Soft tissue repair devices, systems, and methods

Abstract

Methods, devices, and systems are provided for repairing torn soft tissue, such as tendons, while allowing better contact between the torn soft tissue and bone for a better healing process.

Description

Technical Field

[0001] This invention generally relates to the field of tissue repair. In particular, the invention provides apparatus and methods for allowing better contact between two tissues (especially soft tissue such as tendons to bone) to enhance the healing process. Background Technology

[0002] The known surgical approaches to rotator cuff repair (open-face, small-face, and arthroscopic rotator cuff repair) vary because each approach offers a range of advantages and disadvantages.

[0003] Open-cut surgical techniques have long been considered the gold standard for rotator cuff repair, but surgeons are becoming more adept at reducing patient morbidity by minimizing surgical trauma associated with arthroscopic approaches.

[0004] Existing arthroscopic surgical techniques are based on surgical sutures that are manually inserted (usually by needle, manually or mechanically) through one end of the tendon and, for example, by being fixed to the tendon, allow the tendon to be secured to a standard bone anchor / suture anchor at the other end via the suture (see [link to surgical technique]). Figure 1 (This illustrates tendon-to-bone suturing performed using existing tools and methods known in the art).

[0005] When selecting the precise location for suture insertion at the tendon, surgeons use arthroscopic graspers to retract the torn tendon toward the humerus. This individual grasp does not provide surgeons with full traction on the tendon's repositioning, and multiple sutures may be encountered at the end of the procedure. In a permanent grasp made of specific sutures, the forces are unbalanced and concentrated at the insertion point of each individual suture. These unbalanced forces can lead to suture overload and may result in suture failure or, worst of all, unwanted suture dragging, which can cause additional tendon tears. Currently, re-tears at the point of interaction between the suture and the tendon are a common failure in tendon tear repair, with re-tears occurring in the early stages (first six months) indicating healing failure. Therefore, various surgical techniques have been developed to reduce re-tears: single-row; double-row; suture bridges; and knotless suture bridges.

[0006] Several suture threading devices exist that allow for simultaneous suture threading and retraction. Most of these devices reduce surgical complexity but require multiple repetitions and therefore do not shorten the duration of the procedure. Furthermore, no known device includes a mechanism for grasping the tendon in a balanced manner and / or repositioning the suture after it has been secured to the same tendon.

[0007] Biomechanical constructs (tendon-bone) play a crucial role in maintaining bone-tendon proximity to allow for bio-healing, with current practices involving the use of multiple suture anchors (between one and approximately six).

[0008] Even with the aid of suture threaders, existing tendon repair techniques suffer from a relatively high failure rate (especially in large tears), require a high level of expertise from the surgeon, and are time-consuming. Furthermore, current procedures have several limitations: a long limb immobilization period of approximately 2 to 6 weeks to avoid premature re-tears; lengthy rehabilitation leading patients to avoid surgery; the time-consuming nature of tendon repair surgery and the need for multiple knots, sutures, and devices; and a long learning curve for the surgeon.

[0009] Therefore, there is a need for an easy-to-use device and a simple method that enables better tendon grip and fixation, and improved healing of torn tendons. This device and method should be minimally invasive, allowing for correction and adjustment at any point throughout the surgical procedure with minimal damage to the tendon, resulting in better healing and a reduced rate of re-tear, leading to a shorter recovery period and reduced operation / operative time. This repair device and method provides all of these and more, and offers increased anchoring force. Summary of the Invention

[0010] The present invention provides a soft tissue repair device (100) for repairing torn soft tissue. The device (100) substantially comprises: (a) a distal end (101) having at least two spikes (105) configured to have a predetermined length to penetrate only a predetermined thickness of the soft tissue for gripping the soft tissue; and (b) a proximal end (102), wherein: the spikes (105) are inclined relative 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 designed to be anchored to a first plane of bone using a dedicated anchor passing through it; and the proximal end (102) is designed to be anchored to a different plane of the same bone using a dedicated anchor passing through it.

[0011] The present invention also provides a method for repairing torn soft tissue, the method comprising: (a) providing the repair device (100) of the present invention; (b) determining a preferred gripping site (501) of the torn soft tissue, approaching the preferred gripping site with a distal end (101) and passing a spike (105) of the repair device (100) therethrough, thereby gripping the soft tissue by the distal end (101) of the repair device (100); (c) clamping and pulling the distal end (101) to position the soft tissue thereby gripped above a predetermined area of ​​bone, and using (d) attaching the distal end (101) of the soft tissue to the predetermined region of the bone by one or more dedicated anchors (110) passing through the distal end (101) and the soft tissue; (e) bending the proximal end (102) of the repair device (100) relative to the distal end (101) to align the proximal end with a different region of the surface of the bone; and (f) attaching the proximal end (102) to the different region of the bone, thereby repairing the torn soft tissue by attaching the torn soft tissue to the bone using the repair device (100). Attached Figure Description

[0012] Figure 1 This is an illustration of a currently used technique for anchoring torn tendons to bone.

[0013] Figures 2A to 2B A possible configuration of a repair device according to an embodiment of the present invention is shown.

[0014] Figure 3 A possible delivery tool for installing the repair device of the present invention is shown.

[0015] Figures 4A to 4B The present invention illustrates a rotator cuff repair device that anchors to the bone and holds a torn supraspinatus tendon in place.

[0016] Figures 5A to 5I The following steps are shown for anchoring a torn tendon to bone using a repair device and its suitable delivery tool: Figure 5A The delivery tool reached the torn tendon; Figure 5B The delivery tool gripped the torn tendon; Figure 5C The spikes of the repair device were pressed into the torn tendon; Figure 5D The bottom section of the delivery tool retracts to allow the repair device to be precisely placed on the bone; Figure 5E The pin will anchor the tendon repair device to the bone; Figure 5F The delivery tool has been removed; Figure 5G Use another pin, screw, or bone anchor to anchor the proximal end of the repair device to the bone; Figure 5HThe repair device is anchored to the bone while preserving the torn tendon; and Figure 5I The image shows the footprint area on the bone where the repair device will be anchored, as well as the articular cartilage unaffected by the device.

[0017] Figures 6A to 6J Various possible pins for anchoring the repair device to the bone are shown.

[0018] Figures 7A to 7C The use of two repair devices for anchoring the major tendon to the bone is shown.

[0019] Figures 8A to 8B This is a block diagram illustrating two possible ways of using the repair device of the present invention.

[0020] Figures 9A to 9C This is an illustration of the (tissue growth) layer used with the distal end of the device: Figure 9A The layer on the bottom surface is shown for attachment / positioning to the distal end of the device; Figure 9B The sleeve-like layer on two sides of the distal end of the covering device is shown; and Figure 9C A wide (sleeve-like) layer extending significantly beyond the distal end side of the device is shown.

[0021] Figures 10A to 10B This is a side view of the layer with the distal end of the device: Figure 10A A layer is shown on the bottom surface of the device that is attached / positioned to the distal end; and Figure 10B The sleeve-shaped layer on two sides of the distal end of the covering device is shown.

[0022] Figures 11A to 11B A multi-stage anchoring hole / cavity embodiment according to an embodiment of the present invention is shown. Detailed Implementation

[0023] Today, the most common arthroscopic repair technique for rotator cuff tendon tears requires the use of multiple sutures and anchors so that the surgeon can fix the torn tendon back to its footprint at the humeral head. This procedure (rotator cuff repair (RCR)) is a long and relatively complex operation, and there is also the possibility of shortening the tendon as it is pulled toward the anchor point on the bone.

[0024] This invention provides methods, devices, and systems that enable physicians to perform actions more accurately, quickly, and easily, thereby providing surgeons with the ability to simply preview, grasp, pull back torn soft tissue, and fix it to a desired location on a support such as bone. This process significantly reduces surgical complexity and duration while providing strong biomechanical support and potentially faster healing.

[0025] This invention provides a soft tissue repair device (100) for achieving better soft tissue-bone contact and balanced force distribution at the attachment point, thereby reducing the risk of re-tear / detachment. It achieves reliable anchoring of the soft tissue through a single insertion movement and optionally causes minimal damage to both the soft tissue (and bone) simultaneously, while providing a better soft tissue-bone contact area during recovery. In some embodiments, the procedure for attaching the soft tissue to the bone is reversible, allowing for improved / refined contact between the soft tissue repair device and the soft tissue during the attachment procedure. Furthermore, this method and repair device (100) eliminate the need for additional sutures currently required in vertical soft tissue tears. The soft tissue repair device of this invention allows for optimal soft tissue-bone contact / fixation and contact pressure, which helps reduce healing time and / or the risk of separation.

[0026] As used interchangeably in this document, the terms “support” and “bone” refer to any hard surface to which the repaired soft tissue will be anchored / attached, and include both natural bone and artificial bone, or any other artificial structure.

[0027] As used in this article, the term "soft tissue" refers to tendons, ligaments, and other soft tissues that may require repair, particularly connective tissues.

[0028] As used herein, the terms "torn tendon" and "torn soft tissue" refer to both completely torn soft tissue / tendons and partially torn soft tissue / tendons that still have some connection to the bone. Partial tendon tears include, but are not limited to, for example, small crescent-shaped, medium crescent-shaped, large U-shaped, V-shaped, L-shaped, and inverted L-shaped tears. Acute and chronic tears are also considered.

