WO2017062677A1

WO2017062677A1 - Respiratory assembly

Info

Publication number: WO2017062677A1
Application number: PCT/US2016/055834
Authority: WO
Inventors: Stuart Heatherington; Haans PETRUSCHKE; Michael Sturdevant
Original assignee: Snap Cpap, Llc
Priority date: 2015-10-06
Filing date: 2016-10-06
Publication date: 2017-04-13
Also published as: CN108025156A; JP7040773B2; AU2016334080B2; MX2018004168A; CA2999190A1; CN108025156B; JP2018530389A; AU2016334080A1; BR112018007048B1; KR20180056776A; BR112018007048A2

Abstract

A respiratory assembly is provided. The assembly includes a base engaged with at least one connector and in fluid communication with a hose or fluid source for allowing the gaseous flowthrough between the at least one connector, the base and the hose or fluid source. The assembly further includes a pair of sockets engaged with the at least one connector, and a pair of posts, each post selectively engageable with at least one of the pair of sockets. Each post includes a flange that defines an opening therethrough, the openings in fluid communication with each corresponding socket of the pair of sockets. Each post further includes an adhesive adhered to each flange and configured for sealably engaging a patient's nare.

Description

RESPIRATORY ASSEMBLY

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. Patent Application 14/876,099 filed

October 6, 2015, U.S. Patent Application 26/916,445 filed September 13, 2016, U.S. Patent

Application 26/916,453 filed September 13, 2016, U.S. Patent Application 26/916,474 filed September 13, 2016 and U.S. Provisional Patent Application 62/495,576 filed September 13, 2016, the contents each of which are hereby incorporated by reference in their entirety.

[0002] This application is related to U.S. Patent Application 13/672,946 filed November 9,

2012 and issued as U.S. Patent 9,149,595, which claims priority to U.S. Provisional Patent Application 61/562,056 filed on November 21, 2011, now expired, the contents of which are each hereby incorporated by reference in their entirety.

TECHNICAL FIELD

[0003] This disclosure is related to a respiratory assembly, and more particularly a respiratory assembly having a nostril engaging portion for providing sealable engagement with a treatment fluid.

BACKGROUND

[0004] Continuous positive air pressure (CPAP) masks are used for treating patients having any number of sleeping or breathing disorders during sleeping. CPAP masks can deliver a treatment fluid, such as ambient air or oxygen enriched air to a patient under a predetermined or desired pressure setting. [0005] CPAP masks suffer from many disadvantages. For example, CPAP masks are bulky, making them less aesthetically and ergonomically pleasing. CPAP masks must provide sealable engagement with the patient's skin in order to maintain a sealed environment for achieving the desired pressure for treatment fluid delivery. This sealable engagement leaves wear marks on the patient's skin and may require undesirable amounts of time for the wear marks to disappear. Accordingly, many patients feel uncomfortable in public until the wear marks have disappeared, and male patients may not be able to shave their faces and female patients not be able to apply makeup until the wear marks have disappeared. These depressions or marks may be the result of the masks enveloping the mouth and/or the nostril, as well as the straps or connections that may be positioned about the patient's head.

[0006] Due to the bulky nature of conventional CPAP masks, the masks occupy a large portion of a person's face. This restricts the person's ability to move their head during sleep because laying on the side of one's face may contact the CPAP mask and dislodge the mask from sealable engagement with the patient, thereby evacuating the pressure in the mask assembly. This is undesirable as either the patient is not receiving treatment gases under the ideal pressures or the patient is awakened.

[0007] Accordingly, there is a need for an improved CPAP respiratory assembly that addresses the disadvantages associated with conventional CPAP machines and masks. Further, there is a need for a CPAP respiratory assembly that is strapless and maskless, thereby addressing the bulky and mark- forming nature of conventional CPAP machines and masks.

SUMMARY

[0008] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[0009] According to at least one embodiment, a respiratory assembly is provided. The respiratory assembly includes a base engaged with at least one connector and a hose or fluid source for allowing the gaseous flowthrough between the at least one connector and the hose or fluid source; a pair of sockets engaged with the at least one connector; a pair of posts, each post selectively engageable with at least one of the pair of sockets, wherein each posts includes: a flange that defines an opening therein, the openings in gaseous communication with each corresponding socket of the pair of sockets; an adhesive applied to each flange and configured for sealably engaging a patient's nare.

