Variable stiffness guidewire

• US 7,867,176 B2
• Filed: 12/27/2005
• Issued: 01/11/2011
• Est. Priority Date: 12/27/2005
• Status: Expired due to Fees

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Hojeibane, Hikmat, Wu, Mina
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US11/318,825
• Publication Number:
  US 20070149951A1
• Time in Patent Office: 1,841 Days
• Field of Search: 600/585, 604/526
• US Class Current: 600/585
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09158 when heated
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A guidewire navigable through body vessels of a human subject for delivery of a catheter or the like is provided. The guidewire has a tube which receives a corewire that protrudes beyond a distal portion of the tube. The protruding portion of the corewire is surrounded by a spring and shapeable into a curve or arc. The cross-sectional shape of the spring may be varied in order to promote bending flexibility and curvature or to favor curvature of a chosen type. The corewire is axially movable with respect to the tube, which compresses or stretches the spring to change the stiffness of the spring. The tube has a proximal portion comprised of a relatively rigid material, such as stainless steel, while a distal portion is comprised of a more flexible material, such as a nitinol.

Claims

1. A variable stiffness guidewire for navigating through body vessels, comprising:

a tube having a proximal portion substantially comprised of a first material and a distal portion substantially comprised of a second material, wherein said second material is different from and more flexible at human body temperature than said first material;

an elongated corewire received by the tube and including a distal end, a proximal end, and a protruding portion extending beyond the distal portion of the tube;

a unitary coiled spring surrounding at least said protruding portion of said corewire, said spring having a distal end associated with said distal end of said corewire and a proximal end associated with said distal portion of said tube, wherein said corewire is axially movable with respect to said tube to adjust the total length of the spring and thus the stiffness of said spring;

the unitary coiled spring having a plurality of cross-sectional shapes, wherein a plurality of coil lengths of the spring have a first portion with a first cross-sectional shape that is substantially flat and a second portion with a second cross-sectional shape that is substantially circular with a given diameter, said substantially flat first cross-sections are diametrically opposed to said substantially circular second cross-sections, the first cross-sections being along a first longitudinal side of the coiled spring that is diametrically opposed to a second longitudinal side of the unitary coiled spring, and said substantially flat first cross-sections each have a length and a width shorter than the length, and said length extends substantially parallel to said corewire at its said protruding portion, said substantially parallel length being greater than the given diameter of said substantially circular second cross-sections, the second longitudinal side being longer than the first longitudinal side when respective flat first cross-section widths and circular second cross-sections of adjacent coil lengths engage each other, whereby the unitary coiled spring exhibits pre-shaped curvature bending; and

a non-rotation system comprising a longitudinal pathway along one of said tube or corewire and a follower on the other of said tube or corewire, said follower being slidable with respect to said pathway and at least partially received within the pathway.

2. The guidewire of claim 1, wherein said second material has shape memory properties.

3. The guidewire of claim 1, wherein said second material is a nitinol material.

4. The guidewire of claim 1, wherein said first material is stainless steel and said second material is a nitinol material.

5. The guidewire of claim 4, wherein said proximal end of said corewire includes a portion having an increased diameter for contacting said proximal portion of said tube to prevent downstream movement of said corewire with respect to said tube.

6. The guidewire of claim 4, wherein said distal end of said spring is connected to and movable with said distal end of said corewire and wherein said proximal end of said spring is connected to and movable with said distal portion of said tube.

7. The guidewire of claim 6, further comprising a separation gap between adjacent coils of said spring and wherein downstream movement of said corewire with respect to said tube generally increases the separation gap to thereby decrease the stiffness of the coil, and wherein upstream movement of said corewire with respect to said tube generally decreases the separation gap to thereby increase the stiffness of the coil.

8. The guidewire of claim 7, wherein said separation gap is variable between approximately 0 inches in a maximum stiffness configuration and approximately 0.010 inch in a minimum stiffness configuration.

9. The guidewire of claim 1, further comprising an atraumatic weld associated with said distal end of said corewire.

10. The guidewire of claim 1, further comprising a plurality of corewires receivable by said tube.

11. The guidewire of claim 1, wherein at least a portion of said corewire is shapeable.

12. The guidewire of claim 1, wherein at least a portion of said distal portion of said tube is shapeable.

13. The guidewire of claim 1, wherein said spring has a varying pitch.

14. The guidewire of claim 1, further comprising a sheath covering said protruding portion of said corewire.

15. The guidewire of claim 14, wherein said sheath is heat-shrunk over said spring for providing a fluid-tight seal.

16. The guidewire of claim 1, wherein the stiffness of the spring is variable by changing said length.

17. The guidewire of claim 16, wherein said length is varied by axially moving the corewire with respect to the tube.

18. The guidewire of claim 16, wherein said proximal end of the spring is engageable with the distal portion of the tube and said distal end of the spring is engageable with the corewire.

19. The guidewire of claim 1, further comprising a separation gap between adjacent coils, wherein the separation gap is approximately 0 inches in a maximum stiffness configuration and the separation gap is approximately 0.10 inch in a minimum stiffness configuration.

20. The guidewire of claim 1, wherein the spring has a varying pitch.

21. The guidewire of claim 1, wherein said substantially flat cross-sections and said substantially circular cross-sections are arranged in an alternating pattern.

22. The guidewire of claim 1, wherein said second material is transformable between an austenitic state and a martensitic state and wherein said proximal and distal portions of the tube are connected at a joint formed by transforming the distal portion from the martensitic state to the austenitic state to engage the proximal portion.

26. The guidewire of claim 1, wherein said follower comprises an inward radial projection of the tube and said pathway comprises a channel defined in the corewire.

27. The guidewire of claim 1, where said non-rotation system is configured to allow the corewire to be received by the tube in only one angular orientation.

23. A variable stiffness guidewire for navigating through body vessels, comprising:

a tube having a proximal portion substantially comprised of a first material and a distal portion substantially comprised of a second material transformable between an austenitic state and a martensitic state, wherein said proximal and distal portions are connected at a joint formed by transforming the distal portion from the martensitic state to the austenitic state to engage the proximal portion;

an elongated corewire received by the tube and including a distal end, a proximal end, and a protruding portion extending beyond the distal portion of the tube;

a unitary coiled spring surrounding at least said protruding portion of said corewire, said spring having a distal end associated with said distal end of said corewire and a proximal end associated with said distal portion of said tube, wherein said corewire is axially movable with respect to said tube to adjust the total length of the spring and thus the stiffness of said spring; and

the unitary coiled spring having a plurality of cross-sectional shapes, wherein a plurality of coil lengths of the spring have a first portion with a first cross-sectional shape that is substantially flat and a second portion with a second cross-sectional shape that is substantially circular with a given diameter, said substantially flat first cross-sections are diametrically opposed to said substantially circular second cross-sections, the first cross-sections being along a first longitudinal side of the coiled spring that is diametrically opposed to a second longitudinal side of the unitary coiled spring, and said substantially flat first cross-sections each have a length and a width shorter than the length, and said length extends substantially parallel to said corewire at its said protruding portion, said substantially parallel length being greater than the given diameter of said substantially circular second cross-sections, the second longitudinal side being longer than the first longitudinal side when respective substantially flat cross-section widths and substantially circular second cross-sections of adjacent coil lengths engage each other, whereby the unitary coiled spring exhibits pre-shaped curvature bending, engage each other.

24. The guidewire of claim 23, wherein the distal portion of the tube engages an outer surface of the proximal portion of the tube at the joint.

25. The guidewire of claim 23, wherein the distal portion of the tube engages an inner surface of the proximal portion of the tube at the joint.