阅读说明：本技术 固定构件、组件及相关系统和方法 (Fixation members, assemblies, and related systems and methods ) 是由 D·伽马奇 S·约翰逊 J·阿尔及利亚 D·斯潘奇尼尔 D·康奈利 R·泰斯 于 2019-12-04 设计创作，主要内容包括：本发明公开了一种用于固定在解剖结构内的缝合锚定件,该缝合锚定件包括在锚定件主体的第一位置处与锚定件主体接触的致动构件。锚定件主体沿伸长方向伸长并且限定中心轴线。在中性构型中,锚定件主体是平坦的,并且限定沿横向方向的厚度和沿侧向方向的宽度,该宽度大于该厚度。锚定件主体具有第一尾部和第二尾部,该第一尾部和第二尾部沿着致动构件的一部分从锚定件主体的第一位置到第二位置编织在一起。致动构件被构造成向编织锚定件主体施加力,以便以沿第二方向增加其最大厚度的方式致动锚定件主体,该第二方向与伸长方向成角度地偏移。(A suture anchor for fixation within an anatomical structure includes an actuating member in contact with an anchor body at a first location of the anchor body. The anchor body is elongated in an elongation direction and defines a central axis. In the neutral configuration, the anchor body is planar and defines a thickness in the transverse direction and a width in the lateral direction that is greater than the thickness. The anchor body has first and second tail portions braided together along a portion of the actuating member from a first position to a second position of the anchor body. The actuating member is configured to apply a force to the braided anchor body to actuate the anchor body in a manner that increases its maximum thickness in a second direction that is angularly offset from the direction of elongation.)

1. A suture anchor for fixation within an anatomical structure, the suture anchor comprising:

an anchor body elongated in an elongation direction, the anchor body defining a central axis, the anchor body having a planar geometry in a neutral configuration such that in the neutral configuration, the anchor body defines a thickness in a transverse direction and a width in a lateral direction, wherein the transverse direction is perpendicular to the central axis, the lateral direction is perpendicular to the transverse direction, and the width is greater than the thickness in the neutral configuration; and

an actuating member contacting the anchor body at a first location of the anchor body, the anchor body having first and second anchor body tails extending away from the first location, the first and second anchor body tails braided together along a portion of the actuating member from the first location of the anchor body to a second location spaced apart from the first location so as to define a braided suture anchor construct,

wherein the actuation member is configured to apply a force to the anchor body so as to actuate the anchor body from a first configuration in which the anchor body defines a first maximum thickness along a second direction angularly offset from the elongation direction to an expanded configuration in which the anchor body defines a second maximum thickness along the second direction, wherein the second maximum thickness is greater than the first maximum thickness.

2. The suture anchor of claim 1, wherein the first anchor body tail and the second anchor body tail contact each other at the second location such that the first location and the second location define a first end and a second end of the braided suture anchor construct, and the braided suture anchor construct defines a length extending in a longitudinal configuration direction between the first end and the second end.

3. The suture anchor of claim 2, wherein the actuation member comprises:

a first actuation member tail extending from the first position and away from the portion of the actuation member; and

a second actuation member tail extending from the second position and away from the portion of the actuation member.

4. The suture anchor of claim 3, wherein the actuation member penetrates at least one of the first anchor body tail and the second anchor body tail at the second location.

5. The suture anchor of claim 4, wherein a portion of the anchor body is folded so as to define a loop extending from the first position, the braided suture anchor construct being bent such that 1) the first and second actuation member tails each extend through the loop, and 2) the loop extends around at least one of the first and second ends of the braided suture anchor construct.

6. The suture anchor of claim 5, wherein the actuation member does not penetrate the anchor body at the first position.

7. The suture anchor of claim 4, wherein the actuation member penetrates the anchor body at the first location, one of the first anchor body tail portion and the second anchor body tail portion is cut adjacent the second location, the other of the first anchor body tail and the second anchor body tail extending from the second location and penetrating the anchor body at a third location adjacent the first location, the braided suture anchor construct is bent such that the second end of the braided suture anchor construct extends toward the first end, and the other of the first anchor body tail portion and the second anchor body tail portion defines a connecting member that connects the first end and the second end of the braided suture anchor construct together.

8. The suture anchor of claim 4, wherein:

the braided suture anchor construct is bent such that 1) the suture anchor defines a distal end at an apex of the bend, and 2) the first and second ends of the braided suture anchor construct extend substantially equidistant from the distal end along the elongation direction; and is

The suture anchor further includes a connecting member interconnecting the first end and the second end of the braided suture anchor construct with respect to a direction substantially perpendicular to the direction of elongation.

9. The suture anchor of claim 8, wherein the connecting member is a tape wrapped around the first and second ends of the braided suture anchor construct, and the tape penetrates at least one of the first anchor body tail and the second anchor body tail.

10. The suture anchor of claim 4, wherein the anchor body has adjoining first and second end portions that are clamped together at the first location, and the actuation member penetrates each of the adjoining first and second end portions at the first location.

11. The suture anchor of claim 4, wherein the anchor body is wrapped around the actuating member at the first location, and the first and second anchor body tails are braided in a double helix around the portion of the actuating member from the first location to the second location.

12. The suture anchor of claim 1, wherein the actuation member comprises a mandrel embedded therein and extending in the elongation direction, wherein the mandrel is configured to swell in the second direction in response to exposure to an aqueous environment.

13. The suture anchor of claim 1, wherein the anchor body is bunched as it transitions from the first configuration to the expanded configuration.

14. The suture anchor of claim 1, wherein the anchor body is configured to translate along the actuation member before and after transitioning from the first configuration to the expanded configuration.

15. The suture anchor of claim 1, wherein the first and second anchor body tails are braided with the portion of the actuation member into a three-strand alternating braid.

16. A system for anatomical fixation, comprising:

an insertion instrument having an elongated body portion elongated in an elongation direction, the insertion instrument including an anchor carrier at a distal portion of the elongated body portion; and

a suture anchor for fixation within a target location of an anatomical structure, the suture anchor configured to be carried by the anchor carrier, the suture anchor comprising:

an anchor body elongated along a central axis, wherein in a neutral configuration of the anchor body, the anchor body has a planar geometry defining a length, a thickness, and a width along the central axis, wherein in the neutral configuration, the length is greater than the width and the width is greater than the thickness; and

an actuating member contacting the anchor body at least at first and second locations of the anchor body, the anchor body having first and second anchor body tails extending away from the first location and braided together along a portion of the actuating member to the second location so as to define a braided suture anchor construct, wherein the first and second locations define first and second ends of the braided suture anchor construct,

wherein the actuation member is configured to apply a force to the anchor body so as to actuate the anchor body from a first configuration to an expanded configuration such that a maximum thickness of the anchor body increases in a second direction when the anchor body transitions from the first configuration to the expanded configuration, wherein the second direction is angularly offset from the elongation direction.

17. The system of claim 16, wherein:

the anchor carrier includes a fork structure having tines extending in a distal direction along the elongation direction;

in the first configuration, the suture anchor is at least partially disposed between the tines relative to a lateral instrument direction perpendicular to the elongation direction, wherein the braided suture anchor construction is bent such that:

the suture anchor defines a distal end at an apex of the bend, and

the braided suture anchor construct defines a first portion and a second portion extending substantially parallel to each other from the distal end in a proximal direction opposite the distal direction, wherein the actuation member has a first actuation member tail and a second actuation member tail extending in the proximal direction alongside the elongate body portion of the insertion instrument from the first and second positions of the anchor body, respectively.

18. The system of claim 17, wherein:

folding a portion of the anchor body so as to define a loop at the first location, the first and second actuating member tails each extending through the loop such that the loop extends around the first and second ends of the braided suture anchor construct at least when the anchor body is in the first configuration; and is

The anchor carrier extends through the collar, and the prong structure engages the distal end of the suture anchor.

19. The system of claim 17, wherein:

the actuation member penetrating the anchor body at the first location, one of the first and second anchor body tails being cut adjacent the second location, the other of the first and second anchor body tails extending from the second location and penetrating the anchor body at a third location adjacent the first location, such that the other of the first and second anchor body tails defines a connecting member connecting the first and second ends of the braided suture anchor construct together; and is

The anchor carrier extends alongside the connecting member, and the prong structure engages the distal end of the suture anchor.

20. The system of claim 17, wherein:

the suture anchor includes a connecting member wrapped around the first and second ends of the braided suture anchor construct relative to a direction substantially perpendicular to the direction of elongation in a manner interconnecting the first and second ends; and is

The anchor carrier extends through the wrapped connecting member and the prong structure engages the distal end of the suture anchor.

21. The system of claim 17, further comprising an instrument assembly including the insertion instrument and an outer tube defining a cannula sized to enable the elongate body portion of the insertion instrument carrying the suture anchor to translate through the cannula and to the target location of the anatomical structure.

22. The system of claim 16, further comprising an instrument assembly including the insertion instrument and an outer tube defining a cannula sized to enable the elongate body portion of the insertion instrument carrying the suture anchor to translate through the cannula and to the target location of the anatomical structure,

wherein the elongate body portion of the insertion instrument is tubular and defines a second cannula defining an inner diameter less than the first maximum thickness of the anchor body such that:

the suture anchor extends in a distal direction along the elongation direction from a distal end of the elongate body portion;

the distal end of the elongate body portion is configured to push the suture anchor through the first cannula and to the target location;

the actuation member has first and second actuation member tails extending from the first and second locations of the anchor body, respectively, and passing through the second cannula in a proximal direction opposite the distal direction.

Technical Field

The present invention relates generally to devices, systems, and methods for repairing and anchoring damaged tissue, and more particularly to devices, systems, and methods for anchoring sutures to tissue.

Background

Tissue (such as cartilage, skin, muscle, bone, tendons, and ligaments) is injured and often requires surgical intervention to repair the injury and promote healing. Surgical procedures to repair tissue damage are typically performed using sutures attached to one or more anchoring devices implanted in or adjacent to the damaged tissue. Sutures may also be passed through or around tissue to secure the prosthesis according to a variety of surgical techniques. The suture may also interconnect two or more anchors for performing the repair. Suture anchors have been manufactured with bodies formed from a variety of materials, including non-absorbable materials such as metals and durable polymers, and bioabsorbable materials such as absorbable polymers, bioceramics, absorbable composites, and treated bone. Anchors that are themselves composed entirely, or at least substantially, of suture material are referred to herein as "full suture anchors" or simply "suture anchors," and such anchors may be particularly advantageous in connection with certain types of tissue repair. For example, suture anchors have shown advantages over fixation within bone material because the relatively soft and pliable nature of woven suture material allows the suture anchor to generally fit within a smaller pre-drilled hole in bone relative to other types of bone anchors, thereby reducing the amount of bone that must be removed prior to insertion of the anchor.

In addition, the suture may be coupled through or around the suture anchor in a fixed or sliding manner (e.g., using eyelets or other passages in the anchor body), and may be secured using a fixed or sliding knot, interference between anchor components, interference between the anchor and the surrounding tissue, or other means. Some suture anchors are designed to slide a suture one-way through or around the anchor, thereby enabling tightening of the surgical repair by tensioning a portion of the suture relative to the anchor. In its many surgical applications, suture anchors are used with sutures to reattach damaged tendons or ligaments to bone, tighten damaged tissue around articulated joints, and repair tears in cartilage, such as torn meniscal cartilage in the knee. In some applications, two or more anchors engaged by an adjustable length suture enable a tear of tissue to be cinched closed or otherwise stabilize the damaged tissue.

It is very important in suture anchor design to maximize the holding strength, such as the holding strength of the anchor in bone, to minimize the risk of the anchor breaking or pulling out, such as from bone, when the attached suture is tensioned against the anchor. Some of the disadvantages of suture anchors, as the case may be, may include: because of the difficulty in deploying certain types of suture anchors, the fixation strength may be lower than other anchor types; and to effect expansion of the suture anchor in hard bone material, such as cortical bone. Other problems observed with suture anchors include relaxation (i.e., loosening) and creep over time, as well as long term micro-motion at the anchor interface. These problems can reduce the amount of compression applied to the repair. In addition, over time, gaps may be introduced into the repair, which is not optimal for healing.

Disclosure of Invention

In one embodiment of the present disclosure, a suture anchor for fixation within an anatomical structure includes an actuating member in contact with an anchor body at a first location of the anchor body. The anchor body is elongated in an elongation direction and defines a central axis. In the neutral configuration, the anchor body is planar and defines a thickness in the transverse direction and a width in the lateral direction that is greater than the thickness. The anchor body has first and second tail portions braided together along a portion of the actuating member from a first position to a second position of the anchor body. The actuating member is configured to apply a force to the braided anchor body to actuate the anchor body in a manner that increases its maximum thickness in a second direction that is angularly offset from the direction of elongation.

In another embodiment of the present disclosure, a system for anatomical fixation includes an insertion instrument having an elongated body portion elongated in an elongation direction. The insertion instrument includes an anchor carrier at a distal portion of the elongate body portion and a suture anchor configured to be carried by the anchor carrier. The suture anchor is configured for fixation within a target location of an anatomical structure. The suture anchor includes an actuating member in contact with the anchor body at a first location thereof. The anchor body is elongated in an elongation direction and defines a central axis. In the neutral configuration, the anchor body is planar and defines a thickness in the transverse direction and a width in the lateral direction that is greater than the thickness. The anchor body has first and second tail portions braided together along a portion of the actuating member from a first position to a second position of the anchor body. The actuating member is configured to apply a force to the braided anchor body to actuate the anchor body in a manner that increases its maximum thickness in a second direction that is angularly offset from the direction of elongation.

