BR112018007048B1 - breathing set - Google Patents

Abstract

RESPIRATORY SET. A breathing kit is provided. The assembly includes a base coupled with at least one connector and in fluid communication with a hose or fluid source to allow flow of gaseous flow between the at least one connector, the base and the hose or fluid source. The set further includes a pair of sockets mated with at least one connector, and a pair of speakers, each speaker selectively matable with at least one of the pair of sockets. Each column includes a lip defining an opening therethrough, the openings in fluid communication with each corresponding socket of the pair of sockets. Each column further includes an adhesive adhered to each ridge and configured to sealably engage a patient's nostril.

Description

CROSS REFERENCE TO RELATED ORDERS

[001] This application is a continuation in part of the 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 of each of which are incorporated herein by reference in their entirety.

[002] This application is related to the U.S. Patent Application. 13/672,946 filed November 9, 2012 and granted as a U.S. Patent. 9,149,595, which claims priority to the U.S. Provisional Patent Application. 61/562,056 filed November 21, 2011, now expired, the contents of which are each incorporated herein by reference in their entirety.

TECHNICAL FIELD

[003] This disclosure relates to a breathing assembly, and more particularly a breathing assembly having a nose coupling portion for providing sealable engagement with a treatment fluid.

FUNDAMENTALS

[004] Continuous positive air pressure (CPAP) masks are used to treat patients having any number of sleep or breathing disorders during sleep. CPAP masks can deliver a treatment fluid, such as room air or oxygen-enriched air, to a patient at a predetermined or desired pressure setting.

[005] CPAP masks suffer from many disadvantages. For example, CPAP masks are bulky, making them less aesthetically and ergonomically pleasing. CPAP masks must provide a sealable engagement with the patient's skin in order to maintain a sealable environment to achieve the desired pressure for delivery of treatment fluid. This sealable coupling leaves wear marks on the patient's skin and may require undesirable amounts of time for the wear marks to disappear. Consequently, many patients feel uncomfortable in public until the wear marks are gone, and male patients may not be able to shave their face and female patients may not be able to apply makeup until the wear marks are gone. These depressions or marks can be the result of the masks that enclose the mouth and/or the nostril, as well as the straps or connections that can be positioned in relation to the patient's head.

[006] Due to the bulky nature of conventional CPAP masks, the masks take up a large part of the person's face. This restricts the person's ability to move their head during sleep because it places the side of the face that can contact the CPAP mask and dislodges the mask from the sealable clip with the patient, thereby evacuating pressure in the mask assembly. This is undesirable as the patient is not receiving treatment gases at optimal pressures or the patient is awake.

[007] Consequently, there is a need for an improved CPAP breathing kit that addresses the disadvantages associated with conventional CPAP machines and masks. Furthermore, there is a need for a CPAP breathing kit that is strapless and maskless, thereby addressing the bulky and mask-forming nature of conventional CPAP masks and machines.

SUMMARY

[008] 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.

[009] According to at least one modality, a breathing set is provided. The breathing assembly includes a base coupled with at least one connector and a hose or fluid source to allow flow of gaseous flow between the at least one connector and the hose or fluid source; a pair of sockets coupled with the at least one connector; a pair of columns, each column selectively attachable to at least one of the pair of sockets, each of the columns including: a lip defining an aperture therein, the apertures in gaseous communication with each corresponding socket of the pair of sockets; an adhesive applied to each ridge and configured for sealable engagement of a patient's nostril.

[010] According to at least one modality, a breathing set is provided. The breathing assembly includes: a base coupled with at least one connector and a hose or fluid source to allow flow of gaseous flow between the at least one connector and the hose or fluid source; a pair of sockets coupled with the at least one connector; a pair of clip assemblies, each clip assembly selectively attachable to at least one of the pair of sockets, wherein each clip assembly defines: a clip flange in engagement with a sheet including an adhesive for attaching a patient's nostril; a clamp opening in gaseous communication with each corresponding socket of the pair of sockets; at least one clip rib for selectively mating at least one socket rib of one of the pair of sockets.

