# US 12,178,586 B2 · Predictive QRS detection and R-to-R timing systems and methods

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- Number: US 12,178,586 B2
- Document ID: US12178586B2
- Status: Granted
- Kind: B2
- Application number: 17/707,424
- Filed: 2022-03-29
- Published: 2022-09-15
- Granted: 2024-12-31
- Earliest claimed: 2019-05-02
- Assignees: NuPulseCV, Inc.; North Carolina State University
- Applicants: NuPulseCV, Inc.; North Carolina State University
- Inventors: Robert M. Smith; Nagarjuna Reddy Chinta; Ryan Daniel McCormick; Douglas Edward Ivers; Cranos M. Williams; Divyakumar Mahiman Badheka; Hubert Troy Nagle, Jr.; Sai Bhargav Dasari; Shamim Samadi
- Web page: https://patentgrep.com/patent/US12178586B2

## CPC

- A61B 5/0215: by means inserted into the body
- A61B 5/346: Analysis of electrocardiograms
- A61B 5/347: Detecting the frequency distribution of signals
- A61B 5/352: Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/7278: {Artificial waveform generation or derivation, e.g. synthesizing signals from measured signals}
- A61M 60/135: inside a blood vessel, e.g. using grafting
- A61M 60/139: inside the aorta, e.g. intra-aortic balloon pumps
- A61M 60/295: Balloon pumps for circulatory assistance
- A61M 60/50: Details relating to control
- A61M 60/515: Regulation using real-time patient data
- A61M 60/843: Balloon aspects, e.g. shapes or materials
- A61B 5/6853: {with a balloon}
- A61B 5/726: {using Wavelet transforms}
- A61M 2230/06: Heartbeat rate only
- 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 present disclosure is directed towards systems and methods built for predictively timing the inflation and/or deflation of an intra-aortic balloon pump. A controller operates in three states: (1) initialization state, (2) learning state, and (3) peak detection state. The controller decomposes a patient's electrocardiogram signal to a power signal. It then learns characteristics of the patient's electrocardiogram signal during the learning state and computes adaptive threshold parameter values. During the peak detection state, the controller applies the learnt threshold parameter values on a current electrocardiogram signal to identify occurrence and timings of R peaks in the electrocardiogram signal. The R-to-R peak timings are then used to trigger inflation of an intra-aortic balloon pump.

## Claims

### Claim 1

A system for operating intra-aortic balloon pumps, the system comprising:
at least one intra-aortic balloon pump configured to be placed in the proximity of a heart of a patient; and
at least one controller configurably connected to the at least one intra-aortic balloon pump, wherein the at least one controller comprises at least one processor and at least one non-transitory memory, wherein the at least one controller is configured to:
detect successive QRS complexes in an electrocardiograph (ECG) signal of the patient by generating a power signal corresponding to the ECG signal, detecting when the value of the power signal is greater than a threshold R-peak value, and associating a QRS complex with the time when the value of the power signal is greater than the threshold R-peak value;
predict the occurrence of a future R-wave in the ECG signal using the detected successive QRS complexes; and
control the intra-aortic balloon pump based on the predicted occurrence of the future R-wave.

### Claim 2 (depends on 1)

The system of claim 1, wherein the at least one controller is configured to inflate the intra-aortic balloon pump based on the predicted occurrence of the future R-wave.

### Claim 3 (depends on 1)

The system of claim 1, wherein the at least one controller is configured to deflate the intra-aortic balloon pump based on the predicted occurrence of the future R-wave.

### Claim 4 (depends on 1)

The system of claim 1, wherein the threshold R-peak value is based on a historic ECG signal of the patient.

### Claim 5 (depends on 4)

The system of claim 4, wherein the at least one controller is configured to generate the historic power signal based on the historic ECG signal and wherein the threshold R-peak value is a function of two or more peak values associated with the historic power signal.

### Claim 6 (depends on 1)

The system of claim 1, wherein the predicted occurrence of the future R-wave represents an amount of time from a previously detected QRS complex in the ECG signal, the amount of time being a function of the time intervals between the detected successive QRS complexes.

### Claim 7 (depends on 1)

The system of claim 1, wherein the at least one controller generates the power signal by applying a transformation signal to the ECG signal.

### Claim 8 (depends on 7)

The system of claim 7, wherein the transformation signal is a wavelet transformation.

### Claim 9 (depends on 1)

The system of claim 1, wherein the at least one controller is further configured to:
determine if a QRS complex has not been detected within a window of time in which it is expected; and
adjust the threshold R-peak value in response to said determination.

### Claim 10 (depends on 1)

The system of claim 1, wherein the at least one controller is further configured to:
determine if a detected QRS complex is a false positive; and
adjust the threshold R-peak value in response to said determination.

### Claim 11

A computer implemented method for operating intra-aortic balloon pumps, the method comprising:
detecting successive QRS complexes in an electrocardiograph (ECG) signal of the patient by generating a power signal corresponding to the ECG signal, detecting when the value of the power signal is greater than a threshold R-peak value, and associating a QRS complex with the time when the value of the power signal is greater than the threshold R-peak value;
predicting the occurrence of a future R-wave in the ECG signal using the detected successive QRS complexes; and
controlling the intra-aortic balloon pump based on the predicted occurrence of the future R-wave.

### Claim 12 (depends on 11)

The method of claim 11, the method further comprises one or more of:
inflating the intra-aortic balloon pump based on the predicted occurrence of the future R-wave; and
deflating the intra-aortic balloon pump based on the predicted occurrence of the future R-wave.

### Claim 13 (depends on 11)

The method of claim 11, wherein the threshold R-peak value is based on a historic ECG signal of the patient.

### Claim 14 (depends on 13)

The method of claim 13, further comprising generating the historic power signal based on the historic ECG signal, wherein the threshold R-peak value is a function of two or more peak values associated with the historic power signal.

### Claim 15 (depends on 11)

The method of claim 11, wherein the predicted occurrence of the future R-wave represents an amount of time from a previously detected QRS complex in the ECG signal, the amount of time being a function of the time intervals between the detected successive QRS complexes.

### Claim 16 (depends on 11)

The method of claim 11, further comprising generating the power signal by applying a transformation signal to the ECG signal.

### Claim 17 (depends on 16)

The method of claim 16, wherein the transformation signal is a wavelet transformation.

### Claim 18 (depends on 11)

The method of claim 11, further comprising:
determining one or more of:
that a QRS complex has not been detected within a window of time in which it is expected; and
that a detected QRS complex is a false positive; and
adjusting the threshold R-peak value in response to said determination.
