Joint bioscaffolds

Patent metadata

Field	Value
Publication number	US-9848987-B2
Application number	US-201615009565-A
Country	US
Kind code	B2
Filing date	Jan 28, 2016
Priority date	Feb 27, 2009
Publication date	Dec 26, 2017
Grant date	Dec 26, 2017

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 bioscaffold for replacement and regeneration of a temporomandibular joint (TMJ) meniscus, 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 raised central core having a curved top surface, and the core is surrounded by a substantially flat peripheral brim extending around the core, wherein the core comprises a gel or particulate powder extracellular matrix and has a circular or elliptical base and a height above the base and composition that permits the core to elastically deform under stress, and a 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 condylar head of a mandible or a zygomatic bone in the TMJ as a replacement for a TMJ meniscus following TMJ meniscectomy.

2. The bioscaffold of claim 1 , wherein the circular base has a substantially uniform diameter, and the elliptical base has a major diameter and a minor diameter.

3. The bioscaffold of claim 1 , wherein the gel or particulate extracellular matrix powder within the core allows compression of the core to allow it to deform under stress when the implant is affixed to the articulating surface of the TMJ.

4. The bioscaffold of claim 3 , wherein the core comprises salt-precipitated lyophilized and fractured extracellular matrix powder consisting essentially of particles having a particle size from 10 to 400 microns.

5. The bioscaffold of claim 4 , wherein the particles have an average particle size of 150 to 200 microns.

6. The bioscaffold of claim 3 , wherein the core comprises the particulate powder.

7. The bioscaffold of claim 3 , wherein the raised core comprises an acellular and noncrosslinked extracellular matrix.

8. The bioscaffold of claim 1 , wherein the implant comprises one or more layers of a biocompatible material.

9. The bioscaffold of claim 1 , wherein the core is encased in a plurality of layers of extracellular matrix.

10. The bioscaffold of claim 9 , wherein the plurality of layers of extracellular matrix comprise at least one of the top or bottom sheets being formed from two layers of biocompatible material encapsulating the core.

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

12. The bioscaffold of claim 11 , wherein at least a portion of the top or bottom sheets comprises basement membrane.

13. The bioscaffold of claim 11 , 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.

14. The bioscaffold of claim 1 , wherein the bioscaffold additionally comprises a synthetic elastomeric polymer that imparts flexibility to the bioscaffold, wherein the bioscaffold is more elastic than native TMJ disc.

15. The bioscaffold of claim 1 , wherein the core comprises a top surface for articulating with the zygomatic bone, wherein the top surface is concave, convex, biconcave, biconvex, or a combination thereof.

16. The bioscaffold of claim 15 , wherein the core comprises a convex pillow extending from the base.

17. The bioscaffold of claim 1 , wherein the core forms a nonplanar pillow 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.

18. The bioscaffold of claim 1 , further comprising surgical attachment sites in the brim.

19. A method for replacing and regenerating a TMJ meniscus of a subject after the meniscus has been surgically removed, the method comprising:
implanting the bioscaffold of claim 1 at an articulating site of the TMJ of a mammal by securing the brim to an attachment site in the TMJ on the condylar head of the mandible or zygomatic bone of the mammal.

20. The method of claim 19 further comprising removing substantially all of a temporomandibular joint (TMJ) meniscus from a mammal thereby creating the attachment site, and replacing the TMJ meniscus with the bioscaffold.

21. The method of claim 20 wherein the method further comprises affixing the bioscaffold to the attachment site for a sufficient period of time to induce reconstruction of the TMJ meniscus in vivo.

Assignees

• Univ Of Pittsburgh—Of The Commonwealth System Of Higher Education
• Univ Of 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