US2021402092A1PendingUtilityA1

Continuous glucose monitoring injection device

68
Assignee: BECTON DICKINSON COPriority: Aug 1, 2014Filed: Sep 9, 2021Published: Dec 30, 2021
Est. expiryAug 1, 2034(~8.1 yrs left)· nominal 20-yr term from priority
A61M 2205/52A61M 2205/582G16H 40/67A61M 2205/35A61M 2005/1402G16H 40/63A61M 2205/581A61M 2205/3306A61M 2005/1726A61M 5/1723A61M 2205/502G16H 15/00A61M 2205/3592G16H 20/13A61M 2005/31588A61M 2205/3368A61M 5/31545G16H 50/20A61B 5/14532A61M 5/14248A61M 5/24A61M 2205/3561A61M 2230/201A61M 2205/583A61M 2230/005G16H 20/17A61M 5/14244A61M 2230/63A61M 2205/3584A61M 2205/3553G16H 20/10
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Claims

Abstract

An electronic insulin delivery device receives glucose data from a glucose monitor and sets a bolus dose amount. The device may take the form of an insulin pen with automatic priming and accurate dosing provided by a motor in connection with an encoder. The device may communicate with and be controlled by a smart phone device. The smart phone device provides a user interface to receive user data including patient weight, insulin to carbohydrate ratio and exercise factor, and to send instructions to the device, including dose amount. The dose amount is determined taking into account glucose level and trend, and other factors. The delivery device may be in continuous communication with the glucose monitor and smart phone to provide for near real-time adjustments in glucose treatment. Glucose data, insulin injection data, and other relevant data may be stored and accessible to interested parties.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An electronic delivery device for delivering a bolus of medicament to a patient, comprising:
 a medicament cartridge;   a needle configured to deliver the bolus of medicament from the medicament cartridge;   a receiver configured to wirelessly connect to one or more external devices, the receiver configured to receive continuous glucose monitoring information from the one or more external devices; and   a processor configured to:
 read the received continuous glucose monitoring information; 
 determine a patient status based on the received continuous glucose monitoring information; 
 determine if a notification should be initiated; and 
 initiate a notification if a determination is made to initiate the notification. 
   
     
     
         2 . The device of  claim 1 , further comprising a housing having a user interface configured to display the notification. 
     
     
         3 . The device of  claim 1 , wherein the electronic delivery device is further configured to indicate the notification through auditory, visual, or tactile feedback. 
     
     
         4 . The device of  claim 1 , further comprising a memory for storing the received continuous glucose monitoring information, wherein the processor is configured to read the continuous glucose monitoring information from the memory to determine the patient status. 
     
     
         5 . The device of  claim 1 , further comprising a transmitter configured to transmit the notification to an external device. 
     
     
         6 . The device of  claim 1 , wherein the processor is further configured to determine an appropriate bolus dose for the patient, based on the continuous glucose monitoring information. 
     
     
         7 . The device of  claim 6 , further comprising a dose setting mechanism configured to set a medicament delivery amount corresponding to the determined bolus dose. 
     
     
         8 . The device of  claim 6 , wherein the continuous glucose monitoring information comprises a most recent blood glucose value received from the one or more external devices, wherein the processor is configured to determine the appropriate bolus dose for the patient based on the most recent blood glucose value received from the one or more external devices. 
     
     
         9 . The device of  claim 1 , wherein the delivery device is configured to prime the cartridge and needle prior to medicament delivery. 
     
     
         10 . The device of  claim 9 , wherein the processor is configured to initiate a notification that the delivery device is prepared for injection after priming of the cartridge and needle. 
     
     
         11 . The device of  claim 1 , further comprising a blood glucose monitoring sensor and blood glucose monitoring test strip, wherein the blood glucose monitoring sensor is configured to measure blood glucose from the blood glucose monitoring test strip. 
     
     
         12 . The device of  claim 11 , wherein the processor is configured to determine an appropriate bolus dose for the patient based on the measured blood glucose. 
     
     
         13 . The device of  claim 1 , wherein the one or more external devices comprise one or more continuous glucose monitors. 
     
     
         14 . The device of  claim 1 , wherein the continuous glucose monitoring information comprises blood glucose concentration measurement data. 
     
     
         15 . The device of  claim 1 , wherein the processor is configured to generate a plot of blood glucose history based on the continuous glucose monitoring information. 
     
     
         16 . The device of  claim 1 , wherein the patient status comprises one or more of a high or low glucose reading, a requirement of an insulin dose, a required insulin dosage amount, and a requirement of emergency medical treatment. 
     
     
         17 . A method in an electronic delivery device for delivering medicament to a patient, comprising:
 receiving continuous glucose monitoring information from one or more external devices;   setting a bolus dosage amount based on the continuous glucose monitoring information;   activating a user interface on the delivery device or an external device to display a notification; and   delivering medicament from a cartridge of the delivery device to the patient through a needle.   
     
     
         18 . The method of  claim 17 , wherein the notification comprises the bolus dosage amount. 
     
     
         19 . The method of  claim 17 , further comprising measuring blood glucose from a blood glucose monitoring test strip using a blood glucose monitoring sensor within the electronic delivery device. 
     
     
         20 . The method of  claim 17 , wherein delivering medicament from the cartridge comprises activating a motor connected to a displacement gear. 
     
     
         21 . The method of  claim 20 , further comprising:
 sensing movement of an encoder in connection with the motor;   providing signals indicative of encoder movement to a controller of the delivery device; and   adjusting the bolus dosage amount setting based on the signals received by the controller.   
     
     
         22 . The method of  claim 20 , further comprising setting a medicament priming amount, wherein the motor is adapted to prime the medicament cartridge and needle prior to delivery. 
     
     
         23 . The method of  claim 17 , further comprising:
 storing in a memory the continuous glucose monitoring information from the one or more external devices; and   reading the continuous glucose monitoring from the memory and determining medicament delivery information comprising delivery success status, does amount, and time of medicament delivery.   
     
     
         24 . The method of  claim 17 , further comprising priming the cartridge and needle prior to medicament delivery. 
     
     
         25 . The method of  claim 24 , further comprising initiating a notification that the delivery device is prepared for injection after priming of the cartridge and needle. 
     
     
         26 . The method of  claim 17 , wherein the continuous glucose monitoring information comprises a most recent blood glucose value received from the one or more external devices, wherein setting the bolus dosage amount is based at least partially on the most recent blood glucose value. 
     
     
         27 . The method of  claim 17 , wherein the one or more external devices comprise one or more continuous glucose monitors. 
     
     
         28 . The method of  claim 17 , wherein the continuous glucose monitoring information comprises blood glucose concentration measurement data. 
     
     
         29 . The method of  claim 17 , further comprising generating a plot of blood glucose history based on the continuous glucose monitoring information.

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