[0029] Therefore, this invention provides a technique for tendon-bone reattachment, for example, in rotator cuff repair, to achieve better healing and faster, easier surgery. This invention provides a minimally invasive, sutureless, gripping, and reattachment system comprised of a soft tissue repair device that provides dispersed forces for stabilizing the tendon and maximizing the contact area between the tendon and bone, thereby allowing for faster healing, earlier physical therapy, and a shorter recovery period. Furthermore, the repair device of this invention is designed to reduce the duration and complexity of current arthroscopic tendon repair surgeries (including redo surgeries).

[0030] In a first aspect, the present invention provides a repair device (100) for repairing torn soft tissue. The device (100) substantially comprises: (a) a distal end (101) having at least two spikes (105) configured to have a predetermined length for penetrating only a predetermined thickness of soft tissue for gripping the soft tissue; and (b) a proximal end (102), wherein: the spikes (105) are designed such that they form a predetermined angle other than 90° with respect to the surface of 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 designed to be anchored to a first plane of bone using a dedicated anchor passing through it; and the proximal end (102) is designed to be anchored to a different plane of the same bone using a dedicated anchor passing through it.

[0031] In some embodiments 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 spike (105) has a length shorter than or equal to the thickness of the soft tissue to allow penetration only into a predetermined thickness of the soft tissue for gripping the soft tissue, while avoiding leaving / protruding from the other side of the soft tissue (i.e., not reaching and damaging the bone (400)), thereby preventing unintentional damage to the bone.

[0032] In some embodiments, the repair device (100) further includes an intermediate flexible region (106) designed to allow the proximal end (102) to bend and / or rotate relative to the distal end (101).

[0033] In a specific embodiment, the repair device (100) includes: (a) a distal end (101) having a spike (105) designed to penetrate into 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 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 anchored to a first plane of bone using a dedicated anchor passing through it; and the proximal end (102) is designed to be anchored to a different plane of the same bone using a dedicated anchor passing through it.

[0034] In some embodiments, the repair device (100) according to any embodiment is made essentially entirely of a flexible or semi-rigid material, which allows the device (100) to be bent and adjusted to the surface / bone. In such a configuration, the flexibility of the distal end (101) and / or the proximal end (102) enables perfect adjustment to, for example, bone (400), thereby reducing the risk of extension / protrusion edges that may interfere with or irritate nearby tissues and improving the healing process.

[0035] In some embodiments, the repair device (100) according to any embodiment also includes one or more attachment elements designed to enable retention of the device (100) by a delivery tool (such as the arthroscopic tool (200) of the present invention). Non-limiting examples of such attachment elements are bio-adhesives as well as protrusions and recesses: within the body of the device, along the periphery of or on the surface of the distal end (101), proximal end (102), or intermediate flexible region (106), or any combination thereof.

[0036] In a specific embodiment of the above-described repair device (100), the soft tissue is a tendon. In a more specific embodiment, the tendon is the rotator cuff tendon.

[0037] In another aspect, the present invention provides a soft tissue repair device (100) as defined above for repairing torn soft tissue. In a specific embodiment, the device (100) includes: (a) a distal end (101) having at least two spikes (105) configured to have a predetermined length for penetrating only a predetermined thickness of the soft tissue to grip it (meaning the spikes may not penetrate the entire thickness of the soft tissue); and (b) a proximal end (102), wherein: the spikes (105) are inclined at a predetermined angle other than 90° relative to the surface of 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 designed to be anchored to a first plane of bone using a dedicated anchor therethrough; and the proximal end (102) is designed to be anchored to a different plane of the same bone using a dedicated anchor therethrough.

[0038] In a specific embodiment, the present invention provides a tendon repair device (100) for repairing torn tendons, the device (100) comprising: (a) a distal end (101) having one or more dedicated anchoring holes (103) and a spike (105) designed to penetrate the tendon and attach the device to the tendon; (b) a proximal end (102); and (c) an intermediate flexible region (106) designed to allow rotational movement of the proximal end (102) relative to the distal end (101) (e.g., about axis X), wherein: (i) the distal end (101) is designed to be anchored to a first plane of bone using dedicated anchors passing through one or more dedicated anchoring holes (103); and (ii) the proximal end (102) is designed to be anchored to different planes of the same bone using dedicated anchors passing through one or more dedicated anchoring holes (104).

[0039] In some embodiments of the device (100) for repairing torn soft tissue according to any of the above embodiments, the device (100) includes: (a) a distal end (101) having a spike (105) designed to penetrate into the 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 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 anchored to a first plane of bone using a dedicated anchor passing through it; and the proximal end (102) is designed to be anchored to a different plane of the same bone using a dedicated anchor passing through it.

[0040] The present invention also provides a repair device (100) as defined above for repairing torn soft tissue by: (a) determining a preferred gripping site (501) of the torn soft tissue, bringing the preferred gripping site close to a distal end (101) and passing a spike (105) of the repair device (100) through the preferred gripping site, thereby gripping the soft tissue through the distal end (101) of the repair device (100); (b) clamping and pulling the distal end (101) to position the soft tissue thereby gripped above a predetermined area of ​​bone, and using a spike (105) through the distal end (101) to repair torn soft tissue. The distal end (101) and one or more dedicated anchors (110) of the soft tissue attach the distal end (101) having the soft tissue thus gripped to the predetermined region of the bone; (c) bend the proximal end (102) of the repair device (100) relative to the distal end (101) to align the proximal end with a different region of the surface of the bone; and (d) attach the proximal end (102) to the different region of the bone, thereby repairing the torn soft tissue by attaching the torn soft tissue to the bone using the repair device (100).

[0041] In a specific embodiment of the above-described uses, the tissue is a tendon, and the soft tissue repair device (100) is a tendon repair device.

[0042] Note that the repair device (100) according to any of the above embodiments is structured such that it can be anchored to at least two surfaces of the bone, one of which is the superior articular surface and the other is the lateral surface (in Figure 5I (As shown in the diagram). This is possible because of the flexibility between the distal end (101) and the proximal end (102) of the device, or because of the intermediate flexible region (106) (if present) that provides flexibility and allows the proximal end (102) to bend relative to the distal end (101) to conform to the curve of the bone. Such anchoring on both surfaces improves the stability and robustness of the device when traction is applied on both surfaces, i.e., when the soft tissue retracts. In this way, the risk of pulling the anchor out of the bone is significantly reduced.

[0043] In some embodiments of the repair device (100) of the present invention, the intermediate flexible region (106) is configured in a pre-bent shape and is intended to return to the pre-bent shape such that when the device is forcibly opened (“straightened” or “folded in half”), for example during placement within a delivery device for insertion into the body, it quickly returns to its bent shape once the pressure is removed from it, i.e., when it leaves the delivery device.

[0044] In some embodiments, the repair device (100) according to any of the above embodiments is rigid. In alternative embodiments, it has a degree of flexibility or semi-rigidity, while the spikes are rigid. In other embodiments, the repair device (100) is made of a solid plate. In alternative embodiments, the repair device (100) is configured as a perforated or mesh plate, wherein the size of the holes is fixed or varied. In a specific embodiment, the spikes are perforated. Such a perforated or mesh structure allows tissue to grow into the cavity, thereby strengthening the adhesion between the repair device (100) and the soft tissue.

[0045] According to some embodiments of the present invention, the number of spikes (105) in the device (100) according to any of the above embodiments can vary depending on the mechanical properties and size of the soft tissue involved. Thus, in some embodiments of the present invention, the device (100) comprises 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).

[0046] In other embodiments, the number of spike rows and / or columns is greater than 1 and less than 10,000. And the distance between two adjacent spikes (105) is about 1 μm to about 30 mm, or any other suitable distance or range.

[0047] In other embodiments, the length of the spike is greater than about 1 μm and less than about 30 mm.

[0048] In another embodiment, the thickness of the spike (105) is about 1 μm and less than about 10 mm.

[0049] In some embodiments, the repair device (100) according to any of the above embodiments further includes a locking mechanism designed to prevent pull-out of the anchors (110, 111) therethrough to anchor the device (100) to the bone (400). Non-limiting examples of such locking mechanisms are click mechanisms, sliding caps that slide over dedicated anchoring holes (103, 104) after the anchors are inserted, etc. In alternative or additional embodiments, the locking mechanism is part of the anchors themselves, such that after the anchors have passed through the device (100) and been placed in the bone, they are tightly locked to prevent the device from being released from the anchors and the bone. In further alternative or additional embodiments, the locking mechanism is bioglue.

[0050] In a second aspect, the present invention also provides the use of a soft tissue repair device (100) according to any of the above embodiments for repairing torn soft tissue by: (a) determining a preferred gripping site (501) of the torn soft tissue, bringing the preferred gripping site (501) close to the distal end (101) and through the spike (105) of the repair device (100), thereby gripping the soft tissue through the distal end (101) of the repair device (100); (b) clamping and pulling the distal end (101) to position the soft tissue thereby gripped in a predetermined area of ​​bone. Above, and using one or more dedicated anchors (110) passing through the distal end (101) and soft tissue, the distal end (101) having the soft tissue thus grasped is attached to the predetermined area of ​​the bone; (c) the proximal end (102) of the repair device (100) is bent relative to the distal end (101) to align with a different area of ​​the surface of the bone; and (d) the proximal end (102) is attached to the different area of ​​the bone, thereby repairing the torn soft tissue by attaching the torn soft tissue to the bone using the repair device (100).

[0051] In a specific embodiment, the tissue is a tendon, and the soft tissue repair device (100) is a tendon repair device.