[0010] According to at least one embodiment, a respiratory assembly is provided. The respiratory assembly includes: a base engaged with at least one connector and a hose or fluid source for allowing the gaseous flowthrough between the at least one connector and the hose or fluid source; a pair of sockets engaged with the at least one connector; a pair of cleat assemblies, each cleat assembly selectively engageable with at least one of the pair of sockets, wherein each cleat assembly defines: a cleat flange in engagement with a sheet including an adhesive for engaging a patient's nare; a cleat opening in gaseous communication with each corresponding socket of the pair of sockets; at least one cleat ridge for selectively engaging at least one socket ridge of one of the pair of sockets.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The foregoing summary, as well as the following detailed description of preferred embodiments, is better understood when read in conjunction with the appended drawings. For the purposes of illustration, there is shown in the drawings exemplary embodiments; however, the presently disclosed invention is not limited to the specific methods and instrumentalities disclosed. In the drawings:

[0012] FIG. 1 illustrates a perspective view of a respiratory mask and a patient for being treated according to one or more embodiments disclosed herein;

[0013] FIG. 2 illustrates a perspective view of a mask according to one or more embodiments disclosed herein.

[0014] FIG. 3 illustrates a perspective view of a nasal assembly and a patient for being treated according to one or more embodiments disclosed herein;

[0015] FIG. 4 illustrates a perspective view of a portion of a nasal assembly according to one or more embodiments disclosed herein;

[0016] FIGS. 5A and 5B illustrate respective perspective and side views of a nasal assembly for use with a respiratory mask according to one or more embodiments disclosed herein;

[0017] FIG. 6 illustrates a perspective view of respiratory assembly having a base and a single connector according to one or more embodiments disclosed herein;

[0018] FIG. 7 illustrates a back view of respiratory assembly having a base and two connectors according to one or more embodiments disclosed herein;

[0019] FIG. 8 illustrates a perspective view of a base of a respiratory assembly having two base openings according to one or more embodiments disclosed herein;

[0020] FIG. 9 illustrates a bottom view of a base of a respiratory assembly having two base openings according to one or more embodiments disclosed herein;

[0021] FIG. 10 illustrates a back view of a base of a respiratory assembly having two base openings according to one or more embodiments disclosed herein; [0022] FIG. 11 illustrates a back view of a base of a respiratory assembly having four base openings and two caps according to one or more embodiments disclosed herein;

[0023] FIG. 12 illustrates a cleat assembly and rotateable socket assembly according to one or more embodiments disclosed herein;

[0024] FIGS. 13A-13D illustrate a socket assembly and a post according to one or more embodiments disclosed herein;

[0025] FIG. 14A illustrates a perspective view of a socket assembly having a clamp lock according to one or more embodiments disclosed herein;

[0026] FIG. 14B illustrates a top view of a socket assembly having a clamp lock according to one or more embodiments disclosed herein;

[0027] FIG. 14C illustrates a side view of a socket assembly having a clamp lock according to one or more embodiments disclosed herein;

[0028] FIG. 14D illustrates a bottom view of a socket assembly having a clamp lock according to one or more embodiments disclosed herein.

DETAILED DESCRIPTION

[0029] The presently disclosed invention is described with specificity to meet statutory requirements. However, the description itself is not intended to limit the scope of this patent. Rather, the inventors have contemplated that the claimed invention might also be embodied in other ways, to include different steps or elements similar to the ones described in this document, in conjunction with other present or future technologies.

[0030] FIG. 1 illustrates a respiratory assembly installed upon a patient 1 according to at least one embodiment. Such an embodiment is described in detail in U.S. Patent Application 13/672,946 filed November 9, 2012 and issued as U.S. Patent 9, 149,595. The respiratory assembly is generally designated as 10 throughout the drawings. The assembly 10 includes a nasal assembly 12. The nasal assembly 12 may include at least one post 14 with a nasal engaging portion 16 on or about a first end thereof for delivering treatment gases to the nasal cavity of the patient 1. The post 14 may be configured for providing a flush, sealable engagement with the patient's nares.

[0031] The respiratory assembly 10 may include a mask assembly 20 having an inlet 22 for receiving treatment gases from a fluid source 41 and at least one receptacle 24 for being sealably engaged with the post 14. The fluid source 41 may be a continuous positive airway pressure (CPAP) machine, a fluid tank, a humidifier, or some other fluid source. The post 14 may be selectively engageable with the receptacle 24, such that the engagement is permanent or only when desired by the patient. Alternatively, the post 14 may be selectively engageable directly with a tube 28 carrying treatment gases therethrough.

