United States Patent
`
`[191
`
`[11] Patent Number:
`4,782,832
`Trimble et al.
`[45] Date of Patent:
`Nov. 8, 1988
`
`
`[75]
`
`[73] Assignee:
`
`[54] NASA]; PUFF WIT]-I ADJUSTABLE SEALING
`NIEANS
`Inventors: Russell L. Trimble, Overland Park,
`Kans.; Roger J. Dolida, Kingwood,
`Tex-9 F"°d°’i°“ R° Rm‘ Philip M‘
`Metzlef» 13°11‘ °f 0"e’1a“d Park’
`Kans.
`Puritan-Bennett Corporation,
`Lenexav K3“
`[21] APPL N0-5 799331
`Jul. 30, 1987
`[22] Filed:
`
`Int. CL4 ....;........................................
`[5
`U.S. Cl. .........................................
`[58] Field of Search ...................... 128/207.18, 204.18,
`128/207.13
`
`[56]
`
`References Cited
`us. mm vocwms
`7,476 7/1850 Lane .
`.
`855,439
`5/1907 Clark .............................. 128/207.18
`1,109,313
`9/1914 Browne 6131- -
`1.162.416 11/1915 Teter -
`1v532s449 6/1927 M°K°55°“ -
`2,016,212 5/1934 O’Connell
`.
`2,122,897 7/1938 Straw .
`2,185,997
`1/1940 Heidbrink ...................... 128/207.18
`2,241,535
`5/1941 Boothby et al.
`.
`2,245,969
`6/1941 Francisco ....................... 128/207.18
`2,259,817 10/1941 Hawkins ......................... 128/207.18
`2,300,273 10/1942 Connell
`.
`13752971 5/1945 K151‘ -
`2»4°3»135 9/1945 F°x -
`313571428 12/1957 C‘“'1S°“ '
`3'362’4°4
`1/1968 Beasley '
`3,503,543 4/1970 Aulicono ................... 123/207.13 x
`1]:i;3iI:a1'
`'
`6/1975 Baker _
`3,889,671
`3/1978 Elem _
`4,07-M04
`5/1979 Brekke et a1_ _
`4,151,843
`4,210,174 7/1930 E1-oss ,
`4,249,527
`2/1931 K0 et a1.
`4,255,540
`5/1931 panzik ,
`4,334,533
`5/1932 Henkin _
`4,354,488 10/1982 Bartos .
`4,367,735
`1/1983 Dali ................................ 128/207.18
`FOREIGN PATENT DOCUMENTS
`
`_
`
`.
`W082/03548 10/1982 PCT Int’l App].
`.
`W084/02080 6/1984 PCT Int’l Appl.
`»W086/06638 11/1936 PC,T1m’1,API=1- -
`315:: Eggggm ‘
`1/1962 Urtilited Kingdoirg '
`888546
`2l47506A 5/1985 United Kingdom :
`OTHER PUBLICATIONS
`Martin, R. J. et al., “Acute and Long-Term Ventilatory
`Effects of Hyperoxia in the Adult Sleep Apnea Syn-
`amine", Am. Rev. Respir. Dis. 1982; 125:175—13o.
`Rapapol-1;’ D_ M_ et al” “Reversal of the ‘Pickwickian
`Syndrome’ by Long_Term Use of Nocturnal N353-
`1-Airway Pressure”, The New England Journal ofMean’.
`cine, Medical Intelligence, vol. 307, No. 15, Oct. 7, 1982,
`pp. 931-933.
