SOFT TISSUE REPAIR DEVICES, SYSTEMS, AND METHODS
FIELD OF THE INVENTION
[001] The present invention relates in general to the field of tissue repair. Specifically, the invention provides devices and methods for allowing better contact between two tissues, specifically a soft-tissue like a tendon to bone, for enhanced healing process.
BACKGROUND
[002] Known surgical methods of rotator cuff repair (open, mini-open, and all- arthroscopic cuff repair) vary, as each method provides an array of advantages and disadvantages.
[003] The open surgical technique has long been considered the gold standard of rotator cuff repair, but surgeons are becoming more adept at decreasing patient morbidity through decreased surgical trauma from an all- arthroscopic approach.
[004] Existing arthroscopic surgical techniques are based on surgical sutures that are manually inserted (usually by a needle- either manually or mechanically) through the tendon on one end, and secured thereto, e.g., by binding, thereby allowing fixation of the tendon via said sutures to a standard bone anchor/suture anchor at the other end (see Fig. 1 illustrating a sutured tendon to a bone performed by the existing tools and methods known in the art).
[005] When choosing the precise location for the suture insertion at the tendon, the surgeon uses an arthroscopic grasper to pull the tom tendon toward the Humerus bone. This individual grasp does not provide the surgeon with the full pulling effect over the tendon's relocation, that the multi sutured tendon would experience at the end of the procedure. In a permanent grip made by a specific suture the forces are unbalanced and concentrated at the insertion point of each individual suture. Those unbalanced forces can cause an overload on a suture and can lead to suture failure or worst, unwanted suture dragging that may lead to additional tendon tear. Currently, the common failure in tendontear repairs happens in the interaction point between the stitching thread and the tendon, wherein re-tears occurring during early stage (first six months) represent a failure to heal. Accordingly, various surgical techniques were developed to decrease re-tears: single row; double row; suture bridge; and knotless suture bridge. [006] There are currently several ‘suture passer’ devices that allow simultaneous suture passing and retrieval. Most of these devices reduce the procedure’s complexity but require multiple repetitions and therefore do not shorten the duration of the procedure. Moreover, none of the known devices includes means for grasping the tendon in a balanced manner and/or relocating the sutures after securing them to the same tendon.
[007] The biomechanical construct (tendon-bone) has a critical effect on maintaining bone-tendon proximity to allow biological healing, wherein current practice includes the usage of multiple suture anchors (between 1 to about 6).
[008] Even with the help of suture passers, tendon repair in existing technologies suffers from a relatively high failure rate (in particular in large tears), requires high expertise of the operating surgeon, and takes a long time. In addition, current procedures have many limitations: long limb immobilization period of about 2-6 weeks to avoid early re-tears; long rehabilitation, causing patients to avoid surgery; the tendon repair procedure is timeconsuming and requires multiple knots, sutures, and devices; and the procedures require a long learning curve for surgeons.
[009] Accordingly, a need exists for an easy-to-use device and a simple method that enable better tendon grasping and fixation, and improved healing of a torn tendon, which are minimally invasive, enable to perform corrections and adjustments at any point throughout the surgical procedure, cause minimal damage to the tendon, enables better healing and reduced re-tear rate, and subsequently leads to shorter rehabilitation period, and reduce the operation/procedure time. The present repair device and method provide all of these and more and provide increased anchoring and fixation forces.
SUMMARY OF INVENTION
[010] The present invention provides a soft-tissue repair device (100) for repairing torn soft-tissue. The device (100) comprises essentially of: (a) a distal-end (101) having at least two spikes (105) configured with a predetermined length for penetrating only through predetermined thickness of the soft-tissue for grasping the same; and (b) a proximal-end (102), wherein: said spikes (105) are inclined at a predefined angle other than 90° with respect to said distal-end (101); a connection between the distal-end (101) and the proximal-end (102) enables a rotation of one relative to the other; the distal-end (101) is designed to be anchored to a first plane of a bone with dedicated anchors that pass therethrough; and said proximal-end (102) is designed to be anchored to a different plane of the same bone with a dedicated anchor that passes therethrough.
[Oil] The present invention further provides a method for repairing a torn soft-tissue, the method comprising: (a) providing a repair device (100) of the invention; (b) determining a preferred grip-site (501) of said tom soft-tissue, approaching the same with the distal-end (101) and threading the spikes (105) of said repair device (100) therethrough , thereby grasping said soft-tissue by said distal-end (101) of said repair device (100); (c) clamping and pulling said distal-end (101) to position said soft-tissue grasped thereby above a predetermined area of a bone and affixing said distal-end (101) with said soft-tissue grasped thereby to said predetermined area of the bone using one or more dedicated anchors (110) threaded through said distal-end (101) and soft-tissue; (d) bending the proximal-end (102) of said repair device (100) respective to said distal-end (101) to align same with a different area of said bone’s surface; and (e) affixing said proximal-end (102) to said different area of the bone, thereby repairing said torn soft-tissue by affixing it to the bone using said repair device (100).
BRIEF DESCRIPTION OF DRAWINGS
[012] Fig. 1 is an illustration of one of the currently used techniques to anchor a torn tendon to a bone.
[013] Figs. 2A-2B illustrate one possible configuration of a repair device according to embodiments of the invention.
[014] Fig. 3 illustrates a possible delivery tool for installing the repair device of the invention.
[015] Figs. 4A-4B illustrate a rotator cuff repair device of the invention anchored to a bone and holding a torn Supraspinatus tendon in place.
[016] Figs. 5A-5I illustrate possible steps for anchoring a tom tendon to a bone using the repair device and a suitable delivery tool therefor: Fig. 5A: the delivery tool reaches the torn tendon; Fig. 5B: the delivery tool grasps the torn tendon; Fig. 5C: spikes of the repair device are pressed into the torn tendon; Fig. 5D: the bottom section of the delivery tool is retracted to allow accurate and precise placement of the repair device on the bone; Fig. 5E: pins anchor the repair device holding the tendon to the bone; Fig. 5F : the delivery tool is removed; Fig. 5G: another pin or screw or bone anchor is used to anchor the proximal end of the repair device to the bone; Fig. 5H: the repair device is anchored to the bone while holding the torn tendon; and Fig. 51: illustrates a footprint area on a bone onto which the repair device is to be anchored, as well as the articular cartilage that is unaffected by the device.
[017] Figs. 6A-6J illustrate various possible pins for anchoring the repair device to the bone.
[018] Figs. 7A-7C illustrate the use of two repair devices for anchoring a large tendon to a bone.
[019] Figs. 8A-8B are block diagrams illustrating two possible ways to use the repair device of the invention.
[020] Figs. 9A-9C are illustrations of the use of a (tissue-growth) layer with the distal- end of the device: Fig. 9A illustrates layers attached/positioned to the bottom surface of the device’s distal-end; Fig. 9B illustrates sleeve-like layers covering both faces of the device’s distal-end; and Fig. 9C illustrates a wide (sleeve-like) layer that extends significantly beyond the device’s distal-end sides.
[021] Figs. 10A-10B are side-view illustrations of the layer with the distal-end of the device: Fig. 10A illustrates a layer attached/positioned to the bottom surface of the device’ s distal-end; and Fig. 10B illustrates sleeve-like layer covering both faces of the device’s distal-end.
[022] Figs. 11A-11B illustrate multistep anchor holes/cavities implementation, according to an embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[023] Today, when a Rotator Cuff tendon is torn, the most common arthroscopic repair technique requires using multiple sutures and anchors in order for the surgeon to secure the torn tendon back to its footprint at the Humeral head. This procedure (Rotator Cuff Repair (RCR)) is a long and relatively complicated procedure that also potentially shortens the tendon due to its pulling towards the anchoring point on the bone.
[024] The present invention provides methods, apparatuses, and systems, whereby physicians' actions become more accurate, quicker, and simple to perform, providing the surgeon with the ability to preview, grip, pull back, and fix a torn soft-tissue to a desired location on a support, such as the bone, in a simple process that reduces procedure complexity and duration significantly, while providing strong biomechanical support and potentially faster healing. [025] The present invention provides a soft-tissue repair device (100) for achieving better soft-tissue-bone contact and balanced force distribution onto the attachment point to thereby reduce the risk of re-tear/detachment, achieving a reliable anchoring of the soft- tissue by a single insertion movement, and optionally while causing minimum damage to the soft-tissue (and bone), and offering better soft-tissue-bone contact area during the recovering period. In certain embodiments, the procedure of attaching the soft-tissue to the bone is reversible, thereby allowing improving/refining the contact between the soft-tissue repair device and the soft-tissue during the attachment procedure. Moreover, the present method and repair device (100) may spare additional sewing, which is currently needed in vertical soft-tissue tears. The soft-tissue repair device of the invention allows optimal soft- tissue-bone contact/fixation and contact pressure, which assist in reducing the healing time and/or reduce the risk of separation.
