Vacuum Timing Algorithm Biopsy Device
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Solution Overview
Problem
Current biopsy systems lack an efficient and user-friendly method for obtaining and handling tissue samples, particularly in stereotactic and ultrasound-guided procedures, with existing devices often requiring complex mechanisms and not addressing issues like tissue sample handling and disposal of sharp components.
Innovation Solution
A biopsy system comprising a probe and holster with integrated sensors, a needle and cutter mechanism, and a vacuum control module, allowing for efficient tissue sampling and sample handling, with features like removable needle and cutter components for sharps reduction and a tissue sample holder for easy collection and alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If complex mechanisms are used in existing biopsy devices, then tissue sampling capability is achieved, but device complexity increases and ease of operation decreases
Solution Approach 1:
The biopsy device is divided into separate functional modules: a disposable biopsy needle assembly containing the cutter and sample collection mechanism, and a reusable handle assembly containing the vacuum control and firing mechanism. This segmentation allows the complex sampling mechanism to be pre-assembled and tested as a separate unit, reducing overall device complexity while maintaining sampling capability.
Solution Approach 2:
The sharp cutter component is extracted as a separate replaceable element within the needle assembly. After use, only the needle assembly with the contaminated cutter is discarded, while the handle assembly is reused. This extraction simplifies the overall device structure and improves ease of operation by eliminating the need to clean or sterilize the entire device.
2Reliability
If integrated biopsy systems are used, then tissue sampling is achieved, but ease of operation and user-friendliness decrease
Solution Approach 1:
The biopsy needle assembly is designed as a self-contained, pre-loaded unit that requires no assembly or preparation by the user. The cutter is pre-positioned, the vacuum seals are pre-formed, and the entire assembly is ready for immediate use. After the procedure, the entire needle assembly is discarded as a single unit, eliminating complex cleanup or reassembly steps and significantly improving ease of operation.
3Productivity
If traditional biopsy devices are used, then tissue samples are obtained, but sample handling and disposal of sharp components become difficult
Solution Approach 1:
The sharp cutter, tissue sample collection chamber, and disposal mechanism are merged into a single disposable needle assembly. The cutter is positioned within the needle shaft, and the sample collection chamber is integrated at the distal end. After use, the entire assembled unit is discarded together, eliminating separate handling steps for sharp components and tissue samples, thereby improving ease of operation and safety.
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 system enables efficient and safe tissue sampling with reduced complexity, facilitating user-friendly operation and improved handling of tissue samples, while also addressing the disposal of sharp components.
Implementation Method 1
A vacuum control module is in communication with the inner cannula and operable to create a vacuum
Data Source
AI summary
A biopsy system has a cutter defining a cutter lumen along an axis. One conduit in the system is configured to provide fluid communication along the cutter lumen axis; while another conduit in the system is configured to provide fluid communication lateral to the cutter lumen axis. The system may be operated in a variety of modes, including a sample cycle, a clear probe cycle, a cutter positioning cycle, an aspirate cycle, and a maintenance vacuum pulse cycle. The operational modes are selectable by a user. Depending on the mode selected by the user, the communication of vacuum, saline, or atmospheric air through the conduits, or the sealing of the conduits, will vary as a function of the axial position of the cutter.


