Extracorporeal devices and methods for facilitating cessation of undesired behaviors

• US 9,420,971 B2
• Filed: 11/10/2014
• Issued: 08/23/2016
• Est. Priority Date: 10/24/2009
• Status: Active Grant

• Current Assignee: Pivot Health Technologies Incorporated
• Original Assignee: Carrot Sense, Inc.
• Inventors: Utley, David Scott, Utley, Jack Denton, Utley, Kathryn Mary, Utley, Alek Denton, Utley, Haley Grace, Utley, MacKenzie Taylor, Utley, Emma Kathryn
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): Sands, Davin K
• Application Number:
  US14/537,070
• Publication Number:
  US 20150065825A1
• Time in Patent Office: 652 Days
• Field of Search: 607/900
• US Class Current: 1/1
• CPC Class Codes: A24F 47/00 Smokers' requisites not otherwise provided for
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• 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 5/1171 based on the shapes or appearances of their bodies or parts thereof
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4845 Toxicology, e.g. by detection of alcohol, drug or toxic products A61B5/4848 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/70 relating to mental therapies, e.g. psychological therapy or autogenous training
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

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 configured to be easily carried or worn including test units such as carbon monoxide blood level sensors 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. Devices and methods disclosed are particularly suited to use in smoking cessation treatment and programs.

Claims

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

a housing configured and dimensioned to be carried or worn by the patient;

a graphical user interface disposed in said housing, said interface configured to prompt the patient and receive informational inputs by the patient;

a photoplethysmogram (PPG) sensing unit configured to detect carbon monoxide in the patient'"'"'s blood and disposed in said housing, the PPG sensing unit being configured to receive a biological input from the patient and output information representative of the content of the biological input,

a storage module within said housing containing instructions comprising instructions for;

a) executing a predetermined test protocol including a number and timing of patient test prompts, said protocol further comprising;

prompting the patient through the user interface to provide a biological input to the test element at selected intervals corresponding to the number and timing of patient test prompts,

determining the completeness of the biological input, and

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

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

c) associating the test element output with a specific biological input,

d) transferring said test result information including the test element output associated with a specific biological input to a network or storage device, and

e) receiving instructions for altering the predetermined test protocol based on a remote evaluation of said test result information; and

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

2. The apparatus of claim 1, wherein the 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 user interface.

3. The apparatus of claim 1, further comprising an identification device disposed in said housing 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.

4. The apparatus of claim 1, wherein said apparatus is adapted for use in a smoking cessation treatment program and said PPG sensing unit is configured to detect the presence of a marker indicating smoking behavior.

5. The apparatus of claim 1, wherein said apparatus is configured to communicate with a remote station through at least one of a wireless or cellular network, removable storage device or wired connection for said transfer of test result information and said receipt of instructions.

6. The apparatus of claim 1, wherein said instructions further comprise instructions for associating informational inputs through the graphical user interface with specific patient biological inputs, and transferring said associated informational inputs with said test result information.

7. The apparatus of claim 1, wherein said sensing unit is configured to detect carbon monoxide levels in the patient'"'"'s blood based on carboxyhemoglobin detection.

8. The apparatus of claim 1, wherein the sensing unit comprises at least one of a light transmissive or light reflectance sensor.

9. An apparatus for use in connection with smoking cessation treatment of a patient, the apparatus comprising:

a housing configured and dimensioned to be carried or worn by the patient, and including a sensing unit configured to sense carbon monoxide levels in the patient when actuated by the patient and to output carbon monoxide level information;

a graphical user interface operatively connected with said sensing unit, said interface configured to prompt the patient actuate the sensing unit and receive informational inputs by the patient;

a storage module operatively connected with said sensing unit and graphical user interface containing instructions comprising instructions for;

a) executing a predetermined test protocol including a number and timing of patient test prompts, said protocol further comprising;

prompting the patient through the user interface to actuate the sensing unit at selected intervals corresponding to the number and timing of patient test prompts,

determining the completeness of a sensing event, and

providing additional patient sensing unit actuation prompts based on said completeness determination,

b) generating user readable indicator based on said sensing event and displaying said output on the graphical user interface,

c) associating the test element output with a specific sensing event,

d) correlating the carbon monoxide levels sensed in the patient with a time when the levels were sensed,

e) estimating a number of cigarettes and time of smoking per day based on the correlated carbon monoxide levels and time sensed,

f) transferring said test result information including the test element output associated with a specific sensing event to a network or storage device; and

g) receiving instructions for altering the predetermined test protocol based on a remote evaluation of said test result information; and

an execution module communicating with the graphical user interface, the sensing unit and the storage module, the execution module configured to execute said instructions.

10. The apparatus of claim 9, wherein the sensing unit comprises a photoplethysmogram (PPG) based sensor.

11. The apparatus of claim 10, wherein the sensing unit further comprises a patient removable light transmitter-receiver for placement on the patient'"'"'s skin in response to a patient test prompt.

12. The apparatus of claim 9, wherein said sensing unit is configured to determine patient carbon monoxide levels based on sensed carboxyhemoglobin levels.

13. A method of treating a patient, comprising:

determining a patient treatment protocol including a patient self-test protocol, the self-test protocol including plural patient test prompts at intervals defined by the patient treatment protocol;

configuring a patient device with said self-test protocol to prompt the patient at the patient test prompt intervals to provide biological inputs to said patient device, the patient device further configured to analyze the biological inputs for presence of carbon monoxide levels and generate a data set representative of said analysis, the data set including association of specific patient prompts with responsive biological input results;

correlating carbon monoxide levels sensed in the patient with a time when the levels were sensed;

receiving said data set representative of the analysis of the patient biological inputs;

tracking one or more interventions with the patient with respect to the correlated time and sensed levels;

determining an effect of the one or more interventions on the patient;

evaluating the patient treatment protocol based on said data set; and

altering or maintaining the patient treatment protocol based on said evaluating.

14. The method of claim 13, further comprising, when said evaluation results in altering the patient treatment protocol with an altered patient self-test protocol, reconfiguring the patient device with the altered patient self-test protocol.

15. The method of claim 13, wherein the patient self-test protocol includes at least one prompt to enter requested information to said patient device through a graphical user interface, said requested information to be included in the data set, said requested information including at least information regarding patient state temporally associated with select protocol events.

16. The method of claim 13, wherein said determining a patient treatment protocol comprises:

collecting patient behavior data related to patient conduct with respect to smoking by the patient; and

analyzing said patient behavior data.

17. The method of claim 16, wherein the patient self-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.

18. The method of claim 13, further comprising providing communication between said patient device and a health care provider device through a network, and said reconfiguring comprises remotely reconfiguring the patient self-test protocol in the patient device through a communications network.

19. The method of claim 13, wherein said patient device includes a comprises a photoplethysmogram (PPG) sensing unit and said prompting comprises prompting the patent to place a light transmitter-receiver for placement on the patient'"'"'s skin for carbon monoxide level measurement.