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Title:
TENDON CONNECTORS AND SYSTEM FOR USE
Document Type and Number:
WIPO Patent Application WO/2020/234855
Kind Code:
A1
Abstract:
The present disclosed subject matter is directed to a connector and system of these connectors, for connecting tissues such as torn, severed, or ruptured tendons. The connector comprises: a body including oppositely disposed first and second ends and laterally dispose sides, and each of the laterally disposed sides including at least one lateral spike, the at least one lateral spike moveable between a first position, where each of the at least one lateral spikes is substantially flush with a respective lateral surface of the body, and a second position, where each of the at least one lateral spikes extends outward, so as to protrude from the respective lateral side of the body.

Inventors:
KHOURY BASHIR (IL)
MENIS MICHAEL (IL)
KAHANA SHAY (IL)
Application Number:
PCT/IB2020/054941
Publication Date:
November 26, 2020
Filing Date:
May 25, 2020
Export Citation:
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Assignee:
EQUINDON LTD (IL)
International Classes:
A61B17/11; A61B17/00; A61B17/04; A61B17/06; A61F2/02; A61F2/08
Foreign References:
US20090216326A12009-08-27
US20110125188A12011-05-26
US20050085833A12005-04-21
Attorney, Agent or Firm:
FRIEDMAN, Mark (IL)
Download PDF:
Claims:
CLAIMS:

1. A tissue connector comprising:

a body including oppositely disposed first and second ends and laterally disposed sides, and each of the laterally disposed sides including at least one lateral spike, the at least one lateral spike moveable between a first position, where each of the at least one lateral spikes is substantially flush with a respective lateral surface of the body, and a second position, where each of the at least one lateral spikes extends outward, so as to protrude from the respective lateral side of the body.

2. The tissue connector of claim 1, wherein the body additionally comprises:

an upper side and a lower side, oppositely disposed with respect to each other; and,

at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike moveable between a first position, where the at least one longitudinal spike is between planes defined by upper and lower surfaces of the body, the upper and lower surfaces extending along the respective upper and lower sides of the body, and a second position, where the at least one longitudinal spike extends outward, so as to protrude from at least one of the upper side of the body or the lower side of the body.

3. The tissue connector of claim 1, wherein the body is made of a shape memory material, and the first position and the second position for each of the at least one lateral spikes is trained into the body.

4. The tissue connector of claim 2, wherein the body is made of a shape memory material, and the first position and the second position for each of the at least one lateral spikes is trained into the body, and, the first position and the second position for the at least one longitudinal spike is trained into the body.

5. The tissue connector of claims 3 and 4, wherein the shape memory material includes Nitinol.

6. The tissue connector of claim 1, wherein the at least one lateral spike on each of the lateral sides of the body includes a plurality of lateral spikes on said each of the lateral sides of the body.

7. The tissue connector of claim 6, wherein the at least one longitudinal spike includes a plurality of longitudinal spikes.

8. The tissue connector of claim 7, wherein the body is made of a shape memory material, and the first position and the second position for each of the lateral spikes is trained into the body, and, the first position and the second position for the longitudinal spikes is trained into the body.

9. The tissue connector of claim 8, wherein the shape memory material includes Nitinol.

10. The tissue connector of claims 1 and 2, wherein the first end includes a rounded head. 11. The tissue connector of claims 1 and 2, wherein the second end includes at least one aperture extending through the body.

12. The tissue connector of claim 1, wherein a longitudinal axis extends through the body and is centrally located with respect to the lateral sides of the body, such that the connector is symmetric about the longitudinal axis.

13. The tissue connector of claim 2, wherein a longitudinal axis extends through the body and is centrally located with respect to the lateral sides of the body and the upper and lower sides of the body, such that the connector is symmetric about the longitudinal axis.

14. A tissue connector comprising:

a body including oppositely disposed first and second ends and laterally disposed sides, and each of the laterally disposed sides including at least one lateral spike extending outward, so as to protrude from the respective lateral side of the body.

15. The tissue connector of claim 14, wherein the body additionally comprises:

an upper side and a lower side, oppositely disposed with respect to each other; and,

at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike protruding from at least one of the upper side of the body or the lower side of the body.

16. The tissue connector of claim 14, wherein the at least one lateral spike on said each of the laterally disposed sides includes a plurality of lateral spikes.

17. The tissue connector of claim 15, wherein, the at least one lateral spike on said each of the laterally disposed sides includes a plurality of lateral spikes, and, the at least one longitudinal spike includes a plurality of longitudinal spikes.

18. A tissue connector comprising:

a body including oppositely disposed upper and lower sides; and,

at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike moveable between a first position, where the at least one longitudinal spike is between planes defined by upper and lower surfaces of the body, the upper and lower surfaces extending along the respective upper and lower sides of the body, and a second position, where the at least one longitudinal spike extends outward, so as to protrude from at least one of the upper side of the body or the lower side of the body.

19. The tissue connector of claim 18, wherein the body is made of a shape memory material, and, the first position and the second position for the at least one longitudinal spike is trained into the body.

20. The tissue connector of claim 19, wherein the shape memory material includes Nitinol. 21. The tissue connector of claim 20, wherein the at least one spike includes a plurality of longitudinal spikes.

