Sterile Sensing Device Packaging for Insertion Tool Loading
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Solution Overview
Problem
Existing urological sensing devices face challenges in maintaining sterility and ease of operation during insertion into a body cavity.
Innovation Solution
A kit comprising a sensing device and packaging assembly with a tray and bag configuration that preserves sterility and allows for easy transition to an operational state, along with an insertion tool for seamless insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the sensing device is fully enclosed in the packaging assembly to preserve sterility, then sterility is maintained, but the button cannot be engaged to transition the device to operational state
Solution Approach 1:
The packaging assembly is segmented into multiple components: a tray with base and cover, and an outer bag. The tray provides first level protection while the bag provides second level protection. This segmentation allows the button to be accessible through the bag while the tray remains enclosed, resolving the contradiction between sterility preservation and button engagement.
Solution Approach 2:
The transparent bag acts as an intermediary between the enclosed sterile environment and the user's finger. It allows mechanical force to be transmitted from the user's finger through the bag to engage the button, while maintaining the sterile barrier. This intermediary resolves the contradiction by enabling operation without breaking sterility.
2Reliability
If the tray fully encloses the sensing device for protection, then device protection is improved, but access to the button is lost
Solution Approach 1:
The packaging is divided into two functional layers: the tray that provides structural protection and enclosure, and the outer bag that provides accessibility. This segmentation allows each component to fulfill its specific function without interfering with the other, enabling both protection and button access.
Solution Approach 2:
The design moves the button accessibility issue to a different dimensional layer. Instead of trying to access the button through the tray enclosure, the button is positioned such that it can be accessed through the outer bag dimension, while the tray maintains its protective enclosure. This dimensional separation resolves the contradiction.
3Ease of operation
If the housing is made transparent and flexible to allow button engagement, then ease of operation is improved, but protection of internal electronic components may be compromised
Solution Approach 1:
The protection function is segmented from the button engagement function. The rigid housing protects internal components while the outer bag provides the flexible interface for button engagement. This segmentation allows each component to optimize for its specific function without compromise.
Solution Approach 2:
The outer bag serves as an intermediary that provides the flexible, engageable surface needed for button operation, while the rigid housing maintains its protective function. The intermediary transfers the engagement force without requiring the housing itself to be flexible, thus protecting internal components while enabling operation.
Data Source
AI summary
Various packaging assemblies and methods for preserving sterility of a sensing device prior to insertion into a body cavity of a subject are described herein. Some implementations of a packaging assembly include: a bag comprising an interior, the bag at least partially comprising a transparent material; and a tray configured to be positioned within the interior of the bag and configured to retain and protect the sensing device, wherein the tray comprises an opening configured to allow a button of the sensing device to be engaged via a portion of the bag, thereby allowing the sensing device to be transitioned from a non-operational state to an operational state when retained by the tray and positioned within the interior of the bag. Such operational state can be one in which the sensing device can be wirelessly paired with a separate electronic device, for example, to enable wireless data transmission.