Guidewire system

• US 6,428,489 B1
• Filed: 12/22/1999
• Issued: 08/06/2002
• Est. Priority Date: 12/07/1995
• Status: Expired due to Term

• Current Assignee: McDermott Will & Emery LLP
• Original Assignee: Precision Vascular Systems, Inc. (Boston Scientific Corporation)
• Inventors: Wells, David, Jacobsen, Stephen C., Davis, Clark
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/470,607
• Time in Patent Office: 958 Days
• Field of Search: 600/585, 604/164.13, 604/528, 604/264
• US Class Current: 600/585
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A catheter guidewire includes an elongate solid body about which a catheter may be threaded for guidance to a target location in a vasculature passageway of a body. The elongate body includes a proximal end and a distal end, with the distal end being curved. Cuts are formed either by saw-cutting, laser cutting or etching at spaced-apart locations along the length of the body to increase its lateral flexibility. Integral beams are also formed within the body to maintain its torsional strength. The relative location and size of cuts and beams may be selectively adjusted so as to control the direction and degree of flexure, and the change in torsional stiffness relative to flexibility.

Claims

1. A guiding element configured for introduction into a body lumen to guide a catheter to a predetermined location comprising:

an elongate body having a longitudinal axis;

a plurality of transverse beams integrally formed in said elongate body and extending generally crosswise of the longitudinal axis, said beams being spaced apart by openings along the length of the body;

at least one axial beam extending generally parallel with the longitudinal axis. disposed intermediate and connecting at least two adjacent transverse beams, and wherein said axial beam and at least one of said adjacent transverse beams are configured so that strain in the transverse beam induced by at least one of torsion and bending of the elongate body, and strain in the axial beam induced by at least one of torsion and bending of the elongate body are substantially the same; and

,

wherein the element is configured so that the interaction of the transverse beams with the openings and longitudinal beams increases the lateral flexibility of the body more than it reduces the torsional stiffness thereof.

2. A guiding element as recited in claim 1, wherein a plurality of adjacent longitudinal beams are rotated with respect to each other about the longitudinal axis through an angle of about 80-90 degrees.

3. A guiding element as recited in claim 2, wherein the elongate body comprises a tube.

4. A guiding element as recited in claim 3, wherein a plurality of axial beams are disposed intermediate a plurality of transverse beams, and wherein said strain in each of said axial beams is substantially the same as said strain in at least one adjacent transverse beam.

5. A guiding element as recited in claim 4, wherein a maximum strain in an axial beam is substantially the same as a maximum strain in a transverse beam.

6. A guiding element as recited in claim 4, wherein two axial beams are disposed intermediate eight transverse beams.

7. A guiding element as recited in claim 6, wherein at least two of said eight transverse beams are of a different length.

8. A guiding element as recited in claim 7, wherein the lengths of said two transverse beams differ by about 1 to 10 percent.

9. A guiding element as recited in claim 8, wherein the difference is due to a difference in angular displacement of adjacent axial beams of about 5 degrees.

10. A guiding element as recited in claim 9, wherein the difference is in a same direction for a plurality of adjacent axial beams.

11. A guiding element as recited in claim 10, wherein the axial beams are positioned so that a helical pattern of axial beam placement is created.

12. A guiding element as recited in claim 1, wherein edges of said beam are rounded.

13. A guiding element as recited in claim 1, wherein at least a portion of the elongate body is configured in accordance with a design process wherein the lateral bending flexibility is increased in comparison with torsional flexibility, by adjusting at least one of the size and shape of the axial and transverse beams to maximize torsional stiffness and torque transmission while holding lateral flexibility constant.

14. A guiding element as recited in claim 1, wherein the strain in the axial and transverse beams are substantially the same when the guidewire is subjected to torsion forces.

15. A guiding element as recited in claim 14, wherein the strain in the axial and transverse beams are substantially the same when the guidewire is subjected to both bending and torsion forces.

16. A guide member element, comprising:

a guidable elongate member having a longitudinal axis, said guidable elongate member being configured for insertion into a body lumen and guiding to a location within anatomy of a patient, said elongate member including a proximal end and a distal end, and further comprising;

a plurality of axial beam elements, and

a plurality of transverse beam elements,

said longitudinal and transverse beam elements enabling increased flexibility of the elongate member, and said longitudinal and transverse beam elements enabling transfer of torsional forces distally along the elongate member, said transverse and axial beam elements being configured so that a maximum strain due to torsional forces occurring in a transverse beam element is substantially the same as a maximum strain due to torsional forces occurring in an adjacent axial beam element, whereby a magnitude of torsional force that can be transferred distally by the elongate member is increased.

17. A guidable elongate member as recited in claim 16, wherein the elongate member comprises a tube.

18. A guidable elongate member as recited in claim 17, wherein a pair of axial beams are disposed intermediate transverse beams.

19. A guidable elongate member as recited in claim 18, wherein the angular spacing in one rotational direction between adjacent pairs of axial beams is about 80 to 90 degrees.

20. A guidable elongate member as recited in claim 19, wherein the angular spacing in one direction is about 85 degrees.

21. A guidable elongate member as recited in claim 19, wherein the positioning of pairs of axial beams comprises a helical configuration.

22. A guidable elongate member as recited in claim 16, wherein the elongate member is polished.

23. A guidable elongate member as recited in claim 22, wherein the elongate member is polished by an abrasive spray.

24. A guidable elongate member as recited in claim 16, wherein the elongate member is formed of a superelastic material.

25. A guidable elongate member as recited in claim 16, wherein the superelastic material comprises a Nickel-Titanium alloy.

26. A guidable elongate member as recited in claim 16, further comprising transverse and axial beams configured to provide differing flexibility at different locations along the longitudinal axis of the elongate member.

27. A guidable elongate member as recited in claim 16, further comprising transverse and axial beams configured to provide a preferred bending direction at a location along the longitudinal axis.

28. A guidable elongate member as recited in claim 27, wherein the preferred bending direction configuration facilitates access of the guidable elongate member to a particular target location within the patient'"'"'s anatomy.

29. A guidable elongate element as recited in claim 16, wherein lateral flexibility at a first location along the longitudinal axis differs from lateral flexibility at a second location.

30. A guidable elongate element as recited in claim 16, further comprising an identification marking which is specific to a lateral flexibility characteristic of the guidewire.

31. A guidable elongate element as recited in claim 16, further comprising an identification marking which is specific to a production lot.

32. A guidable elongate member, configured for insertion into a body lumen and guiding to a target location within anatomy of a patient, comprising an elongate member having a proximal end and a distal end, and further comprising a plurality of axial beam elements and a plurality of transverse beam elements, said longitudinal and transverse beam elements enabling increased lateral bending flexibility of the elongate member, and said longitudinal and transverse beam elements enabling transfer of torsional forces distally along the elongate member, said transverse and axial beam elements being configured so that a maximum strain due to torsional and bending forces occurring in a transverse beam element is substantially the same as a maximum strain due to torsional and bending forces occurring in an adjacent axial beam element, whereby a magnitude of torsional force that can be transferred distally by the elongate member is increased and bending of the elongate member is facilitated.