METHODS, SYSTEMS AND DEVICES FOR NON-INVASIVE OPEN VENTILATION FOR PROVIDING VENTILATION SUPPORT

• US 20100252041A1
• Filed: 04/02/2010
• Published: 10/07/2010
• Est. Priority Date: 04/02/2009
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Cipollone, Joseph, Eghbal, Darius, Aguirre, Joey, Allum, Todd, Wondka, Anthony D., Kapust, Gregory, Gerber, Anthony
• Granted Patent: US 10,046,133 B2
• Time in Patent Office: Days
• US Class Current: 128/204.230
• CPC Class Codes: A61M 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/0006 with means for creating vibrations in patients' airways
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/0096 High frequency jet ventilation
• CPC Class Codes: A61M 16/0493 with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block
• CPC Class Codes: A61M 16/0605 Means for improving the adaptation of the mask to the patient
• CPC Class Codes: A61M 16/0622 having an underlying cushion
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0677 Gas-saving devices therefor
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0688 by means of an adhesive
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0841 for sampling
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/0883 Circuit type
• CPC Class Codes: A61M 16/101 using an oxygen concentrator
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/127 : by Venturi effect, i.e. entrainment mixers
• CPC Class Codes: A61M 16/16 : Devices to humidify the respiration air A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/201 : Controlled valves
• CPC Class Codes: A61M 16/208 : Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• 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 2016/0024 : with an on-off output signal, e.g. from a switch
• CPC Class Codes: A61M 2016/0027 : pressure meter
• CPC Class Codes: A61M 2016/0036 : in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0661 : with customised shape
• CPC Class Codes: A61M 2202/0007 : introduced into the body
• CPC Class Codes: A61M 2202/0208 : Oxygen
• CPC Class Codes: A61M 2202/03 : Gases in liquid phase, e.g. cryogenic liquids
• CPC Class Codes: A61M 2205/0205 : Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
• CPC Class Codes: A61M 2205/17 : with redundant control systems
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2230/40 : Respiratory characteristics

Abstract

A system for providing ventilation support to a patient may include a ventilator, a control unit, a gas delivery circuit with a proximal end in fluid communication with the ventilator and a distal end in fluid communication with a nasal interface, and a nasal interface. The nasal interface may include at least one jet nozzle at the distal end of the gas delivery circuit; and at least one spontaneous respiration sensor for detecting respiration in communication with the control unit. The system may be open to ambient. The control unit may receive signals from the at least one spontaneous respiration sensor and determine gas delivery requirements. The ventilator may deliver gas at a velocity to entrain ambient air and increase lung volume or lung pressure above spontaneously breathing levels to assist in work of breathing, and deliver ventilation gas in a cyclical delivery pattern synchronized with a spontaneous breathing pattern.

Claims

1. A system for providing ventilation support to a patient, the system comprising:

a ventilator;

a control unit;

a gas delivery circuit with a proximal end in fluid communication with the ventilator and a distal end in fluid communication with a nasal interface; and

a nasal interface comprising;

at least one jet nozzle at the distal end of the gas delivery circuit; and

at least one spontaneous respiration sensor for detecting respiration, wherein the at least one spontaneous respiration sensor is in communication with the control unit,

wherein the system is open to ambient,

wherein the control unit receives signals from the at least one spontaneous respiration sensor and determines gas delivery requirements,

wherein the ventilator delivers gas at a velocity to entrain ambient air and increase lung volume or lung pressure above spontaneously breathing levels to assist in work of breathing, and

wherein the ventilator delivers ventilation gas in a cyclical delivery pattern synchronized with a spontaneous breathing pattern.

2. The system of claim 1, wherein the at least one jet nozzle is adapted to be positioned in free space and aligned to directly deliver ventilation gas into an entrance of a nose.

3. The system of claim 1, wherein the nasal interface comprises a support for the at least one jet nozzle.

4. The system of claim 1, wherein a patient may spontaneous breathe ambient air through the nose.

5. The system of claim 1, wherein the nasal interface further comprises:

at least one outer tube with a proximal lateral end of the outer tube adapted to extend toward a side of a nose;

at least one coupler at a distal section of the outer tube for impinging at least one nostril and positioning the at least one outer tube relative to the at least one nostril;

at least one opening in the distal section adapted to be in fluid communication with the nostril; and

at least one aperture in the at least one outer tube in fluid communication with ambient air, wherein the at least one aperture is in proximity to the at least one jet nozzle, and

wherein the at least one jet nozzle is positioned within the outer tube at the proximal lateral end and in fluid communication with a pressurized gas supply.

