Super elastic alloy guidewire

• US 6,139,510 A
• Filed: 10/31/1995
• Issued: 10/31/2000
• Est. Priority Date: 05/11/1994
• Status: Expired due to Term

• Current Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Palermo, Thomas J.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/545,672
• Time in Patent Office: 1,827 Days
• Field of Search: 600/585, 600/933, 604/95, 604/96, 604/280, 604/281, 604/282
• US Class Current: 600/585
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/10 Macromolecular materials
• 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 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09033 with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires

Abstract

This invention is a surgical device. It is a guidewire for use in a catheter and is used for accessing a targeted site in a lumen system of a patient'"'"'s body. The guidewire may be of a high elasticity metal alloy, preferably a Ni-Ti alloy, having specified physical parameters, and is especially useful for accessing peripheral or soft tissue targets. A special variation of the inventive guidewire includes the concept of coating the wire with a one or more lubricious polymers to enhance its suitability for use within catheters and with the interior of vascular lumen. The "necked" guidewire tip also forms a specific variant of the invention.

Claims

1. A guidewire suitable for guiding a catheter within a body lumen, comprising an elongated, flexible metal wire core of a super-elastic alloy having a UP of 75 ksi±

10 ksi, an LP of 25 ksi±

7.5 ksi measured at 3% strain and a RS of less than 0.25% where measured in a stress-strain test to 6% strain, in which at least a portion of the guidewire is coated with a polymeric material and additionally comprising a tie layer disposed between the polymeric layer and the guidewire core.

2. The guidewire of claim 1, where the guidewire has a eccentricity ratio of 1±

10^-4.

3. The guidewire of claim 1, having a distal section, a middle section, and a proximal section.

4. The guidewire of claim 1, in which the super-elastic alloy is Ni-Ti.

5. The guidewire of claim 3, in which the distal section is tapered to a point.

6. The guidewire of claim 5, in which the distal section is coated with a malleable metal.

7. The guidewire of claim 6, in which the malleable metal is selected from the group consisting of gold, nickel, silver, platinum, palladium and alloys thereof.

8. The guidewire of claim 6, in which the at least a portion of the malleable metal coating on the distal portion is covered by an outer coil comprising platinum, tungsten, or an alloy thereof.

9. The guidewire of claim 4, in which the distal section comprises a proximal tapered portion and a constant diameter distal portion.

10. The guidewire of claim 9, in which the distal section is coated with a malleable metal.

11. The guidewire of claim 10, in which the malleable metal is selected from the group consisting of gold, silver, platinum, palladium and alloys thereof.

12. The guidewire of claim 11, in which the at least a portion of the malleable metal coating on the distal portion is covered by an outer coil comprising platinum, tungsten, or an alloy thereof.

13. The guidewire of claim 11, wherein an inner coil surrounds the constant diameter distal portion.

14. The guidewire of claim 13, wherein the inner coil comprises a radiopaque metal selected from the group consisting of platinum, tungsten, or an alloy of the two.

15. The guidewire of claim 14, wherein a metallic ribbon secures the wire core to the inner coil and further to the outer coil.

16. The guidewire of claim 4, in which the distal section comprises a necked down portion of smaller diameter than its surrounding distal section.

17. The guidewire of claim 16, in which at least a portion of the necked down section of the distal portion is covered by an outer coil.

18. The guidewire of claim 4, in which the outer coil is connected at its distal end by a ribbon joined to the necked down section of the distal portion.

19. The guidewire of claim 18, in where an inner coil is secured between the ribbon and the necked down section all within the outer coil.

20. The guidewire of claim 1 where the polymeric material comprises polymers produced from monomers selected from ethylene oxide;

2-vinyl pyridine;

N-vinylpyrrolidone;

polyethylene glycol acrylates such as mono-alkoxy polyethylene glycol mono(meth) acrylates, including mono-methoxy triethylene glycol mono (meth) acrylate, mono-methoxy tetraethylene glycol mono (meth) acrylate, polyethylene glycol mono (meth) acrylate;

other hydrophilic acrylates such as 2-hydroxyethylmethacrylate, glycerylmethacrylate;

acrylic acid and its salts;

acrylamide and acrylonitrile;

acrylamidomethylpropane sulfonic acid and its salts, cellulose, cellulose derivatives such as methyl cellulose ethyl cellulose, carboxymethyl cellulose, cyanoethyl cellulose, cellulose acetate, polysaccharides such as amylose, pectin, amylopectin, alginic acid, and cross-linked heparin.

21. The guidewire of claim 1, where the tie layer disposed between the polymeric layer and the guidewire core is a heat shrunk tubing.

22. The guidewire of claim 21, where the tie layer disposed between the polymeric layer and the guidewire core is a heat shrunk tubing comprising a material selected from polyethylene terephthalate and polyurethane.

