Granted Patent B2

US 12,377,193 · App. 16/310,029 · Granted Aug 5, 2025

Inventors: Martha M. Murray (Sherborn, MA); Braden C. Fleming (East Greenwich, RI)

Assignees: The Children's Medical Center Corporation; Rhode Island Hospital

A61L27/386A61F2/08A61L27/24A61L27/54A61F2/0063A61L27/58A61L2430/10

Abstract

Claims (42)

1. A device for ligament or tendon repair comprising:

a fixation device capable of forming a stable attachment to a first bone;

a suture having a length, the suture being attachable to a ruptured end of a ligament or tendon, wherein the ruptured end of the ligament or tendon is configured to be connected to a second bone;

multiple distinct biodegradable collagen scaffolds positioned along the length of the suture, the multiple distinct collagen scaffolds each having a first end, a second end opposite the first end, a width, a length that extends from the first end to the second end, where the length is longer than the width, and a collagen concentration of greater than 400 mg/mL, wherein the scaffolds are configured to be positioned at a ruptured end into the gap between the ruptured ligament or tendon and the first bone, and wherein the fixation device is attached only indirectly to the scaffold, the suture extends through the multiple distinct collagen scaffolds along the lengths of the scaffolds and is slidable along the scaffolds, and the multiple distinct collagen scaffolds are configured to regulate cell function at a target site.

2. The device of claim 1 , wherein the scaffolds are beads.

3. The device of claim 1 , wherein the device for ligament or tendon repair comprises 2-30 scaffolds.

4. A kit, comprising the device of claim 1 and further comprising instructions for surgical repair of a ligament or tendon using the device.

5. The device of claim 1 , wherein the scaffolds have a total surface area that is greater than a single scaffold used to repair a ligament or tendon injury.

6. The device of claim 1 , wherein the first containment device and the second containment device are sutures and the first scaffold is threaded and slidable along the length of the first suture and the second scaffold is threaded and slidable along the length of the second suture.

7. The device of claim 1 , wherein the scaffolds are beads.

8. The device of claim 1 , wherein the device for ligament or tendon repair comprises 2-30 scaffolds.

9. A device for ligament or tendon repair comprising:

a set of distinct biodegradable scaffolds comprising 2-30 scaffolds, each scaffold having a collagen concentration of greater than 400 mg/mL, a length of 1-20 mm, a width that is less than 50 mm, and a volume that is less than 100 mL, and each scaffold being capable of absorbing at least 5 mL of blood, wherein the scaffold is configured to be positioned at a ruptured end into the gap between the ruptured ligament or tendon and a bone;

at least one fixation device configured to be secured to the bone; and

a suture threaded along the length of each scaffold of the set of distinct biodegradable scaffolds to position the scaffold between the ruptured end of the ligament or tendon and the bone.

10. The device of claim 9 , wherein the scaffolds are compressible expandable scaffolds.

11. The device of claim 9 , wherein the scaffolds are collagen sponges.

12. The device of claim 11 , wherein the collagen sponges comprise type I soluble collagen.

13. The device of claim 11 , wherein the collagen sponges comprise type I soluble collagen and wherein the collagen sponges are prepared from a solution of solubilized collagen in a concentration of less than or equal to 500 mg/ml.

14. The device of claim 9 , wherein the scaffolds are hydrophilic.

15. The device of claim 9 , wherein each of the scaffolds in the set are the same.

16. The device of claim 9 , wherein at least one of the scaffolds in the set is different from the other scaffolds in the set.

17. The device of claim 16 , wherein the at least one different scaffold has a different size than the other scaffolds.

18. The device of claim 17 , wherein the at least one different scaffold is larger than the other scaffolds.

19. The device of claim 17 , wherein the at least one different scaffold is smaller than the other scaffolds.

20. The device of claim 17 , wherein the at least one different scaffold is shaped as a sphere.

21. The device of claim 17 , wherein the at least one different scaffold is shaped as a cylinder.

22. The device of claim 17 , wherein the at least one different scaffold is larger than the other scaffolds.

23. The device of claim 16 , wherein the at least one different scaffold has a different shape than the other scaffolds.

24. The device of claim 16 , wherein the at least one different scaffold is comprised of a different biodegradable polymer than the other scaffolds.

25. The device of claim 16 , wherein the at least one different scaffold has a different size than the other scaffolds.

26. A kit, comprising the device of claim 9 and further comprising one or more containers to house the set of distinct biodegradable scaffolds, and instructions for surgical repair of a ligament or tendon using the device.

27. The kit of claim 26 , further comprising a containment device housed in one or more of the containers.

28. The kit of claim 27 , wherein the containment device is a suture.

29. The kit of claim 28 , wherein the scaffolds are threaded onto the suture.

30. The device of claim 9 , wherein the scaffolds are collagen sponges.

31. The device of claim 9 , wherein the scaffolds are hydrophilic.

32. A device for ligament or tendon repair comprising:

a suture having a first end and a second end, the second end being attachable to a ruptured end of a ligament or tendon connected to a bone;

a set of multiple distinct biodegradable scaffolds having resistance to degradation by synovial fluid and configured to regulate cell function at a target site, the set of multiple distinct biodegradable scaffolds having:

a first scaffold having a collagen concentration of greater than 400 mg/mL and less than or equal to 500 mg/mL, a length of 1-20 mm, a width of at least 0.5 mm, and a volume of at least 1.0 mL, and positioned along the length of the suture at a ruptured end into the gap between the ruptured ligament or tendon and a bone; and

a second scaffold having a collagen concentration of greater than 400 mg/ml and less than or equal to 500 mg/mL, a length of 1-20 mm, a width of at least 0.5 mm, and a volume of at least 1.0 mL, and positioned along the length of the suture at a ruptured end into the gap between the ruptured ligament or tendon and a bone.

Assignments (1)

Continuity (2)

References Cited (400)