Catheter Voice Prosthesis Assembly Single-Step Deployment
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Solution Overview
Problem
Current methods for inserting a voice prosthesis into a tracheoesophageal puncture require multiple steps and devices, including dilation, sizing, and placement, which can be cumbersome and may not be gentle on the fistula, especially during surgical procedures.
Innovation Solution
A catheter and voice prosthesis assembly where the voice prosthesis is inserted into a hollow tubing on the catheter, with the esophageal flange folded inside and the tracheal flange outside, allowing for single-step dilation, sizing, and placement through the catheter, which is then pulled out to deploy the flange, facilitating a more efficient and gentle procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If multiple separate devices (dilator, sizer, inserter) are used for voice prosthesis insertion, then each device can be optimized for its specific function, but the procedure becomes cumbersome and increases the number of insertions required
Solution Approach 1:
The patent combines the dilator, sizer, and inserter functions into a single integrated catheter assembly. The catheter includes a dilator element for dilation, a sizer element for sizing, and a voice prosthesis for insertion, all within one device structure that can be inserted through the puncture in a single procedure.
Solution Approach 2:
The catheter assembly performs multiple functions simultaneously: it dilates the puncture, sizes the voice prosthesis, and facilitates insertion. This multi-functional design eliminates the need for separate specialized devices and reduces procedural steps.
2Object-affected harmful factors
If multiple insertions are performed (dilation then sizing), then each function can be performed optimally, but the fistula is subjected to repeated trauma
Solution Approach 1:
By merging dilation and sizing functions into one catheter assembly, the invention enables both functions to be performed during a single insertion through the fistula, thereby reducing repeated trauma to the delicate tissue structure.
Solution Approach 2:
The dilator element is positioned within the catheter assembly beforehand, allowing it to perform dilation during the same insertion maneuver that delivers the sizer and voice prosthesis, eliminating the need for separate preliminary dilation procedures.
3Ease of operation
If the voice prosthesis is inserted through the catheter with flanges folded inside, then the catheter can be pulled out to deploy the flange, but the device structure becomes more complex
Solution Approach 1:
The voice prosthesis is nested within the catheter with its flanges folded inside the catheter lumen. The catheter acts as a protective sheath that contains the folded flanges during insertion, then is pulled out to deploy them into their functional position.
Solution Approach 2:
The flanges transition from a static folded state inside the catheter to a dynamic deployed state outside the catheter after insertion. This dynamic transformation allows the same structure to serve both protective and functional purposes at different stages of the procedure.
Data Source
Figure 1~3
Figure 2
Figure 4
AI summary
A catheter and voice prosthesis assembly include an elongated flexible body (16) having a hollow voice prosthesis tubing (20) disposed on a first end of the elongated flexible body. A voice prosthesis (30) is received in the hollow voice prosthesis tubing. The voice prosthesis having an interior esophageal flange (36) at a first end and an exterior tracheal flange (32) at a second end, with the voice prosthesis being received in the hollow voice prosthesis tubing with the interior esophageal flange being folded within the hollow voice prosthesis tubing and the exterior tracheal flange being disposed exterior to the hollow voice prosthesis tubing.