[026] The terms “support” and “bone” as used herein interchangeably refer to any hard surface onto which the repaired soft-tissue is to be anchored/affixed, and include both natural and synthetic bone(s), or any other artificial structure.
[027] The term “soft-tissue” as used herein refers to a tendon, ligament, and other soft tissues that may require mending, particularly connecting tissues.
[028] The terms “torn tendon” and “torn soft-tissue” as used herein refer to both a soft- tissue/tendon that was completely tom and to a soft-tissue/tendon that is partially torn and still has some connection to the bone. Partial tears of a tendon include, but are not limited to, e.g., a small crescent, moderate crescent, large-U, and V- and L-shaped and reversed L-shaped tears. Both acute and chronic torn scenarios.
[029] Accordingly, the present invention provides technology for tendon-bone reattachment, e.g., in Rotator Cuff repair, for achieving better healing, and a quicker and easier procedure. The present invention provides a minimally invasive, suture-less, gripping & reattaching system composed of a soft-tissue repair device that provides distributed forces for securing the tendon and maximizing contact area between tendon and bone and thus, allowing faster healing, earlier physical therapy, and shorter rehabilitation period. In addition, the repair device of the invention is designed to reduce the duration and complexity of current arthroscopic tendon repair surgeries including re-do procedures. [030] In a first aspect, the present invention provides a repair device (100) for repairing torn soft-tissue. The device (100) comprises essentially of: (a) a distal-end (101) having at least two spikes (105) configured with a predetermined length for penetrating only through predetermined thickness of the soft-tissue for grasping the same; and (b) a proximal-end (102), wherein: said spikes (105) are designed such that they are at a predefined angle other than 90° relative to the surface of the distal end (101); a connection between the distal-end (101) and the proximal-end (102) enables a rotation of one relative to the other; the distal- end (101) is designed to be anchored to a first plane of a bone with dedicated anchors that pass therethrough; and said proximal-end (102) is designed to be anchored to a different plane of the same bone with a dedicated anchor that passes therethrough.
[031] In certain embodiments of the soft-tissue repair device (100) according to any of the embodiments above, the length of the spikes (105) is determined according to the thickness of the soft-tissue, namely, the spikes (105) have a length that is shorter or equivalent to the thickness of the soft-tissue to allow penetrating only through the predetermined thickness of the soft-tissue for grasping the same, while avoiding exiting/protruding from the other side thereof (i.e., without reaching and damaging the bone (400)), thereby preventing unintentional damage to the bone.
[032] In certain embodiments thereof, the repair device (100) further comprises an intermediate flexible region (106) designed to allow bending and/or rotational movement of said proximal-end (102) respective to said distal-end (101).
[033] In specific embodiments, the repair device (100) comprises (a) a distal-end (101) having spikes (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 a bone with dedicated anchors that passes therethrough; and said proximal-end (102) is designed to be anchored to a different plane of the same bone with dedicated anchors that passes therethrough.
[034] In certain embodiments, the repair device (100) according to any of the embodiments is made essentially entirely of a flexible or semi-rigid material that allows bending and adjusting of the device (100) to the face of the surface/bone. In such a configuration, the flexibility of the distal-end (101) and/or the proximal-end (102) enables perfect adjustment thereof to the, e.g., bone (400) thereby reducing the risk of extending/ protruding edges that may interfere with or irritate nearby tissues, and improving the healing process. In certain embodiments, the repair device (100) according to any of the embodiments further comprises one or more clinging elements designed to enable holding of the device (100) by a delivery tool, such as the arthroscopic tool (200) of the invention. Non-limiting examples of such clinging elements are bio-glue and protrusions and recesses within the device’s body, along the perimeter or within the surface of the distal-end (101), the proximal-end (102), or the intermediate flexible region (106), or any combination thereof. [035] In specific embodiments of the above repair device (100), the soft-tissue is a tendon. In more specific embodiments, the tendon is a rotator cuff tendon.
[036] In another aspect, the present invention provides a soft-tissue repair device (100) as defined above for use in repairing a tom soft-tissue. In specific embodiments, the device (100) comprises: (a) a distal-end (101) having at least two spikes (105) configured with a predetermined length for penetrating only through a predetermined thickness of the soft- tissue for grasping the same (this means that the spike may not penetrate through the entire thickness of the soft-tissue); and (b) a proximal-end (102), wherein: said spikes (105) are inclined at a predefined angle other than 90° relative to the surface of the distal end (101); a connection between the distal-end (101) and the proximal-end (102) enables a rotation of one relative to the other; the distal-end (101) is designed to be anchored to a first plane of a bone with dedicated anchors that pass therethrough; and said proximal-end (102) is designed to be anchored to a different plane of the same bone with a dedicated anchor that passes therethrough.
[037] In specific embodiments, the present invention provides a tendon repair device
(100) for use in repairing a torn tendon, the device (100) comprising: (a) a distal-end (101) having one or more dedicated anchor holes (103) and spikes (105), said spikes (105) are designed to penetrate into 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) (e.g., about an axis X) relative to the distal-end (101), wherein: (i) the distal-end (101) is designed to be anchored to a first plane of a bone with dedicated anchors that pass through the one or more dedicated anchor holes (103); and (ii) said proximal-end (102) is designed to be anchored to a different plane of the same bone with dedicated anchors that pass through one or more dedicated anchor holes (104).
[038] In certain embodiments of the device (100) for use in repairing a tom soft-tissue according to any of the embodiments above, the device (100) comprises: (a) a distal-end
(101) having spikes (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 a bone with dedicated anchors that passes therethrough; and said proximal-end (102) is designed to be anchored to a different plane of the same bone with dedicated anchors that pass therethrough.
[039] The present invention further provides a repair device (100) as defined above for use in repairing a tom soft-tissue by: (a) determining a preferred grip-site (501) of said tom soft-tissue, approaching the same with the distal-end (101) and threading the spikes (105) of said repair device (100) therethrough , thereby grasping said soft-tissue by said distal- end (101) of said repair device (100); (b) clamping and pulling said distal-end (101) to position said soft-tissue grasped thereby above a predetermined area of a bone and affixing said distal-end (101) with said soft-tissue grasped thereby to said predetermined area of the bone using one or more dedicated anchors (110) threaded through said distal-end (101) and soft-tissue; (c) bending the proximal-end (102) of said repair device (100) respective to said distal-end (101) to align same with a different area of said bone’s surface; and (d) affixing said proximal-end (102) to said different area of the bone, thereby repairing said torn soft-tissue by affixing it to the bone using said repair device (100).
[040] In specific embodiments of the above uses, the tissue is a tendon, and the soft-tissue repair device (100) is a tendon repair device.
[041] Notably, the structure of the repair device (100) according to any of the embodiments above, is such that it can be anchored to at least two faces of the bone, where one face is the upper articular surface, and the other is the lateral surface (illustrated in Fig. 51). This is enabled thanks to the flexibility between the device’s distal-end (101) and proximal-end (102), or due to the intermediate flexible region (106) (if present) that provides flexibility and allows the proximal-end (102) to flex relative to the distal-end (101) to fit the bone’s curve. Such anchoring on two surfaces improves the device’s stability and sturdiness when pulling forces are applied thereon, i.e., when the soft-tissue is retracted. In such a way, the risk of pulling the anchor out of the bone is dramatically reduced.
[042] In certain embodiments of the repair device (100) of the invention, the intermediate flexible region (106) is constructed as a pre -bent shape and is aspired to return to said prebent shape, such that when the device is forced open (“straighten” or “folded in half’), e.g., during placement inside a delivery device for insertion into the body, it snaps back into its bent shape once pressure is removed therefrom, i.e., when it exits a delivery device.
[043] In certain embodiments, the repair device (100) according to any of the embodiments above is rigid. In alternative embodiments, it is somewhat flexible or semirigid, while the spikes are rigid. In yet other embodiments, the repair device (100) is made of a solid plate. In alternate embodiments, the repair device (100) is constructed as a perforated or mesh-like plate, wherein the size of the holes is either fixed or differential. In specific embodiments, the spikes are perforated. Such perforation or mesh-like structure enables tissue to grow into the cavities to thereby strengthen the binding of the repair device (100) to the soft-tissue.
[044] According to some embodiments of the invention, the number of spikes (105) in the device (100) according to any of the embodiments above may vary according to the mechanical properties and dimensions of the soft-tissue involved. Accordingly, in some embodiments of the invention, the device (100) comprises from 1 to 1000; from 2 to 750; from 3 to 500; from 4 to 400; from 5 to 300; from 5 to 250; from 5 to 200; from 5 to 150; from 5 to 100; from 7 to 100; from 8 to 100; from 9 to 100; from 10 to 100; or from 10 to 50 spikes (105).