[0052] In some embodiments, the soft tissue repair device (100) according to any of the above embodiments includes in the distal end (101) one or more dedicated anchor holes (103) through which a dedicated anchor can pass for attaching the distal end (101) and the torn soft tissue to the bone; and / or one or more dedicated anchor holes (104) in the proximal end (102) through which a dedicated anchor can pass.

[0053] In such a case, when the device (100) does not include such a dedicated anchoring hole, the anchor can be pushed through the device at any point. Note that even if the device does include such a dedicated anchoring hole, the anchor can still be inserted into the bone (400) through the device (100) at a location different from that of such holes (103, 104).

[0054] In some embodiments of the soft tissue repair device (100) according to any of the above embodiments, one or more of the one or more dedicated anchoring holes (103, 104) are multi-level / multi-stage holes (1101) that can prevent undesirable pull-out of the anchors (110, 111) and provide a more secure attachment of the device (100), and / or prevent the formation of protrusions to produce smoothness.

[0055] In some embodiments, the device (100) according to any of the above embodiments includes one or more anchoring holes (103, 104). In a specific embodiment, the anchoring holes (103, 104) are multi-stage holes (1101), i.e., having a groove, notch, or recess designed to enclose the head of the anchor, and thus enabling flush mounting of the anchor (i.e., without the head of the anchor protruding above the upper surface of the device). Figure 11A In another or alternative embodiment, the multi-level hole (1101) allows for tilted mounting of the anchor while minimizing or even eliminating the protrusion of the anchor head on the upper surface of the device. Figure 11B ).

[0056] Anchor (110) is obliquely inserted through the stepped hole (1101), with its head (1110) abutting against the step (1101a) of the stepped hole (1101). This angled insertion / installation of the anchors (110, 111) also prevents undesirable withdrawal and makes installation easier. In some embodiments, the dimensions of the stepped hole (1101) are suitably set to allow flush installation of the anchors (110, 111), wherein the head of the anchor is fully submerged in the stepped hole, so that the head of the anchor is not higher than the upper surface of the device (100) to avoid interference with, for example, the acromion bone, thereby reducing the risk of irritation to nearby tissues (such as the acromion) and promoting the healing process.

[0057] In another specific embodiment, the multi-level hole (1101) allows the anchor (110, 111) to be inserted at an angle (i.e., not perpendicular to it) through the device (100) and via the soft tissue (300) to reach the bone (400), such that the head of the anchor is completely or almost completely below the upper surface of the device (100), thereby reducing the risk of irritating nearby tissues (such as the acromion).

[0058] As used herein, the term "spiked spike" refers to one or more protrusions / spiked objects set in or on a platform. A platform with spikes may be referred to herein as the distal end (101) of a spike-based element or device.

[0059] In some embodiments of the repair device (100) according to any of the above embodiments, the spike (105) has a sharp / pointed edge / point designed to allow the spike to penetrate into soft tissue smoothly and easily, wherein the remainder of the spike (i.e., its shaft / body) is blunt / sharp so that when force is applied thereon (e.g., when pulled or pressed), the remainder of the spike does not damage the soft tissue.

[0060] In some embodiments of the repair device (100) according to any of the above embodiments, the area where the spike (105) is located is referred to as the spike-based element, and the repair device also includes a locking mechanism located between the spike-based element and an anchor passing through the distal end of the device (100), wherein the locking mechanism is designed to prevent spontaneous pull-out of the anchor passing through it for anchoring the device (100) to the bone (400).

[0061] In some embodiments of the soft tissue repair device (100) according to any of the above embodiments, the spikes (105) are configured such that they distribute the traction force applied to the attached soft tissue (e.g., between all the spikes), thereby reducing the risk of damaging the soft tissue and / or tearing / ripping the repair device from the soft tissue. In a specific embodiment, this is achieved by providing a separate gripping point between each spike and the soft tissue, thereby distributing the traction force applied to the soft tissue between all gripping points.

[0062] In some embodiments of the repair device (100) according to any of the above embodiments, the spikes (105) are designed such that they can be inserted into the soft tissue at a predetermined angle, removed from the soft tissue if necessary, for example, to fix or adjust the connection between the device and the torn soft tissue, minimize any additional damage to the soft tissue, and then reinserted into the soft tissue.

[0063] In some embodiments of the soft tissue repair device (100) according to any of the above embodiments, the spikes (105) are: serrated, varied (length, dispersion throughout the distal end (101), and / or diameter), personalized, and / or perforated. The spikes (105) may even vary for different patients. This variation improves the fixation of the repair device (100) to the soft tissue. In a further or alternative embodiment, the spikes (105) are claw-shaped. In a further alternative embodiment, the spikes are positioned / manufactured at a predetermined angle (i.e., at an angle other than 90°) relative to the surface area of ​​the distal end (101). In several variations of the device (100), the spikes (105) may be asymmetrically dispersed throughout the distal end (101).

[0064] In some embodiments of the soft tissue repair device (100) according to any of the above embodiments, the spikes (105) are: gradually configured to diffuse the traction force applied thereon due to the traction of the soft tissue, and / or roughened or barbed to prevent undesirable release of the soft tissue.

[0065] In some embodiments of the device (100) according to any of the above embodiments, the spike (105) is not positioned upright, i.e., it has an angle other than 90° relative to its base. The spike (105) may be at any desired angle relative to its base, for example, from about 1° to about 179°, such as from about 80° to about 100°. In some embodiments, the spike (10) is shaped according to a specified insertion movement path. Therefore, the angle or curve of the spike will correspond to the element best suited for each use.

[0066] In some embodiments of the soft tissue repair device (100) according to any of the above embodiments, the spikes (105) are foldable and / or retractable, meaning they can lie flat against the distal end (101) of the device, allowing them to extend outwards before use. This prevents unintentional damage to tissues during insertion of the device (100) into the body, makes insertion easier, and simplifies storage.

[0067] In some embodiments, the spikes (105) may be cut from the surface of the device and bent into their final shape, i.e., forming an inherent part derived from the same material “sheet” / “block”. Alternatively, the spikes (105) may originate from several separate elongated elements, as separate rows of spikes, inserted into the platform and fastened / secured together in their final configuration. In both options, empty spaces are formed between the spikes, enabling the regeneration of soft tissue.

[0068] In some embodiments, the soft tissue repair device (100) according to any of the above embodiments includes a tissue growth aperture (101a) forming a scaffold through which tissue can grow. In alternative or additional embodiments, the device (100) has a scaffold structure that allows tissue to grow through it. Such a configuration facilitates tissue healing and accelerates the healing process.

[0069] In some embodiments of the repair device (100) according to any of the above embodiments, its distal end (101) and / or its proximal end (102) comprises or has a perforated structure that allows soft tissue to grow therein. The perforated structure also allows fluid to pass through, for example, to allow factor and tissue growth into the perforations in the device (100). In specific embodiments, the device is constructed / manufactured using powder metallurgy or any other similar technique to produce a controlled porous structure that allows such soft tissue to grow inward within the device, thereby improving the fixation of the device to the soft tissue. In some other embodiments, the anchor (110) itself is perforated to allow fluid to pass through, for example, from the bone marrow toward the torn soft tissue, thereby further promoting the healing process.

[0070] In some embodiments, the repair device (100) according to any of the above embodiments can be manufactured in any suitable manner, such as by 3D printing to construct a personalized device for each patient based on, for example, the torn soft tissue and the patient’s medical / physical characteristics (i.e., personalized medicine).

[0071] Note that the term “patient” as used herein refers to both humans and animals, and the device (100) and method of the present invention are used or modified according to the patient.

[0072] In some embodiments, the repair device (100) or any component thereof according to any of the above embodiments is made of biocompatible and / or biodegradable materials. This means that its presence should not cause severe inflammation and / or graft rejection. Non-limiting examples of such materials are: metals and their alloys; polymers and copolymers (including bioactive / biodegradable polymers / copolymers); ceramics; bioglass polymers / ceramics or any combination thereof. In a specific embodiment, the device (100) is made of a biodegradable material, meaning that it does not need to be removed after the soft tissue has fully healed and the device is no longer needed, and it simply degrades in a harmless manner, leaving the healed soft tissue firmly anchored to the bone. In another specific embodiment, this also applies to the anchor (110).

[0073] In some embodiments, the repair device (100) according to any of the above embodiments constitutes or acts as a scaffold for soft tissue growth, i.e., 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 and / or onto the repair device (100) itself, thereby promoting faster and better healing. A non-limiting example of such a scaffold material is biotextiles.

[0074] In some embodiments, the repair device (100) according to any of the above embodiments includes and / or is coated with supplementary materials, such as drug-releasing materials, immunosuppressive / immunosuppressive materials, growth factors, stem cells, anti-inflammatory substances, healing / regeneration-mediated substances, hormones, tissue-generating materials, etc., to help soft tissue repair and / or the fusion of soft tissue with the repair device and / or the target area / site or other parts of the torn soft tissue.

[0075] In some embodiments, the repair device (100) according to any of the above embodiments undergoes further processing, such as vibratory polishing and / or electropolishing, to smooth its sharp edges, thereby reducing / eliminating potential damage to surrounding tissues during insertion of the device into the patient's body and / or when anchored to bone.

[0076] Note that the size and width of the repair device (100) according to any of the above embodiments can be adjusted as needed (e.g., based on the size of the soft tissue / tendon, the point of rupture of the soft tissue / tendon, the size of the bone, or any combination thereof). Therefore, under certain conditions, i.e., when the torn soft tissue is large and has a relatively large surface area, a single repair device (100) may not be sufficient to securely anchor it to the bone. In such cases, two or more repair devices (100) may be used to anchor a single soft tissue / tendon to the bone. Alternatively, a wider single repair device (100) can be used. In its specific implementation, the wider repair device is capable of bending in the middle (except for its central flexible region) to allow it to bend according to the surface of the bone. In another or alternative implementation, the length of the repair device (100) can be modified, i.e., made longer or shorter as needed, thereby enabling more efficient and accurate bridging of the distance between the soft tissue and the bone.

