Compliant hydrophilic coatings for medical devices

Patent metadata

Field	Value
Publication number	US-10759957-B2
Application number	US-201715712809-A
Country	US
Kind code	B2
Filing date	Sep 22, 2017
Priority date	Sep 22, 2017
Publication date	Sep 1, 2020
Grant date	Sep 1, 2020

Abstract

Example compliant hydrophilic coatings including a base coat and a lubricious top coat for coating a medical device including a flexible substrate. The coatings exhibit reduced cracking and peeling in response to deformation or expansion of the flexible substrate. Example techniques for coating a medical device including a flexible substrate with compliant hydrophilic coatings.

First claim

What is claimed is:

1. A medical device comprising:
a flexible substrate defining a major surface; and
a compliant hydrophilic coating at least partially covering the major surface, wherein the compliant hydrophilic coating comprises a base coat and a lubricious top coat, wherein the base coat comprises a copolymer of a thermoplastic elastomer and ethyl acrylate,
wherein the compliant hydrophilic coating exhibits substantially no cracking or flaking in response to an expansion of the flexible substrate to 500% of an original size of the flexible substrate.

2. The medical device of claim 1 , wherein the base coat further comprises at least one of polyethylene oxide or N-vinyl pyrrolidone, and wherein the thermoplastic elastomer comprises at least one of a styrene-isoprene thermoplastic elastomer or a polyolefin elastomer.

3. The medical device of claim 1 , wherein the lubricious top coat comprises sodium hyaluronate and azaridine, or comprises a polymer selected from the group consisting of polyvinylpyrrolidone, polyethylene oxide, polypropylene oxide, polyacrylamide, methyl cellulose, polyacrylic acids, polyvinyl alcohols and combinations thereof.

4. The medical device of claim 1 , wherein the base coat is a product of thermal curing of a base coat precursor comprising a solvent, wherein the base coat precursor comprises, per 100 weight units of the solvent, about 2 weight units of ethyl acrylate, about 2 weight units of a styrene-isoprene thermoplastic elastomer, and about 1 weight unit of polyethylene oxide.

5. The medical device of claim 1 , wherein the base coat is a product of thermal curing of a base coat precursor comprising a solvent, wherein the base coat precursor comprises, per 100 weight units of the solvent, about 2 weight units of ethyl acrylate, about 2 weight units of a styrene-isoprene thermoplastic elastomer, about 2 weight units of a polyolefin elastomer, and about 1 weight unit of N-vinyl pyrrolidone.

6. The medical device of claim 1 , wherein the lubricious top coat is a product of thermal curing of a top coat precursor comprising water, wherein the top coat precursor comprises, per 100 weight units of water, between about 0.4 and about 40 weight units of sodium hyaluronate, between about 0.02 and 0.2 weight units of aziridine, and between 0.02 and 0.1 weight units of a surfactant.

7. The medical device of claim 1 , wherein the base coat is a product of ultraviolet (UV) curing of a base coat precursor comprising a solvent, wherein the base coat precursor comprises, per 100 weight units of the solvent, about 1.5 weight units of ethyl acrylate, about 1.5 weight units of a polyolefin elastomer, about 1 weight unit of N-vinyl pyrrolidone, and about 0.1 weight units of a UV photoinitiator.

8. The medical device of claim 7 , wherein the lubricious top coat is a product of UV curing of a top coat precursor comprising water, wherein the top coat precursor comprises, per 100 weight units of water, between about 0.2 and about 20 weight units of sodium hyaluronate, about 0.5 weight units of aziridine, about 10 weight units of polyvinyl methyl ether maleic anhydride, and between about 0.01 and about 0.05 weight units of the UV photoinitiator.

