Sterile Blister Pack Removal Site for Controlled Surgical Access
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Solution Overview
Problem
Current methods for removing sterile products from blister packs during eye surgery require non-sterile users to open the pack, leading to potential contamination and increased procedural complexity due to the need for hand disinfection.
Innovation Solution
A blister pack design with defined pressure points or removable lugs that allows controlled removal of sterile items without requiring non-sterile users to perform hand disinfection, by inverting the pack onto a sterile surface and pressing specific points or actuating lugs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a non-sterile user opens the blister pack manually, then the pack can be accessed, but hand disinfection is required which complicates and lengthens the surgical procedure
Solution Approach 1:
The blister pack is pre-designed with a sterile barrier layer and a defined removal site that allows the sterile contents to be accessed without manual opening by non-sterile personnel. The removal site is prepared in advance with specific structural features (such as a removable lug or pressure point) that enable controlled access while maintaining sterility, eliminating the need for hand disinfection before access.
2Ease of operation
If a non-sterile user opens the blister pack manually, then the pack can be accessed, but accidental contamination and loss of sterility become more likely
Solution Approach 1:
A sterile barrier layer is introduced as an intermediary between the non-sterile external environment and the sterile contents. This barrier layer can be manually manipulated by non-sterile personnel without compromising sterility, as it acts as a protective interface. The removal site is designed to allow penetration or access through this barrier in a controlled manner that maintains the sterile field integrity.
Solution Approach 2:
The blister pack is segmented into distinct functional zones: a non-sterile external portion that can be manually handled, a sterile barrier layer that maintains contamination protection, and a sterile contents compartment. The removal site is positioned at the interface between these segments, allowing controlled access that separates manual handling from sterile contact.
3Reliability
If defined pressure points or removable lugs are added to the blister pack, then controlled sterile removal is enabled, but device complexity increases
Solution Approach 1:
Rather than making the entire blister pack complex, the structural features (removable lugs or pressure points) are localized only at the removal site. The rest of the blister pack maintains its simple, conventional structure. This localized approach allows controlled sterile removal while minimizing added complexity to the overall device.
Data Source
AI summary
A system and method for systematic, controlled removal of sterile products from blister packs for use during surgery is disclosed.