(12) United States Patent
`WOOd
`
`USOO6478O26B1
`(10) Patent No.:
`US 6,478,026 B1
`(45) Date of Patent:
`Nov. 12, 2002
`
`(54) NASAL VENTILATION INTERFACE
`
`(76) Inventor: Thomas J. Wood, 1909 Tebeau St.,
`Waycross, GA (US) 31501
`
`c:
`- - -
`(*) Notice: Spy stylists
`U.S.C. 154(b) by 0 days.
`
`4,493,614 A 1/1985 Chu et al. ..................... 417/22
`4,549.542 A 10/1985 Chien .................... 128/201.24
`4,587,967 A 5/1986 Chu et al. .
`... 128/204.21
`4,601.465 A 7/1986 Roy ............................ 272/99
`4,617,637 A 10/1986 Chu et al. ................... 364/505
`4,699,139 A * 10/1987 Marshall et al. ....... 128/207.18
`4,706,664 A 11/1987 Snook et al. .......... 128/204.23
`4.753.233 A 6/1988 Grimes .................. 128/2O7.18
`2 - -2
`f
`eS
`f
`(List continued on next page.)
`(21) Appl. No.: 09/524,371
`FOREIGN PATENT DOCUMENTS
`(22) Filed:
`Mar. 13, 2000
`DL146688
`2/1981
`............ 128/207.18
`DE
`O
`O
`O532214
`1/1941
`GB
`Related U.S. Application Data
`WO-90/01963
`WO
`* 3/1990 ............ 128/207.18
`(60) Provisional application No. 60/124.323, filed on Mar. 13,
`1999.
`Primary Examiner John G. Weiss
`ASSistant Examiner Teena Mitchell
`(51) Int. Cl." ............................................... A61M 15/08
`(52) U.S. Cl. .............................. 20.207 (74) Attorney, Agent, or Firm-Richard C. Litman
`(58) Field of Search ....................... 128/207.18, 207.13,
`(57)
`ABSTRACT
`128/207. 12, 203.29, 204.12, 204.26, 205.27,
`-
`205.29, 206.11, 206.15, 206.18; 600/529, A nasal ventilation interface comprising a hollow body
`538 532
`having at least one and preferably two nasal apertures, and
`s
`at least one and preferably two inhale apertures, and at least
`one and preferably two nasal insert tubes each associated
`References Cited
`with one of the nasal apertures and having an annular sleeve
`that forms a seal with a nostril of the patient. The hollow
`U.S. PATENT DOCUMENTS
`body has at least one and preferably two exhale apertures
`1,125,542 A * 1/1915 Humphries ............ 128/207.18
`and at least one valve assembly associated with the exhale
`3.670.726 A 6/1972 Mahon et al. .............. 128/188
`apertures that is capable of preventing air from passing
`3.739,774. A
`6/1973 Gregory. ... 128/142.7
`through the exhale aperture upon the patient inhaling and
`3,861,385 A
`1/1975 Carden ......
`... 128/145.8
`allowing air to pass through the exhale aperture upon
`3.902.486 A 9/1975 Guichard ......
`... 128/140 N
`exhaling. The hollow body may also have at least one and
`3,905,361 A 9/1975 Hewson et al. .......... 128/145.5
`preferably two filters for retaining heat and moisture from
`4,106,505 A * 8/1978 Salter et al. ........... 128/207.18
`the exhale air and transferring the retained heat and moisture
`3.25 A
`E.
`son, Jr. et al. .... .6.
`4,367,735 A
`1/1983 Dali ...
`"... into the inhale air.
`4,406.283 A 9/1983 Bir ........................ 128/207.18
`4,422,456 A * 12/1983 Tiep ...................... 128/207.18
`10 Claims, 8 Drawing Sheets
`
`(56)
`
`2--1-2
`
`SOIl . . . . . . . . . . . . . . . . . . . . . . . . .
