Atrial isolator and method of use

• US 6,461,327 B1
• Filed: 08/07/1998
• Issued: 10/08/2002
• Est. Priority Date: 08/07/1998
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embolx, Inc.
• Inventors: Kram, Cynthia, Addis, Bruce
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): BIANCO, PATRICIA
• Application Number:
  US09/131,158
• Time in Patent Office: 1,523 Days
• Field of Search: 604/96, 604/98, 604/101, 604/533, 604/96.01, 604/97.01, 604/99.01, 604/101.01, 604/101-3-1, 604/98.01, 604/102-1-1, 604/532-33, 604/104, 604/103, 604/164.01, 604/164-9-1, 604/264, 604/523, 604/500, 604/506-509, 606/191-192, 606/194-195, 606/198, 128/898
• US Class Current: 604/101.04
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

An atrial isolator comprising two tubular members, two lumens, drainage ports, and expandable occluders. The expandable occluders are adapted to engage an opening of the superior vena cava into the right atrium or the inferior vena cava and right tricuspid valve into the right atrium. The second tubular member is inserted into the lumen of the first tubular member to provide a displacement between the first expandable occluder and the second expandable occluder which is adjustable. A cardioplegia port is located between the two expandable occluders and in communication with a cardioplegic lumen. Methods of using such an atrial isolator are also disclosed, particularly to provide circulatory isolation of the heart and coronary blood vessels, and cardioplegia delivery.

Claims

1. An atrial isolator, comprising:

a first tubular member having a proximal end, a distal end, and a lumen therebetween, the distal end having one or more drainage ports in fluid communication with the lumen;

a first expandable occluder mounted on the distal end of the first tubular member and distal to the one or more drainage ports of the first tubular member, the first expandable occluder adapted to engage an opening of the superior vena cava into the right atrium;

a second tubular member having a proximal end, a distal end, and first and second lumens therebetween, the distal end of the second tubular member having one or more drainage ports in fluid communication with the first lumen of the second tubular member, the distal end of the second tubular member having one or more cardioplegia delivery ports in fluid communication with the second lumen of the second tubular member, the one or more cardioplegia delivery ports located proximal the one or more drainage ports of the second tubular member;

a second expandable occluder mounted on the distal end of the second tubular member and located between the one or more drainage ports of the second tubular member and the one or more cardioplegia delivery ports, the second expandable occluder adapted to engage an opening of an inferior vena cava and a tricuspid valve into a right atrium; and

a locking mechanism to lock the first occluder and the second occluder at a fixed displacement,

wherein the second tubular member is slideably inserted into the lumen of the first tubular member to provide adjustable displacement between the first expandable occluder and the second expandable occluder, and wherein the one or more cardioplegia delivery ports is in fluid communication with a right atrium when the second tubular member is placed to allow the second expandable occluder to engage an opening of an inferior vena cava and a tricuspid valve into a right atrium.

2. The atrial isolator of claim 1, wherein the first and second expandable occluders each comprise a balloon, and the first and second tubular members each comprise a balloon inflation lumen.

3. The atrial isolator of claim 1, wherein said one or more drainage ports of the first tubular member comprises a plurality of drainage ports.

4. The atrial isolator of claim 1, wherein said one or more drainage ports of the second tubular member comprises a plurality of drainage ports.

5. The atrial isolator of claim 1, wherein said one or more cardioplegia delivery ports of the second tubular member comprises a plurality of cardioplegia delivery ports.

6. An atrial isolator, comprising:

a first tubular member having a proximal end, a distal end, and a lumen therebetween, the distal end having one or more drainage ports in fluid communication with the lumen;

a first expandable occluder mounted on the distal end of the first tubular member and distal to the one or more drainage ports of the first tubular member, the first expandable occluder adapted to engage an opening of the superior vena cava into the right atrium;

a second tubular member having a proximal end, a distal end, and first and second lumens therebetween, the distal end of the second tubular member having one or more drainage ports in fluid communication with the first lumen of the second tubular member, the distal end of the second tubular member having a plurality of cardioplegia delivery ports in fluid communication with the second lumen of the second tubular member, the plurality of cardioplegia delivery ports located proximal the one or more drainage ports of the second tubular member; and

a second expandable occluder mounted on the distal end of the second tubular member and located between the one or more drainage ports of the second tubular member and the one or more cardioplegia delivery ports, the second expandable occluder adapted to engage an opening of an inferior vena cava and a tricuspid valve into a right atrium,

wherein the second tubular member is slideably inserted into the lumen of the first tubular member to provide adjustable displacement between the first expandable occluder and the second expandable occluder, and wherein the one or more cardioplegia delivery ports is in fluid communication with a right atrium when the second tubular member is placed to allow the second expandable occluder to engage an opening of an inferior vena cava and a tricuspid valve into a right atrium.

7. The atrial isolator of claim 6, wherein the first and second expandable occluders each comprise a balloon, and the first and second tubular members each comprise a balloon inflation lumen.

8. The atrial isolator of claim 6, wherein said one or more drainage ports of the first tubular member comprises a plurality of drainage ports.

9. The atrial isolator of claim 6, wherein said one or more drainage ports of the second tubular member comprises a plurality of drainage ports.

