Document made available under
`Patent Cooperation Treaty (PCT)
`
`the
`
`International application number: PCT/NZ05/000023
`
`International filing date:
`
`18 February 2005 (18.02.2005)
`
`Document type:
`
`Certified copy of priority document
`
`Document details:
`
`Country/Office: NZ
`531332
`Number:
`Filing date:
`23 February 2004 (23.02.2004)
`
`Date of receipt at the International Bureau: 14 March 2005 (14.03.2005)
`
`Remark: Priority document submitted or transmitted to the International Bureau in
`compliance with Rule 17.1(a) or (b)
`
`World Intellectual Property Organization (WIPO) - Geneva, Switzerland
`Organisation Mondiale de la Propriete Intellectuelle (OMPI) - Geneve, Suisse
`
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`EXHIBIT 1007 - PAGE 1
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`Afin`s1',..1 Economic
`Development
`Menotti
`oliangn
`latellecttal Property Office
`of New Zealand,;
`
`PCT/NZ2005/000023
`
`CERTIFICATE
`
`This certificate is issued in support of an application for Patent registration in a country
`outside New Zealand pursuant to the Patents Act 1953 and the Regulations thereunder.
`
`I hereby certify that annexed is a true copy of the Provisional Specification as filed on
`23 February 2004 with an application for Letters Patent number 531332 made by
`FISHER & PAYKEL HEALTHCARE LIMITED.
`
`Dated 3 March 2005.
`
`Neville Harris
`Commissioner of Patents, Trade Marks and Designs
`
`330 High Street, Lower Hutt and 17 Toop Street, Seaview
`po Box 30687, Lower Hutt, New Zealand or DX SX 11129, Wellington
`Phone: +64 4 560 1600, Fax: +64 4 56C 1691, wwWiponz.govt.rrz
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`5 3 1 3 32
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`NEW ZEALAND
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`PATENTS ACT, 1953
`
`PROVISIONAL SPECIFICATION
`
`"Breathing Assistance Apparatus"
`
`We, FISHER & PAYKEL HEALTHCARE LIMITED, a company duly incorporated
`under the laws of New Zealand of 15 Maurice Paykel Place, East Tamaki, Auckland, New
`Zealand do hereby declare this invention to be described in the following statement:
`
`Intellectual Property
`Office of NZ
`2 3 FEB 2004
`
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`FIELD OF INVENTION
`
`The present invention relates to apparatus for treating sleep apnoea. More specifically,
`the present invention provides a nasal positive airway pressure device.
`
`SUMMARY OF THE PRIOR ART
`
`Obstructive Sleep Apnoea (OSA) is a sleep disorder that affects up to at least 5% of
`
`the population in which muscles that normally hold the airway open relax and ultimately
`collapse, sealing the airway. The sleep pattern of an OSA sufferer is characterised by
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`repeated sequences of snoring, breathing difficulty, lack of breathing, waking with a start and
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`then returning to sleep. Often the sufferer is unaware of this pattern occurring. Sufferers of
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`OSA usually experience daytime drowsiness and irritability due to a lack of good continuous
`sleep.
`
`In an effort to treat OSA sufferers, a technique known as Continuous Positive Airway
`
`Pressure (CPAP) was devised. A CPAP device consists of a gases supply (or blower) with a
`conduit connected to supply pressurised gases to a patient, usually through a nasal mask. The
`pressurised air supplied to the patient effectively assists the muscles to keep the patient's
`airway open, eliminating the typical OSA sleep pattern.
`
`The procedure for administering CPAP treatment has been well documented in both
`the technical and patent literature. Briefly stated, CPAP treatment acts as a pneumatic splint
`of the airway by the provision of a positive pressure, usually in the range 4 to 20 cm H2O.
`The air is supplied to the airway by a motor driven blower whose outlet passes via an air
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`delivery hose to a nose (or nose and/or mouth) mask sealingly engaged to a patient's face by
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`means of a harness or other headgear. An exhaust port is provided in the delivery tube
`
`proximate to the mask. More sophisticated forms of positive airway pressure devices, such as
`bi-level devices and auto-titrating devices, are described in US Patent No. 5148802 of
`Respironics, Inc. and US Patent No. 5245995 of Rescare Limited, respectively.