`
`
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`
`200
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`216
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`

`US 6,478,026 B1
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`4,774,946 A 10/1988 Ackerman et al. ..... 128/207.18
`4.793,343 A 12/1988 Cummins, Jr. et al. . 128/204.17
`4,840,169 A 6/1989 Folsom ...................... 128/863
`4,850,346 A 7/1989 Michel et al.
`... 128/2O6.15
`4,899,740 A 2/1990 Napolitano ............ 128/202.22
`4.915,105 A * 4/1990 Lee ..............
`... 128/205.27
`4.967,742 A 11/1990 Theodorou ............. 128/202.13
`5,000,173 A 3/1991 Zalkin et al. .......... 128/204.21
`5,011,474 A 4/1991 Brennan ...................... 604/54
`5,022,900 A 6/1991 Bar-Yona et al.
`... 55/316
`5,025,805 A * 6/1991 Nutter ..........
`128/207.18
`5,038,772 A
`8/1991 Kobe et al.
`128/205.41
`5,074,297 A 12/1991 Venegas ................ 128/204.18
`5,113,857 A * 5/1992 Dickerman et al. .... 128/207.18
`5,121,745 A 6/1992 Israel .................... 128/202.28
`5,127,397 A
`7/1992 Kohnke ..
`... 128/2O2.28
`5,137,017 A * 8/1992 Salter ........
`... 128/207.18
`D333,015 S
`2/1993 Farmer et al. ................. D29/8
`5,188,101 A 2/1993 Tumolo .....
`... 128/207.18
`5,265,592 A 11/1993 Beaussant .............. 128/201.24
`
`5,265,595 A 11/1993 Rudolph ................ 128/204.18
`5,271,391. A 12/1993 Graves .................. 128/207.18
`5,299.599 A
`4/1994 Farmer et al. ......... 137/625.22
`5,335,656 A * 8/1994 Bowe et al. ........... 128/207.18
`5,372,130 A 12/1994 Stern et al. ............ 128/205.25
`5,375,593 A 12/1994 Press .............
`... 128/207.18
`5,385,141 A 1/1995 Granatiero ........
`... 128/201.19
`5,394,568 A 3/1995 Brostrom et al. .............. 2/452
`5,396,885 A 3/1995 Nelson .................. 128/204.18
`5,398,676 A 3/1995 Press et al. ............ 128/204.23
`5,400,776 A * 3/1995 Bartholomew ......... 128/200.24
`5,425,359 A
`6/1995 Liou ..................... 128/206.11
`5,437.267 A * 8/1995 Weinstein et al. ..... 128/200.23
`5,509,409 A * 4/1996 Weatherholt ........... 128/207.18
`5,526.806 A 6/1996 Sansoni .........
`... 128/207.18
`5,533,506 A 7/1996 Wood .................... 128/207.18
`5,682,881 A * 11/1997 Winthrop et al. ...... 128/207.18
`5,740,799 A * 4/1998 Nielsen ................. 128/207.18
`5,794,619 A * 8/1998 Edelman et al. ....... 128/207.18
`5,906.203 A * 5/1999 Klockseth et al. ..... 128/205.24
`* cited by examiner
`
`
`
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`U.S. Patent
`US. Patent
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`Nov. 12, 2002
`Nov. 12, 2002
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`Sheet 1 of 8
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`U.S. Patent
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`Nov. 12, 2002
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`US 6,478,026 B1
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`U.S. Patent
`US. Patent
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`Nov. 12, 2002
`Nov. 12, 2002
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`50
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`46 (‘
`46
`G
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`44 H
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`50
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`50
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`48
`43
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`so
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`46
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`r
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`U.S. Patent
`US. Patent
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`Nov. 12, 2002
`Nov. 12, 2002
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`Sheet 4 of 8
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`U.S. Patent
`US. Patent
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`Nov. 12, 2002
`Nov. 12, 2002
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`Sheet 5 of 8
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`U.S. Patent
`US. Patent
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`Nov. 12, 2002
`Nov. 12, 2002
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`Sheet 6 of 8
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`U.S. Patent
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`Nov. 12, 2002
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`Sheet 7 of 8
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`U.S. Patent
`US. Patent
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`Nov. 12, 2002
`Nov. 12, 2002
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`Sheet 8 of 8
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`1
`NASAL VENTILATION INTERFACE
`
`This application claims priority from provisional appli
`cation Ser. No. 60/124,323, filed Mar. 13, 1999.
