Integrated Ear Tube Insertion System with Retractable Cutting Sheath
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Solution Overview
Problem
The placement of middle ear ventilation tubes is challenging due to difficulties in aligning the flange and maintaining the tube within the tympanic membrane, often requiring multiple instruments and general anesthesia, which is costly and painful, especially for children.
Innovation Solution
A system comprising a handle assembly and a nose assembly with a cutting sheath that retracts to deploy the ventilation tube across the membrane, allowing for minimally invasive placement and reducing pain, cost, and procedural time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple surgical instruments are used to manipulate the tube into the incision, then the tube placement can be achieved, but the device complexity increases and the procedure becomes more difficult
Solution Approach 1:
The patent combines multiple surgical instruments into a single integrated insertion device. The device includes a handle assembly with a nose assembly that can be inserted through the incision, and a shaft assembly with a distal end that can be advanced through the nose assembly. This integrated design allows the clinician to manipulate and position the ventilation tube using one device instead of multiple separate instruments, thereby reducing device complexity while maintaining placement reliability.
2Object-affected harmful factors
If general anesthesia is administered to reduce pain during repeated manipulation, then patient comfort is improved, but the cost and risks increase
Solution Approach 1:
The insertion device is designed to facilitate self-contained manipulation and positioning of the ventilation tube. The handle assembly provides ergonomic controls and the nose assembly can be advanced through the incision without requiring repeated manipulation under anesthesia. The device enables the clinician to perform the procedure with minimal tissue trauma and without requiring general anesthesia, thereby eliminating the associated costs and risks while maintaining patient comfort.
3Manufacturing precision
If the tube is manipulated repeatedly to achieve proper alignment, then the tube can be positioned correctly, but the time required for the procedure increases
Solution Approach 1:
The device is designed with pre-configured components that facilitate rapid tube positioning. The nose assembly and shaft assembly are pre-assembled to work together, allowing the clinician to advance the tube through the incision in a single continuous motion rather than through repeated manipulation. The handle assembly includes controls that enable precise positioning of the distal end within the nose assembly, achieving proper alignment quickly and efficiently, thereby reducing procedural time while maintaining alignment precision.
Data Source
AI summary
An insertion system includes a handle assembly and a nose assembly removably attached to the handle assembly and including an insertion end. The handle assembly includes a main body, a nose interface and an actuating element. The nose assembly includes a nose, a positioning rod extending from the nose to a distal end, a cutting sheath surrounding a distal end of the positioning rod and including a cutting edge, an actuation member having a proximal end coupled to the actuating element when the nose assembly is attached to the handle assembly and a distal end attached to the cutting sheath, a ventilation tube positioned distal to the distal end of the positioning rod and proximal to the insertion end. The cutting sheath retracts from around the ventilation tube and along the positioning rod when the actuating element on the handle assembly is moved.