Methods and devices for providing mechanical ventilation with an open airway interface

• US 8,677,999 B2
• Filed: 08/21/2009
• Issued: 03/25/2014
• Est. Priority Date: 08/22/2008
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Wondka, Anthony D., Cipollone, Joseph, Freitag, Lutz, Allum, Todd A.
• Primary Examiner(s): GINSBERG, OREN ISAAC
• Application Number:
  US12/545,708
• Publication Number:
  US 20100071693A1
• Time in Patent Office: 1,677 Days
• Field of Search: 128/200.14, 12820018-20022, 128/202.27, 128/203.12, 128/203.22, 12820325-20326, 128/204.18, 12820424-20425, 128/204.29, 128/205.11, 128/205.25, 128/207.14, 128/207.18, 128/911, 128/912
• US Class Current: 128/204.25
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/0465 Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
• CPC Class Codes: A61M 16/0468 with valves at the proximal end limiting exhalation, e.g. during speaking or coughing air passages from trachea to oesophagus or to pharynx, artificial epiglottis A61F2/203
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/085 Gas sampling
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/101 using an oxygen concentrator
• CPC Class Codes: A61M 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• 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 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 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/201 Controlled valves
• CPC Class Codes: A61M 16/205 used for exhalation control
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2016/0027 : pressure meter
• CPC Class Codes: A61M 2016/003 : with a flowmeter
• CPC Class Codes: A61M 2016/1025 : the O2 concentration
• CPC Class Codes: A61M 2016/103 : the CO2 concentration
• 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 2205/3368 : Temperature
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/435 : partial O2 pressure (P-O2)
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity

Abstract

Methods, systems and devices are described for providing mechanical ventilation support of a patient using an open airway patient interface. The system includes gas delivery circuit and patient interface configurations to optimize performance and efficiency of the ventilation system. A ventilation system may include a ventilator for supplying ventilation gas. A patient interface may include distal end in communication with a patient airway, a proximal end in communication with ambient air, and an airflow channel between the distal end and the proximal end. A gas delivery circuit may be adapted to attach to the patient interface without occluding the patient interface to allow ambient air to flow from outside the patient interface to the patient airway. The ventilation gas may entrain air from ambient and from the patient airway.

Claims

1. A ventilation system comprising:

a ventilator for supplying ventilation gas;

a patient interface having a generally hollow cylindrical configuration defined by a central lengthwise axis and opposed open ends having substantially equivalent cross-sectional areas and including an open distal end with a distal opening axis coaxial with the central lengthwise axis and being in communication with a patient airway, an opposed open proximal end with a proximal opening axis coaxial with the central lengthwise axis and being in communication with ambient air, and an airflow channel between the distal end and the proximal end;

a gas delivery circuit, wherein the gas delivery circuit is adapted to attach to the patient interface in a coaxial relationship to the proximal opening axis of the open proximal end without occluding the patient interface to allow ambient air to flow from outside the patient interface to the patient airway and to allow patient spontaneous breathing to flow from inside, the patient interface to outside along the central lengthwise axis and the proximal opening axis without obstruction; and

wherein the ventilation gas entrains air from ambient and from the patient airway.

2. The ventilation system of claim 1, wherein the ambient air flows through the patient interface at least during application of the ventilation gas.

3. The ventilation system of claim 1, wherein the patient interface is selected from the group consisting of:

an airway tube;

a mask;

a cannula; and

combinations thereof.

4. The ventilation system of claim 1, wherein the ventilator as is delivered in a cycle selected from the group consisting of:

as a volume synchronized with the patient'"'"'s inspiratory cycle, in which the volume is selected by the user;

continuously;

as a volume delivered cyclically at a rate determined by the ventilator;

as a volume cyclically synchronized with the patients breathing, and with a back up rate to deliver a mandatory number of breaths over a period of time;

as a volume cyclically during an inspiratory cycle to reduce the work of breathing, and during an expiratory cycle to create PEEP; and

combinations thereof.

5. The ventilation system of claim 1, further comprising one or more fenestrations between the distal end and the proximal end of the patient interface, and a nozzle on a distal end of the as delivery circuit, wherein the nozzle is located within the patient interface, and wherein the nozzle is positioned in proximity to the one or more fenestrations when supplying ventilation gas.

6. The ventilation system of claim 5, wherein the ambient air flows through the patient interface at least during application of the ventilation gas.

7. The ventilation system of claim 5, wherein the patient interface is selected from the group consisting of:

an airway tube;

a mask;

a cannula; and

combinations thereof.

8. The ventilation system of claim 5, wherein the ventilator gas is delivered in a cycle selected from the group consisting of:

as a volume synchronized with the patient'"'"'s inspiratory cycle, in which the volume is selected by the user;

continuously as a volume delivered cyclically at a rate determined by the ventilator as a volume cyclically synchronized with the patients breathing, and with a back up rate to deliver a mandatory number of breaths over a period of time;

as a volume Cyclically murine an inspiratory cycle to reduce the work of breathing, and during an expiratory cycle to create PEEP; and

combinations thereof.

