Medical device with antimicrobial layer

• US 20060118122A1
• 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:
  US11/337,996
• Publication Number:
  US 20060118122A1
• 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

19. A method comprising:

providing a medical device comprising a hydrophobic polymer;

providing a mixture comprising a hydrophilic polymer and a water-soluble glass, wherein the water-soluble glass has a quantity of metal substantially dispersed therein; and

extruding a layer of the mixture over at least a portion of the hydrophobic polymer.

20. The method, as set forth in claim 19, wherein the metal comprises copper, gold, silver, zinc, magnesium, boron, iodine, manganese, selenium, chromium, allium or a combination thereof.

21. The method, as set forth in claim 19, wherein the metal comprises substantially elemental metal, metal ions, metal oxide or a combination thereof.

22. The method, as set forth in claim 19, wherein the hydrophobic polymer comprises a conduit.

23. The method, as set forth in claim 22, wherein the mixture is extruded onto an inner surface of the conduit, an outer surface of the conduit, or both.

24. The method, as set forth in claim 22, comprising:

providing a cuff on an end of the conduit.

25. The method, as set forth in claim 24, wherein the mixture is extruded onto at least a portion of the cuff or the conduit.

26. The method, as set forth in claim 19, wherein the mixture and the hydrophobic polymer are co-extruded.

27. The method, as set forth in claim 19, wherein the layer is between 0.002 mm-2.5 mm in thickness.

28. The method, as set forth in claim 19, wherein the water-soluble glass comprises a phosphorous-based glass.

29. The method, as set forth in claim 19, wherein the hydrophilic polymer comprises polyurethane.

30. The method, as set forth in claim 19, wherein the hydrophilic polymer comprises medical grade hydrophilic thermoplastic polyurethane.

31. The method, as set forth in claim 19, 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.

32. The method, as set forth in claim 19, 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.

33. The method, as set forth in claim 19, 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.

34. The method, as set forth in claim 19, wherein the water-soluble glass comprises about 0.1-50% by weight of the mixture.

35. The method, as set forth in claim 19, wherein the hydrophobic polymer comprises polyvinyl chloride, polyethylene, polyurethane, polydimethylsiloxane, polyester, silicone, or rubber.

36. The method, as set forth in claim 19, wherein the medical device comprises an endotracheal tube.

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

38-1. The medical device, as set forth in claim 38, 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.

58. A medical device comprising:

a device wall, wherein at least a portion of the device wall is an extrusion, the extrusion being formed from a mixture comprising a hydrophobic polymer substrate, a hydrophilic polymer and a water-soluble glass, wherein the water-soluble glass has a quantity of metal substantially dispersed therein.

59. The medical device, as set forth in claim 58, wherein the metal comprises copper, gold, silver, zinc, magnesium, boron, iodine, manganese, selenium, chromium, allium or a combination thereof.

60. The medical device, as set forth in claim 58, wherein the metal comprises substantially elemental metal, metal ions, metal oxide or a combination thereof.

61. The medical device, as set forth in claim 58, wherein the medical device comprises a conduit.

62. The medical device, as set forth in claim 58, wherein the conduit comprises a cuff.

63. The medical device, as set forth in claim 58, wherein the water-soluble glass comprises a phosphorous-based glass.

64. The medical device, as set forth in claim 58, wherein the hydrophilic polymer comprises polyurethane.

65. The medical device, as set forth in claim 58, wherein the hydrophilic polymer comprises medical grade hydrophilic thermoplastic polyurethane.

66. The medical device, as set forth in claim 58, 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.

67. The medical device, as set forth in claim 58, 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.

68. The medical device, as set forth in claim 58, 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.

69. The medical device, as set forth in claim 58, wherein the water-soluble glass comprises about 0.1-50% by weight of the compounded mixture.

70. The medical device, as set forth in claim 58, wherein the hydrophobic polymer comprises polyvinyl chloride, polyethylene, polyurethane, polydimethylsiloxane, polyester, silicone, or rubber.

71. The medical device, as set forth in claim 58, wherein the medical device comprises an endotracheal tube.

72. The medical device, as set forth in claim 58, wherein the medical device comprises an indicator of carbon dioxide concentration, a bronchodilator, an anti-inflammatory agent, or a local anesthetic.

73. The medical device, as set forth in claim 58, comprising a ventilation device operatively connected to the medical device.

74. An endotracheal cuff comprising:

a hydrophobic polymer substrate, and

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

75. The endotracheal cuff, as set forth in claim 74 wherein the metal comprises copper, gold, silver, zinc, magnesium, boron, iodine, manganese, selenium, chromium, allium or a combination thereof.

76. The endotracheal cuff, as set forth in claim 74, wherein the metal comprises substantially elemental metal, metal ions, metal oxide or a combination thereof.

77. The endotracheal cuff, as set forth in claim 74, comprising a conduit.

78. The endotracheal cuff, as set forth in claim 74, comprising a co-extruded hydrophobic polymer.

79. The endotracheal cuff, as set forth in claim 74, wherein the extrusion is between 0.002 mm-2.5 mm in thickness.

80. The endotracheal cuff, as set forth in claim 74, wherein the water-soluble glass comprises a phosphorous-based glass.

81. The endotracheal cuff, as set forth in claim 74, wherein the hydrophilic polymer comprises polyurethane.

82. The endotracheal cuff, as set forth in claim 74, wherein the hydrophilic polymer comprises medical grade hydrophilic thermoplastic polyurethane.

83. The endotracheal cuff, as set forth in claim 74, 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.

84. The endotracheal cuff, as set forth in claim 74, 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.

85. The endotracheal cuff, as set forth in claim 74, 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.

86. The endotracheal cuff, as set forth in claim 74, wherein the water-soluble glass comprises about 0.1-50% by weight of the mixture.

87. The endotracheal cuff, as set forth in claim 74, wherein the hydrophobic polymer comprises polyvinyl chloride, polyethylene, polyurethane, polydimethylsiloxane, polyester, silicone, or rubber.

88. The endotracheal cuff, as set forth in claim 74, comprising an endotracheal tube.

89. The endotracheal cuff, as set forth in claim 74, wherein the extrusion comprises an indicator of carbon dioxide concentration, a bronchodilator, an anti-inflammatory agent, or a local anesthetic.

90. The endotracheal cuff, as set forth in claim 74, comprising a ventilation device operatively connected to the endotracheal cuff by a conduit.