Lever Arm Activator for Biological Indicator Ampule Fracture
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Solution Overview
Problem
Current self-contained biological indicators require significant user force to fracture the vial containing the growth-promoting medium, leading to potential damage and complex operation for activating the indicator.
Innovation Solution
A device with a first lever arm and a second lever arm that moves to deform the casing, fracturing the ampule and exposing microorganisms to the growth-promoting medium, allowing for simple and sealed activation of the biological indicator.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a self-contained biological indicator uses a sealed housing with an ampule containing growth-promoting medium, then the reliability of the sterilization test is improved, but the ease of operation deteriorates because significant user force is required to fracture the vial
Solution Approach 1:
The patent introduces a separate activation device as an intermediary tool between the user and the biological indicator. This device includes a fracturing mechanism with a protrusion that applies force to fracture the ampule. The intermediary device allows the user to activate the sealed biological indicator without directly applying excessive force to the fragile housing, thus maintaining reliability while improving ease of operation.
2Ease of operation
If the biological indicator housing is made fragile to allow easy fracturing, then the ease of operation is improved, but the strength of the housing deteriorates, leading to potential damage during handling and transport
Solution Approach 1:
The patent divides the system into separate components: a strong sealed housing containing the biological indicator and ampule, and a separate activation device. The housing maintains full strength for protective handling and transport, while the activation device provides the fracturing function. This segmentation allows the housing to be strong without needing to be fragile for activation purposes.
Solution Approach 2:
The activation device serves as an intermediary that performs the fracturing action externally. The device includes a fracturing surface with a protrusion that concentrates force on a specific point of the ampule, enabling controlled fracture without compromising the housing's overall strength and integrity during normal handling.
3Reliability
If multiple operations are required to seal and activate the biological indicator, then the reliability of the process is improved, but the device complexity increases
Solution Approach 1:
The patent combines multiple functions into a single integrated activation device: the housing for the biological indicator, the fracturing mechanism with protrusion, and the sealing cap all form one unified device. This merging allows the user to perform sealing and activation in a single operation by simply closing the cap, reducing device complexity while maintaining process reliability through built-in mechanical interlocks and proper sequencing.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device enables easy, one-handed operation to activate and seal the biological indicator, reducing the risk of damage and simplifying the process, while being inexpensive to manufacture.
Implementation Method 1
A second lever arm has a protrusion extending from a surface thereof and is moveable relative to the first lever arm to deform a casing of the biological indicator thereby fracturing an ampule within the casing
Data Source
AI summary
The present invention provides a device for activating a self-contained biological indicator. The biological indicator includes a casing, an ampule having a growth-promoting medium disposed therein and microorganisms. The ampule and microorganisms are disposed within the casing. The device is comprised of a first lever arm having a cavity formed therein. The cavity is dimensioned to receive a biological indicator. A second lever arm has a protrusion extending from a surface thereof and is moveable relative to the first lever arm to deform a casing of the biological indicator thereby fracturing an ampule in the casing and exposing microorganisms in the casing to a growth-promoting medium in the ampule of the biological indicator.