Flexible material fixation devices, kits

Abstract

A flexible material fixation device configured for fixing a flexible material to a bone, the device comprising: an anchor having a distally tapering structure, the anchor sized and shaped to fit into a hole in a bone, where the anchor is formed from a single unitary portion where the anchor is configured to be inserted into the hole in the bone; the anchor is sized for insertion into a hole in a bone and exerts sufficient pressure on one of the tissue and the artificial material such that the one of the tissue and the artificial material is anchored to the bone.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 544,459, filed October 17, 2023, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This invention relates to apparatus and methods for fixing flexible materials to bone, and more particularly to fixing flexible tissues or artificial materials to bone. Background Technology

[0004] Various medical procedures require securing flexible materials or tissues—such as tendons or other connective tissues—to the bone. Exemplary procedures include biceps tendon fixation or rotator cuff repair. The biceps tendon connects the biceps brachii muscle to the bone. Biceps tendon problems can include inflammation, irritation, or tendon detachment from the bone.

[0005] In biceps tendon fixation, the biceps tendon is detached from the glenoid fossa and reattached to the humerus. Known techniques for biceps tendon fixation using existing tools require multiple steps that are difficult to perform via an arthroscopic approach.

[0006] The following publications are considered to represent prior art:

[0007] U.S. Patent Nos. 10,881,388, 9,706,984, and 9,775,597, and U.S. Patent Publications Nos. 2018 / 0125473 and 2018 / 0333153. Summary of the Invention

[0008] The present invention aims to provide an improved flexible material fixing device. It should be noted that any embodiment discussed herein is to be understood as including any of the options and / or features described herein according to some embodiments.

[0009] According to one aspect of some embodiments of the present invention, a flexible material fixation device for fixing a flexible material to bone is provided, the device comprising:

[0010] An anchor having a distally tapering structure, the anchor being sized and shaped to fit into a hole in bone, wherein the anchor is formed from a single integral part, and wherein the anchor is sized to insert into a hole in bone and apply sufficient pressure to one of tissue and artificial material such that the one of tissue and artificial material is anchored to bone.

[0011] According to some embodiments of the present invention, the flexible material is a ligament.

[0012] According to some embodiments of the present invention, the flexible material is a flexible man-made material.

[0013] According to some embodiments of the present invention, the anchoring member includes a proximal portion having a first average cross-sectional area and a distal portion having a second average cross-sectional area, the first average cross-sectional area being larger than the second average cross-sectional area, wherein the ratio of the second average cross-sectional area to the first average cross-sectional area is at most 1:1.5.

[0014] According to some embodiments of the present invention, the anchor includes a proximal portion having a first average diameter and a distal portion having a second average diameter, the first average diameter being larger than the second average diameter, wherein the ratio of the second average diameter to the first average diameter is at most 1:1.5.

[0015] According to some embodiments of the present invention, the average diameter is measured at 10% of the axial length of the anchor.

[0016] According to some embodiments of the present invention, the anchor has an internal channel extending along a longitudinal axis from the proximal portion of the anchor to the distal portion of the anchor.

[0017] According to some embodiments of the present invention, the anchor has one of a circular cross-sectional profile and an elliptical cross-sectional profile.

[0018] According to some embodiments of the present invention, the anchor has one of the following:

[0019] Smooth outer surface;

[0020] The outer surface includes at least one of bumps and protrusions;

[0021] The outer surface includes an array of bumps and protrusions.

[0022] Textured outer surface;

[0023] Includes the outer surface of at least one circular ring; and

[0024] Including the outer surface of the thread.

[0025] According to some embodiments of the present invention, the anchor has an outer surface including at least one of a protrusion and a projection, and the extension of the protrusion or projection is less than 20% of the thickness of the anchor. According to some embodiments of the present invention, the anchor has an outer surface including a plurality of rings, the plurality of rings including a farthest ring and a nearest ring, wherein the radial dimension of the farthest ring is smaller than the radial dimension of the nearest ring.

[0026] According to some embodiments of the present invention, the anchor includes a tip having a width in the range of 2 mm to 4 mm.

[0027] According to some embodiments of the present invention, the anchor has a longitudinal axis and an outer surface comprising a plurality of rings, wherein each of the rings has a proximal side substantially perpendicular to the longitudinal axis of the anchor.

[0028] According to some embodiments of the present invention, the anchor includes at least one longitudinally oriented groove extending toward the distal portion of the anchor.

[0029] According to some embodiments of the present invention, the at least one groove:

[0030] Angled relative to the longitudinal axis of the anchor, or

[0031] It is a spiral groove extending from the distal end of the anchor to the proximal side.

[0032] According to some embodiments of the present invention, each groove in the at least one groove extends radially into the anchoring member by 10%-80% of the anchoring member material.

[0033] According to some embodiments of the present invention, the at least one groove extends through the entire thickness of the anchor.

[0034] According to some embodiments of the present invention, the at least one groove has an equal length.

[0035] According to some embodiments of the present invention, the at least one groove comprises at least two grooves having different lengths.

[0036] According to some embodiments of the present invention, the at least one groove includes a plurality of grooves that are radially and equidistantly distributed around the anchor.

[0037] According to some embodiments of the present invention, the at least one groove includes a plurality of grooves radially and non-equidistantly distributed around the anchor.

[0038] According to some embodiments of the present invention, the device includes a suture extending distally from the anchor.

[0039] According to some embodiments of the present invention, the anchor has an internal channel extending from a proximal portion of the anchor to a distal portion of the anchor, wherein a portion of the stitch extends through the internal channel of the anchor.

[0040] According to some embodiments of the present invention, the suture is axially movable relative to the anchor.

[0041] According to some embodiments of the invention, the device includes a control knob for manually adjusting the length of a portion of the suture.

[0042] According to some embodiments of the invention, a portion of the stitch extends through the anchor.

[0043] According to some embodiments of the present invention, the stitch is a single strand extending distally from the anchor.

[0044] According to some embodiments of the invention, a portion of the suture defines a loop.

[0045] According to some embodiments of the present invention, the suture includes a portion extending distally from the flexible material fastening device, the portion being sized and shaped to form a loop, wherein the distally extending suture portion includes a first suture end capable of attaching to the fastening device.

[0046] According to some embodiments of the present invention, the fastening device includes an attachment location, wherein the first suture end includes a portion sized and shaped to be attached to the attachment location by geometric interference at the attachment location.

[0047] According to some embodiments of the present invention, the portion of the first suture end is releasably inserted into a hole or recess at the attachment location; and wherein at least one of the following is true:

[0048] The first suture end can be released from the attachment position; and

[0049] The device includes a second suture end that can be released from the proximal portion of the device.

[0050] According to some embodiments of the invention, after the anchor is deployed, the size and shape of the anchor are adapted to maintain tissue fixation relative to bone without knotting the suture.

[0051] According to some embodiments of the present invention, the device includes an inserter having a sleeve shaft having a distal end; wherein the anchor is sized and shaped to be releasably mounted onto the distal end of the sleeve shaft.

[0052] According to some embodiments of the present invention, the anchoring member is releasably and securely attached to the sleeve shaft by friction between the anchoring member and the sleeve shaft.

[0053] According to some embodiments of the invention, the device includes a suture extending distally from the anchor, wherein the suture is sized and shaped to pass through the sleeve shaft.

[0054] According to some embodiments of the present invention, the anchor includes at least one longitudinally oriented groove extending toward a distal portion of the anchor, wherein the size and shape of the stitch are adapted to pass through the at least one groove.

[0055] According to some embodiments of the present invention, the anchor is sized and shaped to be screwed into a hole in the bone.

[0056] According to some embodiments of the invention, the anchor is sized and shaped to be inserted into a hole in the bone by applying a distal force to the anchor.

[0057] According to one aspect of some embodiments of the present invention, a method for attaching a flexible material to bone is provided, the method comprising:

[0058] The flexible material is captured in a ring attached to the anchor, the ring having a first diameter;

[0059] The diameter of the ring is reduced to a second diameter, wherein the ring having the second diameter secures the flexible material to the anchor; and

[0060] The anchor, on which the flexible material is fixed, is inserted into a hole in the bone.

[0061] According to one aspect of some embodiments of the present invention, a method for attaching a flexible material to bone is provided, the method comprising:

[0062] A retainer extends from the anchor to capture the flexible material;

[0063] The flexible material is captured by the curved portion of the retainer to secure it to the anchor; and

[0064] The anchor, on which the flexible material is fixed, is inserted into a hole in the bone.

[0065] According to one aspect of some embodiments of the present invention, a kit for attaching a flexible material to bone is provided, the kit comprising:

[0066] Anchors with pre-selected sizes and shapes; and

[0067] Description for indicating the drill bit size suitable for drilling a hole in the bone for a pre-selected anchor, wherein the description indicates the drill bit size according to the condition of the flexible material.

[0068] According to some embodiments of the invention, the kit includes at least one drill bit for drilling holes in bone.

[0069] According to some embodiments of the present invention, each of the at least one drill bit includes a stop for preventing the anchor from moving proximally.

[0070] According to one aspect of some embodiments of the present invention, a flexible material fixation device for fixing a flexible material to bone is provided, the device comprising:

[0071] Anchors of a size and shape suitable for fitting into holes in the bone; and

[0072] An introducer of a size and shape suitable for mounting the anchoring element thereon, wherein the introducer is formed of a single integral part and has no parts that can move relative to each other.

[0073] According to some embodiments of the present invention, the anchor is attached to the introducer.

[0074] According to some embodiments of the present invention, the anchor is mounted on the introducer.

[0075] According to one aspect of some embodiments of the present invention, a flexible material fixing device is provided, the device comprising:

[0076] Anchors of a size and shape suitable for fitting into holes in the bone; and

[0077] An introducer of a size and shape suitable for mounting the anchoring element thereon, wherein the introducer does not extend distally beyond the anchoring element.

[0078] According to some embodiments of the present invention, the single strand is at least partially formed of a nickel-titanium alloy.

[0079] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While embodiments of the invention may be practiced or tested using methods and materials similar to or equivalent to those described herein, exemplary methods and / or materials are described below. In case of any conflict, this specification (including definitions) shall prevail. Furthermore, these materials, methods, and embodiments are for illustrative purposes only and are not necessarily restrictive. Attached Figure Description

[0080] Some embodiments of the invention are described herein by way of example only and in conjunction with the accompanying drawings. Detailed description is now given with reference to the accompanying drawings, and it should be emphasized that the details shown are merely illustrative and used to illustrate embodiments of the invention. In this regard, the description in conjunction with the accompanying drawings will enable those skilled in the art to understand how embodiments of the invention can be practiced.

[0081] In the attached diagram:

[0082] Figure 1A and Figure 1BThis is a simplified schematic diagram of a flexible material fixation device constructed and operable according to an embodiment of the present invention, showing a tissue preloading operation orientation, wherein... Figure 1B Also shown is a flexible material to which a flexible material fixation device of the present invention is attached to bone according to some embodiments;

[0083] Figure 2A and Figure 2B for Figure 1A and Figure 1B A simplified schematic diagram of a portion of a flexible material fixing device, wherein, according to some embodiments, in Figure 2B In the image, the flexible material fixation device is shown to have a tissue loading operation orientation with a tapered hole located in adjacent bone;

[0084] Figure 2C According to some embodiments Figure 2B A simplified schematic diagram of the cylindrical hole portion in the adjacent bone of the flexible material fixation device;

[0085] Figure 2D According to some embodiments Figure 2C A simplified schematic diagram of the portion of the flexible material fixation device, showing the state after the anchor has been partially inserted into a hole in the bone;

[0086] Figure 3A and Figure 3B for Figure 1A and Figure 1B A simplified schematic diagram of a flexible material fixing device, wherein... Figure 3B In the diagram, the flexible material fixation device is shown in an operational orientation for attaching tissue to bone, wherein in Figure 3B In the image, the hole in the bone is a tapered hole, and the state of the flexible material fixation device after the anchor and the flexible material are inserted into the hole in the bone is shown.

