IP Library Granted Patent US 12,290,667
Granted Patent B2
US 12,290,667 · App. 17/806,881 · Granted May 6, 2025

Therapy assist information and/or tracking device and related methods and systems

Inventors: John Sjolund (Los Altos, CA); Ambika Srinath (San Francisco, CA); Andrew Bochenko (Redwood City, CA); George Crothall (Oceanside, CA); Bryan Mazlish (Palo Alto, CA); Lane Desborough (Thousand Oaks, CA); Jennifer Martin Block (Menlo Park, CA); Sarah Matarese (San Jose, CA); Linda Mackowiak (Cazenovia, NY)
Assignee: Bigfoot Biomedical, Inc.
A61M5/31546A61B5/0004A61B5/14532A61B5/4836A61B5/4839A61B5/7405A61B5/7435A61B5/7455A61B5/746A61K38/28A61M5/003A61M5/168A61M5/20A61M5/31525A61M5/3202G16H20/13G16H20/17G16H20/60G16H40/63G16H40/67G16H50/20G16H50/30A61B5/14546A61B5/681A61M2005/14208A61M2005/2006A61M5/24A61M2005/3125A61M2205/18A61M2205/3306A61M2205/3561A61M2205/3584A61M2205/502A61M2205/505A61M2205/581A61M2205/582A61M2205/583A61M2209/06A61M2230/201
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Quick Facts
Patent No.
US 12,290,667
App. No.
17/806,881
Granted
May 6, 2025
Kind
B2
Abstract

A monitoring feature, such as, for example, a pen cap, for an insulin delivery device may include at least one circuit adapted to detect at least one of a capping or decapping of the pen cap from an insulin pen and a processor for using information to the at least one of a capping or decapping of the pen cap. A monitoring feature for an insulin delivery device includes at least one circuit adapted to detect use of the insulin delivery device.

Claims (118)

1. An accessory for an insulin pen, the accessory comprising:

at least one user interface to display a time since at least one of a capping or decapping of the accessory via one or more indicators; and

a controller comprising:

at least one processor; and

at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the controller to:

detect at least one of a capping or a decapping of the accessory from an insulin pen; and

responsive to the accessory being capped on or uncapped from the insulin pen, determine a missed dose.

2. The accessory of claim 1 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

output an alarm based on the missed dose.

3. The accessory of claim 2 , wherein the alarm comprises a missed long-acting dose alarm or a missed rapid-acting dose alarm.

4. The accessory of claim 1 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

output a notification based on the missed dose.

5. The accessory of claim 4 , wherein the notification comprises coaching for a user based on the missed dose.

6. The accessory of claim 1 , further comprising an adapter configured to couple the accessory to the insulin pen.

7. The accessory of claim 1 , wherein the accessory comprises a pen cap.

8. The accessory of claim 4 , wherein the notification comprises a time and a dose amount for a correction dose.

9. The accessory of claim 1 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

receive glucose data from a glucose monitor.

10. The accessory of claim 9 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

automatically display the received glucose data.

11. The accessory of claim 1 , wherein the accessory is configured to be utilized with one or more of a long-acting insulin pen or a rapid-acting insulin pen.

12. The accessory of claim 1 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

receive patient-specific therapy parameters from one or more of an application operating on a remote device or manually.

13. The accessory of claim 12 , wherein the patient-specific therapy parameters comprise one or more of dose parameters or timing parameters.

14. The accessory of claim 12 , wherein the patient-specific therapy parameters are received from a healthcare provider device.

15. The accessory of claim 1 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

communicate one or more of capping and uncapping data to an application on a remote device.

16. The accessory of claim 1 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

communicate one or more of capping and uncapping data to an application on a remote device via a BLUETOOTH communication protocol.

17. The accessory of claim 1 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

wirelessly pair the accessory with a remote device.

18. The accessory of claim 1 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

responsive to the accessory being capped on or uncapped from the insulin pen for at least a threshold period of time, infer a dosing event.

19. The accessory of claim 1 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

responsive to the accessory being capped on or uncapped from the insulin pen for less than a threshold period of time, determine that a dosing event has not occurred.

20. The accessory of claim 1 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

receive a manual input indicating a dosing event; and

communicate dosing data to a remote device associated with the dosing event.

21. The accessory of claim 1 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

cause the one or more indicators to represent a notification that active insulin remains within a user based on a time of a previous capping or decapping of the accessory and a current time.

22. The accessory of claim 21 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

determine a time associated with a previous capping or decapping of the accessory; and

cause the one or more indicators to disable display of a recommended dose based on a current time and the time associated with the previous capping or decapping of the accessory.

23. A pen cap for an insulin delivery device comprising:

at least one user interface comprising at least one indicator for indicating a time since at least one of a capping or decapping of the pen cap; and

a controller comprising:

at least one processor; and

at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the pen cap to:

detect motion of the pen cap; and

responsive to the pen cap being capped on or uncapped from the unsulin delivery device, determine a missed dose.

24. The pen cap of claim 23 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

output an alarm based on the missed dose.

25. The pen cap of claim 24 , wherein alarm comprises a missed long-acting dose alarm or a missed raid-acting dose alarm.

26. The pen cap of claim 23 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

output a notification based on the missed dose.

27. The pen cap of claim 26 , wherein the notification comprises coaching for a user based on the missed dose.

28. The pen cap of claim 23 , further comprising an adapter configured to couple the pen cap to the insulin delivery device.

29. The pen cap of claim 23 , wherein the pen cap comprises a universal pen cap usable with multiple insulin delivery devices.

