His Bundle Pacing Threshold Testing Automation

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Solution Overview

Problem

Current cardiac stimulation devices lack the ability to automatically identify and configure settings for efficient His bundle pacing, which is crucial for optimizing heart function in patients with conduction disorders and heart failure, as they often require manual adjustment and may not adapt to changing patient conditions.

Innovation Solution

The development of a cardiac stimulation system that performs automated capture threshold testing to determine the minimum energy and rate required for His bundle pacing, using a method that involves applying a series of impulses with varying energies, measuring response characteristics, and storing templates to classify capture types, allowing for dynamic adjustment of output settings to ensure optimal pacing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If manual adjustment of pacing settings is used, then device complexity is reduced, but adaptability to changing patient conditions deteriorates

Engineering Contradiction:
Improveadaptability to changing patient conditionsVSAvoiddevice complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The cardiac stimulation device performs automated capture threshold testing and self-configures its output settings without requiring manual intervention. The device automatically applies test impulses, measures response characteristics, classifies capture types, and adjusts pacing parameters to maintain optimal His bundle capture, enabling the system to adapt to changing patient conditions autonomously

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The device performs preliminary capture threshold testing to determine the minimum energy and rate required for His bundle pacing before actual pacing begins. By pre-determining optimal settings through automated testing and template classification, the system prepares the appropriate pacing parameters in advance, ensuring immediate adaptability when pacing is initiated or conditions change

Inventive Principle:
Principle #10Preliminary action

2Adaptability or versatility

If automated capture threshold testing is performed, then adaptability improves, but use of energy increases

Engineering Contradiction:
Improveautomated configuration capabilityVSAvoidenergy consumption
Core Design Contradiction:
Adaptability or versatilityVSUse of energy by moving object

Solution Approach 1:

The automated capture threshold testing is performed partially - specifically at initialization and when capture is lost - rather than continuously. The device applies test impulses only when necessary to determine minimum energy requirements or to verify continued capture, avoiding unnecessary energy consumption while maintaining adaptability when it matters most

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The device performs capture threshold testing periodically at specific intervals (initialization, capture loss detection) rather than continuously. This periodic automated testing allows the system to adapt to changing conditions when needed while conserving energy during stable periods when continuous monitoring would not provide additional benefit

Inventive Principle:
Principle #19Periodic action

3Productivity

If manual configuration is used, then ease of operation is maintained, but productivity deteriorates

Engineering Contradiction:
Improveinitialization speedVSAvoidease of configuration
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The cardiac stimulation device automatically configures its own pacing settings through automated capture threshold testing without requiring manual intervention from clinicians. The system independently applies test impulses, measures responses, classifies capture types using stored templates, and adjusts output parameters, significantly accelerating initialization and reducing the time required to achieve optimal pacing configuration

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The device performs preliminary automated testing and configuration before clinical use begins. By pre-determining capture thresholds and optimal pacing parameters through automated impulse testing and response classification, the system eliminates time-consuming manual configuration steps, enabling rapid initialization while maintaining clinical effectiveness

Inventive Principle:
Principle #10Preliminary action

4Reliability

If non-optimal pacing settings are used, then device complexity is reduced, but hemodynamic efficiency deteriorates

Engineering Contradiction:
Improvehemodynamic efficiencyVSAvoidconfiguration complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The cardiac stimulation device automatically determines optimal pacing settings through automated capture threshold testing and self-configures output parameters to ensure reliable His bundle capture. The system measures response characteristics, classifies capture types using stored templates, and adjusts pacing voltage and rate to maintain hemodynamically efficient operation, eliminating the need for complex manual optimization while ensuring reliable performance

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The device employs feedback mechanisms by measuring response characteristics following test impulses and using this information to classify capture types and adjust pacing settings. The system continuously monitors whether optimal capture is maintained and modifies output parameters accordingly, ensuring hemodynamic efficiency through closed-loop control without requiring complex external configuration

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS12042651B2Systems and methods for automated capture threshold testing and associated his bundle pacing
Publication Date: 2024.07.23 PACESETTER INC
  • US12042651B2 patent drawing
  • US12042651B2 patent drawing
  • US12042651B2 patent drawing

AI summary

A method of pacing a His bundle of a patient heart using a stimulation system including a memory, a pulse generator, a stimulating electrode and at least one sensing electrode includes applying a plurality of impulses through the stimulating electrode to induce a plurality of responses from the patient heart. Each impulse of the plurality of impulses is delivered at a different impulse energy corresponding to a respective output setting of the stimulation system. The response characteristics for each of the plurality of responses are measured and each impulse is assigned a classification based on whether the respective response characteristics indicate capture of one or both of the His bundle and a ventricle of the patient heart. The output setting and classification for each impulse is then stored in the memory.