrument shaft, and after removal, is configured to allow proximal translation of the release sheath while still covering the second distal tip and exposing the first distal tip. Further, the release sheath can include a second section that can be disposed distally of the first section and is configured to be removed from being disposed around the first instrument shaft and the second instrument shaft. Further, after removal, the second section can allow proximal translation of the release sheath and expose the second distal tip.

[0019] The surgical instrument can further include a suture structure according to an example as disclosed above or otherwise disclosed herein, coupled to the surgical instrument, with a first anchor held by the first distal tip, a second anchor held by the second distal tip, and first and second tails of the first flexible member fixed to the second handle.

[0020] Yet another example of the present disclosure is a method of fixing soft tissue to bone. The method includes navigating 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 bone at a second position. The anchor has a first tightenable loop of a suture structure coupled thereto. The method further includes disposing the first anchor at the second position by withdrawing the first distal tip from the first and second positions. Withdrawing includes proximally withdrawing the first insertion shaft 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, and the second anchor has a second tightenable loop of a suture structure coupled thereto. The method further includes navigating a second distal tip of the second first insertion shaft through soft tissue at a third position and inserting the anchor into the bone at a fourth position, and disposing the second anchor at the fourth position by withdrawing the second distal tip from the third and fourth positions. The withdrawing operation includes disposing a spanning portion of the suture structure across the soft tissue, the spanning portion fixing and coupling a first adjustment mechanism of the first tightenable loop to a second adjustment mechanism of the second tightenable loop. The method further includes tightening the spanning portion against the soft tissue by at least one of (1) applying tension to a first tail of the suture structure extending from the first adjustment mechanism, applying tension including tightening the first loop and pulling the first adjustment mechanism toward the first anchor, and (2) applying tension to a second tail of the suture structure extending from the second adjustment mechanism, applying tension including tightening the second loop and pulling the second adjustment mechanism toward the second anchor.

[0021] The second anchor can include a third tightenable loop of the second suture structure coupled thereto. The method can further include navigating the distal tip of an insertion shaft carrying a third anchor through soft tissue at a fifth location after disposing the second anchor at a fourth location and inserting the third anchor into bone at a sixth location. The third anchor can have a fourth tightenable loop of the second suture structure coupled thereto. The method can further include disposing the third anchor at the sixth location by withdrawing the distal tip from the fifth and sixth locations, the withdrawing operation including disposing a second spanning portion of the second suture structure across the soft tissue. The second spanning portion can fix and couple a third adjustment mechanism of the third tightenable loop to a fourth adjustment mechanism of the fourth tightenable loop. Still further, the method can include tensioning the spanning portion against the soft tissue by at least one of (1) applying tension to a third tail of the second suture structure extending from the third adjustment mechanism, applying tension tightening the third loop and pulling the third adjustment mechanism toward the second anchor, and (2) applying tension to a fourth tail of the second suture structure extending from the fourth adjustment mechanism, applying tension tightening the fourth loop and pulling the fourth adjustment mechanism toward the third anchor, which can include tautening.

[0022] The suture structure can be formed from a single flexible member and, in at least some embodiments, can be coupled to two bone anchors (e.g., full suture anchors, or toggle anchors, or other suitable anchors for securing to bone) for use in various soft tissue repair procedures. The single flexible member can include two self-locking mechanisms, such as splices or knots formed therein, that are spaced a substantially fixed distance apart, each self-locking mechanism defining a loop portion. Each loop portion extends from a respective self-locking mechanism, and each loop portion is coupled to an anchor, such as a soft anchor. Exemplary structures can also be used with push-in rigid anchors, which are positioned and retained within bone by axially pushing them into place. A sliding tail formed from the flexible member and extending from the self-locking mechanism can be operable to contract or otherwise make smaller a corresponding loop portion, which in turn draws each anchor toward the self-locking mechanism.

[0023] In one exemplary embodiment, a suture structure formed from a flexible member includes a first trap formed within the flexible member, a first tail of the flexible member extending from the first trap, a spanning portion of the flexible member, a second trap formed within the flexible member, and a second tail of the flexible member extending from the second trap. The first finger trap creates a first loop extending from the first finger trap and defines a first loop opening. The spanning portion extends from the first finger trap and connects the first finger trap to the second finger trap. The second finger trap creates a second loop extending from the second finger trap and the second loop defines a second loop opening. The first tail is configured to slide relative to the first finger trap 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 trap to reduce the size of the second loop opening. The spanning portion is configured to prevent expansion of the loop opening when the suture is manipulated into a locked configuration. The spanning portion allows a force that can otherwise loosen the structure to be transmitted to the opposing finger traps, thereby preventing expansion of the loop opening when the suture is manipulated into a locked configuration.

[0024] At least one of the adjustment mechanisms can be a knot, such as a self-locking knot. Non-limiting examples of such knots include a figure-eight hitch, an extended figure-eight hitch, or a prusik-type knot. The flexible member can be spliced at the locations of the first and second knots. The fixed body can be coupled to the spanning portion of the flexible member. For example, the spanning portion can pass through a plurality of through holes provided in the fixed body.

[0025] The suture structure may also include a release configuration. In some such embodiments, the suture may be configured to move between a locking configuration and a release configuration by adjusting the relative loading of the spanning portion and / or the tail portion (i.e., the first tail and / or the second tail). In one 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 extending along it, first and second sides, and first and second through-holes. The flexible member includes a first portion having a first tail, a first knot formed on the first portion, and a first loop portion. The first tail extends through the first through-hole, the first knot is disposed 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 portion having a second tail, a second knot formed on the second portion, 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 further includes a spanning portion extending across the fixed body from the first knot to the second knot. The first knot and the second knot are further configured to prevent expansion of the loop such that the tension on the bridge portion is adjustable.

[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-eight hitch, an extended figure-eight hitch, or a prusik-type knot. The flexible member may be spliced at the positions of the first knot and the second knot.

Brief Description of the Drawings

[0027] This disclosure will be more fully understood by reading the following detailed description in conjunction with the accompanying drawings.

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5A

Figure 5B

Figure 6

Figure 7A

Figure 7B

Figure 8

Figure 9

Figure 10A

Figure 10B

Figure 10C

Figure 11A

Figure 11B

Figure 11C

Figure 12A

Figure 12B

Figure 12C

Figure 13A

Figure 13B

Figure 13C

Figure 14A

Figure 14B

Figure 14C

Figure 14D

Figure 14E

Figure 14F

Figure 15A

Figure 15B

Figure 15C

Figure 15D

Figure 15E

Figure 15F

Figure 15G

DETAILED DESCRIPTION OF THE INVENTION

[0028] Here, specific exemplary embodiments are described so as to provide a thorough understanding of the structure, function, manufacture, and principles of operation of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the present disclosure is defined only by the claims. Features illustrated or described in connection with one exemplary embodiment can be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. Further, in the present disclosure, components having the same reference numerals in the embodiments generally have similar features. Additionally, insofar as linear dimensions 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 combination with such systems, devices, and methods. It will be recognized by those skilled in the art that dimensions corresponding to such linear and circular dimensions can be readily determined for any geometric shape. The size and shape of the systems and devices, and of their components, can depend at least on the anatomical structure of the subject within which the systems and devices are used, the size and shape of the components with which the systems and devices are used, and the methods and procedures in which the systems and devices are used.

[0029] The drawings provided in this specification are not necessarily to scale. Further, to the extent that arrows are used to illustrate the direction in which a component can be tensioned or pulled, these arrows are illustrative only and are not intended to limit in any way the direction in which an individual component can be tensioned or pulled. One of ordinary skill in the art will recognize other methods and directions for achieving the desired tension or movement. Similarly, in some embodiments, the movement of one component is described relative to another component, but one of ordinary skill in the art will recognize that other movements are possible. Additionally, various terms may be used interchangeably throughout the disclosure, which will be understood by one of ordinary skill in the art. By way of non-limiting example, the terms "suture", "filament", and "suture filament" may be used interchangeably with each other and with "flexible member".

[0030] The present disclosure is generally directed to methods and devices for securing soft tissue, including but not limited to ligaments, tendons, and grafts, to bone or other desired locations within a subject (e.g., human, animal). The surgical implants described herein generally include a suture structure formed from a flexible member such as a suture (also referred to as a filament or suture filament), the suture structure being passed through or otherwise associated with two suture anchors such that each suture anchor is slidably disposed on an adjustable loop of the suture structure, and a fixed length spanning portion extends between adjustment mechanisms (e.g., knots, splices, finger traps) of each adjustable loop. Those skilled in the art will understand that the flexible member includes, but is not limited to, sutures, filaments, suture filaments, woven sutures or filaments, monofilaments, and other materials used to form them and / or other "soft" components such as soft anchors, and any component that can be flexible for use in surgical procedures such as those provided herein. The size of each adjustable loop can be adjusted by using the ends of the suture to manipulate one or both of the interconnected loops of the suture. FIGS. 1-9 illustrate examples of surgical implants having a suture structure and two anchors and their use. The examples include using multiple suture structures in series with multiple anchors and using the spanning portions of each suture structure that extend across the tissue between the anchors from each of a plurality of continuous points to secure tissue across a plurality of continuous points.

[0031] Examples of the present disclosure also include surgical instruments for use with suture structures, the instruments having separate first and second insertion shafts, each carrying one of two anchors, such that the instrument can be delivered to the surgical site to implant both anchors without removing the entire instrument. In some examples, the surgical instrument is an assembly of two separable insertion instruments, one having an insertion point that extends distally beyond the other insertion point such that one of the anchors of the surgical implant can be implanted at the most distal end of the assembly. After the first implant, the portion of the insertion instrument used to implant the first anchor is withdrawn or otherwise at least partially separated from the other (e.g., the assembly is separated), leaving the insertion shaft of the remaining instrument to implant the second anchor of the surgical implant.

