SYSTEM AND METHOD FOR DILATING AND ADJUSTING FLEXIBILITY IN A GUIDING DEVICE

• US 20130066345A1
• Filed: 09/14/2011
• Published: 03/14/2013
• Est. Priority Date: 06/29/2011
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Wilkinson, Matthew
• Granted Patent: US 9,095,370 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61M 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

This disclosure is directed to systems and methods for providing a guiding device having a dilatable, drilling tip. The tip is formed by wound helical members such that resistance to rotation in an unwinding direction dilates the tip. The helical members are configured so that the dilatable tip increases in stiffness when the helical members are tensioned by a resistance to rotation in the winding direction. In some embodiments, application of relative force between coaxial inner and outer tubular members is used to control the dilation, stiffness and drilling of the guiding member.

Claims

1. A guiding device comprising an elongated body and a dilatable tip, wherein the tip includes a plurality of helical members having a wound configuration such that resistance to rotation in an unwinding direction dilates the tip and wherein the helical members form threads configured to provide a drilling action when the guiding device is rotated in a winding direction.

2. The guiding device of claim 1, wherein the helical members are formed from a nickel-titanium alloy.

3. The guiding device of claim 1, wherein the dilatable tip is configured to increase in stiffness when the helical members are tensioned by a resistance to rotation in the winding direction.

4. The guiding device of claim 1, wherein the elongated body comprises a solid guidewire.

5. The guiding device of claim 4, wherein the helical members are wound in an overlapping configuration.

6. The guiding device of claim 4, wherein the distal tip is configured to exhibit a deflected configuration when the helical members are untensioned and exhibit a substantially straight configuration when the helical members are tensioned.

7. The guiding device of claim 1, wherein the elongated body comprises an outer tubular member disposed coaxially over an inner tubular member, wherein a proximal end of the helical members is secured adjacent a distal end of the outer tubular member and wherein a distal end of the helical members is secured adjacent a distal end of the inner tubular member.

8. The guiding device of claim 7, further comprising an elastic membrane supported by the helical members.

9. The guiding device of claim 7, wherein axial movement of outer tubular member with respect to inner tubular member causes the helical members to deflect radially so that the tip of the guiding device dilates.

10. The guiding device of claim 7, wherein the tip is configured so that application of axial force to outer tubular member in a proximal direction relative to inner tubular member increases stiffness in the tip.

11. The guiding device of claim 7 further comprising a knob secured to a proximal end of the outer tubular member, wherein the knob is coaxially disposed over the inner tubular member and is configured to allow the application of rotational and axial force to outer tubular member relative to the inner tubular member.

12. The guiding device of claim 7, wherein the inner tubular member further comprises a lumen configured to receive an elongated device for performing an intravascular procedure.

13. A method of treating occlusive vascular disease of a blood vessel, comprising the steps of:

a) providing a guiding device comprising an elongated body and a dilatable tip, wherein the tip includes a plurality of helical members having a wound configuration and wherein the helical members form threads;

b) advancing the guiding device through the blood vessel until the tip is adjacent an occlusive lesion;

c) rotating the guiding device in a winding direction so that the threads drill into the lesion; and

d) radially displacing a portion of the lesion by rotating the guiding device in an unwinding direction to dilate the tip.

14. The method of claim 13, further comprising the step of stiffening the tip by rotating the guiding device in the winding direction against resistance.

15. The method of claim 13, wherein the elongated body comprises an outer tubular member disposed coaxially over an inner tubular member, wherein a proximal end of the helical members is secured adjacent a distal end of the outer tubular member, wherein a distal end of the helical members is secured adjacent a distal end of the inner tubular member and wherein the step of radially displacing the lesion comprises applying a rotation force to the outer tubular member in the unwinding direction relative to the inner tubular member.

16. The method of claim 13, wherein the elongated body comprises an outer tubular member disposed coaxially over an inner tubular member, wherein a proximal end of the helical members is secured adjacent a distal end of the outer tubular member, wherein a distal end of the helical members is secured adjacent a distal end of the inner tubular member and wherein the step of radially displacing the lesion comprises applying an axial force to the outer tubular member in a distal direction relative to the inner tubular member.

17. The method of claim 13, wherein the elongated body comprises an outer tubular member disposed coaxially over an inner tubular member, wherein a proximal end of the helical members is secured adjacent a distal end of the outer tubular member, wherein a distal end of the helical members is secured adjacent a distal end of the inner tubular member and further comprising the step of stiffening the tip by applying a rotation force to the outer tubular member in the winding direction relative to the inner tubular member.

18. The method of claim 13, wherein the elongated body comprises an outer tubular member disposed coaxially over an inner tubular member, wherein a proximal end of the helical members is secured adjacent a distal end of the outer tubular member, wherein a distal end of the helical members is secured adjacent a distal end of the inner tubular member and further comprising the step of stiffening the tip by applying an axial force to the outer tubular member in a proximal direction relative to the inner tubular member.

19. The method of claim 13, further comprising the step of centering the guiding device in the vessel by dilating the tip.

20. The method of claim 19, further comprising the step of advancing an intravascular device through a lumen of the inner tubular member of the centered guiding device.