Systems and methods for remotely processing data collected by a drug delivery device

Patent metadata

Field	Value
Publication number	US-12569622-B2
Application number	US-202318111064-A
Country	US
Kind code	B2
Filing date	Feb 17, 2023
Priority date	Jun 3, 2014
Publication date	Mar 10, 2026
Grant date	Mar 10, 2026

Abstract

Systems and methods are disclosed for processing sensor data collected by a drug delivery device with an external computing device. The drug delivery device may include a reservoir and a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient. The drug delivery device may further include one or more sensors configured to generate sensor data representative of a condition and/or operational state of the drug delivery device, and a communication module configured to transmit information to the external computing device. The external computing device may process the information received from the drug delivery device according to information stored in a memory of the external computing device to determine the condition or the operational state of the drug delivery device and/or generate instructional or informational prompts to be displayed to a user or patient.

First claim

What is claimed is:

1 . A system comprising:
a drug delivery device comprising:
a reservoir;
a stopper movably disposed in the reservoir;
a delivery member having a proximal end in fluid communication with or configured to be in fluid communication with the reservoir and a distal end configured to be received within a patient;
one or more sensors comprising at least one sensor configured to monitor movement of the stopper in the reservoir;
a first communication module;
a first controller operably coupled with the one or more sensors and the first communication module, the first controller being configured to:
use the one or more sensors to determine at least one of a condition or an operational state of the drug delivery device, and
control the first communication module to transmit a communication representative of at least one of the condition or the operational state of the drug delivery device; and

an external computing device comprising:
a second communication module configured to receive the communication from the first communication module;
a display;
a memory; and
a second controller operably coupled with the display to cause the display to display at least one of an instructional prompt or an informational prompt based on the communication from the first communication module, wherein the at least one of an instructional prompt or an informational prompt comprises an amount of a drug delivered to the patient determined at least partly based on information from the at least one sensor configured to monitor movement of the stopper in the reservoir.

2 . The system of claim 1 , wherein:
the first controller is configured to:
use the one or more sensors to determine a temperature or a temperature history of the drug delivery device, and
control the first communication module to transmit a communication representative of the temperature or the temperature history of the drug delivery device; and
the second controller is:
configured to compare the temperature or the temperature history of the drug delivery device to information stored in the memory of the external computing device to determine if the temperature or the temperature history of the drug delivery device is acceptable; and
in response to a determination that the drug delivery device has an acceptable temperature or an acceptable temperature history, cause the display to display an instructional prompt instructing a user to dispose the drug delivery device on or against a skin of the patient.

3 . The system of claim 1 , wherein:
the first controller is configured to:
use the one or more sensors to determine if the drug delivery device contacts a skin of a patient, and
control the first communication module to transmit a communication representative of contact between the drug delivery device and the skin of the patient; and
in response to a determination that the drug delivery device contacts the skin of the patient, the second controller is operably coupled to the display to cause the display to display an instructional prompt instructing a user to correctly orient the drug delivery device relative to the skin of the patient.

4 . The system of any one of claim 1 , wherein:
the first controller is configured to:
use the one or more sensors to determine an orientation of the drug delivery device, and
control the first communication module to transmit a communication representative of the orientation of the drug delivery device; and
in response to a determination that the orientation of the drug delivery device is acceptable, the second controller is operably coupled to the display to cause the display to display an instructional prompt instructing a user to actuate the drug delivery device.

5 . The system of any one of claim 1 , wherein:
the first controller is configured to:
use the one or more sensors to determine if the user has actuated the drug delivery device, and
control the first communication module to transmit a communication indicating that the drug delivery device has been actuated by the user; and
in response to a determination that the drug delivery device has been actuated by a user, the second controller is operably coupled to the display to cause the display to display an instructional prompt instructing a user to wait for completion of a delivery of a medicament from the reservoir to the patient.

6 . The system of any one of claim 1 , wherein:
the first controller is configured to:
use the one or more sensors to determine if a delivery of a medicament from the reservoir to the patient has been completed, and
control the first communication module to transmit a communication representative of completion of delivery of a medicament from the reservoir to the patient; and
in response to a determination that the delivery of the medicament from the reservoir to the patient has been completed, the second controller operably coupled to the display to cause the display to display an instructional prompt instructing a user to discard the drug delivery device.

7 . The system of claim 1 , the one or more sensors comprising a temperature sensor configured to detect a temperature of a medicament within the reservoir.

8 . The system of claim 1 , the one or more sensors comprising at least one of:
a skin contact sensor including at least one of a pressure sensor, a capacitance sensor, a resistance sensor, or an inductance sensor, or an orientation sensor.

9 . The system of claim 1 , the external computing device comprising at least one of a smartphone, a smartwatch, a smart wearable device, a personal computer, a laptop computer, a smart television, a smart appliance, a smart automobile, a networked computer, or a tablet computer.

10 . The system of claim 1 , the first communication module being configured to communicate with the second communication module via at least one of Bluetooth, Bluetooth low energy, radio-frequency identification (RFID), Zigbee, Wi-Fi, or near field communication (NFC).

11 . The system of claim 1 , wherein the reservoir comprises a medicament, the medicament being selected from the group consisting of: TNF inhibitors, antibodies to the calcitonin gene-related peptide receptor, granulocyte colony stimulating factors, erythropoiesis stimulating agents, apelin receptor agonists, antibodies to proprotein convertase subtilisin/kexin Type 9 (PCSK9), and tissue inhibitors of metalloproteinases.

12 . A method of using a system comprising a drug delivery device and an external computing system, the drug delivery device comprising a reservoir, a stopper movably disposed in the reservoir, at least one sensor configured to monitor movement of the stopper in the reservoir, and a delivery member having a proximal end in fluid communication or configured to be in fluid communication with the reservoir and a distal end configured to be received within a patient, the external computing device comprising a memory, the method comprising:
determining at least one of a condition or an operational state of the drug delivery device; transmitting a communication representative of at least one of the condition or the operational state from the drug delivery device; receiving the communication from the drug delivery device at the external computing device; processing the communication received from the drug delivery device according to information stored in the memory of the external computing device; and displaying, by the external computing device, at least one of an instructional prompt or an informational prompt based on the communication received from the drug delivery device, wherein the at least one of an instructiona

Assignees

• Amgen Inc

Inventors

• Mccullough Adam B
• Taha Basel Hasan
• Ward Jimmie L
• Folk Christopher R
• Badelt Steven William
• Tamtoro Ferry
• Yang Huaying
• Lee Mark Ka Lai
• Yin Desheng
• Gibson Scott R
• Busby Donald
• Shultz Peter V
• Kogler Keith P

Classifications

• G06Q10/40

  Business processes related to social networking or social networking services · CPC title

• A61M2205/3576

  with non implanted data transmission devices, e.g. using external transmitter or receiver · CPC title

• A61M5/3257

  Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means · CPC title

• A61M5/3202

  Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001) · CPC title

• A61M5/24

  Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic {(ampoules or carpules A61J1/06)} · CPC title