Patient-Intermediated Cardiac Pacing Therapy Management
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Solution Overview
Problem
Implantable medical devices (IMDs) such as cardiac pacemakers may inaccurately determine a patient's activity level, leading to inappropriate pacing rates, causing adverse effects like lightheadedness, shortness of breath, or discomfort, due to reliance on accelerometer signals that do not accurately reflect the patient's actual activity level during activities like bicycling or swimming.
Innovation Solution
A system that allows patients to request specific therapy parameters, such as heart rate, through a personal device, which the IMD compares to allowable values to ensure appropriate cardiac pacing, adjusting based on patient input and physiological data, enabling more accurate pacing rate adjustments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Extent of automation
If the IMD uses accelerometer signals to determine patient activity level, then the device can automatically adjust pacing rates, but the activity level determination becomes inaccurate during activities like bicycling or swimming
Solution Approach 1:
The patent introduces a patient intermediary device (smartphone or tablet with application) that serves as a mediator between the patient's actual activity level and the IMD's pacing rate determination. The patient manually inputs activity level information through the intermediary device, which then transmits this accurate information to the IMD, resolving the inaccuracy caused by relying solely on accelerometer signals.
Solution Approach 2:
The system implements feedback by allowing patients to provide feedback about their actual activity level through the patient intermediary device. This feedback loop enables the IMD to receive corrected activity level information that reflects the patient's true physiological state, thereby improving the accuracy of pacing rate adjustments.
2Productivity
If the IMD adjusts pacing rates based on inaccurate activity level determination, then therapy delivery is automated, but adverse effects like lightheadedness, shortness of breath, or discomfort occur
Solution Approach 1:
The patient intermediary device acts as a mediator that provides accurate activity level information to the IMD, preventing the delivery of inappropriate pacing therapy. By introducing this intermediary layer, the system avoids the harmful effects of automated decisions based on inaccurate sensor data.
Solution Approach 2:
The patient takes active responsibility for providing accurate activity level information through the patient intermediary device, essentially self-correcting the activity level determination. This self-service approach ensures that the pacing rate adjustments are based on accurate patient-provided information rather than potentially inaccurate accelerometer signals.
3Ease of operation
If the system allows patient requests for therapy parameters, then patient comfort is improved, but the device complexity increases
Solution Approach 1:
The patent leverages the patient's existing personal device (smartphone or tablet) as an intermediary, eliminating the need to build a complex new patient interface from scratch. By using this existing device with a downloaded application, the system provides patient control capabilities while avoiding the complexity of designing and manufacturing a dedicated patient controller.
Solution Approach 2:
The patient intermediary device serves multiple functions: it provides the user interface for patient control, stores patient information, communicates with the IMD, and can potentially serve other health-related purposes. This multi-functionality reduces overall system complexity by consolidating multiple functions into a single existing device.
Data Source
AI summary
In some examples, controlling delivery of therapy includes using an implantable medical device comprising at least one electrode. Processing circuitry of a system comprising the device may receive, from an application running on a patient personal device, a patient request entered by the patient into the application. The processing circuitry may further determine, based on the patient request, a requested value of a therapy parameter, compare the requested value to information stored in a memory of the medical device system, the information indicating one or more allowable values of the therapy parameter, determine that the requested value is one of the allowable values based on the comparison of the requested value of the therapy parameter to the one or more allowable values, and control the implantable medical device to deliver cardiac pacing via the at least one electrode according to the requested value for a period of time.