23. The guidewire of claim 21, where the tie layer disposed between the polymeric layer and the guidewire core is a heat shrunk tubing and further comprises a radiopaque material.

24. The guidewire of claim 1, where the tie layer disposed between the polymeric layer and the guidewire core is deposited by plasma.

25. The guidewire of claim 1 additionally comprising a catheter sheath.

26. A guidewire suitable for guiding a catheter within a blood vessel, comprising an elongated flexible metal wire core having a distal section including a necked down portion having a diameter smaller than a linearly contiguous section just distal of the necked down portion;

an outer coil surrounding at least a portion of the distal section, such portion of the distal section comprising at least the smaller diameter portion; and

a metallic ribbon securing the outer coil to the smaller diameter portion of the distal section.

27. The guidewire of claim 26, wherein an inner coil is located within the smaller diameter portion of the distal section.

28. The guidewire of claim 26, wherein the wire core comprises a material selected from the group consisting of high elasticity alloys, stainless steel, platinum, palladium, rhodium and alloys thereof.

29. The guidewire of claim 28, where the material is a Ni-Ti alloy.

30. The guidewire of claim 26, wherein the outer coil comprises a radiopaque material selected from the group consisting of platinum, tungsten, or an alloy of the two.

31. The guidewire of claim 26, wherein the inner coil comprises a radiopaque material selected from the group consisting of platinum, tungsten or an alloy of the two.

38. The guidewire of claim 26, wherein said section just distal of the necked down portion is substantially flattened and has a width greater than said diameter of said necked down portion.

32. A guidewire suitable for guiding a catheter within a blood vessel, comprising an elongated flexible metal wire core of a super-elastic alloy having a tie layer disposed about at least a portion of the core, where said tie layer has been shrunk onto the wire core, where said tie layer comprises at least one of NYLON, polyethylene, polystyrene, polyurethane and polyethylene terephthalate, and where said tie layer further comprises one or more radio opaque material selected from barium sulfate, bismuth trioxide, bismuth carbonate, tungsten and tantalum.

33. The guidewire of claim 32, where the super-elastic alloy material is a Ni-Ti alloy.

34. The guidewire of claim 33, where the tie layer comprises at least one of NYLON, polyethylene, polystyrene, polyurethane, and polyethylene terephthalate.

35. The guidewire of claim 34, where the tie layer comprises polyethylene terephthalate or polyurethane.

36. The guidewire of claim 34, where the tie layer further comprises one or more radio opaque materials selected from barium sulfate, bismuth trioxide, bismuth carbonate, tungsten, and tantalum.

37. The guidewire of claim 32, additionally comprising a layer disposed about the tie layer comprising polymers produced from monomers selected from ethylene oxide;

2-vinyl pyridine;

N-vinylpyrrolidone;

polyethylene glycol acrylates such as mono-alkoxy polyethylene glycol mono(meth) acrylates, including mono-methoxy triethylene glycol mono (meth) acrylate, mono-methoxy tetraethylene glycol mono (meth) acrylate, polyethylene glycol mono (meth) acrylate;

other hydrophilic acrylates such as 2-hydroxyethylmethacrylate, glycerylmethacrylate;

acrylic acid and its salts;

acrylamide and acrylonitrile;

acrylamidomethylpropane sulfonic acid and its salts, cellulose, cellulose derivatives such as methyl cellulose ethyl cellulose, carboxymethyl cellulose, cyanoethyl cellulose, cellulose acetate, polysaccharides such as amylose, pectin, amylopectin, alginic acid, and cross-linked heparin.

39. The guidewire of claim 32, where said tie layer comprises polyethylene terephthalate or polyurethane.

41. The guidewire of claim 32, where the super-elastic alloy material is a Ni-Ti alloy.

40. A guidewire suitable for guiding a catheter within a blood vessel, comprising an elongated flexible metal wire core of a super-elastic alloy having a tie layer disposed about at least a portion of the core, where said tie layer has been shrunk onto the wire core, and a layer disposed about said tie layer, said layer disposed about said tie layer comprising polymers produced from monomers selected from ethylene oxide;

2-vinyl pyridine;

N-vinylpyrrolidone;

polyethylene glycol acrylates such as mon-alkoxy polyethylene glycol mono(meth) acrylates, including mono-methoxy triethylene glycol mono(meth) acrylate, mono-methoxy tetraethylene glyco mono(meth) acrylate, polyethylene glycol mono(meth) acrylate;

other hydrophilic acrylates such as 2-hydroxyethylmethacrylate, glycerylmethacrylate;

acrylic acid and its salts;

acrylamide and acrylonitrile;

acrylamidomethylpropane sulfonic acid and its salts;

cellulose;

cellulose derivatives such as methyl cellulose, ethyl cellulose, carboxymethyl cellulose, cyanoethyl cellulose, cellulose acetate;

polysaccharides such as amylose, pectin, amylopectin, alginic acid, and cross-linked heparin.