Interactive apparatus and method for real-time profiling of inhalation efforts

• US 10,675,421 B2
• Filed: 05/12/2016
• Issued: 06/09/2020
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Mannkind Corporation
• Original Assignee: Mannkind Corporation
• Inventors: Overfield, Dennis, Sahi, Carl R., Adamo, Benoit, Kinsey, P. Spencer, McLean, Scott, Polidoro, John M., Smutney, Chad C.
• Primary Examiner(s): Anderson, Catharine L
• Application Number:
  US15/152,965
• Publication Number:
  US 20160256640A1
• Time in Patent Office: 1,489 Days
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0025 with caps
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/003 with a flowmeter
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• 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 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2206/10 Flow characteristics
• CPC Class Codes: A61M 2209/086 Docking stations
• CPC Class Codes: A61M 2230/40 Respiratory characteristics
• CPC Class Codes: G09B 23/28 for medicine

Abstract

Described herein are interactive apparatus and methods for sensing and measuring real-time characteristic patterns of a subject'"'"'s use of a dry powder inhalation system. The devices can be used in a wired or wireless communication mode to communicate with a display to assess the subject'"'"'s usage of the inhalation system, to evaluate the performance of the inhalation system and/or to detect the characteristics profile of a dry powder formulation emitted from the inhalation system in use.

Claims

1. A dry powder inhalation detection system comprising:

a dry powder inhaler including a mouthpiece,

a unit dose cartridge structurally configured for said dry powder inhaler, and

an attachable interactive training device comprising at least one sensor attached to or within the mouthpiece in communication air conduits of said dry powder inhaler, wherein the at least one sensor detects at least one signal generated from said dry powder inhaler and transmits in real-time said at least one signal to at least one external device comprising a microprocessor by wireless communication for analysis of said at least one signal to generate data for real-time display of an inhalation maneuver concurrently being performed by a user.

2. The dry powder inhalation detection system of claim 1, wherein said at least one signal is a sound signal.

3. The dry powder inhalation detection system of claim 2, wherein the sound signal is an amplitude of the sound signal, a frequency of the sound signal or combinations thereof.

4. The dry powder inhalation detection system of claim 2, wherein an analog to digital converter communicates said at least one sound signal to a microprocessor configured to analyze and process said at least one sound signal.

5. The dry powder inhalation detection system of claim 1, wherein said at least one sensor is configured to further measure said at least one signal.

6. The dry powder inhalation detection system of claim 1, wherein said at least one sensor is a microphone.

7. The dry powder inhalation detection system of claim 1, wherein said cartridge comprises a dry powder for pulmonary delivery.

8. The dry powder inhalation detection system of claim 7, wherein the dry powder comprises diketopiperazine microparticles.

9. The dry powder inhalation detection system of claim 7, wherein the dry powder comprises at least one active ingredient.

10. The dry powder inhalation detection system of claim 9, wherein said at least one active ingredient comprises insulin, GLP-1, or analogues thereof.

11. The dry powder inhalation detection system of claim 1, wherein said dry powder inhaler has a resistance value between about 0.065 (√

kPa)/liter per minute and about 0.200 (√

kPa)/liter per minute.

12. The dry powder inhalation detection system of claim 1, wherein said at least one external device is an analog to digital converter.

13. The dry powder inhalation detection system of claim 1, wherein said at least one external device is a display device.

14. The dry powder inhalation detection system of claim 13, wherein said display device is a computer monitor.

15. The dry powder inhalation detection system of claim 1, wherein said at least one sensor is a pressure sensor, temperature sensor, sound sensor, or optical sensor.

16. The dry powder inhalation detection system of claim 1, wherein said at least one sensor is a pressure sensor.

17. An attachable monitoring system for a dry powder inhaler comprising:

an interactive monitoring device comprising at least one sensor configured to attach to or within a mouthpiece of the dry powder inhaler, wherein said at least one sensor is in communication with air conduits of said dry powder inhaler to measure real-time changes in air pressure or air flow;

an analog to digital converter;

a data storage medium, said data storage medium including a set of machine-readable instructions that are executable by a processing device to implement an algorithm, said algorithm comprising instructions for manipulating said data including the steps of;

transmitting and analyzing said data in real time by receiving said data from said at least one sensor;

filtering said data;

transforming said data;

analyzing said data; and

monitoring a patient using said data.

18. The interactive monitoring system of claim 17, wherein said at least one sensor is a microphone.

19. The interactive monitoring system of claim 17, wherein said interactive monitoring device is a detachable device.