0
`United States Patent
`
`[19]
`
`[11] Patent Number:
`
`4,919,128
`
`
`Kopala et al.
`[45] Date of Patent:
`Apr. 24, 1990
`
`[54] NASAL ADAPTOR DEVICE AND SEAL
`[75]
`Inventors:
`John A. Kopala' John E. Remmers,
`both of Calgarbj, Canada
`.
`.
`.
`.
`.
`_
`::.1l1lVe1:S1::C}’ 'tI‘ecénolodgies International
`[73] Assignee.
`nc"
`er a’
`am a
`[21] Appl. No.: 236,941
`
`FOREIGN PATENT DOCUMENTS
`
`7/1926 France ............................ 128/204.11
`608528
`Primary Examiner—Edgar S. Burr
`Assmam Examl.ner_Kimber1y L Asher
`Attorney, Agent, or Firm—Burns, Doane, Swecker &
`Mathis
`
`[22] Filed:
`
`Aug. 26,1988
`
`[57]
`
`ABSTRACI‘
`
`A nasal adaptor device and seal for delivering gases
`under pressure to the nasal airway of an individual
`including an aerodynamically contoured manifold to
`receive gases from an inlet and to divide the gases for
`flow to a pair of flange members, preferaly having a
`non-slpherical curvled “Egg-sthat;1i1ed"
`surface,’
`-
`mem ers are, comp emen ary o
`enares 0 an in ivi
`ual without cannulating the nares to provide a seal to
`withstand positive pressure of gases to be distributed to
`the nasal airways. The devices and nares seals of this
`invention are especially useful in treatment of obstruc-
`five Sleep a flea and in Ventilation of individuals for
`.
`.
`.
`.
`.
`.
`whom p0S1tlVC pressure ventilation is indicated.
`.
`
`20 Claims, 2 Drawing Sheets
`
`RMD 1025
`
`[51]
`Int. Cl.5 ..................... A61M 15/00; A6lM 16/06
`
`[52] U.S. Cl. .................. .. 128/207.18; 128/205.25
`[58] Field of Search .................... .. 128/203.22, 204.11,
`128/204-.13, 204-12, 205-25, 205-21, 205-27.
`207-13. 207-13. 207-17, D1G- 26
`References Cited
`U'S' PATENT DOCUMENTS
`844,097 2/1907 Caldwell ........................ 128/203.22
`-- - -- 123/207-13
`2,135,997
`1/ 1940 Hfiidbrink - --- -
`
`'
`2’292’568
`3/1943 Kainerfi ‘*1’
`128/20338
`8/1945 Heidbrink .............. 128/206.27
`2,383,649
`2,664,084 12/1953 Hammermann
`128/204.11
`2,331,487
`4/1953 Fafilaw ............_
`_A 128/DIG. 26
`4,151,843
`5/1979 Brekke et al.
`. ... .
`. .. .. 128/205.25
`4,782,832 11/ 1988 Trimble et al.
`.............. .. 128/207.18
`
`
`
`[56]
`
`1
`
`RMD 1025
`
`

`
`US. Patent
`
`Apr. 24, 1990
`
`Sheet 1 of2
`
`4,919,128
`
`2
`
`

`
`U.S. Patent
`
`PA
`
`0991|.4,2L
`
`Sheet 2 of2
`
`4,919,128
`
`3
`
`

`
`1
`
`NASAL ADAPTOR DEVICE AND SEAL
`
`4,919,128
`
`5
`
`l0
`
`15
`
`20
`
`45
`
`50
`
`55
`
`FIELD OF THE INVENTION
`The invention relates to devices for delivering gases
`to the nasal airway at pressures at or above ambient
`pressure.
