PROVISIONAL
`PATENT APPLICATION
`TRANSMITTAL
`(Only for Provisional applications under 37 C.F.R. § 1.53(c))
`
`Attorney Docket No.
`
`02-02 PV
`
`First Named Inventor or Application Identifier
`
`HO et al.
`Express Mail Label No. EV 196251473 US
`
`This is a request for filing a PROVISIONAL APPLICATION
`for patent under 37 C.F.R. § 1.53(c).
`
`ADDRESS TO:
`
`Mail Stop PROVISIONAL PATENT APPLICATION
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Given Name (First and Middle)
`
`Family Name
`
`Residence (City and either State or Foreign Country)
`
`INVENTOR(S)
`
`Peter
`Jerome
`Richard J.
`Lance
`Derrick
`
`2227 Chapparal Drive, Pittsburgh, Pennsylvania, 15239
`224 Elliott Road, Monroeville, Pennsylvania, 15146-1932
`3503 Sunnyvale Drive, Allison Park, Pennsylvania, 15101
`34B Murrysville Road, Trafford, Pennsylvania, 15085
`335 Nicklow Road, Markleton, Pennsylvania, 15551
`1 Additional inventors are being named on the 1 separately numbered sheets attached hereto
`
`Ho
`Matula
`Lordo
`Busch
`Andrews
`
`f-,
`:I',
`c••-
`•o
`to
`‘ 47°
`,..".."/"
`co C=I
`ir....r.
`a%
`.-I
`
`'
`
`PATIENT INTERFACE ASSEMBLY AND SYSTEM USING SAME
`
`TITLE OF THE INVENTION
`
`CORRESPONDENCE ADDRESS
`
`Customer No. and Bar Code Label
`
`
`MINN MI1011111
`30031
`PATENT
`TRADEMARK
`OFFICE
`
`1
`I
`q
`
`ENCLOSED APPLICATION PARTS (check all that apply)
`Specification - Number of Pages: 25
`Assignment and Cover Sheet.
`q Certificate of Mailing by Express Mail
`Drawing(s) - Number of Sheets: 25
`Other (specify)
`METHOD OF PAYMENT OF FILING FEES FOR THIS PROVISIONAL APPLICATION FOR PATENT
`Filing Fee Amount
`$ 160.00
`Assignment Recording Fee
`
`$
`
`r ausnedererstugrnn et: recorded Assignment to
`
`I Fee Transmittal Form Attached.
`A A check or money order is enclosed to cover the filing fees (check no. 273173).
`I The Commissioner is hereby authorized to charge any deficiency in the filing fee or credit any overpayment to
`Deposit Account Number: 50-0558.
`The invention was made by an agency of the United States or under a contract with an agency of the United States Government.
`
`No.
`Yes, the name of the U.S. Government agency and the Government Contract Number are:
`
`Total
`
`$ 160.00
`
`q
`
`Respectfully submitted,
`
`Signature :
`Typed Name: Michael W. Haas
`Telephone:
`(724) 387-5026
`
`Date: August 18, 2003
`Reg. No.: 35,174
`Fax: (724) 387-5021
`
`RI-106 (Rev. 04/2003)
`
`RMD
`EXHIBIT 1021 - PAGE 1
`
`

`

`PROVISIONAL
`PATENT APPLICATION
`TRANSMITTAL
`(Only for Provisional applications under 37 C.F.R. § 1.53(c))
`
`Attorney Docket No.
`
`02-02 PV
`
`First Named Inventor or Application Identifier
`
`HO et al.
`
`August 18, 2003
`Filing Date:
`Express Mail Label No. EV 196251473 US
`
`PROVISIONAL PATENT APPLICATION COVER SHEET
`ADDITIONAL PAGE
`(page 2 of 2)
`
`TITLE OF THE INVENTION
`
`PATIENT INTERFACE ASSEMBLY AND SYSTEM USING SAME
`
`Given Name (Fiat and Middle)
`
`Family Name
`
`ADDITIONAL INVENTOR(S)
`Residence (City and either State or Foreign Country)
`
`Luke
`
`Chris
`
`Stonis
`
`Von Dohlem
`
`c/o Fitch, 10350 Olentangy River Road, PO Box 360, Worthington,
`Ohio, 43085
`
`c/o Fitch, 10350 Olentangy River Road, PO Box 360, Worthington,
`Ohio, 43085
`
`RI-106a Additional Inventors (Rev. 03/2000)
`
`RMD
`EXHIBIT 1021 - PAGE 2
`
`

