Integrated Myringotomy Cutter and Tube Holder

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Solution Overview

Problem

Current methods for inserting ventilation tubes into the tympanic membrane often require a two-step process, necessitate multiple tool set changes, and are not adaptable to varying tympanic membrane angles, limiting their applicability and increasing procedural time and discomfort for patients, especially children.

Innovation Solution

A device and method that allow for a single-step incision and insertion of commercially available ventilation tubes of different sizes and shapes, using a pivot tool set with a rotating mechanism and integrated sensors for automatic or semi-automatic operation, capable of accommodating a wide range of tympanic membrane angles, minimizing trauma and procedure time.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a two-step procedure with multiple tool set changes is used for ventilation tube insertion, then the insertion can be performed with specialized custom-made tubes, but the procedure time increases and patient discomfort increases

Engineering Contradiction:
Improveinsertion accuracyVSAvoidprocedure time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent combines the incision-making tool and ventilation tube holder into a single integrated tool set. The holder member is directly coupled to the cutter member, allowing both incision and tube insertion to be performed without changing tool sets. This merging eliminates the time loss associated with tool set changes while maintaining insertion accuracy through the integrated design.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The ventilation tube is pre-loaded onto the holder member before the procedure begins. This preliminary action allows the tube to be ready for immediate insertion after incision, eliminating the need to handle separate tube loading steps during the procedure and reducing overall procedure time while ensuring proper tube positioning.

Inventive Principle:
Principle #10Preliminary action

2Manufacturing precision

If custom-made ventilation tubes are used with specialized systems, then the insertion can be controlled precisely, but the adaptability to different patients and tube specifications is reduced

Engineering Contradiction:
Improvetube positioning accuracyVSAvoidtube size and shape variety
Core Design Contradiction:
Manufacturing precisionVSAdaptability or versatility

Solution Approach 1:

The holder member is designed with universal features that can accommodate different sizes and shapes of commercially available ventilation tubes. The engagement features include adjustable elements that can adapt to various tube geometries while maintaining precise positioning and control during insertion, thus achieving both precision and versatility.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The holder member incorporates dynamic adjustment capabilities that allow it to adapt its configuration to match different tube specifications. This dynamic design enables the holder to maintain secure engagement and precise control across a range of tube types without requiring custom-made tubes for each specific application.

Inventive Principle:
Principle #15Dynamics

3Manufacturing precision

If the procedure duration is extended to ensure proper tube insertion, then the insertion accuracy can be improved, but the need for general anesthesia increases in pediatric patients

Engineering Contradiction:
Improveinsertion accuracyVSAvoidgeneral anesthesia exposure
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The integrated tool set enables the critical insertion steps to be performed rapidly in a single continuous motion without pausing for tool set changes. The cutter and holder work together seamlessly to complete the incision and tube insertion in one swift action, reducing the procedure duration to a matter of seconds, which is sufficient to maintain accuracy while minimizing anesthesia requirements.

Inventive Principle:
Principle #21Skipping (Rushing through)

Solution Approach 2:

The holder member is designed to automatically position and guide the ventilation tube into the incision without requiring additional manual manipulation or adjustment steps. This self-service design eliminates time-consuming manual positioning steps while maintaining insertion accuracy, allowing the procedure to be completed quickly and efficiently.

Inventive Principle:
Principle #25Self-service

4Ease of manufacture

If multiple tool sets are used for different steps of the procedure, then each step can be optimized for its specific function, but the device complexity and ease of operation are reduced

Engineering Contradiction:
Improvefunctional optimizationVSAvoidnumber of tool sets
Core Design Contradiction:
Ease of manufactureVSDevice complexity

Solution Approach 1:

The patent merges the previously separate incision tool and tube holder into a single integrated tool set. The holder member is directly coupled to the cutter member, combining multiple functions into one device. This reduces the number of tool sets from two or more to just one, simplifying the overall system while maintaining functional optimization through careful design of the integrated components.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The integrated tool set is designed with multi-functional capabilities, where the holder member can accommodate different tube types and the cutter can be adjusted for different incision requirements. This universal design allows a single tool set to perform multiple functions that previously required separate specialized tools, reducing complexity while maintaining functional optimization.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentEP3681450B1Device for incision and insertion of a ventilation tube
Publication Date: 2024.09.04 NATIONAL UNIVERSITY OF SINGAPORE
  • EP3681450B1 patent drawingFigure 1~2(a)
  • EP3681450B1 patent drawingFigure 2(b)~2(d)
  • EP3681450B1 patent drawingFigure 2(e)~3(b)

AI summary

Disclosed is a device for incision and insertion of a ventilation tube during myringotomy, comprising a cutter member configured to make an incision; a holder member configured to dispose the ventilation tube in an orientation in which a longitudinal axis of the ventilation tube is substantially perpendicular to the cutter member; and a pusher member configured to apply a pushing force to a first end of the ventilation tube in a direction substantially perpendicular to the longitudinal axis, the first end of the ventilation tube being disposed closer to the cutter member than a second end of the ventilation tube; wherein the holder member comprises a pivot element configured to releasably engage the second end of the ventilation tube such that the ventilation tube is pivotable under the pushing force applied to the first end of the ventilation tube by the pusher member, for insertion of the first end of the ventilation tube into the incision.