Medical Device Packaging with Sterile Insertion Window
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Solution Overview
Problem
Medical devices with internal power sources and reusable components face challenges in maintaining sterility during the insertion and reuse of non-sterile components, as existing packaging methods may damage components or require separate bulky support devices, and there is a need for efficient sterilization techniques that do not compromise the sterility of the device.
Innovation Solution
The design of a medical device package system that allows for the insertion of non-sterile components into a sterile medical device while maintaining the device's sterility, using a flanged bushing and cap system to seal the device and prevent contamination, and employing sterilization methods like gamma radiation or electron beam processing to ensure cleanliness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single package contains all components including reusable components, then packaging simplicity is improved, but sterility maintenance deteriorates because different components require different sterilization techniques
Solution Approach 1:
The package is divided into a sterile barrier portion containing the reusable component and a non-sterile portion containing the disposable component. This segmentation allows each component to be sterilized appropriately independently, with the sterile barrier portion maintaining sterility through the sterilization process while the non-sterile portion does not require sterilization.
Solution Approach 2:
A sterile barrier component acts as an intermediary between the reusable component and the external environment. This barrier maintains sterility during the sterilization process and during use, allowing the reusable component to be sterilized while protecting it from contamination when not in use.
2Reliability
If separate bulky support devices are used to connect reusable components, then sterility is maintained, but device portability deteriorates
Solution Approach 1:
The reusable component is integrated directly into the disposable component housing, eliminating the need for separate bulky support devices. The sterile barrier portion is merged with the reusable component, creating a compact integrated assembly that maintains sterility without requiring additional external support structures.
Solution Approach 2:
The reusable component is nested within the disposable component housing, with the sterile barrier portion containing the reusable component. This nested arrangement allows the reusable component to be protected and sterilized while integrated into a compact package structure, eliminating the need for separate support devices.
3Productivity
If reusable components are inserted through the package, then component reuse is enabled, but package sterility deteriorates due to potential contamination
Solution Approach 1:
The reusable component is pre-packaged in the sterile barrier portion before the sterilization process. This preliminary packaging allows the component to be sterilized in its final housing, ensuring sterility is maintained before the component is removed and used. The sterile barrier is designed to be broken or opened in a controlled manner that maintains sterility until the moment of use.
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
Enables the reuse of medical device components over multiple uses, reduces environmental impact by allowing recycling, and maintains the sterility of the device during component insertion and use, while also accommodating different sterilization needs for various components.
Implementation Method 1
Such sterilization methods may include gamma radiation, electron beam processing, x-ray radiation, or ultraviolet light irradiation
Implementation Method 2
Such sterilization methods may include gamma radiation, electron beam processing, x-ray radiation, or ultraviolet light irradiation
Implementation Method 3
Such sterilization methods may include gamma radiation, electron beam processing, x-ray radiation, or ultraviolet light irradiation
Data Source
AI summary
A system for inserting components into a medical device includes a container and an attachment member. The attachment member is coupled to a sidewall having an opening and is configured to be coupled to a medical device. Utilizing the attachment member and opening, an insertable component may be inserted into a medical device within the container while limiting the risk of contamination to the interior of the container. Alternatively, a cutting knob and an alignment member mounted to a container may be used. Cutting knob and alignment member are coupled and a knife on cutting knob is rotated about alignment member to create an opening in the container to access the interior of the medical device. Another alternative includes sandwiching an insertable component between an attachable member and the medical device while the attachable member and medical device are contained within flexible packaging that may be torn away.