Vessel occlusion device for embolic protection system

• US 20040015184A1
• Filed: 06/06/2003
• Published: 01/22/2004
• Est. Priority Date: 12/21/2000
• Status: Active Grant

• Current Assignee: Andy E. Denison, Paul F. Muller, William J. Boyle
• Original Assignee: Andy E. Denison, Paul F. Muller, William J. Boyle
• Inventors: Muller, Paul F., Boyle, William J., Denison, Andy E.
• Granted Patent: US 7,048,758 B2
• Time in Patent Office: Days
• 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 17/12136 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, comprising:

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, 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; and

an occluding device for occluding and blocking a blood vessel, adapted to be positionable at a location relative to the 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 by an interventional instrument, and to be contracted to unblock the blood vessel and enable the recovery of any residual embolic material.

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

3. The system of claim 1, wherein the position of the occluding device relative to the interventional procedure site comprises a position distal to the interventional procedure site.

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

5. The system of claim 1, wherein the collateral blood supply system comprises a vascular system which includes a plurality of vessels, including a common vessel which bifurcates into a pair of branch vessels, the guide catheter is adapted to be positionable in the common vessel relative to the interventional procedure site, and the interventional procedure site is located in at least one of the plurality of vessels.

6. The system of claim 1, wherein the distal end of the guide catheter includes an occluding device for occluding and blocking a blood vessel.

7. 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.

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

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

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

11. The system of claim 4, wherein the recovery system includes a recovery device, for enabling the recovery of the occluding device and embolic material captured in the occluding device.

12. The system of claim 5, wherein the interventional procedure site is located in one of the pair of branch vessels, and the occluding device is adapted to be positioned in the other of the pair of branch vessels.

13. The system of claim 5, wherein the blood supply flow reversal system is adapted to enable anatomical contralateral blood supply flow.

14. The system of claim 11, 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 occluding device to enable the trapping therein and recovery of embolic material captured by the occluding device, by enabling the removal of the occluding device.

15. The system of claim 11, 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.

16. The system of claim 11, 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.

17. The system of claim 12, further comprising an occluding device located at the distal end of the guide catheter, and adapted to be positionable in the common vessel.

18. The system of claim 12, wherein the 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.

19. The system of claim 13, wherein the vascular system comprises the carotid artery.

20. 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, comprising:

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, 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; and

means for occluding and blocking a blood vessel, adapted to be positionable at a location relative to the 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.

21. 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, in a system which comprises 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, 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, and an occluding device for occluding and blocking a blood vessel, adapted to be positionable at a location relative to the 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 embotic 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 any residual embolic material, wherein the method comprises:

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

expanding the occluding device within the blood vessel at the location relative to the interventional procedure site, so as to prevent and block the flow of blood past the occluding device, and to enable the capture in the occluding device of embolic material which may be released into the blood vessel during the therapeutic interventional procedure.