CA2219342A1 - Antimicrobial impregnated catheters and medical implants and method for impregnating the same - Google Patents
Antimicrobial impregnated catheters and medical implants and method for impregnating the sameInfo
- Publication number
- CA2219342A1 CA2219342A1 CA002219342A CA2219342A CA2219342A1 CA 2219342 A1 CA2219342 A1 CA 2219342A1 CA 002219342 A CA002219342 A CA 002219342A CA 2219342 A CA2219342 A CA 2219342A CA 2219342 A1 CA2219342 A1 CA 2219342A1
- Authority
- CA
- Canada
- Prior art keywords
- medical implant
- impregnating
- antimicrobial
- group
- metallic
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/16—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/54—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/26—Penis implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
- A61L2300/406—Antibiotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/80—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special chemical form
- A61L2300/802—Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Materials For Medical Uses (AREA)
Abstract
A non-metallic antimicrobial impregnated medical implant, such as a catheter, and a method for impregnating a non-metallic medical implant with an antimicrobial agent is provided. The method for making the impregnated implant comprises the steps of forming an antimicrobial composition of an effective concentration to inhibit the growth of organisms, such as staphylococci, other gram-positive bacteria, gram-negative bacilli and Candida and applying the antimicrobial composition to at least a portion of the medical implant under conditions where the antimicrobial composition permeates the material of the medical implant. The antimicrobial composition is formed by dissolving an antimicrobial agent in an organic solvent, adding a penetrating agent to the composition, and adding an alkalinizing agent to the composition. The antimicrobial composition is preferably heated to a temperature between about 30 ~C and 70 ~C prior to applying the composition to the medical implant to enhance the adherence of the antimicrobial agent to the medical implant material. After the impregnated implant is removed from the antimicrobial solution, the impregnated implant is allowed to dry, then rinsed with a liquid and milked to remove excess granular deposits and ensure uniform color of the impregnated implant.
Claims (52)
1. A method for impregnating a non-metallic implant with an antimicrobial agent comprising the steps of:
forming an antimicrobial composition of an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated implants by Dissolving the antimicrobial agent in a organic solvent , adding a penetrating agent to the composition;
adding an alkalinizing agent to the composition;and applying the antimicrobial composition to at least a portion of medical implant under conditions where the antimicrobial composition permeates the matorial of the medical implant.
forming an antimicrobial composition of an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated implants by Dissolving the antimicrobial agent in a organic solvent , adding a penetrating agent to the composition;
adding an alkalinizing agent to the composition;and applying the antimicrobial composition to at least a portion of medical implant under conditions where the antimicrobial composition permeates the matorial of the medical implant.
2. The method for impregnating a non-metallic medical implant according to claim 1 , wherein the alkalinizing agent is selected is select from the group consisting of sodium hydroxide,potassium hydroxide,ammonis in water,diethylamine,and triethylamine.
3. The method for impregnating a non-metallic medical implant according to claim 1 ,wherein the alkalinizing agent comprises sodium hydroxide.
4. The method for impregnating a non-metallic medical implant according to claim 1,further comprising the step of heating the solution.
5. The method for impregnating a non-metallic medical implant according to claim 4, wherein the solution is heated to a temperature between about 30°C and 70°C.
6. The method for impregnating a non-metallic medical implant according to claim 1, wherein the step of applying the antimicrobial composition to the medical implant comprises dipping the implant in the composition for a period ofbetween 15 and 120 minutes, and removing the impregnated medical implant from the antimicrobial composition.
7. The method for impregnating a non-metallic medical implant according to claim 6, wherein the medical implant is dipped in the solution for a period of approximately 60 minutes.
8. The method for impregnating a non-metallic medical implant according to claim 1, further comprising the steps of rinsing with a liquid and milking the impregnated medical implant.
9. The method for impregnating a non-metallic medical implant according to claim 1, wherein the bacterial and fungal organisms are selected from the group consisting of gram-positive bacteria, gram-negative bacilli and Candida.
10. The method for impregnating a non-metallic medical implant according to claim 1, wherein the organic solvent is selected from the group consisting of alcohols, ketones, ethers, aldehydes, acetonitrile, acetic acid, methylene chloride and chloroform.
11. The method for impregnating a non-metallic medical implant according to claim 10, wherein the organic solvent is methanol.
12. The method for impregnating a non-metallic medical implant according to claim 1, wherein the penetrating agent is selected from the group consisting of esters, ketones, methylene chloride and chloroform.
13. The method for impregnating a non-metallic medical implant according to claim 12, wherein the penetrating agent is an ester selected from the group consisting of butyl acetate, ethyl acetate, propyl acetate, amyl acetate and combinations thereof.
14. The method for impregnating a non-metallic medical implant according to claim 1, wherein the step of forming an antimicrobial composition further comprises adding a salt exhibiting a high ionic strength.
15. The method for impregnating a non-metallic medical implant according to claim 1, wherein the medical implant is made from a material selected from the group consisting of silicone, polyurethane, polyethylene, polytetrafluoroethylene, polyethylene tetraphthalate and polyethylene tetraphthalate sealed with gelatin,collagen or albumin.
