Needle Handle Vacuum Chamber for Endobronchial Sampling
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Solution Overview
Problem
Current endobronchial ultrasound systems and transbronchial needle aspiration procedures face challenges with vacuum generation during sample collection, as the stylet movement generates minimal suction and is prone to contamination and component bending/kinking, due to the lack of a sealed vacuum chamber at the needle tip.
Innovation Solution
A device with a sheath, medical device, stylet, and handle assembly, featuring a vacuum chamber and plunger system that creates suction at the distal end by pneumatically isolating a volume of space, allowing for effective vacuum generation without stylet movement, using a plunger that seals with the chamber wall and a tab mechanism to control pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If stylet movement is used to generate suction, then sample collection is enabled, but the vacuum generated is very small and easily lost due to lack of sealing
Solution Approach 1:
The device is segmented into distinct functional components: a sealed chamber portion isolated from the sheath lumen, a stylet with separate lumens, and a plunger device. This segmentation allows the chamber to maintain a sealed vacuum environment independent of the stylet manipulation, resolving the contradiction between enabling suction and preventing contamination.
Solution Approach 2:
The plunger device acts as an intermediary mechanism between the operator and the vacuum generation system. By manipulating the plunger rather than directly moving the stylet, the system generates reliable vacuum while maintaining sealing integrity and reducing contamination risk through the intermediate plunger-stylt tab connection.
2Ease of operation
If manual stylet manipulation is performed, then vacuum is generated, but procedural time increases and risk of bending/kinking components occurs
Solution Approach 1:
The functions of stylet manipulation and vacuum generation are merged into a single integrated action. Moving the stylet proximally automatically drives the plunger device to move proximally within the chamber, simultaneously achieving both stylet repositioning and vacuum generation in one motion, thereby reducing procedural time and simplifying operation.
Solution Approach 2:
The stylet is pre-configured with tabs that engage the plunger device before the procedure begins. This preliminary arrangement ensures that when the stylet is moved, the plunger is automatically driven to create vacuum, eliminating the need for separate manual plunger manipulation and reducing procedural steps.
3Productivity
If a sealed vacuum chamber is implemented, then suction efficiency is improved, but device complexity increases
Solution Approach 1:
The vacuum chamber is nested within the existing handle structure, and the plunger device is nested within the chamber portion. The stylet passes through both the chamber and needle assembly. This nested configuration achieves sealed vacuum functionality while utilizing the existing device architecture, minimizing the increase in overall device complexity.
Solution Approach 2:
The chamber portion utilizes a sealed environment created by flexible sealing surfaces between rigid components. The plunger device creates a dynamic seal against the chamber wall during movement, maintaining vacuum integrity without requiring complex rigid sealing structures, thus improving sampling efficiency with moderate complexity increase.
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
This solution enhances suction efficiency at the needle tip, reducing procedural time and risk of contamination, while maintaining effective sample collection without the need for manual stylet manipulation, thereby improving the reliability and safety of the sampling process.
Implementation Method 1
a plunger device configured to slide within the chamber portion and configured to pneumatically isolate a proximal portion of the volume of space from a distal portion of the volume of space
Implementation Method 2
Proximal movement of the stylet and the plunger device cause a suction effect (i.e., reduced pressure) at the distal end of the sheath, the medical device and/or the stylet
Data Source
AI summary
A device having a sheath, a medical device, a stylet, a handle and a plunger device. The handle includes portions connected proximal ends of the sheath, the medical device and the stylet and a chamber portion connected to the actuator. The chamber portion includes a volume of space configured to volumetrically connect to at a lumen of the medical device, the sheath or the stylet and a plunger device configured to be slidably received within the chamber portion. The plunger device is able to pneumatically isolate a proximal portion of the volume of space from a distal portion of the volume of space. Proximal movement of the stylet and the plunger device cause a suction effect (i.e., reduced pressure) at the distal end of the sheath, the medical device and/or the stylet.