Biopsy Device Vacuum Chamber Concentric Cutter Design
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Solution Overview
Problem
Current biopsy devices often provide inadequate tissue samples, leading to the need for multiple samples, increased patient trauma, and higher costs due to cumbersome designs, slow operation, and high expenses, while also risking infection and requiring complex charging processes.
Innovation Solution
A biopsy device with a cannula and a cutter mechanism that uses a vacuum generating mechanism and biasing devices to efficiently acquire tissue samples, featuring a compact design with a vacuum chamber concentric with the cutter, allowing for rapid and precise tissue acquisition, and a purge valve for easy sample ejection, facilitating easier manipulation and reduced infection risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If spring-loaded core biopsy devices or vacuum-assisted biopsy devices are used, then tissue samples can be acquired, but the tissue sample acquired may be insufficient or inadequate to make a proper histological assessment
Solution Approach 1:
The patent combines the vacuum chamber and cutter mechanism into a single integrated biopsy device, allowing simultaneous vacuum application and tissue cutting in one operational cycle. This merging of functions ensures adequate tissue sample acquisition while maintaining reliability for proper histological assessment.
Solution Approach 2:
The vacuum chamber is pre-charged to a predetermined vacuum level before the cutting action occurs. This preliminary vacuum preparation ensures that when the cutter advances, tissue is already drawn into the cutting path, guaranteeing adequate sample quantity and quality in a single pass.
2Ease of operation
If vacuum-assisted biopsy devices with motorized hand-held units and control modules are used, then tissue samples can be acquired, but the cable and tubing can limit freedom of movement making it more difficult to position the hand-held unit
Solution Approach 1:
The patent extracts the vacuum generation function from a separate control module and integrates it directly into the hand-held biopsy device. This eliminates the need for external cables and tubing, providing complete freedom of movement while positioning the device.
Solution Approach 2:
The vacuum chamber is nested within the handle assembly of the biopsy device, with the cutter mechanism integrated inside the vacuum chamber structure. This nested arrangement consolidates multiple components into a compact, cable-free hand-held unit that is easy to position.
3Productivity
If vacuum-assisted biopsy devices with reusable battery-powered motorized hand-held units are used, then tissue samples can be acquired, but these devices are relatively slow in operation, thereby increasing the time and trauma associated with the biopsy procedure
Solution Approach 1:
The biopsy device uses a rapid cyclic operation where the vacuum chamber is quickly charged to predetermined vacuum levels and the cutter rapidly advances and retracts in periodic cycles. This periodic action enables multiple tissue samples to be acquired in rapid succession, significantly reducing total procedure time.
Solution Approach 2:
The vacuum chamber is designed to charge to predetermined vacuum levels rapidly, and the cutter mechanism is optimized for quick advancement and retraction. These parameter optimizations (vacuum pressure levels, actuation speeds) enable fast operational cycles that reduce procedure time while maintaining effective tissue acquisition.
4Reliability
If biopsy devices with complex parts and manual charging mechanisms are used, then devices can be fully disposable, but multiple charging strokes can delay the time required for further operational cycles
Solution Approach 1:
The vacuum chamber is pre-charged to a predetermined vacuum level as part of the initial device preparation, eliminating the need for multiple charging strokes during the procedure. This preliminary charging action ensures the device is ready for immediate use and reduces delays between operational cycles.
Solution Approach 2:
The biopsy device is designed as a disposable unit with integrated vacuum chamber that can be rapidly prepared and used once, then discarded. This eliminates infection risk from reusable components while the simple vacuum chamber design allows rapid preparation without complex multi-stroke charging mechanisms.
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 effectively acquires adequate tissue samples quickly, reducing the number of samples needed, minimizing trauma and costs, and providing a cost-effective, easy-to-use solution for improved patient care.
Implementation Method 1
a vacuum generating mechanism in air-flow communication with the cannula and tissue-receiving cavity, a first biasing device operating the vacuum generating mechanism to produce a vacuum in the tissue-receiving cavity
Implementation Method 2
a second biasing device advancing the cutter across the tissue-receiving cavity
Data Source
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AI summary
Biopsy devices (10, 10' ) for acquiring tissue samples (59). In embodiments, exemplary biopsy devices include a cutter (127), a cannula (13) including a tissue-receiving cavity (42), a vacuum generating mechanism (17) and a tissue cutting mechanism (15). Vacuum generating mechanism draws tissue (47) into tissue-receiving cavity and tissue cutting mechanism cuts a tissue sample (59). Vacuum generating mechanism may provide positive air pressure for tissue sample ejection.