`
`FIELD OF THE INVENTION
`The present invention relates generally to nasal ventila
`tion Systems, and more particularly, to a valved nasal ven
`tilation interface for Supporting respiration.
`
`BRIEF DESCRIPTION OF THE PRIOR ART
`Nasal ventilators generally consist of tubes and other
`means for delivering gases adapted for use with the nasal or
`oral passage of a patient. Typically, a nasal ventilation
`System comprises a gas Source and a mechanical ventilator
`Such as a continuous positive airway pressure System
`(CPAP), bi-level positive airway pressure system (BIPAP),
`or intermittent (non-continuous) positive pressure (IPPB).
`The gas is often room air or oxygen-enriched air, but can be
`a mixture of other gases.
`The gas is transported by a thin flexible tube made of an
`inert material. The tube terminates in an opening which can
`be inserted into the patient's nostrils. Typically, a pair of
`smaller nasal insert tubes protrude from the tube or the tube
`Splits at a Y-junction into two Smaller tubes, cach Smaller
`nasal insert tube carrying gas to one nostril, thereby increas
`ing the fraction of inspired oxygen.
`Conventional nasal tube Systems do not provide a positive
`Seal between the nasal insert tubes and the nostrils. Most
`nasal ventilation Systems therefore include a mask that fits
`over the nose and is intended to provide a Space of oxygen
`enriched air for inhalation into the lungs for respiration.
`Such Systems frequently Suffer from air leaking out around
`the mask, creating an inability to assure ventilation in many
`patients.
`For example, conventional nasal ventilation Systems use
`head gear and/or Straps to bind the mask in place, but in
`order to minimize the leakage of the air the Straps must be
`Sufficiently tight. The mask, headgear, and/or Straps thereby
`exert more than a minor pressure on the patient's face and/or
`head, resulting in Such masks and headgear tending to be
`rather constraining and uncomfortable.
`Additionally, most Systems are usually very position
`dependent, whereby if the mask is moved slightly with
`respect to the facial contour or with respect to the nose, air
`leakage occurs. With Such Systems, the mask can become
`uncomfortable when not in position, thus requiring the
`patient to remain rather Still in order to alleviate the dis
`comfort and to maintain oxygen inspiration. As a result
`many patients lose interest in using the nasal mask.
`Also, Some ventilation Systems have exhalation valves for
`the treatment of breathing problems. Various valve Systems
`have been devised but they all function similarly. Typically,
`the exhalation valve is positioned at the ventilator or in the
`tubing at least a foot or more from the patient, and the air that
`is exhaled by the user is trapped in this “dead Space”
`between the patient and the valve. Such ventilation systems
`with exhale valves are typically bulky and heavy. The
`patient thus has to have a tidal volume (breath) that is a little
`larger than otherwise needed to compensate for the dead
`Space. This larger tidal Volume is noticeable by the patient
`and can be a nuisance while trying to Sleep Soundly.
`Related types of nasal tube systems include low flow
`oxygen Systems which merely provide oxygen concentra
`tion. These Systems typically provide nasal insert tubes that
`
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`are loosely inserted into the nasal cavities without a mask.
`Such Systems are low pressure Systems for providing oxygen
`enrichment to the ambient air that the patient breathes, are
`not ventilators (do not provide positive pressure for forced
`ventilation/breathing), and could not function as ventilation
`Systems because of the lack of a Seal between the cannula
`interface and the patient, the Smaller tubing size, and the low
`preSSure of the System.