22. A tissue connector comprising:

a body including an upper side and a lower side, oppositely disposed with respect to each other; and,

at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike protruding from at least one of the upper side of the body or the lower side of the body.

23. The tissue connector of claim 22, wherein the at least one longitudinal spike includes a plurality of longitudinal spikes.

24. A method for connecting tissue comprising:

obtaining a first tissue connector comprising:

a body including oppositely disposed first and second ends and laterally disposed sides, and each of the laterally disposed sides including at least one lateral spike, the at least one lateral spike moveable between a first position, where each of the at least one lateral spikes is substantially flush with a respective lateral surface of the body, and a second position, where each of the at least one lateral spikes extends outward, so as to protrude from the respective lateral side of the body;

placing the first tissue connector, with said each of the at least one lateral spikes in the first position, into a syringe proximate to a first tissue portion; and,

pushing the first tissue connector out of the syringe and into the first tissue portion, with the first end of the body being the leading end, such that upon contact with the first tissue portion, each of the at least one lateral spikes moves from the first position to the second position.

25. The method of claim 24, additionally comprising:

obtaining a second tissue connector comprising:

a body including oppositely disposed first and second ends and laterally disposed sides, and each of the laterally disposed sides including at least one lateral spike, the at least one lateral spike moveable between a first position, where each of the at least one lateral spikes is substantially flush with a respective lateral surface of the body, and a second position, where each of the at least one lateral spikes extends outward, so as to protrude from the respective lateral side of the body;

placing the second tissue connector, with said each of the at least one lateral spikes in the first position, into a syringe proximate to a second tissue portion;

pushing the second tissue connector out of the syringe and into the second tissue portion, with the first end of the body being the leading end, such that upon contact with the second tissue portion, each of the at least one lateral spikes moves from the first position to the second position; and,

joining the first connector to the second connector at the respective second ends of the first connector and the second connector, causing joining of the first tissue portion and the second tissue portion. 26. The method of claim 25, wherein the first connector and the second connector each include an aperture at the second end of the connector, and the joining the first connector to the second connector at the respective second ends of the first connector and the second connector includes using one or more of wires, strings, clips, and rivets through the apertures.

27. The method of claims 25 and 26, wherein the first and second tissue portions each include a tendon portion.

28. The method of claim 27, wherein the tendon portion is at least one of a human tendon or an equine tendon.

29. The method of claims 25 and 26, wherein each of the tissue portions is selected from the group consisting of ligaments, blood vessels, lymph vessels, nervous tissue and organs.

30. The method of claim 29, wherein the each of the tissue portions is at least one of human or equine tissue.

31. A method for connecting tissue comprising:

obtaining a first tissue connector comprising:

a body including oppositely disposed first and second ends, laterally disposed sides, and an upper side and a lower side, oppositely disposed with respect to each other; each of the laterally disposed sides including at least one lateral spike, the at least one lateral spike moveable between a first position, where each of the at least one lateral spikes is substantially flush with a respective lateral surface of the body, and a second position, where each of the at least one lateral spikes extends outward, so as to protrude from the respective lateral side of the body, and, at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike moveable between a first position, where the at least one longitudinal spike is between planes defined by upper and lower surfaces of the body, the upper and lower surfaces extending along the respective upper and lower sides of the body, and a second position, where the at least one longitudinal spike extends outward, so as to protrude from at least one of the upper side of the body or the lower side of the body;

placing the first tissue connector, with said each of the at least one lateral spikes in the first position, and the at least one longitudinal spike in the first position, into a syringe proximate to a first tissue portion; and,

pushing the first tissue connector out of the syringe and into the first tissue portion, with the first end of the body being the leading end, such that upon contact with the first tissue portion, each of the at least one lateral spikes moves from the first position to the second position, and the at least one longitudinal spike moves from the first position to the second position.

32. The method of claim 31, additionally comprising:

obtaining a second tissue connector comprising:

a body including oppositely disposed first and second ends, laterally disposed sides, and an upper side and a lower side, oppositely disposed with respect to each other; each of the laterally disposed sides including at least one lateral spike, the at least one lateral spike moveable between a first position, where each of the at least one lateral spikes is substantially flush with a respective lateral surface of the body, and a second position, where each of the at least one lateral spikes extends outward, so as to protrude from the respective lateral side of the body, and, at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike moveable between a first position, where the at least one longitudinal spike is between planes defined by upper and lower surfaces of the body, the upper and lower surfaces extending along the respective upper and lower sides of the body, and a second position, where the at least one longitudinal spike extends outward, so as to protrude from at least one of the upper side of the body or the lower side of the body;

placing the second tissue connector, with said each of the at least one lateral spikes in the first position, and the at least one longitudinal spike in the first position, into a syringe proximate to a second tissue portion;

pushing the second tissue connector out of the syringe and into the second tissue portion, with the first aid of the body being the leading end, such that upon contact with the second tissue portion, each of the at least one lateral spikes moves from the first position to the second position, and the at least one longitudinal spike moves from the first position to the second position; and,

joining the first connector to the second connector at the respective second ends of the first connector and the second connector, causing joining of the first tissue portion and the second tissue portion.