[0032] Exemplary Suture Structures and Implants Figure 1 is a schematic view of one exemplary embodiment of a surgical implant 100 including a multi-loop tensionable suture structure 200 spanning between a plurality of suture anchors 300a, 300b. The suture structure 200 can 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 structure 200 can be formed from a single flexible member or a plurality of flexible members. The first and second adjustment mechanisms 220a, 220b can be knots such as self-locking knots, or splices within the suture such as finger trap configurations. In at least some examples, the adjustment mechanisms 220a, 220b are self-locking such that tension on the loop portions 210a, 210b (e.g., by applying tension to the tails 230a, 230b to tighten the respective loops 210a, 210b) prevents movement (e.g., loosening or releasing of the loop) of the respective tails 230a, 230b back into the loop portions 210a, 210b through the adjustment mechanisms 220a, 220b. The suture structure 200 can include a length of suture between the first adjustment mechanism 220a and the second adjustment mechanism 220b, which can be positioned to span at least in the installation configuration across a portion of tissue between the positions where the loops 210a, 210b extend into the tissue, and is thus at least sometimes referred to herein as the spanning portion 290. The spanning portion 290 can, in at least some examples, 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 suture extending between the proximal end portions 220at and 220bt of the respective adjustment mechanisms 220a, 220b. In at least some examples, it can be advantageous to keep the length of the spanning portion 290 as small as possible, for example, to allow the anchor placement between two anchors to be as close as possible. In some non-limiting embodiments, the spanning portion can have a length in the range of approximately 1 mm to approximately 10 mm, or in the range of approximately 3 mm to approximately 5 mm.The one-way locking effectiveness of adjustment mechanisms 220a and 220b can generally increase with the increase in lengths 292a and 292b up to a range of approximately 3 mm to approximately 5 mm. However, the effectiveness of the structure when locking the loop does not depend on the span length 291. Generally, a smaller span length 291 can allow for a closer arrangement of the anchors within each of the loops. A span length 291 in the range of approximately 3 mm to approximately 5 mm, including the size of the anchors, the depth of the anchor placement into the bone, and the thickness of the tissue being spanned, allows the surgeon to place the anchors as close to each other as desired (without placing them on top of each other). One of ordinary skill in the art will understand that other lengths are possible, at least in part, depending on, among other factors understood by one of ordinary skill in the art, the type of procedure being performed, the patient's anatomical structure, and / or the surgeon's preference.

[0033] The surgical implant 100 also includes a first anchor 300a disposed on a first loop 210a of the suture structure 200 and a second anchor 300b disposed on a second loop 210b of the suture structure 200. These anchors include rigid anchors, such as Healix Ti (trademark) anchors, Healix Advance (trademark) anchors, Helix Advance Knotless (trademark) anchors, Healix BR (trademark) anchors, Healix PEEK (trademark) anchors, Healix Transtend (trademark) anchors, Bioknotless (registered trademark) anchors, Gryphon (registered trademark) anchors, Fastin (registered trademark) anchors, Versalok (registered trademark) anchors, Microfix (registered trademark) anchors, Minilok (trademark) anchors, Micro-Quickanchor (registered trademark) anchors, and Tacit (registered trademark) anchors, each of which is also commercially available from DePuy Synthes, and soft anchors, such as VERSALOOP (trademark) anchors, which are also commercially available from DePuy Synthes. Some exemplary embodiments of other soft suture anchors that can be used with the present disclosure include those described in Sengun U.S. Patent No. 9,345,567, the entire content of which is incorporated herein by reference. The anchors 300a, 300b in the illustrated embodiment are soft anchors that can be constructed from a woven material such as suture material. In some examples, the anchors 300a, 300b can be slidably disposed on their respective loops 210a, 210b such that the sutures of the loops 210a, 210b can slide through the anchors 300a, 300b. This arrangement allows, for example, the anchors 300a, 300b to be placed within tissue such as bone, and then the tension on the tails 230a, 230b of the respective loops 300a, 300b can tighten the loops by advancing the sutures through the anchors 210a, 210b, making it possible to pull the loop adjustment mechanism closer to the anchors 300a, 300b.

[0034] As shown, the surgical implant 100 can also include additional lengths of suture 499a, 499b that extend to and through each anchor 300a, 300b. In some examples, one or both of these additional lengths of suture 499a, 499b can be, for example, set sutures 499a, 499b that help guide each anchor 300a, 300b to a desired or specified position by pulling on the set sutures 499a, 499b to actuate each anchor 300a, 300b into a locked configuration or otherwise set, and / or move each anchor 300a, 300b to a desired or specified position at the surgical site, and / or actuate each anchor 300a, 300b into a locked configuration or otherwise set at a desired or specified position. Setting the anchors 300a, 300b into a locked configuration can also, or alternatively, include applying tension to each anchor 300a, 300b to cause the anchor to be adjusted from its initial configuration, in which the anchor has a lower profile, width, and / or diameter and can more easily pass through a smaller incision and / or opening to reach the surgical site, to a locked configuration in which the anchor can have a greater width or diameter than its initial configuration (e.g., in a “bundled” or “compressed” configuration), helping to prevent the anchor from coming out of or otherwise moving from its desired or specified position when force is applied to the anchor. The additional lengths of suture 499a, 499b can be passed through each anchor 300a, 300b in a manner similar to the suture of loops 210a, 210b, which can include, for example, passing through the same path as the suture of loops 210a, 210b in which the anchors 300a, 300b are disposed. In other examples, the additional lengths of suture that pass through the anchor are loops of another suture structure 200, as shown in more detail in FIG. 6.

[0035] FIG. 2 is a schematic view of the multi-loop tensionable suture structure 200 of FIG. 1 without an anchor. The length of the spanning portion 290 is shown as the length of the suture between the first adjustment mechanism 220a and the second adjustment mechanism 220b, more specifically, the length between the proximal end portions 220at, 220bt of the adjustment mechanisms 220a, 220b (e.g., region 291). The length of each of the first and second adjustment mechanisms is also shown as the length of the suture between the spanning portion 290 and the entrances of the tails 230a, 230b into the respective adjustment mechanisms 220a, 220b on the sides of the adjustment mechanisms forming the loops (e.g., regions 292a, 292b). In some non-limiting embodiments, the adjustment mechanisms 220a, 220b can have a length in the range of approximately 1 mm to approximately 10 mm, or in the range of approximately 3 mm to approximately 5 mm (e.g., a finger trap configuration where the trap is extended to provide additional strength and locking). Those skilled in the art will understand that other lengths are possible, at least in part, depending on, among other factors understood by those skilled in the art, the type of procedure being performed, the patient's anatomical structure, and / or the surgeon's preference. The spanning portion includes visible marks such as different colors and / or patterns (e.g., stripes) to distinguish the center of the suture structure 200 during tightening of the loops in a constrained surgical environment, allowing the user to center the spanning portion between the openings in the tissue through which the loops 210a, 210b (and, optionally, part or all of the adjustment mechanisms 220a, 220b) extend.

[0036] Figure 3 shows one exemplary soft anchor 300a that is used with the multi-loop tensionable suture structure 200 of Figure 1. The soft anchor 300a can have a generally circular and / or donut-shaped material arrangement with one or more passages, three passages 301, 302, 303 as shown in the figure, through which the suture can pass through the anchor. In the illustrated embodiment, the first passage 301 and the third passage 303 are disposed on both sides of the passage 302. The first and third passages 301, 303 can be arranged to allow the suture to pass from the outer surface (e.g., facing away from the anchor 300a) to the inner surface (e.g., facing inwardly toward another inner surface portion of the anchor 300a). The second passage 302 is arranged as a tunnel extending between one inner surface position and another inner surface position, and can functionally reverse the direction of the suture disposed therein. During operation, as shown in Figure 3, the suture of the first loop 210a of the suture structure 200 extends into the anchor 300a through the first passage 301 (e.g., portion 211), then spreads to the inner portion of the anchor (e.g., portion 212) and into the second passage 302 (e.g., portion 213), where the suture spreads away from the inner portion (e.g., portion 214) again and passes through the third passage 303 (e.g., portion 215) and returns from the anchor 300a. Additionally, as shown in Figure 3, a first additional length of suture 499a can be coupled to the first anchor 300a through the same passages 301, 302, 303 as the flexible member of the first loop 210a. The passages 301, 302, 303 can slide the suture such that the anchor 300a can move along the suture and / or the suture can move through the anchor 300a.

[0037] Figure 4 shows another exemplary soft anchor 300a' that is used with the multi-loop tensionable suture structure 200 of Figure 1. The soft anchor 300a' includes a single passageway 304 that extends between two outer positions of the soft anchor 300a', and as shown, can extend through most of the soft anchor 300a', such that the passageway 304 allows a suture to enter and exit the soft anchor 300a' from substantially the same side (e.g., the upper side with respect to the figure) with the direction reversed, and extend through the opposite side (e.g., the lower side with respect to the figure), enabling the soft anchor 300a' to be secured to the suture. Similar to the soft anchor 300a of Figure 3, the soft anchor 300a' of Figure 4 can have a first additional length of suture 499a that extends through the passageway 304. Figures 3 and 4 show two possible arrangements, but other arrangements (such as suture paths for both loops of suture 200 and set sutures 499 that cross through, within, and around the anchor 300 at multiple locations, but are not limited to these) are possible and are included herein.

[0038] In both examples of the anchors of Figures 3 and 4, the anchors 300a, 300a' may be coupled to one or more sutures during manufacture of the anchors 300a, 300a', and / or the sutures may be passed through the passageways 301 - 304 prior to use. Further, those skilled in the art will understand the various other configurations and techniques that can be used to associate the structure 200, or other structures provided herein or derivable otherwise from the present disclosure, with many different types of anchors. The structure 200 and sutures 499a, 499b can enter and exit any number of passageways that are formed within or otherwise provided as part of the anchor.

