Metabolic and cardiopulmonary monitor

• US 10,390,733 B2
• Filed: 11/05/2012
• Issued: 08/27/2019
• Est. Priority Date: 11/07/2011
• Status: Active Grant

• Current Assignee: LifeLens Technologies, LLC
• Original Assignee: LifeLens Technologies, LLC
• Inventors: Toth, Landy, Schwartz, Robert, Martin, Roy
• Primary Examiner(s): Berhanu, Etsub D
• Application Number:
  US14/356,083
• Publication Number:
  US 20140275857A1
• Time in Patent Office: 2,486 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/0228 Microwave sensors
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/083 Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• 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 5/7415 Sound rendering of measured values, e.g. by pitch or volume variation A61B5/741 takes precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/021 operated by electrical means A61M16/202 – A61M16/205 take precedence
• CPC Class Codes: A61M 16/0672 Nasal cannula assemblies for oxygen therapy
• CPC Class Codes: A61M 16/0841 for sampling
• CPC Class Codes: A61M 16/085 Gas sampling
• CPC Class Codes: A61M 16/1065 : in the expiratory path
• CPC Class Codes: A61M 2016/0027 : pressure meter
• CPC Class Codes: A61M 2016/102 : Measuring a parameter of the content of the delivered gas
• CPC Class Codes: A61M 2016/1025 : the O2 concentration
• CPC Class Codes: A61M 2202/0208 : Oxygen
• CPC Class Codes: A61M 2205/7536 : allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
• CPC Class Codes: A61M 2210/0618 : Nose
• CPC Class Codes: A61M 2210/0625 : Mouth
• CPC Class Codes: A61M 2230/43 : Composition of exhalation

Abstract

Systems and methods for monitoring and/or assessing metabolic and/or cardiopulmonary parameters of a subject are disclosed. Systems and methods for high speed monitoring of metabolic parameters of a subject in a substantially unrestricted setting are disclosed. Further disclosed are wearable systems and methods for substantially unobtrusive monitoring of a breath stream from a subject. Also disclosed are wearable systems and methods for real-time monitoring of the respiratory function and/or one or more disease states of a subject. Data systems to coordinate simultaneous monitoring of one or more metabolic and/or cardiopulmonary parameters of a plurality of subjects are also disclosed.

Claims

1. A wearable system for monitoring metabolic and/or cardiopulmonary parameters of a subject, comprising:

a control unit adapted to be worn by the subject, configured to analyze a breath gas sample obtained from a breath stream of the subject; and

a sampling module configured to operably communicate the breath gas sample from the breath stream of the subject to the control unit, the control unit configured to generate one or more signals based on an analysis of the breath gas sample, the signals being at least partially reflective of at least one metabolic and/or cardiopulmonary parameter of the subject;

wherein the sampling module comprises;

an interfacing component configured for at least partial insertion in a nasal cavity or an oral cavity of the subject;

one or more sensory elements coupled to the interfacing component configured to measure one or more physiological or dimensional parameters of the nasal cavity or the oral cavity of the subject;

a tube with a lumen;

one or more sensing membranes positioned within the lumen of the tube; and

one or more shrouds surrounding at least a portion of the tube where the sensing membranes are positioned, the one or more shrouds configured to reduce ambient light from reaching the sensing membranes, the one or more shrouds configured to be at least partially opaque over one or more designated wavelengths of interest for exciting the one or more sensing membranes;

the tube providing a first path for an inbound breath gas sample from a subject side of the sampling module towards the one or more sensing membranes and a second path for an outbound breath gas sample to continue past the one or more sensing membranes towards the control unit;

wherein the control unit comprises;

an emitter configured to deliver an excitation signal to the one or more sensing membranes causing at least one of the one or more sensing membranes to emit a fluorescent signal;

a detector configured to collect at least a portion of the emitted fluorescent signal;

wherein the sampling module further comprises an identification component comprising one or more identification markers and calibration information; and

wherein the control unit comprises a system for reading the identification component from the sampling module such that the identification markers and calibration information are utilized by the control module to estimate at least one property of the one or more sensing membranes, and to utilize the estimated at least one property to calibrate the emitted fluorescent signal.

2. The wearable system in accordance with claim 1, comprising a connector configured for detachably connecting the sampling module to the control unit.

3. The wearable system in accordance with claim 2, wherein the sampling module comprises a boom element, shaped so as to extend from an ear of the subject to a mouth of the subject, configured to interface with the breath stream of the subject.

4. The wearable system in accordance with claim 2, wherein the interfacing component is configured for placement within the oral cavity of the subject.

5. The wearable system in accordance with claim 4, wherein the interfacing component comprises a tooth clip, for attachment to one or more teeth of the subject.

6. The wearable system in accordance with claim 4, wherein the interfacing component comprises a mouthguard, configured to provide operable retention of the interfacing component within the oral cavity of the subject.

7. The wearable system in accordance with claim 4, wherein the physiological or dimensional parameters include a pallet parameter, a body acoustic parameter, a motion parameter, a bite parameter or an oral cavity volume.

8. The wearable system in accordance with claim 1, wherein at least one of the one or more sensing membranes is arranged along the wall of the lumen.

9. The wearable system in accordance with claim 1, wherein at least one of the one or more sensing membranes is sensitive to the concentration of a constituent of the breath gas sample selected from the group consisting of oxygen, carbon dioxide, nitrous oxide, nitric oxide, nitric dioxide, carbon monoxide, and water vapor.

10. The wearable system in accordance with claim 1, wherein at least one of the one or more sensing membranes is sensitive to temperature and/or humidity.

11. The wearable system in accordance with claim 1, wherein at least one of the one or more sensing membranes comprises a transition metal complex, a ruthenium and/or copper complex, and/or a vapochromic chromophore.

12. The wearable system in accordance with claim 1, wherein at least one of the one or more sensing membranes has a thickness greater than zero and less than 20 um, less than 10 um, or less than 2 um.

13. The wearable system in accordance with claim 1, wherein at least one of the one or more sensing membranes comprises two or more fluorophores including a first fluorophore sensitive to temperature having a first emission spectrum and at least a second fluorophore sensitive to one or more constituents of the breath gas sample having a second emission spectrum different than the first emission spectrum.

14. The wearable system in accordance with claim 1, wherein the control unit comprises means for controlling the emitter and monitoring the detector to determine if the sampling module is operably connected to the control unit.

15. The wearable system in accordance with claim 1, comprising a substantially unrestricting respiratory flow sensor, adapted for placement into the breath stream of the subject, configured to operably generate a flow signal related to the breath stream of the subject and communicate the flow signal to the control unit.

16. The wearable system in accordance with claim 1, further comprising a respiratory volume sensor, adapted for placement onto a chest and/or an abdomen of the subject, configured to operably generate a volumetric signal representative of a respiratory volume of the subject and communicate said volumetric signal to the control unit.

17. The wearable system in accordance with claim 1, wherein the control unit comprises a radio and a processor, configured in electrical communication with each other, the radio and processor configured to wirelessly communicate the one or more signals to a user device, a communication system and/or an external coordination device.

18. The wearable system in accordance with claim 1, wherein the control unit further comprises one or more gas sensors arranged in operable fluid communication with the breath gas sample, configured to analyze the breath gas sample.

19. The wearable system in accordance with claim 18, wherein the one or more of the gas sensors is selected from the group consisting of an electrochemical oxygen sensor, a nondispersive infrared (NDIR) carbon dioxide sensor, a volatile organic compound sensor, a laser spectrometer, a nitric oxide sensor, an acetone sensor, and a hydrogen sensor.

20. The wearable system in accordance with claim 1, wherein the sampling module is disposable.

21. The wearable system in accordance with claim 1, wherein at least one of the control unit and the sampling module comprises at least one optical filter positioned with respect to the detector to selectively prevent ambient light and one or more designated emitter light wavelengths from reaching the detector.

22. The wearable system in accordance with claim 1, wherein the one or more sensory elements is configured to measure one or more parameters associated with temperature, flow velocity, flow acoustic or a pressure level of the breath gas sample.

23. The wearable system in accordance with claim 1, wherein one of the control unit and the sampling module includes an activity sensor.

24. The wearable system in accordance with claim 23, wherein the activity sensor includes one of an accelerometer, a gyroscope, an electromyography (EMG) sensor, an inclinometer, a GPS, a proximity detector and a pedometer.

25. The wearable system in accordance with claim 1, wherein the sampling module includes a bolus of a medicament or chemical for release into the subject.

26. The wearable system in accordance with claim 1, wherein the control unit includes:

a micropump in fluid communication with the sampling module, the micropump configured to operably draw the breath gas sample from the breath stream of the subject; and

one or more adjunct sensors, the one or more adjunct sensors comprising at least one of a flow sensor and a differential pressure sensor, the one or more adjunct sensors being configured;

to monitor a fluid state proximate the one or more sensing membranes;

to generate an output forming a compensation signal for calibrating readings of the one or more sensing membranes; and

to generate a pump control signal adjusting operation of the micropump to maintain a designated operable flow rate of the breath gas sample.

27. A method for monitoring a disease state of a subject comprising:

communicating, utilizing a sampling module, a breath gas sample from a breath stream of the subject to a control unit adapted to be worn by the subject;

monitoring and analyzing the breath gas sample utilizing the control unit; and

generating, utilizing the control unit, one or more signals based on the analysis, the signals being at least partially reflective of at least one metabolic and/or cardiopulmonary parameter of the subject;

wherein the sampling module comprises;

a tube with a lumen;

one or more sensing membranes positioned within the lumen of the tube; and

one or more shrouds surrounding at least a portion of the tube where the one or more sensing membranes are positioned, the one or more shrouds configured to reduce ambient light from reaching the one or more sensing membranes, the one or more shrouds configured to be at least partially opaque over one or more designated wavelengths of interest for exciting the one or more sensing membranes;

the tube providing a first path for an inbound breath gas sample from a subject side of the sampling module towards the one or more sensing membranes and a second path for an outbound breath gas sample to continue past the one or more sensing membranes towards the control unit;

wherein the control unit comprises;

an emitter configured to deliver an excitation signal to the one or more sensing membranes causing the one or more sensing membranes to emit a fluorescent signal; and

a detector configured to collect at least a portion of the emitted fluorescent signal;

a micropump in fluid communication with the sampling module, the micropump configured to operably draw the breath gas sample from the breath stream of the subject; and

one or more adjunct sensors, the one or more adjunct sensors comprising at least one of a flow sensor and a differential pressure sensor, the one or more adjunct sensors being configured;

to monitor a fluid state proximate the one or more sensing membranes;

to generate an output forming a compensation signal for calibrating readings of the one or more sensing membranes; and

to generate a pump control signal adjusting operation of the micropump to maintain a designated operable flow rate of the breath gas sample;

wherein the sampling module further comprises an identification component comprising one or more identification markers and calibration information;

wherein analyzing the breath gas sample with the control unit comprises utilizing the identification markers and calibration information from the sampling module to estimate at least one property of the one or more sensing membranes and utilizing the estimated at least one property to calibrate the emitted fluorescent signal; and

wherein the sampling module includes an interfacing component configured for at least partial insertion in a nasal cavity or an oral cavity of the subject, and the method further includes measuring one or more physiological or dimensional parameters of the nasal cavity or the oral cavity of the subject with one or more sensory elements coupled to the interfacing component.

28. The method of claim 27, wherein estimating the at least one property of the one or more sensing membranes comprises estimating degradation utilizing a lifetime emitter energy from a pre-calculated degradation curve provided by the identification component.

29. The method of claim 27, wherein the interfacing component is configured for placement within the oral cavity of the subject, and the physiological or dimensional parameters include a pallet parameter, a body acoustic parameter, a motion parameter, a bite parameter or an oral cavity volume.

30. A wearable system for monitoring metabolic and/or cardiopulmonary parameters of a subject, comprising:

a control unit adapted to be worn by the subject, configured to analyze a breath gas sample obtained from a breath stream of the subject; and

a sampling module configured to operably communicate the breath gas sample from the breath stream of the subject to the control unit, the sampling module including;

an interfacing component configured for at least partial insertion in a nasal cavity or an oral cavity of the subject;

one or more sensory elements coupled to the interfacing component configured to measure one or more physiological or dimensional parameters of the nasal cavity or the oral cavity of the subject;

a tube with a lumen;

one or more sensing membranes positioned within the lumen of the tube; and

the tube providing a first path for an inbound breath gas sample from a subject side of the sampling module towards the one or more sensing membranes and a second path for an outbound breath gas sample to continue past the one or more sensing membranes towards the control unit; and

wherein the control unit comprises;

an emitter configured to deliver an excitation signal to the one or more sensing membranes causing at least one of the one or more sensing membranes to emit a fluorescent signal; and

a detector configured to collect at least a portion of the emitted fluorescent signal.

31. The wearable system in accordance with claim 30, wherein the interfacing component is configured for placement within the oral cavity of the subject, and the physiological or dimensional parameters include a pallet parameter, a body acoustic parameter, a motion parameter, a bite parameter or an oral cavity volume.