SMA Medical Connector Blocking Until Sterilization Heating
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Solution Overview
Problem
Existing medical consumables face challenges in effective cleaning and disinfection, leading to potential Hospital Acquired Infections (HAIs) with reusable options and high costs and waste with single-patient use options.
Innovation Solution
Incorporating a shape-memory alloy (SMA) in medical connectors that change shape at specific temperatures to block and unblock connections, ensuring thorough cleaning and sterilization before reuse.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multi-patient use consumables are used, then cost-effectiveness is improved, but risk of hospital acquired infections increases due to inadequate cleaning
Solution Approach 1:
The SMA element is pre-configured to automatically change shape when exposed to sterilization temperatures, blocking the connector before use. This preliminary action ensures that the device is guaranteed to be sterilized before patient contact, eliminating the need for manual verification of cleaning effectiveness while maintaining cost-effectiveness through reusable design
Solution Approach 2:
The device performs self-verification of sterilization through the temperature-dependent shape change of the SMA element. During autoclaving or sterilization processes, the SMA automatically transforms to block the connector if proper heating occurs, providing self-certification that the device has been adequately sterilized without requiring external monitoring
2Reliability
If single-patient use consumables are used, then infection risk is reduced, but cost and electronic waste increase
Solution Approach 1:
The patent transforms a traditionally disposable device into a reusable one by incorporating a temperature-responsive SMA element that enables automatic sterilization verification. The lead wire with SMA connector can withstand multiple sterilization cycles, extending its service life from single-use to multi-patient use while maintaining infection prevention standards
Solution Approach 2:
The SMA element's phase transition temperature is specifically selected to match standard sterilization temperatures (e.g., 121°C or 134°C). This parameter change allows the device to differentiate between sterilization conditions: at sterilization temperatures the SMA blocks the connector, while at lower temperatures it remains open for normal operation, enabling reusable design with guaranteed sterilization
3Reliability
If manual cleaning procedures are used, then disinfection can be performed, but time consumption and labor burden increase
Solution Approach 1:
The patent replaces manual mechanical cleaning verification with an automated thermodynamic system. Instead of relying on staff to manually clean and verify lead wires, the SMA element automatically responds to sterilization temperature exposure by changing shape, providing objective verification that eliminates time-consuming manual cleaning procedures while ensuring disinfection effectiveness
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
Ensures thorough disinfection and sterilization of medical connectors, preventing HAIs and reducing waste while maintaining cost-effectiveness.
Implementation Method 1
a component of the medical connector comprises a shape-memory alloy (SMA)
Implementation Method 2
heating the medical connector to a sufficient temperature to change a shape of the SMA to an unblocked state
Data Source
Figure 1
Figure 2A~2C
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AI summary
A method of ensuring an electrical connector for a medical device is disinfected or sterilized is disclosed. The method comprises: receiving the medical connector in a blocked state, wherein a component of the medical connector comprises a shape-memory alloy (SMA); and heating the medical connector to a sufficient temperature to change a shape of the SMA to an unblocked state. A medical connector comprising the SMA material is also disclosed.