`US Patent No. 5477852 of Airways Ltd, Inc. discloses a nasal positive airway pressure
`device that has a pair of nasal members each having a cannula tip to be inserted into the nares
`of the patient. Each cannula is tapered from a substantially circular cross-section outside the
`patient's nostril to a substantially oval cross-section at the tip inserted into the nostril. An
`inflatable cuff surrounds each cannula with the interior space of the cuff communicating with
`the lumen of the cannula through at least one aperture in the sidewall of the cannula. The
`nasal members are connected to one or more flexible hoses that, in turn, are connected to a
`source of positive air pressure. In use, positive air pressure is supplied to each cannula tip
`through the air hoses and nasal members. The positive air pressure inflates the cuffs to hold
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`the nasal members in place and to effect treatment. The nasal device of US Patent No.
`5477852 is attached to headgear that is located about a patient's head; this headgear could be
`considered by many patients as cumbersome and uncomfortable.
`Conventional nasal masks used for administrating CPAP treatment are also considered
`uncomfortable and cumbersome, also prior art nasal masks and the like are noisy (due to air
`
`leaks). These disadvantages in many cases are a formidable obstacle to patient acceptance of
`such treatment. Therefore, a substantial number of patients either cannot tolerate treatment or
`
`choose to forego treatment. It is believed a substantial number of such patients could benefit
`from a nasal positive airway pressure apparatus that is more convenient to use and
`comfortable to wear, thereby resulting in increased treatment compliance.
`As oxygen is supplied as a dry gas it is well known in the art to either heat and/or
`humidify gases before delivering them for breathing by a patient.
`In particular when
`delivering oxygen, or oxygen / air mixture, it has proven beneficial to humidify the gases first.
`In WO 01/41854 of Vapotherm, Inc. a system is disclosed that allows the delivery of
`humidified oxygen through a nasal cannula. This system uses a narrow bore conduit and
`nasal cannula with a high resistance to gas flows, thereby requiring the oxygen be of a high
`pressure. Air, as well as oxygen can also be passed down the conduit and nasal cannula and it
`too must be of a high pressure. This system allows the delivery of high flows of oxygen
`enriched air to the patient, but is limited in the flows achievable due to the narrow bore of the
`cannula resulting in high resistance gas flow and excessive velocity and noise upon exiting
`
`the cannula. Furthermore, the narrowness of the nasal cannula in this system allows easy
`expiration of gases between the prongs and nares and therefore does not create any positive
`airway pressure.
`Trimmed Technologies, Inc. manufactures a nasal cannula device called the
`NASALAIRETM. In this device air or oxygen travels down a wide bore conduit to nasal
`cannula. The NASALAIRETM creates a physical seal between the nares and itself, and relies
`on the absence of leaks around itself and the nares to deliver pressure supplied by a
`continuous positive airway pressure (CPAP) blower to the airway of the wearer.
`SUMMARY OF THE INVENTION
`It is an object of the present invention to provide a breathing assistance apparatus
`which goes someway to overcoming the above mentioned disadvantages or which will at least
`provide the public a useful choice.
`Accordingly in a first aspect the present invention consists in a breathing assistance
`apparatus comprising:
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`nasal cannula, shaped to fit within a user's flares,
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`a pressurised source of gases,
`transportation means adapted to, in use, be in fluid communication with said source of
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`gases and said nasal cannula and adapted to in use convey said gases to said user,
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`wherein said nasal cannula are adapted to deliver said humidified gases to said user,
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`said nasal cannula including at least one prong allowing high flow delivery of said humidified
`gases and creates positive airway pressure in said patient's airway, the at least one prong
`
`having an end that is flared outwardly, such that in use, said flared end seals within said user's
`
`nares.
`
`Preferably said nasal cannula has two nasal prongs.
`Preferably said prongs are oval and shaped to follow the contours of human nares.
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`Preferably said prongs are angled toward one another to prevent dislodgement from
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`said user's nares and assist in flow of gases into the user's nasal passages.
`Preferably said prongs each have a step formed in them such that in use the sides of
`said prong abut the user's nasal septum so as to prevent said prongs from dislodging from said
`user's nares.
`
`Preferably each of said prongs include a protrusion formed opposite said step that
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`assists in correct orientation of said prongs within said user's nares
`Preferably said nasal cannula includes a body that has a plurality of apertures that act
`
`as a bias flow outlet vent for gases exhaled by said user.
`
`Preferably said nasal cannula is connected to said transportation means by way of a
`
`ball and socket joint.
