Apparatus, system and method for measuring resistance of an inhaler

• US 8,538,707 B2
• Filed: 03/11/2010
• Issued: 09/17/2013
• Est. Priority Date: 03/11/2009
• Status: Active Grant

• Current Assignee: Mannkind Corporation
• Original Assignee: Mannkind Corporation
• Inventors: Adamo, Benoit, McLean, Scott, Smutney, Chad C., Polidoro, John M., Sahi, Carl R.
• Primary Examiner(s): Armand, Marc
• Assistant Examiner(s): DALBO, MICHAEL J
• Application Number:
  US12/722,464
• Publication Number:
  US 20100235116A1
• Time in Patent Office: 1,286 Days
• Field of Search: 702/45
• US Class Current: 702/45
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• 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 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 16/201 Controlled valves
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2209/02 Equipment for testing the apparatus
• CPC Class Codes: G01F 1/00 Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow measuring a proportion of the volume flow G01F5/00
• CPC Class Codes: G01L 13/00 Devices or apparatus for measuring differences of two or more fluid pressure values
• CPC Class Codes: G01N 7/00 Analysing materials by measuring the pressure or volume of a gas or vapour

Abstract

An apparatus, a closed-loop system and method for measuring the resistance of inhalation systems and/or devices are disclosed.

Claims

1. An apparatus, comprising:

a first device comprising a first chamber configured to mount an inhaler and having a first valve;

a second device comprising a second chamber having a second valve;

wherein said second device is movable and sealably attachable to said first device;

a pressure controller connected to said first device, and comprising a pressure sensor which communicates a first set of signals to a first microprocessor and integrally connected to a power source;

a flow controller connected to said second device and comprising a flow sensor and a pressure sensor which communicate a second set of signals with a second microprocessor configured to detect and analyze signals from said second chamber; and

said first microprocessor and said second microprocessor configured to control opening and closing first valve and second valve, respectively and corresponding to said first chamber and said second chamber.

2. The apparatus of claim 1, further comprising a third microprocessor to read output from corresponding sensors output and implement an algorithm to analyze the measurements and calculate resistance values of the inhaler.

3. The apparatus of claim 1, wherein said first device is configured to hold an inhaler in place and create a seal between the first chamber and the second chamber of the second device.

4. The apparatus of claim 1, wherein the first set of signals and the second set of signals generate data that when analyzed are correlated to resistance to airflow of the device.

5. The apparatus of claim 1, wherein the apparatus is used to measure resistance to airflow of an inhaler when the first device and the second device are configured as a closed loop system devoid of ambient air.

6. A method for measuring the resistance to airflow of an inhaler, comprising:

attaching an inhaler including an inhaler air pathway to a first device comprising a first chamber, a first valve, a pressure controller including a pressure sensor which communicates a first set of signals to a first microprocessor and integrally connected to a power source, and a holder for said inhaler so that an air pathway from the first chamber and through the inhaler air pathway is formed;

attaching a second device comprising a second chamber to said first device to enclose said inhaler within the second chamber, wherein the second device includes a second valve and a flow controller comprising a flow sensor and a pressure sensor which communicate a second set of signals to a second microprocessor configured to detect and analyze signals from said second chamber;

actuating the apparatus to obtain a controlled constant pressure environment in the second chamber; and

simultaneously measuring pressure differential across the inhaler and flow rate through the inhaler by controlling opening and closing of the first valve and the second valve by said first microprocessor and said second microprocessor respectively to generate pressure and flow rate measurements.

7. The method of claim 6, wherein the controlled constant pressure environment is maintained by a closed-loop algorithm.

8. The method of claim 6, wherein pressure and flow rate measurements from various test set points of the inhaler are analyzed with an algorithm to generate a resistance value for the inhaler.

9. The method of claim 8, wherein the pressure and flow rate measurements are made at predetermined pressure drop settings for the inhaler.

10. A method for determining resistance to airflow of an inhaler, comprising:

attaching an inhaler including an inhaler air pathway to a first device comprising a first chamber, a first valve, a pressure controller including a pressure sensor which communicates a first set of signals to a first microprocessor and integrally connected to a power source, and a holder for said inhaler so that an air pathway from the first chamber and through the inhaler air pathway is formed;

attaching a second device comprising a second chamber to said first device to enclose said inhaler within the second chamber, wherein the second device includes a second valve and a flow controller comprising a flow sensor and a pressure sensor which communicate a second set of signals to a second microprocessor configured to detect and analyze signals from said second chamber;

actuating the apparatus to obtain a controlled constant pressure environment in the second chamber;

determining a range of measurements at which square root of the pressure differential versus flow rate curve for an inhaler type is linear to yield predetermined value settings;

obtaining pressure differential and flow rate measurements by controlling opening and closing of the first valve and the second valve by said first microprocessor and said second microprocessor respectively at various predetermined value settings within the linear range for a second inhaler and; and

determining the slope of the curve to obtain a resistance value for the inhaler.

11. The method of claim 10, wherein the predetermined flow rate settings are greater than 0.1 L/min.

12. The method of claim 10, wherein at least three predetermined value settings are used to measure pressure differential and flow rate and determine the resistance value of the inhaler.

13. The method of claim 10, further comprising the step of measuring flow rate and square root of the pressure differential across an inhaler in an apparatus comprising a first chamber and a second chamber;

wherein said inhaler is installed in the second chamber.

14. The method of claim 12, wherein a linear regression of pressure and flow data collected at the at least three predetermined value settings results in a coefficient of determination greater than 0.9.