[045] In other embodiments, the number of spikes rows and/or columns is higher than 1 and below 10,000. And the distance between two adjacent spikes (105) is from about 1 m to about 30 mm, or any other suitable distance or distance range.
[046] In other embodiments, the length of the spikes is higher than about 1 pm and lower than about 30 mm.
[047] In another embodiment, the thickness of the spikes (105) is about 1 pm and is lower than about 10 mm.
[048] In certain embodiments, the repair device (100) according to any of the embodiments above further comprises a locking mechanism designed to prevent the pullout of the anchors (110,111) passing therethrough for anchoring the device (100) to the bone (400). Non-limiting examples of such a locking mechanism are click-ones, a slidable cover that is slid over the dedicated anchor holes (103,104) after an anchor is inserted, etc. In alternative or additional embodiments, the locking mechanism is part of the anchors themselves, such that after an anchor passes through the device (100) and placed in the bone, it is locked tight to prevent release of the device from the anchors and the bone. In further alternative or additional embodiments, the locking mechanism is a bioglue.
[049] In a second aspect, the present invention further provides use of a soft-tissue repair device (100) according to any of the embodiments above, for repairing a torn soft-tissue, by: (a) determining a preferred grip-site (501) of said tom soft-tissue, approaching the same with the distal-end (101) and threading the spikes (105) of said repair device (100) therethrough , thereby grasping said soft-tissue by said distal-end (101) of said repair device (100); (b) clamping and pulling said distal-end (101) to position said soft-tissue grasped thereby above a predetermined area of a bone and affixing said distal-end (101) with said soft-tissue grasped thereby to said predetermined area of the bone using one or more dedicated anchors (110) threaded through said distal-end (101) and soft-tissue; (c) bending the proximal-end (102) of said repair device (100) respective to said distal-end (101) to align same with a different area of said bone’s surface; and (d) affixing said proximal-end (102) to said different area of the bone, thereby repairing said torn soft-tissue by affixing it to the bone using said repair device (100).
[050] In specific embodiments, the tissue is a tendon, and the soft-tissue repair device
(100) is a tendon repair device.
[051] In certain embodiments, the soft-tissue repair device (100) according to any of the embodiments above comprises one or more dedicated anchor hole(s) (103) in the distal- end (101) through which dedicated anchors can be threaded for affixing said distal-end
(101) and tom soft-tissue to the bone; and/or one or more dedicated anchor hole(s) (104) in the proximal-end (102) through which dedicated anchors can pass.
[052] In such cases when the device (100) does not comprise such dedicated anchor holes, the anchors can be pushed through the device at any point. Notably, even if the device does comprise such dedicated anchor holes, anchors can still be inserted to the bone (400) through the device (100) at locations other than such holes (103,104).
[053] In certain embodiments of the soft-tissue repair device (100) according to any of the embodiments above, one or more of said one or more dedicated anchor hole(s) (103,104) are multistage/multistep holes (1101) that can prevent undesired extraction of the anchor(s) (110,111) and provide firmer affixing of the device (100), and/or prevent formation of a bulge create a smooth.
[054] In certain embodiments, the device (100) according to any of the embodiments above, comprises one or more anchor holes (103,104). In specific embodiments thereof, said anchor holes (103,104) are multistep holes (1101), i.e., have a grove, niche, or recess designed to engulf the anchor’s head and thus enable flush installation of the anchor (i.e. without having the head of the anchor extending above the device’s upper surface) (Fig 11A). In further or alternative embodiments, the multistep holes (1101) enable an inclined installation of the anchor while minimizing or even eliminating the bulginess of the anchor’s head over the device’s upper surface (Fig. 11B).
[055] the anchor (110) is threaded inclined through multistep hole (1101) with its anchorhead (1110) resting against step (1101a) of the multistep hole (1101). Such angular threading/installation of the anchors (110,111) also prevents undesired extraction thereof and enables easier installation. In certain embodiments, the multistep holes (1101) are suitably sized to enable flush installation of the anchors (110,111) where the anchor-heads are entirely sunk therein thereby the anchor-heads are not higher then the upper surface of the device (100) to not interfere with, e.g., the acromion bone, thereby reducing the risk of irritating nearby tissues, such as the acromion, and facilitating the healing process.
[056] In further specific embodiments, the multistep hole (1101) allows insertion of anchors (110,111) through the device (100) and to the bone (400), via the soft-tissue (300), in an angled way (i.e., not perpendicular thereto) such that the anchor’s head is either completely or nearly completely below the upper surface of the device (100), thereby reducing the risk of irritating nearby tissues, such as the acromion.
[057] The term “spikes” as used herein refers to one or more projections/thorns set in or on a platform. The platform with the spikes may be referred to herein as a spike-based element or the device’s distal-end (101).
[058] In certain embodiments of the repair device (100) according to any of the embodiments above, the spikes (105) have a sharp/pointed edge/point that is designed to enable smooth and easy penetration of the spikes into a soft tissue, wherein the rest of the spike, namely its pole/body is blunt/dull so that it will not damage the soft tissue when force is applied thereon, e.g., when pulling or pressing.
[059] In certain embodiments of the repair device (100) according to any of the embodiments above, the area where the spikes (105) are present is referred to as a spikebased element, and the repair device further comprises a locking mechanism between said spike-based element and the anchor(s) passing through the distal-end of the device (100), wherein the locking mechanism is designed to prevent spontaneous pullout of the anchor(s) that pass therethrough for anchoring the device (100) to the bone (400). [060] In certain embodiments of the soft-tissue repair device (100) according to any of the embodiments above, the spikes (105) are arranged such that they distribute the pulling force applied onto the attached soft-tissue (e.g., between all of the spikes), thereby reducing the risk of damage to the soft-tissue and/or the risk of tearing/ripping the repair device off of the soft-tissue. In specific embodiments, this is achieved by providing an individual gripping point between each of said spikes and said soft-tissue, thereby distributing the pulling force applied on the soft-tissue between all of the gripping points.
[061] In certain embodiments of the repair device (100) according to any of the embodiments above, the spikes (105) are designed such that they can be inserted into the soft-tissue at a predefined angle, removed-therefrom if needed, e.g., to fix or adjust the binding of the device to the torn soft-tissue, minimizing any additional damage to the soft- tissue, and subsequently reinserted into the soft-tissue.
[062] In certain embodiments of the soft-tissue repair device (100) according to any of the embodiments above, the spikes (105) are: serrated, differential (in length, in distribution across the distal-end (101), and/or in diameter), personalized and/or perforated. The spikes (105) may even be differential for different patients. This differentially improves the securing of the repair device (100) to the soft-tissue. In further or alternative embodiments, the spikes (105) are claw -shaped. In further alternative embodiments, the spikes are positioned/fabricated at a predefined angle, i.e., at an angle other than 90° relative to the surface area of the distal-end (101). In several variants of the device (100), the spikes (105) may be asymmetrically distributed across the distal-end (101).
[063] In certain embodiments of the soft-tissue repair device (100) according to any of the embodiments above, the spikes (105) are: arranged gradually to spread the pulling forces applied thereon due to pulling of the soft-tissue, and/or roughed or barbed to prevent undesired release of the soft-tissue.
[064] In certain embodiments of the device (100) according to any of the embodiments above, the spikes (105) are not an upright position, i.e., have an angle other than 90° relative to their base. The spikes (105) may be in any desired angle relative to their base, e.g., from about 1° to about 179°, such as from about 80° to about 100°. In some embodiments, the spikes (10) are shaped according to the designated insertion movement pathway. Accordingly, the angle or curve of the spikes will correspond to the element most suitable for each use. [065] In certain embodiments of the soft-tissue repair device (100) according to any of the embodiments above, the spikes (105) are foldable and/or extractable, meaning that they can be flat against the device’s distal -end (101), such that they can be extended outwardly before use. This prevents unintentional damage to tissues during insertion of the device (100) into the body, enables easier insertion to the body, and simplifies storage thereof.
[066] In certain embodiments, the spikes (105) may be a cutout from the surface of the device and bend to their final shape, i.e., constituting an inherent part originating from the same "sheet"/"block" of material. Alternatively, the spikes (105) can originate from several individual elongated elements as separated rows of spikes, inserted into a platform and tightened/secured together in their final configuration. In both options, empty spaces are formed between the spikes, enabling the regeneration of the soft-tissue.
[067] In certain embodiments, the soft-tissue repair device (100) according to any of the embodiments above, comprises tissue-growth apertures (101a) forming a scaffold that enables tissue growth across therethrough. In alternative or added embodiments, the device (100) has a scaffold structure that enables tissue growth across therethrough. Such configurations assist in tissue healing and speed up the healing process.
