Extracorporeal Devices and Methods For Facilitating Cessation of Undesired Behaviors

• US 20110263947A1
• Filed: 10/22/2010
• Published: 10/27/2011
• Est. Priority Date: 10/24/2009
• Status: Active Grant

• Current Assignee: Pivot Health Technologies Incorporated
• Original Assignee: Carrot, Inc.
• Inventors: Utley, Haley Grace, Utley, Alek Denton, Utley, Kathryn Mary, Utley, David Scott, Utley, Emma Kathryn, Utley, Jack Denton, Utley, MacKenzie Taylor
• Granted Patent: US 9,675,275 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/4845 Toxicology, e.g. by detection of alcohol, drug or toxic products A61B5/4848 takes precedence

Abstract

Devices, Methods and Systems are disclosed for assisting patients in behavioral modification and cessation programs aimed at terminating undesired behaviors such as smoking, alcohol use and others. Patient devices with automated patient prompting for self-testing, analysis of test results and data logging are included in a networked system with a specifically designed treatment modality.

Claims

1. A method for facilitating cessation of undesired behavior in a patient, comprising:

configuring a patient device with a predetermined test protocol including patient test prompts;

prompting the patient in accordance with said predetermined test protocol to provide at least one biological input to said patient device, the biological input being correlated to the undesired behavior;

analyzing said patient biological input to said patient device;

generating a machine readable data set representative of the patient input based on said analyzing;

associating said data set with a specific patient biological input;

evaluating the predetermined test protocol based on said data set; and

altering or maintaining the predetermined test protocol based on said evaluation.

2. The method of claim 1, further comprising

determining whether the patient properly provided a biological input in response to said prompting;

and

re-prompting the patient to provide said at least one biological input when said determining result is negative.

3. The method of claim 1, wherein said altering comprises remotely reconfiguring the test protocol in the patient device through a communications network.

4. The method of claim 1, further comprising:

prompting the patient to input requested information to said patient device through a user interface; and

associating the requested information with the data set associated with a specific patient biological input.

5. The method of claim 4, wherein said evaluating is additionally based on the requested information associated with said data set.

6. The method of claim 4, further comprising transmitting said data set and associated requested information to a health care provider device.

7. The method of claim 3, further comprising:

communicating with the patient device through a network; and

prompting the patient to provide at least one biological input outside of the predetermined test protocol.

8. The method of claim 3, further comprising displaying said data set and associated requested information on a healthcare provider device.

9. The method of claim 1, further comprising:

collecting data related to the patient undesired behavior; and

analyzing said patient behavior data to determine the predetermined test protocol.

10. The method as in claim 9, wherein the predetermined test protocol includes one at least one of the following parameters:

active period during day, type of signal, number of prompts per day, variability of number of prompts each day, min/max prompts per day, characterization of night time prompts, ability to defer prompts due to other activities, manner in which deferred prompts are handled and grouping of prompts during the day.

11. The method of claim 1, further comprising:

determining patient compliance in response to said prompting; and

re-prompting the patient if non-compliance determined.

12. The method of claim 11, further comprising:

permitting the patient to delay a biological input in response to said prompting for a set time period; and

re-prompting the patient after said set time period

13. The method of claim 1, wherein:

the test protocol comprises a part of a patient treatment protocol;

said evaluating further comprises evaluating the treatment protocol; and

said altering or maintaining comprises altering or maintaining the treatment protocol.

14. The method of claim 11, wherein said treatment protocol comprises a course of therapy to facilitate cessation the undesired behavior based at least in part on biological inputs from the patient device.

15. The method of claim 1, wherein said prompting comprises at least one of instructing the patient to place a disposable strip or a portion of the patient device in the oral cavity, and/or to blow into an inlet in the patient device.

16. The method of claim 15, wherein said prompting further comprises instructing the patient to place the test strip in a test receptacle in said patient device.

17. The method of claim 1, further comprising linking the patient device with a health care provider device comprises intermittently by direct connection or by intermittent network connection for synchronizing said devices.

18. The method of claim 1, further comprising providing communication between said patient device and a health care provider device through a network.

19. The method of claim 18, wherein said communication is provided in real time, wherein each biological input associated data set is uploaded to the healthcare provider device upon acquisition.

20. The method of claim 18, further comprising providing feedback to the patient through said health care provider device communication with the patient device.

21. The method of claim 4, wherein said requested information comprises information regarding patient life events temporally associated with select test protocol events.

22. The method of claim 4, wherein said requested information comprises at least one of blood pressure, quality of life scores, voluntary behavior reporting, quality of life survey questions, body weight, current drug therapy dosing, blood, and heart rate.

23. The method of claim 8, further comprising displaying trend data, including at least one of a total number of days in the program, baseline smoking behavior compared to current smoking behavior, number of cigarettes avoided in last period of time, number of hours, days, months, and years of lifetime saved, time to goal of smoking cessation, daily results, weekly results, progress towards goal displayed numerically or graphically.

28. The system of claim 1, wherein the test element comprises a detector configured to detect substances in saliva.

29. The system of claim 1, wherein the patient device and healthcare provider device are configured for communication through a network.

30. The system of claim 29, wherein the network is a telephone network.

31. The system of claim 29, wherein the network is a computer network.

32. The system of claim 29, wherein the network is the Internet.

36. The system of claim 1, wherein the PD storage module further includes instructions for delaying said determining the completeness of biological input for a set period in response to a patient input through the PD user interface.

