Surgical Biopsy Device with Segmented Cutting Element
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Solution Overview
Problem
Current biopsy devices face challenges such as incomplete tissue severing, prolonged procedures, exposure to bio-hazards, and increased trauma due to multiple insertions, with a need for reliable vacuum application, disposable designs, and compatibility with multiple imaging modalities.
Innovation Solution
A surgical device featuring a housing with a cutting element comprising an outer and inner cannula, a spool, and a spring, where the spool translates the outer cannula distally and the piston translates the inner cannula to sever tissue effectively, allowing for single insertion and efficient tissue removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If multiple insertions are performed to obtain sufficient tissue for pathology, then complete tissue sampling is achieved, but patient trauma and procedure time increase
Solution Approach 1:
The device segments the tissue sampling process into multiple discrete cuts within a single insertion. The cutting element includes multiple notches or cutting edges that sequentially sever tissue as the device is advanced, allowing multiple tissue samples to be obtained without removing and reinserting the device between samples.
Solution Approach 2:
The device maintains continuous useful action by keeping the cutting element engaged with tissue throughout a single insertion. The cutting element progressively severs tissue through multiple cuts as it advances, eliminating the interruption and reinsertion required by traditional methods, thereby maintaining continuous tissue sampling action.
2Device complexity
If traditional cutting mechanisms are used, then device simplicity is maintained, but tissue severing reliability decreases
Solution Approach 1:
The cutting element is designed to dynamically engage and sever tissue through controlled advancement. The cutting mechanism transitions from a static blade to a dynamic cutting element that progressively severs tissue through multiple notches or edges as it moves forward, improving reliability by ensuring complete separation at each cutting stage.
Solution Approach 2:
The cutting element is pre-configured with multiple notches or cutting edges before insertion. These pre-positioned cutting features are designed to sequentially engage tissue at predetermined intervals during advancement, ensuring reliable and complete tissue severing without requiring complex real-time adjustments during the procedure.
3Ease of manufacture
If reusable devices are used, then cost is reduced, but exposure to bio-hazards increases
Solution Approach 1:
The device is designed as a disposable single-use instrument that can be manufactured at low cost. After a single biopsy procedure, the entire device is discarded, eliminating the need for sterilization and reducing cross-contamination risks. The low manufacturing cost allows this disposable approach to be economically viable, preventing bio-hazard exposure while maintaining affordability.
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 device ensures complete tissue severing with minimal attempts, reduces exposure to bio-hazards, and is compatible with various imaging modalities, enhancing procedural efficiency and patient safety.
Implementation Method 1
A spring is positioned between the spool and the piston. The spool is translated distally to translate the outer cannula towards the distal end.
Data Source
AI summary
A surgical system is disclosed. The surgical system comprises a housing, a surgical device and an adapter. The housing includes a distal end. The surgical device comprises, a cutting element extending from the housing at the distal end. The cutting element is selectively rotated and translated relative to a tissue biopsy area. The adapter is configured to selectively and detachably receive the surgical device. The adapter secures the surgical device thereto by at least one latching mechanism such that the surgical device is prevented from moving independently from the adapter.