US5019096A
Expired / Lapsed
US
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Infection-resistant compositions, medical devices and surfaces and methods for preparing and using same
Assignee: Columbia University
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Filing: 1988-10-14
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Granted: 1991-05-28
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Expires: 2008-10-14
Abstract
Abstract A method of preparing an infection-resistant medical device comprising one or more matrix-forming polymers selected from the group consisting of biomedical polyurethane, biomedical silicones and biodegradable polymers, and antimicrobial agents, especially a synergistic combination of a silver salt and chlorhexidine (or its salts); also disclosed are medical devices having the synergistic composition therein or compositions thereon.
Inventors
- 👤 Charles L. Fox, Jr.
- 👤 Shanta M. Modak
- 👤 Lester A. Sampath
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 14:42
CPC Classifications
A; A61; A61L; A61L31/00; A61L31/14; A61L31/16; A01; A01N; A01N25/00; A01N25/24; A01N47/00; A01N47/40; A01N47/42; A01N47/44; A01N59/00; A01N59/16; A61B; A61B42/00; A61B42/10; A61L15/00; A61L15/16; A61L15/42; A61L15/46; A61L17/00; A61L17/005; A61L2/00; A61L2/16; A61L27/00; A61L27/28; A61L27/34; A61L27/50; A61L27/54; A61L29/00; A61L29/08; A61L29/085; A61L29/14; A61L29/16; A61L31/08; A61L31/10; A41; A41D; A41D19/00; A41D19/0055; A41D31/00; A41D31/04; A41D31/30; A41D31/305; A61L2300/00; A61L2300/10; A61L2300/102; A61L2300/104; A61L2300/20; A61L2300/204; A61L2300/206; A61L2300/40; A61L2300/404; A61L2300/45; A61M; A61M25/00; A61M25/0043; A61M2025/0056; A61M25/0009; Y; Y10; Y10S; Y10S623/00; Y10S623/92; Y10S623/921
Claims Analysis
Total Claims: 73
Claim 1
Independent Claim
79 words
A method for making an infection-resistant material comprising incorporating an effective amount of an antimicrobial agent in a matrix comprising a polymeric component selected from the group consisting of biomedical polyurethanes, biomedical silicones, biodegradable polymers and combinations thereof, wherein the matrix is effective to provide controlled release of the antimicrobial agent at a level sufficient to suppress infection when in contact with fluids, and wherein the antimicrobial agent includes synergistically effective amounts of a silver salt and a biguanide.
Claim 2
Independent Claim
79 words
A method for making an infection-resistant material comprising incorporating an effective amount of an antimicrobial agent in a matrix comprising a polymeric component selected from the group consisting of biomedical polyurethanes, biomedical silicones, biodegradable polymers and combinations thereof, wherein the matrix is effective to provide controlled release of the antimicrobial agent at a level sufficient to suppress infection when in contact with fluids, and wherein the antimicrobial agent includes synergistically effective amounts of a silver salt and a biguanide.
Claim 3
Dependent Claim
42 words
A method according to claim 1, wherein the silver salt is selected from the group consisting of silver acetate, silver benzoate, silver carbonate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein and silver sulfadiazine.
Claim 4
Dependent Claim
20 words
A method according to claim 1, wherein the biguanide is selected from the group consisting of chlorhexidine, and salts thereof.
Claim 5
Dependent Claim
19 words
A method according to claim 2, the biguanide is selected from the group consisting of chlorhexidine, and salts thereof.
Claim 6
Dependent Claim
13 words
A method according to claim 4, wherein the silver salt is silver sulfadiazine.
Claim 7
Dependent Claim
19 words
A method according to claim 1, wherein the matrix comprises a mixture of biomedical silicone and a biodegradable polymer.
Claim 8
Dependent Claim
13 words
A method according to claim 6, wherein the biodegradable polymer is poly(lactic acid).
Claim 9
Dependent Claim
42 words
A method according to claim 5, wherein the silver salt is selected from the group consisting of silver acetate, silver benzoate, silver carbonate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein and silver sulfadiazine.
Claim 10
Dependent Claim
19 words
A method according to claim 8, the biguanide is selected from the group consisting of chlorhexidine, and salts thereof.
Claim 11
Dependent Claim
13 words
A method according to claim 8, wherein the silver salt is silver sulfadiazine.
