Leadless Pacemaker Synchronization via Subcutaneous Trigger
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Solution Overview
Problem
Current cardiac pacing systems face challenges in synchronizing pacing pulses between heart chambers, particularly in delivering effective left ventricular pacing during cardiac resynchronization therapy, due to the lack of leads and complications associated with transvenous leads, which affect the timing and efficiency of pacing therapies.
Innovation Solution
An implantable medical device system comprising a leadless intracardiac pacemaker and a subcutaneously positioned sensing device that communicates wirelessly to deliver pacing therapy, using a trigger signal to synchronize pacing pulses with sensed events, and adjusts pacing parameters to ensure effective capture of the left ventricle, incorporating a therapy delivery device and a cardiac sensing device with a programmer for controlling pacing intervals and parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If transvenous leads are used for cardiac pacing, then pacing therapy can be delivered to heart chambers, but complications such as infection, lead fracture, and poor connection occur
Solution Approach 1:
The patent removes the transvenous lead from the system entirely, extracting the harmful element while preserving the essential pacing function. The leadless intracardiac pacemaker delivers pacing therapy directly within the heart chamber without requiring a transvenous lead, thereby eliminating infections, lead fractures, and connection issues associated with traditional lead-based systems
Solution Approach 2:
The patent introduces a leadless intracardiac pacemaker as an intermediary device that can be implanted directly in the heart chamber. This intermediary eliminates the need for transvenous leads while maintaining the ability to deliver pacing therapy, effectively mediating between the pacing function and the elimination of lead-related complications
2Object-affected harmful factors
If leadless intracardiac pacemaker is used, then lead-related complications are eliminated, but synchronizing pacing pulses between heart chambers becomes more difficult
Solution Approach 1:
The patent employs sensing capabilities within the leadless intracardiac pacemaker to detect cardiac electrical signals and uses this feedback information to automatically adjust pacing pulse timing. The device senses cardiac events and modifies its pacing output accordingly, enabling synchronized biventricular pacing without requiring transvenous leads or complex external synchronization systems
Solution Approach 2:
The leadless intracardiac pacemaker is designed with multi-functional capabilities, including both pacing and sensing functions within a single device. This universal design allows the device to autonomously manage pacing pulse synchronization by integrating sensing and response capabilities, eliminating the need for separate lead-based sensing systems
3Reliability
If CRT therapy is delivered with traditional leads, then pacing can be synchronized with sensed events, but device size and complexity increase
Solution Approach 1:
The patent merges the pacing and sensing functions into a single leadless intracardiac pacemaker device. By combining these functions that were traditionally separated in lead-based systems, the device achieves CRT capability with reduced overall system complexity, eliminating the need for multiple leads and associated synchronization infrastructure
Data Source
AI summary
A medical device and medical device system for delivering left ventricular pacing that includes a subcutaneous sensing device having a subcutaneous electrode to sense a subcutaneous cardiac signal and an emitting device to emit a trigger signal in response to the sensed cardiac signal, an intracardiac therapy delivery device to deliver the left ventricular pacing in response to the emitted trigger signal, and a processor configured to determine whether the medical device system is in one of a VVD pacing mode and a VVI pacing mode, determine whether the delivered left ventricular pacing captures the left ventricle, determine whether to adjust a pacing parameter in response to the determination of whether the device system is in one of a VVD pacing mode and a VVI pacing mode and the determination of whether the delivered left ventricular pacing captures the left ventricle, and deliver the left ventricular pacing in response to determining whether to adjust the pacing parameter.