Combined Voice Prosthesis Dilator and Sizer for Fistula Management
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Solution Overview
Problem
Current voice prosthesis insertion procedures require separate dilator and sizer devices, necessitating multiple insertions, which can be harsh on the fistula and increase the risk of infection and procedural complexity for clinicians.
Innovation Solution
A combined voice prosthesis dilator and sizer device that integrates dilation and sizing functions into a single device, allowing for gentler fistula management with a single insertion, reducing the risk of infection and simplifying the clinical process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate dilator and sizer devices are used, then each device can be optimized for its specific function, but the procedure requires multiple insertions increasing complexity and infection risk
Solution Approach 1:
The patent combines the dilator and sizer into a single integrated device with a shaft that performs both dilation and sizing functions. The shaft includes a dilation portion and a sizing portion that can be inserted together through the fistula in a single procedure, eliminating the need for separate insertions and reducing procedural complexity while maintaining functional optimization.
Solution Approach 2:
The shaft is designed as a multi-functional element that simultaneously serves as both a dilator and a sizer. The dilation portion expands the fistula opening while the sizing portion measures the internal dimensions, allowing one device to perform multiple functions that previously required separate specialized devices.
2Reliability
If separate dilator and sizer devices are used, then each device can be specialized, but the number of insertions increases the risk of infection
Solution Approach 1:
By merging the dilator and sizer into a single device, the patent reduces the number of times the fistula is penetrated and instruments are introduced. This single insertion approach minimizes the opportunity for bacterial contamination and infection while maintaining the functional specialization through the differentiated portions of the shaft.
3Reliability
If separate dilator and sizer devices are used, then each device can be optimized for its specific function, but more devices and materials are required
Solution Approach 1:
The patent integrates multiple functions into a single device, reducing the quantity of instruments and materials required. The shaft combines the dilation and sizing functions in one unit, eliminating the need for separate dilator and sizer devices, and reducing the overall number of items the clinician must handle and sterilize.
4Ease of operation
If a single combined device is used, then the procedure is simplified and infection risk is reduced, but the device must perform multiple functions
Solution Approach 1:
The shaft is segmented into distinct functional portions: a dilation portion for expanding the fistula and a sizing portion for measuring internal dimensions. This segmentation allows each portion to be optimized for its specific function while being integrated into a single device that simplifies the overall procedure by eliminating the need for multiple separate instruments.
Data Source
Figure 1~4
Figure 2~3
AI summary
A voice prosthesis dilator and sizer device (10) is provided including an elongated member (12) having a first end with a tip (14) and a flange (16) and a second end with a stop portion (18). The elongated member (12) includes an intermediate portion with a measuring area (20) disposed adjacent to the flange (16) and including measuring indicia (22) thereon and having a dilation area (24) adjacent to the second end. The elongated member (12) also includes a recessed region adjacent to the flange (16) to receive the flange (16) in a folded position upon insertion into the non-dilated fistula. The dilation area (24) has a larger diameter than the measuring area (20).