WO2011080605A1 - Ensemble coussinet comprenant une enveloppe externe et un élément de support - Google Patents

Ensemble coussinet comprenant une enveloppe externe et un élément de support Download PDF

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Publication number
WO2011080605A1
WO2011080605A1 PCT/IB2010/055230 IB2010055230W WO2011080605A1 WO 2011080605 A1 WO2011080605 A1 WO 2011080605A1 IB 2010055230 W IB2010055230 W IB 2010055230W WO 2011080605 A1 WO2011080605 A1 WO 2011080605A1
Authority
WO
WIPO (PCT)
Prior art keywords
wall
outer casing
patient
pad assembly
interface device
Prior art date
Application number
PCT/IB2010/055230
Other languages
English (en)
Inventor
Peter Chi Fai Ho
Lance Ranard Busch
Original Assignee
Koninklijke Philips Electronics N.V.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Koninklijke Philips Electronics N.V. filed Critical Koninklijke Philips Electronics N.V.
Publication of WO2011080605A1 publication Critical patent/WO2011080605A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
    • A61M16/0644—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position
    • A61M16/0655—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position in the form of a linear or curvilinear slide

Definitions

  • the present invention pertains to a foam insert filled pad for use with a support system for a patient interface device, and, in particular to a forehead support system for a patient interface device for supplying a flow of gas to a patient.
  • the invention further pertains to a gas delivery system that incorporates such a forehead support system using such a foam insert filled pad.
  • NMV non-invasive ventilation
  • CPAP continuous positive airway pressure
  • variable airway pressure such as a bi-level pressure that varies with the patient's respiratory cycle or an auto-titrating pressure that varies with the monitored condition of the patient.
  • Typical pressure support therapies are provided to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or congestive heart failure (CHF).
  • OSA obstructive sleep apnea
  • COPD chronic obstructive pulmonary disease
  • CHF congestive heart failure
  • a patient interface device which is typically a nasal or nasal/oral mask
  • a patient interface device which is typically a nasal or nasal/oral mask
  • a ventilator or pressure support system 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.
  • a headgear having upper and lower straps, each having opposite ends threaded through connecting elements provided on the opposite sides and top of a mask.
  • the pad assembly for use with a patient interface device in delivering a flow of gas to an airway of a patient.
  • the pad assembly includes an outer casing having a housing portion and a mounting portion.
  • the housing portion includes a first wall and a second wall defining a hollow cavity therebetween.
  • the first wall is structured to engage a portion of the patient and the mounting portion is structured to couple the outer casing to the patient interface device .
  • the pad assembly further includes a support element disposed substantially within the cavity of the outer casing.
  • a patient interface device including a mask shell, a seal member, and a support having a pad assembly.
  • the mask shell having a patient side and an outer side opposite the patient side adapted for receiving a flow of gas.
  • the seal member having a first end portion adapted to contact a first area of a patient's face to form a seal therewith and a second end portion opposite the first end portion, the second end portion coupled to the mask shell.
  • the support member coupled to the mask shell.
  • the pad assembly including an outer casing having a housing portion and a mounting portion.
  • the housing portion having a first wall and a second wall defining a hollow cavity therebetween.
  • the first wall is structured to engage a portion of the patient
  • the mounting portion is structured to couple the outer casing to the support member, the pad assembly further including a support element disposed substantially within the cavity of the outer casing.
  • a further embodiment of the present invention provides a method of providing a customizable pad assembly for use with a patient interface device for delivering a flow of gas to an airway of a patient.
  • the method includes providing an outer casing having a housing portion and a mounting portion.
  • the housing portion having a first wall and a second wall defining a hollow cavity therebetween.
  • the first wall being structured to engage a portion of the patient, and the mounting portion being structured to couple the outer casing to the patient interface device.
  • the method further including providing a plurality of support elements, each support element being disposable substantially within the cavity of the outer casing.
