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US006387379B1
(12) United States Patent ao) Patent No.: us 6,387,379 Bi
Goldberg et al. (45) Date of Patent: May 14,2002
Page 2
(54) BIOFUNCTIONAL SURFACE MODIFIED OCULAR IMPLANTS, SURGICAL INSTRUMENTS, MEDICAL DEVICES, PROSTHESES, CONTACT LENSES AND THE LIKE
(75) Inventors: Eugene P. Goldberg, Gainesville, FL (US); Ali Yahiaoui, Roswell, GA (US); Khalid Mentak, Goleta (MA); Theresa Rivero Erickson, Salt Lake City, UT (US); James Seeger, Gainesville, FL (US)
(73) Assignee: University of Florida, Gainesville, FL (US)
( * ) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days.
(21) Appl. No.: 08/202,647
(22) Filed: Feb. 28, 1994
Related U.S. Application Data
(63) Continuation-in-part of application No. 07/859,016, filed on Mar. 30, 1992, now Pat. No. 5,290,548, which is a continuation-in-part of application No. 07/592,483, filed on Oct. 5, 1990, now Pat. No. 5,130,160, which is a continuation-inpart of application No. 07/592,482, filed on Oct. 5, 1990, now Pat. No. 5,100,689, which is a continuation-in-part of application No. 07/592,478, filed on Oct. 5, 1990, now Pat. No. 5,108,776, which is a continuation-in-part of application No. 07/555,377, filed on Jul. 19, 1990, now Pat. No. 5,080,893, which is a continuation-in-part of application No. 07/304,479, filed on Feb. 1, 1989, now Pat. No. 4,961,954, which is a continuation-in-part of application No. 07/037, 153, filed on Apr. 10, 1987, now Pat. No. 4,806,382, application No. 08/202,647, which is a continuation-in-part of application No. 08/003,682, filed on Jan. 13, 1993, now Pat. No. 5,376,400.
(51) Int. CI.7 A61L 27/16; A61L 27/34;
A61L 27/54
(52) U.S. CI 424/400; 427/492; 427/495;
427/496; 427/498; 427/507; 427/535; 427/536; 427/539; 427/491; 427/2.1; 427/2.12; 606/151;
606/159; 604/93; 623/8; 523/106
(58) Field of Search 424/78.18, 400;
427/492, 495, 496, 498, 507, 535-36, 539, 491, 2.1, 2.12; 606/151, 159; 604/93; 623/8;
523/6
A method for modifying the surface of a material adapted for contact with tissue of a human or non-human animal to impart biofunctional, bioactive or biomimetic properties to the surface comprising:
(a) exposing the surface to a solution comprising (1) an ethylenically unsaturated monomer or mixture thereof capable, via the ethylenic unsaturation, of gamma irradiation or electron beam induced polymerization, and (2) at least one biofunctional agent; and
(b) irradiating the surface with gamma or electron beam irradiation in the presence of the solution to thereby form on the surface a graft polymerized coating, the coating having physically entrapped therein or chemically bonded thereto molecules of the at least one biofunctional agent which imparts biofunctional or biomimetic properties to the surface;
wherein the gamma or electron beam irradiation induced polymerization is conducted under one of the following conditions:
A.
(i) monomer concentration in the solution in the range of from about 0.1% to about 50%, by weight;
(ii) total gamma or electron beam dose in the range of from about 0.001 to less than about 0.50 Mrad; and
(iii) gamma dose rate in the range of from about 10 to about 2,500 rads/min., or electron beam dose rate in the range of from about 10 to about 10s rads/min.;
B.
(i) hydrophilic monomer(s) graft under conditions which may include monomer pre-soak or plasma gamma surface modification (especially for metal or glass substrates in latter case); and
(ii) graft polymerization of monomer(s) with bioactive/ biofunctional molecules using (i) as substrate;
C.
(i) HydrograftTM as in A or B above followed by dehydration and adsorption of bioactive/ biofunctional molecules into the hydrophilic polymer graft;
wherein the biological properties of the biofunctional agent are substantially maintained.
51 Claims, 8 Drawing Sheets