Disposable Biopsy Needle with Integrated Tissue Sensing
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Solution Overview
Problem
Existing biopsy devices require complex cleaning and disinfection procedures due to their non-disposable nature, which can be cumbersome and inefficient, and often rely on external imaging systems for tissue localization, which may not provide real-time characterization.
Innovation Solution
A removable biopsy device system with a handle, an inner needle equipped with tissue sensing units and a disposable outer sheath that includes a cutting edge, allowing for easy attachment and detachment of sensing units, and a control unit for analyzing tissue properties, facilitating real-time tissue characterization and sample acquisition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the biopsy device is made disposable to avoid cleaning and disinfection, then the ease of operation and infection control are improved, but the device complexity and cost increase
Solution Approach 1:
The biopsy device is divided into two separable components: a reusable handle containing the sensing unit and connection elements, and a disposable needle assembly containing the inner needle, outer sheath, and sampling cavity. This segmentation allows the complex sensing components to be reused while the disposable portion is discarded after single use, resolving the contradiction between ease of cleaning and device complexity
Solution Approach 2:
The needle assembly with inner needle, outer sheath, and sampling cavity is designed as a disposable component that is discarded after a single use, eliminating the need for complex cleaning and disinfection procedures. The reusable handle contains the expensive sensing unit that would be damaged by sterilization processes, thus resolving the contradiction between ease of operation and device complexity
2Measurement precision
If external imaging systems are used for tissue localization, then the measurement capability is provided, but the real-time tissue characterization capability is lost
Solution Approach 1:
The biopsy device merges two previously separate functions into one integrated system: external imaging for localization and internal sensors for real-time tissue characterization. The sensing unit with multiple sensors (impedance, temperature, pressure) is integrated into the needle assembly, allowing simultaneous localization and real-time tissue property measurement, thus resolving the contradiction between measurement precision and loss of information
Solution Approach 2:
The sensing unit acts as an intermediary between the external imaging system and the tissue sample. While external imaging provides initial localization, the sensors in the sensing unit (positioned at the tip and along the inner needle) provide real-time feedback on tissue properties during the biopsy procedure, bridging the gap between external localization and internal tissue characterization
3Device complexity
If the sensing unit is permanently integrated into the handle, then the device complexity is reduced, but the adaptability and ease of repair are worsened
Solution Approach 1:
The device is segmented into a reusable handle and disposable needle assembly, with the sensing unit located in the handle. The handle can be reused across multiple procedures while the needle assembly is discarded. This segmentation provides adaptability by allowing the handle to work with different needle assemblies and enables easy replacement of the sensing unit if needed, resolving the contradiction between device complexity and adaptability
Solution Approach 2:
The handle with the sensing unit is designed as a universal platform that can accommodate different disposable needle assemblies for various biopsy applications. The standardized connection interface between the handle and needle assembly allows the same handle to be used with different sensors and needle configurations, providing adaptability while maintaining manageable device complexity
Data Source
AI summary
A biopsy system includes a handle for receiving a removable biopsy device which includes an inner needle having a distal tip configured for piercing tissue, a tissue sensing unit for characterizing tissue properties, a recess formed longitudinally in the inner needle proximal to the distal tip for receiving a tissue portion from a region of interest, an outer sheath configured to move relatively to the inner needle, and a connector element for receiving sensing signals from the tissue sensing unit. The handle includes a socket tiltable between a rest position and a tilted position, and having a sliding channel, and a connection board. The connector element includes a coupling matrix while the connection board has a receiving matrix. Fixation pins in one matrix cooperate with holes in a second matrix to facilitate alignment of the connector element with the connection board.