SYSTEMS AND METHODS FOR TREATING A VESSEL USING FOCUSED FORCE

• US 20080082050A1
• Filed: 05/10/2007
• Published: 04/03/2008
• Est. Priority Date: 05/11/2006
• Status: Active Grant

• Current Assignee: Y-Med, Inc. (Becton, Dickinson & Co)
• Original Assignee: Y-Med, Inc. (Becton, Dickinson & Co)
• Inventors: Shaked, Yoav, Solar, Ronald J., Lieber, Glen
• Granted Patent: US 7,901,378 B2
• Time in Patent Office: Days
• US Class Current: 604/164.13
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61K 31/47 Quinolines; Isoquinolines
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

Systems and methods for treating a vessel include devices having a main elongated element with a balloon at its distal end, an auxiliary elongated element wherein a distal end of the auxiliary elongated element is proximal to the balloon, and a core wire having a internal core wire portion and an external core wire portion, wherein the external core wire portion is external to the balloon. In some embodiments, a distal connecting element is attached to the distal end of the balloon. In some embodiments, the distal connecting element is positioned at a rotational distance from the auxiliary elongated element. In some embodiments, the balloon is a fixed wire balloon. Inflation of the balloon causes guidewires positioned within the device and external core wires to be pushed up against the lesion, providing a focused force for cracking the lesion.

Claims

1. A device for introduction into a vessel, the device comprising:

a main elongated element having a main elongated element proximal end and a main elongated element distal end;

a balloon positioned at said main elongated element distal end;

an auxiliary elongated element having an auxiliary elongated element proximal end and an auxiliary elongated element distal end, said auxiliary elongated element distal end positioned proximal to said balloon; and

a core wire comprising an internal core wire portion positioned within said main elongated element and attached to said main elongated element at a core wire attachment point and an external core wire portion positioned distally with respect to said internal core wire portion, said external core wire portion external to and running alongside said balloon.

2. The device of claim 1, wherein said main elongated element is a catheter shaft.

3. The device of claim 1, further comprising a distal connecting element positioned at a distal end of said balloon.

4. The device of claim 3, wherein said distal connecting element is at a rotational distance from said auxiliary elongated element, and wherein said distal connecting element and said auxiliary elongated element are at rotational distances from said external core wire portion.

5. The device of claim 4, wherein said rotational distances are between 60 and 120 degrees.

6. The device of claim 3, wherein said distal connecting element is in line with said auxiliary elongated element.

7. The device of claim 1, wherein said balloon is a fixed wire balloon.

8. The device of claim 1, wherein said auxiliary elongated element is positioned at least partially inside of said main elongated element.

9. The device of claim 1, wherein the device is an over-the-wire catheter and wherein said auxiliary elongated element runs along an entire length of the device.

10. The device of claim 9, further comprising an occlusion balloon positioned proximal to said auxiliary elongated element distal end.

11. The device of claim 1, wherein said auxiliary elongated element proximal end is positioned at a point along said main elongated element, such that a guidewire placed through said auxiliary elongated element may exit at said auxiliary elongated element proximal end for rapid exchange.

12. The device of claim 1, wherein said external core wire portion further comprises a coil wrapped around at least a portion thereof, said coil-wrapped portion being positioned adjacent to said balloon.

13. The device of claim 1, wherein said external core wire portion comprises at least one radiopaque marker.

14. The device of claim 1, wherein said main elongated element comprises a flexible portion and wherein said internal core wire portion is positioned along an entire length of said flexible portion.

15. The device of claim 14, wherein said flexible portion comprises an entire length of said main elongated element.

16. The device of claim 1, wherein said attachment point comprises multiple attachment points.

17. A device for introduction into a vessel, the device comprising:

a main elongated element having a main elongated element proximal end and a main elongated element distal end;

a balloon positioned at said main elongated element distal end;

an auxiliary elongated element having an auxiliary elongated element proximal end and an auxiliary elongated element distal end, said auxiliary elongated element distal end positioned proximal to said balloon; and

a distal connecting element positioned at a distal end of said balloon, wherein said distal connecting element is at a rotational distance from said auxiliary elongated element.

