Disposable Programming Key for Infusion Pump Parameter Security
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Solution Overview
Problem
Ambulatory infusion pumps, particularly elastomeric and smart pumps, face challenges with accuracy, safety, and user complexity, leading to potential clinical errors and adverse drug events due to variables affecting flow rates and the need for specialized personnel to operate and maintain them.
Innovation Solution
A medical device programming assembly that includes a programmable, non-transitory computer-readable storage device with a data connector and fastener coupling, allowing for secure and tamper-proof programming of medical treatment parameters, which can be easily integrated with infusion pumps to ensure accurate and safe administration of medications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If digital interfaces are incorporated into medical devices to assist programming, then ease of operation is improved, but device complexity increases
Solution Approach 1:
The patent employs disposable programming keys that are pre-configured with treatment parameters. These single-use keys eliminate the need for complex digital programming interfaces on the pump itself, while still providing ease of operation through simple key insertion. The disposable nature avoids the need for programmable memory and complex user interfaces on the reusable pump unit.
Solution Approach 2:
The programming key acts as an intermediary carrier between the user and the pump's memory system. Instead of requiring direct digital interaction with the pump's programming interface, the user programs parameters onto a separate key device, which then transfers them to the pump. This mediates the complexity by isolating the programming functionality from the main pump unit.
2Measurement precision
If sophisticated electronics are incorporated into medical devices, then measurement precision is improved, but reliability deteriorates
Solution Approach 1:
The programming key is a disposable component that contains the treatment parameters. By making this critical programming element single-use, the patent eliminates the risk of electronic corruption, software errors, or programming mistakes affecting future uses. Each new key provides a fresh, reliable programming source without carrying over potential electronic degradation or software bugs from previous operations.
Solution Approach 2:
The system separates the pump into reusable hardware components and disposable programming components. The sophisticated electronics for precise flow control remain in the reusable pump, while the programming functionality is segmented into disposable keys. This segmentation protects the reliable electronic pumping system from the potential failures associated with reusable programmable interfaces.
3Ease of operation
If ambulatory infusion pumps are made smaller for portability, then ease of operation is improved, but manufacturing precision requirements increase
Solution Approach 1:
The disposable programming key contains all treatment parameters and identification data in a compact form factor. This allows the pump itself to remain small and portable without requiring large internal memory or complex programming interfaces. The precision requirements are shifted to the manufacturing of the simple disposable key, which can be produced with standard tolerances rather than requiring high-precision electronics in the portable pump unit.
Data Source
AI summary
The present invention relates to medical device programming assemblies, systems and methods for programming a medical treatment parameter on a medical device, via a programming key. The programming key may be adapted to mate with the medical device which comprises a programmable, non-transitory, computer readable storage device. The storage device comprises a data connector which is configured to mate with a corresponding data connector on the medical device. The storage device may be affixed to a fastener coupling configured to mate with a corresponding coupling on the medical device when the data connector is brought into proximity with the corresponding data connector on the medical device. The programming key is configured to occupy a space formed within the medical device when the data connector and fastener coupling are mated with the corresponding data connector and fastener coupling of the medical device.