Arterial aspiration

• US 5,928,192 A
• Filed: 07/24/1997
• Issued: 07/27/1999
• Est. Priority Date: 07/24/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embol X Inc (Edwards Lifesciences Corporation)
• Inventors: Maahs, Tracy D.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US08/899,606
• Time in Patent Office: 733 Days
• Field of Search: 606/192, 606/194, 604/96, 604/101, 604/907, 604/919
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A balloon occlusion device for aspirating embolic material from a blood vessel, such as from the aorta during cardiac surgery. The device includes an arterial cannula having a proximal end adapted to receive blood from a bypass-oxygenator machine, a distal end adapted to enter an artery, and a blood flow lumen extending between the proximal end and an outlet on the distal end. The cannula has an aspiration port proximate to the outlet, which communicates with an aspiration lumen. The cannula also includes an inflatable balloon attached to the cannula between the outlet and the aspiration port and capable of assuming an inflated condition for occluding a blood vessel. To use the device, the distal end of the cannula is introduced into a blood vessel, such as the aorta, the outlet is oriented downstream for delivering blood, and the balloon is inflated to occlude the vessel. Fluid may then be flushed into and aspirated out through the aspiration port as desired to remove loose embolic material from the vessel upstream of the balloon. Optionally, the device may include a second deployable balloon for further occluding the vessel at a second location.

Claims

1. An arterial cannula for aspirating a blood vessel and thereby removing loose embolic material within the vessel, the arterial cannula comprising:

a cannula having a proximal end, a distal end adapted to enter an artery, and a blood flow lumen extending between the proximal end and an outlet on the distal end, wherein the distal end includes a curved portion extending substantially perpendicularly to a longitudinal axis of the cannula;

a port proximal the curved portion of the distal end on the cannula proximate to the outlet, the port communicating with a lumen that extends proximally from the port along the cannula; and

an expandable occluder attached to the cannula between the outlet and the port, the occluder being capable of assuming an expanded condition for occluding a blood vessel.

2. The arterial cannula of claim 1, wherein the occluder is a balloon.

3. The arterial cannula of claim 2, wherein the inflatable balloon has an annular shape, and is attached on the curved outlet portion adjacent to the outlet.

15. The arterial cannula of claim 1, wherein the port is farther from the distal end of the cannula than the curved portion of the distal end of the cannula.

16. The arterial cannula of claim 1, wherein the port is within the curved portion of the distal end of the cannula.

17. The arterial cannula of claim 1, wherein the port is nearer to the distal end of the cannula than the curved portion of the distal end of the cannula.

4. An arterial cannula for aspirating a blood vessel and thereby removing loose embolic material within the vessel, the arterial cannula comprising:

a cannula having a proximal end adapted to receive blood from a bypass-oxygenator machine, a distal end adapted to enter an artery, and a blood flow lumen extending between the proximal end and an outlet on the distal end;

an aspiration port on the cannula proximate to the outlet, the aspiration port communicating with an aspiration lumen that extends proximally from the aspiration port along the cannula;

a first inflatable balloon attached to the cannula between the outlet and the aspiration port, the first balloon being capable of assuming an inflated condition for occluding a blood vessel; and

a second inflatable balloon deployable from the distal end of the cannula, the second balloon being capable of assuming an inflated condition for occluding a blood vessel.

5. The arterial cannula of claim 4, wherein the second balloon is attached to an elongate tubular member, the elongate tubular member being slidably received in the aspiration lumen, whereby the second balloon may be slidably deployed from and retracted into the aspiration port.

6. A method of aspirating embolic material from the aorta, the method comprising the steps of:

providing a cannula having a curved distal end, an outlet and a port on its distal end, and having a first expandable occluder between the outlet and the port;

introducing the distal end of the cannula into the aorta;

orienting the outlet in a downstream direction within the aorta;

expanding the first occluder to occlude the aorta, thereby providing a fluid-tight seal between an upstream portion and a downstream portion of the aorta;

introducing fluid through the port into the upstream portion of the aorta; and

withdrawing the fluid from the upstream portion of the aorta through the port, thereby aspirating loose embolic material from the upstream portion of the aorta.

7. The method of claim 6, wherein the first expandable occluder is a balloon.

8. The method of claim 6, comprising the additional step of delivering blood from the outlet of the cannula into the downstream portion of the aorta.

9. The method of claim 6, wherein the cannula includes a second expandable occluder retractably deployable from the cannula, and wherein the method comprises the additional steps of:

deploying the second occluder into the upstream portion of the aorta; and

expanding the second occluder to isolate a region within the aorta extending from the first occluder to the second occluder.

10. The method of claim 9, wherein the second expanding occluder is a balloon.

11. The method of claim 6, wherein the cannula is introduced into the aorta by thorascopic access.

12. A method of aspirating embolic material from the aorta during cardiac surgery, the method comprising the steps of:

providing a cannula having an outlet and an aspiration port on its distal end, and having an inflatable balloon between the outlet and the aspiration port;

introducing the distal end of the cannula into the aorta;

orienting the outlet in a downstream direction within the aorta, thereby orienting the aspiration port in an upstream direction;

inflating the balloon to occlude the aorta, thereby providing a fluid-tight seal between an upstream portion and a downstream portion of the aorta;

delivering blood from a bypass-oxygenator machine through the outlet of the cannula into the downstream portion of the vessel;

introducing fluid through the aspiration port into the upstream portion of the aorta; and

withdrawing the fluid from the upstream portion of the aorta through the aspiration port, thereby aspirating loose embolic material from the upstream portion of the aorta.

13. The method of claim 12, wherein the cannula includes a second balloon retractably deployable from the cannula, and wherein the method comprises the additional steps of:

deploying the second balloon into the upstream portion of the aorta towards the coronary arteries; and

inflating the second balloon to further occlude the aorta, thereby providing a fluid-tight seal between the upstream portion of the aorta and the coronary arteries.

14. An arterial cannula for aspirating a blood vessel and thereby removing loose embolic material within the vessel, the arterial cannula comprising:

a cannula having a proximal end, a distal end, and a lumen extending between the proximal end and an outlet on the distal end;

an aspiration port on the cannula proximate to the outlet, the aspiration port communicating with an aspiration lumen that extends proximally from the aspiration port along the cannula;

a first inflatable balloon attached to the cannula between the outlet and the aspiration port, the first balloon being capable of assuming an inflated condition for occluding a blood vessel; and

a second inflatable balloon deployable from the distal end of the cannula, the second balloon being capable of assuming an inflated condition for occluding a blood vessel, wherein the second balloon is attached to an elongate tubular member, the elongate tubular member being slideably received in the aspiration lumen, whereby the second balloon may be slideably deployed from and retracted into the aspiration port.