MEDICAMENT DELIVERY DEVICES WITH WIRELESS CONNECTIVITY AND EVENT DETECTION

• US 20180204636A1
• Filed: 01/16/2018
• Published: 07/19/2018
• Est. Priority Date: 01/17/2017
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: EDWARDS, Eric S., EDWARDS, Evan T., MEYERS, Paul F., BRIGGS, Samuel Jefferson, PERKINS, George McGee, VAN WYK, Eugene Johannes, BURKE, Mitchell Frederick, SCAMMELL, Eric William
• Granted Patent: US 10,332,623 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A computer-implemented method includes establishing a communications link, via a short-range wireless protocol, between a mobile computing device and a medicament delivery device. A user input selecting a motion profile of the medicament delivery device is then received in response to an input prompt. A wireless signal is received from the medicament delivery device, the wireless signal associated with an actual motion profile of the medicament delivery device. A notification is produced to indicate a motion difference between the actual motion profile and the target motion profile. In some embodiments, the method optionally includes modifying the target motion profile based on the motion profile over a time period of at least one week, the notification indicating a motion difference between the motion profile and the modified target motion profile.

Claims

1. A computer-implemented method, comprising:

establishing a communications link, via a short-range wireless protocol, between a mobile computing device and a medicament delivery device;

receiving, in response to an input prompt, a user input selecting a target motion profile of the medicament delivery device;

receiving, from the medicament delivery device, a wireless signal associated with an actual motion profile of the medicament delivery device;

analyzing the actual motion profile to determine if a magnitude of the actual motion profile is outside of a threshold associated with the target motion profile; and

producing a notification when the magnitude of the actual motion profile is outside of the threshold.

2. The computer-implemented method of claim 1;

wherein;

the target motion profile includes one of an on-person motion profile or a fixed location motion profile; and

the actual motion profile includes in any of a position, a velocity, an acceleration, or an orientation of the medicament delivery device during a time period.

3. The computer-implemented method of claim 2, wherein the time period is at least one week, the method further comprising:

modifying the target motion profile based on the motion profile over the time period, the notification indicating a motion difference between the motion profile and the modified target motion profile.

4. The computer-implemented method of claim 2, wherein the time period is at least 24 hours.

5. The computer-implemented method of claim 2, wherein:

the magnitude of the actual motion profile includes an amount of a change in the position of the medicament delivery device during the time period; and

the notification indicates that the magnitude is outside of the threshold associated with the target motion profile.

6. The computer-implemented method of claim 1, wherein the wireless signal is a first wireless signal and the notification is a first notification, the method further comprising:

receiving, from the medicament delivery device, a second wireless signal to maintain the communications link, the second wireless signal being periodic;

determining, based on the second wireless signal, a relative position between the mobile computing device and the medicament delivery device; and

producing a second notification when the relative position exceeds a relative position threshold.

7. The computer-implemented method of claim 6, wherein:

the producing the second notification includes producing the second notification when the second wireless signal is not received within a time period, and producing the second notification after the producing the first notification.

8. The computer-implemented method of claim 1, wherein the medicament delivery device is any one of an auto-injector, a pen injector, a medication pump, a prefilled syringe, a nasal delivery device or an inhaler.

9. The computer-implemented method of claim 1, wherein the medicament delivery device is a first medicament delivery device, the input prompt is a first input prompt, the user input is a first user input, the wireless signal is a first wireless signal, the target motion profile of the first medicament delivery device is an on-person motion profile, and the notification is a first notification indicating that a change in a position of the first medicament delivery device during a time period is below the threshold associated with the on-person motion profile, the method further comprising:

establishing a second communications link, via the short-range wireless protocol, between the mobile computing device and a second medicament delivery device;

receiving, in response to a second input prompt, a second user input selecting a fixed location motion profile for the second medicament delivery device;

receiving, from the second medicament delivery device, a second wireless signal associated with an actual motion profile of the second medicament delivery device; and

suppressing a second notification indicating that a change in a position of the second medicament delivery device during a time period is below the threshold associated with the on-person motion profile.

10. The computer-implemented method of claim 1, wherein the wireless signal is a first wireless signal and the notification is a first notification, the method further comprising:

receiving, from the medicament delivery device, a second wireless signal associated with a temperature profile of the medicament delivery device; and

producing a second notification when the temperature profile is outside of a predetermined temperature range.

11. The computer-implemented method of claim 1, wherein the wireless signal is a first wireless signal and the notification is a first notification, the method further comprising:

receiving, from the medicament delivery device, a second wireless signal associated with a temperature profile of the medicament delivery device, the notification is based on both the motion difference and a temperature difference between the temperature profile and a predetermined temperature range.

12. The computer-implemented method of claim 1, wherein the producing the notification is performed by a first application that is executed by a processor of the mobile computing device, the wireless signal is a first wireless signal and the notification is a first notification, the method further comprising:

receiving, from the medicament delivery device, a second wireless signal associated with a temperature profile of the medicament delivery device;

receiving, from a second application executed by the processor of the mobile computing device, a temperature information;

determining, within the first application and based on the temperature information received from the second application, a temperature range; and

producing a second notification when the temperature profile is outside of the temperature range.

