Nasal continuous positive airway pressure device and system

• US 8,534,286 B2
• Filed: 08/25/2009
• Issued: 09/17/2013
• Est. Priority Date: 12/02/2005
• Status: Active Grant

• Current Assignee: Vyaire Medical Consumables LLC
• Original Assignee: Carefusion 2200 Corporation (Becton, Dickinson & Co)
• Inventors: Pierro, Brian, Harrington, Steven M., Bridges, Bruce K., Gaylord, Douglas
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US12/547,140
• Publication Number:
  US 20090301495A1
• Time in Patent Office: 1,484 Days
• Field of Search: 128/200.24, 128/203.12, 128/203.22, 128/204.11, 128/204.18, 128/207.18, 128/911, 128/912, 128/204.12, 128/204.24, 128/204.25, 128/206.11, 128/207.15, 128/207.13, 128/DIG.26, 600/529, 600/532, 600/543
• US Class Current: 128/207.13
• CPC Class Codes: A61M 16/0057 Pumps therefor
• 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 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 2206/16 Rotating swirling helical flow, e.g. by tangential inflows

Abstract

An nCPAP device including a generator body defining first and second fluid flow circuits each including a tube and first and second nozzles. The tube defines a passageway forming an axial centerline. The first and second nozzles are associated with the tube and each defines an inlet and an outlet. The inlets are open to a fluid supply, whereas the outlets are open to the passageway. Each nozzle is adapted to emit a fluid jetstream from the outlet along a flow direction axis. The nozzles are arranged such that the flow direction axes are non-parallel relative to each other and relative to the axial centerline. This configuration readily induces vortex shedding during an expiratory phase, thus facilitating jet fluid flow disruption and reducing a patient'"'"'s work of breathing.

Claims

1. A nasal continuous positive airway pressure (nCPAP) device for use with an nCPAP system, the device comprising:

a generator body defining a patient side and an exhaust side, and forming first and second fluid flow circuits each including a tube defining a passageway, wherein at least one of the first and second fluid flow circuits further includes at least three nozzles disposed at circumferential locations about the corresponding passageway, each nozzle defining an inlet end open to a fluid supply and an outlet end open to the passageway, wherein each nozzle is adapted to emit a fluid jetstream from the outlet end along a respective flow direction axis.

2. The device of claim 1, wherein each passageway has a respective axial centerline and the respective flow direction axes of the at least three nozzles are non-parallel relative to each other and relative to the corresponding passageway axial centerline.

3. The device of claim 1, wherein at least two of the at least three nozzles are transversely aligned relative to the corresponding passageway axial centerline.

4. The device of claim 1, wherein the at least three nozzles are arranged relative to the corresponding passageway such that at least two of the flow direction axes intersect within the passageway.

5. The device of claim 4, wherein the at least three nozzles are arranged such that at least two of the flow direction axes intersect at the axial centerline.

6. The device of claim 1, wherein the second fluid flow circuit further includes at least three nozzles disposed at circumferential locations about the passageway of the second fluid flow circuit.

7. The device of claim 1, wherein at least one of the outlet ends of the at least three nozzles have a variable diameter as a function of an element slidably disposed relative to the at least one of the outlet ends.

8. The device of claim 1, wherein the at least three nozzles are arranged such that the corresponding flow direction axes each define an included angle in the range of 40-80°

from the axial centerline of the corresponding passageway.

9. The device of claim 1, wherein each tube defines a distal region extending from the outlet ends of the nozzles to the distal end, an intermediate region extending from the outlet ends toward the proximal end, and a proximal region extending from the intermediate region to the proximal end, and further wherein the passageway along the intermediate region immediately adjacent the outlet ends defines an increased diameter as compared to a diameter of the passageway at the proximal region.

10. The device of claim 1, wherein the first and second fluid circuits are identical.

11. The device of claim 1, wherein the tube of the first fluid circuit and the tube of the second fluid circuit are juxtaposed relative to one another.

12. The device of claim 1, wherein the inlet ends of all of the nozzles of the first and second fluid circuits are all fluidly connected to a common manifold.

13. The device of claim 1, wherein each of the tubes further forms a radial slot open to the corresponding passageway adjacent the proximal end thereof, and further wherein the generator body forms a pressure monitoring port fluidly connected to the radial slots.

14. The device of claim 1, wherein the generator body includes a housing within which the tubes are at least partially disposed and forming an opening adjacent the proximal end, respectively, the device further comprising:

a patient interface piece including a base forming a pair of lumens each sized for mounting about the proximal end of a respective one of the tubes; and

an interface portion fluidly connected to the lumens and adapted for fluid connection to a patient'"'"'s nares;

wherein the housing and the base are configured such that upon final assembly, the base nests within the opening.

15. The device of claim 14, wherein the housing and the base are configured such that upon final assembly, a pressure monitoring fluid circuit is defined from the lumens to a pressure monitoring port formed in the housing.

16. The device of claim 14, wherein the interface portion is one of a nasal mask and a pair of prongs.

17. The device of claim 1, wherein the generator body further includes:

a housing within which the tubes are at least partially disposed, the housing including a side wall terminating at an open face; and

first and second flanges extending from opposite sides, respectively, of the side wall, wherein an open-ended gap is defined between each of the flanges and the side wall, the gap adapted to receive a strap for securing the generator body to a patient.

