Malleable Guide Rail Actuation for Balloon Dilation

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Solution Overview

Problem

Current dilation instruments lack adjustability to effectively access different anatomical structures, such as Eustachian tubes and paranasal sinus passageways, limiting their versatility in medical procedures.

Innovation Solution

The development of dilation instruments equipped with malleable guide rails that can be bent to various angles and positions, combined with translational and rotational actuators, allowing for precise adjustment and access to diverse anatomical sites.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a fixed guide rail is used in the dilation instrument, then the instrument structure is simple and stable, but the instrument cannot access different anatomical structures effectively

Engineering Contradiction:

Improveaccess to different anatomical structuresVSAvoidinstrument structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The guide rail is designed to be movable rather than fixed, allowing it to be repositioned between a proximal position (retracted into the shaft) and a distal position (extended into the anatomical passageway). This dynamic repositioning capability enables the same instrument to access different anatomical structures such as Eustachian tubes and paranasal sinus ostia without requiring multiple specialized instruments, thereby resolving the contradiction between versatility and structural simplicity.

Inventive Principle:

Principle #15Dynamics

2Adaptability or versatility

If the guide rail is extended distally to reach anatomical structures, then access to deeper structures is improved, but the risk of inadvertent bending or damage increases

Engineering Contradiction:

Improveaccess to anatomical passagewaysVSAvoidguide rail integrity

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The guide rail is repositioned to the proximal position (retracted into the shaft) before insertion into the patient's anatomy. This preliminary action protects the guide rail from inadvertent bending or damage during insertion and manipulation. When needed, the guide rail can be extended distally through the shaft to reach the target anatomical structure, such as the Eustachian tube or sinus ostium, while maintaining its integrity due to the protective proximal retraction during non-use states.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If the guide rail is retracted proximally to protect it from damage, then reliability is improved, but access to distal anatomical structures is limited

Engineering Contradiction:

Improveguide rail protectionVSAvoidaccess to anatomical structures

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The guide rail incorporates a dynamic repositioning mechanism that allows it to switch between a proximal position (retracted into the shaft for protection) and a distal position (extended into the anatomical passageway for access). This dynamic capability resolves the contradiction by enabling the guide rail to be protected when not in use while still providing access to distal structures like the Eustachian tube and paranasal sinus ostia when needed.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The guide rail is designed as a separable component that can be independently positioned relative to the shaft. The guide rail can be retracted proximally into the shaft when protection is needed, and extended distally when access is required. This segmentation allows the guide rail to be independently controlled to balance protection and access requirements without compromising either function.

Inventive Principle:

Principle #1Segmentation

4Adaptability or versatility

If multiple instruments are used to access different anatomical structures, then access versatility is improved, but procedural efficiency decreases

Engineering Contradiction:

Improveaccess to multiple anatomical locationsVSAvoidprocedural efficiency

Core Design Contradiction:

Adaptability or versatilityVSProductivity

Solution Approach 1:

The dilation instrument is designed with a movable guide rail that can be repositioned between proximal and distal positions, enabling a single instrument to access multiple anatomical structures including the Eustachian tube, paranasal sinus ostia, and other head and neck passageways. This multi-functionality eliminates the need for multiple specialized instruments, thereby improving procedural efficiency while maintaining access versatility across different anatomical locations.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS20240382724A1Guide rail actuation assembly for balloon dilation instrument

Publication Date: 2024.11.21 ACCLARENT INC

AI summary

An apparatus includes a body assembly, a guide rail, a dilation catheter, and a guide rail actuation assembly. The guide rail extends distally from the body assembly and has a malleable distal portion with a distal end. The dilation catheter is slidably disposed relative to the guide rail. The dilation catheter includes an expandable element configured to dilate a passageway within a head of a patient. The a guide rail actuation assembly is operable to drive longitudinal movement of the guide rail relative to the body assembly between a distal position and a proximal position. The guide rail actuation assembly is configured to maintain the guide rail at a selected one of the distal position or the proximal position.