Methods, systems and devices for non-invasive open ventilation for treating airway obstructions

• US 9,227,034 B2
• Filed: 04/02/2010
• Issued: 01/05/2016
• 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: Kapust, Gregory, Allum, Todd, Wondka, Anthony D., Cipollone, Joseph, Gerber, Anthony, Eghbal, Darius, Aguirre, Joey, Kassanis, George A.
• Primary Examiner(s): Flick, Jason
• Assistant Examiner(s): BRYANT, ERIC C
• Application Number:
  US12/753,856
• Publication Number:
  US 20100252042A1
• Time in Patent Office: 2,104 Days
• Field of Search: None
• US Class Current: 1/1
• 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 reducing airway obstructions of 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, and at least one spontaneous respiration sensor in communication with the control unit for detecting a respiration effort pattern and a need for supporting airway patency. The system may be open to ambient. The control unit may determine more than one gas output velocities. The more than one gas output velocities may be synchronized with different parts of a spontaneous breath effort cycle, and a gas output velocity may be determined by a need for supporting airway patency.

Claims

1. A system for reducing airway obstructions of 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;

the nasal interface comprising;

at least one jet nozzle;

at least one outer tube including a wall defining a gas flow path therethrough;

at least one entrainment aperture defined in the wall of the at least one outer tube in fluid communication with ambient air, wherein the at least one entrainment aperture is in proximity to the at least one jet nozzle;

at least one spontaneous breathing aperture defined in the wall of the at least one outer tube in fluid communication with ambient air, wherein the at least one spontaneous breathing aperture is in downstream proximity to the at least one entrainment aperture; and

at least one spontaneous respiration sensor in communication with the control unit for detecting a respiration effort pattern and a need for supporting airway patency,

wherein the control unit determines a plurality of baseline gas output velocities, wherein the plurality of baseline gas output velocities are synchronized with different parts of a spontaneous breath effort cycle, and adjusts the plurality of baseline gas output velocities as determined by the need for supporting airway patency.

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 pressurized gas into an entrance of a nose.

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

4. The system of claim 1, wherein the nasal interface further includes:

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

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

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

5. The system of claim 4, wherein the at least one coupler is a nasal cushion.

6. The system of claim 1, wherein the at least one outer tube further includes:

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

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

7. The system of claim 6, wherein ambient air is entrained through either or both of the left outer tube and the right outer tube.

8. The system of claim 1, wherein pressurized gas is provided at the beginning of respiration.

9. The system of claim 1, wherein pressurized gas is provided by ramping.

10. The system of claim 1, further comprising a portable ventilation gas supply, and wherein the ventilator is portable.

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 spontaneous 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 control unit comprises an apnea or hypopnea sensing system, and wherein the control unit adjusts an output of the ventilator based on apnea or hypopnea.

14. The system of claim 1, wherein the at least one outer tube further includes sound reduction features selected from the group consisting of:

a filter for the at least one spontaneous breathing aperture, textured surfaces, a muffler, sound absorbing materials, a fluted entrance of the at least one spontaneous breathing aperture, and combinations thereof.

53. The system of claim 1, wherein the at least one jet nozzle is angled with respect to an axial centerline of the gas flow path, wherein pressurized gas delivered by the at least one jet nozzle is directed away from the axial centerline of the gas flow path toward the wall.

54. The system of claim 1, wherein the at least one entrainment aperture is provided with a fluted entrance.

15. A device for treating sleep apnea, the device comprising:

a ventilator with a control system;

a gas supply;

a nasal interface comprising a manifold adapted to be placed under a nose, the manifold comprising;

at least one wall surrounding a gas flow path;

a gas chamber in the gas flow path;

nasal cushions adapted to be in communication with the nose and in communication with the gas flow path;

a pressure sensing port in communication with the gas chamber;

at least one spontaneous breathing aperture defined in the at least one wall in fluid communication with ambient air, wherein a patient can exhale completely through the at least one spontaneous breathing aperture and inspire through the at least one spontaneous breathing aperture;

a jet nozzle in communication with the gas flow path;

at least one entrainment aperture defined in the at least one wall in proximity to the at least one jet nozzle in fluid communication with ambient air, wherein the at least one spontaneous breathing aperture is in downstream proximity to the at least one entrainment aperture; and

a gas delivery circuit pneumatically connecting the ventilator to the nasal interface and in communication with the jet nozzle;

wherein gas flows from the ventilator through the gas delivery circuit, out the jet nozzle into the manifold gas flow path, into the gas chamber, and through the nasal cushions to the nose, and

wherein the gas delivery into the gas chamber of the manifold creates a positive pressure in the gas chamber, and wherein the positive pressure is controlled at a desired positive pressure by the control system.

