Respiratory drug delivery apparatus including a feedback and compliance device

• US 9,352,107 B2
• Filed: 12/07/2010
• Issued: 05/31/2016
• Est. Priority Date: 01/07/2010
• Status: Active Grant

• Current Assignee: Koninklijke Philips N.V.
• Original Assignee: Koninklijke Philips N.V.
• Inventors: Von Hollen, Dirk Ernest, Denyer, Jonathan Stanley Harold
• Primary Examiner(s): Woodward, Valerie L
• Assistant Examiner(s): Vo, Tu
• Application Number:
  US13/520,970
• Publication Number:
  US 20130008436A1
• Time in Patent Office: 2,002 Days
• Field of Search: 128/200.24, 128/200.14, 128/200.16, 128/200.21, 128/203.12, 128/203.15, 128/203.24, 128/204.14, 434/236, 434/238, 434/127
• US Class Current: 1/1
• CPC Class Codes: A61M 11/006 operated by applying mechanical pressure to the liquid to be sprayed or atomised
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 11/08 Pocket atomisers of the injector type aerosol cans A61M15/009
• CPC Class Codes: A61M 15/0005 with means for agitating the medicament
• CPC Class Codes: A61M 15/0016 located downstream of the dispenser, i.e. traversed by the product
• CPC Class Codes: A61M 15/0018 with exhalation check valves
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• 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 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/43 making noise when used correctly
• CPC Class Codes: A61M 2205/44 making noise when used incorrectly
• 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 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/582 : by tactile feedback
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/8206 : battery-operated

Abstract

A respiratory drug delivery apparatus (2) includes a medication storage and delivery device (8) having an outlet (30) and a feedback and compliance device (32) coupled thereto. The feedback and compliance device has an opening, and the outlet of the medication storage and delivery device is received through the opening. The feedback and compliance device includes: (i) one or more sensors (46, 52, 54, 56), each of the one or more sensors being structured to sense a parameter relating to use of the respiratory drug delivery apparatus without modifying or interfering with a flow of medication introduced by actuation of the medication storage and delivery device, (ii) one or more feedback devices (48, 50, 62), and (iii) a processing unit (42) programmed to cause the one or more feedback devices to provide feedback information to a patient (4) regarding use of the respiratory drug delivery apparatus based on an output of at least one of the one or more sensors.

Claims

1. A respiratory drug delivery apparatus, comprising:

a medication storage and delivery device having an outlet, the medication storage and delivery device being a metered dose inhaler having a canister received in a boot, the outlet being part of the boot; and

a feedback and compliance device coupled to the medication storage and delivery device, and coupled to a valved holding chamber, wherein the valved holding chamber includes a main chamber, an adapter coupled to the main chamber, and an exhalation valve, and wherein;

the feedback and compliance device is structured to be removable attached to the adapter via a connector extending from the feedback and compliance device, the connector being structured to be received and held within a slot provided in the adapter;

the adapter receives and holds the outlet of the boot of the metered dose inhaler, wherein the feedback and compliance device is held and positioned between a portion of the metered dose inhaler and the adapter; and

the feedback and compliance device has an opening, the outlet of the medication storage and delivery device being received through the opening, the feedback and compliance device including;

(i) one or more sensors, individual ones of the one or more sensors being structured to sense a parameter relating to use of the respiratory drug delivery apparatus without modifying or interfering with a flow of medication introduced by actuation of the medication storage and delivery device, wherein the one or more sensors include an infra-red sensor for sensing air temperature moving through the exhalation valve, and an infra-red sensor for sensing a position of the respiratory drug delivery apparatus relative to a face of a patient;

(ii) one or more feedback devices, and

(iii) a processing unit programmed to cause the one or more feedback devices to provide feedback information to a patient regarding use of the respiratory drug delivery apparatus based on an output of at least one of the one or more sensors, wherein the processing unit is programmed to cause the one or more feedback devices to provide feedback information in the form of audible instructions.

2. The respiratory drug delivery apparatus according to claim 1, wherein the feedback information is, visual, or tactile, or a combination thereof.

