Compositions for repair of defects in osseous tissues, and methods of making the same

• US 10,300,170 B2
• Filed: 02/26/2018
• Issued: 05/28/2019
• Est. Priority Date: 06/26/2002
• Status: Active Grant

• Current Assignee: LifeNet Health, Inc.
• Original Assignee: LifeNet Health, Inc.
• Inventors: Masinaei, Leila, Wolfinbarger, Jr., Lloyd
• Primary Examiner(s): Davis, Ruth A
• Application Number:
  US15/904,670
• Publication Number:
  US 20180177916A1
• Time in Patent Office: 456 Days
• CPC Class Codes: A61K 35/32 Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Tissue repair compositions, particularly bone repair compositions, containing demineralized bone fragments and homogenized connective tissues, and methods for making the same. The compositions can be used in the form of an injectable gel, an injectable paste, a paste, a putty, or a rehydratable freeze-dried form.

Claims

1. A tissue repair composition comprising (i) one or more bone component and (ii) uniform connective tissue or skin particles.

2. The tissue repair composition of claim 1, wherein the bone component is a demineralized bone fragment.

3. The tissue repair composition of claim 2, wherein the composition comprises between about 20% and about 80% demineralized bone fragments.

4. The tissue repair composition of claim 2, wherein the tissue repair composition comprises a plurality of demineralized bone fragments.

5. The tissue repair composition of claim 4, wherein the demineralized bone fragments are demineralized bone fibers having an average thickness of between about 0.1 mm and about 0.3 mm and an average width of between about 0.3 mm and about 1.0 mm.

6. The tissue repair composition of claim 1, wherein the composition is in the form of a gel, a paste, a putty, or a rehydratable free-dried form.

7. The tissue repair composition of claim 1, wherein the composition is in the form of a gel.

8. The tissue repair composition of claim 1, wherein the composition is injectable.

9. The tissue repair composition of claim 8, wherein the composition is extrudable through a syringe having at least a 13 gauge tube or needle.

10. The tissue repair composition of claim 1, wherein the composition further comprises water, an aqueous solution, or a water miscible polar organic solvent.

11. The tissue repair composition of claim 1, wherein the composition is aseptic or sterile.

12. The tissue repair composition of claim 1, wherein the bone component and/or the connective tissue or skin is derived from allogenic or xenogenic sources.

13. The tissue repair composition of claim 1, wherein the bone component is cancellous, cortical, or cortico-cancellous bone.

14. The tissue repair composition of claim 13, wherein the composition comprises bone components from more than one type of bone tissue.

15. The tissue repair composition of claim 14, wherein the bone component is a bone particle or a bone fiber.

16. The tissue repair composition of claim 1, wherein the connective tissue or skin particles are prepared from connective tissue or skin obtained from a single source.

17. The tissue repair composition of claim 1, wherein the connective tissue or skin particles are prepared from connective tissue or skin obtained from a single vertebrate source.

18. The tissue repair composition of claim 1, wherein the connective tissue or skin particles are derived from at least one of a human source, a bovine source, an equine source, a porcine source, an ovine source, a caprine source and a piscene source.

19. The tissue repair composition of claim 1, wherein the bone component is a demineralized, cortical bone particle.

20. The tissue repair composition of claim 1, wherein the bone component is a demineralized, cancellous bone.

21. The tissue repair composition of claim 1, wherein the tissue repair composition comprises the connective tissue particles, and the connective tissue particles comprise cartilage tissue.

22. The tissue repair composition of claim 21, wherein the bone component is a demineralized bone.

23. The tissue repair composition of claim 1, said particles having an average diameter of less than about 50 microns.

24. The tissue repair composition of claim 1, wherein the tissue repair composition comprises the connective tissue particles, said particles having an average diameter greater than about 5 microns.

25. The tissue repair composition of claim 1, wherein the tissue repair composition comprises the bone component in an amount of between about 5 wt % and about 80 wt % of the tissue repair composition.

26. The tissue repair composition of claim 1, wherein the tissue repair composition comprises the bone component in an amount of between about 30 wt % and about 50 wt % of the tissue repair composition.