[0077] In some embodiments, the repair device (100) according to any of the above embodiments is constructed 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 based on the specific soft tissue being repaired and the individual characteristics of said soft tissue. Therefore, in some embodiments, the size and shape of the repair device (100) and / or the spike (105) are determined based on the specific patient being treated, the characteristics of the soft tissue, the type of injury / rupture, and the specific anatomy of the patient / tissue, or any combination thereof.

[0078] In some embodiments, the repair device (100) according to any of the above embodiments is customized based on the patient's anatomy and / or the soft tissue being repaired. In such cases, the device (100) is made to the desired width and length and has specific positioning of dedicated anchoring holes (103, 104) to achieve its safer and more accurate anchoring.

[0079] To further aid and promote the healing process, specialized layers positioned at anchor points in the torn soft tissue and bone can be used. Such layers can have various properties and components designed to enhance the healing process in any way, such as the release of growth-inducing materials, inflammation inhibitors, etc. Therefore, in some embodiments, the repair device (100) according to any of the above embodiments also includes one or more layers (900) attached to defined portions of one or more of its surfaces. In a specific embodiment, the layers are tissue growth layers. In a specific embodiment, one of the one or more layers (900) is arranged such that it is located between a defined portion of the distal end (101) of the device and the soft tissue to be repaired.

[0080] In some embodiments of the repair device (100) according to any of the above embodiments, one or more layers (900) are: (i) attached to selected portions at both sides of the device (100); (ii) partially or completely attached at its periphery; or (iii) sleeve-like layers covering both sides of the device (100) or the distal end (101) of the device.

[0081] In some embodiments of the repair device (100) according to any of the above embodiments, the layer (900) or at least one of the one or more layers (900) is: (i) made of a biological material selected from the group consisting of synthetic materials, autologous grafts, allogeneic grafts, xenografts or any combination thereof; (ii) provided with one or more through-holes for passing through the dedicated anchor; (iii) provided with one or more through-markers for guiding the passage of the dedicated anchor; (iv) exceeding the surface area of ​​the device (100); or (v) coated with collagen or bone marrow.

[0082] The layer (900) according to the invention can be made of any suitable material, even any commercially available patch. For example, in some embodiments, the layer (900) is selected from the group consisting of reinforcing meshes, reinforcing patches, bio-inducible layers, and any combination thereof.

[0083] In a third aspect, the present invention provides an arthroscopic tool (200) designed to attach a repair device (100) according to any of the above embodiments to torn soft tissue (300). In some embodiments, the tool includes: (a) a main handle (204); (b) a shaft (203) associated at one end with the main handle (204); and (c) a base arm (201) and a clamp (202) located at the other end of the shaft (203), wherein: the clamp (202) is designed to hold the repair device (100), and the base arm (201) includes a recess or groove that allows the spikes (105) of the repair device (100) to pass through without damage or injury; and the base arm (201) and the clamp (202) are operable via the main handle (204) through a transmission mechanism and are designed to open and grasp the ends of torn soft tissue therebetween, and subsequently release the ends of the torn soft tissue if necessary. In a particular embodiment, the base arm (201) of the tool is retractable and extendable to expose the grasped torn soft tissue and attach it to the bone.

[0084] In some alternative embodiments, the tool (200) includes: (a) a main handle (204); (b) a shaft (203) associated at one end with the main handle (204); and (c) a base arm (201) and a clamp (202) located 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) includes a recess (when in a closed clamping position) allowing the repair device (100) to... The spike (105) of the repair device (100) passes through without being damaged; the base arm (201) and the clamp (202) are operable via the main handle (204) through a transmission component and are designed to open and therebetween grasp the ends of the torn soft tissue for traction (when the spike (105) pierces the soft tissue), and subsequently release the ends of the torn soft tissue if necessary; and the clamp (202) includes an opening that allows the anchor to pass through and reach the bone via the repair device (100) and the soft tissue (300).

[0085] In some embodiments, the tool (200) according to any of the above embodiments is designed to optionally hold one, two or more repair devices (100) in a case, thereby enabling the attachment / use of more than one device without removing the tool from the patient's body.

[0086] In some embodiments, the tool (200) according to any of the above embodiments further includes at least one of the following: optical fiber, illumination unit, clamp or any other gripping component, electromagnet, spring, pressure sensor, tension sensor, soft tissue conveyor or any other component or any combination thereof that may be used during surgery.

[0087] In some embodiments, the tool (200) according to any of the above embodiments further includes a vibrating element or vibration generating unit to facilitate the insertion of the spike (105) into the soft tissue (300). Alternatively, if needed, such a vibrating element or vibration generating unit can be used to reposition the spike (105) in the repaired soft tissue.

[0088] In specific embodiments, the tool (200) according to any of the above embodiments may be entirely or partially electromechanical, and not only mechanical, and its operation may be controlled or fully performed by, for example, a computer (such as robot operation).

[0089] In a fourth aspect, the present invention provides a kit comprising the arthroscopic tool (200) of the present invention and one or more repair devices (100) as described in any of the above embodiments. In a specific embodiment, the kit or repair device (100) further comprises one or more tissue growth layers (900) as described above.

[0090] In a fifth aspect, the present invention provides a system for repairing torn soft tissue (e.g., tendons), the system comprising the arthroscopic tool (200) of the present invention, and one or more repair devices (100) according to any of the above embodiments. In a specific embodiment, the system or repair device (100) further comprises one or more tissue growth layers (900) as described above.

[0091] In some embodiments, the tool (200) according to any of the above embodiments may be used together with the repair device (100) to hold and deliver such a layer (900).

[0092] In a sixth aspect, the present invention provides a method for repairing torn soft tissue, the method comprising: (a) providing a repair device (100) according to any of the above embodiments; (b) passing a spike (105) of the repair device (100) through a preferred gripping portion (501) within the torn soft tissue, thereby gripping the soft tissue by the distal end (101) of the repair device (100); (c) pulling the device (100) to position the soft tissue thereby gripped above a predetermined area of ​​bone, and using the spike (105) through the distal end (101) and the soft tissue (501) to... (d) One or more specialized anchors (110) without contacting the articular cartilage attach the distal end (101) of the soft tissue thus grasped to the predetermined region (502) of the bone; (d) bend 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 of the surface of the bone; and (e) attach the proximal end (102) to the different region of the bone, thereby repairing the torn soft tissue by attaching the torn soft tissue to the bone using the repair device (100). In a specific embodiment, the soft tissue is a tendon. In a more specific embodiment, the tendon is a rotator cuff tendon.

[0093] In some embodiments, the method further includes a preparatory step in which the torn soft tissue is isolated and / or a preferred holding site of the torn soft tissue is determined (501). This determination can be performed by any suitable means, such as MRI, using an internal camera optionally associated with an arthroscopic delivery tool, etc.

[0094] In some embodiments of the method according to any of the above embodiments: (i) the distal end (101) of the repair device (100) includes one or more dedicated anchor holes (103), and the step (c) of attaching the distal end (101) with attached soft tissue to the bone is performed by passing an anchor through the one or more dedicated anchor holes (103); and / or (ii) the proximal end (102) of the repair device (100) includes one or more dedicated anchor holes (104), and the step (e) of attaching 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).

[0095] Note that the above methods avoid contact with or interference with the articular cartilage.

[0096] In some embodiments of the method according to any of the above embodiments, the anchoring in steps (d) and (e) includes the following preparatory steps: (i) drilling a hole in the bone and then inserting a suitable anchor through the device and into the drilled hole; or (ii) punching a hole in the bone and then inserting a suitable anchor through the device and into the hole. Alternatively, when using self-drilling or piercing (e.g., self-punching or self-tapping) anchors, the anchoring in steps (d) and (e) does not require any pre-drilling or punching, and the anchor is simply hammered or drilled directly into the bone. In a particular embodiment, when the device (100) includes dedicated anchoring holes (103, 104), the anchor can pass through such dedicated anchoring holes (103, 104) to pass through the device and into the bone.

[0097] In some embodiments of the method according to any of the above embodiments, the anchors for securing the distal end (101) and proximal end (102) to the bone are selected from the group consisting of: anchors inserted into the bone at different angles to improve grip - nails, expandable anchors, expandable anchors, surgical staples (701), "full suture" anchors, and any combination thereof.

[0098] In some embodiments, when the torn soft tissue is significantly wider than the repair device (100) being used and more than one repair device (100) is required, the method according to any of the above embodiments involves using more than one repair device (100) on the same soft tissue.

[0099] In a specific embodiment, the method according to any of the above embodiments includes the following steps: (a) providing a repair device (100) according to any of the above embodiments; (b) exposing the torn tendon and grasping the free edge of the torn tendon while attaching the distal end (101) of the tendon repair device thereto via the spike; (c) passing the spike (105) of the repair device (100) through a preferred gripping portion (501) within the torn soft tissue, thereby grasping the soft tissue via the distal end (101) of the repair device (100); (d) pulling the device (100) to position the soft tissue thereby grasped above a predetermined area of ​​bone. And using one or more dedicated anchors (110) that pass through the distal end (101) and soft tissue (300) without contacting the articular cartilage, the distal end (101) having the soft tissue thus grasped is attached to the predetermined area (502) of the bone; (e) optionally, the proximal end (102) of the repair device (100) is bent or pre-bent relative to the distal end (101) to align the proximal end (102) with different areas of the surface of the bone; and (f) the proximal end (102) is attached to the different areas of the bone, thereby repairing the torn soft tissue by attaching the torn soft tissue to the bone using the repair device (100).