30. The pen cap of claim 26 , wherein the notification comprises a time and a dose amount for a correction dose.

31. The pen cap of claim 23 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

receive glucose data from a glucose monitor.

32. The pen cap of claim 31 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

automatically display the received glucose data.

33. The pen cap of claim 23 , wherein the pen cap is configured to be utilized with one or more of a long-acting insulin pen or a rapid-acting insulin pen.

34. The pen cap of claim 23 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

receive patient-specific therapy parameters from one or more of an application operating on a remote device or manually.

35. The pen cap of claim 34 , wherein the patient-specific therapy parameters comprise one or more of dose parameters or timing parameters.

36. The pen cap of claim 34 , wherein the patient-specific therapy parameters are received from a healthcare provider device.

37. The pen cap of claim 23 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

communicate one or more of capping and uncapping data to an application on a remote device.

38. The pen cap of claim 23 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

communicate one or more of capping and uncapping data to an application on a remote device via a BLUETOOTH communication protocol.

39. The pen cap of claim 23 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

wirelessly pair the pen cap with a remote device.

40. The pen cap of claim 23 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

responsive to the pen cap being capped on or uncapped from the insulin delivery device for at least a threshold period of time, infer a dosing event.

41. The pen cap of claim 23 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

responsive to the pen cap being capped on or uncapped from the insulin delivery device for less than a threshold period of time, determine that a dosing event has not occurred.

42. The pen cap of claim 23 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

receive a manual input indicating a dosing event; and

communicate dosing data to a remote device associated with the dosing event.

43. The pen cap of claim 23 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

cause the at least one indicator to represent a notification that active insulin remains within a user based on a time of a previous capping or decapping of the pen cap and a current time.

44. The pen cap of claim 43 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

determine a time associated with a previous capping or decapping of the pen cap; and

cause the at least one indicator to disable display of a recommended dose based on a current time and the time associated with the previous capping or decapping of the pen cap.

45. A method of delivering insulin, comprising:

detecting at least one of a capping or decapping of a pen cap from an insulin pen; and

responsive to the pen cap being capped on the insulin pen, determine a missed dose.

46. The method of claim 45 , further comprising outputting an alarm based on the missed dose.

47. The method of claim 45 , further comprising outputtng a notification based on the missed dose.

48. The method of claim 47 , wherein outputting the notification comprises outputting coaching for a user based on the missed dose.

49. A system for managing insulin therapy of a person with diabetes (PWD), the system comprising:

a mobile device comprising an insulin therapy management application; and

an accessory for an insulin delivery device and in wireless communication with the insulin therapy management application of the mobile device, the accessory comprising:

a user interface to display one or more indicators indicating a time since at least one of a capping or decapping of the accessory; and

a controller comprising:

at least one processor; and

at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the controller to:

detect at least one of a capping or a decapping of the accessory from the insulin delivery device; and

responsive to the accessory being capped on or uncapped from the insulin delivery device, determine a missed dose.

50. The system of claim 49 , wherein the insulin therapy management application is configured to provide a dose reminder when at least one of a capping or a decapping of the accessory has not been detected within a given time period.

51. The system of claim 50 , wherein the dose reminder is provided via one or more of an audible alert, a haptic alert, or a visual alert.

52. The system of claim 51 , wherein the visual alert comprises a push notification.

53. The system of claim 49 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

output an alarm based on the missed dose.

54. The system of claim 53 , wherein the alarm comprises a missed long-acting dose alarm or a missed rapid-acting dose alarm.

55. The system of claim 49 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

output a notification based on the missed dose.

56. The system of claim 55 , wherein the notification comprises coaching for a user based on the missed dose.

57. The system of claim 55 , notification comprises a time and a dose amount for a correction dose.

58. The system of claim 49 , wherein the insulin therapy management application is configured to update settings of the accessory.

59. The system of claim 49 , wherein the accessory comprises a battery.

60. The system of claim 49 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

require a manual override to log a dosing event during a threshold period of time.

61. The system of claim 49 , further comprising instructions that, when executed by the at least one processor, cause the controller to:

disregard capping or decapping events of less than 8 seconds.

62. The system of claim 49 , wherein the insulin delivery device comprises an insulin pen, and wherein the accessory comprises a pen cap.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2024
From: SJOLUND, JOHN; SRINATH, AMBIKA; BOCHENKO, ANDREW; CROTHALL, GEORGE; MAZLISH, BRYAN; DESBOROUGH, LANE; BLOCK, JENNIFER MARTIN; MATARESE, SARAH; MACKOWIAK, LINDA
To: BIGFOOT BIOMEDICAL, INC.
Reel/Frame 068660/0277 →
SECURITY INTEREST Recorded Sep 23, 2024
From: BIGFOOT BIOMEDICAL, INC.
To: MADRYN HEALTH PARTNERS, LP
Reel/Frame 069019/0142 →
SECURITY INTEREST Recorded Sep 23, 2024
From: MADRYN HEALTH PARTNERS, LP
To: MADRYN FUND ADMINISTRATION, LLC
Reel/Frame 069019/0188 →
RELEASE OF SECURITY INTEREST Recorded Sep 23, 2024
From: MADRYN FUND ADMINISTRATION, LLC
To: BIGFOOT BIOMEDICAL, INC.
Reel/Frame 069019/0346 →
Continuity (7)
Continuation 17303748 · Jun 7, 2021
Continuation 16218026 · Dec 12, 2018
Provisional Application 62682872 · Jun 9, 2018
Provisional Application 62628808 · Feb 9, 2018
Provisional Application 62597868 · Dec 12, 2017
Provisional Application 62597809 · Dec 12, 2017
Related Publication 20220305207A1 · Sep 29, 2022
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