`Additionally, there are no known portable, wearable
`devices that completely filter out the allergens that trigger
`allergic reactions in asthmatics and allergy Sufferers. There
`are only aeroSol treatments and other medications that treat
`the Symptoms, that is, the allergic reactions themselves.
`Furthermore, when a patient presents to an emergency room
`with Severe bronchial constriction in response to allergens,
`a bronchodilator is typically administered to dilate the
`tracheal airways and bronchioles So that gas exchange is
`maintained in the alveoli of the lungs. However, if bronchial
`dilation is Successful then allergens are also allowed to be
`breathed deeper into the bronchioles. Bronchiole constric
`tion is a bodily reaction to keep any further allergens from
`reaching the Smaller airways. Forced dilation and deeper
`penetration of allergens often results in an even more violent
`reaction after the bronchodilator has lost Some of its thera
`peutic effect. This worsened reaction Sometimes becomes
`life-threatening and can cause death, in particular, to a
`patient with Status asthmaticus.
`Furthermore, present cloth Surgical masks typically worn
`by doctors, Surgeons, and other medical perSonnel do not
`filter out many pathogens. Also, they are hot to the wearer
`and can obstruct the wearer's view, especially when looking
`down during a Surgical procedure. Dentists are concerned
`with spray and do not trust the presently available Surgical
`maskS.
`Accordingly, what is needed but not found in the prior art
`is a nasal interface apparatus that can be used with a positive
`preSSure ventilation System for Supporting respiration, that
`directs substantially all the air delivered to the nasal inter
`face into the patient's lungs, that is comfortable and uncon
`Straining to the patient wearer.
`SUMMARY OF THE INVENTION
`Generally described, the present invention provides a
`nasal ventilation interface comprising a hollow body having
`at least one and preferably two nasal apertures, at least one
`and preferably two inhale apertures, at least one and pref
`erably two connectors each capable of being removably
`attached to at least one of preferably two interface tubes, and
`at least one and preferably two nasal insert tubes each
`asSociated with one of the nasal apertures of the body and
`capable of being inserted into a nostril of a patient. Each
`nasal insert tube has an annular sleeve with a contact Surface
`and a diameter that is greater than a diameter of the nasal
`insert tube So that each annular sleeve contact Surface is
`thereby capable of forming a seal with the nostril. The nasal
`insert tube may be detachably coupled to the hollow body.
`There may also be provided a three-way junction capable of
`being removably connected to a feed tube.
`The hollow body may have at least one exhale aperture
`and at least one valve assembly associated with the exhale
`aperture that is capable of preventing air from passing
`through the exhale aperture upon the patient inhaling and
`allowing air to pass through the exhale aperture upon
`exhaling. The hollow body may also have at least one filter
`that retains heat and/or moisture from air passing there
`through upon inhalation and that transfers the heat and/or
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`3
`moisture to the exhalation air that Subsequently passes
`therethrough upon exhalation.
`In a first embodiment of the present invention, each valve
`assembly comprises a valve member pivotally attached to a
`first inner wall of the and a second valve member pivotally
`attached to a Second inner wall of the body opposite the first
`inner wall. The first and second valve members overlap and
`abut each other So that each valve member may pivot in
`response to the other valve pivoting. In a Second embodi
`ment of the present invention, each Valve assembly com
`prises a one-way inhale valve membrane arranged in the
`body between the nasal aperture and the exhale aperture or
`disposed within the inhale aperture, and a one-way exhale
`Valve membrane disposed within the exhale aperture. In a
`third embodiment of the present invention, the body is
`provided for use without the gas Supply, mechanical
`ventilator, or tubing, Valving may or may not be provided,
`and a filter is provided for Screening out dust, allergens,
`pollen, bacteria, Viruses, pathogens, and other air-borne
`particle matter, So that the invention may be used as a
`portable nasal filtration device.
