VENTILATOR WITH BIOFEEDBACK MONITORING AND CONTROL FOR IMPROVING PATIENT ACTIVITY AND HEALTH

• US 20100083968A1
• Filed: 10/01/2009
• Published: 04/08/2010
• 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: King, Angela, Cipollone, Joseph, Wondka, Anthony D.
• Granted Patent: US 10,252,020 B2
• Time in Patent Office: Days
• US Class Current: 128/204.230
• 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 is described that 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 provide mechanical assistance to respiratory muscles to support work of breathing of a spontaneously breathing patient;

wherein the ventilator is adapted to be coupled to a patient for permitting ambulation of a respiratory compromised patient while supporting the work of breathing; and

wherein the control unit adjusts ventilation based upon activity level of the patient by processing measurements from the at least one breath sensor and the at least one patient activity sensor.

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 is a pedometer to record ambulation of the patient.

5. The ventilator system of claim 1, wherein the at least one patient activity sensor is 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 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.

10. 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.

11. The ventilation system of claim 1, wherein the at least one breath sensor detects an onset or precursor to a respiratory exacerbation, and the control unit executes a change in ventilator parameters to avoid or alleviate the exacerbation.

12. The ventilator system of claim 1, wherein the control unit exports the onset or precursor to a respiratory exacerbation to an external source.

13. The ventilator system of claim 1, 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 respiratory exacerbation, the stored respiratory status parameters prior to the respiratory exacerbation are used to program a signature for predicting future respiratory exacerbations.

14. The ventilator system of claim 1, further comprising a display, and wherein the display indicates an overall health index, wherein the overall health index comprises at least one patient health status measure, and at least one ventilator parameter measure.

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

16. 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 the combination of measurements is used to adjust the ventilation.

17. A method of providing ventilation therapy, the method comprising:

providing mechanical assistance with a ventilator to the respiratory muscles to support the work of breathing of a spontaneously breathing patient;

supplying ventilation gas to the patient with a patient interface that maintains an open airway system to permit the patient to breathe ambient air freely and spontaneously;

providing the ventilation gas with a mobile or wearable apparatus to enable patient mobility and ambulation;

recording a patient activity related parameter;

measuring and recording a spontaneous breathing pattern of the patient;

recording the spontaneous breathing pattern of the patient; and

reporting the patient activity related parameter.

18. The method of claim 17, further comprising recording parameters selected from the group consisting of:

general health level, vital signs, respiratory status, quality of life level, physical activity level, and combinations thereof.

19. The method of claim 17, further comprising administering an exercise or activity test of the patient through the user interface of the ventilator.

20. The method of claim 17, further comprising measuring and recording the spontaneous breathing history of the patient, and reporting the spontaneous breathing history of the patient.

21. The method of claim 17, further comprising detecting a precursor to a respiratory exacerbation.

22. The method of claim 17, further comprising adjusting the supplying of ventilation gas based upon the patient activity.

23. 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 provide mechanical assistance to respiratory muscles to support work of breathing of a spontaneously breathing patient;

wherein the ventilator is adapted to be coupled to a patient for permitting ambulation of a respiratory compromised patient while supporting the work of breathing; and

wherein the control unit adjusts ventilation based upon health status level of the patient by processing measurements from the at least one breath sensor and the at least one health status measuring sensor.

24. The ventilator system of claim 23, wherein the ventilator reports health status to a remote device.

25. The ventilator system of claim 23, wherein the patient interface maintains an open airway system to permit the patient to breathe ambient air freely and spontaneously.

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

27. The ventilator system of claim 23, wherein the control unit detects respiration from the at least one breath sensor and patient health status measure from the at least one health status measuring sensor over a predetermined time and processes the respiration and the health status measure to adjust the ventilation.

28. The ventilator system of claim 27, 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.

29. The ventilator system of claim 23, 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.

30. The ventilator system of claim 23, wherein the control unit records trends from the at least one breath sensor and the at least one health status measuring sensor.

31. The ventilator system of claim 23, wherein the at least one breath sensor detects an onset or precursor to a respiratory exacerbation, and the control unit executes a change in ventilator parameters to avoid or alleviate the exacerbation.

32. The ventilator system of claim 23, wherein the control unit exports the onset or precursor to a respiratory exacerbation to an external source.

33. The ventilator system of claim 23, wherein the control unit comprises a processor and a memory, and wherein the memory stores measured ventilation parameters regarding health status of the patient, and wherein after a respiratory exacerbation, the stored respiratory status parameters prior to the respiratory exacerbation are used to program a signature for predicting future respiratory exacerbations.

34. The ventilator system of claim 23, further comprising a display, and wherein the display indicates an overall health index, wherein the overall health index comprises at least one patient health status measure, and at least one ventilator parameter measure.

35. The ventilator system of claim 23, further comprising a patient interface for inputting health status normal values or health status goals, and wherein the patient interface displays patient health status compared to the at least one health status normal values or health status goals.

36. The ventilator system of claim 23, wherein a user interface for the control unit comprises an input for a health status goal, and wherein the control unit adjusts the ventilator to result in a health status that matches as close as possible to the health status goal.

37. The ventilator system of claim 23, wherein the at least one breath sensor measures respiration rate and the at least one health status measuring sensor measures patient health status, and the combination of measurements is used to adjust the ventilation.

38. A method of providing ventilation therapy, the method comprising:

providing mechanical assistance with a ventilator to the respiratory muscles to support the work of breathing of a spontaneously breathing patient;

supplying ventilation gas to the patient with a patient interface that maintains an open airway system to permit the patient to breathe ambient air freely and spontaneously;

providing the ventilation gas with a mobile or wearable apparatus to enable patient mobility and ambulation;

recording a health status related parameter;

measuring and recording a spontaneous breathing pattern of the patient;

recording the spontaneous breathing pattern of the patient; and

reporting the health status related parameter.

39. The method of claim 38, further comprising recording parameters selected from the group consisting of:

general health level, vital signs, respiratory status, quality of life level, physical activity level, and combinations thereof.

40. The method of claim 38, further comprising administering an exercise or activity test of the patient through the user interface of the ventilator.

41. The method of claim 38, further comprising measuring and recording the spontaneous breathing history of the patient, and reporting the spontaneous breathing history of the patient.

42. The method of claim 38, further comprising detecting a precursor to a respiratory exacerbation.

43. The method of claim 38, further comprising adjusting the supplying of ventilation gas based upon the health status of the patient.

44. A mobility assist device comprising:

a portable ventilator with a control unit, the control unit comprising a processor and a memory;

a health status measuring device, wherein the health status measuring device measures at least one parameter indicating the current health status of a patient relative to a current activity level or a health goal; and

wherein information from the health status measuring device is used to adjust the control unit to adjust the ventilation parameters.

45. The mobility assist device of claim 44, wherein the control unit adjusts the ventilation parameters based on information from both the health status measuring device and information from at least one breath sensor.