33. The method of claim 32, wherein the first connector and the second connector each include an aperture at the second end of the connector, and the joining the first connector to the second connector at the respective second ends of the first connector and the second connector includes using one or more of wires, strings, clips, and rivets through the apertures.

34. The method of claim 32, wherein the first and second tissue portions each include a tendon portion.

35. The method of claim 34, wherein the tendon portion is at least one of a human tendon or an equine tendon.

36. The method of claim 32, wherein each of the tissue portions is selected from the group consisting of ligaments, blood vessels, lymph vessels, nervous tissue and organs.

37. The method of claim 36, wherein the each of the tissue portions is at least one of human or equine tissue.

38. A method for connecting tissue comprising:

obtaining a first tissue connector comprising:

a body including oppositely disposed first and second ends, and an upper side and a lower side, oppositely disposed with respect to each other; and, at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike moveable between a first position, where the at least one longitudinal spike is between planes defined by upper and lower surfaces of the body, the upper and lower surfaces extending along the respective upper and lower sides of the body, and a second position, where the at least one longitudinal spike extends outward, so as to protrude from at least one of the upper side of the body or the lower side of the body; placing the first tissue connector, with the at least one longitudinal spike in the first position, into a syringe proximate to a first tissue portion; and,

pushing the first tissue connector out of the syringe and into the first tissue portion, with the first end of the body being the leading end, such that upon contact with the first tissue portion, the at least one longitudinal spike moves from the first position to the second position.

39. The method of claim 38, additionally comprising:

obtaining a second tissue connector comprising:

a body including oppositely disposed first and second ends, and an upper side and a lower side, oppositely disposed with respect to each other; and, at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike moveable between a first position, where the at least one longitudinal spike is between planes defined by upper and lower surfaces of the body, the upper and lower surfaces extending along the respective upper and lower sides of the body, and a second position, where the at least one longitudinal spike extends outward, so as to protrude from at least one of the upper side of the body or the lower side of the body;

placing the second tissue connector, with the at least one longitudinal spike in the first position, into a syringe proximate to a second tissue portion;

pushing the second tissue connector out of the syringe and into the second tissue portion, with the first end of the body being the leading end, such that upon contact with the second tissue portion, the at least one longitudinal spike moves from the first position to the second position; and,

joining the first connector to the second connector at the respective second ends of the first connector and the second connector, causing joining of the first tissue portion and the second tissue portion.

40. The method of claim 39, wherein the first connector and the second connector each include an aperture at the second end of the connector, and the joining the first connector to the second connector at the respective second ends of the first connector and the second connector includes using one or more of wires, strings, clips, and rivets through the apertures.

41. The method of claim 39, wherein the first and second tissue portions each include a tendon portion.

42. The method of claim 41, wherein the tendon portion is at least one of a human tendon or an equine tendon.

43. The method of claim 39, wherein each of the tissue portions is selected from the group consisting of ligaments, blood vessels, lymph vessels, nervous tissue and organs.

44. The method of claim 43, wherein the each of the tissue portions is at least one of human or equine tissue.

Description:
TENDON CONNECTORS AND SYSTEM FOR USE

CROSS REFERENCES TO RELATED APPLICATIONS

This application is related to and claims priority from commonly owned U.S. Provisional Patent Application Serial No. 62/851,689, entitled: Tendon Connectors And System For Use, filed on May 23, 2019, the disclosure of which is incorporated by reference in its entirety herein.

TECHNICAL FIELD

The present disclosed subject matter relates to connectors for body tissues, in particular to connectors for tendons.

BACKGROUND

A tendon is a band of fibrous connective tissue that usually connects muscle to bone and is capable of withstanding tension. A normal tendon is shown, for example, in FIG. 1A. When tendons tear, either fully or partially (a full tear shown, for example in FIG. IB), they need to be repaired surgically.

In a conventional tendon repair operation, the surgeon makes at least one cut through the skin in the area above the injured tendon so they can see the tendon and look for injuries. The surgeon then removes any damaged tendon tissue. Next, the tom ends of the tendon are sewn back together. The connection of the tendon rads is made with conventional sutures by conventional suturing techniques. With the tendon reconnected, the surgeon sews the cut skin back together with medical stitches, and the wound is covered. Additionally, a splint or similar dressing may be applied to the body outside and proximate to the tendon repair site, in order to reduce tension on the tendon while it heels.

SUMMARY OF THE DISCLOSED SUBJECT MATTER

The present disclosed subject matter is directed to a connector and system of these connectors, for connecting tissues such as tom, severed, or raptured tendons. Typically, two connectors are coupled, for example, by being joined together, to connect severed or tom ends of the tendon. With the connectors with tendon ends joined or conjugated together, a net is placed over the connected tendon, e.g., the conjugated ends thereof, to provide additional securement of the tendon ends together and allow for reconnection, for example, by providing a compression force on the conjugated tendon ends.