In another embodiment of the present disclosure, a suture anchor includes an anchor for fixation within an anatomical structure, the anchor including an anchor body that elongates in an elongation direction and is configured to swell in a direction transverse to the elongation direction in response to exposure to an aqueous environment. The anchor further includes an actuating member configured to apply tension to the anchor body to actuate the anchor body from the first configuration to the expanded configuration. In the first configuration, the anchor body defines a first maximum thickness along a second direction that is angularly offset from the direction of elongation. In the expanded configuration, the anchor body defines a second maximum thickness along the second direction, wherein the second maximum thickness is greater than the first maximum thickness.

In another embodiment of the present disclosure, a suture anchor includes an anchor for fixation within an anatomical structure. The suture anchor includes an expandable anchor body configured to be actuated from a first configuration in which the anchor body is elongated in a longitudinal direction and defines a first maximum thickness in a second direction angularly offset from the longitudinal direction to an expanded configuration in which the expandable portion defines a second maximum thickness in the second direction, the second maximum thickness being greater than the first maximum thickness. The suture anchor also includes an actuation member configured to apply tension to the anchor body to actuate the anchor body from the first configuration to the expanded configuration. The actuation member is elongated along a second longitudinal direction and is capable of swelling along a direction transverse to the second longitudinal direction in response to exposure to an aqueous environment.

In yet another embodiment of the present disclosure, an anchor for fixation within an anatomical structure includes an anchor body that is elongated in a longitudinal anchor direction and defines a total thickness in a transverse anchor direction perpendicular to the longitudinal anchor direction. The anchor body is configured to swell in a transverse anchor direction so as to increase the overall thickness in response to exposure to an aqueous environment. The anchor also includes a suture attached to the anchor body. The suture defines a longitudinal suture direction and is configured to contract along the longitudinal suture direction in response to exposure to an aqueous environment. The suture is further configured to transition the anchor body from the first configuration to the second configuration in response to tension applied to the suture such that the transition increases the overall thickness in the transverse anchor direction.

In another embodiment of the invention, a method of preparing an anchor for fixation within an anatomical structure includes braiding a plurality of fibers and at least one mandrel together to form a braided construct that is elongated in a longitudinal direction. The at least one axial core is configured to contract in a longitudinal direction and swell in a direction transverse to the longitudinal direction in response to exposure to an aqueous environment.

In another embodiment of the invention, the fixation element includes a body that is elongated along a central axis and defines a plurality of elongated cores. Each of the elongate cores defines a central core axis extending parallel to the central axis. The weave fibers extend between each adjacent core. Further, each of the cores is configured to contract in a direction in which its central core axis is oriented in response to a water-containing environment. The body connects the first anatomical structure to the second anatomical structure so as to reduce a distance between the first anatomical structure and the second anatomical structure.

In further embodiments of the present disclosure, a method of repairing an anatomical structure comprises deploying any of the anchors and/or fixation elements described herein.

Drawings

The foregoing summary, as well as the following detailed description of exemplary embodiments of the suture anchor constructions of the present application, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the suture anchor constructions of the present application, the drawings show illustrative embodiments. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown. In the drawings:

fig. 1A is a perspective view of a fixation kit including at least one suture anchor and an insertion instrument for positioning the anchor at a target location of an anatomical structure, according to an embodiment of the present disclosure;

FIG. 1B is an enlarged perspective view of the suture anchor at the distal end of the insertion instrument shown in FIG. 1A;

FIG. 1C is a side elevational view of the forked distal tip of the insertion instrument illustrated in FIG. 1A;

FIG. 1D is a front elevational view of the forked distal tip of the insertion instrument illustrated in FIG. 1A;

fig. 1E is a side elevation view of the anchor deployed within an anatomical structure, showing the anchor in a first configuration;

FIG. 1F is a side elevational view of the anchor deployed within the anatomy and actuated into an expanded configuration by an actuating member;

FIG. 1G is a side elevation view of the anchor deployed within an anatomical structure and swollen into a further expanded configuration;

FIG. 2A is a top plan view of an anchor body configured as a two-dimensional textile structure;

FIG. 2B is an end view of the anchor body of FIG. 2A;

fig. 2C is an enlarged plan view of a portion of an anchor body according to an embodiment of the present disclosure;

FIG. 2D is a cross-sectional view of the anchor body taken along section line 2D-2D shown in FIG. 2C;

FIG. 2E is an enlarged cross-sectional view of the axial core of the anchor body taken along section line 2C-2C shown in FIG. 2B;

fig. 2F is a system diagram of an apparatus for constructing an anchor body constructed in accordance with the embodiment shown in fig. 1A-2B and 1E-7; and is

Fig. 2G is a plan view of a braid pattern that may be used to construct an anchor body according to yet another embodiment of the present disclosure;

FIGS. 3A-3E illustrate method steps for forming the anchor shown in FIG. 1B;

fig. 4A-4J illustrate method steps for forming a suture anchor according to another embodiment of the present disclosure;

FIG. 4K is a side elevational view of the anchor loaded onto the insertion instrument, as constructed in accordance with the steps shown in FIGS. 4A-4J;

fig. 4L-4M are opposite side elevational views of the anchor shown in fig. 4K with straps interconnecting folded ends of the anchor, according to embodiments of the present disclosure;

fig. 4N is a front elevational view of an intermediate step of constructing an anchor having a connecting member for interconnecting the ends of the anchor, according to another embodiment of the present disclosure;

FIG. 4O is a side elevational view of the anchor of FIG. 4M loaded onto the insertion instrument;

fig. 5A-5K illustrate method steps for forming a suture anchor defining a proximal loop interconnecting folded ends of the anchor, according to another embodiment of the present disclosure;

FIGS. 5L-5M are opposite side elevational views of the anchor of FIG. 5K loaded onto an insertion instrument;

fig. 6A is a plan view of a suture anchor similar to that shown in fig. 4K, but having an alternative first end configuration, according to another embodiment of the present disclosure;

FIG. 6B is an enlarged plan view of the first end of the suture anchor shown in FIG. 6A;

fig. 7A-7E illustrate method steps for forming a suture anchor having an anchor body helically wrapped around an actuating member, according to another embodiment of the present disclosure;

FIG. 7F is a side elevational view of the suture anchor of FIG. 7E loaded onto an insertion instrument;

fig. 8A-8C are plan views of suture anchors having a splicing configuration according to another embodiment of the present disclosure;

fig. 9 is a plan view of a suture anchor including two anchor bodies coupled together according to yet another embodiment of the present disclosure;

fig. 10A is a plan view of a suture anchor including a bifurcated anchor body according to another embodiment of the present disclosure;

fig. 10B is a plan view of a suture anchor including a bifurcated and spliced anchor body according to yet another embodiment of the present disclosure;

FIG. 11 is a plan view of a suture anchor including a pair of anchor bodies according to additional embodiments of the present disclosure;

FIG. 12A is a perspective view of an insertion instrument for positioning a suture anchor at a target location of an anatomical structure according to another embodiment of the present disclosure;

FIG. 12B is an enlarged perspective view of the distal tip of the insertion instrument of FIG. 12A;

FIG. 12C is an enlarged perspective view of the fork structure of the distal tip shown in FIG. 12B;

12D-12E are cross-sectional end views of the distal tip taken along section lines 12D-12D and 12E-12E, respectively, shown in FIG. 12A;

FIG. 12F is a perspective view of the proximal end of the insertion instrument of FIG. 12A;

FIG. 12G is a partially exploded perspective view of an instrument assembly including the insertion instrument and guide member shown in FIG. 12A, according to an embodiment of the present disclosure;

FIG. 12H is a cross-sectional side view of the instrument assembly shown in FIG. 12G in a fully seated configuration;

FIG. 12I is an enlarged cross-sectional side view of the distal portion of the instrument assembly of FIG. 12H;

fig. 12J is an enlarged perspective view of the distal end of the guide member shown in fig. 12G;

FIG. 12K is an enlarged cross-sectional side view of the proximal portion of the instrument assembly illustrated in FIG. 12H;

12L-12P illustrate method steps for deploying an anchor within a target site using the instrument assembly shown in FIGS. 12G-12K; and is

Fig. 13A-13B illustrate plan views of an insertion instrument assembly for positioning a suture anchor at a target location of an anatomical structure according to another embodiment of the present disclosure.

Detailed Description

The present disclosure relates to sutures having a configuration that is insertable into an anatomical structure (such as a pre-drilled hole in a bone) in a first configuration, and thereafter expandable according to one or more expansion modes that provide increased anchor fixation strength. In addition, the suture anchors described below may reduce slack in the suture-based anatomical repair and even reduce gaps, if any, resulting in a more stable healing environment. Further, the suture anchors described below are configured to avoid, mitigate, and even actively reduce loss of compression on the prosthesis, thereby increasing the chances of healing occurring.

Referring now to fig. 1A-1G, a fixation kit 100 may include at least one suture anchor 10 configured to meet the foregoing objectives and loaded onto an insertion instrument 102 configured to inject the anchor 10 into an anatomical structure 1. The suture anchor 10 can include an anchor body 50 and an actuating member 20. It will be appreciated from the description below that the anchor body 50 can be configured to iterate from a first or initial configuration to an expanded configuration. The actuating member 20 can apply an actuating force to the anchor body 50 to expand the anchor body 50 from the first configuration to the expanded configuration. Accordingly, actuation member 20 may also be referred to as a "surgical suture. Further, one or both of the actuating member 20 and the anchor body 50 can swell in response to exposure to an aqueous environment, as described in more detail below.

The insertion instrument 102 may comprise a proximal end 104 and a distal end 106 spaced apart from each other along a longitudinal instrument direction L defining an insertion direction X of the anchor 10. The distal end 106 is spaced apart from the proximal end 104 in the longitudinal instrument direction L in the distal direction D. In one example, the insertion direction X may be defined by the distal direction D. The proximal end 104 is spaced from the distal end 106 in the proximal direction P along the longitudinal instrument direction L and opposite the distal direction D. It should be understood that the longitudinal instrument direction L is bidirectional, wherein the distal direction D and the proximal direction P are each a unidirectional component of the longitudinal instrument direction L.

The instrument 102 defines an elongated body portion 114 elongated in a longitudinal instrument direction L and a distal tip 108 extending from the body portion 114. The distal tip 108 may define the distal end 106 of the insertion instrument 102. The instrument 102 can be configured to carry the anchor 10 during insertion into the anatomical site. For example, the distal tip 108 can be configured to carry the anchor body 50 of the anchor 10 when the anchor body 50 is in the initial or first configuration. Thus, the distal tip 108 may be referred to as an "anchor carrier" and may be characterized as being located at a distal portion of the body portion 114.

In one example, the distal tip 108 can define a fork structure 110 that includes a pair of tines 112 extending from a body portion 114 in a distal direction D. Tines 112 can define respective inner surfaces 113 that generally face each other and splay away from each other as the tines extend in distal direction D. The distal tip 108 is configured to receive at least a portion of the anchor 10 between the tines 112 and, in particular, between the inner surfaces 113. Thus, the tines 112 can be disposed on either side of the anchor 10 when the distal tip 108 supports the anchor 10. Thus, the instrument 102 can be configured to maintain the position of the anchor 10 relative to the distal tip 108 during insertion. The tines 112 can define respective outer surfaces that are opposite the inner surfaces and that are aligned with respective outer surfaces of the body portion 114 of the instrument 102. During operation, the anchor body 50 can be supported by the distal tip 108, and the distal tip 108 can be inserted into a target location of the anatomical structure 1 in order to drive the anchor body 50 to the target location. The target location may be defined by a hole extending into the anatomical structure 1. As will be understood below, the actuating member 20 can be attached to the anchor body 50 such that a portion of the actuating member 20 can also be supported by the distal tip 108 and driven into the target position. It should be understood that the instrument 102 has been described according to one example, and that other instrument distal tip structures and geometries are within the scope of the present disclosure.

The insertion instrument 102 may include a handle 116 extending from the elongate body portion 114 in the proximal direction P. The handle 116 may define the proximal end 104 of the insertion instrument 102. Thus, the elongated body portion 114 may extend between the distal tip 108 and the handle 116. The insertion instrument 102 may also include at least one channel 118 extending into the handle 116 and extending through the handle 116 in the longitudinal instrument direction L. In one example, the insertion instrument 102 can include a pair of channels 118 opposite one another. For example, the channels 118 can be opposite one another along the transverse instrument direction T, and the tines 112 can be opposite one another along a lateral instrument direction a that is angularly offset relative to the transverse instrument direction T. In one example, the lateral instrument direction a and the transverse instrument direction T may be perpendicular to each other. Further, the lateral instrument direction a and the transverse instrument direction T may each be perpendicular to the longitudinal instrument direction L. The elongated body portion 114 may define planar surfaces that oppose each other along the transverse instrument direction T. The planar surfaces may extend along respective planes defined by the longitudinal instrument direction L and the lateral instrument direction a.

The at least one channel 118 can be configured to receive the actuating member 20 of the anchor 10 when the anchor 10 is driven into a target position of the anatomical structure 1 during an anchor insertion procedure. The handle 116 may be configured to receive an insertion force, such as an impacting force (e.g., from a mallet), that drives the distal tip 108, and thus the anchor 10, into the anatomy.

