Implantable Device Header Splitline Rounding

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Solution Overview

Problem

Implantable medical device headers with multiple silicone portions often form sharp edges at the mating areas, which can cause damage during assembly or insertion, leading to potential injury and manufacturing challenges.

Innovation Solution

The implementation of a splitline feature with rounded outer edges for the silicone portions of the header, where the edges are rounded to a radius of greater than 8 thou, 10 thou, or 15 thou, or feature a radius undercut, indentation, or machining at the splitline to prevent sharp edges.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If multiple silicone portions are mated together to form the header, then the header can be assembled from separate components, but sharp edges are formed at the mating areas causing damage during assembly or insertion

Engineering Contradiction:
Improveheader assemblyVSAvoidsharp edge damage
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by rounding the outer edges of the silicone portions before they are mated together. This pre-rounding of edges (to a radius of greater than 8 thou, 10 thou, or 15 thou) prevents sharp edge formation at the splitline before assembly occurs, thereby eliminating the harmful effect of sharp edges while maintaining the benefit of modular assembly

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent applies spheroidality by introducing curved surfaces at the outer edges of the silicone portions where they meet. The rounded edges (with specified radius values) replace the sharp angular edges that would naturally form at the mating surfaces, converting the harmful sharp geometry into a beneficial curved geometry that prevents damage during assembly and insertion

Inventive Principle:
Principle #14Spheroidality (Curvature)

2Object-affected harmful factors

If polishing is used to remove sharp edges, then smooth edges can be achieved, but additional manufacturing steps and time are required

Engineering Contradiction:
Improvesharp edge eliminationVSAvoidmanufacturing cycle time
Core Design Contradiction:
Object-affected harmful factorsVSProductivity

Solution Approach 1:

The patent eliminates the need for post-assembly polishing by performing the edge rounding action during the molding or forming process itself. The silicone portions are provided with already-rounded outer edges before assembly, making the harmful sharp edges non-existent from the start rather than requiring a separate corrective polishing step afterward

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent extracts the edge rounding operation from the post-assembly polishing process and incorporates it into the initial silicone portion formation process. By taking out the sharp edge creation step and replacing it with direct rounded edge formation during molding, the need for subsequent polishing operations is eliminated, thereby improving productivity

Inventive Principle:
Principle #2Taking out (Extraction)

Data Source

PatentUS20240226585A1Header splitline feature
Publication Date: 2024.07.11 CARDIAC PACEMAKERS INC
  • US20240226585A1 patent drawing
  • US20240226585A1 patent drawing
  • US20240226585A1 patent drawing

AI summary

An implantable medical device can include a housing including electronic devices within the housing, and a header attached to the housing. The header can include a first silicone portion configured to surround a first portion of internal electronics of the header, and a second silicone portion configured to surround a second portion of internal electronics of the header. The header can further include a splitline where the first silicone portion abuts the second silicone portion, wherein an outer edge of the first silicone portion and an outer edge of the second silicone portion are rounded at the splitline to prevent a sharp edge that may cause damage during assembly or insertion.