Voice Prosthesis Valve Hardness and Microbial Resistance

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Solution Overview

Problem

Voice prostheses for laryngectomees often fail due to microbial infestation, which causes distortion of the valve mechanism, leading to leakage and the need for frequent cleaning or replacement, as the thin, soft materials used are susceptible to colonization by microorganisms.

Innovation Solution

A voice prosthesis design featuring a valve with an elastomeric seat and a movable valve member made from harder materials, where the valve member is stiffened by a hard insert or antimicrobial coating, reducing microbial growth and improving sealing efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If soft, pliable biocompatible materials are used for the voice prosthesis body, then biocompatibility and comfort are improved, but susceptibility to microbial infestation and distortion increases

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidmicrobial infestation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies different material properties to different parts of the voice prosthesis. The body section uses soft, pliable biocompatible materials for comfort and biocompatibility, while the valve element uses harder, more rigid materials (such as silicone rubber with higher durometer or other elastomers) that are resistant to microbial distortion. This local differentiation of material quality allows each component to optimize its properties for its specific function.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The voice prosthesis combines multiple materials with different properties within a single device. The body section may use medical-grade silicones or other soft elastomers, while the valve element uses harder elastomeric materials or composite structures that provide both biocompatibility and resistance to microbial infestation. This composite approach allows the device to simultaneously achieve comfort, biocompatibility, and durability.

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If a thin valve element is used, then the valve can close effectively against the valve seat, but it becomes susceptible to distortion by microbial colonies

Engineering Contradiction:
Improvevalve closure efficacyVSAvoidresistance to microbial distortion
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The valve element is designed with localized structural features that provide rigidity where needed while maintaining overall flexibility. The valve element may have a thicker cross-section or internal reinforcement in the sealing region to resist microbial distortion, while maintaining thinness in other areas for effective closure. The material composition is also optimized locally to provide both flexibility for sealing and rigidity for microbial resistance.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The valve element incorporates curved or arched geometries that provide structural strength while maintaining flexibility. The arching or domed shape of the valve element creates inherent structural rigidity that resists distortion from microbial colonies, while the curved surface allows the valve to flex and close effectively against the valve seat during operation.

Inventive Principle:
Principle #14Spheroidality (Curvature)

3Ease of operation

If the voice prosthesis is left in place for extended periods, then convenience is improved, but the risk of microbial infestation and device failure increases

Engineering Contradiction:
ImproveconvenienceVSAvoiddevice longevity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The valve element is designed as a separate, removable component from the voice prosthesis body. This allows the valve element to be extracted and replaced independently when it becomes infested with microbes or shows signs of wear, while the main body section can remain in place. This extraction approach maintains convenience by avoiding complete device removal while addressing reliability issues with the valve component.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The design allows for selective replacement of the valve element when it becomes compromised by microbial infestation. The old valve element is discarded and replaced with a new one, while the main body section is retained and reused. This approach extends the overall device longevity by recovering the valuable body section while replacing only the consumable valve component.

Inventive Principle:
Principle #34Discarding and recovering

Data Source

PatentEP1733703B1Voice prosthesis device
Publication Date: 2009.07.22 HELIX MEDICAL LLC (N D GES D STAATES DELAWARE) PLYMOUTH
  • EP1733703B1 patent drawingFigure 1
  • EP1733703B1 patent drawingFigure 2~4
  • EP1733703B1 patent drawingFigure 5~7

AI summary

A voice prosthesis device (20) provides a passageway (36) between a tracheal end (24) of the device and an esophageal end (26) of the device (20). A valve in the passageway (36) includes a seat (54) having a first hardness and a movable valve member (52) having a second hardness harder than the first hardness. The movable valve member (52) closes against the seat (54) to close the valve.