Sinus Ostia Dilation via Incremental Member Series
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Solution Overview
Problem
Current methods for dilating sinus ostia, such as balloon catheters, often result in sinus ostial fracture and require invasive procedures, which can lead to complications and prolonged recovery times, and do not effectively accommodate individual anatomical variations.
Innovation Solution
A system comprising a series of members with progressively larger diameters and flexible distal ends, equipped with guard wires and handles for controlled insertion and dilation, allowing for safe and efficient enlargement of sinus ostia without fracture, enabling the delivery of medical devices and therapeutic agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If balloon catheters are used to dilate sinus ostia, then dilation is achieved, but sinus ostial fracture occurs and invasive procedures are required
Solution Approach 1:
The dilation process is divided into multiple sequential steps using a series of members with progressively larger diameters. Each member dilates the sinus ostium to a specific degree, allowing controlled expansion without exceeding the fracture threshold. This segmented approach replaces the single-step balloon dilation that causes fracture.
Solution Approach 2:
The system changes the diameter parameter progressively through multiple members (e.g., 0.5mm, 0.7mm, 1.0mm, 1.5mm, 2.0mm, 2.5mm, 3.0mm). Each member introduces a controlled increment in diameter, allowing the sinus ostium to adapt and expand gradually without sudden stress that would cause fracture.
2Ease of operation
If stiff-shaft preshaped balloon catheters are used, then catheter positioning is achieved, but anatomical variations cannot be accommodated
Solution Approach 1:
Each member in the series is constructed with a flexible shaft that can bend and conform to the patient's unique anatomical pathways. The flexibility allows the members to navigate tortuous anatomy and reach the sinus ostium regardless of individual anatomical variations, while the progressive diameter design maintains adequate rigidity for effective dilation.
Solution Approach 2:
The series of members is designed to be universally applicable to all patients regardless of their specific anatomical variations. The flexible construction and progressive diameter design allow the same set of members to adapt to different nasal cavity configurations, sinus ostium locations, and anatomical pathways through selective use of appropriate members.
3Productivity
If sinus ostial fracture is induced, then bone removal is achieved, but recovery time is prolonged and additional surgeries are required
Solution Approach 1:
Instead of inducing fracture to remove bone (a harmful approach), the invention converts the dilation process into a beneficial, controlled expansion that achieves bone remodeling without fracture. The progressive members gently expand the sinus ostium, converting the harmful fracture mechanism into a beneficial controlled deformation that promotes healing and avoids the need for additional surgical interventions.
Data Source
AI summary
A system for dilating the sinus ostia with a device including a series of elongated members, each having a central channel and increasing outer diameters where the members are positioned one over the other such that the members are advanced to incrementally dilate the sinus ostia. The central channels of each member allow for various procedures to be performed including, for example, the application of wireless energy (e.g., ultrasonic, RF, etc.) to the sinus ostia, the introduction of an irrigating fluid and aspiration from the sinus ostia, and the introduction of a drug to the sinus ostia.