Burrowing-Nose Biostimulator for Deep Septal LBB Pacing
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Solution Overview
Problem
Existing leadless pacemakers are not suitable for left bundle branch (LBB) pacing due to their rigid design, which can interfere with cardiac tissue and structures, and often fail to reach the LBB effectively, leading to potential interference with heart function during contraction.
Innovation Solution
A biostimulator with a burrowing nose and fixation mechanisms, such as a helical electrode or burrowing ridge, that screws into the target tissue to embed the device deeply, minimizing exposure within the heart chamber and reducing interference with adjacent structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing leadless pacemakers are placed at the interventricular septal wall for LBB pacing, then the device can be implanted, but the rigid body extends into contact with cardiac tissue and structures during heart contraction, causing interference with heart function
Solution Approach 1:
The pacemaker body is divided into distinct functional segments: a compressed electronics compartment, a separate fixation mechanism with burrowing nose, and a pacing electrode. This segmentation allows each component to perform its specific function while minimizing overall interference with cardiac structures during contraction.
Solution Approach 2:
The pacemaker transitions from a conventional linear elongated body to a compact three-dimensional configuration with the electronics compartment compressed in one dimension and the fixation mechanism extending in another. This dimensional reconfiguration reduces the device's projection into the cardiac chamber during contraction.
2Length of moving object
If existing leadless pacemakers are used for LBB pacing, then the device can be implanted, but the electrodes are designed to superficially contact the septal wall rather than be driven deep into the septal wall, preventing effective reach to the LBB
Solution Approach 1:
The burrowing nose with fixation mechanism performs preliminary anchoring action by screwing into the interventricular septal wall before the pacing electrode is positioned. This preliminary fixation enables the electrode to be driven deep into the septal wall to reach the LBB without compromising device stability.
Solution Approach 2:
The burrowing nose acts as an intermediary mechanism that mediates between the pacemaker body and the septal wall. It provides a secure anchoring interface that enables deep electrode penetration while minimizing the exposed length of the pacemaker body in the cardiac chamber.
3Stability of the object's composition
If existing leadless pacemakers are implanted at the septal wall, then the device can be positioned, but the proximal end flails within the heart chamber as the heart beats, causing cyclical contact with adjacent structures
Solution Approach 1:
The burrowing nose with fixation mechanism provides a counterbalancing anchoring force that opposes the flailing motion of the pacemaker body during cardiac contraction. This fixation mechanism effectively counteracts the dynamic forces that would otherwise cause cyclical contact with adjacent cardiac structures.
Solution Approach 2:
The fixation mechanism with burrowing nose provides beforehand anchoring that cushions and protects the pacemaker body from harmful flailing motions. This preliminary securing prevents cyclical contact with adjacent structures before such contact can occur during heartbeats.
Data Source
AI summary
A biostimulator and a biostimulator system for septal pacing, is described. The biostimulator includes a burrowing nose to allow the biostimulator to embed within a target tissue. The embedded biostimulator has a reduced exposed length within a heart chamber, and is less likely to interfere with adjacent heart structures. Embodiments include burrowing ridges on a nose or a housing of the biostimulator to affix the embedded biostimulator to the target tissue. Other embodiments are also described and claimed.