Expandable Structure for Voice Prosthesis Placement

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Solution Overview

Problem

The traditional procedure for creating a tracheo-esophageal puncture in laryngectomy patients is challenging due to scarring and cervical spine mobility issues, making it difficult to insert a rigid esophagoscope and increasing the risk of puncturing the posterior wall, which requires significant caution to avoid damage.

Innovation Solution

An expandable structure with a mechanical linkage that can be inserted through an endoscope, expanding to facilitate puncture placement and collapsing to capture a guide wire, allowing for safer and more precise placement of a voice prosthesis by distending the esophageal wall and maintaining the posterior wall away from the puncture site.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a rigid esophagoscope is used for traditional puncture placement, then the procedure can be performed with simple equipment, but it becomes difficult or impossible to place in patients with scarring or cervical spine mobility issues

Engineering Contradiction:

Improveadaptability to patients with scarring or cervical spine mobility issuesVSAvoidease of insertion

Core Design Contradiction:

Adaptability or versatilityVSEase of operation

Solution Approach 1:

The esophagoscope is transformed from a rigid structure to a flexible structure that can adapt to various patient anatomies including those with scarring or cervical spine mobility issues. The flexible distal end can navigate through difficult passages while the proximal end remains maneuverable for the operator.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The esophagoscope incorporates a flexible distal end that can bend and conform to the patient's anatomy, allowing insertion in patients who cannot accommodate rigid instruments due to scarring or mobility restrictions.

Inventive Principle:

Principle #30Flexible shells and thin films

2Ease of manufacture

If the esophagus is accessed in its collapsed state, then the puncture can be created with minimal preparation, but the posterior wall is in close proximity to the anterior wall increasing the risk of puncture damage

Engineering Contradiction:

Improveease of puncture creationVSAvoidrisk of posterior wall damage

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The esophagus is distended with fluid or gas before the puncture is created. This preliminary action separates the anterior and posterior walls, creating a safer working space and reducing the risk of damaging the posterior wall during needle insertion.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

By distending the esophagus before puncture, a cushioning space is created between the anterior and posterior walls. This cushioning effect protects the posterior wall from accidental puncture damage while allowing safe access through the anterior wall.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Reliability

If caution is exercised to avoid puncturing the posterior wall, then patient safety is improved, but the procedure becomes more complex and time-consuming

Engineering Contradiction:

Improvepatient safetyVSAvoidprocedure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

Distending the esophagus before puncture creates a safer working environment that reduces the need for extreme caution during needle insertion. The pre-created space makes the procedure more straightforward while maintaining high safety standards.

Inventive Principle:

Principle #10Preliminary action

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

This method enables safer and more accurate placement of a voice prosthesis by reducing the risk of posterior wall damage and improving visualization during the procedure, making it suitable for patients previously unsuited for traditional methods.

Implementation Method 1

an expandable structure with a mechanical linkage that can be inserted through an endoscope, expanding to facilitate puncture placement

Methodology Applied

Scientific EffectRadial expansion:

Implementation Method 2

a movable component moveable between a range of positions effecting the range of diameters; and a mechanical linkage disposed between the movable component and the expandable structure

Methodology Applied

Scientific EffectMechanical linkage:

Data Source

PatentUS12121214B2Apparatus and method for placement of device along wall of a body lumen

Publication Date: 2024.10.22 UNIV OF MARYLAND

AI summary

An apparatus includes: a expandable structure formable into three dimensional shapes including a range of diameters and corresponding lengths; a movable component moveable between a range of positions effecting the range of diameters; and a mechanical linkage disposed between the movable component and the expandable structure. The expandable structure is configured to fit inside a working channel of an endoscope when the expandable structure is collapsed. The mechanical linkage is configured to move the collapsed expandable structure through the working channel to a selected location past a distal end of the endoscope and to increase and decrease a diameter of the expandable structure in response to changes in the position of the movable component when the expandable structure is at the selected location.