System and method for inter-device arrhythmia detection and confirmation

Patent metadata

Field	Value
Publication number	US-12431248-B2
Application number	US-202318325147-A
Country	US
Kind code	B2
Filing date	May 30, 2023
Priority date	Jun 17, 2022
Publication date	Sep 30, 2025
Grant date	Sep 30, 2025

Abstract

System for arrhythmia detection and confirmation includes implantable medical device (IMD) having a sensing circuit for sensing cardiac activity (CA) for one or more cardiac cycles and generating one or more CA signals. An implantable pressure sensor (IPS) includes IPS sensing circuit for sensing pressure during the one or more cardiac cycles and generating one or more pressure signals. IMD and IPS include communications circuits for communicating with each other and/or an external device. One or both of IMD or IPS includes memory for storing program instructions and processor(s) for analyzing one of the CA or pressure signals, for one or more cardiac cycles, to detect a candidate arrhythmia. In response to detecting candidate arrhythmia, the processor(s) obtain another one of CA or pressure signals for cardiac cycles corresponding to the one or more cardiac cycles, and confirm or deny candidate arrhythmia based on the other one of the signals.

First claim

What is claimed is:

1. A system for arrhythmia detection and confirmation, comprising:
an implantable pressure sensor (IPS);
an implantable medical device (IMD) comprising:
an IMD sensing circuit configured to sense cardiac activity (CA), on-demand and in real-time, for one or more cardiac cycles and to generate one or more CA signals based on the CA;
an IMD communications circuit configured to communicate with at least one of the IPS or an external device;

wherein the IPS comprises:
an IPS sensing circuit configured to sense pressure, on-demand and in real-time, during the one or more cardiac cycles and to generate one or more pressure signals based on the pressure; and
an IPS communications circuit configured to communicate with at least one of the IMD or the external device;

wherein at least one of the IMD or IPS further comprises:
memory configured to store program instructions; and
one or more processors that, when executing the program instructions, are configured to:
analyze one of the CA or pressure signals, for the one or more cardiac cycles, to detect a candidate arrhythmia;
in response to the detection of the candidate arrhythmia, obtain an other one of the CA or pressure signals for cardiac cycles corresponding to the one or more cardiac cycles; and
confirm or deny the candidate arrhythmia based on the other one of the CA or pressure signals.

2. The system of claim 1 , wherein the one or more processors and memory are housed in the IMD, the one or more processors configured to:
direct the IMD communications circuit to transmit, to at least one of the IPS communications circuit or the external device, a request for the pressure signals;
receive the pressure signals from at least one of the IPS communications circuit or the external device; and
analyze the pressure signals, for the one or more cardiac cycles, to confirm or deny the candidate arrhythmia.

3. The system of claim 1 , wherein the one or more processors and memory are housed in the IPS, the one or more processors configured to:
direct the IPS communications circuit to transmit, to at least one of the IMD communications circuit or the external device, a request for the CA signals;
receive the CA signals from at least one of the IMD communications circuit or the external device; and
analyze the CA signals, for the one or more cardiac cycles, to confirm or deny the candidate arrhythmia.

4. The system of claim 1 , the one or more processors further configured to:
analyze both of the CA and pressure signals to determine a CA-based rate and to determine a pressure-based rate; and
confirm or deny the candidate arrhythmia based on a comparison of the CA and pressure-based rates.

5. The system of claim 1 , the one or more processors further configured to:
compare the pressure signals, for the one or more cardiac cycles, relative to a template for a normal sinus rhythm to determine when the pressure signals indicate a pressure-indicated arrhythmia; and
confirm or deny the candidate arrhythmia based on the comparison of the pressure signals.

6. The system of claim 1 , wherein the one or more processors is further configured to:
analyze the CA signals to identify the candidate arrhythmia to be a ventricular tachycardia;
compare the pressure signals, for the one or more cardiac cycles, relative to a template for a normal sinus rhythm to determine when the pressure signals have morphological features that correspond to the normal sinus rhythm; and
determine the candidate arrhythmia to be an atrial fibrillation and not the ventricular tachycardia initially identified based on the CA signals based on the comparison of the pressure signals.

