Soft tissue repair apparatus, system, and method

Abstract

This invention provides a method, apparatus, and system for repairing torn soft tissue, such as tendons. This improves the contact between the torn soft tissue and bone, thereby achieving a better healing process.

Description

Technical Field

[0001] The present invention generally relates to the field of tissue repair. Specifically, it provides an apparatus and method for improving the contact between two tissues, particularly soft tissues such as tendons and bones, and promoting the healing process.

Background Art

[0002] Known tendon plate repair techniques (open surgery, mini-open surgery, total arthroscopic tendon plate repair) have their respective advantages and disadvantages, so the techniques vary.

[0003] The open surgical method has long been the gold standard for tendon plate repair, but surgeons are becoming proficient in techniques to reduce patient complications through a reduction in surgical trauma with a total arthroscopic approach.

[0004] Existing arthroscopic surgical techniques are based on surgical sutures that are manually inserted (usually manually or mechanically using a needle) from one end of the tendon and fixed by ligation or the like. This enables the tendon to be fixed via the suture at one end and to a standard bone anchor / suture anchor at the other end (Figure 1 shows a tendon sutured to bone using existing tools and techniques).

[0005] When precisely selecting the suture insertion position on the tendon, the surgeon uses an arthroscopic grasper to pull the torn tendon in the direction of the humerus. This individual grasping does not provide the surgeon with the complete pulling effect on tendon repositioning such that a multi-point sutured tendon would experience at the end of the surgery. With permanent grasping by a specific suture, the force becomes unbalanced and concentrates at each suture insertion point. This unbalanced force overloads the suture, causing suture breakage or, in the worst case, undesirable suture dragging, which may lead to further tendon rupture. Currently, a common failure in tendon rupture repair occurs at the interaction point between the suture and the tendon. Re-rupture occurring in the early stage (the first 6 months) indicates a failure of healing. Therefore, various surgical techniques have been developed to reduce re-rupture: single-row suture, double-row suture, suture bridge, suture bridge without knots.

[0006] Currently, several "suture path devices" exist that allow for the simultaneous insertion and retrieval of sutures. While most of these devices reduce the complexity of the procedure, they require multiple operations and therefore do not shorten the procedure time. Furthermore, none of the known devices have means for evenly grasping the tendon or for repositioning the suture after it has been fixed to the same tendon.

[0007] The biomechanical structure (tendon-bone) is crucial for maintaining the proximity of bone and tendon to enable biological healing, and current methods use multiple suture anchors (1 to approximately 6).

[0008] Even with the aid of suture threading devices, tendon repair using existing techniques suffers from a relatively high failure rate (especially in cases of large ruptures), requires a high level of expertise from the surgeon, and is time-consuming. Furthermore, current procedures have many limitations. A long period of limb immobilization of approximately 2-6 weeks is required to avoid premature re-rupture, and the lengthy rehabilitation period forces patients to avoid surgery. Tendon repair procedures are time-consuming and require multiple knots, sutures, and devices. In addition, these procedures require a long learning curve for surgeons. [Overview of the project] [Problems that the invention aims to solve]

[0009] Therefore, there is a need for user-friendly and simple devices and methods that improve tendon grip and fixation and promote the healing of ruptured tendons. These are minimally invasive, can be modified or adjusted at any point during the surgical process, minimize tendon damage, promote healing, and reduce the re-rupture rate. As a result, this leads to shorter rehabilitation periods and shorter surgical times. This repair device and method achieves all of these goals and provides enhanced anchoring and fixation strength. [Means for solving the problem]

[0010] The present invention provides a soft tissue repair device (100) for repairing torn soft tissue. The device (100) essentially comprises (a) a distal end (101) having at least two spikes (105) configured to penetrate only a predetermined thickness of soft tissue and grasp it therewith, and (b) a proximal end (102), wherein the spikes (105) are inclined with respect to the distal end (101) at a predetermined angle other than 90°. The connection between the distal end (101) and the proximal end (102) allows one to rotate relative to the other. The distal end (101) is configured to be fixed to the first plane of the bone by a dedicated anchor passing through it. The proximal end (102) is configured to be fixed to different planes of the same bone by a dedicated anchor that passes through it.

[0011] The present invention further provides a method for repairing torn soft tissue. This method includes the following steps: (a) Prepare the repair device (100) of the present invention. (b) Determine a preferred grasping site (501) of the torn soft tissue, bring the distal end (101) close to the preferred grasping site, pass the spike (105) of the repair device (100) through the preferred grasping site, thereby grasping the soft tissue with the distal end (101) of the repair device (100). (c) The distal end (101) is grasped and pulled to position the grasped soft tissue above a predetermined area of ​​the bone, and the distal end (101) is fixed to the predetermined area of ​​the bone together with the grasped soft tissue using one or more dedicated anchors (110) that are passed through the distal end (101) and the soft tissue. (d) The step of bending the proximal end (102) of the repair device (100) relative to the distal end (101) to align it with different regions of the bone surface; and (e) A step of repairing the torn soft tissue by fixing the proximal end (102) to the different region of the bone, thereby fixing the torn soft tissue to the bone using the repair device (100). [Brief explanation of the drawing]

[0012] [Figure 1] This shows an example of a technique currently used to fix a ruptured tendon to bone. [Figure 2A] This shows one example configuration of a repair device according to an embodiment of the present invention. [Figure 2B] This shows one example configuration of a repair device according to an embodiment of the present invention. [Figure 3] This document describes possible installation tools for the repair device of the present invention. [Figure 4A] The present invention shows a rotator cuff repair device that is fixed to the bone and holds the ruptured humeral head tendon in a predetermined position. [Figure 4B] The present invention shows a rotator cuff repair device that is fixed to the bone and holds the ruptured humeral head tendon in a predetermined position. [Figure 5A-5I] The following shows a possible procedure for fixing a ruptured tendon to bone using a repair device and a suitable delivery tool: Figure 5A: The delivery tool reaches the ruptured tendon; Figure 5B: The delivery tool grasps the ruptured tendon; Figure 5C: The spikes of the repair device are pressed into the ruptured tendon; Figure 5D: The lower part of the delivery tool is retracted to precisely and accurately position the repair device on the bone; Figure 5E: Pins secure the repair device, which holds the tendon, to the bone; Figure 5F: The delivery tool is removed; Figure 5G: The proximal end of the repair device is secured to the bone using another pin, screw, or bone anchor; Figure 5H: The repair device is secured to the bone while holding the ruptured tendon; Figure 5I: The footprint area on the bone where the repair device is secured and the articular cartilage unaffected by the device are shown. [Figure 6A-6J] This shows various pins used to secure the repair device to the bone. [Figure 7A-7C] This example shows the use of two repair devices to fix a large tendon to bone. [Figures 8A-8B] This is a block diagram showing two methods for using the repair apparatus of the present invention. [Figures 9A-9C]An example of the use of a (tissue growth) layer at the distal end of the device is shown. FIG. 9A shows a layer attached / disposed on the bottom surface of the distal end of the device. FIG. 9B shows a sleeve-shaped layer covering both sides of the distal end of the device. FIG. 9C shows a wide (sleeve-shaped) layer extending significantly beyond the side surface of the distal end of the device. [Figure 10A-10B] A side view of the distal end of the device and the layer is shown. FIG. 10A shows a layer attached / disposed on the bottom surface of the distal end of the device. FIG. 10B shows a sleeve-shaped layer covering both sides of the distal end of the device. [Figure 11A-11B] The implementation of a multi-stage anchor hole / cavity according to an embodiment of the present invention is shown.

Mode for Carrying Out the Invention

[0013] Currently, when the rotator cuff tendon is ruptured, in the most common arthroscopic repair, a surgeon needs to use multiple sutures and anchors to fix the ruptured tendon to the attachment on the humeral head. This surgery (rotator cuff repair (RCR)) takes a long time and is a relatively complex procedure, and since the tendon is pulled towards the fixation point on the bone, there is also a possibility of shortening the tendon.

[0014] The present invention provides a method, device, and system that enable a physician to perform operations more accurately, quickly, and simply. This allows a surgeon to anticipate, grasp, and retract the state of a damaged soft tissue before fixing it at a desired position on a support (e.g., bone). This simple process can significantly reduce the complexity and time required for surgery while providing strong biomechanical support and promoting healing.

[0015] The present invention provides a soft tissue repair device (100) that improves the contact between soft tissue and bone and equalizes the distribution of forces to the attachment points, thereby reducing the risk of retear and detachment. It securely fixes the soft tissue with a single insertion operation, minimizes damage to the soft tissue (and bone) as necessary, and improves the contact area between the soft tissue and bone during the recovery period. In certain embodiments, the procedure for fixing the soft tissue to the bone is reversible, allowing for improvement and adjustment of the contact. In certain embodiments, the procedure for fixing the soft tissue to the bone is reversible, and it is possible to improve and adjust the contact between the soft tissue repair device and the soft tissue during the fixation procedure. Further, the method and repair device (100) may eliminate the need for additional sutures currently required for vertical soft tissue tears. The soft tissue repair device of the present invention enables optimal soft tissue-to-bone contact / fixation and contact pressure, contributing to a shorter healing time and / or a reduced detachment risk.

[0016] As used herein, the terms "support" and "bone" refer to any hard surface to which the repaired soft tissue is fixed, including natural bone, synthetic bone, and other artificial structures.

[0017] As used herein, the term "soft tissue" refers to tendons, ligaments, and other soft tissues, particularly connective tissues, that may require repair.

[0018] As used herein, the terms "torn tendon" and "torn soft tissue" refer to both completely torn soft tissue / tendon and soft tissue / tendon that is partially torn but still retains some connection to the bone. Partial tendon tears include, for example, small crescent-shaped, medium crescent-shaped, large U-shaped, V-shaped, L-shaped, and reverse L-shaped tears, but are not limited thereto. Both acute and chronic tear scenarios are included.

[0019] Therefore, the present invention enables better healing and faster, easier treatment in tendon-bone reattachment techniques, such as rotator cuff repair. The present invention provides a minimally invasive, suture-free grasping and reattachment system comprising a soft tissue repair device that fixes the tendon and provides a dispersive force to maximize the contact area between the tendon and bone. This enables accelerated healing, earlier initiation of physical therapy, and a shorter rehabilitation period. Furthermore, the repair device of the present invention is designed to reduce the time and complexity required for current arthroscopic tendon repair surgery, including reoperations.

