# US 9,433,794 B2 · Pulse generator system and method for medical use

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- Number: US 9,433,794 B2
- Document ID: US9433794B2
- Status: Granted
- Kind: B2
- Application number: 14/666,006
- Filed: 2015-03-23
- Published: 2015-10-01
- Granted: 2016-09-06
- Earliest claimed: 2014-03-31
- Assignees: Osypka Medical GmbH
- Applicants: Osypka Medical GmbH
- Inventors: Markus J. Osypka; Clemens Feige; Marcel D. Gestewitz; Thomas Fiedler
- Web page: https://patentgrep.com/patent/US9433794B2

## CPC

- A61N 1/3712: {Auto-capture, i.e. automatic adjustment of the stimulation threshold}
- A61N 1/3625: {External stimulators}
- A61N 1/37247: {User interfaces, e.g. input or presentation means}
- A61N 1/3993: {User interfaces for automatic external defibrillators}
- 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

An electrical pulse generator system such as a cardiac pacemaker or defibrillator system includes an impedance measuring device which measures the impedance across pacemaker leads, a display device, and a controller which controls the display device to display at least the measured impedance upon each stimulation pulse, or an image showing the relationship between a first applied electrical signal, measured impedance, and a resulting electrical signal which varies according to Ohm's Law. The system may include a short circuit detector and a pulse amplitude control module which switches between normal mode and safe mode operation based on short circuit detection, with different maximum stimulation pulse amplitudes in the normal and safe modes.

## Claims

### Claim 1

A monitoring and control system for a medical pulse generator,
comprising:
a control input for operator input of a selected nominal amplitude for a control parameter which varies stimulation pulse amplitude of a medical pulse generator, the control parameter comprising voltage or current;
an impedance monitoring module configured for connection to stimulation leads of the medical pulse generator to measure impedance during a stimulation pulse;
a short circuit detection module which is configured to detect a short circuit condition; and
an amplitude setting control module connected to the operator control input and associated with the impedance monitoring module and short circuit detection module, the amplitude setting control module being configured to select normal mode operation or safe mode operation of the pulse generator based on input from the short circuit detection module and to set a limited nominal amplitude for normal mode operation and a predetermined safety amplitude for safe mode operation;
wherein the system operates in normal mode when no short circuit is detected and the impedance is within predetermined minimum and maximum levels, and operates in a safe mode if a short circuit is detected;
the nominal amplitude in the normal mode comprising the operator selected nominal amplitude up to the preset limited nominal amplitude and comprising the preset limited nominal amplitude if the operator selected nominal amplitude at the control input is greater than the preset limited nominal amplitude when the control parameter is voltage or less than the preset limited nominal amplitude when the control parameter is current;
the amplitude in the safe mode comprising the operator selected amplitude up to the predetermined safety amplitude and comprising the predetermined safety amplitude if the operator selected amplitude is greater than the predetermined safety amplitude when the control parameter is voltage or less than the predetermined safety amplitude when the control parameter is current; and
an alarm device, the impedance monitoring module having an output connected to the alarm device and being configured to actuate the alarm device if a short circuit is detected again during safe mode operation of the system.

### Claim 2 (depends on 1)

The system of claim 1, wherein the pulse generator parameter controlled by the user comprises the stimulation pulse voltage, the preset limited nominal amplitude comprises a maximum stimulation pulse voltage for the normal mode, and the predetermined safety amplitude in the safe mode comprises a predetermined safety mode voltage less than the maximum stimulation pulse voltage, wherein the nominal amplitude in the normal mode comprises the stimulation pulse voltage set by an operator up to the maximum stimulation pulse voltage and comprises the maximum stimulation pulse voltage if the operator selected stimulation pulse voltage exceeds the maximum stimulation pulse voltage, and the stimulation pulse voltage in the safe mode comprises the operator selected voltage up to the predetermined safety mode voltage and comprises the predetermined safety mode voltage if the operator selected voltage exceeds the safety mode voltage.

### Claim 3 (depends on 2)

The system of claim 2, wherein the normal mode maximum amplitude is in the range from 17 to 20 volts and the predetermined safety amplitude is in the range from 7 to 9 volts.

### Claim 4 (depends on 3)

The system of claim 3, wherein the short circuit condition comprises detection of an impedance less than about 130 ohms.

### Claim 5 (depends on 4)

The system of claim 4, wherein the pulse generator is a cardiac pacemaker.

### Claim 6 (depends on 1)

The system of claim 1, wherein the pulse generator parameter controlled by the operator comprises a current, the preset limited nominal amplitude in the normal mode comprises a preset minimum applicable current, and the predetermined safety amplitude in the safety mode comprises a predetermined safety mode current greater than the preset minimum applicable current in the normal mode, wherein the nominal amplitude in the normal mode comprises a nominal current set by the operator if greater than or equal to the preset minimum applicable current and comprises the preset minimum applicable current if the operator selected nominal current is less than the preset minimum applicable current, and the applicable current in the safe mode comprises the operator selected nominal current if greater than or equal to the predetermined safety mode current and comprises the predetermined safety mode current if the operator selected nominal current is less than the safety mode current.

