Devices and methods for tendon repair

• US 9,539,084 B2
• Filed: 03/06/2015
• Issued: 01/10/2017
• Est. Priority Date: 01/23/2012
• Status: Active Grant

• Current Assignee: ExsoMed Corporation (Berkshire Hathaway Incorporated)
• Original Assignee: Exsomed International IP, LLC
• Inventors: Champagne, Lloyd P., Zoldos, Jozef
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/640,657
• Publication Number:
  US 20150182325A1
• Time in Patent Office: 676 Days
• Field of Search: 623 1311- 132
• US Class Current: 1/1
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/1146 of tendons
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/128 for applying or removing clamps or clips
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0817 Structure of the anchor
• CPC Class Codes: A61F 2002/0858 Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
• CPC Class Codes: A61F 2002/087 Anchor integrated into tendons, e.g. bone blocks, integrated rings
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

Disclosed is a device and method for repairing a partially or totally ruptured tendon. The device comprises an implant placed inside or outside of the tendon on either side of the rupture in order to strengthen the ruptured area during repair. Once positioned inside the tendon, the tendon is held in place so it can heal either by sewing or stapling through the tendon and implant, or by any other suitable method that utilizes the implant to provide strength to the ruptured area. In this manner the tendon can heal with less chance of rupturing again prior to healing.

Claims

1. A tendon repair device for being positioned inside of a tendon that includes a partial or complete rupture, the rupture separating the tendon into a first section and a second section, the tendon repair device including:

an implant having a body that is configured to be inserted into the first section of the tendon, and into the second end of the tendon;

the implant having an outer surface that that grips the tendon into which the implant is inserted; and

the outer surface having one of a the group consisting of;

a spiraled configuration, a criss cross or cruciate pattern in cross section, and a plurality of ribs extending from the outer surface.

2. The tendon repair device of claim 1 wherein the implant is comprised of biodegradable or non-biodegradable material.

3. The tendon repair device of claim 1 wherein the implant is comprised of a mesh.

4. The tendon repair device of claim 3 wherein the implant is a mesh having mesh dimensions of approximately 6 cm×

3 mm.

5. The tendon repair device of claim 1 wherein the implant further comprises a series of stiplets.

6. The tendon repair device of claim 1 that has a hollow interior.

7. The tendon repair device of claim 1 that includes an antibiotic to inhibit the growth of bacteria.

8. The tendon repair device of claim 7 that is made of a material and the antibiotic is included within the material.

9. The tendon repair device of claim 7 that is made of a material and wherein the antibiotic is coated on the material.

10. The tendon repair device of claim 1 that includes a growth enhancing agent.

11. The tendon repair device of claim 10 that is impregnated with a growth enhancing agent.

12. The tendon repair device of claim 1 that has a hollow interior and textured interior surface.

13. The tendon repair device of claim 1 wherein the outer surface has outwardly extending ribs that are spaced apart 0.5-3 mm or less.

14. The tendon repair device of claim 5 wherein each stiplet extends about 0.5-2 mm from the rest of the outer surface.

15. The tendon repair device of claim 5 wherein each stiplet is spaced about 0.5-2 mm from the next closest stiplet.

16. The tendon repair device of claim 1 wherein the outer surface further includes wide areas alternating with narrow areas.

17. The tendon repair device of claim 16 wherein there is a difference in diameter between each narrow area and each wide area, and the difference in diameter is between 0.5 mm and 4 mm.

18. The tendon repair device of claim 1 that includes openings for receiving a needle, a staple, a rivet or another solid structure.

19. The tendon repair device of claim 1 that has a body portion, a first end and a second end, and a needle attached to the first end.

20. The tendon repair device of claim 19 that has a needle attached to the second end.

21. The tendon repair device of claim 19 wherein the needle attached to the first end has a curved portion and a straight portion, and is designed to imbed the insert a predetermined distance into the tendon.

22. The tendon repair device of claim 20 wherein the needle attached to the second end has a curved portion and a straight portion, and is designed to imbed the insert a predetermined distance into the tendon.

23. The tendon repair device of claim 19 wherein the needle is configured to imbed the body of the implant 0.5 cm to 5 cm inside each end of the tendon.

24. The tendon repair device of claim 23 wherein the needle has a wide enough base to match the width of the implant to connect to the body portion.

39. The tendon repair device of claim 1 that includes a fabric.

40. The tendon repair device of claim 39 wherein the fabric is one or more of:

woven, knitted, braided, and twisted.

41. The tendon repair device of claim 39 wherein the fabric comprises an absorbable material selected from the group consisting of:

polyglactin, polycaprolate, poliglecaprone, polysorb, polyglygolic acid, polylactic acid, polydioxanone, caprolactone, collagen, surgical gut, and combinations thereof.

42. The tendon repair device of claim 39 wherein the fabric comprises a non-absorbable material selected from the group consisting of:

polypropylene, polyester, nylon, silk, cotton, metal, and combinations thereof.

25. A tendon repair device for repairing a tendon that has been ruptured into a first end and a second end, the device comprising a hollow tube having a first end and second end, wherein the first end of the tendon is received in the first end of the hollow tube and the second end of the tendon is received in the second end of the hollow tube.

26. The tendon repair device of claim 25 wherein the hollow tube has an inner surface that includes raised portions that retain the first end of the tendon and the second end of the tendon.

27. The tendon repair device of claim 26 wherein the raised portions comprise one or more of:

ribs, backward angled ribs, barbs, and backward angled barbs, and stiplets.

28. The tendon repair device of claim 26 that has an interior diameter of between 2 mm and 20 mm.

29. The tendon repair device of claim 26 wherein the raised portions extend .5 mm-5 mm from the inner surface.

30. The tendon repair device of claim 26 that is physically connected to the tendon by one or more of sutures, staples, rivets, or clamps to help retain the ends of the tendon within the implant.

31. The tendon repair device of claim 26 that has a circular outer surface.

32. The tendon repair device of claim 26 that includes an antibiotic to inhibit the growth of bacteria.

33. The tendon repair device of claim 32 wherein the hollow tube is made of material and the antibiotic is included within the material.

34. The tendon repair device of claim 32 wherein the antibiotic is coated on the tube.

35. The tendon repair device of claim 26 that includes a growth enhancing agent.

36. The tendon repair device of claim 26 that has an inner surface and wherein the growth enhancing agent is on the inner surface.

37. The tendon repair device of claim 35 that is made of a material and the growth enhancing agent is included within the material.

38. The tendon repair device of claim 26 that has a textured inner surface to assist in retaining the first and the second end of the tendon.

43. The tendon repair device of claim 25 that includes a fabric.

44. The tendon repair device of claim 43 wherein the fabric is one or more of:

woven, knitted, braided, and twisted.

45. The tendon repair device of claim 43 wherein the fabric comprises an absorbable material selected from the group consisting of:

polyglactin, polycaprolate, poliglecaprone, polysorb, polyglygolic acid, polylactic acid, polydioxanone, caprolactone, collagen, surgical gut, and combinations thereof.

46. The tendon repair device of claim 43 wherein the fabric comprises a non-absorbable material selected from the group consisting of:

polypropylene, polyester, nylon, silk, cotton, metal, and combinations thereof.