SYSTEM AND METHOD FOR PHYSIOLOGICAL MONITORING

• US 20120071731A1
• Filed: 09/21/2011
• Published: 03/22/2012
• Est. Priority Date: 09/22/2010
• Status: Active Grant

• Current Assignee: Janell M. Gottesman
• Original Assignee: Janell M. Gottesman
• Inventors: Gottesman, Janell M.
• Granted Patent: US 9,017,256 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 2503/40 Animals
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• 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 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• 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: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence

Abstract

Apparatus, systems, and methods for monitoring a sensor module mounted in a sensor platform, wherein the sensor platform includes an adhesive side and a pocket, wherein the pocket is designed to receive the sensor module, to facilitate sensing by the sensor module of physiological attributes, and to allow insertion and removal of the sensor device from the pocket.

Claims

1. A method of monitoring a mammal, comprising:

providing a sensor module;

mounting the sensor module in a sensor platform, wherein the sensor platform includes an adhesive side and a pocket, wherein the pocket is designed to receive the sensor module, to facilitate sensing by the sensor module of physiological attributes, and to allow insertion and removal of the sensor device from the pocket; and

attaching the sensor platform to the mammal; and

collecting, via the sensor module, physiological information about the mammal.

2. The method according to claim 1, wherein the sensor module includes an implantable sensor device and wherein the sensor platform, when attached to the mammal, creates an environment that mimics aspects of a subcutaneous environment for the implantable sensor device.

3. The method according to claim 1, wherein the sensor platform has a shape that conforms to the xiphoid process and wherein attaching includes attaching the sensor platform in the vicinity of the xiphoid process.

4. The method of claim 1, wherein mounting the sensor module includes inserting the sensor module into the pocket and closing the pocket so as to keep the sensor module inside the pocket.

5. An apparatus for monitoring physiological attributes of a mammal, comprising:

a sensor device; and

a sensor platform having an adhesive side and a pocket for receiving the sensor device, wherein the pocket is designed to allow insertion and removal of the sensor device from the pocket and to facilitate sensing by the sensor device of physiological attributes.

6. The apparatus according to claim 5, wherein the sensor device is an implantable sensor module and wherein the sensor platform, when attached to the mammal, creates an environment that mimics aspects of a subcutaneous environment for the implantable sensor module.

7. The apparatus according to claim 5, wherein the implantable sensor module is an implantable cardiac monitor.

8. The apparatus according to claim 5, wherein the sensor platform has a shape designed to conform to a particular part of the mammal'"'"'s anatomy.

9. The apparatus according to claim 5, wherein the sensor platform includes release sheets that protect the adhesive side of the sensor platform.

10. A sensor platform for sensing physiological attributes of a mammal, comprising:

a tape strip having an adhesive side;

a sensor pocket attached to the tape strip; and

a sensor module;

wherein the tape strip and the sensor pocket are designed to allow insertion and removal of the sensor module from the sensor pocket and to facilitate sensing by the sensor module of physiological attributes of the mammal.

11. The sensor platform of claim 10, wherein the sensor pocket is attached to the tape strip.

12. The sensor platform of claim 10, wherein the sensor pocket is integral to the tape strip.

13. The platform according to claim 10, wherein the sensor platform, when attached to the mammal, creates an environment that mimics aspects of a subcutaneous environment for the implantable sensor module.

14. The platform according to claim 10, wherein the sensor pocket includes an adhesive strip used to secure the pocket after the sensor module is inserted in the sensor pocket.

15. The platform according to claim 10, wherein the pocket includes one or more sensor windows.

16. The platform according to claim 15, wherein the pocket is designed to receive two or more sensor modules and wherein the pocket includes means for providing a degree of isolation between sensors in the sensor modules.

17. The platform according to claim 10, wherein the platform includes one or more electrical conductors, wherein the electrical conductors are designed to extend electrodes from the sensor module.

18. The platform according to claim 17, wherein the sensor module receives a sensor device and conforms electrodes of the sensor device to the one or more sensor platform electrical conductors.

19. A system for sensing physiological attributes of a mammal, comprising:

a sensor device having a communications interface;

a sensor platform having an adhesive side and a pocket for receiving the sensor device, wherein the pocket is designed to allow insertion and removal of the sensor device from the pocket and to facilitate sensing by the sensor device of physiological attributes; and

a monitoring system that communicates with the sensor device over the communications interface, wherein the monitoring system processes data received from the sensor device and detects physiological conditions as a function of the received data.

