INTERACTIVE APPARATUS AND METHOD FOR REAL-TIME PROFILING OF INHALATION EFFORTS

• US 20090314292A1
• Filed: 06/19/2009
• Published: 12/24/2009
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Mannkind Corporation
• Original Assignee: Mannkind Corporation
• Inventors: Smutney, Chad C., Adamo, Benoit, McLean, Scott, Kinsey, P. Spencer, Polidoro, John M., Sahi, Carl R., Overfield, Dennis
• Granted Patent: US 9,364,619 B2
• Time in Patent Office: Days
• US Class Current: 128/203.150
• 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 system comprising:

a dry powder inhaler

a cartridge structurally configured for said dry powder inhaler, and

a sensor in communication with said dry powder inhaler, wherein said sensor detects at least one signal generated from said dry powder inhaler and sends said at least one signal to at least one device for analysis, storage, printing or display.

2. The dry powder inhalation system of claim 1, wherein said sensor is configured within said dry powder inhaler or adaptable to said dry powder inhaler.

3. The dry powder inhalation system of claim 1, wherein said signal is a sound signal

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

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

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

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

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

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

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

11. The dry powder inhalation 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 system of claim 1, wherein said sensor is configured to transmit said sound signal by wire or wireless communication mode to said at least one device.

13. The dry powder inhalation system of claim 3, 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.

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

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

16. The dry powder inhalation system of claim 15, wherein display device is a computer monitor.

17. A monitoring system for a dry powder inhaler comprising:

a monitoring device comprising at least one sensor;

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;

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

19. The monitoring system of claim 17, wherein said monitoring device is provided within said inhaler.

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

21. The monitoring system of claim 20, wherein said detachable device is mountable on an inhaler.

22. The monitoring system of claim 17, wherein said monitoring device provides a graphical display which is a real-time graphical representation of an inhalation.

23. A method for measuring pressure differential during an inhalation maneuver, comprising:

providing an inhaler to a subject wherein said inhaler comprises a sensor configured to detect at least one amplitude of sound signal, at least one frequency of sound signal or combinations thereof generated from said inhaler,

having said subject inhale for at least one second;

analyzing said at least one amplitude of sound signal, said at least one frequency of sound signal, or combinations thereof using an algorithm provided with a computer system to generate a data set; and

displaying, printing, or storing said data set as a function of time and pressure.

24. An interactive dry powder inhalation system for monitoring an inhalation performed by a user, comprising:

a dry powder inhaler comprising a cartridge and having a resistance to flow values between 0.065 (√

kPa)/liter per minute and 0.200 (√

kPa)/liter per minute;

a transducer configured to detect a signal generated from the inhaler in use, and

a display device configured to display in real-time an inhalation maneuver performed by a user.

25. The interactive dry powder inhalation system of claim 24, wherein the transducer senses and measures a pressure differential within the inhaler.

26. The interactive dry powder inhalation system of claim 24, wherein the transducer is a flow meter configured to sense and measure flow rate through air conduits of the dry powder inhaler.

27. The interactive dry powder inhalation system of claim 24, wherein the transducer is a microphone configured to sense and measure a sound signal generated from within the inhaler.

28. The interactive dry powder inhalation system of claim 24, wherein the inhalation maneuver is displayed on a display device as a graph of pressure versus time.

29. The interactive dry powder inhalation system of claim 24, further comprising a microprocessor which communicates with the transducer by wire connections or wireless.

31. The sensing and monitoring device of claim 27, wherein the detachable device communicates signals to an analog to digital converter configured to communicate signals to a microprocessor and/or a display device.

30. A sensing and monitoring device for adapting to a dry powder inhaler, comprising:

a detachable device structurally configured to adapt to a dry powder inhaler;

said detachable device comprising a microphone for detecting sound generated in said dry powder inhaler; and

wherein the dry powder inhaler has a resistance to flow value between 0.065 (√

kPa)/liter per minute and 0.200 (√

kPa)/liter per minute.

32. A sensing and monitoring device for a dry powder inhalation system, wherein the dry powder inhalation system comprises a dry powder inhaler and a cartridge and the sensing and monitoring device is configured to be embedded within a wall of the dry powder inhaler.

33. The sensing and monitoring device of claim 32, wherein the device is a microphone configured to detect a sound signal generated in use by the dry powder inhalation system.

34. The sensing and monitoring device of claim 32, wherein the sound signals from the microphone are transmitted to a receiver for analysis, storage and/or display.

35. The sensing and monitoring device of claim 32, wherein the sensing and monitoring device is configured to detect signals generated in use from a dry powder inhaler and cartridge system with or without a dry powder formulation.

36. A sensing and monitoring device for a dry powder inhalation system, wherein the dry powder inhalation system comprises a dry powder inhaler and a cartridge and the sensing and monitoring device comprises a microphone configured to detect sound signals generated from a dry powder formulation emitted from the dry powder inhalation system.