Implantable Medical Device Automated Test Sequences for Expedited Discharge
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Solution Overview
Problem
Current implantable medical device (IMD) procedures require extensive hospital stays and increased exposure to pathogens due to the need for manual device testing and potential incomplete or inaccurate results from qualification tests, which can delay patient discharge and increase procedure costs.
Innovation Solution
An IMD configured to automatically initiate and perform device test sequences within a short time post-implantation, including impedance checks, electrogram tests, pacing capture threshold determinations, and physiologic metric measurements, and transmit results to a remote monitoring system, allowing for expedited patient discharge and reduced exposure to pathogens.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual device testing is performed at the time of implant, then device functionality can be confirmed, but patient discharge is delayed and exposure to pathogens increases
Solution Approach 1:
The system performs device qualification tests automatically at predetermined times (e.g., at midnight or at specific hours) following implantation, allowing tests to be completed before the patient would normally be discharged. This preliminary automated testing ensures device functionality is confirmed without delaying discharge.
Solution Approach 2:
The IMD performs self-testing through automated device test sequences that qualify the device and leads without requiring manual intervention by clinicians. The device autonomously executes impedance checks, electrogram tests, and other qualification tests, eliminating the need for extended manual testing periods.
2Measurement precision
If multiple qualification tests are performed manually, then complete device evaluation is achieved, but procedure complexity and costs increase
Solution Approach 1:
The system replaces manual mechanical testing procedures with automated electronic testing sequences executed by the IMD itself. The device autonomously performs impedance measurements, electrogram analyses, and other qualification tests that would otherwise require manual clinician intervention and complex testing equipment.
Solution Approach 2:
The IMD is designed to perform multiple different qualification tests through a single automated test sequence, including impedance checks, electrogram tests, and other device evaluations. This multi-functional approach consolidates what would otherwise require multiple separate manual testing procedures into one unified automated process.
3Loss of time
If qualification tests are performed immediately post-implant, then device status is confirmed early, but tests may fail due to unstable cardiac rhythm
Solution Approach 1:
The system schedules qualification tests to occur at predetermined times following implantation (e.g., at midnight or at specific intervals), allowing the patient's cardiac rhythm to stabilize before testing begins. This timing strategy ensures tests are performed when cardiac conditions are more favorable for successful qualification.
Solution Approach 2:
The IMD performs qualification tests at periodic intervals following implantation rather than attempting all tests immediately. The device can retry failed tests at subsequent predetermined times, allowing multiple opportunities for successful qualification as the patient's cardiac rhythm stabilizes over time.
Data Source
AI summary
An implantable medical device (IMD) performs, within a first predetermined time following an implantation, a first device test sequence over an evaluation period. The device test sequence includes at least two of: detecting an impedance for at least one electrical path having at least one electrode, and comparing the impedance to a first predetermined impedance threshold to determine a connection status of the IMD; comparing, over an electrogram (EGM) test period, at least one EGM event of the patient against a first predetermined EGM event threshold; determining a first pacing capture threshold of the IMD; and detecting at least one clinical or patient-specific physiologic metric, and comparing the physiologic metric to a first predetermined physiologic metric threshold. The IMD transmits within a second predetermined time a status signal to an external device indicating a status of at least one of the diagnostic tests in the first device test sequence.