CA2462335A1 - Composite guidewire - Google Patents

Composite guidewire Download PDF

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Publication number
CA2462335A1
CA2462335A1 CA002462335A CA2462335A CA2462335A1 CA 2462335 A1 CA2462335 A1 CA 2462335A1 CA 002462335 A CA002462335 A CA 002462335A CA 2462335 A CA2462335 A CA 2462335A CA 2462335 A1 CA2462335 A1 CA 2462335A1
Authority
CA
Canada
Prior art keywords
distal
guidewire
section
proximal
flexibility
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002462335A
Other languages
French (fr)
Other versions
CA2462335C (en
Inventor
Peter Skujins
Brian R. Reynolds
Greg Schultz
Brice Shireman
Bruce H. Asmus
Ron Tanaka
Michael Swee
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Ltd Barbados
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US09/972,276 external-priority patent/US6918882B2/en
Application filed by Individual filed Critical Individual
Publication of CA2462335A1 publication Critical patent/CA2462335A1/en
Application granted granted Critical
Publication of CA2462335C publication Critical patent/CA2462335C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/0905—Guide wires extendable, e.g. mechanisms for extension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • A61M2025/09141—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque made of shape memory alloys which take a particular shape at a certain temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip

Abstract

Alternative designs, materials and manufacturing methods for guidewires. Som e embodiments pertain to a composite guidewire having proximal (14) and distal (16) section, and a connector (18) adapted and configured for permanently joining the proximal section (14) to the distal section (16). In some embodiments, at least one of the sections (16) is made of a linear-elastic nickel-titanium alloy. Several alternative guidewire tip designs including coiled safety/shaping structures are also disclosed.

Claims (83)