As shown in fig. 1B, the anchor body 50 can be elongated in an elongation direction D1. The elongation direction D1 may coincide with the insertion direction X when the anchor body 50 is in the first configuration. The actuating member 20 can be connected to the anchor body 50 when the anchor body 50 is in the first configuration. In embodiments of the present disclosure, both the anchor body 50 and the actuating member 20 can be made of suture material. The suture material of anchor body 50 can be the same as the suture material of actuating member 20. Alternatively, the anchor body and the actuating member 20 can be made of different suture materials. In one example, the suture material may be a woven suture material. The actuating member 20 may also be referred to as an "engaging" element because it is configured to directly or indirectly connect or engage the anchor body 50 (and thus the anatomical structure 1 to which the anchor body 50 is anchored) to another anchoring device. By way of non-limiting example, the anchoring device may be another suture anchor or any suitable alternative structure (not necessarily a suture anchor) and/or another anatomical structure 1, such as cartilage, muscle, bone, tendon and/or ligament. The actuation member 20 defines a central longitudinal axis 25 extending in a respective longitudinal suture direction LS of the actuation member 20. It should be understood that the longitudinal axis 25 of the actuation member 20 and the longitudinal suture direction LS need not be straight and both will be determined by the current path along which the actuation member 20 extends. The suture material configuration of the anchor body 50 can allow the anchor body 50 to fold or otherwise bend (such as in a U-shape or V-shape) over the distal tip 108 of the insertion instrument 102, which facilitates insertion of the anchor body 50 into a small bore hole in a target location of the anatomical structure 1, and also helps to maintain the shape of the anchor body 50 during insertion. In such embodiments, the folded or otherwise curved suture anchor 10 defines a distal end 15 at the apex of the curve or fold and a proximal end 17 spaced from the distal end 15 in the proximal direction P. In one example, the bore may have a diameter in the range of about 2.0mm (about 0.079 inches) or less. In further embodiments, the bore may have a diameter in the range of less than 1.0mm (less than about 0.039 inches) to about 5.0mm (about 0.236 inches).

As described above, at least a portion of the anchor 10 (such as one or both of the actuating member 20 and the anchor body 50) can be configured to swell when exposed to an aqueous environment (such as occurs in vivo). For example, one or both of the actuating member 20 and the anchor body 50 can include at least one axially extending resilient core that swells when exposed to an aqueous environment. It should be understood that the actuating member 20 may be DYNACORD available from DePuy Synthesis Mitek Sports Medicine, Raynham, MA^TMOr DynaTape. Further, the actuating member 20 may be constructed in accordance with any of the embodiments more fully described in U.S. patent 8,8701,915 issued 10-28 2014 in the name of Mayer et al, the entire disclosure of which is incorporated herein by reference. Thus, the actuating member 20 preferably comprises a mandrel that dissolves radially (i.e., in a radial direction perpendicular to its central axis) in response to exposure to an aqueous environmentExpands and contracts axially (i.e., in a direction oriented along its central axis). Radial swelling and axial contraction of the mandrel causes the anchor body itself to radially swell and axially contract in a similar manner. Thus, the actuation member 20 can be configured to avoid or reduce slack in the system, and if formed by gaps in the anatomy to which the actuation member 20 is connected, such gaps can be "pulled", thereby creating a more stable healing environment. In addition, the swellability of the anchor body 50 (and thus of the actuating member 20) increases the overall radial expansion of the device. Thus, the swellability of the anchor body 50 may result in additional fixation of the anchor body 50 in the target location of the anatomical structure. In addition, the inclusion of certain substances, such as tricalcium phosphate (TCP), within the core of the actuating member 20 and/or anchor body 50 also promotes bone ingrowth of the anchor body, which will increase fixation strength and reduce the likelihood of micromotion. Thus, it can be seen that the suture anchor 10 of the present disclosure is capable of being secured within bone in a variety of modes.

In other embodiments, the actuation member 20 may be at least partially absorbed within an aqueous environment, such as within a patient. In such embodiments, the actuation member 20 may be an orthiocrorod having a Polydioxanone (PDS) core^TMBrand suture and/or PERMACORD^TMBrand sutures, both available from DePuy Synthesis Mitek Sports Medicine.

Referring now to fig. 1E-1G, the anchor 10 may be inserted into a target location of the anatomical structure 1, which may be configured as a pre-formed hole (by way of non-limiting example, the hole having been drilled or cut) within the anatomical structure 1, by driving or otherwise advancing the distal tip 108 of the insertion instrument 102 (with the anchor 10 loaded thereon) into the anatomical structure 1. In other embodiments, the anchor 10 can be loaded onto and/or into an insertion instrument capable of piercing the anatomical structure 1 to a target location while loading the anchor 10. Once the anchor body 50 is inserted into the target location of the anatomical structure 1 at the desired depth, the insertion instrument 102 can be withdrawn. In one example, the insertion instrument 102 can be withdrawn without the need for additional members, such as push rods or the like, to push against the anchor body 50 as the instrument is withdrawn. In particular, the anchor body 50 can be sized against the anatomical structure 1 such that when the instrument 102 is withdrawn, frictional holding forces between the anchor body 50 and the anatomical structure 1 hold the anchor body 50 in the target position. It should be understood that in other embodiments, insertion instrument 102 can be configured to extend within the guide member in order to advance anchor 10 through the guide member to a target location of anatomical structure 1. Alternatively or additionally, it should be understood that the pusher member may be supported against the anchor body 50 when the instrument 102 is withdrawn. The anchor body 50 is configured such that once it is deployed into the anatomical structure 1, the anchor body 50 can be expanded within the anatomical structure 1. In particular, the anchor body 50 can be expandable according to a plurality of expansion modes, including at least a first expansion mode and a second expansion mode. For example, the first expansion mode may be defined by iteration from the first configuration to the expanded configuration. The second expansion mode may be defined by swelling of the anchor body 50 in response to exposure to an aqueous environment.

Referring now to fig. 1E and 1F, actuating member 20 is configured to apply an actuating force, particularly a tensile force FT, to anchor body 50 sufficient to actuate anchor body 50 in the first expanded mode from the first configuration C1 (fig. 1E) to the expanded configuration C2 (fig. 1F). In particular, in the first configuration C1, the anchor body 50 defines a first maximum thickness T1 along a respective second direction D2 that is angularly offset relative to a respective elongation direction D1 of the anchor body 50. When the anchor body 50 is in the expanded configuration C2, the anchor body 50 defines a second maximum thickness T2 in the second direction D2, and the second maximum thickness T2 is greater than the first maximum thickness T1. It should be understood that first maximum thickness T1 and second maximum thickness T2 each refer to the overall thickness of anchor body 50 relative to the respective second direction D2 and are not limited to thicknesses measured between two opposing points on anchor body 50 that intersect a single linear axis oriented along second direction D2. For example, the locations of the anchor body 50 defining the maximum thickness may be spaced apart from one another along the elongation direction D1 of the anchor body 50. It should be appreciated that the first expansion mode may occur in response to application of a tension force FT, for example, from the actuation member 20.

In the first expansion mode, the various regions of the anchor body 50 may be "bunched together" (this action may also be referred to as "bunching") in order to achieve the second maximum thickness T2. The first expansion mode may also be referred to as the "primary" expansion mode, as it provides primary fixation of the anchor body 50 in the target location of the anatomical structure 1. It should be understood that as used herein, the terms "gather", "gathering", "bunching", "gathering together", and derivatives thereof refer to the action of causing at least a portion of anchor body 50 to overlap itself in a second direction D2 that is angularly offset from elongation direction D1.

Referring now to fig. 1F and 1G, one or both of the actuating member 20 and anchor body 50 can be configured to swell in a manner that causes the anchor 10 to transition from the expanded configuration C2 (fig. 1F) to the additional expanded configuration C3 (fig. 1G). The additional expanded position may also be referred to as a second expanded configuration C3 in a second direction D2. The anchor 10 can be configured to swell to the second expanded configuration C3 in response to exposure of one or both of the actuating member 20 and the anchor body 50 to an aqueous environment (such as an in vivo environment). In a further expanded configuration C3, the anchor body 50 defines a third maximum thickness T3 measured along the second direction D2, wherein the third maximum thickness T3 is greater than the second maximum thickness T2. Furthermore, the inventors have observed that when anchor 10 swells from the expanded configuration C2 to the further expanded configuration C3, actuating member 20 and/or anchor body 50 of the present disclosure expand outwardly in substantially all directions extending from the geometric center of anchor body 50. It will be appreciated that the second expansion mode occurs more gradually and over a longer period of time than the first expansion mode, and thus may provide a secondary fixation of the anchor 10 in the target position of the anatomical structure 1.

Referring now to fig. 2A and 2B, the anchor body 50 comprises a suture material, particularly a woven suture material. The anchor body 50 can be configured to define a substantially flat ribbon-like geometry. In such embodiments, the anchor body 50 can be fabricated from a flat braid, such as a flat suture braid, that allows the anchor body 50 to be substantially flat when in a neutral configuration, and also allows the anchor body 50 to come together, such as to come together in a spherical configuration, when a tension force FT is applied by the actuation member 20. The anchor body 50 can define a length L1 measured along a longitudinal anchor direction LA that is oriented along the central axis 55 of the anchor body 50. The anchor body 50 can further define a thickness t measured along a transverse anchor direction TA, and a width W measured along a lateral anchor direction AA, wherein the longitudinal anchor direction LA, the transverse anchor direction TA, and the lateral anchor direction AA are perpendicular to one another. When the anchor body 50 is in the neutral configuration, the length L1 is preferably greater than the width W, and the width W is preferably greater than the thickness t. For example, the width W may be several times the thickness t when in a neutral configuration. In such embodiments, the anchor body 50 can be characterized as having a flat, substantially planar structure that can be folded or otherwise manipulated as desired to form a three-dimensional anchor construct alone or in combination with the actuating member 20. Anchor body 50 (which may also be referred to as strap 65) includes a first end 51 and a second end 52 spaced apart from each other so as to define a length L1, which length L1 may be in the range of about 5.0mm to about 100.0 mm. The anchor body 50 also extends from first and second lateral edges 53, 54 spaced apart from one another so as to define a width W. The strip 65 also has a first side 57 and a second side 58 (which in this embodiment are substantially flat when the strip 65 is in a neutral configuration) spaced from each other along the transverse anchor direction TA so as to define a thickness t.

It should be understood that the central axis 55 and the longitudinal anchor direction LA need not be straight, and both are determined by the current path along which the anchor body 50 extends. When the anchor body 50 is folded or otherwise manipulated into a non-neutral configuration (e.g., resulting in the central axis 55 and the longitudinal anchor direction LA being non-straight), the anchor body 50 may define an overall thickness (e.g., T1-T3) that is greater than the thickness T. Further, as described above, the anchor body 50 is also configured to transition (such as by actuation via the actuation member 20) from the first configuration C1 to expand in response to tension applied to the actuation member 20Configuration C2, which increases the overall thickness of the anchor body 50 in the transverse anchor direction TA. It will be appreciated that the configuration of the strip 65 provides significant advantages in relation to the manufacturability of the anchor. For example, the flat geometry allows for easier suturing or splicing of the actuation member 20 by the strip 65. The tape 65 may be a flexible flat braid suture material comprising ultra-high molecular weight polyethylene (UHMWPE) flat braid (such as 100% UHMWPE flat braid, such as PERMATAPE available from DePuy Synthesis Mitek Sports Medicine^TM) Or another flexible material in the form of a strip.

Referring now to fig. 2C-2G, an embodiment of the anchor body 50 will be described wherein the anchor body 50 is further configured to swell in an aqueous environment. In such embodiments, the anchor body 50 can swell in the transverse anchor direction TA. When anchor body 50 is configured to swell strip 65, strip 65 may be a woven, knitted, or braided structure that surrounds and encapsulates the material that provides the swelling function. For example, as shown in fig. 2B-2D, swellable strips 65 may include at least one core structure 80 extending parallel to central axis 55. Each core structure 80 defines a central core axis 82 that may extend substantially parallel to the central axis 55 of the swellable strip 65. Thus, the at least one core structure 80 may be referred to as an "axial core" 80 or simply as a "core" 80.

As shown in fig. 2E, the at least one core 80 may be configured to swell in a radial direction R perpendicular to its core axis 82 in response to exposure of the at least one core 80 to an aqueous environment. The core 80 preferably includes a thin elastomeric polymer thread 84 in combination with one or more osmotically active substances (i.e., water-absorbing substances) that causes the core 80 to swell. The polymeric threads 84 may be a filamentary polymeric material (of the type that is non-degradable, partially degradable, or fully degradable). For example, the polymer filaments 84 may be constructed as thermoplastic elastomers (polyurethane, polyester), cross-linked elastomers (silicone, polyurethane, elastin, collagen) or gels (polyethylene glycol, alginate, chitosan). The osmotically active component may include one or both of salt (NaCl) and tricalcium phosphate (TCP, which also advantageously promotes bone ingrowth in the core), although other osmotic materials may also be employed, such as other biocompatible inorganic salts and aqueous solutions thereof, calcium chloride, calcium carbonate, or organic osmotically active molecules, e.g., low molecular weight polysaccharides such as dextran, may be used. In one example, the core 80 includes a thin line of silicone bonded with fine salt crystals 86 and TCP. The amount of salt and TCP contained within the core 80 may range from about 2 wt% to about 40 wt%. It should be understood that the polymer strands 84 may be extruded from the melt or from solution, and the salt (NaCl) particles are preferably co-extruded or mixed into the polymer mass prior to extrusion. It should be understood that by way of non-limiting example, the core 80 may be formed by other methods such as molding.

It will be appreciated that the osmotically active substance may also or alternatively be embedded in a biocompatible gel or hydrogel (e.g., from alginate, chitosan or copolymers thereof, polyacrylate, polyethylene glycol, etc.). The effect which in principle is comparable to that of osmotically active substances can also be achieved by using hydrogels alone. According to Fick's law, it is particularly important to attach to the membrane surrounding the swelling system, by virtue of its pair H₂The permeation and diffusion properties of O and also by virtue of its thickness severely influence the permeation kinetics. Of course, the membrane may be composed of several layers, or may also have a stable or soluble diffusion-inhibiting layer. If hydrogels are used, such film-like properties can also be achieved by means of a significantly increased crosslinking density towards the outside. A concentration difference affecting permeability is achieved between the wire core and the patient's peripheral blood or interstitial and/or intracellular fluid. It should be understood that in embodiments employing hydrogels in the manner described above, such hydrogel film structures may also be referred to as mandrels 80.

