Elastic Seeker Balloon for Sinus Dilation
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Solution Overview
Problem
Current balloon sinuplasty systems face challenges in visualizing and accessing paranasal sinus ostia due to the complex anatomy of the nasal cavity, requiring multiple instruments and personnel, leading to invasive procedures with significant recovery periods and costs.
Innovation Solution
The development of a seeker device with an elastic distal portion that changes shape from a constrained configuration to a default configuration with curves, allowing for easier access to anatomical structures, and a simplified inflation mechanism that enables one physician to perform procedures without additional assistance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional endoscope and multiple instruments are used to access sinus ostia, then visualization and access can be achieved, but the procedure becomes complex requiring multiple personnel and leading to invasive surgery with lengthy recovery
Solution Approach 1:
The seeker device combines multiple functions (access, dilation, and visualization guidance) into a single integrated instrument. The elastic distal portion with predetermined curvature allows the device to navigate complex nasal anatomy and access sinus ostia while the attached balloon catheter provides dilation capability, eliminating the need for separate guide catheters, wires, and multiple instruments required in conventional FESS procedures
Solution Approach 2:
The seeker device serves multiple purposes: it acts as a guide to visualize and access the sinus ostium through its elastic curved distal portion, provides structural support for the balloon catheter during advancement, and enables dilation when the balloon is inflated. This multi-functional design replaces the need for separate specialized instruments for each step of the procedure
2Reliability
If FESS is performed to treat chronic sinusitis, then sinus drainage can be improved, but significant tissue removal results in invasive surgery with painful recovery and multiple office visits
Solution Approach 1:
The invention changes the fundamental parameter of tissue interaction from cutting and removal (FESS) to gentle dilation (balloon sinuplasty). By inflating the balloon within the sinus ostium, the procedure expands the drainage pathway without removing surrounding tissue, thereby maintaining drainage improvement while eliminating the need for painful packing and lengthy recovery associated with tissue resection
Solution Approach 2:
The invention converts the harmful effect of tissue removal and inflammation from FESS into a beneficial non-invasive dilation process. Instead of cutting through inflamed tissue and causing post-operative pain, the balloon gently expands the narrowed ostium, allowing the tissue to heal in its new, more open configuration, thereby transforming a harmful invasive procedure into a beneficial minimally invasive one
3Object-affected harmful factors
If balloon sinuplasty is performed without tissue removal, then post-operative symptoms are reduced, but visualization and access to sinus ostia remain challenging due to complex nasal anatomy
Solution Approach 1:
The seeker device incorporates an elastic distal portion with a predetermined curved configuration that mirrors the natural anatomy of the nasal passage. This curvature allows the device to follow the physiological path through the nasal cavity and precisely reach the sinus ostia, solving the visualization and access problem by conforming to rather than fighting against the complex anatomical geometry
4Reliability
If multiple instruments and personnel are required for balloon sinuplasty, then access to sinus ostia can be achieved, but the procedure cost and complexity increase
Solution Approach 1:
The seeker device merges the functions of the guide catheter, guidewire, and balloon catheter into a single integrated instrument. The elastic curved distal portion provides the guidance function, while the attached balloon provides the dilation function, allowing one physician to perform the entire procedure without requiring an assistant to manage separate instruments, thereby simplifying the procedure and reducing costs
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
The seeker device facilitates easier access and dilation of sinus ostia with reduced complexity and cost, minimizing post-operative pain and recovery time, and allowing for more comfortable procedures in a physician's office setting.
Implementation Method 1
a seeker device including a proximal shaft and an elastic distal portion having a default shape with at least one curve configured to facilitate advancement of a distal end of the elastic distal portion into a desired location within the ear, nose or throat
Data Source
AI summary
A device for dilating a structure in an ear, nose or throat of a patient includes a handle, a shaft extending from the handle, an elastic distal portion extending from the shaft, a balloon disposed over at least part of the elastic distal portion, and an inflation tube extending from the handle and coupled with the balloon via an inflation lumen. The inflation tube is bendable to form a kink in the tube and thus push inflation fluid out of the inflation tube and through the inflation lumen to inflate the balloon. In other embodiments, a bendable hydraulic tube is used to push fluid through a device to actuate other types of hydraulically driven mechanisms.