Method and system for closed chest blood flow support

• US 6,808,508 B1
• Filed: 09/13/2000
• Issued: 10/26/2004
• Est. Priority Date: 09/13/2000
• Status: Expired due to Term

• Current Assignee: Cardiacassist Inc. (LivaNova Plc)
• Original Assignee: Cardiacassist Inc. (LivaNova Plc)
• Inventors: Marous, John C. III, Yu, Yih-Choung, Zafirelis, Zafiris G., Lehmann, Kirk A., Johnson, Gregory A.
• Primary Examiner(s): Huson, Gregory L.
• Assistant Examiner(s): LE, HUYEN D
• Application Number:
  US09/661,413
• Time in Patent Office: 1,504 Days
• Field of Search: 604/6.11, 604/8-10, 604/27, 604/30, 604/35, 604/39, 604/40, 604/43, 604/48, 604/131, 604/151, 604/500, 604/4, 604/4.01, 604/6.06, 604/6.16, 604/96.01, 604/532, 600/16
• US Class Current: 604/131
• 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 system for assisting flow of blood by a patient'"'"'s heart. The system includes a transseptal cannula adapted to be inserted percutaneously in the femoral vein and extend through the atrial septum from the right atrium to the left atrium. The system includes a blood pump mechanism having a blood pump for pumping blood received from the transseptal cannula that has been oxygenated at specified flow rates over a range of physiological pressures. The blood pump is connected to the transseptal cannula. The system includes a perfusion cannula adapted to be inserted percutaneously in the femoral artery for returning oxygenated blood to the atrial system of the patient. The perfusion cannula is connected to the blood pump. A method for assisting blood flow by a patient'"'"'s heart. The method includes the steps of inserting percutaneously in the femoral vein of the patient and extending through the atrial septum from the right atrium to the left atrium a transseptal cannula. Next there is the step of inserting percutaneously in the femoral artery a perfusion cannula for returning oxygenated blood to the arterial system of the patient. Then there is the step of pumping blood with a blood pump connected to the transseptal cannula and the perfusion cannula at specified flow rates over a range of physiological pressures.

Claims

1. A system for assisting flow of blood by a patient'"'"'s heart comprising:

a transseptal cannula adapted to be inserted percutaneously in the femoral vein and extend through the atrial septum from the right atrium to the left atrium;

an extracorporeal blood pump mechanism having a blood pump for pumping blood received from the left atrium through the transseptal cannula that has been oxygenated, the blood pump inlet connected to the transseptal cannula, the blood pump mechanism includes a transseptal clamp mechanism which clamps the blood pump to the transseptal cannula to avoid undesired disconnection of the blood pump and the transseptal cannula and undesired leaks in a connection joint formed between the blood pump and the transseptal cannula; and

a perfusion cannula adapted to be inserted percutaneously in the femoral artery for returning oxygenated blood to the arterial system of the patient, the perfusion cannula connected to the blood pump outlet, and tubing which connects the blood pump to the transseptal cannula and the perfusion cannula, the blood pump connected by the tubing which is within three feet in length of where the transseptal cannula and the perfusion cannula are positioned to enter the patient.

2. A system as described in claim 1 wherein the clamp mechanism clamps the tubing between the blood pump and the transseptal cannula.

3. A system as described in claim 2 wherein the tubing has a continuous smooth inner surface.

4. A system as described in claim 3 wherein the blood pump is a pulsatile, electrical or pneumatic pump having an inflow valve and a perfusion valve.

5. A system as described in claim 3 wherein the blood pump pumps a continuous flow of blood.

6. A system as described in claim 5 wherein the blood pump has a rotor and a stator.

7. A system as described in claim 6 wherein the blood pump mechanism includes a controller connected to the blood pump through which the operation of the blood pump speed is adjusted.

8. A system as described in claim 7 wherein the blood pump includes an impeller which moves against the blood, and the controller adjusts the operation of the blood pump by changing impeller speed.

9. A system as described in claim 8 wherein the controller estimates blood flow rate through the pump only by measuring impeller speed and stator current.

10. A system as described in claim 9 wherein the pump has a hydrodynamic bearing between the rotor and the stator.

11. A system as described in claim 10 wherein the blood pump mechanism includes a fluid reservoir and a fluid pump connected to the fluid reservoir and the blood pump to pump fluid to the blood pump and the hydrodynamic bearing.

12. A system as described in claim 11 wherein the fluid reservoir and the fluid pump connected to the blood pump form an infusion system, and the infusion system is used to monitor for bearing system faults and anticoagulation faults.

13. A system as described in claim 12 wherein the fluid reservoir includes predetermined concentrations of drugs.

14. A system as described in claim 13 wherein the pump controller provides current to the blood pump and the controller includes a battery that provides energy to run the controller and the blood pump, the battery is used for powering the blood pump and controller when the patient is being moved between remote locations.

15. A system as described in claim 14 wherein the blood pump is made of biocompatible materials which have no effect on blood or the patient.

16. A system as described in claim 8 wherein the blood pump mechanism includes an electromagnetic or ultrasonic flow probe in communication with the blood pump and the controller measures flow of blood through the pump with the electromagnetic or ultrasonic flow probe.

17. A system as described in claim 8 wherein the blood pump is a centrifugal pump or an axial pump.

18. A system as described in claim 17 wherein the blood pump mechanism includes a controller connected to the blood pump through which the operation of the blood pump speed is adjusted.

19. A system as described in claim 18 wherein the controller monitors for single point faults, detects and manages them, and alerts users of fault status.

20. A system as described in claim 19 wherein the pump is a pulsatile pump having a stroke time, and the controller adjusts the operation of the blood pump by adjusting stroke time.

