Researchers Submit Patent Application, “Systems And Methods For Remotely Processing Data Collected By A Drug Delivery Device”, for Approval (USPTO 20230201461): Patent Application

2023 JUL 13 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- From Washington, D.C., NewsRx journalists report that a patent application by the inventors Badelt, Steven William (Los Angeles, CA, US); Busby, Donald (Thousand Oaks, CA, US); Folk, Christopher R. (San Diego, CA, US); Gibson, Scott R. (Thousand Oaks, CA, US); Kogler, Keith P. (Simi valley, CA, US); Lee, Mark Ka Lai (Newbury Park, CA, US); McCullough, Adam B. (Westlake Village, CA, US); Shultz, Peter V. (Woodland Hills, CA, US); Taha, Basel Hasan (Westlake Village, CA, US); Tamtoro, Ferry (San Ramon, CA, US); Ward, Jimmie L. (Camarillo, CA, US); Yang, Huaying (Vernon Hills, IL, US); Yin, Desheng (Thousand Oaks, CA, US), filed on February 17, 2023, was made available online on June 29, 2023.

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: “The present disclosure generally concerns systems and methods for use with drug delivery devices and relating to the processing of sensor data collected by the drug delivery devices to determine their condition and/or operational state and improve their usability for patients and other users.

“Drugs can be administered through the use of drug delivery devices, such as autoinjectors or on-body injectors or infusers. These devices may replace older delivery systems using the combination of a syringe and a vial containing the drug or medicament, or a pre-filled syringe. Autoinjectors and on-body injectors may be used to automate the injection and delivery or administration process, thereby simplifying the process for certain patient groups or sub-groups for which use of the syringe/vial combination or pre-filled syringe systems is disadvantageous, whether because of physiological or psychological impediments.

“Even with the use of drug delivery devices, such as autoinjectors, patients may experience challenges during the initial use of the drug delivery device after they have been prescribed a drug that is delivered or administered through the use of a drug delivery device. For example, the user may be uncertain whether the injection should be delayed after a drug delivery device has been removed from cold storage, such as in a refrigerator, and if the injection should be delayed, how long it should be delayed. Additionally, the user may be uncertain whether the medication inside the drug delivery device is the medication prescribed for them. Further, the user may be uncertain whether the medication has expired. Still further, the user may also be uncertain if the actions and their sequence necessary to correctly operate the drug delivery device.

“In addition, the condition and use of drug delivery devices is of importance to other parties, such as drug device manufacturers, pharmacies, health care providers and insurers. For instance, information regarding the condition of the drug delivery device along the supply chain may be relevant to whether the drug delivery device will be in good working order when it arrives for use with the patient. Information regarding the location of the drug delivery device along the supply chain may be relevant to the manufacturer and the pharmacy to ensure that adequate supplies are available for the pharmacy to delivery to the user. The compliance information mentioned above may be important to the healthcare providers and insurers, as well as to the patient, because compliance with a therapy regimen may have a direct impact on the success of the therapy.

“To address some of the foregoing challenges, it is possible to include one or more sensors onboard the drug delivery device to monitor its condition and use. However, the analysis, storage, communication and other processing of sensor data collected by the one or more sensors may require the use of relatively expensive computer hardware including microprocessors, memories, Internet-accessible communication modules, etc. Since the drug delivery device may be a disposable, single-use device, or otherwise have a limited lifespan, it may be undesirable from an economic perspective to incorporate such expensive computer hardware into the drug delivery device itself.

“As set forth in more detail below, the present disclosure sets forth various systems and methods that embody advantageous alternatives to existing drug delivery systems and methods, and that may address one or more of the challenges or needs mentioned above.”

As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors’ summary information for this patent application: “According to an aspect of the disclosure, a system includes a drug delivery device and an external computing device. The drug delivery device may include a reservoir, a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient, one or more sensors configured to generate sensor data representative of at least one of a condition or an operational state of the drug delivery device, and a first communication module coupled to the one or more sensors and configured to transmit the sensor data. The external computing device may include a second communication module configured to receive the sensor data from the first communication module, a processor coupled to the second communication module, and a memory coupled to the processor. The memory may store non-transitory computer-readable instructions that, when executed by the processor, cause the processor to determine at least one of the condition or the operational state of the drug delivery device based on the sensor data.