[0020] In a first embodiment, the present invention provides a repair device (100) for repairing torn soft tissue. The apparatus (100) essentially comprises the following: (a) A distal end (101) having at least two spikes (105) configured to be of a predetermined length for grasping soft tissue by penetrating only a predetermined thickness of the soft tissue. (b) A proximal end (102), wherein the spike (105) is designed to make a predetermined angle other than 90° with respect to the surface of the distal end (101), and the connection between the distal end (101) and the proximal end (102) allows one to rotate relative to the other, and the distal end (101) is designed to be fixed to a first plane of bone by a dedicated anchor passing through it, and the proximal end (102) is designed to be fixed to a different plane of the same bone by a dedicated anchor passing through it.

[0021] In a particular embodiment of the soft tissue repair device (100) according to any of the above embodiments, the length of the spike (105) is determined according to the thickness of the soft tissue. That is, the length of the spike (105) is shorter than or equal to the thickness of the soft tissue in order to penetrate only to a predetermined thickness in order to grasp the soft tissue, and to avoid protruding from the other side (i.e., without reaching and damaging the bone (400)), thereby preventing unintended damage to the bone.

[0022] In a particular embodiment, the repair device (100) further comprises an intermediate flexible region (106) designed to allow the proximal end (102) to bend and / or rotate relative to the distal end (101).

[0023] In a specific embodiment, the repair device (100) comprises (a) a distal end (101) having a spike (105) designed to penetrate soft tissue and attach the device to the soft tissue, (b) a proximal end (102), and (c) an intermediate flexible region (106) designed to allow flexion and / or rotational movement of the proximal end (102) relative to the distal end (101), wherein the distal end (101) is designed to be fixed to a first plane of bone by a dedicated anchor passing through there, and the proximal end (102) is designed to be fixed to a different plane of the same bone by a dedicated anchor passing through there.

[0024] In certain embodiments, the repair device (100) according to any embodiment is composed of a material that is essentially fully flexible or semi-rigid, allowing the device (100) to be bent and adjusted to the shape of the surface / bone. In such a configuration, the flexibility of the distal end (101) and / or proximal end (102) allows for complete adjustment to, for example, the bone (400), thereby reducing the risk of edge protrusion / extension that may interfere with or irritate neighboring tissues and improving the healing process.

[0025] In a particular embodiment, the repair device (100) according to any embodiment further comprises one or more attachment elements designed to allow the device (100) to be held by a delivery tool, such as the arthroscopic instrument (200) of the present invention. Non-limiting examples of such gripping elements include bioadhesives and projections or recesses within the device body, around or on the distal end (101), proximal end (102), intermediate flexible portion (106), or any combination thereof.

[0026] In a particular embodiment of the repair device (100) described above, the soft tissue is a tendon. More specifically, the tendon is a rotator cuff tendon.

[0027] In another embodiment, the present invention provides a soft tissue repair device (100) as defined above, which is used for the repair of soft tissue. In a specific embodiment, the device (100) comprises the following: (a) A distal end (101) having at least two spikes (105) configured to be of a predetermined length to penetrate only a predetermined thickness of the soft tissue and grasp the soft tissue (meaning that the spikes do not have to penetrate the entire thickness of the soft tissue), and (b) A proximal end (102) wherein the spike (105) is inclined at a predetermined angle other than 90° with respect to the surface of the distal end (101), and the connection between the distal end (101) and the proximal end (102) allows one to rotate relative to the other, and the distal end (101) is designed to be fixed to a first plane of bone by a dedicated anchor passing through it, and the proximal end (102) is designed to be fixed to a different plane of the same bone by a dedicated anchor passing through it.

[0028] In a particular embodiment, the present invention provides a tendon repair device (100) used to repair a ruptured tendon. The device (100) has the following configuration: (a) A distal end (101) having one or more dedicated anchor holes (103) and spikes (105), wherein the spikes (105) are designed to penetrate a tendon and attach the device to the tendon; (b) Proximal end (102); and (c) an intermediate flexible region (106) designed to allow rotational movement (e.g., around axis X) of the proximal end (102) relative to the distal end (101), wherein (i) the distal end (101) is designed to be fixed to a first plane of bone by a dedicated anchor passing through one or more dedicated anchor holes (103); and (ii) the proximal end (102) is designed to be fixed to a different plane of the same bone by a dedicated anchor passing through one or more dedicated anchor holes (104).

[0029] In a particular embodiment of the soft tissue tear repair device (100) according to any of the above embodiments, the device (100) includes: (a) A distal end having a spike (105) designed to penetrate soft tissue and attach the device to the soft tissue; (b) Proximal end (102); and (c) An intermediate flexible region (106) designed to allow bending and / or rotational movement of the proximal end (102) relative to the distal end (101), wherein the distal end (101) is designed to be fixed to a first plane of the bone by a dedicated anchor passing through there, and the proximal end (102) is designed to be fixed to a different plane of the same bone by a dedicated anchor passing through there.

[0030] The present invention further provides a repair device (100) for use in repairing bone and soft tissue, as defined above. This repair device (100) includes the following steps: (a) Determine a preferred grasping site (501) for the bone or soft tissue, bring the distal end (101) close to that site, pass the spike (105) of the repair device (100) through it, and grasp the soft tissue with the distal end (101) of the repair device (100). (b) The distal end (101) is grasped and pulled to position the grasped soft tissue above a predetermined area of ​​the bone, and the distal end (101) is fixed to the predetermined area of ​​the bone together with the grasped soft tissue using one or more dedicated anchors (110) that are passed through the distal end (101) and the soft tissue. (c) bending the proximal end (102) of the repair device (100) relative to the distal end (101) to align the proximal end (102) with a different area on the surface of the bone; and (d) fixing the proximal end (102) to the different area of ​​the bone, thereby repairing the torn soft tissue by fixing the torn soft tissue to the bone using the repair device (100).

[0031] In a particular embodiment of the above-described application, the tissue is a tendon, and the soft tissue repair device (100) is a tendon repair device.

[0032] In particular, the structure of the repair device (100) according to any of the above embodiments can be fixed to at least two surfaces of the bone. One is the articular surface and the other is the lateral surface (see Figure 5I). This is made possible by the flexibility between the distal (101) and proximal (102) ends of the device, or by the flexibility provided by an intermediate flexible region (106) (if present). This allows the proximal (102) to bend relative to the distal (101) and conform to the curve of the bone. This type of fixation to two surfaces improves the stability and robustness of the device when tensile forces are applied, i.e., when soft tissue is pulled back. This significantly reduces the risk of the anchor being pulled out of the bone.

[0033] In a particular embodiment of the repair device (100) of the present invention, the intermediate flexible region (106) is configured as a pre-bent shape and is designed to return to the pre-bent shape. This ensures that when the device is forcibly opened ("straightened" or "folded in half"), for example, when placed in a delivery device for internal insertion, it snaps back to the bent shape when the pressure is released, i.e., when it is removed from the delivery device.

[0034] In certain embodiments, the repair device (100) according to any of the above embodiments is rigid. In another embodiment, the device itself is somewhat flexible or semi-rigid, and the spikes are rigid. In yet another embodiment, the repair device (100) is composed of a solid plate. In yet another embodiment, the repair device (100) is composed of a perforated or mesh-like plate. The size of the holes may be fixed or differential. In certain embodiments, the spikes are perforated. Such a perforated or mesh-like structure allows tissue to grow into the cavity, thereby strengthening the bond between the repair device (100) and the soft tissue.

[0035] According to some embodiments of the present invention, the number of spikes (105) of the apparatus (100) according to any of the above embodiments may vary depending on the mechanical properties and dimensions of the relevant soft tissue. Accordingly, in one embodiment of the present invention, the apparatus (100) has 1 to 1000, 2 to 750, 3 to 500, 4 to 400, 5 to 300, 5 to 250, 5 to 200, 5 to 150, 5 to 100, 7 to 100, 8 to 100, 9 to 100, 10 to 100, or 10 to 50 spikes (105).

[0036] In other embodiments, the number of spike rows and / or columns is greater than 1 and less than 10,000. The distance between two adjacent spikes (105) is approximately 1 μm to approximately 30 mm, or other appropriate distances or distance ranges.

[0037] In other embodiments, the spike length is longer than approximately 1 μm and shorter than approximately 30 mm.

[0038] In another embodiment, the thickness of the spike (105) is approximately 1 μm and less than approximately 10 mm.

[0039] In certain embodiments, the repair device (100) according to any of the above embodiments further includes a locking mechanism designed to prevent the withdrawal of anchors (110, 111) that pass through the device to fix the device (100) to the bone (400). Non-limiting examples of such a locking mechanism include a click mechanism and a sliding cover that slides over dedicated anchor holes (103, 104) after anchor insertion. In another or additional embodiment, the locking mechanism is part of the anchor itself and is securely locked to prevent the device from being released from the anchor and bone after the anchor has passed through the device (100) and been positioned in the bone. In yet another or additional embodiment, the locking mechanism is a bioadhesive.

[0040] In a second embodiment, the present invention further provides a method for using a soft tissue repair device (100) according to any of the above embodiments to repair torn soft tissue by the following steps: (a) Determining a preferred grasping site (501) of the torn soft tissue, bringing the distal end (101) close to it, passing the spike (105) of the repair device (100) through it, and grasping the soft tissue with the distal end (101) of the repair device (100); (b) The step of gripping and pulling the distal end (101) to position the grasped soft tissue above a predetermined area of ​​the bone, and fixing the distal end (101) together with the grasped soft tissue to the predetermined area of ​​the bone using one or more dedicated anchors (110) that pass through the distal end (101) and the soft tissue; (c) Bending the proximal end (102) of the repair device (100) relative to the distal end (101) to align the proximal end (102) with a different region on the surface of the bone; and (d) Fixing the proximal end (102) to the different region of the bone, thereby repairing the torn soft tissue by fixing the torn soft tissue to the bone using the repair device (100).

[0041] In a particular embodiment, the tissue is a tendon, and the soft tissue repair device (100) is a tendon repair device.

