Voice Prosthesis Gel Cap Atraumatic Insertion
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Solution Overview
Problem
Current voice prosthesis insertion methods are traumatic and difficult, leading to incomplete insertion risks and complications such as aspiration or expulsion, due to the large retention collar, which can deter patients and clinicians from using tracheoesophageal puncture voice restoration techniques.
Innovation Solution
A dissolvable gel cap is used to reduce the size of the esophageal flange, allowing atraumatic insertion, with a strap and inserter system providing external visual and tactile feedback for proper deployment confirmation, eliminating the need for rotational confirmation and reducing tissue trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a large retention collar is used to improve prosthesis retention, then the prosthesis is less likely to dislodge, but insertion becomes more difficult and traumatic to surrounding tissue
Solution Approach 1:
The retention collar is segmented into multiple flexible segments that can compress together during insertion to reduce the profile, then expand after insertion to provide retention. This allows the collar to be small during insertion (reducing tissue trauma) but large during use (providing retention).
Solution Approach 2:
The retention collar transitions from a compressed state during insertion to an expanded state during use. The collar is dynamically adjustable in size, being small when needed for insertion and large when needed for retention, resolving the contradiction between insertion ease and retention reliability.
2Reliability
If a large retention collar is used to improve prosthesis retention, then the prosthesis is less likely to dislodge, but insertion completeness is reduced due to difficulty of insertion
Solution Approach 1:
The segmented collar compresses during insertion to fit through the puncture site, then expands to provide retention. This ensures complete insertion is achieved during the procedure while the expanded segments provide the necessary retention reliability.
Solution Approach 2:
The dynamic size change of the retention collar ensures that the prosthesis can be completely inserted in the compressed state, then fully deploy to provide retention, eliminating the trade-off between insertion completeness and retention reliability.
3Reliability
If the prosthesis is inserted with a large retention collar, then retention is improved, but the procedure complexity increases due to difficulty of insertion
Solution Approach 1:
The segmented design allows the collar to be compressed during insertion, simplifying the insertion procedure, then expand to provide retention. This eliminates the need for complex rotational maneuvers or specialized insertion techniques.
Solution Approach 2:
The dynamic compression and expansion of the retention collar simplifies the insertion procedure by allowing straightforward axial insertion, then provides automatic retention upon expansion, reducing overall procedure complexity while maintaining retention reliability.
4Reliability
If the esophageal flange is deployed to its normal dimension for retention, then prosthesis retention is improved, but insertion becomes more traumatic and difficult
Solution Approach 1:
The esophageal flange is segmented to allow compression during insertion, reducing tissue trauma, then expansion after insertion to provide retention. This resolves the contradiction between retention effectiveness and tissue trauma.
Solution Approach 2:
The esophageal flange dynamically changes size from compressed during insertion to expanded during use, providing both atraumatic insertion and effective retention without compromise.
5Object-affected harmful factors
If the esophageal flange is kept folded for easy insertion, then insertion trauma is reduced, but prosthesis retention is compromised
Solution Approach 1:
The segmented flange structure allows it to be compressed during insertion for atraumatic placement, then automatically expand after insertion to provide the necessary retention, eliminating the trade-off between trauma reduction and retention.
Solution Approach 2:
The dynamic size change of the flange from compressed to expanded state provides both atraumatic insertion and effective retention, resolving the contradiction between these two requirements.
6Reliability
If the esophageal flange is deployed immediately for retention, then prosthesis retention is improved, but insertion difficulty and trauma increase
Solution Approach 1:
The segmented flange allows compressed insertion for ease of placement, then automatic expansion for retention, eliminating the need to choose between deployment timing and insertion ease.
Solution Approach 2:
The dynamic size change of the flange provides automatic deployment after insertion, combining the benefits of easy compressed insertion with effective retained deployment without requiring manual intervention.
7Object-affected harmful factors
If a dissolvable gel cap is used to reduce flange size for atraumatic insertion, then tissue trauma is reduced, but the overall device complexity increases
Solution Approach 1:
The dissolvable gel cap serves as a temporary intermediary that protects the flange during insertion, then dissolves to allow flange deployment. This adds minimal complexity while achieving atraumatic insertion and automatic deployment.
Solution Approach 2:
The gel cap changes its physical state from intact (protecting the flange) to dissolved (allowing deployment) through contact with saliva or other body fluids. This parameter change provides automatic deployment with minimal added device complexity.
8Loss of information
If the valve flap is pressed internally to confirm deployment, then deployment verification is possible, but the risk of posterior esophageal wall injury increases
Solution Approach 1:
The prosthesis provides external visual feedback through the position of the inserter relative to the prosthesis body, allowing deployment confirmation without internal manipulation. This eliminates the need for potentially harmful internal pressing while maintaining deployment verification.
Solution Approach 2:
Instead of directly observing the internal valve flap, the system uses the external position of the inserter as a proxy indicator of internal flange deployment. This indirect observation method confirms deployment without requiring invasive internal manipulation.
9Loss of information
If the prosthesis is rotated to confirm flange deployment, then deployment verification is achieved, but tissue trauma increases
Solution Approach 1:
The prosthesis provides external visual feedback through the inserter position that can be observed without rotation, eliminating the need for rotational maneuvers that cause tissue trauma while maintaining deployment confirmation capability.
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 method facilitates gentler and easier insertion with verified deployment feedback, ensuring safer and complete prosthesis placement without risking posterior esophageal wall injury, enhancing the safety and efficacy of voice restoration procedures.
Implementation Method 1
Once in place, saliva or other liquid can be swallowed to dissolve the capsule and allow the esophageal flange to expand to its normal dimension
Implementation Method 2
The flange has a use orientation in which it projects generally outwardly from the outside surface of the body and an insertion orientation in which it is resiliently folded toward the axis of the body
Data Source
Figure 1~2
Figure 3
Figure 4~5
AI summary
A gel cap (22) is loaded on a folded flange (24) of a voice prosthesis (26) which is loaded on an end portion of an inserter (74), wherein a tip (78) of the end portion (80) is pressed against a valve flap (31) of the voice prosthesis (26). The voice prosthesis (26) includes a strap (32) that is stretched for engagement with an attachment portion (79) on the inserter (74). The voice prosthesis (26), gel cap (22), and inserter (74) are inserted into the tracheoesophageal puncture. The patient then swallows fluids to cause the gel cap (22) to dissolve to allow the esophageal flange (24) to deploy, whereby upon deployment of the esophageal flange (24), the tip (78) of the end portion (80) of the inserter presses (74) the valve flap (31) open, allowing the inserter (74) to move axially relative to the voice prosthesis (26) until a stop collar (77) of the inserter (74) engages the voice prosthesis (26) providing external visual confirmation to the user that the gel cap (22) has dissolved and the esophageal flange (24) has deployed.