IP Library Granted Patent US 12,233,201
Granted Patent B2
US 12,233,201 · App. 16/906,651 · Granted Feb 25, 2025

Inhaler system

Inventors: Amir Zur (Cambridge, MA); Xinyu Liu (Winchester, MA); Mark Milton-Edwards (Cheshire, GB)
Assignee: Norton (Waterford) Limited
A61M15/0001A61B5/087A61M15/0025A61M15/009A61M2016/0024A61M2016/0027A61M16/14A61M2202/064A61M2205/3334A61M2205/3375A61M2205/505A61M2205/52A61M2205/581A61M2230/40G06F3/0488G06F3/167
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Quick Facts
Patent No.
US 12,233,201
App. No.
16/906,651
Granted
Feb 25, 2025
Kind
B2
Abstract

Provided is a system comprising an inhaler. The inhaler comprises a use determination system. The use determination system is configured to determine a parameter relating to airflow during a use of the inhaler by a subject. The use determination system also assigns a time to the use. The system also comprises a user interface, and a processing module. The processing module is configured to determine inhalation information from the parameter, and control the user interface to issue a notification that the inhalation information is available. The notification is issued at a notification time. The processing module is configured to implement a deliberate time delay such that the notification time is delayed relative to the time assigned to the use.

Claims (58)

1. A system comprising:

an external device comprising a processor, memory, and a transceiver; and

an inhaler comprising a medicament, a processor, memory, and a transmitter, the processor of the inhaler configured to:

determine a parameter relating to airflow during a use of the inhaler by a subject;

assign a time to the use; and

send, to the external device, the parameter relating to the airflow and the time of the use; and

wherein the processor of the external device is configured to:

receive the parameter relating to airflow and the time of the use;

determine inhalation information from the parameter relating to airflow; and

control a user interface to issue a notification at a notification time that the inhalation information is available, the processor of the external device configured to implement a deliberate time delay such that the notification time is delayed relative to the time assigned to the use, and wherein the time delay is a shorter deliberate time delay when the use of the inhaler by the subject is categorized as a no inhalation event or an excessive inhalation event as opposed to a low inhalation event or a good inhalation event.

2. The system of claim 1 , wherein the deliberate time delay is configured such that the notification time is at least 5 minutes after the time assigned to the use.

3. The system of claim 2 , wherein the deliberate time delay is configured such that the notification time is less than 48 hours after the time assigned to the use.

4. The system of claim 1 , wherein the processor of the external device is configured to assign a time-and-date stamp to the use based on the time of the use provided by the inhaler.

5. The system of claim 4 , wherein the deliberate time delay is configured such that the notification time is a predetermined time on a day which is subsequent to the day included in the time-and-date stamp.

6. The system of claim 4 , wherein the time to the use assigned by the inhaler is a relative count determined based on an internal counter of the inhaler, and wherein the external device of a server is configured to determine a local mean time based on the relative count.

7. The system of claim 1 , wherein the inhaler comprises a mechanical switch configured to be actuated prior to, during, or after use of the inhaler; and

wherein the inhaler comprises a pressure sensor or an acoustic sensor for detecting the parameter.

8. The system of claim 7 , wherein the inhaler comprises a mouthpiece through which the user performs an inhalation, and a mouthpiece cover, and wherein the mechanical switch is configured to be actuated when the mouthpiece cover is moved to expose the mouthpiece.

9. The system of claim 1 , wherein the inhalation information indicates one or more of:

the no inhalation event in which no inhalation is detected by the processor of the inhaler;

the low inhalation event in which an inhalation is detected by the processor of the inhaler, but the parameter relating to the airflow is equal to or lower than a first predetermined threshold;

the excessive inhalation event in which an inhalation is detected by the processor of the inhaler, but the parameter relating to the airflow is higher than a second predetermined threshold;

a fair inhalation event in which an inhalation is detected by the processor of the inhaler, and the parameter relating to the airflow is higher than the first predetermined threshold, lower than the second predetermined threshold, and equal to or lower than a third predetermined threshold, said third predetermined threshold being between the first and second predetermined thresholds; or

the good inhalation event in which an inhalation is detected by the processor of the inhaler, and the parameter relating to the airflow is equal to or lower than the second predetermined threshold and higher than the third predetermined threshold.

10. The system of claim 9 , wherein the parameter relating to the airflow is a value of peak inhalation flow, and wherein the first predetermined threshold is 30 liters per minute, the second predetermined threshold is 200 liters per minute, and the third predetermined threshold is 45 liters per minute.

11. The system of claim 9 , wherein the no inhalation event is recorded when no inhalation is detected by the processor of the inhaler following a predetermined time elapsing following actuation of a mechanical switch of the inhaler, the mechanical switch being configured to be actuated prior to, during, or after use of the inhaler.

12. The system of claim 1 , wherein the external device comprises a personal computer, a tablet computer, or a smart phone, and the user interface comprises a touch sensitive display screen of the external device.

13. The system of claim 1 , wherein the inhalation information comprises a peak inhalation flow, an inhalation volume, a time to peak inhalation flow, or an inhalation duration of the airflow during the use of the inhaler.

14. The system of claim 1 , wherein the inhalation information indicates an error message indicating that an air vent of the inhaler is blocked or obstructed during the use of the inhaler.

