Medical device with antimicrobial layer

• US 20060118121A1
• Filed: 01/24/2006
• Published: 06/08/2006
• Est. Priority Date: 04/29/2003
• Status: Abandoned Application

• Current Assignee: Adin M. Potter, Paul W. Martens, Robert L. Nieto, Robert Virag
• Original Assignee: Adin M. Potter, Paul W. Martens, Robert L. Nieto, Robert Virag
• Inventors: Martens, Paul W., Virag, Robert, Potter, Adin M., Nieto, Robert L.
• Application Number:
  US11/337,995
• Publication Number:
  US 20060118121A1
• Time in Patent Office: Days
• US Class Current: 128/207.140
• CPC Class Codes: A61F 2002/046 Tracheae
• CPC Class Codes: A61L 2300/102 Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
• CPC Class Codes: A61L 2300/104 Silver, e.g. silver sulfadiazine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• 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
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0443 Special cuff-wall materials A61M16/0481, A61M16/0422 take precedence
• CPC Class Codes: A61M 39/162 with antiseptic agent incorporated within the connector

Abstract

A medical device includes a conduit for a fluid. The conduit has a wall formed of a hydrophobic polymer with a hydrophilic polymer layer extruded over it, and an antimicrobial substantially dispersed within the hydrophilic polymer. The antimicrobial compound may be a predetermined amount of phosphorus-based glass having a predetermined quantity of a metal such as silver substantially dispersed therein. The medical device may be an endotracheal tube made by providing a hydrophobic polymer, a hydrophilic polymer and an antimicrobial compound, forming the hydrophobic polymer, the hydrophilic polymer and the antimicrobial compound into a conduit, and forming a cuff on an end of the conduit.

Claims

1. A method comprising:

providing a medical device comprising a hydrophobic polymer layer; and

molding an antimicrobial layer on at least a portion of the medical device, wherein the antimicrobial layer comprises a hydrophilic polymer and a water-soluble glass, wherein the water-soluble glass has a quantity of metal substantially dispersed therein.

2. The method, as set forth in claim 1, wherein the metal comprises copper, gold, silver, zinc, magnesium, boron, iodine, manganese, selenium, chromium, allium or a combination thereof.

3. The method, as set forth in claim 1, wherein the metal comprises substantially elemental metal, metal ions, metal oxide or a combination thereof.

4. The method, as set forth in claim 1, wherein molding comprises co-molding, blow molding, insert molding, injection molding, or compression molding.

5. The method, as set forth in claim 1, wherein the hydrophobic polymer layer comprises a conduit.

6. The method, as set forth in claim 5, wherein the antimicrobial layer is disposed over an inner surface of the conduit, an outer surface of the conduit, or both.

7. The method, as set forth in claim 5, comprising:

providing a cuff on an end of the conduit.

8. The method, as set forth in claim 7, wherein the antimicrobial layer is disposed over at least a portion of the cuff.

9. The method, as set forth in claim 1, wherein the antimicrobial layer is between 0.002 mm-2.5 mm in thickness.

10. The method, as set forth in claim 1, wherein the water-soluble glass comprises a phosphorous-based glass.

11. The method, as set forth in claim 1, wherein the hydrophilic polymer comprises polyurethane.

12. The method, as set forth in claim 1, wherein the hydrophilic polymer comprises medical grade hydrophilic thermoplastic polyurethane.

13. The method, as set forth in claim 1, wherein the metal is adapted to be released from the water-soluble glass at an elution rate of up to about 0.01 μ

-grams/cm²/day.

14. The method, as set forth in claim 1, wherein the metal is adapted to be released from the water-soluble glass at an elution rate of between about 0.01 and about 1.0 μ

-grams/cm²/day.

15. The method, as set forth in claim 1, wherein the metal is adapted to be released from the water-soluble glass at an elution rate of about 0.4 μ

-grams/cm²/day.

16. The method, as set forth in claim 1, wherein the water-soluble glass comprises about 0.1-50% by weight of the antimicrobial layer.

17. The method, as set forth in claim 1, wherein the hydrophobic polymer comprises polyvinyl chloride, polyethylene, polyurethane, polydimethylsiloxane, polyester, silicone, or rubber.

18. The method, as set forth in claim 1, wherein the medical device comprises an endotracheal tube.

19. The method, as set forth in claim 1, wherein the mixture comprises an indicator of carbon dioxide concentration, a bronchodilator, an anti-inflammatory agent, or a local anesthetic.

20. A medical device comprising:

a hydrophobic polymer substrate, wherein at least a portion of the hydrophobic polymer is molded with a layer comprising a hydrophilic polymer and a water-soluble glass, wherein the water-soluble glass has a quantity of metal substantially dispersed therein.

21. The medical device, as set forth in claim 20, wherein the metal comprises copper, gold, silver, zinc, magnesium, boron, iodine, manganese, selenium, chromium, allium or a combination thereof.

