# US 2023/0405334 A1 · Device for Detecting a Signal from a Human or Animal Organism

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- Number: US 2023/0405334 A1
- Document ID: US20230405334A1
- Status: Published application
- Kind: A1
- Application number: 18/247,706
- Filed: 2021-10-05
- Published: 2023-12-21
- Earliest claimed: 2020-10-08
- Assignees: BIOTRONIK SE & Co. KG
- Applicants: BIOTRONIK SE & Co. KG
- Inventors: Ingo WEISS
- Web page: https://patentgrep.com/patent/US20230405334A1

## CPC

- A61B 5/363: Detecting tachycardia or bradycardia
- A61N 1/36514: {controlled by a physiological quantity other than heart potential, e.g. blood pressure (controlled by two or more physical parameters A61N1/36585)}
- A61B 5/7203: {for noise prevention, reduction or removal}
- A61B 5/7221: {Determining signal validity, reliability or quality (preventing, reducing or removing noise induced by motion artefacts A61B5/7207; noise originating from a therapeutic or surgical apparatus A61B5/7217)}
- A61B 5/7267: {involving training the classification device}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- A61N 1/365: controlled by a physiological parameter, e.g. heart potential {(evoked response A61N1/371)}
- A61N 1/3704: {Circuits specially adapted therefor, e.g. for sensitivity control}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

The invention relates to a device for detecting a signal from a human or animal organism which, during operation, carries out the following steps: detecting a signal from a human or animal organism in a time-dependent manner; subdividing a signal segment into first blocks; determining a total number of the first blocks; determining a measure for a signal swing in each of the first blocks; determining a number of first blocks in which the measure for the signal swing is less than a predeterminable first threshold value; calculating a first quotient from the number of first blocks in which the measure for the signal swing is less than the first threshold value and the total number of first blocks; comparing the first quotient with a second threshold value; classifying a state of the human or animal organism as physiological or as pathophysiological as a function of the previous comparison.

## Claims

### Claim 1

An implantable medical device for detecting a cardiac signal from a human or animal organism and for stimulating the human or animal heart, having a processor, a storage unit and a detection unit for detecting a cardiac signal from a human or animal organism,
wherein
the storage unit has a computer-readable program that causes the processor to carry out the following steps when it is executed on the processor:
a) detecting a cardiac signal of a human or animal organism in a time-dependent manner;
b) defining a signal segment which extends over an adjustable first temporal length of the cardiac signal;
c) subdividing the signal segment into first blocks in at least a first section of the signal segment;
d) determining a total number of the first blocks;
e) determining a measure for a signal swing in each of the first blocks (210);
f) determining a number of first blocks in which the measure for the signal swing is less than a predeterminable first threshold value;
g) calculating a first quotient from the number of first blocks in which the measure for the signal swing less than the first threshold value, and the total number of the first blocks;
h) comparing the first quotient with a second threshold value;
i) classifying a cardiac state of the human or animal organism into a first class if the first quotient is greater than the second threshold value, or classifying a cardiac state of the human or animal organism into a second class if the first quotient is not greater than the second threshold value, wherein one of the first and second classes is indicative of a physiological state of the organism and the other of the first and second classes is indicative of a pathophysiological state of the organism.

### Claim 2 (depends on 1)

The device according to claim 1, wherein
the computer-readable program causes the processor to subdivide the cardiac signal into blocks in a plurality of sections, wherein a width of the blocks differs from one another in at least two sections of the plurality of sections, wherein a total number of the blocks is determined in each section, wherein a measure of a signal swing in each of the blocks is determined, wherein a number of blocks, in which the measure for the signal swing is less than a threshold value predeterminable for each section, is determined in each section, wherein for each section, a quotient from the number of blocks in the respective section in which the measure for the signal swing is less than the threshold value and the total number of blocks in the respective section is calculated, wherein the quotient in each section is compared with a further threshold value or a mathematical combination of the quotients of several sections is compared with a further threshold value, wherein the cardiac state of the human or animal organism is classified into the first class if a majority of the quotients or the mathematical combination of the quotients of several sections is greater than the further threshold value or the cardiac state of the human or animal organism is classified into the second class if a majority of the quotients or the mathematical combination of the quotients of several sections is not greater than the further threshold value.