24. A system for facilitating cessation of undesired behavior in a patient, comprising:

a patient device (PD) configured and dimensioned to be carried by the patient, the patient device comprising;

a PD user interface,

a test element configured to receive a biological input from the patient and output information representative of the content of the biological input,

PD storage module containing instructions for a predetermined test protocol, comprising;

prompting the patient through the user interface to provide a biological input to the test element at selected intervals,

determining the completeness of a biological input, and

providing additional patient prompts based on said completeness determination, and

PD execution module communicating with the user interface, the test element and the storage module, the PD execution module configured to execute instructions contained in said PD storage module; and

a health care provider device (HCPD) configured to be accessed by a health care provider, comprising

an HCPD user interface,

HCPD storage module containing instructions for

displaying and manipulating information representative of the content of the biological input, and

revising the predetermined test protocol based on at least one of user input and said information representative of the content of the biological input, and

HCPD execution module communicating with the user interface and storage module, the execution module configured to execute instructions contained in said HCPD storage module,

wherein said patient device and healthcare provider device are configured for communication there between.

25. The system of claim 24, wherein one of the PD or HCPD storage modules contains instructions for generating a machine readable data set based on said test element output information, and for associating said data set with a specific patient biological input.

26. The system of claim 25, wherein one of the PD or HCPD storage module contains instructions for causing the patient device to prompt the patient to input requested information to said patient device through the PD user input and for associating the requested information with a data set associated with a specific patient biological input.

27. The system of claim 24, wherein the test element comprises a detector configured to detect substances in exhaled breath.

33. The system of claim 24, wherein the patient device and health care provider device are configured for communication through a transferrable storage medium.

34. The system of claim 24, wherein the patent device and health care provider device are configured for communication through a direct wired connection.

35. The system of claim 24, further comprising plural said patient devices configured to communicate with at least one said health care provider device.

37. The system of claim 24, wherein:

the patient device further comprises an identification device for acquiring patient identifying information correlated to a biological input; and

said identification device communicating with said storage module and execution module for associating the acquired identifying information with the correlated biological input and storing said associated identifying information.

38. The system of claim 24, wherein the PD storage module further includes instructions for receiving unprompted patient input through the PD user input and for associating said unprompted input with a biological input based on a predetermined algorithm.

39. The system of claim 24, wherein said patient device is contained within a housing.

40. The system of claim 24, wherein said patient device comprises at least two housings, with the test element disposed in one housing and the user interface disposed in a separate housing, and wherein said test element and user interface are configured for wireless communication there between.

41. The system of claim 24, wherein said test element is configured for detecting one or more substances associated with smoking tobacco products.

42. The system of claim 24, wherein said test element is configured for detecting one or more substances associated with smoking of illegal drugs.

43. The system of claim 24, wherein said test element is configured for detecting alcohol.

44. The system of claim 24, wherein the test element is configured for detecting substances associated with oral ingestion or transdermal absorption of specified compounds.

45. The system of claim 44, wherein said specified compounds include one of molecules related to benzodiazepines, narcotics, LSD, GHB, Rohypnol, ketamine, methamphetamine, PCP/phencyclidine, anabolic steroids, and secreted or exhaled metabolites of said substances.

46. The system of claim 24, wherein the test element is configured for detecting one or more substances associated with oral placement of products.

47. The system of claim 24, wherein the test element is configured for detecting one or more substances associated with nasal sniffing of substances of abuse.

48. An apparatus for use in connection with facilitating cessation of undesired behavior in a patient, comprising:

at least one housing configured and dimensioned to be carried by the patient;

a user interface disposed in said at least one housing;

a test element disposed in said at least one housing, the test element being configured to receive a biological input from the patient and output information representative of the content of the biological input,

a storage module containing instructions comprising;

a) executing a predetermined test protocol including,

1) prompting the patient through the user interface to provide a biological input to the test element at selected intervals,

2) determining the completeness of a biological input,

3) providing additional patient biological input prompts based on said completeness determination,

4) prompting the patient to input requested information through said user interface,

b) generating user readable indicator based on said test element output and displaying said output on the user interface,

c) associating the user readable indicator with a specific biological input,

d) associating the requested information with a specific user readable indicator associated with a specific patient biological input, and

e) storing test result information including the user readable indicator and associated requested information in said storage module; and

an execution module communicating with the user interface, the test element and the storage module, the execution module configured to execute said instructions,

wherein said apparatus is configured to communicate through a network for transfer of said test result information.

49. The apparatus of claim 48, wherein the storage module further includes instructions for delaying said determining the completeness of biological input for a set period in response to an patient input through the user interface.

50. The system of claim 49, further comprising an identification device for acquiring patient identifying information correlated to a biological input, said identification device communicating with said storage module and execution module for associating the acquired identifying information with the correlated biological input and storing said associated identifying information.

51. The apparatus of claim 48, wherein said apparatus comprises a single housing.

52. The apparatus of claim 48, wherein said apparatus comprises two housings with the test element disposed in a first housing and said user interface, storage module and execution module disposed in a second housing, said test element and execution module being configured for wireless communication there between.

53. A method for collecting and confirming patient participation in select behaviors, comprising:

configuring a patient device with a predetermined test protocol including patient test prompts;

prompting the patient in accordance with said predetermined test protocol to provide at least one biological input to said patient device, the biological input being correlated to the select behavior;

determining whether the patient properly provided a biological input in response to said rompting;

re-prompting the patient to provide said at least one biological input when said determining result is negative;

analyzing said patient biological input to said patient device;

generating a machine readable data set representative of the patient input based on said analyzing;

associating said data set with a specific patient biological input;

prompting the patient to input requested information to said patient device through a user interface;

associating the requested information with the data set associated with a specific patient biological input;

evaluating the predetermined test protocol based on said data set and the requested information associated with said data set.

54. The method of claim 53, further comprising:

transmitting said data set and associated requested information to a health care provider device; and

displaying said data set and associated requested information on a healthcare provider device.