  • FIG. 1 is a perspective view a patient interface device that includes a forehead support system having a modular pad according to the principles of an exemplary embodiment of the present invention shown (schematically) connected to a gas flow generating device;
  • FIG. 2 is a partial side of the mask and forehead support system of FIG. 1;
  • FIG. 3 is an exploded view of the mask and forehead support system of
  • FIG. 1 is a diagrammatic representation of FIG. 1 ;
  • FIGS. 4-6 and 12 are views of an outer casing of a pad assembly
  • FIGS. 7 and 8 are views of a support element of a pad assembly according to an exemplary embodiment of the invention.
  • FIG. 9 is a view of a pad assembly incorporating the outer casing of FIGS.
  • FIG 10 is a view of a support element of a pad assembly according to another exemplary embodiment of the invention.
  • FIG. 11 is a view of a pad assembly incorporating the outer casing of
  • top, bottom, left, right, upper, lower, front, back, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein.
  • a component that includes pieces that are created separately and then coupled together as a unit is not a "unitary" component or body.
  • the statement that two or more parts or components "engage” one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components.
  • the term “number” shall mean one or an integer greater than one (i.e., a plurality).
  • fastener and “attachment mechanism” refer to any known or suitable securing mechanisms for securing one part to another part, and expressly include, but are not limited to mechanical mechanisms, Velcro, snaps and adhesives.
  • number shall mean one or an integer greater than one (i.e., a plurality).
  • FIGS. 1-3 illustrate an exemplary embodiment of a patient interface
  • Patient interface device 10 functions to communicate a flow of breathing gas between a patient's airway and a pressure generating device 12 (shown schematically), such as a ventilator, CPAP device, autotitrating CPAP device, PPAP, PAV®, or variable pressure device, e.g. a BiPAP® device manufactured and distributed by Phillips Respironics, Inc. of Pittsburgh, Pa., 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.
  • a pressure generating device 12 shown schematically
  • a pressure generating device 12 shown schematically
  • a pressure generating device 12 shown schematically
  • a pressure generating device 12 shown schematically
  • a pressure generating device 12 shown schematically
  • a ventilator such as a ventilator, CPAP device, autotitrating CPAP device, PPAP, PAV®, or variable pressure device, e.g. a BiPAP® device manufactured and distributed by Phillips Respir
  • Patient interface device 10 in the form of a gas delivery mask for delivering a flow of gas to an airway of a patient.
  • Patient interface device 10 includes a mask shell 14 or body portion, which is preferably, but not necessarily, a generally rigid, formed structural shell having an open side that defines an annular portion 16 to which a resilient, relatively soft cushion or seal member 18 is attached.
  • mask shell 14 is substantially triangular in shape, having an upper apex angle 20 and two lower angles 22.
  • Mask shell 14 includes an inlet opening 24 adapted to receive a gas supply conduit 26 (shown schematically).
  • gas supply conduit 26 shown schematically.
  • mask shell 14 is formed from rigid plastic, such as Polycarbonate.
  • Seal member 18 is configured to receive a portion of the patient, such as the nose.
  • FIGS. 1-3 The mask illustrated in FIGS. 1-3 is a typical nasal mask. It is to be
  • the present invention can be used on any patient interface device either nasal, oral, oral-nasal or nasal cannula system, as long as the mask employs a separate support or supports that contact any part of the face other than the sealing area.
  • the exemplary embodiment shown in the figures is a forehead pad piece, which is conventionally placed above the cushion (sealing element) on the forehead of a patient, the present invention may be employed with other external supports (e.g., without limitation, cheek pads).
  • a lower headgear connector assembly 28 includes a pair of first connectors 30 rigidly attached to lower angles 22 of mask shell 14.
  • Lower headgear straps (not shown) in headgear assembly are selectively connected to mask 10 by means of a second connector 32.
  • a pair of second connectors 32 are removably connectable to end portions of headgear straps (not shown) and are also removably connectable to first connectors 30 on each side of mask shell 14.
  • lower headgear connector assembly 28 can be any suitable headgear connector assembly.
  • the headgear can be any suitable headgear, i.e., any conventional headgear used in the patient interface field.