`Accordingly, it is an object of the present invention to
`provide a positive pressure closed System providing for full
`ventilation of a patient with oxygen enrichment capabilities
`typically provided by low pressure oxygen concentrator and
`cannula tubing Systems.
`It is another object of the present invention to provide a
`nasal ventilation interface having improved patient comfort
`for use over extended periods.
`It is a further object of the present invention to provide a
`nasal ventilation interface having increased gas delivery
`efficiency and with minimal or no leakage of gas from the
`nostrils.
`It is still another object of the present invention to provide
`a nasal ventilation interface having automatic Valving for
`inhaling and exhaling.
`It is yet another object of the present invention to provide
`a nasal ventilation interface with a valve assembly that
`decreases the amount of deadspace that is rebreathed by the
`patient.
`It is yet a further object of the present invention to provide
`a nasal ventilation interface that filters the air that is inhaled
`and/or exhaled for heat, moisture, allergens, pollen, bacteria,
`Viruses, pathogens, and other air-borne particle matter.
`These and other objects, features, and advantages of the
`present invention are discussed or apparent in the following
`detailed description of the invention, in conjunction with the
`accompanying drawings and the appended claims.
`
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`FIG. 7 is a side elevation view of the embodiment of FIG.
`1;
`FIG. 8 is a side elevation view of the first valve member
`of the embodiment of FIG. 1 in a first position;
`FIG. 9 is a side elevation view of an alternative first valve
`member of the embodiment of FIG. 1;
`FIG. 10 is a side elevation view of the first valve member
`of the embodiment of FIG. 1 in a second position;
`FIG. 11 is a side elevation view of the first valve member
`of the embodiment of FIG. 1 with a filter;
`FIG. 12 is a side elevation view of the first valve member
`of the embodiment of FIG. 1 with a filter;
`FIG. 13 is a side elevation view of a second embodiment
`of the present invention during the inspiratory cycle;
`FIG. 14 is a side elevation view of the second embodi
`ment of FIG. 13 during the expiratory cycle;
`FIG. 15 is a side elevation view of a third embodiment of
`the present invention;
`FIG. 16 is a side elevation view of a first alternative third
`embodiment of the present invention;
`FIG. 17 is a side elevation view of a second alternative
`third embodiment of the present invention during the
`inspiratory cycle; and
`FIG. 18 is a side elevation view of the second alternative
`third embodiment of FIG. 17 during the expiratory cycle.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`Referring now to FIG. 1, there is illustrated a first embodi
`ment 10 of the present nasal interface invention as typically
`worn by a patient 12. The interface 10 may be connected by
`feed tubing 14 and a feed valve 16 to a mechanical ventilator
`18 and a gas supply 20. The feed tubing 14 may be a thin
`flexible tube made of an inert material Such as polyurethane,
`Silicone, or another material known in the art. It will be
`noted that all components of the interface 10 may be made
`of medical grade biocompatible materials.
`The mechanical ventilator 18 forces a gas Such as air
`through the tubing 14. The mechanical ventilator 18 may be
`provided by a continuous positive airway pressure (CPAP)
`machine for constant air pressure delivered through the
`interface 10 to the patient 12. Alternatively, the mechanical
`ventilator 18 may be provided by a bilateral positive airway
`pressure (BIPAP) machine for intermittent air pressure
`delivered through the interface 10 to the patient 12, whereby
`the pressure is lower during exhale than during inhale to
`facilitate breathing by the patient 12. Other mechanical
`ventilators known by those skilled in the art may be suitable,
`such as IPPB mechanical ventilators. A power source and
`controls (not shown) are provided for operating the
`mechanical ventilator 18.
