(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2005/0028822 A1
`Sleeper et al.
`(43) Pub. Date:
`Feb. 10, 2005
`
`US 20050O28822A1
`
`(54) SEALING NASAL CANNULA
`
`(75) Inventors: Geoffrey P. Sleeper, Bay Village, OH
`(US); David J. Palkon, Tinley Park, IL
`(US)
`
`Correspondence Address:
`PEARNE & GORDON LLP
`1801 EAST 9TH STREET
`SUTE 1200
`CLEVELAND, OH 44114-3108 (US)
`
`(73) Assignee: Tiara Medical Systems, Inc., Lakewood,
`OH
`
`(21) Appl. No.:
`
`10/898,872
`
`(22) Filed:
`
`Jul. 26, 2004
`
`
`
`Related U.S. Application Data
`(60) Provisional application No. 60/493,515, filed on Aug.
`8, 2003.
`
`Publication Classification
`
`(51) Int. Cl. ............................ A62B 7/00; A61M 15/08
`(52) U.S. Cl. ........................................................ 128/207.18
`(57)
`ABSTRACT
`An integrally molded ventilation interface includes a hollow
`bellows-like Structure and two nasal prongs extending from
`a top Surface of the bellows. A pair of headgear Strap flanges
`can also be molded integrally with the ventilation interface.
`The nasal prongs provide a first Sealing interface between an
`outer Surface of the nasal prongs and an inner Surface of the
`patient's nares. The bellows provides a Second Sealing
`interface between a top Surface of the bellows-like Structure
`and a bottom Surface of a patient's nose. The headgear Strap
`flanges provide a third Sealing interface between the venti
`lation interface and a mustache region of the patient's face
`as well as a bottom Surface of the patient's nose.
`
`RMD
`EXHIBIT 1014 - PAGE 1
`
`

`

`Patent Application Publication Feb. 10, 2005 Sheet 1 of 9
`
`US 2005/0028822 A1
`
`
`
`
`
`11 O
`
`RMD
`EXHIBIT 1014 - PAGE 2
`
`

`

`Patent Application Publication Feb. 10, 2005 Sheet 2 of 9
`
`US 2005/0028822 A1
`
`
`
`13O
`
`RMD
`EXHIBIT 1014 - PAGE 3
`
`

`

`Patent Application Publication Feb. 10, 2005 Sheet 3 of 9
`
`US 2005/0028822 A1
`
`
`
`FG. B
`
`RMD
`EXHIBIT 1014 - PAGE 4
`
`

`

`Patent Application Publication Feb. 10, 2005 Sheet 4 of 9
`
`US 2005/0028822 A1
`
`
`
`56O
`
`FG. 1 O
`
`RMD
`EXHIBIT 1014 - PAGE 5
`
`

`

`Patent Application Publication Feb. 10, 2005 Sheet 5 of 9
`
`US 2005/0028822 A1
`
`
`
`F.G. 1 2
`
`RMD
`EXHIBIT 1014 - PAGE 6
`
`

`

`Patent Application Publication Feb. 10, 2005 Sheet 6 of 9
`
`US 2005/0028822 A1
`
`
`
`RMD
`EXHIBIT 1014 - PAGE 7
`
`

`

`Patent Application Publication Feb. 10, 2005 Sheet 7 of 9
`
`US 2005/0028822 A1
`
`
`
`F.G. 1 6
`
`RMD
`EXHIBIT 1014 - PAGE 8
`
`

`

`Patent Application Publication Feb. 10, 2005 Sheet 8 of 9
`
`US 2005/0028822 A1
`
`
`
`RMD
`EXHIBIT 1014 - PAGE 9
`
`

`

`Patent Application Publication Feb. 10, 2005 Sheet 9 of 9
`
`US 2005/0028822 A1
`
`
`
`2OOO
`
`RMD
`EXHIBIT 1014 - PAGE 10
`
`

