Conical Dilator with Wirelock for Voice Prosthesis Insertion
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Solution Overview
Problem
Existing voice prosthesis insertion systems, such as those described in US 6,159,243 and WO9741807, face challenges in pre-loading the voice prosthesis in the dilator without risking plastic deformation of flanges, and require complex attachment mechanisms that are difficult to assemble and maintain, especially during both primary and secondary punctures.
Innovation Solution
A dilator system with a conical body and a voice prosthesis holding portion featuring a central passage and a wirelock mechanism, allowing for pre-loading of the voice prosthesis and a secure attachment to a guide wire without deformation, using flexible materials like thermoplastic elastomers and a wirelock portion for locking the guide wire, facilitating easier assembly and reduced stress on the tracheoesophageal wall.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If the voice prosthesis is pre-loaded in the dilator using existing systems, then the assembly is simplified, but the flanges risk plastic deformation
Solution Approach 1:
The dilator incorporates a flexible membrane with a breaking strength less than the flange's breaking strength. This membrane protects the flange during pre-loading by absorbing stress through controlled rupture, allowing the prosthesis to be loaded without deforming the flange structure.
2Reliability
If a secure attachment mechanism is used to lock the guide wire, then the connection reliability improves, but the device complexity increases
Solution Approach 1:
The attachment mechanism automatically secures the guide wire through self-engagement features. The dilator's design includes inherent locking characteristics that activate during insertion, eliminating the need for complex manual attachment procedures while maintaining high reliability.
3Ease of operation
If the flange is folded and pushed into a gripping cavity, then the holding force is limited, but the risk of disengagement increases
Solution Approach 1:
The flexible membrane design allows the flange to unfold naturally during insertion rather than being forced into a cavity. This maintains the flange's structural integrity and prevents disengagement while still enabling easy insertion through the dilator.
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
The dilator system enables pre-loading of the voice prosthesis without deformation, provides a secure and easy assembly mechanism, and minimizes stress on the tracheoesophageal wall by unfolding flanges during insertion, ensuring effective placement and reduced risk of disengagement.
Implementation Method 1
The dilator is made of a flexible material in order to adapt to the surrounding tissues during insertion
Data Source
Figure 1a~1c
Figure 2~3
Figure 4~6b
AI summary
A dilator (100, 200, 300) for inserting a voice prosthesis, said voice prosthesis comprising a tubular body and radially outwardly extending flanges at the ends of said tubular body, in the tracheoesophageal wall, is provided. The dilator comprises a substantially conical body (101, 201, 301) having a tip portion (102) at the proximal end and a base portion (103) at the distal end thereof. The dilator (100, 200, 300) further comprises a wire lock portion (106), for locking a guide wire thereto. The dilator (100, 200, 300) also comprises a voice prosthesis holding portion (105, 205, 305) connected to said substantially conical body (101, 201, 301) by a connecting portion (104, 204, 304), said holding portion (105, 205, 305) having a central passage. The central passage is configured to have the tubular body of the voice prosthesis positioned therethrough, such that the flanges of the voice prosthesis are substantially unfolded proximally and distally of said central passage. A wire lock portion is also provided.