`The gas Supply 20 may be a tank of oxygen or another gas
`as may be appropriate in a given situation. The oxygen may
`be mixed with air to form oxygen-enriched air, with the
`oxygen concentration controlled by the valve 16. It will be
`understood that other gases or mists can be provided as may
`be desired in a given application.
`Referring now to FIGS. 1 and 2, there may be provided
`two lengths of interface tube 22 each having a first end 24
`and a Second end 26, a three-way tubing junction 28 with
`two connectors 30 each capable of being removably attached
`to one of the first ends 24 of the tube 22, and a hollow body
`32 with two tubing connectors 34 each capable of being
`removably attached to one of the second ends of the tube 22.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`The various features and advantages of the invention will
`be apparent from the attached drawings, in which like
`reference characters designate the same or similar parts
`throughout the figures, and in which:
`FIG. 1 is a side elevation view of a first preferred
`embodiment of the present invention in use by a patient;
`FIG. 2 is a plan view of the embodiment of FIG. 1;
`FIG. 3 is a side elevation view of the hollow body of the
`embodiment of FIG. 1;
`FIG. 4 is a top plan view of FIG. 3.;
`FIG. 5 is a side elevation view of the nasal insert tube of
`the embodiment of FIG. 1;
`FIG. 6 is a front elevation view of the nasal insert tube of
`the embodiment of FIG. 1;
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`The three-way tubing junction 28 may be provided by a “Y”
`junction, a “T” junction, or another junction as is known in
`the art, with the connectors 30 of a type known in the art for
`connecting tubing.
`The tube 22 may be a thin flexible tube made of an inert
`material Such as polyurethane, Silicone, or another material
`known in the art. The tubes 22 may be of a smaller size than
`tube 14 where two tubes 22 carry the same volume of gas as
`the one tube 14. The feed tube 22 size is selected to provide
`a sufficient air volume flow therethrough for full ventilation
`of the patient 12. For example, the size of the feed tube 22
`may be Selected to accommodate about 120 liters per minute
`of air therethrough. On the other hand, typical low pressure
`oxygen cannula tubing is sized to accommodate about 5
`liters per minute.
`Referring now to FIGS. 3 and 4, the hollow body 32 has
`at least one and preferably two nasal apertures 36 defined
`therein, at least one and preferably two inhale apertures 38
`defined therein, at least one and preferably two connectors
`40 associated with each inhale aperture 38 and capable of
`being removably attached to Said Second ends of Said
`interface tubing 22, and at least one exhale aperture 42
`defined the rein. The body 32 may be made of a
`polycarbonate, plastic, polymer, metal, ceramic, composite,
`or other material known in the art. The body 32 may have a
`generally cylindrical, rectangular, or other regular or irregu
`lar shape. The connectors 30 are of a type known in the art
`for connecting tubing.
`Referring now to FIGS. 5 and 6, there is provided at least
`one and preferably two nasal insert tubes 44 each capable of
`being inserted into a nostril of the patient 12. Each nasal
`insert tube 44 has at least one annular sleeve 46 with a
`surface 50 formed thereon for forming a gentle but firm seal
`with the inner wall of one of the patient's nostrils. The
`annular sleeves 46 may be made of a soft pliable material for
`patient comfort Such as a Silicone elastomer or another
`material known in the art for providing a Surface for forming
`the gentle but firm seal between the sleeve 46 and the
`patient's skin. The annular sleeves 46 preferably have a
`generally oval shape for conforming to the shape of the
`patient's nostrils to form the Seal as described herein,
`however, other regular or irregular shapes may be provided.
`In order to secure the interface 10 in place without the
`need for headgear and/or Straps, a force is generated by the
`sleeves 46 on the inner walls of the each nostril. This is
`accomplished by providing each sleeve 46 with a diameter
`that is greater than a diameter of the corresponding nasal
`insert tube 44. The contact surface 50 thereby provides a
`Surface area Sufficient to spread the required Securement
`force over sufficiently large area of the inner walls of the
`nostrils for improved patient comfort. Additionally, the lobes
`of most patient's nostrils are generally angled, and each
`annular sleeve 46 may have an angled end 48 conforming
`thereto for allowing the annular sleeves 46 to be inserted into
`the patient's nostrils no more than is necessary to form the
`Seal.