`BACKGROUND OF THE INVENTION
`
`In the past, various devices have been developed to
`transmit gaseous or liquid media at atmospheric pres-
`sure from a tube to the internal nasal passages. Such
`devices generally consist _of masks which clamp over
`the external nasal area or tubes which cannulate the
`nasal airway. Today, it is highly desirable to transmit air
`to the nasal passages under pressures greater than atmo-
`spheric pressure with a device that is comfortable to
`wear and which provides a leak-free seal between the
`device and the nostrils. For certain disorders, such as
`obstructive sleep apnea, it is important to have a device
`to deliver air in a free-flowing manner under positive
`pressure to the nasal air passage of a sleeping individual,
`and in order to do so, the device must be both comfort-
`able and maintain a seal despite a variety of movements
`of the head, when the individual is exerting no action to
`retain the device in position. It is therefore desirable to
`have a device that is self—retaining and can be tolerated
`for prolonged periods while providing an adequate seal
`with the nostrils of an individual.
`Many of the prior art devices establish a seal with the
`nasal airway by insertion of a tube or the bulbous por-
`tion of a tube into the nasal air passage. This cannulation
`of the nasal airway is unacceptable for long-term use,
`particularly during sleep, inasmuch as any contact of a
`foreign substance with the internal surface of the nose
`causes discomfort and nasal and lachrymal secretions.
`It would therefore be desirable to have a device that
`would contact the nostrils, also used interchangeably
`hereinafter with “nares”, and seal to withstand positive
`pressure, the device being selfretained and presenting
`aerodynamically contoured,
`low-resistance pathway
`for transmission of gases, thereby minimizing the fluctu-
`ations of pressure at the nares.
`SUMMARY OF THE INVENTION
`
`The purpose of the instant invention is to provide a
`nasal adaptor device and seal for delivering gases under
`pressure to the nasal airway. To accomplish this pur-
`pose,
`there is provided a device and seal as a part
`thereof having flange members to contact the nares of
`an individual to receive gases, the seal having a non-
`spherical surface which because of its surface configu-
`ration and port is complementary to the external nares
`of the individual and establishes a seal with no discom-
`fort.
`In one aspect of the invention there is provided a
`nasal adaptor device for delivering gases under pres-
`sures to the nasal airway comprising:
`an inlet means to receive gases to be delivered;
`manifold means connected to said inlet means to di-
`vide the flow of gases that may flow through said inlet
`means into said manifold means, said manifold means
`being aerodynamically contoured to provide a low-
`resistance pathway to direct and guide gases to be dis-
`tributed;
`_
`seal means connected to said manifold means, said
`seal means contacting the nares of an individual to re-
`ceive gases and being complementary to the nares of an
`
`2
`individual without cannulating such nares to provide a
`seal to such nares to withstand positive pressure of gases
`to be distributed; and
`retaining means operatively connected to said seal
`means to maintain contact between said seal means and
`the nares of an individual without undue discomfort to
`the individual.
`Another aspect of the invention is a nasal adaptor seal
`comprising a pair of flange members, each having a
`convex surface, each having a portal therethrough for
`supplying air to the nasal airways,
`the portals being
`positioned to correspond to the nasal openings; the axis
`of each portal being positioned in effective alignment
`with the aerodynamic air flow into and out of the nasal
`airways, said convex surfaces being complementary to
`the nares of an individual without cannulating such
`nares, the perimeter of said surfaces generally corre-
`sponding to a projection of the external meatus of the
`nares of an individual.
`Another aspect of the invention is a nasal adaptor seal
`comprising a pair of flexible flange members, each hav-
`ing a deformable surface, each having conduit means on
`the opposite side from said surface adapted for attach-
`ment
`to a gas manifold means, each having a portal
`therethrough for supplying air to the nasal airways, said
`flange member having a perimeter generally corre-
`sponding_to a projection of the external meatus of the
`nares of an individual, said surface of said flange mem-
`ber being conformable upon Contact with the nares of
`an individual whereby said surface is deformed into a
`convex shape complementary to the nares of an individ-
`ual without cannulating such nares and being so con-
`formable by application of such flange member against
`such nares with a force which does not cause undue
`discomfort to the individual. Preferably the conduit
`means between each flange and the gas manifold is
`flexible, thereby assisting in the flanges being positioned
`on and aligned with the nares.
