Anchors and anchor systems for repairing soft tissue

Abstract

This invention discloses an anchor and anchor system for repairing soft tissue. The anchor includes an anchor body, a suture, and a flexible portion. One end of the suture is connected to the flexible portion, while the other end is free outside the anchor body. The flexible portion is fixed to the distal end of the anchor body under tension by the suture and has a permeable structure. The anchor can be used as a suture-attached anchor: after the anchor is placed in the target object, the free end of the suture passes through the soft tissue and is knotted, fixing the soft tissue to the surface of the target object. The suture free outside the target object after knotting is the soft tissue suture. Alternatively, the anchor can be used as a knotless anchor: the soft tissue suture passes through the permeable structure, placing the anchor in the target object and fixing the soft tissue suture within it. The flexible portion replaces existing terminals. Due to its inherent characteristics, after the anchor is implanted into the bone, the flexible portion is further compressed within the bone marrow tract, occupying almost no space and avoiding increasing the depth of the bone marrow tract.

Description

[0001] This application is a divisional application of the parent application CN202211053505.5, which was filed on August 31, 2022, with application number CN202211053505.5 and invention title "An anchor and anchor system for repairing soft tissue". Technical Field

[0002] This invention belongs to the field of medical device technology, and particularly relates to a knotless anchor for fixing soft tissue sutures in bone, a suture anchor for repairing soft tissue, and an anchor system. Background Technology

[0003] Different implantable devices are used clinically for various soft tissue injuries. Suture anchors are commonly used implantable soft tissue repair devices. Clinical conditions such as rotator cuff tears, knee collateral ligament injuries, and soft tissue injuries of the ankle and elbow joints are usually treated with suture anchors.

[0004] Suture anchors are very small implants. During use, a bone tunnel is first created in the bone using a punch. The anchor is then inserted under the cortical bone using an anchor inserter. Sutures are used to fix the avulsed or torn soft tissue to the bone surface, promoting healing between the soft tissue and bone to achieve a repair effect. However, there is a problem with insufficient fixation strength. Therefore, knotless anchors are used in conjunction with suture anchors to improve the fixation strength between the soft tissue and bone. Specifically, during surgery, the suture anchor is first inserted into the bone, and sutures are used to fix the soft tissue to the bone surface. Then, the sutures are passed through the suture hole of the knotless anchor, and the knotless anchor is inserted into the bone at an appropriate location. The soft tissue sutures are fixed within the bone marrow tract by the compression of the anchor itself.

[0005] However, the existing suture holes for passing through soft tissue sutures are located on the terminals at the distal end of the knotless anchor. The terminal setting undoubtedly increases the length of the knotless anchor, which means that a deeper bone marrow tunnel needs to be drilled in the bone. Summary of the Invention

[0006] To address the above-mentioned technical problems, the first objective of this invention is to provide a knotless anchor for fixing soft tissue sutures in bone. A flexible portion is used instead of the existing terminal. The soft tissue suture is passed through the flexible portion. Since the flexible portion itself is soft and has a large deformation capacity, after the knotless anchor is implanted into the bone, the flexible portion is deformed and compressed and squeezed into the bone marrow tract, occupying almost no space and therefore not increasing the depth of the bone marrow tract.

[0007] A second objective of the present invention is to provide a suture anchor for repairing soft tissue, which does not require any structure for fixing sutures on the anchor body, but instead provides a flexible part on the outer side of the distal end of the anchor body, the flexible part is connected to the suture, and is fixed to the distal end of the anchor body under the pull of the suture.

[0008] The third objective of this invention is to provide an anchor for repairing soft tissue that can function as both a suture anchor and a knotless anchor, achieving structural uniformity and ease of use.

[0009] A fourth objective of this invention is to provide an anchor system for repairing soft tissue.

[0010] To achieve the above objectives, the technical solution of the present invention is as follows:

[0011] A knotless anchor for fixing soft tissue sutures in bone includes an anchor body and a flexible portion. The anchor body has a distal end and a proximal end. The flexible portion is located at the distal end of the anchor body. The flexible portion has a structure through which the soft tissue suture can pass. The flexible portion is fixed at the distal end of the anchor body when under tension.

[0012] After the anchor body is positioned on the target object, the soft tissue suture fixes the soft tissue to the surface of the target object. Then, the soft tissue suture is passed through the flexible part, and the knotless anchor is positioned in the target object, thereby fixing the soft tissue suture in the target object, and the flexible part is in a deformable and compressed state.

[0013] In one embodiment of the present invention, the anchor body has a hollow structure along its axial direction, a traction wire is disposed through the hollow structure and connected to the flexible part at the distal end of the anchor body, the traction wire is configured to be pulled, and the flexible part abuts against the distal end of the anchor body. In another embodiment of the present invention, the permeable structure is a through hole, the traction wire is configured to be pulled, and the diameter of the through hole is adjustable when the flexible part moves along the axial direction of the anchor body.

[0014] In one embodiment of the present invention, while the flexible part moves toward the distal end of the anchor body, the flexible part contracts and deforms, at least partially abutting against the distal end of the anchor body, and the diameter of the thread hole decreases.

[0015] In one embodiment of the present invention, the flexible part includes a self-locking structure, the self-locking structure having a threading hole;

[0016] The traction line is connected to the self-locking structure. When the self-locking structure moves toward the far end of the anchor body, the diameter of the thread hole decreases, and the self-locking structure contracts and deforms until it abuts against the far end of the anchor body.

[0017] In one embodiment of the present invention, the self-locking structure includes a first flexible sleeve and a flexible wire, the two ends of the flexible wire being located inside the first flexible sleeve to form a first annular structure, and the first annular structure creating the threading hole;

[0018] The traction line includes a first traction line and a second traction line. The non-free end of the first traction line is connected to one end of the flexible line, and the non-free end of the second traction line is connected to the other end of the flexible line. The free ends of the first traction line and / or the second traction line are pulled. The portion of the flexible line exposed in the first flexible sleeve enters the first flexible sleeve. The first flexible sleeve abuts against the far end of the anchor body, and at the same time, the diameter of the thread hole is reduced.

[0019] In one embodiment of the present invention, the traction line forms a second loop structure at the distal end of the anchor body, the traction line located at the second loop structure passes through a first flexible locking knot, the second loop structure and the first flexible locking knot form the flexible part, and the second loop structure is configured as the threading hole;

[0020] The soft tissue suture passes through the second loop structure, the traction suture is configured to pull, the first flexible locking knot moves toward the distal end of the anchor body until the first flexible locking knot deforms and abuts against the distal end of the anchor body, and the diameter of the thread hole decreases.

[0021] In one embodiment of the present invention, the first flexible locking knot is a second flexible sleeve, and the second flexible sleeve is sleeved on the traction line.

[0022] In one embodiment of the present invention, the cross-section of the second flexible sleeve is circular or flat.

[0023] In one embodiment of the present invention, the first flexible locking knot has at least a first hole and a second hole, and the traction wire passes through the first hole and the second hole in sequence.

[0024] In one embodiment of the present invention, the first flexible locking junction is a flat sheet structure.

[0025] In one embodiment of the present invention, the flexible part includes a suture loop and a second flexible locking knot passing through the suture loop, the suture loop being configured as the thread hole, and the traction thread and the soft tissue suture passing through the suture loop respectively;

[0026] The traction line is configured to be pulled, and the second flexible locking knot and the loop move toward the distal end of the anchor body. The loop is squeezed and deformed, and partially enters the distal end of the anchor body until the second flexible locking knot deforms and abuts against the distal end of the anchor body.