15. The system of claim 1 , wherein the inhalation information indicates a use error that occurred during the use of the inhaler by the subject.

16. The system of claim 1 , wherein the no inhalation event is characterized by no inhalation being detected by the processor of the inhaler, or is characterized by an inhalation being detected by the processor of the inhaler but the parameter relating to the airflow being equal to or less than a first threshold;

wherein the excessive inhalation event is characterized by an inhalation being detected by the processor of the inhaler but the parameter relating to the airflow being higher than a second threshold; and

wherein the good inhalation event is characterized by an inhalation being detected by the processor of the inhaler, and the parameter relating to the airflow being equal to or lower than the second predetermined threshold and higher than the first predetermined threshold.

17. The system of claim 1 , wherein the medicament comprises a corticosteroid (ICS) or a bronchodilator.

18. The system of claim 1 , wherein the medicament is a short-acting β2-agonist or a rapid-onset long-acting β2-agonist.

19. The system of claim 1 , wherein the medicament is an ICS that comprises one or more of budesonide, beclomethasone (dipropionate), fluticasone (propionate or furoate), mometasone (furoate), ciclesonide, or dexamethasone (sodium).

20. The system of claim 1 , wherein the medicament is selected from albuterol (sulfate), budesonide, beclomethasone (dipropionate), fluticasone (propionate or furoate), formoterol (fumarate), salmeterol (xinafoate), indacaterol (maleate), vilanterol (triphenylacetate), tiotropium (bromide), aclidinium (bromide), umeclidinium (bromide), glycopyrronium (bromide), salmeterol (xinafoate) combined with fluticasone (propionate or furoate), beclomethasone (dipropionate) combined with albuterol (sulfate), and budesonide combined with formoterol (fumarate).

21. The system of claim 1 , wherein the medicament is a bronchodilator β2-adrenergic agonist that comprises one or more of formoterol (fumarate), salmeterol (xinafoate), indacaterol (maleate), bambuterol (hydrochloride), clenbuterol (hydrochloride), olodaterol (hydrochloride), carmoterol (hydrochloride), tulobuterol (hydrochloride), vilanterol (triphenylacetate), albuterol (sulfate) or terbutaline (sulfate).

22. The system of claim 1 , wherein the medicament is a bronchodilator anticholinergic that comprises one or more of tiotropium (bromide), oxitropium (bromide), aclidinium (bromide), umeclidinium (bromide),ipratropium (bromide) glycopyrronium (bromide), oxybutynin (hydrochloride or hydrobromide), tolterodine (tartrate), trospium (chloride), solifenacin (succinate), fesoterodine (fumarate), or darifenacin (hydrobromide).

23. A system comprising:

an external device comprising a processor, memory, and a transceiver; and

an inhaler comprising a processor, memory, and a transmitter, the processor of the inhaler configured to:

determine a parameter relating to airflow during a use of the inhaler by a subject;

assign a time to the use; and

send, to the external device, the parameter relating to the airflow and the time of the use; and

wherein the processor of the external device is configured to:

receive the parameter relating to airflow and the time of the use;

determine inhalation information from the parameter relating to airflow; and

control a user interface to issue a notification at a notification time that the inhalation information is available, the processor of the external device configured to implement a deliberate time delay such that the notification time is delayed relative to the time assigned to the use, and wherein the deliberate time delay is a shorter deliberate time delay when the event is an improper actuation event as opposed to a low inhalation event.

24. A method comprising:

determine a parameter relating to airflow during a use of an inhaler by a subject;

assign a time to the use;

determine inhalation information from the parameter relating to airflow; and

control a user interface to issue a notification at a notification time that the inhalation information is available, wherein the notification is issued at a deliberate time delay such that the notification time is delayed relative to the time assigned to the use, and wherein the time delay is a shorter deliberate time delay when the use of the inhaler by the subject is categorized as a no inhalation event or an excessive inhalation event as opposed to a low inhalation event or a good inhalation event.

25. The method of claim 24 , wherein a time-and-date stamp is associated with the parameter, and wherein the deliberate time delay is configured such that the notification time is a predetermined time on a day which is subsequent to the day indicated by the time-and-date stamp.

26. The method of claim 24 , wherein the no inhalation event is characterized by no inhalation being detected, or is characterized by an inhalation being detected but the parameter relating to the airflow being equal to or less than a first threshold;

wherein the excessive inhalation event is characterized by an inhalation being detected but the parameter relating to the airflow being higher than a second threshold; and

wherein the good inhalation event is characterized by an inhalation being detected, and the parameter relating to the airflow being equal to or less than the second predetermined threshold and greater than the first predetermined threshold.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 1, 2020
From: LIU, XINYU; ZUR, AMIR
To: TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.
Reel/Frame 053663/0475 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 1, 2020
From: TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.
To: NORTON(WATERFORD) LIMITED
Reel/Frame 053663/0585 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 1, 2020
From: MILTON-EDWARDS, MARK
To: TEVA UK LIMITED
Reel/Frame 053663/0712 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 1, 2020
From: TEVA UK LIMITED
To: NORTON (WATERFORD) LIMITED
Reel/Frame 053663/0753 →
Continuity (1)
Related Publication 20210393892A1 · Dec 23, 2021
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