[19]
`United States Patent
`4,944,310
`[11] Patent Number:
`Sullivan
`
`[45] Date of Patent:
`Jul. 31, 1990
`
`4,156,426 5/1979 Gold ...............................128/207.18
`‘ 4,249,527
`2/1981 Ko et al.
`128/204.18
`
`4,266,540
`5/1981 Panzik et al.
`.. 128/205.25
`FOREIGN PATENT DOCUMENTS
`
`701690
`
`1/1941 Fed. Rep. of
`Germany ........................ 128/207.13
`863412 4/1941 France .
`27599 of 1903 United Kingdom ........... 128/207.13
`483502 4/1938 United Kingdom ........... 128/207.12
`OTHER PUBLICATIONS
`
`The Lancet “Reversal of Obstructive Sleep Apnoe .
`”, Apr. 18, 1981, pp. 862, 863, 865.
`
`.
`
`.
`
`Primary Examiner—Max Hindenburg
`_
`Assistant Examz'ner—J_. P. Lacyk
`Attorney, Agent, or Firm—Ladas & Parry
`
`[57] ’
`
`ABSTRACT
`
`A device which may be used in the treatment of snoring
`sickness. An air blower supplies high volume air at
`slightly greater than atmospheric pressure to a flexible
`tube (2). Such air is communicated via tube (2) through
`nose piece (3), further through flexible tube (4) and a
`restrictive air outlet device (9). Communicating with
`nose piece (3) is a face mask (5) adapted to be sealingly
`attached to a patient’s nose and providing communica-
`tion between the patient’s nostrils and the interior of
`nose piece (3). By varying the restriction of device (9)
`the air pressure at the region of nose piece (3) and also
`the patient’s nostrils can be varied.
`
`12 Claims, 3 Drawing Sheets
`
`[54] DEVICE FOR TREATING SNORING
`SICKNESS
`’
`
`i [75]
`
`Inventor:
`
`Colin E. Sullivan, Birchgrove,
`Australia
`
`[73] Assignee:
`
`Somed Pty. Ltd., Australia
`
`[21] Appl. No.: 292,646
`
`[22] Filed:
`
`Dec. 29, 1988
`
`[63]
`
`Related U.S. Application Data
`Continuation of Ser. No. 941,542, Dec. 11, 1986, aban-
`doned, which is a continuation of Ser. No. 773,244,
`Sep. 3, 1985, abandoned, which is a continuation of
`Ser. No. 456,046, filed as PCT AU82/00063 on Apr.
`23, 1982, published as W082/03548 on Oct. 25, 1982,
`e1_>and°r3e.c!:.
`.
`._
`.
`.
`.,
`,
`.
`_
`Foreign Application Priority Data
`[30]
`Apr. 24, 1981 [AU] Australia .......................... PE8570
`
`
`
`A62B 18/02
`Int. Cl.5 .............................
`[51]
`[52] U.S. Cl. ............................... 128/848; 128/205.25;
`128/207.13; 128/207.18
`[58] Field of Search .............. 128/848, 207.12, 207.13,
`128/206.11, 207.18, 204.18, 204.21, 205.24,
`205.25, 204.75, 203.28, 205.11, 200.25
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`6/1927 McKesson ...................... 128/207. 1 3
`1,632,449
`6/1975 Baker ..........
`128/207.13
`3,889,671
`
`3,902,486 10/1975 Guichard
`128/206. 1 1
`4,151,843
`5/1979 Brekke ........................... 128/205.25
`
`
`
`RMD 1015
`
`1
`
`RMD 1015
`
`

`
`US. Patent
`
`Jul. 31, 1990
`
`Sheet 1 of 3
`
`4,944,310
`
`2
`
`

`
`U.S. Patent
`
`Jul. 31, 1990
`
`Sheet 2 of3
`
`4,944,310
`
`3
`
`

`
`US. Patent
`
`mAM
`
`Sheet 3 of 3
`
`4,944,310
`
`4
`
`

`
`1
`
`4,944,310
`
`S
`
`DEVICE FOR TREATING SNORING SICKNESS
`This is a continuation of co-pending application S;
`No. 06/941,542 filed on Dec. 11, 1986, now abandoned
`which is a continuation of Ser. No. 773,244, filed on
`Sept. 3, 1985 now abandoned which is a continuation of
`Ser. No. 456,046 filed as PCT AU82/00063 6:?A"15i7§,
`1 1982, published as W082/03543 on Oct. 25, 1982 now
`abandoned.