`_
`In another aspect this invention provides a breathing
`device in combination with retaining means for holding
`the device in place on the face of an individual and
`adapted to fit around the head of the individual wherein
`the retaining means comprises a pair of flexible mem-
`bers, one end of each attached to a lower portion of the
`breathing device and the other end of each attached to
`an upper portion of the breathing device, the central
`portion each adapted to extend laterally from the
`breathing device, a third flexible member movably at-
`tached at one end to the central portion of the first
`flexible member and movably attached at the other end
`to the second flexible member and adapted for being
`placed around the back of the head of the individual,
`whereby the movable attachments allow adjustment of
`the position of the third member along the central por-
`tion of each of the first and second flexible members to
`thereby provide means for adjustment of the respective
`retaining forces on the upper portion and lower portion
`of the breathing device against the face of the individ-
`ual.
`
`DESCRIPTION OF THE DRAWING
`FIG. 1 is a perspective view of the nasal adaptor
`device secured to the head of an individual.
`FIG. 2 is a side view taken along line 2-2 in FIG. 1.
`FIG. 3 is a back view of the invention taken along
`line 3-3 in FIG. 2.
`
`4
`
`

`
`3
`FIG. 4 is a partial perspective view illustrating details
`of the seal of the nasal adapter device taken along line
`4-4 in FIG. 3.
`FIG. 5 is a cross-sectional view taken along section
`line 5-5 in FIG. 2, illustrating contact of the flange
`members of the seal of the instant invention in contact
`with the nasal passages of an individual, shown in phan-
`tom.
`FIG. 6 is a cross-sectional view similar to FIG. 5
`illustrating the telescoping capability of the flange
`members._
`FIG. 7 is a partial perspective and cross-sectional
`view taken along line 7—7 in FIG. 2.
`FIG. 8 is a view similar to FIG. 7 illustrating the
`rotatability of the flange members.
`FIG. 9A is a cross-sectional view of an illustration of
`an embodiment of a flexible flange member.
`FIG. 9B is a cross-sectional view similar to FIG. 9A
`positioned in contact with the nasal passage (shown in
`phantom) of an individual.
`DESCRIPTION OF PREFERRED EMBODIMENT
`
`15
`
`20
`
`The instant invention provides a device which can be
`used to supply room air or oxygen-enriched air to the
`external opening of the nasal airway under a constant 25
`pressure which exceeds that acting upon the surface of
`the body. This produces a pressure within the upper
`airway that is greater than ambient pressure acting upon
`the external surface of the neck and thereby distending
`or opening the pharyngeal airway. By this action, the 30
`positive pressure delivered to the nasal airway by the
`device can be used to open the pharyngeal airway of
`individuals with obstructive sleep apnea while they
`sleep. This approach is considered to be the best avail-
`able treatment of this disorder. Because of the seal pro-
`vided at the nares, the device also can be used to deliver
`cyclicly varied pressure to assist the breathing of pa-
`tients with impaired capacity for ventilation.
