Systems and methods for competency training and use authorization for dispensing an agent

• US 10,229,607 B2
• Filed: 04/30/2013
• Issued: 03/12/2019
• Est. Priority Date: 04/30/2013
• Status: Active Grant

• Current Assignee: Elwha LLC (Intellectual Ventures LLC)
• Original Assignee: Elwha LLC (Intellectual Ventures LLC)
• Inventors: Baym, Michael H., Cheatham, III, Jesse R., Eckhoff, Philip A., Hyde, Roderick A., Kare, Jordin T., Wood, Jr., Lowell L.
• Primary Examiner(s): Musselman, Timothy A
• Application Number:
  US13/873,991
• Publication Number:
  US 20140322682A1
• Time in Patent Office: 2,142 Days
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: G07C 9/20 involving the use of a pass
• CPC Class Codes: G09B 19/003 Repetitive work cycles; Sequence of movements
• CPC Class Codes: G09B 23/28 for medicine
• CPC Class Codes: G09B 5/02 with visual presentation of the material to be studied, e.g. using film strip
• CPC Class Codes: G09B 7/02 of the type wherein the student is expected to construct an answer to the question which is presented or wherein the machine gives an answer to the question presented by a student
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Systems and methods for competency training and use authorization for dispensing an agent are described, which include: an agent-dispensing device configured to dispense one or more agents to a user, and including a controllable agent-dispensing mechanism and a receiver configured to receive a signal and to activate or deactivate a locking mechanism coupled to the controllable agent-dispensing mechanism; a computing device having a display and a user interface; and a web-based interactive tool accessible on the computing device, the web-based interactive tool including a training module to provide training to the user in proper use of the agent-dispensing device, a verification module to verify a competency of the user in the proper use of the agent-dispensing device, and an activation module responsive to the verification module and operable to provide an activation signal to deactivate the locking mechanism to allow dispensing of the one or more agents after verifying the competency of the user.

Claims

1. A system for competency training and use authorization for dispensing an agent, comprising:

an agent-dispensing device including

at least one reservoir configured to store one or more agents,

a controllable agent-dispensing mechanism in communication with the at least one reservoir,

a locking mechanism coupled to the controllable agent-dispensing mechanism,

a microprocessor including circuitry configured to operate the agent-dispensing device in a dispensing mode or a training mode and switching circuitry configured to switch operation of the agent-dispensing device between the dispensing mode and the training mode,

one or more use sensors located on the agent-dispensing device and responsive to a monitored at least one operational step for use of the agent-dispensing device performed by a user in the training mode,

and a transmission unit including an antenna;

a computing device having a display and a user interface, the computing device operable to receive a signal from the transmission unit of the agent-dispensing device, the signal including information from the one or more use sensors regarding the monitored at least one operational step for use of the agent-dispensing device performed by the user in the training mode;

a caregiver authorization code and a patient authorization code; and

a web-based interactive tool including stored text, images, audio, or video accessible to the user through the display and user interface of the computing device, the web-based interactive tool including

an authorization module configured to receive and verify the caregiver authorization code and the patient authorization code prior to allowing the user access to training, verification, and activation;

wherein the user includes a caregiver, a patient, or both;

a training module configured to provide to the user one or more instructions for performing the at least one operational step for use of the agent-dispensing device in the training mode and to provide prescribing information to the user including a side effect profile of the one or more agents stored in the at least one reservoir;

a verification module configured to receive the information from the one or more use sensors on the agent-dispensing device regarding the monitored at least one operational step for use of the agent-dispensing device performed by the user in the training mode, to provide a written or oral examination to test the user'"'"'s knowledge of the side effect profile of the one or more agents stored in the at least one reservoir, and to verify a competency of the user in the at least one operational step for use of the agent-dispensing device and in the side effect profile of the one or more agents stored in the at least one reservoir based on the user'"'"'s responses in the written or oral examination and the information received from the one or more use sensors on the agent-dispensing device regarding the monitored at least one operational step for use of the agent-dispensing device performed by the user in the training mode; and

an activation module responsive to the verification module and operable to provide an activation signal to the transmission unit of the agent-dispensing device to deactivate the locking mechanism coupled to the controllable agent-dispensing mechanism to allow dispensing of the one or more agents in the dispensing mode from the at least one reservoir of the agent-dispensing device after verifying the competency of the user.