Embodiments of the disclosed subject matter are directed to a tissue connector, for example, for connecting or reconnecting tendons. The tissue connector comprises: a body including oppositely disposed first and second ends and laterally disposed sides, and each of the laterally disposed sides including at least one lateral spike, the at least one lateral spike moveable between a first position, where each of the at least one lateral spikes is substantially flush with a respective lateral surface of the body, and a second position, where each of the at least one lateral spikes extends outward, so as to protrude from the respective lateral side of the body.

Optionally, the tissue connector is such that the body additionally comprises: an upper side and a lower side, oppositely disposed with respect to each other; and, at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike moveable between a first position, where the at least one longitudinal spike is between planes defined by upper and lower surfaces of the body, the upper and lower surfaces extending along the respective upper and lower sides of the body, and a second position, where the at least one longitudinal spike extends outward, so as to protrude from at least one of the upper side of the body or the lower side of the body.

Optionally, the tissue connector is such that the body is made of a shape memory material, and the first position and the second position for each of the at least one lateral spikes is trained into the body.

Optionally, the tissue connector is such that the body is made of a shape memory material, and the first position and the second position for each of the at least one lateral spikes is trained into the body, and, the first position and the second position for the at least one longitudinal spike is trained into the body.

Optionally, the tissue connector is such that the shape memory material includes Nitinol.

Optionally, the tissue connector is such that the at least one lateral spike on each of the lateral sides of the body includes a plurality of lateral spikes on each of the lateral sides of the body.

Optionally, the tissue connector is such that the at least one longitudinal spike includes a plurality of longitudinal spikes.

Optionally, the tissue connector is such that the body is made of a shape memory material, and the first position and the second position for each of the lateral spikes is trained into the body, and, the first position and the second position for the longitudinal spikes is trained into the body.

Optionally, the tissue connector is such that the shape memory material includes Nitinol.

Optionally, the tissue connector is such that the first end includes a rounded head.

Optionally, the tissue connector is such that the second end includes at least one aperture extending through the body. Optionally, the tissue connector is such that a longitudinal axis extends through the body and is centrally located with respect to the lateral sides of the body, such that the connector is symmetric about the longitudinal axis.

Optionally, the tissue connector is such that a longitudinal axis extends through the body and is centrally located with respect to the lateral sides of the body and the upper and lower sides of the body, such that the connector is symmetric about the longitudinal axis.

Embodiments of the disclosed subject matter are also directed to tissue connectors. The tissue connector comprises: a body including oppositely disposed first and second ends and laterally disposed sides, and each of the laterally disposed sides including at least one lateral spike extending outward, so as to protrude from the respective lateral side of the body.

Optionally, the tissue connector is such that the body additionally comprises: an upper side and a lower side, oppositely disposed with respect to each other; and, at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike protruding from at least one of the upper side of the body or the lower side of the body.

Optionally, the tissue connector is such that the at least one lateral spike on each of the laterally disposed sides includes a plurality of lateral spikes.

Optionally, the tissue connector is such that the at least one lateral spike on each of the laterally disposed sides includes a plurality of lateral spikes, and, the at least one longitudinal spike includes a plurality of longitudinal spikes.

Embodiments of the disclosed subject matter are also directed to tissue connectors. The tissue connectors comprise: a body including oppositely disposed upper and lower sides; and, at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike moveable between a first position, where the at least one longitudinal spike is between planes defined by upper and lower surfaces of the body, the upper and lower surfaces extending along the respective upper and lower sides of the body, and a second position, where the at least one longitudinal spike extends outward, so as to protrude from at least one of the upper side of the body or the lower side of the body.

Optionally, the tissue connector is such that the body is made of a shape memory material, and, the first position and the second position for the at least one longitudinal spike is trained into the body.

Optionally, the tissue connector is such that the shape memory material includes Nitinol.

Optionally, the tissue connector is such that at least one spike includes a plurality of longitudinal spikes.

Embodiments of the disclosed subject matter are also directed to tissue connectors. A tissue connector comprises: a body including an upper side and a lower side, oppositely disposed with respect to each other; and, at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike protruding from at least one of the upper side of the body or the lower side of the body.

Optionally, the tissue connector is such that the at least one longitudinal spike includes a plurality of longitudinal spikes.

Embodiments of the disclosed subject matter are directed to a method for connecting tissue. The method comprises: obtaining a first tissue connector comprising: a body including oppositely disposed first and second aids and laterally disposed sides, and each of the laterally disposed sides including at least one lateral spike, the at least one lateral spike moveable between a first position, where each of the at least one lateral spikes is substantially flush with a respective lateral surface of the body, and a second position, where each of the at least one lateral spikes extends outward, so as to protrude from the respective lateral side of the body; placing the first tissue connector, with each of the at least one lateral spikes in the first position, into a syringe proximate to a first tissue portion; and, pushing the first tissue connector out of the syringe and into the first tissue portion, with the first end of the body being the leading end, such that upon contact with the first tissue portion, each of the at least one lateral spikes moves from the first position to the second position.