18. The device of claim 1, wherein the device further includes:

a supply tube fluidly connected to the inlet end of each of the nozzles for supplying pressurized fluid from a supply source to the nozzles;

a pressure monitor tube fluidly connected to the passageways, proximal the nozzle outlet ends, respectively, for sampling fluid pressure within the generator body;

an exhaust port defining a conduit fluidly connected to the distal end of each of the tubes, respectively;

an exhaust tube attached to the exhaust port and fluidly connected to the conduit; and

a patient interface piece including an interface portion fluidly connected to the passageways and adapted for fluid connection to a patient'"'"'s nares.

19. The device of claim 1, wherein the generator body includes:

an exhaust port forming an exhaust conduit;

a jet body forming each of the nozzles, a distal portion of each of the first and second tubes, and a chamber fluidly connected to the distal portions;

a manifold cover assembled between the exhaust port and the jet body, the manifold cover forming a supply port; and

an interface plate forming a proximal portion of each of the first and second tubes, the interface plate being assembled to the jet body such that the corresponding distal and proximal tube portions are fluidly connected to one another to form the first and second tubes;

wherein upon final assembly, the supply port is fluidly connected to the nozzles and the chamber is fluidly connected to the exhaust conduit.

20. The device of claim 19, wherein the jet body, the interface plate, the manifold cover, and the exhaust port are assembled in a stacked relationship.

21. A nasal continuous positive airway pressure (nCPAP) system comprising:

a generator body defining a patient side and an exhaust side, and forming first and second fluid flow circuits each including a tube forming a passageway, wherein at least one of the first and second fluid flow circuits further includes at least three nozzles disposed at circumferential locations about the passageway, each nozzle forming a flow path defined by;

an inlet end open to a fluid supply and an outlet end open to the corresponding passageway, wherein each nozzle is adapted to emit a fluid jetstream from the outlet end along a respective flow direction axis, wherein each tube includes an intermediate region extending from the respective nozzles and a proximal region extending from the intermediate region to the proximal end, the intermediate region defining an increased inner diameter as compared to an inner diameter of the proximal region;

a fluid supply source fluidly connected to the inlet end of each of the nozzles, respectively; and

exhaust tubing fluidly connected to the distal end of each of the passageways;

wherein upon securement of the generator body to a patient'"'"'s nares, the system is configured to generate a continuous positive airway pressure in the patient by delivering fluid from the fluid supply source to the nozzles that in turn emit secondary fluid jetstreams that combine to create a primary fluid jetstream within each of the passageways, the system characterized by an inspiratory phase of operation in which the primary fluid jetstreams each flow continuously toward the patient'"'"'s nares and an expiratory phase of operation in which air exhaled from the patient'"'"'s nares disrupts the jetstreams such that the exhaled air readily flows though the tubes and to the exhaust tubing.

22. The system of claim 21, wherein with respect to each of the first and second flow circuits, each passageway further defines an axial centerline and the flow direction axes of the corresponding at least three nozzles are non-parallel relative to each other and relative to the corresponding axial centerline.

23. The system of claim 21, wherein the second flow circuit includes at least three nozzles disposed at circumferential locations about the passageway.

24. A method for establishing and delivering a continuous positive airway pressure to a patient, the method comprising the steps of:

fluidly connecting a generator body to nares of the patient, the generator body forming first and second fluid flow circuits each including a tube defining a passageway, wherein at least one of the first and second fluid flow circuits further includes at least three nozzles disposed at circumferential locations about the corresponding passageway;

forcing a fluid from a supply source through each of the at least three nozzles thereby emitting a secondary fluid jetstream from each nozzle into the corresponding passageway, wherein at least two of the secondary fluid jetstreams impinge upon each other and combining to form a primary fluid jetstream directed toward the patient.

25. The method of claim 24, wherein the secondary fluid jetstreams are characterized as being low momentum jets.

26. The method of claim 24, wherein each passageway of the first and second fluid flow circuits defines an axial centerline, the secondary fluid jetstreams associated with a respective one of the fluid circuits impinge upon each other approximately at the axial centerline of the corresponding passageway.

27. The method of claim 24, wherein a flow rate of fluid from the supply source is constant.

28. The method of claim 24, further comprising the step of:

monitoring a pressure within the generator body by extracting airflow from a port adjacent the nozzles.

29. The method of claim 24, wherein a single supply source provides the fluid to all of the nozzles.

30. The method of claim 24, wherein an effective flow path diameter of the passageways is greater during periods of patient exhalation as compared to periods of patient inhalation.

31. The method of claim 24, wherein the primary fluid jetstream has a momentum greater than a momentum of the secondary fluid jetstreams.

32. The method of claim 24, such that the at least one of the first and second fluid flow paths has at least four nozzles, wherein the nozzles are arranged relative to the corresponding tube such that the flow direction axis defined by each of the nozzles are non-parallel relative to each other.

33. The method of claim 32, wherein the at least one of the first and second fluid flow paths has at least five nozzles.

34. The method of claim 24, wherein during periods of patient exhalation, exhaled air from the patient disrupts the secondary fluid jetstreams thereby causing a reduction in resistance to flow of the exhaled air.

35. The method of claim 34, wherein the exhaled air causes the secondary fluid jetstreams to generate streamline vortices.