Nested Catheter System for Fallopian Tube Diagnostics
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Solution Overview
Problem
Current diagnostic methods for ovarian cancer are invasive and unreliable, as they often require surgical procedures to access the ovaries or Fallopian tubes, and existing devices are prone to perforation due to the fragile anatomy of the Fallopian tubes, making early detection challenging.
Innovation Solution
A minimally invasive catheter system that accesses the Fallopian tube via an intrauterine approach, uses an introducer catheter to form a fluid-tight seal, and deploys an everting balloon to track the tube's length, allowing for irrigation and cell sampling without causing significant dilation or injury.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional diagnostic devices are introduced into the Fallopian tube, then cell sampling capability is achieved, but the risk of perforation increases due to the fragile anatomy and narrow lumen at the uterotubal junction
Solution Approach 1:
The catheter system employs nested components where an inner catheter is positioned within an outer catheter. The outer catheter provides structural support and protection during navigation through the uterotubal junction, while the inner catheter performs the diagnostic function. This nested configuration allows the flexible inner catheter to benefit from the protective sheath of the outer catheter, reducing perforation risk while maintaining sampling capability
Solution Approach 2:
The uterotubal junction is dilated using a balloon or mechanical dilator before introducing the diagnostic catheter. This preliminary dilation action enlarges the narrow lumen (from approximately 0.3-0.5 mm to a larger diameter), creating a safer passage that reduces the risk of perforation during subsequent catheter insertion while still allowing access to the Fallopian tube for cell sampling
2Ease of operation
If the Fallopian tube lumen is dilated to accommodate diagnostic devices, then device passage is facilitated, but the risk of tissue injury and perforation increases
Solution Approach 1:
The catheter system employs dynamic, adjustable components including balloons that can be inflated to controlled degrees and dilators that can be adjusted to match the specific anatomy of the patient's uterotubal junction. This dynamic approach allows for gradual, controlled dilation that facilitates device passage while minimizing the risk of excessive tissue injury or perforation
Solution Approach 2:
The system utilizes controlled changes in physical parameters such as balloon inflation pressure and dilator diameter to navigate the anatomical challenges of the Fallopian tube. By carefully adjusting these parameters, the system achieves sufficient lumen enlargement for device passage while maintaining tissue integrity and avoiding perforation
3Reliability
If surgical procedures are performed to access the ovaries and Fallopian tubes, then reliable cell sampling is achieved, but patient trauma and recovery time increase
Solution Approach 1:
The catheter system is designed as a multi-functional device that can perform multiple diagnostic tasks through a single minimally invasive access point. The catheter can navigate through the uterotubal junction, sample cells from the Fallopian tube, and potentially perform other diagnostic functions, eliminating the need for separate surgical procedures to access the ovaries and Fallopian tubes
Solution Approach 2:
The catheter acts as an intermediary device that enables diagnostic cell sampling without requiring direct surgical access to the ovaries. By navigating through the natural anatomical passage of the uterotubal junction and Fallopian tube, the catheter provides a minimally invasive pathway to obtain diagnostic samples that would otherwise require complex surgical intervention
Data Source
Figure 1~2D
Figure 3~5B
Figure 6A~6C
AI summary
Methods and devices for performing minimally invasive procedures useful for Fallopian tube diagnostics are disclosed. In at least one embodiment, the proximal os of the Fallopian tube is accessed via an intrauterine approach; an introducer catheter is advanced to cannulate and form a fluid tight seal with the proximal os of the Fallopian tube; a second catheter inside the introducer catheter is provided to track the length of the Fallopian tube and out into the abdominal cavity; a balloon at the end of the second catheter is inflated and the second catheter is retracted until the balloon seals the distal os of the Fallopian tube; irrigation is performed substantially over the length of the Fallopian tube; and the irrigation fluid is recovered for cytology or cell analysis.