`I
`___A__V ___’
`The present invention relates to apparatus which may
`be used, among other things, for the treatment of Ob-Z
`structive Sleep Apnoea, more commonly called snoring
`sickness, which is characterized by occlusion of the
`upper air passage during sleep. It results from a combi- »
`nation of abnormally restricted upper air passages and
`the normal loss of muscle tone in the region of the
`tongue, soft palate and posterior oropharyngeal wall.
`The condition causes the affected patient to asphyxiate
`for periods typically of 30 to 120 seconds duration, 200 1
`to 300 times per night. It is a recognized cause of ‘‘unex- ‘
`pected” death. In less severe cases it often causes exces-
`sive daytime somnolence, heart disorder and brain dam-
`age. Some lung diseases are commonly found in associa-
`tion with “snoring” sickness.
`The syndrome is a common disorder, particularly in
`middle aged overweight males, although a person af-~
`fected may have no awareness of the problem.
`‘
`
`.
`
`.
`,
`BACKGROUND .1..’éRT.
`.
`.
`Prior art methods for overcoming the problem in-
`clude the use of neck collars, respiratory stimulants, loss
`of weight in cases of obesity and tracheostomys which
`are left open at night. Only the tracheostomy has been
`effective in overcoming the problem completely. How-
`ever in cases where immediate life-threatening compli-
`cations are not present, the decision as to whether this
`method should be used or not is obviously difficult.
`It is therefore an object of the present invention to
`provide apparatus which will ameliorate the foregoing
`disadvantages.
`
`_ DISCI_.,QSUR_E OF INVENTION
`_
`Accordingly, in one broad form, the invention may
`be said to consist in apparatus comprising: a length of
`tubing with at least substantial portions thereof being 45
`flexible, having an inlet end for introduction of air
`under pressure and an outlet end; a nose piece including
`a cavity shaped for the insertion of a patients nose
`therein and adapted to be releasably sealed to the pa-
`tients face in an airtight manner; at least one opening in
`an intermediate portion of said tubing forming air com-
`munication between said intermediate portion and said
`cavity; and means to effect resistance to air flow
`through said outlet end of said tubing to maintain air
`pressure in the region of said at least one opening at
`slightly greater than atmospheric air pressure when air
`is forced therethrough.
`BRIEF DESCRIPTION OF DRAWINGS
`By way of example only, one preferred form of the
`invention will now be described with reference to the
`accompanying drawings in which:
`FIG. 1 is a perspective view of a device according to
`the present invention, absent means for providing air
`under pressure, in place on a patient;
`FIG. 2 is a frontal view of the device of FIG. 1;
`FIG. 3 is a detailed view of a portion of the device of
`FIG. 1;
`
`65
`
`2
`FIG. 4 is a side view of the portion of a device similar
`to that of FIG. 3 without the nasal tubes; and
`FIG. 5 shows a number of graphs which compare a
`patients sleep with and without the assistance of the
`device of FIG. 1.
`
`BEST MODE OF CARRYING OUT THE
`INVENTION
`
`In FIG. 1 a head band 1, suitably padded, is adapted
`to fit around the patient’s head in a comfortable yet
`sufficiently firm manner to provide adequate anchorage
`for the attachment of the components described below.
`For this purpose commercially available head bands as
`used with safety hats have been found to be ideal.
`A plastic concertina type flexible tube 2 leads from an
`air blower, or pump means to one side of a rigid tubular
`nostril piece 3 defining a second chamber. Some small
`distance from nostril piece 3 flexible tube 2 is fastened to
`head band 1. Leading out of the opposite side of nostril
`piece 3 is another length of flexible tubing which forms
`the expiratory tube 4. Expiratory tube 4 is also fastened
`to head band 1 so that when the apparatus is placed on
`the patients head it is held firmly in place although it
`offers little discomfort to the wearer. Flexible tubes 2
`and 4 are adapted so that their ends may pass over the
`respective open ends of nostril piece 3. The flexible
`tubes are sealingly secured thereto by light weight elec-
`trical type clamping bands. These bands may also be
`used to so secure flexible tubes 2 and 4 to head band 1.
