Deformable Seal for Bone Conduction Implant Infection Prevention

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Solution Overview

Problem

Percutaneous bone conduction devices face challenges with infections and inflammation at the tissue-implant interface due to bacterial colonization, despite regular cleaning and disinfection, primarily through external and internal routes.

Innovation Solution

Incorporating a deformable element in the bone fixture or structural component that forms an anti-microbial seal when the abutment is tightened, creating a monolithic structure to prevent bacterial entry, with deformable elements such as flanges or annular rings that deform upon torque application to seal the interface between the bone fixture and structural component.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a percutaneous bone conduction device is used with skin penetration for efficient vibratory transmission, then the hearing function is improved, but the risk of infection and inflammation at the tissue-implant interface increases

Engineering Contradiction:

Improvehearing functionVSAvoidinfection risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs an elastomeric seal element that forms a flexible barrier between the abutment and the skin. This elastomeric component creates a waterproof and infection-resistant interface while maintaining the percutaneous connection necessary for bone conduction hearing function. The flexible nature of the elastomeric seal allows it to conform to the interface geometry and prevent bacterial colonization.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The patent introduces an intermediate elastomeric seal element between the abutment and the skin surface. This intermediary component serves as a protective barrier that prevents direct bacterial access to the implant interface while still allowing the mechanical transmission of vibrations for hearing assistance.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If regular cleaning and disinfection of the implant interface is performed, then hygiene is maintained, but bacterial colonization and infections still occur through internal micro-leakage pathways

Engineering Contradiction:

Improvecleaning maintenanceVSAvoidbacterial colonization

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent converts the problematic interface geometry that creates micro-leakage pathways into a beneficial sealing mechanism. The elastomeric seal element is specifically designed to deform and fill the crevices and gaps at the abutment-skin interface, transforming the previously harmful irregular geometry into a positive sealing feature that blocks bacterial access.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The elastomeric seal element provides a continuous flexible barrier that seals the internal micro-leakage pathways between the abutment and skin. This flexible membrane conformally seals the interface geometry, preventing bacterial colonization even in areas that are difficult to reach with cleaning instruments.

Inventive Principle:

Principle #30Flexible shells and thin films

3Adaptability or versatility

If a two-piece implant design with separate fixture and abutment is used, then surgical flexibility and upgradeability are improved, but the number of interfaces increases creating more potential infection routes

Engineering Contradiction:

Improvesurgical flexibilityVSAvoidnumber of interfaces

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The elastomeric seal element is integrated into the abutment component, creating a sealed interface with the skin. This sealing approach maintains the benefits of the two-piece design for surgical flexibility while minimizing infection risk by sealing the critical external interface.

Inventive Principle:

Principle #30Flexible shells and thin films

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The anti-microbial seal significantly reduces the risk of bacterial infection by forming a barrier at the interface, effectively minimizing micro-leakage pathways and enhancing infection prevention.

Implementation Method 1

at least one of the bone fixture or the structural component includes a deformable element configured to deform to form an anti-microbial seal between the bone fixture and the structural component

Methodology Applied

Scientific EffectDeformation: Deformation

Data Source

PatentUS20220061889A1Medical implant system

Publication Date: 2022.03.03 BJORN GORAN

AI summary

An implant including a bone fixture configured to anchor to bone of a recipient, and a structural component configured to be connected to the bone fixture and connect a functional component of the implant to the bone fixture, wherein at least one of the bone fixture or the structural component includes a deformable element configured to deform to form an anti-microbial seal between the bone fixture and the structural component, and the at least one deformable element and the respective at least one bone fixture or structural component form a monolithic structure.