[0042] In a particular embodiment, the soft tissue repair device (100) according to any of the above embodiments is provided with one or more dedicated anchor holes (103) at the distal end (101) through which a dedicated anchor can be passed, thereby fixing the distal end (101) and the soft tissue to the bone, and / or is provided with one or more dedicated anchor holes (104) at the proximal end (102) through which a dedicated anchor can be passed.

[0043] In such cases, if the device (100) does not have such dedicated anchor holes, the anchor can be pushed in from any point on the device. In particular, even if the device has such dedicated anchor holes, the anchor can be inserted into the bone (400) through the device (100) from a position other than such holes (103, 104).

[0044] In a particular embodiment of the soft tissue repair device (100) according to any of the above embodiments, one or more of the one or more dedicated anchor holes (103, 104) are multi-stage / multi-step holes (1101) that prevent unintended dislodgement of the anchors (110, 111), provide more secure fixation of the device (100), and / or prevent the formation of bulges and form a smooth surface.

[0045] In a particular embodiment, the apparatus (100) according to any of the above embodiments comprises one or more anchor holes (103, 104). In a particular embodiment, the anchor holes (103, 104) are multi-stage holes (1101), that is, having grooves, recesses, or recesses designed to enclose the head of an anchor, thereby enabling the anchor to be installed flush (i.e., without the head of the anchor protruding from the top surface of the apparatus) (Figure 11A). In yet another embodiment, the multi-stage holes (1101) allow the anchor to be installed at an angle, while minimizing or completely eliminating the protrusion of the anchor head from the top surface of the device (Figure 11B).

[0046] The anchor (110) is screwed into the multi-stage hole (1101) at an angle, with its anchor head (1110) in contact with the step (1101a) of the multi-stage hole (1101). This angled screwing / installation of the anchors (110, 111) prevents unintended removal of the anchors and facilitates installation. In certain embodiments, the multi-stage hole (1101) is designed to be appropriately sized so that the anchors (110, 111) are completely embedded and the anchor heads do not rise above the top surface of the device (100). This prevents interference with, for example, the acromion bone, thereby reducing the risk of irritating surrounding tissues such as the acromion and promoting the healing process.

[0047] In a more specific embodiment, the multi-stage holes (1101) allow the anchors (110, 111) to be inserted through soft tissue (300), through the device (100), and into the bone (400). This allows for angled insertion (i.e., not perpendicular to it). This ensures that the heads of the anchors are positioned entirely or nearly entirely below the upper surface of the device (100), reducing the risk of irritating nearby tissues such as the acromion.

[0048] In this specification, “spike” means one or more protrusions / thorns provided within or on a platform. A platform having spikes may be referred to in this specification as a spike base element or the distal end (101) of the device.

[0049] In a particular embodiment of the repair device (100) according to any of the above embodiments, the spike (105) has a sharp / pointed edge / tip designed to allow smooth and easy penetration into soft tissue, while the rest of the spike, i.e., its base / body, is blunt / rounded so as not to damage soft tissue when subjected to pulling or pushing forces.

[0050] In a particular embodiment of the repair device (100) according to any of the above embodiments, the region where the spike (105) is located is called the spike base element, and the repair device further includes a locking mechanism between the spike base element and an anchor passing through the distal end of the device (100). This locking mechanism is designed to prevent spontaneous withdrawal of the anchor passing through to fix the device (100) to the bone (400).

[0051] In a particular embodiment of the soft tissue repair device (100) according to any of the above embodiments, the spikes (105) are arranged to distribute the tensile force acting on the attached soft tissue (for example, distributed among all the spikes). This reduces the risk of damage to the soft tissue and / or the risk of the repair device being torn away from the soft tissue. In a particular embodiment, this is achieved by providing individual gripping points between each spike and the soft tissue, thereby distributing the tensile force applied to the soft tissue among all the gripping points.

[0052] In a particular embodiment of the repair device (100) according to any of the above embodiments, the spike (105) is designed to be insertable into soft tissue at a predefined angle, and to be removable from the soft tissue as needed (for example, to fix or adjust the attachment of the device to the damaged soft tissue), and subsequently reinsertable into the soft tissue with minimal additional damage to the soft tissue.

[0053] In certain embodiments of the soft tissue repair device (100) according to any of the above embodiments, the spikes (105) are serrated, differentiated (in length, distribution at the distal end (101), and / or diameter), individualized, and / or perforated. The spikes (105) may also differ from patient to patient. This differentiates the fixation of the repair device (100) to the soft tissue. In yet another embodiment, the spikes (105) are claw-shaped. In yet another embodiment, the spikes are positioned / manufactured at a predetermined angle, i.e., an angle other than 90 degrees with respect to the surface area of ​​the distal end (101). In some modifications of the device (100), the spikes (105) can be distributed asymmetrically across the entire distal end (101).

[0054] In a particular embodiment of the soft tissue repair device (100) according to any of the above embodiments, the spikes (105) are arranged in stages to distribute the tensile force caused by the traction of the soft tissue and / or are roughened or spiky to prevent unintended release of the soft tissue.

[0055] In certain embodiments of the apparatus (100) according to any of the above embodiments, the spike (105) is not in an upright position, i.e., it is at an angle other than 90 degrees with respect to the base. The spike (105) can be formed at any angle with respect to its base, for example, in the range of about 1 to about 179 degrees, or for example, about 80 to about 100 degrees. In some embodiments, the spike (10) is shaped according to a specified insertion motion path. Thus, the angle or curve of the spike corresponds to the element best suited to each application.

[0056] In a particular embodiment of the soft tissue repair device (100) according to any of the above embodiments, the spike (105) is foldable and / or retractable. That is, it can be stored flat against the distal end (101) of the device so that it can be unfolded outward before use. This prevents unintentional damage to tissue when inserting the device (100) into the body, facilitates insertion into the body, and simplifies storage.

[0057] In certain embodiments, the spikes (105) are notches from the surface of the apparatus and bend into the final shape, that is, they constitute a unique portion resulting from the same “sheet” / “block” material. Alternatively, the spikes (105) may be formed from multiple separate elongated elements as isolated spike rows, which are inserted into the platform and tightened / secured in the final configuration. In either option, gaps are formed between the spikes, allowing for the regeneration of soft tissue.

[0058] In a particular embodiment, the soft tissue repair device (100) according to any of the above embodiments comprises tissue growth holes (101a) which form a scaffold that enables tissue growth. In an alternative or additional embodiment, the device (100) has a scaffold structure that enables tissue growth. Such a configuration assists tissue healing and accelerates the healing process.

[0059] In certain embodiments of the repair device (100) according to any of the above embodiments, its distal end (101) and / or proximal end (102) are composed of or have perforated structures that allow soft tissue to grow inside them. These perforated structures further allow the passage of fluids, allowing, for example, factors or tissues to grow in the perforations of the device (100). In certain embodiments, the device is constructed / manufactured using powder metallurgy techniques or other similar techniques to form a controlled porous structure that allows soft tissue to grow inside the device, thereby improving the fixation of the device to the soft tissue. In certain additional embodiments, the anchor (110) itself is perforated to allow the passage of fluids (e.g., fluids from the bone marrow to the damaged soft tissue). This further promotes the healing process.

[0060] In a particular embodiment, the repair device (100) according to any of the above embodiments may be manufactured in any suitable way, for example, by 3D printing to construct a device (i.e., personalized medicine) that is individualized for each patient based on the damaged soft tissue and the patient's medical / physical characteristics.

[0061] In particular, the term "patient" as used herein refers to both humans and animals, and the apparatus (100) and method of the present invention may be adopted or modified depending on the patient.

[0062] In certain embodiments, the reconstructive device (100) or its components according to any of the embodiments described above are composed of biocompatible and / or biodegradable materials. This means that their presence does not cause severe inflammation and / or graft rejection. Non-limiting examples of such materials include metals and their alloys, polymers and copolymers (including bioactive / biodegradable polymers / copolymers), ceramics, bioglass polymers / ceramics, or any combination thereof. In certain embodiments, the device (100) is composed of biodegradable materials. This means that after the soft tissue has completely healed and the device is no longer needed, it does not need to be removed, but simply decomposes in a harmless manner, leaving behind healed soft tissue firmly fixed to the bone. In even more specific embodiments, this also applies to the anchor (110).

[0063] In certain embodiments, the repair device (100) according to any of the above embodiments constitutes or serves as a scaffold for soft tissue growth, that is, it provides support for soft tissue growth, thereby promoting healing. This means that after the torn soft tissue (300) is fixed to the bone (400), the soft tissue grows into the repair device (100) itself, thereby promoting its healing more quickly and effectively. A non-limiting example of such scaffold material is biofiber.

[0064] In certain embodiments, the repair device (100) according to any of the embodiments described above includes or is coated with auxiliary materials such as drug-releasing materials, immunosuppressive materials, growth factors, stem cells, anti-inflammatory substances, healing / regeneration-promoting substances, hormones, and tissue-generating materials. These are intended to assist in the repair of soft tissue and / or the fusion of the soft tissue with the repair device and / or the target region / site or other parts of the damaged soft tissue.

[0065] In certain embodiments, the repair device (100) according to any of the above embodiments is subjected to further processing, such as vibration finishing or electropolishing, to smooth its sharp edges. This reduces or eliminates potential damage to surrounding tissues that may occur when the device is inserted into the patient's body or fixed to the bone.

[0066] In particular, the size and width of the repair device (100) according to any of the above embodiments can be adjusted as needed. For example, they can be adjusted according to the size of the soft tissue / tendon, the point of tear of the soft tissue / tendon, the size of the bone, or any combination thereof. Therefore, under certain conditions, namely when the torn soft tissue is large and has a relatively large surface area, a single repair device (100) may not provide sufficient secure fixation to the bone. In such cases, two or more repair devices (100) can be used to fix a single soft tissue / tendon to the bone. Alternatively, a wider single repair device (100) can be used. In certain embodiments, this wider repair device can be bent in the central part in addition to the intermediate flexible region, and can be curved along the surface of the bone. In yet another embodiment, the length of the repair device (100) can be changed. That is, by making it longer or shorter as needed, it is possible to bridge the distance between the soft tissue and the bone more efficiently and accurately.