`3:351:53:‘*;,:,,*;;*,:‘;“;‘2;,°‘si:r:1,?,,‘:°S%:;;‘:,::;
`During Sleep with Nasal Continuous Positive Airway
`Pressure”, Am, Rev, Respir_ Dis, 1983:128:177—181,
`Sullivan, C. E. et al., “Reversal of Obstructive Sleep
`Apnea by Continuous Positive Airway Pressure Ap-
`plied Through the Nares”, The Lancet, pp. 862-865,
`Apr_ 18’ 1981_
`Primary Examiner—Alan Cohan
`Attorney, Agent, or Firm—Hovey, Williams, Timmons &
`Collins
`-
`ABSTRACT
`[57]
`An improved nasal puff assembly is provided which is
`of particular benefit in the treatment of obstructive
`sleep apnea and which is characterized by a gas-deliv-
`ery puff which fits only in the nose of the patient and is
`therefore of relatively small size end een be eemfenebly
`worn. The nasal puff of the invention advantageously
`includes a plenum chlamber havingfan flillet meld a_ pair of
`laterally spaced out ets, a pair 0 so
`synt etic resin
`nares elements or pillows are operatively coupled with
`the spaced plenum outlets and are designed for ready
`adjustability so that the effective positions thereof can
`be altered individually for permitting custom fitting of
`the nares elements with respect to the nares of different
`patients. In this way a relatively small number of differ-
`ent sizes of nasal puff can be modified to meet the ‘needs
`of virtually all patients.
`
`223220 2/1909 Fed. Rep. of Germany .
`
`12 Claims, 4 Drawing Sheets
`
`
`
`FPH EX. 2002
`
`ResMed v. Fisher & Paykel
`|PR2016-01718
`
`-1-
`
`FPH EX. 2002
`ResMed v. Fisher & Paykel
`IPR2016-01718
`
`

`
`U.S. Patent
`
`N0v.8, 1988
`
`Sheet 1 of 4
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`4,782,832
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`U.S. Patent
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`N0v.8,1988
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`Sheet 3 of4
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`U.S. Patent
`
`Nov.8,1988
`
`Sheet 4 of4
`
`4,782,832
`
`-5-
`
`

`
`1
`
`4,782,832
`
`2
`tory therapy device in the form of a nasal puff of rela-
`tively small size adapted to be worn adjacent the nose of
`a wearer-patient. The nasal device advantageously in-
`cludes a relatively small plenum chamber including
`structure defining an inlet adapted for coupling with a
`source of gas, and a pair of spaced apart, separate gas
`outlets in communication with the inlet. Typically, the
`plenum chamber is advantageously in the form of a
`generally Y-shaped in plan hollow body, with the gas
`outlets being located in the branches of the body. In any
`event, the preferred nasal puff of the invention further
`includes a pair of gas delivery elements each having a
`gas flow passageway therethrough and respectively
`operatively coupled with a corresponding gas outlet for
`conveying gas from the outlet through and out the
`passageway. Each of the gas delivery elements is con-
`figured for insertion into a respective naris of a patient,
`and for this purpose the outer wall of the elements are
`generally frustoconical in shape so as to sealingly en-
`gage the naris-defming surfaces of the nose.
`Finally, it is very desirable to provide means for se-
`lective alteration of the effective position of each of the
`gas delivery elements individually. This in turn permits
`custom fitting of the elements with respect to the nares
`of different patients, so that a single type or size of nasal
`device can comfortably fit a wide variety of users.
`In order to permit alteration of the effective position
`of the nares elements, the elements may be rotatably
`mounted to the plenum housing, and moreover may be
`mounted in appropriate slots permitting selective lateral
`positioning of the elements with respect to each other.
`Furthermore, flexible bellows-type corrugated sections
`can be provided in each of the elements and/or in ap-
`propriate positions in the plenum housing, so as to add
`further ranges of flexibility and adjustability. In order to
`permit a wide range of angular adjustment of the re-
`spective elements, angle shims may be interposed be-
`tween the bases of the elements and the housing,
`whereby the elements may be rotated for adjustment
`purposes. Finally, the elements may be fabricated from
`relatively soft, deformable, shape-retaining synthetic
`resin material permitting manual deformation and alter-
`ation of the effective shape and position of the elements.