`The device of the instant invention provides a unique
`structure suitable for easy and quick fitting to an indi-
`vidual and capable of supplying positive pressure air,
`oxygen or a mixture thereof to'the nasal airway of the
`individual without discomfort to the individual. This
`structure comprises (a) seal means for complementarily
`contacting with and sealing to the nares of an individual
`without cannulating such nares, (b) manifold means for
`connecting the seal means to an inlet means, (c) inlet
`means adapted for supplying gases to the manifold
`means and for positioning above, substantially centered
`on and approximately parallel to the nose of the individ-
`ual, (d) support means connected to the upper portion
`of the inlet means and adapted to rest on the forehead of
`the individual, and (e) retaining means for retaining the
`device in position on the individual. The device of this
`invention having the above structure, as illustrated by
`the embodiments discussed herein, has a number of
`unexpected advantages over prior art devices. The indi-
`vidual wearing this device does not have claustropho-
`bic feelings, as are felt when wearing masks and other
`devices. The individual's vision is not impaired because
`the inlet means is positioned parallel to and centered on,
`but not touching, the bridge of the nose. Thus, the inlet
`means is between -the line of vision of the individual’s
`eyes and does not block the vision of either eye. This
`position of the inlet means also allows the individual to
`wear eyeglasses, which may be essential for reading or
`watching television. The feelings of comfort and free-
`dom afforded by the device of this invention are in part
`
`4,919,128
`
`4
`due to the fact that the device contacts the face of the
`individual only at the nose and the forehead, plus the
`retaining means. In contrast, masks and other prior art
`devices cover a significant portion of an individual‘s
`face. Since the device of this invention does not involve
`substantial facial Contact or coverage, it is effective on
`individuals with beards and mustaches, which fre-
`quently interfere with effective use of masks and prior
`art devices. Moreover, the device of this invention elim-
`inates much of the irritation suffered by individuals with
`skin conditions which masks tend to create or aggra-
`vate.
`~
`The device of this invention includes a seal means
`which seals to the external part of the nares without
`cannulating the nostril. This feature provides comfort
`for the individual because the seal means contacts only
`the tougher exterior skin of the nose at the meatus and
`not the sensitive internal mucous membranes of the
`nose. Thus, this device provides an effective positive
`pressure seal and provides improved comfort for the
`individual. The improved comfort is due to the fact that
`only a small area of skin is contacted by this device and
`because the nasal passages are not cannulated, com-
`pared, respectively, to the large areas of skin covered
`by masks and the prior art cannula devices.
`The instant invention creates a seal with the human
`nasal airway by applying a curved sealing flange mem-
`ber onto the external meatus of each nostril. The flange
`member which is complementary to the nares of the
`individual comprises a pair of flange members perfo-
`rated by a circular port. Such complementary flange
`member includes flange members which are conform-
`able to be complementary to the nares. The particularly
`unique flange member provided by this invention is
`characterized by the port opening being positioned
`inside the perimeter of a compound ellipsoid, the perim-
`eter being inscribed by the projection of each external
`nasal meatus onto a non-spherical, egg-shaped type
`surface. When these unique flanges are pulled cranially
`and dorsally, their surfaces seat in complementary fash-
`ion onto the external meatus of the nares without can-
`nulating the nares, thereby forming a seal capable of
`withstanding 30 to 40 cms of water nasal positive pres-
`sure without a leak. The device and seal (flange) of the
`.instant invention takes advantage of the elastic proper-
`ties of the nostrils distal to the nasal bones and of the
`relative constancy of size of the nasal septum and the
`shape of the external meatus to achieve a competent seal
`in a wide variety of individuals. As the flange members
`are pulled upward and backward, the orifice of each
`nostril is stretched, and forces are distributed evenly
`over the perimeter causing the nostril to expand and
`conform to the curved surface. The upward, medial and
`backward forces exerted on the surface of a flange
`member are countered by oppositely directed forces
`developed in the walls of the nostril causing the external
`orifice of the nares to be tightly applied to the surface of
`the flange member. The device also takes advantage of
`the relatively thin wall of each nasal airway. This thin
`wall means that a relatively small force in the wall of
`the nasal airway is transformed into a relatively large
`surface pressure where the external meatus is applied to
`the surface of the sealing flange. This relatively large
`pressure means that substantial intra-nasal pressures can
`be developed before the seal becomes incompetent. For
`a leak to occur, cavitation must occur between the
`nostril’s surface and the surface of the flange member.