`Each nasal insert tube 44 may be detachably coupled to
`the hollow body 32 so that the interface may be reused by
`merely changing out the sleeves 44 for each new use. This
`may be beneficial in certain applications, for example, for
`hospital or other uses. Where the interface is provided with
`detachable nasal insert tubes 44, the body may be provided
`with at least one and preferably two hollow members 52
`extending from the body 32 (see FIGS. 3 and 4), each hollow
`member capable of detachably receiving one of the nasal
`insert tubes 44. The hollow members 52 may have a shape
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`that is frusto-conical which provides a Smooth transition of
`airflow from the body 32 into the nasal insert tubes 44.
`Alternatively, the hollow members may have a cylindrical or
`other regular or irregular shape.
`Alternatively, the nasal insert tubes 44 may be integrally
`formed with the body 32, an arrangement which may be
`beneficial in home use of the interface 10 where only one
`patient uses the interface 10. For Such applications, the nasal
`insert tubes 44 may extend directly from the body 32 without
`the need for the hollow members 52.
`Referring now to FIGS. 7-10, there is provided at least
`one and preferably two exhale apertures 54 defined in the
`body 32 and at least one valve assembly 56 associated with
`and preferably arranged within the body 32. The valve
`assembly 56 prevents inhalation air 57 from passing through
`the exhale aperture 54 when the patient inhales and allows
`exhale air 59 to pass through the exhale aperture 54 when the
`patient exhales. One of the exhale apertures 54 is arranged
`between one of the inhale apertures 38 and one of the nasal
`apertures 36, and one of the valve assemblies 56 is arranged
`between one of the inhale apertures 38 and one of the nasal
`apertures 36.
`The valve assembly 56 may comprise a first valve mem
`ber 58 having a first end 60 and having a second end 62
`pivotally attached to a first inner wall 64 of the body 32
`between the nasal aperture 36 and the exhale aperture 54.
`The valve assembly 56 may further comprise a second valve
`member 66 having a first end 68 and having a second end 70
`pivotally attached to a second inner wall 72 of the body 32
`opposite the first inner wall 64 and between the exhale
`aperture 54 and the inhale aperture 38. The first valve
`member second end 60 and the second valve member second
`end 68 are capable of overlapping and abutting each other So
`that the valve members 60 and 68 may pivot in response to
`each other thereby providing for controlling the airflow
`through the body 32 as described herein.
`The first valve member 58 is made of a material providing
`for one-way fluid flow therethrough. As shown in FIGS. 8
`and 9, for example, the first valve member may have at least
`one perforation 74 defined therein with at least one biased
`closure member 76 associated therewith Such that the inhale
`air 57 may pass through the perforation 74 in one direction
`only. For example, there may be provided one biased closure
`member 76 for each perforation 74 (see FIG. 8), two biased
`closure members 76 for each perforation 74 (see FIG. 9), or
`other Similar arrangements known in the art. Also, the biased
`closure member 76 may have a generally frusto-conical
`shape whereby air may pass through the perforation 74 from
`the larger conical end through the Smaller conical end, but
`not vice versa. The first valve member 60 may be made of
`a plastic, polymer, metal, composite, or other material
`known in the art. The second valve member 66 is non
`perforated and may be made of a Solid plastic, polymer,
`metal, composite, or other material known in the art.