`By virtue of the relatively small size of the nasal puff
`device of the invention, it can be comfortably worn by
`a patient requiring gas therapy. For this purpose a spe-
`cialized harness is provided to be worn over the head of
`the patient which serves to maintain the nasal mask in its
`operative position.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a side elevational view of a nasal puff and
`harness in accordance with the invention, shown opera-
`tively mounted on a patient;
`FIG. 2 is a side view of one embodiment of a nasal
`
`puff in accordance with the invention, illustrating the
`plenum housing and nares elements;
`FIG. 3 is a sectional view taken along line 3-——3 of
`FIG. 4;
`FIG. 4 is a plan view illustrating the structure de-
`picted in FIGS. 2 and 3, with certain altered positions of
`the respective nares elements being illustrated in phan-
`tom;
`FIG. 5 is a perspective view illustrating another em-
`bodiment of the invention;
`
`NASAL PUFF WITH ADJUSTABLE SEALING
`MEANS
`
`-5
`
`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`The present
`invention is broadly concerned with
`nasal puff devices particularly designed to be comfort-
`able for the wearer and to thereby facilitate treatment of
`breathing disorders such as sleep apnea, ventilation 10
`difficulties or anesthetic gas administration (e.g., nitrous
`oxide). More particularly, it is concerned with such a
`nasal puff device which preferably includes a plenum
`chamber adapted to be coupled to a source of gas such
`as oxygen or air, together with a pair of gas delivery 15
`elements coupled with the plenum chamber and config- V
`ured for insertion into the nares of a patient; very ad-
`vantageously,
`the nares elements include means for
`selective alteration of the effective position thereof
`individually, for permitting custom fitting of the ele- 20
`ments with respect to the nares of different patients.
`2. Description of the Prior Art
`In recent years, the condition of obstructive sleep
`apnea has been recognized as a serious one requiring
`therapeutic intervention. Those suffering from obstruc- 25
`tive sleep apnea (most commonly obese males or obese
`females after menopause) may experience as many as six
`hundred apneaic events per night, each of which may
`last on the order of ten seconds or more. In each of
`these occurrences, there is essentially no air movement 30
`for a significant period and the patient is technically
`suffocating. As a consequence, the oxygen level in the
`blood drops, thereby inducing a high level of conscious-
`ness in the sufferer who then rouses and begins to
`breathe normally again. However,
`repeated occur- 35
`rences of these apneaic events causes a definite lack of
`restful sleep and, by virtue of depleted oxygen levels in
`the blood, can lead to heart problems as well.
`It has been proposed in the past to treat sleep apnea
`by means of continuous positive airway pressure
`(CPAP). This system involves applying a constant gas
`pressure, typically with air, through the nasal passages
`of the patient, so as to prevent negative pressure condi-
`tions within the thorax and to allow air to continuous
`flow through the upper air passageways. CPAP therapy
`has been in use for the last several years, and it is esti-
`mated that approximately five thousand patients are
`now being treated using this technique. Generally
`speaking, CPAP treatment involves placing a mask
`over the nose of the patient by means of a harness or
`other form of headgear, and coupling the mask to a
`source of positive, low pressure air. However, conven-
`tional masks used in this context are relatively cumber-
`some and noisy due to air leaks. Indeed, the problems
`associated with wearing a conventional mask during 55
`periods of attempted sleep are so formidable that many
`patients forego the therapy for this reason alone.
`There is therefore a decided need in the art for a
`respiratory-assist device which can be comfortably
`worn by a patient during relatively long periods of rest 60
`and sleep, without the attendant problems of noise,
`discomfort or improper fit. Such a device would be
`useful not only in connection with sleep apnea therapy,
`but also in other types of respiratory therapy as well.
`SUMMARY OF THE INVENTION
`
`40
`
`45
`
`50
`
`65
`
`The present invention overcomes the problems de-
`scribed above, and provides a greatly improved respira-
`
`-5-
`
`-6-
`
`

`
`3
`FIG. 6 is a plan view similar to that of FIG. 4 and
`depicting in phantom certain adjusted positions of the
`nares elements;
`FIG. 7 is an exploded view of one of the nares ele-
`ments of the embodiments of FIGS. 5 and 6, showing
`the structure of the nares pillow and the underlying
`angled shim;
`FIG. 8 is a perspective view of a spacer element
`forming a part of each nares element assembly of the
`embodiment of FIGS. 5 and 6;
`FIG. 9 is a sectional view taken along line 9--9 of
`FIG. 6 and illustrating the internal construction of the
`embodiments of FIGS. 5 and 6;
`FIG. 10 is a plan view partially in section and with
`phantom lines illustrating different positions of the nares 15
`elements of a third embodiment in accordance with the
`invention;
`FIG. 11 is a sectional view taken along line 11-11 of
`FIG. 10 and with parts broken away for clarity which
`further illustrates the construction of the embodiment of 20
`FIG. 10;
`FIG. 12 is a fragmentary view similar to that of FIG.