2. The system of claim 1, wherein the authorization module of the web-based interactive tool includes circuitry configured to

receive the caregiver authorization code and the patient authorization code;

compare the received caregiver authorization code and the received patient authorization code with a set of approved authorization codes; and

unlock access to at least one of the training module, the verification module, or the activation module if the received caregiver authorization code and the received patient authorization code both satisfy a requirement of the set of approved authorization codes.

3. The system of claim 1, wherein the authorization module of the web-based interactive tool includes circuitry configured to authenticate the user as an authorized user of the agent-dispensing device and to transmit a signal to the agent-dispensing device to incapacitate at least one of the controllable agent-dispensing mechanism, the locking mechanism, the microprocessor, the user sensors, or the transmission unit if the user is not an authorized user.

4. The system of claim 1, wherein the at least one reservoir of the agent-dispensing device includes at least one removable cartridge configured for storing and dispensing the one or more agents, the at least one removable cartridge including a cartridge identification code readable by cartridge identification circuitry associated with the agent-dispensing device, wherein the content of training and verification provided by the web-based interactive tool is based on the cartridge identification code.

5. The system of claim 1, wherein the agent-dispensing device includes a user-device interface.

6. The system of claim 1, wherein the agent-dispensing device includes a user-device interface and user identification circuitry configured to receive user identification input from the user-device interface, compare the received user identification input with a set of stored authorized user identification inputs, and verify the user as an authorized user of the agent-dispensing device.

7. The system of claim 1, wherein the computing device comprises a mobile communication device operably coupled to the agent-dispensing device.

8. The system of claim 1, wherein the one or more instructions for performing the at least one operational step for use of the agent-dispensing device include at least one of one or more text-based instructions, one or more image-based instructions, one or more audio-based instructions, or one or more video-based instructions for performing the at least one operational step for use of the agent-dispensing device.

9. The system of claim 1, wherein the verification module of the web-based interactive tool includes a text-based questionnaire with one or more text-based questions regarding the at least one operational step for use of the agent-dispensing device and regarding the side effect profile of the one or more agents stored in the at least one reservoir.

10. The system of claim 1, wherein the verification module of the web-based interactive tool includes an audio-based questionnaire with one or more audio-based questions regarding the at least one operational step for use of the agent-dispensing device and regarding the side effect profile of the one or more agents stored in the at least one reservoir.

11. The system of claim 1, further comprising:

an image capture device operably coupled to the computing device and operably linked to the verification module of the web-based interactive tool.

12. The system of claim 11, wherein the verification module of the web-based interactive tool includes circuitry configured to receive at least one image of the user training with the agent-dispensing device from the image capture device and to compare the received at least one image with one or more reference images to verify the competency of the user in the at least one operational step for use of the agent-dispensing device.

13. The system of claim 1, wherein the web-based interactive tool includes circuitry configured to send a report to the care-giver regarding a level of competency of the user in the at least one operational step for use of the agent-dispensing device and in the side effect profile of the one or more agents stored in the at least one reservoir.

14. The system of claim 1, wherein the verification module of the web-based interactive tool includes circuitry configured to

generate a set of training results for the user upon completion of the training provided by the training module;

and

certify the user to be competent to use the agent-dispensing device if the generated set of training results for the user meets or exceeds a pre-defined performance threshold.

15. The system of claim 14, wherein the web-based interactive tool includes circuitry configured to send a notification to the care-giver indicating whether or not the generated set of training results for the user meets or exceeds the pre-defined performance threshold.

16. The system of claim 1, wherein the activation module of the web-based interactive tool includes a signal generator, the signal generator configured to transmit the activation signal to the transmission unit of the agent-dispensing device to deactivate the locking mechanism to allow dispensing of the one or more agents from the at least one reservoir of the agent-dispensing device after verifying the competency of the user.

17. The system of claim 1, wherein at least one of the training module, the verification module, or the activation module of the web-based interactive tool is updateable.

