Joint bioscaffolds

Patent metadata

Field	Value
Publication number	US-9314340-B2
Application number	US-201414316163-A
Country	US
Kind code	B2
Filing date	Jun 26, 2014
Priority date	Feb 27, 2009
Publication date	Apr 19, 2016
Grant date	Apr 19, 2016

Abstract

Provided herein are compositions and medical devices, and in particular, biodegradable scaffolds capable of repairing and replacing cartilagenous meniscuses. Also provided herein are methods of using scaffolds for treating degenerative tissue disorders. In certain embodiments, such scaffolds can promote tissue regeneration of a temporal mandibular joint (TMJ) meniscus.

First claim

We claim:

1. A method for regenerating at least a portion of a temporomandibular joint (TMJ) of a subject, the method comprising:
implanting a bioscaffold at the TMJ of a mammal, the bioscaffold comprising a biocompatible, biodegradable, elastomeric implant dimensioned to fit within the TMJ and mimic the size and function of a native TMJ meniscus, the implant comprising a top sheet formed from one or more layers of a biocompatible material, a bottom sheet formed from one or more layers of the biocompatible material, and a raised central core encapsulated between the top and bottom sheets, wherein the core consists essentially of acellular and noncrosslinked extracellular matrix, wherein the top sheet and bottom sheet have substantially the same thickness, and further wherein the top and bottom sheets extend radially from the raised central core to form a brim having surgical attachment sites in the brim, wherein the central core has a circular base with a diameter, or an elliptical base with a major diameter and a minor diameter, and a height and composition of the central core that permits the core to deform under stress, and the diameter or the major and minor diameter is sufficient for the core to carry shear forces between the mandible and the skull when the implant is affixed to an articulating surface in the TMJ; and
attaching the bioscaffold at a TMJ attachment site in the mammal by securing the surgical attachment sites of the brim to the TMJ attachment site in the mammal.

2. The method of claim 1 , wherein the top or bottom sheet is formed from two layers of biocompatible material encapsulating the core.

3. The method of claim 1 , wherein the core comprises a plurality of layers of extracellular matrix.

4. The method of claim 1 , wherein the core comprises a gel or particulate extracellular matrix that is encased in a plurality of layers of extracellular matrix, wherein the gel or particulate extracellular matrix within the core allows compression of the core.

5. The method of claim 4 , wherein the particulate extracellular matrix of the core comprises particles having a particle size from 10 to 400 microns.

6. The method of claim 5 , wherein the particles have an average particle size of 150 to 200 microns.

7. The method of claim 1 , wherein the bioscaffold further comprises a synthetic polymer that imparts flexibility to the bioscaffold.

8. The method of claim 1 , wherein the extracellular matrix is an extracellular matrix gel.

9. The method of claim 8 , wherein the core is concave, convex, biconcave, biconvex, or a combination thereof.

10. The method of claim 1 , wherein top and bottom sheets comprise extracellular matrix of tissue selected from the group consisting of small intestine, urinary bladder, esophagus, skin, liver, spleen, heart, pancreas, ovary, and arteries.

11. The method of claim 1 , wherein the central core has an elliptical base with a major diameter and a minor diameter.

12. The method of claim 1 , wherein the core has a diameter of 8 to 16 millimeters.

13. The method of claim 1 , wherein attaching the bioscaffold at the TMJ attachment site comprises ligating the bioscaffold by one or more of the surgical attachment sites to a skull zygomatic bone.

14. A method comprising:
removing at least a portion of a temporomandibular joint (TMJ) meniscus from a mammal thereby creating a TMJ implantation site;
implanting at the TMJ implantation site a biocompatible, biodegradable, elastomeric implant dimensioned to fit within the TMJ and mimic the size and function of a native TMJ meniscus, the implant comprising a bioscaffold comprising a central core comprising acellular and noncrosslinked extracellular matrix particles or gel, the core extending between a top and bottom sheet, wherein the top and bottom sheets extend laterally from the core in an abutting relationship to form a brim, and further wherein the core extends from the top or bottom sheet to form a nonplanar structure having a height of between 0.5 and 4 cm, wherein the core has a circular base with a diameter, or an elliptical base with a major diameter and a minor diameter, and the height and composition of the core permits the core to deform under stress, and the diameter or major and minor diameter of the core is sufficient for the core to carry shear forces between the mandible and the skull when the implant is affixed to an articulating surface in the TMJ, and wherein the top sheet and bottom sheet extend outwardly from the core to form a brim with surgical attachment sites in the brim for attaching the bioscaffold at or within the implantation site.

15. The method of claim 14 , wherein the core comprises a plurality of layers of extracellular matrix.

16. The method of claim 15 , wherein the core is shaped concave, convex, biconcave, biconvex, or a combination thereof.

17. The method of claim 16 , wherein the core comprises a convex pillow extending from the base.

18. The method of claim 17 , wherein the core comprises a deformable gel.

19. The method of claim 14 , wherein core comprises deformable particulate extracellular matrix particles having a particle size from 10 to 400 microns.

20. The method of claim 19 , wherein the particles have an average particle size of 150 to 200 microns.

21. The method of claim 14 , wherein the bioscaffold further comprises a synthetic elastomeric polymer.

22. The method of claim 14 , wherein the extracellular matrix is an extracellular matrix gel.

23. The method of claim 22 , wherein the extracellular matrix gels at a temperature at or above 25 degrees Celsius.

24. The method of claim 14 , wherein both the top and bottom sheets comprise extracellular matrix of tissue selected from the group consisting of small intestine, urinary bladder, esophagus, skin, liver, spleen, heart, pancreas, ovary, and arteries.

25. The method of claim 14 , wherein at least a portion of the top or bottom sheets comprise a basement membrane.

26. The method of claim 14 , wherein at least one of the top or bottom sheets has an inner surface and an outer surface, and wherein at least a portion of the outer surface comprises basement membrane.

27. The method of claim 14 , wherein the core has a diameter of 8 to 16 millimeters.

28. The method of claim 14 , wherein attaching the bioscaffold comprises ligating the bioscaffold by one or more of the surgical attachment sites to a skull zygomatic bone.

29. A method for replacement or regeneration of a temporomandibular joint (TMJ) meniscus the method comprising:
implanting on an articulating surface in a TMJ a bioscaffold comprising a biocompatible, biodegradable, elastomeric implant dimensioned to fit within the TMJ and mimic the size and function of a native TMJ meniscus, the implant comprising a top sheet and bottom sheet and a raised central elastomeric core encapsulated within the top and bottom sheets, the core comprising acellular and noncrosslinked extracellular matrix particles or gel, wherein the core is deformable under stress to cushion forces between the mandibular condyle and the skull bones with which it articulates when the implant is affixed to an articulating surface in the TMJ, and wherein the top and bottom sheets extend radially from the core in an abutting relationship to form a brim comprising one or more surgical attachment sites, wherein the core is 8-12 mm wide and the implant is 16-20

Assignees

• Univ Pittsburgh—Of The Commonwealth System Of Higher Education

Inventors

• Badylak Stephen F
• Brown Bryan N
• Chung William L

Classifications

• A61L2430/06

  for cartilage reconstruction, e.g. meniscus · CPC title

• A61L27/58

  Materials at least partially resorbable by the body · CPC title

• A61L27/48

  with macromolecular fillers · CPC title

• A61L27/3633

  Extracellular matrix [ECM] · CPC title

• A61L27/14

  Macromolecular materials · CPC title