`10, but illustrating a shifted orientation of one of the legs
`of the plenum housing;
`FIG. 13 is an end view of the embodiment depicted in 25
`FIGS. 10-12 with the lefthand nares element shown in
`
`10
`
`bold lines and in phantom to illustrate the range of
`shiftable movement thereof;
`FIG. 14 is an end View from the end of the device
`opposite that of FIG. 13 and further illustrating in phan-
`tom one of the legs of the plenum housing being rotated
`to different positions;
`FIG. 15 is a perspective view of another embodiment
`in accordance with the invention making use of hollow,
`deformable nares elements;
`FIG. 16 is an exploded sectional view taken along
`line 16-16 of FIG. 15 to further depict the internal
`construction of the nasal mask;
`FIG. 17 is a vertical sectional view of another em-
`bodiment in accordance with the invention which is
`similar to the embodiments of FIGS. 15-16, but in-
`cludes tilled nares elements having a central gas pas-
`sageway therethrough; and
`FIG. 18 is a vertical sectional view of a still further
`embodiment in accordance with the invention wherein
`the nares elements include synthetic resin filled, inflat-
`able members.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`30
`
`35
`
`45
`
`50
`
`55
`
`Turning now to the drawings, a nasal puff assembly
`20 is illustrated in FIG. 1 which broadly includes a nasal
`puff 22 adapted to be worn adjacent the nose of a pa-
`tient, together with a harness assembly 24 adapted to be
`worn over the head of a patient 26. As is readily appar-
`ent from a study of FIG. 1, the harness assembly is
`designed to operatively hold puff 22 adjacent and par-
`tially within the nose of the patient 26.
`Referring now to FIGS. 2-4, it will be seen that the
`puff 22 is in the form of a generally Y-shaped rigid 60
`hollow plenum chamber 28 together with a pair of
`laterally spaced apart nares elements 30. The chamber
`28 includes an angularly oriented tubular inlet 32 cou-
`pled and communicating with a pair of laterally diverg-
`ing outlet legs 34. Each outlet leg 34 is provided with an
`outlet opening in the form of a slot 36 which is generally
`aligned with the longitudinal axis of the corresponding
`leg 34. Further, each leg 34 includes an outwardly ex-
`
`65
`
`4,782,832
`
`4
`tending connection clip 38 (shown fragmentarily in
`FIGS. 2 and 4) permitting connection of the mask to
`harness assembly 24 as will be described. As best seen in
`FIG. 3, the chamber'28 is in effect a hollow body with
`the passageway defined by inlet 32 being in direct com-
`munication with the hollow outlet legs 34, and with the
`respective outlet slots 36.
`Each of the elements 30 is of integral construction
`and includes a somewhat frustoconical but slightly ar-
`cuate hollow outermost section 40 leading to and cou-
`pled with a bellows-type corrugated section 42. As best
`seen in FIG. 3, the section 42 presents at least a pair (and
`preferably a greater number) of axially spaced, circum-
`scribing, outboard peripheral wall segments 43 together
`with inboard, circumscribing wall segments 43a dis-
`posed between and located radially inward of each
`adjacent pair of outboard wall segments 43. Further-
`more, a pair of wall stretches 43b and 43c interconnect
`each inboard wall segments 430 with both of the as-
`soicated outboard wall segments 43. These stretches 43b
`and 43c extend generally transverse to the longitudinal
`axis of the associated gas delivery element, as will be
`readily apparent from a review of FIG. 3. Finally, a
`tubular connector section 44 having a radially expanded
`innermost flange 46 is provided to afford a connection
`between the element and corresponding outlet leg 34. In
`particular, and referring specifically to FIG. 3, it will be
`observed that the element 30 is mounted to an associ-
`ated leg 34 with the tubular connection section 44 being
`received within the slot 36 and with flange 46 serving to
`sealingly maintain the element in covering relationship
`to the slot 36.