[0100] In some embodiments, the method according to any of the above embodiments further includes the following preparatory step: removing some soft tissue / tendon remnants from the soft tissue / tendon footprint (i.e., its original attachment site with a predetermined support (such as bone)) as needed for surgery / medical purposes.

[0101] The absence of sutures between the soft tissue and bone (at the footprint site) maximizes the contact area and prevents physical interference from sutures. Furthermore, sutures in existing methods tend to create porosity due to geometric deformation at the soft tissue. On the other hand, the repair device (100) of the present invention and its diffused spikes reduce these deformations while creating a better contact area with the soft tissue and diffusing the traction force applied to the soft tissue, thereby improving the fixation of the soft tissue to the underlying bone.

[0102] Compared to currently used known technologies, the entire method / operation according to the present invention should take much less operation time, for example, two times, three times, or even four times faster.

[0103] As used herein, the phrase “traction of the distal end (101) to position the soft tissue thereby grasped” means traction of the torn soft tissue / tendon substantially along its original orientation / line of movement (rather than along a lateral, diagonal, or vertical direction). However, limited lateral, diagonal, and / or vertical displacement may be required during the aforementioned traction action.

[0104] In some embodiments of the method according to any of the above embodiments, the insertion of the repair device (100) into the patient is performed when the device (100) is in a folded form, for example, when the spike (105) is folded or concealed, such as when using an arthroscopic tool (200) according to any of the above embodiments. In this configuration, the spike (105) is exposed or protruding when the device (100) is positioned near soft tissue. This reduces the risk of potential tissue damage during insertion of the device into the patient. In alternative or additional embodiments, the entire device (100) is folded such that the spike (105) is “covered” by the proximal end (102) of the device.

[0105] In some embodiments of the method according to any of the above embodiments, the step of pulling back the soft tissue means pulling back the soft tissue / tendon so that the proximal end (102) of the device is positioned above the original footprint of the soft tissue / tendon.

[0106] In contrast to current methods that use sutures to pull torn soft tissue back to its original attachment site for anchoring to bone, this method reduces soft tissue pull-back by using a repair device that allows the torn soft tissue to be balancedly anchored to its original attachment site without physically placing the torn soft tissue at that site, thus avoiding excessive tension on the rotated soft tissue. This significantly improves patient mobility and comfort immediately after soft tissue fixation.

[0107] Furthermore, the repair device (100) is in one of its potential configurations (e.g., Figure 7C In some embodiments of the repair device (e.g., as...), an additional length can be provided that reduces the distance the repaired tissue is pulled (e.g., to restore its connection / attachment at the original attachment site). This reduces the tensile load in the pulled tissue and thus further contributes to providing improved mobility, faster healing, and improved fixation and anchoring capabilities while maintaining strong biomechanical support. Therefore, in certain embodiments of the repair device (e.g., as...), Figure 7CAs shown), and in contrast to currently used repair devices and techniques (which use sutures to pull torn soft tissue back to its original attachment site on a predetermined support (such as bone) for anchoring), this repair device (100) acts as an elongation bridge, thereby reducing the distance the soft tissue needs to be pulled toward the bone. This reduces the total tension on the soft tissue and thus potentially improves patient mobility and comfort. Furthermore, the repair device of the present invention can act as a bridge scaffold and / or a biodegradable bridge scaffold to allow tissue to grow on and / or within it while keeping the soft tissue within its physiological tension range, thereby promoting the healing process and recovery.

[0108] Furthermore, in current methods, soft tissue is substantially anchored to one face of bone using sutures or specific anchoring devices. This means that if high mechanical tension is applied, the anchor can be pulled out of the bone. This is particularly critical because the soft tissue is shortened for anchoring, which increases the traction force applied at the anchoring point. In contrast, the repair device (100) of the present invention is structured such that it is designed to anchor to bone on two different faces, thereby enabling the device to withstand large biomechanical loads until the soft tissue has fully recovered (which may take more than 8 months).

[0109] Any type of anchor (110, 111), such as orthopedic nails or screws, can be used in the method according to the invention. Therefore, in some embodiments of the method for repairing torn soft tissue according to any of the above embodiments, the anchor for securing the distal end (101) to the bone: (i) is inserted into the bone (400) at different angles to improve grip, such as... Figure 6B As shown; (ii) is an expandable anchor, such as Figure 6E As shown; or (iii) is an expandable anchor, such as Figures 6C to 6D As shown; or any combination thereof. In a specific embodiment of the method according to any of the above embodiments, at least one nail and at least one screw are used to anchor the repair device (100) to the bone (400).

[0110] In some embodiments, the anchors used (110, 111) are pins, nails, or screws, or any combination thereof. In a specific embodiment, the anchor includes a "cap" or head that is wider than the body of the anchor, the head being designed to both prevent the device from slipping on the edge of the anchor and to prevent the device from getting stuck in the bone, thus increasing the anchoring strength.

[0111] Under certain conditions, i.e., when the torn soft tissue (300) is large and has a relatively large surface area, a single anchoring repair device (100) may not be sufficient to securely anchor it to the bone (400). In such cases, two or more repair devices (100) may be used in the method according to any of the above embodiments for anchoring the same soft tissue. Alternatively, a single repair device (100) with a wider opening may be used. In its specific embodiment, the wider-opening repair device is capable of bending in the middle (outside its central flexible region) to allow it to bend according to the surface of the bone.

[0112] In some embodiments of the method according to any of the above embodiments, the steps of approaching the preferred gripping site and pulling the distal end (101) are performed along the same line of action.

[0113] In some embodiments of the method according to any of the above embodiments, the repair device (100) can be inserted into the patient during any type of surgery (e.g., "open" surgery, arthroscopic surgery, or any other endoscopic surgery). In a specific embodiment, the repair device (100) can be inserted into the patient in an "open" or folded form, in which case the spike is folded or not exposed during insertion, but only diffuses / enters the body into an upright position at the desired assembly / attachment point to achieve its final open operating geometry.

[0114] In some embodiments, the method according to any of the above embodiments further includes the step of attaching another (e.g., a secondary) repair device (100) to another location and / or orientation at the anchoring area or another nearby anchoring area.

[0115] In some embodiments, the method according to any of the above embodiments further includes the step of using one or more layers (900) (such as tissue growth layers) attached to a defined portion of one or more surfaces of the repair device (100). In a specific embodiment, the layer is part of the repair device (100). In a specific embodiment, one of the one or more layers (900) is arranged such that it is located between a defined portion of the distal end (101) of the device and the soft tissue to be repaired therefrom.

[0116] 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 receive / hold the repair device (100) according to any of the above embodiments, enabling the user to grasp the end of the torn soft tissue and attach the repair device (100) to the end of the soft tissue.

[0117] The tool (200) according to any of the above embodiments can then be used to pull the soft tissue to the desired anchoring position (502) on the bone, and then anchor the repair device (100) to the bone. This can be accomplished, for example, by sliding the lower base arm (201), thereby enabling the device (100) and the soft tissue attached thereto to be attached to the surface of the bone (502) without interference. A special anchoring element (110) can then be inserted through the device (100) and the soft tissue (300) and into the bone (400). Alternatively, the lower base arm (201) is configured such that it does not need to be slid back, for example by having special engravings or grooves that enable the device and the soft tissue attached thereto to be attached to the surface of the bone without interference.

[0118] The device (100), insertion tool (200), and method according to the invention enable surgeons to reliably retain soft tissue with a single insertion movement while simultaneously penetrating the soft tissue at multiple points. Therefore, the invention offers numerous advantages over the prior art: a faster and easier "all-in-one" device and tool that helps surgeons perform actions more accurately and less complexly, enabling surgeons to preview, grasp, pull back, and secure the soft tissue in the desired location with simple surgical preview; allows previewing of the attachment area selected by the surgeon; saves on additional sutures required in vertical tears by including the entire vertical tear in the preview area; reduces the re-tear rate by using balanced force distribution; and provides the optimal soft tissue-bone contact area required to allow for better and shorter healing cycles.

[0119] Note that all the above definitions and implementations relating to the repair device (100), arthroscopic delivery / insertion tool (200), and any method itself are applicable to each other with necessary modifications. For example, an aspect associated with the repair device (100) may be considered as an arthroscopic tool (200) or method, and vice versa.

[0120] In the following detailed description with reference to the accompanying drawings, non-limiting embodiments of the invention are discussed and illustrated. These embodiments and the drawings should be understood as non-limiting examples of implementing the invention. Furthermore, terms such as “optionally,” “for example,” “for instance,” “exemplary,” “likely,” “may,” etc., refer to optional features selected in certain embodiments of the invention for ease of explanation and clarity. However, it should be understood that the optional features mentioned in different embodiments may be used in combination and / or alone to implement other embodiments of the invention.