`

`US 2005/0O28822 A1
`
`Feb. 10, 2005
`
`SEALING NASAL CANNULA
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`0001. The present invention claims priority to U.S. Patent
`Application Ser. No. 60/493,515, filed on Aug. 8, 2003.
`
`FIELD OF THE INVENTION
`0002 The present invention relates generally to ventila
`tion devices, and more particularly, to a nasal ventilation
`interface for a continuous positive airway pressure System.
`
`BACKGROUND OF THE INVENTION
`0.003 Sleep apnea is a potentially life-threatening breath
`ing disorder characterized by brief interruptions of breathing
`during Sleep. There are two types of Sleep apnea: central and
`obstructive. Central Sleep apnea, which is leSS common,
`occurs when the brain fails to Send the appropriate Signals to
`the breathing muscles to initiate respirations. Obstructive
`Sleep apnea occurs when air cannot flow into or out of the
`perSon's nose or mouth although efforts to breathe continue.
`In a given night, the number of involuntary breathing pauses
`or “apneic events' may be as high as 20 to 60 or more per
`hour. Sleep apnea can also be characterized by choking
`Sensations. The frequent interruptions of deep, restorative
`Sleep often leads to excessive daytime sleepineSS and may be
`asSociated with an early morning headache. Early recogni
`tion and treatment of sleep apnea is important because it may
`be associated with irregular heartbeat, high blood pressure,
`heart attack, and Stroke.
`0004 Various forms of positive airway pressure during
`Sleep can be an effective form of therapy for the apnea
`sufferer. Ventilation can be applied in the form of continuous
`positive airway pressure, in which positive preSSure is
`maintained in the airway throughout the respiratory cycle;
`bi-level positive airway pressure System, in which positive
`preSSure is maintained during inspiration but reduced during
`expiration; and intermittent (non-continuous) positive pres
`Sure, in which preSSure is applied when an episode of apnea
`is Sensed. In Such procedures, a patient wears a mask over
`the nose during Sleep, and preSSure from an air blower forces
`air through the nasal passages. Typically, a thin flexible tube
`made of an inert material transports the air. The tube
`terminates in an opening that can be inserted into the
`patient's nostrils. A pair of Smaller nasal insert tubes can
`protrude from the tube or the tube can split at a Y-junction
`into two Smaller tubes, each Smaller nasal insert tube car
`rying gas to one nostril, thereby increasing the fraction of
`inspired oxygen.
`0005 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 respi
`ration. Such Systems frequently Suffer from air leaking out
`around the mask, creating an inability to assure ventilation
`in many patients. 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 requir
`
`ing the patient to remain rather Still in order to alleviate the
`discomfort and to maintain oxygen inspiration.
`
`SUMMARY OF THE INVENTION
`0006 The following presents a simplified summary of the
`invention in order to provide a basic understanding of Some
`aspects of the invention. This Summary is not an extensive
`overview of the invention. It is intended to neither identify
`key or critical elements of the invention nor delineate the
`Scope of the invention. Its Sole purpose is to present Some
`concepts of the invention in a simplified form as a prelude
`to the more detailed description that is presented later.
`0007. The present invention relates to a ventilation inter
`face for a continuous positive airway preSSure System.
`According to a first aspect of the present invention, a
`ventilation interface is provided which includes a nasal
`cannula body. The nasal cannula body includes a pair of
`nasal prongs located on a top portion of the nasal cannula
`body to create a first Sealing interface between the nasal
`cannula body and a nose; and a bellows-like Structure
`integrally molded in a portion of the nasal cannula body to
`create a Second Sealing interface between the nasal cannula
`body and the nose.
`0008 According to another aspect of the present inven
`tion, a ventilation interface is provided having a nasal
`cannula body; and a pair of barrel shaped prongs located on
`a top portion of the nasal cannula body, the barrel shaped
`prongS providing a large Sealing Surface between an outer
`Surface of the prongs and an inner Surface of a patient's
`CS.
`0009. According to yet another aspect of the present
`invention, a ventilation interface is provided, the ventilation
`interface including a nasal cannula body; and a pair of nasal
`prongs located on a top portion of the nasal cannula body,
`the nasal prongs comprising a thin wall that inflates under
`preSSure to create a Sealing Surface with nares of a patient.
`0010. According to yet another aspect of the present
`invention, the ventilation interface includes means for cre
`ating a first Sealing interface between the ventilation inter
`face and a patient's nose; means for creating a Second
`Sealing interface between the ventilation interface and the
`patient's nose; and means for creating a third Sealing inter
`face between the ventilation interface and the patient's nose.
`0011. According to yet another aspect of the present
`invention, a method of manufacturing a ventilation interface
`is provided. The method includes forming a nasal cannula
`body from a flexible material; forming a pair of nasal prongs
`materially integrally with the nasal cannula body; and form
`ing a headgear Strap materially integrally with the nasal
`cannula body.
`0012. The following description and the annexed draw
`ings Set forth in detail certain illustrative aspects of the
`invention. These aspects are indicative, however, of but a
`few of the various ways in which the principles of the
`invention may be employed and the present invention is
`intended to include all Such aspects and their equivalents.
`Other objects, advantages and novel features of the inven
`tion will become apparent from the following detailed
`description of the invention when considered in conjunction
`with the drawings.
`
`RMD
`EXHIBIT 1014 - PAGE 11
`
`

