Implantable pump system having a coaxial ventricular cannula

• US 10,166,319 B2
• Filed: 04/10/2017
• Issued: 01/01/2019
• Est. Priority Date: 04/11/2016
• Status: Active Grant

• Current Assignee: CorWave SA
• Original Assignee: CorWave SA
• Inventors: Botterbusch, Carl N., Lucquin, Silvere, Drevet, Jean-Baptiste, Guignabert, Adrien, Meneroud, Patrick
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US15/484,108
• Publication Number:
  US 20170290967A1
• Time in Patent Office: 631 Days
• Field of Search: None
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 60/174 discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
• CPC Class Codes: A61M 60/268 the displacement member being flexible, e.g. membranes, diaphragms or bladders
• CPC Class Codes: A61M 60/462 Electromagnetic force
• CPC Class Codes: A61M 60/508 Electronic control means, e.g. for feedback regulation
• CPC Class Codes: A61M 60/837 Aspects of flexible displacement members, e.g. shapes or materials
• CPC Class Codes: A61M 60/859 Connections therefor
• CPC Class Codes: A61M 60/88 Percutaneous cables

Abstract

An implantable cardiovascular blood pump system is provided, suitable for use as a left ventricular assist device (LVAD) system, having an implantable cardiovascular 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 cardiovascular pump. The implantable cardiovascular blood pump includes a coaxial inflow cannula and outflow cannula in fluid communication with one another and with a pumping mechanism. The pumping mechanism may be a vibrating membrane pump which may include a flexible membrane coupled to an electromagnetic actuator assembly that causes wavelike undulations to propagate along the flexible membrane to propel blood through the implantable cardiovascular pump. The implantable cardiovascular pump may be programmed to operate at frequencies and duty cycles that mimic physiologic flow rates and pulsatility while avoiding thrombus formation, hemolysis and/or platelet activation.

Claims

1. An implantable cardiovascular pump system comprising,

a housing configured to be implanted in or coupled to a patient'"'"'s heart;

a pump assembly disposed within the housing, the pump assembly comprising an actuator assembly coupled to a circumference of a vibrating membrane, the vibrating membrane unsupported other than at the circumference;

an outflow cannula in fluid communication with the pump assembly, the outflow cannula having an inlet and an outlet; and

an inflow cannula in fluid communication with the pump assembly, the inflow cannula having an inlet and an outlet disposed within the patient'"'"'s heart,

wherein the actuator assembly is configured to cause the vibrating membrane to vibrate to transfer blood from the inlet of the inflow cannula through the housing around the actuator assembly and out the outlet of the outflow cannula, and wherein the outflow cannula is disposed coaxially within the outlet of the inflow cannula.

2. The implantable cardiovascular pump system of claim 1, wherein the housing is configured to be implanted at an apex of the patient'"'"'s heart such that the outflow cannula extends transapically through a left ventricle of the patient'"'"'s heart.

3. The implantable cardiovascular pump system of claim 1, wherein the inflow cannula extends into the housing and is secured to the housing.

4. The implantable cardiovascular pump system of claim 1, wherein the outflow cannula is configured to extend into the housing and is secured to the pump assembly.

5. The implantable cardiovascular pump system of claim 1, wherein the outlet of the outflow cannula is configured to extend through an aortic valve and into an aorta and the outflow cannula is further configured to permit fluid to flow from the pump assembly to the aorta.

6. The implantable cardiovascular pump system of claim 5, further comprising a stent that is coupled to the outlet of the outflow cannula and is configured to expand to engage a wall of the aorta, thereby centering the outflow cannula within the aortic valve.

7. The implantable cardiovascular pump system of claim 1, wherein the outlet of the outflow cannula is configured to terminate in the left ventricle, oriented toward an aortic valve, and is also configured to direct fluid flow from the pump assembly to the aortic valve.

8. The implantable cardiovascular pump system of claim 1, wherein the pump assembly further comprises:

a rigid ring coupled to the vibrating membrane;

a stator assembly coupled to the housing;

an electromagnet assembly coupled to the stator assembly, the electromagnet assembly configured to selectively generate a magnetic field;

first and second suspension rings disposed around and coupled to the stator assembly; and

a magnet ring coupled to the rigid ring and first and second suspension rings by a plurality of posts, the magnet ring suspended around the stator assembly and electromagnet assembly and configured to move towards or away from the electromagnet assembly responsive to the magnetic field.

9. The implantable cardiovascular pump of claim 1, wherein the housing includes a surface having an opening resealably closed by a plug or valve.

10. The implantable cardiovascular pump system of claim 1, further comprising an anchor coupled to the outflow cannula and configured to anchor the outflow cannula to a left ventricular outflow tract.

11. The implantable cardiovascular pump system of claim 1, further comprising:

an outflow conduit with a first end and a second end, the first end coupled to the outlet of the outflow cannula,

wherein the vibrating membrane is configured to vibrate to transfer blood through the outlet of the outflow cannula, into the first end of the outflow conduit, and out the second end of the outflow conduit.

12. The implantable cardiovascular pump system of claim 11, further comprising a stent, wherein the second end of the outflow conduit is configured to extend through an aortic valve and the stent is coupled to the second end of the outflow conduit and configured to expand to engage a wall of an aorta, thereby centering the outflow conduit within the aortic valve.

13. The implantable cardiovascular pump system of claim 11, wherein the second end of the outflow conduit is configured to extend through an aortic valve and the second end of the outflow conduit is sized and configured to permit the aortic valve to open and close around the outflow conduit.

14. The implantable cardiovascular pump system of claim 11, further comprising an anchor configured to couple the second end of the outflow conduit to a left ventricular outflow tract.

15. The implantable cardiovascular pump system of claim 11, further comprising a stent-mounted valve configured to be implanted at the aortic valve, wherein the second end of the outflow conduit is anchored to the stent-mounted valve.

16. The implantable cardiovascular pump system of claim 15, wherein the stent-mounted valve is a transcatheter aortic valve replacement (TAVR).

17. The implantable cardiovascular pump system of claim 11, wherein the pump assembly further comprises:

a rigid ring coupled to the vibrating membrane;

a stator assembly coupled to the housing;

an electromagnet assembly coupled to the stator assembly, the electromagnet assembly configured to selectively generate a magnetic field;

first and second suspension rings disposed around and coupled to the stator assembly; and

a magnet ring coupled to the rigid ring and first and second suspension rings by a plurality of posts, the magnet ring suspended around the stator assembly and electromagnet assembly and configured to move towards or away from the electromagnet assembly responsive to the magnetic field.

18. The implantable cardiovascular pump system of claim 11, wherein the pump assembly disposed within the housing has a coupling section configured to removably couple the pump assembly to the first end of the outflow conduit.

19. The implantable cardiovascular pump system of claim 1, further comprising:

a stent mounted valve configured to be implanted at the aortic valve and also configured to permit blood flow in only one direction,

wherein the outflow cannula is an outflow conduit with a first end and a second end,

wherein the stent mounted valve is coupled to the second end of the outflow conduit, and

wherein the implantable cardiovascular pump is configured to move blood from the inflow cannula, through the housing, through the outflow conduit and out of the stent-mounted valve.

20. The implantable cardiovascular pump system of claim 19, wherein the stent-mounted valve is a transcatheter aortic valve replacement (TAVR).