Implantable pump system having an undulating membrane

• US 10,398,821 B2
• Filed: 05/10/2018
• Issued: 09/03/2019
• Est. Priority Date: 04/11/2016
• Status: Active Grant

• Current Assignee: CorWave SA
• Original Assignee: CorWave SA
• Inventors: Botterbusch, Carl N., Lucquin, Silvere, Monticone, Pier-Paolo, Drevet, Jean-Baptiste, Guignabert, Adrien, Meneroud, Patrick
• Primary Examiner(s): Tejani, Ankit D
• Application Number:
  US15/976,831
• Publication Number:
  US 20180256798A1
• Time in Patent Office: 481 Days
• Field of Search: None
• 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 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/268 the displacement member being flexible, e.g. membranes, diaphragms or bladders
• CPC Class Codes: A61M 60/40 Details relating to driving
• CPC Class Codes: A61M 60/462 Electromagnetic force
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/562 for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow
• CPC Class Codes: A61M 60/569 synchronous with the native heart beat
• CPC Class Codes: A61M 60/585 User interfaces
• CPC Class Codes: A61M 60/837 Aspects of flexible displacement members, e.g. shapes or materials
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/871 Energy supply devices; Converters therefor
• CPC Class Codes: A61M 60/876 Implantable batteries

Abstract

An implantable pump system is provided, suitable for use as a left ventricular assist device (LVAD) system, having an implantable pump, an extracorporeal battery and a controller coupled to the implantable pump, and a programmer selectively periodically coupled to the controller to configure and adjust operating parameters of the implantable pump. The implantable pump includes a flexible membrane coupled to an actuator assembly that is magnetically engagable with electromagnetic coils, so that when the electromagnetic coils are energized, the actuator assembly causes wavelike undulations to propagate along the flexible membrane to propel blood from through the implantable pump. The controller may be programmed by a programmer to operate at frequencies and duty cycles that mimic physiologic flow rates and pulsatility while operating in an efficient manner that avoids thrombus formation, hemolysis and/or platelet activation.

Claims

1. A method of pumping blood from a patient'"'"'s left ventricle to the patient'"'"'s aorta comprising:

delivering blood through an inlet of a housing to a flexible membrane held in tension and rigidly coupled to a magnetic ring;

exciting a first electromagnetic coil positioned above the magnetic ring to attract the magnetic ring thereby moving the magnetic ring upward;

terminating attraction of the magnetic ring to the first electromagnetic coil by ceasing excitement of the first electromagnetic coil;

exciting a second electromagnetic coil positioned below the first electromagnetic coil to the attract the magnetic ring thereby moving the magnetic ring downward; and

terminating attraction of the magnetic ring to the second electromagnetic coil by ceasing excitement of the second electromagnetic coil,

wherein the upward and downward movement of the magnetic ring translates to upward and downward motion of the flexible membrane thereby propagating a wave along the flexible membrane to propel blood towards an outlet of the housing.

2. The method of pumping blood of claim 1, further comprising selectively varying the excitement of the first and second electromagnetic coils to adjust a rate of the upward and downward movement of the magnetic ring to thereby adjust a rate of the propulsion of blood towards the outlet of the housing.

3. The method of pumping blood of claim 1, wherein the flexible membrane is coupled to the magnetic ring via a rigid ring.

4. The method of pumping blood of claim 1, wherein the housing further comprises one or more suspension rings concentrically disposed around and coupled to the first and second electromagnetic coils and the magnetic ring, the one or more suspension rings configured to permit the upward and downward movement of the magnetic ring.

5. The method of pumping blood of claim 4, wherein the one or more suspension rings exert a spring force on the magnetic ring when the magnetic ring moves upward and downward within the housing.

6. The method of pumping blood of claim 4, wherein the magnetic ring is coupled to each of the flexible membrane and the one or more suspension rings by a plurality of posts.

7. A method of pumping blood from a patient'"'"'s left ventricle to the patient'"'"'s aorta, the method comprising:

implanting a pump housing comprising an inlet in fluid communication with the left ventricle and an outlet in fluid communication with the aorta, the pump housing containing an actuator system comprising a stationary component and a moving component, and a flexible membrane coupled to the moving component; and

sending an electrical signal to the actuator system to cause the stationary component to selectively generate a magnetic field such that the moving component reciprocates at a predetermined frequency and amplitude relative to the stationary component, thereby propagating a wave along the flexible membrane to pump blood at a blood flow rate from the inlet to the outlet.

8. The method of claim 7, wherein the stationary component comprises first and second electromagnetic coils and the moving component comprises a magnet, and wherein the magnetic field is selectively generated by sending the electrical signal to selectively energize the first and second electromagnetic coils, thereby causing the magnet to reciprocate between the first and second electromagnetic coils at the predetermined frequency and amplitude.

9. The method of claim 8, wherein sending the electrical signal to selectively energize the first and second electromagnetic coils comprises:

exciting the first electromagnetic coil positioned above the magnet to attract the magnet thereby moving the magnet upward;

terminating attraction of the magnet to the first electromagnetic coil by ceasing excitement of the first electromagnetic coil;

exciting the second electromagnetic coil positioned below the first electromagnetic coil to the attract the magnet thereby moving the magnet downward; and

terminating attraction of the magnet to the second electromagnetic coil by ceasing excitement of the second electromagnetic coil.

10. The method of claim 7, wherein the moving component comprises a magnetic ring concentrically suspended around the stationary component.

11. The method of claim 7, wherein the flexible membrane is coupled to the moving component via a rigid ring.

12. The method of claim 7, wherein the flexible membrane comprises a central aperture such that blood is pumped from the inlet across the flexible membrane through the central aperture and out the outlet.

13. The method of claim 7, wherein the implantable pump housing further comprises one or more suspension rings disposed around and coupled to the stationary component and the moving component, the one or more suspension rings configured to permit the moving component to reciprocate relative to the stationary component.

14. The method of claim 13, wherein the one or more suspension rings exert a spring force on the moving component when the moving component reciprocates relative to the stationary component.

15. The method of claim 13, wherein the moving component is coupled to each of the flexible membrane and the one or more suspension rings by a plurality of posts.

16. The method of claim 7, wherein the pump housing comprises a delivery channel formed between the actuator system and an interior surface of the pump housing adjacent the inlet, and a flow channel formed between a bottom surface of the actuator system and an interior portion of the pump housing adjacent the outlet, the flow channel having the flexible membrane suspended therein such that the flexible membrane pumps the blood from the inlet through the delivery channel and across the flexible membrane within the flow channel to the outlet.

17. The method of claim 7, further comprising selectively varying the magnetic field to thereby adjust the blood flow rate from the inlet to the outlet.

18. The method of claim 7, wherein sending the electrical signal to the actuator system to cause the stationary component to selectively generate a magnetic field comprises sending the electrical signal from a controller operatively coupled to the actuator system.

19. The method of claim 18, wherein the controller is percutaneously coupled to the pump housing.

20. The method of claim 18, further comprising energizing the controller via an extracorporeal battery.