Vessel treatment devices

• US 7,753,951 B2
• Filed: 10/08/2007
• Issued: 07/13/2010
• 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, Solar, Ronald J., Lieber, Glen
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US11/868,568
• Publication Number:
  US 20080033525A1
• Time in Patent Office: 1,009 Days
• Field of Search: 623/1.11, 623/1.34, 623/1.35, 606191-198, 606/200
• US Class Current: 623/1.35
• 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 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• 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 2025/0183 : Rapid exchange or monorail catheters
• 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
• 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 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

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 system for positioning of a stent at a bifurcation, the system comprising:

a catheter having a main body, said main body having a main body proximal end and a main body distal end;

a balloon positioned at said main body distal end, said balloon having a balloon proximal end and a balloon distal end, said balloon having an inflated configuration and a pre-inflated configuration;

a wire positioned at said balloon distal end, said wire immovable with respect to said balloon while said balloon is in said pre-inflated configuration;

a core wire positioned through said balloon;

an auxiliary elongated element having an auxiliary elongated element proximal end, an auxiliary elongated element distal end, and a balloon contacting portion, said balloon contacting portion positioned alongside at least a portion of said balloon, said auxiliary elongated element distal end attached to said catheter;

a stent positioned on said balloon, said stent having stent edges; and

at least three radiopaque markers, said radiopaque markers immovable with respect to said catheter main body, comprising at least one radiopaque marker longitudinally aligned with each of said stent edges, and wherein at least two of said radiopaque markers are positioned on said core wire and at least one of said radiopaque markers is positioned on said balloon contacting portion of said auxiliary elongated element.

2. The system of claim 1, wherein said wire is a fixed wire attached to said balloon distal end.

3. The system of claim 1, wherein said wire is a movable wire when said balloon is in said inflated configuration, and wherein when said balloon is in said pre-inflated configuration, said wire is trapped inside said balloon and stent so that said wire is immovable with respect to said balloon.

4. The system of claim 1, wherein said stent has a stent opening, and wherein said stent edges comprise a stent distal end, a stent proximal end, a stent opening distal end and a stent opening proximal end.

5. The system of claim 4, wherein said stent is positioned around at least a portion of said auxiliary elongated element, and wherein said auxiliary elongated element distal end is positioned at said stent opening.

6. The system of claim 5, wherein said auxiliary elongated element distal end is positioned 0.25-1 mm proximal to said stent opening distal end.

7. The system of claim 4, wherein said at least three radiopaque markers comprise four radiopaque markers.

8. The system of claim 7, wherein one of said four radiopaque markers is positioned on said auxiliary elongated element and is aligned with said stent opening proximal end.

9. The system of claim 7, wherein one of said four radiopaque markers is positioned on said auxiliary elongated element and is aligned with said stent opening distal end.

10. The system of claim 7, wherein one of said four radiopaque markers is positioned on said auxiliary elongated element and is aligned with said stent proximal end.

11. The system of claim 1, wherein said stent comprises a stent proximal end and a stent distal end, and wherein said auxiliary elongated element distal end is positioned proximal to said stent proximal end, said balloon contacting portion of said auxiliary elongated element is positioned at said balloon proximal end.

12. The system of claim 11, wherein said at least three radiopaque markers comprise two radiopaque markers on said core wire and longitudinally aligned with said stent proximal end and said stent distal end, and one radiopaque marker on said auxiliary elongated element balloon contacting portion.

13. The system of claim 1, wherein said stent comprises a stent proximal end and a stent distal end, at least a portion of said balloon contacting portion of said auxiliary elongated element positioned alongside said balloon and under said stent, wherein said auxiliary elongated element distal end is distal to said stent distal end.

14. The system of claim 13, wherein said at least three radiopaque markers comprise two radiopaque markers on said core wire and longitudinally aligned with said stent proximal end and said stent distal end, and one radiopaque marker on said auxiliary elongated element distal end.

15. The system of claim 13, wherein said at least three radiopaque markers comprise one radiopaque marker on said core wire and longitudinally aligned with said stent proximal end, one radiopaque marker on said auxiliary elongated element and longitudinally aligned with said stent distal end, and one radiopaque marker on said core wire and distal to said stent distal end.

16. A method for treating a vessel at a bifurcation, the method comprising:

providing a catheter with a main body, a balloon positioned at a distal end of said main body, said balloon having an inflated configuration and an pre-inflated configuration, a wire positioned at a distal end of said balloon, said wire immovable with respect to said balloon while said balloon is in said pre-inflated configuration, a core wire positioned through said balloon, an auxiliary elongated element positioned alongside at least a portion of said balloon and having a distal end attached to said catheter so as to form a crotch point, a stent positioned on said balloon, said stent having stent edges, at least three radiopaque markers immovable with respect to the catheter main body, comprising at least one radiopaque marker longitudinally aligned with each of said stent edges, and wherein at least two of said radiopaque markers are positioned on said core wire and at least one of said radiopaque markers is positioned on said auxiliary elongated element;

positioning a guidewire within a branch vessel;

introducing said catheter over said guidewire and in a main vessel into a vicinity of the bifurcation;

rotating said catheter until said at least one radiopaque marker positioned on said auxiliary elongated element is at a vertical distance from said at least two radiopaque markers positioned on said core wire and is adjacent a branch vessel;

advancing said catheter until said crotch point prevents further advancement of said catheter and until at least one of said at least three radiopaque markers is aligned with an opening of the branch vessel; and

deploying the stent by inflating the balloon.

17. The method of claim 16, further comprising:

releasing said wire upon inflation of the balloon such that said wire is movable with respect to said balloon;

deflating said balloon;

removing said catheter from the main vessel, leaving said guidewire in the branch vessel and said wire in the main vessel.