Low friction guidewire with off-center core

• US 6,461,311 B2
• Filed: 02/15/2001
• Issued: 10/08/2002
• Est. Priority Date: 03/04/1998
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Elton, Richard, Teague, Gary, DuBois, Tom
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US09/784,578
• Publication Number:
  US 20010009981A1
• Time in Patent Office: 600 Days
• Field of Search: 600/434, 600/435, 600/585
• US Class Current: 600/585
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09108 Methods for making a guide wire
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: C08L 39/06 Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C08L 71/02 Polyalkylene oxides
• CPC Class Codes: C08L 75/00 Compositions of polyureas or polyurethanes; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 75/02 Polyureas
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

A flexible, kink-resistant, low-friction guidewire for positioning a medical instrument through tortuous passageways within a patient is disclosed. The guidewire includes a core wire which remains substantially free of any residual strain when it is positioned within the patient, a metal coil about the core wire and extending substantially the entire length of the core, a primer coating on the coil and a hydrophilic, lubricous coating on the primer coating. The core wire is preferably a superelastic metal alloy such as Nitinol. The metal coil is preferably formed from a wire with a rectangular cross section. The primer is preferably one which reacts with species of isocyanate or hydroxyl, and the hydrophilic, lubricous coating is preferably a cross-linked polymer selected from the group of polyurethane, polyurea, and polyurethaneurea, complexed with a hydrophilic complexing species such as poly(ethylene oxide) or polyvinylpyrrolidone. A method for manufacturing and coating such a guidewire is also disclosed.

Claims

1. A guide wire for positioning a medical instrument through tortuous passageways within a patient, comprising:

a flexible core wire which remains substantially free of any residual strain when positioned within the patient;

a metal coil enveloping the core wire for substantially its entire lengths,

the core wire being positioned off-center within the coil;

a primer coating on the metal coil; and

a hydrophilic, lubricous coating disposed over the primer coating.

2. The guide wire as in claim 1, wherein the primer is a polymer that reacts with species of isocyanate or hydroxyl.

3. The guide wire as in claim 2, wherein the hydrophilic, lubricous coating is a cross-linked polymer complexed with a hydrophilic complexing species.

4. The guide wire as in claim 3, wherein the cross-linked polymer is selected from the group of polyurethane, polyurea, and polyurethaneurea.

5. The guide wire as in claim 3, wherein the hydrophilic complexing species has a molecular weight greater than 10,000.

6. The guide wire as in claim 3, wherein the hydrophilic complexing species is one of poly(ethylene oxide) and a polyvinylpyrrolidone.

7. The guide wire as in claim 3, wherein the hydrophilic, lubricous coating is free of an osmolality increasing compound.

8. The guide wire as in claim 1, wherein the hydrophilic, lubricous coating is a cross-linked polymer complexed with a hydrophilic complexing species.

9. The guide wire as in claim 8, wherein the cross-linked polymer is selected from the group of polyurethane, is polyurea, and polyurethaneurea.

10. The guide wire as in claim 8, wherein the hydrophilic complexing species is one of poly(ethylene oxide) and a polyvinylpyrrolidone.

11. The guide wire as in claim 1, wherein the metal coil is made from a wire having a rectangular cross section.

12. The guide wire as in claim 1, wherein the coil has a proximal end and a distal end, and further comprising an elongated safety wire extending between proximal and distal ends of the coil.

13. The guidewire as in claim 1, wherein the core wire has a tapering distal segment.

14. The guide wire as in claim 1, wherein the core wire terminates proximal to the distal end of the coil.

15. The guidewire as in claim 1, wherein the core wire terminates in a radiused tip and has a substantially constant diameter along its length.

16. The guidewire as in claim 1, wherein the core wire is movable relative to the metal coil.

17. The guide wire as in claim 16, wherein the primer is a polymer that reacts with species of isocyanate or hydroxyl.

18. The guide wire as in claim 1, wherein the primer is a polymer that reacts with species of isocyanate or hydroxyl, the hydrophilic, lubricous coating is a cross-linked polymer complexed |with a hydrophilic complexing species, the cross-linked polymer being selected from the group of polyurethane, polyurea, and polyurethaneurea, and the hydrophilic complexing species being one of poly(ethylene oxide) and polyvinylpyrrolidone.

19. The guide wire as in claim 1, wherein the hydrophilic coating is one of a thermoplastic solvent soluble material and a thermoplastic solvent dispersable material.

20. The guide wire as in claim 1, wherein the hydrophilic coating is one of a solvent soluble and a solvent dispersable blend of a stabilizing polymer and a hydrophilic material.

21. The guide wire as in claim 1, wherein the hydrophilic coating comprises a first layer being a reactive base coat and a second, outer layer being a hydrophilic material.

22. The guide wire as in claim 1, wherein the coil has a proximal end and a distal end, wherein both the primer and the hydrophilic coating terminate distal to the proximal end of the coil, the proximal end of the coil being uncoated.

23. The guidewire as in claim 1, wherein a portion of the primer is not covered with the hydrophilic coating.

24. The guide wire as in claim 1, wherein the core wire is made from one of the group consisting of steel and a superelastic alloy.

25. The guide wire as in claim 1, further comprising a safety wire fixedly positioned relative to the coil.

26. The guide wire as in claim 25, wherein the off-center core wire abuts both the safety wire and the coil.

27. The guide wire as in claim 25, wherein the safety wire is formable.

28. A method for producing a flexible, kink resistant, lubricious guidewire suitable for an intended application, comprising the steps of:

providing an elongated superelastic core wire having a predetermined stiffness at preselected locations along its length;

disposing a helically wound metal coil about the entire length of the core wire with the core wire being positioned off-center within the coil, the coil increasing the overall diameter of the guidewire to substantially a preselected diameter providing additional stiffness there to such that the core wire and coil assembly possess a stiffness suitable for the intended application;

applying a polymeric primer layer to the exterior of at least a portion of the helically wound metal coil; and

applying a hydrophilic, lubricious coating layer over at least a portion of the primer layer.

29. A method as in claim 28, including the additional step of extending a safety wire substantially the full length of the coil within the coil and affixing the safety wire to at least the proximal and distal ends of the coil.

30. A method as in claim 29, wherein the safety wire is affixed to the helically wound coil by a welding process.