[0027] In one embodiment of the present invention, the cross-section of the wire forming the loop is circular or flat.

[0028] In one embodiment of the present invention, the second flexible locking knot is a third flexible sleeve, which is sleeved on the line forming the loop.

[0029] In one embodiment of the present invention, the cross-section of the third flexible sleeve is circular or flat.

[0030] In one embodiment of the present invention, the second flexible locking knot has at least a third hole and a fourth hole, and the wire forming the loop passes through the third hole and the fourth hole in sequence.

[0031] In one embodiment of the present invention, the second flexible locking junction is a flat sheet structure.

[0032] In one embodiment of the present invention, the flexible part is a knot, which is fixed at the distal end of the anchor body when the knot is pulled.

[0033] The present invention also provides a suture anchor for repairing soft tissue, comprising an anchor body, a flexible portion, and a suture, wherein one end of the suture is connected to the flexible portion and the flexible portion is disposed at the distal end of the anchor body, and the other end of the suture is free outside the proximal end of the anchor body.

[0034] When the flexible part is pulled by the suture, it is fixed at the distal end of the anchor body and is at least partially located outside the anchor body. The flexible part is used to fix the suture and prevent the suture from detaching from the anchor body.

[0035] After the anchor body is placed into the target object, the flexible part is fixed inside the target object and pulls the suture, which is deformed and compressed. The free end of the suture passes through the soft tissue and fixes the soft tissue to the surface of the target object, thereby repairing the soft tissue.

[0036] In one embodiment of the present invention, the anchor body is provided with a first inner cavity along its axial direction to allow a suture to pass through, one end of the suture is connected to the flexible part, and the other end is free outside the proximal end of the anchor body.

[0037] In one embodiment of the present invention, the suture is configured to be pulled, and the flexible portion moves toward the distal end near the anchor body until it abuts against the distal end of the anchor body.

[0038] In one embodiment of the present invention, the flexible portion abuts against the distal end of the anchor body.

[0039] The present invention also provides an anchor for repairing soft tissue, comprising an anchor body, a flexible part and a suture, wherein the flexible part is located outside the distal end of the anchor body, one end of the suture is connected to the flexible part and the other end is free outside the anchor body, the flexible part is fixed to the distal end of the anchor body when pulled by the suture, and the flexible part has a passable structure.

[0040] The anchor is a suture anchor: after the anchor is placed in the target object, the flexible part located in the target object pulls the suture, the free end of the suture passes through the soft tissue, and fixes the soft tissue to the surface of the target object to achieve soft tissue repair. The suture free outside the target object is a soft tissue suture.

[0041] The anchor is a knotless anchor: the soft tissue suture is inserted through the insertable structure, and the anchor is placed in the target object to fix the soft tissue suture in the target object. The soft tissue suture forms a suture bridge on the surface of the target object to further fix the soft tissue.

[0042] In one embodiment of the present invention, the anchor body is provided with a first inner cavity along its axial direction to allow a suture to pass through, one end of the suture is connected to the flexible part, and the other end passes through the first inner cavity and is free outside the proximal end of the anchor body.

[0043] In one embodiment of the present invention, the suture is configured to be pulled, and the flexible part abuts against the distal end of the anchor body, thereby fixing the flexible part.

[0044] In one embodiment of the present invention, the suture is configured to be pulled, the flexible part is movable along the axial direction of the anchor body, and the size of the insertable structure is adjustable during the movement of the flexible part.

[0045] In one embodiment of the present invention, the perforated structure is a thread hole, through which the soft tissue suture is passed. The flexible part moves toward the distal end near the anchor body, the diameter of the thread hole decreases, and the flexible part partially abuts against the distal end of the anchor body to fix the flexible part.

[0046] The present invention also provides an anchor system for repairing soft tissue, including an inserter and knotless anchors for fixing soft tissue sutures in bone, suture anchors for repairing soft tissue sutures, or anchors for repairing soft tissue as described in the above embodiments.

[0047] The inserter includes an inner shaft and an outer shaft. The proximal end of the anchor body is connected to the outer shaft, and the distal end of the anchor body is connected to the inner shaft. The flexible part is pulled by the suture and is located at the distal end of the inner shaft. The flexible part is fixed at the distal end of the inner shaft when it is pulled.

[0048] The anchor is a suture anchor: the inner shaft is inserted into the preset target object, the suture is configured to be pulled, the flexible part is fixed at the far end of the inner shaft, the inserter configures the anchor body into the target object along the inner shaft, the free end of the suture passes through the soft tissue, fixes the soft tissue to the surface of the target object, and realizes the repair of soft tissue. The suture outside the target object is a soft tissue suture.

[0049] The anchor is a knotless anchor: the inner shaft is inserted into a preset target object, the soft tissue suture is configured to be pulled, and after adjusting the tension of the soft tissue suture, the suture is configured to be pulled. The flexible part is fixed at the distal end of the inner shaft, and the inserter positions the anchor body into the target object along the inner shaft. The soft tissue suture forms a suture bridge on the surface of the target object. In a specific embodiment, among the outer shaft, inner shaft, and anchor body, at least the inner shaft has a hollow structure along the axial direction. One end of the suture is connected to the flexible part, and the other end passes through the hollow structure of the inner shaft and the anchor body, and is free outside the anchor body.

[0050] Because the present invention adopts the above technical solution, it has the following advantages and positive effects compared with the prior art:

[0051] The knotless anchor provided by this invention has a flexible portion at the distal end of the anchor body. This flexible portion has a structure through which soft tissue sutures can pass. When the flexible portion is stretched, it is fixed to the distal end of the anchor body. Therefore, after the suture anchor is implanted, the free soft tissue sutures can be passed through the flexible portion before the knotless anchor is implanted into the bone, simultaneously fixing the soft tissue sutures in the bone. At the same time, the flexible portion is deformed and compressed by the compression of the anchor body and the bone marrow tract, occupying almost no space. Therefore, it avoids increasing the depth of the bone marrow tract, increases the safety of the surgery, and relatively increases the safety and comfort for the patient.

[0052] In one embodiment of the present invention, a flexible portion is traction-guided at the distal end of the anchor body via a traction wire. The free end of the traction wire can be pulled freely to change the distance between the flexible portion and the anchor body. By pulling the free end of the traction wire, the flexible portion can abut against the distal end of the anchor body, thus fixing the flexible portion to the distal end of the anchor body and preventing the flexible portion from completely entering the anchor body. Before implanting the anchor body into the bone, soft tissue sutures are inserted into the permeable structure of the flexible portion, and the free end of the traction wire is pulled to pre-fix the flexible portion. Then, the anchor body is implanted into the bone, and the flexible portion and soft tissue are also implanted into the bone. Due to the flexibility and large deformability of the flexible portion, its volume becomes very small under the compression of the anchor body implanted in the bone, occupying almost no space. Therefore, the depth of the bone tunnel is equal to the length of the anchor body, avoiding increasing the depth of the bone marrow tract, increasing the safety of the surgery, and relatively increasing the safety and comfort for the patient.