“According to another aspect of the disclosure, a system includes a drug delivery device and an external computing device. The drug delivery device may include a reservoir, a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient, one or more sensors, a first communication module, and a first controller coupled to the one or more sensors and the first communication module. The first controller may be 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 the condition or the operational state of the drug delivery device. The external computing device may include a second communication module configured to receive the communication from the first communication module, a display, a memory, and a second controller coupled to the display, the memory, and the second communication module. The second controller may be configured to control the display to display at least one of an instructional prompt or an informational prompt based on the communication from the first communication module.

“According to yet another aspect of the disclosure, a method of using a system comprising a drug delivery device and an external computing device is provided. The drug delivery device may include a reservoir, a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient, one or more sensors configured to generate sensor data, and a first communication module. The external computing device may include a memory and a second communication module. The method may include: (a) collecting sensor data with the drug delivery device; (b) transmitting the sensor data from the drug delivery device with the first communication module; © receiving the sensor data from the drug delivery device at the external computing device with the second communication module; and (d) determining, with the external computing device, at least one of a condition or an operational state of the drug delivery device based on the sensor data.

“According to still another aspect of the disclosure, a method of using a system comprising a drug delivery device and an external computing device is provided. 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 external computing device may include a memory. The method may include: (a) determining at least one of a condition or an operational state of the drug delivery device; (b) transmitting a communication representative 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; and (d) processing the communication received from the drug delivery device according to information stored in the memory of the external computing device.”

The claims supplied by the inventors are:

“1. A system comprising: a drug delivery device comprising: a 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; 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.

“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 the 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 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; and processing the communication received from the drug delivery device according to information stored in the memory of the external computing device.

“13. The method of claim 12, comprising displaying at least one of an instructional prompt or an informational prompt according to: (i) the communication received from the drug delivery device, and (ii) the information stored in the memory of the external computing device.

“14. The method of claim 12, wherein the determining of the at least one of the condition or the operational state of the drug delivery device comprises determining, with the drug delivery device, a temperature or a temperature history of the drug delivery device based on the sensor data.

“15. The method of claim 14, comprising: comparing the temperature or the temperature history of the drug delivery device to the 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, displaying an instructional prompt instructing a user to dispose the drug delivery device on or against a skin of the patient.

“16. The method of claim 17, the determining of the at least one of the condition or the operational state of the drug delivery device comprising determining, with the drug delivery device, if the drug delivery device is disposed on or against a skin of a patient based on the sensor data.

“17. The method of claim 16, comprising, in response to a determination that the drug delivery device is disposed on or against the skin of the patient, displaying an instructional prompt instructing a user to correctly orient the drug delivery device relative to the skin of the patient.

“18. The method of claim 17, the determining of the at least one of the condition or the operational state of the drug delivery device comprising determining, with the drug delivery device, an orientation of the drug delivery device based on the sensor data.

“19. The method of claim 18, comprising: comparing the orientation of the drug delivery device to the information stored in the memory of the external computing device to determine if the orientation of the drug delivery device relative to a skin of a patient is acceptable; and in response to a determination that the orientation of the drug delivery device is acceptable, displaying an instructional prompt instructing a user to actuate the drug delivery device.

“20. The method of claim 17, the determining of the at least one of the condition or the operational state of the drug delivery device comprising determining, with the drug delivery device, if the drug delivery device has been actuated by a user based on the sensor data.

“21. The method of claim 20, comprising, in response to a determination that the drug delivery device has been actuated by the user, displaying an instructional prompt instructing a user to wait for completion of a delivery of a medicament from the reservoir to the patient.”

There are additional claims. Please visit full patent to read further.

For additional information on this patent application, see: Badelt, Steven William; Busby, Donald; Folk, Christopher R.; Gibson, Scott R.; Kogler, Keith P.; Lee, Mark Ka Lai; McCullough, Adam B.; Shultz, Peter V.; Taha, Basel Hasan; Tamtoro, Ferry; Ward, Jimmie L.; Yang, Huaying; Yin, Desheng. Systems And Methods For Remotely Processing Data Collected By A Drug Delivery Device. U.S. Patent Application Number 20230201461, filed February 17, 2023 and posted June 29, 2023. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(20230201461)&db=US-PGPUB&type=ids

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