`

`US 2005/0O28822 A1
`
`Feb. 10, 2005
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0013 FIG. 1 illustrates a perspective view of a nasal
`ventilation interface in accordance with an aspect of the
`present invention.
`0.014
`FIG. 2 illustrates a front view of a swivel compo
`nent in accordance with an aspect of the present invention.
`0.015
`FIG. 3 illustrates a perspective view of the nasal
`cannula body employed in the nasal ventilation interface of
`FIG. 1 in accordance with an aspect of the present invention.
`0016 FIG. 4 illustrates another perspective view of the
`nasal cannula body employed in the nasal ventilation inter
`face of FIG. 1 in accordance with an aspect of the present
`invention.
`0017 FIG. 5 illustrates a perspective view of another
`nasal cannula body in accordance with an aspect of the
`present invention.
`0.018
`FIG. 6 illustrates a perspective view of another
`nasal cannula body in accordance with an aspect of the
`present invention.
`0019 FIG. 7 illustrates a perspective view of a top
`portion of the nasal cannula body of FIG. 6 in accordance
`with an aspect of the present invention.
`0020 FIG. 8 illustrates a bottom view of the top portion
`of the nasal cannula body of FIG. 6 in accordance with an
`aspect of the present invention.
`0021 FIG. 9 illustrates a perspective view of a bottom
`portion of the nasal cannula body of FIG. 6 in accordance
`with an aspect of the present invention.
`0022 FIG. 10 illustrates another perspective view of the
`bottom portion of the nasal cannula body of FIG. 6 in
`accordance with an aspect of the present invention.
`0023 FIG. 11 illustrates a perspective view of another
`nasal ventilation interface in accordance with an aspect of
`the present invention.
`0024 FIG. 12 illustrates a front view of another nasal
`cannula body in accordance with an aspect of the present
`invention.
`0.025
`FIG. 13 illustrates a perspective view of the nasal
`cannula body of FIG. 12 in accordance with an aspect of the
`present invention.
`0.026
`FIG. 14 illustrates a front view of another nasal
`cannula body in accordance with an aspect of the present
`invention.
`0027 FIG. 15 illustrates a top view of the nasal cannula
`body of FIG. 14 in accordance with an aspect of the present
`invention.
`0028 FIG. 16 illustrates a perspective view of another
`nasal ventilation interface in accordance with an aspect of
`the present invention.
`0029 FIG. 17 illustrates a perspective view of a nasal
`cannula body employed in the nasal ventilation interface of
`FIG. 16 in accordance with an aspect of the present inven
`tion.
`
`0030 FIG. 18 illustrates a perspective view of an elbow
`component in accordance with an aspect of the present
`invention.
`0031 FIG. 19 illustrates an exploded view of the elbow
`component of FIG. 18 in accordance with an aspect of the
`present invention.
`0032 FIG. 20 illustrates a perspective view of a combi
`nation face mask and nasal cannula body in accordance with
`an aspect of the present invention.
`0033 FIG. 21 illustrates another perspective view of the
`combination face mask and nasal cannula body of FIG. 20
`in accordance with an aspect of the present invention.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`0034. The present invention provides a nasal ventilation
`interface having at least two Sealing interfaces. The present
`invention will now be described with reference to the
`drawings, wherein like reference numerals are used to refer
`to like elements throughout. It is to be appreciated that the
`various drawings are not necessarily drawn to Scale from
`one figure to another nor inside a given figure, and in
`particular that the size of the components are arbitrarily
`drawn for facilitating the reading of the drawings. In the
`following description, for purposes of explanation, numer
`ouS Specific details are set forth in order to provide a
`thorough understanding of the present invention. It may be
`evident, however, that the present invention may be prac
`ticed without these specific details.
`0035 Turning initially to FIG. 1, an example of a nasal
`ventilation interface 100 in accordance with a first aspect of
`the present invention is illustrated. The nasal interface 100
`comprises a base portion 110 and a swivel component 120.
`The base portion 110 includes a nasal cannula body 130
`materially integral with two supply tubes 140. The base
`portion 110 is manufactured from one or more inert mate
`rials, Such as polyurethane, Silicone, or the like. The Supply
`tubes 140 are employed to deliver air pressure from a
`ventilation device (not shown) to a patient via the nasal
`cannula body 130. In particular, the ventilation device forces
`a gas, Such as air, through the Supply tubes 140 and can be
`provided by a continuous positive airway pressure machine,
`a bi-level positive airway pressure machine, an intermittent
`(non-continuous) positive pressure machine, or any other
`Suitable machine to deliver air to the patient.
`0036 For sleep apnea therapy, the ventilation device will
`usually Supply room air at a preSSure of between five and
`fifteen centimeters of water. The room air may be Supple
`mented with oxygen if desired by Splicing an oxygen Supply
`line into the Supply hose or using a triple port connector. It
`is normally unnecessary to humidify or add moisture to the
`air Supplied by the ventilation device in using the nasal
`interface of the present invention, as the nasal interface is
`designed to avoid Stripping moisture from the nares. Thus,
`moisture does not have to be added to relieve patient
`discomfort from drying or burning Sensations in the nasal
`airways.
`0037 Each of the Supply tubes 140 includes an end
`portion, which is coupled to the swivel component 120 to
`facilitate easy manipulation of the supply tubes 140 for
`patient comfort. Turning now to FIG. 2, the Swivel compo
`
`RMD
`EXHIBIT 1014 - PAGE 12
`
`