[0053] In one embodiment of the present invention, the perforated structure is a suture hole. Soft tissue sutures are inserted into the suture hole, and the free end of the suture is pulled. As the flexible part moves axially along the anchor body, the diameter of the suture hole can be adjusted; that is, the diameter of the suture hole can be increased or decreased. In actual surgery, when it is necessary to connect soft tissue sutures, the diameter of the suture hole can be increased, making it easier for clinicians to insert the soft tissue sutures into the flexible part. Furthermore, multiple soft tissue sutures can be connected according to surgical needs. In contrast, the diameter of the existing terminal suture hole is fixed, making it difficult for clinicians to insert soft tissue sutures and preventing the insertion of multiple sutures.

[0054] The suture anchor provided by this invention has a flexible portion on the distal exterior of the anchor body. The flexible portion connects to a suture and is fixed to the distal end of the anchor body under the tension of the suture. One end of the suture is connected to the flexible portion, while the other end remains free outside the anchor body. After the anchor body is implanted into the bone, the free end of the suture can penetrate soft tissue to fix and repair it; the other end of the suture is fixed to the bone by the flexible portion. Therefore, using the suture anchor of this invention eliminates the need for any suture-fixing structure on the anchor body. The anchor body can be implanted into the bone using a universal inserter, greatly facilitating clinicians. Furthermore, since the anchor body itself has no other structures, it fuses more easily with the bone, relatively reducing the patient's healing period; it also reduces the production cost of the suture anchor.

[0055] In addition, after the suture anchor is implanted into the bone, the flexible part deforms and compresses due to the force of the anchor body and the bone compression. The flexible part hardly occupies the space of the bone marrow tract in the bone, so it does not increase the depth of the bone marrow tract.

[0056] Knotless anchors and suture anchors have different applications, but this invention unifies their structures. As a suture anchor, it eliminates the need for a special structure on the anchor body to fix the suture; as a knotless anchor, it eliminates the need for terminals that increase the depth of bone drilling. For manufacturers, the resulting products have a wider range of applications, and only one mold needs to be developed to produce products for both applications, reducing costs. For hospitals, only one type of anchor product needs to be stocked, eliminating the need for separate storage. Attached Figure Description

[0057] Figure 1 This is a schematic diagram of the flexible part including a self-locking structure after the anchor and inserter are assembled in an embodiment of the present invention. Figure 1 ;

[0058] Figure 2 for Figure 1 Enlarged view of the self-locking structure;

[0059] Figure 3This is a schematic diagram of the flexible part including a self-locking structure after the anchor and inserter are assembled in an embodiment of the present invention. Figure 2 ;

[0060] Figure 4 This is a schematic diagram illustrating the structure of another embodiment of the flexible part after the anchor and inserter are assembled in this invention. Figure 1 ;

[0061] Figure 5 for Figure 4 Enlarged view of the flexible section;

[0062] Figure 6 This is a schematic diagram illustrating the structure of another embodiment of the flexible part after the anchor and inserter are assembled in this invention. Figure 2 ;

[0063] Figure 7 This is a schematic diagram of another embodiment of the flexible part after the anchor and inserter are assembled in this invention.

[0064] Figure 8 for Figure 7 A schematic diagram of the flexible section in the relaxed state of the central traction line;

[0065] Figure 9 This is a schematic diagram illustrating the structure of another embodiment of the flexible part after the anchor and inserter are assembled in this invention. Figure 1 ;

[0066] Figure 10 for Figure 9 Enlarged view of the flexible section;

[0067] Figure 11 This is a schematic diagram illustrating the structure of another embodiment of the flexible part after the anchor and inserter are assembled in this invention. Figure 2 ;

[0068] Figure 12 This is a schematic diagram illustrating the structure of another embodiment of the flexible part after the anchor and inserter are assembled in this invention. Figure 1 ;

[0069] Figure 13 for Figure 12 Enlarged view of the flexible section;

[0070] Figure 14 This is a schematic diagram illustrating the structure of another embodiment of the flexible part after the anchor and inserter are assembled in this invention. Figure 2 ;

[0071] Figure 15 This is a schematic diagram of another embodiment of the flexible part in this invention;

[0072] Figure 16As used in the embodiments of the present invention Figure 15 A schematic diagram of the flexible part, the anchor and inserter, and the traction line in the tightened state.

[0073] Figure 17 This is a schematic diagram illustrating the structure of another embodiment of the flexible part after the anchor and inserter are assembled in this invention. Figure 1 ;

[0074] Figure 18 for Figure 17 Enlarged view of the flexible section;

[0075] Figure 19 This is a schematic diagram illustrating the structure of another embodiment of the flexible part after the anchor and inserter are assembled in this invention. Figure 2 ;

[0076] Figure 20 This is a schematic diagram of an embodiment of the present invention in which the flexible part is a knotted thread after the knotless anchor is assembled with the inserter.

[0077] Figure 21 As described in the embodiments of the present invention Figure 20 A schematic diagram showing the state of the anchor after implantation in the implementation method;

[0078] Figure 22 This is a schematic diagram of another embodiment of the present invention in which the flexible part is a knot after the anchor and inserter are assembled.

[0079] Figure 23 As described in the embodiments of the present invention Figure 22 A schematic diagram showing the state of the anchor after implantation in the implementation method;

[0080] Figure 24 This is a schematic diagram of another embodiment of the present invention in which the flexible part is a knot after the anchor and inserter are assembled.

[0081] Figure 25 This is a diagram showing the state of the anchor after it has been implanted into the bone in an embodiment of the present invention. Detailed Implementation

[0082] The present invention provides a detailed description of an anchor and anchor system for repairing soft tissue, in conjunction with the accompanying drawings and specific embodiments. The advantages and features of the invention will become clearer from the following description. Obviously, the described embodiments are only some, not all, of the embodiments of the invention. The components of the embodiments of the invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0083] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0084] It should be noted that similar labels in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0085] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this invention is in use. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention. In addition, the terms "first," "second," "third," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0086] Furthermore, terms such as "horizontal" and "vertical" do not imply that components must be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0087] In the description of this application, "proximal end" refers to the end closer to the operator, and "distal end" refers to the end farther away from the operator.

[0088] It's important to note that typical suture anchors require one end of the suture to be fixed to the anchor body, while the other end remains free. Once the anchor body is implanted into the bone, the other end of the suture is also fixed within the bone. A guide is then used to pass the free suture through the soft tissue, fixing the avulsed or torn soft tissue to the bone surface, promoting healing and achieving a repair effect. Therefore, suture anchors, with the suture securing the soft tissue, are called suture anchors. They typically have a suture hole or other structure with suture attachment at a certain point on the anchor body. Generally, the anchor body has protruding side ears with suture holes. For example, some suture anchors on the market have wings on the side tail with suture holes. Due to the function of the wings, the implantation process is more difficult and requires the use of special tools.

[0089] While suture anchors can repair soft tissue, they suffer from insufficient fixation strength. Therefore, knotless anchors are often used in conjunction with suture anchors. After the suture anchor is implanted into the bone, the soft tissue is fixed to the bone surface with sutures. The sutures are then passed through the suture hole of the knotless anchor. Simultaneously, the knotless anchor is implanted into the bone, and the soft tissue sutures are also fixed within the bone. Currently, typical knotless anchors have a terminal attached to the distal end of the anchor body, with a suture hole on the terminal through which the soft tissue sutures are passed. For existing knotless anchors, adding a terminal undoubtedly increases the depth of the bone marrow tunnel. Although the anchor itself is small, creating a bone marrow tunnel in human bone is already a necessity; creating a deeper bone marrow tunnel would pose a greater risk of injury to the patient.