1. A guidewire, comprising:
a proximal section having a distal end;
a distal section comprising a linear elastic nickel-titanium alloy, the distal section having a proximal end; and a connector disposed adjacent the distal end of the proximal section and the proximal end of the distal section, the connector adapted and configured for permanently joining the proximal section to the distal section.
2. A guidewire as in claim 1, wherein the proximal section has a first flexibility and the distal section has a second flexibility, and wherein the distal end of the proximal section and the proximal end of the distal section overlap to define a region that blends the first flexibility with the second flexibility.
3. A guidewire as in claim 1, wherein the distal end of the proximal section has a reduced size, and the proximal end of the distal section has a reduced size.
4. A guidewire as in claim 3, wherein the reduced size portions have a uniform profile.
5. A guidewire as in claim 3, wherein the reduced size portions have a taper.
6. A guidewire as in claim 3, wherein the reduced size portions have an interlocking shape.
7. A guidewire as in claim 1, wherein the distal end of the proximal section and the proximal end of the distal section are joined to define a butt joint.
8. A guidewire as in claim 1, wherein the distal end of the proximal section defines a tapered portion and the proximal end of the distal section defines a tapered portion, and the tapered portions at least partially overlap each other.
9. A guidewire as in claim 8, wherein the connector comprises connector material disposed between the tapered portions.
10. A guidewire as in claim 1, wherein the proximal section comprises a metal or metal alloy.
11. A guidewire as in claim 10, wherein the metal or metal alloy comprises stainless steel, nickel-titanium alloy, nickel-chromium alloy, nickel-chromium-iron alloy, cobalt alloy, or combinations thereof.
12. A guidewire as in claim 11, wherein the proximal section comprises stainless steel.
13. A guidewire as in claim 1, wherein the guidewire further includes an outer structure disposed about at least a portion of the distal section.
14. A guidewire as in claim 13, wherein the outer structure comprises a polymer sleeve.
15. A guidewire as in claim 14 wherein the guidewire further includes a flat ribbon attached to the distal section.
16. A guidewire of claim 14, wherein the guidewire further comprises a coil disposed about a portion of the distal section, the coil having a distal portion that extends distally of the distal section.
17. A guidewire of claim 13, wherein the outer structure comprises a first coil disposed about a portion of the distal section.
18. A guidewire of claim 17, wherein the guidewire further includes an inner coil disposed about a portion of the distal section at least partially within the first coil, the inner coil having a distal portion that extends distally of the distal section.
19. The guidewire of claim 18, wherein the inner coil is adapted and configured to be a safety structure.
20. A guidewire as in claim 17, wherein the guidewire further includes a flat ribbon attached to the distal section.
21. A guidewire of claim 1, wherein the connector comprises a metal or a metal alloy.
22. A guidewire of claim 21, wherein the metal or a metal alloy comprises stainless steel, nickel-titanium alloy, nickel-chromium alloy, nickel-chromium-iron alloy, cobalt alloy, nickel, or combinations thereof.
23. A guidewire as in claim 22, wherein the connector comprises a nickel-chromium-iron alloy.
24. A guidewire of claim 1, wherein the connector comprises a polymer or a metal-polymer composite.
25. A guidewire as in claim 1, wherein the connector comprises a tubular member disposed about the distal end of the proximal section and the proximal end of the distal section.
26. A guidewire, comprising:
a proximal section having a distal end, wherein the distal end of the proximal section includes a flexibility transition region;
a distal section comprising a linear-elastic nickel-titanium alloy, the distal section having a proximal end, wherein the proximal end of the distal section includes a flexibility transition region; and a connector disposed adjacent the distal end of the proximal section and the proximal end of the distal section, the connector adapted and configured for joining the proximal section to the distal section.
