DRUG DELIVERY DEVICE

• US 20130151162A1
• Filed: 04/26/2011
• Published: 06/13/2013
• Est. Priority Date: 04/26/2010
• Status: Abandoned Application

• Current Assignee: Sagentia Limited
• Original Assignee: Sagentia Limited
• Inventors: Harris, David, Ansell, Iain, Simpson, Richard, Bonham, Peter, Grubb, Scott
• Application Number:
  US13/643,761
• Publication Number:
  US 20130151162A1
• Time in Patent Office: Days
• US Class Current: 702/19
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/021 operated by electrical means A61M16/202 – A61M16/205 take precedence
• CPC Class Codes: A61M 2016/003 with a flowmeter
• 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 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: G01F 1/66 by measuring frequency, phase shift or propagation time of electromagnetic or other waves, e.g. using ultrasonic flowmeters
• CPC Class Codes: G01F 1/666 by detecting noise and sounds generated by the flowing fluid
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/13 delivered from dispensers

Abstract

Drug delivery devices are described that include sensors and processing circuitry that can detect operating events, such as flow rates and drug delivery, in various types of inhalers, such as dry powder inhalers, metered dose inhalers, nasal inhalers and nebulisers. The information determined by the processing circuitry can be used to provide feedback to the user or can be stored or transmitted for subsequent analysis. This information can be used to improve clinical trials by providing information about the way in which the inhalers under test are being used.

Claims

1. A drug delivery system comprising:

a drug delivery device having a body with a mouthpiece and a microphone mounted on the body for sensing sounds made by the drug delivery device during operation; and

processing circuitry operable to process the signal obtained from the microphone to determine operating conditions of the drug delivery device;

wherein the processing circuitry comprises;

means for tracking the energy in the acoustic signal received from the microphone during an inhalation;

means for converting the tracked energy into a flow profile for at least part of the inhalation using stored first calibration data;

means for processing the signal obtained from the microphone to detect the timing of the delivery of a medicament during the inhalation; and

means for comparing the detected timing of said delivery relative to said flow profile with stored second calibration data to determine if the delivery of the medicament meets a desired delivery condition.

18. A system according to claim 1, wherein the processing circuitry is mounted within the body of the drug delivery device.

19. A system according to claim 1, wherein the drug delivery device is a metered dose inhaler or a dry powder inhaler.

10. A drug delivery system comprising:

a drug delivery device having a body with a mouthpiece and a microphone mounted on the body for sensing sounds made by the drug delivery device during operation; and

processing circuitry operable to process the signal obtained from the microphone to determine operating conditions of the drug delivery device;

wherein the processing circuitry comprises;

means for determining a dominant frequency or a harmonic thereof in the acoustic signal received from the microphone; and

means for converting the determined dominant or harmonic frequency into a flow rate value using stored calibration data.

20. A drug delivery system comprising:

a drug delivery device having a body with a mouthpiece and a microphone mounted on the body for sensing sounds made by the drug delivery device during operation; and

processing circuitry operable to process the signal obtained from the microphone to determine operating conditions of the drug delivery device;

wherein the processing circuitry is operable to;

track the energy in the acoustic signal received from the microphone during an inhalation;

convert the tracked energy into a flow profile for at least part of the inhalation using stored first calibration data;

process the signal obtained from the microphone to detect the timing of the delivery of a medicament during the inhalation; and

compare the detected timing of said delivery relative to said flow profile with stored second calibration data to determine if the delivery of the medicament meets a desired delivery condition.

2. A system according to claim 20, wherein the processing circuitry is arranged to output a response based on the determination, and preferably wherein the output comprises an audible and/or visual output to the user;

or provides a data output for analysis on a remote device.

3. A system according to claim 20, wherein said second calibration data defines a desired timing relative to a peak flow rate.

4. A system according to claim 20, wherein said first calibration data defines a look up table or an equation.

5. A system according to claim 20, wherein the processing circuitry is operable to divide the signal obtained from the microphone into a sequence of blocks of signal samples and is operable to determine the energy of the signal within each block of samples to track the energy during the inhalation.

6. A system according to claim 5, wherein the processing circuitry is operable to process the samples in each block to make a determination whether or not the medicament was delivered during the block.

7. A system according to claim 20, wherein said processing circuitry is operable to detect the timing of the delivery of a medicament by detecting the signal level at a characteristic frequency associated with the drug delivery device.

8. A system according to claim 7, wherein the processing circuitry is operable to detect the timing of the delivery of a medicament by band pass filtering the acoustic signal at the characteristic frequency and detecting if the signal level exceeds a threshold value.

9. A system according to claim 7, wherein the processing circuitry is operable to detect the timing of the delivery of a medicament using a frequency transform, such as a cosine transform, at the characteristic frequency.

21. A drug delivery system comprising:

a drug delivery device having a body with a mouthpiece and a microphone mounted on the body for sensing sounds made by the drug delivery device during operation; and

processing circuitry operable to process the signal obtained from the microphone to determine operating conditions of the drug delivery device;

wherein the processing circuitry is operable to;

determine a dominant frequency or a harmonic thereof in the acoustic signal received from the microphone; and

convert the determined dominant or harmonic frequency into a flow rate value using stored calibration data.

11. A device according to claim 21, wherein the processing circuitry is operable to track the dominant or harmonic frequency in the acoustic signal to determine a flow profile for at least a part of the inhalation.

12. A device according to claim 11, wherein the processing circuitry is further arranged to

process the signal obtained from the microphone to detect the timing of the delivery of a medicament during the inhalation.

13. A device according to claim 12, wherein the processing circuitry is further arranged to compare the detected timing of said delivery relative to said flow profile with stored second calibration data to determine if the delivery of the medicament meets a desired delivery condition.

14. A device according to claim 12, wherein said processing circuitry is arranged to detect a change in the mean signal level of at least a portion of the signal obtained from the microphone to detect said timing of the delivery of a medicament during the inhalation.

15. A device according to claim 14, wherein said processing circuitry is arranged to detect a change in the mean signal level for an upper frequency band of the signal obtained from the microphone.

16. A device according to claim 21, wherein the processing circuitry is arranged to determine a spectrum of the signal obtained from the microphone and to process the spectrum to identify said dominant or harmonic frequency.

17. A device according to claim 21, wherein the processing circuitry is further arranged to determine the energy within the signal obtained from the microphone and to determine a flow rate measurement from the determined energy and stored calibration data.

22. Processing circuitry for use in processing signals obtained from a microphone of a drug delivery device to determine operating conditions of the drug delivery device, the processing circuitry being operable to:

track the energy in the acoustic signal received from the microphone during an inhalation;

convert the tracked energy into a flow profile for at least part of the inhalation using stored first calibration data;

process the signal obtained from the microphone to detect the timing of the delivery of a medicament during the inhalation; and

compare the detected timing of said delivery relative to said flow profile with stored second calibration data to determine if the delivery of the medicament meets a desired delivery condition.

24. A tangible computer implementable instructions product comprising computer implementable instructions for causing a programmable processor device to become configured as the processing circuitry according to claim 22.

23. Processing circuitry for use in processing signals obtained from a microphone of a drug delivery device to determine operating conditions of the drug delivery device, the processing circuitry being operable to:

determine a dominant frequency or harmonics thereof in the acoustic signal received from the microphone; and

convert the determined dominant or harmonic frequency into a flow rate value using stored calibration data.

25. A tangible computed implementable instructions product comprising computer implementable instructions for causing a programmable process device to become configured as the processing circuitry according to claim 23.