Biopsy Valve Assembly Dynamic Vacuum Control
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Solution Overview
Problem
Current biopsy devices lack an efficient mechanism for obtaining tissue samples with precise control over fluid flow and vacuum pressure, which can lead to incomplete or damaged samples due to inadequate fluid communication and vacuum management.
Innovation Solution
The biopsy device employs a valve assembly with two valves and a control unit that manage fluid flow and vacuum pressure through a sequence of operational states, including vacuum, venting, and saline supply, to effectively obtain and flush tissue samples using a cannula with a rotating cutter and lateral aperture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a vacuum source is used to obtain tissue samples, then tissue sample collection is improved, but sample damage may occur due to inadequate vacuum management
Solution Approach 1:
The patent implements dynamic vacuum control through a valve assembly that transitions between multiple operational states (vacuum state, venting state, saline flush state). The vacuum source is selectively connected to or disconnected from the needle/cutter assembly based on the operational phase, allowing the system to adapt vacuum pressure dynamically rather than maintaining constant vacuum. This resolves the contradiction by enabling efficient tissue collection during the vacuum state while preventing sample damage during venting and flush states.
Solution Approach 2:
The patent employs periodic cycling through distinct operational states: vacuum state for tissue sample acquisition, venting state for pressure equalization, and saline flush state for sample ejection. This periodic action allows the system to efficiently collect tissue samples during vacuum phases while protecting samples during subsequent venting and flushing phases, thereby resolving the contradiction between collection efficiency and sample integrity.
2Device complexity
If fluid flow control is simplified, then device complexity is reduced, but incomplete sample collection may result due to inadequate fluid management
Solution Approach 1:
The patent segments fluid control into distinct operational phases managed by a valve assembly with multiple valves (first valve for vacuum control, second valve for saline flush control). Each valve handles a specific aspect of fluid management, allowing independent optimization of each control function. This segmentation enables complete sample collection through coordinated vacuum application and saline flushing while maintaining manageable device complexity through modular valve design.
Solution Approach 2:
The valve assembly acts as an intermediary between the vacuum source/saline source and the needle/cutter assembly. It mediates fluid flow by selectively connecting or disconnecting these sources based on operational state, providing precise fluid management without requiring direct complex control mechanisms at the needle level. This intermediary approach ensures complete sample collection while keeping the overall device complexity manageable.
3Productivity
If vacuum pressure is increased for better tissue sample obtention, then tissue sample collection is improved, but tissue damage may occur
Solution Approach 1:
The patent implements dynamic vacuum pressure control through timed transitions between operational states. The vacuum source is connected at controlled pressure during the tissue sample acquisition phase, then disconnected during venting and flushing phases. This dynamic pressure management enables efficient tissue obtention when vacuum is applied while preventing tissue damage by eliminating continuous high-pressure exposure, resolving the contradiction between obtention efficiency and tissue integrity.
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 enables precise control over the biopsy process, ensuring complete tissue sample collection and efficient flushing, reducing sample damage and improving the overall effectiveness of the biopsy procedure.
Implementation Method 1
a vacuum source and a valve assembly in fluid communication with the needle of the biopsy device
Implementation Method 2
a saline source and the valve assembly in fluid communication with one another and with the needle
Data Source
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AI summary
A biopsy assembly includes a biopsy device, a vacuum source, and a valve assembly, The biopsy device includes a body, a needle extending distally from the body, and a cutter translatable relative to the needle. The needle includes a lateral tissue receiving aperture. The cutter is translatable to selectively close the lateral tissue receiving aperture of the needle. The valve assembly is in fluid communication with the needle. The valve assembly includes a first valve, a second valve, and tubular member. Each of the first valve and the second valve selectively provide atmospheric venting or vacuum to the needle. The tubular member is coupled with the vacuum source and includes a first and second connector extending transversely from the tubular member. The first and second connectors couple to the first and second valves to provide vacuum to the first and second valves.