[0067] In a particular embodiment, the repair device (100) according to any of the embodiments described above may be configured in any shape and size. For example, it may have a rectangular, elliptical, or square shape with a width of about 1 mm to about 100 mm and a length of about 1 mm to about 100 mm. It should be noted that the shape and size of the repair device (100) are determined according to the specific soft tissue to be repaired and the individual characteristics of said soft tissue. Thus, in a particular embodiment, the size and shape of the repair device (100) and / or the spike (105) are determined based on the specific patient to be treated, the characteristics of the soft tissue, the type of injury / tear, the specific anatomical structure of the patient / tissue, or any combination thereof.

[0068] In a particular embodiment, the repair device (100) according to any of the above embodiments is custom-made according to the patient's anatomical structure and / or the soft tissue to be repaired. In this case, the device (100) is not only manufactured to the desired width and length, but also to enable more secure and precise fixation by positioning dedicated anchor holes (103, 104) in specific locations.

[0069] To further support and accelerate the healing process, a dedicated layer can be used, positioned at the fixation point between the torn soft tissue and bone. This layer may have various properties and components designed to promote the healing process in any way possible, such as by releasing growth promoters or anti-inflammatory agents. Thus, in a particular embodiment, the repair device (100) according to any of the above embodiments further includes one or more layers (900) attached to a predetermined portion of one or more of its surfaces. In a particular embodiment, the layer is a tissue growth layer. In a particular embodiment, one of the one or more layers (900) is positioned between a predetermined portion of the distal end (101) of the device and the soft tissue to be repaired thereby.

[0070] In a particular embodiment of the repair device (100) according to any of the above embodiments, one or more layers (900) are (i) attached to selected portions on both sides of the device (100); (ii) fixed to part or all of the periphery; or (iii) sleeve-like layers covering both sides of the device (100) or the distal end (101) of the device.

[0071] In a particular embodiment of the repair device (100) according to any of the above embodiments, a layer (900), or at least one of the one or more layers (900), is composed of a biomaterial selected from the group consisting of synthetic materials, autologous grafts, allografts, xenografts, or any combination thereof; (ii) having one or more thread openings for passing a dedicated anchor; (iii) having one or more thread markings for guiding the thread insertion of the dedicated anchor; (iv) exceeding the surface area of ​​the device (100); or being coated with collagen or bone marrow.

[0072] The layer (900) according to the present invention can be made from any suitable material, and may be a commercially available patch. For example, in a particular embodiment, the layer (900) is selected from the group consisting of augmentation mesh, augmentation patch, bioinduction layer, and any combination thereof.

[0073] In a third aspect, the present invention provides an arthroscopic instrument (200) designed to attach a repair device (100) according to any of the above embodiments to damaged soft tissue (300). In a particular embodiment, the instrument includes: (a) a main handle (204); (b) a shaft (203) with one end connected to the main handle (204); and (c) a base arm (201) and clamp (202) positioned at the other end of the shaft (203), wherein the clamp (202) is designed to hold the repair device (100). The base arm (201) has a recess or groove through which the spike (105) of the repair device (100) can pass without damage. The base arm (201) and clamp (202) are actuated by a means of transmission via the main handle (204) and are designed to open and grasp the tip of the torn soft tissue between them and release the tip of the torn soft tissue as needed. In certain embodiments, the base arm (201) of the tool is retractable and used to expose the grasped torn soft tissue and fix it to the bone.

[0074] In a particular alternative embodiment, the tool (200) includes: (b) a shaft (203) with one end connected to the main handle (204); and (c) a base arm (201) and clamp (202) positioned at the other end of the shaft (203), wherein: the clamp (202) is configured to hold the repair device (100); and the base arm (201) has a recess (in the closed position) through which the spike (105) of the repair device (100) can pass without damage. The base arm (201) and clamp (202) are actuated by a transmission means via the main handle (204) and are designed to open and grasp the tip of torn soft tissue between them, pull it (while the spike (105) penetrates the soft tissue), and release the tip of the torn soft tissue as needed. The clamp (202) also has an opening for passing an anchor through the repair device (100) and soft tissue to the bone. It has an opening for (300) to pass through.

[0075] In certain embodiments, the tool (200) according to any of the above embodiments is designed to hold one, two, or more repair devices (100). These are optionally housed in a cartridge, allowing for the attachment / use of multiple devices without removing the tool from the patient's body.

[0076] In a particular embodiment, the tool (200) according to any of the embodiments described above further includes at least one of the following: a fiber optic cable, an illumination unit, forceps or other gripping means, an electromagnet, a spring, a pressure sensor, a tension sensor, a soft tissue transport belt, or other components that may be useful during surgery, or any combination thereof.

[0077] In certain embodiments, the tool (200) according to any of the above embodiments further includes a vibrating element or vibration generating unit to facilitate the penetration of the spike (105) into the soft tissue (300). Alternatively, if necessary, such a vibrating element or vibration generating unit may be used to readjust the position of the spike (105) within the repaired soft tissue.

[0078] In certain embodiments, the tool (200) according to any of the above embodiments may be not only mechanical but also fully or partially electromechanical. Its operation may be controlled, for example by a computer or fully performed (for example, as in robotic operation).

[0079] In a fourth aspect, the present invention provides a kit comprising an arthroscopic tool (200) of the present invention and one or more repair devices (100) according to any of the above embodiments. In a particular embodiment, the kit or repair device (100) further comprises one or more tissue growth layers (900) as described above.

[0080] In a fifth aspect, the present invention provides a system for repairing torn soft tissue (e.g., tendons). The system comprises an arthroscopic instrument (200) of the present invention and one or more repair devices (100) according to any of the embodiments described above. In a particular embodiment, the system or repair device (100) further comprises one or more tissue growth layers (900) as described above.

[0081] In a particular embodiment, the apparatus (200) according to any of the above embodiments can hold and supply such a layer (900) together with the repair device (100).

[0082] In a sixth embodiment, the present invention provides a method for repairing torn soft tissue. The method comprises the following steps: (a) preparing a repair device (100) according to any of the embodiments described above; (b) passing a spike (105) of the repair device (100) through a preferred gripping site (501) in the torn soft tissue, thereby gripping the soft tissue with the distal end (101) of the repair device (100); (c) pulling the device (100) to position the gripped soft tissue over a predetermined area of ​​bone, and fixing the distal end (101) together with the gripped soft tissue to the predetermined area of ​​bone (502) using one or more specially designed anchors (110) without touching the articular cartilage. In this process, one or more specially designed anchors (110) are passed through the distal end (101) and the soft tissue (300) without touching the articular cartilage. (d) The proximal end (102) of the repair device (100) is bent relative to the distal end (101) and brought into contact with another area of ​​the bone surface. (e) The proximal end (102) is fixed to the different area of ​​the bone, thereby repairing the torn soft tissue by fixing the soft tissue to the bone using the repair device (100). In certain embodiments, the soft tissue is a tendon. In more specific embodiments, the tendon is a rotator cuff tendon.

[0083] In certain embodiments, the method further includes a preliminary step of separating the torn soft tissue and / or determining a preferred grasping site (501) of the torn soft tissue. The determination can be made by any suitable means, such as MRI or the use of an internal camera optionally combined with an arthroscopic delivery device.

[0084] In a particular embodiment of the method according to any of the above embodiments: (i) the distal end (101) of the repair device (100) is provided with one or more dedicated anchor holes (103), and step (c) of fixing the soft tissue attached to the distal end (101) to the bone is performed by passing anchors through the one or more dedicated anchor holes (103). and / or (ii) the proximal end (102) of the repair device (100) is provided with one or more dedicated anchor holes (104), and step (e) of fixing the proximal end (102) to the bone (400) is performed by passing one or more dedicated anchor screws (111) through the one or more dedicated anchor holes (104).

[0085] In particular, the above methods avoid touching or interfering with the articular cartilage.

[0086] In certain embodiments of the method according to any of the above embodiments, the fixation in steps (d) and (e) includes the following preliminary steps: (i) drilling a hole in the bone, then inserting a suitable anchor through the device and fixing it in the drilled hole; or (ii) drilling a hole in the bone, then inserting a suitable anchor through the device and fixing it in the hole. Alternatively, if a self-drilling or self-piercing (e.g., self-punching or self-tapping) anchor is used, the fixation in steps (d) and (e) does not require prior drilling or piercing, and the anchor is simply driven directly into the bone or drilled. In certain embodiments, if the device (100) has dedicated anchor holes (103, 104), passing the anchor through the device into the bone may be done through such dedicated anchor holes (103, 104).

[0087] In a particular embodiment of the method according to any of the above embodiments, the anchors used to fix the distal end (101) and proximal end (102) to the bone are selected from the following group: anchor nails inserted into the bone at different angles to improve grip, inflatable anchors, expandable anchors, staples (701), "all-suture" anchors, and any combination thereof.

[0088] In a particular embodiment, if the torn soft tissue requires a significantly broader range of repair devices (100) than the repair device (100) used, the method according to any of the above embodiments includes using multiple repair devices (100) on the same soft tissue.

[0089] In a specific embodiment, the method according to any of the above embodiments includes the following steps: (a) preparing a repair device (100) according to any of the above embodiments; (b) Separating the ruptured tendon and, while grasping the free end of the ruptured tendon, attaching the distal end (101) of the tendon repair device to the ruptured tendon via the spike; (c) Passing the spike (105) of the repair device (100) through a preferred gripping site (501) in the torn soft tissue, thereby gripping the soft tissue with the distal end (101) of the repair device (100); (d) Pulling the device (100) to position the grasped soft tissue above a predetermined area of ​​bone, and fixing the distal end (101) having the grasped soft tissue to the predetermined area (502) of bone using one or more dedicated anchors (110) that penetrate the distal end (101) and the soft tissue (300); (e) The step of arbitrarily bending the proximal end (102) of the repair device (100) relative to the distal end (101), or bending it beforehand, to align it with different areas of the bone surface; and (f) A step of repairing the torn soft tissue by fixing the proximal end (102) to the different region of the bone, thereby fixing the torn soft tissue to the bone using the repair device (100).

[0090] In certain embodiments, the method according to any of the embodiments described above further includes a preliminary step of removing some soft tissue / tendon residue from the soft tissue / tendon footprint, i.e., the original attachment site to a given support such as bone. This is done as required by surgical / medical needs.

