Gateway platform for biological monitoring and delivery of therapeutic compounds

• US 8,632,463 B2
• Filed: 04/25/2006
• Issued: 01/21/2014
• Est. Priority Date: 06/29/2001
• Status: Expired due to Fees

• Current Assignee: PhiloMetron Inc.
• Original Assignee: PhiloMetron Inc.
• Inventors: Drinan, Darrel, Edman, Carl F., Merz, Diethard
• Primary Examiner(s): Thomson, Bill
• Assistant Examiner(s): JIAN, SHIRLEY XUEYING
• Application Number:
  US11/410,519
• Publication Number:
  US 20070060800A1
• Time in Patent Office: 2,828 Days
• Field of Search: 600300-301, 600/547
• US Class Current: 600/300
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• 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 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes 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 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• 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: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10S 128/904 : Telephone telemetry

Abstract

The invention relates to methods and devices for remote or distributed continuous monitoring of physiologically relevant states. The invention provides for methods to automatically detect deviations or other states in physiological parameters and automatically alert a measured subject, user or other authorized party. The device provides for a universal platform for sensors, and further provides for the automatic compensation or distribution of devices or bioactive agents at appropriate levels and/or intervals in response to deviations or other states sensed in various physiological parameters.

Claims

1. A system for ambulatory physiological monitoring, the system comprising:

at least one patch configured for affixing on at least a portion of a subject, said patch comprising a bio-interface head, said bio-interface head having a BIH identifier for identifying said bio-interface head, said bio-interface head comprising at least one sensor having an analog output, said patch further comprising at least one control and communication module communicatively coupled to said bio-interface head, said at least one control and communication module having a CCM identifier for identifying each control and communication module, said at least one control and communication module comprising an analog to digital converter configured to convert said analog output to a digital signal, said at least one control and communication module further comprising at least one transceiver, said at least one sensor being configured to sense one or more physiological parameters, said at least one control and communication module further comprising signal encryption circuitry configured to encrypt said digital signal to generate encrypted sensor data, said at least one control and communication module further comprising a display capable of displaying at least a portion of said digital signal; and

a data collection unit communicatively coupled to said at least one control and communication module, said data collection unit comprising at least one transceiver configured to receive said encrypted sensor data and said BIH and CCM identifiers from said at least one control and communication module, said BIH and CCM identifiers being unencrypted;

wherein said bio-interface head is removably coupled to said control and communication module such that said bio-interface head may be replaced with a new bio-interface head.

2. The system of claim 1, additionally comprising a remote data management system comprising a computer-based system configured for storing and processing sensor data, the remote data management system configured to receive said encrypted sensor data and said unencrypted BIH and CCM identifiers from said data collection unit and process said encrypted sensor data.

3. The system of claim 2, wherein said data collection unit further comprises a processor configured to process said encrypted sensor data before sending said encrypted sensor data to said remote data management system.

4. The system of claim 2, wherein said remote database management system is configured to establish an individual baseline parameter value.

5. The system of claim 2, wherein the remote data management system provides feedback to the data collection unit and/or the at least one control and communication module.

6. The system of claim 5, wherein said feedback comprises diagnostic knowledge.

7. The system of claim 5, wherein said feedback comprises actions and/or instructions.

8. The system of claim 5, further comprising a plurality of control and communication modules.

9. The system of claim 2, wherein the remote data management system is configured to perform one or more of summarizing sensor data, detecting deviations or abnormalities, determine a mode of action, transmit instructions to the subject or other authorized personnel.

10. The system of claim 1, wherein the portion is a thorax of said subject.

11. The system of claim 1, further comprising a timer for associating at least one measurement from the at least one sensor with an absolute time of measurement.

12. The system of claim 1, further comprising a plurality of data collection units.

13. The system of claim 1, wherein the at least one sensor measures electrical impedance.

14. A system for ambulatory physiological monitoring, the system comprising:

at least one patch configured for affixing on at least a portion of a subject, said patch comprising a bio-interface head, said bio-interface head having a BIH identifier for identifying said bio-interface head, said bio-interface head comprising at least one sensor having an analog output, said patch further comprising at least one control and communication module communicatively coupled to said bio-interface head, said at least one control and communication module having a CCM identifier for identifying each control and communication module, said at least one control and communication module comprising an analog to digital converter configured to convert said analog output to a digital signal, said at least one control and communication module further comprising at least one transceiver, said at least one sensor being configured to sense one or more physiological parameters, said at least one control and communication module further comprising signal encryption circuitry configured to encrypt said digital signal to generate encrypted sensor data, wherein the at least one control and communication module is configured to process said sensor data to determine data integrity and to detect system errors; and

a data collection unit communicatively coupled to said at least one control and communication module, said data collection unit comprising at least one transceiver configured to receive said encrypted sensor data and said BIH and CCM identifiers from said at least one control and communication module, said BIH and CCM identifiers being unencrypted.

15. The system of claim 14, additionally comprising a remote data management system comprising a computer based system configured for storing and processing sensor data, the remote data management system configured to receive said encrypted sensor data and said unencrypted BIH and CCM identifiers from said data collection unit and process said encrypted sensor data.

16. The system of claim 15, wherein the remote data management system provides feedback to the data collection unit and/or the at least one control and communication module.

17. The system of claim 15, wherein the remote data management system is configured to perform one or more of summarizing sensor data, detecting deviations or abnormalities, determine a mode of action, transmit instructions to the subject or other authorized personnel.

18. The system of claim 14, wherein the portion is a thorax of said subject.

19. The system of claim 14, comprising a plurality of control and communication modules.

20. The system of claim 14, wherein the at least one sensor measures electrical impedance.

21. A system for ambulatory physiological monitoring, the system comprising:

an article of clothing configured to be worn by a subject;

at least one patch configured to be placed on at least a portion of said subject, said patch comprising a bio-interface head, said bio-interface head having a BIH identifier for identifying said bio-interface head, said bio-interface head comprising at least one sensor having an analog output, said patch further comprising at least one control and communication module communicatively coupled to the bio-interface head, said at least one control and communication module having a CCM identifier for identifying each control and communication module, said at least one control and communication module comprising an analog to digital converter configured to convert said analog output to a digital signal, said at least one control and communication module further comprising at least one transceiver, said at least one sensor being configured to sense one or more physiological parameters, said at least one control and communication module further comprising signal encryption circuitry configured to encrypt said digital signal to generate encrypted sensor data, said at least one control and communication module further comprising a display capable of displaying at least a portion of said digital signal, wherein said control and communication module is integrated into said article of clothing; and

a data collection unit communicatively coupled to said at least one control and communication module, said data collection unit comprising at least one transceiver configured to receive said encrypted sensor data and said BIH and CCM identifiers from said at least one control and communication module, said BIH and CCM identifiers being unencrypted;

wherein said bio-interface head is removably coupled to said control and communication module such that said bio-interface head may be replaced with a new bio-interface head.