  • a typical headgear assembly comprises a headpiece (not shown) that overlies a portion of the patient's crania and with a pair of lower headgear straps and a pair of upper headgear straps extending therefrom to adjustably connect the headgear to the mask.
  • a forehead support 34 according to the illustrated exemplary
  • Forehead support 34 in this embodiment is provided at upper apex angle 20.
  • FIG. 2 Forehead support bracket 40 includes a forehead pad assembly 50 (FIGS. 2 and 3) on the patient contacting side which is discussed in further detail below.
  • Each end portion 42 of forehead support bracket 40 may include a connector element 44 for securing an upper headgear strap 46.
  • connector element 44 is a female receiving slot for receiving a male quick release element 48 attached to an upper headgear strap 46.
  • FIGS. 1-3 connector element 44 is a female receiving slot for receiving a male quick release element 48 attached to an upper headgear strap 46.
  • other connection mechanisms could be used.
  • Pad assembly 50 forms the actual contact point of forehead support
  • bracket 40 to the forehead of the patient (shown in phantom line in FIG. 2) and includes an outer casing 52 and a support element 54.
  • Outer casing 52 has a generally hollow springy structure preferably formed from a rubbery material such as silicone or thermoplastic elastomer (TPE) or other suitable material, which is preferably
  • outer casing 52 will be relatively easy to wipe clean, and will also function to prevent the undesired entry of moisture into support element 54 contained therein, as will be described below.
  • outer casing 52 was molded in a silicone rubber with hardness about 20 to 40 Shore A with a wall thickness from about 0.75 millimeters to about 1.5 millimeters.
  • outer casing 52 includes a mounting portion 56 and a housing portion 58.
  • Mounting portion 56 is of slightly curved shape and includes a first side 60, an opposite second side 62 and an opening 64 passing therebetween.
  • a number of coupling mechanisms 66 extend from first side 60 of mounting portion 56 for use in coupling pad assembly 50 to forehead support bracket 40.
  • coupling mechanisms 66 comprise protrusions that are connectable to respective openings (not illustrated) on forehead support bracket 40.
  • housing portion 58 is
  • First wall 68 and second wall 70 of housing portion 58 generally define a cavity 72 therebetween, as shown in hidden line drawing in FIG. 5.
  • FIGS. 7 and 8 show an exemplary support element 54 according to an embodiment of the invention in which support element 54 is custom formed from a "closed" cell skinned foam material, such as a silicone-foam material formed to cooperatively fit within cavity 72 of housing portion 58 of outer casing 52, as shown by phantom line in the pad assembly 50 of FIG. 9.
  • the flexible nature of outer casing 52 and support element 54 allow for the insertion of support element 54 into outer casing 52 via opening 64. Once installed, outer casing 52 substantially surrounds support element 54.
  • a silicone-foam material having a density (pcf) of about 14.5, a softness (Shore 000) of about 20-25, and an average cell size (mm in diameter) of about 0.5 (fairly uniform ranging from about 0.2 to 0.8) in open cell structure, has been employed.
  • a polyurethane foam either Ester or Ether having a density (pcf) of about 8.5, a softness (Shore 000) of about 20-25, and an average cell size (mm in diameter) of about 0.5 (fairly uniform ranging from about 0.2 to 0.8) in open cell structure, has been employed.
  • support element 54 may also be formed from an "open" cell soft foam material such as, for example without limitation, any non structural foam with compression and expansion capability, typical materials are Polystyrene and Polyurethane.
  • Such "open” cell foam material may be die cut, such as shown by support element 54' of FIG. 10.
  • Such "open” cell material may be suitably formed to have a desired shape, such as, for example without limitation, the shape of support element 54 of FIGS. 7-9. In either case, the rather soft nature of support element 54' will generally result in support element 54' contouring to the shape of cavity 72 as shown in phantom line in the pad assembly 50' of FIG. 11.
  • support element 54 may also be formed from any suitable resilient cushioning material, and may include, for example and without limitation, more than one element and/or different sizes or variations of elements formed from alternative materials, such as gel, foam, silicone, or viscoelastic foam or memory foam. Additionally, the selection of the particular material employed as support element 54 or, at minimum, particular attributes of the material, may be left up to the end user (patient) to allow for custom tailoring of the pad assembly 50 by the patient. In such instances, a number of different types of interchangeable support elements 54 would be supplied from which the patient could pick and choose as desired.

