Methods and devices for occluding a vessel and performing differential perfusion

• US 6,210,363 B1
• Filed: 02/23/1999
• Issued: 04/03/2001
• Est. Priority Date: 02/23/1999
• Status: Expired due to Fees

• Current Assignee: Cardeon Corporation
• Original Assignee: Cardeon Corporation
• Inventors: Robinson, Janine, Olsen, Eric, Esch, Brady, Samson, Wilfred, Macoviak, John
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/256,263
• Time in Patent Office: 770 Days
• Field of Search: 604/96, 604/500, 604/4, 604/99.02, 604/28, 128/634
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

The present invention includes an apparatus and methods for differentially perfusing a patient undergoing cardiopulmonary bypass. A cardiopulmonary bypass machine is configured to provide hypothermic oxygenated blood and normothermic oxygenated blood to an aortic balloon catheter. The catheter has arch perfusion ports and corporeal perfusion ports and is introduced into a patient'"'"'s aorta and navigated transluminally until the occlusion balloon is located in the descending aorta. The occlusion balloon is inflated and hypothermic oxygenated blood is perfused to the arch vessels while normothermic oxygenated blood is perfused to the corporeal circulation. This procedure offers the benefit of cerebral protection from embolic events during cardiopulmonary bypass surgery.

Claims

1. An aortic catheter for segmenting and selectively perfusing a patient'"'"'s aorta comprising:

(a) an elongated shaft having a proximal end, a distal end and a length sufficient to be inserted into an ascending aorta and guided transluminally in an antegrade direction such that said distal end is positioned in a descending aorta when in the operative position and said proximal end resides external to the patient when in an operative position;

(b) a proximal portion of said elongated shaft having an inner coil reinforced shaft whose internal diameter defines a corporeal perfusion lumen and an outer coil reinforced shaft, said inner coil reinforced shaft and said outer coil reinforced shaft configured in a coaxial relationship such that an annular space is created therebetween;

(c) an arch perfusion lumen defined by said annular space terminating as at least one arch perfusion port positioned along the length of said elongated shaft;

(d) a distal portion of said elongated shaft defined by said inner coil reinforced shaft and terminating as at least one or more corporeal perfusion ports;

(e) a flow control regulator positioned proximal to said distal end and distal to said at least one arch perfusion ports, said flow control regulator sized and configured to at least partially occlude the aorta; and

(f) a distal tip configured for insertion into the ascending aorta.

2. The aortic catheter of claim 1, wherein said elongated shaft is from 4 to 30 cm in length.

3. The aortic catheter of claim 1, wherein said corporeal perfusion lumen is connected to a ⅜

inch to ¼

inch barb reducer for connection to a perfusion pump.

4. The aortic catheter of claim 3, wherein said barb connector is coupled to a luer fitting for withdrawing fluid samples and injecting medications.

5. The aortic catheter of claim 1, wherein said arch perfusion lumen is connected to a ¼

inch barb connector for connection to a perfusion pump.

6. The aortic catheter of claim 5, wherein said barb connector is coupled to a luer fitting for monitoring perfusion pressure.

7. The aortic catheter of claim 1, wherein said inner coil reinforced shaft has an internal diameter of approximately 0.025″

to 0.3″

.

8. The aortic catheter of claim 1, wherein said outer coil reinforced shaft has an internal diameter of approximately 0.15″

to 0.35″

.

9. The aortic catheter of claim 1, wherein said corporeal perfusion lumen is sized and configured to communicate blood flow at a flow rate of approximately 0.5 L/min to 8 L/min with a pressure drop of approximately 0 mm Hg to 300 mm Hg.

10. The aortic catheter of claim 1, wherein said arch perfusion lumen is sized and configured to communicate blood flow at a flow rate of approximately 0.1 L/min to 3 L/min with a pressure drop of approximately 0 mm Hg to 300 mm Hg.

11. The aortic catheter of claim 1, wherein the combined flow rate of the arch perfusion lumen and the corporeal perfusion lumen is of approximately 0.6 L/min to 10 L/min with a pressure drop approximately of 0 mm Hg to 300 mm Hg.

12. The aortic catheter of claim 1, further comprising an actuation lumen, said actuation lumen having a proximal end and a distal port in fluid communication with said flow control regulator.

13. The aortic catheter of claim 12, wherein said flow control regulator is a balloon.

14. The aortic catheter of claim 13, wherein said balloon is made of a material selected from the group consisting of polymers and elastomers.

15. The aortic catheter of claim 13, wherein said balloon has an inflated outer diameter of approximately 0.5 to 4.0 cm.

16. The aortic catheter of claim 13, wherein said balloon has a radiopaque marker positioned within said balloon.

17. The aortic catheter of claim 1, wherein said flow control regulator is in the form of an actively deployed peripheral flow control valve regulator.

18. The aortic catheter of claim 1, wherein said flow control regulator is in the form of an actively deployed central flow control valve regulator.

19. The aortic catheter of claim 1, wherein said flow control regulator is in the form of an actively deployed peripheral flow control valve regulator with at least one actuating balloon.

20. The aortic catheter of claim 1, wherein said flow control regulator is a passively deployed peripheral flow control valve regulator.

21. The aortic catheter of claim 20, wherein said passively deployed peripheral flow control valve regulator has at least one leaflet.

22. The aortic catheter of claim 1, wherein said flow control regulator is a passively deployed central flow control valve regulator.

23. The aortic catheter of claim 1, wherein said distal tip is formed of a temperature sensitive material.

24. The aortic catheter of claim 1, wherein said elongated shaft has a curvature configured to conform to a patient'"'"'s aortic arch anatomy.

25. The aortic catheter of claim 1, wherein said at least one arch perfusion port comprises from 1 to 16 external holes.

26. The aortic catheter of claim 1, wherein said at least one corporeal perfusion port comprises from 1-8 external holes.