`

`r
`
`FEE TRANSMITTAL
`(Effective 01/01/2003)
`
`"Express Mail" Label No. EV 196251473 US
`\TOTAL AMOUNT OF PAYMENT
`$ 160.00
`
`Application Number
`Filing Date
`First Named Inventor
`Confirmation Number
`Group Art Unit
`Examiner's Name
`Attorney Docket No.
`
`Not Yet Assigned
`August 18, 2003
`HO et al.
`Unknown
`Unknown
`Unknown
`02-02 PV
`
`METHOD OF PAYMENT
`1.® indicated fees and credit any over payments to:
`50-0558
`
`The Commissioner is hereby authorized to charge
`
`Deposit
`Account
`Number
`Deposit
`Account
`Name
`
`Respironics, Inc.
`
`E Charge any additional 0 Charge the Issue Fee set
`fee required under 37
`C.F.R. §§ 1.16, 1.17
`1.19 and 1.20
`2. [E] Payment Enclosed:
`Check (Check No. 273173)
`
`forth in 37 C.F.R. § 1.18
`
`FEE CALCULATION (fees effective 10/01/00)
`
`1. FILING FEE
`
`Large Entity Small Entity
`Fee
`($)
`Fee
`($) Fee Description Fee Paid
`1001 750
`2001 375 Utility filing fee
`
`1002 330
`
`2002 165 Design filing fee
`
`1003 520
`
`2003 260 Plant filing fee
`
`1004 750
`
`2004 375 Reissue filing fee
`
`1005 160
`
`2005 80 Provisional filing fee
`
`160.00
`
`Fee Paid
`
`FEE CALCULATION (continued)
`3. ADDITIONAL FEES
`
`Large Entity Small
`Fee
`Fee
`Fee
`Code
`Code
`($)
`
`Entity
`Fee
`($)
`
`1051
`
`1052
`
`130
`
`50
`
`2051
`
`2052
`
`65
`
`25
`
`Fee Description
`Surcharge - late filing fee or declaration
`
`Surcharge - late provisional filing fee or
`or cover sheet
`
`1811
`
`100
`
`1811
`
`100
`
`Certificate of Correction
`
`1812
`
`2,520
`
`1812
`
`2,520 For filing a request for reexamination
`
`576
`
`25
`
`576
`
`1805
`
`1,840*
`
`1805
`
`25
`
`Additional filing receipt, duplicate or corrected
`due to applicant error
`1,840* Requesting publication of SIR after Examiner
`action
`
`1251
`1252
`1253
`
`1254
`
`1255
`
`1401
`
`1402
`
`1403
`
`110
`410
`930
`
`1,450
`
`1,970
`
`320
`
`320
`
`280
`
`2251
`2252
`2253
`
`2254
`
`2255
`
`2401
`
`2402
`
`2403
`
`55
`205
`465
`
`725
`
`985
`
`160
`
`160
`
`140
`
`Extension for response within first month
`Extension for response within second month
`Extension for response within third month
`
`Extension for response within fourth month
`
`Extension for response within fifth month
`
`Notice of Appeal
`
`Filing a brief in support of an appeal
`
`2. CLAIMS
`
`Total Claims
`
`Ind. Claims
`
`SUBTOTAL (1)
`
`$ 160.00
`
`Extra Fee from
`Claims Below Fee Paid
`x
`18 =
`
`-
`
`*
`
`x
`
`84 =
`
`Multiple Dependent Claims add
`
`280 =
`
`* Enter Highest Number Previous Paid For
`Large Entity Small Entity Fee Description
`Fee
`($)
`Fee
`($)
`1202 18
`2202 9
`1201 84
`2201 42
`
`Claims in excess of 20
`Independent claims in excess of 3
`
`1203 280
`
`2203 140 Multiple dependent claim
`
`1204 84
`
`2204
`
`1205 18
`
`2205
`
`42 Reissue independent claims
`over original patent
`9 Reissue claims in excess of 20
`and over original patent
`
`1451
`
`1452
`
`1,510
`
`110
`
`1451
`
`2452
`
`1453
`
`1,300
`
`2453
`
`1501
`1502
`
`1814
`
`1460
`
`1807
`
`1806
`8021
`
`1809
`
`1801
`
`1,300
`470
`
`110
`
`130
`
`50
`
`180
`40
`
`750
`
`750
`
`2501
`2502
`
`2814
`
`1460
`
`1807
`
`1806
`8021
`
`2809
`
`2801
`
`Other Fee (specify)
`
`Request for oral hearing
`1,510 Petition to institute a public use proceeding
`Petition to revive unavoidably abandoned
`application
`Petition to revive unintentionally abandoned
`application
`
`650
`
`55
`
`650
`235
`
`55
`
`130
`
`50
`
`180
`40
`
`375
`
`375
`
`Utility issue fee (or reissue)
`Design issue fee
`
`Statutory Disclaimer
`
`Petitions to the Commissioner
`
`Petitions related to provisional applications
`
`Submission of Information Disclosure Stmt
`Recordingeach patent assignment per
`property (times number of property)
`Filing a submission after final rejection
`(37 C.F.R. § 1.129(a))
`Request for Continued Examination
`
`SUBTOTAL (2)
`
`$ 0.00
`
`SUBTOTAL (3)
`
`$ 0.00
`
`SUBMITTED BY
`Typed or
`Printed Name
`Signature
`
`Michael W. Haas
`
`A ecz
`
`e4
`
`;
`
`Date August 18, 2003
`
`Reg. Number
`
`35,174
`
`Deposit Account
`Number
`
`50-0558
`
`411.111/1 a locos 19/M \
`
`RMD
`EXHIBIT 1021 - PAGE 3
`
`