`

`US 2005/0O28822 A1
`
`Feb. 10, 2005
`
`nent 120 comprises a substantially cylindrical element 122
`for coupling with a tube of the ventilation device and a
`hemispherical element 124 having two tubular engaging
`portions 126 projecting therefrom. The two tubular engaging
`portions 126 are utilized for coupling with end portions of
`the Supply tubes 140 of the ventilation interface 100. The
`cylindrical element 122 and the hemispherical element 124
`are operable to swivel with respect to each other. For
`instance, the cylindrical element 122 and the hemispherical
`element 124 can swivel about each other by 360. It is to be
`appreciated that any Suitable Structure contemplated for
`Swiveling the ventilation interface 100 with the tube of the
`ventilation device can be utilized.
`0038 Turning back to FIG.1, the nasal interface 100 also
`includes headgear Strap flanges 150, which are coupled to
`the base portion 110, to facilitate utilization of headgear
`Straps (not shown). Each of the headgear Strap flanges 150
`includes at least one aperture 160 for receiving a portion of
`the headgear Straps therethrough. When nasal prongs of the
`nasal cannula body 130 are inserted into nares of the patient,
`the headgear Strap fastens around the patient's head and
`applies backward pressure to the nasal cannula body 130. A
`first Sealing interface is thus created via the headgear Strap
`Securing the nasal interface 100 against the patient's mus
`tache region. In addition to this backward preSSure, the
`flanges 150 are positioned in Such a way that the headgear
`Strap applies an angular, upward pressure (e.g., approxi
`mately a 45-degree angle) to a bellows portion of the nasal
`cannula body 130, which will be described in further detail
`below. This angular, upward pressure creates a Second
`sealing interface between the nasal cannula body 130 and
`the patient's nose.
`0039. The supply tubes 140 can be shaped to extend
`along a base of the nasal cannula body 130 and bend
`downward near the headgear Strap flanges 150. AS a result,
`the headgear Straps Support weight and torque produced by
`the supply tubes 140, thereby decreasing the chance of the
`Supply tubes 140 disturbing a Sealing means and potentially
`breaking a seal between the ventilation interface 100 and the
`patient. Alternatively or additionally, the Supply tubes 140
`can be looped over the patient's ears.
`0040 Turning now to FIG.3, the nasal cannula body 130
`of the ventilation interface 100 is shown in greater detail.
`The nasal cannula body 130 is an arcuate, hollow body
`formed of a flexible material, Such as a Silicone elastomer,
`for example. The nasal cannula body 130 includes two
`Substantially barrel-shaped nasal prongS 210 projecting from
`a top surface 220 of the nasal cannula body 130 and formed
`materially integrally there with. The nasal prongS 210 are
`hollow to form a continuous flow path, or conduit, for
`passage of inhaled and exhaled gases between the patient's
`nasal air passages and air chamber. Further, the nasal prongs
`210 operably create a third sealing interface between the
`nasal prongS 210 and the patient's nares via the barrel
`shaped structure. The barrel shape is defined by a diameter
`of a central portion of the nasal prongS 210 being greater
`than diameters at end portions of the nasal prongS 210.
`Employing Such a barrel shape Structure creates a large, even
`Sealing Surface when inserted into the patient's nares. For
`instance, when inserted into the nares of the patient, the
`barrel Shape of each of the prongS 210 is compressed in a
`radial direction Such that a Substantially uniform pressure is
`applied across the outer Surface of each of the prongS 210
