Nasal Interface Apparatus

Abstract

A a nasal airway interface apparatus includes a body section having a gas delivery connector for receiving a gas from a source of gas, two nasal interfaces, and strap connectors for attaching a head strap. Each nasal interface of the two nasal interfaces extends from the body section, has an insertion tip that has an opening that is distal from the body section, and a flattened side for sealing against a septum of a nose. Two exhalation manifolds are provided for exhausts, each of the two exhalation manifolds have a plurality of holes for expelling exhalation gases. Gas flows in a substantially linear path from the gas delivery connector, through the body section, through the two nasal interfaces and out the openings.

Claims

1. A nasal airway interface apparatus comprising: a body section having a gas delivery connector for receiving a gas from a source of gas, two nasal interfaces, and strap connectors for attaching a head strap; each nasal interface of the two nasal interfaces extends from the body section, has an insertion tip that has an opening that is distal from the body section, and a flattened side for sealing against a septum of a nose; two exhalation manifolds, each of the two exhalation manifolds having a plurality of holes for expelling exhalation gases; and whereas gas flows in a substantially linear path from the gas delivery connector, through the body section, through the two nasal interfaces and out the openings.

2. The nasal airway interface apparatus of claim 1, wherein each of the two nasal interfaces have insertion bulges that bulge outward for sealing against a respective nostril of the nose.

3. The nasal airway interface apparatus of claim 1, wherein the body section, including the two nasal interfaces, comprises a soft, pliable material.

4. The nasal airway interface apparatus of claim 3, wherein the soft, pliable material is medical grade silicon.

5. The nasal airway interface apparatus of claim 3, wherein the soft, pliable material is type IV silicon.

6. The nasal airway interface apparatus of claim 3, wherein each of the two exhalation manifolds is made from a material that is harder than the soft, pliable material.

7. The nasal airway interface apparatus of claim 6, wherein the material is polycarbonate.

8. The nasal airway interface apparatus of claim 6, wherein the material is polypropylene.

9. A nasal airway interface apparatus comprising: a body section made of a soft, pliable material and having a gas delivery connector for receiving a gas from a source of gas, two nasal interfaces, and means for holding the body section; each nasal interface of the two nasal interfaces extends from the body section, has an insertion tip that has an opening at and end that is distal from the body section, and a flattened side for sealing against a septum of a nose; two exhalation manifolds made of a stiff plastic material, each of the two exhalation manifolds having a plurality of holes for expelling exhalation gases; and whereas gas flows in a substantially linear path from the gas delivery connector, through the body section, through the two nasal interfaces and out the openings.

10. The nasal airway interface apparatus of claim 9, wherein each of the two nasal interfaces bulge outward for sealing against a respective nostril of the nose.

11. The nasal airway interface apparatus of claim 9, wherein the soft, pliable material is medical grade silicon.

12. The nasal airway interface apparatus of claim 9, wherein the soft, pliable material is type IV silicon.

13. The nasal airway interface apparatus of claim 9, wherein the stiff plastic material is polycarbonate.

14. The nasal airway interface apparatus of claim 9, wherein the stiff plastic material is polypropylene.

15. A method of delivering positive airway pressure to a user, the method comprising: inserting an insertion tip of each of two nasal interfaces into a respective nostril of the user until an insertion bulge of each of the two nasal interfaces abut an outer edge of respective nostrils of the user, each of the two nasal interfaces extending into the respective nostril of the user and each of the two nasal interfaces connected to a body section; the insertion bulge of each insertion tip sealing against an edge of the respective nostrils of the user; and during inhalation, gas from a gas delivery connector flowing through the body section and through the two nasal interfaces and into the respective nostrils of the user, thereby providing positive airway pressure to the user.

16. The method of claim 15, wherein a flattened side of each of the two nasal interfaces sealing against a septum of a nose of the respective nostrils.

17. The method of claim 15, wherein during exhalation, exhalation gas from the user flowing through the body section and exiting through exhalation manifolds.

18. The method of claim 17, wherein the body section, including the two nasal interfaces, comprises a soft, pliable material.

