Flexible Catheter Navigation for Sinus Ostia Access
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current treatments for sinusitis, such as Functional Endoscopic Sinus Surgery, face challenges including significant post-operative pain, bleeding, nasal packing discomfort, and limited effectiveness for patients with less severe disease, due to the use of rigid instruments that require anatomical structure manipulation and the need for multiple disposable catheters to accommodate individual anatomical variations.
Innovation Solution
Development of flexible or rigid elongate devices and systems for navigating complex nasal anatomy, including guidewires, balloon catheters, and tubular guides, that allow for minimally invasive procedures like dilation, tissue modification, and imaging using endoscopic and radiographic modalities to access and treat sinus ostia with minimal trauma and anatomical disruption.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If rigid instruments are used for sinus surgery, then surgical effectiveness is improved, but post-operative pain and trauma to non-pathogenic structures increase
Solution Approach 1:
The patent employs flexible catheters with balloons instead of rigid surgical instruments. The flexible catheter can navigate through the nasal cavity and sinus ostia without requiring manipulation of non-pathogenic anatomical structures, while the balloon provides effective dilation of the sinus openings. This flexibility eliminates the trauma and pain associated with rigid instrument use while maintaining surgical effectiveness.
Solution Approach 2:
The surgical procedure is divided into separate functional components: navigation to the sinus ostium, dilation of the opening, and delivery of therapeutic agents. Each function is performed by a specialized component of the catheter system (navigation catheter, balloon, drug delivery mechanism), allowing effective treatment without the need for aggressive surgical manipulation.
2Adaptability or versatility
If multiple disposable catheters are used to accommodate individual anatomical variations, then adaptability is improved, but device complexity and cost increase
Solution Approach 1:
The catheter incorporates a steerable distal end that can be dynamically adjusted during the procedure to navigate different anatomical configurations. This dynamic steering capability allows a single catheter design to adapt to various patient anatomies without requiring multiple specialized catheters, reducing complexity while maintaining versatility.
Solution Approach 2:
The catheter system is designed as a multi-functional device that combines navigation, dilation, and drug delivery capabilities in a single instrument. This universal design eliminates the need for multiple separate catheters and disposable components, simplifying the overall procedure while accommodating individual anatomical variations through the steerable mechanism.
3Ease of operation
If anatomical structures are manipulated to access sinus ostia, then access to deep areas is improved, but trauma to non-pathogenic structures increases
Solution Approach 1:
The flexible catheter can be advanced through the nasal cavity and bent to follow the natural anatomy to reach the sinus ostia without requiring manipulation or resection of intervening structures. The flexibility allows the catheter to navigate tortuous paths while leaving non-pathogenic anatomical structures intact, eliminating the trauma associated with traditional surgical access methods.
4Reliability
If traditional surgical methods are used, then treatment effectiveness for severe sinus disease is improved, but post-operative complications such as bleeding and packing discomfort increase
Solution Approach 1:
The patent extracts the essential therapeutic function (dilation and treatment of sinus ostia) from the aggressive surgical procedure. By using a flexible catheter with a balloon to deliver treatment through the natural ostium opening, the method achieves effective treatment without the bleeding, pain, and packing complications associated with traditional surgical resection and manipulation of anatomical structures.
Data Source
AI summary
Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.) into the paranasal sinuses or other structures in the ear, nose or throat. Specific devices (e.g., tubular guides, guidewires, balloon catheters, tubular sheaths) are provided as are methods for manufacturing and using such devices to treat disorders of the ear, nose or throat.