Clinical study product dispensing device

• US 10,157,265 B1
• Filed: 09/21/2017
• Issued: 12/18/2018
• Est. Priority Date: 09/21/2017
• Status: Active Grant

• Current Assignee: RAI STRATEGIC HOLDINGS, INC. (British American Tobacco PLC)
• Original Assignee: RAI STRATEGIC HOLDINGS, INC. (British American Tobacco PLC)
• Inventors: Darnell, John H.
• Primary Examiner(s): Collins, Michael
• Application Number:
  US15/711,529
• Time in Patent Office: 453 Days
• Field of Search: 700231-244
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 7/0076 Medicament distribution means with pill counting devices A61J7/02; with time indication A61J7/04; containers or packages with special means for dispensing contents B65D83/00
• CPC Class Codes: A61J 7/0427 with direct interaction with a dispensing or delivery system
• CPC Class Codes: A61J 7/0445 for preventing drug dispensing during a predetermined time period
• CPC Class Codes: A61J 7/0463 for multiple patients
• CPC Class Codes: A61J 7/0481 working on a schedule basis
• CPC Class Codes: A61M 11/042 electrical
• CPC Class Codes: A61M 15/06 Inhaling appliances shaped like cigars, cigarettes or pipes
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/3653 by Joule effect, i.e. electric resistance
• 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 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8237 Charging means
• CPC Class Codes: A61M 2209/02 Equipment for testing the apparatus
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A dispensing device and a method of operating a dispensing device for use in studying a consumable unit used by a clinical study participant are provided. The device comprises a housing that includes a delivery aperture and a compartment configured to store an unconsumed consumable unit therein. The device further includes a dispensing mechanism located within the housing and configured to release the stored unconsumed consumable unit to the clinical study participant via the delivery aperture upon verifying the identity of the clinical study participant and a controller configured to interface with the dispensing mechanism and the user input device. A user input device is also included and is configured to receive input from the clinical study participant corresponding to identification information relating to the clinical study participant and is further configured to receive input from the clinical study participant in response to one or more questionnaires relating to consumption of the consumable unit.

Claims

1. A dispensing device for use in studying a consumable unit used by a clinical study participant, said device comprising:

a housing that includes a delivery aperture and a compartment configured to store an unconsumed consumable unit therein;

a user input device configured to receive input from the clinical study participant corresponding to the identity of the clinical study participant;

a dispensing mechanism located within the housing and configured to release the stored unconsumed consumable unit to the clinical study participant via the delivery aperture upon verification of the identity of the clinical study participant; and

a controller configured to interface with the dispensing mechanism and the user input device,

wherein the user input device is further configured to receive input from the clinical study participant in response to one or more questionnaires relating to consumption of the consumable unit.

2. The dispensing device of claim 1, further comprising a reader located in the housing configured to gather data from the unconsumed consumable unit.

3. The dispensing device of claim 1, wherein the housing further includes a spent unit aperture and a second compartment configured to receive at least a portion of a consumed consumable unit via the spent unit aperture.

4. The dispensing device of claim 3, further comprising a reader located in the housing and configured to gather data from the consumed consumable unit.

5. The dispensing device of claim 1, wherein the input corresponding to the identity of the clinical study participant comprises a user number or access code.

6. The dispensing device of claim 1, wherein the consumable unit comprises an aerosol delivery device.

7. The dispensing device of claim 1, wherein the controller is further configured to control the dispensing mechanism according to a clinical study protocol.

8. The dispensing device of claim 1, wherein the user input device further comprises a display configured to display information to the clinical study participant.

9. The dispensing device of claim 8, wherein the information conveyed to the clinical study participant includes the one or more questionnaires relating to consumption of the consumable unit.

10. The dispensing device of claim 1, wherein the controller is further configured to control transfer of data to a remote device.

11. The dispensing device of claim 1, wherein the device is configured to be hand-held.

12. The dispensing device of claim 11, further comprising a rechargeable battery configured to provide power to the dispensing mechanism, the user input device, and the controller.

13. A method of operating a dispensing device for use in studying a consumable unit used by a clinical study participant, said method comprising:

storing an unconsumed consumable unit inside a compartment of a housing that includes a delivery aperture;

receiving input via a user input device from a clinical study participant corresponding to the identity of the clinical study participant;

releasing the stored unconsumed consumable unit using a dispensing mechanism located within the housing to the clinical study participant via the delivery aperture upon verification of the identity of the clinical study participant; and

receiving further input from the clinical study participant via the user input device in response to one or more questionnaires relating to consumption of the consumable unit.

14. The method of claim 13, further comprising gathering data from the unconsumed consumable unit using a reader located in the housing.

15. The method of claim 13, further comprising receiving into a second compartment at least a portion of a consumed consumable unit via a spent unit aperture of the housing.

16. The method of claim 15, further comprising gathering data from the consumed consumable unit using a reader located in the housing.

17. The method of claim 13, wherein the input corresponding to the identity of the clinical study participant comprises a user number or access code.

18. The method of claim 13, wherein consumable unit comprises an aerosol delivery device.

19. The method of claim 13, further comprising controlling the dispensing mechanism according to a clinical study protocol.

20. The method of claim 13, further comprising displaying information to the clinical study participant via a display portion of the user input device.

21. The method of claim 20, wherein the information conveyed to the clinical study participant includes the one or more questionnaires relating to consumption of the consumable unit.

22. The method of claim 13, further comprising transferring data to a remote device.