Implantable Device Electrode Flagging via Impedance Testing
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Solution Overview
Problem
Current implantable medical devices and controllers lack the capability to automatically take preventive actions based on electrode integrity metrics, such as impedance measurements, which can lead to potential harm if non-functional or suspect electrodes are used for therapeutic stimulation.
Innovation Solution
A controller system that includes a control module and electrode interface to obtain integrity metric measurements, flag non-functional electrodes, and automatically inhibit therapeutic stimulation delivery to those electrodes, while allowing user override options.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If impedance testing is performed manually with external controllers, then electrode functionality can be verified, but the process is time-consuming and does not provide automatic preventive action
Solution Approach 1:
The system performs impedance testing automatically during the implantation procedure itself, before therapeutic stimulation begins. The controller executes test protocols that measure impedance values and compare them against predetermined thresholds, flagging non-functional electrodes in advance before they can cause harm. This preliminary automated verification eliminates the need for separate manual testing steps.
Solution Approach 2:
The controller continuously monitors impedance values during implantation and provides real-time feedback about electrode functionality. When impedance values fall outside acceptable ranges, the system automatically flags the affected electrodes and prevents their use in therapy, creating a closed-loop feedback system that ensures only functional electrodes are activated for treatment.
2Reliability
If all electrodes are tested for impedance, then non-functional electrodes can be identified, but the complexity of the testing system increases
Solution Approach 1:
The electrode testing process is divided into distinct phases: initial impedance measurement, threshold comparison, flagging of non-functional electrodes, and selective activation of functional electrodes. Each phase is handled by dedicated software routines in the controller, breaking down the complex testing process into manageable, automated segments that reduce overall system complexity while maintaining comprehensive testing coverage.
Solution Approach 2:
The implantable medical device controller is designed to perform multiple functions: it delivers therapeutic stimulation, monitors impedance values, compares measurements against thresholds, flags non-functional electrodes, and manages therapy delivery. This multi-functional controller consolidates what would otherwise require separate testing equipment and manual procedures into a single integrated system.
3Productivity
If non-functional electrodes are used for therapy, then treatment can proceed quickly, but patient safety is compromised
Solution Approach 1:
The system takes preliminary action to prevent harm by automatically flagging non-functional electrodes before therapy begins. Impedance values are measured and compared against predetermined thresholds during implantation, and electrodes that fail to meet functional criteria are flagged and excluded from therapy delivery. This preliminary safety check prevents the harmful scenario of using non-functional electrodes while maintaining efficient therapy setup.
Solution Approach 2:
The controller automatically performs impedance testing, compares values against thresholds, flags non-functional electrodes, and manages therapy delivery without requiring continuous manual intervention. The system serves itself by autonomously ensuring electrode functionality and patient safety, eliminating the need for external monitoring and reducing the risk of human error in identifying and managing non-functional electrodes.
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
Prevents potential harm to patients by ensuring only functional electrodes are used for therapeutic stimulation, enhancing safety and reliability in implantable medical device operations.
Implementation Method 1
A common test is to check the impedance between pairs of electrodes. During testing, an electrode can be driven with a signal having known electrical characteristics. The signal may be measured, e.g., on another electrode or electrodes, and the impedance computed between electrodes using known fundamental relationships.
Implementation Method 2
the coil and its housing is taken inside the sterile field, e.g., using a sterile bag. For example, United States Patent Application Publication No. 2006/0036186, Goetz et al, Automatic ImpedanceMeasurement of an Implantable Medical Device
Data Source
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AI summary
Method, controller and system for an implantable medical device having a plurality of electrodes, the implantable medical device capable of delivering therapeutic stimulation to a patient, comprising a control module, a user interface operatively coupled to the control module, the user interface providing control of the control module by a medical professional or other user, and an electrode interface operatively coupled between the plurality of electrodes and the control module. The control module uses the electrode interface to obtain a plurality of measurements of impedance values for a plurality of selected pairs of individual ones of the plurality of electrodes. The control module flags electrodes using the plurality of measurements of impedance values of the selected pairs of individual ones of the plurality of electrodes comparative to a range, and the delivery of therapy on flagged electrodes is inhibited.