[0039] Figures 5A and 5B are diagrams of a multi-loop tensionable suture structure 200 spanning between a plurality of suture anchors 300a, 300b in an implanted configuration. Anchor 300b can be of the same nature as suture anchor 300a, but they can be of different configurations or entirely different anchor types (e.g., one can be a soft anchor and the other can be a hard anchor). In Figure 5A, a surgical implant 500 including suture structure 200 and first and second anchors 300a, 300b is implanted within tissues 50, 60. As shown, soft tissue 50 is above a second tissue 60 that can be bone, and the first and second anchors 300a, 300b are disposed at respective distinct positions within the second tissue 60. Figure 5A shows tissues 50, 60 as translucent to enable the anchors 300a, 300b and loops 210a, 210b to be shown, and Figure 5B shows tissues 50, 60 as opaque to better show the actual placement of structure 200 over soft tissue 50. Returning to Figure 5A, from each anchor 300a, 300b, loop portions 210a, 210b can extend through soft tissue 500. More specifically, the first loop portion 210a can extend through a first position 51a, and the second loop portion 210b can extend through a second position 51b. A spanning portion 290 can extend across the surface of soft tissue 50 and connect the loop portions 210a, 210b. During operation, each anchor 300a, 300b to which respective loop portions 210a, 210b of suture structure 200 are coupled can pass through soft tissue 50 and into the second tissue 60. Thereafter, tails 230a, 230b can be pulled simultaneously or sequentially to tighten loops 210a, 210b and pull spanning portion 290 against the surface of soft tissue 50. In Figure 5B, it can be more readily seen that the positions of adjustment mechanisms 220a, 220b are adjacent to, or generally abut, or even enter into, respective positions 51a, 51b where loop portions 210a, 210b extend through soft tissue 50 and connect to anchors 300a, 300b.This specification also includes examples that include placing and securing an anchor within a single tissue layer (such as 50), through and beyond both of two tissue layers (such as 50 and 60), and / or within or through and beyond a third or fourth or subsequent tissue layer.

[0040] Exemplary techniques for using surgical implants 100, 500, and other implants provided herein or otherwise derivable from the present disclosure are described herein in the context of FIG. 5A. Related disclosure is further provided below with respect to at least FIGS. 15A-15G, which disclosure focuses on the insertion instrument rather than the implant. First, the soft tissue 50 to be repaired can be perforated by passing the sharp tip of the insertion instrument through the soft tissue 50. Next, a location within a second tissue 60 (e.g., bone) can be located where the first anchor 300a is to be embedded. Then, a hole can be formed in the second tissue 60 at the desired location of the first anchor 300 (e.g., by driving an insertion tool into the bone to an appropriate depth). Next, depending on the type of instrument and / or anchor being used, the central sharp core of the insertion tool is removed, 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 a second anchor 300b at a different location, and then the spanning portion can be tensioned against the soft tissue 50 by pulling on the tails 230a, 230b to tighten the loops 210a, 210b. As described in FIGS. 6-7B, this process can be repeated multiple times using additional anchors and suture structures for a chain connected across all of the embedded anchors, and the spanning portion is bridged across the soft tissue 50 between each anchor location. Also included herein are examples for creating holes through and / or within tissue using the anchor itself at the end of the insertion tool and / or using the insertion tool with the anchor retained thereon, such that upon removal of the tool, the anchor remains in place (without the need for a separate step of first creating a hole and / or without the need to temporarily leave any portion of the insertion tool within the tissue prior to placing the anchor and without the need for a subsequent step of placing the anchor).

[0041] FIG. 6 is a schematic side view of an exemplary embodiment of a plurality of multi-loop tensionable suture structures 600 connected in overlapping succession to a series of anchors. In FIG. 6, the plurality 600 includes a first implant 601 that includes a first suture structure 200 and first and second anchors 300a, 300b. The plurality also includes second and third implants 601, 602, up to an Nth implant (e.g., 60N), each with 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. Thus, the first anchor 300a of the first implant 601, like the second anchor 300n + 1 of the final implant 60N, is coupled to only a single structure 200, and all intervening implants are coupled to one anchor of each adjacent implant. The example also includes using a plurality of multi-loop structures (such as plurality 600) to connect the first and final implants to each other with a multi-loop tensionable suture structure, similar to the other adjacent anchor pairs of FIG. 6, and / or having additional anchors or a plurality of anchors, similar to plurality 600, connected to one or more of the anchors within the plurality of multi-loop structures via the multi-loop tensionable suture structure. In this way, to create the different plurality of multi-loop structures described, a given one or more anchors within such structures can have more than two multi-loop tensionable suture loops associated therewith. Each structure 200 can include first and second adjustment mechanisms 220a, 220b, as discussed herein. The anchors are individually labeled (e.g., 300a - d, 300n, 300n + 1), but their association with each respective implant can be established prior to insertion, but need not be. For example, prior to insertion of the second anchor 300b of the first implant 601, the first loop 210a' can be coupled to the first anchor 300a. Thus, each subsequent suture structure after the first can be pre-installed using only a single "second" anchor and the loop portion configured to be coupled to the second anchor of the adjacent implant.Alternatively, a plurality of implants 600 can be manufactured together and provided as a set having a predetermined number of implants, with each connection between the loops and the anchors already established. Further alternatively, the implant can be coupled to an already implanted anchor to form at least a portion of a plurality of multi-loop tensionable suture structures 600.

[0042] Figures 7A and 7B are diagrams of the installation of a plurality of implants 601, 602, 603, each having a multi-loop tensionable suture structure 200, 200', 200'' arranged to span across a series of anchors 300a, 300b, 300c, 300d in a state where the anchors 300a, 300b, 300c, 300d are disposed within a second tissue 60 and the structures 200, 200', 200'' extend across the soft tissue 50 above the second tissue 60. The anchors 300c, 300d can be of the same nature as the suture anchors 300a, 300b, although they can be of different configurations or entirely different anchor types (e.g., one or more can be soft anchors and one or more others can be hard anchors). In some embodiments, the anchors can all be suture anchors, toggle anchors, or other suitable anchors for fixing tissue to bone. Similar to FIG. 5A, in FIG. 7A, the first and second tissues 50, 60 are translucent to show the anchors 300a, 300b, 300c, 300d within the second tissue. Each structure 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 FIGS. 5A and 5B. In FIG. 7A, each structure 200, 200', 200'' can penetrate the soft tissue 50 at two unique positions, which is optional, and as shown in FIG. 7B, the loops of adjacent structures can also penetrate the soft tissue at the same position. In the illustrated embodiment, the suture structures 601, 602, 603 together define a tensionable structure having three spans and four anchor points.

[0043] One exemplary technique for using surgical implants 601, 602, 603 is described here in the context of FIG. 7A. First, anchors 300a - d with a suture or suture loop spanning between pairs of anchors are successively 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 way, at which point tension can be applied to the associated suture end 200 to cinch the span between the first two anchors. Alternatively, the suture end 200 can be left without tension applied until a later time. After placing the third anchor in the same manner as the first and second anchors, tension can be applied to the suture end 200', or it can be left without tension applied until later. Subsequent anchors can be placed as desired, and suture ends such as 200'' can be tensioned or left without tension applied after the placement of each subsequent anchor. After placement of all anchors within a plurality of multi - loop structures, any suture ends that have been left without tension applied can be tensioned as desired to cinch the spans between each pair of the placed anchors.

[0044] FIG. 8 is a photograph of an exemplary implant 80 having a multi-loop tensionable suture structure 800 spanning between a plurality of soft suture anchors 83a, 83b. The suture structure 800 is made from a single length of suture 801 formed into two separate loop portions 810a, 810b by passing respective tails 830a, 830b of the suture 801 through finger traps 820a, 820b. The finger traps 820a, 820b are formed in adjacent regions of the suture 801 with a spanning portion 890 extending therebetween. Each soft anchor 83a, 83b is slidably disposed over one of each of the loops 810a, 810b in a manner as described in FIG. 3. Additional lengths of suture 999a, 999b are also passed through each soft anchor 83a, 83b along their respective loop portions 810a, 810b. The additional lengths of suture 999a, 999b can perform a function similar to that of the additional lengths of suture 499a, 499b of FIG. 1. FIG. 9 shows the finger trap adjustment mechanisms 820a, 820b in more detail. Each finger trap 820a, 820b can include a substantially stationary trap formed in suture portions 812a, 812b adjacent to the spanning portion 890. The stationary trap is an area through which the moving portions 811a, 811b of the suture pass, and the lengths of suture extending from the traps on the opposite sides of the loop portions 810a, 810b are tensionable tails 830a, 830b that can be pulled to tighten the loops 810a, 810b.

[0045] Alternatively, the knots can be used for constructing loops 810a, 810b of the structure 200, thereby enabling the fabrication of structures 800, 800 using non-spliceable suture threads. Even if the suture thread is spliceable, the configuration of the structure 800 can be such that no splice is used, at least with respect to the locations where the adjustment mechanisms 820a, 820b are located. The use of knots as opposed to splices can, in at least some instances, provide enhanced safety and better versatility for manufacturing one-way shrink loops, among other advantages, at least by enabling the use of suture threads that are not compatible with alternative locking mechanisms such as splices. Thus, the knot examples provided herein do not include splices as previously used in medical applications and can be described as non-spliced. The adjustment mechanisms 820a, 820b can generally include various mechanisms including self-locking mechanisms, which can include, for example, splices, finger traps, knots, and other arrangements known to those skilled in the art.

[0046] The adjustment mechanisms 820a, 820b can be formed on the filament 801 in many different ways. In the illustrated embodiment shown in detail in FIG. 9, the adjustment mechanisms 820a, 820b are finger traps. More generally, the adjustment mechanisms 820a, 820b can also be knots such as a lark's head knot and / or a single strand single loop slip knot type. When these adjustment mechanisms 820a, 820b are disposed within a structure such as the structure 800, they can exhibit self-locking behavior due to the tension on the spanning portion 890 that pulls both sleeve portions of the finger trap when, for example, the loops 810a, 810b are pulled and tightened. The illustrated embodiment in no way limits the type and / or number of adjustment mechanisms 820a, 820b that can be used as knots in conjunction with the suture structures (e.g., structures 200, 800) provided herein to achieve the desired function of the structure. The finger trap shown in FIG. 9, as well as the knot, are some non-limiting examples of self-locking adjustment mechanisms and self-locking mechanisms, and the adjustment mechanisms can more generally be used in place of the finger traps and knots described herein. Those skilled in the art, in view of the present disclosure, will recognize other adjustment mechanisms 820a, 820b suitable for use in conjunction with the structures and implants of the present disclosure, such as tooth and claw arrangements, which can be advantageously used with a monofilament flexible member (e.g., a suture) where splicing may not be possible due to the monofilament nature of the flexible member.

[0047] The operation of a single flexible member to form each of the tails 830a, 830b, the loop portions 810a, 810b, the adjustment mechanisms 820a, 820b, and the spanning portion 890 can be achieved in various ways. The order in which the various features of the structure 800 (e.g., tails, loop portions, adjustment mechanisms, spanning portion, etc.) are formed is typically not important. As generally shown, the single flexible member includes two end portions that terminate at the tails 830a, 830b. In one exemplary embodiment, the flexible member extends from the first tail 830a and is formed into the first loop 810a by passing through the first adjustment mechanism 820a formed in the suture thread and then returning. Additionally, the second tail is formed into the second loop 810b by being returned through the second adjustment mechanism 820b formed in the suture thread.

