Self-Contained Biological Indicator Ampule Breakage
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Solution Overview
Problem
Current biological sterilization indicators face challenges in ensuring effective sterilization of medical devices, particularly in diffusion-restricted spaces, and suffer from inefficiencies in confirming sterilization efficacy, which can lead to inventory management issues and potential patient safety risks due to the need for manual handling and potential contamination during incubation.
Innovation Solution
A self-contained biological sterilization indicator with a housing design that includes a first and second enclosure, an ampule with a liquid growth medium, and an insert with stress concentrators to facilitate easy ampule breakage and prevent liquid lock formation, allowing for robust transportation and accurate post-sterilization analysis without contamination from glass shards.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the ampule is made robust for transportation, then transportation reliability is improved, but the force required for ampule breakage increases
Solution Approach 1:
The housing is divided into two separate enclosures: a first enclosure that houses the ampule during transportation and a second enclosure that receives the growth medium after ampule breakage. This segmentation allows the ampule to be protected during transport while enabling easy access and breakage when needed, as the ampule only needs to break within the confined first enclosure space.
Solution Approach 2:
An insert structure acts as an intermediary between the ampule and the second enclosure. The insert includes a platform with a void that receives the broken ampule and guides the growth medium into the second enclosure. This intermediary structure facilitates the transition from the robust, protected state during transport to the functional state after breakage, requiring minimal force to operate.
2Measurement precision
If manual handling and incubation processes are used, then sterilization confirmation is achieved, but contamination risk and time consumption increase
Solution Approach 1:
The growth medium is contained within the sealed ampule until the sterilization cycle is complete. After sterilization, the ampule is broken to release the growth medium into the second enclosure where it contacts the indicator. This extraction sequence ensures that the growth medium (which could potentially contaminate) is only introduced after the sterilization process is complete and the indicator is ready to receive it, thereby minimizing contamination risk while maintaining accurate sterilization confirmation.
Solution Approach 2:
The system is designed to be self-contained, with all components (ampule, growth medium, indicator, enclosures) integrated into a single unit. The indicator automatically contacts the growth medium after ampule breakage without requiring external manual handling or transfer operations. This self-service design eliminates the need for personnel to manually handle potentially contaminated materials, reducing contamination risk while maintaining sterilization confirmation accuracy.
3Ease of operation
If glass shards are present during analysis, then ampule breakage is confirmed, but measurement accuracy is compromised
Solution Approach 1:
The housing is segmented into a first enclosure that contains the ampule and breakage process, and a second enclosure that receives the growth medium for analysis. The insert structure with its platform and void further segments the space to guide the growth medium away from glass shards. This spatial segmentation ensures that glass shards remain confined to the first enclosure while the growth medium is directed into the clean second enclosure for analysis, maintaining measurement precision while confirming ampule breakage.
Solution Approach 2:
The insert structure serves as an intermediary that mediates between the ampule breakage event and the growth medium analysis. The insert's platform with void receives the broken ampule and channels the growth medium into the second enclosure, acting as a barrier that prevents glass shards from contaminating the analysis area. This intermediary structure allows ampule breakage confirmation while protecting the measurement accuracy by keeping glass shards separate from the growth medium.
Data Source
AI summary
A biological sterilization indicator is disclosed that in some embodiments comprises a housing having a first enclosure and a second enclosure, an ampule containing a liquid growth medium, and an insert disposed at least partially in the first enclosure. The insert may have a platform including a top surface, an abutment surface, and a side surface, as well as a first void disposed in the platform and configured to allow passage of a first volume of the liquid growth medium into the second enclosure and a second void disposed through at least a portion of the side surface and configured to allow passage of a second volume of the liquid growth medium into the second enclosure. Methods of using the indicator are also disclosed.