Rotatable Intracardiac Device Header Assembly for Compact Implantable Systems
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Solution Overview
Problem
Existing implantable intracardiac devices face challenges with large dimensions, complex manufacturing processes, and difficulties in device removal due to fixed rotation with the fixation mechanism.
Innovation Solution
A manufacturing method for a header assembly with a conically formed base ring, a header cap, and a header base, allowing for uniaxial assembly and automation, with a tine-based fixation mechanism that enables rotational freedom during device removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If a standard header design is used in implantable intracardiac devices, then the device can accommodate fixation mechanisms, but the header takes space from critical components like battery or electronics module, affecting device longevity and therapeutic features
Solution Approach 1:
The header assembly incorporates a rotatable base ring that can rotate relative to the housing, allowing the fixation tines to be positioned at different angles. This dynamic capability enables the device to adapt to different implantation orientations and patient anatomies while maintaining a compact header design that preserves space for critical components.
Solution Approach 2:
The header assembly is divided into distinct modular components: a header cap, a header base, and a separately rotatable base ring with fixation tines. This segmentation allows each component to be optimized independently - the header cap and base can be minimized to save space, while the base ring provides the necessary fixation functionality with rotational freedom.
2Reliability
If fixation mechanisms with anti-rotation features are used, then the device can be securely fixed to tissue, but rotation of the device relative to the fixation mechanism is prohibited, adding procedural challenge during device removal
Solution Approach 1:
The base ring is designed to be rotatable relative to the housing, allowing the fixation tines to be oriented at different angles during implantation to match the optimal tissue engagement direction. During removal, the base ring can be rotated to align the tines with the withdrawal direction, reducing tissue resistance and facilitating easier extraction compared to fixed anti-rotation designs.
3Manufacturing precision
If sophisticated alignment methods are used to fixate the tine array to the housing, then precise positioning can be achieved, but the manufacturing process becomes complex and hard to automate
Solution Approach 1:
The base ring is pre-formed with the fixation tines attached in a predetermined configuration. This preliminary preparation allows the base ring to be treated as a single modular unit that can be easily attached to the housing without requiring complex alignment procedures during final assembly. The pre-established geometry of the base ring ensures proper positioning while simplifying the manufacturing process.
4Strength
If manual cleaning is performed after manufacturing using silicone adhesive, then assembly can be secured, but the process requires additional manual intervention and increases manufacturing time
Solution Approach 1:
The base ring is integrally formed with the fixation tines as a single piece structure. This merging of components eliminates the need for separate adhesive bonding steps and subsequent manual cleaning operations. The integral construction provides sufficient mechanical strength for secure attachment while enabling fully automated manufacturing processes without reducing assembly bonding reliability.
Data Source
AI summary
A manufacturing method for a header assembly for an implantable intracardiac device, wherein the header assembly comprises at least one tine extending from a conically formed base ring, further comprising a header cap and a header base, wherein the header cap and the header base each comprises a supporting side surface corresponding to the conical form of the base ring, the method comprising:an assembly step, wherein the base ring is placed between the header base and the header cap such that the base ring is located adjacent the supporting header base side surface and the supporting header cap side surface, anda subsequent fixing step, wherein the header cap is permanently fixed to the header base such that the base ring is located in a base ring groove formed by the supporting header cap side surface and the supporting header base side surface.