[0048] The example of FIG. 8 shows adjustment mechanisms 820a, 820b as finger trap configurations, but other configurations are possible. One such example is the use of figure-eight or extended figure-eight lashings to form a loop portion. During operation, the tail is freely pulled through the figure-eight lashing to contract the loop portion. By applying tension to the contracted tail (e.g., suture forming the spanning portion), the suture structure can be placed in a locked configuration. Another exemplary structure includes a suture knotted with a prusik knot to form a loop portion, a tightening tail to form a spanning portion, and a sliding tail to provide tightening of the loop. The prusik knot can be created, for example, by piercing the end of the suture through the central portion of the suture. During operation, the sliding tail is freely pulled through the prusik knot to contract the loop portion. By applying tension to the contracted tail (e.g., to the spanning portion by tightening both loops), the suture structure can be placed in a locked configuration. The use of knots allows for greater versatility in the manufacturability of the one-way contractile loop structure 400 by enabling the use of suture 500 that is not compatible with alternative locking mechanisms (e.g., splices). One such example is a suture having a solid core, such as DePuy Synthes Dynacord™ suture available from DePuy Synthes Sports Medicine (Mitek) (Raynham, MA). The Dynacord™ suture is constructed with a solid core provided for the ability of the suture to contract when hydrated. Additional information regarding such suture configurations is provided at least in U.S. Patent No. 8,870,915 (Mayer et al.), the content of which is incorporated herein by reference in its entirety. The contractile behavior of the structures provided herein (e.g., implant 100 and / or structures 200, 800) can be used in conjunction with Dynacord™ technology to resist loss of repair due to creep, reapproximate tissue with a gap formed, and / or maintain a compressive force on the approximated tissue.The presence of the solid core and its typical close relationship with the braiding of the suture can provide the attraction of locking mechanisms such as knots outside the core of the suture.

[0049] In the exemplary embodiment of FIG. 8, the surgical structure 800 is formed from a single flexible member. Those skilled in the art will understand that the disclosure provided herein can be adapted to formations using multiple flexible members. For example, in some examples, a bridge portion similar to the spanning portion 890 can be formed by tying or otherwise connecting two separate flexible members together, and each flexible member has one knot, one looped portion, and one sliding tail similar to the adjustment mechanisms 820a, 820b, the looped portions 810a, 810b, and the sliding tails 830a, 830b formed therein. The bridge portion can be a third flexible member or the end of one of the first flexible member and the second flexible member that form the first loop portion 810a and the second loop portion 810b. The use of a single flexible member can provide benefits, especially in terms of ease of manufacture and / or formation, strength, and reliability. The use of multiple flexible member types can provide benefits in the adaptability of the structure 800 for more easily having different performance characteristics at different positions along the structure.

[0050] The surgical structures and implants provided herein can be used in a variety of procedures for fixing soft tissue grafts to bone. One common procedure is the repair of a torn rotator cuff or torn glenoid labrum in a patient's shoulder.

[0051] Examples of the present disclosure also include suture structures housed within a sterile package in a ready-to-use configuration. This includes options such as having a plurality of loop tensionable structures assembled with a plurality of anchors, each anchor being on its own insertion machine shaft, and assembling their shafts together within an insertion instrument. The instrument, insertion machine shaft, structure, and anchor can be clean and sterile, can be held within a thermoformed tray or other such tray, and further, can be housed within a single pouch or multiple pouches and held within a box to function as a barrier to keep the ready-to-use complete assembly clean and sterile, and can be easily handled during its final packaging at the company's manufacturing site. Thereafter, the package can be opened and used for a single treatment in an operating room or treatment room of a surgical center, and then, the unimplanted components can be appropriately discarded and / or disassembled for recycling. Another option includes having one or more of the other sub-components of the implant and instrument components that are packaged separately from the multi-loop tensionable structure, insertion machine shaft, insertion instrument, or other components or sub-components. In the first option described, all components can be transported together and presented to the surgeon in a single package without the need for assembly. In the second option described, some components, such as the insertion machine shaft or insertion instrument, can be packaged in a non-sterile manner and provided for cleaning and sterilization at the hospital or surgical center site. In this scenario within the second option, after each treatment case is used, or alternatively, as needed, reusable instrument components can be re-cleaned and re-sterilized for subsequent reuse. Further, in this second option, for example, in some cases, after opening separate packages and before using the instrument and implant in a treatment case, some assembly (such as, for example, assembling the implant onto the insertion machine shaft in some cases) may be required. Also, in this second option, the components can be transported in different packages, and for a particular treatment case, the surgeon can determine which instrument and implant components may be required, and can order only those components to be prepared and brought close to the site of the treatment case.

[0052] As discussed herein, at least some portions of the structures and devices disclosed herein can be designed to be discarded after a single use and / or at least some portions of the structures and devices can be designed to be used multiple times. However, in either case, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembling the device, subsequently cleaning or replacing certain parts, and then reassembling. Specifically, the device can be disassembled and any number of specific parts or components of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing certain parts, the device can be reassembled for later use in a reconditioning facility or by the surgical team immediately prior to a surgical procedure. One of ordinary skill in the art will understand that various techniques for disassembly, cleaning / replacement, and reassembly are available for reconditioning the device. The use of such techniques and the devices reconditioned thereby are all within the scope of this application.

[0053] Preferably, the invention described herein will be processed prior to surgery. First, new or used devices and / or structures are obtained and, if necessary, cleaned. The devices and / or structures can then be sterilized. In one sterilization technique, the devices and / or structures are placed within a closed and sealed container such as a plastic or TYVEK bag. The container, along with the devices and / or structures, is then placed in a radiation field that can penetrate the container, such as gamma rays, X-rays, or high-energy electrons. The radiation kills bacteria on the devices and / or structures and within the container. The sterilized devices and / or structures can then be stored within the sterilization container. The sealed container keeps the devices and / or structures in a sterile state until opened at a medical facility.

[0054] The apparatus and / or structure is preferably sterilized. This can be done by various methods known to those skilled in the art, such as beta or gamma radiation, ethylene oxide, steam, and liquid baths (e.g., low-temperature immersion).

[0055] Exemplary insertion device Figures 10A - 15G present exemplary surgical instruments for installing suture implants such as implants 80, 100, 500, 600, etc., which are disclosed herein or otherwise derivable from the present disclosure. Figure 10A is an isometric view of a double - insertion instrument 1000 for use in installing an embodiment of a multi - loop tension - impartable suture structure disclosed herein. Since the instrument 1000 can be an assembly of a first insertion device 1100 and a second insertion device 1200, the instrument 1000 is referred to as a double - insertion instrument and refers to their arrangement for providing the insertion of a first anchor using the first device 1100 and then providing a reconfiguration for the subsequent insertion of a second anchor via the second insertion device 1200, as described hereinafter. In some examples, each of the first and second insertion devices 1100, 1200 can be an individual sub - assembly of a surgical instrument assembly that includes both a first and a second sub - assembly, and each sub - assembly can have, for example, a handle and a shaft component. The first insertion device 1100 can include a first proximal handle 1120 and a first insertion shaft 1110 that extends distally. The second insertion device 1200 can include a second proximal handle 1220 and a second insertion shaft 1210 that extends distally. Figure 10A shows the first and second insertion devices 1100, 1200 coupled to each other having the first and second handles 1120, 1220 combined to form a single - handle arrangement. The two insertion shafts 1110, 1210 can extend together from the combined handles 1120, 1220, and the first distal tip 1111 of the first insertion shaft 1110 extends beyond the second distal tip 1211 of the second insertion shaft 1210 to enable the use of the first distal tip 1111 without interference from the second distal tip 1211 while the first and second devices 1100, 1200 are combined. The first and second distal tips 1111, 1112 can be configured to hold an anchor and insert it into tissue.The first and second insertion shafts 1110, 1210 are arranged substantially parallel to each other and can have the same spread along their overlapping portions (e.g., between the handle and the second distal tip 1211).

[0056] FIG. 10B is a top view of the double insertion instrument assembly 1000, showing a second spindle 1229 having a winding channel 1228 on a second proximal handle 1220 that can be used to manage a suture extending from an anchor held by the second distal tip 1211. Also shown, as in FIG. 10C, is an example of a latch mechanism formed by a flexible portion 1121 of the first proximal handle 1120 that can be used to control fixing the handles 1120, 1220 together. FIG. 10C is a cross-sectional view of the double insertion instrument assembly 1000, more clearly showing the arrangement of the insertion shafts 1110, 1210 and the coupling of the handles 1120, 1220. Starting from the handle, the first proximal handle 1120 can hold the proximal end of the first insertion shaft 1110, and the proximal end portion 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 insertion of the first distal tip 1111 into hard tissue such as bone. The first proximal handle 1120 can also include a first spindle 1129 having a winding channel for managing a suture extending from an anchor held by the first distal tip 1111.

[0057] As shown in FIG. 10C, the proximal extension 1230 of the second proximal handle 1220 extends into the distal opening cavity 1126 of the first proximal handle 1120 to more fully engage the two handles (e.g., rotationally and otherwise locked) when coupled, and can improve their feel to the user as a single handle. The flexible portion 1121 of the first proximal handle 1120 can control the engagement of a latch 1122 that extends into the proximal opening recess 1222 of the second proximal handle 1220, and when latched, can maintain the assembled configuration of the first and second handles 1120, 1220 together. Pressing the flexible portion 1121 toward the central axis of the first handle 1120 disengages the latch 1122 and allows the first insertion device 1100 to be separated from and withdrawn from the second insertion device 1200, as shown in more detail by FIGS. 12A and 12B. Continuing to refer to FIG. 10C, the first insertion shaft 1110 can extend through the second handle 1220 and distally extend alongside (and beyond) the second insertion shaft 1210. The distal tips 1111, 1211 of each insertion shaft 1110, 1210 can include terminal notches 1112, 1212 configured to hold an anchor such as the soft anchors shown herein, and the shafts can further include notches 1113, 1213 proximal to the terminal notches 1112, 1212, which can function as seats for a portion of the anchor to seat when carried by the insertion shafts before and during insertion. The distal tips 1111 and 1211 can also be configured to allow for tissue penetration (e.g., by terminating in a pointed end). This can allow for the insertion and placement of an anchor, such as those within the assembly 80, directly into and / or through soft tissue and into and / or through bone tissue without the need for prior preparation or hole creation.