Claim 12
Independent Claim
87 words
A method of preparing an infection-resistant article comprising the steps of (a) dispersing an effective amount of an antimicrobial agent and a matrix forming polymeric material selected from the group consisting of biomedical polyurethanes, biomedical silicones, biodegradable polymers and combinations thereof in a solvent to form a first coating vehicle; (b) applying the first coating vehicle to the article to form a first coating and; (c) preparing a second coating vehicle and applying said second coating vehicle to the coated article to form a second coating thereon.
Claim 13
Independent Claim
87 words
A method of preparing an infection-resistant article comprising the steps of (a) dispersing an effective amount of an antimicrobial agent and a matrix forming polymeric material selected from the group consisting of biomedical polyurethanes, biomedical silicones, biodegradable polymers and combinations thereof in a solvent to form a first coating vehicle; (b) applying the first coating vehicle to the article to form a first coating and; (c) preparing a second coating vehicle and applying said second coating vehicle to the coated article to form a second coating thereon.
Claim 14
Dependent Claim
40 words
A method according to claim 11, wherein the antimicrobial agent is selected from the group consisting of silver and its salts, biguanides, polymyxin, tetracycline, aminoglycosides, rifampicin, bactitracin, neomycin, chloramphenicol, miconazole, quinolones, penicillins, nonoxynol 9, fusidic acid, cephalosporins and combinations thereof.
Claim 15
Dependent Claim
45 words
A method according to claim 12, wherein the antimicrobial agent includes a silver salt selected from the group consisting of silver acetate, silver benzoate, silver carbonate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein and silver sulfadiazine.
Claim 16
Dependent Claim
23 words
A method according to claim 12, wherein the antimicrobial agent includes a biguanide selected from the group consisting of chlorhexidine and salts thereof.
Claim 17
Dependent Claim
30 words
A method according to claim 14, wherein the antimicrobial agent includes a salt of chlorhexidine selected from the group consisting of chlorhexidine acetate, chlorhexidine gluconate, chlorhexidine hydrochloride and chlorhexidine sulfate.
Claim 18
Dependent Claim
15 words
A method according to claim 11, wherein the matrix forming polymeric material includes poly(lactic acid).
Claim 19
Dependent Claim
14 words
A method according to claim 11, wherein the infection-resistant article is a medical device.
Claim 20
Dependent Claim
33 words
A method according to claim 17, wherein the medical device is selected from the group consisting of catheters, gloves, contraceptives, wound dressings, drainage tubes, wound clips, implants, sutures, vascular grafts and hernia patches.
Claim 21
Dependent Claim
13 words
A method according to claim 18, wherein the antimicrobial agent includes a biguanide.
Claim 22
Dependent Claim
15 words
A method according to claim 19, wherein the biguanide is chlorhexidine or a salt thereof.
Claim 23
Dependent Claim
14 words
A method according to claim 18, wherein the antimicrobial agent includes a silver salt.
Claim 24
Dependent Claim
14 words
A method according to claim 21, wherein the antimicrobial agent further includes a biguanide.
Claim 25
Dependent Claim
15 words
A method according to claim 22, wherein the biguanide is chlorhexidine or a salt thereof.
Claim 26
Dependent Claim
57 words
A method according to claim 18, wherein the device is formed from expanded PTFE having interstices therein, and wherein the said matrix is incorporated by applying a coating comprising the antimicrobial agent and matrix polymers in a solvent thereof to a preformed device causing the coating material to enter into the interstices and drying the treated device.
Claim 27
Dependent Claim
12 words
A method according to claim 24, wherein the matrix comprises poly(lactic acid).
Claim 28
Dependent Claim
18 words
A method according to claim 24, wherein the antimicrobial agent includes pipracil and chlorhexidine or a salt thereof.
Claim 29
Dependent Claim
14 words
A method according to claim 26, wherein the chlorhexidine is included as chlorhexidine acetate.
Claim 30
Dependent Claim
24 words
A method according to claim 24, wherein the matrix comprises a biodegradable polymer and the antimicrobial agent comprises a silver salt and a biguanide.