Optionally, the method is such that it additionally comprises: obtaining a second tissue connector comprising: a body including oppositely disposed first and second ends and latoally disposed sides, and each of the laterally disposed sides including at least one lateral spike, the at least one lateral spike moveable between a first position, where each of the at least one lateral spikes is substantially flush with a respective lateral surface of the body, and a second position, where each of the at least one lateral spikes extends outward, so as to protrude from the respective lateral side of the body; placing the second tissue connector, with each of the at least one lateral spikes in the first position, into a syringe proximate to a second tissue portion; pushing the second tissue connector out of the syringe and into the second tissue portion, with the first end of the body being the leading end, such that upon contact with the second tissue portion, each of the at least one lateral spikes moves from the first position to the second position; and, joining the first connector to the second connector at the respective second ends of the first connector and the second connector, causing joining of the first tissue portion and the second tissue portion.

Embodiments of the disclosed subject matter are also directed to another method for connecting tissue. The method comprises: obtaining a first tissue connector comprising: a body including oppositely disposed first and second aids, laterally disposed sides, and an upper side and a lower side, oppositely disposed with respect to each other; each of the laterally disposed sides including at least one lateral spike, the at least one lateral spike moveable between a first position, where each of the at least one lateral spikes is substantially flush with a respective lateral surface of the body, and a second position, where each of the at least one lateral spikes extends outward, so as to protrude from the respective lateral side of the body, and, at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike moveable between a first position, where the at least one longitudinal spike is between planes defined by upper and lower surfaces of the body, the upper and lower surfaces extending along the respective upper and lower sides of the body, and a second position, where the at least one longitudinal spike extends outward, so as to protrude from at least one of the upper side of the body or the lower side of the body; placing the first tissue connector, with each of the at least one lateral spikes in the first position, and the at least one longitudinal spike in the first position, into a syringe proximate to a first tissue portion; and, pushing the first tissue connector out of the syringe and into the first tissue portion, with the first end of the body being the leading end, such that upon contact with the first tissue portion, each of the at least one lateral spikes moves from the first position to the second position, and the at least one longitudinal spike moves from the first position to the second position.

Optionally, the method is such that it additionally comprises: obtaining a second tissue connector comprising: a body including oppositely disposed first and second ends, laterally disposed sides, and an upper side and a lower side, oppositely disposed with respect to each other; each of the laterally disposed sides including at least one lateral spike, the at least one lateral spike moveable between a first position, where each of the at least one lateral spikes is substantially flush with a respective lateral surface of the body, and a second position, where each of the at least one lateral spikes extends outward, so as to protrude from the respective lateral side of the body, and, at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike moveable between a first position, where the at least one longitudinal spike is between planes defined by upper and lower surfaces of the body, the upper and lower surfaces extending along the respective upper and lower sides of the body, and a second position, where the at least one longitudinal spike extends outward, so as to protrude from at least one of the upper side of the body or the lower side of the body; placing the second tissue connector, with each of the at least one lateral spikes in the first position, and the at least one longitudinal spike in the first position, into a syringe proximate to a second tissue portion; pushing the second tissue connector out of the syringe and into the second tissue portion, with the first end of the body being the leading end, such that upon contact with the second tissue portion, each of the at least one lateral spikes moves from the first position to the second position, and the at least one longitudinal spike moves from the first position to the second position; and, joining the first connector to the second connector at the respective second ends of the first connector and the second connector, causing joining of the first tissue portion and the second tissue portion.

Embodiments of the disclosed subject matter are directed to other methods for connecting tissue. These methods comprise: obtaining a first tissue connector comprising: a body including oppositely disposed first and second ends, and an upper side and a lower side, oppositely disposed with respect to each other; and, at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike moveable between a first position, where the at least one longitudinal spike is between planes defined by upper and lower surfaces of the body, the upper and Iowa: surfaces extending along the respective upper and lower sides of the body, and a second position, where the at least one longitudinal spike extends outward, so as to protrude from at least one of the upper side of the body or the lower side of the body; placing the first tissue connector, with the at least one longitudinal spike in the first position, into a syringe proximate to a first tissue portion; and, pushing the first tissue connector out of the syringe and into the first tissue portion, with the first end of the body being the leading end, such that upon contact with the first tissue portion, the at least one longitudinal spike moves from the first position to the second position.

Optionally, the method is such that it additionally comprises: obtaining a second tissue connector comprising: a body including oppositely disposed first and second ends, and an upper side and a lower side, oppositely disposed with respect to each other; and, at least one longitudinal spike disposed along the body in the direction between the first and the second end of the body, the at least one longitudinal spike moveable between a first position, where the at least one longitudinal spike is between planes defined by upper and lower surfaces of the body, the upper and lower surfaces extending along the respective upper and lower sides of the body, and a second position, where the at least one longitudinal spike extends outward, so as to protrude from at least one of the upper side of the body or the lower side of the body; placing the second tissue connector, with the at least one longitudinal spike in the first position, into a syringe proximate to a second tissue portion; pushing the second tissue connector out of the syringe and into the second tissue portion, with the first end of the body being the leading end, such that upon contact with the second tissue portion, the at least one longitudinal spike moves from the first position to the second position; and, joining the first connector to the second connector at the respective second ends of the first connector and the second connector, causing joining of the first tissue portion

Optionally, all of the three embodiment methods above are such that the first connector and the second connector each include an aperture at the second end of the connector, and the joining the first connector to the second connector at the respective second ends of the first connector and the second connector includes using one or more of wires, strings, clips, and rivets through the apertures.

