Integrated Helix Mount Header for Leadless Biostimulator Feedthroughs
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Solution Overview
Problem
Existing leadless biostimulators have separate helix mounts and electrical feedthrough assemblies, which increase manufacturing complexity, cost, and risk of mechanical failure due to threaded connections, and require additional insulators and gaskets for electrical isolation.
Innovation Solution
A leadless biostimulator with a header assembly that integrates a helix mount into the electrical feedthrough assembly, using a ceramic portion to electrically isolate the flange from the electrode and employing threadless connectors for easy assembly, reducing components and manufacturing complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate helix mount and electrical feedthrough assembly are used, then electrical isolation can be achieved using insulators and gaskets, but device complexity and manufacturing complexity increase
Solution Approach 1:
The patent combines the helix mount and electrical feedthrough assembly into a single integrated unit. The helix mount body directly provides electrical isolation between the flange and electrode without requiring separate insulators and gaskets. This merging eliminates multiple components and simplifies the overall device structure while maintaining reliable electrical isolation.
2Reliability
If separate helix mount and electrical feedthrough assembly are used, then electrical isolation can be achieved, but manufacturing complexity and cost increase
Solution Approach 1:
By integrating the helix mount and electrical feedthrough assembly into one component, the patent reduces the number of manufacturing steps. The single-piece construction eliminates the need to manufacture, assemble, and seal multiple separate parts, thereby reducing manufacturing complexity and cost while ensuring reliable electrical isolation.
3Ease of operation
If threaded connections are used to fasten helix mount to electrical feedthrough, then mechanical assembly is achieved, but risk of mechanical failure increases
Solution Approach 1:
The patent integrates the helix mount and electrical feedthrough assembly into a single monolithic structure, eliminating threaded connections entirely. This integration removes the mechanical failure pathways associated with threads while maintaining ease of assembly through simplified manufacturing processes such as casting or machining the integrated component as one piece.
4Reliability
If additional insulators and gaskets are used for electrical isolation, then electrical reliability is achieved, but component quantity and cost increase
Solution Approach 1:
The integrated helix mount design incorporates electrical isolation functionality directly into the mount body structure. The helix mount body itself acts as the insulator between the flange and electrode, eliminating the need for separate insulator and gasket components. This reduces component quantity while maintaining electrical reliability.
5Adaptability or versatility
If multiple separate components are used, then assembly flexibility is maintained, but assembly process complexity increases
Solution Approach 1:
By integrating the helix mount and electrical feedthrough assembly into a single component, the patent simplifies the assembly process to a single installation step. The integrated design maintains adaptability through configurable electrode positions and helix orientations within the unified structure, while eliminating the complexity of assembling multiple separate components.
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 design enhances mechanical stability and electrical reliability while lowering costs and simplifying assembly processes, eliminating the need for additional insulators and gaskets.
Implementation Method 1
The helix mount includes a ceramic portion between the flange and the electrode. For example, the ceramic portion can be radially between the flange and the electrode. Accordingly, a shortest path between the flange and the electrode may intersect the ceramic portion of the helix mount, and the ceramic portion can electrically isolate the flange from the electrode.
Data Source
AI summary
A biostimulator, such as a leadless pacemaker, including a header assembly having an electrical feedthrough assembly incorporating a helix mount, is described. The header assembly includes a fixation element mounted on the helix mount. The helix mount is mounted on a flange of the electrical feedthrough assembly, and thus, the fixation element can attach the leadless biostimulator to a target tissue. An electrode of the electrical feedthrough assembly is mounted within the flange to deliver a pacing impulse to the target tissue. A ceramic portion of the helix mount is disposed between the flange and the electrode to block an electrical path between the electrode and the flange. Accordingly, the helix mount both retains the fixation element on the leadless biostimulator and electrically isolates the flange and electrode components of the electrical feedthrough. Other embodiments are also described and claimed.