It should be understood that swellable strips 65 may comprise a single core 80, or, as shown in fig. 2C and 2D, more than one core 80, such as two, three, four, five, six, seven, eight, or more than eight axial cores 80. In embodiments in which swellable strips 65 include a single core 80, core 80 preferably extends along central axis 55 or at least along a winding pattern that intersects central axis 55 at one or more locations. In other single core embodiments, the core 80 may be offset from the central axis 55 and may extend parallel to the central axis 55. In embodiments in which swellable strips 65 include more than one core 80, at least a first core 80 and a second core 80 may extend alongside lateral edges 53, 54 of swellable strips 65 so as to be remote from central axis 55. Alternatively, one of the cores 80 in a multiple core 80 embodiment (or the core 80 of a single core 80 embodiment) may extend along the central longitudinal axis 55. As shown in fig. 2D, each core 80 may have a circular cross-sectional shape in a plane orthogonal to the core axis 82, but by way of non-limiting example, other cross-sectional shapes are also within the scope of the present disclosure, such as non-circular, oval, square, rectangular, or irregular shapes. In embodiments involving cores 80 having circular cross-sectional shapes, each such core 80 preferably has an initial (i.e., neutral or non-swelling) diameter D4, which is preferably in the range of about 0.004 inch (about 0.102mm) to about 0.040 inch (about 1.016 mm). In addition, each core 80 (regardless of shape) has a durometer (i.e., hardness) preferably in the range of about 20A to about 90A.

As shown in fig. 2C and 2D, the swellable strip 65 is constructed by weaving, knitting or braiding one or more cores 80 with a plurality of fibers 90. These fibers 90 may have a material composition including, for example, polyethylene terephthalate (PET), ultra-high molecular weight polyethylene (UHMWPE), Polydioxanone (PDS), polypropylene (PP), and nylon, and may be monofilament fibers or multifilament fibers, and may be employed with or without a colorant as desired. Swellable strips 65 may be constructed by a knitting mechanism such as "flat knitting machine" 300 schematically depicted in fig. 2F. The swellable strips 65 are preferably configured such that the first plurality of fibers 90a are woven in a manner so as to surround the cores 80 with the woven fibers 90a (or individually around each core 80 in a multi-core embodiment), as shown in FIG. 2D. In this manner, the first plurality of fibers 90a may effectively define a sheath or skin around each of the one or more cores 80, as shown in fig. 2D-2E. The first plurality of fibers 90a is preferably pre-braided around each of the one or more cores 80. Subsequently, referring to fig. 2F, one or more of the cores 80 with their pre-braided sheaths 90a may be advanced as one or more corresponding "axial" threads through the carrier frame 302 (such as through corresponding tubes or channels 304 in the frame 302) and toward the convergence zone 306 of the braiding mechanism 300. The carrier frame 302 is configured to support a plurality of carriers 308, such as horn gears, that collectively define a spool passage. The second plurality of fibers 90b is carried by a plurality of spools 310 loaded onto a carrier 308. Thus, the second plurality of fibers 90b may be referred to as carrier fibers 90 b. When activated, the carrier 308 moves the bobbin 310 along a bobbin path that is collectively configured to define the weave pattern of the mechanism. In this manner, one or more mandrels 80 may be advanced through the channel to bypass the frame 302 and thereafter will be braided together in an interconnected manner via a second plurality of fibers 90b unwound from the spool. As shown in fig. 2D, upon completion of the weaving process for a multi-core embodiment, the cores 80 are preferably interconnected within the strip structure 50 and laterally aligned with one another such that each core 80 may be intersected by a single linear axis 88 extending perpendicular to either the central core axis 82 and/or the central strip axis 55 when the swellable strips 65 are in a neutral configuration. It should be understood that the fiber sheath 90b surrounding each core 80 is optional and need not be included to allow swellable strips 65 to perform advantageously.

It should be understood that the braiding mechanism 300 may be a flat braiding mechanism and may be of a commercially available type, and may employ 4 to 50 carriers and 2 to 50 spools, the number of carriers and spools being selectable according to the particular desired braiding pattern. Additionally or alternatively, one or more cores 80 may extend as carrier filaments of the fibers through the braiding mechanism (i.e., some of the spools may be loaded with cores 80) such that one or more swellable cores 80 are included as interconnecting fibers within the swellable strips 65. Referring now to fig. 2G, in other embodiments, swellable strips 65 may be formed in a knitted or woven pattern, such as in the warp and weft types, as such terms are known in the textile industry. In such embodiments, the one or more cores 80 may be woven or knitted as warp fibers or filaments 85, weft fibers or filaments 87, or warp and weft filaments or fibers 85, 87. Optionally, all warp and weft threads or fibers 85, 87 may comprise core 80 threads.

Swellable strips 65 configured as described above provide several advantages over prior art suture anchor bodies. The radial swelling capability (i.e., the second expansion mode described above) enhances expansion of the anchor body 50 within the anatomical structure 1 (such as below the bone surface within the pre-drilled hole), thereby increasing anchor fixation strength. In addition, in embodiments including TCP within the core 80, TCP promotes bone ingrowth into the anchor body 50, which further increases fixation strength and reduces the likelihood of micro-motion between the anchor body 50 and the anatomical structure to which it is anchored. It will be appreciated that the configuration of the strip 65 also provides significant advantages in relation to the manufacturability of the anchor. For example, as described above, the flat geometry allows for easier suturing or splicing of the actuation member 20 by the tape 65. Moreover, in embodiments employing a core 80 that extends alongside the lateral edges 53, 54 of the tape 65, the central portion of the tape 65 (i.e., along the central longitudinal axis 55) may have a pronounced geometry that further facilitates suturing, puncturing, or otherwise penetrating the tape 65 with the actuation member 20. For example, the use of a core 80 that extends alongside the lateral edges 53, 54 of the strip 65 and not the use of a core 80 along the central axis 55 may advantageously provide the strip 65 with a "trough" or "valley" extending longitudinally along its central axis 55, which may allow the center of the strip 65 to be located more quickly and accurately, such as during a procedure that requires piercing of the strip 65 with a needle carrying the actuation member 20. In such a process, a groove or valley at the center of the strip 65 may prevent needle slippage or other undesirable consequences. It should be appreciated that the grooves or valleys may provide both advantageous visual guidance and mechanical positioning relative to the strip 65. Additionally, the use of a core 80 extending alongside the lateral edges 53, 54 of the strip 65 may also prevent the actuating member 20 from cutting, abrading, or otherwise damaging or reducing the structural integrity of the anchor body 50.

It should also be appreciated that the tape 65 having at least one swellable core 80 as described above provides a number of additional advantages over prior art anchor bodies and over prior art sutures. For example, such swellable strips 65 may be based on, for example, patient specificationsThere is a need for use in repair procedures as an anchor body that provides fixation, as a connecting suture that provides tension between structures, or as both an anchor body that provides fixation and a connecting suture that provides tension. Thus, in some embodiments, by way of non-limiting example, the swellable strips 65 may be used as a means of joining an anatomical structure with any other type of anchor (such as HEALIX available from DePuy Synthesis Mitek Sports Medicine)^TMOr HEALIX ADVANCE^TMAnchors) interconnected sutures. In such embodiments, the ability of swellable strips 65 to axially contract over time in response to exposure to an aqueous environment can advantageously avoid or reduce the slack observed in prior art sutures, and can also provide enhanced, sustained anatomical reduction in repair, resulting in a more stable healing environment. The unique design and function of swellable strips 65 makes them useful in a variety of surgical applications.

Referring to fig. 3A-3E, an exemplary method of constructing the anchor 10 with the strip 65 will now be described. It should be understood that the strips 65 according to this embodiment may optionally be swellable upon exposure to an aqueous environment, although the strips 65 need not have such swellability. To form the anchor 10 according to one exemplary method, the anchor body 50 can be penetrated, as shown in fig. 3A, to define a first penetration 56 in a strip 65, such as by piercing with a needle 60 having an aperture 62 through which the actuating member 20 passes. It should be emphasized that, as used herein, the terms "pierce" and "penetrate," and their corresponding derivatives, explicitly refer to the action of an object (e.g., a needle) performing each of the following: 1) entering the strip 65 itself from one of the ends 51, 52, edges 53, 54, sides 57, 58 (which includes the interface between any of 51, 52, 53, 54, 57); 2) advancing through the strip 65 itself; and 3) away from the strip itself from one of the ends 51, 52, edges 53, 54 or sides 57, 58 of the strip 65 (which includes the interface between any of 51, 52, 53, 54, 57). The terms "pierce" and "penetrate," and their corresponding derivatives, do not refer to the act of an object extending only through: 1) a loop or eyelet or other such structure defined by a folded or similarly manipulated portion of the anchor body 50, or 2) a pre-existing structure defined by the anchor body 50, such as a bifurcation, aperture, hole or other such structure.

After or simultaneously with the penetrating or puncturing step, the actuation member 20 may be advanced through the first penetration 56 such that the actuation member 20 extends through the strip 65 from one of the sides 57, 58 to the other of the sides 57, 58. Preferably, the first penetration 56 is located at a longitudinal midpoint between the ends 51, 52. First penetration 56 is also preferably located at or substantially near the midpoint of the width between edges 53, 54. In embodiments where the strip 65 includes one or more swellable members (e.g., cores 80) that extend longitudinally or are otherwise spaced from the central axis 55 along or near one or both of the edges 53, 54, positioning the first penetration at or near the midpoint of the width has the benefit of avoiding piercing of the swellable members. The strip 65 may be folded at the first penetration 56, such as along a folding axis 59 that is substantially perpendicular to the longitudinal axis 25 of the actuation member 20 that coincides with the first penetration 56. It should be understood that the free longitudinal portions of the anchor body 50 on either side of the first penetration 56 may be referred to as first and second anchor body "limbs" or "tails" 64, 66.

As shown in fig. 3B, anchor body 50 can be braided with actuating member 20 to form braided suture anchor 10. In particular, anchor tails 64, 66 can be braided with actuating member 20 into a simple three-member alternating braid (also referred to as a "simple three-strand braid"). As shown in fig. 3C, the second anchor tail 66 may optionally be folded over the actuating member 20 and abutted against the first anchor tail 64 at a bearing or pinch point, and one or both of the first and second anchor tails 64, 66 may optionally be pierced with a needle 60 at an additional or second penetration 68. For example, in some embodiments, both of the first and second anchor tails 64, 66 can be pierced at the second penetration 68 (which can be characterized as a joint penetration 68) at the point of pinching. In such embodiments, as shown in fig. 3D-3E, a needle 60 having an actuation member 20 passed through an eyelet 62 may be advanced through the joint penetration 68 with the actuation member 20 until the actuation member 20 is pulled cleanly through the second penetration 68. Second penetrator 68 (including embodiments in which second penetrator 68 is an articular penetrator 68) is configured to prevent, inhibit, or at least reduce the likelihood of braided suture anchor 10 unraveling. It is to be understood that the anchor body 50 can be braided with the actuating member 20 using only the first penetrating portion 56 or optionally without the actuating member 20 penetrating the anchor body 50 to form the braided suture anchor 10.

In addition, the remaining portions of anchor tails 64, 66 (i.e., those extending from braided suture anchor 10) may be cut or otherwise trimmed to avoid obstruction by the completed braided suture anchor 10 shown in fig. 3E. The cut or trimmed ends of the anchor body tails 64, 66 may be further stitched, crimped, fused or melted (such as with a heat dump device), bonded (such as with a settable adhesive), or otherwise subjected to a finishing process to prevent the ends from fraying or otherwise weakening. The braided structure of the suture anchor 10 of this embodiment, and the actuating member 20 passing through only one, two, or three penetrators 56, 68 of the anchor body 50 (i.e., three if it is contemplated that the second penetrator 68 co-penetrates both tails 64, 66), or optionally no penetrators of the anchor body 50, allows the actuating member 20 to slide substantially freely (i.e., with minimal, negligible, or marginal resistance) through the anchor body 50 even after the anchor body 50 has been actuated to the expanded configuration C2. Thus, it can also be said that the anchor body 50 of this embodiment is free to slide along the actuating member 20. Further, the braided structure of the anchor 10 is such that when the anchor is actuated from the first configuration C1 to the expanded configuration C2, the anchor bodies 50 will bunch together in a more uniform manner throughout the anchor bodies 50 relative to prior art braided suture anchors. While not being bound by a particular theory, the present inventors believe that the more uniform bunching described above is primarily caused by consistent interweaving (i.e., "braiding" in the current embodiment) of the anchor body 50 and the actuating member 20. Referring again to fig. 1F, it has been observed that the braided suture anchor 10 of the present embodiment, after deployment, assumes a more cylindrical, gathered configuration (i.e., expanded configuration C2) than other suture anchors.

With reference to fig. 4A-4K, another exemplary method of constructing braided suture anchor 10 with tape 65 and actuating member 20 will now be described. As in the examples described above, the suture anchor 10 of the present embodiment is configured such that the anchor body 50 is substantially free to slide along the actuation member 20 before and after transitioning to the expanded configuration C2. Thus, it can also be said that the actuating member 20 of this embodiment is substantially free to slide through the anchor body before and after transitioning to the expanded configuration C2. It should be understood that the strips 65 according to this embodiment may optionally be swellable upon exposure to an aqueous environment, although the strips 65 need not have such swellable functionality.

