Remote-Activated Power Circuit for Sterilized Trial Stimulators
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Solution Overview
Problem
Electronic medical devices, particularly trial stimulators for implantable neurological stimulation systems, face the challenge of being safely sterilized in flammable environments like those containing ethylene oxide gas, which can ignite due to residual electrical energy.
Innovation Solution
A power control circuit using a bi-stable switch to manage energy storage in the devices, ensuring they are discharged to a safe level before sterilization, and allowing remote activation without breaking the sterile packaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the device maintains full battery charge and power for pre-use testing and programming, then functionality and ease of operation are improved, but the risk of ignition in flammable sterilization environments increases
Solution Approach 1:
The device performs power reduction to safe levels before sterilization and maintains this reduced state throughout storage. This preliminary action ensures that when the device is later activated for use, it has already been prepared for safe handling in flammable environments, eliminating the need for post-sterilization power management
Solution Approach 2:
The power control circuit dynamically adjusts the battery power level based on the device state - maintaining full power during active use for optimal performance, automatically reducing to safe levels during sterilization and storage to prevent ignition, and enabling seamless transitions between these states
2Object-affected harmful factors
If the device is discharged to safe energy levels for sterilization safety, then ignition risk is reduced, but battery charge and functionality are compromised
Solution Approach 1:
The system dynamically controls power delivery based on operational state. During sterilization and storage, power is reduced to safe levels to prevent ignition. When activated for use, full battery power is restored to ensure adequate energy availability for testing and operation, creating a dynamic balance between safety and functionality
Solution Approach 2:
The power control circuit changes the energy parameter of the battery based on contextual requirements - maintaining high energy levels during active use for full functionality, and automatically reducing energy levels to safe thresholds during sterilization and storage to eliminate ignition risks
3Reliability
If remote activation is implemented without breaking packaging, then sterilization integrity is maintained, but device complexity increases
Solution Approach 1:
The patent replaces mechanical activation methods (which would require breaking the sterile packaging) with a magnetic field-based activation system. A magnet applied to the external surface of the packaging triggers the power control circuit to activate the device, eliminating the need to breach the sterile barrier while still enabling controlled activation
Solution Approach 2:
The magnetic field serves as an intermediary between the external activation command and the internal device activation. The magnet externally applied to the packaging creates a magnetic field that penetrates the packaging material and triggers the bi-stable switch inside, providing a non-contact activation mechanism that preserves sterilization integrity
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 the safe sterilization of electronic medical devices by preventing ignition risks while maintaining functionality and battery charge, facilitating pre-use testing and programming.
Implementation Method 1
A power control circuit can be used with a trial stimulator to reduce the amount of energy stored in the trial stimulator to a level that allows the trial stimulator to be safely exposed to (e.g., placed in) a flammable sterilizing gas after manufacture and prior to use
Implementation Method 2
The bi-stable switch can be triggered to change states via a remotely actuatable switch from outside a sealed packaging in which the circuit is placed so as not to break the sealed package in the process of reactivating the medical device
Data Source
AI summary
A power control circuit for use with devices that will be placed in a flammable sterilizing gas includes a bi-stable switch that is configured to produce an output to place the circuitry of a connected device in a run state or a sleep state. The bi-stable switch controls one or more transistors to drain energy from energy storage devices in the circuitry of the connected device to a level below an ignition level of a sterilizing gas. A remotely actuatable switch can be actuated from outside of a packaging in which the power control circuit is placed to cause the bi-stable switch to produce an output that puts the circuitry in the run state without removing the power control circuit from the packaging.