Helical Work Element for Soft Tissue Biopsy and De-bulking
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Solution Overview
Problem
Current medical devices are inadequate for performing soft tissue biopsies, solid and semi-solid material removal, de-bulking, and endovascular procedures, particularly in terms of single insertion, multiple sample capabilities, and efficient tissue penetration and retrieval.
Innovation Solution
A medical device with a flexible work element featuring a helical outer tube and inner tube structure, capable of differential rotation to expose a sharpened coring tip for tissue penetration, capture, and transport, and designed for both single and multiple sample procedures, including endovascular applications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If current medical devices are used for soft tissue biopsy and material removal, then basic tissue sampling is possible, but single insertion multiple sample capability and efficient tissue penetration are inadequate
Solution Approach 1:
The device divides the biopsy function into segmented components: a reusable outer sheath and disposable work elements. Each work element is a self-contained unit with its own cutting edge and tissue capture mechanism, allowing multiple samples to be obtained through sequential deployment of different work elements from a single insertion point.
Solution Approach 2:
The outer sheath serves multiple functions: it provides structural support, guides the work elements, contains the biopsy mechanism, and can be reused across multiple procedures. This multi-functionality allows the system to achieve multiple sample capability without proportionally increasing overall device complexity.
2Object-affected harmful factors
If current devices perform tissue penetration and retrieval, then basic biopsy is achieved, but tissue trauma and procedural efficiency are suboptimal
Solution Approach 1:
The work elements are pre-sharpened and pre-configured with cutting edges and tissue capture mechanisms before insertion. The sharpened coring tip is prepared in advance to enable clean penetration with minimal trauma, while the tissue capture structure is pre-formed to efficiently retrieve the sample in a single motion.
Solution Approach 2:
The device extracts only the necessary tissue core through a focused sharpened coring tip, removing minimal tissue while obtaining the required sample. The captured tissue is then extracted from the body through the same access point, eliminating the need for additional incisions or traumatic retrieval methods.
3Reliability
If disposable work elements are used, then sterility and safety are improved, but cost and waste increase
Solution Approach 1:
The device segments the disposable component (work element) from the reusable component (outer sheath). This allows only the sterility-critical work element to be disposable, while the structural outer sheath is reused. The segmented design minimizes waste by making disposable only what is necessary for sterility and single-use functionality.
4Adaptability or versatility
If the device is designed for portability and adaptability, then versatility across procedures is improved, but device complexity increases
Solution Approach 1:
The outer sheath is designed as a universal platform that can accommodate different types of work elements for various procedures including soft tissue biopsy, endovascular material removal, and de-bulking. This universal design allows a single outer sheath device to be adapted for multiple procedures by simply changing the work element, without increasing the complexity of the main device structure.
Data Source
AI summary
A soft tissue biopsy or material collection device may comprise a work element consisting of an outer tube with external sheath and formed from a tapered helical structure over an internal tube structure configured to open and close its distal end to perform penetration, coring, capturing, parting off and transporting multiple material samples in a single or multiple insertion procedure.