Urinary Placement Catheter With Tactile Stylet Feedback
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Solution Overview
Problem
Existing inserter devices for deploying intravesical devices into the bladder face challenges such as poor user handling, inadequate lubrication management, and lack of operational feedback, leading to potential trauma and uncertainty in device deployment.
Innovation Solution
The development of an inserter assembly comprising a placement catheter with a receiving funnel and a stylet, where the stylet includes a paddle for secure handling and a paddle-funnel engagement mechanism providing tactile feedback, facilitating smooth deployment of intravesical devices with enhanced operational control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a simple catheter design is used for intravesical device deployment, then device complexity is reduced, but user handling and operational control deteriorate
Solution Approach 1:
The catheter is divided into distinct functional segments: a receiving funnel portion for device loading and alignment, a lumen for device passage, and a deployment mechanism with stylet and paddle. This segmentation allows each portion to be optimized for its specific function while maintaining overall simplicity.
Solution Approach 2:
A removable stylet with paddle acts as an intermediary tool that facilitates device deployment through the catheter. The stylet provides mechanical advantage for pushing the intravesical device through the lumen, while the paddle engages with the receiving funnel to provide tactile feedback and control during the procedure.
2Ease of operation
If adequate lubrication is provided to prevent trauma, then ease of operation improves, but device complexity increases
Solution Approach 1:
The receiving funnel portion is pre-loaded with lubrication before the deployment procedure. This preliminary application of lubricant to the funnel and lumen surfaces ensures smooth passage of the intravesical device without requiring complex lubrication management systems during the procedure.
Solution Approach 2:
The catheter design allows the lubricant to be applied in advance by the user themselves, without requiring additional specialized equipment or systems. The simple funnel structure enables direct lubricant application and distribution.
3Loss of information
If a paddle-funnel engagement mechanism is added for tactile feedback, then operational feedback improves, but device complexity increases
Solution Approach 1:
The paddle on the stylet is designed to engage with the receiving funnel structure, creating tactile feedback when the intravesical device is properly positioned and deployed. This mechanical engagement provides the user with sensory information about deployment status without requiring electronic sensors or complex feedback systems.
Solution Approach 2:
The paddle and funnel engagement mechanism uses simple, inexpensive mechanical components that provide sufficient feedback for the procedure. The design prioritizes functional effectiveness over durability, as the catheter and stylet are typically disposable single-use items.
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 3A~3C
AI summary
An inserter assembly (200) for deploying an intravesical device into a urinary bladder of a patient includes a placement catheter (210), a receiving funnel (220), and a stylet (230). The placement catheter defines a lumen extending from a proximal catheter end to an exit opening. The receiving funnel is secured to the placement catheter. The stylet is removably received through the receiving funnel within the lumen. The stylet includes a stylet body and a paddle (238). The stylet body is dimensioned to drive the intravesical device through the lumen and the exit opening into the bladder. The paddle is fixed to the stylet body about the proximal stylet end and is engageable with the receiving funnel. The paddle optionally includes a fitting (242) being lockably engageable with the receiving funnel to removably secure the stylet to the placement catheter.