[0087] Figure 3C for Figure 2C A simplified schematic diagram of the portion of the flexible material fixing device, wherein, according to some embodiments, in Figure 3C In the middle, the anchoring element has been further pushed into the cylindrical hole;

[0088] Figure 3D and Figure 3E This is a schematic diagram of an anchoring element that forms part of a flexible material fixing device according to some embodiments;

[0089] Figures 4A to 4C According to another alternative embodiment, the configuration Figure 1A and Figure 1B A schematic diagram of an anchoring element, according to some embodiments, as part of a flexible material fixing device, wherein... Figure 4A This is a perspective view facing the near side. Figure 4Band Figure 4C Different planar side views of the anchoring element that forms part of the flexible material fixing device. Figure 4B and Figure 4C Two different planar side views of an anchor that forms part of the flexible material fixing device according to some embodiments;

[0090] Figure 4D This is another alternative embodiment of an anchor that forms part of a flexible material fixing device according to some embodiments;

[0091] Figures 4E to 4H A schematic cross-sectional view of an anchor and flexible material that form part of a flexible material fixation device according to some embodiments, after its insertion into a bone cavity.

[0092] Figure 5A and Figure 5B This is a simplified schematic diagram of a flexible material fixation device constructed and operable according to another embodiment of the present invention, which, according to some embodiments, is shown in a tissue preloading operation orientation;

[0093] Figure 6A A top perspective view of a portion of a flexible material fixation device according to some embodiments, in a tissue preloading operation orientation;

[0094] Figure 6B Configuration according to some embodiments Figures 5A-5B A side view of the inner sleeve shaft of a part of a flexible material fixation device in the orientation of a tissue preloading operation;

[0095] Figure 6C Configuration according to alternative embodiments Figures 5A-5B A side view of the inner sleeve shaft of a portion of a flexible material fixation device in the orientation of a tissue preloading operation;

[0096] Figure 6D According to some embodiments Figure 6C The end view of the inner sleeve shaft shown is in the tissue preloading operation orientation;

[0097] Figures 6E to 6H They are respectively Figures 6A-6D Various views of the internal components of a flexible material fastening device, the device being positioned in a flexible material fastening operation orientation; and

[0098] Figure 7A and Figure 7B This is a flowchart illustrating a method for attaching flexible material to bone using the flexible material fixation device discussed herein, according to some embodiments. Detailed Implementation

[0099] The present invention relates to apparatus and methods for fixing tissue to bone, and more particularly to fixing flexible materials to bone.

[0100] Overview

[0101] According to one aspect of some embodiments, it relates to a flexible material fixation device for securing tissue (such as flexible tissue or soft tissue like tendons) to bone. Those skilled in the art will understand that the term "soft tissue" can include any tissue softer than bone, such as ligaments, which, while rigid and possessing a degree of stiffness, still exhibit flexibility. According to some embodiments, the flexible material fixation device includes an anchor formed from a single integral portion and an inserter or introducer, the inserter optionally including a handle portion. The anchor may have a distally tapered structure, optionally generally tapered, optionally symmetrical in shape, and optionally have a rounded (blunt, rounded) tip, wherein the distal portion has a smaller cross-sectional profile than the proximal portion. Optionally, according to some embodiments, the anchor may have a tip with a width in the range of at least 2mm-4mm, for example, 2mm-2.5mm, 2.5mm-3mm, or 3mm-4mm. Preferably, according to some embodiments, the tip of the anchor 120 is not sharp to avoid damage to the soft tissue 160. While this application refers to tapered anchors, those skilled in the art will understand that, alternatively, according to some embodiments, the anchor may taper distally as described herein, or be otherwise constructed such that the proximal portion of the anchor is wider than the distal portion. Optionally, the anchor may be shaped as an asymmetrical cone, i.e., tilted to one side relative to the longitudinal axis of the anchor. Optionally, according to some embodiments, the anchor may be cylindrical or hexagonal, and may have a groove along one side therein to accommodate flexible or soft tissue. Optionally, the groove may be deeper at its distal portion.

[0102] The dimensions of the anchor, including its length, the cross-sectional profile of the distal portion of the anchor, and the cross-sectional profile of the proximal portion of the anchor, can be selected based on a variety of factors, including the type of flexible material to be attached to the bone, the width of the flexible material, and the surgeon's preference. The ratio of the cross-sectional profiles of the distal and proximal portions of the anchor can be up to 1:1.5, for example, 1:3, 1:4, or 1:5.

[0103] According to some embodiments, the fixation device can fix the flexible or soft tissue (e.g., tendon or xenograft) or artificial material (e.g., artificial flap) to the bone by pressing or clamping the flexible or soft tissue (or xenograft or artificial material) between the anchor and the wall of a hole formed in the bone. Although this application refers to flexible or soft tissue or tendon, those skilled in the art will understand that this can include any tissue, xenograft, or artificial material intended to be attached to bone as described herein.

[0104] A particular potential advantage of flexible material fixation devices with distally tapered or conical anchors is that the smaller end of the tapered / conical structure of the anchor is used to push the flexible or soft tissue into the hole in the bone and attach it to the bone. When inserting the flexible or soft tissue into the hole using the smaller end of the tapered / conical anchor, the resistance may be less, thereby potentially reducing trauma to the flexible or soft tissue.

[0105] According to some embodiments, the size of the anchor can be selected based on the size of the hole in the bone. The size and shape of the anchor are designed such that at least one of the anchor and the bone can apply pressure and sufficient friction to the flexible or soft tissue, so that the flexible or soft tissue can be anchored relative to the bone.

[0106] The anchor may have a smooth surface structure. Alternatively, the anchor may have a surface structure including, for example, threads or protrusions, i.e., an uneven surface, which can provide friction between the anchor and the inner surface of a hole in the bone; or it may have at least one circular ring to allow the anchor to better secure flexible or soft tissue to the bone. Optionally, the anchor may have threads with rounded edges so as not to cut the flexible or soft tissue to be attached to the bone.

[0107] Optionally, the outer surface of the anchor may include a plurality of rings, such as one to five rings, including a farthest ring and a nearest ring, wherein the farthest ring is smaller in the radial direction than the nearest ring. Optionally, each ring may have a proximal side substantially perpendicular to the longitudinal axis of the anchor.

[0108] The anchor may include an internal channel extending longitudinally through the anchor. The size and shape of the internal channel may allow at least one thread, wire, or other strand to extend through the anchor. Furthermore, the internal channel may also allow a delivery rod to extend through it.

[0109] The flexible material fixation device may include a suture or other flexible or soft tissue retainer extending distally from the anchor, such as a tweezer-like mechanism or clamp. Those skilled in the art will understand that, according to some embodiments, the term "suture" may be replaced by any other flexible or soft tissue retainer discussed herein.

[0110] According to some embodiments, the suture may be part of the anchor. Alternatively, the suture may be part of a delivery system and may be used to attach a ligament to the device. Additionally, according to some embodiments, the suture may or may not rotate with the anchor.

[0111] Optionally, the suture may be permanently attached to the anchor. The suture may extend a predetermined distance from the distal portion of the anchor to form a loop extending distally from the flexible material fixation device, wherein the size and / or length of the loop is adjustable, optionally via a control knob on the handle portion of the operating device, to secure the flexible or soft tissue to the anchor before insertion into the bone cavity. Optionally, the loop may be manually adjustable. Optionally, the suture extends through an internal channel in the anchor. The size and shape of the loop are adapted to surround the flexible or soft tissue to be attached to the bone. After the loop is wrapped around the flexible or soft tissue, the loop size / length may be reduced to secure the flexible or soft tissue more tightly to the anchor.

[0112] Optionally, the anchor may include at least one longitudinally oriented groove extending toward a distal portion of the anchor. The at least one longitudinally oriented groove allows the anchor to have increased flexibility, at least at its distal portion, thereby allowing the distal portion of the anchor to be radially compressed and facilitating insertion of the anchor into a hole in the bone. Furthermore, the at least one longitudinally oriented groove allows the anchor to have increased flexibility, thereby enabling more secure insertion into a hole in the bone without causing trauma to flexible or soft tissues. Optionally, according to some embodiments, the groove may be angled relative to the longitudinal axis of the anchor, or may be helical.

[0113] Optionally, the suture is sized and shaped to pass through the at least one groove, such that the suture can extend laterally relative to the longitudinal axis of the anchor. According to some embodiments, this allows flexible or soft tissue to be secured to the distal end of the anchor, thereby allowing the flexible or soft tissue to be inserted into the hole along with the anchor as it is pushed into the bone cavity. Alternatively, according to some embodiments, this allows the flexible or soft tissue to be secured to the side of the anchor, thereby allowing the flexible or soft tissue to be inserted into the hole in the bone along the side of the anchor, rather than at the distal end of the anchor. This allows the anchor to be inserted further into the hole in the bone, while the flexible or soft tissue is not located distal to the anchor because it is located on the side of the anchor. Those skilled in the art will understand that, similarly, any embodiment discussed herein may also include the grooves as described herein.

[0114] Furthermore, since the hole in the bone can be cylindrical, and the anchor can be tapered distally or conical, these features, combined with the longitudinally extending groove, provide a particular advantage in some embodiments: the pressure applied to the flexible or soft tissue at the distal portion of the anchor may be less during insertion into the bone hole. Furthermore, providing at least one groove allows for better control of the pressure applied to the flexible or soft tissue during anchor insertion into the bone hole, as the anchor can have higher compliance with the bone forming the hole.

[0115] Optionally, at least one proximal groove may be provided on the anchor. Optionally, proximal and distal grooves may be provided simultaneously at different circumferential locations on the anchor. Optionally, the at least one groove may potentially mitigate trauma to the flexible or soft tissue by allowing the anchor to partially shield it from pressure and / or friction exerted by bone on the flexible or soft tissue.

[0116] The flexible material fastening device may include an inserter on which an anchor can be mounted. The inserter may have a sleeve shaft with a distal end, wherein the anchor is sized and shaped to be releasably mounted on the distal end of the sleeve shaft, for example, through friction between the distal end of the sleeve shaft and the anchor. The anchor can be releasably and securely attached to the sleeve shaft. The sleeve shaft is sized and shaped to allow sutures to pass through it and extend distally from the anchor.

[0117] The anchor can be screwed into a hole in the bone, or it can be inserted into a hole in the bone by applying an axial force toward the distal direction. A potential advantage of screwing the anchor into a hole in the bone is that the anchor thread can deform flexible or soft tissue; that is, when the anchor and the tendon attached to it are inserted into the hole in the bone, the flexible or soft tissue can conform to the anchor thread. Additionally, by screwing the anchor into the hole in the bone, the surgeon can obtain feedback based on the resistance of the anchor relative to the bone during the insertion action.