`
`5
`
`

`
`4,919,128
`
`5
`A key feature of the device is that a seal is formed by
`contact of the surface of the flange member with the
`skin of the nostril. That is, the device does not touch the
`internal mucous membranes of the nose. This restricted
`contact is essential for at least two reasons: first, stimu-
`lation of pressure and touch receptors of the external
`skin is well tolerated, whereas pressure of an external
`object on the internal mucous membranes of the nose is
`noxious, painful and unpleasant, often eliciting second-
`ary reflexes, e.g., tearing and nasal hypersecretion; and
`second, the skin of the external nostril is highly durable,
`so that prolonged contact with a foreign substance
`under modest pressures causes no deterioration in the
`surface, whereas the mucous membrane breaks down
`and erodes under conditions of prolonged contact with
`foreign objects. Thus, the curved sealing flange of the
`instant invention can be used comfortably and repeat-
`edly for long periods. By contrast, a device which
`forms a seal between an external tube and the nasal
`airway by contacting the mucous membrane of the
`surface of the internal nasal air passage causes pain and
`degrades the surface of the air passage when used re-
`peatedly or for prolonged periods. Such mucous mem-
`brane contact also allows increased risk of infection.
`In the description of the present invention above and
`in the following particular embodiments, it will be rec-
`ognized that various configurations and embodiments
`can be constructed incorporating the nasal adaptor seals
`and the nasal adaptor devices of the present invention.
`In addition,
`it will be recognized that the seals and
`devices of this invention can be sized for adult, juvenile
`or infant use.
`With reference to the drawings, FIG. 1 illustrates the
`nasal adaptor device shown generally at 10 secured to
`the head of an individual. Device 10 includes an inlet
`means 12 to receive gases to be delivered, manifold
`means 14 connected to the inlet means 12 to divide the
`flow of gases that may flow through the inlet means,
`and seal means in the form of flange members 16. As
`will be later appreciated, the manifold means 14 is aero-
`dynamically contoured to provide a low-resistance
`pathway for gases to be distributed.
`Flange members 16 are preferably movably con-
`nected to the manifold means 14. As can be seen in
`FIGS. 1 and 2, the flange members 16 contact the nares
`18 of the individual and are complementary to the nares
`of the individual without cannulating the nares to pro-
`vide a seal that will withstand substantial positive pres-
`sure of gases to be distributed.
`The device of this invention can be used with conven-
`tional means for retaining it in proper position on the
`individual. However, FIG. 1 illustrates a preferred re-
`taining means which comprises a pair of straps 22 and 26
`operatively connected to the flange members 16 via the
`manifold means 14 and inlet means 12 via the forehead
`support strut 27 to maintain contact between the flange
`members and the individual without undue discomfort
`to the individual. The retaining means further comprises
`a strap 24 that can be placed ‘around the back of the
`head of the individual, usually above the ears of the
`individual, and is connected to said first strap 22-and the
`second strap 26 which are connected to manifold means
`14 and the upper portion of the inlet means 12, such as
`by support means 27. In this configuration, strap 24 can
`be adjusted up or down at attachment area 25 on straps
`22 and 26 in order to adjust the distribution of the reten-
`tion force on the forehead versus the nose of the indi-
`vidual. A preferred embodiment ofthis retaining means
`
`6
`comprises straps 22 and 26 having a small cross section
`which cover less surface area of the facial area and a
`wider strap 24 for the comfort on the back of the indi-
`vidual’s head.
`Inlet means 12 preferably comprises an air supply
`tube which is connected to the manifold means 14 at one
`end of the air supply tube and support strut 27 near the
`other end, which support strut has pad 28 adapted to
`contact the forehead of an individual. Support strut 27
`can preferably be adjustable in position along the upper
`length of inlet tube 12 to provide additional adjustment
`to fit the particular size and shape of the individual‘s
`head. It can be seen in FIG. 2 that the air supply tube is
`spaced from the bridge of the nose of an individual so as
`not to unduly impair vision of the individual and to
`allow eyeglasses to be worn when the device is in
`proper position on the individual’s head.