`

`Certificate of Mailing by "Express Mail"
`
`EV 196251473 US
`"Express Mail" label number
`
`August 18, 2003
`Date of Deposit
`
`I hereby certify that this correspondence is being deposited with the United States Postal
`Service "Express Mail Post Office to Addressee" service on the date indicated above and
`is addressed to:
`
`Mail Stop Provisional Patent Application
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450.
`
`Signature of person mailing correspondence
`
`Michael W. Haas
`Typed or printed name of person mailing correspondence
`
`Note: Each paper must have its own certificate of mailing by "Express Mail".
`
`RI-108 (Rev. 04/2003)
`
`RMD
`EXHIBIT 1021 - PAGE 4
`
`

`

`APPLICATION UNDER UNITED STATES PATENT LAWS
`
`Invention:
`
`PATIENT INTERFACE ASSEMBLY AND SYSTEM USING SAME
`
`Inventor(s):
`
`Peter HO
`Jerome MATULA Jr.
`Richard J. LORDO
`Lance BUSCH
`Derrick ANDREWS
`Luke STONIS
`Chris VON DOHLEM
`
`Attorney Docket No. 02-02 PV
`
`Customer No.
`
`1111111111 1111111111111111111111
`
`30031
`
`PATENT TRADEMARK OFFICE
`
`This is a:
`
`N Provisional Application
`111 Regular Utility Application
`
`O Continuing Application
`
`O PCT National Phase Application
`
`[11 Design Application
`
`El Reissue Application
`
`O Substitute Specification
`
`[1] Marked-Up Specification
`
`SPECIFICATION
`
`RI-100 (Rev. 10/02)
`
`RMD
`EXHIBIT 1021 - PAGE 5
`
`

`

`PATIENT INTERFACE ASSEMBLY AND SYSTEM USING SAME
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`
`[01]
`
`The present invention pertains to patient interface assembly, a system for
`
`supplying a flow of gas to a patient that incorporates such an assembly, and to a patient
`
`interface device and a headgear for use in such an assembly.
`
`2. Description of the Related Art
`
`[02]
`
`There are numerous situations where it is necessary or desirable to deliver
`
`a flow of breathing gas non-invasively to the airway of a patient, i.e., without intubating
`
`the patient or surgically inserting a tracheostomy tube in their trachea. For example, it is
`
`known to ventilate a patient using a technique known as non-invasive ventilation. It is
`
`also known to deliver continuous positive airway pressure (CPAP) or variable airway
`
`pressure, which varies with the patient's respiratory cycle or a monitored condition of the
`
`patient, to treat a medical disorder, such as sleep apnea syndrome, in particular,
`
`obstructive sleep apnea (OSA), or congestive heart failure. Non-invasive ventilation and
`
`pressure support therapies involve the placement of a patient interface device, which is
`
`typically a nasal or nasal/oral mask, on the face of patient to interface the ventilator or
`
`pressure support device with the airway of the patient so that a flow of breathing gas can
`
`be delivered from the pressure/flow generating device to the airway of the patient.
`
`[03]
`
`Because such patient interface devices are typically worn for an extended
`
`period of time, a variety of concerns must be taken into consideration. For example, in
`
`providing CPAP to treat OSA, the patient normally wears the patient interface device all
`
`night long while he or she sleeps. One concern in such a situation is that the patient
`
`interface device is as comfortable as possible, otherwise the patient may avoid wearing
`
`the interface device, defeating the purpose of the prescribed pressure support therapy.
`
`[04]
`
`Typically patient interface devices include a mask shell having a cushion
`
`attached to the shell that contacts the surface of the patient. The mask shell and cushion
`are held in place by a headgear that wraps around the head of the patent. The mask and
`headgear form the patient interface assembly. A typical headgear includes flexible,
`
`RMD
`EXHIBIT 1021 - PAGE 6
`
`

