High performance wires for use in medical devices and alloys therefor

• US 5,720,300 A
• Filed: 02/21/1995
• Issued: 02/24/1998
• Est. Priority Date: 11/10/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Jansen, Lex P., Wright, John A. Jr., Raman, L. Ven, Fagan, John R.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/391,010
• Time in Patent Office: 1,099 Days
• Field of Search: 606/198, 604/95, 128/772, 148/606
• US Class Current: 600/585
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

An elongate flexible wire-like medical device, such as a guidewire for use with a catheter, is formed with a shaft in which the difference between the magnitude of the tensile yield stress and compressive yield stress of the shaft is substantially reduced. The guidewire exhibits superior kink resistance without compromising other desirable characteristics and enables a guidewire to be made in a smaller diameter without loss of performance. The guidewire shaft may be formed from a precipitation hardenable alloy such as an alloy of nickel, cobalt, molybdenum and chromium (MP35N and Elgiloy), 455PH stainless steel or stainless steel alloy 1RK91. Also disclosed is a process for increasing the modulus of elasticity of an alloy of nickel, cobalt molybdenum and chromium. Further, the disclosure relates to an improved management and manufacturing process for constructing the tip of a medical guidewire.

Claims

1. A medical guidewire for use with a catheter comprising an elongate flexible shaft having a compressive yield stress that is not substantially disproportionate to its tensile yield stress.

2. A guidewire as defined in claim 1 wherein the magnitude of the compressive yield stress is greater than about 60% of the magnitude of the tensile yield stress.

3. A guidewire as defined in claim 1 wherein the magnitude of the compressive yield stress is greater than about 70% of the magnitude of the tensile yield stress.

4. A guidewire as defined in claim 1 wherein the magnitude of the compressive yield stress is greater than about 80% of the magnitude of the tensile yield stress.

5. A guidewire as defined in claim 1 wherein the magnitude of the compressive yield stress lies in a range that is between about 60% and about 85% of the magnitude of the tensile yield stress.

25. A guidewire as defined in either one of claims 1 or 6 in which the guidewire shaft has a diameter no greater than about 0.020 inches.

6. A medical guidewire for use with a catheter comprising an elongate, flexible shaft in which the degree of compressive strain and the degree of tensile strain at the yield point in bending are not substantially disproportionate.

7. A medical guidewire for use with a catheter comprising an elongate flexible shaft having a stress/strain curve in which the yield points in tension and compression are not substantially disproportionately located along the curve.

8. A medical guidewire for use with a catheter comprising an elongate, flexible shaft in which the degrees of compressive strain and tensile strain at the yield point are less disproportionate than in an identically dimensioned guidewire shaft formed from stainless steel that has not been precipitation hardened.

9. A medical guidewire for use with a catheter comprising an elongate flexible shaft that has a compressive yield stress that is greater than the compressive yield stress of an identically dimensioned shaft formed from stainless steel that has not been precipitation hardened.

10. A medical guidewire as defined in claim 9 further comprising the modulus of elasticity being greater than about 29,000,000 p.s.i.

11. A medical guidewire as defined in claim 9 wherein the modulus of elasticity of the guidewire shaft is greater than that of nitinol alloy.

12. A guidewire for use with a catheter comprising:

an elongate flexible shaft formed from a precipitation hardened alloy.

13. A guidewire as defined in claim 12 wherein the alloy comprises an alloy of nickel, cobalt, molybdenum and chromium.

14. A guidewire as defined in claim 13 wherein the alloy comprises MP35N.

15. A guidewire as defined in claim 13 wherein the alloy further includes less than about 10%, by weight, iron.

16. A guidewire as defined in claim 15 wherein the alloy comprises Elgiloy.

17. A guidewire as defined in claim 12 wherein the alloy comprises Sandvik 1RK91.

18. A guidewire as defined in claim 12 wherein the alloy comprises a precipitation hardenable martensitic stainless steel alloy comprising, in percent by weight, about 10% to 14% chromium, between about 7% to 11% nickel, molybdenum between about 0.5% to 6%, cobalt up to about 9%, copper between about 0.5% to 4%, aluminum between about 0.05% to 0.6%, titanium between about 0.4% to 1.4%, carbon and nitrogen not exceeding 0.05%, with iron as the remainder and the content of any other element of the periodic table not exceeding 0.5%.

