Medical device with antimicrobial layer

• US 20040220534A1
• Filed: 04/29/2003
• Published: 11/04/2004
• Est. Priority Date: 04/29/2003
• Status: Abandoned Application

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Martens, Paul W., Virag, Robert, Nieto, Robert L.
• Application Number:
  US10/425,030
• Publication Number:
  US 20040220534A1
• Time in Patent Office: Days
• US Class Current: 604/265
• 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 medical device comprising:

a conduit for a fluid;

said conduit comprising a wall having an outer surface, said wall comprising a hydrophobic polymer;

an outer layer disposed on said outer surface, said outer layer comprising a first quantity of a hydrophilic polymer having an antimicrobial compound substantially dispersed therein;

wherein said antimicrobial compound comprises a predetermined amount of phosphorus-based glass having a predetermined quantity of a metal substantially dispersed therein; and

wherein said wall and said outer layer are formed by extrusion.

2. The medical device of claim 1, wherein said metal is selected from the group consisting of:

copper,

gold,

powdered silver,

substantially elemental silver,

silver ions,

silver oxide, and

combinations thereof.

3. The medical device of claim 1, wherein said wall further comprises an inner surface;

an inner layer disposed on said inner surface, said inner layer comprising a second quantity of said hydrophilic polymer having said antimicrobial compound substantially dispersed therein; and

wherein said inner layer is formed by extrusion.

4. The medical device of claim 3, wherein a thickness of said inner layer is within a range of about 0.002 mm-2.5 mm.

5. The medical device of claim 1, wherein a thickness of said outer layer is within a range of about 0.002 mm-2.5 mm.

6. The medical device of claim 1, wherein a third quantity of said hydrophilic polymer having said antimicrobial compound substantially dispersed therein is substantially dispersed within said wall.

7. The medical device of claim 1, comprising further a cuff having a cuff outer surface disposed around said medical device, a cuff outer layer disposed on said cuff outer surface, said cuff outer layer comprising a fourth quantity of said hydrophilic polymer having said antimicrobial compound substantially dispersed therein;

and

wherein said cuff outer layer is formed by extrusion.

8. The medical device of claim 1, wherein said hydrophilic polymer comprises polyurethane.

9. The medical device of claim 1., wherein said hydrophilic polymer comprises medical grade hydrophilic thermoplastic polyurethane.

10. The medical device of claim 1, wherein said metal is releasable from said antimicrobial compound.

11. The medical device of claim 10, wherein said metal is released at an elution rate of up to about 0.01 μ

-grams/cm²/day.

12. The medical device of claim 10, wherein said metal is released at an elution rate of between about 0.01 and about 1.0 μ

-grams/cm²/day.

13. The medical device of claim 10, wherein said metal is released at an elution rate of about 0.4 μ

-grams/cm²/day.

14. The medical device of claim 1, wherein said predetermined amount of phosphorus-based glass comprises about 0.1-50% of a weight of said antimicrobial compound.

15. The medical device of claim 1, wherein said hydrophobic polymer comprises a material selected from the group consisting of:

PVC,

PE,

PU,

PDMS,

polyester,

silicone, and

rubber.

16. The medical device of claim 1, wherein said medical device comprises an endotracheal tube.

17. The medical device of claim 1, wherein said medical device is selected from the group consisting of:

a catheter,

a stent,

a feeding tube,

a breathing circuit,

an intravenous tube,

a circuit,

an airway accessory,

a connector,

an adapter,

a filter,

a humidifier,

a nebulizer, and

a prosthetic.

18. The medical device of claim 1, wherein said antimicrobial compound comprises further an agent selected from the group consisting of:

an indicator of a carbon dioxide concentration,

a bronchodilator,

an anti-inflammatory agent, and

a local anesthetic.

19. A method of making the medical device of claim 1 comprising the actions of:

providing a hydrophobic polymer;

extruding said hydrophobic polymer to form a wall;

producing an antimicrobial compound comprising a predetermined amount of phosphorus-based glass having a predetermined quantity of a metal substantially dispersed therein;

mixing said antimicrobial compound and a hydrophilic polymer; and

extruding a layer of said hydrophilic polymer having said antimicrobial compound substantially dispersed therein over an outer surface of said wall.

20. The method of making the medical device of claim 19, further comprising the action of extruding a layer of said hydrophilic polymer having said antimicrobial compound substantially dispersed therein over an inner surface of said wall.

21. The method of making the medical device of claim 19, further comprising the action of forming a cuff on an end of said conduit.

22. A system for making a medical device comprising:

means for providing a hydrophobic polymer;

means for extruding said hydrophobic polymer to form a wall;

means for producing an antimicrobial compound comprising a predetermined amount of phosphorus-based glass having a predetermined quantity of a metal substantially dispersed therein;

means for mixing said antimicrobial compound and a hydrophilic polymer; and

means for extruding a layer of said hydrophilic polymer having said antimicrobial compound substantially dispersed therein over an outer surface of said wall.

23. A medical device comprising:

a conduit for a fluid;

said conduit comprising a wall having an outer surface, said wall comprising a hydrophobic polymer;

an outer layer disposed on said outer surface, said outer layer comprising a first quantity of a hydrophilic polymer having an antimicrobial compound substantially dispersed therein;

wherein said antimicrobial compound comprises a predetermined amount of phosphorus-based glass having a predetermined quantity of a metal substantially dispersed therein; and

wherein said wall and said outer layer are formed by molding.

24. The medical device of claim 23, wherein said molding is selected from the group consisting of:

overmolding,

insert molding,

blow-molding,

laminate blow-molding,

injection molding, and

compression molding.