20. The system of claim 19, wherein the sensor device is capable of capturing and storing data representative of physiological attributes sensed from a mammal, and of transmitting the stored data periodically to the monitoring system.

21. The system of claim 20, wherein the sensor device includes a processor and wherein the processor analyzes the stored data before transmitting data representative of its analysis to the monitoring system.

22. The system of claim 19, wherein the communications interface includes a wireless interface.

23. The system of claim 19, wherein the sensor device is implemented in a field programmable device and wherein the monitoring system includes a mechanism for programming the field programmable device.

24. The system of claim 19, wherein the sensor device is implemented in a first and a second portion of a field programmable device and wherein the monitoring system includes a mechanism for programming the field programmable device;

wherein the first portion of the field programmable device includes a sensor implementation approved by an agency and wherein the second portion of the field programmable device includes a module which operates on data received from the sensor implementation; and

wherein the mechanism for programming implements levels of approval for changes to portions of the field programmable device, wherein changes to the first portion are limited to a first set of approved personnel while changes to the second portion are less restricted.

25. An adhesive envelope sensor platform for sensing physiological attributes of a mammal, comprising:

a patch having an axis; and

a sensor module;

wherein the patch is designed so that when the patch is folded along its axis it forms an envelope that encloses the sensor module, wherein the envelope formed includes a skin-side, wherein the skin-side of the patch is designed to facilitate sensing by the sensor module of physiological attributes of the mammal.

26. The platform according to claim 25, wherein the sensor platform, when attached to the mammal, creates an environment that mimics aspects of a subcutaneous environment for an implantable sensor device.

27. The platform according to claim 25, wherein the skin-side includes an adhesive that can be used to attach the envelope to the skin of the mammal.

28. The platform according to claim 25, wherein the patch, when folded includes one or more sensor windows that line up with the sensor module.

29. The platform according to claim 25, wherein the platform includes electrical conductors, wherein the electrical conductors are designed to extend electrodes from the sensor module.

30. The platform according to claim 29, wherein the sensor module receives a sensor device such that electrodes of the sensor device contact the sensor platform electrical conductors.

31. The platform according to claim 29, wherein the sensor module includes an axis, wherein the sensor module receives a sensor device and folds along the sensor module axis to secure electrodes of the sensor device to the sensor platform electrical conductors.

32. A system for monitoring the autonomic nervous system, the system comprising:

a cardiac sensor, wherein the cardiac sensor monitors heart rate activity;

an accelerometer; and

a processor, wherein the processor determines from data captured by the accelerometer and data captured by the cardiac sensor whether a physiological stress response is driven by other than physical activity.

33. A system for monitoring the autonomic nervous system, the system comprising:

a respiration sensor, wherein the respiration sensor monitors changes in respiration;

an accelerometer; and

a processor, wherein the processor determines from data captured by the accelerometer and data captured by the respiration sensor whether a change in respiration is driven by other than physical activity.

34. A method for monitoring the parasympathetic branch of the nervous system of an individual, the method comprising:

capturing, via a cardiac sensor, data representing heart rate activity;

capturing movement data via an accelerometer;

processing the data from the cardiac sensor and the movement data from the accelerometer to look for patterns of heart rate recovery and patterns of increasing heart rate variability; and

displaying changes in the patterns of heart rate recovery and patterns of heart rate variability over time.

35. A method for monitoring performance of the branches of the autonomic nervous system of an individual, the method comprising:

capturing, via a cardiac sensor, data representing heart rate activity;

capturing movement data via an accelerometer;

processing the data from the cardiac sensor and the accelerometer to capture activation and recovery patterns of the nervous system as a function of the cardiac sensor data and the movement data; and

displaying the activation and recovery patterns.

36. The method of claim 35, wherein processing includes contextualizing the captured activation and recovery patterns to activities by the individual.

37. A method for enhancing tone and control of the branches of the autonomic nervous system of an individual, the method comprising:

capturing, via a cardiac sensor, data representing heart rate activity;

capturing movement data via an accelerometer;

processing the data from the cardiac sensor and the accelerometer to capture activation and recovery patterns of the nervous system as a function of the cardiac sensor data and the movement data;

contextualizing the captured activation and recovery patterns to aspects of the individual; and

conveying recommendations to the individual.