CONTROL OF BLOOD FLOW ASSIST SYSTEMS

• US 20130041204A1
• Filed: 02/09/2012
• Published: 02/14/2013
• Est. Priority Date: 02/18/2011
• Status: Active Grant

• Current Assignee: Vascor, Inc.
• Original Assignee: David M. Reilly, Douglas J. Koebler, Marlin Stephen Heilman
• Inventors: HEILMAN, MARLIN STEPHEN, KOEBLER, DOUGLAS J., KOHLER, CHARLES ROBERT, WAGNER, JON DAVID, REILLY, DAVID M.
• Granted Patent: US 8,876,686 B2
• Time in Patent Office: Days
• US Class Current: 600/17
• CPC Class Codes: A61M 2039/224 of the slide-valve type
• CPC Class Codes: A61M 2039/226 Spindles or actuating means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 39/223 Multiway valves
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• 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 60/226 the blood flow through the rotating member having mainly radial components
• CPC Class Codes: A61M 60/422 the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/523 using blood flow data, e.g. from blood flow transducers
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/546 of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: A61M 60/592 Communication of patient or blood pump data to distant operators for treatment purposes
• CPC Class Codes: A61M 60/825 Contact bearings, e.g. ball-and-cup or pivot bearings
• CPC Class Codes: A61M 60/892 Active valves, i.e. actuated by an external force

Abstract

In one aspect, an implantable pump system for assisting blood flow in a patient includes a blood flow path comprising a flexible conduit, at least one valve in fluid connection with the flexible conduit, a drive system in operative connection with the valve to move the valve in a reciprocating manner, an implantable control system and at least one sensor in communicative connection with the control system. The sensor is adapted to measure at least one property of blood. The control system is adapted to control movement of the valve on the basis of data regarding position of the valve with respect to time or a derivative thereof (that is, position, velocity, acceleration or a derivative thereof) in combination with data of the measured at least one property of blood from the sensor.

Claims

1. An implantable pump system for assisting blood flow in a patient, comprising:

a blood flow path comprising a flexible conduit;

at least one valve in fluid connection with the flexible conduit;

a drive system in operative connection with the valve to move the valve in a reciprocating manner;

an implantable control system;

and at least one sensor in communicative connection with the control system, the sensor being adapted to measure at least one property of blood, wherein the control system is adapted to control movement of the valve on the basis of data regarding position of the valve with respect to time or a derivative thereof in combination with data of the measured at least one property of blood from the sensor.

2. The implantable pump system of claim 1 wherein the implanted control system is adapted to be in communicative connection with an external system to provide data to a caregiver.

3. The implantable pump system of claim 1 wherein the measured blood property is at least one of blood flow rate or blood pressure.

4. The implantable pump system of claim 3 wherein blood flow rate is measured and the control system integrates the blood flow rate during a systolic period to compute stroke volume or the control system integrates stroke volumes over a period of time to compute cardiac output.

5. The implantable pump system of claim 2 wherein the implanted control system receives communication from the external system to adjust at least one parameter of pump system control based on data from the at least one sensor.

6. The implantable pump system of claim 1 wherein the control system comprises a heart pacemaker to control heart rate to achieve a determined level of blood flow assist.

7. The implantable pump system of claim 1 wherein the control system is adapted to provide blood flow assist primarily during at least one of an isovolumic contraction period or a latter half of systole.

8. The implantable pump system of claim 3 wherein the degree of pump assist is determined based on the unassisted cardiac output and the incremental level of cardiac output desired by the caregiver to return the patient to a predetermined cardiac output condition.

9. The implantable pump system of claim 1 wherein the degree of pump assist is determined by at least one of a number of valve assist cycles or a frequency of the valve assist cycles.

10. The implantable pump system of claim 1 wherein a measured pressure between the heart and the moving valve pump is used to control the level of valve assist.

11. The implantable pump system of claim 1 wherein a P wave of an electrocardiogram is sensed and used to time operation of the moving valve.

12. The implantable pump system of claim 1 further comprising an implanted communication system in communicative connection with the control system, the implanted communication system being adapted to transmit information from the at least one sensor to an external system and to receive information transmitted wirelessly from the external system, the control system being adapted to control operation of the pump system as a result of information transmitted from the external system.

13. The implantable pump system of claim 1 wherein the at least one sensor is adapted to measure at least one property of blood when the valve is not being moved and is in an open state so that blood from the heart can flow therethrough to provide data during unassisted blood flow from the heart and is adapted to measure at least one property of blood when the valve assembly is being moved to provide data during assisted blood flow.

14. A system for assisting blood flow in a patient, comprising:

an implantable pump system for assisting in blood flow from the heart;

an implantable control system for communicative connection with the implantable pump system comprising a pacemaker system that is operative to control heart rate and the pump system interdependently to achieve a determined level of blood flow assist.

15. The system of claim 14 wherein the pacemaker is adapted to increase heart rate to achieve a determined level of blood flow assist.

16. The system of claim 14 wherein the pacemaker is adapted to increase heart rate to a rate at least 20 higher than a normal heart rate for the patient.

17. The system of claim 14 wherein the pump system is a moving valve pump system comprising a valve assembly which is movable within the blood flow path of the pump system.

18. A pump system for assisting blood flow in a patient, comprising:

a blood flow path comprising a flexible conduit;

at least one valve in fluid connection with the flexible conduit;

a drive system in operative connection with the valve to move the valve in a reciprocating manner; and

a control system in operative connection with the drive system, the control system is adapted to receive a signal of rhythm of the heart, the control system further adapted to begin movement of the valve via the drive system during the isovolumic contraction phase.

19. The pump system of claim 18 wherein a P wave is used to time beginning of movement of the valve during the isovolumic contraction phase.

20. A pump system for assisting blood flow in a patient, comprising:

a blood flow path comprising a flexible conduit adapted to be placed with the ascending aorta;

at least one valve in fluid connection with the flexible conduit;

a drive system in operative connection with the valve to move the valve in a reciprocating manner;

a control system in operative connection with the drive system; and

a flow sensor in communicative connection with the control system and in fluid connection with the blood flow path, wherein data of increasing blood flow from the heart occurring early in systole is sensed by the flow sensor and transmitted to the control system, the control system being adapted to time initiation of movement of the valve by the drive system at least in part on the basis of the data.