Optionally, all of the three embodiment methods above are such that the first and second tissue portions each include a tendon portion.

Optionally, all of the three embodiment methods above are such that the tendon portion is at least one of a human tendon or an equine tendon.

Optionally, all of the three embodiment methods above are such that each of the tissue portions is selected from the group consisting of ligaments, blood vessels, lymph vessels, nervous tissue and organs.

Optionally, all of the three embodiment methods above are such that each of the tissue portions is at least one of human or equine tissue.

Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosed subject matter pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the disclosed subject matter, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the present disclosed subject matter are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the disclosed subject matter. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the disclosed subject matter may be practiced.

Attention is now directed to the drawings, where like reference numerals or characters indicate corresponding or like components. In the drawings:

FIG. 1 A is a photograph of a healthy and normal tendon;

FIG. IB is a photograph of a completely tom or severed tendon;

FIG. 2A-1 is a top (side) perspective view of a first embodiment of a connector in a non -extended position;

FIG. 2A-2 top of the first embodiment of the connector in an extended position;

FIG. 2B is a side view of the connector of FIG. 2A-2;

FIGs. 2C-1 to 2C-3 are illustrations detailing the insertion and deployment of the connector of the first embodiment into a tendon;

FIG. 3A-1 top (side) perspective view of a first embodiment of a connector in a non-extended position;

FIG. 3 A-2 is a top view of a second embodiment of a connector in an extended position;

FIG. 3B-1 is a top view of the Section AA of FIG. 3 A;

FIG. 3B-2 is a side view of the Section AA of FIG. 3B-1;

FIG. 3C is a side view of the connector of FIG. 3A;

FIG. 4 is a perspective view of a net in accordance with embodiments of the disclosed subject matter; and,

FIG. 5 is a diagram showing tendon portions joined in accordance with embodiments of the disclosed subject matter.

DETAILED DESCRIPTION

In this document, references are made to directions such as upper, lower, upward, downward, top, bottom, inward, outward, proximal, distal, and lateral. These directional references are used to show example orientations of the disclosed subject matter, and are not limiting in any way.

FIGs 2A-1, 2A-2, and 2B show a connector 100 including a body 102, extending between a distal end 104 and a proximal end 106. A longitudinal axis LA (FIG. 2A-2) extends through the center of the body 102 between the distal end 104 and the proximal end 106. Spikes 120, also known as lateral spikes, are positioned along the lateral sides 102a of the body 102.

As the connector 100 is made, for example, of Nitinol (a nickel-titanium alloy), a shape memory (and superelastic) material, the shape of the spikes 120 is trained into the material. For example, when the connector is“cool”, such as at ambient temperature, e.g., room temperature, the connector 100 is in the collapsed or non-extended position, for example, prior to being deployed in the body, as shown in FIG. 2A-1. In the collapsed or non-extended position, the spikes 120 are flush or substantially flush with the lateral surfaces 102x of the body 102, so as to be coplanar or substantially coplanar along each of the lateral sides 102a of the body 102 of the connector 100. Should additional cooling be needed, the connector 100 may be cooled with nitrogen, to maintain the connector 100 in the collapsed or non-extended position. When the connector 100 becomes“hot”, such as at body temperature, e.g., approximately 37 Degrees Celsius, when the connector 100 is deployed in the body, the connector 100, for example, becomes elastic, such that the spikes 120 move (extend) outward, as the connector 100 moves to the extended position, as shown in FIG. 2A-2. Staying in FIG. 2A-2, the body 102 is, for example, a flat plate, and is formed of repeating segments 108, which extend between notches 110 in the body 102. The segments 108, are, for example, identical or similar to each other, with the distal most segment ending in a head 111 and the most proximal segment ending in a tail 112. The body 102, and hence the connector 100, is, for example, symmetric with respect to the longitudinal axis LA.

Each segment 108 includes a head portion 114, which extends to an outwardly tapered midsection 116 (going from the distal end 104 to the proximal end 106), which extends to a tail portion 118. Spikes 120, which terminate in points 121, extend angularly outward, e.g., horizontally, from the body 102, along the lateral sides 102a of the body 102. The spikes 120 extend outward (with respect to the body 102), for example, at an angle a, which is, for example, from approximately 1 to approximately 75 degrees with respect to the lateral surfaces 102x. The notches 110 are circular, but include an open area 110a, allowing for inward movement of the respective spike 120, and for example, spring-like behavior due to the material of the body 102 coupled with the notch 110.

The distal end 104 is rounded or blunt, at the head 111, to initially receive the tendon or other tissue. The proximal end 106 includes the tail 112, with an aperture 124 extending through the body 102. Through the apertures 124, for example, connectors 100 are joined or coupled as part of a tendon repair procedure, where, for example, tendon portions or ends on two connectors 100 are conjugated or joined. While a single aperture 124 extending through the body 102 is shown, multiple apertures extending through the body are also permissible.

The connector 100 is, for example, a flat or two-dimensional (2D) member (or 2D connector), as the spikes 120 protrude or otherwise extend outward laterally. This flat body 102 is suitable for use with flat tendons, tissues and the like.

