System and method for physiological monitoring

• US 9,017,256 B2
• Filed: 09/21/2011
• Issued: 04/28/2015
• Est. Priority Date: 09/22/2010
• Status: Active Grant

• Current Assignee: Janell M. Gottesman
• Original Assignee: Milieu Institute, LLC
• Inventors: Gottesman, Janell M.
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): SORIANO, BOBBY GILES
• Application Number:
  US13/238,957
• Publication Number:
  US 20120071731A1
• Time in Patent Office: 1,315 Days
• Field of Search: 600300-301
• 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, a release sheet protecting the 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, wherein attaching includes removing the release sheet to expose the adhesive side and affixing the platform directly to the mammal via the adhesive side; and

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

wherein the sensor platform further includes a pocket adhesive protected by a pocket adhesive release sheet, wherein mounting the sensor module includes inserting the sensor module into the pocket, removing the pocket adhesive release sheet and closing the pocket with the pocket adhesive; and

wherein the sensor platform includes one or more electrical conductors, wherein the electrical conductors are designed to connect to electrodes from the sensor device when the sensor device is installed in the pocket.

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.

22. The apparatus of claim 1, wherein, when the pocket receives a sensor device, the pocket conforms electrodes of the sensor device to the one or more electrical conductors.

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

a sensor platform having an adhesive side and a release sheet protecting the adhesive side;

a pocket, attached to the sensor platform, wherein the pocket is designed to allow insertion and removal of the sensor device from the pocket and, when the sensor platform is affixed to a mammal via the adhesive side, to facilitate sensing by the sensor device of physiological attributes of the mammal; and

a pocket adhesive protected by a pocket adhesive release sheet, wherein the pocket adhesive is positioned to secure the sensor device within the pocket after the pocket adhesive release sheet is removed; and

wherein the pocket includes one or more electrical conductors, wherein the electrical conductors are designed to connect to electrodes from the sensor device when the sensor device is installed in the pocket.

5. The apparatus according to claim 4, wherein the sensor platform, when attached to the mammal, creates an environment that mimics aspects of a subcutaneous environment.

6. The apparatus according to claim 4, wherein the sensor platform has a shape designed to conform to a particular part of the mammal'"'"'s anatomy.

23. The apparatus of claim 4, wherein, when the pocket receives a sensor device, the pocket conforms electrodes of the sensor device to the one or more electrical conductors.

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

a tape strip having an adhesive side and a release sheet which, when removed, exposes the adhesive side;

a sensor pocket attached to the tape strip; and

a pocket adhesive protected by a pocket adhesive release sheet;

wherein the tape strip and the sensor pocket are designed to allow insertion and removal of the sensor module from the sensor pocket and, when affixed to a mammal via the adhesive side, to facilitate sensing by the sensor module of physiological attributes of the mammal; and

wherein the pocket adhesive is positioned to secure the sensor module within the sensor pocket after the pocket adhesive release sheet is removed; and

wherein the sensor pocket includes one or more electrical conductors, wherein the electrical conductors are designed to connect to electrodes of a sensor module when the sensor module is installed in the sensor pocket.

8. The sensor platform of claim 7, wherein the sensor pocket is attached to the tape strip.

9. The sensor platform of claim 7, wherein the sensor pocket is integral to the tape strip.

10. The platform according to claim 7, wherein the sensor platform, when attached to the mammal, creates an environment that mimics aspects of a subcutaneous environment for an implantable sensor module.

11. The platform according to claim 7, wherein the pocket adhesive is positioned on the sensor pocket.

12. The platform according to claim 7, wherein the pocket includes one or more sensor windows.

13. The platform according to claim 12, 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.

14. The platform according to claim 7, wherein the platform includes one or more electrical conductors, wherein the electrical conductors are designed to extend electrodes from the sensor module.

21. The platform according to claim 7, wherein the pocket adhesive is positioned on a side of the pocket;

and

wherein the adhesive side includes a hydrocolloid layer treated to enhance electrical conductivity, wherein the hydrocolloid layer includes a hydrocolloid with adhesive properties and wherein the hydrocolloid layer, when attached to the mammal, enhances the connectivity of a sensor module installed in the sensor pocket.

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

a sensor device having a communications interface;

a sensor platform having an adhesive side, a release sheet protecting the 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, when affixed to a mammal via the adhesive side, to facilitate sensing by the sensor device of physiological attributes of the mammal; 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;

wherein the sensor platform further includes a pocket adhesive protected by a pocket adhesive release sheet, wherein the pocket adhesive is positioned to secure the sensor device within the pocket after the pocket adhesive release sheet is removed; and

wherein the sensor platform includes one or more electrical conductors, wherein the electrical conductors are designed to connect to electrodes from the sensor device.

16. The system of claim 15, 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.

17. The system of claim 16, 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.

18. The system of claim 15, wherein the communications interface includes a wireless interface.

19. The system of claim 15, 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.

20. The system of claim 15, 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.

24. The system of claim 15, wherein the sensor platform receives a sensor device and conforms electrodes of the sensor device to the one or more sensor platform electrical conductors when the sensor device is installed in the pocket.