[0090] Therefore, the structures of anchors with wires and knotless anchors are different. Each type of anchor has a single application scenario, and it is necessary to develop molds or production processes for both types of anchors, which increases production costs. For hospitals, it is necessary to keep both types of anchors on hand and store them according to their functions.

[0091] Example 1

[0092] For the reasons stated above, the purpose of this embodiment is to provide a knotless anchor for fixing soft tissue sutures in bone. See below. Figure 1-24 It includes an anchor body 1 and a flexible part. The anchor body 1 has a proximal end 102 and a distal end 101. The flexible part is located at the distal end 101 of the anchor body 1. The flexible part is pulled by a traction line 6. The flexible part is positioned at the distal end 101 of the anchor body 1. The traction line 6 is pulled, and the flexible part can move along the axial direction of the anchor body 1. The flexible part has a soft tissue suture 5 that can be inserted.

[0093] In this embodiment, the anchor body 1 has a hollow structure along its axial direction. The traction line passes through the hollow structure and is connected to the flexible part at the distal end 101 of the anchor body 1. The free end 603 of the traction line 6 is located at the proximal end 102 of the anchor body 1. By pulling the free end of the traction line 6, the flexible part at least partially abuts against the distal end 101 of the anchor body 1, thereby fixing the flexible part to the distal end 101 of the anchor body 1. The anchor body may not have a hollow structure. Multiple traction wire holes can be provided on the anchor body, and the far end of the anchor body also has a traction wire hole. One end of the traction wire is connected to the flexible part, and the other end starts from the traction wire hole at the far end and passes through the traction wire holes on the anchor body in sequence, so that the traction wire spirally wraps around the anchor body and extends freely outside the anchor body. Alternatively, the anchor body can have a hollow structure, which also allows the traction wire to spirally wrap around the anchor body. Therefore, as long as the implementation method can be implemented so that the traction wire can be pulled freely and the flexible part is fixed to the far end of the anchor body, it is not necessary to limit it to the traction wire passing through the hollow structure and connecting to the flexible part in this embodiment.

[0094] At the free end 603, the traction line 6 is pulled, and the flexible part moves toward the far end 101 close to the anchor body 1. The flexible part is fixed at the far end 101 of the anchor body 1. The flexible part can be completely abutted against the far end or partially abutted against the far end, so that the flexible part is fixed. The free end 603 of the traction line 6 is located at the proximal end of the anchor body 1.

[0095] After the suture anchor is implanted into the bone, soft tissue sutures fix the soft tissue to the bone surface. Then, the soft tissue suture is connected to a flexible portion, and the free end 603 of the traction suture 6 is pulled, pre-fixing the flexible portion. A pre-designed bone marrow tunnel is then created in the bone (or the flexible portion can be connected to the suture first). The anchor body 1 is then implanted into the bone tunnel. Simultaneously, the flexible portion is implanted into the bone, thus fixing the soft tissue sutures within the bone. Due to the inherent softness of the flexible portion, under the compression of the anchor body 1, the deformation and compression of the flexible portion hardly occupies the space of the bone marrow tunnel, thus avoiding the creation of a deep bone marrow tunnel and improving safety. For the patient, this avoids greater harm, relatively increasing safety and reducing the postoperative healing period.

[0096] Therefore, by using a flexible portion instead of the existing terminals, the depth of the bone marrow tract is reduced. The depth of the bone marrow tract is the same as the length of the anchor body 1, while simultaneously fixing soft tissue sutures within the bone marrow tract. Thus, by using the knotless anchor of this embodiment, patients can avoid less damage and relatively shorten the postoperative healing period.

[0097] In this embodiment, the traction suture 6 is a medical suture, and the anchor body 1 may include a generally elongated body having a proximal end 102 and a distal end 101, with a hollow structure extending between the two. See also Figure 1-22 The anchor body 1, with its elongated body, can have various constructions, shapes, and sizes, such as teeth, threads, barbs, protrusions, etc. However, in embodiments 4, 6, 9, 11, 16, and 20-23, the elongated body may include surface structures such as one or more ridges, flanges, or ribs extending around the elongated body and facilitating insertion into the medullary tract without rotation of the anchor body 1. In other embodiments, such as Figure 1 , 3 As shown in 7, 12, 14, 17, 19, and 24, the elongated subject may include a surface structure of the form of multiple continuous threads extending around the elongated subject and facilitating rotation into the bone marrow tract. The distal end 101 of the anchor body 1 may be constructed as tapered or bullet-shaped, with the diameter of the anchor body 1 decreasing slightly from the proximal end 102 to the distal end 101, which facilitates the introduction of the anchor body 1 into the bone tunnel.

[0098] The anchor body 1 can be formed of various materials, such as biodegradable materials, blends of biodegradable materials and inorganic materials, metal alloys with good bone compatibility, such as polyetheretherketone (PEEK), alloys, or magnesium alloys, or stainless steel, or metal materials with a polymer coating, etc.

[0099] In one embodiment of this invention, the threading structure is a threading hole 7 through which the soft tissue suture 5 passes. The diameter of the threading hole 7 is adjustable as the flexible part moves axially along the anchor body 1. That is, the diameter of the threading hole 7 can be increased or decreased. In actual surgery, when it is necessary to connect the soft tissue suture 5, the diameter of the threading hole 7 can be increased, making it easier for clinicians to thread the soft tissue suture 5 into the flexible part. This facilitates operation and allows for the connection of multiple soft tissue sutures 5 as needed. However, the diameter of the existing terminal threading hole is fixed, making it difficult for clinicians to thread soft tissue sutures and preventing the threading of multiple sutures.

[0100] As the flexible part moves toward the distal end 101 of the anchor body 1, it contracts and deforms, at least partially abutting against the distal end 101 of the anchor body 1, thus reducing the diameter of the thread hole 7. Pulling the free end 603 of the traction thread 6 causes the flexible part to move closer to the anchor body 1. Simultaneously, the flexible part contracts and deforms, further reducing the diameter of the thread hole 7. At this time, the flexible part can also lock the soft tissue suture 5 within the thread hole 7.

[0101] Before detailing the implementation of the flexible section, it is necessary to understand the actuator, i.e., the inserter, that pushes the knotless anchor into the bone marrow tract. In this embodiment, see [reference needed]. Figure 1 , 3 -4, 6-7, 9, 11-12, 14, 16-17, 19-24, The inserter includes an inner shaft 3 and an outer shaft 4. The inserter has a distal end and a proximal end. The outer shaft 4 is located near the proximal end of the inserter, and the inner shaft 3 is near the distal end of the inserter. The inner shaft 3 and the outer shaft 4, like the anchor body 1, have a hollow structure along the axial direction. The proximal end 102 of the anchor body 1 is connected to the outer shaft 4, and the proximal end of the inner shaft 3 is connected to the distal end 101 of the anchor body 1. The traction line 6 passes through the outer shaft 4, the anchor body 1, and the inner shaft 3, and pulls the flexible part at the distal end of the inner shaft 3.

