Arterial occluding cannula and methods of use

• US 6,689,149 B2
• Filed: 03/05/2001
• Issued: 02/10/2004
• Est. Priority Date: 07/24/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Maahs, Tracy D.
• Primary Examiner(s): Woo, Julian W.
• Application Number:
  US09/799,484
• Publication Number:
  US 20010023357A1
• Time in Patent Office: 1,072 Days
• Field of Search: 606/192-194, 606/108, 606/198, 604/96.01, 604/101.03, 604/102.01, 604/102.02, 604/102.03, 604/164.11, 604/164.13, 600/104, 128/898
• US Class Current: 606/194
• 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 comprising:

an elongate tubular member 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, 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 second lumen that extends proximally from the port along the cannula; and

a medical device adapted for insertion through the second lumen and beyond the port into the aorta.

2. The arterial cannula of claim 1, wherein the medical device comprises an elongate tubular member having an expandable occluder on a distal end.

3. The arterial cannula of claim 2, wherein the expandable occluder comprises an inflatable balloon.

4. The arterial cannula of claim 3, wherein the inflatable balloon has an annular shape and is sealed to the outer wall of the medical device.

5. The arterial cannula of claim 1, wherein the radius of the blood flow lumen is sized to minimize the risk of hemolysis.

6. The arterial cannula of claim 1, wherein the two lumens are substantially isolated from one another.

7. 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, a blood flow lumen and an aspiration lumen, each lumen extending between a proximal portion of the cannula and the distal end thereof and being substantially isolated from one another, wherein each lumen is adapted to extend out of the blood vessel when the cannula is deployed;

an aspiration port on the distal end communicating with the aspiration lumen;

a blood flow outlet on the distal end communicating with the blood flow lumen; and

a medical device adapted for insertion through the aspiration lumen and beyond the aspiration port into the blood vessel.

8. The arterial cannula of claim 7, wherein the blood flow outlet is located on a downstream portion of the distal end, and the aspiration port is located on an upstream portion of the distal end.

9. The arterial cannula of claim 7, wherein the medical device comprises an elongate tubular member having an expandable occluder on a distal end.

10. The arterial cannula of claim 9, wherein the expandable occluder comprises an inflatable balloon.

11. The arterial cannula of claim 10, wherein the inflatable balloon has an annular shape and is sealed to the outer wall of the medical device.

12. The arterial cannula of claim 7, wherein the radius of the blood flow lumen is sized to minimize the risk of hemolysis.

13. A method for occluding the aorta, said method comprising the steps of:

providing a cannula having an outlet and a port on its distal end, the outlet on the opposite side of the catheter from the port;

introducing the distal end of the cannula into the aorta;

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

introducing a medical device through the port into the aorta; and

deploying the medical device into the aorta towards the coronary arteries.

14. The method of claim 13, wherein the medical device comprises an elongate catheter having a first expandable occluder on a distal end, and wherein the method further comprises the step of expanding the first expandable occluder to occlude the aorta, thereby isolating the coronary arteries from a position downstream of the expandable occluder.

15. The method of claim 14, wherein the first expandable occluder comprises an inflatable balloon.

16. The method of claim 14, comprising the additional step of delivering blood through the outlet downstream of the first expandable occluder.

17. The method of claim 14, wherein the cannula comprises a second expandable occluder mounted axially around its distal end between the outlet and the port, and wherein the method comprises the additional step of expanding the second expandable occluder to form a second occlusion of the aorta downstream of the first expandable occluder, thereby isolating a region within the aorta from the first expandable occluder to the second expandable occluder.

18. The method of claim 17, further comprising the steps of:

introducing aspiration fluid through the port into the isolated region; and

withdrawing the aspiration fluid through the port, thereby aspirating loose embolic material from the isolated region.

19. The method of claim 13, wherein the cannula is introduced into the aorta by thorascopic access.

20. The method of claim 13, wherein the cannula is introduced into the aorta by direct access.