`FIG. 7 shows the second valve member 66 pivoted to a
`first position where the second valve member 66 substan
`tially covers the exhale aperture 54 in response to a force
`thereon from the patient 12 inhaling air 57 through the inhale
`aperture 38. In this first position, the exhale aperture 54 is
`substantially covered by the second valve member 66 alone,
`by a combination of the second valve member 66 and the
`first valve member 58, or by a combination of the second
`valve member 66, the first valve member 58, and a stop that
`will be described hereinafter. The first valve member 58
`pivots to a first position in response to the pivoting of the
`Second valve member 66 as a result of the second end 68 of
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`RMD
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`the second valve member 60 contacting and forceably
`moving the second end 60 of the first valve member 58. The
`first valve member 58 is thereby suitably positioned to
`receive a force from the exhale air 59 as will described
`immediately hereinafter.
`FIG. 10 shows the first valve member 58 pivoted to a
`Second position in response to a force thereon from the
`patient 12 exhaling air 59 through the nasal aperture 36.
`When the first valve member 58 pivots to the second
`position, the first valve member second end 60 contacts the
`Second valve member second end 68 and forces the second
`valve member 66 to a second position. In this second
`position, the exhale aperture 54 is not covered So that the
`exhale air 59 may pass through the exhale aperture 54.
`In order to limit the range of pivotal motion of the valve
`members 58 and 66 and thereby maintain their second ends
`60 and 68 in abutting contact, there may be provided at least
`one and preferably two stops 74 and 76 arranged within the
`body 32. The first stop 74 limits the pivoting motion of the
`first valve member 58 to the first position and the second
`stop 76 limits the pivoting motion of the second valve
`member 66 to the second position. The stops 74 and 76 may
`be provided by rods, bars, tabs, arms, or the like extending
`across or into the body 32.
`Alternatively to or in combination with the stops 74 and
`76, the range of pivotal motion of the valve members 58 and
`66 may be accomplished by the second end 60 of the first
`Valve member 58 having an angled portion and the Second
`end 68 of the second valve member 66 having a yoke or the
`like defined thereon that receives the angled second end 60
`when the valve members 58 and 66 are pivoted to the first
`positions. In another alternative, the second end 68 of the
`Second valve member 66 has an angled portion and the
`second end 60 of the first valve member 58 has a yoke or the
`like defined thereon that receives the angled second end 66
`when the valve members are pivoted to the first positions.
`Referring now to FIGS. 11-12, at least one and preferably
`two filters 78 may be provided within the body 32. The
`filters 78 retain heat and/or moisture from the exhale air 57
`passing therethrough. When the patient then draws his or her
`inhale air 59, heat and/or moisture retained by the filters 78
`is absorbed into the inhale air 59 thereby providing for
`increased comfort of the patient 12. The filters 78 may be
`provided by an air-permeable filter material Such as a fabric,
`plastic, fiber, composite, or other material known by those
`skilled in the art. The filters 78 may be arranged within the
`body 32 between the nasal aperture 36 and the exhale
`aperture 54, outside the body 32 adjacent the exhale aperture
`54, or in another position as will be understood by those
`skilled in the art.
`Referring now to FIGS. 13-14, there is provided a second
`embodiment 100 of the present invention. Similar to the first
`embodiment 10 described hereinabove, the second embodi
`ment 100 has a body 102 with at least one and preferably two
`inhale apertures 104, at least one and alternatively two or
`more exhale apertures 106, at least one and preferably two
`nasal apertures 108, and at least one valve assembly 110.
`Each valve assembly 110 may comprise at least one and
`preferably two one-way inhale valve membranes 112 and at
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`least one and alternatively two one-way exhale Valve mem
`branes 114. The inhale valve membranes 112 may be
`arranged in the body 102 between one of the nasal apertures
`108 and one of the exhale apertures 106 or may be disposed
`within the inhale aperture 104. The exhale valve membranes
`114 may be disposed within the exhale apertures 106. The
`one-way inhale and exhale membranes 112 and 114 may be
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`provided of a material similar to that of the first valve
`member 58 of the first embodiment 10. The valve assembly
`110 thereby prevents inhalation air 116 from passin