9. The medical device of claim 1 , wherein the base coat is a product of thermal curing of a base coat precursor comprising propylene glycol methyl ether acetate (PGMEA) as solvent, wherein the base coat precursor comprises, per 95 weight units of PGMEA, about 2 weight units of a 2% weight/volume solution of a styrene-isoprene thermoplastic elastomer ethyl acrylate in acetone, about 2 weight units of ethyl acrylate, and about 1 weight unit of 900 Dalton polyethylene oxide dissolved in methanol, and wherein the top coat is a product of thermal curing of a top coat precursor comprising water as solvent, wherein the top coat precursor comprises, per 100 weight units of water, about 2 weight units of sodium hyaluronate, about 0.05 weight units of aziridine, about 0.05 weight units of a surfactant, and about 2 weight units of 900 Dalton polyethylene oxide dissolved in methanol.

10. The medical device of claim 1 , wherein the medical device comprises a balloon comprising the flexible substrate.

11. The medical device of claim 1 , wherein the medical device comprises an elongated member comprising the flexible substrate.

12. A method comprising:
applying a base coat precursor comprising a copolymer of a thermoplastic elastomer and ethyl acrylate, and a solvent on a major surface defined by a flexible substrate of a medical device;
applying a top coat precursor on the base coat precursor; and
curing the base coat precursor and the top coat precursor to form a compliant hydrophilic coating including a base coat at least partially covering the substrate and a lubricious top coat on the base coat,
wherein the compliant hydrophilic coating exhibits substantially no cracking or flaking in response to an expansion of the flexible substrate to 500% of an original size of the flexible substrate.

13. The method of claim 12 , wherein the curing comprises thermal curing at least one of the base coat precursor and the lubricious top coat precursor.

14. The method of claim 12 , wherein the base coat precursor further comprises at least one of polyethylene oxide or N-vinyl pyrrolidone, and wherein the thermoplastic elastomer comprises at least one of a styrene-isoprene thermoplastic elastomer or a polyolefin elastomer.

15. The method of claim 12 , wherein the top coat precursor comprises sodium hyaluronate and azaridine, or comprises a polymer selected from a group consisting of polyvinylpyrrolidone, polyethylene oxide, polypropylene oxide, polyacrylamide, methyl cellulose, polyacrylic acids, polyvinyl alcohols, and combinations thereof.

16. The method of claim 12 , wherein curing the base coat precursor comprises thermal curing, and wherein the base coat precursor comprises a solvent, and per 100 weight units of the solvent, about 2 weight units of ethyl acrylate, about 2 weight units of a styrene-isoprene thermoplastic elastomer, and about 1 weight unit of polyethylene oxide.

17. The method of claim 12 , wherein curing the base coat precursor comprises thermal curing, and wherein the base coat precursor comprises a solvent, and per 100 weight units of the solvent, about 2 weight units of ethyl acrylate, about 2 weight units of a styrene-isoprene thermoplastic elastomer, about 2 weight units of a polyolefin elastomer, and about 1 weight unit of N-vinyl pyrrolidone.

18. The method of claim 12 , wherein curing the top coat precursor comprises thermal curing, and wherein the top coat precursor comprises water, and wherein the top coat precursor comprises, per 100 weight units of water, between about 0.4 and about 40 weight units of sodium hyaluronate, between about 0.02 and 0.2 weight units of aziridine, and between 0.02 and 0.1 weight units of a surfactant.

19. The method of claim 12 , wherein curing the base coat precursor comprises ultraviolet (UV) curing, and wherein the base coat precursor comprises a solvent, and per 100 weight units of the solvent, about 1.5 weight units of ethyl acrylate, about 1.5 weight units of a polyolefin elastomer, about 1 weight unit of N-vinyl pyrrolidone, and about 0.1 weight units of a UV photoinitiator.

Assignees

• Covidien Lp

Inventors

• Wang Edwin
• Bon Edwin

Classifications

• A61L29/085 Primary

  Macromolecular materials · CPC title

• A61L2420/02

  Methods for coating medical devices · CPC title

• A61L2420/08

  Coatings comprising two or more layers · CPC title

• A61L29/14

  Materials characterised by their function or physical properties {, e.g. lubricating compositions} · CPC title

• C08L23/16

  Ethylene-propylene or ethylene-propylene-diene copolymers · CPC title