METHODS, SYSTEMS AND DEVICES FOR NON-INVASIVE OPEN VENTILATION FOR TREATING AIRWAY OBSTRUCTIONS

• US 20100252042A1
• 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: Gerber, Anthony, Cipollone, Joseph, Eghbal, Darius, Aguirre, Joey, Allum, Todd, Wondka, Anthony D., Kapust, Gregory
• Granted Patent: US 9,227,034 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 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;

a nasal interface comprising;

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,

wherein the system is open to ambient, and

wherein the control unit determines more than one gas output velocities, wherein the more than one 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.

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 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; and

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,

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 outer tube.

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

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

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

12. 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.

13. 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.

14. 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.

15. 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.

16. 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 the nose, the manifold comprising;

a gas flow path;

a gas chamber in the gas flow path;

tubular nasal cushions adapted to be in communication with the nostril gas flow path and in communication with the manifold gas flow path;

a pressure sensing port in communication with the gas chamber;

a spontaneous breathing aperture in communication with the gas flow path wherein the patient can exhale completely through the spontaneous breathing aperture, and inspire through the spontaneous breathing aperture; and

a jet gas delivery nozzle in communication with the gas delivery circuit and in communication with the manifold gas flow path; and

a gas delivery circuit pneumatically connecting the ventilator to the nasal interface;

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

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

17. The device of claim 16, wherein the nose is in fluid communication with ambient air.

18. The device of claim 16, wherein the control system determines more than one gas output velocities, wherein the more than one 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.

19. The device of claim 16, wherein the control system adjusts an output of the ventilator to match a patient'"'"'s needs based on information from the pressure sensing port.

20. The device of claim 16, 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.

21. The device of claim 16, 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.

22. The device of claim 16, 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.

23. A device for treating sleep apnea, 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.

24. The device of claim 23, 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.

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

26. The device of claim 23, wherein a patient may spontaneous breathe ambient air through the nose.

27. The device of claim 23, 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.

28. The device of claim 27, wherein the at least one coupler is a nasal cushion.

29. The device of claim 23, 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.

30. The device of claim 29, wherein ambient air is entrained through the left outer tube or the right outer tube.

31. The device of claim 23, wherein ventilation gas is provided at the beginning of respiration.

32. The device of claim 23, wherein ventilation gas is provided by ramping.

33. The device of claim 23, wherein the control system adjusts an output of the ventilator to match a patient'"'"'s needs based on information from the pressure sensing port.

34. The device of claim 23, 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.

35. The device of claim 23, 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.

36. The device of claim 23, 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.

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

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

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 a 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 pressurized gas output velocities, wherein the more than one 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; 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, and

wherein the patient nasal airway is open to ambient.

38. The method of claim 37, 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.

39. The method of claim 37, wherein the nasal interface comprises a support for the at least one jet nozzle.

40. The method of claim 37, 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,

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.

41. The method of claim 40, wherein the at least one coupler is a nasal cushion.

42. The method of claim 37, 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.

43. The method of claim 42, wherein ambient air is entrained through the outer tube.

44. The method of claim 37, wherein the pressurized gas is provided at the beginning of respiration.

45. The method of claim 37, wherein the pressurized gas is provided by ramping.

46. The method of claim 37, wherein a tip of the at least one jet nozzle is directed toward an inner wall of an outer tube.

47. The method of claim 37, wherein the nasal interface comprises a sound reducer.

48. The method of claim 37, further comprising turning a pressurized gas source on, and monitoring for a predetermined time without delivering therapy.

49. The method of claim 37, further comprising, after the predetermined time, activating the pressurized gas source to deliver a therapeutic gas flow.

50. The method of claim 37, wherein the supply of ventilation gas is adjusted to meet the needs of a patient based on information from the at least one sensor.

51. The method of claim 37, further comprising detecting speaking, and wherein the supply of ventilation gas is adjusted based on whether or not a patient is speaking.

52. The method of claim 37, further comprising detecting apnea or hypopnea, and wherein the supply of ventilation gas is adjusted based on apnea or hypopnea.

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

providing a ventilator, a gas delivery circuit, and a nasal interface;

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 user'"'"'s face, wherein the nasal interface allows the user to inhale and exhale ambient air across or through the nasal interface without breathing being restricted;

turning ventilator power on causing the ventilator to enter a mode of patient monitoring without delivering therapy; and

wherein after a delay after turning the ventilator power on, at a predetermined time, the ventilator delivers a therapeutic gas flow of ventilation gas to a user'"'"'s nasal airway through the gas delivery circuit and the nasal interface.

54. The method of claim 53, wherein the therapeutic gas flow is adjusted to meet the needs of the user based on information from at least one sensor.

55. The method of claim 53, further comprising detecting speaking, and wherein the supply therapeutic gas flow is adjusted based on whether or not a patient is speaking.

56. The method of claim 53, further comprising detecting apnea or hypopnea, and wherein the therapeutic gas flow is adjusted based on apnea or hypopnea.