Leadless Pacemaker Replacement With Address-Switched Therapy Handover
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Solution Overview
Problem
The challenge of safely replacing a leadless cardiac pacemaker without interrupting therapy in pacemaker-dependent patients, as there is no lead to move from one implant to another, and ensuring the new electrode placement is adequate for continuous therapy.
Innovation Solution
A programming device that sends wireless command signals to change the address of the implanted medical device and replacement device, allowing independent communication, and coordinates the transition of therapy from the old device to the new device through a series of command signals and communication protocols, ensuring temporary and permanent deactivation and activation states.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the new leadless pacemaker is implanted in an inactive state to avoid competing with the old device, then device safety is improved, but therapy interruption risk increases because the electrode tissue interface is untested
Solution Approach 1:
The new pacemaker is activated in advance during the implantation procedure before the old device is deactivated. This preliminary activation allows the new device to be tested with the electrode-tissue interface while the old device continues to provide backup therapy, thus avoiding therapy interruption while ensuring safety through coordinated deactivation only after successful activation and testing.
2Ease of operation
If the programming device uses a fixed address for communication, then communication simplicity is improved, but the ability to manage multiple devices (old and new pacemakers) simultaneously deteriorates
Solution Approach 1:
The programming device dynamically changes the address of the old pacemaker during the replacement process. Initially, both devices communicate using a fixed address. When the new pacemaker is implanted and tested, the programming device changes the old device's address to a different value, allowing simultaneous independent communication with both devices without conflict, thus maintaining communication simplicity while enabling multi-device management.
3Productivity
If the old pacemaker is deactivated immediately upon implantation of the new device, then device replacement efficiency is improved, but therapy continuity deteriorates because the new electrode placement may be inadequate
Solution Approach 1:
The old pacemaker remains activated and provides continuous therapy during the implantation and testing of the new device. The deactivation of the old device is delayed until after the new device has been successfully activated and its electrode-tissue interface has been confirmed adequate. This ensures continuous useful action (therapy delivery) throughout the replacement process, maintaining both efficiency and reliability.
Data Source
AI summary
The present invention relates to a system and method for replacing an implanted medical device with an implantable medical replacement device, wherein a programming device sends a command signal to the medical device to change an address of the medical device to a new address being different from an address of the replacement device to allow independent communication of the programming device with both the medical device and the replacement device.