Referring now to fig. 4A, the anchor body 50 can be a strip 65 having a length L1 (see fig. 2A), which can be predetermined and can be in the range of about 20mm to about 120mm, more specifically about 40mm to about 100mm, and preferably about 50mm to about 70 mm. It should be understood that the construction of the anchor 10 may optionally begin with a continuous uncut length of the anchor body 50, such as a length unwound from a reel or other storage configuration. The width W of the strip 65 may be in the range of about 0.5mm to about 5.0mm, more specifically in the range of about 1.0mm to about 3.0mm, and preferably in the range of about 1.3mm to about 2.7 mm. Actuating member 20 preferably has a swellable core 80, as described above. The actuating member 20 defines an overall length, measured along its longitudinal axis 25, which may range from about 18 inches to about 48 inches, and is preferably about 36 inches.

One or both of the anchor body 50 and the actuating member 20 can be marked to provide one or more reference points for constructing the suture anchor 10 according to one or more specified parameters, such as length. For example, the operator may mark anchor body 50 at first location 31, preferably at longitudinal midpoint 31a of anchor body 50 along central axis 55. First location 31 may also be located at the midpoint of the width between edges 53, 54 of anchor body 50.

The operator can also mark anchor body 50 at a pair of second locations 32, which in the example shown are spaced equidistant from first location 31 by a distance L3, as measured along central axis 55. Distance L3 represents the target design length for anchor 10 constructed in accordance with the present example. The operator may further index the actuation member at a first position 41 and a second position 42 that are spaced apart from each other by a distance L4, as measured along the longitudinal axis 25 of the actuation member 20. In the present example, distance L4 is substantially equal to distance L3, and thus also represents the target design length of anchor 10. The distances L3 and L4 will effectively determine the length L5 (see fig. 4J) of the finished suture anchor 10 formed in accordance with the present example. The distances L3 and L4 may be in the range of about 10mm to about 68mm, more specifically in the range of about 20mm to about 45mm, and preferably in the range of about 26mm to about 30 mm.

Referring now to fig. 4B, an operator can penetrate actuating member 20 through anchor body 50 at first location 31, thereby forming a first penetration 56 at first location 31. Preferably, the operator advances actuating member 20 through first penetration 56 until first position 42 of actuating member 20 is aligned with first position 31 of anchor body 50. The operator may fold anchor body 50 at first penetration 56, such as along a fold axis 59 that is substantially perpendicular to longitudinal axis 25 of actuating member 20 coincident with penetration 56 (i.e., at first location 31). An operator can clamp anchor body 50 and actuating member 20 together at first location 31, for example, with clamp 44, thereby maintaining the relative positions of anchor body 50 and actuating member 20 at first location 31. The clip 44 is preferably configured to precisely clamp the anchor body 50 and the actuating member 20 together at the first penetration 56, and preferably defines a clip width of about 2.0mm or less as measured along the longitudinal axis 25 of the actuating member 20 (and/or along the central axis 55 of the anchor body 50) so as not to disrupt the braiding adjacent the clip 44. It will be appreciated that first location 31 defines first end 31b of braided suture anchor construct 30 formed according to subsequent steps of the present example. As used herein, the term "suture anchor construct" refers to an anchor 10 that includes an anchor body 50 and an actuating member 20 in a predetermined or intermediate stage of construction, formation, fabrication, or manufacture. The first end 31b of the braided suture anchor construct 30 may also define the first end 11 of the completed anchor 10.

It is also to be understood that the braiding steps described below refer to "crossovers" or "picks", each of which refers to an example in which one of the braiding elements of the suture anchor construct 30 (i.e., the actuating member 20 or anchor body 50) crosses over another one of the braiding elements. More specifically, in this example, each intersection or latitude refers to a condition in which one of the first anchor body tail 64, the second anchor body tail 66, and the actuating member 20 intersects the other of the first anchor body tail 64, the second anchor body tail 66, and the actuating member 20. The anchor body 50 and gripping portions of the actuating member 20 effectively define a "starting point" of the braided suture anchor construct 30 from which a crossing or weft can be formed. As shown, the braided elements of suture anchor construct 30 (i.e., anchor body tails 64, 66 and actuating member 20) can be characterized as extending away from first position 31 toward one of a left position PL, a center position PC, and a right position PR relative to one another. In the illustrated example of the starting point, the first anchor body tail portion 64 extends to a left position PL, the actuating member 20 extends to a center position PC, and the second anchor body tail portion 66 extends to a right position PR. Subsequent crossovers or wefts can be characterized with respect to the left position PL, the center position PC and the right position PR. In particular, the picks in this example are each described as beginning at a center position P and crossing over to a left position PL or a right position PR, which can be characterized as a "center-to-outside" pick description. It should be understood that in other embodiments, picks can each be described as beginning from either the left position PL or the right position PR and crossing over to the center position PC, which can be characterized as a "outside-to-center" pick description. In this example, the picks are performed on the anchor body tails 64, 66 and the actuating member 20 according to a simple three-strand weave pattern. Furthermore, the present example shown in FIGS. 4A-5K is a nineteen pick (P1-P19) design, although the braided suture anchor construct 30 may have more or less than nineteen picks P19. It should also be understood that one or more of the marking steps described above may be performed after applying the fixture 44 to the first location 31. For example, an operator may mark anchor body tails 64, 66 and second positions 32, 42 of actuating member 20, respectively, after grasping first position 31.

To begin the braiding process, the operator can cross actuating member 20 from a center position PC across second anchor body tail 66 to a right position PR, as shown in fig. 4C, defining a first weft thread P1. As shown in fig. 4D, the operator can cross-traverse the second anchor body tail 66 from the center position PC over the first anchor body tail 64 to the right side position PR, thereby defining a second weft thread P2. As shown in fig. 4E, the operator can cross-traverse the first anchor body tail 64 from the center position PC across the actuation member 20 to the right side position PR, thereby defining a third weft thread P3. As shown in fig. 4F, the operator can cross actuating member 20 from center position PC across second anchor body tail 66 to left position PL, thereby defining a fourth weft thread P4. As shown in fig. 4G, the operator can cross-over the second anchor body tail 66 from the central position PC across the first anchor body tail 64 to the right side position PR, thereby defining a fifth weft thread P5.

Referring now to FIG. 4H, the operator may continue to construct braided suture anchor construct 30 in a similar manner by sequentially performing the following intersections (each intersection starting from center position PC): crossing first anchor body tail portion 64 across actuation member 20 (to left position PL) to define a sixth weft stitch P6, crossing actuation member 20 across second anchor body tail portion 66 (to right position PR) to define a seventh weft stitch P7, crossing second anchor body tail portion 66 across first anchor body tail portion 64 (to left position PL) to define an eighth weft stitch P8, crossing first anchor body tail portion 64 across actuation member 20 (to right position PR) to define a ninth weft stitch P9, crossing actuation member 20 across second anchor body tail portion 66 (to left position PL) to define a tenth weft stitch P10, crossing second anchor body tail portion 66 across first anchor body tail portion 64 (to right position PR) to define an eleventh anchor weft stitch P11, crossing first anchor body tail portion 64 across actuation member 20 (to left position PL) to define a twelfth weft stitch P12, crossing actuation member 20 across second anchor body tail portion 66 (to right position PR) to define a thirteenth weft thread P13, crossing second anchor body tail portion 66 across first anchor body tail portion 64 (to left position PL) to define a fourteenth weft thread P14, crossing first anchor body tail portion 64 across actuation member 20 (to right position PR) to define a fifteenth weft thread P15, crossing actuation member 20 across second anchor body tail portion 66 (to left position PL) to define a sixteenth weft thread P16, crossing second anchor body tail portion 66 across first anchor body tail portion 64 (to right position PR) to define a seventeenth weft thread P17, crossing first anchor body tail portion 64 across actuation member 20 (to left position PL) to define an eighteenth weft thread P18, and crossing the actuating member 20 across the second anchor body tail 66 (to the right position PR) to define a nineteenth weft thread P19.

Referring now to fig. 4I, with the nineteenth weft stitch P19 formed, the operator may prepare to attach the actuating member 20 to the first and second anchor body tails 64, 66 at their second locations 32 so as to form the second end 32b of the braided anchor body construct 30, which may also define the second end 12 of the completed anchor 10. In this example, the operator is also prepared to have the second position 42 of the actuating member 20 substantially coincide with the second position 32 of the anchor body tails 64, 66. To prepare for such attachment, the operator can position the second anchor body tail 66 over the first anchor body tail 64 to align the second positions 32 of the anchor body tails 64, 66 with one another. The operator may also pass the actuating member 20 through the eyelet 62 of the needle 60 and penetrate the needle 60 at the second location 32 through the first anchor body tail 64 and the second anchor body tail 66, forming a second penetration 68 at the second location 32. The operator advances the needle 60 through the second penetration 68 until the actuation member 20 is pulled cleanly through the joint penetration 68. As described above, because the second penetration 68 of the present embodiment extends through both the first anchor body tail 64 and the second anchor body tail 66, the second penetration 68 may be characterized as an articular penetration. The first suture tail 21 can be said to extend from the first end 31b of the braided suture anchor construct 30 away from the braided suture anchor construct, and the second suture tail 22 can be said to extend from the second end 32b of the braided suture anchor construct 30 (i.e., from the second penetration 68) away from the braided suture anchor construct.

Referring now to fig. 4J, at the second penetration 68 (i.e., at the second location 32), the actuating member 20 preferably penetrates the first and second anchor body tail portions 64, 66 from their sides 57, 58, the actuating member 20 crossing them at a nineteenth latitude P19 to and through their opposite sides 57, 58. The second location 32 defines a second end 32b of the braided suture anchor construct 30. The braided suture anchor construct 30 has a length L5 measured along the central axis 35 of the braided suture anchor construct 30 between its first end 31b and second end 32 b. The length L5 may be in the range of about 10mm to about 60mm, more specifically in the range of about 20mm to about 30mm, and preferably in the range of about 23mm to about 27 mm. It will be appreciated that the first end 31b and the second end 32b of the braided suture anchor construct 30 correspond to the first end 11 and the second end 12 of the completed suture anchor 10. Similarly, the central axis 35 of the braided suture anchor construct 30 also defines the central axis of the completed suture anchor 10. Thus, the central axis 35 may also be referred to as the central axis of the anchor 10.

As described above with reference to the embodiment shown in fig. 3E, the remainder of the anchor tails 64, 66 extending from the second location 32 to their respective ends 51, 52 can be cut or otherwise trimmed to avoid obstruction by the completed braided suture anchor construct 30. The clip anchor body tail portions 64, 66 can have a clip length L6 measured from the penetration portion 68 to the respective end 51, 52. Trim length L6 is preferably in the range of about 0.5mm to about 4mm, although other trim lengths L6 (including lengths shorter than 0.5mm and longer than 4 mm) are also within the scope of the embodiments described herein, including lengths between 0mm and 0.5 mm. The cut or trimmed ends of the anchor body tails 64, 66 may be further stitched, crimped, fused or melted (such as with a heat dump device), bonded (such as with a settable adhesive), or otherwise subjected to a finishing process to prevent the ends from fraying or otherwise weakening. In addition, any of the trimming processes described above may be employed to attach the trimmed ends 51, 52 together to enhance structural integrity at the second end 32b of the braided suture anchor construct 30 and further prevent obstruction of the construct 30 during use.

It should be understood that instead of penetrating actuating member 20 through anchor body 50 at first location 31, anchor body 50 may be folded or wrapped around actuating member at first location 31, and anchor body tails 64, 66 may be woven with actuating member 20 from first location 31 to second location 32 in other manners.

Referring now to fig. 4K, anchor 10 can be folded or bent, such as into a U-shape or V-shape, which can facilitate loading of anchor 10 onto and/or into an insertion instrument, such as onto distal tip 108 of insertion instrument 102 described above. As shown, the anchor 10 can be bent such that the distal end 106 of the instrument 102 engages the anchor 10 at an apex of the bend that is substantially at the axial midpoint of the anchor 10 (i.e., substantially halfway between the first end 11 and the second end 12 of the anchor 10 along its central axis 35).

Referring now to fig. 4L and 4M, connecting member 38 may be attached to anchor 10 at or near first end 11 and second end 12 thereof, thereby interconnecting or otherwise coupling together first end 11 and second end 12 of anchor 10 relative to a second direction D2 that is angularly offset relative to elongation direction D1. As shown, the second direction D2 may be substantially perpendicular to the elongated direction D1. The connecting member 38 may be a strap that may be penetrated through the anchor body 50 at or near each of the first and second ends 11, 12 of the anchor 10, such as through one or both of the first and second anchor body tails 64, 66. The connecting strap 38 may extend substantially completely around the anchor 10, such as by wrapping around the anchor 10 substantially in the second direction D2.The connecting straps 38 may be tied together or otherwise interconnected with themselves. The interface tape 38 may be constructed of any variety of implantable suture materials, such as flexible biocompatible materials, which may also be non-absorbable. By way of non-limiting example, such belt materials include ultra-high molecular weight polyethylene (UHMWPE), nylon, polypropylene, Polydioxanone (PDS) (such as orthiocroid)^TM) Polyester suture material (such as polyethylene terephthalate (PET), particularly 4-0 suture size produced by Ethicon US, LLC headquartered in Bridgwalt, N.J.)With polyethylene terephthalate. The inventors have observed that the presence of the connecting band 38 at the proximal end 17 of the anchor 10 advantageously enhances the retention of the anchor 10 on the insertion instrument 102 before deployment in the target position of the anatomical structure 1. It should be appreciated that the characteristics of the connecting band 38 may be customized as desired to enhance retention on the instrument 102 and/or fixation within the target site.

Referring now to fig. 4N and 4O, an alternative connecting member 38a for connecting the first and second ends 11, 12 of the anchor 10 will now be described. As shown in fig. 4N, suture anchor 10 may be constructed in accordance with the steps described above with reference to fig. 4A-4J, except that one of anchor body tail portions 64, 66 may define connecting member 38a that extends beyond second location 32 (and thus also beyond second penetration portion 68) by a distance L7 that is greater than the trimmed length L6 of the other anchor body tail portion 66, 64. It should be understood that while the illustrated example shows the second anchor body tail portion 66 as defining the connecting member 38a, in other embodiments, the first anchor body tail portion 64 may define the connecting member 38 a. Anchor body 50 may be pierced at a third penetration 67 located adjacent first location 31.