`In a second aspect the present invention consists in a breathing assistance apparatus
`
`comprising:
`
`nasal cannula, shaped to fit within a user's nares,
`a pressurised source of gases,
`humidification means adapted to, in use, be in fluid communication with said source
`of gases and adapted to in use humidify said gases,
`humidified gases transport means adapted to, in use, be in fluid communication with
`said humidification means and adapted to in use convey said humidified gases to said cannula,
`heating means disposed within said transport means and adapted to in use heat said
`gases as they pass through said transport means,
`wherein said nasal cannula are adapted to deliver said humidified gases to said user,
`said nasal cannula including at least one prong allowing high flow delivery of said humidified
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`gases and creates positive airway pressure in said patient's airway, the at least one prong
`having an end that is flared outwardly, such that in use, said flared end seals within said user's
`nares.
`
`Preferably said nasal cannula has two nasal prongs.
`
`Preferably said prongs are oval and shaped to follow the contours of human nares.
`Preferably said prongs each have a step formed in them such that in use the sides of
`said prong abut the user's nasal septum so as to prevent said prongs from dislodging from said
`user's nares.
`Preferably each of said prongs include a protrusion formed opposite said step that
`assists in correct orientation of said prongs within said user's nares
`Preferably said nasal cannula includes a body that has a plurality of apertures that act
`as a bias flow outlet vent for gases exhaled by said user.
`Preferably said nasal cannula is connected to said transportation means by way of a
`ball and socket joint.
`This invention may also be said broadly to consist in the parts, elements and features
`referred to or indicated in the specification of the application, individually or collectively, and
`
`any or all combinations of any two or more of said parts, elements or features, and where
`specific integers are mentioned herein which have known equivalents in the art to which this
`invention relates, such known equivalents are deemed to be incorporated herein as if
`individually set forth.
`The invention consists in the forgoing and also envisages constructions of which the
`following gives examples.
`BRIEF DESCRIPTION OF THE DRAWINGS
`One preferred form of the present invention will now be described with reference to
`the accompanying drawings.
`Figure 1 is a block diagram of a system providing humidified continuous positive
`airway pressure to a user as might be used in conjunction with the nasal cannula present
`invention.
`Figure 2 is a perspective view of the nasal cannula of the present invention.
`Figure 3 is a side view of the nasal cannula of Figure 2.
`Figure 4 is a plan view of the nasal cannula of Figure 2.
`Figure 5 is a prong end view of the nasal cannula of Figure 2
`Figure 6 is an exploded view of the nasal cannula of Figure 2.
`Figure 7 is an alternative embodiment of a nasal cannula of the present invention.
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`Figure 8 is yet another embodiment of a nasal cannula of the present invention.
`
`DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
`Whether used in a hospital environment or in a home environment, the nasal cannula
`of the present invention will generally have associated three main pieces of apparatus. Firstly
`an active humidifier that controls the temperature of a heater plate heating a body of water to
`
`achieve a desired temperature and humidity of the gases being humidified. Secondly a
`transport conduit from the humidifier to the patient is also required, which is preferably
`heated to reduce condensation, or "rain out". Thirdly a cannula designed to fit up into the
`nasal cavity and deliver humidified, pressurized gases. In particular, the nasal cannula of the
`present invention has two flared end prongs that seal within a patient's nares. The cannula
`prongs are shaped such that a step is created between them such that the prongs abut the
`user's nasal septum in use. Furthermore, the gripping action of the sides of the prongs to the
`user's septum in use prevents the prongs from dislodging from the user's nares.
`With reference to Figure 1 a humidified Continuous Positive Airway Pressure (CPAP)
`system is shown in which a patient 1 is receiving humidified and pressurised gases through
`the nasal cannula 2 of the present invention, that are connected to a humidified gases
`
`transportation pathway or inspiratory conduit 3. It should be understood that delivery systems
`could also be VPAP (Variable Positive Airway Pressure) and BiPAP (Bi-level Positive
`Airway Pressure) or numerous other forms of respiratory therapy. Inspiratory conduit 3 is
`connected to the outlet 4 of a humidification chamber 5 that contains a volume of water 6.
`
`Inspiratory conduit 3 may contain heating means or heater wires (not shown) which heat the
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`walls of the conduit to reduce condensation of humidified gases within the conduit.
`Humidification chamber 6 is preferably formed from a plastics material and may have a
`highly heat conductive base (for example an aluminium base) which is in direct contact with a
`heater plate 7 of humidifier 8. Humidifier 8 is provided with control means or electronic
`controller 9 that may comprise a microprocessor based controller executing computer
`software commands stored in associated memory.
