IP Library › Granted Patent US 12,728,216
Granted Patent B2
US 12,728,216 · App. 17/931,098 · Granted Sep 8, 2026

Apparatus, system and method for detecting and monitoring inhalations

Inventors: John J. Pocreva, III (Lagrangeville, NY); Benoit Adamo (South Salem, NY); Brendan Laurenzi (Rutland, MA); Chad C. Smutney (Watertown, CT); P. Spencer Kinsey (Sandy Hook, CT)
Assignee: MANNKIND CORPORATION
A61M15/008A61K38/28A61K47/22A61M15/0028A61M15/0065G09B5/02G09B23/28A61B5/087A61B2562/08A61M15/0021A61M15/0043A61M2016/0021A61M2016/0027A61M2016/0033A61M16/161A61M2202/064A61M2205/13A61M2205/3306A61M2205/3313A61M2205/3331A61M2205/3344A61M2205/3358A61M2205/3368A61M2205/3375A61M2205/3553A61M2205/3561A61M2205/3569A61M2205/3584A61M2205/3592A61M2205/50A61M2205/502A61M2205/52A61M2205/583A61M2205/587A61M2205/6018A61M2205/6054A61M2205/6063A61M2205/6081A61M2205/8206A61M2206/10A61M2230/40
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Quick Facts
Patent No.
US 12,728,216
App. No.
17/931,098
Granted
Sep 8, 2026
Kind
B2
Abstract

Described herein are an interactive apparatus and methods for sensing and measuring real-time characteristic patterns of a subject's use of a dry powder inhalation system. The inhaler device can be used in a wireless communication mode to communicate with a display to assess the subject's usage of the inhalation system concurrently as the inhalation is performed and thus the subject's inhalation can be evaluated as well as the performance of the inhalation system. The system can also detect the identity of the medicament, its dosage, lot, expiration, etc. and the characteristics profile of a dry powder formulation emitted from the inhalation system in use.

Claims (46)

1 . A method of monitoring and detecting data for dry powder inhaler user training, comprising:

displaying an instruction to load a medicament in the dry powder inhaler;

reading medicament data relating to medicament or inhaler information via a contactless identification sensor comprising a laser beam, a Doppler sensor, an infrared sensor or another sensing beam configured to detect information encrypted or coded by color in areas or parts of the dry powder inhaler, an inhaler cartridge or another medicament package;

identifying absolute pressure data before inhalation by a user via an absolute pressure sensor configured to obtain an absolute pressure;

adjusting for atmospheric conditions;

displaying instruction to begin an inhalation maneuver;

obtaining pressure differential data and flow data during the inhalation by the user via a differential pressure sensor detecting a pressure drop and a flow sensor detecting flow measured in an inhaler conduit of the dry powder inhaler and having been adjusted by the absolute pressure data for the atmospheric conditions;

computing a threshold of a minimum inhalation effort the user must exert to effectively inhale the medicament by relating the medicament data and the pressure differential data;

determining whether the user passed or failed the inhalation maneuver based on the computed threshold; and

displaying the inhalation effort as a positive inhalation effort vs. time curve along with the threshold corresponding to the medicament data, the inhalation effort accounting for the pressure differential data adjusted by the absolute pressure data and flow data.

2 . The method of claim 1 , further comprising a step of transmitting an indication of whether a user inhalation profile met, failed to meet, or exceeded the computed threshold.

3 . The method of claim 2 , wherein the transmitting step comprises transmitting for display on a remote processing system such as a smart phone, tablet, computer or other wireless radio enabled device.

4 . The method of claim 3 , wherein the transmitting step comprises transmitting the medicament data and the pressure differential data to the remote processing system via wireless transmission.

5 . The method of claim 4 , further providing an application configured for the remote processing system to display the inhalation effort vs. time curve along with the threshold corresponding to the medicament data.

6 . The method of claim 1 , wherein the dry powder inhaler comprises a cartridge and a dry powder formulation.

7 . The method of claim 6 , wherein the dry powder formulation comprises a diketopiperazine and at least one active ingredient.