As shown in fig. 4O, the braided suture anchor construct 30 may be folded or bent to load onto the distal tip 108 of the insertion instrument such that the second end 12 of the anchor 10 extends toward the first end 11 of the anchor 10. Connecting member 38a may extend from second end 12 and through third penetration 67, thereby connecting first end 11 and second end 12 of anchor 10. As described above, connecting member 38a interconnects or otherwise couples first end 11 and second end 12 of anchor 10 together relative to a second direction D2 that is angularly offset relative to a direction of elongation D1 (such as substantially perpendicular to the direction of elongation) of the instrument with which anchor 10 is to be loaded. In this embodiment, connecting member 38a will extend across a single side of distal tip 108 of instrument 102. Prior to or after loading the anchor 10 of this embodiment onto and/or into an insertion instrument, connecting member 38a may be tightened as necessary to reduce the distance between first end 11 and second end 12 of anchor 10 in second direction D2. Additionally, the free end 52 of the connecting member 38a can be cut or otherwise trimmed prior to or after loading the anchor 10 onto and/or into an insertion instrument. Similar to the connecting strap 38 described above, the inventors have observed that the presence of the anchor body tail 66 forming the connecting member 38a of the present embodiment advantageously enhances retention of the anchor 10 on the insertion instrument 102 prior to deployment within the target location of the anatomical structure 1. It should be appreciated that the characteristics of the connecting member 38a may be customized as desired to enhance retention on the instrument 102 and/or fixation within the target site.

With reference to fig. 5A-5K, an exemplary method of constructing the braided suture anchor 10 from the actuating member 20 and anchor body 50 such that the anchor body 50 defines a connecting member connecting the first end 11 and the second end 12 of the anchor 10 will now be described. As in the exemplary embodiments described above, the suture anchor 10 of the present embodiment is configured such that the anchor body 50 is substantially free to slide along the actuating member 20 before and after transitioning to the expanded configuration C2. Thus, it can also be said that the actuating member 20 of this embodiment is substantially free to slide through the anchor body before and after transitioning to the expanded configuration C2. It should be understood that the strips 65 according to this embodiment may optionally be swellable upon exposure to an aqueous environment, although the strips 65 need not have such swellable functionality.

Referring now to fig. 5A, the anchor body 50 can be a strip 65 having a length L1, which can be predetermined and can range from about 20mm to about 130mm, more specifically from about 40mm to about 105mm, and preferably from about 50mm to about 70 mm. As noted above, the construction of the anchor 10 can optionally begin with a continuous uncut length of the anchor body 50. The width W of the strip 65 may be in the range of about 0.5mm to 5.0mm, more specifically in the range of about 1.0mm to about 3.0mm, and preferably in the range of about 1.3mm to about 2.7 mm. Actuating member 20 preferably has a swellable core 80 and has an overall length, measured along its longitudinal axis 25, in the range of about 18 inches to about 48 inches, and preferably about 36 inches.

One or both of the anchor body 50 and the actuating member 20 can be marked to provide one or more reference points for constructing the suture anchor 10 according to one or more specified parameters, such as length. For example, the operator may mark anchor body 50 at a pair of longitudinally spaced locations 31, which may be individually or collectively referred to as first locations 31. In the illustrated example, the pair of first locations 31 are spaced apart from each other by a distance L2, as measured along the central axis 55 of anchor body 50. It should be understood that the pair of first locations 31 may optionally be equally spaced along central axis 55 from longitudinal midpoint 31a of anchor body 50. Thus, in such embodiments, one of first locations 31 is located on first anchor body tail 64 and the other of first locations 31 is located on second anchor body tail 66. Further, in such embodiments, the pair of first locations 31 will be equally spaced from the first and second ends 51, 52 of the first and second anchor body tails 64, 66. Longitudinal midpoint 31a of anchor body 50 may also be marked for reference in constructing suture anchor 10, regardless of whether the pair of first locations 31 are equidistant from longitudinal midpoint 31 a.

The operator may also mark anchor body 50 at a pair of second locations 32, which in the example shown are spaced equidistant from respective first locations 31 by a distance L3, as measured along central axis 55. Thus, first location 31 and second location 32 on first anchor body tail portion 64 are spaced from each other a distance L3, and first location 31 and second location 32 on second anchor body tail portion 64 are also spaced from each other a distance L3, which distance L3 represents a target design length for anchor 10 constructed in accordance with the present example. The operator may further index the actuation member at a first position 41 and a second position 42 that are spaced apart from each other by a distance L4, as measured along the longitudinal axis 25 of the actuation member 20. In the present example, distance L4 is substantially equal to distance L3, and thus also represents the target design length of anchor 10. The distances L3 and L4 will effectively determine the length L5 (see fig. 5J) of the finished suture anchor 10 formed in accordance with the present example. As in the above examples, the distances L3 and L4 may be in the range of about 10mm to about 68mm, more specifically in the range of about 20mm to about 45mm, and preferably in the range of about 26mm to about 30 mm.

Referring now to fig. 5B, a portion of anchor body 50 can be folded, preferably by folding anchor body 50 over itself, such that a selected one of first side 57 and second side 58 (first side 57 shown in fig. 5A) contacts itself at the pair of first locations 31, thereby forming a pinch point at which the pair of first locations 31 collectively effectively define a single first location 31 of anchor body 50 from which collar 40 extends. Thus, once formed, collar 40 may define an apex at longitudinal midpoint 31a of anchor body 50 along central axis 55. The collar 40 has a length along the central axis 55 defined by a distance L2. The operator can position actuating member 20 between the pinched portions of anchor body 50, particularly such that actuating member 20 is positioned between selected sides 57, 58 of anchor body 50 at pinch point 31. Preferably, actuating member 20 is positioned such that actuating member first position 41 substantially coincides with anchor body 50 first position 31. An operator can clamp the clamped anchor body 50 and actuating member 20 together at first location 31, for example, with clamp 44, thereby maintaining the configuration of collar 40 and the relative positions of anchor body 50 and actuating member 20 at first location 31. It will be appreciated that the first location 31 defines a first end 31b of a braided suture anchor construct 30 formed in accordance with the present example. The first end 31b of the braided suture anchor construct 30 may also define the first end 11 of the completed anchor 10.

In this example, a weft thread will be described as starting from either the left side position PL or the right side position PR and crossing over to the center position PC, which as described above can be characterized as a "from outside to center" weft thread description. At first location 31, actuating member 20 crossing cross over second anchor body tail 66 may be characterized by a first weft stitch P1, and anchor body 50 folded such that first anchor body tail 64 crosses over actuating member 20 at first location 31 may be characterized by a second weft stitch P2 of braided suture anchor construct 30 formed according to the present example. First and second picks P1 and P2 extend first and second anchor body tails 64 and 20 and actuating member 20 away from first position 31 such that actuating member 20 extends to a left position PL, first anchor body tail extends to a center position PC, and second anchor body tail 66 extends to a right position PR. From these relative positions, subsequent picks can be made on the anchor body tails 64, 66 and the actuating member 20 according to a simple three-strand weave pattern. The present example shown in FIGS. 5A-5K is a nineteen pick design (P1-P19), but a braided suture anchor construct may have more or less than nineteen picks P19.

It should also be understood that one or more of the above-described marking steps may be performed after collar 40 is formed, and may also be performed after actuating member 20 is positioned at the clamping point. For example, the anchor body 50 can be folded to define the loop 40 having a desired length, the first and second anchor body tails 64, 66 can be pinched together, and the actuating member 20 can be positioned between the anchor body tails 64, 66 at the pinch point, as described above. From this configuration, the operator can mark the first location 31 on the construct, such as on the second side 58 (i.e., outwardly facing) of the anchor body 50. With first position 31 marked, the operator can measure desired lengths L3, L4 on anchor body tails 64, 66 and actuating member 20, and mark second positions 32, 42 accordingly. Other options for marking the construct to facilitate formation of the braided suture anchor construct 30 are also within the scope of the embodiments described herein.

As shown in fig. 5C, the second anchor body tail portion 66 can be folded over the first anchor body tail portion 64 from a right side position PR to a center position PC, thereby defining a third weft thread P3. In this case, "folding" the second anchor body tail portion 66 over the first anchor body tail portion 64 means that the first side 57 of the second anchor body tail portion 66 contacts the second side 58 of the first anchor body tail portion 64 at the third weft thread P3. Thus, as shown, the second side surfaces 58 of both the first anchor body tail portion 64 and the second anchor body tail portion 66 are visible downstream of the third weft yarn P3. As shown in fig. 5D, actuating member 20 can cross over second anchor body tail portion 66 (from left position PL to center position PC) defining a fourth weft yarn P4. As shown in fig. 5E, the first anchor body tail 64 may cross over the actuation member 20 (from the right side position PR to the center position PC) defining a fifth weft thread P5. In this example, the first anchor body tail portion 64 can cross over the actuating member 20 without folding, that is, the first anchor body tail portion 64 cross over the actuating member 20 such that the same side (second side 58) of the first anchor body tail portion 64 is visible immediately upstream and downstream of the fifth weft thread P5 in fig. 5E. The embodiment shown in FIGS. 5A-5J may involve folding of one of the anchor body tail portions 64, 66 at only the third weft stitch P3, with subsequent anchor body tail picks P5-6, P8-9, P11-12, P14-15, and P17-18 involving no folding intersections. However, it should be understood that one or more of these subsequent anchor body tail picks, and at most all picks, may involve folding the respective anchor body tail 64, 66. As shown in fig. 5F, the second anchor body tail portion 66 may cross over the first anchor body tail portion 64 (from the left position PL to the center position PC) defining a sixth weft thread P6. As shown in fig. 5G, the actuating member 20 can cross over the second anchor body tail 66 (from the right side position PR to the center position PC) defining a seventh weft thread P7.

Referring now to fig. 5H, the operator may proceed in a similar manner to construct the braided suture anchor construct 30 by sequentially performing the following operations: crossing first anchor body tail 64 across actuating member 20 to define an eighth weft yarn P8, crossing second anchor body tail 66 across first anchor body tail 64 to define a ninth weft yarn P9, crossing actuating member 20 across second anchor body tail 66 to define a tenth weft yarn P10, crossing first anchor body tail 64 across actuating member 20 to define an eleventh weft yarn P11, crossing second anchor body tail 66 across first anchor body tail 64 to define a twelfth weft yarn P12, and crossing actuating member 20 across second anchor body tail 66 to define a thirteenth weft yarn P13. As shown in FIG. 5I, the operator may further proceed in a similar manner to construct braided suture anchor construct 30 by sequentially performing the following operations: crossing first anchor body tail 64 across actuation member 20 to define a fourteenth weft pick P14, crossing second anchor body tail 66 across first anchor body tail 64 to define a fifteenth weft pick P15, crossing actuation member 20 across second anchor body tail 66 to define a sixteenth weft pick P16, crossing first anchor body tail 64 across actuation member 20 to define a seventeenth weft pick P17, crossing second anchor body tail 66 across first anchor body tail 64 to define an eighteenth weft pick P18, and crossing actuation member 20 across second anchor body tail 66 to define a nineteenth weft pick P19.

With continued reference to fig. 5I, with the nineteenth weft stitch P19 formed, the operator may prepare to attach the actuating member 20 to the first and second anchor body tails 64, 66 at their second locations 32 so as to form the second end 32b of the braided anchor body construct 30, which may also define the second end 12 of the completed anchor 10. In this example, the operator is also prepared to have the second position 42 of the actuating member 20 substantially coincide with the second position 32 of the anchor body tails 64, 66. To prepare for such attachment, the operator can position the second anchor body tail 66 over the first anchor body tail 64, and can further align the second locations 32 of the anchor body tails 64, 66 with one another. The operator may also pass the actuating member 20 through the eyelet 62 of the needle 60 and penetrate the needle 60 at the second location 32 through the first anchor body tail 64 and the second anchor body tail 66, forming a second penetration 68 at the second location 32. The operator advances the needle 60 through the second penetration 68 until the actuation member 20 is pulled cleanly through the second penetration 68, which may be characterized as an articular penetration. The first suture tail 21 can be said to extend from the first end 31b of the braided suture anchor construct 30 away from the braided suture anchor construct, and the second suture tail 22 can be said to extend from the second end 32b of the braided suture anchor construct 30 (i.e., from the second penetration 68) away from the braided suture anchor construct.

Referring now to fig. 5J, at the second penetration 68, the actuating member 20 preferably penetrates the first anchor body tail portion 64 before penetrating the second anchor body tail portion 66. In other words, referring to fig. 5J, the actuating member 20 penetrates the anchor body tails from the sides 57, 58 (i.e., side 57) of the anchor body tails 64, 66 not visible in fig. 5J to and through the opposite sides 58, 57 (i.e., side 58) of the anchor body tails visible in fig. 5J. The braided suture anchor construct 30 has a length L5 measured along the central axis 35 of the braided suture anchor construct 30 between its first end 31b and second end 32 b. The length L5 may be within the ranges described above with reference to fig. 4J of the above example. As described above, the first end 31b and the second end 32b of the braided suture anchor construct 30 correspond to the first end 11 and the second end 12 of the completed suture anchor 10. Similarly, the central axis 35 of the braided suture anchor construct 30 also defines the central axis of the completed suture anchor 10.

