Devices and methods for detecting an analyte in salivary fluid

• US 8,898,069 B2
• Filed: 08/28/2009
• Issued: 11/25/2014
• Est. Priority Date: 08/28/2009
• Status: Active Grant

• Current Assignee: Gearbox LLC (Intellectual Ventures LLC)
• Original Assignee: The Invention Science Fund I, L.L.C. (Intellectual Ventures LLC)
• Inventors: Hood, Leroy E., Jung, Edward K. Y., Sweeney, Elizabeth A., Tegreene, Clarence T., Wood, Lowell L. Jr.
• Primary Examiner(s): Le, Michelle L
• Application Number:
  US12/584,055
• Publication Number:
  US 20110054938A1
• Time in Patent Office: 1,915 Days
• US Class Current: 705/2
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: G01N 33/14 Beverages
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10T 436/163333 Organic [e.g., chemical warfare agents, insecticides, etc.]

Abstract

Methods and systems are described herein for detecting one or more analyte in salivary fluid. Systems include: a discrete oral component configured for complete enclosure in a human oral cavity; at least one sensor configured to detect one or more analyte in salivary fluid; and an external device including a port configured for communication with the discrete oral component. Methods include: detecting one or more analyte within salivary fluid with at least one sensor integral to a discrete oral component, wherein the discrete oral component is configured to be completely enclosed in the oral cavity and includes one or more flavorant; and communicating information from the discrete oral component to at least one external device.

Claims

1. A system for detecting one or more analyte in salivary fluid, comprising:

a discrete oral component configured for complete enclosure in a human oral cavity without protrusion therefrom or attachment thereto, the discrete oral component configured to release at least one medicinal agent responsive to the presence of a substance in the salivary fluid;

at least one sensor incorporated within the discrete oral component and configured for removal therefrom, wherein the sensor specifically identifies the one or more analyte in the salivary fluid and generates a signal that the identification has been made; and

an external device including a port including a cavity configured for physical contact with the discrete oral component and including one or more devices for detection of the signal from the sensor.

2. The system of claim 1, comprising:

at least one flavorant, wherein the discrete oral component releases the at least one flavorant through passive displacement during contact with salivary fluid.

3. The system of claim 1, wherein the discrete oral component comprises:

at least one signaling element configured to signal contact with salivary fluid after a preset period of time.

4. The system of claim 1, wherein the discrete oral component includes at least one selective medium including cellulose with pores sized to allow diffusion of certain sized molecules.

5. The system of claim 1, wherein at least a portion of the discrete oral component is in a dehydrated form prior to contact with salivary fluid.

6. The system of claim 1, wherein at least a portion of the discrete oral component is an electronic chip sensor module configured for removal from the discrete oral component and replacement.

7. The system of claim 1, wherein the discrete oral component includes a transmucosal sampling mechanism.

8. The system of claim 1, wherein the discrete oral component comprises:

at least one recognition element configured to recognize a substance.

9. The system of claim 1, wherein the discrete oral component comprises:

at least one compound configured to be physiologically incorporated into a body of a user; and

at least one matrix configured to retain the at least one compound until the at least one compound contacts the salivary fluid.

10. The system of claim 1, wherein the discrete oral component comprises:

at least one reservoir including the at least one medicinal agent therein, wherein the at least one reservoir is operably connected to one or more time sensing device.

11. The system of claim 1, wherein the at least one sensor includes at least one biosensor including a piezoresistive micro-cantilever.

12. The system of claim 1, wherein the at least one sensor includes at least one chemical sensor including a single-walled carbon nanotube capacitor.

13. The system of claim 1, wherein the at least one sensor is a cantilever-based sensor that is configured to be directly responsive to at least one of the one or more analyte.

14. The system of claim 1, wherein the at least one sensor is configured to be responsive to a metabolite of at least one of the one or more analyte.

15. The system of claim 1, wherein the external device is configured to communicate with a network.

16. The system of claim 1, wherein the one or more analyte comprises:

at least one metabolite, wherein the metabolite is a metabolic product generated by physiology of a user of the discrete oral component.

17. The system of claim 1, comprising:

an instrument for placement and retrieval of the discrete oral component.

18. A method for detecting one or more analyte in salivary fluid comprising:

swallowable positioning a discrete oral component within an oral cavity, wherein the discrete oral component is configured to be completely enclosed in the oral cavity without protrusion therefrom or attachment thereto and includes one or more flavorant;

identifying the one or more analyte in salivary fluid with at least one sensor integral to the discrete oral component;

generating a first signal from the at least one sensor that the one or more analyte has been identified;

detecting the first signal from the at least one sensor with at least one external device;

releasing one or more agent responsive to the use of the discrete oral component;

identifying the one or more agent or a metabolite of the one or more agent in the salivary fluid with the at least one sensor;

generating a second signal from the at least one sensor that the one or more agent or the metabolite of the one or more agent has been identified; and

detecting the second signal from the at least one sensor with the at least one external device.

19. The method of claim 18, wherein identifying the one or more analyte comprises:

collecting a sample of salivary fluid with the discrete oral component.

20. The method of claim 18, wherein identifying the one or more analyte comprises:

providing one or more flavorant configured to be responsive to a physical condition of the discrete oral component, wherein the discrete oral component releases the at least one flavorant through passive displacement.

21. The method of claim 18, wherein identifying the one or more analyte comprises:

binding one or more analyte with a recognition element.

22. The method of claim 18, wherein identifying the one or more analyte comprises:

sequestering at least one of the one or more analyte with the discrete oral component.