[0121] According to the present invention, Figures 2A to 2BA possible configuration of the repair device (100) is shown. The device (100) includes a distal end (101) and dedicated anchoring holes (103) (one or more), the distal end (101) being adapted with spikes (105) extending therefrom, and the dedicated anchoring holes (103) for dedicated anchoring elements to pass through to secure the device (100) and the soft tissue thereby grasped 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 underlying bone can be considered as the support (e.g., as shown in the image). Figures 4A to 4B (as shown); the proximal end (102) has a dedicated anchoring hole (104) for securing the device (100) to the lateral surface of the bone; and an intermediate flexible region (106) that allows the proximal end (102) to be positioned relative to the distal end (101) around a virtual X-axis (by... Figure 2B (Indicated by the dashed lines) This allows for easy rotation, facilitating the fitting attachment of the device (100) to a non-flat support. Note that the length of the entire device (100) and / or any of its segments (i.e., the distal end (101), proximal end (102), and flexible region (106)), as well as the size and number of the dedicated attachments and corresponding attachment holes (103, 104), can vary depending on needs and the patient's physiological capabilities. For example, the device can be longer or wider depending on needs and physiological limitations, the flexible region (106) can be extended, the distal end (101) can be longer and / or wider, etc. Furthermore, the type of dedicated attachments (110, 111) can be determined based on the tissue being repaired, the nature of the support to which the soft tissue is attached, and the expected attachment load.

[0122] Figures 2A to 2B The image further illustrates a tissue growth aperture (101a) extending through the distal end (101), which forms a mesh structure that allows tissue to grow throughout the device (100). In some embodiments, the proximal end (102) also includes an aperture (101a).

[0123] Furthermore, the spike (105) may be serrated and include edge teeth (105a) to ensure unidirectional penetration through the soft tissue thereby gripped. It should be readily understood that the outer surface of the spike (105) is sufficiently blunt and without any sharp edges that could damage the soft tissue. In some embodiments, the spike (105) is angled at less than 90° to the opposite angle to the direction of traction on the soft tissue (300) to resist internal tensile loads in the soft tissue / tendon (300) and to prevent the spike (105) from being undesirably or spontaneously released / pulled out of the soft tissue, thereby preventing release of the grip of the device (100). The spike (105) may also be designed to have a claw-like curved shape that allows it to smoothly penetrate into the soft tissue / tendon (300), for example, as... Figures 5B to 5CAs discussed in the article. However, the spike (105) can have different shapes, such as a backward-sloping cone or other shapes, to support its non-destructive insertion through the tendon / soft tissue (300) and the device (100) to firmly grip it.

[0124] In different applications of the device (100) according to any of the above embodiments, different variations of the device (100) can be selected, including different numbers, shapes, and sizes of attachment holes (103, 104) and spikes (105), to create sufficient load distribution on the soft tissue thereby repaired, while providing a firm grip on the soft tissue by means of the device (100) and securely attaching the device (100) to a predetermined support. Furthermore, the holes (103, 104) may include one or more multi-stage anchor head cavities (1101) to achieve flush mounting of the anchors (110, 111).

[0125] Figure 3 A possible configuration of a delivery tool (200) according to the invention is shown, which is used to perform the tissue repair method of the invention to repair torn soft tissue, for example, using the repair device (100) of the invention under standard arthroscopic manipulation. As shown, the delivery tool (200) may include a base arm (201) and a clamp (202) for delivery and attachment of the device (100). The clamp (202) and the base arm (201) may be operated by a transmission component through a delivery shaft (203) and by a user of the delivery tool (200) who manipulates various actuators mounted in the main handle (204) of the delivery tool (200). The actuators include a clamp actuator (205), which, when pressed, causes the clamp (202) of the tool to rotate upward relative to the base arm (201). The clamp (202) is held in a press-locked state by a ratchet mechanism (206) (i.e., the clamp (202) remains in its rotating state accordingly), which can be released by pressing the release button (205a) of the clamp actuator (205). The lower base arm (201) of the tool can be retracted and extended by the operating lever (207).

[0126] Note that although a mechanical device is shown in this article, it should be noted that the device may be electronic, and all moving parts (such as levers and actuators) may be electrically powered and operated by pressing a button.

[0127] It should be noted that although the base arm (201) can be retracted, an alternative delivery tool (200) in which the base arm (201) cannot be retracted can be used.

[0128] In some embodiments, the clamp (202) further includes one or more temporary attachment elements for holding the device (100) under a predetermined attachment force and releasing the device (100) when the predetermined attachment force is exceeded (e.g., the device (100) is firmly attached to the bone (400)). Figures 5A to 5H (To be discussed further). In alternative or additional embodiments, the device (100) itself also includes alternative or corresponding temporary attachment elements designed to interact with the clamp (202) to prevent it from falling off until the device (100) is anchored to the bone. Figure 3 An anchoring entry port (208) in the clamp (202) is also shown, which is designed to secure the anchoring element through the soft tissue (300) and the device (100), as shown in the reference. Figure 5E Further explanation.

[0129] Figures 4A to 4B and Figures 7A to 7C An exemplary repair of the rotator cuff tendon (300) using a repair device (100) according to an embodiment of the present invention is shown. Figures 4A to 4B and Figures 7A to 7C In this configuration, two anchoring pins (110) secure the distal end (101) of the device (100) to the footprint area on the articular surface of the bone (400) without contacting the articular cartilage, and a single anchoring screw (111) secures the proximal end (102) to the lateral surface of the bone. As can be seen, Figure 4A Figure 4C illustrates the use of a single repair device (100), while Figures 7A to 7C The use of two repair devices (100) placed adjacent to each other is shown to secure larger / wider soft tissue, or to support higher tensile loads within the remaining length of soft tissue that must be stretched before being attached to bone (400).

[0130] Each anchor pin (110) is independently anchored (i.e., anchored to bone) to maximize fixation stability, thereby preventing undesirable detachment or movement of the attached tissue and thus shortening the healing process. While a single anchor pin (110) may be sufficient, in some embodiments, two (or more) anchor pins are used, one designed to bear significant attachment loads while the second provides supplementary stability. In another embodiment, one or both anchor pins (110) and / or anchor screws (111) are made of a biodegradable material that dissipates along the healing process of the repaired tissue.

[0131] Figures 5A to 5HAn exemplary method for repairing a torn soft tissue tendon (300) according to an embodiment of the present invention is shown. Tendon repair is performed by repositioning and attaching the distal / edge portion of the severed / torn tendon to its original footprint (i.e., its original attachment site (502) on the bone (400)). Furthermore, the tendon repair surgery can be performed arthroscopically, using a delivery tool (200) to carry the repair device (100) of the present invention toward the distal edge of the torn tendon (300), grasp, pull, and reposition it to its original footprint, and attach the tendon (300) there. Figure 8A and Figure 8B A block diagram is provided illustrating similar and alternative steps for repairing torn soft tissue using the repair device (100) of the present invention.

[0132] According to certain embodiments of the invention, tendon repair surgery begins with the surgeon determining the preferred gripping site (501) of the torn tendon (300). Figure 5A (For example, the desired portion of soft tissue). The surgeon manipulates the delivery tool (200) holding the device (100) toward the gripping site (501), and rotates upward the clamp (202) to which the device (100) is attached. Figure 5B The tendon (300) is clamped at the gripping site (501) by re-engaging the clamp (202) and the base arm (201) (e.g., by pressing the release button (205a)). During this process, the device's spikes (105) pass through the tendon (300) and grip it to prevent movement. The surgeon can then verify that the gripping site (501) is properly grasped and make adjustments as needed.

[0133] The spike (105) penetrates the holding portion (501) of the soft tissue in a fixed movement according to the shape / angle / radius of the spike and the moving angle of the clamp (202). The fixed movement of the clamp (202) guides the spike into the soft tissue. In some embodiments, a driving force for inserting the spike (105) into the soft tissue (300) is gradually applied to limit puncture of the soft tissue at the holding portion (501). Such a controlled driving force can be provided by a suitable drive mechanism, such as, but not limited to, a spring, hydraulic, electric, or electromagnetic drive unit with a predetermined spring coefficient integrated within the delivery tool (200).

[0134] While firmly grasping the tendon (300) at the distal end (101) of the verification device, the surgeon pulls the delivery tool (200) to position the device (100) and tendon (300) thus grasped at the intended reattachment site (such as the footprint / attachment site (502) of the torn tendon (300) on the bone (400)). Figure 5CAbove (marked with a dashed box). In some embodiments, the surgeon then withdraws the base arm (201) of the delivery tool to clear the pathway for the tendon to enter the footprint (502). Figure 5D This allows the tendons (300) on the tissue to descend uninterruptedly. In some embodiments, the delivery tool (200) is designed to attach the torn soft tissue to the bone without requiring the retraction of the tool's base arm (201). In such embodiments, the step of retracting the lower section of the tool (i.e., the base arm (201)) is unnecessary, and the surgeon simply attaches the torn soft tissue to the bone (400) after retracting it to the desired location / position.

[0135] Next, the surgeon (optionally) passes through the anchor into the orifice (208) (in Figure 3 (further shown in the image) and optionally, a hole is drilled in the upper surface of the bone through the anchoring hole (103) (if present), and then a special anchoring element-pin (110) is installed through it, which also passes through the through hole (103) at the distal end (101) and the grasped soft tissue into the bone. Figure 5E The drilling and anchor installation described above can be performed using suitable drilling and anchoring tools (i.e., depending on the type of anchor (110, 111) selected).