16. The method for impregnating a non-metallic medical implant according to claim 1, wherein the medical implant is a vascular catheter selected from the group consisting of peripherally insertable central venous catheters, dialysis catheters, long term tunneled central venous catheters, peripheral venous catheters, short-term central venous catheters, arterial catheters and pulmonaryartery Swan-Ganz catheters.
17. The method for impregnating a non-metallic medical implant according to claim 1, wherein the medical implant is a urinary catheter.
18. The method for impregnating a non-metallic medical implant according to claim 1, wherein the medical implant is a vascular graft.
19. The method for impregnating a non-metallic medical implant according to claim 1, wherein the medical implant is selected from the group consisting of vascular catheter ports, wound drain tubes, hydrocephalus shunts, peritoneal dialysis catheters,pecemaker capsules, artificial urinary sphincters, small or temporary joint replacements, urinary dilators, long term urinary devices, tissue bonding urinary devices, penile prostheses and heart valves.
20. The method for impregnating a non-metallic medical implant according to claim 1, wherein the antimicrobial agent is selected from the group consisting of antibiotics, antiseptics, disinfectants and synthetic moieties.
21.The method of impregnating a non-metallic medical implant according to claim 20,wherein the antimicrobial agent is an antibiotic selected from the group consisting of tetracyclines,penicillins,macrolides,rifampin and combinations thereof.
22. The method for impregnating a non-metallic medical implant according to claim 20,wherein the antimicrobial agent is an antibiotic comprising a combination of minocycline and rifampin.
23. The method for impregnating a non-metallic medical implant according to claim 20,wherein the antimicrobial agent is an antiseptic comprising hexachiorophene.
24. A method for impregnating a catheter formed of a polymeric material whith an antimicrobial agent comprising the steps of:
forming an antimicrobial solution of an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated implants by dissolving an alkalinizing agent selected from the group consisting of sodium hydroxide and potassium hydroxide in methanol,dissolving minocycline and rifampin in the solutoin,adding a penetrating agent selected from the group consisting of butyl acetate,ethyl acetate and combinations thereof to the solution;
heating the antimicrobial solution to a temperature of between about 30°C
and 70°C;
dipping at least a portion of the catheter in said antimicrobial solution under conditions where the antimicrobial solution permeates the polymeric material of the catheter ; and removing the catheter from the solution.
forming an antimicrobial solution of an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated implants by dissolving an alkalinizing agent selected from the group consisting of sodium hydroxide and potassium hydroxide in methanol,dissolving minocycline and rifampin in the solutoin,adding a penetrating agent selected from the group consisting of butyl acetate,ethyl acetate and combinations thereof to the solution;
heating the antimicrobial solution to a temperature of between about 30°C
and 70°C;
dipping at least a portion of the catheter in said antimicrobial solution under conditions where the antimicrobial solution permeates the polymeric material of the catheter ; and removing the catheter from the solution.
25. The method for impregnating a catheter according to claim 24, wherein the polymeric material is selected from the group consisting of rubber, plastic, silicone, polyurethane, polyethylene, polytetrefluoroethylone, polyethylenetetraphthalate and polyethylene tetraphthalate sealed with galatin, collagan or albumin.
26. The method for impregnating a catheter according to claim 24, wherein the bacterial and fungal organisms are selected from the group consisying of gram-positive bacteria, gram-negative bacilli and Candida.
27. A method for impregnating a catheter formed of a polymeric material with an antimicrobial agent comprising the steps of:
forming an antimicrobial solution of an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated implants by dissolving an alkalinizing agent selected from the group consisting of sodium hydroxide and potassium hydroxide in methanol, dissolving minocycline and rifampin in the solution , adding methylene chloride to the solution:
heating the antimicrobial solution to a temperature of between about 30°C
and 70°C;
dipping at least a portion of the catheter in said antimicrobial solution under condition wherein the antimicrobial solution permeates the polymeric material of the catheter;and removing the catheter from solution.
forming an antimicrobial solution of an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated implants by dissolving an alkalinizing agent selected from the group consisting of sodium hydroxide and potassium hydroxide in methanol, dissolving minocycline and rifampin in the solution , adding methylene chloride to the solution:
heating the antimicrobial solution to a temperature of between about 30°C
and 70°C;
dipping at least a portion of the catheter in said antimicrobial solution under condition wherein the antimicrobial solution permeates the polymeric material of the catheter;and removing the catheter from solution.
28. The method for impregnating a catheter according to claim 27,wherein the polymeric material is selected from the group consisting of silicone,polyurethane, polythylene,polytetrafluoroethylene,polyethylene tetraphalate and polyethylene teraphthalate sealed with gelatin,collagen or albumin.
29. The method for impregnating a catheter according to claim 27, wherein the bacterial and fungal organisms are selected from the group consisting of gram-positive bacteria,gram-negative bacilli and Candida.
