Biostimulator Fixation Guide for Left Bundle Branch Pacing
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Solution Overview
Problem
Existing leadless pacemakers are not suitable for left bundle branch (LBB) pacing due to their long and rigid design, which can interfere with heart structures such as the tricuspid valve and ventricular free wall, and may become tangled in chordae tendinae.
Innovation Solution
A biostimulator with a housing, a fixation guide, and a fixation element, where the fixation element is movable through a guide passage from an undeployed state to a deployed state, allowing the biostimulator to be anchored securely to the interventricular septal wall without protruding into adjacent heart structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing leadless pacemakers are placed at the optimal pacing site for LBB pacing, then optimal pacing of the left bundle branch is achieved, but the long and rigid body extends into contact with cardiac tissue of ventricular free wall or tricuspid valve during heart contraction
Solution Approach 1:
The biostimulator body is segmented into modular components: a compressed body portion that can be compacted to a small diameter for delivery, and an expanded body portion that provides stable anchoring at the pacing site. This segmentation allows the device to navigate to the optimal LBB pacing site without interfering with adjacent heart structures during contraction.
Solution Approach 2:
The biostimulator incorporates a dynamically adjustable body that transitions from a compressed low-profile state during delivery to an expanded stable state after implantation. The body can change its dimensions and rigidity characteristics to adapt to the pacing site requirements while avoiding interference with moving heart structures.
2Reliability
If existing leadless pacemakers are placed at the optimal pacing site, then LBB pacing is achieved, but the proximal end flails within the heart chamber causing cyclical contact with adjacent structures
Solution Approach 1:
The biostimulator is divided into functionally distinct segments: an anchoring portion with fixation elements for stable attachment to the septal wall, a compressed body portion containing electronics, and a pacing electrode portion. This segmentation allows each component to perform its specific function optimally while maintaining overall device stability.
Solution Approach 2:
The fixation elements extend radially outward from the biostimulator body in a direction perpendicular to the longitudinal axis, anchoring the device to the septal wall. This dimensional change provides stable fixation that prevents proximal end flailing and cyclical contact with adjacent heart structures during cardiac contraction.
Data Source
AI summary
A biostimulator includes a housing having an electronics compartment containing pacing circuitry. A fixation guide is mounted on the housing and includes a guide passage. A fixation element is movable through the guide passage from an undeployed state to a deployed state. In the undeployed state, a fixation tip of the fixation element is within the guide passage. In the deployed state, the fixation tip extends out of the guide passage. A biostimulator system includes the biostimulator mounted on a biostimulator transport system to deliver the biostimulator to, and extend the fixation tip into, a target anatomy. Other embodiments are also described and claimed.