13. A computer-implemented method, comprising:

transmitting, from a radio of an electronic circuit system associated with a medicament delivery device, a first wireless signal to establish a communications link between a mobile computing device and the medicament delivery device;

receiving, from a sensor of the electronic circuit system, a motion signal associated with at least one of a position, a velocity, an acceleration, or an orientation of the medicament delivery device;

storing, in a memory of the electronic circuit system, a motion profile of the medicament delivery device, the motion profile including the motion signal received during a time period; and

transmitting, from the radio, a second wireless signal associated with the motion profile of the medicament delivery device.

14. The computer-implemented method of claim 13, wherein the time period is at least one week, the method further comprising:

producing, via a predictive module implemented in at least one of the memory or a processing device of the electronic circuit system, a target motion profile based on the motion profile over the time period;

storing, in the memory of the electronic circuit system, a motion difference between the motion profile at a first time and the target motion profile; and

transmitting, from the radio, a third wireless signal associated with the motion difference.

15. The computer-implemented method of claim 13, wherein:

the electronic circuit system is coupled to at least one of a housing of the medicament delivery device or a cover configured to receive at least a portion of the medicament delivery device, the medicament delivery device including a medicament container within the housing; and

the sensor is an accelerometer that detects at least one of the position, the velocity, the acceleration, or the orientation of at least one of the housing or the cover.

16. The computer-implemented method of claim 13, wherein the motion profile of the medicament delivery device is produced by a motion module including at least one of the sensor, an amplifier, a filter, or an analog to digital converter.

17. The computer-implemented method of claim 13, wherein the medicament delivery device includes an actuator configured to initiate delivery of a medicament, the sensor is a first sensor, and the electronic circuit system including a second sensor configured to produce an actuation signal in response to movement of the actuator, the method further comprising:

receiving, from the second sensor, the actuation signal; and

transmitting, from the radio, a third wireless signal associated with actuation of the medicament delivery device.

18. The computer-implemented method of claim 17, further comprising:

storing, in the memory of the electronic circuit system, an actuation profile of the medicament delivery device, the actuation profile including the actuation signal and a time stamp associated with the actuation signal.

19. The computer-implemented method of claim 17, wherein the second sensor is a switch configured to move between a first state and a second state.

20. The computer-implemented method of claim 14, wherein the electronic circuit system includes a removal sensor configured to produce a removal signal in response to removal of the portion of the medicament delivery device from the cover, the method further comprising:

receiving, from the removal sensor, the removal signal; and

transmitting, from the radio, a third wireless signal associated with removal of the portion of the medicament delivery device from the cover.

21. The computer-implemented method of claim 14, wherein the receiving the motion signal from the accelerometer is performed at a first sample rate, the electronic circuit system including a removal sensor configured to produce a removal signal in response to removal of the portion of the medicament delivery device from the cover, the method further comprising:

receiving, from the removal sensor, the removal signal; and

receiving the motion signal from the accelerometer at a second sample rate, the second sample rate greater than the first sample rate.

22. The computer-implemented method of claim 20, further comprising:

storing, in the memory of the electronic circuit system, a cover removal profile, the cover removal profile including the removal signal and a time stamp associated with the removal signal.

23. The computer-implemented method of claim 20, wherein the removal sensor is a switch configured to move between a first state and a second state.

24. An apparatus, comprising:

a medicament delivery device; and

an electronic circuit system coupled to at least one of a housing of the medicament delivery device or a cover configured to receive a portion of the medicament delivery device, the electronic circuit system including;

a sensor configured to produce a motion signal associated with at least one of a position, a velocity, an acceleration, or an orientation of at least one of the housing or the cover;

a motion module implemented in at least one of a memory or a processing device, the motion module configured to receive the motion signal and determine, based on the motion signal, a motion profile associated with the medicament delivery device; and

a radio configured to electronically communicate with a computing device via a short-range wireless communication protocol, the radio sending a first wireless signal to establish a communications link between the computing device and the medicament delivery device, the radio sending a second wireless signal associated with the motion profile of the medicament delivery device.

25. The apparatus of claim 24, wherein the medicament delivery device is any one of an auto-injector, a pen injector, a medication pump, a prefilled syringe, a nasal delivery device or an inhaler.

26. The apparatus of claim 24, wherein the sensor is an accelerometer that detects at least one of the position, the velocity, the acceleration, or the orientation of at least one of the housing or the cover.

27. The apparatus of claim 24, wherein the electronic circuit system further includes:

a predictive module implemented in at least one of the memory or the processing device, the predictive module configured to determine a target motion profile based on the motion profile received over a time period; and

a notification module implemented in at least one of the memory or the processing device, the notification module configured to produce a notification signal indicating a motion difference between the motion profile and the target motion profile,

the radio sending a third wireless signal associated with the notification signal.

28. The apparatus of claim 24, wherein:

the motion profile is a daily motion profile; and

the timer period at least a month.

29-64. -64. (canceled)