[0058] Figures 11A and 11B show the first and second proximal handles 1120, 1220 coupled to each other and viewed from two different angles. As shown in FIG. 11A, channel 1227 extends distally from channel 1228 of the second spindle 1229 of the second handle 1220, and thus, suture threads from an anchor of an assembly such as 80 held on an insertion shaft 1210 (not shown) can be placed on the second spindle 1229 and thereby managed and extend to the insertion shaft 1120 (not shown), providing a path therein and along it. On the other side, as shown in FIG. 11B, another channel 1226 extends along the entire second handle 1220 to connect the channel 1128 of the first spindle 1129 of the first handle 1120 to the proximal end of the second handle 1220, thereby placing additional suture threads from an anchor of an assembly such as 80 held on an insertion shaft 1110 (not shown) and providing a passageway therein and along it that can be managed on the first spindle 1129. Placing the suture threads in this way can help hold the suture threads firmly against accidental premature disengagement from the inserter assembly 1000, such as may occur if the user's hand holding the assembly 1000 contacts the suture threads. Also visible in FIG. 11B are two passageways 1232, 1231 (e.g., bores) through which the first insertion shaft 1110 and the second insertion shaft 1210 can extend distally through the second handle 1220. The first insertion shaft 1110 can extend out of the first bore 1231, and the second insertion shaft 1210 can extend out of the second bore 1232. Returning to FIG. 11A, bore 1131 of the first handle 1120 is shown that can be used to hold the first insertion shaft and allow its proximal end to extend proximally from the first handle 1120.

[0059] By pressing the flexible portion 1121 of the first handle 1120, the tooth 1122 can be disconnected from the corresponding mechanism 1223 disposed within the recess 1222 of the second handle 1220, thereby enabling the first handle to be decoupled and separated from the second handle 1220 as shown in FIG. 11C and as will be discussed in more detail below with respect to FIGS. 12A and 12B. Continuing to refer to FIG. 11C, a flat portion 1235 of the proximal extension 1230 of the second handle is shown, which can provide rotational locking of the first and second handles 1120, 1220 when engaged with the corresponding flat section of the cavity 1126 of the first handle 1120 when coupled. During operation, with the first insertion shaft 1110 extending through the bore within the second proximal handle 1220, separation of the first handle 1120 can be effected by translating the first handle 1120 proximally away from the second handle 1220 until the first insertion shaft 1110 is completely withdrawn from the second handle 1220. FIGS. 12A and 12B show the removal (or insertion) of the first insertion device 1100 from the second insertion device 1200 with the first insertion shaft 1110 not completely withdrawn from the second handle 1220. The proximal end portion 1215 of the second insertion shaft 1210 appears to extend proximally beyond the proximal end of the second handle 1220. This arrangement can enable the second insertion shaft 1210 to be struck with a hammer or other tool to facilitate insertion of the second distal tip 1211 into hard tissue such as bone. After the first insertion device 1100 has been used for the first insertion, the first insertion device can be completely removed from the second insertion device 1200 at the surgical repair site before using the second insertion device for the second insertion operation. FIG. 12C shows the second insertion device with the first insertion device separated and completely removed. In this configuration of FIG. 12C, the second insertion device 1200 can be used alone to place and insert an anchor following the placement and insertion of a previous anchor.

[0060] Examples of the double-insertion instrument of the present invention can also include the use of a detachable sheath. The detachable sheath can be, for example, a cannula with a frangible and / or bendable section and longitudinal perforations or other features to allow for selectively removing a portion radially from the shaft. The detachable sheath can be configured to surround the two insertion shafts 1110, 1210 and a surgical implant (e.g., the surgical implant 100 of FIG. 1, the implant 80 of FIG. 8 as shown in FIG. 13A), or any other suture structure), and can be configured to protect the surgical implant carried by the insertion shafts 1110, 1210, for example, by completely covering the implant from the insertion shafts 1110, 1210 and the handles 1120, 1220 to the first distal tip 1111. In the illustrated embodiment, the detachable sheath can include proximal segments 1301, 1302, 1303 (see FIGS. 13C and 14D) that can be frangible, bendable, and / or otherwise separable from the proximal portion of the insertion shafts 1110, 1210 without separating the remaining portion(s) of the detachable sheath. In this way, removal of one or more proximal segments from the insertion shafts 1110, 1211 allows the remaining portion(s) of the detachable sheath to be advanced proximally and, for example, exposes the first distal tip 1111 for use. Subsequent removal of one or more additional proximal segments can allow the second distal tip 1211 to be exposed for use. Thus, the examples of detachable sheaths disclosed herein provide modular protection and can be maintained partially over a particular region to protect those regions (e.g., the second anchor during insertion of the first anchor) before they need to be exposed for use.

[0061] FIG. 13A is a photograph of the double insertion instrument assembly 1000 of FIG. 10A in an immediately useable configuration having the implant 80 of FIG. 8 and the release sheath 1300 disposed about the implant 80 and the insertion shafts 1110, 1210. The suture tails of the suture structure 800 are wound about the second spindle 1229 together with the additional suture 499b coupled to the second anchor, and the additional suture 499a coupled to the first anchor is wound about the first spindle 1129. FIG. 13B is an enlarged photograph of the distal end of the double insertion instrument assembly 1000. The first anchor 83a of the structure 800 is held within the distal tip 1111 of the first insertion shaft 1110, and the second anchor 83b is held within the distal tip 1211 of the second insertion shaft 1210, and the tails 820a, 820b and the additional sutures 499a, 499b extend proximally along the shafts 1110, 1210 and inside the release sheath 1300. In FIG. 13B, the release sheath 1300 extends beyond the distal tip 1111 and completely covers the implant 80. FIG. 13C shows the proximal end of the release sheath 1300 in contact with the handle of the double insertion instrument 1000. The release portion 1301 is shown after being removed from the shafts 1110, 1210 and after the release sheath 1300 has been translated proximally. FIG. 13C also shows the tails 830a, 830b wound about the second spindle 1229 together with the second additional suture 999b, and the first additional suture 999a wound about the first spindle 1129. As described below, the first release portion 1301 can be used to assist the user in separating a further release portion, and with the first release portion 1301 removed, the most distal end of the instrument 1000 can still be covered.

[0062] Figures 14A - 14C are photographs of the double - insertion instrument assembly 1000 and the suture structure 80 showing the operation of the release sheath 1300 before insertion of the first anchor 83a of the suture structure 80. Note that the first and second anchors (and associated additional sutures) of the implant 80 can be reversible, and as shown in FIGS. 14A - 14F, the first anchor can be reversed from the orientation shown in FIG. 8. The designation of the first anchor installed first is maintained even if the colors of the additional sutures 999a, 999b indicate that the anchors are installed in reverse order as per the naming convention used above. From the initial configuration of FIGS. 13A - 13C, a first step of removing the second release portion 1302 of the sheath 1300 is shown in FIG. 14A, and arrow 1401 indicates the movement of the second release portion 1302 from the shafts 11100, 1210. When the second portion 1302 is removed, the release sheath 1300 is moved proximally, as indicated by arrow 1402 in FIG. 14B, retracting the distal end 1310 of the release sheath 1300 and exposing the first distal tip 1111 and the first anchor 83b. At this position in FIG. 14C, a first insertion operation can be performed using the instrument 1000 to install the first anchor 83a into the tissue.

[0063] Figures 14D - 14F are photographs of the double - insertion instrument assembly 1000 and the suture structure 80, showing the operation of the detachment sheath 1300 before insertion of the second anchor 83b of the suture structure 80. From the configuration of FIG. 14C, upon completion of the first insertion operation, the first additional suture can be unwound from the first spindle 1129, and the first insertion device 1100 can be removed from the second insertion device 1200. However, this operation is not shown as having been performed in FIGS. 14D - 14F, and thus, although not shown, it can be assumed that the first shaft and the first handle no longer exist in the following steps. In FIG. 14D, the third detachment portion 1303 of the detachment sheath 1300 can be removed from the second insertion shaft, as indicated by arrow 1403. Thereafter, as shown in FIG. 14E, the detachment sheath 1300 can be translated proximally (as indicated by arrow 1404), exposing the second distal tip 1211 and the second anchor 83b, which is also shown in FIG. 14F. From this configuration of FIGS. 14E and 14F, a second insertion operation can be performed using the second insertion device 1200 to install the second anchor 83b. Exemplary installation operations showing the separation of the double - insertion instrument 1000 are provided in FIGS. 15A - 15G.

[0064] In FIG. 15A, the double insertion instrument 1000 assembly is shown in an initial state where the first and second handles are coupled together. Although the surgical implants 80, 100 are not shown, they are assumed to be present in the configuration of FIGS. 13A - 13C, for example, and on each of the two shafts, soft tissue anchors (e.g., anchors 83a, 83b) are pre - loaded for implantation, and the associated sutures are held on the handles 1120, 1220. As described above, in the assembled configurations of FIGS. 13A - 13C and FIG. 15A, the longer first insertion shaft 1110, attached more proximally to the handle, presents the first of the anchors for embedding into bone through soft tissue, such as by hitting 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 the first step, as shown in FIG. 15A, the instrument 1000 can be brought close to the surgical repair site, and the first distal tip 1111 can be navigated to the desired first position of the soft tissue (as indicated by arrow 1501). In the next step, as shown in FIG. 15B, the first anchor can be implanted into the second tissue at a second position by imparting an impact to the proximal end of the first shaft with the mallet 1520 (as indicated by arrow 1521) to drive the first distal tip 1111 into the second tissue at the second position. With the first anchor installed, the first additional suture (e.g., 999a of FIG. 8) can be unwound from the first proximal handle (as indicated by arrow 1502). With the suture disengaged from the first proximal handle, the flexible portion (e.g., 1121 of FIG. 10C) can be depressed (as indicated by arrow 1503) to release the first proximal handle 1120 from the second proximal handle 1220, and then, as shown in FIG. 15E, the first proximal handle can be pulled proximally (as indicated by arrow 1504) until the first shaft 1110 is free from the second proximal handle 1220, leaving the second anchor on the second shaft attached to the second handle. The second distal tip 1211 can then be navigated to a third position (e.g., a position on soft tissue different from the first position) (as indicated by arrow 1505).As shown in FIG. 15F, the implantation of the second anchor can be performed by striking the proximal end of the second handle with a mallet 1520 or other impact tool to place the second anchor into or through the soft tissue and into or through the second tissue at a fourth location (e.g., a location within the second tissue different from the second implantation location of the first anchor). With the second anchor installed, the suture structure and the tails of the second additional sutures can be unwound from the second spindle (as indicated by arrow 1506), at which point the second insertion device 1200 can be removed. The spanning portion of the structure between the two anchors can then be tensioned via the tails to complete the repair, resulting in, for example, the installed configurations of FIGS. 5A and 5B.

