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

• US 9,962,467 B2
• Filed: 04/17/2015
• Issued: 05/08/2018
• 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
• Application Number:
  US14/689,221
• Publication Number:
  US 20150217023A1
• Time in Patent Office: 1,117 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 method of preparing a tissue repair composition comprising,

providing at least one connective tissue and at least one bone tissue from at least one cadaver,

freeze-drying the connective tissue,

crudely fragmenting the connective tissue,

adding at least one of water, an aqueous solution;

or a water miscible polar organic solvent to the crude fragments to produce a mixture,

homogenizing the mixture to produce a connective tissue homogenate,

fragmenting the bone tissue,

demineralizing the bone fragments, freeze-drying the demineralized bone fragments,

selecting demineralized bone fragments of a particular range, and

combining the selected demineralized bone fragments with the connective tissue homogenate to produce the tissue repair composition.

2. The method of claim 1, further comprising packaging the tissue repair composition.

3. The method of claim 2, further comprising sterilizing the packaged tissue repair composition.

4. The method of claim 1, wherein the connective tissue is fascia.

5. The method of claim 1, wherein the connective tissue and the bone tissue are obtained from a single cadaver.

6. The method of claim 1, wherein the aqueous solution comprises isotonic saline.

7. The method of claim 1, wherein the connective tissue homogenate is heated.

8. The method of claim 1, further comprising heating the tissue repair composition.

9. The method of claim 1, wherein a blender is employed for the homogenizing.

10. The method of claim 1, wherein the mixture is heated to a temperature of about 100°

C.

11. The method of claim 10, wherein a microwave oven is used for the heating.

12. The method of claim 11, wherein the connective tissue homogenate is heated and homogenized a second time before being combined with the demineralized bone fragments.

13. The method of claim 1, wherein sieves are employed for the selecting.

14. The method of claim 1, wherein the selected demineralized bone fragments have an average diameter of between 250 and 150 microns.

15. The method of claim 1, wherein the composition comprises between about 5 wt % and about 80 wt % of the selected demineralized bone fragments.

16. A tissue repair composition prepared by a method comprising,

providing at least one connective tissue and at least one bone tissue from a cadaver,

freeze-drying the connective tissue,

crudely fragmenting the connective tissue,

adding at least one of water, an aqueous solution, and a water miscible polar organic solvent to the crude fragments,

heating the water, aqueous solution, or solvent with the crude fragments to produce a mixture,

homogenizing the mixture to produce a connective tissue homogenate,

fragmenting the bone tissue, demineralizing the bone fragments,

freeze-drying the demineralized bone fragments,

selecting demineralized bone fragments having an average size within a particular range, and

combining the selected demineralized bone fragments of the particular range with the connective tissue homogenate to produce the tissue repair composition.