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Last Updated: March 28, 2024

Claims for Patent: 9,706,944


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Summary for Patent: 9,706,944
Title:Apparatus and method for simulating inhalation efforts
Abstract: An inhalation simulation system is provided for use with inhalers in particular breath-powered dry powder inhalers. The simulation system can recreate a patient\'s inhalation profile obtained with an inhaler adapted with a sensing and monitoring device for the detection of characteristic signals generated from the inhaler in use, which signals are transmitted to a computer with an algorithm which is configured to analyze the signals and generate new signals via a transmitter to actuate the inhalation simulation system component parts so that a subject\'s inhalation profile is replicated simultaneously or in real-time, or stored for later use. Methods of measuring the performance of inhalers are also provided.
Inventor(s): Adamo; Benoit (Mount Kisco, NY), Polidoro; John M. (Coventry, CT), Overfield; Dennis (Fairfield, CT), Sahi; Carl R. (Coventry, CT), Laurenzi; Brendan (New Milford, CT), Smutney; Chad C. (Watertown, CT), Kinsey; P. Spencer (Sandy Hook, CT)
Assignee: MannKind Corporation (Valencia, CA)
Application Number:14/667,539
Patent Claims:1. An apparatus comprising: a first acoustic sensor in communication with a first breath-powered dry powder inhaler, the first sensor configured to monitor an inhalation maneuver of a patient and transmit a signal corresponding to the inhalation maneuver; a processing device comprising a microprocessor and a storage medium having an algorithm stored therein, the device configured to receive the signal from the first sensor and processing the signal using the algorithm to generate a data set that is analyzed, stored, printed, transmitted, and/or displayed; a controller that receives the data set and in turn controls a motor that is attached to a calibrated syringe pump that upon actuation by the controller generates a pressure differential in a second breath-powered dry powder inhaler that is attached to an anatomically correct artificial airway; a display in communication with the processing device and configured to graphically display both the inhalation maneuver and data collected as a result of the pressure differential, wherein the pressure differential is modeled after the inhalation maneuver.

2. The apparatus of claim 1, wherein the first sensor is located within the first inhaler or configured to attach to the first inhaler.

3. The apparatus of claim 1, wherein the first inhaler and the second inhaler are breath-powered dry powder inhalers each comprising a sensor and a microprocessor built within the respective inhalers or provided in a device attachable to the inhalers.

4. The apparatus of claim 1, wherein the first sensor is a microphone.

5. The apparatus of claim 1, wherein the second inhaler comprises a cartridge comprising a dry powder for pulmonary delivery.

6. The apparatus of claim 5, wherein the cartridge comprises a dry powder comprising diketopiperazine microparticles.

7. The apparatus of claim 6, wherein the dry powder comprises at least one active ingredient.

8. The apparatus of claim 7, wherein the at least one active ingredient comprises insulin, GLP-1, growth hormone, sumatriptan, parathyroid hormone, or analogs thereof.

9. The apparatus of claim 6, wherein the first sensor is configured to transmit the signal by wire or wireless communication mode to the processing device.

10. The apparatus of claim 6, wherein an analog to digital converter communicates the signal to the microprocessor that is configured to analyze and process the signal.

11. The apparatus of claim 6, further comprising a signal conditioning circuitry and a wired or wireless communication interface.

12. The apparatus of claim 6, wherein data generated from the signal are processed by the microprocessor to generate a data set that recreates the patient's inhalation profile.

13. The apparatus of claim 6, wherein the first and second inhalers are structurally identical.

14. The apparatus of claim 5, wherein the dry powder comprises at least one active ingredient.

15. The apparatus of claim 14, wherein the at least one active ingredient comprises insulin, GLP-1, growth hormone, sumatriptan, parathyroid hormone, or analogs thereof.

16. A method for simulating an inhalation maneuver by a subject, the method comprising: monitoring the inhalation maneuver by way of a first acoustic sensor located in or attached to a first breath-powered dry powder inhaler; transmitting a signal generated by the first acoustic sensor to a device comprising a microprocessor and a storage medium having an algorithm stored therein; processing the signal using the algorithm to generate a data set; and performing the following with the data set: storing the data set in the storage medium, and transmitting the data set in the form of a second signal to a controller configured to control a motor that is attached to a calibrated syringe pump that upon actuation by the controller generates a pressure differential in a second breath-powered dry powder inhaler that is attached to an anatomically correct artificial airway, wherein the pressure differential is modeled after the inhalation maneuver.

17. The method of claim 16, wherein the airway is configured with a mouth connected to the second inhaler.

18. The method of claim 16, wherein the first inhaler is adapted with a radio transmitter.

19. The method of claim 16, wherein the first inhaler is adapted with a wireless or wired jacket comprising a microphone that can convert a sound signal generated within the first inhaler into an electrical impulse configured to communicate with a radio signal receiver that is in communication with the microprocessor.

20. The method of claim 16, wherein the first and second inhalers are structurally identical.

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