Method and system for closed chest blood flow support

• US 8,454,549 B2
• Filed: 01/20/2011
• Issued: 06/04/2013
• Est. Priority Date: 09/13/2000
• Status: Expired due to Fees

• Current Assignee: Cardiacassist Inc. (LivaNova Plc)
• Original Assignee: Cardiacassist Inc. (LivaNova Plc)
• Inventors: Zafirelis, Zafiris G., Marous, John C. III, Yu, Yih-Choung, Lehmann, Kirk A., Johnson, Greg A.
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US13/010,366
• Publication Number:
  US 20110160518A1
• Time in Patent Office: 866 Days
• Field of Search: 604/4.01, 604/6.1, 604/6.11, 604 8- 9, 604/264, 604/267, 604/131, 604/151, 600/16, 422 44- 45, 623/3.1, 623/3.13, 623/3.26, 623/3.27, 623/3.28
• US Class Current: 604/6.11
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 60/117 for assisting the heart, e.g. transcutaneous or external ventricular assist devices
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/232 Centrifugal pumps
• CPC Class Codes: A61M 60/237 the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
• CPC Class Codes: A61M 60/546 of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: A61M 60/554 of blood pressure
• CPC Class Codes: A61M 60/824 Hydrodynamic or fluid film bearings
• CPC Class Codes: A61M 60/829 : having a purge fluid supply

Abstract

A pumping system for assisting a patient'"'"'s heart includes a blood pump disposed outside the patient'"'"'s body and having an inlet and an outlet. An inlet cannula is configured for insertion percutaneously into the vascular system of the patient, and in fluid communication with the blood pump inlet to provide blood to the blood pump. An outlet perfusion cannula is configured for insertion percutaneously into the vascular system of the patient, and in fluid communication with the blood pump outlet to provide blood to the patient'"'"'s vascular system. A control system is provided to control the blood pump and includes at least two control units for redundant control of the blood pump. Each control unit includes a watchdog for monitoring the control unit. A variation of the pumping system includes a bidirectional cannula for insertion percutaneously into the vascular system of the patient and to extend into the patient'"'"'s heart.

Claims

1. A pumping system for assisting a human patient'"'"'s heart, comprising:

a blood pump disposed outside the patient'"'"'s body and having an inlet and an outlet;

an inlet cannula configured for insertion percutaneously into the vascular system of the patient, and in fluid communication with the blood pump inlet to provide blood to the blood pump;

an outlet perfusion cannula configured for insertion percutaneously into the vascular system of the patient, and in fluid communication with the blood pump outlet to provide blood to the patient'"'"'s vascular system; and

a control system to control the blood pump, the control system comprising at least two control units for redundant control of the blood pump, and each control unit comprising a watchdog for monitoring the control unit.

2. A pumping system as claimed in claim 1, wherein the blood pump includes an electromagnetic or ultrasonic flow probe in communication with the blood pump outlet.

3. A pumping system as claimed in claim 2, wherein the control system is programmed to initiate an alarm condition when blood outflow from the blood pump outlet falls below a predetermined rate as measured by the electromagnetic or ultrasonic flow probe.

4. A pumping system as claimed in claim 1, wherein the blood pump is a centrifugal pump or an axial pump.

5. A pumping system as claimed in claim 1, wherein tubing connects the blood pump to the inlet cannula and to the outlet perfusion cannula and has sufficient length to position the blood pump within about three feet of where the inlet cannula and the outlet perfusion cannula are connected to the blood pump.

6. A pumping system as claimed in claim 1, wherein the control system has a primary control unit and a backup control unit to control operation of the blood pump.

7. A pumping system as claimed in claim 6, wherein the primary control unit and the backup control unit each comprise an integral display.

8. A pumping system as claimed in claim 6, wherein operational control of the blood pump is switched from the primary control unit to the backup control unit manually.

9. A pumping system as claimed in claim 6, wherein the primary control unit and the backup control unit are programmed for parallel operation but only one of the primary control unit and the backup control unit actively controls operation of the blood pump.

10. A pumping system as claimed in claim 9, wherein during the parallel operation of the primary control unit and the backup control unit, information exchange therebetween does not occur.

11. A pumping system as claimed in claim 1, wherein the control system comprises an operator panel.

12. A pumping system as claimed in claim 11, wherein the operator panel has the control units.

13. A pumping system as claimed in claim 12, wherein the control units comprise a primary control unit and a backup control unit to control operation of the blood pump.

14. A pumping system as claimed in claim 13, wherein operational control of the blood pump is switched from the primary control unit to the backup control unit manually.

15. A pumping system as claimed in claim 1, wherein the blood pump is a pulsatile, electrical, or pneumatic pump.

16. A pumping system for assisting a human patient'"'"'s heart, comprising:

a bidirectional cannula for insertion percutaneously into the vascular system of the patient and to extend at least into the patient'"'"'s heart;

a blood pump mechanism disposed outside the patient'"'"'s body and connected to the bidirectional cannula and having a blood pump for pumping blood into the vascular system of the patient via the bidirectional cannula; and

a control system to control the blood pump, the control system comprising at least two control units for redundant control of the blood pump, and each control unit comprising a watchdog for monitoring the control unit.

17. A pumping system as claimed in claim 16, wherein the blood pump includes an electromagnetic or ultrasonic flow probe in communication with the blood pump outlet.

18. A pumping system as claimed in claim 17, wherein the control system is programmed to initiate an alarm condition when blood outflow from the blood pump outlet falls below a predetermined rate as measured by the electromagnetic or ultrasonic flow probe.

19. A pumping system as claimed in claim 16, wherein the blood pump is a centrifugal pump or an axial pump.

20. A pumping system as claimed in claim 16, wherein tubing connects the blood pump to the inlet cannula and to the outlet perfusion cannula and has sufficient length to position the blood pump within about three feet of where the inlet cannula and the outlet perfusion cannula are connected to the blood pump.

21. A pumping system as claimed in claim 16, wherein the control system has a primary control unit and a backup control unit to control operation of the blood pump.

22. A pumping system as claimed in claim 21, wherein the primary control unit and the backup control unit each comprise an integral display.

23. A pumping system as claimed in claim 21, wherein operational control of the blood pump is switched from the primary control unit to the backup control unit manually.

24. A pumping system as claimed in claim 21, wherein the primary control unit and the backup control unit are programmed for parallel operation but only one of the primary control unit and the backup control unit actively controls operation of the blood pump.

25. A pumping system as claimed in claim 24, wherein during the parallel operation of the primary control unit and the backup control unit, information exchange therebetween does not occur.

26. A pumping system as claimed in claim 16, wherein the control system comprises an operator panel.

27. A pumping system as claimed in claim 26, wherein the operator panel has the control units.

28. A pumping system as claimed in claim 27, wherein the control units comprise a primary control unit and a backup control unit to control operation of the blood pump.

29. A pumping system as claimed in claim 28, wherein operational control of the blood pump is switched from the primary control unit to the backup control unit manually.

30. A pumping system as claimed in claim 16, wherein the blood pump is a pulsatile, electrical, or pneumatic pump.