BRIEF DESCRIPTION OF THE DRAWINGS

[011] The above summary, as well as the following detailed description of preferred embodiments, is best understood when read in conjunction with the accompanying drawings. For purposes of illustration, it is shown in exemplary embodiments of the drawings; however, the presently disclosed invention is not limited to the specific methods and instruments disclosed. In the drawings:

[012] FIG. 1 illustrates a perspective view of a respiratory mask and a patient being treated in accordance with one or more embodiments disclosed herein;

[013] FIG. 2 illustrates a perspective view of a mask in accordance with one or more embodiments disclosed herein.

[014] FIG. 3 illustrates a perspective view of a nasal assembly and a patient being treated in accordance with one or more embodiments disclosed herein;

[015] FIG. 4 illustrates a perspective view of a portion of a nose assembly in accordance with one or more embodiments disclosed herein;

[016] FIGS. 5A and 5B illustrate respective perspective and side views of a nose assembly for use with a respiratory mask in accordance with one or more embodiments disclosed herein;

[017] FIG. 6 illustrates a perspective view of a breathing assembly having a base and a single connector in accordance with one or more embodiments disclosed herein;

[018] FIG. 7 illustrates a rear view of a breathing assembly having a base and two connectors in accordance with one or more embodiments disclosed herein;

[019] FIG. 8 illustrates a perspective view of a base of a breathing assembly having two base openings in accordance with one or more embodiments disclosed herein;

[020] FIG. 9 illustrates a bottom view of a base of a breathing assembly having two base openings in accordance with one or more embodiments disclosed herein;

[021] FIG. 10 illustrates a rear view of a breathing assembly base having two base openings in accordance with one or more embodiments disclosed herein;

[022] FIG. 11 illustrates a rear view of a base of a breathing assembly having four base openings and two caps in accordance with one or more embodiments disclosed herein;

[023] FIG. 12 illustrates a clamp assembly and rotatable socket assembly in accordance with one or more embodiments disclosed herein;

[024] FIGS. 13A-13D illustrate a socket and column assembly in accordance with one or more embodiments disclosed herein;

[025] FIG. 14A illustrates a perspective view of a socket assembly having a clamp latch in accordance with one or more embodiments disclosed herein;

[026] FIG. 14B illustrates a top view of a socket assembly having a clamp lock in accordance with one or more embodiments disclosed herein;

[027] FIG. 14C illustrates a side view of a socket assembly having a clamp lock in accordance with one or more embodiments disclosed herein;

[028] FIG. 14D illustrates a bottom view of a socket assembly having a clamp lock in accordance with one or more embodiments disclosed herein.

DETAILED DESCRIPTION

[029] The presently disclosed invention is described with specificity to meet legal requirements. However, the description itself is not intended to limit the scope of this patent. Instead, the inventors considered that the claimed invention could also be incorporated in other ways, to include different steps or elements similar to those described in this document, in conjunction with other current and future technologies.

[030] FIG. 1 illustrates a breathing assembly installed on a patient 1 according to at least one embodiment. One such embodiment is described in detail in the U.S. Patent Application. 13/672,946 filed November 9, 2012 and granted as a U.S. Patent. 9,149,595. The breathing set is generally designated as 10 in all drawings. Assembly 10 includes a nasal assembly 12. Nasal assembly 12 may include at least one column 14 with a nasal coupling portion 16 at or over a first end thereof for delivering treatment gases to the nasal cavity of patient 1. The column 14 can be configured to provide a sealable, flush engagement with patients' nostrils.

[031] Breathing 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 sealingly coupled with the column 14. The fluid source 41 may be a continuous positive airway pressure (CPAP) machine, a fluid tank, a humidifier, or some other source of fluid. The column 14 may be selectively attachable with the receptacle 24, such that the coupling is permanent or only when desired by the patient. Alternatively, the column 14 may be selectively couplable directly with a tube 28 carrying treatment gases therethrough.

[032] As illustrated in FIG. 2, the inlet 22 may include a swivel joint 36 to allow pivoting movement of the inlet 22 over the mask assembly 20. The inlet 22 may be a hose 40 to provide depot flow of treatment gases from the fluid source 41. at entry 22.

