SURFACE MODIFICATION FOR COATING

• US 20100286766A1
• Filed: 05/07/2010
• Published: 11/11/2010
• Est. Priority Date: 05/08/2009
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Ye, Qingshan
• Granted Patent: US 9,289,540 B2
• Time in Patent Office: Days
• US Class Current: 623/1.46
• CPC Class Codes: A61L 33/0017 using a surface active agent
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses or catheter
• CPC Class Codes: B32B 27/283 comprising polysiloxanes
• CPC Class Codes: B32B 27/285 comprising polyethers
• CPC Class Codes: B32B 27/34 comprising polyamides
• CPC Class Codes: B32B 27/365 comprising polycarbonates
• CPC Class Codes: B32B 27/40 comprising polyurethanes
• 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 428/31507 Of polycarbonate
• CPC Class Codes: Y10T 428/31551 Of polyamidoester [polyurethane, polyisocyanate, polycarbamate, etc.]
• CPC Class Codes: Y10T 428/31678 Of metal
• CPC Class Codes: Y10T 428/31725 Of polyamide

Abstract

A modified medical device substrate surface designed to improve adhesion of biomimetic surfactants to the medical device surface, thus reducing the risk of thrombosis is described. The surface modification is accomplished through either an application of a tie layer of a hydrophobic material on the substrate surface intermediate the biomimetic coating or through incorporation of a hydrophobic dopant in the polymeric substrate prior to extrusion or molding. Either method creates a hydrophobically modified surface that enhances the biomimetic surfactant bonding strength.

Claims

1. A substrate surface modified with a hydrophobic material to improve adhesion between a biomimetic surfactant and the substrate surface, the modified substrate comprising:

a substrate surface that is in contact with a hydrophobic tie layer, placed between the substrate surface and the biomimetic surfactant; and

wherein a tie layer bottom surface hydrophobically bonds with the substrate surface and a tie layer top surface hydrophobically bonds with the biomimetic surfactant.

2. The substrate of claim 1 wherein an alkyl chain of the biomimetic surfactant hydrophobically associates with the hydrophobic material creating a bond therebetween.

3. The substrate of claim 1 wherein the hydrophobic material is selected from the group consisting of an unsaturated long chain carboxylic acid amide, polyurethane polycarbonate copolymer, silicone polycarbonate copolymer and parylene.

4. The substrate of claim 1 wherein the hydrophobic material is erucamide.

5. The substrate of claim 1 wherein the biomimetic coating material is selected from the group consisting of poly(N-vinyldextran aldonamide-co-N-vinylhexanamide), poly(N-vinyl dextran aldonamide-co-N-vinyl dodecanoamide) (PNVDA-co-PNVL), poly(N-vinyl hexyl amine-co-N-vinyl heparinamine) (PNVHA-co-PNVHep A), poly(N-vinyl hexyl amine-co-N-vinyl heparinamine-co-N-vinyl maltonoamide) (PNVHA-co-PN-VHepA-co-PNVM), and poly(N-vinyl-5-peptidyl-pentylamine-co-N-vinyl-dextranaldonamine-co-N-vinyl hexyl amine (PVAm(Pep:

Dex;

Hex)).

6. The substrate of claim 1 wherein the substrate material is selected from the group consisting of silicon, polyurethane, polyether block amide (PEBA), stainless steel, titanium, gold, platinum, palladium, silver, polycarbonate and polyurethane.

7. The substrate of claim 1 wherein the substrate surface is a surface selected from the group of medical devices comprising of a pacemaker, a defibrillator, a neurostimulator, an introducer, a lead, a catheter and a stent.

8. The substrate of claim 1 wherein the thickness of the hydrophobic tie layer is from about 0.1 nanometers to about 2.5 nanometers.

9. The substrate of claim 1 wherein the thickness of the hydrophobic tie layer is from about 2.5 nanometers to about 1 micrometer.

10. The substrate of claim 1 wherein the thickness of the hydrophobic tie layer is from about 1 micrometer to about 100 micrometers.

11. A substrate modified with a dopant to improve adhesion between a biomimetic surfactant and a substrate surface, the dopant comprising:

a dopant mixture of a hydrophobic component and a solvent that is incorporated into the substrate during processing of the substrate; and

wherein the hydrophobic component bonds with the biomimetic surfactant.

