Anal Swab Sheath Locking Mechanism for Sample Integrity
Solution Overview
Problem
Current devices for collecting and transporting cytological cell samples for anal cancer detection do not adequately account for the anatomical differences between the cervix and the anus/anal canal, leading to inefficiencies in sample collection and preservation.
Innovation Solution
A device comprising a collection assembly with a swab head, support shaft, plunger, and sheath that allows for secure collection and storage of cytological samples, featuring a lock mechanism for ensuring the swab head is properly extended and sealed within a containment vial for transport, facilitating one-handed operation and self-administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If cervical Pap smear devices are used for anal cancer detection, then sample collection can be performed, but the devices do not account for anatomical differences between cervix and anus leading to collection inefficiency
Solution Approach 1:
The device features a sheath with a specific opening configuration and swab head design tailored to the anal canal's anatomical structure, rather than using a generic cervical sampling design. The sheath opening allows proper swab deployment in the anal region while the swab head dimensions and shape are optimized for anal tissue contact, creating local quality adaptations for this specific anatomical site.
Solution Approach 2:
The device inverts the traditional cervical Pap smear approach by designing the sheath and swab deployment mechanism from the anal canal's perspective rather than adapting cervical tools for anal use. The sheath opening is positioned and sized to facilitate anal tissue access, and the swab head is configured to be deployed in reverse orientation compared to cervical sampling, fundamentally inverting the design paradigm to match anal anatomy.
2Ease of operation
If a simple swab collection method is used, then the procedure is easy to perform, but sample preservation and transport reliability are insufficient
Solution Approach 1:
The device merges the collection swab, storage container, and transport vial into a single integrated unit. The sheath encloses the swab head and support shaft, while the containment vial is configured to receive and seal the entire collection assembly, combining multiple functions (collection, preservation, transport) into one unified device that maintains sample integrity throughout the process.
Solution Approach 2:
The device employs a nested structure where the swab head is contained within the sheath, the support shaft is enclosed by the sheath, and the entire collection assembly is received within the containment vial. This nested doll configuration allows compact storage, secure transport, and controlled sample release while maintaining simplicity of use.
3Device complexity
If the swab head is not properly sealed within the containment vial, then the device structure is simple, but sample contamination and loss occur during transport
Solution Approach 1:
The device performs preliminary sealing actions by configuring the sheath with an integrated seal that engages with the containment vial before sample transport begins. The seal is pre-positioned to close the sheath opening, and the vial is designed to receive and lock the sealed assembly, preventing contamination before transport issues can occur rather than relying on post-collection sealing.
Solution Approach 2:
The sheath acts as an intermediary barrier between the swab head and the external environment during transport. The containment vial then serves as a second intermediary layer, creating a nested protective system where the sheath seal and vial closure work together to prevent sample contamination without requiring complex sealing mechanisms.
Data Source
AI summary
A biological sample collection, storage, and transport device includes a collection assembly and a sheath, wherein the collection assembly includes a support shaft, a swab head, and a handle, the swab head mechanically couples to a distal support shaft end, the handle couples to a proximal support shaft end, and the collection assembly slideably couples to the sheath and is configurable in a retracted position with the swab head entirely disposed within the sheath or an extended position with the swab head extending outside of the sheath. A distal sheath end includes an aperture, the aperture having a circumference large enough to allow the swab head to pass through said aperture when the collection assembly is configured in the extended position, and a seal is applied to the distal sheath end after the swab head has collected a biological sample and the collection assembly has been reconfigured into the retracted position.