Hydrophilic coatings for medical implements

• US 7,015,262 B2
• Filed: 05/01/2002
• Issued: 03/21/2006
• Est. Priority Date: 05/01/2002
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Leong, Koon-wah
• Primary Examiner(s): Yoon, Tae H.
• Application Number:
  US10/137,017
• Publication Number:
  US 20030207987A1
• Time in Patent Office: 1,420 Days
• Field of Search: 523/105, 523/112, 524/603, 422/61, 427/2.1, 427/2.24, 427/2.28
• US Class Current: 523/205
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence

Abstract

Compositions, methods, devices and kits utilizing water-based hydrophilic coating formulations on medical implements. The composition for applying a coating comprises a sulfonated polyester, water, and a surface active agent. Methods for coating a medical implement comprise providing an aqueous dispersion comprising sulfonated polyester and surface active agent, contacting the medical implement with the aqueous dispersion, and drying the medical implement. Methods for acquiring a sample of bodily fluid from a patient comprise coating a needle with a sulfonated polyester, penetrating the needle into the patient, and drawing bodily fluid through the needle.

Claims

1. A method for forming a hydrophilic coating on a medical implement, comprising:

(a) providing an aqueous dispersion comprising sulfonated polyester and surface active agent;

(b) contacting said medical implement in said aqueous dispersion; and

(c) drying said medical implement.

2. The method of claim 1 wherein providing said aqueous dispersion of said sulfonated polyester and surface active agent comprises between approximately 0.5% and approximately 30% of sulfonated polyester by weight in water and between approximately 0.1% and approximately 5% of surface active agent by weight in water.

3. The method of claim 1 wherein said surface active agent comprises at least one surfactant from the group consisting of poly (oxyethylene-co-oxypropylene )block polymer, ethylene oxide-propylene oxide-ethylene oxide triblock copolymer, N-oleyl-N-methyl taurate, and di-isooctylsulphosuccinate.

4. The method of claim 1 wherein said contacting said medical implement in said aqueous dispersion comprises dipping said medical implement into said aqueous dispersion.

5. The method of claim 1 wherein said sulfonated polyester comprises a sulfonated poly(alkylene phthalate).

6. The method of claim 1 wherein said sulfonated polyester comprises a polymeric compound having the structure

where n is an integer having a value between 3 and 100,000.

7. The method of claim 1 wherein said sulfonated polyester comprises a sulfonated poly(ethylene isophthalate).

8. The method of claim 1 wherein said sulfonated polyester comprises poly(ethylene 4-sodiosulfenyl isophthalate).

9. The method of claim 1 wherein drying said medical implement comprises;

heating the coated medical implement at approximately about 60°

C. to about 120°

C.

10. The method of claim 1 wherein said medical implement is a lancing implement.

11. The method of claim 1 wherein the medical implement is a microneedle.

12. A medical implement, comprising a needle having a coating thereon comprising a sulfonated polyester.

13. The medical implement of claim 12, wherein said coating comprises of between approximately 80% and approximately 98% weight of said sulfonated polyester, and between approximately 20% and approximately 2% by weight of surface active agent.

14. The medical implement of claim 13 wherein said sulfonated polyester comprises a sulfonated poly(alkylene phthalate).

15. The medical implement of claim 14 wherein said sulfonated polyester comprises a sulfonated poly(ethylene isophthalate).

16. The medical implement of claim 15 wherein said sulfonated polyester comprises poly(ethylene 4-sodiosulfenyl isophthalate).

17. A kit for drawing a sample of a bodily fluid, comprising the medical implement of claim 13, and a test strip configured to receive said sample of bodily fluid.