[0032] As illustrated in FIG. 2, the inlet 22 may include a swivel joint 36 for allowing swiveling movement of the inlet 22 about the mask assembly 20. The inlet 22 may be a hose 40 for providing flowthrough of treatment gases from the fluid source 41 to the inlet 22.

[0033] The receptacle 24 may include a tube 28 configured for flexible movement to position the nasal assembly 12 to various sizes of respective patients' noses. The mask assembly 20 may be configured for sealable engagement with the patient's mouth by an adhesive pad 42 selectively engageable therewith and carried by the mask body 46. Within the mask body 46 may be defined a chamber 58 through which treatment gases flow from the inlet 22. In this manner, in one operative condition, the mask assembly 20 may be sealably engaged with both the patient's mouth area while the nasal assembly 12 may be also engaged with the patient's nares or nasal area. In this operative condition, treatment gases may be being supplied to both the patient's mouth and their nasal area simultaneously. The mask body 46 may further define a socket recess 38 for cooperating with a joint described further herein.

[0034] Alternatively, panel 44 may be provided for sealable engagement with the mask assembly 20 in order to seal off the chamber 58 so that treatment gases do not pass into the area surrounding the patient's mouth and instead pass only through to the nasal assembly 12. In this manner, the one or more devices 10 disclosed herein may be appropriately configured for both CPAP applications in which the patient receives treatment gases to both their mouth and nose and in CPAP applications where the patient receives treatment gases to only their nose. Additionally, one or more plugs 48 may be provided for use with the mask assembly 20 to seal receptacles 24 if the patient does not desire use of the nasal engaging configuration provided herein. Accordingly, the respiratory assembly 10 described herein may have three distinct modes of operation: one in which treatment gases are being supplied to the patient's mouth only, one in which treatment gases are being supplied to the patient's nose only, and one in which treatment gases are being supplied to the patient's nose and mouth.

[0035] In one or more embodiments, the inlet 22 may further include a ball and socket joint 50 as illustrated in FIG. 2, with ball being represented as 50 and socket recess being represented by 38. The ball and socket joint allows for rotational movement of the inlet 22. The ball 50 may define a plurality of vents 52 for allowing flow of treatment gases therethrough. The vents 52 may be adjustable in size and location such that manipulation of all exhaled fluids such as carbon dioxide from the patient is controlled and titratable such that the flow rate of fluids can be altered to a desired setting. In alternative embodiments, as depicted in FIGS. 3 and 4, each tube 28 of the pair of tubes 28, each post 14 of the pair of posts 14, or both may include vents or vent opening 52 for allowing gaseous flowthrough. Further, the vent openings 52 may be adjustable for titration of gases therethrough. In some embodiments, vents 52 may be comprised of polymeric fibers, membranes or webs with extremely small thickness from nanoscale to microscale. Polymeric fibers may be produced by electrospinning PTFE (polytetrafluoroethylene).

[0036] In one or more embodiments, the mask body 46 may include an adjustable mechanism that allows the tubing from the post 14 to be altered, moved or elevated to accommodate a patient's facial structure, primarily the distance between the nose and the oral housing port on or inside body 46, thereby allowing for ideal facial angles and facial length that might add to a patient's comfort. To further increase comfort, usability and effectiveness of the respiratory assembly 10, nasal assembly 12 and/or mask assembly 20, software and printing capabilities can be employed to customize the shape and contour of the various components respiratory assembly 10 and/or nasal assembly 12. For example, but not limited to, the nasal engaging portion 16 of the nasal assembly 12 may be specifically contoured to fit each nasal passage of the patient 1. Such customization can be achieved by digitally scanning the features of a patient's face to create a CAD model or for 3D printing. Further, various portions, or the whole of, the mask body 46 and/or adhesive pad 42 may be customized to more effectively fit the facial contours of the patient 1. Such customization may be applied to any

component of the respiratory assembly 10, including, but not limited to, the nasal assembly 12, the base 90, the connector 91, the socket 94, the cleat assembly 80, the sheet 30, and/or the splitter 60.