In an operative mode, the tendon portion or end is advanced over the distal end 104 toward the proximal end 106 of the connector 100, and/or the connector 100 is moved inward, into the tendon (led by the distal end 104). The tendon is moved to at least the proximal end 106 to or proximate to the aperture 124, so the tendon portion can be properly joined to another tendon portion similarly positioned on another connector 100. For example, the connectors 100 can be tied together by wires, strings, clips, rivets, and the like, through the apertures 124. Optionally, the tendon ends can be further joined by methods such as suturing the actual tendon ends together, by using a sleeve 300 (as detailed below), or other external connector.

Attention is now directed to HGs. 2C-1 to 2C-3, showing an example deployment of a connector 100 in a tendon (tendon end) 150. The connector 100, in the collapsed or non-extended position (as shown in FIG. 2A-1), is in the needle portion 154 of a syringe 156. The connector 100 is positioned in the needle portion 154 such that the distal end 104 of the connector 100 is proximate to the opening 157 of the needle 154. The needle portion 154 has been inserted into the tendon 150, as shown in FIG. 2C-1. As the syringe plunger 158 is pushed downward (toward the tendon 150), the connector 100 is pushed out of the needle portion 154 into the tendon 150. With the connector 100 now at body temperature in the tendon, the connector 100 moves to the extended position, as the spikes 120 exposed to the tendon 150 at body temperature extend outward, as shown in FIG. 2C-2. The connector 100 is pushed into the tendon 150 via pushing of the syringe plunger 158, for example, to a depth such that all of the spikes 220 move to extend outward, and the aperture 124 at the proximal end 106 of the connector 100 is reachable, and/or extends outside of the tendon 150, as shown in FIG. 2C-3. At this time, the connector 100 is deployed in the tendon 150, and the needle portion 154 is removed from the tendon 150. As the spikes 120 taper outward proximally (toward the proximal end 106 of the connector 100), they prevent large movements of the connector 100 in the proximal direction (with respect to the connector 100).

The other end of the tendon 150 may now have a connector 100 deployed therein, in accordance with the same procedure. The connectors 100 can now be joined, for example, at their apertures, by wires, strings, clips, rivets, and the like, which extend through both of the apertures 124 of each connector 100.

FIGs. 3A-1, 3A-2, 3B-1, 3B-2 and 3C show a connector 200 similar in all aspects to the connector 100, with similar structures to those of the connector 100 having the same element number, but in the“200s”, with differences noted below. The connector 200 and its body 202 is also symmetric about the Longitudinal Axis LA’ (similar to the Longitudinal Axis LA for the connector 100), both laterally (between the lateral sides 202a) and vertically (between the upper side 202bl and the lower side 202b2) of the body 202. The connector 200 differs from the connector 100 in that it adds (in addition to the spikes 220, also known as lateral spikes, on the lateral sides 202a of the body 202) spikes 230, also known as longitudinal spikes, as these spikes 230 are positioned longitudinally along the body 202, so as to be moveable into positions where the spikes 230 protrude vertically, ether upward or downward, from the body 202.

Like the connector 100, the connector 200 is also made, for example, of Nitinol, a shape memory material, the shape of the spikes 220, 230 is trained into the material. For example, when the connector is“cool”, such as at ambient temperature, e.g., room temperature, the connector 200 is in the collapsed or non-extended position, for example, prior to being deployed in the body, as shown in FIG. 3A-1. In the collapsed or non-extended position, the spikes 220 are flush or substantially flush with the lateral surfaces 202x of the body 202, so as to be coplanar or substantially coplanar along each of the lateral sides 202a of the body 202 of the connector 200. Similarly, in the collapsed or non-extended position, the spikes 230 are flush or substantially flush with the respective upper 202yl and lower 202y2 surfaces of the body 202, so as to be coplanar or substantially coplanar along the respective upper 201bl and lower 202b2 sides the body 202 of the connector 200. Should additional cooling be needed, the connector 200 may be cooled with nitrogen, to maintain the connector 200 in the collapsed or non-extended position. When the connector 200 becomes“hot”, such as at body temperature, e.g., approximately 37 Degrees Celsius, when the connector 200 is deployed in the body, the connector 200, for example, becomes elastic, such that the spikes 220 move (extend) outward, as the connector 200 moves to the extended position, as shown in FIG. 3A-2.

As shown in FIG. 3B-1, each spike 230 (cut into the body 202, resulting in a channel 230a extending through the body 202, separating the spike 230 from the body 202) terminates in a point 231. Each spike 230, for example, moves angularly outward (upward from the top or upper side of 202b 1 of the body 202) or downward (from the bottom or lower side 202b2 of the body 202), from the body 202 (from an initial position, flush with the flat body 202), to an angle Q (e.g., between approximately 1 and approximately 75 degrees) with respect to the upper 202yl or lower 202y2 surfaces of the body 202. This outward movement to the angle Q, occurs, for example, when the connector 200 is in the body and subject to a change in temperature, as shown in FIG. 3B-2. When the vertical spikes 230 are flat and flush with the upper 202yl and lower 202y2 body surfaces, the spikes 230 sit in apertures or wells 232 cut into the body 202. When the spikes 230 move outward, i.e., upward or downward, due to the temperature change from entering the body, the spikes 230 typically orient in accordance with their shape memories (e.g., trained shape memories). For example, the spikes 230 may alternate between an upward extending spike 230, followed by a downward extending spike 230. However, random patterns of upward and downward oriented spikes 230 are also permissible, as are all spikes 230 being upward oriented spikes, or all downward oriented spikes. Alternate connectors, similar to the connector 200, may have only have one or more longitudinal spikes 230.