Claim 31
Independent Claim
88 words
A method of preparing an infection-resistant article comprising incorporating into the article an effective amount of an infection-resistant material in a matrix, the matrix comprising a polymeric component selected from the group consisting of biomedical polyurethanes, biomedical silicones, biodegradable polymers and combinations thereof and an antimicrobial agent, wherein the matrix is effective to provide controlled release of the antimicrobial agent at a level sufficient to suppress infection when in contact with fluids, and wherein the antimicrobial agent includes synergistically effective amounts of a silver salt and a biguanide.
Claim 32
Independent Claim
88 words
A method of preparing an infection-resistant article comprising incorporating into the article an effective amount of an infection-resistant material in a matrix, the matrix comprising a polymeric component selected from the group consisting of biomedical polyurethanes, biomedical silicones, biodegradable polymers and combinations thereof and an antimicrobial agent, wherein the matrix is effective to provide controlled release of the antimicrobial agent at a level sufficient to suppress infection when in contact with fluids, and wherein the antimicrobial agent includes synergistically effective amounts of a silver salt and a biguanide.
Claim 33
Dependent Claim
42 words
A method according to claim 29, wherein the silver salt is selected from the group consisting of silver acetate, silver benzoate, silver carbonate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein and silver sulfadiazine.
Claim 34
Dependent Claim
20 words
A method according to claim 29, wherein the biguanide is selected from the group consisting of chlorhexidine and salts thereof.
Claim 35
Dependent Claim
20 words
A method according to claim 30, wherein the biguanide is selected from the group consisting of chlorhexidine and salts thereof.
Claim 36
Dependent Claim
13 words
A method according to claim 32, wherein the silver salt is silver sulfadiazine.
Claim 37
Dependent Claim
13 words
A method according to claim 29, wherein the polymer is a biomedical polyurethane.
Claim 38
Dependent Claim
19 words
A method according to claim 29, wherein the polymer is a mixture of biomedical silicone and a biodegradable polymer.
Claim 39
Dependent Claim
13 words
A method according to claim 35, wherein the biodegradable polymer is poly(lactic acid).
Claim 40
Dependent Claim
16 words
A method according to claim 14, wherein the antimicrobial agent includes silver or a salt thereof.
Claim 41
Dependent Claim
45 words
A method according to claim 37, wherein the antimicrobial agent includes a silver salt selected from the group consisting of silver acetate, silver benzoate, silver carbonate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein and silver sulfadiazine.
Claim 42
Dependent Claim
64 words
A method according to claim 29, wherein the infection-resistant material is incorporated as a coating on the article, and wherein the coating is formed by dispersing the matrix forming polymeric material in a solvent to form a coating vehicle, incorporating the antimicrobial agent in the coating vehicle to form a coating composition, coating a preformed article with the coating composition, and drying the coating.
Claim 43
Dependent Claim
42 words
A method according to claim 39, wherein the silver salt is selected from the group consisting of silver acetate, silver benzoate, silver carbonate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein and silver sulfadiazine.
Claim 44
Dependent Claim
20 words
A method according to claim 39, wherein the biguanide is selected from the group consisting of chlorhexidine, and salts thereof.
Claim 45
Dependent Claim
19 words
A method according to claim 40, the biguanide is selected from the group consisting of chlorhexidine, and salts thereof.
Claim 46
Dependent Claim
13 words
A method according to claim 42, wherein the silver salt is silver sulfadiazine.
Claim 47
Independent Claim
62 words
A method of preparing an infection-resistant medical device which comprises: (a) preparing a mixture of silver or a silver salt and a biguanide in effective amounts; and (b) applying said mixture as a coating to a surface of the medical device, such that upon exposure to a fluid, the silver or its salt and the biguanide are released in synergistic infection-resistant amounts.
Claim 48
Independent Claim
62 words
A method of preparing an infection-resistant medical device which comprises: (a) preparing a mixture of silver or a silver salt and a biguanide in effective amounts; and (b) applying said mixture as a coating to a surface of the medical device, such that upon exposure to a fluid, the silver or its salt and the biguanide are released in synergistic infection-resistant amounts.
Claim 49
Dependent Claim
16 words
The method of claim 44, wherein the mixture is affixed to the surface of the device.
Claim 50
Dependent Claim
16 words
The method of claim 44, wherein the mixture is applied to the surface as a powder.
Claim 51
Dependent Claim
17 words
The method of claim 44, wherein the mixture is applied as an ingredient of a polymeric coating.
