Modular Needle Biopsy Device with Integrated Protection
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Solution Overview
Problem
Current fine needle aspiration devices for endoscopic ultrasound and endobronchial ultrasound procedures face challenges such as cumbersome attachment to echo-endoscopes, sub-optimal ergonomics, frequent needle kinking or deformation, and lack of needle safety features, leading to prolonged procedures and increased risk of needle stick injuries and blood-borne pathogen exposure.
Innovation Solution
A modular needle biopsy device with a detachable needle housing member, integrated catheter drive, and needle protection mechanism that includes a compressible needle protection shaft and hub to prevent inadvertent piercing and enhance ergonomics, along with echogenic surface features to improve ultrasound visibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional fine needle aspiration devices are used with multiple handles and cap screw arrangements, then the device can be attached to echo-endoscope, but the procedure time is significantly prolonged and ergonomics are sub-optimal
Solution Approach 1:
The device is divided into separate functional modules: a handle assembly with integrated controls and a needle assembly with独立的 depth control. This segmentation allows each module to be optimized independently and attached via a quick-connect mechanism, eliminating the need for multiple handles and cap screw arrangements, thereby reducing procedural time while maintaining ergonomic operation.
Solution Approach 2:
Multiple control functions (needle depth control, catheter drive, and aspiration control) are merged into a single integrated handle assembly with unified controls. This consolidation eliminates the need for multiple independent handles and cap screw mechanisms, streamlining the operation and significantly reducing the time required to perform the procedure while improving ergonomics.
2Reliability
If traditional fine needle aspiration devices are used with male fitting adapters screwed onto female luer port, then the device can be attached to echo-endoscope, but the attachment process is cumbersome and procedure time is prolonged
Solution Approach 1:
The handle assembly and needle assembly are pre-configured with complementary quick-connect interfaces that enable immediate attachment without requiring screwing or threading operations. The pre-engineered interface geometry ensures secure connection upon engagement, maintaining attachment reliability while eliminating the time-consuming screwing process of traditional male fitting adapters.
Solution Approach 2:
The traditional mechanical screwing attachment system (male fitting adapters screwed onto female luer ports) is replaced with a quick-connect mechanical interface that uses lever-action or bayonet-style coupling. This substitution maintains secure attachment reliability while reducing the attachment process from multiple screwing operations to a single swift motion, significantly decreasing procedure time.
3Ease of operation
If traditional fine needle aspiration devices are used without integrated needle protection, then the needle can be freely manipulated, but the risk of needle stick injuries and blood-borne pathogen exposure is increased
Solution Approach 1:
A protective sheath is nested within the handle assembly that automatically receives and contains the needle tip when the needle is retracted. The sheath is positioned such that it envelops the needle during storage and transport, providing continuous protection while allowing free manipulation during the procedure. This nested configuration maintains ease of operation while eliminating needle stick injuries and blood-borne pathogen exposure risks.
Solution Approach 2:
An intermediate protective mechanism is introduced between the needle and the external environment. This mechanism includes a retractable shield or fixed sheath that acts as a mediator, allowing the needle to be freely manipulated during use while automatically protecting the sharp tip during attachment, detachment, and storage operations, thereby preventing needle stick injuries and pathogen transmission.
4Ease of manufacture
If needles with smooth cylindrical surfaces are used, then the needle can be easily manufactured, but the needle is difficult to image using ultrasonography due to specular surface finish
Solution Approach 1:
The needle surface is given different qualities at different locations: the shaft maintains a smooth cylindrical surface for ease of manufacture and insertion, while the tip and bevel areas are treated with echogenic coatings or textured surfaces to enhance ultrasound reflectivity. This local differentiation allows the needle to be easily manufactured overall while providing sufficient ultrasound visibility at the critical imaging regions without compromising manufacturing simplicity.
Solution Approach 2:
The surface parameters of the needle are modified by applying echogenic coatings (such as tungsten, barium, or specialized polymer coatings) or creating micro-textured surfaces at specific locations. These parameter changes increase the ultrasound reflectivity and visibility of the needle while maintaining the overall smooth cylindrical geometry for ease of manufacture. The coating thickness and surface roughness are controlled to optimize echogenicity without significantly increasing manufacturing complexity.
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 device facilitates safer, more efficient needle handling and protection, reducing procedural time and the risk of needle stick injuries while enhancing imaging capabilities through improved ultrasound reflectivity.
Implementation Method 1
a compressible needle protection shaft and hub to prevent inadvertent piercing
Implementation Method 2
echogenic surface features to improve ultrasound visibility
Data Source
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AI summary
A needle biopsy device comprising: a handle member, having proximal (804) and distal (808) portions; a proximal handle member (802) disposed to the proximal portion (804) of the handle member; a distal handle member (810) disposed to the distal portion (808) of the handle member; a sheath lumen (818) disposed within the handle member and extending from the distal portion (808) of the handle member; an exchangeable needle housing member (812) partially disposed within the proximal handle member (802), including a exchangeable needle (828) disposed within the sheath lumen (818); a needle protection member (822) partially disposed within the proximal handle member (802) for receiving the needle (828), wherein the device includes an engageable member (824) disposed within the proximal handle member (802) for facilitating the engagement of the needle protection member (822) within the proximal handle member (802); and the needle protection member (822) includes a needle protection hub (820) and a needle protection shaft (822).