27. The system of claim 1, wherein the training module of the web-based interactive tool is configured to assign a value for each of the monitored at least one operational step for use of the agent-dispensing device performed by the user in the training mode based on feedback from the one or more use sensors;

and wherein the verification module is configured to certify the user is competent to use the agent-dispensing device if the assigned value for each of the monitored at least one operational step for use of the agent-dispensing device performed by the user in the training mode meets or exceeds a pre-defined performance threshold.

28. The system of claim 1, wherein the side effect profile of the one or more agents stored in the at least one reservoir includes at least one of a contraindication, a warning, a precaution, an adverse reaction, a drug interaction, drug dependency, use in a specific population, or overdose.

18. A method of verifying user competency of an agent-dispensing device, comprising:

providing a web-based interactive tool to a user through a computing device in communication with the agent-dispensing device, the web-based interactive tool including stored text, images, audio, and/or video, and

an authorization module to provide access to the web-based interactive tool to authorized users based on receipt of a caregiver authorization code and a patient authorization code;

a training module to provide to the user training in at least one operational step for use of the agent-dispensing device and a side effect profile of one or more agents stored in the agent-dispensing device,

a verification module to verify a competency of the user in the at least one operational step for use of the agent-dispensing device and in the side effect profile of the one or more agents stored in the agent-dispensing device, and

an activation module responsive to the verification module and operable to provide an activation signal to deactivate a locking mechanism of the agent-dispensing device;

receiving the caregiver authorization code and the patient authorization code with the authorization module of the web-based interactive tool;

comparing the received caregiver authorization code and the received patient authorization code with a set of approved authorization codes;

unlocking access to at least one of the training module, the verification module, or the activation module of the web-based interactive tool if the received caregiver authorization code and the received patient authorization code both satisfy a requirement of the set of approved authorization codes;

training the user in the at least one operational step for use of the agent-dispensing device using the training module of the web-based interactive tool and one or more use sensors on the agent-dispensing device for monitoring the at least one operational step for use of the agent-dispensing device performed by the user in a training mode;

training the user in the side effect profile of the one or more agents stored in the agent-dispensing device;

receiving a signal with the computing device from a transmission unit of the agent-dispensing device, the signal including information from the one or more use sensors on the agent-dispensing device regarding the monitored at least one operational step for use of the agent-dispensing device performed by the user in the training mode;

verifying the competency of the user in the at least one operational step for use of the agent-dispensing device and in the side effect profile of the one or more agents stored in the agent-dispensing device using the verification module of the web-based interactive tool based on user responses in the training module and the received information from the one or more use sensors on the agent-dispensing device regarding the monitored at least one operational step for use of the agent-dispensing device performed by the user in the training mode; and

activating the agent-dispensing device with the activation module of the web-based interactive tool by providing the activation signal to deactivate the locking mechanism coupled to the controllable agent-dispensing mechanism to allow dispensing of the one or more agents from the agent-dispensing device in a dispensing mode after verifying the competency of the user in the at least one operational step for use of the agent-dispensing device and in the side effect profile of the one or more agents.

19. The method of claim 18, wherein providing the web-based interactive tool to the user through the computing device includes providing the web-based interactive tool to the user through the computing device via the Internet.

20. The method of claim 18, wherein training the user in the at least one operational step for use of the agent-dispensing device using the training module includes training the user with one or more of text-based training, image-based training, audio-based training, or video-based training associated with the training module.

21. The method of claim 18, wherein verifying the competency of the user in the at least one operational step for use of the agent-dispensing device and in the side effect profile of the one or more agents stored in the agent-dispensing device using the verification module includes administering a questionnaire to the user using the computing device, assigning a questionnaire score based on the user'"'"'s answers to the questionnaire, and determining if the assigned questionnaire score meets or exceeds a pre-defined questionnaire score threshold stored in the verification module.

22. The method of claim 18, wherein verifying the competency of the user in the at least one operational step for use of the agent-dispensing device using the verification module includes capturing one or more images of the user with an image capture device coupled to the computing device while the user is training with the agent-dispensing device, assigning a performance score based on comparing the captured one or more images with a set of reference images in the verification module, and determining if the assigned performance score meets or exceeds a pre-defined performance score threshold stored in the verification module.