[033] The receptacle 24 may include a tube 28 configured for flexible movement to position the nose assembly 12 in various sizes of the patients' respective noses. Mask assembly 20 may be configured for sealable engagement with the patient's mouth by an adhesive pad 42 selectively attachable thereto and carried by mask body 46. Within mask body 46, a chamber 58 may be defined through which gases from treatment flow from the inlet 22. Thus, in an operative condition, the mask assembly 20 can be sealably coupled with the patient's mouth area while the nose assembly 12 can also be coupled with the patients' nostril or area. nasal. In this operative condition, treatment gases can be delivered directly to the patient's mouth and nasal area simultaneously. The mask body 46 may further define a socket recess 38 to cooperate with a joint described further herein.

[034] Alternatively, panel 44 may be provided for sealable engagement with mask assembly 20 so as to seal off chamber 58 so that treatment gases do not pass into the area around the patient's mouth and instead pass through. only through the nasal assembly 12. In this way, one or more devices 10 disclosed herein may be properly configured for both CPAP applications where the patient receives treatment gases for both their mouth and nose and in CPAP applications where the patient receives treatment gases for his nose only. Additionally, one or more plugs 48 may be provided for use with the mask assembly 20 to seal the receptacles 24 if the patient does not wish to use the nasal docking configuration provided herein. Accordingly, the breathing assembly 10 described here can have three distinct modes of operation: one in which treatment gases are being delivered to the patient's mouth only, one in which treatment gases are being delivered to the patient's nose only, and a in which treatment gases are being delivered to the patient's nose and mouth.

[035] 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 at 50 and socket recess being represented at 38. The ball and socket joint allow for rotational movement of the inlet 22. The ball 50 may define a plurality of vents 52 to allow the flow of treatment gases through the inlet 22. her. The vents 52 may be adjustable in size and location such that the handling of all exhaled fluids such as carbon dioxide from the patient is controlled and titratable such that the fluid flow rate 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 column 14 of the pair of columns 14, or both may include vents or vent opening 52 to allow the flow of gaseous flow. In addition, the vent openings 52 may be adjustable for titrating gases therethrough. In some embodiments, the vents 52 may be comprised of polymeric fibers, membranes, or webs with extremely small thicknesses from the nanoscale to the microscale. Polymer fibers can be produced by electrospinning PTFE (polytetrafluoroethylene).

[036] In one or more embodiments, the mask body 46 may include an adjustable mechanism that allows the tubes from the column 14 to be altered, moved or elevated to accommodate the structure of the patient's face, particularly the distance between the nose and the oral housing port on or within the body 46, thereby considering ideal facial angles and facial length that can enhance patient comfort. To further enhance the comfort, usability and effectiveness of the breathing set 10, the nose set 12 and/or the mask set 20, software and printing capabilities can be used to customize the shape and contour of the various components of the breathing set 10 and/or nasal assembly 12. For example, but not limited to, the nasal coupling portion 16 of the nasal assembly 12 can be specifically contoured to fit each nasal passage of patient 1. Such customization can be achieved by digitally scanning the features of a patient's face. patient to create a CAD model or for 3D printing. In addition, various portions, or the entire body of the mask 46 and/or adhesive padding 42 can be customized to more effectively fit the facial contours of the patient 1. Such customization can be applied to any component of the breathing assembly 10, including but not limited to not limited to nose assembly 12, base 90, connector 91, socket 94, clip assembly 80, sheet 30, and/or divider 60.

[037] FIG. 3 illustrates a nasal assembly 12 installed in a patient 1 according to at least one embodiment. The nose assembly 12 may include a pair of tubes 28, each in gaseous communication with a hose 40 or a source of fluid 41. The pair of tubes 28 and the hose 40 may be unitarily formed. Alternatively, a divider 60 may be positioned between each of the pair of tubes 28 and the hose 40 or fluid source 41. The divider 60 may be coupled with each of the pair of tubes 28 and the hose 40 or fluid source 41. to allow flow of gaseous flow between each of the pair of tubes 28 and the hose 40 or the fluid source 41. The divider 60, pair of tubes 28 and hose 40 may be unitarily formed.