`

`adjustable straps that extend from the mask to attach the mask to the patient. While such
`
`conventional interface devices are generally well accepted, there remains a class of
`
`patients that do not find these devices to be sufficiently comfortable, too bulky, or
`
`otherwise inadequate. Thus, alternative techniques for interfacing a pressure support
`
`system to the airway of a patient are desired.
`
`SUMMARY OF THE INVENTION
`
`[05]
`
`Accordingly, the present invention provides a patient interface assembly
`
`that addresses the above-identified concerns and that overcomes shortcomings of
`
`conventional patient interface assemblies. The patient interface assembly of the present
`
`invention provides the patient with improved patient interface stability and overall
`
`comfort.
`
`[06]
`
`The present invention further provides a system for delivering a flow of
`
`gas to a patient that addresses the above identified concerns and that does not suffer from
`
`the shortcomings of conventional techniques. This is achieved by providing a system for
`
`delivering a flow of gas to a patient that includes a gas flow generating device capable of
`
`producing a flow of gas and a conduit having a first end portion operatively coupled to
`
`the gas flow generating device and a second end portion. The conduit carries the flow of
`
`gas from the gas flow generating device. The system includes a patient interface
`
`assembly comprising a patient interface device operatively coupled to the second end
`
`portion of the conduit and a headgear.
`
`[07]
`
`The patient interface device, in one embodiment of the present invention,
`
`is a nasal interface device having a nasal cushion and a pair of laterally spaced nares
`
`elements for insertion into the nostrils of the patient. A formable support is preferably
`
`mounted to the nasal cushion for providing support for the nasal cushion while allowing
`
`for adjustments to provide increased fit and comfort of the nasal cushion. The nasal
`
`cushion is coupled to a coupling elbow or cradle having exhaust diffusion plates.
`
`[08]
`
`The headgear assembly of the present invention includes a substantially
`
`rigid, minimal contact harness assembly. The headgear of an exemplary embodiment
`
`includes an adjustment assembly that allows for a simultaneous adjustment of multiple
`
`straps.
`
`2
`
`RMD
`EXHIBIT 1021 - PAGE 7
`
`

`

`[09]
`
`A length adjustment assembly in one embodiment adjusts the distance
`
`between an adjustment assembly and the nasal interface device to accommodate patients
`
`having different facial sizes. The adjustment assembly is a position adjustment
`
`mechanism which provides a force adjustment by an integrated spring. The adjustment
`
`assembly allows a cantilevered support to support the patient interface device without a
`
`set of headgear straps located at the patient interface device.
`
`[10]
`
`These and other features and characteristics of the present invention, as
`
`well as the methods of operation and functions of the related elements of structure and
`
`the combination of parts and economies of manufacture, will become more apparent upon
`
`consideration of the following description and the appended claims with reference to the
`
`accompanying drawings, all of which form a part of this specification, wherein like
`
`reference numerals designate corresponding parts in the various figures. It is to be
`
`expressly understood, however, that the drawings are for the purpose of illustration and
`
`description only and are not intended as a definition of the limits of the invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a side perspective view of a patient interface assembly according
`
`to the principles of the present invention;
`
`FIG. 2 is a front view of the patient interface assembly of FIG. 1;
`
`FIG. 3 is an exploded view of a nasal interface device and cradle in the
`
`patient interface assembly of FIG. 1;
`
`FIG. 4 is a side view of the nasal interface device and cradle of FIG. 4;
`
`FIG. 5 is an exploded view of the nasal interface device and formable
`
`support in the patient interface assembly of FIG. 1;
`
`FIG. 6 is an exploded view of the cradle and the exhaust diffusion plates
`
`in the patient interface assembly of FIG. 1;
`
`FIG. 7 is a perspective view of the exhaust diffusion plates of FIG. 6;
`
`FIG. 8 is a cross-sectional view of the exhaust diffusion plates of FIG. 7;
`
`FIG. 9 is an exploded view of the length adjustment assembly and the
`
`adjustment assembly in the patient interface assembly of FIG. 1;
`
`[11]
`
`[12]
`
`[13]
`
`[14]
`
`[15]
`
`[16]
`
`[17]
`
`[18]
`
`[19]
`
`3
`
`RMD
`EXHIBIT 1021 - PAGE 8
`
`

