Implantable Cardiac Monitor Pocket Stability Detection

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Solution Overview

Problem

Implantable cardiac monitors (ICMs) face challenges in accurately detecting pocket stability due to movement and fluid variations within the implant pocket, leading to incorrect readings and potential misdiagnosis of arrhythmias or brady episodes.

Innovation Solution

A computer-implemented method and system that processes impedance data to separate impedance waveforms over cardiac cycles, analyzes characteristics, and compares them to baseline data to determine pocket stability, distinguishing between true arrhythmias and false readings caused by pocket changes, using alternating current signals and electrocardiogram signals to output alerts and adjust signal quality indicators.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If the ICM is tightly secured within the pocket, then the device stability is improved, but the ICM can still move and reposition within the pocket causing reading variations

Engineering Contradiction:
ImproveICM positioning stabilityVSAvoidICM reading accuracy
Core Design Contradiction:
Stability of the object's compositionVSMeasurement precision

Solution Approach 1:

The patent introduces an intermediary system consisting of impedance sensors and processing circuitry that indirectly measures pocket stability by detecting changes in electrical impedance around the ICM. This intermediary measurement system allows the device to detect pocket movements and fluid variations without requiring direct mechanical fixation, thereby resolving the contradiction between secure positioning and measurement accuracy.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces mechanical stabilization methods (physical securing of the ICM) with an electrical field-based detection system. By using impedance measurements to monitor pocket stability and compensate for movements, the system substitutes mechanical constraints with electrical field sensing and signal processing to maintain reading accuracy despite physical movement.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If fluid levels and tissue variances within the pocket are monitored, then reading accuracy is improved, but the complexity of the detection system increases

Engineering Contradiction:
ImproveICM reading accuracyVSAvoiddetection system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent makes the existing ICM electrodes and electrical circuitry perform multiple functions: they continue to monitor cardiac electrical activity while simultaneously serving as impedance sensors to detect pocket stability, fluid levels, and tissue variations. This multi-functionality approach improves measurement accuracy without adding separate dedicated sensors or complex detection hardware.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system uses its own operational electrical signals to perform self-diagnosis of pocket stability. The same electrical fields used for cardiac monitoring automatically provide impedance data about the surrounding tissue environment, allowing the device to self-assess its implantation conditions without external intervention or additional complex monitoring systems.

Inventive Principle:
Principle #25Self-service

3Measurement precision

If impedance data processing is performed to separate impedance waveforms, then pocket stability detection accuracy is improved, but the computational load and processing time increase

Engineering Contradiction:
Improvepocket stability detection accuracyVSAvoidprocessing time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent performs preliminary processing of impedance data by continuously tracking and storing baseline impedance characteristics during normal operation. When arrhythmia detection is needed, the system compares current impedance waveforms against these pre-established baselines, enabling rapid pocket stability assessment without requiring extensive real-time computation or retrospective analysis of large datasets.

Inventive Principle:
Principle #10Preliminary action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach enhances the accuracy of ICM readings by differentiating between arrhythmias and pocket instability, reducing unnecessary medical interventions and improving diagnostic precision.

Implementation Method 1

measuring an impedance waveform across a pair of electrodes of the ICM

Methodology Applied
Scientific EffectElectrical Impedance: Electrical Resistance

Data Source

PatentUS20220088383A1Method for detecting pocket stability for an implantable cardiac monitor
Publication Date: 2022.03.24 PACESETTER INC
  • US20220088383A1 patent drawing
  • US20220088383A1 patent drawing
  • US20220088383A1 patent drawing

AI summary

A computer implemented method for detecting pocket stability for an implantable cardiac monitor, including under control of one or more processors in the ICM, collecting impedance data over at least one cardiac cycle. The impedance data is processed to separate an impedance waveform that varies over the at least one cardiac cycle in a manner representative of cardiac functionality over the at least one cardiac cycle. A characteristic of interest is analyzed from the impedance waveform over the at least one cardiac cycle. A pocket stability state of the ICM is identified and recorded based on the analyzing operation.