[0118] One potential advantage of inserting the anchor into the bone foramen by applying a distal axial force is that the anchor does not rotate, thus avoiding the application of rotational forces to the tendon portion adjacent to the anchor. Additionally, by applying a distal axial force to insert the anchor into the foramen, the anchor does not rotate, thus potentially reducing the risk of soft tissue detachment.

[0119] The flexible material fixation device can fix tissue to bone without damaging the tissue. Optionally, since the anchor can be distally tapered / conical, the ligament can be stretched to the desired degree (by hand or with a tool) when the anchor is inserted into a hole in the bone. The friction between the anchor, the ligament, and the bone prevents arbitrary movement (e.g., wobbling) of the ligament, so that the ligament can remain in place and immobile after the anchor is further inserted into a hole in the bone.

[0120] After the anchor is inserted into the hole in the bone, the end of the suture can be cut off if necessary. Optionally, it is not necessary to knot the suture. Optionally, it can be removed by pulling one end of the suture. This may be advantageous in embodiments where the suture is made of a non-degradable material, such as a metal or alloy.

[0121] According to another aspect of some embodiments, it relates to a flexible material fixation device for securing tissue (such as flexible or soft tissues like tendons) to bone, said flexible material fixation device comprising an anchor, an inserter, and a monofilament, thread, cord, or band, such as a monofilament suture. According to some embodiments, the monofilament may be made of a material such as nitinol, which is rigid enough to form a J-shaped hook portion that can hook the flexible or soft tissue, thereby pulling it back and holding it adjacent to the anchor, after which the anchor holding the flexible or soft tissue can be inserted into a hole in the bone.

[0122] Alternatively, the monofilament may extend distally from the flexible material fixation device and be sized and shaped to selectively wrap around and attach to the flexible or soft tissue to form a closed loop around the flexible or soft tissue. Optionally, the proximal end or proximal portion of the monofilament may be attached to an anchor, or alternatively, to a location proximal to the anchor, such as the handle portion of the device. The monofilament may include another end that can be attached to the flexible material fixation device and / or inserter. This other end may optionally include an extension, such as a knot, for anchoring the loop and optionally temporarily maintaining it closed. Optionally, the flexible material fixation device includes an opening or recess into which the extension may be inserted, optionally by engaging or snapping the extension into the opening / recess. According to some embodiments, the monofilament may slide through an opening in the inserter, and by releasing the proximal end of the monofilament, the monofilament may be allowed to slide through the opening, thereby releasing the anchor from the inserter. Alternatively, according to some embodiments, the augmentation portion is releasably inserted into the opening / recess such that, after the anchor is inserted into the bone, the augmentation portion can be released from the opening / recess, thereby releasing the flexible or soft tissue from the flexible material fixation device. The augmentation portion can be released, for example, manually, optionally using a tool, removing it from the opening / recess.

[0123] A further feature of the embodiments shown or described herein is that the flexible material fixation devices shown and described herein can be used in procedures for attaching soft tissue to bone, such as attaching tendons to bone, and any procedure for connecting flexible or soft tissue to bone can be implemented using any of the embodiments shown or described herein.

[0124] According to one aspect of some embodiments, it relates to a kit for attaching a flexible material to bone. The kit may include an anchor having a preselected size and shape; and instructions for indicating the size of a drill bit suitable for drilling a hole in the bone for the preselected anchor, wherein the instructions may indicate the drill bit size based on the condition of the flexible material. The condition may include several factors, such as calcification of the flexible material, scar tissue on the flexible material, and the thickness of the flexible material.

[0125] According to some embodiments, the kit may include at least one drill bit for drilling holes in bone, as described herein. According to some embodiments, each of the at least one drill bit may include a stop for preventing proximal movement of the anchor, as described herein.

[0126] Before detailing at least one embodiment of the present invention, it should be understood that the present invention is not necessarily limited to the construction details, component arrangements, and / or methods shown in the following description and / or drawings. The present invention can have other embodiments or be implemented or performed in various ways.

[0127] Now refer to Figure 1A and Figure 1B This is a simplified schematic diagram of a flexible material fixation device 100 constructed and operable according to an embodiment of the present invention and a procedure performed using the flexible material fixation device, showing a state in tissue preloading orientation. The flexible material fixation device 100 may include an anchor 120 and an inserter 102 located proximal to the anchor 120, the inserter 102 having a handle portion. The device may have any suitable dimensions, for example, a length in the range of 10cm-19cm and a diameter of approximately 5mm-8.5mm, for example, 8.5mm at the proximal end of the anchor and approximately 4mm at the distal end of the anchor.

[0128] like Figure 1A As shown, according to some embodiments, the flexible material fixation device 100 may include an inserter 102 and an anchor 120. The inserter 102 may include a sleeve shaft 104 having a proximal end (not shown) and a drive mechanism (not shown), a handle (not shown), and a distal end 106 disposed at the proximal end. According to some embodiments, the inserter 102 is shown having a wider proximal portion and a narrower distal portion. However, those skilled in the art will understand that, alternatively, according to some embodiments, the inserter 102 may have the same width along its entire length, or may taper distally, or may have any other suitable configuration. This configuration may potentially prevent slippage when the anchor 120 is pushed into or screwed into a hole 170 in bone 150, optionally the humerus. Optionally, the inserter may include a stop (not shown) located proximal to the anchor 120 to prevent proximal movement of the anchor when it is pushed into or screwed into the hole 170 in bone 150.

[0129] As discussed in detail herein, because the anchor 120 has a distally tapering structure, and its distal portion can be used to insert soft tissue 160 into the hole 170 in the bone 150 (see, for example, see...). Figure 2DAccording to some embodiments, the inserter 102 does not need to extend distally beyond the anchor 120 on which it is mounted. This may have advantages over prior art devices, in which the inserter includes a retractable portion that must extend distally beyond the anchor to introduce soft tissue into a hole in the bone, and then must retract back into the inserter to remove it from the hole in the bone. In contrast, according to some embodiments, the inserter 102 may be formed from a single integral part, without components that can move relative to each other. This could potentially allow for a simpler design of the inserter 102, thereby reducing costs and avoiding mechanical complexity.

[0130] The inner sleeve shaft 108 may optionally be inserted through the sleeve shaft 104 and may project distally from the distal end 106 of the sleeve shaft 104. According to some embodiments, the sleeve shaft 104 and the inner sleeve shaft 108 may be arranged concentrically along a common longitudinal axis 109. According to some embodiments, the inner sleeve shaft 108 has a distal end 110, which preferably projects distally from the distal end 106 of the sleeve shaft 104. Optionally, according to some embodiments, the sleeve shaft 104 and the inner sleeve shaft 108 may be integrally formed as a single piece. Alternatively, according to some embodiments, the sleeve shaft 104 and the inner sleeve shaft 108 may be detachably attached components or telescopably movable relative to each other, such that the inner sleeve shaft can be stored within the sleeve shaft 104. Alternatively, after inserting the anchor 120 into the hole 170 in the bone 150, retracting the inner sleeve shaft 108 into the sleeve shaft 104 can facilitate the release of the anchor 120 from the inner sleeve shaft.

[0131] Anchor 120 can be formed from any suitable material, such as PEEK (polyetheretherketone), titanium, and biocomposite materials. According to some embodiments, anchor 120 preferably has a stiffness greater than that of bone. Alternatively, according to some embodiments, anchor 120 may have a stiffness less than that of bone. Further, alternatively, according to some embodiments, anchor 120 may have a stiffness substantially the same as that of bone. According to some embodiments, anchor 120 may have elastic properties.

[0132] The length of the anchor 120 can be in the range of 8mm-30mm, for example, it can be selected from 8mm-12mm, 12mm-18mm, 18mm-24mm or 24mm-30mm. For example, for biceps tendon fixation, the length of the anchor 120 can be approximately 19mm.

[0133] According to some embodiments, the anchor 120 may have a distally tapered or generally conical configuration, with its proximal end 122 having a diameter or width D4 ( Figures 3B-3C The diameter or width of this part is greater than the diameter or width D3 of the distal end 124 of the anchor. Figures 3B-3CThe diameter / width D4 of the proximal portion of the anchor can be in the range of 4.5mm-12mm, depending on the size of the mid-bone hole, for example, it can be selected from 4.5mm-7mm, 7mm-10mm, or 10mm-12mm. The diameter / width D3 of the distal portion of the anchor can be in the range of 1.0mm-4.5mm, for example, it can be selected from 1.4mm-2.2mm, 2.2mm-4mm, or 4mm-5mm. For example, for biceps tendon fixation, the anchor 120 may include a proximal portion with a width / diameter of 7mm-10mm and a distal portion with a width / diameter of approximately 4.5mm.

[0134] It should be noted that, according to some embodiments, the maximum diameter of the anchor 120 (i.e., located at the proximal portion of the anchor 120) may be greater than or less than the diameter of the hole 170 in the bone 150; or, alternatively, according to some embodiments, the anchor may have a diameter substantially the same as the hole 170 in the bone 150. For example, according to some embodiments, the maximum diameter of the anchor 120 may be 1 mm larger than the hole 170 to 2 mm smaller than the hole 170.

[0135] According to some embodiments, the anchor 120 may optionally have a circular cross-sectional profile at any point along its length. The ratio of the cross-sectional profile of the anchor portion at or up to 20% of the distance from the distal end 124 to the cross-sectional profile of the anchor portion at or up to 20% of the distance from the proximal end may be at most 1:1.5 (or 1:at least 1.5), such as 1:2, 1:3, 1:4, or 1:5. For example, according to some embodiments, the anchor may have a proximal portion with a diameter D4 in the range of 5mm-10mm, such as 5mm-6mm, 6mm-8mm, 8mm-8.5mm, and 8.5mm-10mm, and a distal portion with a diameter D3 in the range of 3mm-6mm, such as 3mm-4mm, 4mm-5mm, or 5mm-6mm. For example, according to some embodiments, the anchor may have a proximal width or diameter of 8mm-8.5mm and a distal width or diameter of 4mm. Preferably, the anchor has a proximal portion with a diameter of about 8 mm to 8.5 mm and a distal portion with a diameter of about 4 mm. Optionally, the ratio of the average diameter / cross-sectional area of ​​the last 2 mm of the proximal portion of the anchor 120 to the average diameter / cross-sectional area of ​​the last 2 mm of the distal portion of the anchor 120 can be at most 1:1.5 (or 1:at least 1.5), for example, 1:2, 1:3, 1:4, or 1:5. Optionally, the diameter of the anchor can be non-uniformly tapered. Alternatively, the anchor 120 can have a cylindrical configuration. Still alternatively, the anchor 120 can have a non-circular cross-sectional profile. For example, the anchor 120 can have a recess, such as an elongated, shallow axial groove extending from the proximal portion of the anchor 120. This configuration can provide the anchor with a structure in which ligaments can reside. This can potentially reduce trauma to the ligaments when the anchor 120 is inserted into the hole 170 in the bone 150, as discussed herein.

[0136] Anchor 120 may form an internal channel 126, the size of which allows anchor 120 to be fixedly and releasably attached to the distal end 106 of sleeve shaft 104, for example by snap-fit ​​or thread, so that anchor 120 and sleeve shaft 104 can move together when anchor 120 is attached to bone.

[0137] It should be noted that the anchor 120 has a distal end 124 and a proximal end 122. According to some embodiments, the anchor may optionally be frictionally attached to the sleeve shaft 104. According to some embodiments, the anchor 120 may be mounted on the distal portion of the inner sleeve shaft 108 such that the distal end 124 of the anchor 120 is generally arranged adjacent to the distal end 110 of the inner sleeve shaft 108. It should be noted that, according to some embodiments, the anchor 120 is preferably externally threaded.

