# US 10,765,791 B2 · Determination of cardiac parameters for modulation of blood pump support

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- Number: US 10,765,791 B2
- Document ID: US10765791B2
- Status: Granted
- Kind: B2
- Application number: 16/003,669
- Filed: 2018-06-08
- Published: 2018-12-13
- Granted: 2020-09-08
- Earliest claimed: 2017-06-09
- Assignees: ABIOMED, Inc.
- Applicants: Abiomed, Inc.
- Inventors: Christian Moyer; Scott C. Corbett; Ahmad El Katerji; David Weber
- Web page: https://patentgrep.com/patent/US10765791B2

## CPC

- A61B 5/0215: by means inserted into the body
- A61B 5/029: Measuring blood output from the heart, e.g. minute volume
- A61M 60/13: by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
- A61M 60/216: including a rotating member acting on the blood, e.g. impeller
- A61M 60/237: the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
- A61M 60/422: the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
- A61M 60/523: using blood flow data, e.g. from blood flow transducers
- A61M 60/531: using blood pressure data, e.g. from blood pressure sensors
- A61M 60/538: Regulation using real-time blood pump operational parameter data, e.g. motor current
- A61M 60/546: of blood flow, e.g. by adapting rotor speed
- A61M 60/585: User interfaces
- A61M 60/857: Implantable blood tubes
- A61M 2205/18: with alarm
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/3365: Rotational speed
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2210/125: Heart
- A61M 2210/127: Aorta
- A61M 2230/30: Blood pressure (A61M2230/04 takes precedence)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The systems, devices, and methods presented herein use a blood pump to obtain measurements of cardiac function. The system can quantify the functioning of the native heart by measuring certain parameters/signals such as aortic pressure or motor current, then calculate and display one or more cardiac parameters and heart function parameters, such as left ventricular pressure, left ventricular end diastolic pressure, or cardiac power output. These parameters provide valuable information to a user regarding current cardiac function, as well as positioning and function of the blood pump. In some embodiments, the system can act as a diagnostic and therapeutic tool. Providing cardiac parameters in real-time, along with warnings about adverse effects and recommendations to support cardiac function, such as increasing or decreasing the volumetric flow rate of blood pumped by the device, administering pharmaceutical therapies, and/or repositioning the blood pump allow clinicians to better support and treat cardiovascular disease.

## Claims

### Claim 1

A method for providing cardiac support to a heart, comprising:
operating a blood pump positioned in the heart, the blood pump having a cannula and including a motor operating at a motor speed and drawing a variable motor current to provide a level of cardiac support to the heart;
measuring at a controller coupled to the blood pump, an aortic pressure;
measuring, at the controller, the motor current and the motor speed;
determining a pressure gradient across the cannula associated with the motor current and the motor speed;
using a processor to calculate, from the aortic pressure and the pressure gradient across the cannula associated with the motor current and the motor speed, a calculated cardiac parameter;
recording, in a memory, the calculated cardiac parameter;
determining, based on the calculated cardiac parameter, a heart function parameter;
determining, based on at least one of the calculated cardiac parameter and the heart function parameter, a recommended change to the level of cardiac support provided by the blood pump; and
generating for display the recommended change.

### Claim 2 (depends on 1)

The method of claim 1, the method further comprising:
accepting a user input in response to the displayed recommended change to the level of cardiac support provided by the blood pump; and
adjusting the motor speed to adjust the level of cardiac support according to the user input.

### Claim 3 (depends on 2)

The method of claim 2, wherein adjusting the motor speed according to the user input comprises increasing the motor speed to increase the flow of blood from the heart.

### Claim 4 (depends on 2)

The method of claim 2, wherein adjusting the motor speed according to the user input comprises decreasing the motor speed to wean the heart from the cardiac support.

### Claim 5 (depends on 2)

The method of claim 2, wherein the calculated cardiac parameter is at least one of a left-ventricular pressure, a left ventricular end diastolic pressure, an aortic pulse pressure, and a mean aortic pressure.

### Claim 6 (depends on 5)

The method of claim 5, wherein the heart function parameter is selected from a cardiac output and a cardiac power output.

