Surgical Instrument Sterilization Enclosure With Integrated Sensor
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Solution Overview
Problem
Existing sterilization systems for surgical instruments lack sensors to measure characteristics during the sterilization process, leading to potential failure in achieving the desired level of sterilization, as apertures can be impeded or filters occluded, preventing exposure to sterilant agents, and lack notification systems for healthcare professionals.
Innovation Solution
A sterilization enclosure equipped with sensors to measure characteristics within the enclosure during the sterilization process and notification devices to communicate the sterilization status, ensuring instruments are exposed to threshold process conditions for effective sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If containers are sealed and stored in sterilizer compartments for empirically determined threshold periods, then instruments should achieve desired sterilization levels, but apertures can be impeded or filters occluded preventing sterilant agent exposure
Solution Approach 1:
The sensor is installed in the container before sterilization to proactively detect aperture blockage or filter occlusion conditions. This preliminary detection enables early warning before sterilization failure occurs, allowing corrective action to be taken while the sterilization process can still be adjusted or repeated.
Solution Approach 2:
The notification device provides real-time feedback to healthcare professionals about the sterilization status of instruments in the container. When the sensor detects that threshold process conditions have not been met, the notification device alerts staff to the problem, enabling them to take corrective action such as re-sterilizing the instruments.
2Loss of information
If no sensors are installed in containers, then container structure remains simple, but sterilization status cannot be verified and under-sterilization may go undetected
Solution Approach 1:
The patent replaces manual monitoring and record-keeping of sterilization processes with an automated sensor-based detection system. The sensor electronically monitors sterilant agent exposure and automatically communicates status information, eliminating the need for manual tracking and reducing human error in determining sterilization adequacy.
Solution Approach 2:
The notification device acts as an intermediary between the sensor inside the container and healthcare professionals outside the container. It translates sensor data into actionable information that staff can understand and respond to, bridging the gap between the sterilization process and human decision-making.
3Reliability
If containers lack notification devices, then device complexity is reduced, but healthcare professionals cannot be alerted to sterilization failures
Solution Approach 1:
The notification device provides real-time feedback to healthcare professionals about the sterilization status of instruments in the container. When the sensor detects that threshold process conditions have not been met, the notification device alerts staff to the problem, enabling them to take corrective action such as re-sterilizing the instruments.
Solution Approach 2:
The sterilization monitoring system is self-monitoring and self-reporting, requiring minimal human intervention. The sensor automatically detects sterilization status and the notification device automatically communicates problems to staff, eliminating the need for manual checking of sterilization records or conditions.
Data Source
AI summary
A sterilization container or enclosure for holding one or more surgical instruments, the sterilization container formed to allow sterilant to enter and residual sterilant to exit so that the one or more surgical instruments disposed within the sterilization container can be subjected to a sterilization process. A sensor for measuring a characteristic of an environment may be disposed inside the sterilization container during the sterilization process and configured to generate a signal representative of the measured environmental characteristic. The sensor is disposed on one of the one or more surgical instruments disposed within the sterilization container during the sterilization process and configured to provide data regarding a nature of the environment within the sterilization container to which the surgical instrument is exposed during the sterilization process.