[0138] According to some embodiments, a particular feature is that the suture 130 may be at least partially received within the inner cannula shaft 108, and a portion of the suture 130 may extend distally from the distal end 110 of the inner cannula shaft 108 and the distal end 124 of the anchor 120. The suture may be of any suitable type, depending on the surgical procedure, such as FiberWire manufactured by Arthrex. Specifically, as... Figure 1A As shown, a portion of the suture 130 extending distally from the distal end 110 of the inner cannula shaft 108 is in the form of a loop 140, which, according to some embodiments, may extend distally to a longitudinal length D1. According to some embodiments, the length of D1 may be in the range of approximately 10 mm to 20 mm, thereby making the loop 140 large enough to capture soft tissue. For example, in biceps tendon fixation, according to some embodiments, the loop 140 may extend distally to a longitudinal length D1 of approximately 10 mm.

[0139] For details, please refer to the following: Figure 1B According to some embodiments, the flexible material fixation device 100 is shown in a tissue preloading operation orientation. The device 100 is shown adjacent to bone 150 and flexible material or soft tissue 160, such as a tendon. As can be seen, in this operation orientation, the soft tissue 160 has been detached from the bone 150 and may optionally be cut to shorten its length as described herein. According to some embodiments, the soft tissue 160 may pass through a loop 140 formed by sutures 130 to secure the soft tissue to an anchor, thereby holding the soft tissue in place relative to the anchor 120 before inserting the anchor 120 and the soft tissue 160 into a hole 170 in the bone 150.

[0140] Now refer to Figure 2A and Figure 2B This is a simplified schematic diagram of a soft tissue fixation device 100, wherein, according to some embodiments, in Figure 2B In the middle, device 100 is shown in the orientation of tissue loading operation.

[0141] According to some embodiments, a particular feature is that the longitudinal length of the suture 130 extending distally from the anchor 120 is adjustable. Specifically, as shown... Figure 2A and Figure 2BAs shown, once the soft tissue 160 has been loaded through the loop 140 of the suture 130, according to some embodiments, the length of the loop 140 can be adjusted by manipulating at least one proximal end of the suture 130 (not shown), for example, by pulling at least one proximal end of the suture in the handle portion (not shown) of the device 100. By adjusting the length of the loop 140 to shorten the loop, the soft tissue 160 can be pulled back towards the anchor 120, thereby securing the soft tissue to the anchor and preventing it from moving when the anchor is inserted into the hole 170 in the bone. Optionally, a component, such as a spool or reel, optionally circular in shape, may be provided as part of or adjacent to the soft tissue fixation device 100. According to some embodiments, it may optionally be located in the handle portion (not shown) of the device 100 for winding at least one proximal end of the suture 130 to adjust the length of the loop 140. Optionally, an adjustment mechanism, such as a slider, may be provided to shorten the loop 140, for example, by 10 mm to 20 mm. Optionally, the adjustment mechanism can be locked. In this way, the length of the suture 130 can be adjusted so that it extends distally from the distal end 124 of the anchor 120 to a longitudinal length D2. Figure 2B ), which is smaller than the longitudinal length D1 ( Figure 1A and Figure 1B According to some embodiments, the loop 140 may be reduced from length D1 to length D2 in the range of 3mm-15mm, depending on the width of the soft tissue to be attached to bone 150. According to some embodiments, for example, in biceps tendon fixation, where the typical diameter of the biceps ligament is 5mm-8mm, the loop 140 may be reduced to approximately 3mm-6mm, thereby allowing the biceps ligament to be secured to the anchor 120 before attachment to bone 150. By adjusting the suture length, according to some embodiments, the soft tissue 160 may be pulled back towards the device 100 before deployment of the anchor 120, as will be discussed further herein.

[0142] It should be noted that, according to some embodiments, a drive mechanism (not shown), such as a drive mechanism including a slider or a motor, may be provided to pull at least one end of the suture 130 proximally relative to the anchor 120, thereby tightening the soft tissue 160 toward the anchor 120. It should be understood that, according to some embodiments, this proximal pull of the suture 130 by an axial or rotating mechanism can adjust the size of the suture loop from D1 to D2.

[0143] Figure 2BIt is also shown that, according to some embodiments, a hole 170 is already formed in the bone 150 before the anchor 120 is inserted into the bone. According to some embodiments, this hole can be formed by any suitable method, such as drilling with a drill bit (not shown). According to some embodiments, the hole is preferably cylindrical. The length of the formed hole 170 can be pre-selected and can be selected from the range of 8mm-33mm, for example, 8mm-12mm, 12mm-16mm, 16mm-19mm, 19mm-22mm, 22mm-25mm, 25mm-28mm, or 28mm-33mm, depending on the length of the anchor 120. Optionally, the hole length can be approximately 8mm. For example, for biceps tendon fixation, the hole 170 can be drilled to a depth of approximately 19mm-22mm. Optionally, as described herein, the diameter of the hole can be pre-selected based on the material and elastic properties of the anchor 120. According to some embodiments, the diameter of the hole 170 can be selected from the range of 2.5mm-13mm, such as 2.5mm-5mm, 5mm-8mm, 8mm-10mm, or 10mm-13mm. For example, for biceps tendon fixation, according to some embodiments, the diameter of the hole 170 can be 8mm.

[0144] It should be noted that, according to some embodiments, since the anchor 120 may be slightly wider than the hole 170 in the bone at a certain portion of its length, the bone directly surrounding / tightly wrapped around the hole 170 may be immediately compressed when the anchor 120 is inserted into the hole 170.

[0145] Alternatively, if the anchor 120 is compressible as described herein, then according to some embodiments, the proximal end of the anchor may be wider than the diameter of the hole 170, for example, by 1 mm to 2 mm. Even so, space may still be provided within the hole 170 for the soft tissue 160, or alternatively, the soft tissue 160 may be arranged within a shallow groove (not shown) in the anchor 120.

[0146] According to some embodiments, the anchor 120 may have a generally circular cross-sectional profile, for example... Figure 4A As shown, it may have an elliptical cross-sectional profile, and the anchor may have different cross-sectional profiles at its proximal and distal portions. Such a structure allows for better fixation of the soft tissue 160 to the anchor and can potentially control the compressive effects of the anchor and / or bone on the soft tissue 160 while achieving its anchoring effect.

[0147] It should be noted that, according to some embodiments, any optional features described in relation to the anchor 120 having a circular cross-sectional profile may also be applied to the anchor having an elliptical cross-sectional profile.

[0148] According to some embodiments, the anchor 120 may also have external threads and / or a ring ( Figure 3D ) or bumps or protrusions ( Figure 3E (or other textured outer surfaces, as described herein.) According to some embodiments, the extension of the ring, bump, or protrusion may be less than 20% of the thickness of the anchor 120. The anchor may have threads with a depth in the range of 0.5 mm to 1.1 mm, such as 0.5 mm to 0.7 mm, 0.7 mm to 0.9 mm, or 0.9 mm to 1.1 mm.

[0149] Optionally, according to some embodiments, the anchor may be provided with 3 to 10 rings 128, which are equidistantly arranged along the anchor 120; or alternatively, according to some embodiments, they are not equidistantly arranged along the anchor. Optionally, according to some embodiments, the rings 128 are provided only on the proximal portion of the anchor, such that they can engage with the cylindrical holes 170 in the bone 150, for example... Figure 3C As shown. Optionally, the anchor 120 may include a plurality of protrusions 129 or other protrusions, such as 10-100 protrusions or other protrusions. According to some embodiments, the protrusions 129 or other protrusions may be arranged in a certain pattern, such as an array of protrusions 129. Alternatively, according to some embodiments, the anchor 120 may be provided with randomly arranged protrusions 129. Optionally, according to some embodiments, the protrusions 129 or protrusions are only provided on the proximal portion of the anchor 120.

[0150] It should be noted that, as described herein, according to some embodiments, rings, protrusions or other protrusions on the anchor 120 may prevent or reduce slippage of the soft tissue 160 relative to the anchor when the anchor and soft tissue are inserted into the hole 170 in the bone 150.

[0151] Anchor 120 may have a circular channel 126 extending therethrough. This configuration of anchor 120 allows the edge of soft tissue 160 to be positioned along the short axis of anchor 120 at the distal (narrower) portion of anchor 120, or within a shallow groove along the distal (narrower) portion of anchor 120, as described herein, so that when anchor 120 is inserted into hole 170 in bone 150, anchor 120 can contact bone 150, while the soft tissue 160 inserted into hole 170 can be isolated from bone cortex. At the proximal (wider) portion of anchor 120, soft tissue 160 can be pressed against softer / more crushable cancellous bone. This allows the force exerted by the user to anchor anchor 120 to bone 150 to separate the force that clamps soft tissue 160 between anchor 120 and bone 150, thereby potentially achieving better attachment of soft tissue 160 relative to bone 150.

[0152] In embodiments where the anchor 120 has an elliptical cross-sectional profile, the anchor 120 may optionally include a textured surface, saddle-shaped protrusions, angular spikes, forked teeth, or other protrusions or projections, such as two protrusions located on the side of the anchor, to be positioned on either side of the soft tissue 160 for stabilizing the soft tissue 160 when it is pushed into the hole 170 in the bone 150.

[0153] An anchor can be screwed into a hole 170 in bone 150 to attach soft tissue to bone without further damaging bone 150. Alternatively, according to some embodiments, the anchor 120 itself can be used to form the hole 170 within bone 150.

[0154] According to some embodiments, a kit (not shown) is provided, including an anchor 120 and a mating drill head (not shown), optionally including a stop to prevent the drill from penetrating bone 150 beyond a preselected depth. Optionally, according to some embodiments, the drill head is sized and shaped to drill a hole 170 of desired size and shape in bone 150. Optionally, the anchor 120 itself may include the drill head. Optionally, as described herein, the drill head is sized and shaped to drill a cylindrical hole 170 or a tapered hole 170 in bone 150.

[0155] A longitudinally extending guide (not shown) can be used to align the inserter 102 and anchor 120 with a hole 170 in the bone 150. The guide may have a handle portion at its proximal end and a distal end intended to be positioned on or near the portion of the bone 150 where the hole 170 is to be drilled. The distal end of the guide may include a textured or toothed surface for holding the guide in place on the bone 150. Optionally, the guide can be used to align a drill bit (not shown) with the location of the hole 170 to be drilled in the bone 150, and after the hole 170 has been drilled in the bone 150, the guide can also be used to align the anchor 120 with the hole 170.

[0156] It should be noted that, according to some embodiments where the anchor 120 is screwed into the hole 170 in the bone 150, when the anchor 120 is screwed into the hole 170 in the bone 150 (or screwed into the bone 150 and simultaneously forming the hole), the inner sleeve shaft 108 and the anchor 120 thereon rotate about the axis 109. However, according to some embodiments, the suture 130 surrounding the soft tissue 160 extends through the inner sleeve shaft 108 and the internal channel 126 of the anchor 120, such that the suture 130 does not rotate with the anchor. Instead, the suture 130 holds the soft tissue 160 in a position adjacent to the bone 150, allowing the anchor to screw into the bone 150, i.e., the anchor can rotate about the suture 130 passing through the sleeve shaft 108, while pushing the end 162 of the soft tissue 160 into the hole 170.

