Implantable Heart Monitoring System for Rejection Detection

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Solution Overview

Problem

Current methods for monitoring transplanted hearts and congestive heart failure are invasive, costly, and inconvenient, with limitations in detecting rejection episodes and providing continuous monitoring, leading to potential complications and increased treatment costs.

Innovation Solution

A non-invasive system for monitoring heart function involves registering and analyzing electrical signals from the heart, generating reference waveforms, and comparing them to detect any deviations, using an implantable registering unit connected to the heart with electrodes and a local data unit for data processing and transmission, allowing for continuous remote monitoring.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If endomyocardial biopsy (EMB) procedures are used to monitor transplanted hearts, then rejection detection capability is improved, but patient risk and procedure complexity increase due to invasive nature

Engineering Contradiction:
Improverejection detection capabilityVSAvoidpatient risk
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical invasive EMB procedure with an electrical signal-based monitoring system. Implantable electrodes record intracardiac electrograms, and rejection is detected through analysis of electrical signal characteristics (amplitude, morphology, frequency) rather than physical tissue sampling. This substitution eliminates procedural risks while maintaining diagnostic capability.

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

Solution Approach 2:

The patent introduces electrical signals as an intermediary to detect rejection. Instead of directly observing tissue changes through biopsy, the system uses intracardiac electrograms as a mediator that reflects myocardial physiological state. Changes in electrical signal properties indicate rejection episodes, allowing indirect but safe monitoring.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If multiple endomyocardial biopsies are performed at regular intervals to detect early rejection, then rejection detection sensitivity is improved, but treatment cost and patient burden increase

Engineering Contradiction:
Improverejection detection sensitivityVSAvoidtreatment cost
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The patent implements continuous monitoring through implantable electrodes that continuously record intracardiac electrograms. Unlike periodic EMB procedures, the system provides uninterrupted electrical signal acquisition, enabling real-time rejection detection without repeated invasive procedures. This continuous action maintains high detection sensitivity while eliminating the cumulative costs and burdens of multiple biopsies.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The implantable monitoring system is self-contained, with electrodes and recording devices permanently positioned within the heart. The system autonomously continuously monitors electrical signals without requiring external intervention or repeated hospital visits for biopsy procedures, thereby eliminating ongoing treatment costs and patient burden while maintaining detection sensitivity.

Inventive Principle:
Principle #25Self-service

3Measurement precision

If endomyocardial biopsy procedures are used for heart monitoring, then rejection detection capability is improved, but ease of operation deteriorates due to invasive hospital visits

Engineering Contradiction:
Improverejection detection capabilityVSAvoidpatient convenience
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent replaces the mechanical invasive EMB procedure requiring hospital visits with an electrical signal-based system. Implantable electrodes continuously record intracardiac electrograms, and rejection is detected through remote analysis of electrical signal characteristics. This substitution eliminates the need for repeated hospital trips while maintaining diagnostic capability.

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

Solution Approach 2:

The system provides continuous monitoring through permanently implanted electrodes that continuously record electrical signals. Data can be transmitted remotely for analysis, eliminating the need for periodic hospital visits required by EMB procedures. This continuous action maintains detection capability while dramatically improving patient convenience.

Inventive Principle:
Principle #20Continuity of useful action

4Measurement precision

If the number of myocardial leads is increased to improve rejection detection sensitivity, then measurement precision is improved, but device complexity increases

Engineering Contradiction:
Improverejection detection sensitivityVSAvoidnumber of leads
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent makes each intracardiac electrode multi-functional. The same electrodes that record intracardiac electrograms for rejection detection also serve as pacing electrodes and impedance sensing elements. This universality allows comprehensive monitoring with minimal leads, improving rejection detection sensitivity without proportionally increasing device complexity.

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

Solution Approach 2:

The patent combines multiple monitoring functions into a single integrated system. Intracardiac electrogram recording, pacing, and impedance monitoring are merged into one device with shared electrodes and processing circuitry. This integration achieves high rejection detection sensitivity while minimizing the number of separate components and leads required.

Inventive Principle:
Principle #5Merging (Combining)

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 system enables early detection of heart rejection with high sensitivity and specificity, reducing the risk of invasive procedures and treatment costs by providing continuous monitoring and prompt intervention.

Implementation Method 1

registering an electrical signal from a patient's heart, the electrical signal configured as a series of waveforms

Methodology Applied
Scientific EffectElectrical signal detection: Conduction (electrical)

Data Source

PatentUS10499828B2System and method for heart monitoring
Publication Date: 2019.12.10 COMPLETE MEDICAL SOLUTIONS LLC
  • US10499828B2 patent drawing
  • US10499828B2 patent drawing
  • US10499828B2 patent drawing

AI summary

The present invention provides systems and methods for monitoring a heart. According to one embodiment, the system includes an implantable registering unit for registering an electrical signal from the heart. The system includes a local data unit in operable communication with registering unit. The local data unit may be placed in communication with a computer, which may be at a location remote from the local data unit. The computer is adapted to receive the data from the local data unit corresponding to the registered electrical signal and to compare the registered electrical signal to a reference electrical signal to determine whether the heart is functioning properly.