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  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

L'ensemble coussinet (50) ci-décrit peut être utilisé avec un masque d'administration de gaz (10) destiné à administrer un flux de gaz aux voies aériennes d'un patient. Il comprend une enveloppe externe (52) et un élément de support (54). L'enveloppe externe comporte une partie logement (58) et une partie montage (56). La partie logement a une première paroi (68) et une seconde paroi (70) définissant une cavité creuse (72) entre elles. La première paroi est structurée de façon à venir au contact d'une partie du patient, et la partie montage est structurée de façon à relier l'enveloppe externe au dispositif d'interface Patient. L'élément de support est sensiblement agencé à l'intérieur de la cavité de l'enveloppe externe.
PCT/IB2010/055230 2009-12-28 2010-11-17 Ensemble coussinet comprenant une enveloppe externe et un élément de support WO2011080605A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US29033809P 2009-12-28 2009-12-28
US61/290,338 2009-12-28

Publications (1)

Publication Number Publication Date
WO2011080605A1 true WO2011080605A1 (fr) 2011-07-07

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2010/055230 WO2011080605A1 (fr) 2009-12-28 2010-11-17 Ensemble coussinet comprenant une enveloppe externe et un élément de support

Country Status (1)

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WO (1) WO2011080605A1 (fr)

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4907584A (en) 1988-03-03 1990-03-13 Mcginnis Gerald E Respiratory mask
US5243971A (en) 1990-05-21 1993-09-14 The University Of Sydney Nasal mask for CPAP having ballooning/moulding seal with wearer's nose and facial contours
US5517986A (en) 1993-09-28 1996-05-21 Respironics, Inc. Two-point/four-point adjustable headgear for gas delivery mask
US5570689A (en) 1993-09-30 1996-11-05 Respironics, Inc. Respiratory mask having a vertically adjustable spacer element that limits seal deformation on a wearer's face
US6119693A (en) 1998-01-16 2000-09-19 Resmed Limited Forehead support for facial mask
US6357441B1 (en) 1996-07-26 2002-03-19 Resmed Limited Nasal mask and mask cushion therefor
EP1205205A2 (fr) * 2000-11-14 2002-05-15 GOTTLIEB WEINMANN GERÄTE FÜR MEDIZIN UND ARBEITSSCHUTZ GMBH & CO. Dispositif d'appui
WO2003105921A2 (fr) * 2002-06-14 2003-12-24 Map Medizin-Technologie Gmbh Coussin de masque et coussinet frontal pour un masque respiratoire, masque respiratoire, ainsi qu'outil de moulage et procede pour leur production
DE102005033649A1 (de) * 2005-07-19 2007-01-25 Map Medizin-Technologie Gmbh Stirnauflageeinrichtung für eine Atemmaskenanordnung
US20070163594A1 (en) * 2005-12-20 2007-07-19 Ho Peter C F Patient interface device with dampening cushion
DE102007022639A1 (de) * 2007-05-15 2008-11-20 Weinmann Geräte für Medizin GmbH & Co. KG Dichtesenkung bei Gelen und Silikonfüllungen
US20080289633A1 (en) * 2007-04-11 2008-11-27 Resmed Limited Mask with gel component

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4907584A (en) 1988-03-03 1990-03-13 Mcginnis Gerald E Respiratory mask
US5243971A (en) 1990-05-21 1993-09-14 The University Of Sydney Nasal mask for CPAP having ballooning/moulding seal with wearer's nose and facial contours
US5517986A (en) 1993-09-28 1996-05-21 Respironics, Inc. Two-point/four-point adjustable headgear for gas delivery mask
US5570689A (en) 1993-09-30 1996-11-05 Respironics, Inc. Respiratory mask having a vertically adjustable spacer element that limits seal deformation on a wearer's face
US6357441B1 (en) 1996-07-26 2002-03-19 Resmed Limited Nasal mask and mask cushion therefor
US6119693A (en) 1998-01-16 2000-09-19 Resmed Limited Forehead support for facial mask
EP1205205A2 (fr) * 2000-11-14 2002-05-15 GOTTLIEB WEINMANN GERÄTE FÜR MEDIZIN UND ARBEITSSCHUTZ GMBH & CO. Dispositif d'appui
WO2003105921A2 (fr) * 2002-06-14 2003-12-24 Map Medizin-Technologie Gmbh Coussin de masque et coussinet frontal pour un masque respiratoire, masque respiratoire, ainsi qu'outil de moulage et procede pour leur production
DE102005033649A1 (de) * 2005-07-19 2007-01-25 Map Medizin-Technologie Gmbh Stirnauflageeinrichtung für eine Atemmaskenanordnung
US20070163594A1 (en) * 2005-12-20 2007-07-19 Ho Peter C F Patient interface device with dampening cushion
US20080289633A1 (en) * 2007-04-11 2008-11-27 Resmed Limited Mask with gel component
DE102007022639A1 (de) * 2007-05-15 2008-11-20 Weinmann Geräte für Medizin GmbH & Co. KG Dichtesenkung bei Gelen und Silikonfüllungen

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