Clamshell Speculum with TECAPEEK Valves for Anatomical Adaptation

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Solution Overview

Problem

Current vaginal speculums are uncomfortable and painful for patients due to their design, which does not adapt to individual anatomical needs, and pose challenges for gynecologists in terms of ease of use and material disposal, with issues related to size, material, anatomy, and valve mechanisms leading to discomfort and inefficiency in examinations.

Innovation Solution

A clamshell speculum with a progressive opening mechanism, made from TECAPEEK, featuring a handle with a central opening and tapered valve ends, designed to distribute pressure evenly and accommodate the vaginal anatomy, allowing for comfortable insertion and use, while being recyclable and easy to produce.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a traditional Cusco's speculum is used to exert retracting force on vaginal walls, then the examination can be performed, but the patient experiences discomfort and pain due to the rigid design not adapting to individual anatomy

Engineering Contradiction:
Improvepatient comfortVSAvoidanatomical adaptability
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The speculum employs a progressive opening mechanism where the valves transition from a closed state during insertion to an open state during examination. The valves are designed to flex and adapt dynamically to the patient's anatomy, allowing the instrument to conform to individual vaginal dimensions while maintaining structural integrity throughout the procedure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The speculum utilizes material properties of TECAPEEK that allow it to change its physical state from rigid during insertion to more flexible during use. The progressive opening mechanism changes the geometric parameters of the valves, allowing them to expand and contract to match different anatomical sizes, thereby improving adaptability without compromising strength.

Inventive Principle:
Principle #35Parameter changes

2Ease of manufacture

If a plastic speculum is used to facilitate insertion and provide visibility, then the examination is easier, but the material cannot withstand high temperature sterilization and creates disposal issues

Engineering Contradiction:
Improvedisposal simplicityVSAvoidsterilization resistance
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent changes the material parameter from conventional plastic to TECAPEEK, a thermoplastic polymer that maintains its structural integrity at sterilization temperatures. This material selection allows the speculum to be autoclaved or chemically sterilized without degradation, resolving the contradiction between ease of disposal and sterilization resistance.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The speculum is made from a composite material structure that combines the flexibility needed for insertion with the heat resistance required for sterilization. TECAPEEK provides a unified material solution that eliminates the need for separate sterilization steps or complex disposal protocols, achieving both manufacturing simplicity and reliability.

Inventive Principle:
Principle #40Composite materials

3Device complexity

If a speculum with a single bend of junction is used, then the structure is simplified, but the retracting force is concentrated on one point causing significant impact on the patient

Engineering Contradiction:
Improvestructural simplicityVSAvoidpressure distribution
Core Design Contradiction:
Device complexityVSStress or pressure

Solution Approach 1:

The speculum divides the retracting structure into multiple valves instead of a single bend. Each valve acts as an independent segment that can apply force to different locations along the vaginal wall. This segmentation distributes the total retracting force across multiple contact points, reducing the pressure concentration at any single point while maintaining overall structural simplicity.

Inventive Principle:
Principle #1Segmentation

4Ease of manufacture

If a speculum with straight and rigid lines is used, then the manufacturing is easier, but the shape is not compatible with vaginal anatomy and requires assembly and disassembly

Engineering Contradiction:
Improveproduction simplicityVSAvoidanatomical compatibility
Core Design Contradiction:
Ease of manufactureVSEase of operation

Solution Approach 1:

The speculum replaces straight rigid lines with curved, organic shapes that follow the natural contour of the vaginal canal. The valves are designed with smooth, tapered edges and curved surfaces that glide along the vaginal walls, improving anatomical compatibility. This curvature is integrated into the molding process, maintaining manufacturing simplicity while achieving better fit and comfort during the examination.

Inventive Principle:
Principle #14Spheroidality (Curvature)

Data Source

PatentEP4450113A1Vaginal speculum
Publication Date: 2024.10.23 IUAV UNIVERSITY OF VENICE
  • EP4450113A1 patent drawingFigure 1
  • EP4450113A1 patent drawingFigure 2
  • EP4450113A1 patent drawingFigure 3~4

AI summary

The invention concerns an instrument (100) for vaginal dilation, comprising two valves (1) joined by a handle (2), characterized in that it presents a clamshell structure, and in that the handle (2) presents a central through opening (6) between two side elements (7) joined at a first junction end (4) and at a second junction end (5), the valves (1) being directly connected transversally to the side elements (7).