Sterile Sensor Packaging With Through-Bag Activation
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Solution Overview
Problem
Existing urological sensors face challenges in maintaining sterility and ease of operation during insertion into a body cavity.
Innovation Solution
A packaging assembly and method that includes a transparent bag and a tray with a pivotable cover to preserve sterility and facilitate 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 to maintain sterility, then sterility is preserved, but the device cannot be activated or operated
Solution Approach 1:
The packaging assembly is segmented into multiple components: a sterile barrier bag that maintains sterility, a tray with a cover that provides structural support and controlled access, and an opening in the tray cover that allows button engagement. This segmentation enables the device to remain sterile while still allowing activation through the opening without compromising the sterile barrier.
Solution Approach 2:
The tray cover acts as an intermediary between the sterile environment and the user's hand. It provides a non-sterile interface (the opening) through which the user can engage the button without breaching the sterile barrier bag, thus maintaining sterility while enabling operation.
2Ease of operation
If the button is made accessible outside the packaging for easy activation, then ease of operation is improved, but sterility may be compromised
Solution Approach 1:
The tray cover has a localized opening that provides just enough access for button engagement while maintaining the integrity of the overall sterile barrier. The opening is positioned and sized to allow finger access to the button through the transparent bag without requiring removal of the sterile packaging.
Solution Approach 2:
The device is designed with the button positioned such that it can be engaged through the packaging materials themselves. The transparent bag and tray cover are configured to allow button engagement before the device is fully removed from packaging, enabling activation while maintaining sterility.
3Ease of operation
If the packaging is made transparent to allow visibility of the button, then ease of operation is improved, but the protective barrier may be less effective
Solution Approach 1:
The packaging bag is made transparent or translucent, allowing the user to visually locate and identify the button position without compromising the sterile barrier. The transparency enables optical detection of the button while the material maintains its protective sterile barrier function.
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.