[0102] In the actual surgical procedure, after the suture anchor is implanted into the bone, the soft tissue suture 5 fixes the soft tissue to the bone surface. Then, a pre-designed medullary tract is created in the bone. The anchor body 1 is connected to the outer shaft 4, and the inner shaft 3 passes through the anchor body 1 and protrudes from the distal end 101 of the anchor body 1. At the same time, the flexible part pulled by the traction suture 6 is also located at the distal end of the inner shaft 3. Then, the soft tissue suture 5 is threaded through the flexible part using a suture guide. The free end 603 of the traction suture 6 is pulled, and the flexible part is pre-fixed at the distal end of the inner shaft 3. The inner shaft 3 carries the flexible part into the medullary tract. At this time, the tension of the soft tissue suture 5 is adjusted, and the traction suture 6 is pulled again to fix the flexible part. The flexible part deforms to form a flexible knot similar to a ball of thread. The inserter taps or rotates the anchor body 1 along the inner shaft 3 into the medullary tract (the appropriate implantation method is selected according to the different shapes of the anchor body 1), while fixing the soft tissue suture 5 in the bone.

[0103] The following schematic diagram shows the assembly of the anchor body 1 and the inserter. The implementation of the flexible part is described in detail with reference to the accompanying drawings.

[0104] In this embodiment one, please refer to the following for details. Figure 1-3 The flexible part includes a self-locking structure, which has a threading hole 7;

[0105] The traction line 6 is connected to the self-locking structure 8. Pulling the free end 603 of the traction line 6 causes the self-locking structure 8 to move toward the distal end 101 of the anchor body 1. At the same time, the diameter of the thread hole 7 decreases, and the self-locking structure 8 contracts and deforms to abut against the distal end 301 of the inner shaft 3, preventing the self-locking structure 8 from entering the distal end 301 of the inner shaft 3. The soft tissue suture 5 is also locked in the thread hole 7.

[0106] Employing a self-locking structure 8 and a traction suture 6, the diameter of the threading hole 7 can be arbitrarily changed. In other words, the diameter of the threading hole 7 can be large or small. When the threading hole 7 is large, the soft tissue suture 5 can be inserted into it, and then the traction suture 6 can be pulled to reduce the diameter of the threading hole 7. Since the anchor body 1, as an implantable medical device for soft tissue injury repair, is inherently very small, and the diameter of the threading hole 7 in existing knotless anchor terminals is fixed, it is very difficult for the surgeon to insert the soft tissue suture 5 into the threading hole 7. However, in this embodiment, the diameter of the threading hole 7 is variable, allowing for the insertion of the soft tissue suture 5 even with a larger diameter. Furthermore, multiple soft tissue sutures 5 can be inserted as needed during surgery, making the operation easy and convenient.

[0107] In another embodiment of this example, the self-locking structure 8 includes a first flexible sleeve 801 and a flexible thread 802. The two ends of the flexible thread 802 are located inside the first flexible sleeve 801 to form a first annular structure. The first annular structure constitutes a thread hole 7, and the soft tissue suture 5 passes through the thread hole 7.

[0108] The traction suture 6 includes a first traction suture 601 and a second traction suture 602. The non-free end of the first traction suture 601 is connected to one end of the flexible suture 802, and the non-free end of the second traction suture 602 is connected to the other end of the flexible suture 802. The free ends 603 of the first traction suture 601 and / or the second traction suture 602 are pulled. The portion of the flexible suture 802 exposed in the first flexible sleeve 801 enters the first flexible sleeve 801. At this time, the diameter of the thread hole 7 decreases, and the first flexible sleeve 801 abuts against the distal end 101 of the anchor body 1, preventing the self-locking structure 8 from entering the distal end 101 of the anchor body 1, thus achieving pre-fixation of the soft tissue suture 5. In specific implementation, the flexible suture 802 can be a medical suture, and the first flexible sleeve 801 can be a cylindrical sleeve similar in flexibility to a medical suture. Therefore, before implantation into the bone, it is necessary to pull the first traction line 601 or the second traction line 602, or pull the first traction line 601 and the second traction line 602 simultaneously. The flexible line 802 enters the first flexible sleeve 801, the diameter of the thread hole 7 decreases, and the shrinkage size of the self-locking structure 8 also decreases. Moreover, the overall self-locking structure 8 is similar to the softness of medical sutures. After implantation into the bone, due to the interaction force between the inner shaft 3 and / or the anchor body 1 and the bone marrow tract, the self-locking structure 8 is squeezed and shrinks again, hardly occupying any space. At the same time, the diameter of the thread hole 7 can be made variable.

[0109] During the surgery, with the first traction line 601 and the second traction line 602 relaxed, the diameter of the threading hole 7 is very large, making it very easy for clinicians to thread the soft tissue suture 5 into the threading hole 7. Moreover, multiple soft tissue sutures 5 can be threaded in as needed for the surgery, which facilitates the operation of clinicians. After the soft tissue suture 5 is inserted into the suture hole 7, the free end 603 of the traction suture 6 is pulled, and the second flexible sleeve is placed against the distal end 301 of the inner shaft 3 (or the inner shaft 3 can be placed in the bone marrow tract). At this time, the soft tissue suture 5 can be freely adjusted in the suture hole 7. Then, the inner shaft 3 is placed in the preset bone marrow tract. The soft tissue suture 5 that is free outside the bone marrow tract needs to be pulled to adjust the tension of the soft tissue suture 5. At the same time, the free ends 603 of the first traction suture 601 and the second traction suture 602 are pulled again to shrink the aperture of the suture hole 7 again. After stabilization, the free end 603 of the traction suture 6 is pre-fixed. Then, the anchor body 1 is implanted into the bone marrow tract through the inserter. After implantation, the excess parts of the first traction suture 601 and the second traction suture 602 are cut off.

[0110] In another embodiment of this example, see [link to previous example]. Figure 4-10The traction line 6 forms a second loop structure at the distal end 101 of the anchor body 1. For example, a traction line 6 passes through the outer shaft 4, the anchor body 1 and the inner shaft 3 in sequence, and forms a second loop structure at the distal end 301 of the inner shaft 3. It then passes through the inner shaft 3, the anchor body 1 and the outer shaft 4 in sequence again. A first flexible locking knot 9, 10, 10' is threaded on the traction line 6 at the second loop structure. The second loop structure and the first flexible locking knot 9, 10, 10' form a flexible part. After the traction line 6 is threaded through the first flexible locking knot 9, 10, 10', its position can also be freely adjusted.

[0111] The second annular structure forms the thread hole 7. The soft tissue suture 5 passes through the second annular structure, pulling the free end 603 of the traction line 6. The first flexible locking knots 9, 10, 10' move toward the distal end 101 of the anchor body 1 until the first flexible locking knots 9, 10, 10' abut against the distal end 101 of the anchor body 1, thereby pre-fixing the soft tissue suture 5.

[0112] In this embodiment, the second ring structure formed at the distal end of the traction thread 6 is used as a threading hole 7. When the traction thread 6 is under tension to prevent loosening, the aperture of the second ring structure can become very large. At the free end 603 of the traction thread 6, the traction thread 6 is pulled, and the second ring structure tightens. Due to the action of the first flexible locking knots 9, 10, 10' abutting against the distal end 301 of the inner shaft 3, the second ring structure is prevented from entering the inner shaft 3 or the anchor body 1, and the soft tissue suture 5 is prevented from entering the inner shaft 3 or the anchor body 1. At the same time, when the free end 603 of the traction thread 6 is tightened, the first flexible locking knots 9, 10, 10' abut against the outer end of the inner shaft 3. The traction thread 6 is pulled further, and the first flexible locking knots 9, 10, 10' form a flexible knot at the distal end 301 of the inner shaft 3, pre-fixing it at the distal end 301 of the inner shaft 3, and similarly pre-fixing the soft tissue suture 5. The first flexible locking knots 9, 10, 10' also have very high flexibility, so after being implanted into the bone, they hardly occupy the space of the bone marrow duct due to the compression effect.

