System and methods for catheter procedures with circulatory support in high risk patients

• US 6,673,040 B1
• Filed: 08/27/1999
• Issued: 01/06/2004
• Est. Priority Date: 04/16/1996
• Status: Expired due to Fees

• Current Assignee: Cardeon Corporation
• Original Assignee: Cardeon Corporation
• Inventors: Macoviak, John A., Samson, Wilfred J.
• Primary Examiner(s): Mendez, Manuel
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/384,467
• Time in Patent Office: 1,593 Days
• Field of Search: 604/96.01, 604/4.01, 604/6.14, 604/6.16, 604/27, 604/28, 604/48, 604/500, 604/507-510, 604/101.01, 604/101.03, 604/101.05, 604/102.02, 604/264, 604/523, 604/173, 604/528, 604/533, 604/912, 604/915, 604/919, 606/192, 606/194
• US Class Current: 604/101.01
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 2210/127 Aorta
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A system and methods are described for performing catheter based procedures on high risk patients that mitigate the risk to the patient and extend the acceptable time window for response when emergencies or complications arise. The system is useful for stopped heart catheter procedures or as a safety backup in beating heart catheter procedures and is compatible with concurrent or sequential surgical interventions. The system combines a therapeutic or diagnostic catheter subsystem with a selective aortic perfusion and cardiopulmonary bypass subsystem. The catheter subsystem may include catheters for angioplasty, stent delivery, atherectomy, valvuloplasty or other diagnostic or therapeutic procedures. The selective aortic perfusion and cardiopulmonary bypass subsystem generally includes catheters and/or cannulas for draining blood from the patient'"'"'s venous or arterial system, a perfusion pump, a blood oxygenator, at least one blood heat exchanger and catheters and/or cannulas for perfusing oxygenated blood into the patient'"'"'s arterial system. The arterial perfusion catheters and/or cannulas are constructed with an upstream flow control member located in the patient'"'"'s ascending aorta and a downstream flow control member located in the patient'"'"'s descending aorta. The external flow control members may take the form of inflatable occlusion balloons and/or selectively deployable external catheter flow control valves. The external flow control members may be mounted on a single elongated catheter or cannula shaft or they may be mounted on separate catheter or cannula shafts for independent placement and deployment.

Claims

1. A system for catheter-based procedures comprising:

a catheter device for performing a diagnostic or therapeutic catheter procedure within a patient; and

a circulatory support catheter having at least one elongated catheter shaft and having an upstream occlusion member adapted for occluding the patient'"'"'s ascending aorta and a downstream occlusion member adapted for occluding the patient'"'"'s descending aorta.

2. The system of claim 1 wherein said upstream occlusion member is an inflatable balloon adapted for occluding the patient'"'"'s ascending aorta and said downstream occlusion member is an inflatable balloon adapted for occluding the patient'"'"'s descending aorta.

3. The system of claim 1 wherein said upstream occlusion member is an external catheter flow control valve adapted for occluding the patient'"'"'s ascending aorta and said downstream occlusion member is an external catheter flow control valve adapted for occluding the patient'"'"'s descending aorta.

4. The system of claim 1 wherein said upstream occlusion member adapted for occluding the patient'"'"'s ascending aorta and said downstream occlusion member adapted for occluding the patient'"'"'s descending aorta are selected from the group consisting of an inflatable balloon and an external catheter flow control valve.

5. The system of claim 1, 2, 3 or 4 wherein said circulatory support catheter further comprises a catheter delivery lumen having an internal diameter sufficient for passage of said catheter device through said catheter delivery lumen.

6. The system of claim 1, 2, 3 or 4 wherein said circulatory support catheter further comprises an arch perfusion lumen having an arch perfusion port located on said elongated catheter shaft between said upstream occlusion member and said downstream occlusion member for perfusing the patient'"'"'s aortic arch vessels.

7. The system of claim 1, 2, 3 or 4 wherein said circulatory support catheter further comprises a corporeal perfusion lumen having a corporeal perfusion port located downstream of said downstream occlusion member.

8. The system of claim 1, 2, 3 or 4 wherein said circulatory support catheter further comprises a coronary perfusion lumen having a coronary perfusion port located upstream of said upstream occlusion member.

9. The system of claim 1, 2, 3 or 4 wherein said circulatory support catheter further comprises a catheter delivery lumen having an internal diameter sufficient for passage of said catheter device through said catheter delivery lumen, an arch perfusion lumen having an arch perfusion port located on said elongated catheter shaft between said upstream occlusion member and said downstream occlusion member for perfusing the patient'"'"'s aortic arch vessels, a corporeal perfusion lumen having a corporeal perfusion port located downstream of said downstream occlusion member and a coronary perfusion lumen having a coronary perfusion port located upstream of said upstream occlusion member.

10. The system of claim 1, 2, 3 or 4 wherein said catheter device comprises a catheter selected from the group consisting of an angioplasty catheter, a stent placement catheter, an atherectomy catheter, a valvuloplasty catheter, an electrophysiology catheter, a transmyocardial revascularization catheter, a patent ductus arteriosus closure catheter, a septal defect repair catheter, an intravascular ultrasonic imaging catheter, a laser angioplasty catheter and a laser ablation catheter.