8 . The method of claim 5 , further providing the application configured to store the medicament data and pressure differential data.

9 . A method of monitoring and detecting use of a dry powder inhaler, comprising:

providing an apparatus body configured for mounting onto or in connection with the dry powder inhaler, the body having at least two sensors comprising a contactless first sensor and a second sensor;

detecting activation of the apparatus body;

detecting an inhalation maneuver;

detecting information encrypted or coded by color in areas or parts of the dry powder inhaler, inhaler cartridge or other medicament package via the contactless first sensor comprising a laser beam, a Doppler sensor, infrared sensor or other sensing beam;

detecting signals generated from an inhaler conduit of the dry powder inhaler via the second sensor comprising an absolute pressure sensor, a third sensor comprising a flow sensor and a fourth sensor comprising a differential pressure sensor by

obtaining absolute pressure data from the absolute pressure sensor;

obtaining flow data from the flow sensor;

obtaining differential pressure data from the differential pressure sensor configured for detecting a pressure drop measured in the inhaler conduit during the inhalation maneuver by a user,

wherein the absolute pressure is used in conjunction with the differential pressure sensor to generate an adjusted pressure for atmospheric conditions before identifying the pressure drop;

generating a threshold profile by relating the detected information and adjusted pressure;

generating a pass or fail status upon completion of the inhalation maneuver based on computed threshold profile; and

displaying a user inhalation profile as a positive inhalation effort vs. time curve along with the threshold profile corresponding to the medicament data, the user inhalation profile accounting for the pressure differential data adjusted by the absolute pressure data and flow data.

10 . The method of claim 9 , further comprising displaying instruction to begin inhalation.

11 . The method of claim 9 , wherein one or more of the generating steps are performed by a microprocessor comprised in the apparatus body.

12 . The method of claim 9 , further comprising generating the user inhalation profile based at least on the adjusted pressure and time.

13 . The method of claim 12 , further comprising determining resultant data of the inhalation maneuver based on comparison of the threshold profile to the user inhalation profile.

14 . The method of claim 12 , further comprising a step of transmitting the status of whether the user inhalation profile met, failed to meet, or exceeded the threshold profile for display.

15 . The method of claim 14 , wherein the transmitting step comprises transmitting for display on a remote processing system such as a smart phone, tablet, computer or other wireless radio enabled device.

16 . The method of claim 15 , wherein the transmitting step comprises transmitting the detected information and the pressure differential data to the remote processing system via wireless transmission.

17 . The method of claim 16 , further providing an application configured for the remote processing system to display the inhalation effort vs. time curve along with the threshold corresponding to the medicament data.

18 . The method of claim 17 , further providing the application configured to store the detected information and pressure differential data.

19 . The method of claim 9 , wherein the dry powder inhaler comprises a cartridge and a dry powder formulation.

20 . The method of claim 19 , wherein the dry powder formulation comprises a diketopiperazine and at least one active ingredient.

21 . The method of claim 9 , further comprising displaying an instruction to load a medicament into the dry powder inhaler.

22 . The method of claim 4 , wherein the transmitting step comprises transmitting to visual indicators that are pass/fail or green/red indicators in the form of light emitting diodes.

23 . The method of claim 9 , wherein the differential pressure sensor detects sound signals generated in the dry powder inhaler.

24 . The method of claim 23 , wherein the sound signals include an amplitude of the sound signal, a frequency of the sound signal, or combinations thereof.

25 . The method of claim 24 , wherein the differential pressure sensor is a microphone.

Assignments (2)
PATENT SECURITY AGREEMENT Recorded Aug 12, 2025
From: MANNKIND CORPORATION
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 072445/0769 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 24, 2024
From: POCREVA, JOHN J., III; LAURENZI, BRENDAN; SMUTNEY, CHAD C.; KINSEY, P. SPENCER
To: MANNKIND CORPORATION
Reel/Frame 066225/0455 →
Continuity (3)
Continuation 16301700 · May 19, 2017
Provisional Application 62338971 · May 19, 2016
Related Publication 20230001112A1 · Jan 5, 2023
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