Flexible Circuit Assembly for Leadless Biostimulator Packaging
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Solution Overview
Problem
Conventional pacemakers have complex connections between leads and pulse generators, leading to infection and morbidity risks, and the miniaturization of leadless biostimulators is necessary to reduce the risk of short-circuiting due to conductive residues during manufacturing.
Innovation Solution
A leadless biostimulator with a flexible circuit assembly that includes a folded substrate to insulate electronic and battery components, using a feedthrough connector and battery connectors on a mounting surface, and additional insulators to prevent short-circuiting, allowing for a compact and reliable device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the biostimulator is miniaturized to reduce device profile, then packaging efficiency is improved, but the risk of short-circuiting between battery and electronic circuitry increases
Solution Approach 1:
The device is divided into distinct conductive regions separated by insulating barriers. The battery and electronic circuitry are spatially segmented and isolated from each other by the folded substrate and insulating coatings, preventing direct electrical contact while maintaining compact dimensions.
Solution Approach 2:
Insulating structures serve as intermediary elements between the battery and electronic circuitry. The folded substrate and insulating coatings act as mediators that physically separate conductive components, preventing short-circuits while allowing the device to maintain a compact form factor.
2Reliability
If conventional pacemaker leads and pulse generators are used, then electrical stimulation can be delivered to the heart, but complex connections increase the risk of infection and morbidity
Solution Approach 1:
The biostimulator integrates the pulse generator, battery, and electrode functions into a single self-contained implantable device. This merging eliminates the need for separate leads and external pulse generators, reducing connection points that could serve as infection pathways while maintaining the ability to deliver electrical stimulation to the heart.
3Reliability
If the flexible substrate is folded to insulate components, then short-circuiting risk is reduced, but manufacturing complexity increases
Solution Approach 1:
A flexible substrate is used to create the insulating barrier between conductive components. The substrate can be folded or shaped to provide effective electrical isolation while maintaining a compact device profile. This approach uses thin film technology that can be integrated into standard manufacturing processes for implantable devices.
Data Source
AI summary
A biostimulator, such as a leadless cardiac pacemaker, having a flexible circuit assembly, is described. The flexible circuit assembly is contained within an electronics compartment between a battery, a housing, and a header assembly of the biostimulator. The flexible circuit assembly includes a flexible substrate that folds into a stacked configuration in which an electrical connector and an electronic component of the flexible circuit assembly are enfolded by the flexible substrate. An aperture is located in a fold region of the flexible substrate to allow a feedthrough pin of the header assembly to pass through the folded structure into electrical contact with the electrical connector. The electronic component can be a processor to control delivery of a pacing impulse through the feedthrough pin to a pacing tip. Other embodiments are also described and claimed.