19. A guidewire as defined in claim 12 wherein the precipitation hardened alloy is formed from a martinsitic stainless steel alloy that is precipitation hardenable by a single step aging treatment and comprising, in percent by weight, about 11.0% to about 12.5% chromium, about 7.5% to about 9.5% nickel, about 0.8% to about 1.4% titanium, about 0.1% to about 0.5% columbium and tantalum, about 1.5% to about 2.5% copper, up to about 0.5% molybdenum, up to about 0.05% carbon, up to about 0.05% manganese, up to about 0.04% phosphorous, up to about 0.03% sulfur and up to about 0.5% silicon with the balance consisting essentially of iron except for incidental impurities.

20. A guidewire as defined in claim 19 wherein the alloy comprises 455 PH precipitation hardened steel.

21. A guidewire as defined in any one of claims 12-20 wherein the shaft has a tapered distal segment.

22. A guidewire as defined in claim 21 wherein the shaft is formed from a single continuous wire of said alloy.

23. A guidewire for use with a catheter comprising an elongate flexible shaft formed from an alloy having a modulus of elasticity no less than about 28,000,000 p.s.i. and a performance index less than 232, said performance index being determined by the formula ##EQU2## wherein PI is the performance index, R is the radius through which the wire may be bent without plastic deformation sufficient to affect the straightness of the wire and D_w is the diameter of the wire.

24. A guidewire as defined in claim 23 wherein the modulus of elasticity is between about 28,000,000 p.s.i. to about 35,000,000 p.s.i.

26. In a guidewire for use with a catheter, the guidewire having an elongate flexible shaft having a proximal end and a distal end and a helical coil attached to the distal end, with the distal end of the helical coil extending distally beyond the distal end of the shaft, the guidewire further having a safety ribbon disposed within the helical coil having its proximal end attached to the shaft and its distal end attached to the distal tip region of the coil, the improvement comprising the safety wire being formed so that it has a compressive yield stress that is not substantially disproportionate to its tensile yield stress.

27. In a guidewire for use with a catheter, the guidewire having an elongate flexible shaft having a proximal end and a distal end and a helical coil attached to the distal end, with the distal end of the helical coil extending distally beyond the distal end of the shaft, the guidewire further having a safety ribbon disposed within the helical coil having its proximal end attached to the shaft and its distal end attached to the distal tip region of the coil, the improvement comprising the safety wire being constructed so that the degree of compressive strain and the degree of tensile strain at the yield point in bending are not substantially disproportionate.

28. In a guidewire for use with a catheter, the guidewire having an elongate flexible shaft having a proximal end and a distal end and a helical coil attached to the distal end, with the distal end of the helical coil extending distally beyond the distal end of the shaft, the guidewire further having a safety ribbon disposed within the helical coil having its proximal end attached to the shaft and its distal end attached to the distal tip region of the coil, the improvement comprising the safety ribbon being formed from a precipitation hardened alloy.

29. A guidewire as defined in claim 28 wherein the alloy comprises an alloy of nickel, cobalt, molybdenum and chromium.

30. A guidewire as defined in claim 28 wherein the alloy further includes less than about 10%, by weight, iron.

31. A guidewire as defined in claim 28 wherein the alloy comprises a precipitation hardenable martensitic stainless steel alloy comprising, in percent by weight, about 10% to 14% chromium, between about 7% to 11% nickel, molybdenum between about 0.5% to 6%, cobalt up to about 9%, copper between about 0.5% to 4%, aluminum between about 0.05% to 0.6%, titanium between about 0.4% to 1.4%, carbon and nitrogen not exceeding 0.05%, with iron as the remainder and the content of any other element of the periodic table not exceeding 0.5%.

32. A guidewire for catheters, comprising a casing;

a core for said casing; and

a junction between said casing and said core, the region of said junction including a precipitation-hardened material.

33. The guidewire of claim 32, wherein said junction comprises a weld.

34. The guidewire of claim 32, wherein said core comprises a wire of said precipitation-hardened material.

35. The guidewire of claim 32, wherein said casing comprises a helical coil.

36. The guidewire of claim 32, wherein said precipitation-hardened material comprises a stainless alloy.

37. The guidewire of claim 36, wherein said stainless alloy is 455PH stainless steel.

38. The guidewire of claim 36, wherein said casing is made of a stainless alloy.

39. The guidewire of claim 36, wherein said casing is made of a radiopaque alloy.

40. The guidewire of claim 37, wherein said casing comprises 30Au-70Pt alloy.