Single-Insertion Biopsy Device with Segmented Sampling Chambers
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Solution Overview
Problem
Current biopsy devices require multiple insertions for obtaining multiple tissue samples, leading to pain and scarring, and often fail to accurately deliver markers to the biopsied site due to additional steps involving different devices.
Innovation Solution
A single-insertion, multiple sampling biopsy device with an outer cannula, stylet, and sheath, where the stylet and sheath translate relative to each other, allowing for simultaneous tissue sampling and marker delivery through a drive unit, enabling multiple samples to be taken without removing the device from the body and ensuring accurate marker placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If multiple insertions are performed to obtain multiple tissue samples, then the quantity of tissue samples is improved, but the trauma to the patient and scarring worsen
Solution Approach 1:
The biopsy device is segmented into multiple independent sampling chambers (first chamber, second chamber, third chamber) that can each capture tissue samples independently. This allows multiple samples to be obtained through a single insertion by sequentially actuating different chambers, thereby increasing sample quantity while avoiding repeated insertions and associated trauma.
Solution Approach 2:
The biopsy device is designed as a multi-functional instrument that can perform multiple sampling operations, marker delivery, and tissue retrieval all through a single insertion. The device universally handles different sampling chambers and functions within one procedural step, eliminating the need for multiple separate insertions and reducing patient trauma.
2Quantity of substance
If multiple insertions are performed to obtain multiple tissue samples, then the quantity of tissue samples is improved, but the time required for the procedure worsens
Solution Approach 1:
The device enables continuous sampling action by maintaining all sampling chambers and associated mechanisms within a single inserted device. Multiple samples can be captured sequentially or simultaneously without removing the device, allowing the useful action of tissue sampling to continue uninterrupted, thereby reducing total procedure time while obtaining multiple samples.
3Measurement precision
If separate devices are used for marker delivery, then the accuracy of marker placement is improved, but the device complexity and number of steps worsen
Solution Approach 1:
The marker delivery system is merged with the biopsy sampling device, integrating the marker reservoir and delivery mechanism into the same device structure that performs tissue sampling. This combination maintains accurate marker placement capability while reducing the number of separate devices and procedural steps required, thereby simplifying the overall process without sacrificing precision.
Solution Approach 2:
The biopsy device is designed as a universal instrument that performs both tissue sampling and marker delivery functions. By incorporating multiple chambers for different functions (sampling and marker delivery) within a single device, it eliminates the need for separate specialized devices, reducing complexity while maintaining the precision of marker placement through integrated design.
Data Source
AI summary
A single-insertion biopsy device includes a cannula having an extraction position at a distal end and a recovery opening at a proximal end. A first elongate element has a first distal end and a second elongate element has a second distal end. The first elongate element and the second elongate element are configured to move between the extraction position and the recovery opening, and to move with respect to each other to define an open configuration and a closed configuration. In the closed configuration, the first and second distal ends are mutually radially opposite such that the first elongate element and the second elongate element surround a volume. A drive unit is configured to move the first elongate element and the second elongate element between the open and closed configurations, and to move the first and second distal ends in unison from the extraction position to the recovery opening.