[038] Coupling of divider 60 with tubes 28 and/or hose 40 or fluid source 41 can be achieved using several different structural configurations. Some structural configurations may allow greater rotational movement between elements 28, 40, 60, while at the same time maintaining a sealable engagement to prevent gas leakage therefrom. The divider 60 may have two coupling ends of the tube 62 for coupling the tubes 28 and a coupling end of the source 64 for coupling the hose 40 or fluid source 41. The tubes 28 may include a tube divider receiver 66. The hose 40 or fluid source 41 may include a source divider receiver 68. In some embodiments, the receivers 66, 68 or mating ends 62, 64 may be circumferentially extending structures coupled with corresponding recess structures. Alternatively, receivers 66, 68 or coupling ends 62, 64 may be tube splitters or sockets coupled with corresponding tube or split ball joints to allow rotational movement of tubes 28 about splitter 60.

[039] In at least one embodiment, such as the embodiment shown in FIG. 4, each column 14 of the nose assembly 12 may include an extending portion 34 to selectively couple a respective receiving portion 35 of the pair of tubes 28. Coupling of the column 14 with the receptacle 24 or tube 28 can be achieved using various configurations. different structures. The extending portion 34 may be a circumferentially extending portion to selectively engage a respective recess receiving portion 35. Alternatively, the extending portion 34 may be a column ball joint and the receiving portion 35 being a tube socket, and wherein the column ball joint 34 and the tube socket 35 are configured for selective coupling to allow rotational movement of the pair of tubes 28 about each of the pair of columns 14, as shown in FIG. . 4. Another alternative embodiment may include the extending portion 34 being a column socket and the receiving portion 35 being a tube ball joint, wherein the column socket 34 and tube ball joint 35 are configured. for selective coupling to allow rotational movement of the pair of tubes 28 around each of the pair of columns 14.

[040] According to some embodiments, the nasal assembly 12 includes a pair of columns 14. FIGS. 5A and 5B illustrate nose assembly 12 in more detail according to at least one embodiment. Post 14 may include a lip 26 configured to mate with a sheet 30 having an adhesive 32 applied thereto, or alternatively, a layer of adhesive 32, or a layer of adhesive inclusive of a sheet 30, to be adhered to and provide sealable mating. with the nostrils of patient 1. Sheet 30 may have any desired shape, and may preferably include an opening therein to allow flow of deposition into an opening 29 defined in column 14. Adhesive 32 may be a pressure sensitive adhesive such as that sheet 30 can be adhered to and removed from the patient's nostrils as desired. The column 16 may include an extending portion 34 at a second end of that which is configured for selective coupling with at least one receptacle 24 or corresponding tube 28 of the pair of tubes 28.

[041] Adhesive 32 (and/or sheet 30) can have variable thickness, adhesive strength 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 around the mating portions of the nostrils, while more flexible in other places. Adhesive 32 may comprise a foam medical tape, a surgical tape, and/or a hypoallergenic tape. Adhesive 32 may comprise a hydrocolloid tape 18 and/or may include a reactive polyurethane layer that confirms more with the nostril as the patient's body temperature warms the adhesive 32. Adhesive 32 may include a chloride foam tape. of polyvinyl or polyolefin and/or an acrylate adhesive layer. In some embodiments, adhesive 32 may include a layer of fabric to adhere to column 14 using a tape or adhesive.

[042] In some embodiments, each column 14 of the pair of columns 14 may include a lip 26 that defines an opening 29 therein, the openings 29 in gaseous communication with each corresponding tube 28 of the pair of tubes 28. In addition, an adhesive 32 or layer of adhesive 32 may be applied to each column 14, each column 14 configured for sealable coupling to a patient's nostril. Adhesive 32 may be applied to a sheet 30 positioned on a nose-facing side of column 14, or the adhesive may be applied directly to the edge 26 of column 14. Adhesive 32 may be pressure sensitive.

