Flexible Tubular Dilator for Atraumatic Instrument Passage
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Solution Overview
Problem
Current surgical dilators for stenotic anatomical orifices require sterilization, skilled assistance, multiple instrumentation, and can cause trauma, leading to increased operating time, anesthetic dosage, and risk of perforation.
Innovation Solution
A flexible tubular device with a metallic core and biasing mechanism that expands from a closed to an open configuration, allowing atraumatic dilation and passage for medical instruments, disposable without re-sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If traditional metallic or plastic dilators are used, then dilation can be achieved, but trauma to the cervical canal and risk of perforation increases
Solution Approach 1:
The dilator employs a flexible tubular member made of soft, compliant material that can conform to the anatomical structure being dilated. This flexibility allows the device to adapt to the cervical canal's natural contours, distributing force evenly and avoiding concentrated stress points that could cause trauma or perforation.
Solution Approach 2:
The dilator transitions from a compressed, low-profile state for insertion to an expanded, rigid state for dilation. This dynamic transformation allows the device to minimize trauma during insertion while providing sufficient structural support during the dilation procedure, thereby reducing the risk of perforation.
2Area of stationary object
If multiple instrumentation with increasing sizes is used, then desired opening is achieved, but operating time and anesthetic dosage increase
Solution Approach 1:
The dilator is designed as a single integrated device with a tubular member that can be incrementally expanded or segmented in its dilation action. This allows the procedure to be performed with one device rather than multiple instruments of increasing size, reducing the number of insertion/removal cycles and minimizing operating time.
Solution Approach 2:
The dilator is designed to provide sufficient expansion beyond the minimum required opening, allowing the practitioner to achieve the desired cervical dilation in a single step or with minimal adjustments, thereby reducing the number of instrumentation steps and overall procedure time.
3Area of stationary object
If traditional dilators are used, then dilation is achieved, but skilled assistance and complex methodology are required
Solution Approach 1:
The dilator incorporates self-retaining features and intuitive expansion mechanisms that allow it to maintain its dilated position without requiring continuous manual stabilization or complex assistance. The device's design enables straightforward insertion and activation, reducing the need for skilled assistance and simplifying the overall methodology.
4Area of stationary object
If force is exerted to achieve dilation, then opening is achieved, but trauma and perforation risk increase
Solution Approach 1:
The flexible tubular member distributes dilating force uniformly across the cervical tissue, preventing concentration of stress at any single point. This even distribution of force achieves the necessary opening while minimizing the risk of trauma and perforation.
Solution Approach 2:
The soft, compliant material of the tubular member acts as a cushion between the dilating force and the cervical tissue. This inherent cushioning effect protects the tissue from excessive or concentrated forces, reducing trauma while still achieving adequate dilation.
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
Enables efficient, trauma-free dilation and passage of medical devices through stenotic orifices, reducing the need for skilled assistance and complex procedures, and minimizing mechanical trauma.
Implementation Method 1
one or more biasing devices configured to retain the tubular member and the plurality of wires in the closed and inactive configuration
Implementation Method 2
removal of the one or more biasing devices causes the plurality of wires to recoil against and exert an outward force on an interior of the tubular member such that the tubular member expands
Data Source
AI summary
A device, comprising: a tubular member which is flexible, the tubular member forming a channel when in an open and active configuration and the tubular member narrowed when in a closed and inactive configuration. The device, once expanded into the open and active configuration provides for a channel. The channel provides for a passthrough for medical instruments.