Sterile Surgical Packaging With Authenticated Secondary-Use Disposal
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Solution Overview
Problem
Surgical instruments face issues due to manufacturing defects, mishandling during transit, environmental extremes, and incompatibility with other equipment, leading to performance problems and disposal challenges.
Innovation Solution
A smart surgical system with a manufacturer-sealed sterile package containing a surgical instrument, a data processor, and memory that catalogs components, determines disposal procedures, and provides guidance through displays or remote communication, adjusting procedures based on location, usage, and performance errors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If surgical instruments are shipped globally and handled by multiple persons through the supply chain, then the instruments can reach various hospitals and surgical centers, but the risk of mishandling, improper storage, and environmental damage increases
Solution Approach 1:
The patent applies preliminary action by pre-packaging surgical instruments in manufacturer-sealed sterile packages before shipment. This ensures that the instruments are protected from mishandling and environmental damage during transit and storage, maintaining their integrity and sterility from the point of manufacture through the entire supply chain until use in the operating room.
2Adaptability or versatility
If surgical instruments are used in diverse geopolitical locations with different regulations, then the system can serve a broader market, but compliance with local disposal regulations becomes more complex
Solution Approach 1:
The patent applies preliminary action by pre-configuring the packaging system with disposable component information and disposal instructions specific to each geopolitical location. The system stores and provides location-specific disposal procedures in advance, allowing surgical teams to comply with local regulations without needing to research or determine proper disposal methods after the procedure.
Solution Approach 2:
The patent applies feedback by providing real-time disposal instructions to the surgical team based on the specific geopolitical location where the procedure is taking place. The system receives location data and automatically provides the appropriate disposal procedures for that region, ensuring compliance with local regulations while simplifying the disposal process for the surgical team.
3Measurement precision
If the surgical package includes comprehensive component cataloging and disposal tracking, then disposal accuracy and compliance improve, but the packaging system complexity increases
Solution Approach 1:
The patent applies universality by designing the manufacturer-sealed sterile package to serve multiple functions: it protects the instrument during shipping, maintains sterility, catalogs all disposable components, tracks usage, and provides disposal instructions. This multi-functional approach consolidates what would otherwise require separate systems into a single integrated packaging solution.
Solution Approach 2:
The patent applies self-service by enabling the packaging system to automatically catalog components, track usage, and provide disposal instructions without requiring external intervention. The system autonomously manages the entire lifecycle from shipment through disposal, reducing the need for additional tracking devices or manual record-keeping.
4Productivity
If real-time tracking and disposal procedure provision are implemented, then supply chain management and compliance improve, but data processing requirements and system resources increase
Solution Approach 1:
The patent applies taking out by extracting the data processing and tracking functions from the main surgical instrument and placing them in the packaging system. This allows the instrument itself to remain simple and focused on its surgical function, while the packaging handles the complex tasks of tracking, data management, and providing disposal instructions.
Data Source
AI summary
Packaging and methods are provided. The packaging includes a manufacturer-sealed, sterile surgical package, a surgical instrument stored within the manufacturer-sealed, sterile package; and at least one secondary-use package contained within the manufacturer-sealed, sterile surgical package. The at least one secondary-use package is configured to receive and sterilely contain one or more components of the surgical instrument following the surgical procedure. The at least one secondary-use package includes at least one authenticator configured to selectively allow access to the at least one secondary-use package.