`

`[20]
`
`[21]
`
`[22]
`
`[23]
`
`[24]
`
`[25]
`
`[26]
`
`[27]
`
`[28]
`
`[29]
`
`[30]
`
`[31]
`
`[32]
`
`[33]
`
`[34]
`
`[35]
`
`FIG. 10 is a side view of the length adjustment assembly and the
`
`adjustment assembly of FIG. 9;
`
`FIG. 11 is a rear perspective view of the length adjustment assembly and
`
`the adjustment assembly of FIG. 9;
`
`FIG. 12 is a cross-sectional view of the length adjustment assembly and
`
`the adjustment assembly of FIG. 9;
`
`FIG. 13 is a perspective view of the headgear and mounting assembly of
`
`FIG.1;
`
`FIG. 14 is a front view of the headgear and mounting assembly in the
`
`patient interface assembly of FIG.1;
`
`FIG. 15 is a top view of the headgear and mounting assembly of FIG.14;
`
`FIGS. 16a-16d show different sizes of the nasal interface device and
`
`support of FIG. 1;
`
`FIGS. 17a-17c are cross-sectional views of the nasal interface device of
`
`FIG. 16a;
`
`of FIG. 16c;
`
`FIGS. 18a and 18c are cross-sectional views of the nasal interface device
`
`FIGS. 18b is a bottom view of the nasal interface device of FIG. 16c;
`
`FIG. 19a is a perspective view of a nasal interface device and an alternate
`
`embodiment for the formable support;
`
`FIG. 19b shows an exploded view of a nasal interface device and cradle
`
`according to another alternate embodiment;
`
`FIG. 19c shows a perspective view of a nasal cushion and support
`
`according to the embodiment of FIG. 19b;
`
`FIG. 20 is a cross-sectional side view of alternate embodiment having a
`
`ball and socket connection;
`
`FIG. 21a is a perspective view of an alternate embodiment for the length
`
`adjustment assembly and the adjustment assembly;
`
`FIG. 21b is a side view of the length adjustment assembly and the
`
`adjustment assembly of FIG. 21a;
`
`4
`
`RMD
`EXHIBIT 1021 - PAGE 9
`
`

`

`[36]
`
`[37]
`
`[38]
`
`[39]
`
`[40]
`
`[41]
`
`FIG. 21c is a cross-sectional side view of the length adjustment assembly
`
`and the adjustment assembly of FIG. 21a;
`
`FIG. 21c is a perspective view of the interior of the press and release
`
`buttons of the length adjustment assembly and the adjustment assembly of FIG. 21a;
`
`FIGS. 22a and 22b are side and perspective views of an alternate
`
`embodiment of the present invention on a patient, and FIG. 22c is a close-up view of the
`
`adjustment assembly of FIG. 22a;
`
`FIG. 23 is a side view of an alternate embodiment of the headgear
`
`assembly;
`
`and
`
`Fig, 24 shows another alternate embodiment of the adjustment assembly;
`
`FIG. 25 show another alternate embodiment of the adjustment assembly
`
`for the harness assembly.
`
`DETAILED DESCRIPTION OF THE PRESENTLY
`PREFERRED EMBODIMENTS OF THE INVENTION
`
`[42]
`
`FIGS. 1-15 illustrate an exemplary embodiment of a patient interface
`
`assembly 10 according to the principles of the present invention. The patient interface
`
`assembly 10 supports a patient interface device 12 on a patient's head. Patient interface
`
`device 12 communicates a flow of breathing gas between the patient's airway and a
`
`pressure generating device 14, such as a ventilator, CPAP device, or variable pressure
`
`device, e.g., a BiPAP® device manufactured and distributed by Respironics, Inc. of
`
`Pittsburgh, PA, or an auto-titration pressure support system. A BiPAP® device is a bi-
`
`level device in which the pressure provided to the patient varies with the patient's
`
`respiratory cycle, so that a higher pressure is delivered during inspiration than during
`
`expiration. An auto-titration pressure support system is a system in which the pressure
`
`varies with the condition of the patient, such as whether the patient is snoring or
`
`experiencing an apnea or hypopnea.
`
`[43]
`
`Communicating a flow of breathing gas between the patient's airway and
`
`a pressure generating device 14 includes delivering a flow of breathing gas to the patient
`
`5
`
`RMD
`EXHIBIT 1021 - PAGE 10
`
`