19. The method of claim 18, wherein the soft, pliable material is medical grade silicon.

20. The method of claim 18, wherein each of the exhalation manifolds are made from a material selected from a group consisting of polycarbonate and polypropylene.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The invention can be best understood by those having ordinary skill in the art by reference to the following detailed description when considered in conjunction with the accompanying drawings in which:

[0039] FIG. 1 illustrates a perspective view of a system of the present invention.

[0040] FIG. 2 illustrates a bottom plan view of a pillow interface of the present invention.

[0041] FIG. 3 illustrates a cross-sectional view of the pillow interface of FIG. 2 along lines 3-3.

[0042] FIG. 4 illustrates a perspective view of the cannula of the present invention.

[0043] FIG. 5 illustrates a cut-away partial view of the cannula of the present invention.

[0044] FIG. 6 illustrates a perspective view of the cannula of the present invention being connected to a source of air flow.

[0045] FIG. 7 illustrates a pillow interface of the present invention abutting against the edge of a nostril.

[0046] FIG. 8 illustrates a cannula with pillow interface of the present invention.

[0047] FIG. 9 illustrates a cannula with pillow interface of the present invention abutting against the edge of a nostril.

[0048] FIG. 10 illustrates a patient-interface view of a nasal interface apparatus of the present invention.

[0049] FIG. 11 illustrates a gas interface view of the nasal interface apparatus of the present invention.

[0050] FIG. 12 illustrates the gas interface side view of the nasal interface apparatus of the present invention with exhalation ports detached.

[0051] FIG. 13 illustrates a side view of the nasal interface apparatus of the present invention.

[0052] FIG. 14 illustrates a top view of the nasal interface apparatus of the present invention.

[0053] FIG. 15 illustrates a perspective view of the nasal interface apparatus of the present invention.

[0054] FIG. 16 illustrates a second perspective view of the nasal interface apparatus of the present invention.

[0055] FIG. 17 illustrates a cross-sectional view of the nasal interface apparatus of the present invention.

[0056] FIG. 18 illustrates the cross-sectional view of the nasal interface apparatus of the present invention showing air flow during inhalation.

[0057] FIG. 19 illustrates the cross-sectional view of the nasal interface apparatus of the present invention showing a portion of a nose interfaced thereto.

[0058] FIG. 20 illustrates a perspective view of the nasal interface apparatus of the present invention being worn by a user.

[0059] FIGS. 21 and 22 illustrate comparison data between the nasal interface apparatus of the present invention and three other popular industry breathing apparatus.

[0060] FIG. 23 illustrates a test system used to measuring resistance flow through a nasal interface apparatus.

DETAILED DESCRIPTION

[0061] Reference will now be made in detail to the presently preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. Throughout the following detailed description, the same reference numerals refer to the same elements in all figures.

[0062] The present invention provides an adequate air volume, allowing for a normal inspiratory cycle and allowing normal adequate exhalation while treating, for example, sleep apneas. The high-volume delivery is provided at decreases air flow velocity, increasing lateral pressure, decreasing of the venturi effect, and increasing the effectiveness of treatment. The present invention is designed so as to not interrupt a patient's normal breathing mechanics; therefore, not interrupting a patient's normal respiratory rate and not interrupting a patient's normal inspiratory/expiratory ratio.

[0063] Work of breathing is greatly diminished. There is reduced turbulence or restriction during the inspiratory cycle with little or no noticeable change in noise throughout the inspiratory/expiratory cycle. The patient is able to exhale completely via the patient's elasticity of the lungs and without the use of any accessory muscles. Respiratory rate typically remains normal at 12 to 14 breaths per minute. The patient maintains normal minute ventilation throughout the night. Heart rate and oxygen saturation remain optimal throughout the night. The patient experiences normal breathing without apneic events. Once initial pressures are set during polysomnography, there is no need for increasing pressures at any time throughout the sleep cycle. These benefits result into a significant increase in compliance to the treatment (e.g., the patient continues to use the system).

[0064] Throughout this description, the continuous positive air pressure system is described in relationship to being used by a user, wearer, patient, etc., interchangeably. There is no limitation as to who will used the continuous positive air pressure system described here within.