[0091] The absence of sutures between the soft tissue and bone (at the attachment site) maximizes the contact area and prevents physical interference caused by sutures. Furthermore, sutures in existing methods tend to create air holes because they cause geometric distortion in the soft tissue. On the other hand, the repair device (100) of the present invention, with its flared spikes, disperses the tensile force on the soft tissue, improves the contact area with the soft tissue, and reduces distortion. This improves the fixation of the soft tissue to the bone beneath it.

[0092] The entire method / procedure according to the present invention can significantly reduce surgical time compared to currently used known techniques. For example, it can be performed two, three, or even four times faster.

[0093] The phrase "pulling the distal end (101) to position the grasped soft tissue" here refers to substantially pulling the ruptured soft tissue / tendon along its original orientation / direction of movement (not lateral, oblique, or vertical). However, limited lateral, oblique, and / or vertical movement may be necessary during the aforementioned pulling motion.

[0094] In certain embodiments of the method according to any of the embodiments described above, when the repair device (100) is inserted into the patient's body, the device (100) is held in a folded form, for example, with the spike (105) folded or concealed. For example, this is the case when using the arthroscopic instrument (200) according to any of the embodiments described above. In this configuration, when the device (100) is positioned near soft tissue, the spike (105) is exposed or pops out. This reduces the risk of tissue damage that may occur when the device is inserted into the patient's body. In another or additional embodiment, the entire device (100) is folded so that the spike (105) is "covered" by the proximal end (102) of the device.

[0095] In a particular embodiment of the method according to any of the embodiments described above, the step of retracting the soft tissue means retracting the soft tissue / tendon so that the proximal end (102) of the device is above the original attachment point of the soft tissue / tendon.

[0096] Current methods involve pulling torn soft tissue back to its original attachment site and fixing it to the bone with sutures. However, this method uses a repair device that evenly fixes the torn soft tissue to its original attachment site without physically positioning it, thereby reducing the pulling of the soft tissue back. This prevents excessive tension from being applied to the soft tissue. As a result, the patient's mobility and comfort immediately after soft tissue fixation are dramatically improved.

[0097] Furthermore, in one of its potential configurations (e.g., Figure 7C), the repair device (100) can provide an auxiliary length that reduces the distance over which the repaired tissue is stretched (e.g., to restore connection / adhesion at the original attachment site). This reduces the tensile load on the stretched tissue. As a result, improved mobility, accelerated healing, and enhanced fixation and anchoring capabilities are further promoted while maintaining strong biomechanical support. Therefore, in a specific configuration, the repair device can provide an auxiliary length that reduces the tensile load on the stretched tissue. This reduces the tensile load on the stretched tissue. As a result, the tensile load on the stretched tissue is reduced (to improve mobility, accelerated healing, and restore connection / adhesion at the fixation and attachment site) while maintaining strong biomechanical support. This further supports improved mobility, accelerated healing, and enhanced fixation and anchoring capabilities while maintaining strong biomechanical support. Therefore, in certain embodiments of the repair device (e.g., shown in Figure 7C), unlike currently used repair devices and techniques, these use suture wires to pull torn soft tissue back to its original attachment site on a predetermined support such as bone and fix it there. In contrast, the present repair device (100) functions as an elongation bridge, shortening the distance the soft tissue needs to be pulled toward the bone. This reduces the overall tension on the soft tissue, potentially improving patient mobility and comfort. Furthermore, the repair device of the present invention functions as a bridge scaffold and / or biodegradable bridge scaffold, allowing tissue growth on and / or within it while keeping the soft tissue within a physiological tension range. This facilitates the healing process and rehabilitation.

[0098] In addition, in current methods, soft tissue is basically fixed to one surface of the bone using sutures or specialized fixation devices. This means that if high mechanical tensile forces are applied, the fixation device may be pulled out of the bone. This is a particularly serious problem because the tensile force on the fixation point increases as the soft tissue is stretched to a shorter length for fixation. In contrast, the structure of the repair device (100) of the present invention is designed to be fixed to two different surfaces of the bone. This allows the device to withstand large biomechanical loads until the soft tissue has fully recovered (which may take more than 8 months).

[0099] In the method of the present invention, any type of anchor (110, 111), such as orthopedic nails or screws, can be used. Therefore, in a particular embodiment of the method for repairing torn soft tissue according to any of the embodiments described above, the anchor used to fix the distal end (101) to the bone may be (i) one inserted into the bone (400) at different angles to improve grip, as shown in Figure 6B; (ii) an inflatable anchor, as shown in Figure 6E; or (iii) an expandable anchor, as shown in Figures 6C and 6D; or any combination thereof. In a particular embodiment of the method according to any of the embodiments described above, at least one nail and at least one screw are used to fix the repair device (100) to the bone (400).

[0100] In certain embodiments, the anchors used (110, 111) are pins, nails, screws, or any combination thereof. In certain embodiments, the anchor has a “cap” or head that is wider than the body of the anchor, and the head is designed to prevent the device from slipping off the edge of the anchor while simultaneously pressing the device against the bone to increase the fixation strength.

[0101] Under certain conditions, namely when the torn soft tissue (300) is large and has a relatively large surface area, a single fixation repair device (100) may be insufficient to securely fix it to the bone (400). In such cases, two or more repair devices (100) can be used to fix the same soft tissue in the method according to any of the embodiments described above. Alternatively, a single repair device (100) with a wide opening can be used. In certain embodiments, a repair device with a wide opening can be bent in the central part in addition to the intermediate flexible region, and can be curved along the surface of the bone.

[0102] In a particular embodiment of the method according to any of the above embodiments, the steps of approaching the preferred gripping site and withdrawing the distal end (101) are performed along the same line of action.

[0103] In a particular embodiment of the method according to any of the embodiments described above, the repair device (100) can be inserted into the patient's body during any surgical procedure, such as “open” surgery, arthroscopic surgery, or other endoscopic surgery. In a particular embodiment, the repair device (100) is inserted into the patient's body in either an “open” or folded form. In the latter case, the spike is folded or not exposed at the time of insertion, but is unfolded / guided to an upright position when it reaches the desired assembly / fixation point in the body, resulting in the final open operating shape.

[0104] In a particular embodiment, the method according to any of the embodiments described above further includes the step of attaching another (e.g., secondary) repair device (100) to another location and / or direction within the anchor area or another adjacent anchor area.

[0105] In a particular embodiment, the method according to any of the embodiments described above further includes the step of using one or more layers (900), such as tissue growth layers, attached to a predetermined portion of one or more faces of the repair device (100). In a particular embodiment, the layers are part of the repair device (100). In a particular embodiment, one of the one or more layers (900) is positioned between a predetermined portion of the distal end (101) of the device and the soft tissue to be repaired thereby.

[0106] In a seventh aspect, the present invention provides an arthroscopic delivery / insertion tool (200) for use in the method according to any of the above embodiments. The tool (200) is designed to house / hold a repair device (100) according to any of the above embodiments and to allow a user to grasp the tip of a torn soft tissue and attach the repair device (100) thereto.

[0107] The tool (200) according to any of the above embodiments can be used to pull soft tissue to a desired fixation position (502) on the bone, and then fix the repair device (100) to the bone. This can be done, for example, by sliding the lower base arm (201). This makes it possible to attach the device (100) and the soft tissue attached thereto to the surface (502) of the bone (400) without interference. A dedicated anchor (110) can then be inserted into the bone (400) through the device (100) and the soft tissue (300). Alternatively, the lower base arm (201) can be configured so that it is not necessary to slide it backward. This can be achieved, for example, by providing special notches or grooves that allow the device and the soft tissue attached thereto to be attached to the surface of the bone without interference.

[0108] The apparatus (100), insertion tool (200), and method according to the present invention enable a surgeon to securely hold soft tissue in a single insertion motion while simultaneously penetrating the soft tissue at multiple points. Thus, the present invention offers many advantages over the prior art: a faster and easier "all-in-one" device and tool that makes the surgeon's actions more precise and convenient, giving the ability to preview, grasp, pull back, and fix soft tissue in place in a simple procedure; enabling the surgeon to preview a selected attachment area; eliminating the need for additional suturing at the vertical tear by including the entire vertical tear area in the preview area; reducing the re-rupture rate by using a balanced force distribution; and ensuring the optimal soft tissue-bone contact area necessary for a better and shorter healing period.

[0109] In particular, all of the above definitions and embodiments relating to the repair device (100), the arthroscopic delivery / insertion tool (200), and the method itself are applicable to each other by analogy. For example, aspects relating to the repair device (100) are considered as referring to the arthroscopic tool (200) or method, and vice versa.

[0110] In the following detailed description, non-limiting embodiments of the present invention will be discussed and illustrated with reference to the accompanying drawings. These embodiments and accompanying drawings should be understood as non-limiting examples for carrying out the present invention. Furthermore, terms such as “optional,” “for example,” “exemplary,” “for example,” and “possible” refer to any features selected in particular embodiments of the present invention for the sake of brevity and clarity of the description. However, it should be understood that any features mentioned in different embodiments may be used in combination or individually to carry out further embodiments of the present invention.

[0111] Figures 2A-2B show one example configuration of the repair device (100) according to the present invention. The device (100) includes a tip (101), the tip of which is provided with a spike (105).

[0112] Figures 2A and 2B show an example configuration of a repair device (100) according to the present invention. The device (100) comprises a tip (101) from which a spike (105) extends and which is provided with one or more dedicated anchor holes. A dedicated anchor is passed through these dedicated anchor holes to fix the device (100) and the soft tissue it grasps to a predetermined support (e.g., adjacent hard tissue such as bone (400)). For example, in the case of rotator cuff repair (RCR), the superior articular surface of the inferior bone is considered the support (e.g., as shown in Figures 4A and 4B). The proximal end (102) is provided with a dedicated anchor hole (104) for fixing the device (100) to the side of the bone. The flexible region (106) in the middle section allows the proximal end (102) to easily rotate relative to the distal end (101) around a virtual X-axis (shown by the dashed line in Figure 2B), thereby enabling the device (100) to be adaptively mounted to non-flat support surfaces. In particular, the length of the entire device (100) and / or each of its parts (i.e., the distal end (101), the proximal end (102), and the flexible region (106)), as well as the size and number of dedicated attachments and corresponding mounting holes (103, 104), can be varied according to the needs and the physiological characteristics of the patient. For example, the device can be made longer or wider, the flexible section (106) can be extended, and the distal end (101) can be made longer and / or wider, all of which are adjustable according to the needs and physiological constraints. Furthermore, the type of dedicated attachment (110, 111) is determined according to the tissue to be repaired, the nature of the support to which the soft tissue is attached, and the expected mounting load.

