Biopsy Device Manifold Alignment and Tissue Sensor
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Solution Overview
Problem
Current biopsy devices lack an efficient mechanism for obtaining and handling tissue samples, particularly in a way that allows for single-handed operation and effective sample collection without being tethered to other devices, while ensuring precise control and sample handling.
Innovation Solution
The biopsy device comprises a probe with a distally extending needle and a cutter actuation mechanism that allows for tissue sampling, integrated with a tissue sample holder and a holster, enabling single-handed operation and sample collection, along with a needle firing mechanism and sensors for tissue detection and feedback.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If biopsy devices are designed for single-handed operation with minimal setup, then ease of operation is improved, but device complexity increases due to integrated mechanisms
Solution Approach 1:
The patent combines multiple functions (needle firing, tissue sampling, vacuum application, and sensor integration) into a single integrated biopsy device that can be operated with one hand. The holster and probe are designed as unified components with integrated actuators and sensors, eliminating the need for separate devices or complex manual manipulation.
Solution Approach 2:
The biopsy device incorporates multiple functionalities within a single device: needle insertion, tissue capture, vacuum application, sample retrieval, and real-time sensing. This multi-functional design allows a single device to perform what previously required multiple separate instruments, improving ease of operation while managing complexity through functional integration.
2Measurement precision
If real-time feedback sensors are integrated into the tissue sample holder, then measurement precision is improved, but device complexity increases
Solution Approach 1:
The patent integrates sensors directly into the tissue sample holder to provide real-time feedback on tissue sample characteristics. This feedback mechanism allows for immediate detection and communication of sample properties, improving measurement precision by enabling continuous monitoring rather than post-procedure analysis.
Solution Approach 2:
The sensors are nested within the tissue sample holder structure, with sensing elements positioned inside or integrated with the sample containment geometry. This nesting approach minimizes additional external components and reduces overall device complexity while maintaining measurement precision through direct contact sensing.
3Productivity
If multiple functions are integrated into a single biopsy device, then productivity is improved, but device complexity increases
Solution Approach 1:
The device applies vacuum pressure in advance during needle insertion to prepare for immediate tissue capture upon reaching the target. This preliminary action ensures that tissue samples are ready to be drawn in real-time, improving productivity by eliminating delays between needle insertion and sample collection.
Solution Approach 2:
The biopsy device maintains continuous vacuum application and real-time sensing throughout the entire sampling process, from needle insertion to sample retrieval. This continuous operation ensures uninterrupted tissue capture and monitoring, maximizing productivity by eliminating idle time and ensuring consistent sample collection.
Data Source
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AI summary
A biopsy system includes a needle, a cutter moveable relative to the needle to sever a tissue sample, a processing module, a tissue sensor, and an indicator. The tissue sensor is operable to sense a tissue sample severed by the cutter. The processing module is operable to drive the indicator based on information from the tissue sensor. The indicator may include an audible indicator and/or a visual indicator. The indication provided by the indicator may vary based on sensed qualities of the tissue sample. The indicator may be integrated into a biopsy instrument or may be provided as part of a remote unit. The biopsy system may also include a multi chamber tissue sample holder. A graphical user interface may indicate which chambers of the tissue sample holder are occupied by tissue samples.