Implantable Medical Device Header Assembly Sealing

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Solution Overview

Problem

Conventional implantable medical device header assemblies are prone to contamination by liquid epoxy, which seeps through gaps between conductive and non-conductive members, rendering the header assembly unusable.

Innovation Solution

A sealed header assembly connector with a hard fill within the internal volume of the header body, where the exterior of the connector is sealed before transferring the liquid state hard fill material, preventing contamination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If liquid epoxy is used to fill the interior volume of the header body to prevent movement of the HA connector, then the HA connector is secured in position, but the epoxy seeps through gaps between conductive and non-conductive members and contaminates the interior of the HA connector

Engineering Contradiction:

Improveposition stability of HA connectorVSAvoidcontamination of HA connector interior

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The interior volume is divided into two separate compartments: a first compartment containing the HA connector with its conductive and non-conductive members, and a second compartment containing the liquid epoxy fill material. A seal member positioned at the interface between these compartments prevents the epoxy from migrating into the HA connector interior, thus maintaining position stability while preventing contamination.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A seal member acts as an intermediary barrier between the HA connector interior and the liquid epoxy. This seal member is positioned to contact both the header body wall and the HA connector exterior, creating a physical barrier that prevents the epoxy from seeping through the gaps between conductive and non-conductive members while still allowing the epoxy to fill the surrounding volume and secure the connector in place.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If the interior volume is completely filled with liquid epoxy to secure the HA connector, then movement is prevented, but the epoxy contaminates the connector interior rendering the header assembly unusable

Engineering Contradiction:

Improvefunctional reliability of header assemblyVSAvoidepoxy contamination

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The interior volume is segmented into a first compartment for the HA connector and a second compartment for the epoxy fill material. The seal member creates a definitive boundary between these compartments, ensuring that the epoxy fills the space around the connector to prevent movement while completely avoiding contamination of the connector interior, thus maintaining functional reliability.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The potential contamination risk is extracted from the system by separating the epoxy fill material from the HA connector interior using a seal member. This allows the epoxy to perform its function of securing the connector in place while being physically excluded from the connector interior, preserving the header assembly's usability.

Inventive Principle:

Principle #2Taking out (Extraction)

3Object-affected harmful factors

If gaps between conductive and non-conductive members are reduced to prevent epoxy infiltration, then contamination is prevented, but manufacturing complexity and difficulty increase

Engineering Contradiction:

Improveepoxy infiltration preventionVSAvoidconnector structure complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

Rather than reducing the gaps between conductive and non-conductive members, a seal member is introduced as an intermediary barrier. This seal member is positioned to contact the exterior of the HA connector and the header body wall, creating a simple and effective barrier that prevents epoxy infiltration without requiring any changes to the connector's internal structure or increasing manufacturing complexity.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The seal member is positioned in advance during assembly to prevent epoxy infiltration before the liquid epoxy is introduced into the interior volume. This preliminary protective action eliminates the need for complex gap control or post-assembly remediation, simplifying the overall manufacturing process while effectively preventing contamination.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS20250152950A1Implantable medical devices and header assemblies for use with same

Publication Date: 2025.05.15 ALFRED E MANN FOUND FOR SCI RES

AI summary

An implantable medical device including an electronics housing, circuitry within the electronics housing, and a header assembly secured to the electronics housing. The header assembly includes a hollow header body defining an internal volume, a header assembly connector located within the internal volume, operably connected to the circuitry, defining an interior configured to receive a lead connector and an exterior, a hard fill within the internal volume, and a seal between the exterior of the header assembly connector and the hard fill.