Sterile Implant Packaging With Electrode Testing Contacts
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Solution Overview
Problem
Existing medical implants, such as pacemakers and neurostimulators, require functional testing of contact electrodes during implantation, necessitating additional specialists in the operating room, leading to complex and costly procedures with potential late detection of malfunctions and resource waste.
Innovation Solution
A packaging system with electrically conductive contact means within the packaging material allows for functional testing of contact electrodes in a sterile packaged state, enabling verification of electrode functionality before implantation without breaking sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If functional testing of contact electrodes is performed during implantation, then electrode functionality can be verified, but additional specialists are required in the operating room leading to complex and costly procedures
Solution Approach 1:
The patent applies preliminary action by performing functional testing of contact electrodes before implantation. The packaging system includes contact means that enable testing while the implant is still in its sterile packaging, allowing functionality verification to be completed in advance rather than during the implantation procedure itself.
2Reliability
If functional testing is performed during implantation, then electrode functionality can be verified, but malfunctions are detected very late after the patient has undergone complex operation
Solution Approach 1:
The packaging system enables preliminary functional testing before implantation by providing contact means within the sterile packaging that allow testing of contact electrodes without breaking sterility. This shifts the testing timing from post-implantation to pre-implantation, preventing late detection of malfunctions.
3Reliability
If functional testing is performed during implantation, then electrode functionality can be verified, but non-functional implants have already been removed from sterile packaging and may have contacted human tissue leading to resource waste
Solution Approach 1:
The system enables preliminary testing while the implant remains in its sterile packaging through contact means that penetrate or interface with the packaging without breaking sterility. This allows non-functional implants to be identified and discarded before they leave the sterile environment, preventing waste of surgical resources and potential contamination.
Solution Approach 2:
The packaging system acts as an intermediary by incorporating contact means within the sterile barrier. This intermediary structure allows electrical contact with the implant's contact electrodes while maintaining the sterile seal, enabling testing without breaking sterility and without the implant needing to be physically removed from its protective packaging.
4Reliability
If additional specialists are required in the operating room for functional testing, then electrode functionality can be verified, but implantation procedures become very costly
Solution Approach 1:
The packaging system provides self-service functionality by incorporating the testing capability directly into the packaging structure. The contact means within the packaging enable functional verification without requiring external testing equipment or additional specialist personnel in the operating room, making the process self-contained and cost-effective.
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 reliable pre-implantation testing of contact electrodes, reducing the need for additional specialists and minimizing waste by allowing for replacement or confirmation of functionality before surgery, thus simplifying and cost-effectively ensuring implant quality.
Implementation Method 1
the packaging body, particularly in its interior, has electrically conductive contact means arranged such that the contact electrode comes into contact with them, or can be brought into contact with them, in the sterile packaged state
Data Source
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AI summary
Packaging body for a medical implant, in particular a pacemaker and/or a neurostimulator, with a contact electrode, comprising packaging material which includes closure means extending along a sealing contour of the packaging material, wherein at least a part of the packaging material and the closure means define a sterile and/or sterilizable interior of the packaging body in which the implant is received in a sterile packaged state, wherein the packaging body, in particular in the interior, has an electrically conductive contact means which is arranged such that the contact electrode of the implant comes into contact with it or can be brought into contact with it in the sterile packaged state.