`
`From the foregoing description of the structure of
`puff 22, it will be readily appreciated that the unit can be
`easily altered to fit a variety of patients. Thus, the ele-
`ments 30 can be rotated as illustrated in phantom in
`FIG. 4 and moreover can be shifted laterally within the
`outlet slots 36 as depicted in the lefthand leg of FIG. 4.
`Finally, it will be appreciated that the corrugated sec-
`tions 42 permit the elements to be manually deformed so
`as to assume the most advantageous angular position for
`a particular patient. Exemplary element positions mak-
`ing use of this feature are shown in phantom in FIG. 3.
`Attention is next directed to FIGS. 5-9 which illus-
`trate another nasal puff 48 in accordance with the in-
`vention. In this instance, the mask includes a somewhat
`Y-shaped in plan hollow plenum chamber 50 having a
`tubular inlet 52 and a pair of hollow diverging outlet
`legs 54, each of the latter having an outlet recess 56
`therein.
`
`In the case of puff 48, each of the nasal elements is in
`the form of an assembly including a hollow rotatable
`body 58, hollow angle shim 60 and finally hollow frus-
`toconical naris pillow 62. In particular, the body 58 (see
`FIG. 8) is formed of rigid synthetic resin material and
`includes a gas inlet 64 and an offset gas outlet 66. Each
`body 58 _is designed to fit within the associated outlet
`recess 56, and for this purpose the recess 56 includes a
`specially configured lower shelf 68 having an opening
`70 therethrough. As illustrated in FIGS. 8 and 9, the
`lowermost end of each body 58 is in the form of a tubu-
`lar extension having a radially expanded connection rim
`72 permitting an axially rotatable retention of the body
`within opening 70.
`The angle shim 60 includes an upstanding tubular
`wall 74 which terminates in an angularly disposed, radi-
`ally enlarged flange portion 76. The central opening
`defined by the shim 60 is coaxially aligned with outlet
`
`-7-
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`

`
`4,782,832
`
`5
`opening 66 of the body 58. A rotatable connection is
`provided between the shim 60 and the upper tubular
`portion of body 58 defining opening 66, by means of a
`recess 78 provided in the internal face of wall 74 receiv-
`ing the upper tubular portion of the body 58.
`Finally, a naris pillow 62 is secured to flange portion
`76 by adhesion or any convenient means. As in the
`above described embodiment, the pillow 62 is formed of
`soft synthetic resin material so as to comfortably fit
`within a naris of a patient. For example, the pillow may 10
`be formed of open or closed cell foam (skinned or un-
`skinned), gel filled skinned materials, or the silicones. Of
`course, the material in actual contact with the patient’s
`skin should be biocompatible. The general shape of the
`pillow 62 is frustoconical in cross section, with a slight 15
`arc in the sidewall thereof. As is evident from a study of
`FIGS. 5-9, each pillow 62 has a central air passageway
`80 therethrough.
`In the use of puff 48, the respective pillows 62 can be
`shifted through the expedient of rotation of the underly- 20
`ing angle shims 60, and in this manner a wide angular
`orientation of the individual pillows can be achieved.
`Further, the individual pivotal bodies 58 can be rotated
`as desired to provide a further range of positions for the
`nares elements. Thus, FIG. 6 illustrates the righthand
`nares element in two possible positions thereof, effected
`through use of the adjustable components of the ele-
`ment as described.
`
`5
`
`25
`
`6
`seen in FIG. 16, the elements 108 are essentially inte-
`grally formed with the forward face 110 of chamber
`106, but by virtue of the soft, deformable synthetic resin
`material used to fabricate the elements 108, they can be
`readily deformed by the user to give a comfortable fit.
