Elastomeric Devices Containing Chlorhexidine/Fatty Acid Salts Made From Fatty Acids of 12 to 18 Carbons

• US 20100069854A1
• Filed: 09/10/2009
• Published: 03/18/2010
• Est. Priority Date: 09/12/2008
• Status: Abandoned Application

• Current Assignee: Teleflex Medical Incorporated (Teleflex Incorporated)
• Original Assignee: Teleflex Medical Incorporated (Teleflex Incorporated)
• Inventors: Rosenblatt, Joel, Do, Hiep, Okoh, Onajite
• Application Number:
  US12/556,928
• Publication Number:
  US 20100069854A1
• Time in Patent Office: Days
• US Class Current: 604/265
• CPC Class Codes: A61L 2300/206 Biguanides, e.g. chlorohexidine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

In a medical device, an antimicrobial agent is combined with an elastomeric polymer material. The antimicrobial agent includes at least one chlorhexidine/fatty acid salt which is a neutralization product of chlorhexidine base and a fatty acid having between 12 and 18 carbon atoms.

Claims

1. A medical device comprising an antimicrobial agent in an elastomeric polymer material, the antimicrobial agent including at least one chlorhexidine/fatty acid salt which is a neutralization product of chlorhexidine base and a fatty acid having between 12 and 18 carbon atoms.

2. The medical device according to claim 1, wherein the fatty acid comprises a straight chain fatty acid.

3. The medical device according to claim 1, wherein the fatty acid comprises between 12 and 16 carbon atoms.

4. The medical device according to claim 1, wherein the chlorhexidine/fatty acid salt comprises a chlorhexidine Laurate (chlorhexidine dodecanoate).

5. The medical device according to claim 1, wherein the chlorhexidine/fatty acid salt comprises a chlorhexidine Myristate (chlorhexidine tetradecanoate).

6. The medical device according to claim 1, wherein the chlorhexidine/fatty acid salt comprises a chlorhexidine Palmitate (chlorhexidine hexadecanoate).

7. The medical device according to claim 1, wherein the chlorhexidine/fatty acid salt comprises a chlorhexidine Stearate (chlorhexidine octadecanoate).

8. The medical device according to claim 1, wherein the antimicrobial agent further comprises:

a mixture comprising a plurality of chlorhexidine/fatty acid salts, wherein each chlorhexidine/fatty acid salt of the plurality of chlorhexidine/fatty acid salts comprises a fatty acid having between 12 and 18 carbon atoms.

9. The medical device according to claim 1, wherein the elastomeric polymer comprises polyurethane.

10. The medical device according to claim 9, wherein the polyurethane is a polyurethane foam.

11. The medical device according to claim 1, wherein the elastomeric polymer comprises a silicone.

12. The medical device according to claim 1, wherein the elastomeric polymer comprises a fluoroelastomer.

13. The medical device according to claim 1, wherein the elastomeric polymer comprises a polyolephin elastomer.

14. The medical device according to claim 1, wherein the elastomeric polymer comprises a latex-type elastomer.

15. A method of making an infection-resistant medical device, the method comprising:

selecting an antimicrobial agent comprising a chlorhexidine/fatty acid salt, wherein the chlorhexidine/fatty acid salt comprises a neutralization product of chlorhexidine base and a fatty acid having between 12 and 18 carbon atoms; and

combining an elastomeric polymer material with an effective amount of the antimicrobial agent.

16. The method according to claim 15, wherein the step of selecting further comprises:

determining a diffusion rate of the antimicrobial agent from the elastomeric polymer material.

17. The method according to claim 15, wherein the step of selecting further comprises:

synthesizing the chlorhexidine/fatty acid salt in a neutralization reaction with the chlorhexidine base and the fatty acid having between 12 and 18 carbon atoms.

18. The method according to claim 17, wherein the step of synthesizing further comprises reacting the chlorhexidine base with a straight chain fatty acid.

19. The method according to claim 18, wherein the step of synthesizing further comprises reacting the chlorhexidine base with a Stearic acid (octadecanoic acid) to synthesize a chlorhexidine Stearate (chlorhexidine octadecanoate).

20. The method according to claim 18, wherein the step of synthesizing further comprises reacting the chlorhexidine base with the fatty acid having between 12 and 16 carbon atoms.

21. The method according to claim 20, wherein the step of synthesizing further comprises reacting the chlorhexidine base with a Lauric acid (dodecanoic acid) to synthesize a chlorhexidine Laurate (chlorhexidine dodecanoate).

22. The method according to claim 21, wherein the step of synthesizing further comprises reacting the chlorhexidine base with a Myristic acid (tetradecanoic acid) to synthesize a chlorhexidine Myristate (chlorhexidine tetradecanoate).

23. The method according to claim 20, wherein the step of synthesizing further comprises reacting the chlorhexidine base with a Palmitic acid (hexadecanoic acid) to synthesize a chlorhexidine Palmitate (chlorhexidine hexadecanoate).

24. The method according to claim 15, wherein the set of selecting further comprises:

selecting a mixture of antimicrobial agents comprising a plurality of chlorhexidine/fatty acid salts, wherein each chlorhexidine/fatty acid salt of the plurality of chlorhexidine/fatty acid salts comprises a fatty acid having between 12 and 18 carbon atoms.

25. The method according to claim 15, further comprising:

selecting a polyurethane to fabricate the elastomeric polymer material.

26. The method according to claim 25, further comprising:

selecting a polyurethane foam to fabricate the elastomeric polymer material.

27. The method according to claim 15, further comprising:

selecting a silicone to fabricate the elastomeric polymer material.

28. The method according to claim 15, further comprising:

selecting a fluoroelastomer to fabricate the elastomeric polymer material.

29. The method according to claim 15, further comprising:

selecting a polyolephin elastomer to fabricate the elastomeric polymer material.

30. The method according to claim 15, further comprising:

selecting a latex-type elastomer to fabricate the elastomeric polymer material.

31. The method according to claim 15, wherein the set of combining further comprises:

soaking the elastomeric polymer material in a solution of the antimicrobial agent.

32. A medical catheter comprising:

an elongated hollow tube;

an exterior surface of the elongated hollow tube including an elastomeric polymer; and

a chlorhexidine/fatty acid salt being disposed in the elastomeric polymer, wherein the chlorhexidine/fatty acid salt is a neutralization product of chlorhexidine base and a fatty acid having between 12 and 18 carbon atoms.

33. A method of optimizing infection resistance in a medical device, the method comprising:

determining a duration of use for the medical device;

selecting an elastomeric polymer to make the medical device;

determining a rate of release for a set of chlorhexidine/fatty acid salts from the elastomeric polymer, the rate of release being determined for the duration of use, the set of chlorhexidine/fatty acid salts being a set of neutralization products of chlorhexidine base and one or more fatty acid having between 12 and 18 carbon atoms; and

selecting a chlorhexidine/fatty acid salt from the set of chlorhexidine/fatty acid salts having a respective rate of release exceeding a predetermined minimum rate of release for the duration of use.

34. A method of optimizing infection resistance in a medical device, the method comprising:

determining a duration of use for the medical device;

selecting an elastomeric polymer to make the medical device;

determining a zone of inhibition for a set of chlorhexidine/fatty acid salts from the elastomeric polymer, the zone of inhibition being determined for the duration of use, the set of chlorhexidine/fatty acid salts being a set of neutralization products of chlorhexidine base and one or more fatty acid having between 12 and 18 carbon atoms; and

selecting a chlorhexidine/fatty acid salt from the set of chlorhexidine/fatty acid salts having a respective zone of inhibition exceeding a predetermined minimum zone of inhibition for the duration of use.