[0136] During the aforementioned traction action of the tendon (300) and the device (100), both are clamped between the clamp (202) and the base arm (201) of the delivery tool (200). Therefore, the majority or all of the traction load is transferred to the tendon (300) as a distributed frictional / force and compressive load rather than a pure shear load, whereas if traction were performed solely by the spike (105), a pure shear load would be transferred to the tendon (300). Furthermore, in embodiments that include a brief withdrawal of the base arm (201) before attaching the tendon (300) to the bone (400), a distributed traction load is applied to the tendon (300) by the spike (105). In this case, a temporary grip of the tendon (300) by the spike (105) is achieved through the predetermined blunt shape, size, and number of spikes (105). In this way, the puncture size and tension of the gripped portion of the tendon (300) are minimized.

[0137] Since the tendon (300) and distal end (101) are attached to the bone, the clamp (202) rotates upward to release the device (100) from the delivery tool (200). Figure 5F ), and the proximal end (102) of the device is bent as needed to align it with the curve of the bone at the lateral surface of the bone ( Figure 5G and Figure 5HThen, the surgeon (optionally) drills again through the dedicated anchoring hole (104) in the proximal end (102) (drilling one or more holes as needed) and screws in the anchoring screw (111) to secure the proximal end (102) of the device to the lateral surface of the bone. Figure 5H This completes the attachment of the device (100) with the grasped soft tissue to the bone (400).

[0138] It should be noted that, Figures 5A to 5H The method steps shown above can be modified as needed. For example, if a self-piercing anchor is used, it is not necessary to drill or punch pre-drill holes in the bone. Furthermore, if the device (100) does not include dedicated anchor holes (103, 104), the channel of the dedicated anchor (110, 111) can extend through the body of the device; that is, the device (100) may include pre-drilled holes (103, 104) or a permeable portion of the anchor, or it may be made entirely of a permeable material for the anchor. Optionally, the device (100) that does not include such dedicated anchor holes (103, 104) may include drill marks on the device indicating the intended drilling location.

[0139] Those skilled in the art should readily understand that Figures 5A to 5H The method shown can be similarly implemented to reconnect / reattach various types of soft tissue to various types of predetermined supports. For example, repairing different torn tendons and other tissues to different bones or artificial implants to which they are attached.

[0140] Figure 5I The final positioning of the device (100) on the bone (without torn tendons) is shown, along with the footprint attachment site (502) for anchoring the device (100) and the articular cartilage region (grey area (503) on the right), which remains unaffected by / does not contact the device (100). Non-limiting examples of the footprint attachment site (502) are the subscapular fossa region, the supraspinatus region, and the infraspinous fossa region.

[0141] It can be noted that, apart from the passage of the anchors (110, 111), Figures 5A to 5HThe tendon repair procedure described herein is performed along a single line of action corresponding to the traction direction of the tendon / soft tissue (300) toward its footprint / original connection site (502) on the bone (400). In this way, the surgeon does not need to cumbersomely manipulate the delivery tool (200) close to the holding site (501) and then back to the footprint / original connection site (502). Furthermore, the transverse line of action for engagement, grasping, and traction of the torn tendon (300) maintains a gap above the repair site, allowing for orthogonal insertion of drilling and anchoring tools and facilitating clear observation of the torn tendon (300) (e.g., from above or in front), for example, by orthogonally inserted arthroscopic cameras. In addition, in some cases, a spike (105) may protrude through the tendon (300). Particularly in such cases, the traction action of the tendon (300) when clamped between the clamp (202) and the base arm (201) prevents undesirable engagement between the spike (105) and the surrounding tissue.

[0142] Figures 6A to 6J Various possible anchors / pins (110) for anchoring the repair device (100) of the present invention to the bone (400) are shown: Figure 6A Two anchoring elements—pins (110)—inserted parallel to each other are shown; Figure 6B Two anchoring elements—pins (110)—are shown inserted at an angle relative to each other to improve the stability and robustness of the device's grip in the bone. Figure 6C , Figure 6D and Figure 6E The potential applications of different types of anchors are shown, which would allow fluid to flow from the humeral bone marrow within the anchor. Under a capillary mechanism, bone marrow fluid can flow upwards towards the bone / tendon surface through the pores in the anchor, thereby increasing the healing potential of torn tissue.

[0143] Figures 6G to 6J An expandable anchor / pin (interchangeable with anchor-pin (110) and anchor-screw (111)) is shown, which expands after or during insertion to enhance its anchoring ability and prevent it from being pulled out of the bone. Furthermore, an expandable anchor / pin of a given diameter can be used instead of an equivalent (in terms of fastening strength) larger non-expandable anchor / pin with a larger diameter, and thus requires a smaller anchoring hole through the soft tissue / tendon (300).

[0144] In some embodiments of the repair device (100) according to any of the above embodiments, the spikes (105) and / or pins (110) have grooves or barbs, and / or are roughened to increase their pull-out force, thereby reducing the risk and preventing undesirable release of soft tissue, and thus preventing soft tissue from being released from the device (100).

[0145] Figures 7A to 7CThe illustration shows a case where two (or more) repair devices are used to anchor the major tendon to the bone. This can be accomplished using a specialized delivery tool (200) that places the repair devices one after another, or two repair devices simultaneously.

[0146] The repair device (100) described above is intended for traction and attachment of torn soft tissue toward its original attachment site. However, in some cases, the torn tissue is too short to be pulled to its original attachment site, and 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, thereby reducing the degree to which the shortened soft tissue needs to be pulled and thus reducing the tension caused by its pulling, such as... Figure 7C As shown. The use of such a bridging repair device (100) is highly advantageous, for example, in cases where the tendon (300) has significantly retracted from its original attachment site. Therefore, pulling the edge of the retracted tendon back to the original attachment site could cause excessive tension in the tendon, which would reduce mobility, increase pain, and prolong the healing process. Note that in such cases (e.g.) Figure 7C As shown), it may not be necessary to use an anchor or spike through the distal end (101) because the distal end (101) is not necessarily positioned above the bone, and the torn soft tissue will be held only by the spike (105), and the device will be anchored only through its proximal end (102).

[0147] Figure 7C The diagram further shows a surgical staple (701) that can be used in place of any anchor (110, 111) or in combination with any anchor.

[0148] In some embodiments, the device (100) according to any of the above embodiments may also have reinforcing capabilities, wherein one or more layers (e.g., having similar or different layer thicknesses of 0.01 mm to 0.5 mm) are attached to predetermined portions of one or more of its surfaces. These layers may be provided as reinforcing mesh / patches and / or bio-inducing layers to promote and assist tissue growth, thereby enhancing the healing process.

[0149] Figures 9A to 9C The use of such a (tissue growth) layer (900) with the distal end (101) of the device (100) for repairing soft tissue (300) is shown. Figure 9AIn this configuration, a tissue growth layer (900) (which may be interchangeably referred to herein as a “patch”) is attached to the bottom surface of the distal end (101), thus positioning it between the device (100) and the holding portion (501) of the repaired soft tissue (300). It should be noted that although the layer (900) is shown as having a surface area larger than that of the distal end (101) of the device, the layer may have a surface area equal to or smaller than that of the distal end (101) of the device. Alternatively, as... Figure 9B As shown, the tissue growth layer (900) is used on both sides of the distal end (101) and can be configured as a sleeve surrounding the device (100) to encourage accelerated tissue growth from both sides and thus promote shorter healing of the repaired soft tissue (300). Figures 10A to 10B A side view of such a layer is provided: a single layer below the distal end of the device ( Figure 10A ), or as a sleeve that completely covers it ( Figure 10B ).

[0150] Optionally, the size of the tissue growth layer (900, 900a) can exceed the surface area of ​​the device (100), such as Figure 9C As shown, this applies to cases such as partially torn soft tissue (300), or when reattachment of torn tissue does not require the use of two (or more) devices (100). In such cases, the extended portion of the tissue growth layer (900, 900a) is designed to provide reinforcement over the entire area of ​​the torn soft tissue (300) and is attached thereto by a suitable attachment (910). Although in Figure 9C The sleeve patch (900a) is shown, but it should be readily recognized that the structure shown can also be achieved by utilizing a single tissue growth layer (900) that exceeds the surface area of ​​the device (100).

[0151] Furthermore, in some embodiments, the layers (900, 900a) may cover only a portion of the surface area of ​​a defined surface of the device (100), for example, to encourage tissue growth only near the distal end (101).

[0152] The patch / layer (900, 900a) may be produced from a material permeable to a dedicated anchor (e.g., any of the anchors that pass through the holes (103, 104)) to allow easy attachment to the designated support (e.g., bone (400)). In an embodiment, the layer (900, 900a) includes pre-formed orifices aligned with the holes (103, 104). Additional orifices may be added to the layer (900, 900a), appropriately sized in some cases to support increased tissue growth rates. Optionally, the layer (900, 900a) may include one or more guide marks indicating drilling / penetration points for anchor-pins (110) and / or anchor-screws (111), particularly where the tissue growth layer (900, 900a) is attached to both sides of the distal end (101) (e.g. Figure 9B (As shown).

[0153] Attachment of layers (900, 900a) to device (100), to each other, or to soft tissue (300) can be achieved by various attachment means, such as by suitable heat sources, sutures, biocompatible adhesives, and different combinations thereof. Specific attachment methods can be selected by those skilled in the art to suit the specific conditions and applications of the invention. Alternatively, physical attachment is not required, and layers (900) are simply deposited on device (100).

