Leadless Pacemaker Triggered by External Cardiac Sensing
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Solution Overview
Problem
Implantable pacemakers face challenges in delivering pacing pulses in synchrony with events in other heart chambers, particularly for cardiac resynchronization therapy (CRT), due to the absence of physical connections between sensing and therapy delivery devices, which complicates the control of leadless intracardiac pacemakers.
Innovation Solution
An implantable medical device system that senses cardiac signals using electrodes outside the cardiovascular system to generate ECG signals, which are used to trigger an intracardiac pacemaker to deliver therapy without a physical connection, utilizing a trigger signal emitted by a sensing device to control the therapy delivery device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If leadless intracardiac pacemakers are used to eliminate transvenous leads, then complications due to infection and lead-related issues are eliminated, but the ability to synchronize pacing pulses with events in other heart chambers is compromised
Solution Approach 1:
The patent introduces a trigger signal as an intermediary communication mechanism between the sensing device and the leadless pacemaker. The sensing device detects cardiac events and generates trigger signals that are transmitted to the pacemaker, which then delivers synchronized pacing pulses. This mediator approach enables synchronization control without requiring physical lead connections.
Solution Approach 2:
The patent replaces the mechanical/physical connection system (transvenous leads) with an electromagnetic signal transmission system. Instead of using physical wires to transmit control signals from the sensing device to the pacemaker, the system uses wireless or electromagnetic trigger signals, thereby eliminating lead-related complications while maintaining synchronization capability.
2Ease of operation
If transvenous leads are used to connect sensing and therapy delivery devices, then synchronization of pacing pulses with cardiac events is achieved, but complications due to infection and lead-related issues occur
Solution Approach 1:
The patent extracts and removes the problematic transvenous leads from the system while retaining the essential function of synchronization. By separating the sensing device and pacemaker into independent leadless components and communicating them via trigger signals, the harmful leads are taken out of the system, eliminating infection risks and lead-related complications.
Solution Approach 2:
The trigger signal serves as an intermediary that transmits synchronization information without requiring physical lead connections. This mediator enables the pacemaker to receive timing information from the sensing device through wireless or electromagnetic transmission, achieving synchronization while avoiding the harmful effects of transvenous leads.
3Ease of manufacture
If trigger signals are used to control leadless pacemaker without physical connections, then minimally invasive implant procedures are enabled and device size is reduced, but the complexity of signal transmission and reception increases
Solution Approach 1:
The patent extracts the complex lead and RF transmitter components from the system, replacing them with simplified leadless devices that communicate via trigger signals. This extraction reduces the physical complexity of the implantation system while enabling minimally invasive procedures, as the trigger signal transmission requires no physical connectors or large RF hardware.
Data Source
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AI summary
A medical device system including an intracardiac pacemaker is configured to receive by an implantable medical device sensing module a first cardiac signal using a first pair of electrodes implanted outside the cardiovascular system and identify a P-wave from the first cardiac signal. The system transmits a wireless trigger signal to the intracardiac pacemaker in response to identifying the P-wave. The intracardiac pacemaker delivers a pacing therapy in response to the trigger signal.