`Controller 9 receives input from sources such as user input means or dial 10 through
`which a user of the device may, for example, set a predetermined required value (preset value)
`of humidity or temperature of the gases supplied to patient 1. The controller may also receive
`input from other sources; for example, temperature and/or flow velocity sensors 11 and 12
`through connector 13 and heater plate temperature sensor 14. In response to the user set
`humidity or temperature value input via dial 10 and the other inputs, controller 9 determines
`when (or to what level) to energise heater plate 7 to heat the water 6 within humidification
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`1 chamber 5. A flow of gases (for example air) is provided to the chamber through inlet 16
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`from a gases supply means or blower 15. As the volume of water 6 within humidification
`chamber 5 is heated, water vapour begins to fill the volume of the chamber above the water's
`surface and is passed out of the humidification chamber 5 through outlet 4. Exhaled gases
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`from the patient's mouth are passed directly to ambient surroundings in Figure 1.
`
`Blower 15 is provided with variable pressure regulating means or variable speed fan
`20 which draws air or other gases through blower inlet 17. The speed of variable speed fan 20
`is controlled by electronic controller 18 (or alternatively the function of controller 18 could
`
`carried out by controller 9) in response to inputs from controller 9 and a user set
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`predetermined required value (preset value) of pressure or fan speed via dial 19.
`
`Flared Prong Nasal Cannula
`The nasal cannula of the present invention is shown in detail in Figures 2 to 6.
`
`Referring to Figures 2 and 6, the nasal cannula 2 comprises three main components; the prong
`part 21, body part 22 and ball connector 23.
`The prong part 21 has two nasal prongs 24, 25, each of which are substantially shaped
`
`to follow the contours of the human nares and in use are placed inside a user's nares. The
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`prongs 24, 25 extend out from a hollow tubular body 26 that in use fits to the body part 22.
`Each of the prongs 24, 25 are integrally moulded with the tubular body 26 in a flexible
`plastics material or rubber, such as silicone, other thermoset elastomers or thermoplastic
`
`elastomers such as KratonTM. The prongs 24, 25 are substantially oval tubular members that
`allow for a passage of gases. In particular, as shown in Figure 5, the prongs are oval in shape
`and angled in the same manner as a human's flares. The prongs 24, 25 are angled toward one
`another (or toward the vertical axis Y) at the top 27, 28 of the prongs and away from one
`another at the bottom 29, 30 of the prongs. Furthermore, the ends 31, 32 of the prongs flare
`outwardly and preferably are formed such that the ends of the prongs are thinner in cross-
`section than the rest of the prongs. The flared thinner section ends 31, 32 of the prongs assist
`with the sealing of the prongs 24, 25 in use within the user's nares. When in use and with
`gases flowing through the prongs the force of the gas pressure will force the prong ends to
`flare outwardly more and seal against the inside of the user's nares.
`The prongs 24, 25 each include a step 33, 34 formed along their lengths. Each of the
`steps 33, 34 are formed on the prongs 24, 25 in an opposing manner such that in use, when the
`prongs are within a user's nares the steps 33, 34 abut the user's nasal septum and form a ledge
`that prevents dislodgement of the prongs. The prongs 24, 25 also have protrusions 35, 36
`formed on their outer edges that abut the sides of the user's nares (opposite to the nasal
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`septum). The protrusions 35, 36 assist preventing the dislodgement of the prongs, especially
`if the user moves his or her head. The protrusions 35, 36 also maintain the prongs within the
`user's nares in a correct orientation such that in use gases flow through the prongs and
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`directly up the user's nasal passages.
`The body part 22 is a tubular passageway in which the prong part 21 is connected at
`one end and a ball joint 37 at the other end. The ball joint 37 extends from the connector 23
`and slots into a complementary shaped (half sphere) socket end 39. The body part 22 also has
`a number of apertures 38 formed in it, which acts as a bias flow outlet vent. Therefore, any
`
`gases exhaled by the user through their nose will exit through the apertures.
`
`The connector 23 is preferably connected to the inspiratory conduit 3 (see Figure 1)
`that supplies gases flow to the cannula 2. The inspiratory conduit 3 may be moulded directly
`to the connector 23 or other connection mechanisms may be used, such as a friction fit formed
`
`between the connector and conduit.