27. A guidewire as in claim 26, wherein the proximal section has a first flexibility and the distal section has a second flexibility, and wherein flexibility transition regions overlap to define a region that blends the first flexibility with the second flexibility.
28. A guidewire as in claim 26, wherein the proximal section is comprised of stainless steel.
29. A guidewire as in claim 26, wherein the guidewire further includes a polymer sleeve disposed about a portion of the distal section.
30. A guidewire of claim 29, wherein the guidewire further includes a coil disposed about a portion of the distal section, the coil having a distal portion that extends distally of the distal section.
31. A guidewire of claim 26, wherein the guidewire further includes a first coil disposed about a portion of the distal section.
32. A guidewire of claim 31, wherein the guidewire further includes an inner coil disposed about a portion of the distal section at least partially within the first coil, the inner coil having a distal portion that extends distally of the distal section.
33. The guidewire of claim 32, wherein the inner coil is adapted and configured to be a safety structure.
34. A guidewire as in claim 26, wherein the connector comprises a nickel-chromium-iron alloy tube.
35. A guidewire as in claim 26, wherein at least a portion of the connector is disposed between the flexibility transition regions.
36. A method of manufacturing a guidewire, comprising the steps of:
providing a proximal section having a distal end;
providing a distal section comprising a linear elastic nickel-titanium alloy, the distal section having a proximal end; and connecting the distal end of the proximal section and the proximal end of the distal section using a the connector adapted and configured for permanently joining the proximal section to the distal section.
37. A method as in claim 36, further comprising the step of forming flexibility transition regions in the distal end of the proximal section and the proximal end of the distal section.
38. A method as in claim 37, wherein the step of forming the flexibility transition regions comprises reducing the size of the proximal and distal ends.
39. A method as in claim 37, wherein the step of connecting the distal end of the proximal section and the proximal end of the distal section includes overlapping the proximal and distal ends.
40. A method of manufacturing a guidewire, comprising the steps of:
providing a proximal section having a distal end, and a flexibility transition region at the distal end;
providing a distal section comprising a linear-elastic nickel-titanium alloy, the distal section having a proximal end, and a flexibility transition region at the proximal end; and joining the flexibility transition regions.
41. A guidewire, comprising:
a proximal section;
a distal section comprising a linear-elastic nickel-titanium alloy; and means for joining the proximal section with the distal section.
42. A guidewire as in claim 41, wherein the proximal section has a first flexibility, and the distal section has a second flexibility, and the means for joining includes a means for joining the proximal section with the distal section such that the first flexibility and the second flexibility are blended.
43. A guidewire, comprising:
a proximal section comprising stainless steel;
a distal section comprising a linear-elastic nickel-titanium alloy; and a connector comprising a nickel-chromium-iron alloy which connects the proximal and distal sections.
44. A guidewire, comprising:
a core wire having a proximal portion and a distal portion;
a coil having a proximal region and a distal region, the proximal region of the coil connected to the distal portion of the core wire, and the distal region of the coil extending distally beyond the distal portion of the core wire; and a polymer sheath disposed around at least a portion of the core wire and the coil, the polymer sheath extending distally beyond the distal portion of the core wire and the distal region of the coil to form a tip.
45. A guidewire as in claim 44, wherein the coil is adapted and configured to be a safety structure.
46. A guidewire as in claim 44, wherein the coil is a flat wire coil.
47. A guidewire as in claim 44, wherein the distal region of the coil has an first outer diameter, and the proximal region of the coil has an second outer diameter different from the first outer diameter.
48. A guidewire comprising:
a core structure comprising a nickel titanium alloy, the core structure having a distal portion;