9. The ventilation system of claim 5, wherein the ventilation system is used to treat a disorder selected from the group consisting of:

lung disease;

a breathing disorder;

a neuromuscular disorder; and

combinations thereof.

10. The ventilation system of claim 5, wherein the ventilation system is used with a portable as supply.

11. The ventilation system of claim 5, wherein a distal tip of the gas delivery circuit is a low profile nozzle.

12. The ventilation system of claim 5, wherein a distal tip of the gas delivery circuit is angled to direct the ventilation gas toward an opening at the distal end of the patient interface.

13. The ventilation system of claim 5, wherein the gas delivery circuit is coupled to the patient interface with a baffle connection.

14. The ventilation system o claim 5, further comprising a heat moisture exchanger.

15. The ventilation system of claim 5, wherein the ventilation gas exits the gas delivery circuit distal end as a jet with an exit speed of approximately 50-approximately 350 meters per second.

16. The ventilation system of claim 5, wherein the entrained air is approximately 25-approximately 300% of the ventilation gas.

17. The ventilation system of claim 5, further comprising one or more sensors.

18. The ventilation system of claim 5, wherein humidity is delivered to the patient airway.

19. The ventilation system of claim 5, wherein the ventilation gas is selected from the group consisting of:

air, oxygen, helium, NO, HeliOx, and combinations thereof.

20. The ventilation system of claim 5, wherein the ventilator is adapted to vary the gas output parameters to achieve a result selected from the group consisting of:

to achieve a desired FI02;

to achieve a desired airway pressure;

to achieve a desired lung volume;

to achieve a desired inspiratory flow rate; and

combinations thereof.

21. The ventilation system of claim 5, wherein a distal tip of the gas delivery circuit is approximately 0-1.5 inches from the proximal end of the patient interlace.

22. The ventilation system of claim 5, wherein the gas delivery circuit contacts an inner surface of the patient interface, and a distal tip of the gas delivery circuit is angled to direct the ventilation gas toward the distal end of the patient interface.

23. The ventilation system of claim 5, further comprising one or more pressure taps for measuring flow through the patient interface.

24. The ventilation system of claim 5, further comprising one or more sensors for measuring oxygen concentration, and wherein the ventilation gas is adjusted based upon measurements from the one or more sensors.

26. The ventilation system of claim 1, wherein the ventilation system is used with portable gas supply.

27. The ventilation system of claim 1, wherein a distal end of the gas delivery circuit comprises two gas delivery exit ports, and wherein the patient interface comprises a left and right nasal cannula.

28. The ventilation system of claim 1, wherein a distal tip of the gas delivery circuit is a low profile nozzle.

29. The ventilation system of claim 1, wherein a distal tip of the gas delivery circuit is angled to direct the ventilation gas toward an opening at the distal end of the patient interface.

30. The ventilation system of claim 1, wherein the gas delivery circuit is coupled to the patient interface with a baffle connection.

31. The ventilation system of claim 1, further comprising a heat moisture exchanger.

32. The ventilation system of claim 1, wherein the ventilation gas exits a distal end of the gas delivery circuit as a jet with an exit speed of approximately 50-approximately 350 meters per second.

33. The ventilation system of claim 1, wherein the entrained air is approximately 25-approximately 300% of the ventilation gas.

34. The ventilation system of claim 1, further comprising one or more sensors.

35. The ventilation system of claim 1, wherein humidity is delivered to the patient airway.

36. The ventilation system of claim 1, wherein the ventilation gas is selected from the group consisting of:

air, oxygen, helium, NO, HeliOx, and combinations thereof.

37. The ventilation system of claim 1, wherein the ventilator is adapted to vary the gas output parameters to achieve a result selected from the group consisting of:

to achieve a desired FI02;

to achieve a desired airway pressure;

to achieve a desired lung volume to achieve a desired inspiratory flow rate; and

combinations thereof.

38. The ventilation system of claim 1, wherein a distal tip of the gas delivery circuit approximately 0-1.5 inches from the proximal end of the patient interface.

39. The ventilation system of claim 1, the gas delivery circuit contacts an inner surface of the patient interface, and a distal tip of the gas delivery circuit is angled to direct the ventilation gas toward the distal end of the patient interface.

40. The ventilation system of claim 1, further comprising one or more pressure taps for measuring flow through the patient interface.

41. The ventilation system of claim 1, further comprising one or more sensors for measuring oxygen concentration, and where in the ventilation gas is adjusted based upon measurements from the one or more sensors.

25. The ventilation system of claim wherein the ventilation system is used to treat a disorder selected from the group consisting of:

lung disease;

a breathing disorder;

a neuromuscular disorder; and

combinations thereof.