Leadless Multi-Site Stimulator Synchronization for Dual-Chamber Pacing
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Solution Overview
Problem
Current leadless pacemakers are limited to single-chamber ventricular pacing, failing to meet the needs of patients requiring dual-chamber systems or cardiac resynchronization therapy, and they lack effective communication between pacing sites, leading to suboptimal physiological responses and high complication rates.
Innovation Solution
A leadless multi-site bioelectronic stimulator system comprising a transmit stimulator device and a receive stimulator device, both with radially expandable stent structures and wireless coils, allowing for synchronized electrical stimulation across multiple anatomical locations, including the heart chambers and various bodily tissues, using a flexible battery and electronic circuits for communication and power transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If leadless pacemakers are designed for single-chamber ventricular pacing only, then device complexity is reduced and ease of manufacture is improved, but adaptability to different patient needs deteriorates
Solution Approach 1:
The system is divided into a transmit stimulator device and one or more receive stimulator devices that can be independently implanted in different anatomical locations. Each device can be configured for specific pacing chambers, enabling dual-chamber or multi-site pacing capabilities without requiring a single complex device to perform all functions.
Solution Approach 2:
The transmit stimulator device is designed with universal functionality to communicate with and control multiple receive stimulator devices at different anatomical sites. This multi-functional architecture allows the system to adapt to various pacing requirements (single-chamber, dual-chamber, cardiac resynchronization therapy) using the same basic device platform.
2Reliability
If transvenous leads and subcutaneous pockets are used in pacemaker systems, then electrical stimulation can be delivered to multiple sites, but the risk of complications increases
Solution Approach 1:
The invention extracts and eliminates the transvenous leads and subcutaneous pocket components from the pacemaker system. By using leadless receive stimulator devices implanted directly in the heart chambers, the system removes the sources of lead-related complications (pneumothorax, cardiac perforation, lead dislodgement, infections) while maintaining the ability to deliver electrical stimulation to multiple pacing sites.
3Adaptability or versatility
If single-chamber leadless pacemakers are used, then device complexity is reduced, but the ability to provide dual-chamber pacing and cardiac resynchronization therapy is lost
Solution Approach 1:
The pacing system is segmented into a transmit device and separate receive devices that can be implanted in different heart chambers. This segmentation allows independent optimization of each device for its specific function while enabling complex pacing strategies through their coordinated interaction.
Solution Approach 2:
The transmit stimulator device acts as an intermediary that wirelessly communicates pacing commands and coordinates the operation of multiple receive stimulator devices. This intermediary function enables dual-chamber pacing and cardiac resynchronization therapy by synchronizing stimulation between different heart chambers without requiring direct physical connections.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system provides advanced stimulation options, reduces complications, and enhances synchronization, making it suitable for dual-chamber pacing and cardiac resynchronization therapy, while minimizing surgical invasiveness and improving patient outcomes.
Implementation Method 1
a wireless transmit coil comprising the first radially expandable stent structure and at least one transmit stimulator electronic circuit configured to transmit a stimulation signal, and at least one receive stimulator device comprising a second radially expandable stent structure, at least one receive stimulator electrode, a wireless receive coil comprising the second radially expandable stent structure
Data Source
AI summary
A leadless multi-site stimulator system comprises a transmit stimulator device comprising a first radially expandable stent structure, a battery electrically coupled to at least one transmit stimulator electrode, a wireless transmit coil comprising the first radially expandable stent structure, and at least one transmit stimulator electronic circuit configured to transmit a stimulation signal, and at least one receive stimulator device comprising a second radially expandable stent structure, at least one receive stimulator electrode, a wireless receive coil comprising the second radially expandable stent structure, and at least one receive stimulator electronic circuit configured to receive a stimulation signal generated from the at least one transmit stimulator electronic circuit. Methods of operating and implanting the system are also disclosed.