6. The system of claim 5, wherein the at least one coupler is a nasal cushion.

7. The system of claim 1, wherein the nasal interface further comprises:

a left outer tube comprising a left distal end adapted to impinge a left nostril, at least one left opening in the left distal end in pneumatic communication with the left nostril, a left proximal end of the left outer tube in fluid communication with ambient air, and wherein the left proximal end of the left outer tube curves laterally away from a midline of a face; and

a right outer tube comprising a right distal end adapted to impinge a right nostril, at least one right opening in the right distal end in pneumatic communication with the right nostril, a right proximal end of the right outer tube in fluid communication with ambient air, and wherein the right proximal end of the right outer tube curves laterally away from the midline of the face.

8. The system of claim 7, wherein ambient air is entrained through the left outer tube or the right outer tube.

9. The system of claim 1, wherein ventilation gas is provided at the beginning of respiration.

10. The system of claim 1, wherein ventilation gas is provided by ramping.

11. The system of claim 1, wherein the control unit adjusts an output of the ventilator to match a patient'"'"'s needs based on information from the at least one respiration sensor.

12. The system of claim 1, wherein the control unit comprises a speaking mode sensing system, and wherein the control unit adjusts an output of the ventilator while the patient is speaking to not be asynchronous with the patient'"'"'s spontaneous breathing.

13. The system of claim 1, wherein the nasal interface further comprises an outer tube, and wherein the outer tube comprises sound reduction features selected from the group consisting of:

a secondary aperture, a filter for the aperture, textured surfaces, a muffler, sound absorbing materials, an angled jet nozzle, non-concentric jet nozzle positions, and combinations thereof.

14. A device for providing ventilatory support to a patient, the device comprising:

a ventilator with a control system;

a gas supply;

a nasal interface open to ambient comprising at least one jet nozzle and at least one breathing sensor; and

a gas delivery circuit pneumatically connecting the ventilator to the at least one jet nozzle for delivering ventilation gas, and

wherein the nasal interface is adapted to locate the at least one breathing sensor in proximity to a nostril entrance, and is adapted to locate the at least one jet nozzle a distance away from the nostril entrance distal to the at least one breathing sensor.

15. The device of claim 14, wherein the ventilator delivers ventilation gas at a velocity to entrain ambient air and increase lung volume or lung pressure above spontaneously breathing levels to assist in work of breathing.

16. The device of claim 14, wherein the ventilator delivers ventilation gas in a cyclical delivery pattern synchronized with a spontaneous breathing pattern.

17. The device of claim 14, wherein the at least one jet nozzle is adapted to be positioned in free space and aligned to directly deliver ventilation gas into an entrance of a nose.

18. The device of claim 14, wherein the nasal interface comprises a support for the at least one jet nozzle.

19. The device of claim 14, wherein a patient may spontaneous breathe ambient air through the nose.

20. The device of claim 14, wherein the nasal interface further comprises:

at least one outer tube with a proximal lateral end of the outer tube adapted to extend toward a side of a nose;

at least one coupler at a distal section of the outer tube for impinging at least one nostril and positioning the at least one outer tube relative to the at least one nostril;

at least one opening in the distal section adapted to be in fluid communication with the nostril; and

at least one aperture in the at least one outer tube in fluid communication with ambient air, wherein the at least one aperture is in proximity to the at least one jet nozzle, and

wherein the at least one jet nozzle is positioned within the outer tube at the proximal lateral end and in fluid communication with a pressurized gas supply.

21. The device of claim 20, wherein the at least one coupler is a nasal cushion.

22. The device of claim 14, wherein the nasal interface further comprises:

a left outer tube comprising a left distal end adapted to impinge a left nostril, at least one left opening in the left distal end in pneumatic communication with the left nostril, a left proximal end of the left outer tube in fluid communication with ambient air, and wherein the left proximal end of the left outer tube curves laterally away from a midline of a face; and

a right outer tube comprising a right distal end adapted to impinge a right nostril, at least one right opening in the right distal end in pneumatic communication with the right nostril, a right proximal end of the right outer tube in fluid communication with ambient air, and wherein the right proximal end of the right outer tube curves laterally away from the midline of the face.

