Method and system for closed chest blood flow support

• US 8,622,949 B2
• Filed: 04/08/2011
• Issued: 01/07/2014
• 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., Yu, Yih-Choung, Marous, John C. III, Lehmann, Kirk A., Johnson, Gregory A.
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US13/082,487
• Publication Number:
  US 20110245582A1
• Time in Patent Office: 1,005 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, 606/16
• 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 method of providing a pumping system for assisting a human patient'"'"'s heart and providing a blood pump to be disposed outside the patient'"'"'s body is disclosed. The blood pump has an inlet and an outlet. An inlet cannula is provided for insertion percutaneously into the vascular system of the patient, and is adapted to be placed in fluid communication with the blood pump inlet to provide blood to the blood pump. An outlet perfusion cannula is provided for insertion percutaneously into the vascular system of the patient, and is adapted to be placed in fluid communication with the blood pump outlet to provide blood to the patient'"'"'s vascular system. The blood pump includes a control system to control the blood pump. The control system includes at least two control units for redundant control of the blood pump, and each control unit includes a watchdog for monitoring the control unit.

Claims

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

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

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

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

wherein the inlet cannula is placed in fluid communication with the blood pump inlet and the outlet perfusion cannula is placed in fluid communication with the blood pump outlet to provide the pump system, and the blood pump comprises 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 method as claimed in claim 1, further comprising providing an electromagnetic or ultrasonic flow probe in communication with the blood pump outlet.

3. A method 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 method 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.

5. A method as claimed in claim 4, wherein the primary control unit and the backup control unit each comprise an integral display.

6. A method as claimed in claim 4, further comprising switching operational control of the blood pump from the primary control unit to the backup control unit manually.

7. A method as claimed in claim 4, 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 during operation of the blood pump.

8. A method as claimed in claim 7, wherein during the parallel operation of the primary control unit and the backup control unit, information exchange therebetween does not occur.

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

10. A method as claimed in claim 9, wherein the operator panel has the control units.

11. A method as claimed in claim 10, wherein the control units comprise a primary control unit and a backup control unit to control operation of the blood pump.

12. A method as claimed in claim 11, wherein operational control of the blood pump is switched from the primary control unit to the backup control unit manually.

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

22. A method as claimed in claim 21, wherein the operator panel has the control units.

23. A method as claimed in claim 22, wherein the control units comprise a primary control unit and a backup control unit to control operation of the blood pump.

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

13. A method of providing a pumping system for assisting a human patient'"'"'s heart, comprising:

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

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

wherein the bidirectional cannula is connected to the blood pump to provide the pumping system, and the blood pump comprises 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.

14. A method as claimed in claim 13, further comprising providing an electromagnetic or ultrasonic flow probe in communication with an outlet of the blood pump.

15. A method as claimed in claim 14, 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.

16. A method as claimed in claim 13, wherein the control system has a primary control unit and a backup control unit to control operation of the blood pump.

17. A method as claimed in claim 16, wherein the primary control unit and the backup control unit each comprise an integral display.

18. A method as claimed in claim 16, further comprising switching operational control of the blood pump from the primary control unit to the backup control unit manually.

19. A method as claimed in claim 16, 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 during operation of the blood pump.

20. A method as claimed in claim 19, wherein during the parallel operation of the primary control unit and the backup control unit, information exchange therebetween does not occur.

25. A method of providing a pumping system for assisting a human patient'"'"'s heart, comprising:

providing a blood pump to be disposed outside of the patient'"'"'s body and comprising an inlet and an outlet and a control system, and configured to have an inlet cannula placed in fluid communication with the blood pump inlet and to have an outlet cannula placed in fluid communication with the blood pump outlet; and

operating the control system to control the blood pump to assist the patient'"'"'s heart, 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.

26. A method as claimed in claim 25, wherein the control system has a primary control unit and a backup control unit to control operation of the blood pump.

27. A method as claimed in claim 26, wherein the primary control unit and the backup control unit each comprise an integral display.

28. A method as claimed in claim 25, further comprising switching operational control of the blood pump from the primary control unit to the backup control unit manually.

29. A method as claimed in claim 26, 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 during operation of the blood pump.

30. A method as claimed in claim 29, wherein during the parallel operation of the primary control unit and the backup control unit, information exchange therebetween does not occur.

31. A method as claimed in claim 25, wherein the control system comprises an operator panel.

32. A method as claimed in claim 31, wherein the operator panel has the control units.

33. A method as claimed in claim 32, wherein the control units comprise a primary control unit and a backup control unit to control operation of the blood pump.

34. A method as claimed in claim 33, wherein operational control of the blood pump is switched from the primary control unit to the backup control unit manually.