`As in the case of the other embodiments described pre-
`-viously, chamber 106 includes an inlet 112 which com-
`municates with the outlet openings 114 in the respective
`nares elements.
`'
`FIG. 17 illustrates an embodiment 104a in accor-
`dance with the invention. In this embodiment a plenum
`chamber 1060 is provided in the form of a hollow body
`leading to a pair of laterally spaced apart openings 115.
`The chamber 106a includes an inlet 112a, and in this
`embodiment it will be seen that an air delivery hose 116
`is coupled with inlet 112a. Nares elements 108a form a
`part of mask 104a and are similar in most respects to the
`hollow elements 108 previously described. In this in-
`stance though, an inner fill 118 is provided of gel or
`other soft deformable material, with the inner fill defin-
`ing a central air passageway 120 communicating with
`the outlet openings 114a. Here again, alteration of the
`effective position of the nares elements 108a in the em-
`bodiment of FIG. 17 is effected by manual deformation
`of these elements as required.
`Attention is next directed to FIG. 18 which depicts a
`final embodiment 104b. In this embodiment a plenum
`chamber 106b is provided in the form of a hollow body
`leading to a pair of laterally spaced apart, upwardly and
`obliquely extending tubular sections 115’. The chamber
`106b includes an inlet 112b with an air delivery hose
`1l6b coupled with the inlet 112b. In this embodiment
`nares elements 108b are each in the form of hollow,
`somewhat egg-shaped, soft, expandable synthetic resin
`outer membranes 109b which surround the respective
`tubular sections 115’. A quantity of synthetic resin foam
`fill l18b is received within each membrane 109b in sur-
`rounding relationship to the corresponding inner tubu-
`lar section 115'. In addition, an elongated, relatively
`thin, tubular inflation/deflation tube 119 is operatively
`coupled to the interior of each of the foam-filled inner
`spaces defined by the membranes 109b and associated
`tubular sections 115’. The outer end of each tube 119
`(not shown) is provided with a fitting permitting appli-
`cation of air via a syringe or other expedient into the
`tube, and alternately pulling of a vacuum therethrough.
`In the use of the embodiment of FIG. 18, a vacuum may
`be drawn through each of the respective tubes 119 in
`order to constrict the nares elements 108b to a relatively
`small size. At this point the nares elements can be in-
`serted into the nasal passages of a patient whereupon
`positive pressure air is fed through the tubes 119 in
`order to inflate the membranes 109b into a comfortable
`comforming relationship to the nares passages of the
`patient. Application of medicinal gas can then proceed
`in the usual fashion. In this connection, the nasal puff
`assembly of this embodiment is in some respects similar
`to the structure described in U.S. Pat. No. 3,640,282,
`which is incorporated by reference herein.
`The preferred harness assembly 24 (see FIG. 1) of the
`invention is adapted to be worn on the head of patient
`26 and includes a main harness strap 122 and a cross
`strap 124. A pair of flexible mask-retaining straps 126
`are respectively secured to main strap 122 as shown,
`and extend to a point for connection with the clips 38
`provided on sides of the nasal puff (such clips have not
`been fully depicted on all of the embodiments de-
`scribed, but it will be understood that these clips or their
`
`30
`
`45
`
`FIGS. 10-14 ‘Illustrate another nasal puff 82. In this
`instance the mask 82 is provided with a hollow bifur-
`cated plenum chamber 84 and a pair of nares elements
`86 respectively coupled with the legs of chamber 84. In
`more detail, it will be observed that the chamber 84
`includes a tubular inlet 88 which is obliquely oriented as
`best seen in FIG. 11 together with a pair of separate 35
`tubular outlet legs 90 extending from and being in com-
`munication with inlet 88. Each of the legs 90 includes a
`tubular connection portion 92 together with a laterally
`extending terminus provided with an elongated outlet
`slot 94 therein. A bellows-type corrugated section 96 40
`serves to interconnect each connection portion 92 and
`the associated laterally extending leg section, so as to
`provide a means of altering the position of each outlet
`leg with respect to the other.