[068] In certain embodiments of the repair device (100) according to any of the embodiments above, its distal-end (101) and/or its proximal-end (102), are composed-of or have a perforated structure that allows soft-tissue to grow therewithin. The perforated structure further allows liquid passage therethrough, e.g., to allow factors and tissue to grow into the perforations in the device (100). In specific embodiments, the device is constructed/manufactured by using powder metallurgy technology, or any other similar technology, to produce controlled porous structure formation to allow such soft-tissue ingrowth within the device, thereby improving the fixation of the device to the soft-tissue. In certain additional embodiments, the anchors (110) themselves are perforated to allow liquid passage therethrough, e.g., from the bone-marrow towards the torn soft-tissue, thereby further facilitating the healing process.
[069] In certain embodiments, the repair device (100) according to any of the embodiments above can be manufactured in any suitable way, such as by 3D printing to construct a personalized device for each patient (i.e. personalized medicine), e.g., based on the tom soft-tissue and the medical/physical characteristics of the patient. [070] Notably, the term “patient” as used herein refers to both humans and animals, and the device (100) and method of the invention are adopted or modified according to the patient.
[071] In certain embodiments, the repair device (100) according to any of the embodiments above, or any component thereof, is made of a biocompatible material(s) and/or biodegradable material(s). 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 co-polymers (including bioactive/biodegradable polymers/ co-polymers); ceramics; bio-glass polymers/ceramics or any combination thereof. In specific embodiments, the device (100) is made of a biodegradable material(s), which means that after the soft-tissue has been fully healed, and the device is no longer needed, there is no need to remove it, and it simply degrades in a non-harmful manner leaving behind a healed soft-tissue strongly anchored to the bone. In further specific embodiments, this applies also to the anchors (110).
[072] In certain embodiments, the repair device (100) according to any of the embodiments above constitutes or acts as a scaffold for growth of the soft-tissue, i.e., it provides support for the soft-tissue to grow on thereby facilitating healing. This means that after fixing the torn soft-tissue (300) to the bone (400), the soft-tissue grows into and/or onto the repair device (100) itself and thereby facilitates faster and better healing thereof. Non-limiting examples of such scaffold materials are bio-textiles.
[073] In certain embodiments, the repair device (100) according to any of the embodiments above, comprises and/or is coated with, supplementary materials, such as drug releasing materials, immunodepression/immunosuppressing materials, growth factors, stem cells, anti-inflammatory substance(s), healing/regeneration-mediated substances, hormones, tissue-generating materials, etc., for assisting in the soft-tissue repair and/or the fusion of the soft-tissue with the repair device and/or the target area/site or other part of the torn soft-tissue.
[074] In certain embodiments, the repair device (100) according to any of the embodiments above undergoes further processing, such as vibration finish and or electropolish, to smoothen sharp edges thereof, thereby reducing/eliminating possible damage to surrounding tissues during insertion of the device into the patient's body and/or when anchored to the bone. [075] Notably, the size and width of the repair device (100) according to any of the embodiments above can be adjusted according to need, e.g., according to the soft-tissue/ tendon’s size, soft-tissue/tendon’s rupture point, bone’s size, etc., or any combination thereof. Accordingly, in certain conditions, i.e., when the torn soft-tissue is large and has a relatively large surface area, a single repair device (100) might be insufficient to anchor it safely 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) may be used. In specific embodiments thereof, the wider repair device is capable of bending in the middle (in addition to its intermediate flexible region) to enable curving according to the bone’s surface. In further or alternative embodiments, the length of the repair device (100) can be modified, i.e., to make it longer or shorter according to need, thereby enabling a more efficient and accurate bridging of the distance between the soft- tissue and the bone.
[076] In certain embodiments, the repair device (100) according to any of the embodiments above is constructed in any shape and size. For instance, it can have a rectangle-, oval-, or square-shape, having a width of from about 1 to about 100 mm, and a length of from about 1 to about 100 mm. It should be noted that the shape and size of the repair device (100) are determined according to the specific soft-tissue being repaired and said soft-tissue’s individual characteristics. Accordingly, in certain embodiments, the size and shape of the repair device (100) and/or the spikes (105) are determined according to the specific patient being treated, the soft-tissue’s characteristics, the type of damage/ rupture, and patent's/tissue's specific anatomy, or any combination thereof.
[077] In certain embodiments, the repair device (100) according to any of the embodiments above is custom-made according to the patient's anatomy and/or the soft- tissue being repaired. In such a case, the device (100) is made in a desired width and length, as well as with specific positioning of the dedicated anchor holes (103,104) to enable a more secure and accurate anchoring thereof.
[078] To further assist and facilitate the healing process, a dedicated layer positioned at the anchoring point of the tom soft-tissue and the bone, may be used. Such a layer may have various characteristics and ingredients that are, e.g., designed to increase the healing process in any way, such as discharging growth-inducing materials, inflammation inhibitors, etc. Accordingly, in certain embodiments, the repair device (100) according to any of the embodiments above further comprises one or more layers (900) attached to a determined portion of one or more faces thereof. In specific embodiments, the layer(s) is a tissue-growth layer(s). In specific embodiments, one of said one or more layers (900) is disposed such that it is to be between a determined portion of the device’s distal-end (101) and the soft-tissue to be repaired thereby.
[079] In certain embodiments of the repair device (100) according to any of the embodiments above, the one or more layers (900): (i) are attached to selected portions at both sides of the device (100); (ii) are partially or entirely attached at their circumference; or (iii) is a sleeve-like layer covering both sides of the device (100) or the device’s distal- end (101).
[080] In certain embodiments of the repair device (100) according to any of the embodiments above, the layers (900), or at least one of said one or more layers (900), are: (i) made of biomaterial selected from the group consisting of: synthetic material, autograft, allografts, xenograft, or any combination thereof; (ii) provided with one or more threading apertures for threading said dedicated anchors; (iii) provided with one or more threading markups for guiding the threading of said dedicated anchors; (iv) exceeds the surface area of the device (100); (v) or coated with collagen or bone marrow.
[081] The layers (900) according to the invention can be made from any suitable material, and can even be any commercial available patch. For instance, in certain embodiments, the layers (900) are selected from the group consisting of: an augmentation mesh, an augmentation patch, a bio-inductive layer, and any combination thereof.
[082] In a third aspect, the present invention provides an arthroscopic tool (200) designed to attach a repair device (100) according to any of the embodiments above to a torn soft- tissue (300). In certain embodiments, the tool comprises: (a) a main handle (204); (b) a shaft (203) associated at one end to said main handle (204); and (c) a base arm (201) and a clamp (202) located at the other end of said shaft (203), wherein: the clamp (202) is designed to hold said repair device (100), and said base arm (201) comprises depressions or grooves that allow the spikes (105) of the repair device (100) to pass through without damaging being damaged; and the base arm (201) and clamp (202) are operable by a transmission means via said main handle (204) and designed to open and grasp a tip of the torn soft-tissue therebetween, and subsequently release the tip of the tom soft-tissue when needed. In specific embodiments thereof, the tool’s base arm (201) is retractable and extendable for exposing the grasped torn soft-tissue and attaching thereof to a bone.
[083] In certain alternative embodiments, the tool (200) comprises: (a) a main handle (204); (b) a shaft (203) associated at one end to said main handle (204); and (c) a base arm
(201) and a clamp (202) located at the other end of said shaft (203), wherein: said clamp
(202) is configured to hold said repair device (100), and said base arm (201) comprises depressions that allow spikes (105) of said repair device (100) to pass through (when in a closed clamp position) without being damaged; said base arm (201) and clamp (202) are operable by a transmission means via said main handle (204) and designed to open and grasp a tip of the torn soft-tissue therebetween for pulling thereof (while the spikes (105) penetrate the soft-tissue), and subsequently release the tip of the torn soft-tissue when needed; and the clamp (202) comprises an opening allowing anchor passage therethrough to the bone via said repair device (100) and the soft-tissue (300).
[084] In certain embodiments, the tool (200) according to any of the above embodiments is designed to hold one, two or more repair devices (100), optionally in a cartridge, thereby enabling attaching/using more than one device without extracting the tool out of the patient’s body.
[085] In certain embodiments, the tool (200) according to any of the embodiments above further comprises at least one of: an optic fiber, an illumination unit, forceps or any other grasping means, electromagnet, springs, pressure sensors, tension sensors, soft-tissue conveyor belt, or any other component that might be of use during surgery, or any combination thereof.
[086] In certain embodiments, the tool (200) according to any of the embodiments above further comprises a vibrating element or a vibration-generating unit, to facilitate penetration of the spikes (105) into the soft-tissue (300). Alternatively, such a vibrating element or a vibration-generating unit may be used to re-position the spikes (105) in the repaired soft-tissue, if the need arises.