`
`and against an inner Surface of a respective naris, thus
`forming a Substantially airtight Seal between the prong 210
`and the naris Over a large Surface area. The nasal prongS 210
`also include a center-to-center distance that corresponds to
`a center-to-center distance between nares of an average user,
`Such as about one centimeter. It is to be appreciated that any
`Suitable center-to-center distance can be employed. Spacing
`the nasal prongS 210 by Such a distance facilitates adjust
`ment of the nasal interface 100 for patient comfort.
`0041 Abellows-like structure (hereinafter referred to as
`“bellows”) 230 is integrally molded in the nasal cannula
`body 130 to create the second sealing interface between the
`nasal cannula body 130 and the patient’s nose. More spe
`cifically, the Second Sealing interface is created between the
`top surface 220 of the nasal cannula body 130 and a bottom,
`triangular shaped area of the nose. The bellows 230 act in a
`manner Similar to a compression Spring to apply a gentle
`upward preSSure to the nose thereby holding the Sealing
`surfaces (e.g., the top surface of the bellows 230 and the
`bottom area of the nose) in Sealing engagement with one
`another. The bellows 230 is adjustable in length between a
`contracted State and an expanded State.
`0042 FIG. 4 depicts a bottom perspective view of the
`nasal cannula body 130. The nasal cannula body 130 further
`includes at least one bleeder port 310 projecting from a
`bottom surface 320 of the cannula body 130. In the example
`illustrated in FIG. 4, two bleeder ports 310 are utilized and
`are axially aligned with the nasal prongs 210. The bleeder
`ports can be cylindrical and have an internal diameter of
`about three millimeters and a length of about 0.25 inches, for
`example. The internal diameter of the bleeder ports 310 are
`ample to permit venting of carbon dioxide exhaled by the
`patient while not being So large as to cause a significant
`pressure drop in the cannula body 130. The axial alignment
`of the bleeder port 310 with the nasal prongs 210 creates a
`direct path for venting of the expired gases. At Substantially
`the Same time, laminar flow of air Supplied by the Supply
`tubes is normal to the bleeder ports 310, such that air
`Supplied by the ventilator must bend about ninety degrees to
`exit through the bleeder ports 310. The effect of this con
`struction is that the bleeder ports 310 are virtually silent in
`operation, mitigating a whistle noise associated with bleeder
`holes in conventional ventilation interfaces.
`0043. As illustrated in FIG. 4, the nasal cannula body
`130 can also includes a Substantially Straight-shaped back
`surface 330. However, it is to be appreciated that the back
`surface 330 of the nasal cannula body 130 can also include
`the bellows-like structure formed in the front Surface 230 of
`the nasal cannula body 130.
`0044 FIG. 5 illustrates an alternative nasal cannula body
`400 that can be employed with a nasal ventilation interface,
`Such as any of those disclosed herein. Although not illus
`trated in detail, the nasal cannula body 400 can include
`headgear Strap flanges for use in conjunction with headgear
`Straps to create a first Sealing interface between the nasal
`cannula body 400 and the patient's face. The headgear strap
`flanges can be configured in a manner Similar to that
`depicted and discussed with respect to FIG. 1. The nasal
`cannula body 400 can also include a bellows structure 430
`to create a Second Sealing interface between a top portion of
`the nasal cannula body 400 and a bottom portion of the
`patient’s nose. The bellows structure 430 operates in a
`
`RMD
`EXHIBIT 1014 - PAGE 13
`
`

