Vessel treatment devices

• US 20060106448A1
• Filed: 10/03/2005
• Published: 05/18/2006
• Est. Priority Date: 03/04/2004
• Status: Active Grant

• Current Assignee: Y-Med, Inc. (Becton, Dickinson & Co)
• Original Assignee: Y-Med, Inc. (Becton, Dickinson & Co)
• Inventors: Shaked, Yoav
• Granted Patent: US 7,766,951 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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: A61F 2250/006 modular
• CPC Class Codes: A61M 2025/0186 Catheters with fixed wires, i.e. so called "non-over-the-wire catheters"
• 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

Abstract

A catheter system for treating lesions is provided. The system is suitable for treatment of bifurcation lesions, has a low profile and provides substantially predictable translational and rotational positioning. In one embodiment, the system includes a fixed wire balloon catheter and a partially attached guidewire lumen, wherein the guidewire lumen is attached to the catheter at a crotch point. The location of the crotch point is predetermined so as to provide substantially predictable positioning. Several embodiments of the system are described for various types of lesions and vessel configurations.

Claims

1. A catheter system comprising:

a catheter body comprising a catheter proximal end and a catheter distal end;

a balloon positioned on said catheter distal end, the balloon having a balloon proximal end and a balloon distal end;

a guidewire lumen attached to said balloon distal end, said guidewire lumen having a length of less than 15 mm; and

a guidewire enclosure having an enclosure distal end and an enclosure proximal end, said guidewire enclosure at least partially attached to said catheter body.

2. The catheter system of claim 1, further comprising a stent positioned on said balloon.

3. The catheter system of claim 2, wherein said stent has a dedicated side opening, and wherein said enclosure distal end is positioned at said side opening.

4. The catheter system of claim 2, wherein said stent has openings and wherein said enclosure distal end is positioned through said openings.

5. The catheter system of claim 1, wherein said balloon in a deflated configuration has an “

S”

shape comprising an upper curved portion and a lower curved portion, wherein said lower curved portion is a containment area for holding a guidewire therein.

6. The catheter system of claim 1, wherein said balloon in a deflated configuration has a hooked “

Y”

shape, wherein a bottom portion of the “

Y”

shape is hooked so as to form a containment area for holding a guidewire therein.

7. The catheter system of claim 6, wherein a portion of the “

Y”

shape includes two upper arms, and wherein said two upper arms form a secondary containment area for holding said guidewire enclosure therein.

8. The catheter system of claim 1, wherein said guidewire enclosure is at least partially positioned within said catheter body.

9. The catheter system of claim 1, wherein said guidewire enclosure is attached to said catheter body at a location on said balloon.

10. The catheter system of claim 9, wherein said location is approximately a center of said balloon.

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

providing a catheter system having a catheter body with a balloon on a distal end thereof, a guidewire lumen attached to a distal end of the balloon, a guidewire enclosure at least partially attached to the catheter; and

a guidewire positioned through said guidewire lumen and through a temporary lumen in the balloon such that said guidewire is immovable with respect to the catheter body;

introducing a tracking guidewire having a distal end and a proximal end into the vessel;

positioning the proximal end of the tracking guidewire in said guidewire enclosure;

advancing said catheter over said tracking guidewire until said catheter reaches the lesion; and

inflating said balloon thereby releasing said guidewire from said temporary lumen.

12. A catheter system comprising:

a catheter body having a catheter proximal end and a catheter distal end;

a fixed wire balloon positioned at said catheter distal end and comprising;

a working length portion having a substantially uniform diameter;

a proximal narrowed portion proximal to said working length portion having a smaller diameter than said substantially uniform diameter of said working length portion; and

a distal narrowed portion distal to said working length portion having a smaller diameter than said substantially uniform diameter of said working length portion; and

a guidewire enclosure having an enclosure proximal end and an enclosure distal end, said guidewire enclosure at least partially attached to said catheter at an attachment point, wherein said attachment point is located proximal to said working length portion of said fixed wire balloon.

13. The catheter system of claim 12, wherein said attachment point is at a junction of said working length portion and said proximal narrowed portion.

14. The catheter system of claim 12, wherein said guidewire enclosure is at least partially positioned within said catheter body.

15. The catheter system of claim 12, wherein said attachment point is proximal to said enclosure distal end.

16. The catheter system of claim 12, wherein said attachment point is at said enclosure distal end.

17. The catheter system of claim 12, further comprising a guidewire positionable within said guidewire enclosure.

18. The catheter system of claim 12, wherein at least a portion of said catheter body is comprised of a rigid material thereby providing a rigid control area, and further comprising a substantially rigid core wire positioned through said fixed wire balloon and connecting a balloon distal end and said rigid control area.

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

introducing a guidewire into the vessel and through the lesion;

providing a catheter having a fixed wire balloon and a guidewire enclosure attached to a proximal end of the fixed wire balloon;

introducing a proximal end of the guidewire into the guidewire enclosure of the catheter;

advancing the catheter over the guidewire until a distal end of the catheter is at the lesion and the guidewire is positioned alongside the balloon; and

inflating the balloon so as to compress the guidewire into the lesion.

20. The method of claim 19, further comprising treating a lesion in a second vessel, the second vessel being connected to the first vessel at a bifurcation, said treating comprising:

at least partially deflating the balloon;

retracting the catheter along the guidewire;

introducing the catheter into the second vessel; and

inflating the balloon.

21. A method for treating a first lesion in a first vessel and a second lesion in a second vessel, the first and second vessel connected at a bifurcation, the method comprising:

introducing a guidewire into the second vessel;

providing a catheter having a fixed wire balloon and a guidewire enclosure attached to a proximal end of the fixed wire balloon;

introducing a proximal end of the guidewire into the guidewire enclosure of the catheter;

advancing the catheter over the guidewire until a distal end of the catheter reaches the bifurcation;

further advancing the catheter past the bifurcation and into the first vessel such that the balloon is positioned alongside the first lesion;

inflating the balloon;

deflating the balloon;

retracting the catheter over the guidewire;

introducing the catheter into the second vessel, such that the guidewire is positioned alongside the balloon; and

inflating the balloon so as to compress the guidewire into the second lesion.

22. A method for treating an intracranial aneurysm in a vessel, the method comprising:

providing a catheter having a fixed wire balloon, an auxiliary elongated element at least partially attached to said balloon, and a stent positioned on said balloon and having a side opening, wherein said elongated element is positioned at said side opening;

introducing said catheter into the vessel;

positioning said catheter such that said side opening is situated at the aneurysm;

deploying said stent;

removing said catheter; and

introducing a coil delivery system for introduction of an embolic coil into the aneurysm.