Disposable Core Needle Biopsy Device with Selectable Firing Modes
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Solution Overview
Problem
Existing biopsy devices, particularly fully disposable ones, lack user flexibility and ease of use due to limited capabilities and complex operation, and existing partially disposable devices are not easily adaptable for single insertion multiple sample procedures.
Innovation Solution
A fully disposable spring-powered core needle biopsy device with multiple user-selectable firing modes, distances, and dual sample acquisition triggers, featuring a cocking mechanism that reduces the force required for operation, and available in various needle gauge and length combinations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a fully disposable biopsy device is used, then device complexity is reduced and ease of manufacture is improved, but capability and ease of use deteriorate
Solution Approach 1:
The device is divided into two main segments: a reusable driver and a disposable probe. This segmentation allows the complex, capable driver to be manufactured once and reused, while the simpler probe is disposable, thus improving ease of manufacture for the disposable portion while maintaining high capability through the reusable driver.
Solution Approach 2:
The reusable driver is designed to accommodate multiple disposable probes and perform multiple functions (tissue sampling, cutting, retrieval). This multi-functionality allows a single device to handle various biopsy procedures, improving adaptability and versatility without requiring multiple specialized devices.
2Device complexity
If a fully disposable biopsy device is used, then device complexity is reduced, but ease of operation deteriorates
Solution Approach 1:
The device incorporates self-aligning and self-locking mechanisms that automatically guide the disposable probe into the correct position on the driver and secure it without requiring complex manual alignment procedures. This self-service functionality simplifies operation despite the device's modular complexity.
Solution Approach 2:
The interface between the driver and disposable probe includes intermediary alignment features and guiding structures that mediate the connection process. These intermediaries ensure proper positioning and secure attachment, making the operation easier and more intuitive for the user.
3Adaptability or versatility
If multiple user-selectable firing modes and distances are added, then adaptability is improved, but device complexity increases
Solution Approach 1:
The device incorporates adjustable and reconfigurable components that allow the firing modes and distances to be changed dynamically during use. The selector assembly and trigger mechanisms can be repositioned or reconfigured to provide multiple operational modes, enabling procedural flexibility without requiring multiple fixed devices.
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 provides procedural flexibility and ease of use by allowing multiple firing modes and distances, reducing the force needed for cocking, and is designed for efficient tissue sampling with improved user preference and accuracy.
Implementation Method 1
A fully disposable spring powered core needle biopsy device
Data Source
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AI summary
A biopsy device includes a cutting cannula mechanism having a cutting cannula and an inner stylet mechanism having an inner stylet coaxial with the cutting cannula. A cocking mechanism is configured to cock the cutting cannula mechanism and the inner stylet mechanism by retracting each of the cutting cannula and the inner stylet in a proximal direction to a cocked position. A trigger device is configured to fire at least one of the inner stylet mechanism and the cutting cannula mechanism to advance a respective at least one of the inner stylet and the cutting cannula from the cocked position in a distal direction. A selector assembly includes a selector switch having an exterior tab accessible by a user. The selector assembly is configured to select between at least two user selectable operating modes and at least two user selectable firing distances.