Methods, apparatus and systems for operating a medical device including an accelerometer

Inventors

Bitan, AsherRamon, ArieRotem, Shachar

Assignees

Eitan Medical Ltd

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Publication Number

US-9855110-B2

Patent

Publication Date

2018-01-02

Expiration Date


Abstract

Disclosed is a medical device, including: a therapeutic component adapted to provide therapeutic functionality while in therapeutic mode and further adapted to enter a device sleep mode (DSM), an accelerometer configured to identify a movement characterization of the therapeutic component and a movement analysis module (MAM) configured to receive the movement characterization from the accelerometer and determine a malfunction parameter wherein the MAM is operable while the therapeutic component is in the DSM.

Core Innovation

A medical device introduces a therapeutic substance into a body of a person during operation in a therapeutic mode, but the therapeutic assembly is adapted to enter a device sleep mode (DSM) in which the assembly is not introducing a therapeutic substance. While in DSM, the device uses an accelerometer mechanically linked to the therapeutic assembly to sense movements of the therapeutic assembly and to generate movement characterization data indicative of at least one sensed movement. A movement analysis module (MAM) receives the movement characterization data during DSM and estimates whether a sensed movement represents a malfunction parameter requiring testing or recalibration before a next use.

Based on the MAM estimation, the device triggers a disabling of the therapeutic assembly upon estimating a malfunction parameter. The device further supports responses to abnormal movement, including generating warnings and triggering a beacon/alarm circuit when a malfunction parameter is detected. The device logs events and later relays stored malfunction parameters, including event time/date information associated with the sensed movement and analysis.

The disclosed movement characterization in DSM includes acceleration and vibration characterized in 1D, 2D, or 3D forms, with associated profiles, axes, and timing information such as time intervals and event time/date. The device uses in-use movement detection to identify dangerous orientation/position changes above predefined orientation thresholds, and it also supports theft/suspicious movement detection. In addition, the device supports multi-block power mode transitions (deep sleep mode, sleep mode, and normal/operative mode) and remote-server learning by relaying events and malfunction parameters, including technician outcomes.

Claims Coverage

The independent claims (two) cover a medical device architecture with DSM sensing by an accelerometer and DSM-time movement analysis by a MAM that estimates a malfunction parameter and triggers disabling, with optional alarm/beacon behavior tied to malfunction estimation.

Device sleep mode malfunction estimation with DSM accelerometer sensing and disabling

A medical device that uses a therapeutic assembly adapted to introduce a therapeutic substance in a therapeutic mode and to enter a device sleep mode (DSM) where it is not introducing the therapeutic substance; an accelerometer circuit mechanically linked to the therapeutic assembly to sense movements during DSM and generate movement characterization data; and a movement analysis module (MAM) configured to, during DSM, receive the movement characterization data to estimate whether the sensed movement represents a malfunction parameter requiring testing or recalibration and to trigger a disabling of the therapeutic assembly upon estimating the malfunction parameter.

Alarm triggering on accelerometer malfunction values and disabling based on malfunction parameter

A medical device comprising a therapeutic assembly adapted to introduce a therapeutic substance into the body of a person; an accelerometer adapted to sense movement and orientation of the therapeutic assembly; a movement analysis module (MAM) with processing circuits configured to receive signals from the accelerometer and to trigger an alarm circuit if the signals match values indicating a malfunction; and triggering a disabling of the therapeutic assembly upon estimating a malfunction parameter.

Across both independent claims, the core coverage requires DSM operation where the therapeutic assembly does not introduce a therapeutic substance, accelerometer-based sensing of movement (including movement and orientation), MAM-based estimation of a malfunction parameter, and disabling of the therapeutic assembly upon such estimation; one claim additionally frames malfunction response via an alarm circuit based on accelerometer signals matching malfunction values.

Stated Advantages

Disabling the therapeutic assembly upon estimating a malfunction parameter.

Estimating whether sensed movement represents a malfunction parameter requiring testing or recalibration before a next use of the device.

Triggering an alarm circuit when accelerometer signals match values indicating a malfunction.

Providing warnings and emitting a beacon based on a detected malfunction parameter.

Documented Applications

Using device sleep mode (DSM) while the therapeutic assembly is not introducing a therapeutic substance, and using movement analysis during DSM to estimate malfunction parameters before a next use.

Generating warnings and beacon/alarm outputs based on detected or estimated malfunction parameters.

Logging events and relaying stored malfunction parameters.

Relaying events and malfunction parameters to a remote server for learning, including technician outcomes.

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