[0037] FIG. 3 illustrates a nasal assembly 12 installed upon a patient 1 according to at least one embodiment. The nasal assembly 12 may include a pair of tubes 28, each in gaseous communication with a hose 40 or a fluid source 41. The pair of tubes 28 and the hose 40 may be unitarily formed. Alternatively a splitter 60 may be positioned between each of the pair of tubes 28 and the hose 40 or the fluid source 41. The splitter 60 may be engaged with each of the pair of tubes 28 and the hose 40 or fluid source 41 for allowing the gaseous flowthrough between each of the pair of tubes 28 and the hose 40 or the fluid source 41. The splitter 60, pair of tubes 28 and hose 40 may be unitarily formed.

[0038] The engagement of the splitter 60 with the tubes 28 and/or hose 40 or fluid source 41 may be achieved using a number of different structural configurations. Some structural configurations may permit greater pivotal movement between the elements 28, 40, 60, while at the same time maintaining a sealable engagement for preventing leakage of gas therefrom. The splitter 60 may have two tube-engaging ends 62 for engaging the tubes 28 and one source-engaging end 64 for engaging the hose 40 or fluid source 41. The tubes 28 may include a tube splitter receiver 66. The hose 40 or fluid source 41 may include a source splitter receiver 68. In some embodiments, the receivers 66, 68 or engaging ends 62, 64 may be circumferentially extending structures engaged with corresponding recess structures. Alternatively, the receivers 66, 68 or engaging ends 62, 64 may be splitter or tube sockets engaged with corresponding tube or splitter ball joints for allowing pivotal movement of the tubes 28 about the splitter 60.

[0039] In at least one embodiment, such as the embodiment depicted in FIG. 4, each post 14 of the nasal assembly 12 may include an extending portion 34 for selectively engaging a respective receiving portion 35 of the pair of tubes 28. The engagement of the post 14 with the receptacle 24 or tube 28 may be achieved using a number of different structural configurations. The extending portion 34 may be a circumferentially extending portion for selectively engaging a respective recess receiving portion 35. Alternatively, the extending portion 34 may be a post ball joint and the receiving portion 35 being a tube socket, and wherein the post ball joint 34 and the tube socket 35 are configured for selective engagement for allowing pivotal movement of the pair of tubes 28 about each of the pair of posts 14, as depicted in FIG. 4. Another alternative embodiment may include the extending portion 34 being a post socket and the receiving portion 35 being a tube ball joint, wherein the post socket 34 and the tube ball joint 35 are configured for selective engagement for allowing pivotal movement of the pair of tubes 28 about each of the pair of posts 14.

[0040] According to some embodiments, the nasal assembly 12 includes a pair of posts 14.

FIGS. 5 A and 5B illustrate the nasal assembly 12 in greater detail according to at least one

embodiment. The post 14 may include a flange 26 configured for engaging with a sheet 30 having an adhesive 32 applied thereon, or alternatively, a layer of adhesive 32, or a layer of adhesive inclusive of a sheet 30, for being adhered and providing sealable engagement with the nostrils of the patient 1. The sheet 30 may have any desired shape, and may preferably include an opening therein for allowing flowthrough in an opening 29 defined in the post 14. The adhesive 32 may be a pressure sensitive adhesive such that the sheet 30 may be adhered and removed from the patient's nostrils as desired. The post 16 may include an extending portion 34 on a second end thereof that is configured for selective engagement with the at least one receptacle 24 or corresponding tube 28 of the pair of tubes 28.

[0041] The adhesive 32 (and/or sheet 30) may have varying thicknesses, adhesive strengths and flexibility. The thickness, adhesive strength and flexibility may vary between each adhesive 32 and/or may vary within each individual adhesive 32 itself. For example, the flexibility of the adhesive 32 may be more rigid about the nostril-engaging portions, while more flexible elsewhere. The adhesive 32 may be comprised of a foam medical tape, a surgical tape and/or a hypoallergenic tape. The adhesive 32 may comprise a hydrocolloid tape 18 and/or may include a polyurethane reactive layer that confirms more with the nostril as the patient's body temperature warms up the adhesive 32. The adhesive 32 may include a polyvinyl chloride or polyolefin foam tape and/or an acrylate adhesive layer. In some embodiments, the adhesive 32 may include a cloth layer for adhering to the post 14 using an adhesive substance or tape.