[0065] Those skilled in the art will understand further features and advantages of the present disclosure based on the provided description and embodiments. Accordingly, the invention is not limited by what has been specifically illustrated and described herein. All publications and references cited herein are hereby expressly incorporated by reference in their entirety.

[0066] Examples of the embodiments described above can include the following.

[0067] 1. A suture structure formed from a first flexible member, a first adjustment mechanism formed in the first flexible member, the first adjustment mechanism forming a first loop extending from the first adjustment mechanism and defining a first loop opening, the first adjustment mechanism; a first tail of the first flexible member extending from the first adjustment mechanism; a spanning portion of the first flexible member extending from the first adjustment mechanism; a second adjustment mechanism formed in the first flexible member, the second adjustment mechanism forming a second loop extending from the second adjustment mechanism, the second loop defining a second loop opening, the second adjustment mechanism; a second tail 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, and a second anchor slidably coupled to a second portion of the suture of the second loop, The first tail is configured to slide relative to the first adjustment mechanism to reduce the size of the first loop opening, thereby reducing the first distance between the first anchor and the first adjustment mechanism. The second tail is configured to slide relative to the second adjustment mechanism to reduce the size of the second loop opening, thereby reducing the second distance between the first anchor and the second adjustment mechanism. The spanning portion of the first flexible member defines a fixed distance along the suture between the first adjustment mechanism and the second adjustment mechanism, a suture structure.

[0068] 2. The suture structure according to Example 1, wherein at least one of the first adjustment mechanism or the second adjustment mechanism includes a self-locking knot.

[0069] 3. The suture structure according to Example 1 or 2, wherein at least one of the first adjustment mechanism or the second adjustment mechanism has a finger trap configuration.

[0070] 4. The first adjustment mechanism includes a first finger trap, and the first tail passes through the first finger trap. The second adjustment mechanism includes a second finger trap, and the second tail passes through the second finger trap. The suture structure according to any one of Examples 1 to 3, wherein the spanning portion is defined by a fixed length of suture between the first finger trap and the second finger trap.

[0071] 5. The suture structure according to Example 4, wherein each of the first and second finger traps defines a length in the range of approximately 2 mm to approximately 10 mm along the first flexible member.

[0072] 6. The fixed length of the spanning portion is in the range of approximately about 2 mm to about 10 mm, the suture structure according to any one of Examples 1 to 5.

[0073] 7. At least one of the first anchor or the second anchor is a soft anchor constructed from a woven fabric material, the suture structure according to any one of Examples 1 to 6.

[0074] 8. The first flexible member is a single continuous flexible member, the suture structure according to any one of Examples 1 to 7.

[0075] 9. Further comprising a second flexible member, the second flexible member extending through the first anchor such that the first anchor is also slidably disposed on the second flexible member, the suture structure according to any one of Examples 1 to 8.

[0076] 10. The first flexible member and the second flexible member extend through the same path passing through the first anchor, the suture structure according to Example 9.

[0077] 11. Further comprising a third flexible member, the third flexible member extending through the second anchor such that the second anchor is also slidably disposed on the third flexible member, the suture structure according to Example 9 or Example 10.

[0078] 12. The second flexible member is the flexible member of the loop of another suture structure according to Example 1, the suture structure according to any one of Examples 9 to 11.

[0079] 13. A method for preparing a surgical implant, 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 within the first flexible member by forming a first adjustment mechanism, such that the first flexible member with the first tail and the first portion of the first flexible member extends from one side of the first adjustment mechanism and the first loop extends from the opposite side of the first adjustment mechanism, with the first anchor slidably disposed on the first flexible member of the first loop. Pass the second tail of the first flexible member through the second anchor. After passing the second tail through the second anchor, creating a second loop within the first flexible member by forming a second adjustment mechanism, such that the first flexible member with the second tail and the second portion of the first flexible member extends from one side of the second adjustment mechanism and the second loop extends from the opposite side of the second adjustment mechanism, with the second anchor slidably disposed on the first flexible member of the second loop. Both the first portion and the second portion of the first flexible member define a spanning portion of the first flexible member that defines a fixed length of the first flexible member between the first adjustment mechanism and the second adjustment mechanism. The tension on the first tail tightens the first loop and reduces the maximum distance between the first anchor and the spanning portion. The tension on the second tail tightens the first loop and reduces the maximum distance between the second anchor and the spanning portion.

[0080] 14. The method according to embodiment 13, wherein at least one of the first adjustment mechanism or the second adjustment mechanism comprises a self-locking knot.

[0081] 15. The method according to embodiment 13 or 14, wherein at least one of the first adjustment mechanism or the second adjustment mechanism comprises a finger trap configuration.

[0082] 16. The first adjustment mechanism comprises a first finger trap, and the first tail passes through the first finger trap. The second adjustment mechanism includes a second finger trap, and the second tail passes through the second finger trap. The spanning portion is defined by a fixed-length suture between the first finger trap and the second finger trap, the method according to any one of embodiments 13 to 15.

[0083] 17. The first flexible member is a single continuous flexible member, the method according to any one of embodiments 13 to 16.

[0084] 18. Further comprising passing the tail of the second flexible member through the first anchor such that the first anchor is also slidably disposed on the second flexible member, the method according to any one of embodiments 13 to 17.

[0085] 19. The first flexible member and the second flexible member extend through the same path passing through the first anchor, the method according to embodiment 18.

[0086] 20. Further comprising passing the tail of the third suture filament through the second anchor such that the second anchor is also slidably disposed on the third suture filament, the method according to embodiment 18 or 19.

[0087] 21. The second suture filament is the suture filament of the loop of another suture structure according to embodiment 1, the method according to any one of embodiments 18 to 20.

[0088] 22. A surgical instrument, A first insertion device, A first insertion machine shaft having a first distal tip configured to hold an anchor and implant it into tissue, A first handle disposed around the proximal end of the first insertion machine shaft, the first insertion device comprising: A second insertion device configured to couple with the first insertion device, the second insertion device comprising: A second insertion device comprising a second insertion shaft having a second distal tip configured to hold an anchor and embed it into tissue; A second handle disposed around a proximal end of the second insertion shaft, the second handle having a bore therethrough and being configured such that when the second insertion device is coupled to the first insertion device, the first insertion shaft is disposed therein; The first handle is configured to removably couple to a distal end of the second handle, whereby the first insertion device can be separated from the second insertion device by pulling the first handle proximally away from the second handle, thereby pulling the first insertion shaft proximally out of the bore of the second handle. A surgical instrument, wherein a first distal tip of the first insertion shaft extends distally beyond a second distal tip of the second insertion shaft when the first and second insertion devices are coupled.

[0089] 23. The surgical instrument according to embodiment 22, wherein a proximal tip of the first insertion shaft extends proximally beyond the first handle.

[0090] 24. The surgical instrument according to embodiment 22 or 23, wherein a proximal tip of the second insertion shaft extends proximally beyond the second handle.

[0091] 25. The surgical instrument according to any one of embodiments 22 to 24, wherein the first insertion shaft and the second insertion shaft are adjacent and substantially parallel along their respective lengths when the first instrument is coupled to the second instrument.

[0092] 26. The first handle includes a latch configured to removably secure the attachment of the first handle to the second handle. The first handle comprises a flexible portion, and the flexible portion controls the engagement with the second handle of the latch and is for enabling the force applied to the flexible portion by the user to release the engagement with the second handle of the latch, the surgical instrument according to any one of Examples 22 to 25.

[0093] 27. The first handle has a first spindle configured to hold a length of suture extending from a first distal tip, the surgical instrument according to any one of Examples 22 to 26.

[0094] 28. The surgical instrument according to Example 27, wherein the second handle has a second spindle configured to hold a length of suture extending from a second distal tip.

[0095] 29. The surgical instrument according to Example 28, wherein the second handle comprises a recess configured to receive a length of suture extending from the first distal tip to the first spindle.

[0096] 30. The surgical instrument according to any one of Examples 22 to 29, further comprising a release sheath disposed around the first instrument shaft and the second instrument shaft and configured to extend from the second handle to the first distal tip, the proximal end of the release sheath defining a first section, the first section being removed from being disposed around the first instrument shaft and the second instrument shaft, and after removal, being configured to allow proximal translation of the release sheath while still covering the second distal tip and exposing the first distal tip.

[0097] 31. The release sheath further comprises a second section, the second section being disposed distally of the first section and removed from being disposed around the first instrument shaft and the second instrument shaft, and after removal, being configured to allow proximal translation of the release sheath and expose the second distal tip, the surgical instrument according to Example 30.

[0098] 32. The surgical instrument according to any one of Examples 22-31, further comprising the suture structure according to Example 1, wherein the first anchor is held by the first distal tip, the second anchor is held by the second distal tip, and the first and second tails of the first flexible member are fixed to the second handle, and the surgical instrument is coupled to the surgical instrument in a state where the first and second tails of the first flexible member are fixed to the second handle.

[0099] 33. The surgical instrument according to any one of Examples 22-32, wherein the first and second handles, when coupled, define a continuous single handle of the surgical instrument.