23. The device of claim 22, wherein ambient air is entrained through the left outer tube or the right outer tube.

24. The device of claim 14, wherein ventilation gas is provided at the beginning of respiration.

25. The device of claim 14, wherein ventilation gas is provided by ramping.

26. The device of claim 14, wherein the control unit adjusts an output of the ventilator to match a patient'"'"'s needs based on information from the at least one respiration sensor.

27. The device of claim 14, wherein the control unit comprises a speaking mode sensing system, and wherein the control unit adjusts an output of the ventilator while the patient is speaking to not be asynchronous with the patient'"'"'s spontaneous breathing.

28. The device of claim 14, wherein the nasal interface further comprises an outer tube, and wherein the outer tube comprises sound reduction features selected from the group consisting of:

a secondary aperture, a filter for the aperture, textured surfaces, a muffler, sound absorbing materials, an angled jet nozzle, non-concentric jet nozzle positions, and combinations thereof.

29. A method for providing ventilation support, the method comprising:

providing a nasal interface for positioning at least one jet nozzle;

delivering ventilation gas from a ventilator to a gas delivery circuit in fluid communication with the at least one jet nozzle;

delivering ventilation gas to a patient nasal airway through the at least one jet nozzle;

sensing spontaneous respiration with at least one sensor in communication with a control unit;

determining ventilation gas delivery requirements;

modifying the delivery of ventilation gas based upon phases of breathing in a cyclical pattern synchronized with the phases of breathing;

wherein the ventilation gas increases lung volume or lung pressure above spontaneously breathing levels to assist in work of breathing,

wherein the ventilation gas entrains ambient air, and

wherein the patient nasal airway is open to ambient.

30. The method of claim 29, wherein the at least one jet nozzle is adapted to be positioned in free space and aligned to directly deliver the ventilation gas into an entrance of a nose.

31. The method of claim 29, wherein the nasal interface comprises a support for the at least one jet nozzle.

32. The method of claim 29, wherein the nasal interface further comprises:

at least one outer tube with a proximal lateral end of the outer tube adapted to extend toward a side of a nose;

at least one coupler at a distal section of the outer tube for impinging at least one nostril and positioning the at least one outer tube relative to the at least one nostril;

at least one opening in the distal section adapted to be in fluid communication with the nostril; and

at least one aperture in the at least one outer tube in fluid communication with ambient air, wherein the at least one aperture is in proximity to the at least one jet nozzle, and

wherein the at least one jet nozzle is positioned within the outer tube at the proximal lateral end and in fluid communication with a pressurized gas supply.

33. The method of claim 32, wherein the at least one coupler is a nasal cushion.

34. The method of claim 29, wherein the nasal interface further comprises:

a left outer tube comprising a left distal end adapted to impinge a left nostril, at least one left opening in the left distal end in pneumatic communication with the left nostril, a left proximal end of the left outer tube in fluid communication with ambient air, and wherein the left proximal end of the left outer tube curves laterally away from a midline of a face; and

a right outer tube comprising a right distal end adapted to impinge a right nostril, at least one right opening in the right distal end in pneumatic communication with the right nostril, a right proximal end of the right outer tube in fluid communication with ambient air, and wherein the right proximal end of the right outer tube curves laterally away from the midline of the face.

35. The method of claim 34, wherein ambient air is entrained through the left outer tube or the right outer tube.

36. The method of claim 29, wherein ventilation gas is provided at the beginning of respiration.

37. The method of claim 29, wherein ventilation gas is provided by ramping.

38. The method of claim 29, wherein the nasal interface is adapted to locate the at least one sensor in proximity to a nostril entrance, and is adapted to locate the at least one jet nozzle a distance away from the nostril entrance distal to the at least one sensor.

39. The method of claim 29, further comprising providing a portable gas supply, and wherein the ventilator is wearable.

40. The method of claim 29, wherein the supply of ventilation gas is adjusted to meet the needs of a patient based on information from the at least one sensor.

41. The method of claim 29, further comprising detecting speaking, and wherein the supply of ventilation gas is adjusted based on whether or not a patient is speaking.