[0042] In some embodiments, each post 14 of the pair of posts 14 may include a flange 26 that defines an opening 29 therein, the openings 29 in gaseous communication with each corresponding tube 28 of the pair of tubes 28. Further, an adhesive 32 or layer of adhesive 32 may be applied to each post 14, each post 14 configured for sealably engaging a patient's nare. The adhesive 32 may be applied to a sheet 30 positioned on a nasal facing side of the post 14, or the adhesive may be applied directly to the flange 26 of the post 14. The adhesive 32 may be pressure sensitive.

[0043] FIG. 6 illustrates a perspective view of respiratory assembly 10 having a base 90 and a single connector 91 according to one or more embodiments disclosed herein. Notably, the

embodiments of FIGS. 6, 8 and 11 are both strapless and maskless - a significant advantage over the prior art, where straps and masks often leave marks on the patient's body. The base 90 may include any number of vents 52. For example, as is illustrated in FIG. 9, the vents 52 may be positioned on the bottom side of the base 90. The base 90 may further include or define a base tube engagement 103 for selectively engaging or coupling to a hose 40 or fluid source 41. The engagement or coupling between the base tube engagement 103 and the hose 40 or fluid source 41 may permit full rotation of the two in relation to each other. The base 90 and base tube engagement 103 may be unitarily formed or formed separately. The base tube engagement 103 may involve any of the engagements described herein, including but not limited to a ball and socket joint, snap engagement, pinch engagement, cleat engagement or other form of engagement. The base tube engagement 103 may include vents 52 or may include a textured or contoured surface for easier maneuverability and operation of the respiratory assembly 10.

[0044] The vents 52 of the present invention may be positioned proximal to any of the regions where fluid flow occurs. For example but not limited thereto the vents 52 may be placed on the base 90, connector 91, posts 14, socket 94, base tube engagement 103, etc. The vents 52 may be

manufactured using a 3D thermoplastic printing process. The vents 52 may be comprised of microscopic pores. The microscopic pores may be created using a matrix of very thin fibrils. The fibrils may be comprised of polytetrafluoroethylene (PTFE).

[0045] The base 90 and single connector 91 may be unitarily constructed or constructed separately. For example, the base 90 may be comprised of a hard plastic and the connector 91 may be comprised of silicone. The base 90, socket 94, posts 14 and/or other components of the respiratory assembly 10 may be comprised of a plastic, for example but not limited to polypropylene or polyethylene, which may be of food or medical grade quality. The possibility of unitary or separate construction, and the inclusion of plastics and silicone, may additionally apply to the embodiments depicted in FIGS. 8 and 11, for example, and other embodiments described herein. The connector 91 of FIG. 6 defines a connector body 92 and two connector arms 93. The connector arms 93 may each be selectively engageable or coupled with a socket 94. The socket 94 may engage or couple the interior of the connector arm 93 (see FIG. 6), the exterior of the connector arm 93 or both the interior and the exterior. In one embodiment, the socket 94 may engage the connector arm 93 (and/or the post 14 may engage the socket 94) by sliding into a grooved cavity of the connector arm 93 (and/or socket 94).

[0046] A base 90 may be provided for receiving the liquid flow from the hose 40 or fluid source 41. The base 90 may further define at least one base opening 96. For example, FIG. 6 depicts an embodiment wherein the base includes a single base opening 96 for selectively engaging or coupling to the connector 91. In other embodiments, such as FIGS. 8 and 11, for example, the base may include more than one base opening 96 - two in FIG. 8 and four in FIG. 11. Any number of base openings 96 may be included for providing various configurations adapted to the contours of various patients 1. Further the engagement or coupling of the one or more base openings 96 and the one or more connectors 91 may be effected using any of the engagements described herein.

[0047] FIG. 7 illustrates a back view of respiratory assembly 10 having a base 90 and a two connectors 91 according to one or more embodiments disclosed herein. The base 90 may define a base concavity 97 for allowing freer movement of the patient's lips, or access thereto, by being shaped away from the patient's face when the respiratory assembly 10 is engaged with the patient's nares. Further, the base 90 may include one or more base bulges 98 and a base dip 99 for minimizing the volume being used by the respiratory assembly 10, thereby allowing greater access to the patient's face and easier manipulation of various components of the respiratory assembly 10.

