Implantable medical device for stimulating the His bundle of a human or animal heart employing an improved distinction between atrial and ventricular signals detected at the His bundle

Patent metadata

Field	Value
Publication number	US-11819696-B2
Application number	US-202017770201-A
Country	US
Kind code	B2
Filing date	Oct 22, 2020
Priority date	Oct 24, 2019
Publication date	Nov 21, 2023
Grant date	Nov 21, 2023

Abstract

An implantable medical device for stimulating a human or animal heart. In operation, the device performs the following steps: a) sensing an atrial electric signal a the first detection unit; b) sensing an electric signal at the His bundle with a second detection unit upon termination of a first time period starting upon sensing the atrial electric signal with the first detection unit and/or starting upon applying a stimulation pulse, wherein the first time period lies in a range of from 10 ms to 100 ms; c) classifying the electric signal sensed with the second detection unit as His bundle activity signal or as ventricular activity signal.

First claim

The invention claimed is:

1. Implantable medical device, comprising:
a processor, a memory unit, a stimulation unit configured to generate a stimulation pulse to stimulate the His bundle of the human or animal heart, a first detection unit configured to detect an electrical signal at an atrium of the same heart, and a second detection unit configured to detect an electrical signal at the His bundle of the same heart,
wherein the memory unit comprises a computer-readable program that causes the processor to perform the following steps when executed on the processor:
a) sense an atrial electric signal with the first detection unit, and transmit the atrial electric signal to the processor;
b) sense an electric signal at the His bundle with the second detection unit upon termination of a first time period starting upon sensing the atrial electric signal with the first detection unit and/or starting upon applying a stimulation pulse, wherein the first time period lies in a range of from 10 ms to 100 ms, and transmit the electric signal to the processor;
c) classify the electric signal sensed with the second detection unit as His bundle activity signal or as ventricular activity signal;
d) stimulate the His bundle with the stimulation unit if no ventricular activity signal has been sensed during a second time period starting upon sensing the atrial electric signal with the first detection unit, wherein the second time period lies in a range of from 15 ms to 300 ms.

2. The implantable medical device according to claim 1 , wherein the computer-readable program causes the processor to set a first sensing threshold, wherein the first sensing threshold is lower than the His bundle activity signal when detected with the second detection unit, but higher than typically expected noise.

3. The implantable medical device according to claim 1 , wherein the computer-readable program causes the processor to set a second sensing threshold, wherein the second sensing threshold is higher than the His bundle activity signal when detected with the second detection unit, but lower than a ventricular activity signal when detected with the second detection unit, and to classify the electric signal sensed with the second detection unit as ventricular activity signal if the electric signal exceeds the second sensing threshold.

4. The implantable medical device according to claim 1 , wherein the computer-readable program causes the processor to set a marker for the electric signal sensed with the second detection unit, the marker comprising an information on a type of the electric signal reflecting the classification of the electric signal and a time information reflecting a delayed sensing time, wherein the delayed sensing time is calculated as original sensing time plus a delay time, wherein the delay time is shorter than the first time period and lies in a range of from 0 to 50 ms, wherein the electric signal is only classified as the His bundle activity signal or as the atrial activity signal if the delayed sensing time does not fall into the first time period.

5. The implantable medical device according to claim 1 , wherein the computer-readable program causes the processor to delay all electric signals sensed by the second detection unit by a delay time, wherein the delay time is shorter than the first time period and lies in a range of from 0 to 50 ms.

6. The implantable medical device according to claim 5 , wherein the computer-readable program causes the processor to set a marker for the electric signal sensed with the second detection unit, the marker comprising an information on a type of the electric signal reflecting the classifying of the electric signal and a time information reflecting a sensing time already comprising the delay time, wherein the electric signal is only classified as the His bundle activity signal or as the atrial activity signal if the sensing time does not fall into the first time period.

7. The implantable medical device according to claim 1 , wherein the implantable medical device comprises a further stimulation unit configured to stimulate an atrium of the same heart.

8. A computer program product comprising computer-readable code that causes a processor to perform the following steps when executed on the processor:
a) receive an atrial electric signal from a first detection unit;
b) receive an electric signal related to His bundle activity from a second detection unit upon termination of a first time period starting upon sensing the atrial electric signal with the first detection unit and/or starting upon applying a stimulation pulse, wherein the first time period lies in a range of from 10 ms to 100 ms;
c) classify the electric signal sensed with the second detection unit as His bundle activity signal or as ventricular activity signal;
d) stimulate the His bundle with a stimulation unit if no ventricular activity signal has been sensed during a second time period starting upon sensing the atrial electric signal with the first detection unit, wherein the second time period lies in a range of from 15 ms to 300 ms.

9. A method of treatment of a human or animal patient in need of such treatment with an implantable medical device for stimulating the human or animal heart, the implantable medical device comprising a processor, a memory unit, a stimulation unit configured to stimulate the His bundle of the human or animal heart, a first detection unit configured to detect an electrical signal at an atrium of the same heart, and a second detection unit configured to detect an electrical signal at the His bundle of the same heart, the method comprising the following steps:
a) sensing an atrial electric signal with the first detection unit;
b) sensing an electric signal at the His bundle with the second detection unit upon termination of a first time period starting upon sensing the atrial electric signal with the first detection unit and/or starting upon applying a stimulation pulse, wherein the first time period lies in a range of from 10 ms to 100 ms;
c) classifying the electric signal sensed with the second detection unit as His bundle activity signal or as ventricular activity signal; and
d) stimulating the His bundle with the stimulation unit if no ventricular activity signal has been sensed during a second time period starting upon sensing the atrial electric signal with the first detection unit, wherein the second time period lies in a range of from 15 ms to 300 ms.

Assignees

• Biotronik Se & Co Kg

Inventors

• Doerr Thomas
• Ershov Sergey
• Radtke Torsten
• Busch Ulrich
• Schneider Peter
• Paule Stefan
• Becker Frank

Classifications

• A61N1/36521 Primary

  the parameter being derived from measurement of an electrical impedance · CPC title

• A61B5/0538

  invasively, e.g. using a catheter · CPC title

• A61N1/056

  Transvascular endocardial electrode systems · CPC title

• A61N1/365

  controlled by a physiological parameter, e.g. heart potential {(evoked response A61N1/371)} · CPC title

• A61N1/368

  comprising more than one electrode co-operating with different heart regions {(A61N1/3622, A61N1/3627 take precedence)} · CPC title