[043] FIG. 6 illustrates a perspective view of breathing assembly 10 having a base 90 and a single connector 91 in accordance with 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 technique, where straps and masks often leave marks on the patient's body. Base 90 may include any number of vents 52. For example, as illustrated in FIG. 9, vents 52 may be positioned on the underside of base 90. Base 90 may further include or define a base tube coupling 103 to selectively engage or couple to a hose 40 or fluid source 41. The engagement or coupling between the base tube coupling 103 and hose 40 or fluid source 41 may allow complete rotation of the two relative to each other. Base 90 and base tube coupling 103 may be formed unitarily or formed separately. Base tube coupling 103 may involve any of the couplings described herein, including, but not limited to, a ball and socket joint, snap coupling, pinch coupling, clamp coupling, or other form of coupling. Base tube coupling 103 may include vents 52 or may include a textured or contoured surface to facilitate maneuverability and operation of breathing assembly 10.

[044] The vents 52 of the present invention can be positioned close to any of the regions where fluid flow occurs. For example, but not limited to, vents 52 can be placed on base 90, connector 91, columns 14, socket 94, base tube coupling 103, etc. The 52 vents can be manufactured using a thermoplastic 3D printing process. The vents 52 may be made of microscopic pores. Microscopic pores can be created using a matrix of very fine fibrils. The fibrils may be made of polytetrafluoroethylene (PTFE).

[045] The base 90 and single connector 91 can be built unitarily or built separately. For example, base 90 may be made of rigid plastic and connector 91 may be made of silicone. The base 90, socket 94, columns 14 and/or other components of the breathing assembly 10 may be comprised of a plastic, for example, but not limited to, polypropylene or polyethylene, which may be of food grade or medical grade. The possibility of unitary or separate construction, and the inclusion of plastics and silicone, may additionally apply to the embodiments shown 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 attachable or mated with a socket 94. The socket 94 may engage or engage the interior of the connector arm 93 (see, FIG. 6), the outside of the connector arm 93 or both the inside and the outside. In one embodiment, socket 94 may engage connector arm 93 (and/or post 14 may engage socket 94) by sliding into a slotted cavity of connector arm 93 (and/or socket 94).

[046] A base 90 may be provided to receive the flow of liquid 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 in which the base includes a single base opening 96 for selectively engaging or mating with 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 to provide various configurations adapted to the contours of various patients 1. In addition, engagement or coupling of one or more base openings 96 and to one or more connectors 91 may be effected. using any of the couplings described here.

[047] FIG. 7 illustrates a rear view of breathing assembly 10 having a base 90 and two connectors 91 in accordance with one or more embodiments disclosed herein. Base 90 may define a base concavity 97 to allow freer movement of, or access to, the patient's lips by being molded further away from the patient's face when breathing assembly 10 is coupled with the patient's nostrils. In addition, base 90 may include one or more protrusions of base 98 and a concavity in base 99 to minimize the volume being used by breathing assembly 10, thereby allowing greater access to the patient's face and facilitating manipulation of various components of the assembly. breathing 10.

[048] The base 90 of FIG. 7 defines two base openings 96 for selectively engaging or mating to each of at least two connectors 91. More than two connectors 91 may be provided such that connectors 91 can be interchanged as desired to vary shape (and therefore , airflow), angle (and therefore position) and/or type, which may include any of the couplings described herein. Each connector 91 may be molded and constructed of materials for deformability such that the connector arms 93 may be flexed with respect to the connector body 92. Sockets 94 may be included in breathing assembly 94 to selectively engage or mate with connectors 91.

[049] FIG. 8 illustrates a perspective view of a base 90 of a breathing assembly 10 having two base openings 96 and a base tube coupling 103 in accordance with one or more embodiments disclosed herein. FIG. 9 illustrates a bottom view of a base 90 of a breathing assembly 10 having two base openings 96 in accordance with one or more embodiments disclosed herein. FIG. 10 illustrates a rear view of a base 90 of a breathing assembly 10 having two base openings 96 in accordance with one or more embodiments disclosed herein.