`

`US 2005/0O28822 A1
`
`Feb. 10, 2005
`
`manner similar to bellows 230, described above, and thus
`further description of the bellows structure 430 will be
`omitted herein for the sake of brevity.
`0.045. A third sealing interface is created by two nasal
`prongS 410 that project from the top portion of the nasal
`cannula body 400. The nasal prongs 410 comprise a sub
`Stantially Straight-shaped, hollow body having two or more
`rings 420 provided around an outer surface thereof. For
`example, the nasal prongS 410 can include three rings, as
`depicted in FIG. 4. In particular, the third sealing interface
`is created between an outer Surface of the rings 420 and an
`inner Surface of a patient's nares when the nasal prongS 410
`are inserted into a nose of a patient. It is to be appreciated
`that the rings 420 can also be used in combination with the
`barrel-shaped nasal prongS 210 described with respect to
`FIG 3.
`FIG. 6 illustrates another example of a nasal can
`0.046
`nula body 500 in accordance with an aspect of the present
`invention. The nasal cannula body 500 comprises a top
`housing portion 510 and a bottom housing portion 520. The
`top housing portion 510 includes a bellows structure 530 and
`two barrel-shaped nasal prongS 540 extending from a top
`surface 550 of the top housing portion 510. The barrel
`shaped nasal prongs 540 and the bellows 530 are employed
`to create Sealing interfaces between the nasal cannula body
`500 and a nose of a patient. When inserted into the nares of
`the patient, the barrel shape of each of the prongs 540 is
`compressed in a radial direction Such that a Substantially
`uniform pressure is applied acroSS its outer Surface against
`an inner Surface of a respective naris, thus forming a
`substantially airtight seal between the prong 540 and the
`naris Over a large Surface area. Alternatively, or additionally,
`two or more rings formed on the nasal prongS provide a
`Sealing interface between the ring(s) and an inner Surface of
`the naris. The bellows 530 act in a manner similar to a
`compression Spring to apply a gentle upward pressure to a
`bottom Surface of the nose, thereby holding the top Surface
`550 of the nasal cannula body 500 and the bottom area of the
`nose in Sealing engagement with each other.
`0047 The bottom housing portion 520 of the nasal can
`nula body 500 forms a base for the bellows 530 and includes
`one or more air inlets 560 to which flexible air supply tubing
`(not shown) can be attached. The inlets 560 extend from
`opposing side portions of the nasal cannula body 500 in a
`direction angled towards the patient when the nasal cannula
`body 500 is in use.
`0048 Turning now to FIGS. 7 and 8, the top housing
`portion 510 of the nasal cannula body 500 is depicted in
`further detail. The top housing portion 510 has an open end
`610, which Serves as an air inlet, located opposite the top
`surface 550. Each of the barrel-shaped nasal prongs 540 is
`hollow and has an outlet 710 (FIG. 7) through which air
`pressure from the open end 610 is communicated to the
`patient. The top housing portion 510 further includes the
`bellows 530 around a circumference of the nasal cannula
`body 500. However, it is to be appreciated that the bellows
`530 can be provided on only a front or back portion of the
`nasal cannula body 500, if desired.
`0049 FIGS. 9 and 10 illustrate the bottom housing
`portion 520 of the nasal interface 500, as described with
`respect to FIG. 5. The bottom housing portion 520 includes
`a base portion 810 having an open area 820 for receiving air
`
`from the one or more air inlets 560. The air inlet(s) 560
