INFANT NASAL INTERFACE MASK

• US 20100258128A1
• Filed: 06/21/2010
• Published: 10/14/2010
• Est. Priority Date: 12/02/2005
• Status: Active Grant

• Current Assignee: Vyaire Medical Consumables LLC
• Original Assignee: CareFusion 2200 Inc (Becton, Dickinson & Co)
• Inventors: Zollinger, Chris, Pierro, Brian
• Granted Patent: US 9,211,387 B2
• Time in Patent Office: Days
• US Class Current: 128/205.250
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0605 Means for improving the adaptation of the mask to the patient
• CPC Class Codes: A61M 16/0611 with a gusset portion
• CPC Class Codes: A61M 16/0616 with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
• 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 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours

Abstract

An infant nasal interface mask for use with a nasal continuous positive airway pressure (nCPAP) system including a mask body and a base. The mask body forms a cavity and is defined by a leading portion, an intermediate shell portion, and a trailing portion. The leading portion terminates in a leading edge forming an aperture open to the cavity and having a generally triangular shape for placement over a patient'"'"'s nose. The trailing portion includes a bellows segment characterized by an increased flexibility as compared to a flexibility of the intermediate shell portion. The base extends from the trailing portion opposite the leading portion and forms at least one longitudinal passage extending through a thickness of the base and fluidly connected to the cavity. The intermediate shell portion is laterally pivotable relative to the base via the bellows segment.

Claims

1. An infant nasal interface mask for use with a nasal continuous positive airway pressure (nCPAP) system, the mask comprising:

a mask body forming a cavity and defined by a leading portion, an intermediate shell portion, and a trailing portion, wherein;

the leading portion terminates in a leading edge forming an aperture open to the cavity and having a generally triangular shape for placement over a patient'"'"'s nose, and

the trailing portion includes a bellows segment characterized by an increased flexibility as compared to a flexibility of the intermediate shell portion; and

a base extending from the trailing portion opposite the leading portion, the base forming at least one passage extending longitudinally through a thickness of the base from an opening in a rear face of the base and permanently fluidly open to the aperture, wherein an axis of the opening intersects the aperture;

wherein the intermediate shell portion is longitudinally moveable and laterally pivotable relative to the base via the bellows segment.

2. The mask of claim 1, wherein the mask body includes a side wall forming at least the intermediate shell and the trailing portions, and further wherein the bellows segment is characterized by the side wall having a reduced cross-sectional thickness along the bellows segment as compared to a nominal thickness of the side wall along at least a segment of the intermediate shell portion.

3. The mask of claim 2, wherein a nominal thickness of the side wall along the bellows segment is at least 50% less than a nominal thickness of the side wall along the intermediate shell portion.

4. The mask of claim 2, wherein the bellows segment is further characterized by the side wall forming a first bend in longitudinal extension from the base.

5. The mask of claim 4, wherein the bellows segment includes the side wall defining a first section extending generally longitudinally from the base and a second section extending generally longitudinally from the first section toward the intermediate shell portion, and further wherein the first section forms the cavity to have a proximally decreasing transverse cross-sectional area to define the first bend relative to the base, and the second section forms the cavity to have a proximally increasing transverse cross-sectional area to define the second bend relative to the first section.

6. The mask of claim 4, wherein the side wall forms a second bend along the bellows segment in longitudinal extension from the base.

7. The mask of claim 1, wherein the mask body includes a side wall forming at least the leading and intermediate shell portions, and further wherein a nominal thickness of the side wall along at least a segment of the leading portion is less than a nominal thickness of the side wall along at least a segment of the intermediate shell portion.

8. The mask of claim 1, wherein the leading portion includes a distal segment extending in a substantially longitudinal fashion from the intermediate shell portion, and a proximal segment extending in a substantially lateral fashion from the distal segment to the leading edge.

9. The mask of claim 8, wherein a wall thickness of the mask body along the proximal segment is less than a wall thickness of the mask body along the intermediate shell portion.

10. The mask of claim 8, wherein a transition from the distal segment to the proximal segment forms a curve in longitudinal cross-section.

11. The mask of claim 1, wherein the leading portion forms a patient contact face in a plane generally perpendicular to a longitudinal axis defined by the base, the patient contact face including a lip region configured for placement at a patient'"'"'s upper lip, and first and second side regions extending from opposite ends of the lip region and connecting at a bridge region formed opposite the lip region to define a triangular-like shape, and further wherein a perimeter of each of the side regions forms an ocular relief.

12. The mask of claim 11, wherein the ocular relief is characterized by the perimeter of the side regions, respectively, defining a concave curvature in extension from the lip region to the bridge region relative to a frontal plane of the mask.

