Biostimulator Header Assembly With Integrated Fixation Mount
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Solution Overview
Problem
Conventional pacemakers face issues such as lead or feedthrough assembly breakage, complex connections, and infection risks due to separate leads and pulse generator components, which are addressed by the development of leadless biostimulators. However, existing leadless biostimulators suffer from increased device size and complexity due to threaded connections and additional components like gaskets and adhesives for hermeticity.
Innovation Solution
A header assembly for biostimulators with an integrated fixation element mount, utilizing a mounting ring on an insulator base and direct connections like brazing joints to eliminate threaded connections, reducing the number of components and assembly steps, thereby minimizing device size and enhancing mechanical stability and electrical reliability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If threaded connections and additional components like gaskets and adhesives are used to achieve hermeticity, then hermeticity and electrical isolation are improved, but device size and complexity increase
Solution Approach 1:
The fixation element mount is integrated directly into the header assembly, merging multiple components (fixation element, mount, and hermetic seal) into a single unified structure. This eliminates the need for separate threaded connections, gaskets, and adhesives, thereby achieving hermeticity without increasing device complexity
Solution Approach 2:
The integrated fixation element mount performs multiple functions simultaneously: it provides mechanical fixation, ensures hermetic sealing, and maintains electrical isolation. This multi-functionality eliminates the need for separate dedicated components for each function, reducing overall device complexity while maintaining reliability
2Strength
If threaded connections are used to attach fixation element to mount, then mechanical stability is improved, but device size increases
Solution Approach 1:
The fixation element mount is integrated directly into the header assembly structure, eliminating the need for separate threaded connections. This merging of components reduces the overall device volume while maintaining mechanical stability through the unified structural design
3Ease of manufacture
If multiple separate components are used in header assembly, then ease of manufacture is improved, but device complexity and potential leak paths increase
Solution Approach 1:
The fixation element mount is integrated as a single component within the header assembly, reducing the total number of parts that need to be manufactured and assembled. This integration simplifies the manufacturing process by reducing assembly steps while simultaneously reducing device complexity and eliminating potential leak paths at component interfaces
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The integrated fixation element mount reduces device size, complexity, and potential leak paths, improving implantation and manufacturability while maintaining hermeticity and electrical isolation, thus enhancing the reliability and functionality of leadless biostimulators.
Implementation Method 1
The mounting ring extends around the central axis within a groove of the insulator base
Implementation Method 2
utilizing a mounting ring on an insulator base and direct connections like brazing joints to eliminate threaded connections
Implementation Method 3
The feedthrough components maintain electrical isolation to other components, and require hermeticity to avoid fluid and electrical leaks
Data Source
AI summary
A biostimulator system includes a biostimulator coupled to a biostimulator transport system. The biostimulator includes a header assembly. The header assembly includes a flange having a central axis. A fixation element mount is mounted on the flange. The fixation element mount includes a mounting ring on an insulator base. The mounting ring extends around the central axis within a groove of the insulator base. A fixation element is coupled to the mounting ring. Other embodiments are also described and claimed.