Pneumatic Vaginal Speculum With Sealed Imaging Passageway
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Solution Overview
Problem
Existing vaginal speculums do not effectively maintain a passageway through the vagina for accessing the cervix or other anatomy, and lack advanced imaging capabilities for detailed examination.
Innovation Solution
A vaginal speculum using pressurized gas to maintain a passageway through the vagina, equipped with a flexible cup, imaging lumen, and a viewing device that captures images at different focal planes, along with a tool channel for additional procedures, and features like an opaque ring to reduce glare and pressure relief ports to manage air flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a rigid traditional speculum is used, then structural strength is maintained, but it cannot effectively maintain a passageway through the vagina for accessing the cervix
Solution Approach 1:
The patent introduces a pneumatic system that inflates a flexible cup with gas to maintain a sealed passageway through the vagina. The inflation lumen allows gas to be introduced into the cup, creating internal pressure that sustains the passageway. This pneumatic mechanism replaces the need for rigid structural strength, enabling the flexible cup to maintain its shape and function as an effective speculum.
Solution Approach 2:
The patent changes the physical state of the cup from deflated to inflated by controlling gas pressure. The flexible cup transitions from a collapsed state to an expanded state when gas is introduced through the inflation lumen. This parameter change (volume and pressure) enables the cup to maintain a stable passageway while remaining structurally flexible.
2Reliability
If pressurized gas is introduced to maintain passageway, then access to cervix is improved, but air leaks and contamination may occur
Solution Approach 1:
The patent employs a flexible cup made of elastomeric material that can deform and conform to the vaginal anatomy. This flexible shell creates a seal through contact pressure rather than rigid barriers. The flexibility allows the cup to adapt to tissue contours, maintaining seal integrity while accommodating natural anatomical variations and reducing the likelihood of leaks.
Solution Approach 2:
The patent incorporates a pressure sensor that continuously monitors the pressure within the flexible cup. This feedback mechanism allows the system to detect pressure changes that may indicate leaks or improper sealing. The controller can then adjust gas flow or alert the user to potential issues, ensuring maintainance of seal integrity throughout the procedure.
3Ease of operation
If viewing device is positioned away from optical window, then ease of operation is improved, but image quality and focus precision deteriorate
Solution Approach 1:
The patent employs a biasing device (such as a spring) that automatically pushes the viewing device against the optical window, ensuring optimal contact and image quality without requiring manual adjustment. The biasing mechanism self-regulates the positioning, maintaining consistent pressure and alignment throughout the procedure, thereby eliminating the need for complex manual positioning systems.
4Ease of operation
If flexible cup with folds is used, then ease of insertion is improved, but sealing effectiveness may be reduced
Solution Approach 1:
The patent employs a dynamic sealing mechanism where the flexible cup's folds are compressed against the vaginal walls by the inflation pressure. The folds transition from a relaxed state during insertion to a compressed, sealed state during use. This dynamic behavior allows the cup to maintain sealing effectiveness while preserving ease of insertion in the deflated state.
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
Provides a stable and clear view of the cervix or vagina with enhanced imaging capabilities, allowing for detailed examination and identification of medical abnormalities, while maintaining a sealed environment to prevent contamination and air leaks.
Implementation Method 1
a biasing device configured to urge the viewing device to abut against an inner surface of the optical window
Implementation Method 2
pressurized gas is flowable from the pressurized gas flow lumen to the vaginal interface element and then flowable through the air opening into a vaginal canal
Data Source
AI summary
A speculum includes a handle including a pressurized gas flow lumen, and a vaginal interface element coupled to a distal end of the housing, which has a flexible cup with folds and an air inlet septum. A probe having an imaging lumen passes through the vaginal interface element. The imaging lumen includes an optical window, a viewing device positioned proximal to the optical window, and a biasing device configured to urge the viewing device to abut against an inner surface of the optical window.