His Bundle Pacing Safety Modes for Implantable Cardiac Systems

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Solution Overview

Problem

Conventional cardiac pacemakers often fail to provide reliable His bundle pacing during device malfunctions, leading to undersupply of the patient.

Innovation Solution

An implantable system with a processor, memory unit, stimulation unit, sensing unit, and diagnostic unit that detects malfunctions and switches to a safety mode tailored for His bundle pacing, ensuring continued effective stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional safety mode (e.g., VVI mode) is activated during device malfunction, then the device ensures basic safety operation, but His bundle pacing capability is lost

Engineering Contradiction:
Improvesafety operationVSAvoidHis bundle pacing capability
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent implements dynamic switching between different safety modes based on the detected malfunction type and device state. The control unit selects from multiple safety modes (first safety mode for general malfunctions, second safety mode specifically for His bundle pacing preservation) to maintain appropriate functionality during different failure scenarios, making the safety response adaptive rather than static

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent changes operational parameters by switching between different pacing modes and configurations. When a malfunction is detected, the control unit modifies stimulation parameters, sensing parameters, and mode of operation to transition from normal His bundle pacing mode to an appropriate safety mode, thereby maintaining therapeutic effect under altered conditions

Inventive Principle:
Principle #35Parameter changes

2Reliability

If the device uses traditional device settings for safety mode, then the device operates safely, but adequate His bundle pacing cannot be maintained

Engineering Contradiction:
Improvesafe operationVSAvoidpacing precision
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The patent prepares multiple safety modes in advance during device programming and configuration. The control unit is pre-programmed with different safety mode configurations including His bundle pacing-specific parameters. When a malfunction occurs, the system can immediately switch to the pre-prepared appropriate safety mode without requiring real-time parameter optimization, ensuring both safety and pacing precision are maintained

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If the right atrial terminal is not addressed in VVI mode, then the mode operates simply, but His bundle pacing cannot take place

Engineering Contradiction:
Improvemode operation simplicityVSAvoidHis bundle pacing reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent makes the safety mode system universal by implementing multiple safety modes that can handle different scenarios. The first safety mode addresses general malfunctions with simple operation, while the second safety mode specifically addresses His bundle pacing preservation. This multi-functional approach allows the system to maintain simplicity when needed while ensuring reliability when His bundle pacing is required

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

Data Source

PatentEP4061478B1Implantable system for stimulating a human heart or an animal heart
Publication Date: 2025.03.05 BIOTRONIK SE & CO KG
  • EP4061478B1 patent drawingFigure 1
  • EP4061478B1 patent drawingFigure 2

AI summary

The invention relates to an implantable system for stimulating a human heart or an animal heart, comprising a processor, a memory unit, a stimulation unit for stimulating a His bundle or another cardiac region of a human heart or an animal heart, a sensing unit for sensing an electrical signal of this heart, and a diagnostic unit for checking functional parameters of the implantable system. During operation, this system carries out the following program: a) detecting, by means of the diagnostic unit, whether at least one malfunction state of the implantable system is present; b) checking (220) whether an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit; c) switching an operating state of the implantable system into a safety mode when a malfunction state was detected, the safety mode being selected at least from a first safety mode (230) and a second safety mode (240), wherein i) the first safety mode (230) is selected when the checking (220) carried out in step b) has shown that no electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit, and ii) the second safety mode (240) is selected when the checking (220) carried out in step b) has shown that an electrode provided for stimulating a His bundle of a human heart or an animal heart is connected to the stimulation unit.