Dilation Catheter with Navigation Sensor and Vent Passageway
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Solution Overview
Problem
Current treatments for Eustachian tube dysfunction, such as obstruction or blockage, often result in hearing impairment and chronic middle ear conditions like serous otitis media, where fluid accumulation leads to recurrent infections and discomfort, with existing methods like the Valsalva maneuver providing only temporary relief and not effectively clearing fluid from the middle ear.
Innovation Solution
A balloon dilation catheter system, comprising a guide catheter and a balloon dilation catheter with a navigation sensor, is used to access and dilate the Eustachian tube, allowing for the expansion of the tube and potential flushing of accumulated fluid, thereby restoring normal ventilation and function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the Valsalva maneuver is used to clear fluid from the middle ear, then temporary pressure relief is achieved, but the fluid accumulation is not effectively cleared and symptoms recur
Solution Approach 1:
The patent extracts and removes the accumulated fluid from the middle ear using a catheter system with a vent passageway that allows direct drainage of fluid through the Eustachian tube, rather than relying on pressure equalization maneuvers that only temporarily relieve symptoms without removing the fluid cause
Solution Approach 2:
The patent introduces a catheter with balloon and vent passageway as an intermediary device to facilitate controlled fluid removal and pressure equalization, providing a more effective and durable solution than direct patient maneuvers
2Reliability
If the Eustachian tube is dilated using a balloon catheter, then the tube expansion improves ventilation, but navigation and positioning precision are challenging without real-time location feedback
Solution Approach 1:
The patent incorporates a navigation sensor in the distal portion of the catheter that provides real-time location feedback, allowing the operator to precisely control catheter positioning and balloon placement within the Eustachian tube, thereby improving dilation accuracy and effectiveness
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 system effectively dilates the Eustachian tube, allowing for improved pressure equalization and fluid drainage, providing long-term relief from middle ear fluid accumulation and associated symptoms like hearing impairment and recurrent infections.
Implementation Method 1
a navigation sensor arranged at the distal shaft portion, distal to the expandable element, wherein the navigation sensor is configured to generate a signal corresponding to a location of the distal shaft portion within the patient
Implementation Method 2
an expandable element disposed on the distal shaft portion proximally of the distal shaft end, wherein the expandable element is configured to expand to dilate an anatomical passageway of a patient
Implementation Method 3
a vent passageway through the distal tip, wherein the vent passageway is configured to permit passage of air therethrough
Data Source
AI summary
A dilation catheter includes a catheter shaft, an expandable element, and a navigation sensor. The catheter shaft has a proximal shaft portion defining a proximal shaft end, a distal shaft portion defining a distal shaft end, and a working lumen extending between the proximal and distal shaft ends. The expandable element is disposed on the distal shaft portion proximally of the distal shaft end, and is configured to expand to dilate an anatomical passageway of a patient. The navigation sensor is arranged at the distal shaft portion, and is configured to generate a signal corresponding to a location of the distal shaft portion within the patient. In various examples, the dilation catheter may further include a bulbous distal tip, and the navigation sensor may be arranged within the bulbous distal tip.