Systems and methods for treating a vessel using focused force

• US 7,901,378 B2
• Filed: 05/10/2007
• Issued: 03/08/2011
• 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: Lieber, Glen, Shaked, Yoav, Solar, Ronald J.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US11/746,682
• Publication Number:
  US 20080082050A1
• Time in Patent Office: 1,398 Days
• Field of Search: 604/164.13
• 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 making of catheters A61M25/0009
• 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, said balloon having a balloon proximal end, a balloon distal end, and an inflation lumen therethrough, said inflation lumen further extending proximal to the balloon through said main elongated element to said main elongated element proximal end; and

a core wire comprising an internal core wire portion positioned within said main elongated element and bonded 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 to receive a guidewire during use, the balloon being pushed along the guidewire upon application of a pushing force to the proximal end of the main elongated element.

4. The device of claim 1, further comprising an auxiliary elongated element having an auxiliary elongated element proximal end and an auxiliary elongated element distal end, the auxiliary elongated element distal end positioned proximal to the balloon.

5. The device of claim 4, wherein said auxiliary elongated element is positioned at least partially inside of said main elongated element.

6. The device of claim 4, wherein the device is an over-the-wire catheter and wherein said auxiliary elongated element runs along an entire length of the device.

7. The device of claim 6, further comprising an occlusion balloon positioned proximal to said auxiliary elongated element distal end.

8. The device of claim 4, 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.

9. The device of claim 4, further comprising a distal connecting element positioned at a distal end of said balloon to receive a guidewire during use, the balloon being pushed along the guidewire upon application of a pushing force to the proximal end of the main elongated element.

10. The device of claim 9, 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.

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

12. The device of claim 9, wherein said distal connecting element is in line with said auxiliary elongated element.

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

14. 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.

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

16. 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.

17. The device of claim 16, wherein said flexible portion comprises an entire length of said main elongated element.

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

19. 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; and

a core wire comprising an internal core wire portion positioned in said main elongated element and bonded 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.

20. The device of claim 19, wherein said external core wire portion is fixedly attached distally of said balloon.

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

22. The device of claim 20, further comprising a distal connecting element positioned at a distal end of the balloon and an auxiliary elongated element, wherein said distal connecting element and said auxiliary elongated element are at rotational distances from said external core wire portion.

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

24. The device of claim 22, wherein said auxiliary elongated element is positioned at least partially inside of said main elongated element.

25. The device of claim 22, 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 20, further comprising a distal connecting element positioned at a distal end of said balloon to receive a guidewire during use, the balloon being pushed along the guidewire upon application of a pushing force to the proximal end of the main elongated element.

28. The device of claim 20, 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.

29. The device of claim 20, wherein said external core wire portion comprises at least one radiopaque marker.

30. The device of claim 20, 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.

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

32. The device of claim 20, wherein said attachment point comprises multiple attachment points.