12. The substrate of claim 11 wherein the concentration of the hydrophobic component in the dopant mixture ranges from about 0.1 to about 10 weight percent.

13. The substrate of claim 11 wherein the concentration of the dopant mixture in the substrate ranges from about 1 to 30 weight percent.

14. The substrate of claim 11 wherein the hydrophobic component comprises an unsaturated long chain carboxylic acid amide.

15. The substrate of claim 11 wherein the solvent is selected from the group consisting of tetrahydrofuran, dimethylsulfoxide, ethanol, methanol, ethylacetate, dimethylformamide, dimethyacetamide, dioxane, N-methylpyrollidone, chloroform, hexane, heptanes, cyclohexane, toluene, formic acid, acetic acid, dichloromethane, and mixtures thereof.

16. The substrate of claim 11 wherein the biomimetic surfactant is selected from the group consisting of poly(N-vinyl dextran aldonamide-co-N-vinyl hexanoamide), poly(N-vinyl dextran aldonamide-co-N-vinyl dodecanoamide) (PNVDA-co-PNVL), poly(N-vinyl hexyl amine-co-N-vinyl heparinamine) (PNVHA-co-PNVHep A), poly(N-vinyl hexyl amine-co-N-vinyl heparinamine-co-N-vinyl maltonoamide) (PNVHA-co-PN-VHepA-co-PNVM), and poly(N-vinyl-5-peptidyl-pentylamine-co-N-vinyl-dextranaldonamine-co-N-vinyl hexyl amine (PVAm(Pep:

Dex;

Hex)).

17. A method for increasing the hydrophobicity of a substrate surface to enhance the adhesion of a biomimetic surfactant polymer to the substrate surface, the method comprising:

a) providing a substrate;

b) incorporating a hydrophobic material with the substrate; and

d) applying the biomimetic surfactant polymer over a substrate surface, wherein a hydrophobic interaction bonds the substrate surface to the biomimetic surfactant polymer.

18. The method of claim 17 wherein the hydrophobic material is a dopant comprising an unsaturated long chain carboxylic acid amide that is incorporated into the substrate during processing of the substrate.

19. The method of claim 17 wherein the hydrophobic material comprises a tie layer that is placed between the substrate surface and the biomimetic surfactant polymer.

20. The method of claim 19 wherein the tie layer comprises a mixture of a hydrophobic component and a solvent.

21. The method of claim 19 wherein the hydrophobic component is selected from the group consisting of an unsaturated long chain carboxylic acid amide, polyurethane polycarbonate copolymer, silicone polycarbonate copolymer, and parylene.

22. The method of claim 20 wherein the solvent is selected from the group consisting of tetrahydrofuran, dimethylsulfoxide, ethanol, methanol, ethylacetate, dimethylformamide, dimethyacetamide, dioxane, N-methylpyrollidone, chloroform, hexane, heptanes, cyclohexane, toluene, formic acid, acetic acid, dichloromethane, and mixtures thereof.

23. The method of claim 17 wherein the substrate surface is selected from the group consisting of silicon, polyurethane, polyether block amide (PEBA), polycarbonate, stainless steel, titanium, gold, platinum, palladium, and silver.

24. The method of claim 17 wherein the substrate surface is a surface selected from the group of medical devices consisting of a pacemaker, a defibrillator, a neurostimulator, an introducer, a lead, a catheter, and a stent.

25. The method of claim 17 wherein the biomimetic surfactant material is selected from the group consisting of poly(N-vinyl dextran aldonamide-co-N-vinyl hexanoamide), poly(N-vinyl dectran aldonamide) (PNVDA-co-PNVH), poly(N-vinyl dextran aldonamide-co-N-vinyl dodecanoamide) (PNVDA-co-PNVL), poly(N-vinyl hexyl amine-co-N-vinyl heparinamine) (PNVHA-co-PNVHep A), poly(N-vinyl hexyl amine-co-N-vinyl heparinamine-co-N-vinyl maltonoamide) (PNVHA-co-PN-VHepA-co-PNVM), and poly(N-vinyl-5-peptidyl-pentylamine-co-N-vinyl-dextranaldonamine-co-N-vinyl hexyl amine (PVAm(Pep:

Dex;

Hex)).