[0048] The base 90 of FIG. 7 defines two base openings 96 for selectively engaging or coupling to each of at least two connectors 91. More than two connectors 91 may be provided such that the connectors 91 may be interchanged as desired, for varying the shape (and therefore airflow), angle (and therefore position) and/or type, which may include any of the engagements described herein. Each connector 91 may be shaped and comprised of materials for deformability, such that the connector arms 93 may be flexed in relation to the connector body 92. Sockets 94 may be included in the respiratory assembly 94 for selectively engaging or coupling to the connectors 91.

[0049] FIG. 8 illustrates a perspective view of a base 90 of a respiratory assembly 10 having two base openings 96 and a base tube engagement 103 according to one or more embodiments disclosed herein. FIG. 9 illustrates a bottom view of a base 90 of a respiratory assembly 10 having two base openings 96 according to one or more embodiments disclosed herein. FIG. 10 illustrates a back view of a base 90 of a respiratory assembly 10 having two base openings 96 according to one or more embodiments disclosed herein.

[0050] FIG. 11 illustrates a back view of a base 90 of a respiratory assembly 10 having four base openings 96 and two caps 102 according to one or more embodiments disclosed herein. The two caps 102 may cover the base openings 96 when not in use and/or when the base openings 96 are not engaged or coupled to connectors 91. The base openings 96 may be similarly sized and shaped such that connectors 91 may be interchanged and repositioned freely amongst each of the openings 96. Such customization permits a patient to selectively engage or couple the connectors 91 to any two openings 96 for a best fit to the patient's nare. By permitting cleat engagements or ball and joint engagements or any other engagement permitting multiple positioning, and/or by providing angled posts 14 and/or connectors 91, the connector 91, connector arm 93 and/or posts 14 may be positioned to best fit the patient's nare when the respiratory assembly 10 is engaged.

[0051] FIG. 12 illustrates a cleat assembly 80 and rotateable socket assembly 94 according to one or more embodiments disclosed herein. The sheet 30 of the respiratory assembly 10 may be embedded with a cleat assembly 80, wherein the cleat assembly 80 defines a cleat flange 82 extending between layers of the sheet 30. Alternatively, the sheet 30 and/or adhesive 32 may be applied to a nasal-facing side of the cleat flange 82 of the cleat assembly 80, similar to the nasal engaging portion 16 of the post 14 described herein. The sheet 30, nasal engaging portion 16 and/or cleat flange 82 may be formed to create various shapes in order to fit the numerous types of nares 4 and nostrils 3 of patients. For example, in FIG. 6 the sheet 30 is substantially circular about the nare 4 and extends outward on one side in a triangular manner with a curved apex; such an embodiment provides a greater surface area for adhering to the patient 1. In FIG. 5, the sheet 30 is substantially circular. Throughout the description, cleat flange 82 and nasal engaging portion 16 may be interchangeable used. In other embodiments, the sheet 30, nasal engaging portion 16 and/or cleat flange 82 may be radially undulating, concave or convex so as to conform to the nostril in a conforming manner. Upon application to the patient 1, the sheet 30 and/or cleat flange 82 may overlap between the nares 4 for providing additional support and adhesion. The cleat flange 82 may be similarly shaped and arranged.

[0052] The cleat flange 82 of the cleat assembly 80 may be rigid for providing support or flexible for conforming to the shape of the patient's nare 4 and nostril 3. The cleat assembly 80 may further define cleat extension 84 extending from a central or inner portion of the cleat flange 82 and away from the patient 1. The cleat extension 84 may be substantially cylindrical, or may be

alternatively shaped, for engaging a post 14 or socket 94 of the nasal assembly 12. The cleat extension 84 may define a plurality of cleat ridges 86 within the interior of the cleat extension 84 - the cleat opening 85 - and/or the exterior of the cleat extension 84. The cleat ridges 86 may each define a distal end 87 positioned further from the cleat flange 82 than the proximal end 88 defined by the cleat ridge 86. The distal and proximal ends 87, 88 may be arranged for permitting either clockwise or counterclockwise rotation of the post 14 or socket 94 in relation to the cleat assembly 80. Further, the cleat ridges 86 may define a tapered edge 89 on the distal end 87 and/or the proximal end 88 for facilitating smooth rotation and locking of the cleat assembly 80 and the post 14 or socket 94.