[0113] Figures 2A-2B further show tissue growth openings (101a) formed at the distal end (101). These form a mesh-like structure, enabling tissue growth across the device (100). In certain embodiments, openings (101a) are also provided at the proximal end (102).

[0114] Furthermore, the spike (105) is serrated and may be equipped with marginal teeth (105a) to ensure unidirectional helical penetration into the grasped soft tissue. It will be readily apparent that the outer surface of the spike (105) is sufficiently blunt and that there are no sharp edges that could damage the soft tissue. In certain embodiments, the spike (105) is inclined at an angle of less than 90° opposite to the tensile direction of the soft tissue / tendon (300) to resist the internal tensile load of the soft tissue / tendon (300) and prevent the spike (105) from undesirably or spontaneously detaching or coming loose from the soft tissue, thereby preventing the device (100) from releasing its grip. The spike (105) may also be designed in a claw-like curved shape to allow smooth helical penetration into the soft tissue / tendon (300), as shown, for example, in Figures 1 and 2, for example, as shown in Figures 5B-5C. However, the spike (105) may have a different shape, such as a posteriorly inclined cone, or other shapes that support secure gripping by the device (100) and allow for insertion without damage to the tendon / soft tissue (300).

[0115] Different variations can be selected for different applications of the apparatus (100) according to any of the embodiments described above. These include different numbers, shapes, and sizes of mounting holes (103, 104) and spikes (105) that provide sufficient load distribution to the entire soft tissue being repaired, while also ensuring secure gripping of the soft tissue by the apparatus (100). Furthermore, the holes (103, 104) may include one or more multi-stage anchor head cavities (1101) to allow for the flat installation of anchors (110, 111).

[0116] Figure 3 shows an example configuration of a delivery tool (200) for carrying out a tissue repair method according to the present invention. This tool is used, for example, to repair damaged soft tissue using the repair device (100) of the present invention under standard arthroscopic procedures. As shown in the figure, the delivery tool (200) may include a base arm (201) and a clamp (202) used for delivery and mounting of the device (100). The clamp (202) and base arm (201) are actuated by a transmission means passed through a delivery shaft (203), and are actuated by the user of the delivery tool (200) by operating various actuators mounted on the main handle (204) of the delivery tool (200). The actuator includes a clamp actuator (205), which, when pressed, rotates the clamp (202) of the tool upward relative to the base arm (201). The clamp (202) is locked in the pressed position by a ratchet mechanism (206) (i.e., the clamp (202) maintains its rotated position). This lock can be released by pressing the release button (205a) on the clamp actuator (205). The lower base arm (201) of the tool can be extended or retracted by operating the lever (207).

[0117] In particular, while a mechanical device is shown here, this device may also be electronic, and all movable parts such as levers and actuators can be electrically operated and operated by the push of a button.

[0118] It should be noted that while the base arm (201) is retractable, it is also possible to use an alternative delivery tool (200) in which the base arm (201) is not retractable.

[0119] In certain embodiments, the clamp (202) further comprises one or more temporary retaining elements for holding the device (100) with a predetermined adhesive force and releasing the device (100) if the predetermined adhesive force is exceeded. For example, the device (100) is released when it is securely attached to the bone (400) (further detailed in Figures 5A-5H). In other embodiments or additional embodiments, the device (100) itself further comprises alternative or corresponding temporary retaining elements designed to interact with the clamp (202) to prevent it from falling out of the clamp (202) until it is fixed to the bone. Figure 3 further shows an anchor access opening (208) provided in the clamp (202). This is designed to allow the anchor to be fixed through the soft tissue (300) and the device (100), as further described in Figure 5E.

[0120] Figures 4A, 4B, and 7A-7C show examples of rotator cuff tendon (300) repair using a repair device (100) according to an embodiment of the present invention. In Figures 4A, 4B, and 7A-7C, two anchor nails (110) fix the distal end (101) of the device (100) to the footprint area on the articular surface of the bone (400) without touching the articular cartilage. A single anchor screw (111) fixes the proximal end (102) to the lateral surface of the bone. Figures 4A-4C show an example of using a single repair device (100), while Figures 7A-7C show an example of using two repair devices (100) placed side by side to fix a larger and wider area of ​​soft tissue, or to support a higher tensile load within the remaining length of soft tissue that needs to be stretched before being fixed to the bone (400).

[0121] Each anchor nail (110) is fixed independently (i.e., to the bone) to maximize fixation stability. This prevents undesirable detachment or displacement of the fixed tissue and shortens the healing process. While a single anchor nail (110) may suffice in some cases, in certain embodiments, two (or more) anchor nails are used, one of which bears the primary adhesion load and the second provides auxiliary stabilization. In another embodiment, one or both anchor nails (110) and / or anchor screws (111) are made of biodegradable material and are dispersed along the healing process of the repaired tissue.

[0122] Figures 5A to 5H show the steps of an exemplary method for repairing torn soft tissue to repair a rotator cuff tendon (300) according to an embodiment of the present invention. Tendon repair is performed by repositioning and fixing the torn / ruptured tip / edge of the tendon to its original attachment site, i.e., the original attachment site (502) on the bone (400). Furthermore, the tendon repair procedure can be performed arthroscopically, in which the repair device (100) of the present invention is delivered to the tip / edge of the torn tendon (300) using a delivery tool (200), grasped and pulled to reposition it to the original attachment site, and the tendon (300) is fixed in that site. Figures 8A and 8B are block diagrams showing similar alternative steps for repairing torn soft tissue using the repair device (100) of the present invention.

[0123] According to embodiments of the present invention, the tendon repair procedure begins with the surgeon determining a preferred grasping site (501) (see Figure 5A) (e.g., a suitable portion of soft tissue) of the ruptured tendon (300). The surgeon operates a delivery tool (200) holding the device (100) toward the grasping site (501) and rotates the clamp (202) to which the device (100) is attached upward (Figure 5B). Then, the clamp (202) and the base arm (201) are reconnected (e.g., by pressing a release button (205a)), and the spike (501) of the device is clamped to the grasping site (501) (e.g., by pressing a release button (205a)). During this time, the spike (105) of the device penetrates the tendon (300), grasping the tendon and preventing it from moving. The surgeon can then verify the proper grasping of the grasping site (501) and make adjustments as necessary.

[0124] The spike (105) penetrates the soft tissue gripping site (501) with a fixed movement, depending on the shape / angle / radius of the spike and the operating angle of the clamp (202). The fixed movement of the clamp (202) guides the spike into the soft tissue. In certain embodiments, the driving force used to insert the spike (105) into the soft tissue (300) is applied gradually to limit the penetration of the soft tissue at the gripping site (501). Such a controlled driving force is provided by an appropriate drive mechanism, such as a spring with a predetermined spring constant, or a hydraulic, electric, or electromagnetic drive unit integrated within the delivery tool (200).

[0125] After confirming a secure grasp of the tendon (300) by the distal end (101) of the device, the surgeon pulls back the delivery tool (200) to position the device (100) and the tendon (300) grasped by it over the intended reattachment site (Figure 5C, indicated by a dotted rectangle), such as the footprint / attachment site (502) of the ruptured tendon (300) on the bone (400). In certain embodiments, the surgeon then pulls back the base arm (201) of the delivery tool to ensure a path for the tendon to reach the footprint (502) (Figure 5D) and allow the tendon (300) to descend over it without interruption. In certain embodiments, the delivery tool (200) is designed to fix the ruptured soft tissue to the bone without the need to pull back the base arm (201) of the tool. In such embodiments, the step of retracting the lower part of the tool (i.e., the base arm (201)) is unnecessary, and the surgeon simply needs to pull the stretched soft tissue to a predetermined position / location and then attach it to the bone (400).

[0126] Next, the surgeon (optionally) drills a hole in the upper surface of the bone through an anchor access opening (208) (further shown in Figure 3) and, optionally, an anchor hole (103) (if present), and places a dedicated anchor nail (110) therein. This anchor nail secures the grasped soft tissue through the hole (103) at its distal end (101) to the bone (Figure 5E). The drilling and anchor placement described above can be performed using appropriate drilling and anchor fixing tools (i.e., depending on the type of anchor (110, 111) selected).

[0127] During the traction operation of the tendon (300) and the device (100), both are sandwiched between the clamp (202) and the base arm (201) of the delivery tool (200). Therefore, most, or all, of the tensile load is transmitted to the tendon (300) as distributed frictional force / force and compressive force, rather than as a pure shear load. If the tendon were pulled only by the spike (105), a pure shear load would be transmitted to the tendon. Furthermore, in embodiments in which the base arm (201) is briefly withdrawn before the tendon (300) is fixed to the bone (400), a distributed tensile load is applied to the tendon (300) by the spike (105). In this case, the temporary gripping of the tendon (300) by the spike (105) is achieved by the predetermined blunt shape, size, and number of the spike (105). In this way, the puncture size and tension of the gripping portion of the tendon (300) are minimized.

[0128] With the tendon (300) and distal end (101) fixed to the bone, the clamp (202) is rotated upward to release the device (100) from the delivery tool (Figure 5F). The proximal end (102) of the device is bent as needed to conform to the curve of the bone on the lateral side (Figures 5G and 5H). Next, the surgeon (optionally) drills through the dedicated anchor hole (104) in the proximal end (102) again (one or more holes as needed) and screws in the anchor screw (111) to fix the proximal end (102) of the device to the lateral surface of the bone (Figure 5H). This completes the process of fixing the device (100) between the grasped soft tissue and the bone (400).