[087] In specific embodiments, the tool (200) according to any of the embodiments above could be a fully- or partially- electromechanical device, and not only mechanical, and its operation may be controlled or completely performed (such as a robotic operation) by, e.g., a computer.
[088] In a fourth aspect, the present invention provides a kit comprising the arthroscopic tool (200) of the invention and one or more repair devices (100) according to any of the embodiments above. In specific embodiments, the kit or the repair devices (100) further comprise one or more tissue-growth layers (900) as described above.
[089] In a fifth aspect, the present invention provides a system for repairing a torn soft- tissue (e.g. a tendon), the system comprising the arthroscopic tool (200) of the invention, and one or more repair devices (100) according to any of the embodiments above. In specific embodiments, the system or the repair devices (100) further comprise one or more tissue-growth layers (900) as described above.
[090] In certain embodiments, the tool (200) according to any of the embodiments above can hold and deliver such layers (900) together with the repair devices (100).
[091] In a sixth aspect, the present invention provides a method for repairing a torn soft- tissue, said method comprising: (a) providing a repair device (100) according to any one of the embodiments above; (b) threading the spikes (105) of said repair device (100) through a preferred grip-site (501) within said torn soft-tissue, thereby grasping said soft- tissue by said distal-end (101) of said repair device (100); (c) pulling said device (100) to position said soft-tissue grasped thereby above a predetermined area of a bone and affixing said distal-end (101) with said soft-tissue grasped thereby to said predetermined area (502) of the bone using one or more dedicated anchors (110) threaded through said distal-end (101) and soft-tissue (300) without touching the articular cartilage; (d) bending the proximal-end (102) of said repair device (100) respective to said distal-end (101) to align same with a different area of said bone’s surface; and (e) affixing said proximal-end (102) to said different area of the bone, thereby repairing said torn soft-tissue by affixing it to the bone using said repair device (100). In specific embodiments, the soft-tissue is a tendon. In more specific embodiments, the tendon is a rotator cuff tendon.
[092] In certain embodiments, the above method further comprises a preliminary step of isolating said torn soft-tissue and/or determining a preferred grip-site (501) of the torn soft- tissue. The determination can be by any suitable means, such as MRI, the use of an internal camera that is optionally associated with an arthroscopic delivery tool, etc.
[093] In certain embodiments of the method according to any of the embodiments above: (i) the distal-end (101) of the repair device (100) comprises one or more dedicated anchor holes (103) and step (c) of affixing the distal-end (101) with the soft-tissue attached thereto to the bone is executed by threading anchors through said one or more dedicated anchor holes (103); and/or (ii) the proximal-end (102) of the repair device (100) comprises one or more dedicated anchor holes (104) and step (e) of affixing the proximal-end (102) to the bone (400) is executed by threading one or more dedicated anchor-screws (111) through said one or more dedicated anchor holes (104).
[094] Notably, the above method avoids touching or interfering with the articular cartilage.
[095] In certain embodiments of the method according to any of the embodiments above, the anchoring in steps (d) and (e) comprises a preliminary step of: (i) drilling holes in the bone, followed by the insertion of a suitable anchor through the device and into the drilled holes; or (ii) punching holes in the bone, followed by the insertion of a suitable anchor through the device and into the holes. Alternatively, when self-drilling or piercing (e.g., self-punching or self-tapping) anchors are used, the anchoring in steps (d) and (e) does not require any predrilling or punching holes, and the anchors are simply hammered or drilled directly into the bone. In specific embodiments, when the device (100) comprises dedicated anchor holes (103,104), the passing of the anchors through the device and into the bone may be through such dedicated anchor holes (103,104).
[096] In certain embodiments of the method according to any of the embodiments above, the anchors used to secure the distal-end (101) and the proximal-end (102) to the bone are selected from the group consisting of: anchor-nails inserted into the bone in different angles to improve grip, inflatable anchors, expandable anchors, staples (701), “all-suture” anchors, and any combination thereof.
[097] In certain embodiments, when the torn soft-tissue is significantly wider that the repair device (100) being used and more than one repair device (100) is needed, the method according to any of the embodiments above involves the use of more than one repair device
(100) on the same soft-tissue.
[098] In specific embodiments, the method according to any of the embodiments above comprises the steps of: (a) providing a repair device (100) according to any one of the embodiments above; (b) isolating said torn tendon and grasping a free edge of said torn tendon while attaching thereto the distal-end (101) of the tendon repair device via said spikes; (c) threading the spikes (105) of said repair device (100) through a preferred gripsite (501) within said torn soft-tissue, thereby grasping said soft-tissue by said distal-end
(101) of said repair device (100); (d) pulling said device (100) to position said soft-tissue grasped thereby above a predetermined area of a bone and affixing said distal-end (101) with said soft-tissue grasped thereby to said predetermined area (502) of the bone using one or more dedicated anchors (110) threaded through said distal-end (101) and soft-tissue (300) without touching the articular cartilage; (e) optionally bending or pre-bending the proximal-end (102) of said repair device (100) respective to said distal-end (101) to align same with a different area of said bone’s surface; and (f) affixing said proximal-end (102) to said different area of the bone, thereby repairing said torn soft-tissue by affixing it to the bone using said repair device (100).
[099] In certain embodiments, the method according to any of the embodiments above further comprises a preliminary step of removing some soft-tissue/tendon residues from the soft-tissue/tendon’ s footprint, i.e., its original attachment site to predetermined support such as the bone (per surgical/medical need).
[100] The absence of sutures between the soft-tissue and the bone (at the footprint site) leaves the contact area to be maximal and prevents physical interference of the sutures. Additionally, the sutures in existing methods tend to create air holes due to creating geometric distortion at the soft-tissue. On the other hand, the present repair device (100), with its spread spikes, reduces those distortions while creating a better contact area with the soft-tissue while spreading the pulling forces applied thereon, thereby improving the fixation of the soft-tissue to its underline bone.
[101] The entire method/procedure according to the invention should take much less operation time compared to known techniques currently being used, e.g., twice as fast, 3- times or even 4-times faster.
[102] The phrase “pulling said distal-end (101) to position said soft-tissue grasped thereby” as used herein refers to the pulling of the torn soft-tissue/tendon substantially along its line of original orientation/movement (rather than sidewise, diagonally, or vertically). Nevertheless, limited sidewise, diagonal, and/or vertical shifting may be required during the abovementioned pulling action.
[103] In certain embodiments of the method according to any of the embodiments above, the insertion of the repair device (100) into the patient's body is carried out while the device (100) is in a folded form, e.g., when the spikes (105) are folded or concealed, for instance when using the arthroscopic tool (200) according to any of the embodiments above. In this configuration, the spikes (105) are exposed or pup out when the device (100) is positioned near the soft-tissue. This reduces the risk of potential tissue damage during the insertion of the device into the patient's body. In alternative or added embodiments, the entire device (100) is folded, such that the spikes (105) are “covered” by the device’s proximal-end (102). [104] In certain embodiments of the methods according to any of the embodiments above, the step of pulling the soft-tissue back means pulling the soft-tissue/tendon back such that the device’s proximal-end (102) is positioned above the soft-tissue/tendon’ s original footprint.
[105] Contrary to current methods, in which the torn soft-tissue is pulled back to its original attachment site for anchoring into the bone using sutures, the instant method reduces the pulling back of the soft-tissue by using a repair device that enables balanced anchoring of the tom soft-tissue to its original attachment site without physically placing the tom soft-tissue at that site, so that no over-tension on the turn soft-tissue is applied. This dramatically improves mobility and comfort to the patient immediately after fixing the soft-tissue.
[106] Moreover, the repair device (100), in one of its potential configurations (e.g., Fig. 7C), could potentially provide supplemental length that reduces the distance that the repaired tissue is pulled (e.g., to restore its connection/attachment at the original attachment site), which reduces the tension load in the pulled tissue and, thus, further assists in providing improved mobility, faster healing, and improved fixation and anchoring capabilities while maintaining strong biomechanical support. Accordingly, in certain embodiments of the repair device (e.g., as illustrated in Fig. 7C), and contrary to currently used repair devices and techniques, which pull the tom soft-tissue using a suture wire back to its original attachment site on predetermined support such as the bone for anchoring thereto, the instant repair device (100) acts as an elongation bridge to thereby reduce the distance the soft-tissue need to be pulled towards the bone. This reduces the overall tension on the soft-tissue and thus potentially improves mobility and comfort to the patient. Moreover, the repair device of the invention may act as a bridge- scaffold and/or biodegradable bridge scaffold to allow tissue growth thereon and/or therein while keeping the soft-tissue in its physiological tension range, thereby facilitating the healing process and rehabilitation.