`For the typical adult application, the inlet tube of the
`inlet means 12 has a preferred internal diameter of 16
`mm and connects to manifold means 14 having an inter-
`nal diameter of 13 mm. Manifold means 14 terminates in
`the seal means. The seal means comprises a pair of
`flange members 16, each flange member 16 having a
`surface 33 which can be a spherical type surface, but
`preferably comprise the above described unique non-
`spherical “egg-shaped” type of surface. The curved
`surface of each flange member 16 has a portal through
`the curved surface, the portal having an axis 32, as can
`be seen in FIG. 3, corresponding generally to the axis of
`gas that may flow through the portal 30. The portals 30
`are preferably from about 10 mm to about 12 mm in
`diameter and are usually centered in the curved surface.
`The perimeter of curved surface 33 of the flange mem-
`bers 16 generally corresponds to a projection of the
`external meatus of the nares of an individual. The “egg-
`shaped" flange member has a longitudinal axis 34 taken
`along the long dimension of the egg shape. As seen in
`FIG. 4-, each portal 30 is preferably centered on axis 34.
`It should be noted that portal 30 may be centered in
`surface 33, but in some embodiments it is preferable that
`surface 33 extend further toward the center of the de-
`vice, i.e., more surface area toward the septum or the
`upper lip of the individual, with less surface area toward
`the outside or front of the device. While the centered
`configuration is generally acceptable, the asymmetrical
`configuration can provide for some individuals im-
`proved comfort and stability, can provide reduced mass
`or bulk, and provide preferred esthetics at the side areas
`of the nose. Additional surface at the rear portions of
`the flanges can provide particular comfort and/or sta-
`bility of the device on an individual because the rear
`portion of flange 16 rests on the upper lip of the individ-
`ual as shown at region 15 in FIG. 2.
`The flanges useful in this device may be a rigid, in-
`flexible material, and can be spherical in shape to pro-
`vide the desired seal which is complementary to the
`nares without cannulating the nares. In this case, the
`positive pressure seal is provided by the pliability of the
`nares themselves. However, in preferred embodiments,
`the flanges are made of a flexible material, such as a
`silicone rubber. The flanges should be sufficiently pliant
`to easily conform to the nares, but not so soft that the
`flange can collapse or cannulate the nose. In a preferred
`form, the flange materials provide some flexibility, but
`is firm enough to cause some conforming of the nares to
`the flange to provide the optimum and most comfort-
`able seal by the flange being complementary to the
`nares. In preferred embodiments the flange will also
`
`6
`
`

`
`30
`
`7
`have the unique “egg-shaped" surface provided by the
`flanges of this invention.
`FIG. 3 illustrates exhaust outlet means in the form of
`outlets 36 which are appropriately sized, e.g., 2.75 mm
`in diameter, and are positioned in each arm of the mani-
`fold means 14. The outlet means 36 can be positioned
`between the flange members 16 and inlet means 12 to
`minimize the distance between the exhaust outlet means
`36 and the flange members 16 to minimize the rebreath-
`ing of expired air. Outlets 36 are preferably directed
`away from patient’s face and body and may be posi-
`tioned close to the flange members 16 for aerodynamic
`efficiency. Conventional sizing and positioning of the
`exhaust ports, such as used in masks for similar applica-
`tions, can be used in the present invention. It has been
`found, however, that a conically tapered (exterior coun-
`tersunk) exhaust port, as shown at 36 in FIG. 2, pro-
`vides reduced noise and increased aerodynamic effi-
`ciency (lower resistance) and is preferred by some indi-
`viduals. Optionally, a single exhaust port, appropriately
`sized (e.g., 4 m), can be located in inlet tube 12, as
`shown at 36a in FIG. 2, instead of the two ports 36 as
`shown. A single exhaust port an inlet means 12 can have
`the advantage of having the exhaust flow more remote
`from the individual's face.