[0053] In alternative embodiments, the cleat ridges 86 and post or socket ridge 110 may be L- shaped and the cleat assembly may further a spring-based ring (not shown) positioned on the cleat flange 82. During engagement of the post 14 or socket 94 with the cleat assembly 80, the ridges may be pushed past each other and the post 14 or socket 94 may be twisted, then, upon release by the patient, the spring-based ring would 'lock' the cleat assembly 80 and post 14 or socket 94 into place. Socket ridge 110 may define a proximal socket end 112 and a distal socket end 114 similar to the proximal and distal ends 87, 88 of the cleat ridge 86.

[0054] Although a socket 94 is depicted in FIG. 12, a post 14 may similarly be selectively engageable with the cleat assembly 80. The socket 94 or post 14 may include position identifiers (A-H) for permitting the patient to selectively engage the socket 94 or post 14 into a particular desired position by lining up the desired position identifier (A-H) with the cleat position identifier 104. The socket 94 or post 14 may further define gripping features 105 for easily rotating the socket head 106. The socket head 106 may be freely rotateable about the socket base 107. In other embodiments (FIGS. 13A-D), the socket base 107 may be shaped for engagement with the connector 91 and/or connector arm 93. Further, the socket 94 or post 14 may include a deformable o-ring 108 for sealing the engagement or coupling of the socket 94 or post 14 to the cleat assembly 80 when engaged. In one embodiment, where the socket 94 engages or couples to the exterior of the connector arm 93, the connector arm 93 may extend within the socket 94 and define an o-ring 108 for sealing the socket-post 94-14 engagement or coupling.

[0055] FIGS. 13A-D illustrate a socket assembly 94 and a post 14 according to one or more embodiments disclosed herein. The post 14 may include a nasal engaging portion 16 which is angled in relation to the post body 17 for enhanced positioning of the nasal engaging portion 16 in relation to a nare. The angle may be 15 degrees or any degree between 0 and 45. The angle may be created by having a portion of the post body 17 'bulge' outwards at an angle, as is depicted in FIGS. 13B and 13C. The intersection of the bulge 17A and the post body 17, or the entire bulge 17A itself, may be flexible or deformable and may be comprised of differing material than the other portions of the post body 17. Alternatively, the post body 17 may remain substantially cylindrical, having a top portion 'sliced' at an angle.

[0056] The socket assembly 94 may include one or more pinchers 117 for engaging and disengaging the socket 94 from the post 14. The pinchers 117 may extend from an collar end 119 of the socket distal the connector 91 at an angle for providing leverage to the pincher 117 when being 'pinched', therefore enabling the collar 119 of the socket to be deformed away from the post 14 for easy release. A socket cavity 118 may be defined by the socket 94 for permitting deformation of the socket 94 when pinched. For example, in FIG. 13D, the socket cavity 118 extends through the collar portion 118 of the socket 94 and horizontally beneath the collar portion 118 for permitting deformation of a left or right half of the collar 118 when the pinchers 117 are pinched. Pinching involves placing pressure on the one or more pinchers 117, either individually or simultaneously, so that the pinchers 117 are flexed towards the socket 94, thereby lifting the collar bead 130 of the collar 119 and releasing the barb 132 of the post 14.

[0057] FIGS. 14A-14D illustrates a socket assembly 94 having a clamp lock 120 according to one or more embodiments disclosed herein. The clamp lock 120 may include two clamp extensions 121. The first clamp extension 121 A may defined a first clamp mound 122A and the second clamp extension 121B may define a second clamp mound 122B. One or both of the clamp mounds 122 may include a clamp ridge 123 for permitting the clamp mounds 122 to be lockingly engaged when the extensions 121 are pinched together. Once engaged, the clamp mounds 122 may be disengaged with a subsequent pinch. In one embodiment, pinching the extensions 121 together engages the bead 130 with the post 14 for securing the post 14 in position. The post 14 may define positioners 132 (small protrusions on the underside of the post, distal from the nasal engaging portion 16) for further securing the post 14 position and resisting rotation of the post 14 when the positioners 132 are engaged with the position apertures 134 defined by the socket 94.