[0154] like Figures 11A to 11B As shown, the dedicated anchoring holes (103, 104) of the device (100) according to any of the above embodiments are implemented as multi-stage holes (1101) (also referred to as anchor head cavities or recesses), which allow the anchors (110, 111) to pass through them at an angle. As shown, although in Figure 11A The middle anchor (110) passes straight down, but in Figure 11B The anchor (110) passes obliquely through the multi-step hole (1101), with its head (1110) abutting against the step (1101a) of the multi-step hole (1101). For simplicity, in Figure 11B A single multi-level hole (1101) is shown as an alternative to the hole (103). However, it should be readily appreciated that a multi-level hole (1101) can be implemented instead of any anchoring hole (103, 104). The angled passage of the anchors (110, 111) prevents undesirable withdrawal and allows for a flexible installation range. In some embodiments, the multi-level hole (1101) is sized to allow flush mounting of the anchors (110, 111), with the anchor head fully recessed therein, so that the anchor head does not protrude above the upper surface of the device (100) to avoid interference with, for example, the acromion bone, thereby reducing the risk of irritation to nearby tissues (e.g., the acromion) and promoting the healing process.

[0155] In some implementations, the multi-level hole (1101) allows the anchor (110, 111) to be inserted into the device (100), soft tissue (300) and bone (400) at an angle (i.e., not perpendicular to it) and with the upper part of the anchor completely or almost completely below the upper surface of the device (100), thereby reducing the risk of irritating nearby tissues (such as the acromion).

Claims

1. A soft tissue repair device (100) for repairing torn soft tissue, the device (100) comprising: a) A distal end (101) having at least two spikes (105) configured to have a predetermined length to penetrate only a predetermined thickness of the soft tissue for gripping the soft tissue; and b) Proximal end (102), in: - The spike (105) is tilted relative 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 of them to rotate relative to the other; - The distal end (101) is configured to be anchored to a first plane of bone using a dedicated anchor passing through it; and - The proximal end (102) is configured to be anchored to a different plane of the same bone using a dedicated anchor that passes through it.

2. The 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, thus allowing it to penetrate the soft tissue without leaving the soft tissue and damaging the bone.

3. The repair device according to claim 1 further includes an intermediate flexible region (106) that allows the proximal end (102) to rotate relative to the distal end (101).

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

5. The repair device according to claim 1, further comprising one or more attachment elements, said one or more attachment elements being designed to hold the device (100) by a delivery tool.

6. The repair apparatus according to claim 1, wherein the apparatus (100) comprises: One or more dedicated anchoring holes (103) in the distal end (101) through which a dedicated anchor can pass to attach the distal end (101) and the torn soft tissue to the bone; and / or one or more dedicated anchoring holes (104) in the proximal end (102).

7. The repair device according to claim 6, wherein one or more of the one or more dedicated anchoring holes (103, 104) are multi-level holes (1101).

8. The repair device according to claim 1, wherein the spike (105) is serrated, coarse, or barbed to prevent undesirable release of the soft tissue.

9. The repair apparatus of claim 1, wherein the apparatus (100) includes a tissue growth aperture (101a) forming a scaffold through which tissue can grow.

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

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

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

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

14. The repair device according to claim 1, wherein the device (100) or at least a portion thereof comprises a drug-releasing material.

15. The repair device according to claim 1, wherein the device (100) is coated with, for example, a drug-releasing material, a healing / regeneration-mediated substance, an immunosuppressant material, a growth factor, stem cells, and / or an anti-inflammatory substance.

16. The repair device according to claim 1, which is made according to the patient's anatomical structure.

17. The repair device of claim 1, wherein the spikes (105) are configured such that they distribute the tensile force applied to the attached soft tissue, thereby reducing the risk of damaging the soft tissue and / or tearing / removing the repair device from the soft tissue.

18. The repair device of claim 17, wherein the spike (105) is progressively configured to distribute the tension applied to the soft tissue.

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

20. The repair device according to claim 1, wherein the spike (105) is differentiated, personalized and / or perforated.

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

22. The repair device according to claim 1, wherein the spike (105) has a sharp / pointed edge / point capable of penetrating into soft tissue, and a blunt rod / body that does not damage the soft tissue when force is applied thereon.

23. The repair apparatus of claim 1, further comprising one or more layers (900) attached to a defined portion of one or more of its surfaces.

24. The repair apparatus of claim 23, wherein one of the one or more layers (900) is arranged such that it is located between a defined portion of the distal end (101) of the apparatus and the soft tissue to be repaired therefrom.

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

26. The repair apparatus of claim 25, wherein the one or more layers (900) are partially or completely attached at their periphery.

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

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

29. The repair device of claim 23, wherein the layer is made of a biological material selected from the group consisting of synthetic materials, autologous grafts, allogeneic grafts, xenografts, or any combination thereof.

30. The repair device according to claim 23, wherein at least one of the one or more layers (900) is provided with one or more through holes for the special anchor to pass through.

31. The repair apparatus of claim 23, wherein at least one of the one or more layers (900) is provided with one or more passage marks for guiding the dedicated anchor through.

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

33. The repair apparatus of claim 23, wherein the one or more layers (900) are selected from the group consisting of reinforcing meshes, reinforcing patches, bio-inducing layers, and any combination thereof.

34. The repair device of claim 23, wherein one or more layers (900) are coated with collagen or bone marrow.

35. An arthroscopic tool (200) for mounting the repair device (100) according to claim 1 to repair torn soft tissue (300), said tool comprising: a) Main handle (204); b) A shaft (203), one end of which is associated with the main handle (204); as well as c) The base arm (201) and the clamp (202), located at the other end of the shaft (203), in: - The clamp (202) is configured to hold the repair device (100), and the base arm (201) includes a recess that (when in the closed clamping position) allows the spikes (105) of the repair device (100) to pass through without being damaged. - The base arm (201) and clamp (202) are operable by a transmission device via the main handle (204) and are designed to open and grasp the ends of the torn soft tissue therebetween for traction of the soft tissue (while the spike (105) pierces the soft tissue), and subsequently release the ends of the torn soft tissue as needed; and - The clamp (202) includes an opening that allows the anchor to pass through the repair device (100) and the soft tissue (300) to reach the bone.

36. The arthroscopic tool (200) of claim 35, wherein the base arm (201) of the tool is retractable and extendable for exposing grasped torn soft tissue and attaching said torn soft tissue to bone.

37. A kit comprising the arthroscopic tool (200) according to claim 35 and one or more repair devices (100) according to claim 1.

38. A method for repairing torn soft tissue, the method comprising: a) Provide the repair device (100) according to claim 1; b) Determine a preferred gripping site (501) for the torn soft tissue, bring the preferred gripping site (501) close to the distal end (101) and pass the spike (105) of the repair device (100) through the preferred gripping site (501) to grasp the soft tissue through the distal end (101) of the repair device (100); c) Clamp and pull the distal end (101) to position the soft tissue thereby grasped above a predetermined area of ​​the bone, and attach the distal end (101) having the soft tissue thereby grasped to the predetermined area of ​​the bone using one or more dedicated anchors (110) passing through the distal end (101) and the soft tissue. d) Bend the proximal end (102) of the repair device (100) relative to the distal end (101) to align the proximal end (102) with different regions of the surface of the bone; as well as e) Attach the proximal end (102) to the different regions of the bone. The torn soft tissue is repaired by attaching it to the bone using the repair device (100).

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

40. The method of claim 38, wherein the distal end (101) of the repair device (100) includes one or more dedicated anchoring holes (103), and the step (c) of attaching the distal end (101) to the bone with the soft tissue attached is performed by passing a dedicated anchor through the one or more dedicated anchoring holes (103).

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

42. The method of claim 38, wherein the anchoring in steps (d) and (e) comprises a preparatory step of drilling a hole in the bone and subsequently inserting a suitable anchor through the device and into the drilled hole.

43. The method of claim 38, wherein the anchoring in steps (d) and (e) includes a preparatory step of punching a hole in the bone and subsequently inserting a suitable anchor through the device and into the hole.

44. The method of claim 38, wherein the anchor for securing the distal end (101) and the proximal end (102) to the bone is selected from the group consisting of: anchors inserted into the bone at different angles to improve grip - nails, expandable anchors, expandable anchors, surgical nails (701), "full suture" anchors, and any combination thereof.

45. The method of claim 38, wherein more than one repair device (100) is used on the same soft tissue.

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

47. The use of the repair device (100) according to claim 1, which is used to repair torn soft tissue by: a) Determine a preferred gripping site for the torn soft tissue, bring the preferred gripping site close to the distal end (101), and pass the spike (105) of the repair device (100) through the preferred gripping site, thereby gripping the soft tissue through the distal end (101) of the repair device (100). b) Clamp and pull the distal end (101) to position the soft tissue thereby grasped above a predetermined area of ​​the bone, and attach the distal end (101) having the soft tissue thereby grasped to the predetermined area of ​​the bone using one or more dedicated anchors (110) passing 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 different regions of the bone surface; and d) Attach the proximal end (102) to the different regions of the bone. The torn soft tissue is repaired by attaching it to the bone using the repair device (100).

48. The repair device (100) according to claim 1, for repairing torn soft tissue by: a) The spike (105) of the repair device (100) is passed through a preferred gripping portion (501) within the torn soft tissue, thereby gripping the soft tissue through the distal end (101) of the repair device (100); b) Clamp and pull the distal end (101) to position the soft tissue thereby grasped above a predetermined area of ​​the bone, and attach the distal end (101) having the soft tissue thereby grasped to the predetermined area of ​​the bone using one or more dedicated anchors (110) passing through the distal end (101) and the soft tissue. c) Bend the proximal end (102) of the repair device (100) relative to the distal end (101) to align the proximal end (102) with different regions of the bone surface; and d) Attach the proximal end (102) to the different regions of the bone. The torn soft tissue is repaired by attaching it to the bone using the repair device (100).

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