`A key aspect of an individual’s acceptance of nasal
`airway positive pressure is the absence of any sensation
`of an impediment to breathing caused by pressure fluc-
`tuations in the nose during breathing. The device of the
`instant invention is aerodynamically designed, i.e., the
`manifold means is designed to minimize fluctuations in
`the nares’ pressure during breathing. Three features of
`the device combine to keep these fluctuations less than
`1 cm of water, about half that previously observed in
`nose masks used for the same medical purpose. These
`features are: (1) low resistance of the conducting tubing,
`the diameter of the manifold means being selected to
`produce the same resistance as the inlet tube; (2) the
`exhaust outlet means being relatively large, allowing a
`high flow during expiration with little increase iii pres-
`sure; and (3) the bias flow is relatively large and is di-
`rected at the nostril’s orifice so that the kinetic energy
`of the stream of gas contributes significantly to the
`pressure at the portal. This high flow system does not
`preclude the use of supplemental oxygen, when needed.
`In fact,
`this device provides increased efficiency of
`oxygen use, because the oxygen can be injected into the
`manifold means 14 close to the flange members where it
`is not diluted by the bias flow. The best aerodynamic
`flow will be achieved using gentle sweeping curves to
`direct the flow of gas to the nasal passage along the axis
`32 of portal 30. For example, for optimum aerodynamic
`flow, the use of a Y junction at manifold 14 may be
`preferred over a T junction because of the decreased
`resistance. However, a T junction may be desired,
`where it provides sufficiently low resistance, because a
`T configuration also can provide convenient additional
`means of adjusting the device to fit various individuals.
`As shown in FIGS. 2 and 3, the individual left and right
`sides 35a and 35b of the manifold means 14 can be made
`rotatable about axis 37 in FIG. 3 and point 37a in FIG.
`2 where axis 37 and projected axis 32 intersect, thereby
`providing additional adaptability for fitting this device
`to various individuals.
`In FIG. 2 optional oxygen inlet means 38 are pro-
`vided so that an oxygen supply can be connected to the
`manifold in order to inject oxygen into the manifold
`means 14- close to the flange members 16. The oxygen
`
`4,919,128
`
`8
`inlet means is a valve type means which opens only
`when an oxygen supply is connected thereto. This ar-
`rangement in the device of this invention provides a
`very efficient means for supplying oxygen to an individ-
`ual.
`As seen in FIG. 3, the nasal adaptor device 10 has a
`longitudinal or vertical plane 40 which bisects the de-
`vice and corresponds to the vertical centerline of the
`device. It can be seen that axis 32 of each portal is posi-
`tioned at an angle A, which is preferably 30“, to the
`vertical centerline plane 40 of the device to provide
`optimum lit for conforming contact of the flanges to the
`nares and to provide a low resistance pathway for gases
`to be distributed through manifold 14 and portals 30.
`This relationship may also be described by saying that
`the portal axes 32 are non-parallel and are inclined
`toward each other at an angle of A of approximately 40°
`relative to a common vertical plane 40 that would inter-
`sect each portal axis 32. Angle A may be varied by
`about :l: 10“, but normally if varied from 30° will prefer-
`ably be more than 30°, such as about 35“ or about 40“.
`As seen in FIG. 2, there is also a relationship, angle B,
`between the portal axis 32 (projected to the side view
`plane) and the inlet tube longitudinal axis 42. This angle
`B will usually be between about 25° and about 30",
`normally about 28°. This angle is somewhat adjustable"
`depending upon the position of forehead support strut
`27 and the thickness of forehead pad 28 arrangement, as
`well as the distance the air supply tube 12 is to be posi-
`tioned above tip of the nose of the individual. Angle B
`can be adjusted to provide the desired position of inlet
`tube 12 above the nose of the individual while maintain-
`ing the desired position of portal axis 32 for smooth air
`flow into the nasal passages. As mentioned above, this
`adjustment can be by rotation about axis 37. This angle
`E can also be adjusted by changing the length X of the
`lower portion of inlet means 12, without changing the
`relationship of axis 32 of portal 30 to the nasal airway.
