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EP-4281145-B1 - STATUS SENSING SYSTEMS FOR CONNECTED INJECTION DEVICE

EP4281145B1EP 4281145 B1EP4281145 B1EP 4281145B1EP-4281145-B1

Inventors

  • PATEL, HEMANT THAKORBHAI
  • SOMLAI, Louis Stevens
  • WIESLER, Adam Nathaniel

Dates

Publication Date
20260506
Application Date
20220218

Claims (15)

  1. A drug-delivery system comprising: a device housing (38) defining an interior volume and an opening (83) in communication with the interior volume; a syringe assembly (22) at least partially disposed within the interior volume, the syringe assembly (22) including a barrel (30) configured to hold a medication and an injection needle (34) extending from the barrel (30); a drive mechanism (24) configured to initiate a dispensing event in which the syringe assembly (22) ejects the medication from the injection needle (34) when the injection needle (34) extends at least partially out of the opening (83); one or more skin contact sensors (122, 123, 124) disposed on the housing adjacent to the opening (83), each skin contact sensor (122, 123, 124) configured to detect contact with skin tissue; one or more syringe assembly sensors (112, 116, 118, 1710, 2012) disposed within the housing configured to output a syringe assembly sensor signal based on at least one of a position of at least part of the syringe assembly (22) and movement of at least part of the syringe assembly (22); and one or more processing circuits (2008) configured to: determine when the one or more skin contact sensors (122, 123, 124) detect contact with skin tissue; determine, based at least in part on the syringe assembly sensor signal, when the syringe assembly (22) initiates the dispensing event, measure a first time duration between when the one or more skin contact sensors (122, 123, 124) detect contact with skin tissue and when the syringe assembly (22) initiates the dispensing event, compare the first time duration against a first pre-programmed threshold time duration, and generate a first user indication signal when the first time duration is greater than the first threshold time duration.
  2. The drug-delivery system of claim 1, wherein: the syringe assembly further comprises a piston (32) configured to slide along a longitudinal axis within the barrel (30) to force the medication out of the injection needle (34); the syringe assembly sensor signal is based on a position of the piston (32); and the one or more processing circuits are configured to determine when the syringe assembly (22) has initiated the dispensing event based on the position of the piston (32).
  3. The drug-delivery system of claim 1, wherein the drive mechanism is configured to move the syringe assembly (22) from a storage position to an injection position in which the injection needle (34) extends at least partially out of the opening (83).
  4. The drug-delivery system of claim 3, wherein the one or more processing circuits are configured to determine when the syringe assembly (22) has initiated the dispensing event by determining when the syringe assembly (22) has moved from the storage position to the injection position, optionally wherein the one or more syringe assembly sensors comprise a syringe position detector switch (1710).
  5. The drug-delivery system of claim 4, wherein the one or more syringe assembly sensors comprise an accelerometer (2012) configured to output the syringe assembly sensor signal based on a sensed acceleration caused by movement of the syringe assembly (22); and the one or more processing circuits are configured to determine when the syringe assembly (22) has initiated the dispensing event based at least in part on the sensed acceleration.
  6. The drug-delivery system of any of claims 1-5, wherein at least one of the one or more processing circuits is disposed: within the device housing (38); and/or within a mobile device (1250) separate from the device housing (38) and in wireless communication with a wireless transmitter disposed within the device housing (38).
  7. The drug-delivery system of claim 1-6, wherein the one or more processing circuits are further configured to: display or play instructions on how to use the drug-delivery system in response to the first user indication signal; and/or transmit the first user indication signal over a network to a remote device.
  8. The drug-delivery system of any of claims 1-7, wherein the one or more processing circuits are further configured to: determine, based at least in part on the syringe assembly sensor signal, when the syringe assembly (22) completes the dispensing event; determine when the one or more skin contact sensors (122, 123, 124) stop detecting contact with skin tissue; measure a second time duration between when the syringe assembly (22) completes the dispensing event and when the one or more skin contact sensors (122, 123, 124) stop detecting contact with skin tissue; compare the second time duration against a second pre-programmed threshold time duration; and generate a second user indication signal when the second time duration is greater than the second threshold time duration.
  9. The drug-delivery system of claim 8, wherein the one or more processing circuits are further configured to: display or play instructions on how to determine when the syringe assembly has completed the dispensing event in response to the second user indication signal; and/or transmit the second user indication signal over a network to a remote device.
  10. The drug-delivery system of any of claims 1-9, wherein the barrel (30) holds the medication.
  11. A method for generating indications regarding a use of a drug-delivery device, the device comprising a device housing (38) defining an interior volume and an opening (83) in communication with the interior volume, a syringe assembly (22) at least partially disposed within the interior volume, the syringe assembly including a barrel (30) configured to hold a medication and an injection needle (34) extending from the barrel (30), a drive mechanism (24) configured to initiate a dispensing event in which the syringe assembly (22) ejects the medication from the injection needle (34) when the injection needle (34) extends at least partially out of the opening (83), one or more skin contact sensors (122, 123, 124) disposed on the housing adjacent to the opening (83), each skin contact sensor (122, 123, 124) configured to detect contact with skin tissue, and one or more syringe assembly sensors (112, 116, 118, 1710, 2012) disposed within the device housing (38) configured to output a syringe assembly sensor signal based on at least one of a position of at least part of the syringe assembly (22) and movement of at least part of the syringe assembly (22), the method comprising: determining when the one or more skin contact sensors (122, 123, 124) detect contact with skin tissue; determining, based at least in part on the syringe assembly sensor signal, when the syringe assembly (22) initiates the dispensing event; measuring a first time duration between when the at least one skin contact sensor (122, 123, 124) detect contact with skin tissue and when the syringe assembly (22) initiates the dispensing event; comparing the first time duration against a first pre-programmed threshold time duration; and generating a first user indication signal when the first time duration is greater than the first threshold time duration.
  12. The method of claim 11, further comprising: displaying or playing instructions on how to use the drug-delivery device in response to the first user indication signal; and/or transmitting the first user indication signal over a network to a remote device.
  13. The method of any of claims 11-12, further comprising: determining, based at least in part on the syringe assembly sensor signal, when the syringe assembly (22) completes the dispensing event; determining when the one or more skin contact sensors (122, 123, 124) stop detecting contact with skin tissue; measuring a second time duration between when the syringe assembly (22) completes the dispensing event and when the one or more skin contact sensors (122, 123, 124) stop detecting contact with skin tissue; comparing the second time duration against a second pre-programmed threshold time duration; and generating a second user indication signal when the second time duration is greater than the second threshold time duration.
  14. The method of claim 13, further comprising: displaying or playing instructions on how to determine when the syringe assembly (22) has completed the dispensing event in response to the second user indication signal; and/or transmitting the second user indication signal over a network to a remote device.
  15. Non-transitory, computer-readable media storing instructions that, when executed by at least one processing circuit, are operable to cause the at least one processing circuit to implement the method of any of claims 11-14.