The connector 200 is, for example, a three-dimensional (3D) member (or 3D connector), with spikes in both the lateral and vertical directions with respect to the body 202a. The connector 200 is typically for use with rounded tendons, tissues. A connector 200 is deployed in the tendon (tendon end), via a syringe and joined to a connector 200 (or 100) in the other tendon end, in accordance with the process shown in FIGs. 2C-1 to 2C-3, and described above for the connector 100.

The connectors 100, 200 are, for example, unitary members, for example, cut, pressed, punched, stamped, or otherwise formed from a sheet of material. The materials are, for example, surgical grade. Shape memory retaining metals (shapes can be trained therein), are typically used to make the connectors 100, 200, and, with Nitinol, as detailed above, being one suitable material. By using Nitinol the spikes 120, 220 are, for example, in some embodiments, trained to extend outward, from the lateral sides 102a, 202a of the respective connector bodies 102, 202, while spikes 230 are trained to extend outward (vertically), i.e., upward and/or downward, from the connector 200 body 202, for example, when the connectors 100, 200 are deployed in the human or animal body for a tendon connection or reconnection procedure, as disclosed herein. Other metals and plastics may be used for the connectors 100, 200, including those that are not shape memory retaining.

Additionally, when attaching/reattaching a tendon or other tissue, one connector may be a 2D connector 100, while the other connector may be a 3D connector 200.

In alternate embodiments, the connectors 100, 200 may be such that the spikes 120, 220 are initially positioned inward (in a non-extended position), so as to be at least substantially coplanar along each of the lateral sides 102a, 202a of the respective body 102, 202, and moveable outward, to an extended position, as shown in FIGs. 2A-2 and 3A-2) when deployed in the human or animal body, including, equine (horse) bodies. The spikes 120, 220, 230 are, for example, trained to move to this extended position (from the non-extended position) upon deployment in the human or animal body, in shape memory material, such as Nitinol.

FIG. 4 shows a net or sleeve 300, which secures the joined connectors 100/200. The net 300 is shown in an open position, prior to its being closed around tissue, e.g., tendon, ends joined together by joined connectors 100/200. The net 300 is, for example, a cylinder or tube, of a circular or rounded cross section, although other cross sectional shapes, such as rectangular, triangular, rounded, or combinations thereof are also permissible. The net 300 is formed of a wire mesh frame 302, to be, for example, flexible. The frame 302 of the net 300 is, for example, is formed of segments 304, connected at joints 306. The ends of the segments 304 may be brought together, to close the net 300 or sleeve around the connected tissue ends held by the connectors 100/200, as a rod end 310 engages a recessed end 311 (formed by a C- shaped recess), to close the segments 304. Other segment 304 ends are aperture ends 314. When the apertures 314a of the respective aperture ends 314 of a segment 304 are aligned, the ends 314 may be joined by pins or the like (not shown), which extend through the apertures 314a, to close the respective segments 304.

The net 300 may also include aperture protrusions 320, with apparatus 320a for accommodating pins and the like, to further secure the net 300 to the tissue it surrounds. There may also be spikes 322 protruding from the net 300 for gripping the tissue and further securing the connection of the connectors 100/200. Additional members for gripping tissue include hooks, barbs and the like. The spikes 322, hooks and barbs may be positioned on the net 300 in any desired orientation, so as to grip tissue, and maintain the tissue in a secured manner. The net 300 is, for example, an integral member, but may be made of segments 304 joined together by welds at joints 306. The net 300 is formed, for example, of a flexible and elastically deformable, and shape memory metal, such as Nitinol or other medical grade metal or plastic.

The connectors 100, 200 and/or the net 300 may be coated with drugs, compounds, lubrication agents, and combinations thereof. The connectors 100, 200 and/or the net 300 define a system (apparatus) for connecting tissues, such as tendons, ligaments, vessels (blood, lymph and the like), nervous tissue, organs, and the like. The system of the connectors 100, 200 and the net 300 may be applied for tendon attachment/reattachment and all other applications detailed above, for human, veterinary, including equine, or other animal use.

The net 300 is also disclosed in commonly owned PCT Patent Application Number PCT/IB2019/054264, entitled: Tendon Connector System, filed on May 23, 2019, published as WO 2019/224758, the disclosure of which is incorporated by reference herein.

FIG. 5 shows two connectors 100/200 with tendon portions or ends 400a, 400b joined via their apertures 124, 224 (FIGs. 2A-1, 2A-2, 3A-1 and 3A-2), enveloped by a net 300. The net 300 may be placed over the location where the connectors 100, 200, are joined, to provide additional securement to the tendon connection and the joined connectors 100/200, with an additional clamping force.

Although the disclosed subject matter has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.