[050] FIG. 11 illustrates a rear view of a base 90 of a breathing assembly 10 having four base openings 96 and two covers 102 in accordance with one or more embodiments disclosed herein. The two caps 102 can cover the base openings 96 when not in use and/or when the base openings 96 are not engaged or mated to the connectors 91. The base openings 96 can be similarly classified and shaped such that connectors 91 can be interchanged and repositioned freely between each of the openings 96. Such customization allows a patient to selectively engage or mate the connectors 91 to any two openings 96 for a better fit to the patient's nostril. By allowing clamp couplings or ball and gasket couplings or any other coupling allowing for multiple placement, and/or by providing angled posts 14 and/or connectors 91, connector 91, connector arm 93 and/or posts 14 can be positioned to better fit to the patient's nostril when breathing set 10 is attached.

[051] FIG. 12 illustrates a clamp assembly 80 and rotatable socket assembly 94 in accordance with one or more embodiments disclosed herein. Sheet 30 of breathing assembly 10 may be embedded with clip assembly 80, where clip assembly 80 defines a clip edge 82 extending between layers of sheet 30. Alternatively, sheet 30 and/or adhesive 32 can be applied to a nose-facing side of the clamp rim 82 of the clamp assembly 80, similar to the nose coupling portion 16 of the column 14 described herein. The sheet 30, nose coupling portion 16 and/or clip rim 82 can be formed to create various shapes to fit the numerous types of nostrils 4 and nostrils 3 of patients. For example, in FIG. 6 sheet 30 is substantially circular around the nostril 4 and extends outward on one side in a triangular fashion with a curved apex; such an embodiment provides a greater surface area to adhere to patient 1. In FIG. 5, sheet 30 is substantially circular. Throughout the description, clip flange 82 and nose coupling portion 16 may be used interchangeably. In other embodiments, the sheet 30, nose coupling portion 16 and/or clip rim 82 may be radially wavy, concave or convex so as to conform to the nostril in a conforming manner. Upon application to patient 1, sheet 30 and/or clip flange 82 may overlap between the nostrils 4 to provide additional support and adhesion. The clip lip 82 may be similarly molded and arranged.

[052] The clamp edge 82 of the clamp assembly 80 can be rigid to provide support or flexible to conform to the shape of the patient's nostril 4 and nostril 3. The clamp assembly 80 may further define the extent of the clamp 84 extending of a central or inner portion of clip rim 82 and away from patient 1. Clip extension 84 may be substantially cylindrical, or may alternatively be shaped, to engage a column 14 or socket 94 of nose assembly 12. Clip extension 84 may define a plurality of clip ribs 86 within the interior of the clip extension 84 - the clip opening 85 - and/or the outside of the clip extension 84. The clip ribs 86 may each define a distal end 87 positioned further from the clamp lip 82 than the proximal end 88 defined by the clamp rib 86. The proximal and distal ends 87, 88 may be arranged to allow clockwise or counterclockwise rotation of the collar. 14 or socket 94 with respect to the clamp assembly 80. In addition, the ribs of the clamp 86 may define a tapered edge 89 at the distal end 87 and/or the proximal end 88 to facilitate smooth rotation and locking of the clamp assembly 80 and column 14 or socket 94.

[053] In alternative embodiments, the clamp ribs 86 and column or socket rib 110 may be L-shaped and the clamp assembly may further have a spring-based ring (not shown) positioned on the clamp lip 82. During coupling the column 14 or socket 94 with the clamp assembly 80, the ribs can be pushed together and the column 14 or socket 94 can be twisted, then released by the patient, the spring based ring would 'lock' clamp 80 and column 14 or socket 94 assembly in place. The socket rib 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 clamp rib 86.

[054] Although a socket 94 is depicted in FIG. 12, a column 14 may similarly be selectively attachable with the clamp assembly 80. The socket 94 or column 14 may include position identifiers (A-H) to allow the patient to selectively engage the socket 94 or column 14 in a particular desired position by aligning The desired position identifier (UM-H) is matched with the clamp position identifier 104. The socket 94 or column 14 may further define gripping features 105 to easily rotate the socket head 106. The socket head 106 may be freely rotatable about socket base 107. In other embodiments (FIGS. 13A-D), socket base 107 may be molded to mate with connector 91 and/or connector arm 93. In addition, socket 94 or column 14 may include a collapsible O-ring 108 for sealing engagement or coupling of socket 94 or column 14 to clamp assembly 80 when coupled. In one embodiment, where the socket 94 engages or couples to the outside of the connector arm 93, the connector arm 93 may extend into the socket 94 and define an O-ring 108 to seal the socket's engagement or engagement. column 94 - 14.

