Low profile catheter for angioplasty and occlusion

• US 6,231,588 B1
• Filed: 08/04/1998
• Issued: 05/15/2001
• Est. Priority Date: 08/04/1998
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Percusurge Inc. (Medtronic Plc)
• Inventors: Zadno-Azizi, Gholam-Reza
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/128,852
• Time in Patent Office: 1,015 Days
• Field of Search: 606/1, 606/110, 606/113, 606/114, 606/127, 606/128, 606/159, 606/167, 606/171, 606/191-200, 604/93.01, 604/99.02, 604/99.011, 604/101.01, 604/101.05, 604/102.01
• US Class Current: 606/200
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A low profile device for simultaneous angioplasty and occlusion includes an angioplasty balloon and an occlusion element which adjoin a common catheter. The occlusion element may be either self-expanding (in which case it is deployed with a sheath that surrounds the catheter) or non-self-expanding (in which case it is deployed with a pull wire that passes through the catheter). The angioplasty balloon is inflated with fluid that either passes through the catheter or a separate tube (or lumen) that adjoins the catheter.

Claims

1. An angioplasty apparatus, comprising:

a catheter;

a therapy balloon that adjoins said catheter, in which said balloon is inflatable to permit a stenosis site in a vessel to be enlarged;

a mechanically deployed expansion element, said expansion element adjoining said catheter, in which said expansion element is expandable to prevent emboli from moving downstream;

a pull wire that deploys said expansion element, in which said catheter surrounds said pull wire,

a hole in said catheter so that said catheter and said balloon are in fluid communication, and

a sealing member that adjoins said pull wire, said sealing member making an internal seal as said expansion element is deployed to isolate a distal end portion of said catheter from fluid in said balloon.

2. The apparatus of claim 1, in which said balloon is in fluid communication with the interior of said catheter, permitting said balloon to be inflated and deflated.

3. The apparatus of claim 1, in which said catheter comprises two lumens, one of said lumens being in fluid communication with said balloon.

4. The apparatus of claim 3, comprising inner and outer tubes that define said two lumens, said outer tube being in fluid communication with said balloon.

5. The apparatus of claim 1, further comprising:

a second hole in said catheter; and

a hole in said pull wire, wherein fluid can be aspirated from outside of said catheter to pass through said second hole in said catheter and said hole in said pull wire.

6. The apparatus of claim 5, comprising at least two lumens, one of said lumens being in fluid communication with said balloon.

7. The angioplasty apparatus of claim 1, in which expansion element is located distal to said balloon.

8. The apparatus of claim 1, wherein said expansion element is expandable to completely occlude the vessel.

9. The apparatus of claim 1, wherein said expansion element includes a membrane that contacts the vessel when said expansion element is expanded.

10. The apparatus of claim 9, wherein said membrane is perforated to allow the perfusion of blood.

11. The apparatus of claim 1, further comprising a device which retracts said pull wire.

12. The apparatus of claim 1, said sealing member contacting a seat that adjoins said catheter to make the internal seal.

13. The apparatus of claim 1, wherein said pull wire retracts a distal portion of said expansion element.

14. The apparatus of claim 13, comprising a ring member attached to a distal portion of said expansion element, said ring member sliding over said catheter as said pull wire is moved.

15. The apparatus of claim 14, further comprising a safety member attached to said catheter, said safety member preventing said ring member from advancing proximally of said safety member.

16. An angioplasty apparatus, comprising:

a catheter,

an angioplasty element that adjoins said catheter, in which said angioplasty element is expandable to permit a stenosis site in a vessel to be enlarged;

a mechanically deployed occlusion element, said occlusion element adjoining said catheter and located distal to said angioplasty element, in which said occlusion element is expandable to permit the vessel to be at least partially occluded;

an opening in said catheter so that said catheter and said angioplasty element are in fluid communication, and

a pull wire that deploys said occlusion element and contacts an inner portion of said catheter to isolate a distal end portion of said catheter from fluid in said angioplasty element.

17. The apparatus of claim 16, in which said angioplasty element includes a balloon.

18. The apparatus of claim 16, wherein said expansion element is expandable to completely occlude the vessel.

19. An angioplasty apparatus, comprising:

a catheter;

an angioplasty element that adjoins said catheter, said angioplasty element being expandable to enlarge a stenosis site in a vessel.

a mechanically deployed expansion element, one end portion of said expansion element adjoining said catheter and another end portion of said expansion element adjoining a member that slides with respect to said catheter, wherein said expansion element is slidable over said catheter, said expansion element preventing emboli from moving downstream when expanded; and

a pull wire that expands said expansion element by moving said slidable member.

20. An angioplasty apparatus, comprising:

a catheter;

an angioplasty element that adjoins said catheter, said angioplasty element being expandable to enlarge a stenosis site in a vessel, said angioplasty element comprising a balloon, said catheter including a hole such that said catheter and said balloon are in fluid communication;

a mechanically deployed expansion element, one end portion of said expansion element adjoining said catheter and another end portion of said expansion element adjoining a member that slides with respect to said catheter, said expansion element preventing emboli from moving downstream when expanded;

a pull wire that expands said expansion element by moving said slidable member, and

a sealing member that adjoins said pull wire, said sealing member making an internal seal as said expansion element is deployed to isolate a distal end portion of said catheter from fluid in said balloon.

21. An angioplasty apparatus, comprising:

a catheter,

an angioplasty element that adjoins said catheter, in which said angioplasty element is expandable to permit a stenosis site in a vessel to be enlarged;

a mechanically deployed expansion element that adjoins said catheter, said expansion element preventing emboli from moving downstream when expanded;

a pull wire that expands said expansion element;

an aspiration opening in said catheter, said opening permitting aspiration of a volume between said angioplasty element and said expansion element, said angioplasty element comprising a balloon, said catheter including a second hole, wherein said balloon receives inflation fluid through said second hole; and

a sealing member that adjoins said pull wire, said sealing member making an internal seal as said expansion element is deployed to isolate a distal end portion of said catheter from fluid in said balloon.

22. An angioplasty apparatus. comprising:

a catheter,

an angioplasty element that adjoins said catheter, in which said angioplasty element is expandable to permit a stenosis site in a vessel to be enlarged;

a mechanically deployed expansion element that adjoins said catheter, said expansion element preventing emboli from moving downstream when expanded;

a pull wire that expands said expansion element; and

an aspiration opening in said catheter, said opening permitting aspiration of a volume between said angioplasty element and said expansion element, said pull wire including a hole which is in fluid communication with said aspiration opening, thereby permitting fluid from said volume to be aspirated through a lumen in said pull wire.

23. An angioplasty apparatus, comprising:

a catheter;

an angioplasty element, said angioplasty element adjoining said catheter and treating a stenosis site in a vessel;

an emboli protection element, said emboli protection element adjoining said catheter and preventing the migration of emboli; and

a pull wire that activates said emboli protection element while enabling actuation of said angioplasty element, wherein said emboli protection element is slidable over said catheter.

24. An angioplasty apparatus, comprising:

a catheter;

an angioplasty element, said angioplasty element adjoining said catheter and treating a stenosis site in a vessel;

an emboli protection element, said emboli protection element adjoining said catheter and preventing the migration of emboli;

a pull wire that activates said emboli protection element while enabling actuation of said angioplasty element; and

a sealing member that adjoins said pull wire, said sealing member making an internal seal as said emboli protection element is deployed to isolate a distal end portion of said catheter from fluid in said angioplasty element.