Conical Intracardiac Header Assembly for Space Optimization
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Solution Overview
Problem
Existing implantable intracardiac devices face challenges with large header designs that occupy space from critical components, complex manufacturing processes, and difficulties in device removal due to fixed rotation with tissue encapsulation, leading to increased costs and procedural complexity.
Innovation Solution
A conically shaped header assembly with a simplified manufacturing method that allows for automated assembly, reduced component count, and rotational freedom of the tine array, utilizing a base ring, header cap, and washer-like spacer for secure fixation and space optimization within the intracardiac device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If a standard header design is used in implantable intracardiac devices, then the device provides structural support and component mounting, but it occupies space from critical components such as battery or electronics module, affecting device longevity and therapeutic features
Solution Approach 1:
The header assembly is divided into multiple components: a header base with conical cavity, a base ring with tines, and a header cap. This segmentation allows each component to be optimized independently and assembled together, reducing the overall volume while maintaining structural integrity and supporting critical components
Solution Approach 2:
The base ring with tines is nested within the conical cavity of the header base, and the header cap encloses the base ring. This nested arrangement maximizes space utilization within the header assembly, minimizing the volume occupied by the header while providing structural support for the battery and electronics module
2Reliability
If sophisticated alignment methods and multiple components are used to fixate the tine array to the medical implant housing, then secure fixation is achieved, but the manufacturing process becomes complex and difficult to automate
Solution Approach 1:
The base ring is integrally formed with the tines as a single piece, eliminating the need for separate fixation components and complex assembly steps. The conical cavity in the header base and the conical outer surface of the base ring provide self-aligning features that simplify the assembly process and enable automation while maintaining secure fixation
3Reliability
If fixation mechanisms with anti-rotation features are used, then the device is 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 fixation mechanism transitions from a static, fixed-rotation design to a dynamic system where the base ring can rotate within the conical cavity of the header base. This rotational freedom is maintained during normal operation but can be utilized during device removal to facilitate extraction, especially when tissue encapsulation varies, thereby improving ease of operation without compromising fixation stability
Data Source
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AI summary
The invention refers to a manufacturing method for a header assembly for an implantable intracardiac device and to a respective manufacturing method for the intracardiac device, wherein the header assembly comprises at least one tine (3, 103) extending from a base ring (33, 133), wherein the base ring (33, 133) is conically formed, further comprising a header cap (2, 102) and a header base (1, 101), wherein the header cap (2, 102) and the header base (1, 101) each comprises a supporting side surface (43, 53, 143, 153) corresponding to the conical form of the base ring (33, 133), wherein the manufacturing method comprises the following steps: - an assembly step, wherein the base ring (33, 133) is placed between the header base (1, 101) and the header cap (2, 102) such that the base ring (33, 133) is located adjacent the supporting header base side surface (53, 153) of the header base (1, 101) and the supporting header cap side surface (43, 143) of the header cap (2, 102), and - a subsequent fixing step, wherein the header cap (2, 102) is permanently fixed to the header base (1, 101) such that the base ring (33, 133) is located in a base ring groove formed by the supporting header cap side surface (43, 143) and the supporting header base side surface (53, 153).