### Claim 7 (depends on 1)

The system of claim 1, wherein the short circuit condition comprises at least one of a measured impedance below a predetermined level and an excess voltage or current.

### Claim 8 (depends on 7)

The method of claim 7, wherein the pulse generator parameter controlled by the user comprises the stimulation pulse voltage, the preset limited nominal amplitude comprises a maximum stimulation pulse voltage for the normal mode, and the predetermined safety amplitude in the safety mode comprises a predetermined safety mode voltage less than the maximum stimulation pulse voltage, whereby, in the normal mode, a stimulation pulse is generated with an amplitude comprising the nominal voltage amplitude set by an operator up to the maximum stimulation pulse voltage and a stimulation pulse is generated at the maximum stimulation pulse voltage if the operator selected nominal voltage amplitude exceeds the maximum stimulation pulse voltage, and in the safe mode, a stimulation pulse is generated at the operator selected nominal amplitude up to the predetermined safety mode voltage and at the predetermined safety mode voltage if the operator selected nominal amplitude exceeds the safety mode voltage.

### Claim 9 (depends on 7)

The method of claim 7, wherein the pulse generator parameter controlled by the operator comprises a current, the stimulation pulse voltage amplitude varying dependent on the operator controlled current, the preset limited nominal amplitude in the normal mode comprises a preset minimum applicable current, and the predetermined safety amplitude in the safety mode comprises a predetermined safety mode current greater than the minimum applicable current in the normal mode, whereby, in the normal mode, a stimulation pulse is generated using the nominal current set by an operator up to the preset minimum applicable current and a stimulation pulse is generated using the preset minimum applicable current if the operator selected nominal current is less than the preset minimum applicable current, and in the safety mode, a stimulation pulse is generated using the operator selected nominal current up to the predetermined safety mode current and using the predetermined safety mode current if the operator selected nominal current is less than the safety mode current.

### Claim 10

A method of controlling operation of a medical pulse generator, comprising:
monitoring a nominal amplitude of a pulse generator parameter set by an operator of a medical pulse generator, the parameter comprising a stimulation voltage or a current;
measuring impedance across pacing wires of the medical pulse generator at each stimulation pulse;
monitoring one or more pulse generator parameters to detect a short circuit condition;
selecting a normal mode operation of the pulse generator when no short circuit condition is detected and the measured impedance following a stimulation pulse is within predetermined minimum and maximum levels, and selecting safe mode operation when a short circuit condition is detected, setting a limited nominal amplitude for normal mode operation and a predetermined safety amplitude for safe mode operation;
in the normal mode, generating a stimulation pulse of amplitude depending on a nominal amplitude set by an operator up to the preset limited nominal amplitude and generating a stimulation pulse using the preset limited nominal amplitude if the operator selected nominal amplitude is greater than the preset limited nominal amplitude when the pulse generator parameter is voltage and less than the preset limited nominal amplitude when the pulse generator parameter is current;
in the safe mode, generating a stimulation pulse using the operator selected nominal amplitude up to the predetermined safety amplitude and generating a stimulation pulse using the predetermined safety amplitude if the operator selected nominal amplitude is greater than the predetermined safety amplitude when the pulse generator parameter is voltage and less than the predetermined safety amplitude when the pulse generator parameter is current; and
actuating an alarm device if a short circuit is detected again during safe mode operation of the system.

### Claim 11 (depends on 10)

The system of claim 10, wherein the pulse generator is a temporary external cardiac pacemaker.

### Claim 12

A medical pulse generator system, comprising:
a pulse generator configured to generate stimulation pulses;
a stimulation pulse controller configured to control the pulse generator to generate a stimulation pulse;
the stimulation pulse controller having a control input for operator selection of a nominal amplitude for a control parameter which varies the stimulation pulse, the control parameter comprising voltage or current;
a lead system configured to connect a stimulation pulse output of the pulse generator to a patient at a tissue interface;
an impedance measurement module connected to the lead system and configured to measure impedance following a stimulation pulse;
a short circuit detection module configured to detect a short circuit condition;
an amplitude setting module connected to the user control input and associated with the impedance monitoring module and short circuit detection module, the amplitude setting control module being configured to select normal mode operation or safe mode operation of the pulse generator based on input from the short circuit detection module and to set a limited nominal amplitude for normal mode operation based on the detected impedance following a previous stimulation pulse and to set a predetermined safety amplitude for safe mode operation;
wherein the system operates in normal mode when no short circuit is detected and the impedance is within predetermined minimum and maximum levels, and operates in a safe mode if a short circuit is detected;
the nominal amplitude in the normal mode comprising the operator selected nominal amplitude up to the preset limited nominal amplitude and comprising the preset limited nominal amplitude if the operator selected nominal amplitude at the control input exceeds the preset limited nominal amplitude when the control parameter is voltage and is less than the preset limited nominal amplitude when the control parameter is current;
the stimulation pulse amplitude in the safe mode comprising the operator selected amplitude up to the predetermined safety amplitude and comprising the predetermined safety amplitude if the operator selected amplitude exceeds the predetermined safety amplitude when the control parameter is voltage and is less than the predetermined safety amplitude when the control parameter is current; and
an alarm device, the impedance measurement module having an output connected to the alarm device and being configured to actuate the alarm device if a short circuit is detected again during safe mode operation of the system.