[0100] 34. A method of fixing soft tissue to bone, the method comprising: navigating the first distal tip of the first insertion shaft of the first instrument carrying the first anchor through the soft tissue at a first position and inserting the first anchor into the bone at a second position, the anchor having a first tightenable loop of a suture structure coupled thereto; disposing the first anchor at the second position by withdrawing the first distal tip from the first and second positions, the withdrawing including withdrawing the first insertion shaft proximally from the second handle of the second instrument, the second instrument having a second insertion shaft with a second distal tip carrying the second anchor, the second anchor having a second tightenable loop of a suture structure coupled thereto; navigating 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; disposing the second anchor at the fourth position by withdrawing the second distal tip from the third and fourth positions, the withdrawing including disposing a spanning portion of the suture structure across the soft tissue, the spanning portion fixing and coupling a first adjustment mechanism of the first tightenable loop to a second adjustment mechanism of the second tightenable loop; positioning the spanning portion relative to the soft tissue; Applying tension to a first tail portion of a suture structure extending from a first adjustment mechanism, wherein applying tension comprises tightening a first loop and pulling the first adjustment mechanism toward a first anchor, and Applying tension to a second tail portion of a suture structure extending from a second adjustment mechanism, wherein applying tension comprises tightening a second loop and pulling the second adjustment mechanism toward a second anchor, and Pinching tightly by at least one of A method comprising

[0101] 35. The second anchor includes a third tightenable loop of a second suture structure coupled thereto, and the method comprises After disposing the second anchor at a fourth position, navigating a distal tip of an insertion shaft carrying a third anchor through soft tissue at a fifth position and inserting the third anchor into bone at a sixth position, wherein the third anchor has a fourth tightenable loop of a second suture structure coupled thereto, and Disposing the third anchor at the sixth position by withdrawing the distal tip from the fifth and sixth positions, wherein withdrawing includes traversing soft tissue to dispose a second spanning portion of the second suture structure, the second spanning portion fixing and coupling a third adjustment mechanism of the third tightenable loop to a fourth adjustment mechanism of the fourth tightenable loop, and The spanning portion, with respect to the soft tissue Applying tension to a third tail portion of a second suture structure extending from a third adjustment mechanism, wherein applying tension comprises tightening a third loop and pulling the third adjustment mechanism toward the second anchor, and Applying tension to a fourth tail portion of a second suture structure extending from a fourth adjustment mechanism, wherein applying tension comprises tightening a fourth loop and pulling the fourth adjustment mechanism toward the third anchor, and Pinching tightly by at least one of The method according to embodiment 34, further comprising

[0102] Those skilled in the art will understand further features and advantages of the present disclosure based on the above embodiments. Therefore, the present disclosure is not limited to the specifically shown and described content, except as indicated by the appended claims. All publications and references cited herein are hereby expressly incorporated by reference in their entirety.

[0103] 〔Embodiment〕 (1) A suture structure formed from a first flexible member, A first adjustment mechanism formed on the first flexible member to form a first loop extending from the first adjustment mechanism, the first loop defining a first loop opening, the first adjustment mechanism; A first tail portion of the first flexible member extending from the first adjustment mechanism; A spanning portion of the first flexible member extending from the first adjustment mechanism; A second adjustment mechanism formed on the first flexible member to form a second loop extending from the second adjustment mechanism, the second loop defining a second loop opening, the second adjustment mechanism; A 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; A second anchor slidably coupled to a second portion of the suture of the second loop; Comprising The first tail portion is configured to slide relative to the first adjustment mechanism to reduce the size of the first loop opening, thereby reducing a first distance between the first anchor and the first adjustment mechanism; The second tail portion is configured to slide relative to the second adjustment mechanism to reduce the size of the second loop opening, thereby reducing a second distance between the first anchor and the second adjustment mechanism; The spanning portion of the first flexible member is a suture structure that defines a fixed distance along the suture between the first adjustment mechanism and the second adjustment mechanism. (2) The suture structure according to embodiment 1, wherein at least one of the first adjustment mechanism or the second adjustment mechanism includes a self-locking knot. (3) The suture structure according to embodiment 1 or 2, wherein at least one of the first adjustment mechanism or the second adjustment mechanism has a finger trap configuration. (4) The first adjustment mechanism includes a first finger trap, and the first tail portion passes through the first finger trap. The second adjustment mechanism includes a second finger trap, and the second tail portion passes through the second finger trap. The suture structure according to embodiment 1, wherein the spanning portion is defined by a suture of a fixed length between the first finger trap and the second finger trap. (5) The suture structure according to embodiment 4, wherein each of the first finger trap and the second finger trap defines a length in a range of approximately 2 mm to approximately 10 mm along the first flexible member.

[0104] (6) The suture structure according to any one of embodiments 1 to 5, wherein the fixed length of the spanning portion is in a range of approximately 2 mm to approximately 10 mm. (7) The suture structure according to any one of embodiments 1 to 6, wherein at least one of the first anchor or the second anchor is a soft anchor constructed from a woven fabric material. (8) The suture structure according to any one of embodiments 1 to 7, wherein the first flexible member is a single continuous flexible member. (9) The suture structure according to any one of embodiments 1 to 8, further comprising a second flexible member, and the second flexible member extends through the first anchor such that the first anchor is also slidably disposed on the second flexible member. (10) The first flexible member and the second flexible member are the suture structure according to Embodiment 9, which extend through the same path passing through the first anchor.

[0105] (11) Further comprising a third flexible member, the third flexible member extends through the second anchor such that the second anchor is also slidably disposed on the third flexible member, the suture structure according to Embodiment 9 or 10. (12) The second flexible member is the flexible member of the loop of another suture structure according to Embodiment 1, the suture structure according to any one of Embodiments 9 to 11. (13) A method for preparing a surgical implant, Passing a first tail portion of the first flexible member through a first anchor, After passing the first tail portion through the first anchor, creating a first loop in the first flexible member by forming a first adjustment mechanism, such that the first anchor is slidably disposed on the first flexible member of the first loop, the first flexible member with the first tail portion and a first portion of the first flexible member extends from one side of the first adjustment mechanism, and the first loop extends from the opposite side of the first adjustment mechanism, Passing a second tail portion of the first flexible member through a second anchor, After passing the second tail portion through the second anchor, creating a second loop in the first flexible member by forming a second adjustment mechanism, such that the second anchor is slidably disposed on the first flexible member of the second loop, the first flexible member with the second tail portion and a second portion of the first flexible member extends from one side of the second adjustment mechanism, and the second loop extends from the opposite side of the second adjustment mechanism, comprising, Both the first portion of the first flexible member and the second portion of the first flexible member define a spanning portion of the first flexible member that defines a fixed length of the first flexible member between the first adjustment mechanism and the second adjustment mechanism. The tension on the first tail tightens the first loop and reduces the maximum distance between the first anchor and the spanning portion. The tension on the second tail tightens the first loop and reduces the maximum distance between the second anchor and the spanning portion. (14) The method according to embodiment 13, wherein at least one of the first adjustment mechanism or the second adjustment mechanism comprises a self-locking knot. (15) The method according to embodiment 13 or 14, wherein at least one of the first adjustment mechanism or the second adjustment mechanism comprises a finger trap configuration.

[0106] (16) The first adjustment mechanism comprises a first finger trap, and the first tail passes through the first finger trap. The second adjustment mechanism comprises a second finger trap, and the second tail passes through the second finger trap. The method according to any one of embodiments 13 to 15, wherein the spanning portion is defined by a fixed-length suture between the first finger trap and the second finger trap. (17) The method according to any one of embodiments 13 to 16, wherein the first flexible member is a single continuous flexible member. (18) The method according to any one of embodiments 13 to 17, further comprising passing a tail 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 embodiment 18, wherein the first flexible member and the second flexible member extend through the same path passing through the first anchor. (20) The method according to embodiment 18 or 19, further comprising passing the tail portion of the third suture filament through the second anchor such that the second anchor is also slidably disposed on the third suture filament.

[0107] (21) The method according to any one of embodiments 18 to 20, wherein the second suture filament is a suture filament of a loop of another suture structure according to embodiment 1. (22) A surgical instrument, A first insertion device, A first insertion machine shaft having a first distal tip configured to hold an anchor and implant it into tissue, A first handle disposed around a proximal end of the first insertion machine shaft, the first insertion device comprising: A second insertion device configured to couple with the first insertion device, the second insertion device comprising: A second insertion machine shaft having a second distal tip configured to hold an anchor and implant it into tissue, A second handle disposed around a proximal end of the second insertion machine shaft, the second handle having a bore therethrough and configured such that when the second insertion device is coupled with the first insertion device, the first insertion machine shaft is disposed therein, the second insertion device comprising: Comprising, The first handle is configured to removably couple to a distal end of the second handle, whereby the first handle can be pulled proximally from the second handle, thereby pulling the first insertion machine shaft proximally out of the bore of the second handle to separate the first insertion device from the second insertion device. The first distal tip of the first insertion machine shaft extends distally beyond the second distal tip of the second insertion machine shaft when the first insertion device and the second insertion device are coupled, a surgical instrument. (23) The proximal tip of the first insertion shaft extends proximally beyond the first handle, the surgical instrument according to embodiment 22. (24) The proximal tip of the second insertion shaft extends proximally beyond the second handle, the surgical instrument according to embodiment 22 or 23. (25) The first insertion shaft and the second insertion shaft are adjacent and substantially parallel along their respective lengths when the first instrument is coupled to the second instrument, the surgical instrument according to any one of embodiments 22 to 24.

[0108] (26) The first handle includes a latch configured to removably secure the coupling of the first handle to the second handle. The first handle includes a flexible portion, and the flexible portion controls the engagement of the latch with the second handle and enables a force applied by a user to the flexible portion to release the engagement of the latch with the second handle, the surgical instrument according to any one of embodiments 22 to 25. (27) The first handle has a first spindle configured to hold a length of suture extending from the first distal tip, the surgical instrument according to any one of embodiments 22 to 26. (28) The second handle has a second spindle configured to hold a length of suture extending from the second distal tip, the surgical instrument according to embodiment 27. (29) The second handle includes a recess configured to receive a length of suture extending from the first distal tip to the first spindle, the surgical instrument according to embodiment 28. (30) Further comprising a detachment sheath disposed around the first instrument shaft and the second instrument shaft and configured to extend from the second handle to the first distal tip, the proximal end of the detachment sheath defining a first section, the first section being removed from being disposed around the first instrument shaft and the second instrument shaft, and after being removed, being configured to allow proximal translational movement of the detachment sheath while still covering the second distal tip and exposing the first distal tip, the surgical instrument according to any one of embodiments 22-29.