3. The respiratory drug delivery apparatus according to claim 1, wherein the one or more sensors include one or more of (i) a motion sensing device for sensing shaking of the medication storage and delivery device, (ii) a flow sensor for sensing inhalation by the patient, or (iii) a force sensing device for sensing actuation of the medication storage and delivery device.

4. The respiratory drug delivery apparatus according to claim 3, wherein the motion sensing device is an accelerometer, wherein the flow sensor is a micro-electro-mechanical system flow sensor, and wherein the force sensing device is a load cell or a strain gauge.

5. The respiratory drug delivery apparatus according to claim 3, wherein the processing unit is programmed to cause the one or more feedback devices to provide feedback information in the form of:

(i) an instruction to shake the medication storage and delivery device in response to determining that the medication storage and delivery device has been inserted into the feedback and compliance device, (ii) an instruction to actuate the medication storage and delivery device in response to determining that the medication storage and delivery device has been shaken, (iii) an instruction to inhale in a first particular manner in response to determining that the medication storage and delivery device has been actuated, and (iv) an instruction whereby the patient is instructed to hold his or her breath in a second particular manner in response to determining that inhalation in the first particular manner has been completed.

6. The respiratory drug delivery apparatus according to claim 3, wherein the processing unit is programmed to cause the one or more feedback devices to provide feedback information in the form of:

(i) a first indication indicating that the medication storage and delivery device has been properly inserted into the feedback and compliance device in response to determining that the medication storage and delivery device has been inserted into the feedback and compliance device, (ii) a second indication indicating that the medication storage and delivery device has been properly shaken in response to determining that the medication storage and delivery device has been shaken, (iii) a third indication indicating that the medication storage and delivery device has been properly actuated in response to determining that the medication storage and delivery device has been actuated, (iv) a fourth indication indicating that inhalation has been properly performed in response to determining that inhalation in a first particular manner has been completed, and (v) a fifth indication indicating that breath hold has been properly performed in response to determining that the patient has held his or her breath in a second particular manner.

7. The respiratory drug delivery apparatus according to claim 6, wherein the one or more feedback devices include a plurality of LEDs and wherein the first indication, the second indication, the third indication, the fourth indication and the fifth indication each comprise causing an associated one of the LEDs to emit light of a certain color.

8. The respiratory drug delivery apparatus according to claim 3, wherein the feedback and compliance device includes an outer housing, wherein the outer housing including a top portion located above the opening, a bottom portion located below the opening, a front side and a rear side, the outlet extending outwardly from the front side, wherein the force sensing device is provided in the housing in the bottom portion.

9. The respiratory drug delivery apparatus according to claim 8, wherein the bottom portion includes a channel extending completely therethrough from the rear side to the front side, the channel being structured to allow fluid flow through the housing, and wherein the flow sensor is positioned in the bottom portion adjacent to the channel.

10. The respiratory drug delivery apparatus according to claim 8, wherein the one or more feedback devices include a plurality of LEDs provided in the top portion on the front side of the housing.

11. The respiratory drug delivery apparatus according to claim 1, wherein the feedback and compliance device includes a housing defining the opening, the housing including a top portion located above the opening, a bottom portion located below the opening, a front side and a rear side, the outlet extending outwardly from the front side, and wherein the infra-red sensors are provided in the top portion on the front side.

12. The respiratory drug delivery apparatus according to claim 1, wherein the one or more feedback devices include a plurality of LEDs, and wherein the processing unit is programmed to cause selected ones of the LEDs to emit light of a certain color based on an output of at least one of the one or more sensors, the feedback information comprising the light of a certain color.

13. The respiratory drug delivery apparatus according to claim 1, wherein the one or more feedback devices include a speaker, and wherein the processing unit is programmed to cause the speaker to provide the audible instructions relating to proper use of the respiratory drug delivery apparatus based on an output of at least one of the one or more sensors.

14. The respiratory drug delivery apparatus according to claim 1, wherein the feedback and compliance device comprises an infra-red sensor for sensing opening of the exhalation valve.

15. The respiratory drug delivery apparatus according to claim 1, wherein the one or more sensors include one or more microphones to detect sounds indicative of inhalation and/or actuation of the medication delivery device.