### Claim 3 (depends on 1)

The device according to claim 1, wherein the computer-readable program causes the processor to indicate a measure for the probability that the classification of the cardiac state of the human or animal organism into the first class or the second class is correct.

### Claim 4 (depends on 1)

The device according to claim 1, wherein the computer-readable program causes the processor (630) to initiate or prevent a therapeutic treatment of the human or animal organism using a therapy unit of the device depending on the classification that has taken place.

### Claim 5 (depends on 1)

The device according to claim 1, wherein the detection unit has at least one sensor which is used to detect at least one of the following parameters of the human or animal organism: an electrical body signal, an impedance, a pressure, a heart sound, a respiratory parameter, a position, a movement, a temperature, a blood oxygen saturation, a pH value, a biochemical marker.

### Claim 6 (depends on 1)

The device according to claim 1, wherein the computer-readable program causes the processor to adapt a length of the first section of the signal segment and/or a further section of the signal segment as a function of a result determined in a previous step of the method performed.

### Claim 7 (depends on 1)

The device according to claim 1, wherein the measure for the signal swing is selected from the group consisting of a maximum-minimum difference, a signal variance and a percentile interval.

### Claim 8 (depends on 1)

The device according to claim 1, wherein the computer-readable program causes the processor to use, in addition to the first quotient, a further variable for classifying the state of the human or animal organism into the first class or the second class.

### Claim 9 (depends on 8)

Device according to claim 8, wherein the further variable is selected from a heart rate, a blood pressure, a breathing frequency and a breathing depth of the human or animal organism.

### Claim 10 (depends on 1)

The device according to claim 1, wherein the computer-readable program causes the processor to subdivide the signal segment into blocks, in a plurality of sections of the signal segment, wherein at least two sections of the plurality of sections overlap one another in regions.

### Claim 11 (depends on 1)

The device according to claim 1, wherein the device has at least one heart rate estimator.

### Claim 12 (depends on 1)

The device according to claim 1, wherein the computer-readable program causes the processor to initiate or prevent a stimulation of a cardiac region of the heart of the human or animal organism by means of a stimulation unit depending on the classification that has taken place.

### Claim 13

A computer program product having computer readable code that causes a processor to carry out the following steps when executed on the processor:
a) detecting a cardiac signal from a human or animal organism in a time-dependent manner by means of a detection unit of a implantable medical device for detecting a cardiac signal from a human or animal organism and for stimulating the human or animal heart;
b) defining a signal segment extends over an adjustable first temporal length of the cardiac signal;
c) subdividing the signal segment into first blocks in at least a first section of the signal segment;
d) determining a total number of the first blocks;
e) determining a measure for a signal swing in each of the first blocks;
f) determining a number of first blocks in which the measure for the signal swing is less than a predeterminable first threshold value;
g) calculating a first quotient from the number of first blocks in which the measure for the signal swing is less than the first threshold value, and the total number of the first blocks;
h) comparing the first quotient with a second threshold value;
i) classifying a cardiac state of the human or animal organism into a first class if the first quotient is greater than the second threshold value, or classifying a cardiac state of the human or animal organism into a second class if the first quotient is not greater than the second threshold value, wherein one of the first and second classes is indicative of a physiological state of the organism and the other of the first and second classes is indicative of a pathophysiological state of the organism.

### Claim 14

A method for signal processing, having the following steps:
a) detecting a cardiac signal from a human or animal organism in a time-dependent manner by means of a detection unit of a implantable medical device for detecting a cardiac signal from a human or animal organism and for stimulating the human or animal heart;
b) defining a signal segment extends over an adjustable first temporal length of the cardiac signal;
c) subdividing the signal segment into first blocks in at least a first section of the signal segment;
d) determining a total number of the first blocks;
e) determining a measure for a signal swing in each of the first blocks;
f) determining a number of first blocks in which the measure for the signal swing is less than a predeterminable first threshold value;
g) calculating a first quotient from the number of first blocks in which the measure for the signal swing is less than the first threshold value, and the total number of the first blocks;
h) comparing the first quotient with a second threshold value.