[0157] It should be noted that, for example, tendons can typically attach to sites located within the joint above bone 150 (within...). Figure 2B (Based on the orientation). However, since the soft tissue 160 is fixed within the hole 170 in the bone 150, according to some embodiments, the tendon can be fixed to a location on the bone that is a certain distance from its original joint attachment location. The applicant points out that attaching the soft tissue 160 to the bone 150 in such a location allows the soft tissue to heal, thereby enabling the patient to recover from their injury and preserving the function of the injured soft tissue without severely limiting joint function.

[0158] It should also be noted that, for example, when soft tissues such as ligaments 160 are attached to bone, the muscles connected to the ligament may be stretched to some extent when the ligament is inserted into the hole 170 in the bone 150. Therefore, before inserting the ligament into the hole 170 in the bone 150, the surgeon can estimate the degree of muscle stretching when the ligament is inserted into the hole 170, and thus position the ligament accordingly relative to the hole 170 and the anchor 120, leaving a certain amount of slack, for example, 0.5cm-1cm, in the length of the muscle and ligament. In this way, as the ligament is inserted into the hole 170 in the bone 150, the amount of slack in the muscle can be gradually consumed, thereby providing appropriate tension to the muscle and ligament at the new attachment point between the ligament and the bone 150.

[0159] Figure 2C It shows Figure 2B A simplified schematic diagram of a cylindrical hole in the bone adjacent to a soft tissue fixation device. It should be noted that, according to some embodiments, in... Figure 2B In the middle, the hole 170 in bone 150 has a tapered shape, such as a truncated cone. Figure 2C Combining Figure 2D and Figure 3C Further explanation.

[0160] Now refer to Figure 3A and Figure 3B , it is Figure 1A and Figure 1B A simplified schematic diagram of a soft tissue fixation device 100, wherein, according to some embodiments, Figure 3B The device 100 is shown in an operational orientation for attaching tissue to bone.

[0161] from Figure 3A and Figure 3BAs can be seen, according to some embodiments, the anchor 120 is inserted into the hole 170 in the bone 150 by screwing it into the hole 170, or by screwing it into the bone 150 and forming the hole 170, or by pressing it into the hole 170 in the bone 150, as described herein. During the insertion of the anchor 120 into the hole 170 in the bone 150, according to some embodiments, soft tissue 160 can be securely held by the ring 140 of the device 100 and supported against the inner surface of the hole 170 in the bone 150. Figure 3B As can be seen in the illustrated embodiment, the soft tissue 160 can remain abutting against the distal end 124 of the anchor 120, and generally relative to the longitudinal axis 109 (see figure). Figure 3A The soft tissue 160 is arranged laterally. Additionally, according to some embodiments, a portion of the soft tissue 160 may extend proximally from the distal end 124 of the anchor and proximally out of the hole 170. Alternatively, according to some embodiments, the end 162 of the soft tissue 160 may be located within the hole 170 in the bone 150 without proximally extending out of the hole 170. According to some embodiments, the suture 130 may also extend proximally from the distal end 124 of the anchor surrounding the soft tissue 160, passing through the internal channel 126 of the anchor, such that after the anchor 120 and the soft tissue 160 are inserted into the hole 170 in the bone 150, at least one proximal portion of the suture can be pulled to release the suture 130 from the soft tissue.

[0162] Figure 3A and Figure 3B It is also shown that, once the soft tissue 160 has been attached to the bone 150, according to some embodiments, the sleeve shaft 104 can be retracted proximally, separating the anchor 120 from the sleeve shaft 104 and leaving the anchor 120 within the hole 170 formed in the bone 150. According to some embodiments, in this way, the anchor 120 secures the soft tissue 160 to the bone 150.

[0163] It should be noted that, although from the accompanying drawings, according to some embodiments, the anchor 120 appears to be completely located within the hole 170 in the bone 150 and flush with the opening of the hole 170, those skilled in the art will understand that, alternatively, according to some embodiments, the proximal portion of the anchor may remain outside the opening of the hole, i.e., located proximal to the hole 170, for example if the anchor is longer than the hole and / or the anchor includes a wider proximal head portion (e.g., similar to a pin head). Furthermore, according to some embodiments, after insertion into the hole 170 in the bone 150, the proximal end 122 of the anchor 120 may be located at a position at most 1 mm away from the opening of the hole 170.

[0164] According to some embodiments, after the soft tissue 160 is attached to the bone 150, the suture end extending proximally from the internal channel 126 of the anchor can be removed, for example by pulling one end of the suture to extract it from the device.

[0165] Now refer to another source Figure 2D and Figure 3C It illustrates, according to some embodiments, the cylindrical hole 170 in the bone 150. Figure 3B Soft tissue fixation devices. It should be noted that in Figure 2D In some embodiments, the distal portion of the anchor 120 is inserted into the proximal portion of the cylindrical hole 170 in the bone 150. For example... Figure 3C As shown, according to some embodiments, as the proximal portion of the anchor 120 is inserted into the proximal portion of the hole 170, the distal portion of the anchor 120 is further advanced into the hole 170, thereby positioning it in the distal portion of the cylindrical hole 170.

[0166] It should be noted that, Figures 3B-3C In the illustrated embodiment, it appears that the soft tissue 160 is positioned relative to the anchor 120 before the anchor is inserted into the hole 170 in the bone 150. According to some embodiments, a portion 162 of the soft tissue 160 may protrude beyond the hole 170 after the soft tissue is fixed to the bone 150. Those skilled in the art will understand that, alternatively, according to some embodiments, if necessary, it can be... Figure 2D The soft tissue 160 is positioned relative to the anchor 120 as shown, such that the portion 162 of the soft tissue 160 does not protrude outside the hole 170, but is located inside the hole 170.

[0167] It should be noted that a cylindrical hole 170 is formed in the bone 150 and a fixation device with a tapered anchor 120 is used. Figure 2C , Figure 2D , Figure 3C This can have potential advantages, as described herein. In particular, according to some embodiments, in the early stages of inserting the anchor 120 and soft tissue 160 into the hole 170, when there is a significant width difference between the distal portion of the anchor and the proximal portion of the hole, the combination of these factors can reduce the friction and / or pressure applied to the soft tissue 160. In contrast, Figure 3B In one embodiment, both the anchor 120 and the hole 170 have a tapered configuration. Figure 2C , Figure 2D , Figure 3C It can be seen that, at least in the distal portion of the anchor 120, there is additional space between the distal portion of the anchor and the cylindrical hole (see, for example, see...). Figure 3C (A partial enlarged view), the friction and / or pressure applied to the soft tissue 160 is less. Therefore, according to some embodiments, due to the less friction between the soft tissue 160 and the bone 150, the trauma to the soft tissue 160 may be less during the insertion of the soft tissue 160 into the hole 170 in the bone 150, and optionally after its insertion into the hole 170 in the bone 150, according to some embodiments.

[0168] Furthermore, it should be noted that, due to the distally tapering structure of the anchor 120, friction with the bone 150 will be low as the anchor 120 and soft tissue 160 begin to insert into the hole 170 in the bone 150. As the anchor 120 advances into the hole 170, friction increases; therefore, according to some embodiments, slippage of the soft tissue relative to the hole 170 and the anchor 120 may be less.

[0169] According to some embodiments, reference is now made to Figure 3D and Figure 3E It illustrates anchoring elements that can form part of a soft tissue fixation device. For example... Figure 3D As shown, the anchor 120 includes a plurality of rings 128, including four independent but similarly shaped rings in the illustrated embodiment, equidistantly arranged along the anchor 120. Alternatively, according to some embodiments, the rings 128 may be irregularly arranged along the anchor 120. Optionally, according to some embodiments, more rings 128 may be provided in the proximal or distal portion of the anchor. Further, as an alternative, according to some embodiments, the rings 128 may have different thicknesses or may have an asymmetrical cross-sectional profile.

[0170] According to some embodiments, reference is now made to Figures 4A-4C It can constitute Figure 1A and Figure 1B A schematic diagram of several exemplary anchors 120 as a part of a soft tissue fixation device 100, wherein Figure 4A This is a perspective view facing the near side. Figure 4B and Figure 4C Different planar side views of the anchoring element that forms part of the device. Figure 4B and Figure 4C Two different planar side views of the anchoring element that forms part of the device, according to some embodiments. Figures 4A-4C Some parts of the anchor shown are structurally and functionally similar to... Figures 1A-3B The corresponding parts of the anchoring components shown are similar, so they will not be discussed again.

[0171] Figure 4A The anchor 120 shown has a channel 126 extending through it and having a hexagonal cross-sectional profile. Those skilled in the art will understand that this structure is only one exemplary embodiment; alternatively, the channel 126 may have any other desired cross-sectional profile, such as a square.

[0172] Optionally, the anchor 120 may include a textured surface, saddle-shaped protrusions, angular spikes, forked teeth, or other protrusions or projections, such as two protrusions located on both sides of the soft tissue and at the distal end 124 of the anchor, for stabilizing the soft tissue 160 when pushing the soft tissue 160 into the hole 170 in the bone 150.

[0173] A particular feature of one embodiment of the present invention is that at least one longitudinal groove 180 may be formed on the outer periphery of the anchor 120 and may extend from the outer surface of the anchor 120 to the internal channel 126 of the anchor. Preferably, according to some embodiments, a set of grooves 180 arranged at angular intervals, such as 2-6 grooves, may be formed on the anchor 120, optionally equidistant along the circumference of the anchor, or optionally non-equidistant along the circumference of the anchor, each groove extending from the distal end 124 of the anchor 120 toward the proximal side. According to some embodiments, the grooves may extend radially into the anchor to 10%-80% of the material of the anchor 120. According to some embodiments, the grooves may have a constant depth along their length. Alternatively, according to some embodiments, the depth of the grooves near the distal end of the anchor may be greater. Each groove may extend radially into the material of the anchor 120 by the same amount, or alternatively by different amounts. According to some embodiments, and as an alternative, the groove 180 may be omitted, and instead, a cut-out or notch 156 may be provided on the anchor 120 (see...). Figure 4H Each cutout or notch may narrow the width of a portion of the anchor 120 at selected portions along the circumference of the anchor. According to some embodiments, such a cutout 156 may extend along a portion of the length of the anchor 120, or it may extend along the entire length of the anchor 120. Those skilled in the art will understand that, according to some embodiments, features of the anchor 120 associated with at least one groove 180 may also be applied to the cutout 156. Optionally, at least some grooves may radially penetrate the entire thickness of the anchor 120. According to some embodiments, the grooves 180 may have the same length, for example, up to 85% of the length of the anchor 120. Alternatively, according to some embodiments, some grooves 180 may extend proximally for a different longitudinal length than other grooves 180, for example, 30%-85% of the length of the anchor 120. The grooves 180 may have the same width, for example, in the range of 0.5mm-1.5mm. Alternatively, the grooves 180 may have different widths, for example, selected from 0.5mm-1.5mm. Each groove may have a semi-circular cross-sectional profile, or alternatively, a rectangular cross-sectional profile.

[0174] According to some embodiments, the depth of the groove 180 can reach 50% of the thickness of the anchor 120, and can be configured to impart elasticity to the anchor 120, thereby reducing or minimizing the compressive forces exerted by the anchor 120 on the soft tissue and bone 150. Additionally, the elasticity imparted to the anchor 120 by the groove 180 can reduce the compressive forces exerted by the distal end 124 of the anchor 120 on the soft tissue 160, while simultaneously tautning the soft tissue 160 within the hole 170 in the bone 150. This is because some of the force applied by the user through the drive mechanism can be absorbed by the elasticity of the anchor 120, as the groove 180 allows for partial radial inward deflection of the distal portion of the anchor 120.

