Sterile Infusion Pump Verification via RF Actuation
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Solution Overview
Problem
Medical devices, such as implantable infusion pumps, require verification of functionality before use while maintaining a sterile environment, which is challenging due to the need for multiple devices and potential delays and increased costs.
Innovation Solution
A method and apparatus that allows for the verification of a medical device's functionality, specifically an implantable infusion pump, by using a test apparatus coupled to the pump's outlet port to detect fluid discharge or pressure changes, providing visual or aural indications through a sealed package using RF command signals, enabling functionality assessment without opening the package.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple devices are supplied to ensure functionality, then reliability is improved, but device complexity and cost increase
Solution Approach 1:
The patent applies preliminary action by performing functionality verification of the infusion pump while it is still sealed in its sterile package, before actual use. A test apparatus is coupled to the pump's outlet port, and the pump is actuated via RF command signal to verify fluid discharge capability. This preliminary testing eliminates the need to supply multiple backup devices, as functionality is confirmed in advance while maintaining sterility.
2Reliability
If functionality is verified before use, then reliability is improved, but maintaining sterile environment becomes difficult
Solution Approach 1:
The patent uses an intermediary approach by introducing a test apparatus that can couple to the pump's outlet port through the sealed package interface. The test apparatus serves as a mediator that allows functionality verification without breaching the sterile barrier. Additionally, RF command signals act as an intermediary to actuate the pump without physical contact, and visual/aural indicators provide remote feedback while maintaining the sterile boundary.
Solution Approach 2:
The patent replaces mechanical interaction with electromagnetic fields by using RF (radio frequency) command signals to actuate the infusion pump from outside the sterile package. This substitution allows the pump to be activated and tested without physical opening of the package. Visual and aural indicators further replace the need for direct mechanical inspection, enabling remote verification while preserving sterility.
3Reliability
If package is opened for testing, then functionality verification is achieved, but sterile environment is compromised
Solution Approach 1:
The patent performs the functionality verification as a preliminary action before the surgical procedure and before opening the sterile package. The pump is tested while still sealed, and the results are observed through visual or aural indicators. This preliminary testing ensures that when the package is eventually opened for surgery, the device is already confirmed to be functional, eliminating delays and the need for additional backup devices.
4Reliability
If multiple devices are supplied, then reliability is improved, but time and cost increase
Solution Approach 1:
The patent performs functionality verification as a preliminary action before surgery, confirming that the pump is operational while still in its sterile package. This advance verification eliminates the need to have multiple backup devices ready and prevents surgical delays caused by discovering device malfunction at the time of use. The preliminary test ensures device availability is confirmed in advance, saving time during the surgical procedure.
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 efficient verification of medical device functionality within a sterile package, reducing the need for multiple devices and minimizing delays and costs, while maintaining a sterile environment.
Implementation Method 1
the pump is actuated (while still in the package) by a command signal generated by a transmitter externally of the package and communicated to a receiver within the infusion pump
Implementation Method 2
The test apparatus is configured to detect pump activity (e.g. a fluid discharge and/or a pressure change at the outlet port) and provide an indication thereof
Implementation Method 3
As liquid is discharged from the outlet port into the tube, the liquid moves the gas/liquid interface, which can be visually observed by the responsible person through the window in the package
Data Source
AI summary
This invention relates to methods, apparatuses and systems for testing the functionality of the pumping mechanism of a medical device, e.g., an implantable infusion pump, while the medical device is contained within a shipping package. The test apparatus enables such functional verification, without opening the shipping package, when the medical device is still contained within the package that has been appropriately sealed to maintain sterility of the medical device.