`A mouldable nose mask 5 is attached to, or formed as
`part of, nostril piece 3. Nose mask 5 is shaped so as to fit
`over most noses and includes a cavity 7 for this purpose.
`Communicating between cavity 7 and the interior of
`nostril piece 3 are two openings 6 which are substan-
`tially aligned respectively with a patients nostrils when
`nose mask 5 is in place. Optional soft nasal tubes 8 can
`be inserted into openings 6, or formed as part of nostril
`piece 3, and are adapted to enter the patient’s nostrils in
`certain difficult cases.
`The air supply in the preferred form consists of a high
`volume air pump similar to a vacuum cleaner running in
`reverse. For this purpose Hitachi (Registered Trade
`Mark) vortex blower model VBOOIS has been found to
`be ideal. The pump may be placed in a sound deadening
`box.
`A variable restriction device 9 in expiratory tube 4 is
`incorporated in its end. This restriction allows the air
`pressure at the nostril piece 3 to be adjusted to suit the
`particular patient using the apparatus. A typical relative
`pressure for a patient may be 6 cm H20 although a
`range from 4 to 15 cms I-I20 would cover most if not all
`individuals. The exact location of restriction device 9 is
`not critical although substantial noise reduction is ob-
`tained if it is some distance from the final opening 10.
`In use a seal is produced from surgical grade silicon,
`such as Dow Corning Silastic 382 (Registered Trade
`Mark), rubber by forming it around the inside of cavity
`7 and placing the apparatus in its working position on
`the patient. The seal and apparatus do not extend down
`over the mouth. This allows breathing through the
`month while the patient is awake even if the apparatus
`is in place but not supplying air. This is an important
`safety aspect.
`While in operation the apparatus provides a normal
`air mixture to the nostrils of the patient at an adjustable
`pressure that is slightly above atmospheric pressure.
`The pressure is initially set at a low level and while the
`patient is asleep it is gradually increased until occlusions
`
`5
`
`

`
`3
`no longer occur. This set pressure should then be ade-
`quate for the patient in the future. Although approx. 4
`liters of air per second is delivered by the pump much of
`this leaves the apparatus, via the end restriction, having
`never been breathed by the patient. The patient inhales
`normally, the excess pressure merely overcoming the
`abnormal resistance of the upper air passages and pre-
`venting their inward collapse.
`FIG. 5 shows a part of a polygraph trace taken from
`a patient with severe sleep apnea, before and during the
`application of continuous positive airway pressure
`(CPAP) via a device of the present invention, in rapid-
`eye-movement sleep. In the left hand panel (without
`CPAP), periods of total absence of airflow at the nose
`are apparent in the nasal pressure trace for up to 45
`seconds at a time, despite vigorous movements of rib-
`cage and abdominal wall. Arterial haemoglobin oxygen
`saturation falls with each apnea as low as 55%. Each
`apnea is terminated by arousal from sleep, indicated by
`bursts of electromyogram activity and movement arti-
`fact on electroencephalogram. A few rapid deep
`breaths follow. Note low voltage, fast electroencepha-
`logram, minimal electromyogram activity, and abun-
`dant rapid-eye-movements between arousals. In the
`right hand panel 9 cm H20 CPAP via the nosemask
`completely prevents obstruction, continuous airflow is
`evidenced on the pressure tracing, arterial oxygen satu-
`ration remains normal, and stable uninterrupted sleep is
`permitted.
`While using the above described device exhaling may
`be slightly affected by the apparatus, and a raised mean
`lung volume may result, but at the disclosed pressures
`no danger would exist or adverse side effects be nor-
`mally encountered.
`The present invention has been described in connec-
`tion with the treatment of obstructive sleep apnea.
`Other uses of the apparatus of the invention will be
`obvious to those skilled in the art and include:
`treatment of severe snoring; assistance of breathing
`during sleep in patients with lung disease;
`in intensive care, post-operative and anaesthetic
`wards to provide continuous positive airway pres-
`sure; and
`with a conventional respirator to provide assisted
`positive pressure ventilation in patients with cen-
`tral sleep apnoea (patients who stop breathing dur-
`ing sleep), or sleep hypo-ventilation (patients who
`don’t breath enough during sleep).