`

`from the pressure generating device and exhausting a flow of gas from the patient to
`
`ambient atmosphere.
`
`[44]
`
`The system for delivering a breathing gas to a patient according to the
`
`present invention comprises a pressure or gas flow generating device 14 that produces a
`
`flow of gas, a conduit 16, which is also referred to as a patient circuit, having a first end
`
`portion 18 operatively coupled to the gas flow generating device and a second end
`
`portion 20. Conduit 16 carries the flow of gas from pressure generating device 14 during
`
`operation of the system to patient interface device 12 coupled to second end portion 20 of
`
`conduit 16. A headgear 22 according to the principles of the present invention, includes a
`
`mounting assembly 24 that couples patient interface device 12 to conduit 16, and an
`
`adjustable harness assembly 26.
`
`[45]
`
`In the illustrated embodiment the patient interface device 12 is a nasal
`
`interface device. However, the present invention also contemplates that other devices for
`
`communicating a flow of gas to an airway of a patient, such as a nasal mask, oral mask,
`
`or mouthpiece, or combination nasal/oral masks, are suitable for use as patient interface
`
`device 12.
`
`[46]
`
`Patient interface device 12 is generally a nasal interface having a nasal
`
`cushion 28 and a pair of laterally spaced nares elements 30 at its distal end for insertion
`
`into the nostrils of the patient. See FIGS. 3-4. The body of nasal cushion 28 includes a
`
`hollow chamber and extends from an oval shaped opening 32 to laterally spaced outlet
`
`legs 34. Each outlet leg 34 is provided with one of nares element 30. The body of nasal
`
`cushion 28 curves about an axis substantially perpendicular to a plane separating the two
`
`nares elements. Each nares element 30 has an opening 36 to communicate with the nasal
`
`passages of the patient. Each of nares elements 30 is substantially dome-shaped having
`
`an elliptical base proportional to anthropometrical data of a nostril opening. Nasal
`
`cushion 28 is preferably formed from a soft cushiony material, such as silicone,
`
`appropriately soft thermoplastic elastomers, closed cell foam, or thin materials.
`
`[47]
`
`The curved surface of nasal cushion 28 includes an inner curved surface
`
`38 and an outer curved surface 40 substantially concentric to inner curved surface 38.
`See FIG. 4. A formable support 42 is preferably mounted to outer curved surface 40.
`
`6
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`EXHIBIT 1021 - PAGE 11
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`Formable support 42 provides support to nasal cushion 28 while allowing for adjustments
`
`to provide increased fit and comfort of the nasal cushion. In the illustrated embodiment,
`
`formable support 42 is substantially T-shaped having a stem portion 44 and a cross
`
`portion 46. See FIG. 5. Cross portion 46 extends from one end of stem portion 44 at a
`
`cross portion midpoint 48. Ends 50 of cross portion 46 curve from midpoint 48.
`
`[48]
`
`In the illustrated embodiment, outer curved surface 40 of nasal cushion 28
`
`includes mounting tabs 52 to mount ends 50 of cross portion 46 of support 42. Ends 50
`
`of the cross portion 46 have through-holes 54 to mount to the corresponding mounting
`
`tabs 52. See FIG. 5.
`
`[49]
`
`Formable support 42 is preferably formed from a formable metal, such as
`
`aluminum. Support 42 can be conformed by pressing on the support with the patient's or
`
`caregiver's fingers. By manipulating the support, the angle of the nasal cushion with
`
`respect to the facial-frontal plane, and/or the angle of nare contact of the nares elements
`
`can be changed.
`
`[50]
`
`Alternatively, formable support 42 could be formed from Nitinol (Nickel
`
`Titanium Naval Ordinance Laboratory), which is known as shape memory metal, or a
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`plastic with a low softening point temperature, such as EVA (Ethylene Vinyl Acetate)
`
`could be used. EVA is commonly used in boil and bite mouthpieces that athletes use.
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`The EVA support in this case could be warmed in hot water and then formed.
`
`[51]
`
`While the illustrated formable support 42 is T-shaped, alternatively, the
`
`support could be Y-shaped. T or Y-shaped supports 42 can be hollow or solid. While the
`
`illustrated embodiments show externally mounted supports, the supports could also be
`
`over-molded within the nasal cushion itself. Alternatively, formable support 42 could be
`
`bonded to the cushion in discreet locations. An alternate shaped formable support 56 is
`
`illustrated in FIG. 19a. In this embodiment, support 56 is formed from a formable wire
`
`generally following the outline of outer curved surface 40 of nasal cushion 28. By having
`
`formable support 56 connected to nasal cushion 28 at discreet locations, there is some
`relative movement between nasal cushion 28 and support 56 during adjustment of the
`support.
`
`7
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`EXHIBIT 1021 - PAGE 12
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`

