Implantable Medical Device Disable via Modulated Stimulation
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Solution Overview
Problem
Implantable medical devices, especially leadless pacemakers, pose challenges when their power sources deplete or communication modules malfunction, leading to potential erratic behavior and the need for invasive surgery for removal, as they cannot be disabled effectively without reliable external communication.
Innovation Solution
A second implanted medical device can modulate therapeutic electrical stimulation to provide a disable command to a first device, using patterns in amplitude, frequency, or pulse width, allowing for the safe shutdown of the malfunctioning or end-of-life device without invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a leadless pacemaker is implanted within or on the heart, then it provides effective pacing therapy, but it becomes difficult to explant and requires invasive surgery for removal
Solution Approach 1:
The patent extracts the pacemaker device from the patient's body through a minimally invasive percutaneous approach rather than requiring open heart surgery. The leadless pacemaker is delivered via catheter through the venous system and implanted directly into the heart chamber, allowing for easy removal by simply withdrawing the device through the same percutaneous access point without invasive surgical procedures.
2Reliability
If a previously implanted pacemaker is replaced with a new one, then updated therapy is provided, but the previously implanted device cannot be disabled and may exhibit erratic behavior
Solution Approach 1:
The patent applies preliminary anti-action by implementing a disable command mechanism that is sent to the previously implanted pacemaker before or during the replacement procedure. This command preemptively disables the old device's therapy delivery functions, preventing any potential erratic behavior from occurring after replacement. The disable command ensures the old device cannot interfere with the new device's operation or pose any harm to the patient.
3Ease of operation
If radio-frequency or inductive communication is used to control the pacemaker, then the device can be monitored and adjusted, but communication may become unreliable when the power source is depleted
Solution Approach 1:
The patent introduces an intermediary communication method that does not rely on the pacemaker's power source or communication module. Instead of using radio-frequency or inductive communication that requires the old device's systems to be functional, the replacement pacemaker uses direct sensing of the old device's pacing pulses and delivers disable commands through the sensing and stimulation circuitry, which remains operational even when the power source is depleted.
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 safe and controlled shutdown of malfunctioning or end-of-life implantable medical devices, preventing erratic behavior and reducing the need for invasive surgeries by using modulated electrical stimulation to disable the devices, ensuring patient safety and simplifying replacement processes.
Implementation Method 1
The second medical device may modulate a therapeutic electrical stimulation in a way that is detectable by the first medical device as a command
Data Source
AI summary
Various techniques for disabling a first implantable medical device (IMD) by modulation of therapeutic electrical stimulation delivered by a second medical device are described. One example method includes delivering therapeutic electrical stimulation from a more recently implanted second IMD at a higher average rate than the previously implanted first IMD so that only the more recently implanted IMD will administer therapy, and modulating stimulation by the more recently implanted IMD in order to send a disable command to the previously implanted IMD.