System and method for dose capture with flow patch and delivery infomatics
Inventors
Srinivasan, Sudarsan • SRINIVASAN, Rita Grace
Assignees
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Publication Number
US-11504009-B2
Publication Date
2022-11-22
Expiration Date
Abstract
An injection sensing device (ISD) (e.g., wearable patch) is paired with an external device (e.g., a medication delivery pen and/or smart phone, iPad, computer) via wireless link or wireline connection. The ISD senses fluctuations in local skin temperature during an injection and provides to the external device captured data from the sensor relating to medicine delivery to a patient to ensure complete delivery and minimize MDD misuse or malfunction or inaccuracies in dosing. The ISD or external device can use captured data and corresponding time stamps to determine flow informatics such as flow rate, total dose delivered, and dose completion status. An LED on the ISD indicates delivery in progress and/or delivery completion.
Core Innovation
An injection sensing device (ISD) is configured for use with a medication delivery device. The ISD includes a thermal sensor configured to be applied to the skin of a patient and proximal to an injection site, where it senses a change in temperature at the injection site and outputs corresponding sensor data.
A processing device receives the sensor data and performs a designated operation when it determines from the sensor data that the patient’s temperature sensed at the injection site has changed by a designated amount in relation to the administration of an injection. In particular, the processing device determines that the temperature began decreasing upon initiation of the injection and thereafter increased to at least the designated amount in relation to the administration.
Based on that determination, the processing device operates an indicator to indicate to the patient that medication delivery via the administration of the injection is complete. The device and associated processing can provide delivery informatics using time stamps associated with the sensor data, and can include estimating delivered medication dose using temperature-change analysis, including calculating an area under a temperature-over-time curve.
Claims Coverage
The independent claims define an injection sensing device having a skin-mounted thermal sensor, processing that detects a temperature-change pattern in relation to injection administration, and an indicator driven by that detection. The inventive features cover temperature-based completion indication, wireless transmission to an external device, and delivery informatics such as flow rate determination and dose estimation using curve-based analysis.
Thermal sensor configured at injection site for temperature change sensing
A thermal sensor configured to be applied to the skin of a patient and proximal to an injection site and to sense a change in temperature of the patient at the injection site and output corresponding sensor data.
Processing device detects designated temperature change relative to injection administration
A processing device configured to receive the sensor data from the thermal sensor and perform a designated operation when the processing device determines from the sensor data that the patient's temperature sensed at the injection site has changed by a designated amount relative to administration of an injection.
Indicator signals completion based on temperature decrease then increase
An indicator, wherein the processing device is configured to perform the designated operation by operating the indicator to indicate to the patient that medication delivery via the administration of the injection is complete in response to the processing device determining that the sensor data indicates that the patient's temperature sensed at the injection site began decreasing upon initiation of the injection and thereafter increasing to at least a designated amount in relation to the administration of the injection.
Wireless communication to external device
A wireless communication circuit configured to wirelessly transmit sensor data from at least one of the thermal sensor or the processing device to an external device over a wireless link.
Dose estimation using a temperature-change curve and area under the curve
The processing device, external device, or ISD software application is configured to determine a delivered medication dose using a determined temperature-change curve and an area under the curve.
Time stamps and analysis to determine flow rate
The processing device is configured to associate time stamps with sensor data including sensed injection-site temperatures, analyze the data, and determine the medication flow rate from the medication delivery device to the patient.
Across the independent-claim coverage provided, the core inventive approach is a thermal sensor at the injection site whose temperature-change pattern relative to injection initiation is used by a processing device to drive an indicator for medication-delivery completion. Further claim coverage also includes delivery informatics such as time-stamp-based analysis for flow rate determination and dose estimation using curve-based temperature analysis, with optional wireless transmission to an external device.
Stated Advantages
Indicates to the patient that medication delivery via the administration of the injection is complete.
Documented Applications
Compliance monitoring using alerts/notifications to users/caregivers, including alarms for under-dosing or misuse/malfunction.
Use with an external device (e.g., a smart phone, tablet, or computer) and ISD software application to receive and act on delivery informatics derived from sensed injection-site temperature changes.
Estimating delivered medication dose and delivery progress/completion status based on sensed temperature changes and curve/area-under-curve analysis.
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