[107] In addition, in today’s methods, the soft-tissue is anchored essentially to one face of the bone using sutures or specific anchoring devices. This means that if a high mechanical pulling force is applied, the anchor might be pulled out of the bone. This is especially critical since the soft-tissue is pulled short for anchoring which increases the pulling forces applied on the anchoring point(s). Contrary to this, the stmcture of the repair device (100) of the invention is such that it is designed to be anchored to the bone on two different faces thereof, thereby enabling the device to withstand large bio-mechanical load until the soft-tissue fully recovers (which may take more than 8 months).
[108] Any type of anchor (110, 111) can be used in the method according to the invention, such as an orthopedic nail or screw. Accordingly, in certain embodiments of the method for repairing a torn soft- tissue according to any of the embodiments above, the anchors used to secure the distal-end (101) to the bone are (i) inserted into the bone (400) in different angles to improve grip as illustrated in Fig. 6B; (ii) inflatable anchors as illustrated in Fig. 6E; or (iii) expandable anchors as illustrated in Figs. 6C-6D; or any combination thereof. In specific embodiments of the method according to any of the embodiments above, at least one nail and at least one screw are used to anchor the repair device (100) to the bone (400).
[109] In certain embodiments, the anchor (110,111) being used is a pin, a nail or a screw, or any combination thereof. In specific embodiments, the anchor comprises a “cap” or head that is wider than the main body of the anchor, said head is designed to both prevent slipping of the device over the edge of the anchor, as well as to snap the device against the bone and increase anchoring strength.
[110] In 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) might not be sufficient to anchor it safely to the bone (400). In such cases, two or more repair devices (100) may be used in the method according to any of the embodiments above for anchoring the same soft-tissue. Alternatively, a single repair device (100) having a wider opening may be used. In specific embodiments thereof, the wider opening repair device is capable of bending in the middle (in addition to its intermediate flexible region) to enable curving according to the bone’s surface.
[111] In certain embodiments of the method according to any of the embodiments above, the steps of approaching the preferred grip-site, and the pulling of the distal-end (101), are performed along the same line of action.
[112] In certain embodiments of the method according to any of the embodiments above, the repair device (100) can be inserted into the patient's body during any surgical type, e.g., "open" surgery, arthroscopic surgery, or any other endoscopic surgery. In specific embodiments, the repair device (100) can be inserted into the patient's body either in an "open" form, or in a folded form, in which case the spikes are folded or not exposed during insertion but are spread/brought into an upright position to its final open operational geometry only inside the body at the desired assembly /attachment point.
[113] In certain embodiments, the method according to any of the embodiments above further comprises a step of attaching another (e.g., secondary) repair device (100) to another location and/or direction at the anchoring area or another nearby anchoring area.
[114] In certain embodiments, the method according to any of the embodiments above further comprises a step of using one or more layers (900), such as tissue-growth layer(s), attached to a determined portion of one or more faces of the repair device (100). In specific embodiments, the layer(s) is part of the repair device (100). In specific embodiments, one of said one or more layers (900) is disposed such that it is to be between a determined portion of the device’s distal-end (101) and the soft-tissue to be repaired thereby.
[115] In a seventh aspect, the present invention provides an arthroscopic delivery/insertion tool (200) for use in the method according to any of the embodiments above. The tool (200) is designed to contain/hold the repair device (100) according to any of the embodiments above, enable the user to grasp a tip of the torn soft-tissue, and attach thereto the repair device (100).
[116] The tool (200) according to any of the embodiments above 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 done, e.g., by sliding the lower base arm (201) thereby enabling attaching the device (100) and the soft-tissue attached thereto to the surface (502) of the bone without interference. Then, dedicated anchors (110) can be inserted through the device (100) and soft-tissue (300) and into the bone (400). Alternatively, the lower base arm (201) is constructed such that there is no need to slide it backwards, e.g., by having special engravings or grooves that enable attaching the device and soft-tissue attached thereto to the surface of the bone without interference.
[117] The devices (100), insertion tools (200) and methods according to the present invention enable the surgeon to achieve a reliable hold of the soft-tissue by only one insertion movement, while penetrating the soft-tissue in multiple points simultaneously. As such, the present invention provides many advantages over those of the prior art: faster and easier "all in one" device and tool that help the surgeon's actions become more accurate and less complicated to perform, giving the surgeon the ability to preview, grip, pull back and fixate the soft-tissue at a desired location in a simple procedure; allowing a preview of the attachment area selected by the surgeon; sparing additional sewing needed in vertical tears by including the entire vertical tear in the preview area; reducing re-tear rate by using balanced force distribution; and allowing optimal soft-tissue-bone contact area that is required for better and shorter healing period.
[118] Notably, all the definitions and embodiments above relating to the repair device (100), the arthroscopic delivery /insertion tool (200), and any method per se, apply mutatis- mutandis to one another, e.g., aspects associated with the repair device (100) are to be considered as referring to the arthroscopic tool (200) or method, and vise-versa.
[119] In the following detailed description, non-limiting embodiments of the present invention are discussed and illustrated, where references are made to accompanying drawings. These embodiments and accompanying drawings should be understood as nonlimiting examples of implementing the present invention. Furthermore, terms such as “optionally“, “for instance”, “for example”, “exemplary”, “e.g.,”, “may”, etc., refer to optional features being selected in certain embodiments of the invention for the sake of simplicity and clarity of explanation. It should be understood, however, that optional features mentioned in different embodiments may be used, in conjunction and/or separately, to implement further embodiments of the present invention.
[120] Figs. 2A-2B illustrate one possible configuration of a repair device (100), according to the invention. Device (100) comprises a distal-end (101) adapted with spikes (105) extending therefrom, as well as dedicated anchor holes (103) (one or more) through which dedicated anchors are threaded to secure device (100) and soft-tissue grasped thereby to predetermined support (e.g., an adjacent hard-tissue such as bone (400)). For example, in the case of Rotator Cuff Repair (RCR), the upper articular surface of the bone below may be considered as support (e.g., as illustrated in Figs. 4A-4B); a proximal-end (102) with a dedicated anchor hole (104) for securing the device (100) to the lateral surface of the bone; and an intermediate flexible region (106) to enable an effortless rotation of proximal-end (102) respective to distal-end (101), about a virtual X-axis (illustrated by a dashed line in Fig. 2B), thus, facilitating the adapted attachment of device (100) to a nonflat support. Notably, the length of the entire device (100) and/or of any of its sections (i.e., the distal-end (101), the proximal-end (102), and the flexible region (106)), as well as the size and number of and dedicated attachments and, correspondingly, attachment holes (103,104), may vary according to need and patient’s physiology. For instance, the device may be longer or wider, the flexible region (106) may be extended, the distal-end (101) may be longer and/or wider, etc., all according to need and physiological constraints. Furthermore, the types of dedicated attachments (110,111) may be determined according to the repaired tissue, the nature of the support to which the soft-tissue is attached, and the expected attachment load.
[121] Further shown in Figs. 2A-2B are tissue-growth apertures (101a) through distal- end (101) forming a mesh-like structure that enables tissue growth across the device (100). In certain embodiments the proximal-end (102) also comprises apertures (101a).
[122] Furthermore, spikes (105) may be serrated, and comprise marginal teeth (105a) to ensure its unidirectional threading through the soft- tissue grasped thereby. It should be readily understood that the external surface of spikes (105) is sufficiently blunt and free of any sharp edges that may possibly damage soft-tissues. In certain embodiments, the spikes (105) are inclined at an angle of less than 90° in an angle opposite to the pulling direction of the soft-tissue (300), to resist the internal tension load in the soft-tissue/tendon (300) and prevent undesirably or spontaneous release/pullout of the spikes (105) from the soft- tissue and thus prevent the release of the grasp of the device (100). The spikes (105) may also be designed with claw-like curved shapes that enable smooth threading thereof into the soft-tissue/tendon (300), e.g., as discussed in Figs. 5B-5C. Nevertheless, the spikes (105) may be differently shaped, for example, as rearward inclined cones or other shapes that support its non-damaging insertion through a tendon/soft-tissue (300) and the firm grasp thereof by the device (100).
[123] In different applications of the device (100) according to any of the embodiments above, different variants thereof may be selected, comprising different numbers, shapes, and sizes of attachment holes (103,104) and spikes (105), to constitute sufficient loading distribution across the soft-tissues repaired thereby, while providing firm grasp of the soft- tissue by the device (100), and firm affixing of the device (100) to a predetermined support. Furthermore, the holes (103,104) may comprise one or more multistep anchor-head cavities (1101) to enable a flush installation of the anchors (110,111).
