Vessel occlusion device for embolic protection system

• US 7,048,758 B2
• Filed: 06/06/2003
• Issued: 05/23/2006
• Est. Priority Date: 12/21/2000
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Boyle, William J., Muller, Paul F., Denison, Andy E.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/457,073
• Publication Number:
  US 20040015184A1
• Time in Patent Office: 1,082 Days
• Field of Search: 606/127, 606/113, 606/114, 606/159, 606/192, 606/198, 606/200, 623/1.11, 623/1.12, 623/1.35
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

A system used in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region, which is capable of capturing embolic material which may be released into a blood vessel during a therapeutic interventional procedure at the site of a lesion in the blood vessel. The system is adapted to be utilized in a collateral blood supply system adapted to enable the flow of blood to bypass the blood vessel upon blocking thereof and to enable the reverse flow of blood through the blood vessel upon unblocking thereof. The system includes a guide wire, including a distal end, adapted to be positioned in a blood vessel relative to an interventional procedure site. A guide catheter, including a distal end, is adapted to enable the interventional procedure to be performed, and to be inserted over the guide wire and through a patient'"'"'s vasculature to a position in the blood vessel relative to the interventional procedure site. An occluding device for occluding and blocking a blood vessel at a location relative to the interventional procedure site is adapted to be positionable at a location relative to he interventional procedure site, to be expandable so as to prevent and block the flow of blood past the occlusion, and to enable the capture of embolic material which may be released into the blood in the blood vessel during the therapeutic interventional procedure, and to be contracted to unblock the blood vessel and enable the recovery of captured embolic material.

Claims

1. A system for capturing embolic material which may be released into a blood vessel during a therapeutic interventional procedure by an interventional instrument at the site of a lesion in the blood vessel, in a collateral blood supply system adapted to enable the flow of blood to bypass the blood vessel upon blocking thereof and to enable the reverse flow of blood through the blood vessel upon unblocking thereof, the collateral blood supply system being a vascular system having a plurality of vessels including a common vessel which bifurcates into a first and second branch vessel, the system comprising:

a first guide wire, including a distal end, adapted to be positioned in the first branch vessel;

a guide catheter, including a distal end, adapted to enable the interventional procedure to be performed, and adapted to be inserted over the guide wire and through a patient'"'"'s vasculature to a position in the common blood vessel;

a first occluding device for occluding and blocking the first branch vessel attached to the first guide wire and adapted to be positionable at a location relative to the interventional procedure site and to enable the capture of embolic material which may be released into the blood in the blood vessel during the therapeutic interventional procedure;

a second occluding device for occluding and blocking blood flow in the common blood vessel and to enable the capture of embolic material which may be released into the blood in the blood vessel during the therapeutic interventional procedure; and

a second guide wire moveable within a lumen extending at least partially along the length of the guide catheter, the second guide wire being adapted to allow an interventional instrument to be slidably moved there along to the site of the interventional procedure in the second branch vessel.

2. The system of claim 1, wherein the first occluding device includes a membrane which is comprised of a material without perfusion holes.

3. The system of claim 2, wherein the first occluding device comprises an expandable balloon, which comprises the membrane.

4. The system of claim 2, wherein the first occluding device comprises a basket which includes the membrane extending thereabout.

5. The system of claim 2, wherein the material without perfusion holes comprises a solid non-porous membrane.

6. The system of claim 1, further comprising a recovery system for enabling the recovery of embolic material.

7. The system of claim 6, wherein the recovery system includes a recovery device, for enabling the recovery of the second occluding device and embolic material captured in the second occluding device.

8. The system of claim 7, wherein the guide catheter further includes an elongated shaft, and the recovery device comprises a recovery sheath, adapted to extend through the elongated shaft of the guide catheter, and to be extendable about and collapse the second occluding device to enable the trapping therein and recovery of embolic material captured by the second occluding device, by enabling the removal of the second occluding device.

9. The system of claim 7, wherein the guide catheter further includes a proximal end, and the recovery system further includes a valve, adapted to be connected to the proximal end of the guide catheter, and adapted to be opened to enable flushing therethrough of embolic material released during the crossing of the lesion by the interventional instrument.

10. The system of claim 7, wherein the guide catheter further includes a proximal end, and the recovery system further includes a vacuum syringe, adapted to be connected to the proximal end of the guide catheter, to apply a vacuum and suction out embolic material therethrough at the conclusion of the therapeutic interventional procedure.

11. The system of claim 1, wherein the second occluding device is located at the distal end of the guide catheter.

12. The system of claim 1, further comprising an interventional instrument, and a system for delivering the interventional instrument to the interventional procedure site, and for enabling the interventional instrument to be deployed at the interventional procedure site.

13. The system of claim 1, wherein the blood supply flow reversal system is adapted to enable anatomical contralateral blood supply flow.

14. The system of claim 13, wherein the vascular system is the carotid artery.

15. The system of claim 1, wherein the second occluding device is adapted to form a generally funnel shaped configuration so as to enable embolic material to substantially freely pass into the guide catheter.

16. A system for capturing embolic material which may be released into a blood vessel during a therapeutic interventional procedure at the site of a lesion in the blood vessel, in a collateral blood supply system adapted to enable the flow of blood to bypass the blood vessel upon blocking thereof and to enable the reverse flow of blood through the blood vessel upon unblocking thereof, the collateral blood supply system being a vascular system having a plurality of vessels including a common vessel which bifurcates into a first and second branch vessel, the system comprising:

a first guide wire, including a distal end, adapted to be positioned in the first branch vessel;

a guide catheter, including a distal end, adapted to enable the interventional procedure to be performed, and adapted to be inserted over the guide wire and through a patient'"'"'s vasculature to a position in the blood vessel relative to the interventional procedure site;

means for occluding and blocking the collateral blood supply system to create an anatomical contralateral blood supply flow through the first and second branch vessels; and

a second guide wire moveable within a lumen extending at least partially along the length of the guide catheter, the second guide wire being adapted to allow an interventional instrument to be slidably moved there along to the site of the interventional procedure in the second branch vessel.

17. A method of capturing embolic material which may be released into a blood vessel during a therapeutic interventional procedure at the site of a lesion in the blood vessel, in a collateral blood supply system adapted to enable the flow of blood to bypass the blood vessel upon blocking thereof and to enable the reverse flow of blood through the blood vessel upon unblocking thereof, the collateral blood supply system being a vascular system having a plurality of vessels including a common vessel which bifurcates into a first and second branch vessel, in a system which comprises a first guide wire, including a distal end, adapted to be positioned in the first branch vessel, a guide catheter, including a distal end, adapted to enable the interventional procedure to be performed, and adapted to be inserted over the first guide wire and through a patient'"'"'s vasculature to a position in the common blood vessel relative to the interventional procedure site, a first occluding device for occluding and blocking the first branch vessel, attached to the first guide wire, a second occlusion device for occluding and blocking the common blood vessel and a second guide wire moveable within a lumen extending at least partially along the length of the guide catheter, the second guide wire being adapted to allow an interventional instrument to be slidably moved there along to the site of the interventional procedure in the second branch vessel, wherein the method comprises:

inserting the first guide wire into the first branch vessel such that the first occluding device is positioned at a location relative to the interventional procedure site;

positioning the guide catheter in the common blood vessel;

deploying the second occluding device in the common blood vessel;

expanding the first occluding device within the blood vessel at the location relative to the interventional procedure site;

positioning the second guide wire into the interventional procedure site in the second branch vessel; and

sliding an interventional instrument along the second guide wire to the interventional procedure site.