16. A method of encouraging proper use of a respiratory drug delivery apparatus including a medication storage and delivery device having an outlet, and a valved holding chamber including a main chamber, an adapter coupled to the main chamber, and an exhalation valve, wherein the medication storage and delivery device is a metered dose inhaler having a canister received in a boot, the outlet being part of the boot, the method comprising:

providing a feedback and compliance device, the feedback and compliance device including one or more sensors, individual ones of the one or more sensors being structured to sense a parameter relating to use of the respiratory drug delivery apparatus without modifying or interfering with a flow of medication introduced by actuation of the medication storage and delivery device;

wherein the one or more sensors include an infra-red sensor for sensing air temperature moving through the exhalation valve of the valved holding chamber, and an infra-red sensor for sensing a position of the respiratory drug delivery apparatus relative to a face of a patient, the valved holding chamber coupled to the feedback and compliance device;

removably attaching the feedback and compliance device to the adapter via a connector extending from the feedback and compliance device, the connector being structured to be received and held within a slot provided in the adapter;

coupling the metered dose inhaler to the feedback and compliance device by inserting the outlet through an opening provided in the feedback and compliance device;

receiving and holding the outlet of the boot of the metered dose inhaler by the adaptor, wherein the feedback and compliance device is held and positioned between a portion of the metered dose inhaler and the adapter; and

providing feedback information to a patient, in the form of audible instructions, regarding use of the respiratory drug delivery apparatus based on an output of at least one of the one or more sensors.

17. The method according to claim 16, wherein the feedback information is visual, or tactile, or a combination thereof.

18. The method according to claim 16, wherein the providing feedback information comprises:

(i) determining in the feedback and compliance device that the medication storage and delivery device has been inserted into the feedback and compliance device and in response thereto providing an instruction to shake the medication storage and delivery device, (ii) determining in the feedback and compliance device that the medication storage and delivery device has been shaken and in response thereto providing an instruction to actuate the medication storage and delivery device, (iii) determining in the feedback and compliance device that the medication storage and delivery device has been actuated and in response thereto providing an instruction to inhale in a first particular manner, and (iv) determining in the feedback and compliance device that inhalation in the first particular manner has been completed and in response thereto providing instruction instructing the patient to hold his or her breath in a second particular manner.

19. The method according to claim 16, wherein the providing feedback information comprises:

(i) determining in the feedback and compliance device that the medication storage and delivery device has been inserted into the feedback and compliance device and in response thereto providing a first indication indicating that the medication storage and delivery device has been properly inserted into the feedback and compliance device, (ii) determining in the feedback and compliance device that medication storage and delivery device has been shaken and in response thereto providing a second indication indicating that the medication storage and delivery device has been properly shaken, (iii) determining in the feedback and compliance device that the medication storage and delivery device has been actuated and in response thereto providing a third indication indicating that the medication storage and delivery device has been properly actuated, (iv) determining in the feedback and compliance device that inhalation in a first particular manner has been completed and in response thereto providing a fourth indication indicating that inhalation has been properly performed, and (v) determining in the feedback and compliance device that the patient has held his or her breath in a second particular manner and in response thereto providing a fifth indication indicating that breath hold has been properly performed.

20. The method according to claim 19, wherein the first indication, the second indication, the third indication, the fourth indication and the fifth indication each comprise a visual indication.

21. The method according to claim 16, wherein the one or more sensors include one or more microphones to detect sounds indicative of inhalation and/or actuation of the medication delivery device.

22. A feedback and compliance device for use with a respiratory medication storage and delivery device, comprising:

a housing having an opening, the opening being structured to receive an outlet of the medication storage and delivery device, the medication storage and delivery device being a metered dose inhaler having a canister received in a boot, the outlet being part of the boot;

one or more sensors, individual ones of the one or more sensors being structured to sense a parameter relating to use of the medication storage and delivery device without modifying or interfering with a flow of medication introduced by actuation of the medication storage and delivery device;

wherein the one or more sensors include an infra-red sensor for sensing air temperature moving through an exhalation valve of a valved holding chamber, and an infra-red sensor for sensing a position of the respiratory drug delivery apparatus relative to a face of a patient, the valved holding chamber coupled to the feedback and compliance device, wherein the valved holding chamber includes a main chamber, an adapter coupled to the main chamber, and wherein;

the feedback and compliance device structured to be removably attached to the adapter via a connector extending from the feedback and compliance device, the connector being structured to be received and held within a slot provided in the adapter;

the adapter receiving and holding the outlet of the boot of the metered dose inhaler, wherein the feedback and compliance device is held and positioned between a portion of the metered dose inhaler and the adapter;

one or more feedback devices; and

a processing unit programmed to cause the one or more feedback devices to provide feedback information to a patient regarding use of the medication storage and delivery device based on an output of at least one of the one or more sensors, wherein the processing unit is programmed to cause the one or more feedback devices to provide feedback information in the form of audible instructions.

