EP-4739222-A2 - SOFT TISSUE REPAIR DEVICES, SYSTEMS, AND METHODS

Abstract

The present invention provides methods, devices and systems for repairing a torn soft-tissue, such as a tendon, while allowing better contact between the torn soft-tissue and the bone, for a better healing process.

Inventors

• MALLAYEV, Itzhak
• SCHEINOWITZ, MICKEY
• HARARI, SHAHAR

Assignees

• STFIX MEDICAL LTD.

Dates

Publication Date

20260513

Application Date

20240703

Claims (1)

1. CLAIMS 1. A soft-tissue repair device (100) for use in repairing a tom soft-tissue, the device (100) comprises: 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 configured to be anchored to a first plane of a bone with dedicated anchors that pass therethrough; and - said proximal-end (102) is configured to be anchored to a different plane of the same bone with a dedicated anchor that passes therethrough. 2. The repair device of claim 1, wherein a length of said spikes (105) is shorter or equivalent to the soft-tissue’s thickness, thus allowing only penetration into said soft-tissue without exiting thereof and damaging the bone. 3. The repair device of claim 1, further comprising an intermediate flexible region (106) that enables rotation of said proximal-end (102) respective to said distal-end (101). 4. The repair device of claim 1, wherein the device is made of flexible material. 5. The repair device of claim 1, further comprising one or more clinging elements designed to enable holding the device (100) by a delivery tool. 6. The repair device of claim 1, wherein said device (100) 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 torn soft-tissue to the bone; and/or one or more dedicated anchor hole(s) (104) in the proximal-end (102). 7. The repair device of claim 6, wherein one or more of said one or more dedicated anchor hole(s) (103,104) are multistep holes (1101). 8. The repair device of claim 1, wherein the spikes (105) are serrated, roughed, or barbed, to prevent undesired release of the soft-tissue. 9. The repair device of claim 1, wherein said device (100) comprises tissue-growth apertures (101a) forming a scaffold that enables tissue growth across therethrough. 10. The repair device of claim 1, wherein said device (100) has a scaffold structure that enables tissue growth across therethrough. 11. The repair device of claim 1, wherein said distal-end (101) and/or said proximal-end (102) have a perforated structure to allow growth of said soft-tissue therewithin. 12. The repair device of claim 1, wherein one or more components of said device (100) are made of a biodegradable material. 13. The repair device of claim 1, wherein said device (100) is made of a biocompatible material(s) or biodegradable material(s). 14. The repair device of claim 1, wherein said device (100) or at least a part thereof comprises a drug releasing material(s). 15. The repair device of claim 1, wherein said device (100) is coated, e.g., with drugreleasing material(s), healing/regeneration-mediated substances, immunosuppressant material(s), growth factors, stem cells, and/or anti-inflammatory substance(s). 16. The repair device claim 1, which is costume-made according to a patient's anatomy. 17. The repair device of claim 1, wherein said spikes (105) are arranged such that they distribute the pulling force applied onto the attached soft-tissue, 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. 18. The repair device of claim 17, wherein said spikes (105) are arranged gradually to distribute the pulling force applied on the soft-tissue. 19. The repair device of claim 1, wherein said spikes (105) are claw-shaped. 20. The repair device of claim 1, wherein said spikes (105) are differential, personalized and/or perforated. 21. The repair device of claim 1, wherein said spikes (105) are asymmetrically distributed across the distal-end (101). 22. The repair device of claim 1, wherein said spikes (105) have a sharp/pointed edge/point to enable penetration into a soft tissue, and a blunt pole/body that does not damage the soft tissue when force is applied thereon. 23. The repair device of claim 1, further comprising one or more layers (900) attached to a determined portion of one or more faces thereof. 24. The repair device of claim 23, wherein 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. 25. The repair of claim 23, wherein said one or more layers (900) are attached to selected portions at both sides of the device (100). 26. The repair device of claim 25, wherein the one or more layers (900) are partially or entirely attached at their circumference. 27. The repair of claim 23, wherein said one or more layers (900) is a sleeve-like layer covering both sides of the device (100) or the device’s distal-end (101). 28. The repair device of claim 23, wherein said one or more layers (900) are tissue-growth layers. 29. The repair device of claim 23, wherein the layers are made of biomaterial selected from the group consisting of: synthetic material, autograft, allografts, xenograft, or any combination thereof. 30. The repair device of claim 23, wherein at least one of said one or more layers (900) is provided with one or more threading apertures for threading said dedicated anchors. 31. The repair device of claim 23, wherein at least one of said one or more layers (900) is provided with one or more threading markups for guiding the threading of said dedicated anchors. 32. The repair device of claim 23, wherein at least one of said one or more layers (900) exceeds the surface area of the device (100). 33. The repair device of claim 23, wherein said one or more layers (900) are selected from the group consisting of: an augmentation mesh, an augmentation patch, a bio-inductive layer, and any combination thereof. 34. The repair device of claim 23, wherein said one or more layers (900) is coated with collagen or bone marrow. 35. An arthroscopic tool (200) for installing a repair device (100) of claim 1 to repair a torn soft-tissue (300), said 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: 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 tom soft- tissue therebetween for pulling thereof (while the spikes (105) penetrate the soft-tissue), and subsequently release the tip of the tom 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). 36. The arthroscopic tool (200) of claim 35, wherein the tool’s base arm (201) is retractable and extendable for exposing the grasped tom soft-tissue and attaching thereof to a bone. 37. A kit comprising the arthroscopic tool (200) of claim 35 and one or more repair devices (100) of claim 1. 38. A method for repairing a torn soft-tissue, said method comprising: a) providing a repair device (100) according to claim 1; b) determining a preferred grip-site (501) of said torn 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 tom soft-tissue by affixing it to the bone using said repair device (100). 39. The method of claim 38, wherein said soft-tissue is a tendon. 40. The method of claim 38, wherein the distal-end (101) of said 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 dedicated anchors through said one or more dedicated anchor holes (103). 41. The method of claim 38, wherein the proximal-end (102) of said 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 anchors (111) through said one or more dedicated anchor holes (104). 42. The method of claim 38, wherein the anchoring in steps (d) and (e) comprises a preliminary step of drilling holes in the bone, followed by the insertion of a suitable anchor through the device and into the drilled holes. 43. The method of claim 38, wherein the anchoring in steps (d) and (e) comprises a preliminary step of punching holes in the bone, followed by the insertion of a suitable anchor through the device and into the holes. 44. The method of claim 38, wherein 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. 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 approaching preferred grip- site of step (b) and the pulling of said distal-end (101) of step (c), are performed along the same line of action. 47. Use of the repair device (100) of claim 1 for repairing a tom soft-tissue by: a) determining a preferred grip-site of said torn 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 tom soft-tissue by affixing it to the bone using said repair device (100). 48. The repair device (100) of claim 1 for use in repairing a tom soft-tissue by: a) 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); 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 tom soft-tissue by affixing it to the bone using said repair device (100).

Description

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