Pacemaker Automatic Mode Adjustment at Implantation
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Solution Overview
Problem
Existing multisite pacemakers with automatic mode commutation features, such as AAISafeR, may incorrectly switch modes due to the absence of lead connection during implantation, leading to inappropriate programming and potential adverse effects in patients with permanent atrio-ventricular blocks, as the device cannot detect conduction until leads are connected.
Innovation Solution
Incorporating automatic detection of implantation to adjust the mode commutation setting at the time of implantation, using techniques like pulse shape analysis to determine lead connection and implantation site, and analyzing atrio-ventricular conduction to set the initial pacing mode, either AAI or DDD, based on the presence of conduction disorders, with an optional delay to stabilize the device post-implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the device is programmed with automatic mode commutation (AAISafeR feature) during manufacturing, then the device can automatically adapt to temporary AV blocks, but it may incorrectly switch to DDD mode during implantation when leads are not yet connected, causing inappropriate programming
Solution Approach 1:
The device performs preliminary detection of implantation status before enabling automatic mode commutation. The implantation detection means activates first, detecting whether leads are properly connected, and only after confirming proper implantation does the device enable the AAISafeR feature. This preliminary action prevents premature mode switching during the implantation process when leads are not yet connected.
Solution Approach 2:
The patent introduces an intermediary detection mechanism (implantation detection means) that mediates between the manufacturing programming (AAISafeR feature) and the actual mode commutation function. This intermediary detects lead connection status and acts as a gatekeeper, enabling or disabling the automatic mode commutation based on implantation status, thus preventing incorrect mode switching.
2Adaptability or versatility
If the device performs periodic tests to allow commutation back to AAI mode, then it can recover from temporary AV blocks, but it creates long ventricular cycles that may be noxious to patients with permanent AV blocks
Solution Approach 1:
The device uses its own detected signals (ventricular activity detection) to make intelligent decisions about mode commutation. The analysis means continuously monitors ventricular activity and uses this self-generated information to determine whether to maintain DDD mode or return to AAI mode, eliminating the need for external practitioner intervention and avoiding harmful periodic tests in permanent AV block patients.
Solution Approach 2:
The patent implements a feedback mechanism where the device continuously analyzes ventricular activity detected by its own sensors and uses this feedback to dynamically adjust mode commutation decisions. The analysis means processes the detected ventricular signals and provides feedback to the mode commutation means, enabling real-time adaptation to the patient's actual conduction status without harmful periodic tests.
3Ease of manufacture
If the device requires practitioner reprogramming to modify standard programming, then it maintains manufacturing simplicity, but it increases the risk of side effects when reprogramming is overlooked
Solution Approach 1:
The device performs self-configuration at implantation by automatically detecting implantation status and analyzing AV conduction. The detection means and analysis means work together to autonomously determine the appropriate programming mode without requiring practitioner intervention, thus eliminating the risk of overlooked reprogramming while maintaining manufacturing simplicity.
Solution Approach 2:
The device performs preliminary detection and analysis during the implantation procedure itself, before the patient leaves the operating room. The implantation detection means and conduction analysis means operate in advance to automatically configure the device appropriately, eliminating the need for subsequent practitioner reprogramming and ensuring correct programming from the start.
Data Source
AI summary
An active implantable medical device of the AAI/DDD type, notably a cardiac pacemaker, including automatic mode adjustment at implantation. The device detects spontaneous atrial and ventricular events, and is able to pace the atrium and ventricle. The device can operate in an AAI mode with ventricular sensing, a DDD mode, and includes automatic mode commutation, able to schedule, as a function of predetermined criteria, commutation from AAI to DDD mode, and reversely from DDD to AAI. The device automatically detects an implantation and has its initial mode of operation adjusted upon detection of the implantation (10). The device temporarily operates (14) in an AAI mode with activation of the means for mode commutation, then analyzes (20) the atrio-ventricular conduction so as to detect whether a potential conduction disorder exists. In case of a potential conduction disorder existing (presence) (24), the device is then set to a DDD mode and the automatic mode commutation is inhibited. Otherwise (26), the device is set to an AAI mode, and the automatic mode commutation remains activated.