[0065] Referring to FIG. 1, a perspective view of a system of the present invention is shown. The system shown in FIG. 1 is a continuous positive air pressure system that receives air flow from a source (not shown), connected to flexible tube 60 at one end by a swivel adapter 62. Current systems typically provide air flow to the flexible tube 60, which is often a 22-millimeter flexible tube 60. The present application requires a source of air flow but is in no way limited to any particular source of a gas (e.g., air, concentrated air, oxygen, etc.) and is not limited in any way to specific plumbing for delivery of such air flow.

[0066] A distal end of the flexible tube 60 connects to an air supply port 42 of the cannula 40. In general, the cannula is substantially hollow. As the continuous positive air pressure system is typically worn while sleeping, the continuous positive air pressure system need be retained to the person using the continuous positive air pressure system.

[0067] Although there is no limitation as to how the continuous positive air pressure system is held to the user, in the embodiment shown, the cannula 40 includes tabs 50 for attaching a retainer 70/72. In some embodiments, the retainer 70/72 includes an adjustable portion 72 for conforming to a head size of a wearer (e.g. having hook/loop material adjustments) and resilient members 70 that provide some amount of tension, holding the cannula 40 in place, and therefore, retaining the interface pillows 10 within the wearer's nostrils. For example, in some embodiments the resilient members 70 are made from medical grade silicone. The interface pillows 10 are describe in detail along with FIGS. 2 and 3.

[0068] Note that interface pillows of the prior art are typically made of a very soft and pliable material and have an overall round cross-sectional shape. When such is inserted into the nostril of a wearer, the round shape must conform to an internal shape of the user's nostrils, leading to both discomfort and impacted air passages that result in higher velocity of air flow and noise.

[0069] Referring to FIGS. 2 and 3 a bottom plan view and a cross-sectional view of the interface pillows 10 is shown. The interface pillows 10 fit into and against the outer portion (entry area) of the wearer's nostrils. In general, the interface pillows 10 are made as pliable members (e.g., deform slightly under pressure) having a body that is elongated with one end for interfacing with a cannula 40 and a distal end for insertion partially into a wearer's nostril.

[0070] Viewing one interface pillow 10 from the bottom (FIG. 2), the insertion depth, d, is defined by a side that slopes outwardly from the insertion tip 20 to a point of insertion 30. The insertion slope is an angle, α, that in some embodiments is 10 degrees from a center axis of the interface pillow 10. Proper insertion is limited by an insertion bulge 35 that prevents over-insertion of the interface pillows 10 into the nostrils of the wearer an provides a seal at seal points 51/52 (see FIG. 7) against the edge of the wearer's nostril 80 and septum 82 (see FIG. 7). Each interface pillow 10 has a connection interface 34 (canula end) for connecting to the cannula 40 (see FIGS. 4-6). In some embodiments, the insertion depth if the insertion area 17, d, is set at approximately 0.25″ for a comfortable depth extending inside the patient's nostril, e.g., an insertion distance of d.

[0071] The cross-sectional shape of the interface pillow 10 is formed to provide an enhanced seal of the insertion bulge 35 against the edges of the wearer's nostril 80 and septum 82 while providing maximum comfort. Note that the view from the bottom shown in FIG. 2 is that of an interface pillow 10 that is to be worn in the left nostril, as the interface pillow 10 that is to be worn in the right nostril is flipped to match the symmetry of the wearer's nose.

[0072] The cross-sectional shape of the interface pillow 10 is shown having three specific nose interface areas 21/22/23. The septum of the wearer's nose is generally flat and relatively unyielding. The septum interface area 21 has a flattened side to rest comfortably against the wearer's septum when inserted (e.g., into the left nostril). The upper interface area 23 is rounded and narrow with respect to the lower interface area 22, as the geometry/shape of most nostrils are wider towards the mouth of the wearer than they are towards the brow of the wearer. In this, the interface area 22 next to the insertion bulge is the widest, dilating the lower region of the wearer's nostril the most, as the lower region of the wearer's nostril is also the least sensitive.

