Modular Biostimulator Layout for Precise Septal Pacing
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing leadless pacemakers face challenges in achieving optimal pacing at the left bundle branch due to limited volume and 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
1Manufacturing precision
If a leadless pacemaker with a long rigid body is used for septal pacing, then the pacing electrode can reach the interventricular septal wall, but the pacemaker body extends into contact with cardiac tissue of ventricular free wall or tricuspid valve during heart contraction
Solution Approach 1:
The pacemaker 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 positioned at the optimal septal site while the housing is anchored at a safer location, eliminating the interference problem caused by long rigid bodies.
Solution Approach 2:
A flexible tether connects the header module to the housing module, serving as an intermediary that allows the header to reach the interventricular septal wall through the limited volume while preventing the housing from interfering with adjacent heart structures during cardiac contraction.
2Manufacturing precision
If multiple approach attempts are made to achieve acceptable positioning, then the pacing electrode can be correctly positioned at the interventricular septal wall, but the procedure time and complexity increase
Solution Approach 1:
The separable modular design allows the header module to be delivered and positioned independently at the target site, enabling more precise and controlled positioning without the constraints of a single integrated device, thereby reducing the need for multiple repositioning attempts.
Solution Approach 2:
The flexible tether provides dynamic positioning capability, allowing the header module to be maneuvered into the correct position on the interventricular septal wall while the housing remains anchored, facilitating accurate positioning in a single attempt rather than requiring multiple rigid repositioning attempts.
3Manufacturing precision
If the limited volume of the upper ventricular area is constrained, then the optimal pacing site for left bundle branch pacing can be accessed, but the delivery of a leadless pacemaker with sufficient components becomes difficult
Solution Approach 1:
By separating the pacemaker into a compact header module that can fit within the limited upper ventricular volume and a separate housing module that can be anchored elsewhere, the design accommodates the spatial constraints while maintaining all necessary functional components.
Solution Approach 2:
The header module with the pacing electrode can be delivered through a catheter or delivery system to the target site, then the housing module is attached, creating a nested configuration that optimizes space utilization in the constrained ventricular environment.
Data Source
Figure 1
Figure 2
Figure 3
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.