Modular Biostimulator Assembly for Precise Left Bundle Branch Pacing
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Solution Overview
Problem
Existing leadless pacemakers face challenges in achieving optimal pacing at the left bundle branch due to limited volume for delivery and potential interference with heart structures, requiring multiple attempts for accurate positioning.
Innovation Solution
A modular biostimulator design comprising a header module with a fixation element and pacing electrode, and a housing module with pacing circuitry, allowing separate delivery and connection within the ventricular chamber, reducing interference with adjacent heart structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a leadless pacemaker is delivered to the optimal pacing site at the upper interventricular septal wall, then pacing accuracy is improved, but the risk of interfering with adjacent heart structures (tricuspid valve, ventricular free wall) increases
Solution Approach 1:
The biostimulator is divided into two separate modules: a header module containing the fixation element and pacing electrode, and a housing module containing the pacing circuitry. This segmentation allows the header to be delivered first to the precise pacing site, followed by the housing module, reducing the risk of interference with adjacent structures while maintaining pacing accuracy.
Solution Approach 2:
The header module is delivered and positioned at the target pacing site before the housing module is delivered. This preliminary positioning allows the pacing electrode to be accurately placed at the upper interventricular septal wall while the housing module follows, minimizing the risk of interference with the tricuspid valve and ventricular free wall.
2Strength
If a long and rigid leadless pacemaker body is used, then structural strength is improved, but maneuverability to reach the interventricular septal wall deteriorates
Solution Approach 1:
By dividing the biostimulator into a compact header module and a separate housing module, each component can be smaller and more flexible than a single long rigid body, improving maneuverability while maintaining structural strength through proper anchoring of the header.
Solution Approach 2:
The header module can be delivered through the delivery system first, followed by the housing module which is then attached to the header. This nested delivery approach allows both components to navigate the delivery path effectively while maintaining their structural integrity.
3Measurement precision
If multiple approach attempts are made to achieve acceptable positioning, then positioning accuracy is improved, but procedure time and fluoroscopic exposure increase
Solution Approach 1:
The header module is pre-loaded with the fixation element and pacing electrode, and is delivered first to the target site. This preliminary delivery allows for accurate positioning in a single attempt, as the header can be precisely placed at the upper interventricular septal wall before the housing module is attached, reducing the need for multiple approach attempts.
4Object-affected harmful factors
If the header module and housing module are delivered separately, then interference with adjacent structures is reduced, but device complexity increases
Solution Approach 1:
The biostimulator is segmented into a header module and a housing module, each with distinct functions. The header module contains the fixation element and pacing electrode for precise positioning, while the housing module contains the pacing circuitry. This segmentation reduces interference with adjacent structures by allowing sequential delivery and attachment within the ventricular chamber.
Solution Approach 2:
A delivery system acts as an intermediary to deliver both the header module and housing module to the target site. The delivery system facilitates the separate delivery and subsequent attachment of the two modules, simplifying the implantation process despite the modular complexity.
Data Source
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AI summary
A biostimulator system includes a biostimulator (100) having a header module (150) and a housing module (152). The header module (150) includes a fixation element (106), a pacing electrode (108), and an electrical pin (304). The housing module (152) includes pacing circuitry that is electrically connected to a power source (206), and an electrical socket (306) to receive and electrically connect the electrical pin (304) to the pacing circuitry. The biostimulator system includes a biostimulator transport system (503) to deliver the header module (150) to an interventricular septal wall (104) and to deliver the housing module (152) to a ventricular chamber. The modules (150, 152) are then electrically connected within the ventricular chamber. Other embodiments are also described and claimed.