18. The device of claim 17, further comprising a core wire comprising an internal core wire portion positioned within said main elongated element and attached to said main elongated element at a core wire attachment point and an external core wire portion positioned distally with respect to said internal core wire portion, said external core wire portion external to and running alongside said balloon.

19. The device of claim 17, wherein said main elongated element is a catheter shaft.

21. The device of claim 18, wherein said distal connecting element and said auxiliary elongated element are at rotational distances from said external core wire portion.

22. The device of claim 21, wherein said rotational distances are between 60 and 120 degrees.

23. The device of claim 18, wherein said distal connecting element is in line with said auxiliary elongated element.

24. The device of claim 17, wherein said auxiliary elongated element is positioned at least partially inside of said main elongated element.

25. The device of claim 17, wherein the device is an over-the-wire catheter and wherein said auxiliary elongated element runs along an entire length of the device.

26. The device of claim 25, further comprising an occlusion balloon positioned proximal to said auxiliary elongated element distal end.

27. The device of claim 18, wherein said external core wire portion further comprises a coil wrapped around at least a portion thereof, said coil-wrapped portion being positioned adjacent to said balloon.

28. The device of claim 18, wherein said external core wire portion comprises at least one radiopaque marker.

29. The device of claim 18, wherein said main elongated element comprises a flexible portion and wherein said internal core wire portion is positioned along an entire length of said flexible portion.

30. The device of claim 29, wherein said flexible portion comprises an entire length of said main elongated element.

31. The device of claim 18, wherein said attachment point comprises multiple attachment points.

32. A method for treating a lesion in a vessel, the method comprising:

providing a device having a main elongated element, a balloon at a distal end of the device, an auxiliary elongated element wherein a distal end of the auxiliary elongated element is proximal to the balloon, and a wire attached to the device and positioned alongside the balloon and on an opposite side of the balloon as the auxiliary elongated element and a distal connecting element at a distal end of the balloon;

inserting a tracking guidewire into the vessel;

backloading the tracking guidewire into the distal connecting element;

advancing the device over the tracking guidewire until the distal end of the device is adjacent to the lesion;

advancing a second guidewire through the auxiliary elongated element; and

inflating the balloon so as to push at least the attached wire and the tracking guidewire against a lesion in the vessel, said pushed attached wire and tracking guidewire each pushing against different sides of the lesion.

33. The method of claim 32, wherein said advancing said second guidewire comprises advancing said second guidewire past the distal end of the balloon, and wherein said inflating the balloon causes said second guidewire to be pushed against the lesion at a different side of the lesion than said attached wire and tracking guidewire.

34. The method of claim 33, wherein said advancing said second guidewire comprises advancing said second guidewire into a branch vessel.

35. The method of claim 32, further comprising advancing the device past the lesion, removing the second guidewire, inflating the balloon, and inserting treatment solution through the auxiliary elongated element and into the vessel in an area of the lesion.

36. The method of claim 32, wherein the device further includes an occlusion balloon proximal to the distal end of the auxiliary elongated element, the method further comprising:

deflating the balloon;

inflating the occlusion balloon; and

delivering a substance to the vessel through the auxiliary elongated element.

37. The method of claim 36, wherein said delivering comprises delivering a medicated solution.

38. The method of claim 36, wherein said delivering comprises delivering a treatment device.

39. The method of claim 36, wherein the auxiliary elongated element further comprises ports at a distal end thereof, and wherein said delivering comprises spraying through the ports.

40. The method of claim 33, further comprising prior to said advancing a second guidewire advancing said device past the lesion, and after said advancing a second guidewire retracting said device proximally so as to position said second guidewire adjacent to the lesion.

41. The method of claim 32, wherein said advancing the second guidewire comprises advancing the second guidewire during advancement of the device, wherein said second guidewire is configured to act as a buddy wire to straighten out tortuous vessels.