[0109] (31) The detachment sheath Further comprising a second section, the second section being disposed distally of the first section and removed from being disposed around the first instrument shaft and the second instrument shaft, and after being removed, being configured to allow proximal translational movement of the detachment sheath and expose the second distal tip, the surgical instrument according to embodiment 30. (32) The first anchor is held by the first distal tip, the second anchor is held by the second distal tip, and the first tail and the second tail of the first flexible member are fixed to the second handle, and further comprising the suture structure according to embodiment 1 coupled to the surgical instrument, the surgical instrument according to any one of embodiments 22-31. (33) The first handle and the second handle, when coupled, define a continuous single handle of the surgical instrument, the surgical instrument according to any one of embodiments 22-32. (34) A method of fixing soft tissue to bone, the method comprising navigating the first distal tip of the first insertion shaft of the first instrument carrying the first anchor through soft tissue at a first position and inserting the first anchor into bone at a second position, the anchor having a first tightenable loop of a suture structure coupled thereto, Disposing the first anchor at the second position by withdrawing the first distal tip from the first position and the second position, wherein the withdrawing includes withdrawing the first insertion shaft proximally from a second handle of a second instrument, the second instrument having a second insertion shaft with a second distal tip carrying a second anchor, the second anchor having a second tightenable loop of the suture structure coupled thereto; Navigating the second distal tip of the second first insertion shaft through the soft tissue at a third position and inserting the anchor into bone at a fourth position; Disposing the second anchor at the fourth position by withdrawing the second distal tip from the third position and the fourth position, wherein the withdrawing includes disposing a spanning portion of the suture structure across the soft tissue, the spanning portion fixing and coupling a first adjustment mechanism of the first tightenable loop to a second adjustment mechanism of the second tightenable loop; The spanning portion relative to the soft tissue; Applying tension to a first tail of the suture structure extending from the first adjustment mechanism, wherein applying the tension tightens the first loop and pulls the first adjustment mechanism toward the first anchor; Applying tension to a second tail of the suture structure extending from the second adjustment mechanism, wherein applying the tension tightens the second loop and pulls the second adjustment mechanism toward the second anchor; Tensing by at least one of; A method comprising. (35) The second anchor includes a third tightenable loop of a second suture structure coupled thereto, and the method includes: After disposing the second anchor at the fourth position, navigate the distal tip of the insertion shaft carrying the third anchor through the soft tissue at a fifth position and insert the third anchor into bone at a sixth position, the third anchor having a fourth tightenable loop of the second suture structure coupled thereto, Disposing the third anchor at the sixth position by withdrawing the distal tip from the fifth and sixth positions, the withdrawing including disposing a second spanning portion of the second suture structure across the soft tissue, the second spanning portion fixing and coupling a third adjustment mechanism of the third tightenable loop to a fourth adjustment mechanism of the fourth tightenable loop, the spanning portion, with respect to the soft tissue, applying tension to a third tail of the second suture structure extending from the third adjustment mechanism, the applying of the tension tightening the third loop and pulling the third adjustment mechanism toward the second anchor, applying tension to a fourth tail of the second suture structure extending from the fourth adjustment mechanism, the applying of the tension tightening the fourth loop and pulling the fourth adjustment mechanism toward the third anchor, tightening by at least one of, The method of embodiment 34, further comprising.

Claims

1. A suture structure formed from a first flexible member, A first adjustment mechanism formed in the first flexible member and forming a first loop extending from the first adjustment mechanism, the first loop defining a first loop opening, a first adjustment mechanism; A first tail portion of the first flexible member extending from the first adjustment mechanism; A spanning portion of the first flexible member extending from the first adjustment mechanism; A second adjustment mechanism formed in the first flexible member and forming a second loop extending from the second adjustment mechanism, the second loop defining a second loop opening, a second adjustment mechanism; A 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; A second anchor slidably coupled to a second portion of the suture of the second loop; Comprising: The first tail portion is configured to slide relative to the first adjustment mechanism to reduce the size of the first loop opening, thereby reducing a first distance between the first anchor and the first adjustment mechanism; The second tail portion is configured to slide relative to the second adjustment mechanism to reduce the size of the second loop opening, thereby reducing a second distance between the first anchor and the second adjustment mechanism; The spanning portion of the first flexible member defines a fixed distance along the suture between the first adjustment mechanism and the second adjustment mechanism. Suture structure.

2. The suture structure 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 structure according to claim 1 or 2, wherein at least one of the first adjustment mechanism or the second adjustment mechanism comprises a finger trap configuration.

4. The first adjustment mechanism comprises a first finger trap, and the first tail portion passes through the first finger trap; The second adjustment mechanism comprises a second finger trap, and the second tail portion passes through the second finger trap; The suture structure according to claim 1, wherein the spanning portion is defined by a fixed length of suture between the first finger trap and the second finger trap.

5. The first finger trap and the second finger trap each define a length in the range of approximately 2 mm to approximately 10 mm along the first flexible member, the suture structure of claim 4.

6. The fixed length of the spanning portion is in the range of approximately 2 mm to approximately 10 mm, the suture structure of claim 1.

7. At least one of the first anchor or the second anchor is a soft anchor constructed from a woven fabric material, the suture structure of claim 1.

8. The first flexible member is a single continuous flexible member, the suture structure of claim 1.

9. Further comprising a second flexible member, the second flexible member extending through the first anchor such that the first anchor is also slidably disposed on the second flexible member, the suture structure of claim 1.

10. The first flexible member and the second flexible member extend through the same path passing through the first anchor, the suture structure of claim 9.

11. Further comprising a third flexible member, the third flexible member extending through the second anchor such that the second anchor is also slidably disposed on the third flexible member, the suture structure of claim 9.

12. The second flexible member is the flexible member of a loop of another suture structure of claim 1, the suture structure of claim 9.

13. A method for preparing a surgical implant, Passing a first tail portion of a first flexible member through a first anchor, After passing the first tail portion through the first anchor, creating a first loop in the first flexible member by forming a first adjustment mechanism, wherein the first flexible member with the first tail portion and a first portion of the first flexible member extends from one side of the first adjustment mechanism, and the first loop extends from the 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 a second tail portion of the first flexible member through a second anchor, After passing the second tail through the second anchor, by forming a second adjustment mechanism, creating a second loop within the first flexible member, such that the second anchor is slidably disposed on the first flexible member of the second loop, the first flexible member with the second tail and the second portion of the first flexible member extends from one side of the second adjustment mechanism, and the second loop extends from the opposite side of the second adjustment mechanism, and comprising both the first portion of the first flexible member and the second portion of the first flexible member define a spanning portion of the first flexible member that defines a fixed length of the first flexible member between the first adjustment mechanism and the second adjustment mechanism, the tension on the first tail tightens the first loop and reduces the maximum distance between the first anchor and the spanning portion, the tension on the second tail tightens the first loop and reduces the maximum distance between the second anchor and the spanning portion, a method.

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

15. The method according to claim 13 or 14, wherein at least one of the first adjustment mechanism or the second adjustment mechanism comprises a finger trap configuration.

16. The first adjustment mechanism comprises a first finger trap, and the first tail passes through the first finger trap, The second adjustment mechanism comprises a second finger trap, and the second tail passes through the second finger trap, The method according to claim 13, wherein the spanning portion is defined by a suture of a fixed length between the first finger trap and the second finger trap.

17. The method according to claim 13, wherein the first flexible member is a single continuous flexible member.

18. The method according to claim 13, further comprising passing a tail 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 passing through the first anchor.

20. The method according to claim 18, further comprising passing a tail portion of the 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 claim 18, wherein the second suture filament is a suture filament of a loop of another suture structure according to claim 1.

22. A surgical instrument, A first insertion device, A first insertion machine shaft having a first distal tip configured to hold an anchor and implant it into tissue, A first handle disposed around a proximal end of the first insertion machine shaft, the first insertion device comprising the first handle; A second insertion device configured to couple with the first insertion device, the second insertion device comprising: A second insertion machine shaft having a second distal tip configured to hold an anchor and implant it into tissue, A second handle disposed around a proximal end of the second insertion machine shaft, the second handle having a bore therethrough and being configured such that when the second insertion device is coupled with the first insertion device, the first insertion machine shaft is disposed therein, the second insertion device comprising the second handle; Comprising, The first handle is configured to removably couple to a distal end of the second handle, whereby the first insertion device can be separated from the second insertion device by pulling the first handle proximally from the second handle, thereby pulling the first insertion machine shaft proximally out of the bore of the second handle. The first distal tip of the first insertion machine shaft extends distally beyond the second distal tip of the second insertion machine shaft when the first insertion device and the second insertion device are coupled, a surgical instrument.

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

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

25. The surgical instrument according to claim 22, wherein the first insertion shaft and the second insertion shaft are adjacent and substantially parallel along their respective lengths when the first instrument is coupled to the second instrument.

26. The first handle includes a latch configured to removably secure the coupling of the first handle to the second handle. The surgical instrument according to claim 22, wherein the first handle includes a flexible portion that controls the engagement of the latch with the second handle and allows a force applied by a user to the flexible portion to release the engagement of the latch with the second handle.

27. The surgical instrument according to claim 22, wherein the first handle has a first spindle configured to hold a length of suture extending from the first distal tip.

28. The surgical instrument according to claim 27, wherein the second handle has a second spindle configured to hold a length of suture extending from the second distal tip.

29. The surgical instrument according to 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 spindle.

30. The surgical instrument according to claim 22, further comprising a release sheath disposed around the first instrument shaft and the second instrument shaft and configured to extend from the second handle to the first distal tip, wherein a proximal end of the release sheath defines a first section that is removed from being disposed around the first instrument shaft and the second instrument shaft, and after removal, is configured to allow proximal translation of the release sheath while still covering the second distal tip and exposing the first distal tip.

31. The release sheath further includes a second section disposed distal to the first section, the second section being removed from being disposed around the first instrument shaft and the second instrument shaft, and after removal, is configured to allow proximal translation of the release sheath and expose the second distal tip, the surgical instrument according to claim 30.

32. The surgical instrument according to claim 22, further comprising the suture structure according to claim 1, wherein the first anchor is held by the first distal tip, the second anchor is held by the second distal tip, and the first tail and the second tail of the first flexible member are fixed to the second handle and are coupled to the surgical instrument.

33. The surgical instrument according to claim 22, wherein the first handle and the second handle, when coupled, define a continuous single handle of the surgical instrument.

Images