Composite Sealing Ring for Implant Header Insulation and Fixation

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Solution Overview

Problem

Current sealing elements in implantable device connection headers lack optimal electrical insulation and mechanical fixation, particularly in medical implants, where existing materials like polycrystalline and silicone-based solutions do not fully meet the requirements for durability and biocompatibility.

Innovation Solution

A sealing ring comprising a high-performance thermoplastic outer ring, such as polyaryl or liquid-crystal polymer, and an inner ring of liquid silicone or polyurethane, arranged in a form-fit engagement, providing enhanced electrical insulation and mechanical attachment within the connection headers of implantable devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If silicone-based sealing elements are used, then electrical insulation is provided, but mechanical fixation and durability are insufficient

Engineering Contradiction:
Improveelectrical insulationVSAvoidmechanical fixation
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The sealing element combines silicone rubber (providing electrical insulation) with a rigid core made of polyaryl or liquid-crystal polymer (providing mechanical strength and fixation). This composite structure allows both materials to contribute their respective advantages, resolving the contradiction between insulation and mechanical fixation.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The sealing element is divided into two functional segments: an outer silicone rubber layer for electrical insulation and an inner rigid core for mechanical support and fixation. This segmentation allows each part to optimize its specific function without compromising the other.

Inventive Principle:
Principle #1Segmentation

2Strength

If polycrystalline or crystalline sapphire materials are used for the core, then mechanical fixation is improved, but biocompatibility and resistance to environmental influences are insufficient

Engineering Contradiction:
Improvemechanical fixationVSAvoidbiocompatibility and environmental resistance
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The invention replaces polycrystalline or sapphire cores with a core made of high-performance thermoplastics (polyaryl or liquid-crystal polymer) that are specifically selected for their biocompatibility and resistance to environmental influences, while maintaining the mechanical fixation function. The outer silicone rubber layer provides additional biocompatibility.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The material parameters of the core are changed from polycrystalline/sapphire to high-performance thermoplastics, altering the chemical composition to achieve better biocompatibility and environmental resistance while maintaining mechanical properties through careful selection of polymer structure and crystallinity.

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If a single-material sealing element is used, then manufacturing is simplified, but optimal performance in both electrical insulation and mechanical fixation cannot be achieved

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidelectrical insulation and mechanical fixation
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The sealing element uses a composite structure with silicone rubber outer layer and thermoplastic core, where each material is selected for its optimal properties. The manufacturing process (co-injection molding) is designed to efficiently produce this composite structure in one step, minimizing the complexity increase.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The sealing element is segmented into functional zones with different materials, where the manufacturing process is optimized to create this segmentation efficiently. The form-fit engagement between segments is designed to be achieved through a single co-injection molding operation, maintaining ease of manufacture.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS11808358B2Sealing ring made of a high-performance thermoplastic material and liquid silicone
Publication Date: 2023.11.07 BIOTRONIK SE & CO KG
  • US11808358B2 patent drawing
  • US11808358B2 patent drawing
  • US11808358B2 patent drawing

AI summary

A sealing ring for a header of an implantable device has an outer ring and an inner ring. The outer ring is formed with, or of, a high-performance thermoplastic material. The inner ring is formed with, or of, liquid silicone or polyurethane. The inner and outer rings are arranged with a form-fit relative to each other. There is also described a method for manufacturing such a sealing ring and also a contact socket and an implantable device with such a sealing ring.