13. The mask of claim 1, wherein the leading portion forms a patient contact face in a plane generally perpendicular to a longitudinal axis defined by the base, the patient contact face including a lip region configured for placement at a patient'"'"'s upper lip, and first and second side regions extending from opposite ends of the lip region and connecting at a bridge region formed opposite the lip region to define a triangular-like shape, and further wherein relative to a side plane of the mask, each of the side regions forms a convex curvature feature.

14. The mask of claim 1, wherein the leading portion forms a patient contact face in a plane generally perpendicular to a longitudinal axis defined by the base, the patient contact face including a lip region configured for placement a patient'"'"'s upper lip, and first and second side regions extending from opposite ends of the lip region and connecting at a bridge region formed opposite the lip region to define a triangular-like shape, and further wherein the lip region defines a septal relief feature.

15. The mask of claim 14, wherein the septal relief feature is characterized by the lip region forming a laterally outward, convex curvature.

16. The mask of claim 1, wherein a first zone of the mask body has an opacity less than an opacity of a second zone to define a viewing window.

17. The mask of claim 16, wherein the intermediate shell portion defines a bottom face and a top face, the mask being configured to generate a desired orientation upon placement over a nose of a patient in which the bottom face is proximate an upper lip of the patient and the top face is adjacent a bridge of the patient'"'"'s nose, and further wherein the first zone is defined in the bottom face to facilitate viewing a patient'"'"'s septum and nares during use.

18. The mask of claim 1, wherein the base is configured to define, in transverse cross-section, opposed first and second side edges, and opposed first and second end edges, and further wherein a transition between the first end edge and the first side edge defines a radius of curvature greater than a radius of curvature defined at a transition between the first end edge and the second side edge.

19. The mask of claim 1, wherein the base forms a pair of passages extending through a thickness thereof, and a channel extending between, and fluidly connected to, the pair of passages.

20. The mask of claim 1, wherein apart from the opening in the rear face and the fluid connection to the cavity, the passage is closed relative to an exterior of the base.

21. The mask of claim 1, wherein the bellows segment includes a plurality of ribs projecting outwardly to resist contraction of the bellows segment.

22. An infant nasal continuous positive airway pressure (nCPAP) device for use in an nCPAP system, the device comprising:

an nCPAP generator including first and second tubes fluidly connected to a fluid supply port, the generator adapted to generate a continuous positive airway pressure within each of the tubes; and

an infant nasal mask mounted to the tubes, the mask comprising;

a mask body forming a cavity and defined by a leading portion, an intermediate shell portion, and a trailing portion, wherein;

the leading portion terminates in a leading edge forming an aperture open to the cavity and having a generally triangular shape for placement over a patient'"'"'s nose, and

the trailing portion includes a bellows segment characterized by an increased flexibility as compared to a flexibility of the intermediate shell portion,

a base extending from the trailing portion opposite the leading portion, the base forming a pair of passages extending in a longitudinal fashion through a thickness of the base and fluidly connected to the cavity, respective ones of the passages being sized for assembly over a respective one of the tubes.

23. The nCPAP device of claim 22, wherein upon final assembly, the nCPAP device is configured such that the intermediate shell portion is laterally pivotably relative to the base and the tubes in a multiplicity of directions.

24. The nCPAP device of claim 22, wherein the nCPAP generator further includes a housing laterally surrounding the tubes, the housing sized to receive the base, and further wherein the base and the housing define corresponding, non-symmetrical perimeter shapes.

25. An infant nasal interface mask for use with a nasal continuous positive airway pressure (nCPAP) system, the mask comprising:

a mask body forming a single cavity and defined by a leading portion, an intermediate shell portion, and a trailing portion, wherein;

the leading portion terminates in a leading edge forming an aperture open to the cavity and having a generally triangular shape for placement over a patient'"'"'s nose,

the leading portion forms a patient contact face in a plane generally perpendicular to a longitudinal axis defined by the base, the patient contact face including a lip region configured for placement a patient'"'"'s upper lip, and first and second side regions extending from opposite ends of the lip region and connecting at a bridge region formed opposite the lip region to define a triangular-like shape, and further wherein the lip region defines a septal relief feature, and

the trailing portion includes a bellows segment characterized by an increased flexibility as compared to a flexibility of the intermediate shell portion; and

a base extending from the trailing portion opposite the leading portion, the base forming at least one passage extending longitudinally through a thickness of the base from an opening in a rear face of the base and fluidly connected to the cavity, wherein an axis of the opening intersects the aperture;

wherein the intermediate shell portion is longitudinally moveable and laterally pivotable relative to the base via the bellows segment.