16. The device of claim 15, wherein the control system determines a plurality of gas output velocities, wherein the plurality of gas output velocities are synchronized with different parts of a spontaneous breath effort cycle, and a gas output velocity is determined by a need for supporting airway patency.

17. The device of claim 15, wherein the control system adjusts an output of the ventilator to match a patient'"'"'s needs based on information from the pressure sensing port.

18. The device of claim 15, wherein the control system comprises a speaking mode sensing system, and wherein the control system adjusts an output of the ventilator while the patient is speaking to not be asynchronous with the patient'"'"'s spontaneous breathing.

19. The device of claim 15, wherein the control system comprises an apnea or hypopnea sensing system, and wherein the control system adjusts an output of the ventilator based on apnea or hypopnea.

20. The device of claim 15, wherein the manifold further comprises sound reduction features selected from the group consisting of:

a filter for the at least one spontaneous breathing aperture, textured surfaces, a muffler, sound absorbing materials, a fluted entrance of the at least one spontaneous breathing aperture, and combinations thereof.

55. The device of claim 15, wherein the at least one jet nozzle is angled with respect to an axial centerline of the gas flow path, wherein pressurized gas delivered by the at least one jet nozzle is directed away from the axial centerline of the gas flow path toward the wall.

21. A device for treating sleep apnea, the device comprising:

a ventilator with a control system;

a gas supply;

a nasal interface including;

at least one jet nozzle;

at least one outer tube including a wall defining a gas flow path therethrough;

at least one entrainment aperture defined in the wall of the outer tube in fluid communication with ambient air, wherein the at least one entrainment aperture is in proximity to the at least one jet nozzle;

at least one spontaneous breathing aperture defined in the wall of the at least one outer tube and in fluid communication with ambient air, wherein the at least one spontaneous breathing aperture is in downstream proximity to the at least one entrainment aperture; 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,

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

22. The device of claim 21, 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.

23. The device of claim 21, wherein the nasal interface comprises a support for the at least one jet nozzle.

24. The device of claim 21, wherein the nasal interface further includes:

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

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

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

25. The device of claim 24, wherein the at least one coupler is a nasal cushion.

26. The device of claim 21, wherein the at least one outer tube further includes:

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

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

27. The device of claim 26, wherein ambient air is entrained through the left outer tube or the right outer tube.

28. The device of claim 21, wherein ventilation gas is provided at the beginning of respiration.

29. The device of claim 21, wherein ventilation gas is provided by ramping.

30. The device of claim 21, wherein the control system adjusts an output of the ventilator to match a patient'"'"'s needs based on information from the pressure sensing port.

31. The device of claim 21, wherein the control system comprises a speaking mode sensing system, and wherein the control system adjusts an output of the ventilator while the patient is speaking to not be asynchronous with the patient'"'"'s spontaneous breathing.

32. The device of claim 21, wherein the control system comprises an apnea or hypopnea sensing system, and wherein the control system adjusts an output of the ventilator based on apnea or hypopnea.

33. The device of claim 21, wherein the at least one outer tube further includes sound reduction features selected from the group consisting of:

a filter for the at least one spontaneous breathing aperture, textured surfaces, a muffler, sound absorbing materials, a fluted entrance of the at least one spontaneous breathing aperture, and combinations thereof.