[055] FIGS. 13A-D illustrate a socket assembly 94 and a column 14 in accordance with one or more embodiments disclosed herein. The column 14 may include a nasal coupling portion 16 that is angled with respect to the body of the column 17 to improve positioning of the nasal coupling portion 16 with respect to a nostril. The angle may be 15 degrees or any degree between 0 and 45. The angle may be created by having a portion of the column body 17 'bulge' outwardly at an angle, as shown in FIGS. 13B and 13C. The intersection of the bulge 17A and the column body 17, or the entire bulge 17A itself, may be flexible or deformable and may be made of a different material than the other portions of the column body 17. Alternatively, the column body 17 it may remain substantially cylindrical, having an upper portion 'split' at an angle.

[056] The socket assembly 94 may include one or more tweezers 117 for attaching and detaching the socket 94 from the column 14. The tweezers 117 may extend from one end of the collar 119 of the socket distal to the connector 91 at an angle. to provide leverage to the collet 117 when being 'pinched', thereby allowing the socket collar 119 to be deformed outwardly from the post 14 for easy release. A cavity of socket 118 may be defined by socket 94 to allow deformation of socket 94 when pinched. For example, in FIG. 13D , socket cavity 118 extends through collar 118 portion of socket 94 and horizontally below collar portion 118 to allow deformation of a left or right half of collar 118 when pliers 117 are pinched. Clamping involves putting pressure on one or more tweezers 117, individually or simultaneously, so that tweezers 117 are flexed toward socket 94, thereby lifting collar lip 130 from collar 119 and releasing burr 132 from column 14 .

[057] FIGS. 14A-14D illustrate a socket assembly 94 having a clamp latch 120 in accordance with one or more embodiments disclosed herein. The clamp latch 120 may include two clamp extensions 121. The first clamp extension 121A may define a first clamp mount 122A and the second clamp mount 121B may define a second clamp mount 122B. One or both of the clamp mounts 122 may include a clamp rib 123 to allow the clamp mounts 122 to be locked together when the extensions 121 are clamped together. Once coupled, the clamp mounts 122 can be decoupled with a subsequent clamp. In one embodiment, pinching the extensions 121 together engages the lip 130 with the post 14 to secure the post 14 in position. The column 14 may define positioners 132 (small protrusions on the underside of the column, distal from the nasal coupling portion 16) to further fix the position of the column 14 and resist rotation of the column 14 when the positioners 132 are coupled with the openings at position 134 defined by socket 94.

[058] In some embodiments, the breathing assembly 10, nasal assembly 12, mask assembly 20, and/or any components thereof may further include an oral device coupling 70 for coupling an oral device 9 coupled with the patient's mouth. For example, but not limited to, the patient may have a mouthguard, mandibular advancement splint, or some other oral device 9 that can be used in conjunction with the breathing assembly 10, nasal assembly 12, and/or mask assembly 20. oral device 70 may selectively engage breathing assembly 10, nasal assembly 12 and/or mask 10 with oral device 9 to stabilize the position of breathing assembly 10, nasal assembly 12 and/or mask 10 with respect to patient 1.

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

[060] While the modalities have been described in relation to the preferred embodiments of the various figures, it should be understood that other similar modalities may be used or modifications and additions may be made to the described embodiment to accomplish the same function without deviating from it. Therefore, the disclosed modalities should not be limited to any single modality, but rather, it should be interpreted in breadth and scope in accordance with the appended claims.

