Smart medication delivery devices for providing users with delivery infomatics and methods of using same
Inventors
Srinivasan, Sudarsan • Bruehwiler, Michel • Montidoro, Tyson • Ramezanifard, Mohammadreza • Constantineau, Cole • Chagnon, Jeffrey • Gisler, Stefan
Assignees
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Publication Number
US-11666701-B2
Publication Date
2023-06-06
Expiration Date
Abstract
A medication delivery device (MDD) (e.g., injection pen, wearable pump) is paired with an external device (e.g., smart phone, iPad, computer) via wireless link or wireline connection. The MDD provides to the external device captured data from the flow sensor relating to medicine delivery to a patient to ensure complete delivery and minimize MDD misuse or malfunction or inaccuracies in dosing. The MDD can have Bluetooth™ and/or near field communication (NFC) communication circuits for proximity-based pairing and connectivity with the external device for real-time or deferred transfer of captured data to the external device, depending on memory and power availability at the MDD. The MDD or external device can use captured data and corresponding time stamps to determine flow infomatics such as flow rate, total dose delivered, and dose completion status. An LED on the MDD indicates states such as powered on, paired, delivery in progress and delivery completion.
Core Innovation
The invention relates to a medication delivery device that senses medication flow from the medication delivery device through a cannula to a patient at a delivery site. The device includes a processing device configured to receive sensor data from the sensor and uses the sensor data to support dose-related determinations. The device further includes a wireless communication circuit configured to transmit the sensor data to an external device on a wireless link.
The medication delivery device provides power control coordinated with user initiation of medication delivery and placement of the MDD in a non-operational state. When powered, the processing device operates an indicator to indicate a first state when the MDD is powered on and not connected to the external device via the wireless link, and a second state when the MDD is powered on and connected via the wireless link. During the second state, the processing device transmits the sensor data to the external device.
The invention also includes determining, using the sensor data received by the processing device, an indication that the cannula may be removed from the delivery site when a predetermined amount of time has elapsed after the sensor data corresponds to a sensed flow rate of medication from the MDD being zero. The disclosed concepts further include timekeeping with corresponding time stamps and memory-based sensor data handling, and pairing and communication can be implemented for different wireless communication modes such as near-field communication (NFC), other wireless links, and wireline communication in certain variants.
Claims Coverage
The independent claim is clm-00001. Based on the provided partial content, the independent claim includes multiple inventive feature groupings spanning sensing, wireless transmission of sensor data with paired connection states, user-initiated power control with termination in a non-operational state, and indicator-driven signaling of a removal condition based on sensor-derived flow cessation and elapsed time. Additional inventive refinements are described in the dependent claims summarized in the provided family summary, including time clock and time stamps, NFC chip, longer-range wireless link with time stamps and stored sensor data, clog detection, and dose verification with an alarm.
Cannula-mounted medication flow sensing
A cannula and a sensor configured to sense flow of medication from the medication delivery device through the cannula to a patient at a delivery site.
Processing of sensor data
A processing device configured to receive sensor data from the sensor.
Wireless transmission of sensor data to an external device
A wireless communication circuit configured to transmit the sensor data from the MDD to an external device on a wireless link.
Indicator-controlled states during powered-on connection and pairing
Operate an indicator to indicate a first state corresponding to the MDD being powered on and not connected to the external device via the wireless link; control pairing of the MDD to the external device and, once the external device is paired with the MDD, operate the indicator to indicate a second state corresponding to the MDD being powered on and connected to the external device via the wireless link; transmit the sensor data to the external device via the wireless link during the second state.
User-initiated power switching with termination in non-operational state
A switch configured to provide a supply of power from a power source to the sensor, the processing device, and the wireless communication circuit when activated upon user initiation of medication delivery, and to terminate the supply of power upon user placement of the MDD in a non-operational state.
Removal indication based on zero flow and elapsed time
Operate the indicator to indicate that the cannula may be removed from the delivery site when a predetermined amount of time has elapsed after the sensor data that the processing device receives corresponds to a sensed flow rate of medication from the MDD being zero.
The independent claim clm-00001 covers a medication delivery device with cannula-based flow sensing, processing of sensor data, wireless transmission to a paired external device, indicator-driven indication of powered-on and paired states, power provision activated upon user initiation and terminated upon non-operational placement, and an indicator-based cannula removal condition derived from sensed zero flow followed by predetermined elapsed time. The dependent claims summarized in the provided content further refine timekeeping and time stamps, NFC implementation, longer-range wireless linking with stored sensor data, clog detection, and dose verification with alarms.
Stated Advantages
Provides indication that the cannula may be removed from the delivery site when sensor data corresponds to zero sensed flow rate and a predetermined amount of time has elapsed.
Enables transmission of sensor data to an external device during a connected/pairing state.
Provides indicator states corresponding to powered-on not connected and powered-on connected via the wireless link.
Terminates supply of power upon user placement of the MDD in a non-operational state.
Enables detection of a clog based on sensed flow rate and activation of an indicator to show the presence of the clog.
Supports dose verification by determining whether a delivered dose differs from a prescribed dose and generating an alarm when it differs.
Documented Applications
Communicate medication delivery sensor data to an external device as part of a smart delivery app context, including indicating powered-on, pairing, delivery-in-progress, and completion states.
Use in medication injection pen and wearable pump or patch pump contexts, including configurations such as pen needle adapter and cannula-mounted sensing.
Use of downstream analysis with the sensor data for completion or removal indication, clog detection, and dose verification with alarms.
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