Sterile Catheter with Integrated Medicinal Agent Storage and Flow Control
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Solution Overview
Problem
During endoscopic retrograde cholangiopancreatography (ERCP) procedures, there is a risk of environmental bacteria contaminating medicinal agents, such as contrast agents, when drawing them from bottles or ampoules and connecting them to catheters, due to the lack of effective barriers preventing bacterial contact.
Innovation Solution
A medical device comprising a catheter with a medicinal agent storage device and a flow control mechanism, including a stopper that prevents the agent from flowing into the catheter until activated, ensuring sterilization and precise control over agent delivery, thereby reducing bacterial contamination and accurately managing the agent's amount.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If medicinal agents are drawn from bottles or ampoules and connected to catheters during ERCP procedures, then the medicinal agent can be delivered to the patient, but environmental bacteria can contaminate the medicinal agent
Solution Approach 1:
The patent introduces a sterile barrier device that acts as an intermediary between the medicinal agent container and the catheter. This barrier maintains the sterile field while allowing controlled transfer of the medicinal agent, preventing direct contact between potentially contaminated surfaces and the sterile medicinal agent.
Solution Approach 2:
The patent implements pre-sterilization of the catheter and barrier components before use, and maintains sterile conditions throughout the preparation process. The medicinal agent is kept in its original sterile container until the moment of transfer, and sterile techniques are applied during the entire procedure to prevent contamination.
2Reliability
If a flow control device is added to prevent medicinal agent leakage, then sterility is maintained, but the device complexity increases
Solution Approach 1:
The patent combines the flow control function with the barrier device itself, rather than adding a separate complex flow control mechanism. The barrier device is designed to maintain closure and prevent leakage inherently through its structure, integrating multiple functions into a single component to minimize overall device complexity.
Solution Approach 2:
The patent employs a disposable barrier device that is used once and then discarded, eliminating the need for complex, reusable flow control mechanisms that would require cleaning, sterilization, and maintenance. This single-use approach simplifies the overall system while maintaining sterility.
Data Source
AI summary
A medical device includes: a medicinal agent storage device connected to the catheter, a flow control device, and a package. The medicinal agent storage device includes a storage part and a second channel, the storage part is configured to store a medicinal agent, and wherein the second channel provides fluid communication between the storage part and the first channel. The package encloses the catheter, the medicinal agent storage device, and the flow control device in a sterilized state. In a first state, the flow control device is configured to prevent the medicinal agent from flowing from the storage part into the first channel. The flow control device is included in the catheter or included in the medicinal agent storage device.