Claims (18)

1. Breathing kit CHARACTERIZED in that it comprises: a base coupled with at least one connector, wherein the base is in fluid communication with a hose or fluid source to allow the flow of gaseous flow between the at least one connector, the base and the hose or fluid source; a pair of sockets separable from the at least one connector, wherein the sockets are selectively mated with the at least one connector, wherein each socket is independently movable with respect to the other socket, wherein each socket defines: a collar; an opening defined by the collar for receiving a post; wherein the collar has a first mode of operation in which a column is engaged with the collar and a second mode of operation in which the column is not engaged with the collar through retraction of a locking member in response to manipulation by a wearer; wherein each column is configured to sealingly engage a patient's nostril so that the column rod does not extend into a patient's respective nostril when the column is engaged with the patient's nostril, each column includes: a lip that defines an aperture therethrough, the apertures in fluid communication with each corresponding socket of the pair of sockets; an adhesive adhered to each ridge and configured for sealable engagement with a patient's nostril; and wherein the breathing assembly is maskless and strapless so that fluid from the hose or fluid source flows through the connector into the patient's nostrils but not into the patient's mouth when the breathing assembly is worn by the patient. 2. Breathing set, according to claim 1, CHARACTERIZED by the fact that the adhesive is pressure sensitive. 3. Breathing set, according to claim 1, CHARACTERIZED by the fact that the adhesive comprises foam. 4. Breathing set, according to claim 1, CHARACTERIZED by the fact that the base defines two openings to couple two connectors. 5. Breathing set, according to claim 1, CHARACTERIZED by the fact that the base defines four openings to couple two connectors and two covers. 6. Breathing assembly, according to claim 1, CHARACTERIZED by the fact that the edge of the columns is inclined in relation to a column body defined by the columns, each column body selectively couples at least one of the pair of sockets. 7. Breathing set, according to claims 4 or 5, CHARACTERIZED by the fact that the connector defines a concavity position at least between two of the openings to provide access to the patient. 8. Breathing set, according to claim 1, CHARACTERIZED by the fact that it also comprises vents for titration fluids. 9. Breathing set, according to claim 1, CHARACTERIZED by the fact that each of the pair of sockets includes clamps to allow selective coupling between the sockets and the columns. 10. Breathing assembly, according to claim 1, CHARACTERIZED by the fact that each of the pair of sockets includes a clamp set to allow selective coupling between the sockets and columns, in which the clamp assembly defines two clamp extensions selectively attachable using at least one clamp rib. 11. Breathing assembly, according to claims 9 or 10, CHARACTERIZED by the fact that selective coupling includes coupling a socket collar with a column burr. 12. Breathing set CHARACTERIZED in that it comprises: a base coupled with at least one connector, in which the base is and in fluid communication with a hose or fluid source to allow the flow of gaseous flow between the at least one connector, base and hose or fluid source; a pair of sockets separable from the at least one connector, where the sockets are selectively mated with at least one connector, where each socket is independently movable with respect to the other socket, where each socket defines: a pair of clamp assemblies, each clip assembly selectively attachable to at least one of the pair of sockets, wherein each clip assembly defines: a clip flange in engagement with a sheet including an adhesive for attaching to a patient's nostril wherein the clip flange is defined in one end of each clip assembly so that each clip assembly does not extend into a respective patient's nostril when the clip assembly is in engagement with the patient's nostril; a clamp opening in fluid communication with each corresponding socket of the pair of sockets; at least one clamp rib for selectively mating at least one socket rib of the pair of sockets; where the breathing set has no mask and no straps so that fluid from the hose or fluid source flows through the at least one connector into the patient's nose but not into the patient's mouth when the breathing set is used by the patient. 13. Breathing set, according to claim 12, CHARACTERIZED by the fact that the adhesive is pressure sensitive or comprises foam. 14. Breathing set, according to claim 12, CHARACTERIZED by the fact that the base defines two openings to couple two connectors. 15. Breathing set, according to claim 12, CHARACTERIZED by the fact that the base defines four openings to couple two connectors and two covers. 16. Breathing set, according to claim 12, CHARACTERIZED by the fact that the clamp edges are inclined in relation to the socket when the clamp sets and the sockets are coupled. 17. Breathing set, according to claims 14 or 15, CHARACTERIZED by the fact that the connector defines a concavity position at least between two of the openings to provide access to the patient. 18. Breathing set, according to claim 1, CHARACTERIZED by the fact that it also comprises vents for titration fluids.

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