Vessel treatment devices

• US 9,504,473 B2
• Filed: 07/16/2010
• Issued: 11/29/2016
• 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): LOUIS, RICHARD G
• Application Number:
  US12/838,286
• Publication Number:
  US 20100286720A1
• Time in Patent Office: 2,328 Days
• Field of Search: 623/1.11, 606/194, 604/94.01, 604/164.13
• US Class Current: 1/1
• 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 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22068 Centering
• 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: 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 2025/0183 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 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• 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 25/0169 : Exchanging a catheter while keeping the guidewire in place
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• 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 method for treating a lesion in a vessel, the method comprising:

providing a catheter having a fixed wire balloon, with a fixed wire attached to a distal end of the balloon and extending distally from the balloon, and a core wire positioned externally alongside the balloon wherein the core wire fixedly attaches to the fixed wire distally from the balloon and wherein the core wire is positioned internally to the catheter in a region proximal to the balloon;

introducing said catheter into the lesion; and

inflating the balloon so as to compress the core wire into the lesion.

2. The method according to claim 1, wherein said catheter further comprises an auxiliary elongated element positioned internally within said catheter, the method further comprising advancing an item through said auxiliary elongated element and to a location which is distal to the lesion.

3. The method according to claim 2, wherein said item is a guidewire.

4. The method according to claim 1, wherein said catheter further comprises an auxiliary elongated element positioned internally within said catheter, the method further comprising advancing a guidewire through said auxiliary elongated element prior to said inflating the balloon.

5. The method according to claim 4, wherein the auxiliary elongated element has a distal exit point proximal to said fixed wire balloon.

6. The method according to claim 4, wherein the auxiliary elongated element has a distal exit point positioned at a rotational distance from said core wire.

7. The method according to claim 1, wherein said catheter further comprises an auxiliary elongated element positioned internally within said catheter, the method further comprising deflating said balloon and thereafter advancing a guidewire through said auxiliary elongated element.

8. The method according to claim 1, wherein the catheter further comprises multiple core wires.

17. The method according to claim 1, wherein the external core wire is fixed to the catheter.

18. The method according to claim 1, wherein the catheter further comprises an internal core wire.

19. The method according to claim 2, wherein the item is separated from the external core wire.

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

introducing a guidewire into the vessel and through the lesion;

advancing a catheter along the guidewire, wherein the catheter comprises a fixed wire balloon, with the fixed wire extending distally from a distal end of the balloon, and an external core wire positioned alongside the balloon wherein the external core wire fixedly attaches to the fixed wire distally from the balloon and wherein the core wire is positioned internally to the catheter in a region proximal to the balloon;

positioning the balloon within the lesion; and

inflating the balloon so as to compress the external core wire into the lesion.

10. The method according to claim 9, wherein the guidewire is positioned alongside the balloon and is compressed into the lesion when the balloon is inflated.

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

providing a catheter having a balloon with a fixed wire extending distally from the balloon with an unexpanded state and an expanded state, and an external core wire positioned alongside the balloon and within folds of the balloon in the unexpanded state wherein the external core wire fixedly attaches to the fixed wire distally from the balloon and wherein the core wire is positioned internally to the catheter in a region proximal to the balloon;

introducing said catheter into the lesion; and

inflating the balloon so as to compress the external core wire into the lesion.

12. The method according to claim 11, wherein a guidewire is positioned alongside the balloon when the balloon is in the unexpanded state.

13. The method according to claim 12, wherein the guidewire and external core wire are positioned alongside the balloon when the balloon is inflated.

14. The method according to claim 13, wherein the guidewire is circumferentially spaced from the external core wire when the balloon is inflated.

15. The method according to claim 11, wherein the catheter further comprises multiple external core wires.

16. The method according to claim 15, wherein the multiple external core wires are split from a single core wire.