Lubricious compound and medical device made of the same

• US 20060240060A1
• Filed: 11/15/2005
• Published: 10/26/2006
• Est. Priority Date: 04/22/2005
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bavaro, Vincent P.
• Application Number:
  US11/274,544
• Publication Number:
  US 20060240060A1
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 29/049 Mixtures of macromolecular compounds
• 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 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: C08J 2371/02 Polyalkylene oxides
• CPC Class Codes: C08J 3/005 Processes for mixing polymers
• CPC Class Codes: C08J 3/28 Treatment by wave energy or particle radiation
• CPC Class Codes: C08L 71/02 Polyalkylene oxides
• CPC Class Codes: C08L 77/12 Polyester-amides
• CPC Class Codes: C10M 111/04 at least one of them being a macromolecular organic compound
• CPC Class Codes: C10M 2209/104 of alkylene oxides containing two carbon atoms only
• CPC Class Codes: C10M 2209/1045 used as base material
• CPC Class Codes: C10M 2217/045 Polyureas; Polyurethanes
• CPC Class Codes: C10M 2217/0453 used as base material
• CPC Class Codes: C10N 2020/09 Characteristics associated with water
• CPC Class Codes: C10N 2040/50 Medical uses
• CPC Class Codes: C10N 2070/00 : Specific manufacturing methods for lubricant compositions

Abstract

The present invention includes a lubricious polymer blend wherein at least one of the polymer materials is a water insoluble polymer and one of the materials is a lubricious water-soluble polymer. The invention includes a method of forming a desired medical device by melt mixing the selected polymers and then forming the polymer blend into the desired shape. The method further includes cross-linking the polymer blend after or before being shaped into the medical device in order to improve the retention of the lubricous polymer during exposure to abrasive forces or to materials which would extract the lubricious surface, such as water. Cross-linking the polymer blend may be improved by adding a cross-linking agent and/or cross-linking he polymer blend in the presence of a selected inert atmosphere.

Claims

1. A method of forming a medical device from a lubricious polymer comprising:

drying a polyethylene oxide of a molecular weight between about 200,000 and about 7,000,000;

drying a polyether block amide;

melt mixing the polymers into a generally uniform blend by feeding the polymers at a desired rate into a compounding extruder;

forming the blend into a desired shape; and

cross-linking the polymer blend.

2. The method of claim 1 wherein cross-linking the polymer further comprises applying radiation to the polymer.

3. The method of claim 1 further comprising adding a cross-linking agent to the blend while melt mixing the polymers.

4. The method of claim 3 wherein the cross-linking agent is a multi-functional allylic compound.

5. The method of claim 4 wherein the mutli-functional allylic compound is one or more of the group comprising triallyl isocyanurate, triallyl cyanurate, triallyl cyclohexane, 1,7 octadiene, 2,4,6 triallyloxy-1,3,5 triazine and 1,9 decadiene.

6. The method of claim 1 wherein cross linking the polymer blend includes exposing the medical device to between about 0.0 and about 5.0 Mrad of radiation.

7. The method of claim 1 wherein cross linking the polymer blend includes exposing the medical device to between about 0.0 and about 10.0 Mrad of radiation.

8. The method of claim 1 further comprising placing the medical device in an inert atmosphere and then exposing the medical device to the desired amount of radiation.

9. The method of claim 8 wherein the inert atmosphere is comprised of one or more of the group consisting of argon and nitrogen.

10. The method of claim 1 wherein drying the polyethylene oxide comprises drying a polyethylene oxide with a molecular weight of about 1,000,000.

11. The method of claim 1 wherein forming the blend into a desired shape further comprises integrating the blend into a medical device.

12. The method of claim 1 wherein the polyethylene oxide and the polyether block amide are in a ratio to produce a polymer that is about 40% polyethylene oxide.

13. A lubricious polymer blend comprising:

a lubricious polymer melt mixed with a structural polymer to form a polymer blend, the blend cross-linked by exposure to a desired amount of radiation after being formed into a desired shape.

14. The polymer blend of claim 13 wherein the lubricious polymer is a polyethylene oxide

15. The polymer blend of claim 13 wherein the structural polymer is a polyether block amide.

16. The polymer blend of claim 13 wherein the polymer blend includes a cross-linking agent.

17. The polymer blend of claim 13 wherein the polymer blend is cross-linked in the presence of an inert atmosphere.

18. The polymer blend of claim 13 wherein the polymer blend is cross linked by exposure to between about 0.0 and about 5.0 Mrad of radiation.

19. The polymer blend of claim 13 wherein the polymer blend is cross linked by exposure to between about 0.0 and about 10.0 Mrad of radiation.

20. The polymer blend of claim 13 wherein the polymer blend is coated onto the surface of a medical device.

21. A lubricous polymer comprising:

a finely dispersed blend of a polyethylene oxide of a molecular weight between about 200,000 and about 7,000,000 and a polyether block amide, the blend including up to about 60% by weight of the polyethylene oxide and about 1% of a cross-linking agent, wherein after being formed into a desired shape the blend is cross-linked sufficiently to substantially reduce the loss of the polyethylene oxide due to dissolution and abrasion.

22. The lubricious polymer blend coating of claim 21 wherein the polymer blend is cross-linked in the presence of an inert atmosphere.

23. The lubricious polymer blend coating of claim 21 wherein the polymer blend is cross-linked by exposure to a desired amount of radiation.

24. The lubricious polymer blend coating of claim 21 wherein the polymer blend is exposed to between about 0.0 and about 5.0 Mrad of radiation.

25. The lubricious polymer blend coating of claim 21 wherein the polymer blend is exposed to between about 0.0 and about 10.0 Mrad of radiation.

26. The lubricious polymer blend coating of claim 21 wherein the cross-linking agent is a multi-functional allylic compound.

27. A method of forming a medical device that presents a lubricious surface comprising:

preparing a finely dispersed and substantially uniform polymer blend of a water soluble lubricious polymer and a water insoluble polymer,

forming a medical device that includes the polymer blend, the medical device including at least one portion formed from the polymer blend; and

cross-linking the polymer blend portion of the medical device.