COATED BIOLOGICAL MATERIAL HAVING IMPROVED PROPERTIES

• US 20120221099A1
• Filed: 01/20/2012
• Published: 08/30/2012
• Est. Priority Date: 02/24/2011
• Status: Abandoned Application

• Current Assignee: Biotronik AG (Biotronik SE & Company KG)
• Original Assignee: Biotronik AG (Biotronik SE & Company KG)
• Inventors: Borck, Alexander, Rzany, Alexander
• Application Number:
  US13/354,392
• Publication Number:
  US 20120221099A1
• Time in Patent Office: Days
• US Class Current: 623/2.1
• CPC Class Codes: A61L 2400/02 Treatment of implants to prevent calcification or mineralisation in vivo
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/30 Inorganic materials
• 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 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: Y10T 428/263 Coating layer not in excess of 5 mils thick or equivalent
• CPC Class Codes: Y10T 428/265 1 mil or less
• CPC Class Codes: Y10T 428/31678 Of metal

Abstract

Some embodiments of the present invention relate to coated biological material for the manufacture of heart valve prostheses, characterized in that the surface of the biological material is covered entirely or partially with a coating which contains or is composed of a biocompatible anorganic material, and to a process for manufacturing such a coated biological material.

Claims

1. A coated biological material for the manufacture of heart valve prostheses, characterized in that the surface of the biological material is covered entirely or partially with a coating comprising a biocompatible anorganic material.

2. The coated biological material according to claim 1, wherein the biological material comprises an extracellular matrix.

3. The coated biological material according to claim 1, wherein the biological material is obtained from one or more of pericardial, cardiac, venous and aortic tissue.

4. The coated biological material according to claim 1, wherein the biological material is one of human, porcine, bovine, or equine origin.

5. The coated biological material according to claim 1, wherein the coating of a biocompatible anorganic material has a mean layer thickness of 10 nm to 100 μ

m.

6. The coated biological material according to claim 1, wherein the biocompatible anorganic material comprises one or more of a metal, a metal alloy, a polymer, a ceramic material or amorphous carbon, preferably tantalum, nickel, titanium, Nitinol, stainless steel, alloys thereof, Co/Cr alloys and amorphous carbon having an sp² hybridization portion of 30% to 70%, and amorphous carbon having an sp³ hybridization portion of 70% to 30% (“

diamond-like carbon”

or DLC).

7. The biological material of claim 1 wherein the material is configured as a valve cusp for use in a heart valve prosthesis.

8. The biological material of claim 1 wherein the material is configured as a valve cusp of a heart valve prosthesis.

18. The coated biological material according to claim 1, wherein:

the biological material is xenogenic;

the layer consists entirely of the biocompatible anorganic material;

the biological material comprises decellularized extracellular matrix; and

,

the layer blocks the biological signature of the xenogenic biological material, thereby preventing rejection reactions when the biological material is in a physiologic environment.

19. The coated biological material according to claim 1, wherein:

the coating consists entirely of the biocompatible anorganic material;

the layer has a mean layer thickness of 100 nm to 3 μ

m; and

,

wherein any imunogenic components of the biological material are thereby insulated from exposure to the surrounding environment by the biocompatible anorganic coating.

9. A process for manufacturing a coated biological material comprising the steps of using pulsed laser deposition (PLD) to deposit a coating on at least a portion of the biological material, the coating comprising a biocompatible anorganic material.

10. The process according to claim 9, wherein a pulsed laser having a frequency of 1 Hz to 300 Hz, a pulse duration of 0.1 ns to 200 ns and/or an energy density of 0.1 J/cm² to 30 J/cm² is used for the pulsed laser deposition.

11. The process according to claim 9, wherein one of a pulsed excimer laser, a CO₂ laser and an Nd:

YAG laser is used for the pulsed laser deposition.

12. The process according to claim 9, wherein the pulsed laser deposition takes place in a vacuum at a pressure that does not exceed 1 mbar.

13. The process according to claim 9, wherein the pulsed laser deposition takes place under aseptic conditions.

14. The process according to claim 9, wherein the biocompatible anorganic material is deposited onto the biocompatible anorganic material with a mean layer thickness of 10 nm to 100 μ

m.

15. The process according to claim 9, wherein the biocompatible anorganic material is comprises one of a metal, a metal alloy, a polymer, a ceramic material or amorphous carbon, preferably tantalum, nickel, titanium, Nitinol, stainless steel, alloys thereof, Co/Cr alloys and amorphous carbon having an sp² hybridization portion of 30% to 70%, or an sp³ hybridization portion of 70% to 30% (“

diamond-like carbon”

or DLC).

16. The process according to claim 9 wherein the layer consists entirely of the biocompatible anorganic material and wherein the biocompatible anorganic material comprises amorphous carbon having one of an sp² hybridization portion of 30% to 70% and an sp³ hybridization portion of 70% to 30%.

17. The process according to claim 9 wherein the layer consists entirely of the biocompatible anorganic material and wherein the mean layer thickness is 100 nm to 3 μ

m.

20. A process for manufacturing a valve cusp of a heart valve prosthesis comprising the steps of:

providing a valve cusp made of a biologic material comprising a decellulariced extracellular matrix;

operating pulsed laser deposition (PLD) at a frequency of 1 Hz to 300 Hz, a pulse duration of 0.1 ns to 200 ns and an energy density of 0.1 J/cm² to 30 J/cm² to coat the surface of the valve cusp with a coating layer having a thickness of between about 100 nm to 3 μ

m, the layer consisting entirely of a biocompatible anorganic material that comprises amorphous carbon having one of an sp² hybridization portion of 30% to 70% and an sp³ hybridization portion of 70% to 30%; and

,

wherein any imunogenic components of the valve cusp are thereby insulated from exposure to the surrounding environment by the biocompatible anorganic coating.