11. A method of performing a catheter based procedure consisting of the steps of:

(a) occluding a patient'"'"'s aorta between the patient'"'"'s coronary arteries and brachiocephalic artery,

(b) occluding the patient'"'"'s aorta downstream of the patient'"'"'s left subclavian artery; and

(c) performing a therapeutic or diagnostic catheter procedure utilizing a therapeutic or diagnostic catheter.

12. The method of performing a catheter based procedure of claim 11 wherein steps (a) and (b) are performed by:

inserting a circulatory support catheter into the patient'"'"'s aorta having at least one elongated catheter shaft, an upstream occlusion member adapted for occluding the patient'"'"'s ascending aorta and a downstream occlusion member adapted for occluding the patient'"'"'s descending aorta.

13. The method of performing a catheter based procedure of claim 12 further comprising the steps of:

delivering said therapeutic or diagnostic catheter through a delivery lumen extending at least in part along the length of said circulatory support catheter and having an internal diameter of sufficient size and diameter for passage of said therapeutic or diagnostic catheter, an arch perfusion lumen having an arch perfusion port located between said upstream occlusion member and said downstream occlusion member for perfusing the patient'"'"'s aortic arch vessels, a corporeal perfusion lumen within said second elongated catheter shaft having a corporeal perfusion port located downstream of said downstream occlusion member and a coronary perfusion lumen within said first elongated catheter shaft having a coronary perfusion port located upstream of said upstream occlusion member.

14. The method of performing a catheter based procedure of claim 11 wherein step (a) is performed by:

inserting into the patient'"'"'s aorta a first catheter having a first elongated catheter shaft and having an upstream occlusion member adapted for occluding the patient'"'"'s ascending aorta.

15. The method of performing a catheter based procedure of claim 11 wherein step (b) is performed by:

inserting into the patient'"'"'s aorta a second catheter having a second elongated catheter shaft and having a downstream occlusion member adapted for occluding the patient'"'"'s descending aorta.

16. The method of performing a catheter based procedure of claim 15 further comprising:

positioning said first catheter and said second catheter coaxially into a patient'"'"'s aorta.

17. The method of performing a catheter based procedure of claim 15 further comprising:

positioning said first catheter and said second catheter collaterally into a patient'"'"'s aorta.

18. The method of performing a catheter based procedure of claim 15 further comprising:

positioning said first catheter and said second catheter contalaterally into a patient'"'"'s aorta.

19. The method of performing a catheter based procedure of claim 15 further comprising:

positioning said first catheter and said second catheter in parallel in a patient'"'"'s aorta.

20. The method of performing a catheter based procedure of claim 15 further comprising:

inserting said first catheter into a first peripheral artery and inserting said second catheter into a second peripheral artery.

21. The method of performing a catheter based procedure of claim 11 wherein steps (a) and (b) are performed by:

expanding an upstream occlusion member adapted for occluding the patient'"'"'s ascending aorta mounted on an elongated catheter shaft of said therapeutic or diagnostic catheter; and

expanding a downstream occlusion member adapted for occluding the patient'"'"'s descending aorta mounted on said elongated catheter shaft of said therapeutic or diagnostic catheter.

22. The method of performing a catheter based procedure of claim 11 wherein steps (a) and (b) are performed by:

inserting said therapeutic or diagnostic catheter into the patient'"'"'s aorta having at least one elongated catheter shaft, an upstream occlusion member adapted for occluding the patient'"'"'s ascending aorta and a downstream occlusion member adapted for occluding the patient'"'"'s descending aorta.

23. The method of performing a catheter based procedure of claim 11 wherein step (a) is performed by inserting said therapeutic or diagnostic catheter into the patient'"'"'s aorta having an upstream occlusion member adapted for occluding the patient'"'"'s ascending aorta, and step (b) is performed by inserting into the patient'"'"'s aorta a circulatory support catheter having a downstream occlusion member adapted for occluding the patient'"'"'s descending aorta.

24. The method of performing a catheter based procedure of claim 11 wherein step (a) is performed by inserting into the patient'"'"'s aorta a circulatory support catheter having an upstream occlusion member adapted for occluding the patient'"'"'s ascending aorta, and step (b) is performed by inserting into the patient'"'"'s aorta said therapeutic or diagnostic catheter having an downstream occlusion member adapted for occluding the patient'"'"'s descending aorta.

25. The method of performing a catheter based procedure of claim 11 wherein steps (a) and (b) are performed by:

occluding the patient'"'"'s ascending and descending aorta with a first and second occlusion balloon.

26. The method of performing a catheter based procedure of claim 11 wherein steps (a) and (b) are performed by:

occluding the patient'"'"'s ascending and descending aorta with a first and second external catheter flow control valve.

27. The method of performing a catheter based procedure of claim 11 wherein said therapeutic or diagnostic catheter is selected from the group consisting of an angioplasty catheter, a stent placement catheter, an atherectomy catheter, a valvuloplasty catheter, an electrophysiology catheter, a transmyocardial revascularization catheter, a patent ductus arteriosus closure catheter, a septal defect repair catheter, an intravascular ultrasonic imaging catheter, a laser angioplasty catheter and a laser ablation catheter.

28. The method of performing a catheter based procedure of claim 11 further comprising the steps of:

inserting a venous catheter into the patient'"'"'s venous system.