`include an end portion 830 to which flexible air supply
`tubing (not shown) can be attached. The air Supply tubing
`can be made of a relatively flexible adjustable material, Such
`as plastic or the like, and is employed as a conduit for
`ventilation. The nasal interface 500 can include a Y-connec
`tor having a first end adapted to receive a Supply hose from
`a mechanical ventilator (not shown) and a second end
`having a pair of ports (not shown) with connectors for
`attachment to the air Supply tubing. It is to be appreciated
`that the Y-connector described with respect to the present
`invention can alternatively be a T-connector, or any other
`three-way tubing connector as is known in the art. A Swivel
`portion can also be coupled to the connector to facilitate easy
`manipulation of the tubing for patient comfort.
`0050 Although not illustrated, it is to be appreciated that
`a headgear Strap or a flange for a headgear Strap can be
`coupled to the bottom housing portion 520 to provide an
`additional Sealing interface. The headgear Strap can fasten
`around the patient's head to apply backward pressure to the
`nasal cannula body 500, thereby securing it against the
`patient's mustache region. Also, the headgear applies an
`angular, upward pressure, at approximately a 45-degree
`angle, to the bellows 530. The spring-like feature of the
`bellows 530 partially absorbs this angular, upward pressure
`and applies gentle preSSure to the bottom of the nose,
`thereby forming an airtight seal between the top surface 550
`of the nasal cannula body 500 and the bottom of the patient's
`OSC
`0051 Turning now to FIG. 11, yet another example of a
`nasal ventilation interface 1000 is illustrated in accordance
`with another aspect of the present invention. The nasal
`ventilation interface 1000 includes a nasal cannula 1010 that
`provides at least two Sealing interfaces between the nasal
`cannula 1010 and a patient’s nose. Nasal prongs 1020,
`which are located on a top surface 1030 of the nasal cannula
`1010, form one sealing interface. The nasal prongs 1020 can
`include a Substantially barrel shaped Structure for providing
`a Sealing interface between an Outer Surface of the prongs
`and the inner nares of the patient. Alternatively, the nasal
`prongs can include a plurality of rings (not shown) formed
`thereon to provide a Sealing interface between the rings and
`the inner nares of the patient. The other Sealing interface is
`formed between the top surface 1030 of the nasal cannula
`1010 and the bottom surface of the patient's nose by
`employing a bellows structure 1040 in conjunction with a
`headgear Strap, as described herein. The nasal ventilation
`interface 1000 also includes air supply tubing 1050 to
`provide air to the patient via the nasal cannula. The tubing
`1050 can be coupled to headgear strap flanges 1060 or can
`be configured to wrap around the patient's ear.
`0.052 FIGS. 12 and 13 depict yet another nasal cannula
`design 1100 in accordance with an aspect of the present
`invention. The nasal cannula 1100 includes at least one
`headgear strap flange 1130 materially integrally formed with
`the nasal cannula body 1100 to provide a first sealing
`interface. It is to be appreciated that the headgear Strap
`flange 1130 can be coupled to tubes of the nasal cannula in
`any conventional manner. The headgear Strap flange 1130
`includes a first aperture 1140 for allowing air Supply tubing
`to pass therethrough and a second aperture 1150 for receiv
`ing the headgear strap. Moreover, the flange(s) 1130 is
`configured Such that the headgear Strap Secures the nasal
`
`RMD
`EXHIBIT 1014 - PAGE 14
`
`

