Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
2001-08-10
2003-04-22
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
C600S300000, C600S345000, C600S365000
Reexamination Certificate
active
06553244
ABSTRACT:
TECHNICAL FIELD
The present invention generally relates to a system for augmenting an alarm signal from an analyte monitoring device, e.g., the GlucoWatch® (Cygnus, Inc., Redwood City, Calif.) biographer glucose monitoring device.
An exemplary device for use with the present invention is the GlucoWatch biographer, a device which monitors glucose levels in an individual user and generates an aural alert signal upon sensing glucose levels outside of a predetermined range, thereby alerting the user that he or she is hypo- or hyper-glycemic, and that corrective action is necessary. Further, the device sounds an alert if glucose levels are falling too rapidly. The device comprises two primary elements, a durable element (comprising a watch-type housing, display element, microprocessor element, electrical connector elements, and may further comprise a power supply) and a consumable element (e.g., an AutoSensor component involved in sampling and signal detection).
In some cases, however, an aural signal provided by an analyte monitoring device may be inadequate to alert an individual user of an analyte monitoring device that the analyte amount or concentration is not within the normal predetermined range. For example, the user may be asleep or physically impaired. Alternately, the user may be a small child or animal who is unable to take the action required, e.g., administering glucose, insulin, or alerting an adult who may provide assistance. In a worst-case scenario, the detected analyte abnormality may render the user incapable of perceiving the signal or of seeking help, such as in the case of insulin shock or diabetic coma.
In such cases, augmentation and/or transmission of the alarm signal to another person or to emergency personnel is desirable.
However, until now, an alarm augmentation system for an analyte monitoring device, e.g., the GlucoWatch biographer, has not been described or suggested.
SUMMARY OF THE INVENTION
The present invention relates to an augmented alarm system for use with an analyte monitoring device.
In a first aspect of the invention, the augmented alarm system constitutes an improvement to a pre-existing analyte monitoring device (for example, a glucose monitoring device) that provides an alert or alarm, e.g., when analyte values (or predicted analyte values) fall outside of a predetermined range. The improvement results from modification of the device's circuitry which renders the device capable of producing a auditory, visual, tactile (or kinesthetic), olfactory, or gustatory stimulus, or variations or combinations thereof. That stimulus serves as the augmented alarm signal.
In one embodiment of this first aspect of the invention, the analyte monitoring device is the GlucoWatch biographer. Typically modification of the device's system comprises changes to the durable element of the system, although the consumable component of the Glucowatch biographer (i.e., the AutoSensor) may also be modified. For example, the iontophoretic channels of the monitoring device's durable element are modified to deliver an electrical current, typically delivered through the ionically conductive material of the consumable element, so as to provide a tactile stimulus that serves as the augmented alarm signal.
In a second aspect of the invention, the augmented alarm system constitutes an improvement to a pre-existing analyte monitoring system, for example, a glucose monitoring device. In this second aspect of the invention, the improvement results from modification of the device's circuitry, typically of the durable element, to provide a connection to a first and/or second signaling component for producing alarm signals to alert a user of the monitoring device (or to alert others) to analyte levels outside of a predetermined range.
In one embodiment of this second aspect of the invention, the analyte monitoring device is the GlucoWatch biographer glucose monitoring device. Some modifications to provide a connection to a first and/or second signaling component include, but are not limited to, modifications to the following elements of the durable component: reconfiguring the confidence loop of the analyte monitoring device, modifying the transmission and receipt lines, modifying the sweat probes, or adding a serial port, which is placed in operative communication with the analyte monitoring device. In one aspect, the connection may be via a wire-like connector or alternately, via a telemetering system. The telemetering system may take a variety of forms, including but not limited to, electromagnetic radiation, capacitance coupling, inductive coupling, infrared coupling, and may further include variations and combinations thereof. In yet another embodiment, the first signaling component may be an auditory stimulus generator, a visual stimulus generator, a tactile stimulus generator (including but not limited to a kinesthetic stimulus generator), an olfactory stimulus generator, a gustatory stimulus generator, or variations or combinations thereof.
In a third aspect of the invention, the augmented alarm system may be an integral part of an analyte monitoring device, for example, a glucose monitoring device. The analyte monitoring device may comprise (a) an acquisition unit capable of at least sensing or detecting analyte concentrations or amounts in a subject; (b) a display unit, operably linked to said acquisition unit, wherein (i) the display unit comprises means to provide an audible alert when an analyte level, in a subject being monitored, is outside of a predetermined range, and (ii) the acquisition unit and the display units are separately housed; and (c) an alarm augmentation system comprising a first signaling component, capable of producing alarm signals to alert a subject in response to analyte levels outside of a predetermined range. The first signaling component is typically operably linked to the display unit. In this embodiment the acquisition unit and the display unit, each operably connected to the other, are typically separately housed. The augmented alarm system may be housed with the display unit, or separately housed as well. In one embodiment, the display unit comprises at least a first signaling component, operably connected to the display unit, for producing augmented alarm signals to alert a user in response to analyte levels outside of a predetermined range.
In one embodiment of this third aspect of the invention, the first signaling component is a stimulus generator capable of generating auditory, visual, tactile (including but not limited to kinesthetic), olfactory or gustatory stimuli, or variations or combinations thereof. In one exemplary embodiment, the first signaling component is an auditory stimulus generator which provides a volume control for varying the volume of auditory stimuli.
In another embodiment of this third aspect, the display unit further includes a transmitter component that is operably linked to the display unit, for transmitting alarm signals to at least one external communication target; it may also provide an operative link between the display unit and the first signaling component. The transmitter component may take the form of a serial port and a wire-like connector, the port being capable of connecting with one or more external communication targets; alternately, the transmitter component may be a telemetering system. A variety of possible telemetering systems may be employed, which include but are not limited to electromagnetic radiation, capacitance coupling, inductive coupling, infrared coupling, and may further include variations or combinations thereof.
In yet another embodiment of the third aspect of the invention, the telemetering system may be capable of connecting with other alarm augmentation system components, including but not limited to first and/or second signaling components.
In still another embodiment, the analyte monitoring device with alarm augmentation system may further include a second signaling component, for example, operably linked to the transmitter component via a telemetering
Lesho Matthew J.
Morley, Jr. Samuel A.
Cygnus Inc.
Fabian Gary R.
Hindenburg Max F.
Mallari Patricia
McClung Barbara G.
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