IP Library Granted Patent US 9,883,819
Granted Patent B2
US 9,883,819 · App. 13/141,048 · Granted Feb 6, 2018

Ingestion-related biofeedback and personalized medical therapy method and system

Inventors: Marc Jensen (Los Gatos, CA); Robert Leichner (Menlo Park, CA); Patrick Beaulieu (San Jose, CA); Kit Yee Au-Yeung (San Francisco, CA); Lawrence Arne (Palo Alto, CA); Mark Zdeblick (Portola Valley, CA); Andrew Thompson (Portola Valley, CA); George Savage (Portola Valley, CA); Timothy Robertson (Belmont, CA); Yashar Behzadi (San Francisco, CA)
Assignee: Proteus Digital Health, Inc.
A61B5/073A61B5/0002A61B5/6833G06F19/322H04B13/005A61B5/021A61B5/024A61B5/1112A61B5/486G06F19/3456G06F19/3481
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Quick Facts
Patent No.
US 9,883,819
App. No.
13/141,048
Granted
Feb 6, 2018
Kind
B2
Abstract

Methods, devices and systems for acquiring information useful to support a patient in implementing and adhering to a medically prescribed therapy plan are provided. The therapy may incorporate biofeedback methods and/or personalized therapy aspects. A method includes steps of receiving, by a receiving device, biometric information associated with an ingestible event marker; analyzing, by a computing device having a microprocessor configured to perform a biometric information analysis, the biometric information; and determining a therapeutic recommendation at least partly on the basis of the analysis and/or integrating biofeedback techniques into patient therapy or activity. A system includes a biometric information module to receive biometric information associated with an ingestible event marker; an analysis module to analyze the biometric information; and a determination module to optionally determine and communicate a therapeutic recommendation at least partly on the basis of the analysis.

Claims (58)

1. A system, comprising:

an ingestible event marker (IEM) configured to generate ingestion information and to emit the ingestion information conductively via an in-body data transmission upon contact with bodily fluid at a target physiological site, the IEM comprising:

first and second electrodes formed of dissimilar materials configured to generate a voltage to energize the IEM when the first and second electrodes contact the bodily fluid;

a first sensor configured to be coupled to a body of a patient and to detect first vital parameter data from the body of the patient;

a second sensor positionable remotely from the body of the patient, wherein the second sensor is configured to detect second vital parameter data by sensing environmental information associated with the body of the patient;

a receiver configured to be electrically coupled to an exterior surface of the body of the patient, wherein the receiver comprises a transceiver to receive the ingestion information conductively via the in-body data transmission from the IEM, the first vital parameter data from the first sensor, and the second vital parameter data from the second sensor; and

a patient management data system (PMDS) communicatively coupled to the transceiver, wherein the PMDS comprises:

a patient database, comprising:

a patient record associated with the patient, wherein the patient record indicates:

patient activity data, comprising:

 expected activities reported by the patient, wherein each of the expected activities is associated with an expected time to engage in the respective expected activities; and

patient history data, comprising:

 detected first vital parameter data received via the transceiver from the first sensor; and

 detected second vital parameter data received via the transceiver from the second sensor; and

an analysis module, configured to:

compare at least one of:

the detected first vital parameter data to a first range of healthy values associated with the first vital parameter to identify an unhealthy first vital parameter value; or

the detected second vital parameter data to a second range of healthy values associated with the second vital parameter to identify an unhealthy second vital parameter value;

correlate at least one of an identified unhealthy first vital parameter value or an identified unhealthy second vital parameter value to an expected activity of the patient activity data; and

select a therapeutic recommendation to at least one of:

bring the identified unhealthy first vital parameter value within the first range of healthy values; or

bring the identified unhealthy second vital parameter value within the second range of healthy values;

wherein the PMDS is further configured to:

transmit the selected therapeutic recommendation to the patient, via the transceiver, at a prospective expected time associated with the correlated expected activity.

2. The system of claim 1 , wherein the patient record further indicates prescription information including a medication prescribed to the patient, wherein the prescribed medication is associated with a medication schedule including prescribed times to administer the medication;

wherein the patient history data further comprises:

ingestion information received via the transceiver from one or more than one IEM ingested by the patient, wherein the one or more than one IEM ingested by the patient comprise the medication; and

attestation information reported by the patient, wherein the attestation information comprises an attestation associated with at least one administered medication; and

wherein the analysis module is further configured to:

determine, based on at least one of the ingestion information or the attestation information, that the prescribed medication has not been administered at a prescribed time of the medication schedule that has passed; and

transmit to the transceiver, after a designated time period since the passed prescribed time, a message to remind the patient to administer the prescribed medication.

3. The system of claim 1 , wherein the patient record further indicates prescription information including a behavior prescribed to the patient, wherein the prescribed behavior is associated with a behavior schedule including prescribed times to perform or to avoid the behavior;

wherein the patient history data further comprises:

attestation information reported by the patient, wherein the attestation information comprises an attestation associated with at least one of a behavior performed or a behavior avoided; and

wherein the analysis module is further configured to:

determine, based on the attestation information, that the prescribed behavior has not been attested to at a prescribed time of the behavior schedule that has passed; and

transmit to the transceiver, after a designated time period since the passed prescribed time, a message to remind the patient to perform or to avoid the prescribed behavior.

