Hybrid biologic-synthetic bioabsorbable scaffolds

• US 7,569,233 B2
• Filed: 04/20/2005
• Issued: 08/04/2009
• Est. Priority Date: 05/04/2004
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Inventors: Whalen, Terrence D., Malaviya, Prasanna, Orban, Janine M., Jenks, Philip J.
• Primary Examiner(s): Weber; Jon P
• Assistant Examiner(s): Srivastava; Kailash C
• Application Number:
  US11/110,169
• Publication Number:
  US 20050249771A1
• Time in Patent Office: 1,567 Days
• Field of Search: None
• US Class Current: 424/422
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation

Abstract

A bioprosthetic device is provided for soft tissue attachment, reinforcement, and or reconstruction. The device comprises a naturally occurring extracellular matrix portion and a synthetic portion.

Claims

1. A method of making a bioprosthetic device, the method comprising the steps of:

coating a synthetic layer with a comminuted naturally occurring extracellular matrix material;

positioning the coated synthetic layer between a first layer of naturally occurring extracellular matrix material and a second layer of naturally occurring extracellular matrix material to make an assembly; and

applying positive pressure to the assembly to initiate lamination of the first and second layers of naturally occurring extracellular matrix material to the coated synthetic layer.

3. The method of claim 1, wherein the applying step comprises pressing the assembly together.

4. The method of claim 1, wherein the applying step comprises pressing the assembly with a pneumatic press.

5. The method of claim 1, wherein the applying step comprises:

positioning the assembly in a press, and

operating the press to exert pressure on assembly.

6. The method of claim 1, further comprising the step of drying the assembly after the applying step.

7. The method of claim 1, wherein both the first and second naturally occurring extracellular matrix material layers comprise a small intestine submucosa (SIS) layer.

8. The method of claim 1, wherein the synthetic layer comprises a fibrous material.

9. The method of claim 1, wherein the coating step comprises immersing the synthetic layer in a suspension of comminuted naturally occurring extracellular matrix material.

10. The method of claim 1, wherein the applying step comprises applying a compressive force that creates an average lamination pressure of approximately 180 psi on the assembly.

11. The method of claim 6, wherein the drying step comprises drying the assembly under vacuum pressure.

12. The method of claim 7, wherein the SIS layer comprises a plurality of SIS strips laminated together.

13. The method of claim 7, wherein the SIS layer comprises a woven mesh of strips of SIS.

14. The method of claim 8, wherein the fibrous material is selected from the group consisting of mesh, textile, and felt.

15. The method of claim 8, wherein the fibrous material is a bioabsorbable material selected from the group consisting of polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polydioxanone (PDO), trimethylene carbonate (TMC), polyvinyl alcohol (PVA), copolyiners thereof, and blends thereof.

2. A method of making a bioprosthetic device, the method comprising the steps of:

coating a synthetic layer with comminuted naturally occurring extracellular matrix material;

positioning the coated synthetic layer between a first layer of naturally occurring extracellular matrix material and a second layer of naturally occurring extracellular matrix material to make an assembly; and

operating a press to exert positive pressure on the assembly to initiate lamination of the first and second layers of naturally occurring extracellular matrix material to the coated synthetic layer.

16. The method of claim 2, wherein the operating step comprises operating a pneumatic press to exert positive pressure on the assembly.

17. The method of claim 2, further comprising the step of drying the assembly after the operating step.

18. The method of claim 2, wherein both the first and second naturally occurring extracellular matrix material layers comprise an SIS layer.

19. The method of claim 2, wherein the SIS layer comprises a woven mesh of strips of SIS.

20. The method of claim 2, wherein the synthetic layer comprises a fibrous material.

21. The method of claim 2, wherein the operating step comprises operating the press to exert a compressive force that creates an average lamination pressure of approximately 180 psi on the assembly.

23. The method of claim 18, wherein the SIS layer comprises a plurality of SIS strips laminated together.

24. The method of claim 20, wherein the fibrous material is selected from the group consisting of mesh, textile, and felt.

25. The method of claim 20, wherein the fibrous material is a bioabsorbable material selected from the group consisting of PLA, PGA, PCL, PDO, TMC, PVA, copolyiners thereof, and blends thereof.

22. The method of 17, wherein the drying step comprises drying the assembly under vacuum pressure.