[0129] The steps of the above method shown in Figures 5A to 5H can be modified as needed. For example, when using a self-penetrating anchor, it is not necessary to drill a preliminary hole in the bone. Also, even if the device (100) does not have dedicated anchor holes (103, 104), a passage path for the dedicated anchors (110, 111) can be provided within the device body. That is, the device (100) may have pre-made holes (103, 104) or anchor permeable parts, or it may be made entirely of anchor permeable material. Optionally, a device (100) that does not have such dedicated anchor holes (103, 104) may be provided with drilling markings indicating the intended drilling location.

[0130] Those skilled in the art will readily understand that the methods shown in Figures 5A to 5H are equally applicable when reconnecting / reattaching multiple different types of soft tissue to various predetermined supports. For example, when repairing different torn tendons or other tissues to different bones or artificial implants connected to them.

[0131] Figure 5I shows the final positioning of the device (100) on the bone (without ruptured tendons), indicating the footprint fixation sites (502) where the device (100) is fixed, and the articular cartilage areas (gray area on the right (503)) that are not affected by / not in contact with the device (100). Non-limiting examples of the attachment sites (502) include the areas of the subscapularis muscle, the humeral head muscle, and the infrahumeral head muscle.

[0132] It should be noted that the tendon repair process shown in Figures 5A-5H, excluding the screwing in of anchors (110, 111), is performed along a single line of action corresponding to the direction of pulling the tendon / soft tissue (300) toward the footprint / original connection site (502) on the bone (400). This method requires the surgeon to perform a simple operation of the delivery tool (200) toward the gripping site (501) and then toward the footprint / original connection site (502). Furthermore, the lateral line of action in capturing, grasping, and pulling the ruptured tendon (300) maintains clearance above the repair site, allowing for orthogonal insertion of drills and anchoring devices and facilitating clear visualization of the ruptured tendon (300) (e.g., from above or the front). This is achieved by orthogonally inserted arthroscopic cameras, etc. In certain cases, a spike (105) may penetrate and protrude from the tendon (300). In particular, in such cases, the pulling motion, which involves sandwiching the tendon (300) between the clamp (202) and the base arm (201), prevents undesirable contact between the spike (105) and the surrounding tissue.

[0133] Figures 6A–6J show various anchors / pins (110) that can be used to fix the repair device (100) of the present invention to bone (400). Figure 6A shows two anchor nails (110) inserted parallel to each other. Figure 6B shows two anchor nails (110) inserted at angles to each other to improve the in-osseal stability and robustness of the device. Figures 6C, 6D, and 6E show examples of the use of different types of anchors that allow fluid flow from the humeral bone marrow within the anchor. Due to capillary action, bone marrow fluid flows upward through the hole in the anchor towards the bone / tendon surface, increasing the healing potential of the damaged tissue.

[0134] Figures 6G–6J show expandable anchors / pins (compatible with anchor nails (110) and anchor screws (111)) that expand after or during insertion to enhance fixation and prevent pull-out from the bone. Furthermore, by using expandable anchors / pins of a given diameter, they can be replaced with thicker non-expandable anchors / pins with equivalent fastening strength, resulting in smaller fixation holes for soft tissue / tendons (300).

[0135] In a particular embodiment of the repair device (100) according to any of the above embodiments, the spikes (105) and / or pins (110) are provided with grooves or barbs, or their surfaces are roughened to increase resistance to extraction, thereby reducing and preventing the risk of unintended release of soft tissue and preventing the detachment of soft tissue from the device (100).

[0136] Figures 7A–7C illustrate the fixation of a large tendon to bone using two (or more) repair devices. This can be achieved by using a specialized delivery tool (200) to place one repair device at a time or both repair devices simultaneously.

[0137] The repair device (100) is designed to pull and fix torn soft tissue towards its original attachment site. However, in certain cases, the torn tissue may be too short to be pulled back to the original attachment site. In such cases, a longer device (100) can be used to provide a bridge between the shortened portion of the torn soft tissue and the original attachment site. This reduces the area over which the shortened soft tissue needs to be pulled back, and as a result, the tension caused by the pull-back is reduced, as shown in Figure 7C. The use of such a bridging repair device (100) is extremely advantageous, for example, when a tendon (300) has retracted significantly from its original attachment site. In this case, pulling the retracted end of the tendon back to the original attachment site can create excessive tension in the tendon, reducing mobility, increasing pain, and potentially prolonging the healing process. In particular, in such cases (as shown in Figure 7C), the distal end (101) is not necessarily located above the bone, so it is not necessary to penetrate the distal end (101) with anchors or spikes. The torn soft tissue is held in place only by the spike (105), and the device is fixed only through the proximal end (102).

[0138] Figure 7C further shows staples (701) that can be used in place of or in combination with either of the anchors (110, 111).

[0139] In certain embodiments, the apparatus (100) according to any of the above embodiments may also be equipped with an augmentation function. In this case, one or more layers (for example, having similar or different layer thicknesses of 0.01 to 0.5 millimeters) are attached to a predetermined portion of one or more surfaces. The layers are provided as augmentation mesh / patch and / or bio-induction layers to promote and assist tissue growth and thereby improve the healing process.

[0140] Figures 9A-9C show an example of using such a (tissue growth) layer (900) on the distal end (101) of a device (100) for the repair of soft tissue (300). In Figure 9A, the tissue growth layer (900) (also referred to herein as a "patch") is attached to the bottom surface of the distal end (101), thereby being positioned between the device (100) and the grasping portion (501) of the repaired soft tissue (300). Although the illustration shows the surface area of ​​the layer (900) to be larger than the distal end (101) of the device, the surface area of ​​the layer may be equal to or less than that of the distal end (101) of the device. Alternatively, as shown in Figure 9B, the tissue growth layer (900) may be used on both sides of the distal end (101) and may be provided in the form of a sleeve that encloses the device (100). This promotes tissue growth from both sides of the device and contributes to shortening the healing time of the repaired soft tissue (300). Figures 10A and 10B show side views of these layers. One is positioned as a single layer beneath the distal end of the device (Figure 10A), and the other is positioned as a sleeve completely covering the distal end (Figure 10B).

[0141] The size of the tissue growth layer (900, 900a) may exceed the surface area of ​​the device (100), as shown in Figure 9C. For example, this may occur when the soft tissue (300) is partially torn or when it is not necessary to use two (or more) devices (100) for the reattachment of the torn tissue. In such cases, the excess portion of the tissue growth layer (900, 900a) is intended to reinforce the entire area of ​​the torn soft tissue (300) and to be fixed to it by an appropriate fixation device (910). Although a sleeve patch (900a) is shown in Figure 9C, it should be easily understood that the illustrated configuration can also be achieved by using a single tissue growth layer (900) that exceeds the surface area of ​​the device (100).

[0142] Furthermore, in certain embodiments, the layers (900, 900a) may cover only a portion of the surface area of ​​a predetermined surface of the device (100) in order to promote tissue growth only near the distal end (101), for example.

[0143] The patch / layer (900, 900a) is manufactured from a material through which a dedicated anchor (e.g., either an anchor passed through holes (103, 104)) can pass, in order to allow for easy attachment to a given support (e.g., bone (400)). In one embodiment, the layer (900, 900a) includes a pre-formed opening aligned with the holes (103, 104). The layer (900, 900a) may have additional auxiliary openings of a size suitable to support increased tissue growth rates under specific circumstances. Optionally, the layer (900, 900a) may include one or more guide markings indicating the drilling / screwing locations for anchor nails (110) and / or anchor screws (111). This is particularly useful when the tissue growth layer (900, 900a) is attached to both sides of the distal end (101) (as shown in Figure 9B).

[0144] Methods for fixing the layers (900, 900a) to the apparatus (100), to each other, or to soft tissue (300) can be obtained by various fixation means, such as a suitable heat source, sutures, biocompatible adhesives, and various combinations thereof. Specific fixation methods can be selected by those skilled in the art to suit the particular conditions and applications of the present invention. Alternatively, the layers (900) can simply be deposited on the apparatus (100) without requiring physical fixation.

[0145] As shown in Figures 11A to 11B, the dedicated anchor holes (103, 104) of the device (100) according to any of the above embodiments are implemented as multi-stage holes (1101) (also called anchor head cavities or recesses) that allow anchors (110, 111) to pass through at an angle. As shown in the figures, in Figure 11A the anchor (110) is screwed straight down, whereas in Figure 11B the anchor (110) is screwed in at an angle through the multi-stage hole (1101), and its anchor head (1110) is in contact with the stepped portion (1101a) of the multi-stage hole (1101). For simplicity, Figure 11B shows a single multi-stage hole (1101) implemented in place of hole (103). However, it should be easily understood that a multi-stage hole (1101) can be implemented in place of the anchor holes (103, 104). The angled thread structure of the anchors (110, 111) prevents unintended removal of the anchors and allows for a flexible mounting range. In certain embodiments, the multi-stage holes (1101) are designed to be of an appropriate size to allow flush installation of the anchors (110, 111) so that the anchors (110, 111) are fully embedded and the anchor heads do not rise above the top surface of the device (100). This reduces the risk of irritating surrounding tissues, such as the acromion, and promotes the healing process.

[0146] In certain embodiments, multi-stage holes (1101) allow anchors (110, 111) to be inserted into the device (100). This allows for angled (i.e., not perpendicular) insertion relative to soft tissue (300) and bone (400). This ensures that the upper part of the anchor is positioned completely or almost completely below the upper surface of the device (100), reducing the risk of irritating nearby tissues such as the acromion.

Claims

1. A soft tissue repair device (100) used to repair torn soft tissue, a) A distal end (101) having at least two spikes (105) configured to be of a predetermined length to penetrate only a predetermined thickness of soft tissue and grasp it; b) comprising a proximal end (102), The spike (105) is inclined at a predetermined angle other than 90 degrees with respect to the distal end (101); The connection between the distal end (101) and the proximal end (102) allows one to rotate relative to the other; The distal end (101) is configured to be fixed to the first plane of the bone by a dedicated anchor that passes through it. The proximal end (102) is configured to be fixed to different planes of the same bone by a dedicated anchor passing through it. Soft tissue repair device.

2. The soft tissue repair device according to claim 1, wherein the length of the spike (105) is shorter than or equal to the thickness of the soft tissue, and allows only penetration into the soft tissue without damaging the bone without protruding from the soft tissue.

