Medication device with protein stabilizing surface coating

• US 6,443,942 B2
• Filed: 06/06/2001
• Issued: 09/03/2002
• Est. Priority Date: 11/01/1996
• Status: Expired due to Term

• Current Assignee: Minimed, Inc. (Medtronic Plc)
• Original Assignee: Minimed, Inc. (Medtronic Plc)
• Inventors: Adomian, Gerald E., Gulati, Poonam S., Van Antwerp, William Peter
• Primary Examiner(s): Beck, Shrive P.
• Assistant Examiner(s): Michener, Jennifer Kolb
• Application Number:
  US09/876,569
• Publication Number:
  US 20010051277A1
• Time in Patent Office: 454 Days
• Field of Search: 427/2.24, 427/2.1, 427/2.25, 427/2.28, 427/2.3, 427/508, 427/402.1, 427/409, 604/890.1, 604/891.1, 604/892.1, 604/67, 604/70, 604/131, 604/151, 623/1, 623/26
• US Class Current: 604/890.1
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 33/06 Use of macromolecular materials grafting of a monomer onto the substrate A61L33/0088
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: Y10S 623/924 Material characteristic
• CPC Class Codes: Y10T 428/31678 Of metal
• CPC Class Codes: Y10T 428/31855 Of addition polymer from unsaturated monomers

Abstract

The present invention provides medical devices such as medication infusion pumps having internal surfaces that are treated to inhibit protein denaturation. In accordance with the invention, hydrophilic internal surfaces and related coating methods are provided to reduce or eliminate accumulation of medication deposits which can otherwise occur when handling complex protein-based medications. Preferred hydrophilic pump surfaces include hydrophilic surfactants (PEO) or (PEG) coatings which exhibit very low protein adsorption characteristics. Several methods are disclosed for producing such treated surfaces including the covalent attachment of hydrophilic surfactants.

Claims

1. A medical device comprising a surface having a polypropylene glycol/polyethylene glycol polymer covalently attached thereto, wherein the polypropylene glycol/polyethylene glycol polymer has a molecular weight of about 1800 Daltons and comprises a compound of the following general formula:

and wherein the surface having the polypropylene glycol/polyethylene glycol polymer covalently attached thereto defines a surface contact angle less than about 45 degrees and exhibits an insulin adsorption profile of less than about 1.0 microgram per square centimeter.

2. The medical device of claim 1 wherein the surface contact angle is less than about 35 degrees.

3. The medical device of claim 1 wherein the surface exhibits an insulin adsorption profile of less than about 0.5 microgram per square centimeter.

4. The medical device of claim 1 wherein the surface exhibits an insulin adsorption profile of less than about 0.1 microgram per square centimeter.

5. The medical device of claim 1, wherein the surface is metallic.

6. The medical device of claim 5, wherein the surface is titanium.

7. The medical device of claim 1, wherein the surface is non-metallic.

8. The medical device of claim 1, wherein the medical device is selected from the group consisting of a prefilled medication cartridge, a syringe and a catheter.

9. The medical device of claim 1 wherein the medical device is externally worn.

10. The medical device of claim 1 wherein the medical device is implantable.

11. A method of inhibiting the denaturation of insulin on a surface comprising covalently attaching to the surface a polypropylene glycol/polyethylene glycol polymer comprising the following general formula:

wherein the polypropylene glycol/polyethylene glycol polymer has a molecular weight of about 1800, and wherein the treatment produces a surface that defines a surface contact angle less than about 45 degrees and exhibits an insulin adsorption profile of less than about 1.0 microgram per square centimeter.

12. The method of claim 11, wherein the polypropylene glycol/polyethylene glycol polymer is covalently attached to the surface by a method selected from the group consisting of polymeric attachment, RF-plasma attachment, grafting, or silane-based primer attachment.

13. The method claim 11 wherein the surface contact angle is less than about 35 degrees.

14. The method of claim 11 wherein the surface exhibits an insulin adsorption profile of less than about 0.1 microgram per square centimeter.

15. The method of claim 11 wherein the surface is metallic.

16. The method of claim 15, wherein the surface is titanium.

17. The method of claim 11, wherein the surface is non-metallic.

18. The method of claim 11, wherein the surface is in a medical device.

19. A process for treating a surface to inhibit the denaturation of insulin on the surface comprising covalently attaching to the surface a polypropylene glycol/polyethylene glycol polymer comprising the following general formula:

wherein the polypropylene glycol/polyethylene glycol polymer has a molecular weight of about 1800, and wherein the process produces a surface that defines a surface contact angle less than about 45 degrees and exhibits an insulin adsorption profile of less than about 1.0 microgram per square centimeter.

20. A surface produced by the process of claim 19.