[0175] According to some embodiments, as described herein, the groove 180 or other groove or slit allows the suture 130 to extend beyond the anchor 120 at least in a position proximal to the distal end 124 of the anchor. This allows the suture loop to surround the soft tissue 160 while the soft tissue 160 is in a lateral position relative to the anchor 120, rather than, for example, as... Figure 2B The soft tissue 160 is located distal to the anchor. Optionally, the suture 130 may extend from a first groove on the anchor and enter a second groove on the anchor, thereby securing the soft tissue 160 distal to the anchor 120. In this way, the soft tissue 160 can be attached to the anchor 120 along the side of the anchor; when the anchor 120 is screwed into the hole 170 in the bone 150, compared to Figure 3B The soft tissue 160 portion forced into the hole 170 is now shorter.

[0176] Furthermore, according to some embodiments, when soft tissue is fixed to the side of anchor 120, this method results in less potential trauma to the soft tissue compared to when the soft tissue is fixed to the distal end of anchor 120.

[0177] Optionally, in embodiments where the soft tissue 160 is secured to the side of the anchor 120, the anchor may not have an axial channel. Optionally, the anchor may include a rounded distal tip, or may have forked teeth or other protrusions or textured surfaces, and may include a saddle-shaped structure to retain the soft tissue 160. Optionally, in embodiments where the anchor does not rotate when inserted into the hole 170 in the bone 150, the outer surface of the anchor does not need to be smoother and / or does not need to have a cylindrical, tapered, or distally tapered shape.

[0178] It should be noted that in embodiments where the soft tissue 160 can be fixed to the side of the anchor 120, in order to firmly attach the soft tissue 160 to the bone 150, the soft tissue does not need to be as Figure 3C That is, extending completely around the anchor—that is, extending from the opening of the hole 170 in the bone 150 toward the distal end of the hole, around the distal end 124 of the anchor, and then folding back proximally toward the opening of the hole 170. Conversely, if necessary, according to some embodiments, the soft tissue 160 can still be firmly attached to the bone 150 by extending only a portion of this path—that is, from the opening of the hole 170 toward the distal end of the hole and around the distal end 124 of the anchor.

[0179] Alternatively, according to some embodiments, the soft tissue 160 may be held by the groove 180 of the anchor 120 without sutures. In this way, the soft tissue 160 fixed in the groove 180 may be pushed into the hole 170 in the bone 150 along with the anchor 120, thereby inserting the soft tissue 160 into the hole 170 in the bone 150 and attaching the soft tissue 160 to the bone 150.

[0180] Optionally, at least one groove 180 may extend axially and be wide and deep enough to allow soft tissue 160 to be located within the groove, thereby protecting the soft tissue as described herein.

[0181] According to some embodiments, further reference is made. Figure 4D It shows an alternative embodiment of the anchor 120 that forms part of the soft tissue fixation device 100. Figure 4D The anchor 120 shown differs from the aforementioned anchors in that it includes a rounded tip at its distal end, through which the internal channel 126 passes, according to some embodiments. It should be noted that, according to some embodiments, the groove 180 may extend distally to... Figure 4D The rounded tip of the anchor 120 in the middle.

[0182] Figures 4E-4H This is a schematic cross-sectional view of the anchor 120, which forms part of a soft tissue fixation device according to some embodiments, and the soft tissue after insertion into the bone 150 through a hole 170. It should be noted that, according to some embodiments, in... Figures 4E-4H In the diagram, each anchor 120 is shown positioned within a hole 170 in the bone 150 after insertion as described herein.

[0183] Specific reference Figure 4E It should be noted that in the illustrated embodiment, the anchor 120 may have a circular cross-sectional profile, and the hole 170 may also have a circular cross-sectional profile, with a diameter larger than that of the anchor 120, as described herein. Thus, according to some embodiments, at each circumferential portion where the soft tissue 160 contacts the anchor 120, the soft tissue 160 can be pressed against the bone 150. Since the cross-sectional profiles of the anchor 120 and the hole 170 are similar, assuming a uniform soft tissue thickness, the pressure applied to the soft tissue 160 at any circumferential location around the anchor 120 can be uniform. Furthermore, since the anchor 120 has a distally tapering structure, as described herein, the pressure applied to the soft tissue 160 in the proximal portion of the anchor 120 can be greater than the pressure applied to the soft tissue in the distal portion of the anchor 120.

[0184] Now refer to Figure 4F It should be noted that, according to some embodiments, the anchor 120 has an elliptical cross-sectional profile with a longer conjugate diameter D5 and a shorter conjugate diameter D6, and the hole 170 may have a circular cross-sectional profile with a diameter larger than the longer conjugate diameter D5 of the anchor 120, as described herein. Thus, according to some embodiments, at each circumferential portion where the soft tissue 160 contacts the anchor 120, the soft tissue 160 can be pressed against the bone 150. However, due to... Figure 4FBecause the cross-sectional profiles of the anchor 120 and the hole 170 are different, even if the soft tissue 160 has a uniform thickness, the magnitude of the pressure applied to the soft tissue 160 at different points around the anchor 120 may be inconsistent. For example, the pressure applied to the soft tissue 160 may be greater near the wider diameter D5 of the anchor 120, while the pressure applied to the soft tissue 160 may be smaller near the shorter diameter D6 of the anchor 120. Furthermore, because the anchor 120 has a distally tapering structure, as described herein, the pressure applied to the soft tissue 160 in the proximal region of the anchor 120 may be greater than the pressure applied to the soft tissue in the distal region of the anchor 120.

[0185] Now refer to Figure 4G It should be noted that, according to some embodiments, the anchor 120 may generally have a circular cross-sectional profile, except at the cut portion 156, while the hole 170 may have a generally circular cross-sectional profile. The diameter of the hole 170 may be larger than the diameter of the anchor 120, as described herein. Thus, according to some embodiments, at each circumferential portion where the soft tissue 160 contacts the anchor 120, the soft tissue 160 may be pressed against the bone 150. However, due to Figure 4G Because the cross-sectional profiles of the anchor 120 and the hole 170 are different, even if the thickness of the soft tissue 160 is uniform, the pressure applied to the soft tissue 160 at various locations around the anchor 120 can be inconsistent. For example, the pressure applied to the soft tissue 160 may be greater on the soft tissue portions on both sides of the excision portion 156, that is, on the soft tissue portions closer to the curved outer periphery of the anchor 120; while the pressure applied to the soft tissue 160 may be smaller on the soft tissue portions closer to the center of the excision portion 156, that is, on the soft tissue portions further away from the curved outer periphery of the anchor 120. Furthermore, because the anchor 120 has a distally tapering structure, as described herein, the pressure applied to the soft tissue 160 in the region of the proximal portion of the anchor 120 may be greater than the pressure applied to the soft tissue in the region of the distal portion of the anchor 120.

[0186] Now refer to Figure 4H It should be noted that, according to some embodiments, the anchor 120 may generally have a circular cross-sectional profile, except at the groove 180 extending longitudinally along the anchor 120 (as described herein), while the hole 170 may have a generally circular cross-sectional profile. The diameter of the hole 170 may be larger than the diameter of the anchor 120, as described herein. Thus, according to some embodiments, at the various circumferential portions where the soft tissue 160 contacts the anchor 120, the soft tissue 160 may be pressed against the bone 150. However, due to Figure 4HBecause the cross-sectional profiles of the anchor 120 and the hole 170 are different, even if the soft tissue 160 has a uniform thickness, the pressure applied to the soft tissue 160 at various locations around the anchor 120 may be inconsistent. For example, the pressure applied to the soft tissue 160 may be greater in the portion of the anchor 120 without the groove 180, while the pressure applied to the soft tissue 160 may be smaller in the portion of the anchor 120 with the groove 180. It should also be noted that, according to some embodiments, a portion of the soft tissue 160 may extend into the groove 180 as shown. Furthermore, because the anchor 120 has a distally tapering structure, as described herein, the pressure applied to the soft tissue 160 in the region of the proximal portion of the anchor 120 may be greater than the pressure applied to the soft tissue in the region of the distal portion of the anchor 120. It should be noted that by providing at least one groove 180, the pressure applied to the soft tissue 160 in the region of the proximal portion of the anchor 120 may be greater than the pressure applied to the soft tissue in the region of the distal portion of the anchor 120.

[0187] Those skilled in the art should understand that Figures 4E-4H For illustrative purposes only, the illustrated embodiments are shown. Other dimensions and shapes of the anchor 120 are possible according to some embodiments, as are other relationships of the anchor 120 to the dimensions and shape of the hole 170 in the bone 150. Additionally, it should be understood that the degree to which the soft tissue 160 can be compressed is only illustrative; according to some embodiments, the soft tissue can be compressed to a thickness as low as 1 mm or less.

[0188] Now refer to Figure 5A and Figure 5B This is a simplified schematic diagram of a soft tissue device 200 constructed and operable according to some embodiments of the present invention, wherein the device 200 is shown in a tissue preloading operation orientation.

[0189] According to some embodiments, the soft tissue fixation device 200 is structurally and functionally compatible with the soft tissue fixation device 100 ( Figure 1A They are largely similar, differing only in the shape of the seam 130 and the way it is attached to the anchor 120. Figures 6A-6D Several examples have been discussed, as well as how they encircle soft tissue 160, which will be discussed in detail below.

[0190] A particular feature of the soft tissue fixation device 200 is that the suture 130 may include a monofilament 203 housed within the inner sleeve shaft 108, and the distal end of the suture 130 extends distally from the distal end 124 of the anchor 120. The advantage of using a monofilament 203 in the anchor 120 is that the pressure on the soft tissue 160, which is wound around or otherwise secured by the monofilament, may be less. Alternatively, according to some embodiments, the suture 130 may also include multiple strands, multiple loops, or braided components (not shown). Figure 5A and Figure 5B As can be seen, according to some embodiments, the suture enlargement portion 204 is disposed at the distal end of the single strand 203. Optionally, according to some embodiments, the suture enlargement portion 204 may include a knot, a heat-fused portion of the strand, or an attached enlargement member.

[0191] The single strand 203 of the suture 130 may extend distally by up to 20 mm from the distal end 124 of the anchor and be configured to capture soft tissue 160, subsequently securing it to an attachment position on the inner sleeve shaft 208. According to some embodiments, it may optionally be locked onto the inner sleeve shaft, such as as described herein. According to some embodiments, the single strand 203 of the suture 130 may be manipulated or pushed distally, or pushed against a surface, optionally manually, optionally using a probe or other suitable tool, to effectively capture the soft tissue, allowing it to be held / supported relative to the device. To secure soft tissue to the anchor, the suture extension 204 may be attached at a proximal position to the distal end of the anchor 120 to an attachment point on the anchor itself, an attachment point on the inner sleeve shaft 208, an attachment point on another portion of the inserter 102, or to a portion of the device 200 located between the anchor 120 and the inserter 102, as will be discussed further below. Optionally, an opening, such as a groove 180, may be provided on the anchor. Figure 4A Alternatively, another opening on the anchor can be used to insert the suture extension 204, thereby allowing the suture extension to be connected at the attachment position to the inner sleeve shaft 208, another part of the inserter 102, or a part of the device 200 located between the anchor 120 and the inserter 102.