[0073] This shape of the insertion area 17 provides both a good seal and improved comfort. The shape of the insertion area 17 enables the interface pillows 10 to be made of a stiffer or thicker material than those of the prior art as there is no need for the insertion area 17 to deform. In such, upon insertion into the nostrils, the insertion area 17 of the interface pillows 10 generally retain their shape and, therefore, do not restrict air flow through the air channel 27. Further, testing has shown that the shape of the insertion area 17 and insertion bulge 35 of the interface pillows 10 maintains the seal as seal points 51/52 even at the highest pressures expected with existing air pressure sources, typically around 20 centimeters of water pressure.

[0074] The insertion area of the cushion which fits against the inside of the nostrils 80/82 is at an angle, α, that in some embodiments is 10 degrees from a center axis of the interface pillow 10. When the interface pillow 10 is pressed against the nostrils, the septum 82 of the nostril remains steadfast while the outside of the nostril 80 are flexible and gives way slightly, for example, 0.10 inch.

[0075] In FIG. 3, a cross section of one interface pillow 10 is shown. This illustrates shows that the insertion area 17 of the interface pillow 10 is angled at an angle of a to reduce pressure from being exerted against the septum. The insertion tip 20 is preferably rounded. Generally, the outside area of the nostril 80 will give way by, for example, 0.10 inches, while the septum 82 remains stationery. The angle of the insertion area 17 compensates for the uneven distribution of pressure against the bottom of the nostrils 80/82 while in use. The result is significantly greater comfort, and much greater seal capacity with much less chance of an air leak resulting in lesser efficiency and increased noise.

[0076] In some embodiments, the wall thicknesses vary. In some such embodiments, at the insertion area 17, the insertion wall thickness w3 is .04 inches and narrows to a wall thickness w2 of 0.03 inches at the insertion bulge 35. These dimensions promote a forgiving feel of the pillows cushion against the bottom edge of the nostril, while maintaining an open-air channel 27 at the insertion area 17 when inserted into the nostrils. At the connection interface 34, the thickness, w1, is, for example, 0.05 inches. Note that in embodiments in which the insertion bulge 35 is made of a thinner, more flexible material (wall thickness w2) than the insertion area 17 (insertion wall thickness w3), the insertion bulge 35 is more flexible and deforms under sealing pressure from the cannula 40 whereas the insertion area 17 is firmer and deforms less, thereby not significantly deforming within the user's nostril and, therefore, not causing turbulence and/or flapping as air flows in/out of the air channel 27. Note that in some embodiments, the geometry of insertion bulge 35 is such that the insertion bulge 35 is closer to the insertion tip 20 at one side of the interface pillow 10 than at the distal side of the interface pillow 10, compensating for the septum 82 extending further from the nose than the outer edges of the nostril 80 (see FIG. 7).

[0077] Referring to FIGS. 4 through 6, perspective views of the cannula 40 of the present invention are shown. The cannula 40 is preferably hollow. The bleed port section 45 of the cannula 40 allows the user to exhale. The bleed port section 45 is placed in the front of the cannula body and directs exhalation air flow in a direction away from the arms/hands of a wearer, especially when the wearer is sleeping on their side. The exhaled air flow is directed at an angle, β, which is, for example, 57 degrees with respect to a lengthwise axis of the cannula 40. The bleed port section 45 is composed of bleed holes 41, each having an internal diameter, for example an internal diameter of 0.02″. In some embodiments, there are approximately 160 bleed holes 41. This provides a 0.05″ square inch cross-sectional flow space per bleed hole 41 which is equivalent to a 0.25″ diameter bleed hole. This flow space for exhaled air is much greater than that of the prior art. This flow space eliminates, or greatly reduces, work of breathing. This volume of flow space for exhaled air is possible because of the high volume of incoming air made available through the open flow space within the interface pillows 10.

[0078] Referring to FIG. 7, an interface pillow 10 of the present invention is shown attached to a canula and abutting against the edge of a nostril 80/82. In FIG. 7, it is shown that the edges of the nostril 80/82 contact the insertion bulge 35, where the insertion bulge 35 seals against the edges of the nostril 80/28. The insertion bulge 35 seals against the outer edges of the nostril 80 at seal points 51 and the insertion bulge 35 seals against the septum 82 at seal points 52. It is also shown, as in the geometry of most noses, that the septum 82 is not even with the outer edges of the nostril 80. Therefore, the insertion bulge 35 is curved slightly downward towards the septum 82 to exert substantially similar pressure against the septum 82 as against the outer edges of the nostril 80.

