Water soluble lubricant for medical devices

• US 6,046,143 A
• Filed: 03/18/1998
• Issued: 04/04/2000
• Est. Priority Date: 08/22/1994
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Khan, Azhar J., Khan, Mohammad A.
• Primary Examiner(s): McAvoy, Ellen M.
• Application Number:
  US09/040,758
• Time in Patent Office: 748 Days
• Field of Search: 508/208
• US Class Current: 508/208
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/428 Vitamins, e.g. tocopherol, riboflavin
• CPC Class Codes: A61L 2300/452 Lubricants
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: B29C 57/00 Shaping of tube ends, e.g. flanging, belling or closing; Apparatus therefor , e.g. collapsible mandrels
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: C08L 83/12 containing polyether sequences

Abstract

This invention relates to a new water soluble lubricant for a medical device, such as a catheter and an introducer needle. The lubricant is a silicone based water soluble compound. Preferably, a silicone surfactant is used such as a block copolymer polyalkylene oxide-modified polydimethylsiloxane. Alternatively, an alkylene oxide modified silicone glycol may be used as the lubricant. In addition, lecithin can be added as a lubricant. The lubrication solution includes a solution stabilizer to clarify the solution and antimicrobial agents to inhibit microbial growth in the water solution or on the coated product. Vitamin E or its derivatives may also be used in the lubrication solution.

Claims

1. A lubrication solution for a medical device, comprising:

a silicone based water soluble lubricant; and

water.

2. The lubrication solution of claim 1, wherein the silicone based water soluble lubricant is a silicone surfactant lubricant.

3. The lubrication solution of claim 2 wherein the silicone surfactant lubricant is a block copolymer polyalkylene oxide-modified polydimethylsiloxane.

4. The lubrication solution of claim 2 wherein the silicone surfactant lubricant is an amino-modified silicone polyether copolymer.

5. The lubrication solution of claim 3 wherein the silicone surfactant lubricant also includes an amino-modified silicone polyether copolymer.

6. The lubrication solution of claim 1 wherein the silicone based water soluble lubricant is an alkylene oxide modified silicone glycol.

7. A medical device having a surface with a silicone based water soluble lubricant deposited thereon.

8. The medical device of claim 7 wherein the silicone based water soluble lubricant is a silicone surfactant.

9. The medical device of claim 8 wherein the silicone surfactant is a block copolymer polyalkylene oxide-modified polydimethylsiloxane.

10. The medical device of claim 9 wherein the silicone surfactant also includes an amino-modified silicone-polyether copolymer.

11. The medical device of claim 8 wherein the silicone surfactant is an amino-modified silicone-polyether copolymer.

12. The medical device of claim 7 wherein the silicone based water soluble lubricant is an alkylene oxide-modified silicone glycol.

13. A method for forming a shaped tip on a catheter comprising:

applying a silicone based water soluble lubricant to a tip of an untipped catheter tubing;

placing the untipped catheter tubing on a mandrel;

heating the untipped catheter tubing to soften the tip of the tubing;

engaging the mandrel with a die to form the catheter tip; and

removing the shaped catheter tubing from the die and mandrel.

14. The method of claim 13 wherein the silicone based water soluble lubricant is applied to a tip of an untipped catheter tubing by applying a lubricant solution of the silicone based water soluble lubricant and water to the tip.

15. The method of claim 14 wherein the silicone based water soluble lubricant is a silicone surfactant.

16. The method of claim 14 wherein the silicone based water soluble lubricant is an alkylene oxide modified silicone glycol.