### Claim 7 (depends on 6)

The method of claim 6, the method further comprising accessing, in the memory, a history of previously recorded cardiac parameters and heart function parameters.

### Claim 8 (depends on 7)

The method of claim 7, the method further comprising generating for display at least one of the calculated cardiac parameter and the heart function parameter as a function of time.

### Claim 9 (depends on 8)

The method of claim 8, wherein the determined recommended change to the motor speed is based on the history of at least one of the previously recorded cardiac parameters and heart function parameters.

### Claim 10 (depends on 9)

The method of claim 9, wherein determining a recommended change in support further comprises:
determining a change in one of the calculated cardiac parameter or the heart function parameter based on the history of previously recorded cardiac parameters and heart function parameters;
determining a recommended alteration in the provided level of cardiac support based on the change; and
converting the recommended alteration in provided level of cardiac support to a recommended change in motor speed.

### Claim 11 (depends on 1)

The method of claim 1, the method further comprising:
determining, based on at least one of the calculated cardiac parameter and the heart function parameter, a suction event at an inflow of the blood pump; and
generating for display a warning of a suction event.

### Claim 12 (depends on 11)

The method of claim 11, the method further comprising:
identifying, based on at least one of the calculated cardiac parameter and the heart function parameter, a cause of the suction event; and
generating for display a recommendation to address the cause of the suction event.

### Claim 13 (depends on 12)

The method of claim 12, wherein identifying the cause of the suction event comprises:
comparing a value of the calculated cardiac parameter to a threshold value, wherein the cardiac parameter is a left ventricular pressure and the threshold is zero; and
comparing a value of the left ventricular pressure over a cardiac cycle to a value of the aortic pressure over a cardiac cycle.

### Claim 14 (depends on 13)

The method of claim 13, wherein the method further comprises:
identifying a diastolic suction event if a minimum value of the left ventricular pressure is less than the threshold in a diastole phase but normal in systolic phase of the cardiac cycle.

### Claim 15 (depends on 13)

The method of claim 13, wherein the method further comprises:
identifying a systolic suction event if a minimum value of the left ventricular pressure is less than the threshold in the diastolic phase, and a value of the left ventricular pressure does not exceed a value of the aortic pressure over the cardiac cycle.

### Claim 16

A percutaneous blood pump system comprising:
a blood pump configured to be positioned in a heart, the blood pump comprising:
a cannula;
a sensor configured to measure an aortic pressure in the heart; and
a motor operable at a motor speed and configured to draw a variable motor current to provide a level of cardiac support to the heart; and
a controller configured to control the motor current and motor speed, the controller comprising:
a memory;
a user interface; and
a processor configured to:
measure the motor current and the motor speed of the motor;
receive an indication of the aortic pressure from the sensor and convert the indication of the aortic pressure to an aortic pressure measurement;
determine a pressure gradient across the cannula associated with the motor current and the motor speed;
calculate at least one cardiac parameter based on the aortic pressure measurement and the pressure gradient across the cannula;
record the at least one calculated cardiac parameter in the memory;
calculate, based on the at least one cardiac parameter, one or more heart function parameters;
determine, based on at least one of the at least one cardiac parameter and the one or more heart function parameters, a recommended change to the level of cardiac support to the heart; and
generate for display on the user interface the recommended change to the level of cardiac support.

### Claim 17 (depends on 16)

The blood pump system of claim 16, wherein the processor is further configured to calculate a left ventricular pressure as a cardiac parameter and a cardiac power output as a heart function parameter.

### Claim 18 (depends on 17)

The blood pump system of claim 17, wherein the processor is further configured to:
record the at least one calculated cardiac parameter in the memory as a first calculated cardiac parameter; and
record a second calculate cardiac parameter in the memory at a later time.

### Claim 19 (depends on 18)

The blood pump system of claim 18, the processor further configured to:
access the first cardiac parameter and the second cardiac parameter in the memory; and
determine a recommended change to the motor speed based on a compared value of the first cardiac parameter to the second cardiac parameter.

### Claim 20 (depends on 16)

The blood pump system of claim 16, the processor further configured to:
determine, based on at least one of the calculated cardiac parameter and the heart function parameter, a suction event at an inflow of the blood pump; and
generate a warning of a suction event for display on the user interface.