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

• US 5,094,876 A
• Filed: 10/05/1990
• Issued: 03/10/1992
• Est. Priority Date: 04/10/1987
• Status: Expired due to Term

• Current Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: University of Florida (State University System of Florida)
• Inventors: Vahiaoui, Ali, Goldberg, Eugene P.
• Primary Examiner(s): LUSIGNAN, MICHAEL R
• Application Number:
  US07/592,484
• Time in Patent Office: 522 Days
• Field of Search: 427/2, 427/36, 522/84, 522/85, 522/167, 604/96, 606/107, 623/1, 623/3, 623/66
• US Class Current: 428/481
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 2/1664 for manual insertion during surgery, e.g. forceps-like instruments
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: Y10S 623/92 Method or apparatus for preparing or treating prosthetic
• CPC Class Codes: Y10T 428/3179 Next to cellulosic
• CPC Class Codes: Y10T 428/31794 Of cross-linked polyester
• CPC Class Codes: Y10T 428/31797 Next to addition polymer from unsaturated monomers

Abstract

An improved method for modifying the plastic surfaces of articles adapted for contacting living tissue by the gamma or electron beam irradiation induced chemical graft coating thereon of a monomer comprising N-vinylpyrrolidone, 2-hydroxyethylmethacrylate or a mixture of the two to form a hydrophilic graft polymer coating, the improvement comprising pre-soaking the ocular implant material in a monomer or a solution comprising a monomer prior to conducting the gamma- or electron beam-irradiation induced graft polymerization in a second solution of a monomer.

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 comprising 2-hydroxyethyl-methacrylate (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), [P(NVP-HEMA)], or

IV. a copolymer of (NVP), (HEMA) or (NVP-HEMA) and said ionic monomer, on said surface, the improvement comprising;

a) 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, and conducting said gamma-irradiation induced graft polymerization in a second aqueous solution of at least one of said monomers under the following conditions;

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

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

d) gamma dose rate in the range of from about 10 to about 2500 rads/min;

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.

2. The method of claim 1 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.

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

4. The method of claim 1 wherein said article is a medical device.

5. The method of claim 1 wherein said article is a prosthetic implant.

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

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

8. The method of claim 7 wherein said vinyl-carboxylic acid is acrylic, methacrylic or crotonic acid.

9. The method of claim 7 wherein said vinylsulfonic acid is sulfoethylmethacrylate, sulfopropylmethacrylate, styrene sulfonic acid or vinylsulfonic acid.

10. The method of claim 1 wherein said ionic monomer is an amino-functional monomer.

11. The method of claim 10 wherein said amino-functional monomer is a vinylpyridine, an amino-styrene, an aminoacrylate or an aminomethacrylate.

12. The method of claim 1 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.

14. An article prepared according to the method of claim 1 or 13.

15. An article according to claim 14 comprising a surgical instrument, medical device, prosthetic implant or contact lens.

13. 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 one-step electron beam-irradiation induced polymerized chemically grafted coating thereon of:

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

2) a monomer comprising 2-hydroxyethyl-methacrylate (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), [P(NVP-HEMA)], or

IV. a copolymer of (NVP), (HEMA) or (NVP-HEMA) and said ionic monomer, on said surface comprising;

a) 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, and conducting said electron beam-irradiation induced graft polymerization in a second aqueous solution of at least one of said monomers under the following conditions;

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

c) total electron beam irradiation dose equivalent to a gamma irradiation dose in the range of from about 0.001 to less than about 0.50 Mrad; and

d) an electron beam irradiation dose rate equivalent to a gamma irradiation dose rate in the range of from about 10 to about 10⁸ rads/min;

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.