Claim 52
Dependent Claim
12 words
The method of claim 44, wherein the silver salt is silver sulfadiazine.
Claim 53
Dependent Claim
12 words
The method of claim 44, wherein the silver salt is silver carbonate.
Claim 54
Dependent Claim
72 words
A method according to claim 44, which comprises: (a) preparing the mixture of (i) a substance selected from the group consisting of chlorhexidine and its salts, and (ii) a silver salt selected from the group consisting of silver sulfadiazine, silver acetate, silver benzoate, silver iodate, silver laurate, silver protein, silver chloride, silver palmitate, silver oxide, silver carbonate and silver nitrate; and (b) applying a mixture to the surface of a medical device.
Claim 55
Dependent Claim
24 words
A method according to claim 45, further comprising the step of treating the surface of the device to render it at least slightly adhesive.
Claim 56
Dependent Claim
13 words
A method according to claim 44, wherein the medical device is a glove.
Claim 57
Dependent Claim
49 words
A method according to claim 52, wherein the glove is a latex and the mixture is applied as a powder to the surface of the glove at a point during the manufacture of the glove when the glove surface is soft, whereby the powder adheres to the glove surface.
Claim 58
Dependent Claim
18 words
A method according to claim 52, wherein the mixture is applied to the surface in a solvent-mediated dispersion.
Claim 59
Dependent Claim
24 words
The method according to claim 11, wherein the silicone in said second coating solution has a concentration in the range of 0.5 to 5%.
Claim 60
Dependent Claim
26 words
The method according to claim 16, wherein the first coating solution additionally contains a polylactic acid at a concentration in the range of 0.2 to 2%.
Claim 61
Dependent Claim
36 words
The method according to claim 27, wherein the coating contains 0.25 to 1% biomedical polyurethane, 0.25 to 1% poly (lactic acid), 1% chlorhexidine acetate and 3% pipracil in a solvent comprising 25% N-ethyl-2-pyrrolidone and 75% tetrahydrofuran.
Claim 62
Dependent Claim
25 words
An infection-resistant medical device comprising an effective amount of an antimicrobial agent comprising silver or a salt thereof and a biguanide in synergistically effective amounts.
Claim 63
Dependent Claim
25 words
An infection-resistant medical device comprising an effective amount of an antimicrobial agent comprising silver or a salt thereof and a biguanide in synergistically effective amounts.
Claim 64
Dependent Claim
33 words
A device according to claim 58, wherein the medical device is selected from the group consisting of catheters, gloves, contraceptives, wound dressings, drainage tubes, wound clips, implants, sutures, vascular grafts and hernia patches.
Claim 65
Dependent Claim
45 words
A device according to claim 58, wherein the antimicrobial agent comprises a silver salt selected from the group consisting of silver acetate, silver benzoate, silver carbonate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein and silver sulfadiazine.
Claim 66
Dependent Claim
20 words
A device according to claim 58, wherein the biguanide is selected from the group consisting of chlorhexidine, and salts thereof.
Claim 67
Dependent Claim
33 words
A device according to claim 61, wherein the medical device is selected from the group consisting of catheters, gloves, contraceptives, wound dressings, drainage tubes, wound clips, implants, sutures, vascular grafts and hernia patches.
Claim 68
Dependent Claim
36 words
An expanded PTFE vascular graft, a substantial proportion of the interstices of which contains a coating composition comprising, by weight, one part biomedical polyurethane, one part poly(lactic acid), one part chlorhexidine acetate, and three parts pipracil.
Claim 69
Dependent Claim
36 words
An expanded PTFE vascular graft, a substantial proportion of the interstices of which contains a coating composition comprising, by weight, one part biomedical polyurethane, one part poly(lactic acid), one part chlorhexidine acetate, and three parts pipracil.
Claim 70
Dependent Claim
15 words
A method according to claim 11, wherein the second coating vehicle comprises a biomedical silicone.
Claim 71
Dependent Claim
12 words
A method according to claim 64, wherein the article is a catheter.
Claim 72
Dependent Claim
12 words
A method according to claim 65, wherein the second coating includes heparin.
Claim 73
Dependent Claim
25 words
A method according to claim 11, wherein the second coating vehicle includes a second antimicrobial agent different from the antimicrobial agent in the first coating.
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