`

`US 2005/0O28822 A1
`
`Feb. 10, 2005
`
`cannula 1100 to the patient in at least two different planes:
`up and towards the face. The nasal cannula body 1100
`further includes a bellows like structure 1120 to provide a
`Second Sealing interface between the nasal cannula body
`1100 and a bottom portion of the patient's nose. Further still,
`the nasal cannula body 1100 includes barrel shaped nasal
`prongS 1110 for providing a third Sealing interface between
`an inner Surface area of the patient's nose and the nasal
`prongs 1110.
`0053 FIGS. 14 and 15 illustrate another alternative
`nasal cannula body 1300 that can be employed with any of
`the nasal ventilation interfaces disclosed herein. The nasal
`cannula body 1300 is shaped such that it substantially
`conforms to contours of a patient's mustache region (See
`FIG. 15) and includes three sealing interfaces. One sealing
`interface is created by two nasal prongS 1310 projecting
`from a top surface of the nasal cannula body 1300. The nasal
`prongs 1310 have thin, ribbed walls, which are adapted to
`inflate under pressure. For example, the nasal prongS 1310
`can be easily and comfortably inserted into a nose of a
`patient in a compressed state, as illustrated in FIGS. 14 and
`15. Then, when a gas flows through the ventilation interface
`via a CPAP machine, for example, the nasal prongs 1310 can
`inflate to create an air tight Sealing Surface between the Outer
`surface of the nasal prongs 1310 and the nares of the patient.
`The nasal prongS 1310 can assume a barrel-shaped structure
`when inflated to provide a large, even Sealing Surface in the
`nares. However, it is to be appreciated that the nasal prongs
`1310 can assume any suitable shape when inflated to provide
`maximum Sealing between the prongS 1310 and the nares.
`0.054 Another sealing interface is created by a bellows
`like structure 1320 formed on a front portion of the nasal
`cannula body 1300. The bellows-like structure 1320 oper
`ates to apply a gentle upward preSSure to the nose Such that
`a top surface of the nasal cannula body 1300 is held in
`Sealing engagement with a bottom Surface of a nose. The
`bellows 1320 is adjustable in length between a contracted
`State and an expanded State. It is to be appreciated that the
`bellows can additionally, or alternatively, be located on a
`back portion of the nasal cannula body 1300.
`0.055
`Integral headgear strap flanges 1330 create yet
`another Sealing interface. The headgear Strap flanges 1330
`are located at an angle Suitable to provide a backward
`pressure to secure the body 1300 against the patients
`mustache region in addition to an upward preSSure to Secure
`the body 1300 against the patient’s nose. For example, the
`headgear Strap flanges 1330 can be located at approximately
`a 45-degree angle with respect to a central axis of inlet ports
`1340 located on the nasal cannula body 1300. The spring
`like feature of the bellows 132