EMBOLECTOMY DEVICE

• US 20080269798A1
• Filed: 07/10/2008
• Published: 10/30/2008
• Est. Priority Date: 09/17/2003
• Status: Abandoned Application

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Bashiri, Mehran, Huffmaster, Andrew, Ramzipoor, Kamal, Nair, Ajitkumar B., Pham, Pete Phong, Parikh, Riten
• Application Number:
  US12/171,033
• Publication Number:
  US 20080269798A1
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 25/0069 Tip not integral with tube

Abstract

An embodiment is a catheter comprising a first elongate shaft having a proximal end, a distal end and a first lumen therethrough, a wire having a proximal end and a distal end at least partially disposed in the first elongate shaft, the distal end extending distally from the first elongate shaft, and a motion control apparatus connected to the proximal end of the wire, further comprising a device attached to the distal end of the wire for changing the shape of an embolus, wherein the device is configured to change the shape of the embolus to unclog a distal catheter lumen.

Claims

1. A method comprising the steps of:

providing a catheter having a wire for fragmenting an embolus at least partially disposed within a lumen of the catheter;

positioning a distal end of the catheter proximate an embolus; and

manipulating the wire to change the shape of the embolus,

wherein the catheter has a proximal end, a distal end and a lumen extending therebetween, the lumen having a longitudinal axis extending from the proximal end to the distal end, wherein the wire has a proximal end and a distal end and a center line extending therebetween that follows the path of the wire, the wire further having a proximal region, an intermediate region and a distal region, and the wire being at least partially disposed in the lumen, wherein the intermediate region has a generally uniform width along its length, and wherein the distal region of the wire includes a distal tip having a uniform profile along a length and a region proximate the distal tip having a maximum width perpendicular to the longitudinal axis of the lumen that is greater than the width of the intermediate region of the wire and wherein the distal tip has a width that is less than that of the proximate region and wherein the intermediate region width is also less than that of the proximate region.

2. The method of claim 1 wherein the step of manipulating the wire includes the step of unclogging a lumen to assist aspiration of the embolus.

3. The method of claim 1 wherein the step of manipulating the wire includes the step of fragmenting an embolus.

4. The method of claim 1 wherein the step of manipulating the wire includes the step of direct operator manipulation of a proximal end of the wire.

5. The method of claim 4, further comprising the step of providing a handle attached to a proximal portion of the wire for direct operator manipulation.

6. The method of claim 1, wherein the embolus is located in a patient'"'"'s vasculature.

7. The method of claim 1 wherein the step of positioning the distal end of the catheter includes the step of positioning the distal end of the wire within the embolus.

8. The method of claim 1 further comprising the steps of

providing a vacuum source fluidly connected to the distal end of the catheter, and operating the vacuum source.

9. The method of claim 8 further comprising the step of flushing a region proximate the embolus with a fluid.

10. The method of claim 1 wherein the distal region of the wire has a maximum width that is less than half the diameter of the blood vessel.

11. The method of claim 10 wherein the proximate region of the distal region has a curved profile parallel to the longitudinal axis.

12. The method of claim 11 wherein the maximum width of the proximate region is at least twice the width of the distal tip.

13. The method of claim 12 wherein the cross-sectional shape of the wire along the center line is a simple closed shape.

16. The method of claim 13 wherein the proximate region has a first section having a first end that has a maximum thickness of material perpendicular to the longitudinal axis and a second end that abuts the distal tip, the proximate region further having a second section having a first end that abuts the first end of the first section and a second end that has a width equal to that of the intermediate region of the wire,

wherein the first section is longer than the second section.

17. The method of claim 16 wherein the first section transitions gradually from the first end of the first section to the second end of the first section.

18. The method of claim 16 wherein the first section is at least twice as long as the second section.

19. The method of claim 16 wherein the magnitude of the tangent of any angle between a first line tangent to a point on the center line in the first section and a second line, coplanar to the first line, that is tangent to a second point on the surface of the wire is less than 0.84, where the second point is defined by the intersection of the surface of the wire and a line that extends through the point on the center line and is perpendicular to the first line.

20. The method of claim 19 wherein the magnitude of the tangent is less than 0.71.

21. The method of claim 19 wherein the magnitude of the tangent is less than 0.58.

22. The method of claim 19 wherein the magnitude of the tangent is less than 0.47.

23. The method of claim 19 wherein the magnitude of the tangent is less than 0.37.

24. The method of claim 1 wherein the distal tip and the intermediate regions have approximately the same cross-sectional areas.

25. The method of claim 24 wherein the distal tip cross-sectional area is equal to that of the intermediate region.

30. The method of claim 1 wherein the wire is free from attachment to a motion control apparatus.

14. (canceled)

15. The method of claim 14 wherein the wire is configured to move rapidly along the longitudinal axis of the lumen proximally and distally.

31. The method of claim 15 wherein the wire is configured to move at no more than 20 Hz.

26. A method comprising the steps of:

providing a catheter having a wire for fragmenting an embolus at least partially disposed within a lumen having a diameter and an elongate axis, the wire having an average thickness;

positioning a distal end of the catheter proximate an embolus;

manipulating the wire by hand to change the shape of the embolus;

providing a vacuum source fluidly connected to the distal end of the catheter; and

operating the vacuum source,

wherein the distal section of the wire has a width perpendicular to the elongate axis that is greater than the average thickness of the wire and less than the diameter of the lumen.

27. The method of claim 26 wherein the cross-sectional shape of the wire is a simple closed shape.

28. The method of claim 26 wherein the width of the distal section of the wire is less than half the diameter of the lumen.

29. The method of claim 26 wherein the wire has a distal tip where the thickness is equal to or less than the average thickness along and wherein the thickness of the distal tip is uniform along a length of the wire.