[0113] In this embodiment, the second annular structure can be directly used to connect the soft tissue suture 5. When the tension of the free end 603 of the traction thread 6 is tightened, the soft tissue suture 5 is pre-fixed. It can also be used as a fixing bridge to achieve soft tissue fixation together with other anchors.

[0114] During the surgery, the free soft tissue suture 5 is first passed through the second ring structure. The free soft tissue suture 5 is pulled to ensure smooth movement. Then, the inner shaft 3 is placed in the bone marrow tract, and the free soft tissue suture 5 is pulled again to adjust its tension. At the same time, the traction suture 6 is pulled to reduce the aperture of the second ring structure. After the tension of the soft tissue suture 5 is stable and the traction suture 6 no longer needs to be pulled, the free end 603 of the traction suture 6 is pre-fixed. Then, the anchor body 1 is inserted into the bone marrow tract along the inner shaft 3 using an inserter to fix the soft tissue suture 5 in the bone.

[0115] In another embodiment of this invention, the first flexible locking knot is a second flexible sleeve 10, 10', which is mounted on the traction line 6. The cross-section of the second flexible sleeve 10, 10' is circular. Figure 4-6 ) or flat ( Figure 7-8 Of course, it can also be square or rectangular, but it needs to meet the requirement that the second flexible sleeve can abut against the end of the inner shaft 3 without entering the inner shaft 3. The shape is not limited here.

[0116] In another embodiment of this example, see [link to previous example]. Figure 9-11 The first flexible locking knot has at least a first hole and a second hole. The traction wire 6 passes through the first hole and the second hole in sequence. When the traction wire 6 is pulled, the first flexible locking knot can also move towards the inner shaft 3 and abut against the distal end 301 of the inner shaft 3. The shape of the first flexible locking knot can be a flat sheet structure or a long cylindrical shape, without limitation.

[0117] In this embodiment, please refer to the specific details. Figure 9-11 The first flexible locking knot 9 is a flat sheet structure with four holes: the first hole 901, the second hole 902, the fifth hole, and the sixth hole 903. The traction wire 6 passes through the first hole 901, the second hole 902, the fifth hole, and the sixth hole 903 in sequence. The traction wire 6 can be pulled freely. The holes on the first flexible locking knot 9 do not have a fixing effect on the traction wire 6, but the traction wire 6 can be fixed in the holes, for example, by gluing it in the holes. However, compared to the implementation method where the traction wire 6 is fixed in the holes but not fixed, after pulling the free end 603 of the traction wire 6, the first flexible locking knot 9 can not only abut against the distal end 301 of the inner shaft 3, but also shrink to form a locking knot abut against the distal end 301 of the inner shaft 3. It has a smaller volume, occupies less space when not squeezed, and is easier to squeeze.

[0118] Another embodiment of this example is described below. Figure 11-19 The flexible part includes a suture loop 11 and a second flexible locking knot 12, 13, 13' passing through the suture loop 11. The suture loop 11 has a thread hole 7, through which the traction thread 6 and the soft tissue suture 5 pass respectively.

[0119] Pull the free end 603 of the traction line 6, and the loop 11 enters the interior of the anchor body 1 until the second flexible locking knots 12, 13, 13' abut against the far end 101 of the anchor body 1.

[0120] like Figure 11-19 As shown, after the anchor body 1 is assembled with the inserter, the wire loop 11 and the second flexible locking knots 12, 13, 13' are located at the distal end 301 of the inner shaft 3. In specific implementation, the wire constituting the wire loop 11 can be circular. Figure 12 ) or flat ( Figure 15 (17-18), of course, it can also be square or rectangular or other forms, which are not limited here. The second flexible locking knot can be a sleeve similar to a cylinder, that is, the third flexible sleeve 13, 13'. The third flexible sleeve is sleeved on the line forming the loop 11. The loop 11 and the third flexible sleeve can move relative to each other or not move relative to each other. The cross-section of the third flexible sleeve can be circular ( Figure 12 , 13 ) or flat ( Figure 15-16 (It can also be other shapes, which will not be elaborated here.)

[0121] The second flexible locking knot can also be constructed as follows: the second flexible locking knot has at least a third hole and a fourth hole, and the wire forming the loop 11 passes through the third hole and the fourth hole in sequence. Specifically, as shown below... Figure 18 Therefore, the second flexible locking knot 12 has four holes, namely the third hole 1201, the fourth hole 1202, the seventh hole, and the eighth hole 1203. The wires forming the loop 11 pass through the third hole 1201, the fourth hole 1202, the seventh hole, and the eighth hole 1203 in sequence. The loop 11 and the second flexible locking knot 12 may or may not move relative to each other. The second flexible locking knot 12 may also have five or more holes, but it must have at least two, which are sufficient to connect the second flexible locking knots in series on the loop 11. The second flexible locking knot 12 can be a flat sheet structure (e.g., Figure 17-19 Other structural forms, such as ), will not be elaborated here.

[0122] In this embodiment, the second flexible locking knots 12, 13, 13' are sleeve-like or flat sheet-like structures threaded onto the suture loop 11. Both the traction thread 6 and the soft tissue suture 5 can be threaded into the suture loop 11. Pulling the free end 603 of the traction thread 6, the suture loop 11, carrying the second flexible locking knots 12, 13, 13', moves towards the inner shaft 3. Most of the suture loop 11 enters the inner shaft 3, but the second flexible locking knots 12, 13, 13' abut against the distal end 301 of the inner shaft 3, preventing the flexible portion from completely entering the inner shaft 3. Furthermore, the second flexible locking knots 12, 13, 13' can form a fixed knot at the distal end 301 of the inner shaft 3, fixing it to the distal end 301 of the inner shaft 3 (see...). Figure 11 ,14 (16, 19). At the same time, the loop 11 and the second flexible locking knot 12, 13, 13' can be used as a fixed bridge, together with other anchors, to fix the soft tissue.

[0123] In another embodiment of this example, see [link to previous example]. Figure 20-24 The flexible part consists of knot 2,2,2”, through which the soft tissue suture 5 passes, with all of the knot 2,2,2” resting against the distal end 301 of the inner shaft 3. Knot 2,2,2” can be a knot tied at the distal end 301 of the inner shaft 3 for the traction suture 6, or it can be a knot 2,2,2” connected to the traction suture 6, through which the soft tissue suture 5 passes. The shape of knot 2,2,2” can be spherical (see [reference]). Figure 20-23 It can also be cylindrical (such as...) Figure 24 (As shown), it can also be other shapes, which will not be elaborated here. Knot 2,2,2” can be used to tie multiple threads according to a rule (such as...). Figure 20-21 The knot 2,2,2” formed by the example shown can also be a knot 2,2,2” formed by winding one or more strands of yarn into a ball. Figure 22-23 (As shown).

[0124] The flexible portion shown in this embodiment can be formed using medical sutures or made of a material with the same softness as sutures. Therefore, it has greater deformability, for example... Figure 1-19 The illustrated flexible portion deforms and shrinks in volume during traction. After the anchor is implanted into the bone, it is further compressed due to the squeezing effect. Therefore, the flexible portion of this invention, after being implanted into the bone, is in a deformed and compressed state, occupying almost no space. Compared to the terminals of existing knotless anchors, this significantly reduces the length of the knotless anchor, thereby reducing the depth of the bone marrow tract. See details. Figure 25 The diagram shows the state of the anchor without knots implanted in the bone. After the anchor body 1 and the flexible part are implanted into the bone 14, the soft tissue suture 5 is fixed in the bone 14. Figure 1-24 The flexible section shown is located within the bone tunnel, and under further traction of the traction line 6, the flexible section forms... Figure 25 The flexible knot 15, resembling a coil of thread, is further compressed within the bone 14 to form... Figure 25 The deformed and compressed state shown can be observed by cutting off the excess soft tissue sutures 5 and traction sutures 6 that are free outside the bone 14.

