Biocompatible scaffolds with tissue fragments

• US 10,603,408 B2
• Filed: 10/31/2016
• Issued: 03/31/2020
• Est. Priority Date: 10/18/2002
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Binette, Francois, Hwang, Julia, Dhanaraj, Sridevi, Gosiewska, Anna
• Primary Examiner(s): Singh, Satyendra K
• Application Number:
  US15/338,895
• Publication Number:
  US 20170049931A1
• Time in Patent Office: 1,247 Days
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2430/06 for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 2430/10 for reconstruction of tendons or ligaments
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/36 containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• 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 27/3612 Cartilage, synovial fluid
• CPC Class Codes: A61L 27/3616 Blood, e.g. platelet-rich plasma
• CPC Class Codes: A61L 27/3817 Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/3895 using specific culture conditions, e.g. stimulating differentiation of stem cells, pulsatile flow conditions
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C12N 5/0068 General culture methods using substrates for specific animal cell type C12N5/06
• CPC Class Codes: C12N 5/0655 Chondrocytes; Cartilage

Abstract

A biocompatible tissue repair implant or scaffold device is provided for use in repairing a variety of tissue injuries, particularly injuries to cartilage, ligaments, tendons, and nerves. The repair procedures may be conducted with implants that contain a biological component that assists in healing or tissue repair. The biocompatible tissue repair implants include a biocompatible scaffold and particles of living tissue, such that the tissue and the scaffold become associated. The particles of living tissue contain one or more viable cells that can migrate from the tissue and populate the scaffold.

Claims

1. A method of treating a living tissue of a subject in need thereof, comprising:

forming a suspension including finely divided tissue fragments and a physiological buffering solution, the tissue fragments being free of bone tissue and comprising tissue selected from the group consisting of cartilage tissue, meniscal tissue, ligament tissue, and tendon tissue;

after forming the suspension, depositing the finely divided tissue fragments upon a biocompatible scaffold to form a tissue implant; and

implanting the tissue implant in a desired position relative to a cartilage tissue to be treated, wherein the finely divided tissue fragments have a size in the range of about 0.1 mm³ to about 3 mm³.

2. The method of claim 1, wherein the biocompatible scaffold comprises a synthetic polymer, a natural polymer, an injectable gel, a ceramic material, autogeneic tissue, allogeneic tissue, xenogeneic tissue, or combinations thereof.

3. The method of claim 1, further comprising affixing the tissue implant in the desired position relative to the tissue to be treated by applying at least one fastener to the tissue implant.

4. The method of claim 1, further comprising, after the depositing and prior to implanting the tissue implant in the desired position relative to the tissue to be treated, incubating the tissue implant for a duration and under conditions effective to allow cells within the sample of tissue to populate the biocompatible scaffold.

5. The method of claim 1, wherein the finely divided tissue fragments include viable cells that can migrate out of the finely divided tissue fragments and populate the biocompatible scaffold.

6. The method of claim 1, further comprising, after the depositing and prior to implanting the tissue implant in the desired position relative to the tissue to be treated, placing an additional biocompatible scaffold over the deposited finely divided tissue fragments such that at least a portion of the finely divided tissue fragments is disposed between the biocompatible scaffold and the additional biocompatible scaffold.

7. The method of claim 1, further comprising, prior to the depositing, filtering and concentrating the suspension to separate the tissue fragments from the physiological buffering solution.

8. The method of claim 1, wherein the depositing includes applying the suspension, including the tissue fragments and the physiological buffering solution, upon the scaffold.

9. A method of treating a living tissue of a subject in need thereof, comprising:

forming a suspension including finely divided tissue fragments and a physiological buffering solution, the tissue fragments comprising tissue selected from the group consisting of meniscal tissue, cartilage tissue, skin, synovial tissue, periosteal tissue, pericardial tissue, fat tissue, bone marrow, tendon tissue, ligament tissue, and combinations thereof;

after forming the suspension, depositing the finely divided tissue fragments upon a biocompatible scaffold to form a tissue implant; and

after the depositing, implanting the tissue implant in a desired position relative to a meniscal tissue to be treated, wherein the finely divided tissue fragments have a size in the range of about 0.1 mm³ to about 3 mm³.

10. The method of claim 9, wherein the biocompatible scaffold comprises a synthetic polymer, a natural polymer, an injectable gel, a ceramic material, autogeneic tissue, allogeneic tissue, xenogeneic tissue, or combinations thereof.

11. The method of claim 9, further comprising, prior to implanting the tissue implant in the desired position relative to the tissue to be treated, incubating the tissue implant for a duration and under conditions effective to allow cells within the sample of tissue to populate the biocompatible scaffold.

12. The method of claim 9, wherein the finely divided tissue fragments include viable cells that can migrate out of the finely divided tissue fragments and populate the biocompatible scaffold.

13. The method of claim 9, further comprising, prior to the depositing, filtering and concentrating the suspension to separate the tissue fragments from the physiological buffering solution.

14. The method of claim 9, wherein the depositing includes applying the suspension, including the tissue fragments and the physiological buffering solution, upon the scaffold.

15. A method of treating a living tissue of a subject in need thereof, comprising:

forming a suspension including finely divided tissue fragments and a physiological buffering solution, the tissue fragments comprising tissue selected from the group consisting of tendon tissue, ligament tissue, synovial tissue, periosteal tissue, fascia, skin, and combinations thereof;

after forming the suspension, depositing the finely divided tissue fragments upon a biocompatible scaffold to form a tissue implant; and

after the depositing, implanting the tissue implant in a desired position relative to a ligament tissue to be treated, wherein the finely divided tissue fragments have a size in the range of about 0.1 mm³ to about 3 mm³.

16. The method of claim 15, wherein the biocompatible scaffold comprises a synthetic polymer, a natural polymer, an injectable gel, a ceramic material, autogeneic tissue, allogeneic tissue, xenogeneic tissue, or combinations thereof.

17. The method of claim 15, further comprising, prior to implanting the tissue implant in the desired position relative to the tissue to be treated, incubating the tissue implant for a duration and under conditions effective to allow cells within the sample of tissue to populate the biocompatible scaffold.

18. The method of claim 15, wherein the finely divided tissue fragments include viable cells that can migrate out of the finely divided tissue fragments and populate the biocompatible scaffold.

19. The method of claim 15, further comprising, prior to the depositing, filtering and concentrating the suspension to separate the tissue fragments from the physiological buffering solution.

20. The method of claim 15, wherein the depositing includes applying the suspension, including the tissue fragments and the physiological buffering solution, upon the scaffold.