[0079] Referring to FIG. 8, a cannula with integrated pillow interface 140 of the present invention is shown. In this embodiment, the cannula 40 (cannula section) and pillows 10 are integrated/formed/molded into an integrated cannula with integrated pillow interface 140. In this, the pillows interface is similar to or the same as the pillow 10 described above. The integrated insertion tip 120, the integrated insertion area 117, and integrated insertion bulge 135 are the same as the insertion tip 20, the insertion area 17, and insertion bulge 35 described with the pillow 10 above, only instead of having a connection interface 34, the integrated pillow is formed as part of the cannula 40 into the cannula with integrated pillow interface 140. The cannula with integrated pillow interface 140 includes several exhalation holes 145 (or bleed holes) for exhausting of exhalation gases from the user. Note that in some embodiments, the exhalation holes 145 are formed at an angle and aimed away from the user so that exhalation gases flow outwardly and away from the user instead of directly at the user. There are nubs 150 for connecting to a head strap 160 (see FIG. 9), the head strap holding the cannula with integrated pillow interface 140 against the user's nose as will be described with FIG. 9.

[0080] In some embodiments, the air delivery connector 152 snap-connects to the air delivery tube 60, forming a swivel connection and allowing for rotating of the air delivery tube 60 for proper positioning.

[0081] FIG. 9 illustrates the cannula with integrated pillow interface 140 of the present invention abutting against the edge of a nose 80. In this view, the integrated insertion bulge 135 is shown abutting the edge of the user's nose 80, forming a seal against the edge of the user's nose 80 (note a portion of the user's head and nose 80 are shown in dashed lines). In this view, the integrated insertion tip 120 and the integrated insertion area 117 are within the user's nose 80 and, therefore, not visible.

[0082] The nubs 150 are shown connected to a head strap 160 and the head strap holds the cannula with integrated pillow interface 140 against the user's nose 80, forming the seal between the user's nose 80 and the integrated insertion bulge 135.

[0083] In the embodiment shown, the air delivery connector 152 snap-connects to the air delivery tube 60, forming a swivel connection, allowing for rotating of the air delivery tube 60 for proper positioning.

[0084] Referring to FIGS. 10 through 20, a nasal interface apparatus 1000 of the present invention is shown. In FIG. 10, a patient-interface view of the nasal interface apparatus 1000 of the present invention is shown. The nasal interfaces 1135 are flattened as shown in FIG. 2 where the septum will press against the nasal interface 1135 as shown in FIG. 2 (septum interface area 21), thereby providing an enhanced seal over the prior devices and increased gas volume as the prior devices were typically round and required deformation in order to create a seal. The nasal interfaces 1135 require minimal deformation and, therefore, the nasal air passages 1137 remain substantially open to allow for maximum volume of gas delivery at a given air pressure.

[0085] Note that the body 1040 of the nasal interface apparatus 1000 with strap connectors 1150, as well as the nasal interfaces 1135 are anticipated to be molded together in the same molding process using a soft, pliable material such as a medical grade silicon, e.g., class IV silicone.

[0086] As shown in FIGS. 11 and 12, in the gas interface view of the nasal interface apparatus 1000, the exhalation manifolds 1045 are visible. The air delivery connector 152 interfaces with an air deliver tube 60 (see FIG. 20). The exhalation manifolds 1045 are fabricated/molded separately from the body 1040, strap connectors 1150, and the nasal interfaces 1135 using a different, harder material such as polycarbonate or polypropylene.

[0087] Cross-sectional area of the holes in the exhalation manifolds 1045 must provide sufficient total area for the user's exhalation gases to escape the integrated cannula with nasal interfaces. As the integrated cannula body 1040 with strap connectors 1150, as well as the nasal interfaces 1135 are anticipated to be molded of a soft pliable material as described above, it is difficult to form precise-sized holes that remain open during use with such material, and it would be easy for these holes to collapse if made from the soft pliable material. Therefore, the exhalation manifolds 1045 are made of a stiffer plastic material with precise holes and the exhalation manifolds 1045 is fastened or press-fit into the body 1040.