[124] Fig. 3 illustrates one possible configuration of a delivery tool (200), according to the invention, for performing the tissue-repair method of the invention to repair a tom soft- tissue using the repair device (100) of the invention, for instance, under a standard arthroscopic maneuver. As illustrated, the delivery tool (200) may comprise a base arm
(201), and a clamp (202) utilized for the delivery and attachment of device (100). Clamp
(202), and base arm (201) are operable by transmission means that are threaded through a delivery shaft (203) and are operated by the user of the delivery tool (200) who manipulates various actuators installed in the main handle (204) of delivery tool (200). The actuators include a clamp actuator (205), that when pressed causes the tool’s clamp (202) to rotate upwardly respective to base arm (201). The clamp (202) remains pressed-locked (i.e., correspondingly clamp (202) remains in its rotated state) using a ratchet mechanism (206), which may be released by pressing a release button (205a) of the clamp actuator (205). The tool’s lower base arm (201) can be retracted and extended by operating a lever (207).
[125] Notably, although a mechanical device is illustrated herein, it is noted that the device can be electronic, and all moving parts, such as the levers and actuators, may be electric and operated by the press of a button.
[126] It should be noted that although the base arm (201) can be retracted, an alternative delivery tool (200) can be used in which the base arm (201) is not retractable.
[127] In certain embodiments, the clamp (202) further comprises one or more temporal clinging elements for holding the device (100) at a predetermined attachment force and releasing the device (100) as the predetermined attachment force is exceeded, for instance, where the device (100) is firmly attached to the bone (400) (as further discussed in Figs. 5A-5H). In alternative or additional embodiments, the device (100) itself further comprises alternative or corresponding temporal clinging elements designed to interact with the clamp (202) to prevent its falling thereof until the device (100) is anchored to the bone. Fig. 3 further shows an anchor access aperture (208) in the clamp (202), designed to enable fastening an anchor through the soft-tissue (300) and the device (100), as further explained in reference to Fig. 5E.
[128] Figs. 4A-4B and 7A-7C illustrate an exemplary repair of a rotator cuff tendon (300) using a repair device (100) according to an embodiment of the present invention. In Figs. 4A-4B and 7A-7C two anchor-nails (110) secure the distal-end(s) (101) of the device (100) to the footprint area on the articular surface of a bone (400) without touching the articular cartilage, and a single anchor-screw (111) secures the proximal-end(s) (102) to the bone’s lateral surface. As seen, Figs. 4A-4C illustrate the use of a single repair device (100), whereas Figs. 7A-7C illustrate the use of two repair devices (100) placed one next to the other to secure a larger/wider soft-tissue, or for supporting higher tension loads within the remaining length of the soft-tissue that has to be stretched before being affixed to the bone (400).
[129] Each anchor-nail (110) is independently anchored (i.e., to the bone) to maximize the fixation stability, thus, preventing undesired detachment or movements of the affixed tissue, and, thus, shorten the healing process. While a single anchor-nail (110) may suffice, in certain embodiments two (or more) anchor-nails are used, one of which is intended to carry the significant attachment load, while the second one provides supplemental stabilization. In another embodiment, one or both anchor-nails (110) and/or anchor-screw (111) are made of biodegradable materials that disperse along the repaired tissue healing process.
[130] Figs. 5A-5H illustrate an exemplary torn soft-tissue repair method steps performed for repairing a rotator cuff tendon (300), according to an embodiment of the invention. The tendon repair is performed by repositioning and affixing the tip/edge portion of the disconnected/tom tendon at its original footprint, namely its original attachment site (502) on the bone (400). Furthermore, the tendon repair procedure may be performed in an arthroscopic procedure while using a delivery tool (200) to carry the repair device (100) of the invention toward the edge of the tip of the torn tendon (300), grasp, pull, and reposition the same at its original footprint, and to affix the tendon (300) thereat. Figs. 8A and 8B provide block diagrams that illustrate similar and alternative steps of repairing a torn soft- tissue using the repair device (100) of the invention.
[131] According to certain embodiments of the invention, the tendon repair procedure begins with the surgeon determining a preferred grip-site (501) of the torn tendon (300) (Fig. 5A) (e.g., an adequate portion of the soft-tissue). The surgeon maneuvers delivery tool (200) holding the device (100) toward the grip-site (501), rotates a clamp (202) with the device (100) attached thereto upwardly (Fig. 5B), and clamps the tendon (300) at the grip-site (501) by re-engaging the clamp (202) and base arm (201) (e.g., by pressing a release button (205a)), during which the device’s spikes (105) thread through the tendon (300) and grasps the same preventing it from moving. Then, the surgeon may verify a proper grasp of the grip-site (501) and perform adjustments if needed.
[132] Spikes (105) penetrate the soft-tissue’s grip-site (501) in a fixed movement according to the spikes' shape/angle/radius and according to the movement angle of the clamp (202). The fixed movement of the clamp (202) guides the spikes into the soft-tissue. In certain embodiments, the driving force used for the insertion of the spikes (105) into the soft-tissue (300) is applied gradually, to limit the puncturing of the soft-tissue at the gripsite (501). Such controlled driving force may be provided by suitable driving mechanisms, such as, but not limited to, a spring of a predetermined spring factor, a hydraulic, electric, or electromagnetic driving unit integrated within the delivery tool (200).
[133] Upon verifying a firm grasp of the tendon (300) by the device’s distal-end (101), the surgeon pulls the delivery tool (200) to position the device (100) and tendon (300) grasped thereby above the intended re-attachment site, such as footprint/attachment site (502) of the tom tendon (300) on the bone (400) (Fig. 5C) (marked with a dotted square). In certain embodiments, the surgeon then withdraws the delivery tool’s base arm (201) to clear out access for the tendon to the footprint (502) (Fig. 5D) and enable uninterrupted descending of the tendon (300) thereon. In certain embodiments, the delivery tool (200) is designed to enable attachment of the tom soft-tissue to the bone without the need to withdraw the tool’s base arm (201). In such embodiments, the step of withdrawing the tool’s lower section (i.e., base arm (201)) is not required, and the surgeon simply attaches the tom soft-tissue to the bone (400) after pulling it to the desired position/location.
[134] Next, the surgeon (optionally) drills holes in the bone’s upper surface through the anchoring access aperture (208) (further shown in Fig. 3) and optionally through the anchor holes (103) (if present) and then installs dedicated anchor-nails (110) therethrough that also thread through hole(s) (103) of distal-end (101) and the grasped soft-tissue into the bone (Fig. 5E). The above drilling and anchor installation may be performed by suitable drilling and anchoring tools (i.e., according to the selected types of anchors (110,111)).
[135] During the above pulling action of the tendon (300) and the device (100), both are clamped between the clamp (202) and base arm (201) of the delivery tool (200) thus a great portion of the pulling load, or its entirety, is transferred to the tendon (300) as a distributed friction/force and compression rather than a pure shear load that would be transferred thereto if pulled solely by the spikes (105). Furthermore, in those embodiments that include withdrawal of the base arm (201) before the affixing of the tendon (300) onto the bone (400), for a short period, a distributed pulling load is applied on the tendon (300) by the spikes (105). In this case, the temporary grasp of the tendon (300) by the spikes (105) is obtained by a predetermined blunt shape, size, and number of the spikes (105). In this manner, the puncturing size and tensioning of the grasped portion of the tendon (300) are minimal. [136] Now that the tendon (300) and distal-end (101) are affixed to the bone, the clamp (202) is being rotated upwardly to release the device (100) from the delivery tool (200) (Fig. 5F), and the device’s proximal-end (102) is bent as required to align the same with the bone’s curve (Figs. 5G and 5H) at the bone’s lateral surface. Then, the surgeon (optionally) drills again (one or more holes according to need) through the dedicated anchor holes (104) in the proximal-end (102) and threads anchor-screw(s) (111) to secure the device’s proximal-end (102) to the bone’s lateral surface (Fig. 5H), thereby completing the affixing of the device (100) with the grasped soft- tissue to bone (400).
[137] It should be noted that the above method steps illustrated in Figs. 5A-5H can be modified according to need. For instance, if self-penetrating anchors are used, there is no need for drilling or punching preliminary holes in the bone. Also, if the device (100) does not comprise dedicated anchor holes (103,104), the passage of the dedicated anchors (110,111) can be carried through the device’s body, namely, the device (100) may comprise premade holes (103,104), or anchor-permeable portions, or may be entirely made of anchor-permeable materials. Optionally, a device (100) that does not comprise such dedicated anchor holes (103,104) may comprise drilling marking(s) that mark the intended drilling locations thereon.
[138] It should be readily understood by a person skilled in the art that the method illustrated in Figs. 5A-5H may be implemented similarly to reconnect/reattach multiple different types of soft-tissues to various types of predetermined supports. For example, to repair different torn tendons and other tissues to different bones or artificial implants connected thereto.
[139] Fig. 51 shows the final positioning of the device (100) on the bone (without the torn tendon) illustrating the footprint attachment site (502) to which the device (100) is anchored, as well as the articular cartilage area (grey area on the right (503)) that remained unaffected/untouched by the device (100). Non-limiting examples of footprint attachment sites (502) are the subscapularis, supraspinatus, and infraspinatus areas.