[0125] The flexible portion of this embodiment, replacing the terminals of existing knotless anchors, not only achieves the same function of fixing the soft tissue suture 5, but also allows for variable dimensions (larger or smaller) of the flexible portion or the suture hole 7, facilitating the insertion of the soft tissue suture 5 into the flexible portion by clinicians. Furthermore, multiple soft tissue sutures 5 can be inserted as needed. More importantly, it reduces the depth of the bone marrow tract. Although the anchor itself is very small as an implant, it reduces the bone marrow tract that is impacted in the patient's bone, increasing safety for the patient and particularly shortening the postoperative healing period.

[0126] In addition, the flexible part of this embodiment, compared with the existing knotless anchors, has fewer terminal components and uses medical sutures as a substitute, which reduces costs and can also reduce medical expenses for patients.

[0127] Example 2

[0128] This embodiment 2 provides a suture anchor for repairing soft tissue sutures, see details below. Figure 1-24 The anchor with thread includes an anchor body 1, a flexible part, and a thread 6. One end of the thread 6 is connected to the flexible part, and the flexible part is located at the distal end 101 of the anchor body 1. The other end of the thread 6 is free outside the proximal end 102 of the anchor body 1.

[0129] The flexible part is fixed to the far end of the anchor body 1 while being pulled by the suture 6, and is at least partially located outside the anchor body 1. The flexible part is used to fix the suture 6 and prevent the suture 6 from detaching from the anchor body 1.

[0130] After the anchor body 1 is implanted into the bone, the flexible part is fixed in the bone to pull the suture 6, which is deformed and compressed. The free end 603 of the suture 6 passes through the soft tissue and fixes the soft tissue to the surface of the target object, thereby repairing the soft tissue.

[0131] In this embodiment, during the process of loosening and tightening the suture 6, the flexible part can move along the axial direction of the anchor body 1. At the free end 603 of the suture 6, the suture is pulled, and the flexible part moves towards the distal end of the anchor body 1 until it is fixed to the distal end of the anchor body 1. While being pulled by the suture 6, the flexible part abuts against the distal end 101 of the anchor body 1, thus achieving fixation to the distal end of the anchor body 1. The flexible part can abut completely or partially.

[0132] The structure of the anchor body 1 is the same as in Embodiment 1, and other implementation methods can also refer to Embodiment 1. The specific structure of the flexible part is as described in Embodiment 1, except that the flexible part does not require the insertion of soft tissue sutures 5, that is, no suture needs to be inserted into the suture hole 7. The function of the flexible part is to fix the suture 6. Figure 1-3Taking the self-locking structure shown as an example, the working process of the suture anchor is described. In the actual operation, a bone marrow tract is pre-drilled at a suitable position on the bone, and then the suture anchor is assembled with the inserter. That is, the proximal end 102 of the anchor body 1 is connected to the outer shaft 4, and the proximal end of the inner shaft 3 is connected to the distal end 101 of the anchor body 1. The first suture 601 and the second suture 602 pass through the outer shaft 4, the anchor body 1 and the inner shaft 3, and the self-locking structure 8 is pulled at the distal end 301 of the inner shaft 3.

[0133] The inner shaft 3 is inserted into the medullary tract. The free ends 603 of the first suture 601 and / or the second suture 602 are pulled. The portion of the flexible suture 802 exposed in the first flexible sleeve 801 enters the first flexible sleeve 801. The first flexible sleeve 801 abuts against the distal end 301 of the inner shaft 3 to prevent the self-locking structure 8 from entering the distal end 301 of the inner shaft 3, thus fixing the flexible part outside the distal end 301 of the inner shaft 3. The first suture 601 and / or the second suture 602 are further pulled, and the flexible part forms a flexible knot. Then, the inserter taps or rotates the anchor body 1 along the inner shaft into the medullary tract (the appropriate implantation method is selected according to the different shapes of the anchor body 1). At the same time, the flexible part is also fixed in the bone. Then, one end of the suture 6 is fixed in the medullary tract. Using the piercing device, the free end 603 of the suture 6 is passed through the soft tissue, fixing the soft tissue to the bone surface. Refer to the diagram of the state of the anchor in the bone. Figure 25 (Soft tissue not shown), flexible parts formed Figure 25 The flexible knot shown has a flexible section without soft tissue sutures 5, and free sutures 6 (not shown) pass through the soft tissue.

[0134] In other specific embodiments of the flexible part, it is also not necessary to insert soft tissue sutures 5 inside the thread hole 7.

[0135] Therefore, in this embodiment, a flexible portion is provided on the outside of the anchor body 1. After the suture anchor is implanted into the bone, the flexible portion is also implanted into the bone. Thus, one end of the suture 6 is fixed in the bone, and the free end 603 of the suture 6 can pass through the soft tissue, thereby fixing the soft tissue to the bone. At the same time, the flexible portion deforms into a flexible knot. The flexible knot is compressed by the action of the bone marrow tract and the anchor, almost occupying the space of the bone marrow tract without increasing the depth of the bone marrow tract. This avoids the need to set a structure for fixing the suture on the outside of the anchor body 1, which reduces production costs and facilitates the implantation of the anchor into the bone. Through the description of Embodiments 1 and 2, the anchor provided by the present invention can be used as a knotless anchor (outer row anchor) or as a suture anchor (inner row anchor). When used as a knotless anchor, the flexible portion replaces the terminal of the existing knotless anchor. It not only achieves the same function of fixing the soft tissue suture 5, but also allows for variable dimensions (larger or smaller) of the flexible portion or the suture hole 7, facilitating the insertion of the soft tissue suture 5 by clinicians. Furthermore, multiple soft tissue sutures 5 can be inserted as needed. More importantly, it reduces the depth of the bone marrow tract. Although the anchor itself is very small as an implant, it reduces the bone marrow tract that is impacted in the patient's bone, increasing safety for the patient and particularly shortening the postoperative healing period.

[0136] In addition, the flexible part of this embodiment, compared with the existing knotless anchors, has fewer terminal components and uses medical sutures as a substitute, which further reduces costs and can also reduce medical expenses for patients.

[0137] As a suture anchor, the flexible part mainly serves to fix the suture inside the bone, fixing one end of the suture in the bone, so that the free end of the suture outside the bone can pass through the soft tissue and fix the soft tissue to the bone surface.

[0138] Although knotless anchors and suture anchors have different applications, their structures have been standardized. As suture anchors, there's no need for special structures on the anchor body to fix the suture; as knotless anchors, there's no need for terminals that increase the depth of bone drilling. For manufacturers, this results in a wider range of applications, and only one mold needs to be developed to produce products for both applications, reducing costs. For hospitals, only one type of anchor product needs to be stocked, eliminating the need for separate storage.

[0139] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they shall still fall within the protection scope of the present invention.