7. The system of claim 1 , wherein the one or more processors is further configured to:
determine when one or more features of the pressure signals positively or negatively exceed at least one corresponding threshold associated with hemodynamic instability; and
identify the candidate arrhythmia to be an atrial fibrillation when all or a subset of the one or more features of the pressure signals positively or negatively exceed the one or more corresponding threshold.

8. The system of claim 1 , wherein in response to confirming the candidate arrhythmia based on the CA signals and denying the candidate arrhythmia based on the pressure signals, the one or more processors is further configured to increase at least one sensitivity setting associated with sensing the cardiac activity.

9. The system of claim 8 , wherein the one or more processors is further configured to:
analyze additional CA signals that are sensed by the IMD sensing circuit, the additional CA signals based on the increased at least one sensitivity setting; and
confirm or deny the candidate arrhythmia based on the analysis of the additional CA signals.

10. The system of claim 1 , wherein in response to the one or more processors confirming the candidate arrhythmia associated with the pressure signals, the one or more processors is further configured to:
identify the candidate arrhythmia as a stable arrhythmia if a magnitude of one or more features of the pressure signals is greater than a hemodynamic threshold; and
identify the candidate arrhythmia as an unstable arrhythmia if the magnitude of the one or more features of the pressure signals is less than the hemodynamic threshold.

11. The system of claim 10 , wherein the one or more features of the pressure signals include at least one of i) pulse pressure, ii) systolic pressure, iii) diastolic pressure, or iv) dP/dt max .

12. The system of claim 1 , wherein in response to the one or more processors confirming the candidate arrhythmia associated with the pressure signals, the one or more processors is further configured to:
identify the candidate arrhythmia as a stable arrhythmia if a variability of one or more features of the pressure signals is greater than a hemodynamic threshold; and
identify the candidate arrhythmia as an unstable arrhythmia if the variability of the one or more features of the pressure signals is less than the hemodynamic threshold.

13. The system of claim 1 , wherein the one or more processors is further configured to:
detect a pause in response to analyzing the CA signals;
in response to detecting a pause, analyze the pressure signals to determine whether ventricular contraction is present or absent; and
in response to the ventricular contraction being present, reject a diagnosis of pause.

14. The system of claim 1 , wherein in response to the confirmation of the candidate arrhythmia, the one or more processors is further configured to treat the candidate arrhythmia.

15. The system of claim 14 , wherein the treatment of the candidate arrhythmia includes delivery of i) ATP, ii) a low voltage shock, iii) a medium voltage shock, or iv) a high voltage shock.

16. A computer implemented method for detecting an arrhythmia, comprising:
sensing cardiac activity (CA), for one or more cardiac cycles, at a sensing circuit within an implantable medical device (IMD);
generating one or more CA signals based on the CA;
sensing pressure, during the one or more cardiac cycles, at an implantable pressure sensor (IPS);
generating a pressure signal based on the pressure;
under control of one or more processors configured with executable instructions, analyzing one of the CA or pressure signals, for the one or more cardiac cycles, to detect a candidate arrhythmia;
obtaining an other one of the CA or pressure signals for cardiac cycles corresponding to the one or more cardiac cycles; and
confirming or denying the candidate a

Assignees

• Tc1 Llc

Inventors

• Gill Jong
• Badie Nima
• Ryu Kyungmoo
• Fischer Avi
• Adamson Philip B

Classifications

• A61N1/3704

  Circuits specially adapted therefor, e.g. for sensitivity control · CPC title

• A61N1/36585 Primary

  controlled by two or more physical parameters · CPC title

• A61B5/686

  Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence) · CPC title

• A61B5/02028

  Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction · CPC title

• A61B5/0215

  by means inserted into the body · CPC title