[0192] Further reference Figure 6A , Figure 6B , Figure 6C and Figure 6D It constitutes Figures 5A-5B Simplified views of various embodiments of the inner sleeve shaft 208, a part of the soft tissue fixation device 200.

[0193] Figure 6A This is a top perspective view of one embodiment of the inner sleeve shaft 208, which includes a groove 210 extending proximally and terminating in an opening or recess 214. According to some embodiments, a portion of the suture 130, such as a monofilament 203, may pass through the inner sleeve shaft 208, and the monofilament 203 may exit the channel via an opening 216 in the distal portion 110 of the inner sleeve shaft 208. It should be noted that, according to some embodiments, in... Figure 6A In this case, the groove may be aligned with the opening or recess 214, as will be explained in further detail below.

[0194] exist Figure 6BIn some embodiments, the groove 210 and the opening or recess 214 are located on one side of the inner sleeve shaft, optionally near its top. According to some embodiments, the groove 210 and the opening / recess 214 are sized and shaped to accommodate the single strand 203 and the suture extension portion 204 of the suture 130, respectively.

[0195] Figure 6C Another embodiment of the inner sleeve shaft 208 is shown, wherein the groove 210 may be formed on the top of the inner sleeve shaft 208, or alternatively, the groove may not be provided (e.g. Figures 6A-6B The groove 210 shown, and the distal portion 110 of the inner sleeve shaft 208 may be formed with a hole or recess 214 for accommodating the suture extension portion 204.

[0196] Figure 6D Another alternative embodiment of the inner sleeve shaft 208 is shown, which has a groove 210 formed therein, and according to some embodiments may optionally not have an opening or recess (e.g. Figures 6A-6C (The opening or recess shown is 214).

[0197] Combination Figures 6E-6H It can be done manually Figures 6A-6D The suture extension 204 shown is pressed into a corresponding opening or recess 214. Optionally, a tool is used to insert the suture extension 204 into the opening or recess 214 and optionally lock it therein. Optionally, the suture extension 204 can snap into the opening or recess 214. Optionally, according to some embodiments, the material of the inner sleeve shaft 208, at least around the opening or recess 214, can be sufficiently flexible to allow the opening / recess to receive the suture extension 204. Optionally, according to some embodiments, the suture extension 204 can snap into the opening / recess 214 by applying force. Optionally, the suture extension 204 itself can be sufficiently flexible to be deformable and / or compressible to allow it to be inserted into the opening / recess 214 and removably retained therein.

[0198] It should be noted that, except in some embodiments where a groove 210 is formed thereon and extends proximally from its distal end 212, according to some embodiments, the inner sleeve shaft 208 is in most respects compatible with... Figure 1A and Figure 1B Similar to the inner sleeve shaft 108. Optionally, as described herein, the groove 210 may terminate at an opening or recess 214, said opening or recess being configured to receive the suture augmentation portion 204.

[0199] Figures 5A-6HA particular feature of the illustrated embodiment of the invention is that the distal end 212 of the inner sleeve shaft 208 can be configured to allow soft tissue 160 to be arranged adjacent to it, and once the anchor 120 is supported on the soft tissue 160, the suture 130 can extend distally relative to the anchor 120, optionally via the anchor channel 126, and form a loop by securing the suture extension 204 within the groove 210 and / or opening / recess 214 of the inner sleeve shaft 208, thereby capturing the soft tissue 160 therein. Optionally, before inserting the suture extension 204 into the groove 210 and / or opening / recess 214 of the inner sleeve shaft 208, it can be optionally routed via an opening or slit in the anchor 120, such as groove 180. Figures 4A-4C () Passes through a portion of anchor 120.

[0200] After the suture extension portion 204 is fixed in the opening / recess 214 of the inner sleeve shaft 208, the soft tissue 160 can be secured to the device 200 by pulling the proximal portion of the suture strands (optionally located in the handle portion of the device 200) to tighten the soft tissue 160. Once the soft tissue 160 is secured to the device 200, according to some embodiments, it can be pressed against... Figure 1A The anchor is inserted into the hole 170 in the bone 150 in a manner similar to that discussed in the embodiments. Alternatively, the anchor 120 may be screwed into the hole 170 in the bone 150, and as described herein, the femur 203 does not rotate with rotation of the anchor 120. Alternatively, as described herein, the anchor 120 may be pressed into the hole 170 in the bone 150.

[0201] Optionally, in an embodiment where the anchor 120 is screwed into the hole 170 in the bone 150, the suture strand 203 may be located between the anchor 120 and the inserter 102, whereby rotation of the inserter 102 and / or removal of the inserter 102 from the anchor 120 releases the proximal end of the suture strand 203. Optionally, the opening / recess 214 may include a distally extending beveled portion to allow the suture extension portion 204 to be released from the opening / recess 214 as the inner sleeve shaft 208 moves proximally relative to the anchor 120.

[0202] According to some embodiments, the inner sleeve shaft 208 may include a rotating panel (not shown) distal to the opening / recess 214 for selectively retaining the suture extension 204 within the opening / recess 214. For example, according to some embodiments, the rotating panel may rotate about the longitudinal axis 109 in a first direction to close the recess 210, thereby preventing the strand 203 from moving out of the recess 210, and retaining the suture extension 204 within the opening / recess 214. When it is necessary to release the suture extension 204 from the opening / recess 214, for example after the anchor 120 and soft tissue 160 are inserted into the hole 170 in the bone 150, the rotating panel may rotate about the longitudinal axis 109 in a second direction opposite to the first direction to allow the strand 203 to be released from the recess 210, thereby also releasing the suture extension 204 from the opening / recess 214.

[0203] After the anchor is inserted into the hole 170 in the bone 150, the suture extension portion 204 can be retained within the opening / recess 214 of the inner cannula shaft 208, and the proximal portion of the suture 130 (optionally located in the handle portion of the device 200) can be released. According to some embodiments, releasing the proximal portion of the suture 130 allows the suture 130 to be pulled distally through the opening 216 as the inserter portion of the device 200 (including the cannula shaft 104 and the inner cannula shaft 208) is pulled proximally and displaced from the surgical site, thereby leaving the anchor 120 within the hole 170 in the bone 150.

[0204] Alternatively, another type of suture or thread can be used instead of the suture, such as shape memory alloy sutures, like nitinol. The advantage of using nitinol sutures is that they are easier to manipulate compared to other sutures, such as suture strand 203. Additionally, the push / pull and / or deformable nitinol sutures can be in a hook or J-shaped configuration to secure the soft tissue 160 relative to the anchor 120 without attaching the distal end of the nitinol suture to the anchor or inserter 102. Alternatively, if the strand 203 is sufficiently rigid and optionally made of metal, it may include barbs or other structures for piercing the soft tissue 160 to hold it relative to the anchor 120. Furthermore, using nitinol sutures allows the device 200 to hold the soft tissue 160 more tightly because the nitinol material can be shortened from the time the device 200 is inserted into the body until the anchor 120 is screwed into the hole 170 in the bone 150. However, in embodiments including Nitinol wire, if necessary, the anchor 120 and soft tissue 160 can be removed as described herein after insertion into the hole 170 in the bone 150.

[0205] Figure 7A The flowchart illustrates a method 300 for attaching soft tissue to bone using the soft tissue fixation device 100 described herein, according to some embodiments.

[0206] According to method 300, in step 302, the soft tissue to be attached to the bone may be captured in a suture loop of an anchor for attachment to the soft tissue fixation device, according to some embodiments. This process may be accomplished by manipulating the loop of a device, for example... Figure 1A The device 100 shown has a ring 140 that extends distally from the anchor 120, and as shown... Figure 2B The end 162 of the soft tissue 160 is shown. In step 304, by pulling the proximal end of the suture, the size of the loop 140 can be changed from D1 ( Figure 1B ) reduced to D2 ( Figure 2A This secures the soft tissue 160 to the anchor 120, according to some embodiments. In step 306, the distal portion of the anchor 120 and the soft tissue 160 secured to the anchor 120 can be inserted into a hole 170 in the bone 150, the hole optionally tapering distally (see...). Figure 2B ) or cylindrical (see Figure 2C The hole may have been pre-formed in the bone as described herein. Alternatively, the anchor 120 may be drilled into the bone 150 to form a hole 170 in the bone. In step 308, the anchor 120 (particularly the proximal portion of the anchor) together with the soft tissue attached to the anchor 120 may be inserted into the hole 170 in the bone 150, and the distal portion of the anchor may be further advanced into the hole in the bone. Optionally, the anchor 120 may now be completely located within the hole 170 in the bone 150, and / or the proximal end of the anchor may be flush with the proximal end of the hole 170 in the bone 150, and the soft tissue 160 may be firmly attached to the bone 150. Optionally, in step 310, if necessary, the suture including the loop 140 may be removed from the surgical site.

[0207] Figure 7B The flowchart illustrates a method 400 for attaching soft tissue to bone using the soft tissue fixation device 200 described herein, according to some embodiments.

[0208] According to method 400, in some embodiments, in step 402, a retainer 130 may extend from the anchor 120 to capture soft tissue 160 to be attached to bone. The retainer may be, for example, a suture, thread, nitinol filament, braided structure, or other distally extending member. In step 404, the soft tissue 160 may be captured by manipulating a portion of the retainer 130 relative to the soft tissue 160. According to some embodiments, the retainer 130 may include barbs or other sharp portions on its distal portion to pierce the soft tissue, thereby retaining it relative to the anchor 120. According to some embodiments, the retainer may include nitinol filament.

[0209] Optionally, according to some embodiments, the retainer 130 may include a J-shaped or hook-shaped structure that can hook or otherwise retain soft tissue 160 relative to the anchor 120, and may also include barbs or other structures that can pierce the soft tissue 160. According to some embodiments, in step 406, the distal portion of the anchor 120, together with the soft tissue 160 secured to the anchor 120, may be inserted into the proximal portion of a hole 170 in the bone 150, the hole optionally being distally tapered or cylindrical, as described herein. According to some embodiments, the hole 170 may have been pre-formed in the bone 150, or alternatively, the hole 170 may be formed when the anchor is inserted into the bone 150. In step 408, according to some embodiments, as the proximal portion of the anchor is inserted into the hole 170 in the bone, the distal portion of the anchor may be further advanced within the hole 170 in the bone 150. Optionally, according to some embodiments, the anchor 120 may now be completely located within the hole 170 in the bone 150, and / or the proximal end of the anchor may be flush with the proximal end of the hole 170 in the bone 150, and the soft tissue 160 may be securely attached to the bone 150. After the soft tissue 160 is attached to the bone 150, optionally, in step 410, the retainer 130 may be removed from the surgical site if necessary.

[0210] Alternatively, according to some embodiments, in step 412, the distal portion of the retainer 130 may be attached to an attachment point on the fixation device 200. This attachment point may be located on a portion of the fixation device 200 proximal to the anchor 120 and may include a hole or recess 214 on the fixation device 200. Attaching the distal portion of the retainer 130 to this attachment point allows the retainer 130 to retain the soft tissue 160 relative to the anchor 120. In step 414, according to some embodiments, the distal portion of the anchor 120, together with the soft tissue 160 fixed to the anchor 120, may be inserted into a proximal portion of a hole 170 pre-formed in the bone 150, which may optionally be distally tapered or cylindrical. In step 416, according to some embodiments, as the proximal portion of the anchor is inserted into the hole in the bone, the distal portion of the anchor may be further advanced within the hole 170 in the bone 150. Optionally, according to some embodiments, the anchor 120 may now be completely located within the hole 170 in the bone 150, and / or the proximal end of the anchor may be flush with the proximal end of the hole 170 in the bone 150, and the soft tissue 160 may be securely attached to the bone 150. After the soft tissue 160 is attached to the bone 150, in step 418, the retainer 130 may be released from the attachment point. Optionally, in step 420, the retainer 130 may be removed from the surgical site.