`The elements 86 are in the form of elongated, out-
`wardly projecting members terminating in hollow, frus-
`toconical, soft synthetic resin nares pillows 98. Connec-
`tion between the pillows 98 and the associated legs 90 is
`afforded by means of a flexible, corrugated, bellows-
`type connection shank 100 which is slotted and presents
`an innermost connection flange 102. The flange 102
`serves to rotatably mount each element 86 within a slot
`94, with the overall size of the shank 100 serving to seal
`the slot regardless of the position of the element. Fur-
`ther, the bellows shanks 100 also provide degrees of 55
`additional adjustability.
`In the case of mask 82, the effective position of the
`elements 86 can be altered by rotation of the elements
`and/or deformation of the bellows shanks 100; shifting
`thereof within their associated slots 94; and/or deforma-
`tion of the legs 90 with respect to the connection por-
`tions 92 through use of the corrugated sections 96. Vari-
`ous possible positions of the nares elements achieved
`through one or more of the aforementioned features are
`illustrated in phantom in FIGS. 10 and 12-14.
`FIGS. 15 and 16 illustrate a simplified nasal puff 104
`including a Y-shaped hollow plenum chamber 106 and a
`pair of soft, deformable hollow nares elements 108. As
`
`50
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`65
`
`-8-
`
`

`
`4,782,832
`
`7
`equivalent, e.g., Velcro strips, are generally provided in
`order to maintain the nasal masks in place).
`In addition, the harness assembly 24 includes an elon-
`gated gas-conveying tube 128 which is adapted for
`coupling with the inlet of the nasal puff and extends
`upwardly along the length of the bridge of the patient’s
`nose and across the patient’s forehead, terminating at
`the top of the patient’s head as at 130. It will be ob-
`served in this respect that the tube 128 is longitudinally
`bifurcated by means of an elongated, central wall 131
`serving to divide the overall tube 128 and present a pair
`of elongated, juxtaposed passageways 131a and 131b.
`The upper end of the tube 128 is provided with a Y-
`shaped fitting leading to a pair of elongated tubes 132a,
`132b. One of the tubes 132a leads to a source of pressur-
`ized air (not shown), whereas tube 132b is an exhaust or
`discharge tube. Use of such a dual or bifurcated tube
`arrangement provides a means for purging patient-
`generated CO2 during exhalation.
`It will thus be seen that the present invention pro-
`vides a greatly improved nasal puff assembly which can
`be comfortably worn during a period of sleep by pa-
`tients suffering from obstructive sleep apnea. Use of
`nares elements of the type described permits an effec-
`tive sealing engagement between the elements and the
`defining surfaces of the patient’s nares, so as to permit
`appropriate gas therapy without undue leakage. At the
`same time, the adjustability of the elements means that
`only a relatively small number of sizes of masks need be
`manufactured and stocked, inasmuch -as a given mask
`may be modified to fit a variety of patients. Also, since
`the sealing surfaces around a patient’s nares are smaller
`than the area around the entire nose, less force is re-
`quired with the nasal puffs of the invention to achieve a
`sealing fit than in the case of conventional nose masks
`which seal around the nose. Thus, the mounting straps
`need not be pulled as tightly with the puff devices
`hereof, giving a more comfortable fit to the patient.
`It will also be appreciated that while the present
`invention has been described chiefly in connection with
`the treatment of sleep apnea, the improved nasal puff
`assemblies hereof may also be used for other gas thera-
`pies.