Claims

1. A knotless anchor for fixing soft tissue sutures in bone, characterized in that, It includes an anchor body, a flexible part, and a traction line, wherein the flexible part is located at the distal end of the anchor body and the flexible part has a structure through which the soft tissue suture can be inserted; The anchor body has a hollow structure along its axial direction, the traction line is configured to pass through the hollow structure and connect to the flexible part at the distal end of the anchor body, the traction line is configured to pull, and the flexible part abuts against the distal end of the anchor body. The threadable structure is a threading hole, the traction line is configured to be pulled, and the diameter of the threading hole can be adjusted when the flexible part moves along the axial direction of the anchor body; The traction line forms a second loop structure at the distal end of the anchor body. The traction line located at the second loop structure passes through the first flexible locking knot. The second loop structure and the first flexible locking knot form the flexible part. The second loop structure is configured as the threading hole. The soft tissue suture passes through the suture hole of the second annular structure, the traction line is configured to pull, the first flexible locking knot moves toward the distal end of the anchor body until the first flexible locking knot contracts and deforms against the distal end of the anchor body, and the diameter of the suture hole decreases. After the anchor body is positioned on the target object, the soft tissue suture fixes the soft tissue to the surface of the target object. Then, the soft tissue suture is passed through the flexible part, and the knotless anchor is positioned in the target object, thereby fixing the soft tissue suture in the target object, and the flexible part is in a deformable and compressed state.

2. The knotless anchor for fixing soft tissue sutures in bone according to claim 1, characterized in that, The first flexible locking knot is a second flexible sleeve, which is sleeved on the traction line.

3. The knotless anchor for fixing soft tissue sutures in bone according to claim 2, characterized in that, The cross-section of the second flexible sleeve is circular or flat.

4. The knotless anchor for fixing soft tissue sutures in bone according to claim 1, characterized in that, The first flexible locking knot has at least a first hole and a second hole, and the traction wire passes through the first hole and the second hole in sequence.

5. The knotless anchor for fixing soft tissue sutures in bone according to claim 4, characterized in that, The first flexible locking junction is a flat sheet structure.

6. A suture anchor for repairing soft tissue, characterized in that, The device includes an anchor body, a flexible portion, and a suture. One end of the suture is connected to the flexible portion, which is positioned at the distal end of the anchor body. The other end of the suture is free outside the proximal end of the anchor body. When the flexible part is pulled by the suture, it is fixed at the distal end of the anchor body and is at least partially located outside the anchor body. The flexible part is used to fix the suture and prevent the suture from detaching from the anchor body. The anchor body has a hollow structure along its axial direction, the suture is configured to pass through the hollow structure and connect to the flexible part at the distal end of the anchor body, the suture is configured to be pulled, and the flexible part moves toward the distal end of the anchor body until it partially abuts against the distal end of the anchor body. The suture forms a second loop structure at the distal end of the anchor body, and the suture located at the second loop structure passes through a first flexible locking knot. The second loop structure and the first flexible locking knot form the flexible portion. The suture is configured to be pulled, and the first flexible locking knot moves toward the distal end of the anchor body until the first flexible locking knot contracts and deforms to abut against the distal end of the anchor body. After the anchor body is placed into the target object, the flexible part is fixed inside the target object and pulls the suture, which is deformed and compressed. The free end of the suture passes through the soft tissue and fixes the soft tissue to the surface of the target object, thereby repairing the soft tissue.

7. The suture anchor for repairing soft tissue according to claim 6, characterized in that, The first flexible locking knot is a second flexible sleeve, which is sleeved on the seam.

8. The suture anchor for repairing soft tissue according to claim 7, characterized in that, The cross-section of the second flexible sleeve is circular or flat.

9. The suture anchor for repairing soft tissue according to claim 6, characterized in that, The first flexible locking knot has at least a first hole and a second hole, and the suture passes through the first hole and the second hole in sequence.

10. The suture anchor for repairing soft tissue according to claim 9, characterized in that, The first flexible locking junction is a flat sheet structure.

11. An anchor for repairing soft tissue, characterized in that, It includes an anchor body, a flexible part, and a suture. The flexible part is located outside the distal end of the anchor body. One end of the suture is connected to the flexible part, and the other end is free outside the anchor body. The flexible part is fixed to the distal end of the anchor body when it is pulled by the suture. The flexible part has a passable structure. The anchor body has a hollow structure along its axial direction, the suture is configured to pass through the hollow structure and connect to the flexible part at the distal end of the anchor body, the suture is configured to be pulled, and the flexible part abuts against the distal end of the anchor body; The threadable structure is a thread hole, the thread is configured to be pulled, and the diameter of the thread hole can be adjusted when the flexible part moves along the axial direction of the anchor body. The suture forms a second loop structure at the distal end of the anchor body, the suture located at the second loop structure passes through a first flexible locking knot, the second loop structure and the first flexible locking knot form the flexible part, and the second loop structure is configured as the thread hole; The suture is configured to be pulled, and the first flexible locking knot moves toward the distal end of the anchor body until the first flexible locking knot contracts and deforms against the distal end of the anchor body, and the diameter of the thread hole decreases. The anchor is a suture anchor: after the anchor is placed in the target object, the flexible part located in the target object pulls the suture, the free end of the suture passes through the soft tissue, and fixes the soft tissue to the surface of the target object to achieve soft tissue repair. The suture free outside the target object is a soft tissue suture. The anchor is a knotless anchor: the soft tissue suture passes through the suture hole of the second annular structure, the soft tissue suture is inserted into the insertable structure, and the anchor is placed into the target object to fix the soft tissue suture in the target object. The soft tissue suture forms a suture bridge on the surface of the target object to further fix the soft tissue.

12. The anchor for repairing soft tissue according to claim 11, characterized in that, The first flexible locking knot is a second flexible sleeve, which is sleeved on the seam.

13. The anchor for repairing soft tissue according to claim 12, characterized in that, The cross-section of the second flexible sleeve is circular or flat.

14. The anchor for repairing soft tissue according to claim 11, characterized in that, The first flexible locking knot has at least a first hole and a second hole, and the suture passes through the first hole and the second hole in sequence.

15. The anchor for repairing soft tissue according to claim 14, characterized in that, The first flexible locking junction is a flat sheet structure.

16. An anchor system for repairing soft tissue, comprising an inserter and a knotless anchor for fixing soft tissue sutures in bone as described in any one of claims 1-5, or a suture anchor for repairing soft tissue as described in any one of claims 6-10, or an anchor for repairing soft tissue as described in any one of claims 11-15; The inserter includes an inner shaft and an outer shaft. The proximal end of the anchor body is connected to the outer shaft, and the distal end of the anchor body is connected to the inner shaft. The flexible part is pulled by the suture and is located at the distal end of the inner shaft. The flexible part is fixed at the distal end of the inner shaft when it is pulled. The anchor is a suture anchor: the inner shaft is inserted into the preset target object, the suture is configured to be pulled, the flexible part is fixed at the far end of the inner shaft, the inserter configures the anchor body into the target object along the inner shaft, the free end of the suture passes through the soft tissue, fixes the soft tissue to the surface of the target object, and realizes the repair of soft tissue. The suture outside the target object is a soft tissue suture. The anchor is a knotless anchor: the inner shaft is inserted into the preset target object, the soft tissue suture is configured to be pulled, after adjusting the tension of the soft tissue suture, the suture is configured to be pulled, the flexible part is fixed at the distal end of the inner shaft, the inserter configures the anchor body into the target object along the inner shaft, and the soft tissue suture forms a suture bridge on the surface of the target object.

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