### Claim 13

A monitoring and control system for a medical pulse generator, comprising:
a control input for operator input of a selected nominal amplitude for a control parameter which varies stimulation pulse amplitude of a medical pulse generator, the control parameter comprising voltage or current;
an impedance monitoring module configured for connection to stimulation leads of the medical pulse generator to measure impedance during a stimulation pulse;
a short circuit detection module which is configured to detect a short circuit condition; and
an amplitude setting control module connected to the operator control input and associated with the impedance monitoring module and short circuit detection module, the amplitude setting control module being configured to select normal mode operation or safe mode operation of the pulse generator based on input from the short circuit detection module and to set a limited nominal amplitude for normal mode operation and a predetermined safety amplitude for safe mode operation;
wherein the system operates in normal mode when no short circuit is detected and the impedance is within predetermined minimum and maximum levels, and operates in a safe mode if a short circuit is detected;
the nominal amplitude in the normal mode comprising the operator selected nominal amplitude up to the preset limited nominal amplitude and comprising the preset limited nominal amplitude if the operator selected nominal amplitude at the control input is greater than the preset limited nominal amplitude when the control parameter is voltage or less than the preset limited nominal amplitude when the control parameter is current; and
the amplitude in the safe mode comprising the operator selected amplitude up to the predetermined safety amplitude and comprising the predetermined safety amplitude if the operator selected amplitude is greater than the predetermined safety amplitude when the control parameter is voltage or less than the predetermined safety amplitude when the control parameter is current;
wherein the pulse generator parameter controlled by the operator comprises a current, the preset limited nominal amplitude in the normal mode comprises a preset minimum applicable current, and the predetermined safety amplitude in the safety mode comprises a predetermined safety mode current greater than the preset minimum applicable current in the normal mode, wherein the nominal amplitude in the normal mode comprises a nominal current set by the operator if greater than or equal to the preset minimum applicable current and comprises the preset minimum applicable current if the operator selected nominal current is less than the preset minimum applicable current, and the applicable current in the safe mode comprises the operator selected nominal current if greater than or equal to the predetermined safety mode current and comprises the predetermined safety mode current if the operator selected nominal current is less than the safety mode current.

### Claim 14

A monitoring and control system for a medical pulse generator, comprising:
a control input for operator input of a selected nominal amplitude for a control parameter which varies stimulation pulse amplitude of a medical pulse generator, the control parameter comprising voltage or current;
an impedance monitoring module configured for connection to stimulation leads of the medical pulse generator to measure impedance during a stimulation pulse;
a short circuit detection module which is configured to detect a short circuit condition; and
an amplitude setting control module connected to the operator control input and associated with the impedance monitoring module and short circuit detection module, the amplitude setting control module being configured to select normal mode operation or safe mode operation of the pulse generator based on input from the short circuit detection module and to set a limited nominal amplitude for normal mode operation and a predetermined safety amplitude for safe mode operation;
wherein the system operates in normal mode when no short circuit is detected and the impedance is within predetermined minimum and maximum levels, and operates in a safe mode if a short circuit is detected;
the nominal amplitude in the normal mode comprising the operator selected nominal amplitude up to the preset limited nominal amplitude and comprising the preset limited nominal amplitude if the operator selected nominal amplitude at the control input is greater than the preset limited nominal amplitude when the control parameter is voltage or less than the preset limited nominal amplitude when the control parameter is current; and
the amplitude in the safe mode comprising the operator selected amplitude up to the predetermined safety amplitude and comprising the predetermined safety amplitude if the operator selected amplitude is greater than the predetermined safety amplitude when the control parameter is voltage or less than the predetermined safety amplitude when the control parameter is current;
wherein the pulse generator parameter controlled by the user comprises the stimulation pulse voltage, the preset limited nominal amplitude comprises a maximum stimulation pulse voltage for the normal mode, and the predetermined safety amplitude in the safe mode comprises a predetermined safety mode voltage less than the maximum stimulation pulse voltage, wherein the nominal amplitude in the normal mode comprises the stimulation pulse voltage set by an operator up to the maximum stimulation pulse voltage and comprises the maximum stimulation pulse voltage if the operator selected stimulation pulse voltage exceeds the maximum stimulation pulse voltage, and the stimulation pulse voltage in the safe mode comprises the operator selected voltage up to the predetermined safety mode voltage and comprises the predetermined safety mode voltage if the operator selected voltage exceeds the safety mode voltage; and
wherein the normal mode maximum amplitude is in the range from 17 to 20 volts and the predetermined safety amplitude is in the range from 7 to 9 volts.