Description

BACKGROUND The present disclosure relates to medication delivery devices, and in particular, to status sensing systems used in connected medication delivery devices. Injection devices in the form of a syringe or which include a syringe are widely employed by medical professionals and patients who self-medicate. Patients suffering from a number of different diseases frequently must inject themselves with medication and a variety of devices have been developed to facilitate such self-medication. In one example, the use of an automatic injection device which includes mechanisms to perform some of the steps of the injection process renders it more convenient for a patient to self-medicate particularly by patients with limited manual dexterity. Automatic injection devices are typically a single use device that is disposed after use. WO 2020/072299 A1 discloses an injection device assembly including a housing, a syringe, a drive mechanism and one or more sensing systems. The drive mechanism advances the syringe from a storage position to an injection position, and a plunger advances the syringe piston from an initial position to a final position. The status sensing system may include one or more main PCB(s) disposed in an end portion of the injection device assembly's housing. The system may determine various parameters related to an operational status of the injection device, including the location of the device components, an amount of medication remaining in the device, a temperature of the medication, and whether or not the device is properly contacting the user's skin before injection. The system may communicate such determined parameters to an external device via a wireless communication link. SUMMARY The scope of the invention is defined in the appended claims. Any "aspect", "example" and "embodiment" of the description not falling within the scope of the claims does not form part of the invention and is provided for illustrative purposes only. In some exemplary embodiments, a drug-delivery system is provided comprising: a device housing defining an interior volume and an opening in communication with the interior volume; a syringe assembly at least partially disposed within the interior volume, the syringe assembly including a barrel configured to hold a medication and an injection needle extending from the barrel; a drive mechanism configured to initiate a dispensing event in which the syringe assembly ejects the medication from the injection needle when the injection needle extends at least partially out of the opening; one or more skin contact sensors disposed on the housing adjacent to the opening, each skin contact sensor configured to detect contact with skin tissue; one or more syringe assembly sensors disposed within the housing configured to output a syringe assembly sensor signal based on at least one of a position of at least part of the syringe assembly and movement of at least part of the syringe assembly; and one or more processing circuits configured to: determine when the one or more skin contact sensors detect contact with skin tissue; determine, based at least in part on the syringe assembly sensor signal, when the syringe assembly initiates the dispensing event, measure a first time duration between when the one or more skin contact sensors detect contact with skin tissue and when the syringe assembly initiates the dispensing event, compare the first time duration against a first pre-programmed threshold time duration, and generate a first user indication signal when the first time duration is greater than the first threshold time duration. In some exemplary embodiments, a drug-delivery system is provided comprising: a device housing defining an interior volume and an opening in communication with the interior volume; a syringe assembly at least partially disposed within the interior volume, the syringe assembly including a barrel configured to hold a medication and an injection needle extending from the barrel; a movable basecap configured to cover the opening; one or more syringe assembly sensors configured to detect at least one of a position of at least part of the syringe assembly and movement of at least part of the syringe assembly; one or more basecap sensors configured to detect when the moveable basecap has been removed from the opening; and one or more processing circuits configured to: determine, based on data output from the one or more syringe assembly sensors, when the syringe assembly initiates a dispensing event, and generate a mis-use indication signal when the one or more basecap sensors detect that the moveable basecap has been removed from the opening and then subsequently replaced to cover the opening before the syringe assembly initiates the dispensing event. In some exemplary embodiments, a drug-delivery system is provided comprising: a device housing defining an interior volume and an opening in communication with the interior volume; a syringe assembly at least