`

`[52]
`
`In FIGS. 19b and 19c, which illustrated further exemplary embodiments
`
`for the formable support, the support is mounted to outer curved surface 40 of nasal
`
`cushion 28 using three pockets 59 provided on outer curved surface 40. Each pocket
`
`receives an end portion of the formable support. The configurations for attaching the
`
`formable support to the nasal cushion shown in FIGS. 3, 4, and 19a-19c provide an
`
`advantage in that the formable support can be readily attached and detached from the
`
`nasal cushion. This allows formable supports of different stiffness to be used in the same
`
`nasal cushion and allows for easy replacement of the nasal cushion or the formable
`
`support.
`
`[53]
`
`Alternative sizes to the nasal cushion illustrated in the embodiment of
`
`FIGS. 1-15 are shown in FIGS. 16a and 16b, which show smaller sizes and FIGS. 16c
`
`and 16d which show larger sizes. Other views of these nasal cushions are shown in
`
`FIGS. 17a-17c, which show the smaller size nasal cushion, and FIGS. 18a-18c, which
`
`show the larger size cushion.
`
`[54]
`
`The present invention contemplates varying a property of the walls
`
`forming nasal cushion 28, outlet legs 34, and nares elements 30, such as the thickness
`
`and/or elasticity, to provide performance improvements in the patient interface, such as
`
`increased comfort, better mask/patient seal, and/or greater customization capability. For
`
`example, FIGS. 17a-17c illustrates a nasal cushion wall 55 that is relatively thick. A base
`
`portion 57 of a nares element wall 61 is also relatively thick, but tapers as the distance
`
`from base portion 57 increases. Between the relatively thick walled based portion 57 of
`
`nares element wall 61 and nasal cushion wall 55 is a relatively thin wall portion 63.
`
`Providing thin wall portion 63 between these two thick walls allows nares element 30 to
`
`articulate relative to nasal cushion 28 so that the nares element better fits the nostrils of
`
`the user. In addition, the formabilty of the nasal cushion is increased by providing a
`
`relatively deep spacing between outlet legs 34. It is to be understood that a similar
`
`function, whereby the nares elements are moveable relative the nasal cushion, can be
`
`achieved without varying the thickness of the walls. For example, a material having a
`
`relatively high degree of elasticity (stretchable) can be provided at location 63, while
`
`8
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`EXHIBIT 1021 - PAGE 13
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`walls 55 and 61 are formed from a material of lower elasticity. Of course, a combination
`
`of varying wall thickness and elasticity are also contemplated by the present invention.
`
`[55]
`
`In the illustrated embodiments, with the possible exception of that shown
`in FIGS. 19b and 19c, stem portion 44 of T-shaped formable support 42 is receivable in
`
`a corresponding notched portion 68 provided in oval shaped opening 60 of cradle 58.
`
`Alternatively, formable support 42 can be mounted to nasal cushion 28 by corresponding
`
`pockets on outer curved surface 40 of nasal cushion 28, as shown in FIGS. 19b and 19c.
`In the present invention, oval shaped opening 32 of nasal cushion 28 is
`
`[56]
`
`coupled to a coupling elbow or cradle 58. Cradle 58 is substantially curved having an
`oval shaped opening 60 that connects to oval shaped opening 32 of nasal cushion 28. In
`
`the illustrated exemplary embodiment, cradle 58 has a double wall construction 62 and a
`
`generally rigid hollow chamber 64. Opposite end 66 is substantially circular. See FIGS.
`
`3-4. It is to be understood, however, that the present invention contemplates joining
`
`nasal cushion 28 and cradle 58 using other configurations for the cooperating parts. For
`
`example, a groove (double wall) can be provided in end 66 of nasal cushion 28 so that the
`
`end of cradle 58 fits into the groove.
`
`[57]
`
`In the illustrated embodiment, tabs 67 are provided on opposing sides of
`nasal cushion 28 at end 66. Corresponding tab receiving slots 69 are provided on cradle
`58 for receiving tabs when the nasal cushion is properly coupled to the cradle. Tabs 67
`
`and slots 69 assist in aligning the cushion with the receiving end of the cradle. To help
`retain cradle 58 and cushion 28 in an engaged relation, tabs 67 and slots 69 are
`configured and arranged so that the tab cannot be easily pulled apart. For example, in the