`Changes in length X of the lower portion of inlet means
`12 can be made, e.g., by telescoping means, to adjust the
`distance between inlet means~12 and the tip of the nose.
`Adjustment by rotation about axis 37 is convenient and
`preferred, to the extent that axis 32 of each portal re-
`mains sufficiently aligned with the nasal airways to
`maintain the desired aerodynamic air flow.
`It can be appreciated that in the present device the
`spacing of the inlet means 12 above the nose of the
`individual overcomes a number of disadvantages of
`prior art devices. With the present invention eyeglasses
`can be worn underneath the device because the inlet
`tube is positioned above the bridge of the nose and does
`not interfere with the wearing of eyeglasses. Likewise,
`inlet tube 12 is centered and positioned vertically above
`the bridge of the nose so that it does not unduly impair
`the vision of the individual. Consequently, the present
`invention essentially eliminates much of the feelings of
`claustrophobia associated with prior art mask-type de-
`vices and eliminates the discomforts associated with
`prior art cannula-type devices.
`It will also be appreciated that the device of the pres-
`ent invention overcomcs other disadvantages of prior
`art devices. For example, the present device provides an
`air-tight seal for positive pressure air flow on all individ-
`uals. The prior art mask-type devices do not provide a
`sufficient positive pressure seal on individuals with mus-
`taches, beards or atypical facial features. The present
`device provides a good seal on those individuals as well,
`because of the direct seal of surface 33 of flange member
`
`7
`
`

`
`4,919,128
`
`15
`
`25
`
`9
`16 to the nares of the individual. Other advantages will
`be apparent to those skilled in the art.
`FIGS. 5-8 illustrate the adjustability of the flange
`members 16. Since the 30° angle A of the portal axis 32
`and the position of the flange surface are somewhat
`critical, the distance between the flanges 16 can be made
`adjustable by telescoping each individual flange mem- I
`ber 16 with respect to manifold means 14. The flange
`members 16 telescope generally along portal axis 32 to
`adjust the distance 3 between the flanges 16, and, conse-
`quently, the distance between portals 30, in order to
`compensate for and accommodate the differences in
`shape and size of septum 19 in various individuals, and
`to accommodate individuals with a wide variety of nose
`configurations. In this way, the preferred 30" angle A
`shown in FIG. 3 is maintained while adjusting the dis-
`tance between the two flange members 16. The tele-
`scoping of the flange members 16 can be seen by a
`comparison of FIGS. 5 and 6.
`Another preferred aspect is illustrated in FIGS. 5 and
`6 in that flange members 16 and the stems 17 of flange
`members 16 may be of flexible material, e.g., silicone
`rubber, to provide additional comfort and ease of fit-
`ting. In such an embodiment, flange 16 and stem 17 flex
`to conform to the nose of the individual. If preferred,
`the telescoping and flexible flange 16 and flexible stem
`17 features may be combined for optimum fitting of
`individuals.
`FIGS. 7 and 8 illustrate rotation of the flange mem-
`bers 16 to further accommodate the wide variety of 30
`nose configurations in individuals. Depending on the
`shape of the nares of an individual and shape of the nasal
`openings, it may be desirable to rotate flange members
`16 about the portal axes 32 to.better fit the individual
`comfortably. FIG. 8 shows flange members 16 rotated
`to bring the small ends of the flanges, which are near the
`tip of the nose of the individual, closer together and the
`ends of the flanges near the face further apart. If de-
`sired, flange members 16 can be rotated in opposite
`directions for better comfort and seal on some individu-
`als.
`FI