As described above, the remainder of the anchor tails 64, 66 extending from the second location 32 to their respective ends 51, 52 can be cut or otherwise trimmed to avoid obstruction by the completed braided suture anchor construct 30. The clip anchor body tail portions 64, 66 can have a clip length L6 measured from the penetration portion 68 to the respective end 51, 52. Trim length L6 is preferably in the range of about 0.5mm to about 4mm, although other trim lengths L6 (including lengths shorter than 0.5mm and longer than 4 mm) are also within the scope of the embodiments described herein. The cut or trimmed ends of the anchor body tails 64, 66 may be further stitched, crimped, fused or melted (such as with a heat dump device), bonded (such as with a settable adhesive), or otherwise subjected to a finishing process to prevent the ends from fraying or otherwise weakening. In addition, any of the trimming processes described above may be employed to attach the trimmed ends 51, 52 together to enhance structural integrity at the second end 32b of the braided suture anchor construct 30 and further prevent obstruction of the construct 30 during use. The first suture tail 21 can be said to extend from the first end 31b of the braided suture anchor construct 30 away from the braided suture anchor construct, and the second suture tail 22 can be said to extend from the second end 32b of the braided suture anchor construct 30 away from the braided suture anchor construct. The second suture tail 22 may be guided through the loop 40 such that both the first suture tail 21 and the second suture tail 22 extend through the loop 40.

Referring now to fig. 5K, to complete the suture anchor 10, the second suture tail 22 can be pulled through the loop 40 (and/or the loop 40 can be advanced along the second suture tail 22) until the second end 12 of the anchor 10 is positioned within the loop 40 or at least immediately adjacent to the loop 40. Thus, the collar 40 preferably surrounds the first and second ends 11, 12 of the anchor 10, thereby interconnecting or otherwise coupling together the first and second ends 11, 12 of the anchor 10 relative to the second direction D2 that is angularly offset relative to the elongation direction D1. As shown, the second direction D2 may be substantially perpendicular to the elongated direction D. The collar 40 may be characterized as a "closed" collar, and may also define the proximal end 17 of the anchor 10 constructed in accordance with the present example. It will be appreciated that the act of bringing the second end 12 of the anchor 10 to the collar 40 also involves bending or folding the anchor 10, such as into a U or V shape, which may facilitate loading of the anchor 10 onto the insertion instrument 102. As shown in fig. 5L and 5M, the anchor 10 of this embodiment may be loaded onto the instrument 102 by advancing the distal end 108 of the instrument 110 through the collar 40 and into engagement with the braided anchor body 50. As shown, the collar 40 may extend completely around the distal tip 108. The inventors have observed that the presence of the closure collar 40 at the proximal end 17 of the anchor 10 advantageously enhances the retention of the anchor 10 on the insertion instrument 102 prior to deployment within the target location of the anatomical structure 1. It should be appreciated that the characteristics of the collar 40 may be customized as desired to enhance retention on the instrument 102 and/or fixation within the target site.

Referring to fig. 6A and 6B, another exemplary method of constructing braided suture anchor 10 with tape 65 and actuating member 20 will now be described. This example is similar to the example described above with reference to fig. 4A-4K, with the primary difference being that instead of first penetrating portion 56 coinciding with first location 31, anchor body 50 may be clamped together at first location 31, and actuating member 20 may penetrate clamped first and second anchor body tails 64, 66 adjacent to but downstream of first location 31. Thus, in this example, first penetration 56 may be characterized as a joint penetration. From the first penetration 56, the actuating member 20 can cross the gripping portion of the second anchor body tail 66 to define a first weft yarn P1. The second anchor body tail portion 66 can then extend from the first penetration portion 56 and cross the pinched portion of the first anchor body tail portion 64 to define a second weft thread P2. The first anchor body tail portion 64 can then cross the actuating member 20 to define a third weft stitch P3 from which the remainder of the suture anchor body construct 30 can be woven in a manner similar to that described above with reference to fig. 4F-4J. As in the examples described above, the suture anchor 10 of the present embodiment is configured such that the anchor body 50 and the actuating member 20 can slide substantially freely relative to one another before and after transitioning to the expanded configuration C2. As noted above, the strips 65 according to this embodiment may optionally be swellable upon exposure to an aqueous environment, although the strips 65 need not have such swellable functionality.

Referring to fig. 7A-7F, an exemplary method of constructing the suture anchor 10 using the tape 65 and the actuating member 20, particularly by wrapping the tape 65 around the actuating member 20, will now be described. As in the examples described above, the suture anchor 10 of the present embodiment is configured such that the actuating member 20 and anchor body 50 can slide substantially freely relative to one another before and after transitioning to the expanded configuration C2. It should be understood that the strips 65 according to this embodiment may optionally be swellable upon exposure to an aqueous environment, although the strips 65 need not have such swellable functionality.

Referring now to fig. 7A, actuating member 20 can be placed in contact with anchor body 50 at a first location 31, which defines the beginning of braided suture anchor construct 30 formed in accordance with the present embodiments. As in the above examples, first location 31 can also define first end 31b of braided suture anchor construct 30. At the first position 31, the actuating member 20 and anchor body 50 can be oriented relative to one another such that, at least at the beginning of the process of forming the braided suture anchor construct 30, the longitudinal axis 25 of the actuating member 20 is angularly offset from the central axis 55 (e.g., substantially perpendicular to the central axis) of the anchor body 50. As shown, first anchor body tail portion 64 and second anchor body tail portion 66 extend away from each other at first location 31.

Referring now to fig. 7B-7E, beginning with one of the first and second anchor body tails 64, 66 (the second anchor body tail shown in fig. 7B), the anchor body tails 64, 66 may each be helically wound about the actuating member 20 in opposite helical directions about the longitudinal axis 25. At each full helical rotation about the longitudinal axis 25, the anchor body tails 64, 66 will cross each other twice. At each successive intersection, the anchor body tails 64, 66 may be interwoven in an alternating manner, defining a helical weave pattern from the first end 31b to the second end 32b of the braided suture anchor construct 30. In the illustrated example, each of the anchor body tails 64, 66 extends about 5.5 helical rotations about the longitudinal axis 25, with the anchor body tails 64, 66 being penetrated by the actuating member 20, thereby defining a first penetration 56 (which is a joint penetration) at a second location 32, which may define the second end 32b of the braided suture anchor construct 30. It should be appreciated that one or both of the anchor body tails 64, 66 may extend less than or greater than 5.5 helical rotations about the longitudinal axis 25, such as in the range of about 2.5 helical rotations to about 30 helical rotations. The braided suture anchor construct 30 defines a length L5 measured along the longitudinal axis 25 of the actuating member 20 from the first end 31b to the second end 32 b. The length L5 may be within the ranges described above with reference to the example shown in fig. 4J. As noted above, it will be appreciated that the first and second ends 31b, 32b and length L5 of the braided suture anchor construct 30 also define the respective first and second ends 11, 12 and length L5 of the suture anchor 10. In addition, the remainder of the anchor tails 64, 66 extending from the second location 32 to their respective ends 51, 52 can be cut or otherwise trimmed to avoid obstruction by the completed suture anchor 10.

Referring now to fig. 7F, the anchor 10 can be folded or bent, such as into a U-shape or V-shape, which can facilitate loading of the anchor 10 onto and/or into an insertion instrument, such as onto the distal tip 108 of the insertion instrument 102 described above. As in the above embodiments, the anchor 10 may be bent or folded over the distal end 106 of the instrument 102 such that the distal end 106 of the instrument 102 engages the anchor 10 at the apex of the bend, which is preferably located substantially at the axial midpoint of the anchor 10. In such embodiments, the folded or otherwise curved suture anchor 10 defines a distal end 15 at the bend or apex of the fold, and defines a proximal end 17 that is substantially aligned with the first and second ends 11, 12 of the anchor 10.

It should also be understood that any of the embodiments of braided suture anchors 10 described above may alternatively employ two separate anchor bodies 50 each having a strap 65 configuration. In such embodiments, the first end 31b of the braided suture anchor construct 30 may include an articulating first penetration 56 through the independent anchor body 50, which may then be braided with the actuation member 20 (or braided along the actuation member 20, as shown in fig. 7A-7E) to an articulating second penetration 58 at the second end 32 b. In further embodiments, two or more separate anchor bodies 50 (each having a strap 65 structure) may be attached to one another, such as by bonding, piercing with a connecting strand (such as a connecting suture), fusing, and/or melting together, which may then be folded or wrapped around the actuating member 20 at the first location 31, and the anchor bodies 50 may be otherwise braided with the actuating member 20 from the first location 31 to the second location 32 to form the braided suture anchor construct 30.

In the braided suture anchor embodiments described above, actuating member 20 is preferably a size 2 suture (5.0mm diameter), and preferably has a swellable core 80, such as a size 2 DYNACORD^TMAlthough other sizes and types of sutures may be used for actuating member 20.

Referring now to fig. 8A-8C, another method of constructing the suture anchor 10 with the actuating member 20 and anchor body 50 will be described. As shown in fig. 8A, the anchor body 50 may be pierced at a plurality of penetrations 70a-n along the length of the anchor body 50, such as by a needle 60 carrying an actuating member 20 in a manner that forms a sinusoidal suture pattern. In other words, the actuating member 20 may extend continuously through: a first penetration portion 70a from the first side 57 to the second side 57 of the strip 65; a second penetration portion 70b from the second side surface 58 to the first side surface 57; a third penetration portion 70c from the first side surface 57 to the second side surface 58; and a fourth penetration portion 70d from the second side surface 58 to the first side surface 57. It should be appreciated that the actuation member 20 may extend through additional or fewer penetrations in a similar manner, as desired. As noted above, the configuration of the strap 65 makes it more readily adaptable for suturing or puncturing the actuating member 20 therethrough. As shown in fig. 8B, the suture anchor 10 may be loaded onto the forked end 110 of the insertion instrument 102, similar to that described above with particular reference to fig. 1A-1B. As shown in fig. 8C, the anchor body 50 can be actuated into the expanded configuration C2 in response to the actuating member 20 applying sufficient tension FT to the anchor body 50.

Referring now to fig. 9, the suture anchor 10 may employ more than one of the strip anchor bodies 50 described above. In particular, the actuating member 20 can be connected to a first anchor body 50a and a second anchor body 50b, both of which have the strap structures described above. In this embodiment, the actuating member 20 co-penetrates the anchor body sides 57, 58 near the first end 51 of the anchor body 50a-50 b. The anchor bodies 50a-50b may then be braided or woven around the actuating member 20 in a "lace" fashion (i.e., the first anchor body 50a and the second anchor body 50a are wrapped around the actuating member 20 in a double helix configuration, or more specifically, the first anchor body 50a is wrapped around the anchor member 20 in a clockwise helical direction and the second anchor body 50b is simultaneously wrapped around the anchor member 20 in a counter-clockwise helical direction). The actuating member 20 then co-penetrates the anchor body sides 57, 58 near the second end 52 of the anchor bodies 50a-50 b. While the present anchor embodiment has been shown as being bunched together in a more oval shape (which tends to provide less fixation strength relative to other embodiments disclosed herein), the increased spacing between the actuating member 20 and the anchor bodies 50a-50b provides increased slidability for this embodiment, which makes this embodiment well suited for repairs where slidability is critical and/or the lower fixation strength is sufficient.

Referring now to fig. 10A-10B, the suture anchor 10 may employ a bifurcated tape anchor body 50. In such embodiments, the actuation member 20 may be woven through the bifurcation 75. As shown in fig. 10B, the actuating member 20 can also be spliced with the anchor body 50, such as via penetrations 74, 76 on opposite longitudinal sides of the bifurcation 75. Advantages of this embodiment include ease of manufacture and also the possibility of use on narrower insertion forks, as the tines can extend through the prongs 75 and grip only the actuation member 20 and thus do not need to span the width W of the anchor body 50. Referring now to fig. 10A, in yet another embodiment employing a bifurcated anchor body 50, the actuating member 20 may simply be advanced through the bifurcation 75 without any braiding, splicing, suturing, or piercing of the anchor body 50.

Referring now to FIG. 11, the suture anchor 10 may employ a pair of anchor bodies 50a-50b, each having a ribbon configuration. In this particular embodiment, the actuating member 20 can be individually spliced through each anchor body 50a-50b to maintain the distance between the anchor bodies 50a-50b when the anchor 10 is in the first configuration C1. In this embodiment, the anchor 10 can be loaded onto an insertion fork that is smaller than previous embodiments (and is about the same size as the embodiment described above with reference to fig. 6A-6B) because the tines 112 can grip the actuation member 20 without crossing over or gripping any of the anchor bodies 50 a-50B. It should be understood, however, that in this embodiment, it may be desirable to couple one or both of the anchor bodies 50a-50b to one or both of the prongs 112. One way in which this can be accomplished is to employ a pre-formed hole or aperture in one or both of the anchor bodies 50a-50b, such as near the second end 52 of the anchor body, so that one of the tines 112 can extend within the hole and grip the respective anchor body 50. Alternatively or in addition, one or both of the anchor bodies 50a-50b can include strands extending from the respective anchor body 50a-50b for connection to one of the tines 112.

In embodiments employing swellable anchor bodies 50, one significant and unexpected advantage of providing a braided suture anchor 10 with an actuating member 20 (or other type of suture) penetrating the anchor body 50 between at least a pair of mandrels 80 is that as the core 80 swells, the core 80 can more tightly compress the actuating member 20 at or near the penetration, which tends to further increase the strength of the associated repair. Such a mechanism can be characterized as effectively tightening the knot (i.e., anchor 10) after the knot has been tightened.

Referring now to fig. 12A-12F, another embodiment of an insertion instrument 1202 for inserting the anchor 102 into a target location (such as a pre-drilled hole in bone) in the anatomy 1 will be described. The insertion instrument 1202 of this embodiment may be substantially similar to the instrument 102 described above. Thus, the instrument 1202 includes an elongated body portion 1214 that is elongated in the longitudinal instrument direction L, and a distal tip 1208 (also referred to herein as an "anchor carrier") that extends from the body portion 1214 in the distal direction D (i.e., the insertion direction X) and defines a distal end 1206 of the insertion instrument 1202. The elongated body portion 1214 defines an outer surface 1215, which may have a circular cross-sectional geometry. The insertion instrument 102 may include a handle 1216 that extends in the proximal direction P from the elongate body portion 1214 and defines a proximal end 1204 of the insertion instrument 1202.