3. The soft tissue repair device according to claim 1, further comprising an intermediate flexible region (106) that allows the proximal end (102) to move relative to the distal end (101).

4. The soft tissue repair apparatus according to claim 1, wherein the apparatus is made of a flexible material.

5. The soft tissue repair apparatus according to claim 1, comprising one or more gripping elements designed to allow the apparatus (100) to be held by a delivery tool.

6. The soft tissue repair device according to claim 1, wherein the device (100) has one or more anchor holes (103) at its distal end (101), through which a dedicated anchor can be passed to fix the distal end (101) and the torn soft tissue to the bone; and / or has one or more dedicated anchor holes (104) at its proximal end (102).

7. The soft tissue repair device according to claim 6, wherein one or more of the one or more dedicated anchor holes (103, 104) is a multi-stage hole (1101).

8. The soft tissue repair device according to claim 1, wherein the spikes (105) are serrated, roughened, or thorn-shaped to prevent undesirable peeling of soft tissue.

9. The soft tissue repair device according to claim 1, wherein the device (100) comprises a tissue growth opening (101a) that penetrates therethrough and forms a scaffold that enables tissue growth.

10. The soft tissue repair device according to claim 1, wherein the device (100) has a scaffold structure that allows tissue to grow through it.

11. The soft tissue repair device according to claim 1, wherein the distal end (101) and / or the proximal end (102) have perforation structures that allow the soft tissue to grow inside.

12. The soft tissue repair apparatus according to claim 1, wherein one or more components of the apparatus (100) are made of a biodegradable material.

13. The soft tissue repair device according to claim 1, wherein the device (100) is made of a biocompatible material or a biodegradable material.

14. The soft tissue repair apparatus according to claim 1, wherein the apparatus (100) or at least a part thereof includes a drug-releasing material.

15. The soft tissue repair apparatus according to claim 1, wherein the apparatus (100) is coated with, for example, a drug-releasing material, a healing / regeneration-promoting substance, an immunosuppressive material, a growth factor, a stem cell, and / or an anti-inflammatory substance.

16. A soft tissue repair device according to claim 1, which is custom-made according to the anatomical structure of the patient.

17. The soft tissue repair device according to claim 1, wherein the spikes (105) are arranged to disperse the tensile force applied to the attached soft tissue, thereby reducing the risk of damage to the soft tissue and / or the risk of the repair device being torn away from the soft tissue.

18. The soft tissue repair apparatus according to claim 17, wherein the spikes (105) are arranged in stages to distribute the tensile force applied to the soft tissue.

19. The soft tissue repair device according to claim 1, wherein the spike (105) is claw-shaped.

20. The soft tissue repair apparatus according to claim 1, wherein the spikes (105) are differentiated, individualized, and / or perforated.

21. The soft tissue repair device according to claim 1, wherein the spikes (105) are distributed asymmetrically at the distal end (101).

22. The soft tissue repair device according to claim 1, wherein the spike (105) has a sharp / pointed edge / tip that allows penetration into soft tissue and a blunt base / body that does not damage soft tissue even when force is applied thereto.

23. The soft tissue repair device according to claim 1, comprising one or more layers (900) attached to a predetermined portion of one or more surfaces.

24. The soft tissue repair device according to claim 23, wherein one of the one or more layers (900) is positioned between a predetermined portion of the distal end (101) of the device and the soft tissue to be repaired thereby.

25. The soft tissue repair apparatus according to claim 23, wherein the one or more layers (900) are attached to selected portions on both sides of the apparatus (100).

26. The soft tissue repair apparatus according to claim 25, wherein one or more layers (900) are partially or completely attached at their periphery.

27. The soft tissue repair apparatus according to claim 23, wherein the one or more layers (900) are sleeve-shaped layers that cover both sides of the apparatus (100) or the distal end (101) of the apparatus.

28. The soft tissue repair apparatus according to claim 23, wherein one or more layers (900) are tissue growth layers.

29. The soft tissue repair apparatus according to claim 23, wherein the layer is made of a biomaterial selected from the group consisting of synthetic materials, autografts, allografts, xenografts, or any combination thereof.

30. The soft tissue repair apparatus according to claim 23, wherein at least one of the one or more layers (900) is provided with one or more thread holes for passing the dedicated anchor.

31. The soft tissue repair apparatus according to claim 23, wherein at least one of the one or more layers (900) is provided with one or more threading markings for guiding the threading of the dedicated anchor.

32. The soft tissue repair apparatus according to claim 23, wherein at least one of the one or more layers (900) exceeds the surface area of ​​the apparatus (100).

33. The soft tissue repair apparatus according to claim 23, wherein the one or more layers (900) are selected from the group consisting of a strengthening mesh, a strengthening patch, a bio-induction layer, and any combination thereof.

34. The soft tissue repair apparatus according to claim 23, wherein one or more layers (900) are covered with collagen or bone marrow.

35. An arthroscopic instrument (200) for repairing damaged soft tissue (300) by installing the soft tissue repair device (100) described in claim 1, a) Main handle (204); b) A shaft (203) connected to one end of the main handle (204); and c) comprising a base arm (201) and a clamp (202) positioned at the other end of the shaft (203), The clamp (202) is configured to hold the soft tissue repair device (100), The base arm (201) has a recess that allows the spike (105) of the soft tissue repair device (100) to pass through without being damaged (when the clamp is in the closed position), The base arm (201) and clamp (202) are actuated by a transmission means via the main handle (204) and are configured to open and grasp the tip of torn soft tissue between them, pull it (while the spike (105) penetrates the soft tissue), and release the tip of the torn soft tissue as needed. The clamp (202) has an opening that allows the anchor to pass through the soft tissue repair device (100) and the soft tissue (300) to the bone. Arthroscopic instruments.

36. The arthroscopic instrument according to claim 35, wherein the base arm (201) of the arthroscopic instrument is retractable and extends to expose the grasped torn soft tissue and fix it to the bone.

37. A kit comprising an arthroscopic instrument (200) according to claim 35 and one or more soft tissue repair devices (100) according to claim 1.

38. A method for repairing torn soft tissue, a) A step of preparing the soft tissue repair device (100) according to claim 1; b) Determining a preferred gripping site (501) of the torn soft tissue, approaching it with the distal end (101) of the soft tissue repair device (100), and passing the spike (105) of the soft tissue repair device (100) through the torn site, thereby gripping the soft tissue with the distal end (101) of the soft tissue repair device (100); c) Grasp the distal end (101) and pull it to position the grasped soft tissue over a predetermined area of ​​bone, and fix the distal end (101) and the grasped soft tissue to the predetermined area of ​​bone using one or more dedicated anchors (110) that pass through the distal end (101) and the soft tissue; d) Bending the proximal end (102) of the soft tissue repair device (100) relative to the distal end (101) and aligning it with another area of ​​the bone surface; e) The procedure includes the steps of fixing the proximal end (102) to a different region of the bone, fixing the soft tissue to the bone using the soft tissue repair device (100), and repairing the torn soft tissue. method.

39. The method according to claim 38, wherein the soft tissue is a tendon.

40. The method according to claim 38, wherein the distal end (101) of the soft tissue repair device (100) is provided with one or more dedicated anchor holes (103), and in step (c), the operation of fixing the distal end (101) to which the soft tissue is attached to the bone is performed by passing dedicated anchors through the one or more dedicated anchor holes (103).

41. The method according to claim 38, wherein the proximal end (102) of the soft tissue repair device (100) is provided with one or more dedicated anchor holes (104), and the step (e) of fixing the proximal end (102) to bone (400) is performed by passing one or more dedicated anchors (111) through the one or more dedicated anchor holes (104).

42. The method according to claim 38, wherein the fixation in steps (d) and (e) includes a preliminary step of drilling holes in the bone, then inserting appropriate anchors through the device and fixing them in the drilled holes.

43. The method according to claim 38, wherein the fixation in steps (d) and (e) includes a preliminary step of drilling holes in the bone, and then inserting appropriate anchors into the holes through the device.

44. The method according to claim 38, wherein the anchors used to fix the distal end (101) and proximal end (102) to the bone are selected from the group consisting of anchor nails, inflatable anchors, expandable anchors, staples (701), "all-saturated" anchors, and any combination thereof, which are inserted into the bone at different angles to improve grip.

45. The method according to claim 38, wherein multiple soft tissue repair devices (100) are used on the same soft tissue.

46. The method according to claim 38, wherein the approach to the preferred gripping portion in step (b) and the withdrawal of the distal end (101) in step (c) are performed along the same line of action.

47. A method for repairing torn soft tissue using the soft tissue repair device (100) according to claim 1, a) A step of determining a preferred grasping site for the torn soft tissue, approaching it with the distal end (101) of the soft tissue repair device (100), and passing the spike (105) of the soft tissue repair device (100) through it, thereby grasping the soft tissue with the distal end (101) of the soft tissue repair device (100); b) Clamping the distal end (101) and pulling it to position the grasped soft tissue over a predetermined area of ​​bone, and fixing the distal end (101) and the grasped soft tissue to the predetermined area of ​​bone using one or more dedicated anchors (110) passed through the distal end (101) and the soft tissue; c) Bending the proximal end (102) of the soft tissue repair device (100) relative to the distal end (101) and aligning it with another area of ​​the bone surface; d) A method comprising the steps of fixing the proximal end (102) to a different region of the bone, fixing the soft tissue to the bone using the soft tissue repair device (100), and repairing the torn soft tissue.

48. A soft tissue repair device (100) according to claim 1 for repairing torn soft tissue, a) The spike (105) of the repair device (100) is passed through a preferred gripping site (501) within the torn soft tissue, thereby gripping the soft tissue with the distal end (101) of the repair device (100), b) Grasp the distal end (101) and pull it to position the grasped soft tissue over a predetermined area of ​​bone, and fix the distal end (101) and the grasped soft tissue to the predetermined area of ​​bone using one or more dedicated anchors (110) that pass through the distal end (101) and the soft tissue; c) The proximal end (102) of the repair device (100) is bent relative to the distal end (101), and this is aligned with another area of ​​the bone surface. d) The proximal end (102) is fixed to a different region of the bone, and the soft tissue is fixed to the bone using the repair device (100) to repair the torn soft tissue. Soft tissue repair device.

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