His Bundle Pacing Optimization for Cardiac Resynchronization

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Solution Overview

Problem

Current cardiac resynchronization therapy (CRT) systems have a low responder rate, with many patients not responding or responding minimally to conventional CRT methods, and there is a need for a system that can automatically adjust settings to optimize His bundle pacing (HBP) for improved cardiac function and synchronization.

Innovation Solution

The development of a cardiac stimulation system capable of automatically programming and optimizing settings for His bundle pacing, including determining capture thresholds and adjusting pacing timing and output to provide cardiac resynchronization therapy (CRT) using HBP, which involves a multi-chamber implantable stimulation system with leads for the right atrium, coronary sinus, right ventricle, and His bundle, and a microcontroller for controlling stimulation therapy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional CRT methods are used, then the treatment is simple to implement, but the responder rate is low

Engineering Contradiction:
Improveresponder rateVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system performs automated optimization of HBP settings without requiring manual intervention. The microcontroller automatically adjusts pacing parameters, captures electrograms, and optimizes therapy settings based on real-time cardiac electrical activity, allowing the system to self-optimize for improved responder rate

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system performs preliminary capture threshold determination and electrogram capture before final therapy delivery. By pre-identifying optimal pacing parameters and capturing baseline electrograms, the system prepares the optimal configuration in advance, improving responder rate while maintaining manageable complexity through structured pre-processing

Inventive Principle:
Principle #10Preliminary action

2Measurement precision

If manual optimization of HBP settings is performed, then precise control is achieved, but time-consuming procedures are required

Engineering Contradiction:
Improvepacing parameter precisionVSAvoidoptimization time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system captures electrograms from the His bundle and uses this feedback to automatically adjust pacing parameters. By continuously monitoring the cardiac electrical activity and comparing it against target parameters, the microcontroller iteratively optimizes pacing settings with high precision without requiring time-consuming manual adjustment

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system replaces manual mechanical adjustment of pacing parameters with automated electronic control. The microcontroller electronically adjusts pulse amplitude, width, and timing based on captured electrograms, achieving precise parameter control instantaneously without manual intervention or time-consuming procedural steps

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

3Reliability

If HBP settings are not optimized, then the system operation is simple, but atrioventricular synchrony is not promoted

Engineering Contradiction:
Improvecardiac synchronizationVSAvoidprogramming complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system automatically promotes atrioventricular synchrony by capturing His bundle electrograms and autonomously adjusting pacing parameters to optimize the timing relationship between atrial contraction and ventricular pacing. The microcontroller self-adjusts AV delays and pacing timing without requiring complex manual programming, achieving reliable cardiac synchronization

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP3877044B1Cardiac stimulation system with automated optimization of his bundle pacing for cardiac resynchronization therapy
Publication Date: 2023.04.26 PACESETTER INC
  • EP3877044B1 patent drawingFigure 1A~1B
  • EP3877044B1 patent drawingFigure 2
  • EP3877044B1 patent drawingFigure 3

AI summary

Systems and methods of performing cardio resynchronization therapy (CRT) on a patient heart include the use of a stimulation system having at least one processor, at least one memory, a pulse generator, a stimulating electrode disposed in proximity to a His bundle of the patient heart, and a sensing electrode adapted to sense electrical activity of the left ventricle (LV) of the patient heart. CRT is provided by applying, using the pulse generator and through the stimulating electrode, a His bundle pacing (HBP) impulse having a first impulse energy. The sensing electrode is then used to measure an LV activation time in response to the HBP impulse. At least one setting of the pulse generator is modified based on the LV activation time such that a subsequent HBP impulse may be provided by the pulse generator via the stimulating electrode using a modified impulse energy.