22. The medical device, as set forth in claim 20, wherein the metal comprises substantially elemental metal, metal ions, metal oxide or a combination thereof.

23. The medical device, as set forth in claim 20, wherein the molded layer is co-molded, blow molded, insert molded, injection molded, or compression molded.

24. The medical device, as set forth in claim 20, wherein the hydrophobic polymer comprises a conduit.

25. The medical device, as set forth in claim 24, wherein the layer is molded on an inner surface of the conduit, an outer surface of the conduit, or both.

26. The medical device, as set forth in claim 24, wherein the conduit comprises a cuff.

27. The medical device, as set forth in claim 26, wherein the layer is co-molded onto at least a portion of the cuff.

28. The medical device, as set forth in claim 20, wherein the layer is between 0.002 mm-2.5 mm in thickness.

29. The medical device, as set forth in claim 20, wherein the water-soluble glass comprises a phosphorous-based glass.

30. The medical device, as set forth in claim 20, wherein the hydrophilic polymer comprises polyurethane.

31. The medical device, as set forth in claim 20, wherein the hydrophilic polymer comprises medical grade hydrophilic thermoplastic polyurethane.

32. The medical device, as set forth in claim 20, wherein the metal is adapted to be released from the water-soluble glass at an elution rate of up to about 0.01 μ

-grams/cm²/day.

33. The medical device, as set forth in claim 20, wherein the metal is adapted to be released from the water-soluble glass at an elution rate of between about 0.01 and about 1.0 μ

-grams/cm²/day.

34. The medical device, as set forth in claim 20, wherein the metal is adapted to be released from the water-soluble glass at an elution rate of about 0.4 μ

-grams/cm²/day.

35. The medical device, as set forth in claim 20, wherein the water-soluble glass comprises about 0.1-50% by weight of the mixture.

36. The medical device, as set forth in claim 20, wherein the hydrophobic polymer comprises polyvinyl chloride, polyethylene, polyurethane, polydimethylsiloxane, polyester, silicone, or rubber.

37. The medical device, as set forth in claim 20, wherein the medical device comprises an endotracheal tube.

38. The medical device, as set forth in claim 20, wherein the layer comprises an indicator of carbon dioxide concentration, a bronchodilator, an anti-inflammatory agent, or a local anesthetic.

39. The medical device, as set forth in claim 20, comprising a ventilation device operatively connected to the medical device.

40. An endotracheal cuff comprising:

a hydrophobic polymer substrate, and

a molded layer covering at least a portion of the hydrophobic polymer substrate, the molded layer comprising a hydrophilic polymer and a water-soluble glass, wherein the water-soluble glass has a quantity of metal substantially dispersed therein.

41. The endotracheal cuff, as set forth in claim 40, wherein the metal comprises copper, gold, silver, zinc, magnesium, boron, iodine, manganese, selenium, chromium, allium or a combination thereof.

42. The endotracheal cuff, as set forth in claim 40, wherein the metal comprises substantially elemental metal, metal ions, metal oxide or a combination thereof.

43. The endotracheal cuff, as set forth in claim 40, comprising a conduit.

44. The endotracheal cuff, as set forth in claim 40, wherein the molded layer is between 0.002 mm-2.5 mm in thickness.

45. The endotracheal cuff, as set forth in claim 40, wherein the water-soluble glass comprises a phosphorous-based glass.

46. The endotracheal cuff, as set forth in claim 40, wherein the hydrophilic polymer comprises polyurethane.

47. The endotracheal cuff, as set forth in claim 40, wherein the hydrophilic polymer comprises medical grade hydrophilic thermoplastic polyurethane.

48. The endotracheal cuff, as set forth in claim 40, wherein the metal is adapted to be released from the water-soluble glass at an elution rate of up to about 0.01 μ

-grams/cm²/day.

49. The endotracheal cuff, as set forth in claim 40, wherein the metal is adapted to be released from the water-soluble glass at an elution rate of between about 0.01 and about 1.0 μ

-grams/cm²/day.

50. The endotracheal cuff, as set forth in claim 40, wherein the metal is adapted to be released from the water-soluble glass at an elution rate of about 0.4 μ

-grams/cm²/day.

51. The endotracheal cuff, as set forth in claim 40, wherein the water-soluble glass comprises about 0.1-50% by weight of the mixture.

52. The endotracheal cuff, as set forth in claim 40, wherein the hydrophobic polymer comprises polyvinyl chloride, polyethylene, polyurethane, polydimethylsiloxane, polyester, silicone, or rubber.

53. The endotracheal cuff, as set forth in claim 40, comprising an endotracheal tube.

54. The endotracheal cuff, as set forth in claim 40, wherein the molded layer comprises an indicator of carbon dioxide concentration, a bronchodilator, an anti-inflammatory agent, or a local anesthetic.

55. The endotracheal cuff, as set forth in claim 40, comprising a ventilation device operatively connected to the endotracheal cuff by a conduit.