[140] It can be noted that, except for the threading of anchors (110, 111), the tendon repair process described in Figs. 5A-5H is performed along a single line of action that corresponds to the pulling direction of the tendon/soft-tissue (300) toward its footprint/original connection site (502) on the bone (400). In this manner, the surgeon is required for non-cumbersome maneuvering of the delivery tool (200) towards the grip-site (501) and, in turn, backward to the footprint/original connection site (502). Furthermore, the lateral line of action of the engagement, grasping, and pulling of the tom tendon (300) maintains clearance above the repairing scene, thus, enabling orthogonal insertion of drilling and anchoring tools, and facilitating a clear view of the torn tendon (300) (e.g. from above or front), such as by an orthogonally inserted arthroscopic camera. Moreover, in certain cases, the spikes (105) may protrude across the tendon (300). Particularly in such cases, the pulling action of the tendon (300), while being clamped between the clamp (202) and base arm (201) prevents undesirable engagement between the spikes (105) and the surrounding tissues.
[141] Figs. 6A-6J illustrate various possible anchors/pins (110) that can be used for anchoring the repair device (100) of the invention to a bone (400): Fig. 6A illustrates two anchor-nails (110) that are inserted in parallel to one another; Fig. 6B illustrates two anchor-nails (110) that are inserted in an angle relative to one another to improve stability and sturdiness of the device’s grip in the bone. Fig. 6C, 6D, and 6E illustrate the potential use of different types of anchors that will allow liquid flow within the anchor from the Humerus Bone marrow. Under the capillary mechanism, bone marrow fluids can flow through the anchor's hole upwards' toward the bone/tendon surface, increasing the healing potential of the torn tissue.
[142] Figs. 6G-6J illustrate expandable anchors/pins (interchangeable with anchor-nails (110) and anchor-screws (111)) that expand after or upon insertion to strengthen their anchoring capabilities and prevent their pullout from the bone. Furthermore, utilizing the expandable anchors/pins of a given diameter may replace equivalent (in terms of fastening strength) bulkier non-expendable anchors/pins of wider diameter and, hence, require smaller anchoring holes through the soft-tissue/tendon (300).
[143] In certain embodiments of the repair device (100) according to any of the embodiments above, the spikes (105) and or the pins (110) have grooves or barbes, and/or are roughed to increase their pullout force thereby reducing the risk and preventing undesired release of the soft-tissue and thus prevent the release of the soft-tissue from the device (100).
[144] Figs. 7A-7C illustrate a situation in which two (or more) repair devices are used for anchoring a large tendon to the bone. This can be done using a dedicated delivery tool (200) that either places one repair device after the other, or places both repair devices simultaneously. [145] Repair device (100) is illustrated herein above as being intended for pulling and affixing a torn soft-tissue towards its original attachment site. Nevertheless, in certain cases, the torn tissue is too short and cannot be pulled to its original attachment site, a longer device (100) may be utilized, thereby providing bridging between a shortened portion of the tom soft-tissue and the original attachment site, thereby reducing the extent to which the shortened soft-tissue needs to be pulled and, thus, reducing the tension induced by its pulling, such as illustrated in Fig. 7C. Such use of a bridging repair device (100) is highly advantageous, for instance, where the tendon (300) is significantly retracted from the original attachment site, hence pulling the edge of the retracted tendon to the original attachment site may induce excessive tension in the tendon which will reduce mobility, increase pain, and prolong the healing process. Notably, in such a case (as illustrated in Fig. 7C), there might not be a need to use anchors or spikes passing through the distal-end (101) since it will not necessarily be positioned above the bone, and the tom soft-tissue will be held solely by the spikes (105) and the device will be anchored only via its proximal-end (102).
[146] Further shown in Fig. 7C are staples (701) that may be used in lieu or in conjunction with any of anchors (110, 111).
[147] In certain embodiments, the device (100) according to any of the embodiments above may also be provided with augmentation capabilities, where one or more layers (e.g., having similar or different layer thicknesses of 0.01-0.5 millimeters) are attached to predetermined portions of one or more of its faces. The abovementioned layers may be provided as an augmentation mesh/patch and/or bio-inductive layer for facilitating and aiding in tissue growth, and thereby enhancing the healing process.
[148] Figs. 9A-9C illustrate the use of such (tissue-growth) layers (900) with the distal- end (101) of device (100), for the repair of a soft-tissue (300). In Fig. 9A the tissue-growth layers (900) (interchangeably referred to herein as “patch(es)”) are attached to the bottom surface of distal-end (101), thus, being positioned between devices (100) and the grip-site (501) of the repaired soft-tissue (300). It should be noted that although the layers (900) are illustrated as having a surface area larger than the device’s distal-end (101), the layer can have a surface area that is equal or smaller than the device’s distal-end (101). Alternatively, as illustrated in Fig. 9B, the tissue-growth layers (900) are utilized at both faces of the distal-end (101) and may be provided in the form of sleeves that encompass the devices (100), thereby encouraging accelerated growth of tissue from both sides thereof and, thus, can facilitate shorter healing of the repaired soft-tissue (300). Figs. 10A-10B provide sideview illustrations of such layers: either as a single layer below the device’s distal-end (Fig. 10A), or as a sleeve covering it completely (Fig. 10B).
[149] Optionally, the size of tissue-growth layers (900,900a) may exceed the surface area of the device (100), as illustrated in Fig. 9C, such as in cases of a partially tom soft-tissue (300) or when the re-attachment of the torn tissue does not require the use of two (or more) devices (100). In such cases, the exceeding portion of the tissue-growth layer (900,900a) is intended to provide augmentation of the entire area of the tom soft-tissue (300) and attached thereto by suitable attachments (910). While a sleeve patch (900a) is shown in Fig. 9C, it should be readily realized that the illustrated configuration may also be implemented by utilizing a single tissue-growth layer (900) which exceeds the surface area of the device (100).
[150] Furthermore, in certain embodiments the layer (900,900a) may cover only part of the surface area of a determined surface of the device (100), for instance, to encourage tissue-growth only near the distal-end (101).
[151] The patch/layers (900,900a) may be produced from materials that are permeable to dedicated anchors (e.g., any of the anchors threaded through holes (103,104)) for enabling an effortless attachment thereof to the determined support (e.g., bone (400)). In an embodiment, the layers (900,900a) comprise pre-made apertures aligned with the holes (103,104). Supplemental apertures in the layers (900,900a) may be added, suitably sized to support an increased tissue growth rate in certain cases. Optionally, the layers (900,900a) may include one or more guiding markings that indicate the drilling/threading point for anchor-nails (110) and/or anchor-screws (111), particularly where tissue-growth layers (900,900a) are attached at both faces of the distal-end (101) (as illustrated in Fig. 9B).
[152] The attachment of the layers (900,900a) to the device (100), to each other, or to soft-tissue (300), may be obtained by various attachment means such as by a suitable heat source, sutures, bio-compatible glue, and different combinations thereof. The specific attachment manner may be selected by an artisan as suitable for specific conditions and applications of the present invention. Alternatively, no physical attachment is needed, and the layer (900) is simply deposited on the device (100).
[153] As illustrated in Figs. 11A-11B the dedicated anchor holes (103,104) of the device (100) according to any of the embodiments above are implemented as multistep holes (1101) (also referred to as anchor-head cavities or recesses) that enable angular threading of anchors (110,111) therethrough. As illustrated, while in Fig. 11A the anchor (110) is threaded straight downwardly, in Fig. 11B the anchor (110) is threaded inclined through multistep hole (1101) with its anchor-head (1110) resting against step (1101a) of the multistep hole (1101). For the sake of brevity, a single multistep hole (1101) is illustrated in Fig. 11B as implemented in lieu of the hole (103). Nevertheless, it should be readily realized that multistep holes (1101) may be implemented instead of any anchor holes (103,104). The angular threading of anchors (110,111) prevents undesired extraction thereof and enables a flexible range of installation. In certain embodiments, multistep holes (1101) are suitably sized to enable flush installation of the anchors (110,111) where the anchor-heads are entirely sunk therein thereby the anchor-heads are not higher then the upper surface of the device (100) to not interfere with, e.g., the acromion bone, thereby reducing the risk of irritating nearby tissues, such as the acromion, and facilitating the healing process.
[154] In certain embodiments, the multistep hole (1101) allows insertion of an anchor (110,111) to the device (100), the soft-tissue (300), and bone (400), in an angled way (i.e., not perpendicular thereto) and in such manner that the upper part of the anchor will either be completely or almost completely below the upper surface of the device (100), thereby reducing the risk of irritating nearby tissues, such as the acromion.