4. The system of claim 1 , wherein the receiver comprises a communication device to communicate the selected therapeutic recommendation to the patient.

5. The system of claim 4 , wherein the communication device is selected from the group consisting essentially of a telephone, a cellular telephone, a computer, a personal digital assistant, and a network appliance.

6. The system of claim 1 , wherein the therapeutic recommendation is further selected based at least partly on genetic information descriptive of the patient.

7. The system of claim 1 , wherein the therapeutic recommendation is further selected based at least partly on biometric information in view of additional patient information.

8. The system of claim 7 , wherein the additional patient information is selected from the group consisting essentially of lifestyle data, patient adherence information, behavioral information, emotional information and diagnostic test information.

9. The system of claim 1 , wherein the therapeutic recommendation is selected from the group consisting essentially of a medicine prescription adjustment, a meditation practice, a relaxation practice, a physical exercise, a period of sleep, a procedural change, a therapy change and a dietary adjustment.

10. The system of claim 1 , further comprising a motion detector configured to be coupled to the patient and to generate a patient motion datum, and wherein the therapeutic recommendation is further selected based at least partly on the patient motion datum.

11. The system of claim 10 , wherein the motion detector is selected from the group consisting essentially of a cellular telephone, an accelerometer and a global positioning signal device.

12. The system of claim 1 , further comprising:

a vital parameter monitor to monitor a health parameter of the patient, wherein the vital parameter monitor is communicatively coupled with the PMDS.

13. The system of claim 12 , wherein the vital parameter monitor is selected from the group consisting essentially of a heart rate monitor, a blood pressure monitor, a respiration monitor, and a patient skin electrical current conductivity monitor.

14. The system of claim 1 , further comprising a patient data input module to receive information from the patient, wherein the patient data input module is communicatively coupled with the PMDS.

15. The system of claim 14 , wherein the patient data input module is bi-directionally communicatively coupled with the PMDS.

16. The system of claim 14 , wherein the patient data input module is selected from the group consisting essentially of a telephone, a cellular telephone, a computer, a personal digital assistant, a network appliance, and an audio recorder.

17. The system of claim 1 , wherein the PMDS stores at least one selectable therapeutic recommendation.

18. The system of claim 1 , further comprising a motion detector to detect and to report movement of the patient to the PMDS.

19. The system of claim 1 , wherein the PMDS is communicatively coupled with an electronic communications network, and wherein the selected therapeutic recommendation is transmitted via the electronic communications network.

20. The system of claim 1 , wherein the target physiological site is a digestive tract internal target site.

21. The system of claim 1 , wherein the environmental information associated with the body of the patient comprises sound detection information, air pressure variation information, light energy reflection information, heat detection information, or any combination thereof.

22. The system of claim 1 , wherein the first vital parameter data comprises at least one of a heart rate, a blood pressure, a respiration rate, a respiration intensity, or electrical skin conductivity.

23. The system of claim 22 , wherein the second vital parameter data comprises at least one of a heart rate, a blood pressure, a respiration rate, a respiration intensity, or electrical skin conductivity.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 18, 2024
From: PROTEUS DIGITAL HEALTH INC.,
To: OTSUKA AMERICA PHARMACEUTICAL, INC.
Reel/Frame 068980/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 18, 2024
From: OTSUKA AMERICA PHARMACEUTICAL, INC.
To: OTSUKA PHARMACEUTICAL CO., LTD.
Reel/Frame 068980/0277 →
CHANGE OF NAME Recorded Nov 2, 2012
From: PROTEUS BIOMEDICAL, INC.
To: PROTEUS DIGITAL HEALTH, INC.
Reel/Frame 029228/0436 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 26, 2012
From: BEAULIEU, PATRICK; SAVAGE, GEORGE
To: PROTEUS BIOMEDICAL, INC.
Reel/Frame 027602/0429 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 26, 2012
From: JENSEN, MARC; LEICHNER, ROBERT; BEAULIEU, PATRICK; AU-YEUNG, KITYEE; ARNE, LAWRENCE; ZDEBLICK, MARK; THOMPSON, ANDREW; SAVAGE, GEORGE; ROBERTSON, TIMOTHY; BEHZADI, YASHAR
To: PROTEUS BIOMEDICAL, INC.
Reel/Frame 027602/0452 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 8, 2011
From: JENSEN, MARC; LEICHNER, ROBERT; BEAULIEU, PATRICK; AU-YEUNG, KITYEE; ARNE, LAWRENCE; ZDEBLICK, MARK; THOMPSON, ANDREW; SAVAGE, GEORGE; ROBERTSON, TIMOTHY; BEHZADI, YASHAR
To: PROTEUS BIOMEDICAL, INC.
Reel/Frame 026875/0525 →
Continuity (3)
Provisional Application 61142869 · Jan 6, 2009
Provisional Application 61260325 · Nov 11, 2009
Related Publication 20110270052A1 · Nov 3, 2011