Expandable Frame Biostimulator for Left Bundle Branch Pacing
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Solution Overview
Problem
Existing leadless pacemakers are not suitable for left bundle branch pacing due to their rigid and long bodies, which can interfere with heart structures and cause cyclical contact, leading to potential heart function interference.
Innovation Solution
A biostimulator with an expandable frame and electrode extension that anchors outside the heart, allowing pacing at the septal wall without interfering with heart structures, using an expandable frame to secure the housing in the inferior vena cava and an electrode extension to engage the target tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a rigid and long body is used in leadless pacemakers, then structural strength is improved, but interference with heart structures increases
Solution Approach 1:
The pacemaker is divided into two separate components: a pulse generator implanted in the inferior vena cava and a pacing lead positioned at the septal wall. This segmentation allows each component to be optimized independently - the pulse generator can have a rigid body for structural strength while the lead is designed to minimize interference with heart structures during pacing.
Solution Approach 2:
A pacing lead acts as an intermediary between the pulse generator and the target tissue. The lead transmits electrical signals from the pulse generator to the septal wall, allowing the pulse generator to remain positioned in the inferior vena cava without directly interfering with heart structures while still achieving effective pacing.
2Strength
If a rigid and long body is used in leadless pacemakers, then structural strength is improved, but cyclical contact with heart structures increases
Solution Approach 1:
By separating the pulse generator from the pacing function, the system eliminates cyclical contact between the rigid body and heart structures. The pulse generator remains stationary in the inferior vena cava while the flexible lead delivers pacing signals, preventing fatigue failure from repeated mechanical contact.
Solution Approach 2:
The pacing lead uses flexible materials that can accommodate heart movement without causing cyclical contact or fatigue. The flexible insulation and electrode structures allow the lead to bend and move with cardiac motion while maintaining electrical function and avoiding mechanical stress on the pulse generator.
3Ease of operation
If the pulse generator is positioned inside the heart chamber, then pacing function is achieved, but interference with heart structures increases
Solution Approach 1:
The pacing lead serves as an intermediary that transmits electrical signals from the pulse generator in the inferior vena cava to the septal wall. This allows the pulse generator to be positioned away from heart structures while still achieving effective pacing function through the lead.
Solution Approach 2:
The system replaces direct mechanical contact between the pulse generator and heart tissue with electrical signal transmission through the lead. Instead of the pulse generator physically interacting with heart structures, it sends electrical impulses through the lead to achieve pacing, eliminating mechanical interference.
Data Source
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AI summary
A biostimulator (200) includes a housing (302), an electrode extension (206), and an expandable frame (320). The housing (302) has a longitudinal axis (304) and an electronics compartment (306) containing pacing circuitry. The electrode extension (206) extends distally between the housing (302) and an electrode (212). The biostimulator (200) includes an expandable frame (320) including several struts (322) disposed about the longitudinal axis (304). Other embodiments are also described and claimed.