34. A method for reducing airway obstructions of a patient, the method comprising:

providing a nasal interface for positioning at least one jet nozzle for delivering pressurized gas to a patient nasal airway, the nasal interface including a gas flow path, wherein at least one spontaneous breathing aperture and at least one entrainment aperture are defined in a wall of an outer tube of the nasal interface and in fluid communication with the gas flow path and ambient air, the at least one entrainment aperture being in proximity to the at least one let nozzle, and the at least one spontaneous breathing aperture being in downstream proximity to the at least one entrainment aperture;

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

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

sensing a respiration effort pattern and a need for supporting airway patency with at least one sensor in communication with a control unit;

determining a plurality of baseline pressurized gas output velocities, wherein the plurality of baseline gas output velocities are synchronized with different parts of a spontaneous breath effort cycle, and adjusting the plurality of baseline gas output velocities as determined by the need for supporting airway patency; and

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

wherein the pressurized gas increases airway pressure, wherein the pressurized gas entrains ambient air via the at least one entrainment aperture, and

wherein the patient nasal airway is open to ambient via the at least one spontaneous breathing aperture.

35. The method of claim 34, wherein the at least one jet nozzle is adapted to be positioned in free space and aligned to directly deliver the pressurized gas into an entrance of a nose.

36. The method of claim 34, wherein the nasal interface comprises further includes a support for the at least one jet nozzle.

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

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

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

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 source.

38. The method of claim 37, wherein the at least one coupler is a nasal cushion.

39. The method of claim 34, wherein the outer tube further includes:

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

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

40. The method of claim 34, wherein the pressurized gas is provided at the beginning of respiration.

41. The method of claim 34, wherein the pressurized gas is provided by ramping.

42. The method of claim 34, wherein a tip of the at least one jet nozzle is directed toward the wall of the outer tube, and wherein pressurized gas delivered by the at least one let nozzle is directed away from an axial centerline of the gas flow path.

43. The method of claim 34, wherein the nasal interface further includes a sound reducer.

44. The method of claim 34, further comprising turning a pressurized gas source on, the ventilator entering a patient-monitoring mode for a predetermined time without delivering a therapeutic gas flow.

45. The method of claim 44, further comprising, after the predetermined time, activating the pressurized gas source to deliver the therapeutic gas flow.

46. The method of claim 34, wherein the supply of ventilation gas is adjusted to meet the needs of a patient based on information from the at least one sensor.

47. The method of claim 34, further comprising detecting speaking, and wherein the supply of pressurized gas is adjusted based on whether or not a patient is speaking.

48. The method of claim 34, further comprising detecting apnea or hypopnea, and wherein the supply of pressurized gas is adjusted based on apnea or hypopnea.

56. The method of claim 34, wherein the at least one jet nozzle is angled with respect to an axial centerline of the gas flow path, wherein pressurized gas delivered by the at least one jet nozzle is directed away from the axial centerline of the gas flow path toward the wall.

49. A method of treating sleep apnea, the method comprising:

providing a ventilator, a gas delivery circuit, and a nasal interface having a gas flow path, the nasal interface including at least one spontaneous breathing aperture and at least one entrainment aperture defined in a wall of an outer tube of the nasal interface in fluid communication with ambient air, wherein the at least one entrainment aperture is in proximity to the at least one jet nozzle, and the at least one spontaneous breathing aperture is in downstream proximity to the at least one entrainment aperture;

connecting a proximal end of the gas delivery circuit to the ventilator;

connecting a distal end of the gas delivery circuit to the nasal interface;

attaching the nasal interface to a face of a user, wherein the nasal interface allows the user to inhale and exhale ambient air across or through the gas flow path of the nasal interface without breathing being restricted;

turning ventilator power on, the ventilator entering into a patient-monitoring mode in which respiratory parameters are measured without delivering a therapeutic gas flow; and

after a predetermined delay following entry into the patient monitoring mode, delivering the therapeutic gas flow from the ventilator through the gas delivery circuit and the nasal interface to a nasal airway of the user.

50. The method of claim 49, wherein the therapeutic gas flow is adjusted to meet the needs of the user based on information from at least one sensor.

51. The method of claim 49, further comprising detecting speaking, and wherein the supply therapeutic gas flow is adjusted based on whether or not the user is speaking.

52. The method of claim 49, further comprising detecting apnea or hypopnea, and wherein the therapeutic gas flow is adjusted based on apnea or hypopnea.