[0211] It is anticipated that many related fastening devices may be developed during the patent lifecycle of this application, and the scope of the terms “fastening device” and / or “anchor” is intended to include all such new technologies a priori.

[0212] The term “about” as used in this article refers to ±10%.

[0213] The terms “comprises,” “comprising,” “includes,” “including,” “having,” and their variant forms, mean “including but not limited to.”

[0214] The term "composed of" means "including and limited to".

[0215] The term "basically composed of" means that the composition, method, or structure may include additional ingredients, steps, and / or components, but only if such additional ingredients, steps, and / or components do not substantially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0216] Unless the context explicitly requires otherwise, the singular forms “a,” “an,” and “the” used herein include the plural meaning. For example, the terms “a compound” or “at least one compound” may include multiple compounds, including mixtures thereof.

[0217] Throughout this application, various embodiments of the invention may be described in a range format. It should be understood that this range format is for convenience and brevity only and should not be construed as a rigid limitation on the scope of the invention. Therefore, a description of a range should be considered as a specific disclosure of all possible subranges within that range and each individual numerical value within that range. For example, a description of the range 1 to 6 should be considered as a specific disclosure of subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and each individual number within that range, such as 1, 2, 3, 4, 5, and 6. This understanding applies regardless of the breadth or narrowness of the range.

[0218] Wherever a range of values ​​is specified herein, it is intended to include any value (fraction or integer) cited within that range. The phrases “variation between the first and second indicators” and “variation from the first to the second indicator” are used interchangeably herein and are intended to include the first and second indicators as well as all fractional and integer values ​​in between.

[0219] As used in this article, the term "method" refers to the manner, means, techniques, and procedures for accomplishing a particular task, including but not limited to those known to those skilled in the art of chemistry, pharmacology, biology, biochemistry, and medicine, or those manner, means, techniques, and procedures that may be readily developed by them based on known manner, means, techniques, and procedures.

[0220] The term “treatment” as used in this article includes eliminating, substantially inhibiting, slowing or reversing the progression of the condition, substantially improving the clinical or aesthetic symptoms of the condition, or substantially preventing the occurrence of the clinical or aesthetic symptoms of the condition.

[0221] It should be understood that certain features of the invention described in different embodiment contexts for clarity may also be provided in combination in a single embodiment. Conversely, various features of the invention described in a single embodiment context for brevity may also be provided separately, or in any suitable sub-combination, or applicable to any other described embodiment of the invention. Unless an embodiment cannot be practiced without such elements, certain features described in different embodiment contexts should not be considered essential features of those embodiments. Furthermore, any priority documents of this application are incorporated herein by reference in their entirety.

Claims

1. A flexible material fixation device configured for fixing a flexible material to bone, the device comprising: An anchor having a distally tapering structure, the anchor being sized and shaped to fit into a hole in bone, wherein the anchor is formed from a single integral part, and wherein the anchor is sized to insert into a hole in bone and apply sufficient pressure to one of tissue and artificial material such that the one of tissue and artificial material is anchored to bone.

2. The flexible material fixing device according to claim 1, wherein, The flexible material is a ligament.

3. The flexible material fixing device according to claim 1, wherein, The flexible material is a flexible man-made material.

4. The flexible material fixing device according to any one of claims 1-3, wherein, The anchor includes a proximal portion having a first average cross-sectional area and a distal portion having a second average cross-sectional area, the first average cross-sectional area being larger than the second average cross-sectional area, wherein the ratio of the second average cross-sectional area to the first average cross-sectional area is at most 1:1.

5.

5. The flexible material fixing device according to any one of claims 1-3, wherein, The anchor includes a proximal portion having a first average diameter and a distal portion having a second average diameter, the first average diameter being larger than the second average diameter, wherein the ratio of the second average diameter to the first average diameter is at most 1:1.

5.

6. The flexible material fixing device according to claim 5, wherein, At least one of the first average diameter and the second average diameter is measured at 10% of the axial length of the anchor.

7. The flexible material fixing device according to claim 1, wherein, The anchor has an internal channel extending along a longitudinal axis from the proximal portion of the anchor to the distal portion of the anchor.

8. The flexible material fixing device according to claim 1, wherein, The anchor has one of a circular cross-sectional profile and an elliptical cross-sectional profile.

9. The flexible material fixing device according to any one of claims 1-3, wherein, The anchor has one of the following: Smooth outer surface; The outer surface of at least one of the protrusions and bumps; The outer surface includes an array of bumps and protrusions. Textured outer surface; Includes the outer surface of at least one circular ring; and Including the outer surface of the thread.

10. The flexible material fixing device according to claim 9, wherein, The anchor has an outer surface including at least one of a protrusion and a projection, wherein the protrusion or projection extends by less than 20% of the thickness of the anchor.

11. The flexible material fixing device according to claim 10, wherein, The anchor has an outer surface comprising a plurality of rings, the plurality of rings including a farthest ring and a nearest ring, wherein the dimension of the farthest ring in the radial direction is smaller than the dimension of the nearest ring in the radial direction.

12. The flexible material fixing device according to any one of claims 1-3, wherein, The anchor includes a tip with a width in the range of 2mm-4mm.

13. The flexible material fixing device according to any one of claims 1-3, wherein, The anchor has a longitudinal axis and an outer surface comprising a plurality of rings, wherein each of the rings has a proximal side that is substantially perpendicular to the longitudinal axis of the anchor.

14. The flexible material fixing device according to any one of claims 1-3, wherein, The anchor includes at least one longitudinally oriented groove extending toward the distal portion of the anchor.

15. The flexible material fixing device according to claim 14, wherein, The at least one groove: Angled relative to the longitudinal axis of the anchor, or It is a spiral groove extending from the distal end of the anchor to the proximal side.

16. The flexible material fixing device according to claim 14, wherein, Each of the at least one groove extends radially into the anchor element by 10%-80% of the anchor element material.

17. The flexible material fixing device according to claim 14, wherein, The at least one groove extends through the entire thickness of the anchor.

18. The flexible material fixing device according to claim 14, wherein, The at least one groove has the same length.

19. The flexible material fixing device according to claim 14, wherein, The at least one groove includes at least two grooves with different lengths.

20. The flexible material fixing device according to claim 14, wherein, The at least one groove includes a plurality of grooves that are radially and equidistantly distributed around the anchor.

21. The flexible material fixing device according to claim 14, wherein, The at least one groove includes a plurality of grooves that are radially and non-equidistantly distributed around the anchor.

22. The flexible material fastening device according to any one of claims 1-3, further comprising a suture extending distally from the anchor.

23. The flexible material fixing device according to claim 22, wherein, The anchor has an internal channel extending along a longitudinal axis from the proximal portion of the anchor to the distal portion of the anchor, wherein a portion of the stitch extends out of the internal channel of the anchor.

24. The flexible material fixing device according to claim 22, wherein, The seam can move axially relative to the anchor.

25. The flexible material fastening device of claim 24, further comprising a control button for manually adjusting the length of a portion of the suture.

26. The flexible material fixing device according to claim 24, wherein, A portion of the seam extends through the anchor.

27. The flexible material fixing device according to claim 22, wherein, The stitch is a single strand extending distally from the anchor.

28. The flexible material fixing device according to claim 24, wherein, A portion of the suture defines a loop.

29. The flexible material fixing device according to claim 24, wherein, The suture includes a portion extending distally from the flexible material fastener, the portion being sized and shaped to form a loop, wherein the distally extending portion of the suture includes a first suture end capable of attaching to the fastener.

30. The flexible material fixing device according to claim 29, wherein, The fastening device includes an attachment location, wherein the first suture end includes a portion sized and shaped to be attached to the attachment location by geometric interference at the attachment location.

31. The flexible material fixing device according to claim 30, wherein, The portion of the first suture end is releasably inserted into the hole or recess at the attachment location; and at least one of the following is true: The first suture end can be released from the attachment position; and The device includes a second suture end that can be released from the proximal portion of the device.

32. The flexible material fixing device according to claim 22, wherein, After the anchor is deployed, the size and shape of the anchor are adapted to maintain the fixation of the tissue relative to the bone without tying the suture.

33. The flexible material fixing device according to any one of claims 1-3, further comprising an inserter having a sleeve shaft having a distal end; in, The anchor is sized and shaped to be releasably mounted on the distal end of the sleeve shaft.

34. The flexible material fixing device according to claim 33, wherein, The anchor is releasably and securely attached to the sleeve shaft by friction between the anchor and the sleeve shaft.

35. The flexible material fastening device according to claim 33, further comprising a suture extending distally from the anchor, wherein, The size and shape of the suture are adapted to pass through the sleeve shaft.

36. The flexible material fixing device according to claim 35, wherein, The anchor includes at least one longitudinally oriented groove extending toward the distal portion of the anchor, and the size and shape of the stitch are adapted to pass through the at least one groove.

37. The flexible material fixing device according to claim 36, wherein, The anchor is sized and shaped to be screwed into a hole in the bone.

38. The flexible material fixing device according to any one of claims 1-3, wherein, The anchor is sized and shaped to be inserted into a hole in the bone by applying a force toward the distal side to the anchor.

39. A method for attaching a flexible material to bone, the method comprising: The flexible material is captured in a ring attached to the anchor, the ring having a first diameter; The diameter of the ring is reduced to a second diameter, wherein the ring with the second diameter secures the flexible material to the anchor. as well as The anchor, on which the flexible material is fixed, is inserted into a hole in the bone.

40. A method for attaching a flexible material to bone, the method comprising: Extending a retainer attached to the anchor to capture one of the flexible material and the artificial material; The flexible material is captured by the curved portion of the retainer to secure it to the anchor. as well as The anchor, on which the flexible material is fixed, is inserted into a hole in the bone.

41. A kit for attaching a flexible material to bone, the kit comprising: Anchors with pre-selected sizes and shapes; as well as Description for indicating the drill bit size suitable for drilling a hole in the bone for a pre-selected anchor, wherein the description indicates the drill bit size according to the condition of the flexible material.

42. The kit of claim 41 further includes at least one drill bit for drilling a hole in the bone.

43. The kit according to claim 42, wherein, Each of the at least one drill bit includes a stop for preventing the anchor from moving proximally.

44. A flexible material fixation device for fixing a flexible material to bone, the device comprising: The size and shape are suitable for fitting into the holes in the bone of the anchor; as well as An introducer of a size and shape suitable for mounting the anchoring element thereon, wherein the introducer is formed of a single integral part and has no parts that can move relative to each other.

45. The flexible material fixing device according to claim 44, wherein, The anchor is attached to the introducer.

46. ​​The flexible material fixing device according to claim 44, wherein, The anchor is mounted on the introducer.

47. A flexible material fixation device for fixing a flexible material to bone, the device comprising: The size and shape are suitable for fitting into the holes in the bone of the anchor; as well as An introducer of a size and shape suitable for mounting the anchoring element thereon, wherein the introducer does not extend distally beyond the anchoring element.

48. The flexible material fixing device according to claim 27, wherein, The single strand is at least partially formed from one of nickel-titanium alloys.

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