23. The feedback and compliance device according to claim 22, wherein the one or more sensors include:

(i) a motion sensing device for sensing shaking of the medication storage and delivery device, (ii) a flow sensor for sensing inhalation by the patient, and (iii) a force sensing device for sensing actuation of the medication storage and delivery device.

24. The feedback and compliance device according to claim 23, wherein the processing unit is programmed to cause the one or more feedback devices to provide feedback information in the form of:

(i) an instruction to shake the medication storage and delivery device in response to determining that the medication storage and delivery device has been inserted into the feedback and compliance device, (ii) an instruction to actuate the medication storage and delivery device in response to determining that the medication storage and delivery device has been shaken, (iii) an instruction to inhale in a first particular manner in response to determining that the medication storage and delivery device has been actuated, and (iv) an instruction instructing the patient to hold his or her breath in a second particular manner in response to determining that inhalation in the first particular manner has been completed.

25. The feedback and compliance device according to claim 23, wherein the processing unit is programmed to cause the one or more feedback devices to provide feedback information in the form of:

(i) a first indication indicating that the medication storage and delivery device has been properly inserted into the feedback and compliance device in response to determining that the medication storage and delivery device has been inserted into the feedback and compliance device, (ii) a second indication indicating that the medication storage and delivery device has been properly shaken in response to determining that the medication storage and delivery device has been shaken, (iii) a third indication indicating that the medication storage and delivery device has been properly actuated in response to determining that the medication storage and delivery device has been actuated, (iv) a fourth indication indicating that inhalation has been properly performed in response to determining that inhalation in a first particular manner has been completed, and (v) a fifth indication indicating that breath hold has been properly performed in response to determining that the patient has held his or her breath in a second particular manner.

26. The feedback and compliance device according to claim 25, wherein the one or more feedback devices include a plurality of LEDs and wherein the first indication, the second indication, the third indication, the fourth indication and the fifth indication each comprise causing an associated one of the LEDs to emit light of a certain color.

27. The feedback and compliance device according to claim 23, wherein the feedback and compliance device includes a housing defining the opening, the housing including a top portion located above the opening, a bottom portion located below the opening, a front side and a rear side, the outlet extending outwardly from the front side, wherein the force sensing device is provided in the housing in the bottom portion.

28. The feedback and compliance device according to claim 27, wherein the bottom portion includes a channel extending completely therethrough from the rear side to the front side, the channel being structured to allow fluid flow through the housing, and wherein the flow sensor is positioned in the bottom portion adjacent to the channel.

29. The feedback and compliance device according to claim 22, comprising an infra-red sensor for sensing opening of the exhalation valve.

30. The feedback and compliance device according to claim 22, wherein the feedback and compliance device includes a housing defining the opening, the housing including a top portion located above the opening, a bottom portion located below the opening, a front side and a rear side, the outlet extending outwardly from the front side, and wherein the infra-red sensors are provided in the top portion on the front side.

31. The feedback and compliance device according to claim 22, wherein the one or more feedback devices include a plurality of LEDs, and wherein the processing unit is programmed to cause selected ones of the LEDs to emit light of a certain color based on an output of at least one of the one or more sensors, the feedback information comprising the light of a certain color.

32. The feedback and compliance device according to claim 22, wherein the one or more feedback devices include a speaker, and wherein the processing unit is programmed to cause the speaker to provide the audible instructions relating to proper use of the respiratory drug delivery apparatus based on an output of at least one of the one or more sensors.

33. The feedback and compliance device according to 22, wherein the one or more sensors include one or more microphones to detect sounds indicative of inhalation and/or actuation of the medication delivery device.