[0058] In some embodiments, the respiratory assembly 10, nasal assembly 12, mask assembly

20, and/or any components thereof may further include an oral device engagement 70 for engaging an oral device 9 engaged with the patient's mouth. For example, but not limited to, the patient may have a mouth guard, mandibular advancement splint or some other oral device 9 that may be used in conjunction with the respiratory assembly 10, nasal assembly 12 and/or mask assembly 20. The oral device engagement 70 may selectively engage the respiratory assembly 10, nasal assembly 12 and/or mask 10 to the oral device 9 for stabilizing the position of the respiratory assembly 10, nasal assembly 12 and/or mask 10 with respect to the patient 1.

[0059] In one or more embodiments, the respiratory assembly 10, or any component thereof, may be provided as a short-term use product, such that the entire system is disposed of and replaced after a predetermined use period. For example, the respiratory assembly 10 may be configured for use as a three month use product, such that the patient receives a new respiratory assembly 10 every three months. In one embodiment, the post 14, cleat assembly 80 may be a disposable product. The patient may install a new adhesive pad 42 and sheet 30 after each use.

[0060] While the embodiments have been described in connection with the preferred embodiments of the various figures, it is to be understood that other similar embodiments may be used or modifications and additions may be made to the described embodiment for performing the same function without deviating therefrom. Therefore, the disclosed embodiments should not be limited to any single embodiment, but rather should be construed in breadth and scope in accordance with the appended claims.

Claims

CLAIMS The invention claimed is:

1. A respiratory assembly comprising:

a base engaged with at least one connector and in fluid communication with a hose or fluid source for allowing the gaseous flowthrough between the at least one connector, the base and the hose or fluid source;

a pair of sockets engaged with the at least one connector;

a pair of posts, each post selectively engageable with at least one of the pair of sockets, wherein each post includes:

a flange that defines an opening therethrough, the openings in fluid communication with each corresponding socket of the pair of sockets;

an adhesive adhered to each flange and configured for sealably engaging a patient's nare.

2. The respiratory assembly of claim 1, wherein the adhesive is pressure sensitive.

3. The respiratory assembly of claim 1, wherein the adhesive comprises foam.

4. The respiratory assembly of claim 1, wherein the respiratory assembly is maskless and strapless.

5. The respiratory assembly of claim 1, wherein the base defines two openings for engaging two connectors.

6. The respiratory assembly of claim 1, wherein the base defines four openings for engaging two connectors and two caps.

7. The respiratory assembly of claim 1, wherein the flange of the posts are angled relative to a post body defined by the posts, each post body selectively engaging the at least one of the pair of sockets.

8. The respiratory assembly of claims 5 or 6, wherein the connector defines a concavity positioned at least between two of the openings for providing access to the patient.

9. The respiratory assembly of claim 1, further comprising vents for titrating fluids.

10. The respiratory assembly of claim 1, wherein each of the pair of sockets includes pinchers for permitting selective engagement between the sockets and the posts.

11. The respiratory assembly of claim 1, wherein each of the pair of sockets includes a clamp assembly for permitting selective engagement between the sockets and the posts, wherein the clamp assembly defines two clamp extensions selectively engageable using at least one clamp ridge.

12. The respiratory assembly of claims 10 or 11, wherein the selective engagement includes engaging a collar of the socket with a barb of the post.

13. A respiratory assembly comprising: a base engaged with at least one connector and in fluid communication with a hose or fluid source for allowing the gaseous flowthrough between the at least one connector, the base and the hose or fluid source;

a pair of sockets engaged with the at least one connector;

a pair of cleat assemblies, each cleat assembly selectively engageable with at least one of the pair of sockets, wherein each cleat assembly defines:

a cleat flange in engagement with a sheet including an adhesive for engaging a patient's nare;

a cleat opening in fluid communication with each corresponding socket of the pair of sockets;

at least one cleat ridge for selectively engaging at least one socket ridge of the pair of sockets.

14. The respiratory assembly of claim 13, wherein the adhesive is pressure sensitive or comprises foam.

15. The respiratory assembly of claim 13, wherein the respiratory assembly is maskless and strapless.

16. The respiratory assembly of claim 13, wherein the base defines two openings for engaging two connectors.

17. The respiratory assembly of claim 13, wherein the base defines four openings for engaging two connectors and two caps.

18. The respiratory assembly of claim 13, wherein the cleat flanges are angled relative to the socket when the cleat assemblies and the sockets are engaged.

19. The respiratory assembly of claims 16 or 17, wherein the connector defines a concavity positioned at least between two of the openings for providing access to the patient.

20. The respiratory assembly of claim 1, further comprising vents for titrating fluids.