Surface modified surgical instruments, medical devices, implants, contact lenses and the like

• US 5,885,566 A
• Filed: 09/25/1996
• Issued: 03/23/1999
• Est. Priority Date: 09/25/1996
• Status: Expired due to Fees

• Current Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: University of Florida (State University System of Florida)
• Inventors: Goldberg, Eugene P.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Shelborne, Kathryne E.
• Application Number:
  US08/719,765
• Time in Patent Office: 909 Days
• Field of Search: 424/78.18, 424/78.24, 424/422, 424/423, 424/427, 424/429
• US Class Current: 424/78.18
• CPC Class Codes: A61F 2/16 Intraocular lenses
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: C08L 33/02 Homopolymers or copolymers of acids; Metal or ammonium salts thereof
• CPC Class Codes: C08L 33/14 of esters containing halogen, nitrogen, sulfur, or oxygen atoms in addition to the carboxy oxygen
• CPC Class Codes: C08L 39/06 Homopolymers or copolymers of N-vinyl-pyrrolidones

Abstract

Improved medical devices and instruments prepared by an improved method of producing hydrophilic, gamma-irradiation induced polymerized and chemically grafted coatings on plastic surfaces of articles adapted for contacting living tissue, the improvement comprising carrying out the graft polymerization in an aqueous solution under specific combinations of the following conditions:

(a) monomer concentration in the range of from about 0.1% to about 50%, by weight;

(b) total gamma dose in the range of from about 0.001 to less than about 0.50 Mrad; and

(c) gamma dose rate in the range of from above about 2,500 to about 10⁸ rads/minute.

Claims

1. In a method for modifying a plastic surface of an article, said surface adapted for contact with living tissue of a human or non-human animal, by the gamma-irradiation induced polymerized, chemically grafted coating thereon of:

(1) a monomer comprising N-vinylpyrrolidone (NVP),

(2) a monomer comprising2-hydroxyethylmethacrylate (HEMA),

(3) a mixture of (NVP) and (HEMA), (NVP-HEMA), or

(4) a mixture of (1), (2) or (3) with up to about 50 wt. %, based on the total monomer weight, of an ionic monomer, salt of an ionic monomer or mixture thereof, so as to form a hydrophilic graft polymer coating of (i) polyvinylpyrrolidone (PVP), (ii) poly-2-hydroxyethylmethacrylate (PHEMA), (iii) a copolymer of (NVP) and (HEMA), or (iv) a copolymer of (NVP), (HEMA) or (NVP-HEMA) and said ionic monomer on said surface, the improvement comprising;

conducting said gamma-irradiation induced graft polymerization in an aqueous solution under the following conditions;

(a) monomer concentration in the range of from about 0.1% to about 50%, by weight;

(b) total gamma dose in the range of from about 0.001 to less than about 0.50 Mrad; and

(c) gamma dose rate in the range of from above 2,500 to about 10⁸ rads/minute.

2. The method of claim 1, further including one or more of the following conditions:

(d) substantially excluding free oxygen from said graft polymerization solution;

(e) maintaining the thickness of said polymer coating in the range of from about 100 Å

to about 100 microns;

(f) including a free radical scavenger in said aqueous graft polymerization solution; and

(g) including in said aqueous graft polymerization solution a swelling solvent for said plastic surface.

3. The method of claim 1, further including the step of pre-soaking said plastic surface in at least one of said monomers or in a first aqueous solution of at least one of said monomers, having a concentration of monomer therein of from about 5% to about 95%, by weight, prior to conducting said gamma-irradiation induced graft polymerization, said pre-soaking in step (a) being conducted for a period of time and at a temperature sufficient to facilitate diffusion of said monomer or monomers into said plastic surface.

4. The method of claim 3, wherein said pre-soaking step is conducted at a temperature in the range of from about 25°

to about 90°

C. and for a period of time of from about 0.5 to about 48 hours.

5. The method of claim 1 or 3, wherein said article is a surgical instrument.

6. The method of claim 1 or 3 wherein said article is a medical device.

7. The method of claim 1 or 3, wherein said article is a prosthetic implant.

8. The method of claim 1 or 3, wherein said article is a soft or hard contact lens.

9. The method of claim 1 or 3, wherein said ionic monomer is a vinylsulfonic acid, a vinylcarboxylic acid or a salt thereof.

10. The method of claim 9, wherein said vinylcarboxylic acid is acrylic, methacrylic or crotonic acid.

11. The method of claim 9, wherein said vinylsulfonic acid is sulfoethylmethacrylate, sulfopropylmethacrylate, styrene sulfonic acid or vinylsulfonic acid.

12. The method of claim 1 or 3, wherein said ionic monomer is an amino-functional monomer.

13. The method of claim 12, wherein said amino-functional monomer is a vinylpyridine, an aminostyrene, an aminoacrylate or an aminomethacrylate.

14. The method of claim 1 or 3, wherein said plastic is selected from the group consisting of polyacrylates, polymethacrylates, polyolefins, ethylene-propylene copolymers, polybutadiene, styrene-butadiene copolymers, styrene-ethylene-butadiene copolymers, polycarbonates, fluorocarbon polymers, polysiloxanes, polyurethanes, polyvinylchloride, polyesters and mixtures thereof.

15. An article of manufacture prepared according to the method of claim 1 or 3.

16. An article according to claim 15, comprising a surgical instrument, medical device, prosthetic implant or contact lens.