Guidewire and tube with lubricious coating

• US 20060240253A1
• Filed: 04/22/2005
• 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: Phillips, Jason R., Bavaro, Vincent P., Biagtan, Emmanuel C.
• Application Number:
  US11/112,649
• Publication Number:
  US 20060240253A1
• Time in Patent Office: Days
• US Class Current: 428/375
• CPC Class Codes: A61L 2400/10 Materials for lubricating medical devices
• 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: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: C08L 71/02 Polyalkylene oxides
• CPC Class Codes: Y10T 428/1393 Multilayer [continuous layer]
• CPC Class Codes: Y10T 428/2933 Coated or with bond, impregnation or core

Abstract

A hydrophilic polymer blend where at least one of the polymer materials is a water insoluble polymer and one of the materials is a hydrophilic water-soluble polymer. The invention includes a method of forming the hydrophilic polymer blend by melt mixing the hydrophilic polymer and the insoluble polymer into a finely dispersed polymer blend, forming strands of the hydrophilic polymer blend, and then pelletizing the strands.

Claims

1. A guidewire with a lubricous coating comprising a blend of a polyethylene oxide with a molecular weight between about 200,000 and about 7,000,000 and a polyether block amide, the blend including up to 60% by weight of the polyethylene oxide, the blend being substantially finely dispersed and forming a lubricious surface when exposed to an aqueous solvent.

2. The guidewire of claim 1 wherein the blend includes between about 35% and about 50% polyethylene oxide.

3. The guidewire of claim 1 wherein the blend includes about 40% polyethylene oxide.

4. The guidewire of claim 1 wherein the polyethylene oxide has a molecular weight of about 1,000,000.

5. The guidewire of claim 1 wherein the blend includes a stabilizer.

6. The guidewire of claim 1 wherein the blend is cross-linked a predetermined amount.

7. The guidewire of claim 6 wherein the blend is electron beam cross-linked.

8. A lubricious guidewire comprising a guidewire with a lubricious layer, the lubricious layer including a finely dispersed blend of a polyethylene oxide with a molecular weight of approximately 1,000,000 and a polyether block amide, the blend including about 40% by weight of the polyethylene oxide, the lubricious layer forming a lubricious surface when exposed to an aqueous solution.

9. A tube with at least one lubricious surface comprising:

a first inner layer formed of a substantially uniform polymer blend of a polyethylene oxide with a molecular weight of between about 200,000 and 7,000,000 and a polyether block amide, the blend including up to 60% by weight of the polyethylene oxide, the inner layer forming a lubricious inner surface when exposed to an aqueous solution; and

a second outer layer formed of a substantially water insoluble polymer.

10. The tube of claim 9 further comprising the outer layer adhered around the inner layer.

11. The tube of claim 9 wherein the polymer blend includes between about 35% and about 50% polyethylene oxide.

12. The tube of claim 9 wherein the polymer blend includes about 40% polyethylene oxide.

13. The tube of claim 9 wherein the outer layer prevents the first inner layer from swelling more than about 5% in diameter upon contact with an aqueous solution at 37°

C.

14. The tube of claim 9 further comprising a third layer disposed between the first inner layer and the second outer layer, the third layer bonding the first inner layer to the second outer layer.

15. The tube of claim 14 wherein the third layer is selected from the group consisting of a graft maleic anhydride and an acrylic acid copolymer.

16. The tube of claim 9 wherein the polyethylene oxide has a molecular weight of about 1,000,000.

17. The tube of claim 9 wherein the polyether block amide has a shore hardness of 72D.

18. The tube of claim 9 wherein the inner layer is between about 0.001 and 0.0025 inches thick.

19. The tube of claim 9 wherein the inner layer is cross-linked a desired amount.

20. A method of forming a medical device with a lubricious surface comprising:

preparing a finely dispersed and substantially uniform polymer blend of polyethylene oxide, the polyethylene oxide molecular weight between about 200,000 and about 7,000,000, and a polyether block amide, the blend including up to 60% by weight of the polyethylene oxide; and

forming a medical device with the polymer blend, the medical device including at least one surface formed from the polymer blend.

21. The method of claim 20 wherein the forming step further comprises one or more of co-extruding, molding, or die forming the polymer blend with a structural article.

22. The method of claim 21 wherein the structural article is formed from a polymer.

23. The method of claim 21 further comprising cross-linking the polymer blend a desired amount.

24. The method of claim 23 wherein the cross-linking is accomplished by exposing the blend to an electron beam.

25. A multilayer tube with at least one lubricious surface comprising:

a lubricious layer including a finely dispersed blend of a polyethylene oxide of approximately 1,000,000 molecular weight and a polyether block amide, the blend including about 40% by weight of the polyethylene oxide, the lubricious layer being between about 0.001 and about 0.0025 inches thick and forming a lubricious inner surface when exposed to an aqueous solution;

a substantially insoluble structural layer integrally formed with the lubricious layer wherein the structural layer constrains the lubricious layer from swelling more than about 5% in diameter upon contact with an aqueous solution at 37°

C.; and

a third layer of a bonding material, the bonding material for securing the inner layer to the outer layer.

26. The multilayer tube of claim 25 wherein the structural layer is a polyamide.

27. A tube with a lubricious inner surface comprising:

an inner layer including a finely dispersed blend of a polyethylene oxide with a molecular weight of approximately 1,000,000 and a polyurethane, the blend including about 40% by weight of the polyethylene oxide, the inner layer being between about 0.001 and about 0.0025 inches thick and forming a lubricious inner surface when exposed to an aqueous solution; and

a substantially insoluble outer layer integrally formed with the inner layer wherein the outer polymer layer constrains the inner hydrophilic layer from swelling more than 5% in diameter upon contact with an aqueous solution at 37°

C.