`We claim:
`
`1. A nasal puff, comprising:
`a plenum chamber including structure defining an
`inlet adapted for coupling with a source of gas, and
`a pair of separate, spaced apart gas outlets in com-
`munication with said inlet; and
`a pair of elongated gas delivery elements each having
`a structure defining gas flow passageway there-
`through and respectively operatively coupled with
`a corresponding gas outlet for conveying gas from
`the outlet through and out said passageway,
`said elements each being configured to present an end
`portion for insertion into a respective naris of a
`patient to receive said gas,
`there being means for selective alteration of the effec-
`tive position of each of said elements individually
`for permitting custom fitting of said elements with
`respect to the nares of different patients,
`said gas delivery element alteration means including,
`for each element, an elongated bellows-type corru-
`gated section forming a part of said passageway-
`defining structure and located between the corre-
`sponding end portion and said plenum chamber,
`each of said corrugated sections including at least a
`pair of axially spaced apart outboard peripheral
`
`8
`wall segments, an inboard wall segment disposed
`between and located radially inward of the out-
`board wall segments, and a pair of wall stretches
`interconnecting said inboard wall segment and
`both of said outboard segments, said wall stretches
`extending generally transverse to the longitudinal
`axis of the associated gas delivery element.
`2. The nasal puff of claim 1, said plenum chamber
`being a generally Y-shaped hollow body, with said
`outlets being located in the branches of said body.
`3. The nasal puff of claim 2, said body being substan-
`tially rigid.
`4. The nasal puff of claim 1, each of said end portions
`of said elements presenting an elongated, generally
`frustoconical outer wall for sealingly engaging the de-
`fining surfaces of a patient’s naris.
`5. The nasal puff of claim 1, each of said outlets com-
`prising an elongated slot, each corresponding element
`including a tubular member received by and slidable
`within the associated slot, whereby each of said ele-
`ments may be bodily shifted to effect an alteration in the
`effective position thereof.
`6. The nasal puff of claim 1, each of said elements
`being rotatable relative to said chamber.
`7. The nasal puff of claim 6, including an angle shim
`interposed between each of said elements and the corre-
`sponding housing outlet.
`8. The nasal puff of claim 1, each of said elements
`being formed of a deformable, shape-retaining soft syn-
`thetic resin material permitting manual alteration of the
`effective shape and effective position of each of said
`elements.
`
`9. The nasal puff of claim 1, said inlet comprising an
`elongated tubular section adapted for connection to a
`flexible hose coupled with said gas source.
`10. The nasal puff of claim 1, including means for
`securing said mask in its operative disposition adjacent
`a patient’s nose with said element end portions inserted
`into the nares of a patient.
`11. A nasal puff, comprising:
`a plenum chamber including structure defining an
`inlet adapted for coupling with a source of gas, and
`a pair of separate, spaced apart gas outlets in com-
`munication with said inlet; and
`a pair of gas delivery elements each having a gas flow
`passageway therethrough and respectively opera-
`tively coupled with a corresponding gas outlet for
`conveying gas from the outlet through and out said
`passageway,
`said elements each being configured for insertion into
`a respective naris of a patient to receive said gas,
`there being means for selective alteration of the effec-
`tive position of each of said elements individually
`for permitting custom fitting of said elements with
`respect to the nares of different patients,
`each of said outlets comprising an elongated slot,
`each corresponding element including a tubular
`member received by and slidable within the associ-
`ated slot, whereby each of said elements may be
`bodily shifted to effect an alteration in the effective
`position thereof.
`12. A nasal puff, comprising:
`a plenum chamber including structure defining an
`inlet adapted for coupling with a source of gas, and
`a pair of separate, spaced apart gas outlets in com-
`munication with said inlet; and
`a pair of gas delivery elements each having a gas flow
`passageway therethrough and respectively opera-
`
`5
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`l0
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`15
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`20
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`25
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`30
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`35
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`40
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`45
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`50
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`55
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`65
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`10
`for permitting custom fitting of said elements with
`respect to the nares of different patients,
`each of said elements being rotatable relative to said
`chamber,
`there being an angle shim interposed
`between each of said elements and the correspond-
`ing housing outlet.
`*
`
`*
`
`*
`
`*
`
`*
`
`'
`
`4,782,832
`
`‘
`
`9
`tively coupled with a corresponding gas outlet for
`conveying gas from the outlet through and out said
`passageway,
`said elements each being configured for insertion into
`a respective naris of a patient to receive said gas,
`there being means for selective alteration of the effec-
`tive position of each of said elements individually
`
`5
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`10
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`15
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`20
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`25
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`30
`
`35
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`40
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`45
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`50
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`55
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`60
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`65
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