23. The method of claim 18, wherein identifying the one or more analyte comprises:

transmucosal sampling.

24. The method of claim 18, wherein identifying the one or more analyte comprises:

identifying at least one metabolite, wherein the metabolite is a metabolic product generated by physiology of a user of the discrete oral component.

25. The method of claim 18, wherein identifying the one or more analyte comprises:

identifying one or more analyte within the salivary fluid with at least one biosensor wherein the at least one biosensor includes a piezoresistive micro-cantilever.

26. The method of claim 18, wherein identifying the one or more analyte comprises:

identifying one or more analyte within the salivary fluid with at least one chemical sensor, wherein the at least one chemical sensor includes a single-walled carbon nanotube capacitor.

27. The method of claim 18, wherein identifying the one or more analyte comprises:

identifying one or more analyte directly.

28. The method of claim 18, wherein identifying the one or more analyte comprises:

identifying one or more metabolite of the one or more analyte.

29. The method of claim 18, comprising:

providing an agent with the discrete oral component, wherein the agent is configured to be physiologically incorporated by the user of the discrete oral component.

30. The method of claim 18, comprising:

collecting and storing multiple results from the at least one sensor.

31. The method of claim 18, comprising:

processing the information from the at least one sensor into at least one result;

associating the at least one result with a physiologic state of the user of the discrete oral component; and

communicating, with the at least one external device, the at least one result and an association to at least one system user.

32. The method of claim 18, comprising:

communicating, with the at least one external device, the identification of the analyte by the sensor within the discrete oral component to at least one system user.

33. The method of claim 18, comprising:

storing the information from the at least one sensor, detected at multiple time points from a single individual.

34. The method of claim 18, comprising:

collecting the salivary fluid with the discrete oral component; and

analyzing collected salivary fluid with the at least one sensor.

35. The method of claim 18, comprising:

communicating a result from an external communication device to one or more network;

receiving information associated with the result from at least one of the one or more network; and

categorizing the result in relation to the information.

36. A method for providing information relating to a health history for at least one individual comprising:

swallowable positioning a discrete oral component within a human oral cavity, wherein the discrete oral component is configured to be completely enclosed in the human oral cavity without protrusion therefrom or attachment thereto and includes one or more flavorant;

sampling salivary fluid at a first time point from the at least one individual utilizing the discrete oral component, the discrete oral component further including at least one diagnostic agent configured for release during use of the discrete oral component;

releasing the at least one diagnostic agent from the discrete oral component at the first time point;

identifying, with at least one sensor incorporated within the discrete oral component, one or more analyte in the salivary fluid from the at least one individual at the first time point;

generating a first signal from the at least one sensor, wherein the first signal is generated as a consequence of the identification of the one or more analyte;

identifying, with the at least one sensor, the at least one diagnostic agent or a metabolite of the at least one diagnostic agent in the salivary fluid from the at least one individual at a second time point;

generating a second signal from the at least one sensor, wherein the second signal is generated responsive to the identification of the at least one diagnostic agent or a metabolite of the at least one diagnostic agent in the salivary fluid;

detecting the first signal and the second signal with an external device including a port including a cavity configured for physical contact with the discrete oral component and including one or more devices for detection of the signal from the sensor;

processing, in the external device, the first signal from the at least one sensor into at least one first result and the second signal from the at least one sensor into at least one second result;

storing the at least one first result and the at least one second result integrated into the health history for the at least one individual in memory; and

indicating the at least one first result and the at least one second result to at least one system user.

37. The method of claim 36, wherein indicating the at least one first result to at least one system user comprises:

communicating the at least one first result to at least one system user through at least one network.

38. The method of claim 36, comprising:

identifying, with at least one sensor incorporated within the discrete oral component, presence of one or more analyte in salivary fluid from the at least one individual at a second time point;

generating a second signal from the at least one sensor, wherein the second signal is generated as a consequence of the identification at the second time point;

detecting the signal with an external device;

processing, in the external device, the second signal from the at least one sensor into at least one second result;

processing the at least one first result and the at least one second result into a health history for the at least one individual;

storing a record of the health history; and

indicating at least a subset of the health history to at least one system user.

39. A system for detecting one or more analyte in salivary fluid, comprising:

a discrete oral component configured for complete enclosure in a human oral cavity without protrusion, the discrete oral component including a shell with a permeable area and a removable module therein;

at least one sensor configured to sense the one or more analyte in salivary fluid, the at least one sensor incorporated within the removable module, the at least one sensor including a reversibly antigen-responsive hydrogel core and at least one type of antibody corresponding to a viral protein; and

an external device including a port configured for size measurement of the removable module, the port including a cavity configured for physical contact with the discrete oral component.

40. A system for detecting one or more analyte in salivary fluid, comprising:

a discrete oral component configured for complete enclosure in a human oral cavity without protrusion therefrom or attachment thereto, the discrete oral component including a shell, the shell including a permeable area having an outermost porous covering and a selective medium internal to the shell, the discrete oral component configured to release at least one medicinal agent responsive to a substance in the salivary fluid;

at least one sensor configured to;

identify the one or more analyte in the salivary fluid;

generate a first signal indicative of the identification of the one or more analyte;

identify the at least one medicinal agent in the salivary fluid or a metabolite of the at least one medicinal agent in the salivary fluid; and

generate a second signal indicative of the identification of the at least one medicinal agent or the metabolite of the at least one medicinal agent in the salivary fluid; and

an external device including at least one device configured to detect the first and the second signals from the at least one sensor, and including a port with a cavity configured for physical contact with the discrete oral component.