`illustrated embodiment, slot 69 has an "arrow" shape and tab 67 is a similar shape. This
`"arrow" shape allows the tab to be readily inserted into the slot due to the wedge-shaped
`tip of the arrow, but prevents disengagement due to the flat back end of the tab abutting
`the flat back ends of the arrow-shaped slot. Of course, other configurations for tab 67
`and slot 69 are provided for accomplishing these functions. In addition, the tab can be
`provided on the cradle and the slot provided in the cushion.
`As shown in FIGS. 4 and 6-8, an outer curved surface 70 of cradle 58
`includes a pair of exhaust diffusion plates 72 having diffusion holes 74 for exhausting
`
`[58]
`
`9
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`EXHIBIT 1021 - PAGE 14
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`exhaled gas from the pressurized system to the atmosphere. Preferably, exhaust diffusion
`
`plates 72 include diffusion holes 74 having a variable tapered internal angle arranged in a
`
`fan pattern. In the illustrated embodiment, exhaust diffusion plates 72 capture a
`
`substantially 180 degree radial diffusion. Although the present invention contemplates
`
`forming the diffusion places and holes in any desired configuration to achieve an almost
`
`infinite number of different diffusion patterns.
`
`[59]
`
`End 66 of cradle 58 is connected to a length adjustment assembly 76,
`
`which adjusts the distance between an adjustment assembly 78 and nasal interface device
`
`12, to accommodate patients having different facial sizes. As shown in FIGS. 1-2 and 9-
`
`12, length adjustment assembly 76 includes a tubular section 80 and an adjustment nut
`
`82. Tubular section 80 is received within adjustment nut 82. A lower end 84 of tubular
`
`section 80 is connected to circular end 66 of cradle 58 using any conventional technique,
`
`such as a friction fitting. Threadings 86 are provided on the exterior of tubular section 80
`
`and an interior of adjustment nut 82. Length adjustment is accomplished by rotating
`
`adjustment nut 82 so that the threadings on adjustment nut 82 engage the threadings on
`
`tubular section 80. Rotating adjustment nut 82 causes tubular section 80 to move up or
`
`down inside a pivot tube 88 coupled to adjustment nut 82. Pivot tube 88 is part of
`
`adjustment assembly 78, which is described in greater detail below.
`
`[60]
`
`Adjustment assembly 78, which is best shown in FIGS. 9-12, is a position
`
`adjustment mechanism with pre-fixed angular locating positions to control the position of
`
`the rigid gas flow conduit relative to the patient's face over a relatively large range of
`
`anlgles, e.g., a 45° range. In addition to this relatively large adjustment capability,
`
`adjustment assembly provides force adjustment by an integrated spring on a secondary
`
`pivoting member over in a narrower range of angles, e.g., 5° range. The adjustment
`
`assembly allows a cantilevered support to support the patient interface device without a
`
`set of headgear straps located at the patient interface device.
`
`[61]
`
`Adjustment assembly 78 includes an adjustment mechanism that itself
`
`includes a mounting bracket 90, an angular pivot housing 92 and pivot tube 88.
`
`Mounting bracket 90 is attached to harness assembly 26 of headgear 22 and comprises a
`pair of substantially parallel mounting bracket arms 94 extending from a harness
`
`-10-
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`RMD
`EXHIBIT 1021 - PAGE 15
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`

`

`assembly attaching portion 96. Each mounting bracket arm 94 is substantially L-shaped
`
`and extends outward from harness assembly attaching portion 96 of mounting bracket 90
`
`to a bend portion 98 before extending upwardly to a distal portion 100. Each distal
`
`portion 100 includes a plurality of spaced locking/adjustment key holes 102. In the
`
`illustrated embodiment, nine key holes 102 are provided on each distal portion 100
`
`corresponding to nine preset positions, which are about 5 degrees apart covering a total
`
`angular range of 45 degrees.
`
`[62]
`
`Bend portion 98 of each mounting bracket arm 94 includes a pivot hole
`
`104. A pivot axis 106 extends between pivot holes 104 in mounting bracket arms 94.
`
`Both angular pivot housing 92 and pivot tube 88 pivot relative to mounting bracket 90
`
`independently about axis 106. Angular pivot housing 92 is mounted between the
`
`mounting bracket arms 94 and includes a substantially circular bracket 108 having an
`
`interior annular opening 11