21. A system as described in claim 20 wherein the pump controller provides current to the blood pump and the controller includes a battery that provides energy to run the controller and the blood pump, the battery is used for powering the blood pump and the controller when the patient is being moved between remote locations.

22. A system as described in claim 1 including a holding mechanism which holds the blood pump and attaches to the patient.

23. A system as described in claim 22 wherein the holding mechanism includes a pump holding portion which holds the pump and a patient portion which is adapted to fit to the leg of the patient and to secure to the pump holding portion.

24. A system as described in claim 23 wherein the pump holding portion is made of plastic having an imprint of the shape of the blood pump in which the blood pump fits to be held by the pump holding portion, and the patient holding portion includes a band with loops and with straps having hooks adapted to wrap about the leg and the pump holding portion to hold the pump holding portion to the leg.

25. A system as described in claim 24 wherein the holding mechanism is adapted to attach to either leg of the patient and allow inflow or out flow to be connected to the contralateral side of the patient.

26. A system as described in claim 25 wherein the holding mechanism is adapted to hold the blood pump in a normal position or at an angle of 20 degrees from the normal position.

27. A system as described in claim 1 including means for delivering additional fluid into oxygenated blood by injecting a specific fluid into the blood pump mechanism.

28. A system as described in claim 27 wherein the delivering means includes an infusion system having an IV bag and the additional fluid is injected into the IV bag, and the fluid delivery depends upon the amount of fluid injected and the constant flow rate of the infusion system.

29. A system as described in claim 1 including a control system having a primary monitor and a backup monitor with a watchdog for monitoring the primary and backup monitors and independent redundant monitoring primary monitor and redundant backup monitor, the primary and backup, and redundant primary and redundant backup monitors each able to detect and manage single point faults of the system without requiring a dedicated 24 hours/day human surveillance.

30. A system as described in claim 1 wherein the pump mechanism has a pump inlet and provides circulatory support of blood flow over an entire physiologic pressure range without cavitation caused by excessive vacuum pressure at the pump inlet.

31. A system as described in claim 1 wherein the pump mechanism includes a motor and a controller having a motor control circuit that monitors motor drive output and initiates a logic signal when motor speed and direction as fed back from the motor does not agree with motor commands being output by the motor control circuit.

32. A system as described in claim 1 including a controller that can detect abnormal flow faults in a <

50 ml/hour fluid flow pump mechanism based on the cyclic pressure profile of the pump mechanism.

33. A system as described in claim 1 wherein the transseptal cannula and the perfusion cannula are each interchangeable to quickly access or redistribute blood to a certain destination in a patient'"'"'s body by changing appropriate sizes of the respective cannula.

34. A method for assisting blood flow by a patient'"'"'s heart comprising the steps of:

inserting percutaneously in the femoral vein of the patient and extending through the atrial septum from the right atrium to the left atrium a transseptal cannula;

inserting percutaneously in the femoral artery a perfusion cannula for returning oxygenated blood to the arterial system of the patient;

clamping a transseptal clamp mechanism to tubing within three feet of length connected to the transseptal cannula and a blood pump to avoid undesired disconnection of the blood pump and the transseptal cannula and undesired leaks at a connection joint formed between the blood pump and the transseptal cannula; and

pumping blood with the blood pump through the tubing connected to the transseptal cannula and within three feet of length connected to the blood pump and the perfusion cannula at specified flow rates over a range of physiological pressures.

35. A method as described in claim 34 wherein the pumping step includes the step of pumping a continuous flow of blood with the blood pump.

36. A method as described in claim 35 wherein the pumping step includes the step of adjusting the flow of blood pumped with a controller connected to the blood pump.

37. A method as described in claim 36 wherein the adjusting step includes the step of adjusting impeller speed of an impeller of the blood pump to attain a desired flow of blood in the patient due to the operation of the blood pump.

38. A method as described in claim 37 including after the pumping step, there is the step of powering the controller and the blood pump with a battery as the patient is moved from a first location to a second location remote from the first location.

39. A method as described in claim 38 including before the pumping step, there are the steps of attaching a holding mechanism for the blood pump to the patient and placing the blood pump in the holding mechanism to hold the blood pump in place relative to the patient.

40. A method as described in claim 39 wherein the attaching step includes the step of attaching the holding mechanism to the leg of the patient.

41. A method as described in claim 40 wherein the placing step includes the step of wrapping straps of a band positioned about the leg of the patient, about the blood pump, and fixing hooks of the straps to loops of the band to secure the blood pump to the leg of the patient.

42. A method as described in claim 34 wherein the pumping step includes the step of pumping pulses of blood through the patient with a pulsatile pump.

43. A method as described in claim 42 wherein the pumping step includes the step of adjusting stroke timing of the pulsatile pump to obtain the desired pulse of blood flow through the patient.

44. A method as described in claim 34 including the step of implementing the inserting steps and the pumping step that can be implemented in a short time so as be practical for emergent use without open-chest surgery.

45. A system for assisting flow of blood by a patient'"'"'s heart comprising:

a transseptal cannula adapted to be inserted percutaneously in a vein and extend through the atrial septum from the right atrium to the left atrium;

an extracorporeal blood pump mechanism having a blood pump for pumping blood received from the left atrium through the transseptal cannula that has been oxygenated, the blood pump inlet connected to the transseptal cannula;

a controller connected to the blood pump through which the operation of the blood pump speed is adjusted; and

a perfusion cannula adapted to be inserted percutaneously in an artery for returning oxygenated blood to the arterial system of the patient, the perfusion cannula connected to the blood pump outlet, the extracorporeal blood pump is disposed within three feet of where the transseptal cannula and the output cannula are positioned to enter the patient.