LASER-ASSISTED GUIDEWIRE HAVING A VARIABLE STIFFNESS SHAFT

• US 20080015558A1
• Filed: 04/04/2007
• Published: 01/17/2008
• Est. Priority Date: 04/04/2006
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Inventors: Harlan, Kenneth
• Granted Patent: US 8,414,568 B2
• Time in Patent Office: Days
• US Class Current: 606/15
• CPC Class Codes: A61B 1/0011 Manufacturing of endoscope parts
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2018/0041 Removal of thrombosis
• CPC Class Codes: A61B 2018/2211 Plurality of fibres
• CPC Class Codes: A61B 2018/263 the conversion of laser energy into mechanical shockwaves taking place in a liquid
• CPC Class Codes: A61M 2025/0915 having features for changing the stiffness
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

Embodiments of the present invention comprise a fiber optic guidewire having a hypotube with a plurality of openings that provide variable stiffness and tracking characteristics between at least one proximal segment and one distal segment of the guidewire. In some embodiments, the guidewire further comprises a mandrel disposed within the hypotube, the mandrel cooperating with the optical fibers to permit the distal end of the hypotube to be shaped as desired by a user. Methods of manufacturing and using the guidewire are also disclosed.

Claims

1. A fiber optic guidewire comprising:

a hypotube having a proximal end and a distal end;

an adhesive plug within the distal end of the hypotube and having a distal face substantially flush with the distal end termination of the hypotube;

a plurality of optical fibers disposed within the hypotube, wherein the optical fibers extend through the adhesive plug and have a distal face terminating substantially at the distal face of the adhesive plug;

the adhesive plug surrounding the optical fibers and bonding the fibers within the distal end of the hypotube; and

the hypotube is comprised of at least one distal segment having an outer surface with a plurality of openings providing variable stiffness and tracking characteristics between at least one proximal segment and one distal segment of the guidewire.

2. The guidewire of claim 1, further comprising a mandrel disposed within the hypotube, with a distal end terminating substantially at the distal end of the hypotube, the mandrel cooperating with the optical fibers to permit the distal end of the hypotube to be shaped as desired by a user.

3. The guidewire of claim 1, wherein the hypotube comprises at least one proximal portion having a first stiffness and at least one a distal portion having a second stiffness less than said first stiffness.

4. The guidewire of claim 1 or claim 2, further comprising a proximal coupler.

5. The guidewire of claim 1, wherein the hypotube comprises a member selected from the group consisting of stainless steel and Nitinol.

6. A fiber optic guidewire comprising:

a hypotube having a proximal end, a distal end, and a segment having an outer surface with a plurality of openings providing variable stiffness and tracking characteristics to the hypotube;

two or more optical fibers disposed within the hypotube; and

an adhesive plug within the hypotube that surrounds the optical fibers and bonds them to the hypotube.

7. The guidewire of claim 7, wherein the adhesive plug extends radially into at least one of the outer surface openings of the hypotube.

8. The guidewire of claim 7, further comprising a mandrel disposed within the hypotube.

9. The guidewire of claim 7, wherein the hypotube comprises at least one proximal portion having a first stiffness and at least one distal portion having a second stiffness less than said first stiffness.

10. The guidewire of claim 7, wherein the hypotube has a flexibility that increases as a linear function of a position along the hypotube extending from a proximal location to a distal location.

11. The guidewire of claim 7, wherein the hypotube has a flexibility that increases as a smooth and continuous function of a position along the hypotube extending from a proximal location to a distal location.

12. The guidewire of claim 7, wherein the hypotube comprises a plurality of hoops such that each hoop is coupled with an adjacent hoop via a brace.

16. The guidewire of claim 7, wherein the adhesive plug is disposed toward the distal end of the hypotube, the guidewire further comprising a second adhesive plug within the hypotube disposed between the distal and proximal ends of the hypotube that surrounds the optical fibers and bonds them to the hypotube, and a third adhesive plug within the hypotube disposed toward the proximal end of the hypotube that surrounds the optical fibers and bonds them to the hypotube.

17. The guidewire of claim 7, further comprising a radiopaque material on or in the hypotube.

18. The guidewire of claim 7, further comprising a hydrophilic material on the hypotube.

19. The guidewire of claim 7, wherein the guidewire comprises a torque efficiency rating within a range from about 70% to about 100%.

20. The guidewire of claim 7, wherein the guidewire comprises a distal tip bending stiffness within a range from about 1 gram to about 6 grams at a deflection distance of about 1.2 cm and a distal tip bending stiffness within a range from about 0.25 gram to about 5 grams at a deflection distance of about 2 cm.

21. The guidewire of claim 7, wherein the guidewire comprises a bending stiffness within a range from about 0.05 grams to about 0.0001 grams at or near a location about 1 cm from the distal end of the hypotube, where the bending stiffness corresponds to a deflection distance of 0.200″

in a one inch span 3 point bend test.

13. The guidewire of claim 13, wherein the length of each hoop is constant.

14. The guidewire of claim 13, wherein the length of each brace is constant.

15. The guidewire of claim 13, wherein the length of each hoop is smaller than the length of the proximal adjacent hoop.

22. A method of manufacturing a guidewire, comprising:

providing a hypotube having a proximal end and a distal end, and a plurality of apertures disposed in a wall of the hypotube between the proximal end and the distal end;

placing two or more optical fibers at least partially within the hypotube; and

introducing an adhesive material into the hypotube, and allowing the material to wick along the optical fibers and into at least one of the plurality of apertures of the wall of the hypotube, such that the adhesive material forms an adhesive plug that fixes the optical fibers relative to the hypotube.

23. The method of claim 22, further comprising inserting a mandrel at least partially within the hypotube.

24. The method of claim 22, wherein the guidewire comprises at least one proximal portion having a first stiffness and at least one a distal portion having a second stiffness less than the first stiffness.