[0088] In the cross-sectional views shown in FIGS. 17 and 18, it is shown that the inhalation gas flow (see inhalation gas flow lines in FIG. 18) is substantially linear from the gas deliver connector 152 to the nasal air passages 137. There are no turns or corners and, therefore, minimal turbulence is created within the body 1040 and only one obstacle is present as needed for an indentation 1180 that provides space for the septum of the user's nose.

[0089] In FIG. 19, the cross-sectional view of the nasal interface apparatus 1000 is shown interfaced to a section of a nose of the user. The septum 82 fits within the indentation 1180 and the edges 80 of the user's nostril rest on the sides of the nasal interfaces 1135, creating a seal without substantially deforming the nasal interfaces 1135. Note that as the septum 82 is substantially flat, the inner-facing sides of the nasal interfaces 1135 are also substantially flat.

[0090] In FIG. 20, the nasal interface apparatus 1000 is shown being worn by a patient or user. Note that the elastic straps that hold the body 1040 and, hence, the nasal interfaces 1135 within the nostrils 80/82 are not shown for clarity and brevity reasons.

[0091] Referring to FIGS. 21 and 22, comparison data between the nasal interface apparatus 1000 and three other popular industry breathing apparatus are shown. The data presented in FIG. 21 comes directly from an analysis done by Valley Inspired Products, document number 22007, ISO 17510:2015 Nasal Pillows Interface Evaluation, origination date Dec. 4, 2022 and updated by Revision A on Dec. 11, 2022. This report clearly shows the advantages of the above-described nasal interface apparatus 1000.

[0092] The test utilized a setup for resistance flow (per the report) is shown in FIG. 23.

[0093] The graphs of FIG. 21 and FIG. 22 are taken directly from the test results published Dec. 11, 2022. In FIG. 21, measurements for resistance to flow are shown. In this, the test results show that at a flow rate of 50 liters per minute, the nasal interface apparatus 1000 described above had a resistance to flow, or pressure drop, of only 0.2 liters per minute 1202, while the three other popular industry breathing apparatus had resistances to flow, or pressure drops, of: 1.3 liters per minute 1204, 1.0 liters per minute 1206, and 0.9 liters per minute 1208. At a flow rate of 100 liters per minute, the nasal interface apparatus 1000 described above had a resistance to flow, or pressure drop, of only 0.6 liters per minute 1212, while the three other popular industry breathing apparatus had resistances to flow, or pressure drops, of: 4.8 liters per minute 1214, 3.7 liters per minute 1216, and 3.4 liters per minute 1218.

[0094] In FIG, 22, measurements for exhalation flow are shown (e.g., exhalation rates). In this, the test results show that at a flow rate of 50 liters per minute, the nasal interface apparatus 1000 described above. In FIG. 22, the X-axis is pressure within the mask (e.g., 4 cm H.sub.2O, 8 cm H.sub.2O, etc.) and the Y-axis is exhaust flow rate (e.g., through exhaust orifices). The nasal interface apparatus 1000 as described above measured substantial increases of exhaust flow at all internal pressures as identified in extrapolated line 1220. The measurements for the competitors 1222/1224/1226 were significantly lower than the measurements for the nasal interface apparatus 1000.

[0095] The measurements reported in FIGS. 21 and 22 clearly demonstrate the improvements provided by the nasal interface apparatus 1000 described above. Note that the product names of the competitive products, C1, C2, and C3, are blanked for copyright reasons. The actual report is available if needed.

[0096] Equivalent elements can be substituted for the ones set forth above such that they perform in substantially the same manner in substantially the same way for achieving substantially the same result.

[0097] It is believed that the system and method as described and many of its attendant advantages will be understood by the foregoing description. It is also believed that it will be apparent that various changes may be made in the form, construction and arrangement of the components thereof without departing from the scope and spirit of the invention or without sacrificing all of its material advantages. The form herein before described being merely exemplary and explanatory embodiment thereof. It is the intention of the following claims to encompass and include such changes.