As in the above-described embodiments, the distal tip 1208 can define a fork structure 1210 that includes a pair of tines 1212 extending distally from the elongate body portion 1214 and spaced apart from one another in the lateral instrument direction. The tines 1212 thus define a recess 1213 at the distal end 1206 that can be configured to receive at least a portion of the anchor 10. The distal tip 1208 may also define one or more surfaces or "platforms" 1220, 1222 positioned opposite each other along the transverse instrument direction T. As shown, the platform may include a first or proximal pair of platforms 1220 extending distally in a stepped-down manner from an outer surface 1215 of the elongate body portion 1214. The platforms may also include a second or distal pair of platforms 1222 extending distally from the first pair of platforms 1220 in a further stepped-down manner. Distal tip 1208 can be configured such that anchor 10 can be folded or otherwise bent over distal tip 1208 as described above, which aids in inserting anchor 10 into a small bore hole and also helps to maintain the shape of anchor 10 during insertion. In particular, when in the initial configuration C1, the anchor 10 can be folded or bent over the distal tip 1208 such that the apex of the bent anchor 10 can extend at least partially within the recesses 1213 between the tines 1212 of the fork structure 1210 and the remainder of the anchor 10 extending to its proximal end 17 can interface with the distal platform 1222 and optionally the proximal platform 1220. It should be understood that other tine 1212 and recess 1213 configurations may be employed on the distal tip 1208. By way of non-limiting example, the tines 1212 can project distally to a greater or lesser extent than shown in fig. 12C. Additionally or alternatively, the recesses 1213 may define a deeper or shallower profile, such as a shallower profile defining a substantially single radius in a plane oriented along the longitudinal direction L and the lateral direction a. As shown in fig. 12D, one or both of distal platforms 1222 may be concave, allowing anchor 10 to nest at least partially within distal platform 1222 during insertion. As shown in fig. 12E, one or both of proximal platforms 1220 may also be concave, allowing at least respective portions of actuation member tails 21, 22 to nest therein during insertion.

The handle 1216 preferably includes a retaining structure configured to retain a proximal portion of the actuating member 20 in a manner that maintains the position of the anchor 10 relative to the distal tip 1208 during insertion. As shown in fig. 12A, the retaining structure may include a channel 1224, for example, defined by the body 1217 of the handle 1216, and configured to receive a proximal portion of the actuation member 20, such as one or both of the tail portions 21, 22 of the actuation member. The channel 1224 may extend from the distal end 1226 to the proximal end 1204 of the handle 1216 along the longitudinal instrument direction L. Referring now to fig. 12F, the channel 1224 may also extend across the proximal surface 1227 of the handle 1216 at the proximal end 1204. The handle body 1217 may include a projection 1228 that extends within the channel 1224 and interfaces with the opposing sidewall 1230 of the channel 1224 in a manner that defines a clamping slot 1232 therebetween. One or both of the projection 1228 and the opposing sidewall 1230 can define a tapered lead-in surface configured to facilitate guiding one or both of the actuating member tails 21, 22 into the clamping slot 1232. It should be understood that other retaining structure configurations are also within the scope of the present disclosure. The proximal surface 1227 of the handle 1216 may be configured to receive an insertion force, such as an impact force (e.g., from a mallet), that drives the distal tip 1208 and the anchor 10 loaded thereon into a target site of the anatomical structure 1.

Referring now to fig. 12G, the insertion instrument 1202 can be configured for use with the guide member 1240. Accordingly, insertion instrument 1202 and guide member 1240 may be collectively referred to as instrument assembly 1242. The guide member 1240 may include a handle 1244 having a proximal surface 1246 defining a proximal end 1248 of the guide member 1240. The guide member 1240 includes an elongated guide tube 1250 extending distally from a handle 1244 and defining a distal end 1252.

As shown in fig. 12H-12J, the guide tube 1250 defines a central cannula 1254 that is configured to receive the elongate body portion 1214 of the insertion instrument 1202 therein and to guide the elongate body portion 1214 to a target site. The guide member 1240 and the insertion instrument 1202 are cooperatively dimensioned such that when the distal surface 1226 of the instrument handle 1216 abuts the proximal surface 1246 of the guide member handle 1244, the distal tip 1208 of the insertion instrument 1202 extends distally beyond the distal end 1252 of the guide tube 1250, which may be referred to as a "fully seated" position of the instrument 1202 relative to the guide member 1240. In particular, when the insertion instrument 1202 is fully seated relative to the guide member 1240, the entire anchor 10 loaded onto the distal tip 1208 may be positioned distal of the distal end 1252 of the guide tube 1250. It will be appreciated that the distance in the longitudinal direction L between the distal surface 1226 of the instrument handle 1216 and the proximal surface 1246 of the guide member handle 1244 may provide the surgeon with a visual indication of the depth to which the anchor 10 (loaded on the distal tip 1208 of the instrument) extends relative to the target location. Guide tube 1250 may define one or more apertures 1256 allowing external visualization within cannula 1254. The guide tube 1250 may also be configured to guide the movement of a tapping device (such as a drill or awl) through the cannula 1254 and to a target site prior to inserting the elongate body portion 1214 into the cannula 1254. As shown in fig. 12I and 12J, the distal end 1252 of the guide tube 1250 may have a geometry for grasping with bone at a target site, such as a saw tooth geometry. It should be understood that other distal end geometries for grasping with bone are within the present embodiment, including a "fishmouth" geometry, by way of non-limiting example. As shown in fig. 12H and 12K, the cannula 1254 of the guide tube 1250 may be in open communication with the central bore 1258 of the guide member handle 1244. The central bore 1258 may have a proximal portion that flares outwardly in the proximal direction P and also aligns with the channel 1224 of the instrument handle 1216 in the proximal direction P. Accordingly, the actuation member 20 can extend proximally through the cannula 1254 and into the central bore 1258, and then through the passage 1224.

With reference to fig. 12L-12P, deployment of the suture anchor 10 into a target location of a bone 1 using the instrument assembly 1242 will now be described. As shown in fig. 12L, guide tube 1250 may be inserted into the patient along an insertion axis 1260 that intersects the target location of bone 1 until distal end 1252 of guide tube 1250 contacts bone 1. As shown, the distal end 1252 may "bite" into or otherwise grasp the bone 1. With the distal end 1252 in contact with the bone 1, as shown in fig. 12M, a hole opener 1262, such as a drill, may be advanced through the guide tube 1250 and may form a hole 3 in the bone 1 at a target location. Once the hole 3 is formed, the hole opener 1262 may be withdrawn from the guide tube 1250. As shown in fig. 12N, insertion instrument 1202 with anchor 10 loaded on its distal tip 1208 can be advanced through guide tube 1250 until anchor 10 extends distally therefrom and into aperture 3. It will be appreciated that the impact may be applied to the proximal surface 1227 of the instrument handle 1216 as desired (such as with a mallet) until the insertion instrument 1202 is fully seated against the guide member 1240 or the anchor 10 is otherwise advanced to a satisfactory depth within the bore 3. As shown in fig. 12O, after anchor 10 has reached a satisfactory depth within bore 3, actuating member 20 (such as tails 21, 22 thereof) may be disengaged from the retaining structure of instrument handle 1216, and instrument 1202 and guide member 1240 may be withdrawn from the patient, leaving anchor 10 in bore 3 substantially in the initial configuration C1. As shown in fig. 12P, the surgeon may then apply an actuation force (i.e., tension) to actuation member tails 21, 22, thereby transitioning anchor 10 to expanded configuration C2.

Referring now to fig. 13A and 13B, in other embodiments, the insertion instrument assembly may employ an outer tube 1350, which may be similar to guide tube 1250 described above, and may employ an insertion instrument that includes an inner push tube 1355 configured to push the anchor 10 into a target location, such as a pre-shaped hole 3 in bone. The push-in tube 1355 defines a central bore 1357 having an inner diameter sized to receive the actuating member 20 therein but narrow enough to prevent the anchor 10 from residing therein. The instrument assembly of this embodiment may employ one or more removable retention features for selectively maintaining the longitudinal position of the inner tube 1355 relative to the guide tube 1350 (such as when the assembly is advanced to a target location), and for selectively allowing the inner tube 1355 to be advanced along the guide tube 1350 to advance the anchor 10 into a bone hole. Such a pushing mechanism may also assist in transitioning the anchor 10 to the expanded configuration C2.

It should be understood that in embodiments of the suture anchors described herein, the actuating member 20 need not pass through any longitudinal opening (e.g., a hollow core, tunnel, passage, or cannula) extending through the anchor body 50. Thus, any of the suture anchors 10 described herein may include an actuating member 20 that does not pass through any longitudinal opening (e.g., a hollow core, tunnel, passage, or cannula) extending through the anchor body 50.

In addition, the suture anchor 10 described above with reference to fig. 1A-1B, 1E-1F, 3A-3E, and 8A-8C has been tested in a 2.0mm (about 0.079 inch) diameter hole in 55Durometer saw bone media at a rate of 10 inches per minute and has shown good fixation characteristics. The suture anchor 10 described above with reference to fig. 4A-7F has been tested in a 1.85mm (about 0.073 inch) diameter hole in 55Durometer saw bone media at a rate of 10 inches per minute and has exhibited an average holding strength of 157.5N. By way of non-limiting example, the fixation strength of a single anchor 10 is found to vary based on factors such as anchor design, number of picks in the braided construct, and anchor length L5.

It should also be understood that the dimensions and dimensions of the strap anchor bodies 50, 50a-50b and the actuating member 20 provided above are for illustrative purposes, and that the strap 65 is adapted to be scaled up and down in size as desired.

It should also be understood that the suture anchors 10 described herein may be injected, inserted, or otherwise deployed with various types and configurations of insertion devices and instruments other than those described above. For example, the suture tails 21, 22 are configured so as to be capable of connection with various types of instruments that employ suture ears (suture cleats), tensioners, or other mechanisms for controlling the operation and/or manipulation of the suture tails for anchoring purposes, including mechanical expansion of the anchor body. For example, the actuation member 20 (such as one or both of its suture tails 21, 22) is operably coupled to a tensioning device having a handle and an actuator, such as by way of non-limiting example, a slider, a dial, a knob (e.g., a pull or rotary knob), and/or a trigger (e.g., a scissor handle) or other feature manipulated by a physician. Such a tensioning device may also include a tension limiter, such as a shear pin or other frangible member or mechanism, configured to fail or otherwise stop transmitting the tension force FT to the suture tail once the tension force FT reaches a predetermined limit, which may also provide a tactile and/or audible indication to the physician that the anchor 10 has transitioned to the expanded configuration C2.

It should also be understood that the suture anchors 10 described herein are believed to be capable of deployment within the anatomy and provide sufficient anchor fixation strength even when the anchor 10 is mechanically expanded to less than its maximum extent, thereby utilizing the swelling mode of expansion to supplement less than the total mechanical expansion. In such cases, it will be appreciated that swelling may further allow the anchor 10 to maintain its fixation over time after surgery. Further, the suture anchors 10 described herein are capable of deployment within an anatomical structure even in the swelling mode without expansion, and provide sufficient anchor fixation strength due to mechanical expansion alone.

It should be understood that the swellable strip anchor body 50 described above may also serve as a connecting means for engaging at least one anatomical structure with at least one of: another anatomical structure, a plurality of other anatomical structures, an anchor member, and/or a plurality of anchor members (including prior art anchor members, and also including non-textile anchors). In this manner, the strip anchor body 50 may be used for anatomical reduction, such as to repair or restore gaps between anatomical structures. By way of non-limiting example, any of the anchor bodies 50 described herein can connect an anatomical structure with another type of anchor (such as the above-mentioned HEALIX)^TMOr HEALIX ADVANCE^TMAnchors) are used. The inventors have discovered through their own tests that the tape 50 described herein, including the swellable core, can operate effectively and advantageously when used for suturing (i.e., tensioning and/or anatomic repositioning) functions. Further, it should be understood that the above-described strap 50 may be configured in such a mannerAnd implantation to provide both anchoring and suturing functions.

It should also be understood that, by way of non-limiting example, each of the above-described anchor bodies 50 may also be employed with more than one actuating member 20, such as in embodiments involving dual or triple load anchors.

It should also be understood that the actuating member 20 disclosed above may also be employed with other types of anchors, including expanding the knot anchors with anchor bodies other than the strip 65 disclosed above. In one such example, the actuating member 20 can be configured in such a manner (e.g., pre-knotted, woven, and/or braided) so as to also define an anchor body that is mechanically expandable in response to tension applied to one or more "tails" of the actuating member 20. The actuating member 20 disclosed herein may also be employed with other types of knot anchors. In these embodiments, the swellability of the actuation member 20 can provide additional expansion to the anchor. It should also be understood that the actuating member 20 disclosed herein may also be employed with other types of anchors (including rigid anchors) as desired. In each of these embodiments, the swellability of the actuation member 20 may provide the advantage of contracting along at least a portion of its length between the connecting members, in order to reduce the distance between the connecting members, which may maintain compression across the prosthesis and reduce any gaps, if any.

It should also be understood that methods of using any of the above-described anchoring members 50 and/or actuating members 20 in anatomical repair are within the scope of the present disclosure.

Although the present disclosure has been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Furthermore, the scope of the present disclosure is not intended to be limited to the specific embodiments described in the specification. One of ordinary skill in the art will readily appreciate from the disclosure that processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure.