Ventilator with biofeedback monitoring and control for improving patient activity and health

• US 10,252,020 B2
• Filed: 10/01/2009
• Issued: 04/09/2019
• Est. Priority Date: 10/01/2008
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Wondka, Anthony D., King, Angela, Cipollone, Joseph
• Primary Examiner(s): Louis, LaToya M
• Application Number:
  US12/572,033
• Publication Number:
  US 20100083968A1
• Time in Patent Office: 3,477 Days
• Field of Search: 12820418, 12820421, 12820423, 12820426
• CPC Class Codes: A61M 16/0461 Nasoendotracheal tubes
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/0677 Gas-saving devices therefor
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/125 Diluting primary gas with ambient air
• CPC Class Codes: A61M 2016/0015 inhalation detectors
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0413 with detectors of CO2 in exhaled gases
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/42 Rate
• CPC Class Codes: A61M 2230/432 partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A respiratory support ventilator apparatus mechanically supports the work of respiration of a patient. The ventilator apparatus is highly portable and optionally wearable so as to promote mobility and physical activity of the patient, and to improve the overall health of the patient. The respiratory support ventilator may monitor a physical activity level and overall health status of the patient, and process this information. The information is used to track efficacy of the ventilation therapy relative to activity level and quality of life, and or to titrate or optimize the ventilation parameters to improve, maintain or optimize the physical activity level and overall health status of the patient.

Claims

1. A ventilator system comprising:

a ventilator comprising a ventilation gas source, a ventilation gas delivery circuit, and a control unit;

a patient interface in communication with the ventilation gas delivery circuit;

at least one breath sensor;

at least one patient activity sensor;

wherein the ventilator is adapted to be coupled to a patient for permitting ambulation of the patient while performing a portion of work for respiratory muscles of the patient by providing ventilation gas delivery, the ventilator capable of providing the ventilation gas delivery at an instantaneous flow rate of over 30 liters per minute; and

wherein the control unit predicts a chronic obstructive pulmonary disease exacerbation based upon measurements from the at least one breath sensor and the at least one patient activity sensor and adjusts the ventilation gas delivery based upon the prediction to avoid or alleviate the chronic obstructive pulmonary disease exacerbation,

wherein the control unit comprises a processor and a memory, and wherein the memory stores measured ventilation parameters regarding activity level of the patient, and wherein after a chronic obstructive pulmonary disease exacerbation, the measured ventilation parameters stored in the memory prior to the chronic obstructive pulmonary disease exacerbation are used to program a signature for predicting future chronic obstructive pulmonary disease exacerbations.

2. The ventilator system of claim 1, wherein the ventilator reports activity level to a remote device.

3. The ventilator system of claim 1, wherein the patient interface maintains an open airway system to permit the patient to breathe ambient air freely and spontaneously.

4. The ventilator system of claim 1, wherein the at least one patient activity sensor includes a pedometer to record ambulation of the patient.

5. The ventilator system of claim 1, wherein the at least one patient activity sensor includes an actigraphy sensor to record activity level of the patient.

6. The ventilator system of claim 1, wherein the control unit executes a patient exercise test mode.

7. The ventilator system of claim 1, wherein the control unit detects respiration from the at least one breath sensor and patient activity measure from the at least one patient activity sensor over a predetermined time and processes the respiration and the patient activity measure to adjust the ventilation.

8. The ventilator system of claim 7, wherein the respiration is a measure of consecutive breaths over the predetermined time, and ventilation is adjusted after a predetermined number of breaths at a predetermined rate.

9. The ventilator system of claim 8, wherein the control unit records trends from the at least one breath sensor and the at least one patient activity sensor.

10. The ventilation system of claim 9, wherein the trends indicate an onset or precursor to a chronic obstructive pulmonary disease exacerbation, and the control unit predicts the chronic obstructive pulmonary disease exacerbation based upon the trends.

11. The ventilator system of claim 10, wherein the control unit exports the trends indicating an onset or precursor to a chronic obstructive pulmonary disease exacerbation to an external source.

12. The ventilator system of claim 1, wherein the at least one breath sensor measures respiration information selected from the group consisting of:

spontaneous breath rate, spontaneous breathing I;

E ratio, spontaneous inspiratory and expiratory time, spontaneous depth of breathing, and combinations thereof.

13. The ventilator system of claim 1, further comprising a user interface for inputting health status normal values or health status goals, and wherein the user interface displays patient health status compared to the at least one health status normal values or health status goals.

14. The ventilator system of claim 1, wherein the at least one breath sensor measures respiration rate and the at least one patient activity sensor measures patient activity, and a combination of measurements by the at least one breath sensor and the at least one patient activity sensor is used to adjust the ventilation.

15. The ventilator system of claim 1, wherein the control unit adjusts the ventilation gas delivery further based upon at least one overall health goal.

16. The ventilator system of claim 15, wherein the at least one overall health goal includes increased patient well-being expressed on a well-being scale.

17. The ventilator system of claim 16, wherein the well-being scale is selected from the group consisting of Borg scale, comfort scale, dyspnea scale, tiredness scale, ease of breathing scale, quality of life scale, and combinations thereof.

18. The ventilator system of claim 1, wherein the ventilator introduces a medication other than oxygen through the ventilation gas delivery circuit in response to the prediction.

19. The ventilator system of claim 1, wherein the ventilator predicts the chronic obstructive pulmonary disease exacerbation based upon one or more factors selected from the group consisting of coughing, type of cough, mucus production level, breath rate, activity level, SpO₂, EtCO₂, and depth of breathing.

20. A ventilator system comprising:

a ventilator comprising a ventilation gas source, a ventilation gas delivery circuit, and a control unit;

a patient interface in communication with the ventilation gas delivery circuit;

at least one breath sensor;

at least one health status measuring sensor;

wherein the ventilator is adapted to be coupled to a patient for permitting ambulation of a patient while performing a portion of work for respiratory muscles of the patient by providing ventilation gas delivery, the ventilator capable of providing the ventilation gas delivery at an instantaneous flow rate of over 30 liters per minute; and

wherein the control unit predicts a chronic obstructive pulmonary disease exacerbation based upon measurements from the at least one breath sensor and the at least one health status measuring sensor and adjusts the ventilation gas delivery based upon the prediction to avoid or alleviate the chronic obstructive pulmonary disease exacerbation,

wherein the control unit comprises a processor and a memory, and wherein the memory stores measured ventilation parameters regarding the patient health status, and wherein after a chronic obstructive pulmonary disease exacerbation, the measured ventilation parameters stored in the memory prior to the chronic obstructive pulmonary disease exacerbation are used to program a signature for predicting future chronic obstructive pulmonary disease exacerbations.

21. The ventilator system of claim 20, wherein the ventilator reports patient health status to a remote device.

22. The ventilator system of claim 20, wherein the patient interface maintains an open airway system to permit the patient to breathe ambient air freely and spontaneously.

23. The ventilator system of claim 20, wherein the control unit executes a patient exercise test mode.

24. The ventilator system of claim 20, wherein the control unit detects respiration from the at least one breath sensor and patient health status from the at least one health status measuring sensor over a predetermined time and processes the respiration and the patient health status to adjust the ventilation.

25. The ventilator system of claim 24, wherein the respiration is a measure of consecutive breaths over the predetermined time, and ventilation is adjusted after a predetermined number of breaths at a predetermined rate.

26. The ventilator system of claim 20, wherein the at least one breath sensor measures respiration information selected from the group consisting of:

spontaneous breath rate, spontaneous breathing I;

E ratio, spontaneous inspiratory and expiratory time, spontaneous depth of breathing, and combinations thereof.

27. The ventilator system of claim 20, wherein the control unit records trends from the at least one breath sensor and the at least one health status measuring sensor.

28. The ventilator system of claim 27, wherein the trends indicate an onset or precursor to a chronic obstructive pulmonary disease exacerbation, and the control unit predicts the chronic obstructive pulmonary disease exacerbation based on the trends.

29. The ventilator system of claim 28, wherein the control unit exports the trends indicating an onset or precursor to a chronic obstructive pulmonary disease exacerbation to an external source.

30. The ventilator system of claim 20, wherein the control unit adjusts the ventilator to result in the health status that matches as close as possible to the health status baseline value.

31. The ventilator system of claim 20, wherein the at least one breath sensor measures respiration rate and the at least one health status measuring sensor measures the patient health status, and a combination of measurements by the at least one breath sensor and the at least one health status measuring sensor is used to adjust the ventilation.

32. The ventilator system of claim 20, wherein the ventilator introduces a medication other than oxygen through the ventilation gas delivery circuit in response to the prediction.

33. The ventilator system of claim 20, wherein the ventilator predicts the chronic obstructive pulmonary disease exacerbation based upon one or more factors selected from the group consisting of coughing, type of cough, mucus production level, breath rate, activity level, SpO₂, EtCO₂, and depth of breathing.