Sub-epidermal electric warning device
Inventors
Hadvary, Paul • Tschirky, Hansjorg • Dinger, Rudolf • Michot, Jean-Pierre
Assignees
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Publication Number
US-10149974-B2
Publication Date
2018-12-11
Expiration Date
Abstract
A sub-epidermal electric warning device has electrodes penetrating through the patient's epidermis and bipolar electric warning signals are transmitted to the sub-epidermal tissue by these electrodes. A device for surveillance of vital signs, analyte levels, or treatment parameters is using a sub-epidermal electric warning device for notifying the patient in situations requiring intervention.
Core Innovation
The invention provides a sub-epidermal electric warning device that includes electrodes configured to penetrate through a patient's epidermis into skin and to transmit an electric warning signal to sub-epidermal tissue. An electric stimuli applied to the electrodes creates bipolar current pulses of alternating positive and negative polarity as the mechanism for the warning signal. The device is intended to generate an electric warning signal at sub-epidermal tissue using low-voltage operation and low current stimulation as described.
The device includes an inserter that provides sub-epidermal insertion of the electrodes into the skin. In a ready-to-use position, the inserter is configured so that the inserter keeps the skin away from contacting a tip of the electrodes, where the electrodes are fixedly positioned by a bottom of a casing of the device. Upon activation, the inserter pulls the skin towards the tip of the electrodes with a velocity to effect piercing of the skin and sub-epidermal insertion of the electrodes.
As further described, the generator and warning signal delivery include bipolar pulse timing using alternating positive and negative polarity pulses delivered in pulse pairs and repetition. The electric warning signal is delivered with increasing intensity over time until the electric warning signal is recognized and confirmed by the patient, as described. The circuitry approach supports improved recognition without perceptual fading by using rapid switch-on behavior tied to polarity switching as described.
The device is further described as integrating with systems that provide warning inputs, including a pump system for subcutaneous fluid injection and a sensor system for monitoring physiological, analyte, and treatment parameters. The disclosed subcutaneous pump functional abnormalities and sensor-determined abnormal values are transmitted to control elements to produce an electric warning signal. The overall device is contrasted with optical, acoustic, and vibration alarms and with skin-surface electric alarms requiring higher voltage/current.
Claims Coverage
The independent claim defines a sub-epidermal electric warning device with 2 inventive features: electrodes that penetrate epidermis and deliver bipolar alternating polarity pulses for a sub-epidermal warning signal, and an inserter that keeps skin away from electrode tips in a ready-to-use position and pulls skin toward the tips at activation to pierce and insert the electrodes. Dependent claims refine the bipolar pulse timing, increasing intensity until patient recognition, and add system inputs from sensor abnormalities and pump functional abnormalities, as well as detailed inserter and skin-attachment mechanics with adhesive and concealment of electrode tips.
Sub-epidermal electrodes and bipolar alternating polarity warning signal generation
Electrodes configured to penetrate through a patient's epidermis into a skin; a generator of an electric warning signal transmitted to sub-epidermal tissue by the electrodes, wherein an electric stimuli applied creates bipolar current pulses of alternating positive and negative polarity.
Inserter that keeps skin away in ready-to-use position and pulls skin to pierce at activation
An inserter configured such that in a ready-to-use position, the inserter keeps the skin away from contacting a tip of the electrodes fixedly positioned by a bottom of a casing, and upon activation pulls the skin towards the tip of the electrodes with a velocity to effect piercing of the skin and sub-epidermal insertion of the electrodes.
Pulse sequencing with positive/negative pulse timing
Bipolar current pulses delivered as positive and negative pulse pairs with positive/negative pulses within 1 to 100 milliseconds and successive pulse pairs within 0.2 to 5 seconds.
Increasing intensity until patient recognition and confirmation
An electric warning signal delivered with increasing intensity over time until the electric warning signal is recognized and confirmed by the patient.
Sensor-driven warning generation upon abnormal vital-sign values
A sensor system that measures vital-sign abnormalities and sends resulting signals to control elements to produce an electric warning signal.
Pump abnormality-driven warning generation
A pump system for subcutaneous fluid injection that, upon pump functional abnormalities, sends input signals to control elements to generate the electric warning signal.
Adhesive skin-attachment surface with concealed electrode tips and release-actuated insertion
An inserter with an adhesive skin attachment surface including holes or recesses, wherein a spring-type retraction mechanism conceals the tip of the electrodes in a ready-to-use position until a release and actuation element actuates electrode insertion and control element activation.
Overall, the claim set covers a sub-epidermal electric warning device that uses epidermis-penetrating electrodes delivering bipolar alternating positive/negative polarity pulses, combined with an inserter that prevents skin contact with electrode tips in a ready state and performs piercing insertion upon activation. The dependent features further specify bipolar pulse timing, increasing-intensity delivery until patient recognition/confirmation, and warning generation driven by sensor abnormal values and pump functional abnormalities, together with inserter skin-attachment concealment mechanics using adhesive and a release-actuated, spring-type retracted configuration.
Stated Advantages
Improved recognition without perceptual fading.
Allows clear low-voltage stimulation compared to high-voltage/current skin-surface electric alarms.
Reduced variability/safety risk as described.
Advantages over optical, acoustic, and vibration alarms.
Documented Applications
Warning upon abnormal sensor values, including physiological, analyte, and treatment-parameter monitoring with a subcutaneously implanted sensor.
Warning upon pump functional abnormalities in a pump system for subcutaneous fluid injection, integrated with therapy such as closed-loop therapy (e.g., insulin pump/glucose sensor) as described.
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