`The above described apparatus is merely one example
`of an embodiment of the present invention. Various
`modifications can be made without departing from the
`scope of the present invention. For example flexible
`tubes 2 and 4, nostril piece 3 and nose mask 5 might be
`moulded in one piece from plastics material.
`I claim:
`1. Apparatus for maintaining continuous positive
`airway pressure, said apparatus comprising a nose piece
`shaped to fit over the nose of a user and defining a first
`chamber; a large bore inlet tube entering into a second
`chamber attached to said nose piece and in fluid com-
`munication with said first chamber only via at least one
`orifice interconnecting said chambers, said second
`chamber having a large bore exit to the atmosphere
`including continually open resistance means to provide
`a resistance to the flow of gases through said exit and
`being located adjacent to said exit; and means to releas-
`ably seal said nose piece against the facial skin of said
`user adjacent to said nose to effect a pressure tight seal
`of said first chamber; said inlet tube connected to a high
`
`30
`
`35
`
`4,944,310
`
`4
`volume supply of air to cause a high volume of air to
`flow through said inlet tube, into said second chamber
`and out said resistance means, said resistance means
`causing the pressure within said second chamber to be
`elevated above, and maintained above, atmospheric
`pressure, said at least one orifice transiriitting said ele-
`vated pressure to said first chamber, and the flow of air
`passing between said second chamber and said first
`chamber through said orifice being substantially equal
`to the air inhaled and exhaled by said user via the nose.
`2. Apparatus as claimed in claim 1 wherein said resis-
`tance means is located at a location spaced from said
`second chamber.
`3. Apparatus as claimed in claim 1 wherein said exit
`opens into a length oflarge bore tube separate from said
`inlet tube.
`4. Apparatus as claimed in claim 1 wherein said resis-
`tance means comprises an aperture of reduced size rela-
`tive to said large bore exit.
`5. Apparatus as claimed in claim 1 wherein said resis-
`tance means is variable and said inlet, second chamber
`and exit are dimensioned to receive a high volume flow
`of approximately 4 liters per second.
`6. Apparatus as claimed in claim 1 wherein said resis-
`tance means is dimensioned to raise the pressure within
`said first and second chambers to a pressure above at-
`mospheric pressure within the range of from 4 centime-
`ters to 15 centimeters water gauge.
`7. Apparatus as claimed in claim 1 wherein said at
`least one orifice is located in said first chamber at a
`location opposite the nostrils of said nose.
`8. Apparatus as claimed in claim 7 wherein said at
`least one orifice comprises a pair of orifices.
`9. Apparatus as claimed in claim 1 wherein said sec-
`ond chamber is substantially cylindrical having an inter-
`nal diameter substantially equal to the bore of said inlet
`tube.
`10. Apparatus as claimed in claim 1 wherein said inlet
`tube and exit are located at opposite sides of said second
`chamber.
`11. Apparatus as claimed in claim 1 wherein it pump
`means is connected to the large bore inlet tube and
`supplies a high volume of air.
`12. Apparatus for maintaining continuous positive
`airway pressure, said apparatus comprising a nose piece
`shaped to fit over the nose of a user and defining a first
`chamber; a large bore inlet tube entering into a second
`chamber attached to said nose piece and in fluid com-
`munication with said first chamber only via at least one
`orifice interconnecting said chambers, said second
`chamber having a large bore exit to the atmosphere
`including continually over resistance means to provide
`a resistance to the flow of gases through said exit and
`being located adjacent to said exit; and means to releas-
`ably seal said nose piece against the facial skin of said
`user adjacent to said nose to effect a pressure tight seal
`of said first chamber; a pump connected to said inlet
`tube to supply a high volume of air flow through said
`inlet tube, into said second chamber, and out of said
`second chamber and to atmosphere by way of said resis-
`tance means, said resistance means causing the pressure
`within said second chamber to be elevated above, and
`maintained above, atmospheric pressure, said at least
`one orifice transmitting said elevated pressure to said
`first chamber, and the flow of air passing between said
`second chamber and said first chamber through said
`orifice being substantially equal to the air inhaled and
`exhaled by said user via the nose.
`0'
`#1
`It
`It
`3
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`6