30. An implantable medical device comprising:
a medical implant comprising a non-metallic material; and an antimicrobial composition,of an effective concentration to inhibit the growth of bacterial an fungal organisms,coating the surface of the implant and impregnating the non-metallic material of the medical implant;
wherein the antimicrobial composition comprises a mixture of an antimicrobial agent,an organic solvent and a penetrating agent.
a medical implant comprising a non-metallic material; and an antimicrobial composition,of an effective concentration to inhibit the growth of bacterial an fungal organisms,coating the surface of the implant and impregnating the non-metallic material of the medical implant;
wherein the antimicrobial composition comprises a mixture of an antimicrobial agent,an organic solvent and a penetrating agent.
31. The implantable medical device according to claim 30, wherein the bacterial and fungal organisms are selected from the group consisting of staphylococci, other gram-positive bacteria, gram-negative bacilli and Candida.
32.The implantable medical device according to claim 30,wherein the non-metallic material is selected from the group consisting of rubber,plastic, silicone, polyethylene tetraphthalate sealed with gelatin,collagen or albumin.
33. The implantable medical device according to claim 30, wherein the antimicrobial composition comprises a mixture of an antimicrobial agent , an organic solvent and a penetrating agent .
34. The implantable medical device according to claim 30 , wherein the organic solvent is selected from the group consisting alcohols,ketones , ethers,aldehydes, acetonitrile ,acetic acid , methylene chloride and chloroform.
35. The implantable medical device according to claim 34,wherein the organic solvent is methanol.
36. The implantable medical device according to claim 30, wherein the penetrating agent is select from the group consisting of esters,ketones,methylene chloride and chloroform.
37. The implantable medical device according to claim 36,wherein the penetrating agent is an ester selected from the group consisting of butyl acetate, ethyl acetate,propyl acetate, amyl acetate and combinations thereof.
38. The implantable medical device according to claim 30, wherein the mixture further comprises an alkalinizing agent.
39. The implantable medical device according to claim 38,wherein the alkalinizing agent is select from the group consisting of sodium hydroxide, potassium hydroxide,ammonia in water,diethylamine,and triethylamine.
40. The implantable medical device according to claim 38, wherein the alkalinizing agent comprises sodium hydroxide.
41. The implantable medical device according to claim 30, wherein the mixture further comprises a salt exhibiting a high ionic strength.
42. The implantable medical device according to claim 30, wherein the antimicrobial agent is selected from the group consisting of antibiotics,antiseptics, disinfectants and synthetic moeities.
43. The implantable medical device according to claim 42, wherein the antimicrobial agent is an antibiotic selected from the group consisting of tatracyclines, penicillins ,macrolides,rifampin and combinations thereof.
44. The implantable medical device according to claim 42,wherein the antimicrobial agent antibiotic comprising a combination of minocycline and rifampin.
45. The implantable medical device according to claim 42, wherein the antimicrobial agent is an antiseptic comprising hexachlorophene.
46. The implantable medical device according to claim 30, wherein the medical implant is a urinary catheter.
47. The implantable medical device according to claim 30, wherein the medical implant is a vascular catheter selected from the group consisting of peripherally insertable central venous catheters, dialysis catheters, long term tunneled central venous catheters, peripheral venous catheters, short-term central venous catheters, arterial catheters and pulmonary artery Swan-Ganz catheters.
48. The implantable medical device according claim 30, wherein the medical implant is a vascular graft.
49. The implantable medical device according to claim 30, wherein the medical implant is selected from the group consisting of vascular catheter ports, wound drain tubes, hydrocephalus shunts, peritoneal dialysis catheters, pacemaker capsules, artificial urinary sphincters, small or temporary joint replacements, urinary dilators, long term urinary devices, tissue bonding urinary devices, penile prostheses and heart valves.
50. The method for impregnating a non-metallic medical implant according to claim 1, wherein the medical implant is made from rubber or plastic.
51. The method for impregnating a catheter according to claim 25 or 28, wherein the medical implant is made from rubber or plastic.
52. The method for impregnating an implantable medical device according to claim 30, wherein the medical implant is made of rubber or plastic.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/427,379 | 1995-04-24 | ||
US08/427,379 US5624704A (en) | 1995-04-24 | 1995-04-24 | Antimicrobial impregnated catheters and other medical implants and method for impregnating catheters and other medical implants with an antimicrobial agent |
PCT/US1996/005776 WO1996033670A1 (en) | 1995-04-24 | 1996-04-22 | Antimicrobial impregnated catheters and medical implants and method for impregnating the same |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2219342A1 true CA2219342A1 (en) | 1996-10-31 |
CA2219342C CA2219342C (en) | 2010-10-26 |
Family
ID=23694621
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2219342A Expired - Lifetime CA2219342C (en) | 1995-04-24 | 1996-04-22 | Antimicrobial impregnated catheters and medical implants and method for impregnating the same |
Country Status (8)
Country | Link |
---|---|
US (2) | US5624704A (en) |
EP (1) | EP0830107B1 (en) |
JP (2) | JPH11504241A (en) |
AU (1) | AU705163B2 (en) |
CA (1) | CA2219342C (en) |
DE (1) | DE69633177T2 (en) |
ES (1) | ES2248809T3 (en) |
WO (1) | WO1996033670A1 (en) |
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- 1995-04-24 US US08/427,379 patent/US5624704A/en not_active Expired - Lifetime
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1996
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2006
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