a flat wire coil having a proximal region and a distal region, the proximal region of the coil connected to the distal portion of the core wire, and the distal region of the coil extending distally beyond the distal portion of the core wire; and an outer structure disposed about at least a portion of the distal portion of the core and the flat wire coil.
49. A guidewire as in claim 48, wherein the outer structure is a polymer sheath.
50. A guidewire as in claim 48, wherein the outer structure is an outer coil.
51. A guidewire as in claim 50, wherein the outer coil is a round wire coil.
52. A guidewire as in claim 48, wherein the core structure comprises a linear elastic nickel titanium alloy.
53. A guidewire as in claim 48, wherein the distal region of the coil has an first outer diameter, and the proximal region of the coil has an second outer diameter different from the first outer diameter.
54. A guidewire as in claim 53, wherein the coil has an outer diameter that tapers to become narrower as the coil extends distally.
55. A guidewire, comprising:
a core wire having a proximal section having a distal end, and a distal section having a proximal end and a distal end;
a connector disposed adjacent the distal end of the proximal section and the proximal end of the distal section, the connector adapted and configured for permanently joining the proximal section to the distal section;
an inner coil having a proximal region and a distal region, the proximal region of the coil connected to the distal end of the distal section, and the distal region of the coil extending distally beyond the distal end of the distal section; and an outer structure disposed about at least a portion of the distal section and the inner coil.
56. A guidewire as in claim 55, wherein the outer structure is a polymer sheath.
57. A guidewire as in claim 56, wherein polymer sheath extends distally beyond the distal region of the coil to form a tip.
58. A guidewire of claim 55, wherein the outer structure is an outer coil.
59. A guidewire as in claim 55, wherein the inner coil is a flat wire coil.
60. A guidewire, comprising:
a proximal section having a distal end, wherein the distal end of the proximal section has a reduced size;
a distal section having a proximal end, wherein the proximal end of the distal section has a reduced size, and wherein the proximal end of the distal section overlaps the distal end of the proximal section; and a connector disposed adjacent the distal end of the proximal section and the proximal end of the distal section, the connector adapted and configured for permanently joining the proximal section to the distal section.
61. A guidewire as in claim 60, wherein the proximal section has a first flexibility and the distal section has a second flexibility, and wherein the distal end of the proximal section and the proximal end of the distal section overlap to define a region that blends the first flexibility with the second flexibility.
62. A guidewire as in claim 60, wherein the reduced size portions have a uniform profile.
63. A guidewire as in claim 60, wherein the reduced size portions have a taper.
64. A guidewire as in claim 60, wherein the reduced size portions have an interlocking shape.
65. A guidewire as in claim 61, wherein the proximal section is comprised of stainless steel.
66. A guidewire as in claim 65, wherein the distal section is comprised of a nickel-titanium alloy.
67. A guidewire as in claim 66, wherein the connector is comprised of a nickel-chromium-iron alloy.
68. A guidewire as in claim 60, wherein the connector comprises a tubular member disposed about the distal end of the proximal section and the proximal end of the distal section.
69. A guidewire as in claim 68, wherein the tubular connector has an outside diameter that is the same as an outside diameter of the proximal section.
70. A guidewire as in claim 69, wherein the tubular connector has an outside diameter that is the same as an outside diameter of the distal section.
71. A guidewire as in claim 60, wherein at least a portion of the connector is disposed between the tapered distal end of the proximal section and the tapered proximal end of the distal section.
72. A guidewire, comprising:
a proximal section having a distal end, wherein the distal end of the proximal section includes a flexibility transition region;
a distal section having a proximal end, wherein the proximal end of the distal section includes a flexibility transition region; and a connector disposed adjacent the distal end of the proximal section and the proximal end of the distal section, the connector adapted and configured for joining the proximal section to the distal section.
73. A guidewire as in claim 72, wherein the proximal section has a first flexibility and the distal section has a second flexibility, and wherein flexibility transition regions overlap to define a region that blends the first flexibility with the second flexibility.
74. A guidewire as in claim 73, wherein the proximal section is comprised of stainless steel.
75. A guidewire as in claim 74, wherein the distal section is comprised of a nickel-titanium alloy.
76. A guidewire as in claim 75, wherein the connector comprises a nickel-chromium-iron alloy tube.
77. A guidewire as in claim 72, wherein at least a portion of the connector is disposed between the flexibility transition regions.
78. A method of manufacturing a guidewire, comprising the steps of:
providing a proximal section having a distal end, and a flexibility transition region at the distal end;
providing a distal section having a proximal end, and a flexibility transition region at the proximal end; and joining the flexibility transition regions.
79. A method as in claim 78, further comprising the step of forming the flexibility transition regions.
80. A method as in claim 78, wherein the step of forming the flexibility transition regions comprises reducing the size of the proximal and distal ends.
81. A method as in claim 79, wherein the step of joining the flexibility transition regions includes overlapping the proximal and distal ends.
82. A guidewire, comprising:
a proximal section having a first flexibility;
a distal section having a second flexibility; and means for joining the proximal section with the distal section such that the first flexibility and the second flexibility are blended.
83. A guidewire, comprising:
a proximal section comprising stainless steel;
a distal section comprising nickel-titanium alloy; and a connector comprising a nickel-chromium-iron alloy which connects the proximal and distal sections.
CA2462335A 2001-10-05 2002-10-04 Composite guidewire Expired - Fee Related CA2462335C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US09/972,276 US6918882B2 (en) 2001-10-05 2001-10-05 Guidewire with stiffness blending connection
US09/972,276 2001-10-05
US10/086,992 US7074197B2 (en) 2001-10-05 2002-02-28 Composite guidewire
US10/086,992 2002-02-28
PCT/US2002/031959 WO2003030982A2 (en) 2001-10-05 2002-10-04 Composite guidewire

Publications (2)

Publication Number Publication Date
CA2462335A1 true CA2462335A1 (en) 2003-04-17
CA2462335C CA2462335C (en) 2010-12-07

Family

ID=26775392

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2462335A Expired - Fee Related CA2462335C (en) 2001-10-05 2002-10-04 Composite guidewire

Country Status (7)

Country Link
US (3) US7618379B2 (en)
EP (1) EP1432467B1 (en)
JP (1) JP4494782B2 (en)
AT (1) ATE312640T1 (en)
CA (1) CA2462335C (en)
DE (1) DE60208057T2 (en)
WO (1) WO2003030982A2 (en)

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