`Although a ball and socket joint, as described above, between the body part 22 and
`connector 23 is preferred other connections may be utilised, such as a flexible piece of
`silicone, or other appropriate connection. The connection between the cannula body and
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`connector must be able to be flexed or rotated to allow for the inspiratory conduit 3 to be
`moved without causing the dislodgement of the nasal cannula 2 from the user's nares.
`In the preferred form of the nasal cannula 2 of the present invention the body part 22
`
`and connector 23 are preferably made from a hard or rigid plastics material, such as
`polypropylene, polycarbonate or acetyl. In other forms the body part 22 and connector 23
`may be of different plastics materials to allow for increased slidability between these parts.
`The prong part 21 may be supplied in various different sizes such that different sized
`user's may remove an existing prong part and simply attach a different sized flexible plastics
`prong part over the body part 22.
`To provide additional comfort for the user or ensure the nasal cannula of the present
`invention do not fall from a user's nares, the nasal cannula may be used in combination with a
`headgear strap. For example, Figure 1 shows a headgear strap 40 extending from the nasal
`cannula 2. The ends of the headgear strap that attach to the cannula may attach to extensions
`(or loops) 40, 41 on the body part 22 of the cannula shown in Figure 2, or may attach about
`other appropriate areas of the cannula, for example, about the connector 23.
`The abovementioned embodiment of the nasal cannula 2 of the present invention is
`preferably a wide bore pronged cannula used for high flow conditions. A further embodiment
`of the present invention is shown in Figure 7. In this alternative embodiment of the nasal
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`1 cannula 42 the prongs 43, 44 are preferably small bore prongs for use with lower flow
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`conditions. The prongs 43, 44 are similarly shaped to the prongs 24, 25 detailed above, but
`may not seal in the same manner as the abovementioned prongs due to the smaller size of the
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`-9-
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`prongs. In fact these prongs may not seal at all in use within the user's nares.
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`Furthermore, in this alternative embodiment the nasal cannula 42 is smaller and
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`weights less as it is only comprised of a prong body 45 and prongs 43, 44, where the body 45
`is connected to a small tube that is formed with corrugations or bellows 48 that connect to an
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`inspiratory tube or conduit 47 (similar to the inspiratory conduit 3 described above) that
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`receives a supply of gases.
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`The corrugations of bellows 48 will bend or move when a weight or force is placed on
`the cannula, thereby preventing dislodgement of the cannula 42 form a user's face in use. In
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`particular, the corrugations or bellows 48 prevent in use transferral of the torque onto the
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`cannula 42 when a user moves his or her head.
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`The body 45 of the cannula 42 is provided with a number of apertures 48 that allows
`for gases exhaled by the users to be expelled into the ambient air.
`The prong body and prongs of this embodiment of the cannula of the present invention
`are preferably formed a flexible plastics material or rubber, such as silicone, other thermoset
`elastomers or thermoplastic elastomers such as KratonTm.
`In yet another embodiment of the nasal cannula of the present invention the cannula
`
`may be provided with corrugated or baffled sections on the prongs as illustrated in Figure 8.
`
`The nasal cannula 49 of this embodiment is similar to that of Figure 2 but the prongs 50, 51
`
`have a series of corrugations 52, 53 formed in them. The corrugations 52, 53 allow for
`movement of each of the prongs 50, 51 for a better user fit, and allow for movement of the
`cannula 49 without causing dislodgement of the prongs from the user's nares.
`
`DATED THIS 23 DAY OFF.el:WitOPL1
`A J
`PER
`AGENT FCvI
`
`PPLICANT
`
`InteHectuai Property
`Office of NZ
`2 3 FEB 2004
`R EcEiv EE
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`119 15
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`20
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`Figure 1
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`40
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`Figure 1
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`24
`24
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`25
`25
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`34
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`26
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`z 2
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`23
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`Figure 2
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`2
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`22
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`21
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`23
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`37
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`32
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`25
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`36
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`26
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`38
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`39
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`Figure 3
`Figure 3
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`2
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`24
`24
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`35
`35
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`21
`21
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`22
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`23
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`37
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`38
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`33
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`32
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`34
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`38
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`Figure 4
`Figure 4
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`Figure 5
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`37
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`23
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`39
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`Figure 6
`Figure 6
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`5 3 1 3 3 2
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`44
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`43
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`42
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`45
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`48
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`1
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`Figure 7
`Figure 7
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`49
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`47
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`52
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`50
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`51
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`53
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`Figure 8
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