Medical device system having an implanted medical device and an external device
Inventors
Keenan, David • John, Michael Sasha
Assignees
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Publication Number
US-9486153-B2
Publication Date
2016-11-08
Expiration Date
Abstract
Disclosed is a system having an implanted component and external component which are configured to provide a test of wireless communication in order to assess the success or failure of such communication and to store attributes related to such test in a memory log. To provide the communication test the implantable and external components can attempt wireless communication according to communication test parameters which relate to number of times to retry communication, duration of sending communication test signals, durations of waiting for communication test signals and the schedule of the communication tests. The schedule of tests may be period or may change over time in order to become more or less frequency according to a programmable schedule that may also decrease if the communication tests are successful and indicate patient compliance in keeping the external components close by. The communication tests can assist in determining if the patient is maintaining external components within a suggested proximity (e.g. 6 feet) of the patient and may assist to determine if transmission or reception difficulties are the source of communication failure. A physician programmer can provide for programming, conducting, summarizing and assessing the results of communication tests.
Core Innovation
The invention relates to a medical device system comprising an implanted medical device and an external device having wireless communication circuitry with a transceiver, random access memory, and a processor. The processor is configured to periodically activate the wireless communication circuitry in an attempt to communicate a plurality of proximity test signals with the implanted medical device.
For each periodic activation, the processor determines whether a proximity signal has been received from the implanted device within a certain time after the activation, thereby generating proximity test receipt results. The processor applies a test to the plurality of proximity test receipt results to determine whether a proximity failure condition exists, thereby generating proximity test results.
When a proximity failure condition exists, the processor takes at least one action of storing information regarding the proximity failure in the random access memory or sending a proximity test failure condition notification. When the proximity failures in the random access memory meet a selected proximity test criterion, the processor further sends notification to the patient and/or a remote station, and can document proximity test receipt results for patient or caregiver notification.
The problem is the detection of a proximity failure condition in communications between the implanted medical device and the external device during scheduled wireless proximity testing, and the related notification and documentation of compliance or non-compliance with maintaining the implanted medical device within a predetermined proximity of the external device.
Claims Coverage
The document provides three independent claims (clm-00001, clm-00019, clm-00020). Across the independent claims, there are inventive features that cover scheduled wireless proximity testing, receipt-result evaluation to detect a proximity failure condition, and failure-driven storage and notification pathways, including patient notification and remote-station notification based on selected criteria.
Scheduled proximity test signal communication
The processor is configured to periodically activate wireless communication circuitry in an attempt to communicate a plurality of proximity test signals with the implanted medical device; or, the processor is configured to periodically activate wireless communication circuitry to transmit a plurality of proximity test signals with the implanted medical device.
Receipt-result generation within a time window
For each of the activations, determine whether a proximity signal has been received from the implanted device within a certain time after the activation, thereby generating a plurality of proximity test receipt results; or, when the external device receives an acknowledge signal responsive to at least one proximity test signal, store the acknowledge signal and generate a proximity test receipt result indicating that both were received.
Proximity failure condition testing
Apply a test to the plurality of proximity test receipt results to determine whether a proximity failure condition exists, thereby generating a plurality of proximity test results; or, when the external device does not receive an acknowledge signal responsive to at least one proximity test signal, store the proximity test signal and generate a proximity test receipt result indicating there was no acknowledge signal sent from the implanted medical device defining a proximity failure.
Failure storage and failure notification
Operative when a proximity failure condition exists, take at least one of the following actions: store information regarding the proximity failure in the random access memory or send a proximity test failure condition notification; or, store failures in random access memory.
Criterion-based patient and/or remote-station notification and documentation
When the proximity failures in the random access memory meet a selected first proximity test criterion, send notification to the patient; or, when the proximity failures in the random access memory meet a selected proximity test criterion, send notification to a remote station; or, when a plurality of proximity failures stored in the random access memory meets a selected proximity test criteria, document said test receipt results, whereby a patient or caregiver is notified as to compliance or non-compliance with maintaining the implanted medical device within a predetermined proximity.
The independent claims collectively define a medical device system that performs periodic proximity test communications, generates receipt results based on whether signals (or acknowledge signals) are received, applies testing to determine a proximity failure condition, stores failure information and/or sends failure notifications, and uses selected criteria on stored failures to trigger patient and/or remote-station notifications and documentation for compliance or non-compliance with predetermined proximity.
Stated Advantages
Provides notification to the patient when proximity failures meet a selected first proximity test criterion.
Provides notification to a remote station when proximity failures in random access memory meet a selected proximity test criterion.
Enables documentation of proximity test receipt results for patient or caregiver notification regarding compliance or non-compliance with maintaining predetermined proximity.
Documented Applications
Notifying patient or caregiver about compliance or non-compliance of maintaining the implanted medical device within a predetermined proximity of the external device based on scheduled wireless proximity testing results.
Sending notification to the patient and/or to a remote station when proximity failures meet selected proximity test criteria.
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