10. The atrial isolator of claim 6, further comprising a locking mechanism to lock the first occluder and the second occluder at a fixed displacement.

11. A method for sealing the atrium of a patient during cardiopulmonary bypass, comprising the steps of:

providing an atrial isolator comprising a first tubular member having a lumen, a first expandable occluder mounted on the distal end thereof. and one or more drainage ports located proximal the expandable occluder and in fluid communication with the lumen, a second tubular member having first and second lumens, a second expandable occluder mounted on a distal end thereof, one or more drainage ports located distal of the second occluder and in fluid communication with the first lumen, and one or more cardioplegia delivery ports located proximal of the second expandable occluder and in fluid communication with the second lumen;

making an incision in the patient to provide access to the superior vena cava;

inserting a distal end of the atrial isolator into the superior vena cava;

positioning the atrial isolator within the right atrium;

expanding the first and second expandable occluders;

adjusting the displacement between the first and second expandable occluders so that the first expandable occluder engages an opening of a superior vena cava into a right atrium, while the second expandable occluder engages an opening of an inferior vena cava and a tricuspid valve into a right atrium;

locking the first occluder and second occluder at a fixed displacement; and

infusing cardioplegia solution into a right atrium through the one or more cardioplegia delivery ports.

12. The method of claim 11, further comprising the steps of withdrawing venous blood from the superior vena cava through the drainage port on the first tubular member and withdrawing venous blood from the inferior vena cava through the drainage port on the second tubular member.

13. The method of claim 11, further comprising the step of infusing cardioplegia retrograde through a right atrium into a coronary sinus.

14. The method of claim 11, wherein the step of providing an atrial isolator comprises providing an atrial isolator wherein the first and second tubular members each have a plurality of drainage ports.

15. The method of claim 11, wherein the step of providing an atrial isolator comprises providing an atrial isolator wherein the second tubular member has a plurality of cardioplegia delivery ports.

16. A method for sealing the atrium of a patient during cardiopulmonary bypass, comprising the steps of:

providing an atrial isolator comprising a first tubular member having a lumen, a first expandable occluder mounted on the distal end thereof, and one or more drainage ports located proximal the expandable occluder and in fluid communication with the lumen, a second tubular member having first and second lumens, a second expandable occluder mounted on a distal end thereof, one or more drainage ports located distal of the second occluder and in fluid communication with the first lumen, and one or more cardioplegia delivery ports located proximal of the second expandable occluder and in fluid communication with the second lumen;

making an incision in the patient to provide access to the superior vena cava;

inserting a distal end of the atrial isolator into the superior vena cava;

positioning the atrial isolator within the right atrium;

expanding the first and second expandable occluders;

adjusting the displacement between the first and second expandable occluders so that the first expandable occluder engages an opening of a superior vena cava into a right atrium, while the second expandable occluder engages an opening of an inferior vena cava and a tricuspid valve into a right atrium; and

infusing cardioplegia solution retrograde through a right atrium into a coronary sinus.

17. The method of claim 16, further comprising the steps of withdrawing venous blood from the superior vena cava through the drainage port on the first tubular member and withdrawing venous blood from the inferior vena cava through the drainage port on the second tubular member.

18. The method of claim 16, further comprising the step of locking the first occluder and second occluder at a fixed displacement.

19. The method of claim 16, wherein the step of providing an atrial isolator comprises providing an atrial isolator wherein the first and second tubular members each have a plurality of drainage ports.

20. The method of claim 16, wherein the step of providing an atrial isolator comprises providing an atrial isolator wherein the second tubular member has a plurality of cardioplegia delivery ports.

21. A method for sealing the atrium of a patient during cardiopulmonary bypass, comprising the steps of:

providing an atrial isolator comprising a first tubular member having a lumen, a first expandable occluder mounted on the distal end thereof, and one or more drainage ports located proximal the expandable occluder and in fluid communication with the lumen, a second tubular member having first and second lumens, a second expandable occluder mounted on a distal end thereof, one or more drainage ports located distal of the second occluder and in fluid communication with the first lumen, and a plurality of cardioplegia delivery ports located proximal of the second expandable occluder and in fluid communication with the second lumen;

making an incision in the patient to provide access to the superior vena cava;

inserting a distal end of the atrial isolator into the superior vena cava;

positioning the atrial isolator within the right atrium;

expanding the first and second expandable occluders;

adjusting the displacement between the first and second expandable occluders so that the first expandable occluder engages an opening of a superior vena cava into a right atrium, while the second expandable occluder engages an opening of an inferior vena cava and a tricuspid valve into a right atrium; and

infusing cardioplegia solution into a right atrium through the plurality of cardioplegia delivery ports.

22. The method of claim 21, further comprising the steps of withdrawing venous blood from the superior vena cava through the drainage port on the first tubular member and withdrawing venous blood from the inferior vena cava through the drainage port on the second tubular member.

23. The method of claim 21, further comprising the step of infusing cardioplegia retrograde through a right atrium into a coronary Sinus.

24. The method of claim 21, wherein the step of providing an atrial isolator comprises providing an atrial isolator wherein the first and second tubular members each have a plurality of drainage ports.

25. The method of claim 21, further comprising the step of locking the first occluder and second occluder at a fixed displacement.