23. The method of claim 18, wherein verifying the competency of the user in the at least one operational step for use of the agent-dispensing device using the verification module includes activating the training mode on the agent-dispensing device, monitoring the at least one operational step for use of the agent-dispensing device in the training mode with the one or more use sensors on the agent-dispensing device, assigning a value for each of the monitored at least one operational step, transmitting a signal from the agent-dispensing device to the computing device with information regarding the assigned value for each of the monitored at least one operational step, and determining if the assigned value for each of the monitored at least one operational step meets or exceeds a pre-defined value threshold stored in the verification module.

24. The method of claim 18, wherein verifying the competency of the user in the at least one operational step for use of the agent-dispensing device and in the side effect profile of the one or more agents stored in the agent-dispensing device with the verification module of the web-based interactive tool includes

generating a set of training results for the user upon completion of the training module;

and

certifying the user is competent to use the agent-dispensing device if the set of training results for the user meets or exceeds a pre-defined performance threshold.

25. The method of claim 18, wherein activating the agent-dispensing device with the activation module of the web-based interactive tool by providing the activation signal to deactivate the locking mechanism includes sending a wireless activation signal to deactivate the locking mechanism.

26. The method of claim 18, further comprising:

re-verifying a competency of the user in the at least one operational step for use of the agent-dispensing device after a time interval, in response to an event, or a combination thereof.

29. A system for competency training and use authorization for dispensing an agent, comprising:

a replaceable cartridge including one or more agents, the replaceable cartridge including a cartridge identification code;

an agent-dispensing device including

a docking site sized and positioned to accept the replaceable cartridge including the one or more agents;

a holding reservoir positioned to accept the one or more agents from the replaceable cartridge;

a controllable agent-dispensing mechanism in communication with the holding reservoir;

a locking mechanism operably coupled to the controllable agent-dispensing mechanism;

a microprocessor including

cartridge identification circuitry configured to read the cartridge identification code,

operating circuitry configured to operate the agent-dispensing device in a dispensing mode or a training mode, and

switching circuitry configured to switch operation of the agent-dispensing device between the dispensing mode and the training mode,

one or more use sensors located on the agent-dispensing device and responsive to a monitored at least one operational step for use of the agent-dispensing device performed by a user in the training mode,

and a transmission unit including an antenna;

a computing device having a display and a user interface, the computing device operable to receive a signal from the transmission unit of the agent-dispensing device, the signal including information regarding the cartridge information code and information from the one or more use sensors regarding the monitored at least one operational step for use of the agent-dispensing device performed by the user in the training mode; and

a web-based interactive tool including stored text, images, audio, or video accessible to the user through the display and user interface of the computing device, the web-based interactive tool including

a training module configured to receive the information regarding the cartridge identification code and to provide to the user a specific set of instructions for performing the at least one operational step for use of the agent-dispensing device in the training mode based on the cartridge identification code and provide to the user prescribing information including a side effect profile of the one or more agents stored in the replaceable cartridge;

a verification module configured to receive the information from the one or more use sensors on the agent-dispensing device regarding the monitored at least one operational step for use of the agent-dispensing device performed by the user in the training mode, to provide a written or oral examination to test the user'"'"'s knowledge of the side effect profile of the one or more agents stored in the replaceable cartridge, and to verify a competency of the user in the at least one operational step for use of the agent-dispensing device and in the side effect profile of the one or more agents stored in the replaceable cartridge based on the user'"'"'s responses in the written or oral examination and the information received from the one or more use sensors on the agent-dispensing device regarding the monitored at least one operational step for use of the agent-dispensing device performed by the user in the training mode; and

an activation module responsive to the verification module and operable to provide an activation signal to the transmission unit of the agent-dispensing device to deactivate the locking mechanism coupled to the controllable agent-dispensing mechanism to allow dispensing of the one or more agents in the dispensing mode from the holding reservoir after verifying the competency of the user.

30. The system of claim 29, further comprising:

a caregiver authorization code and a patient authorization code; and

an authorization module associated with the web-based interactive tool and including circuitry configured to receive and verify the caregiver authorization code and the patient authorization code prior to allowing the user access to at least one of the training module, the verification module, and the activation module, wherein the user includes a caregiver, a patient, or both.