WO2000021600A1 - Nasal respirator for treating respiratory disorders, in particular sleep apnea - Google Patents

Nasal respirator for treating respiratory disorders, in particular sleep apnea Download PDF

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Publication number
WO2000021600A1
WO2000021600A1 PCT/FR1999/002447 FR9902447W WO0021600A1 WO 2000021600 A1 WO2000021600 A1 WO 2000021600A1 FR 9902447 W FR9902447 W FR 9902447W WO 0021600 A1 WO0021600 A1 WO 0021600A1
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WO
WIPO (PCT)
Prior art keywords
mask
ring
user
shell
fixing
Prior art date
Application number
PCT/FR1999/002447
Other languages
French (fr)
Inventor
Pierre Biellette De Villemeur
Original Assignee
Taema
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 Taema filed Critical Taema
Priority to EP99947541A priority Critical patent/EP1121172A1/en
Priority to AU60950/99A priority patent/AU6095099A/en
Priority to JP2000575572A priority patent/JP2002527155A/en
Publication of WO2000021600A1 publication Critical patent/WO2000021600A1/en

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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
    • A61M16/0683—Holding devices therefor

Definitions

  • ⁇ .TCSTTNT ⁇ TTY TP A TTIRENT.
  • the present invention relates to a nasal respiratory mask capable of being used to treat or prevent respiratory disorders in a user, such as sleep apnea.
  • respiratory masks are commonly used for various and varied purposes, in particular for administering oxygen or mixtures of oxygen-enriched air to persons suffering from pulmonary problems, for administering anesthetic gases during the preoperative phase, for administering pressurized air for people suffering from respiratory disorders, for example sleep apnea, as part of a CPAP (Continous Positive Airway Pressure) type of treatment or a treatment using two pressure levels .
  • CPAP Continuous Positive Airway Pressure
  • Breathing masks therefore make it possible to interface between barometric and / or volumetric medical ventilation devices and patients to be supplied with respiratory assistance gas.
  • respiratory masks are made by molding plastic materials and shaped to fit the contours of the user's nasal region.
  • nasal breathing masks there are two main types of nasal breathing masks, namely: - those covering the nasal region, and
  • the seal is produced around the nose, as described in documents DE-A-8813445 or FR-A-2749176.
  • the seal is made at each nostril.
  • Masks with nasal tips have the advantage of avoiding contact with the bridge of the patient's nose, which bridge of the nose is an area usually very sensitive to the support of industrial masks.
  • masks of this type are difficult to maintain in a good position because of the small contact surface with the face, which is limited to a part of the internal region of the nostrils. It follows that the masks covering at least the nose are the most used.
  • the layout of the gas supply may vary, but the majority of them have a central gas supply orifice, the connection of which to the gas supply circuit of the breathing assistance device or the source of pressurized gas is produced using a connector or similar device.
  • the mask may include several gas supply ports, as described in document US-A-4,944,310.
  • the document EP-A-462701 proposes a nasal mask comprising a shell shaped to cover the nasal region of the user. , on which the shell is mounted a membrane of an elastomeric material capable of distending to define a chamber having an externally convex end region with thin walls which can swell outwards when the mask is in use, that is to say when placed in position on the user's nose.
  • document WO-A-96/28207 describes a facial ventilation mask provided with a concave rigid shell with an orifice for connection to a ventilation device, which shell has a particular shape encompassing not only the entire nose and of the mouth, but also a good part of the face, namely the whole of the adjacent part of the face defined externally by the malar bone, the scale of the temporal bone and the lower maxilla.
  • This very form mask extension is intended to improve the sealing of the mask, that is to say to minimize gas leaks, by means of a continuous pressing of the internal surface of the mask on the aforementioned regions of the face.
  • this mask has many drawbacks, in particular in terms of space and discomfort for the patient, in particular when the latter must wear the mask during his sleep to fight against sleep-disordered breathing, such as sleep apnea.
  • a first object of the present invention is therefore to propose a nasal mask which does not have the drawbacks of existing masks.
  • Another object of the present invention is also to provide a nasal respiratory mask whose weight is compatible with night use and which has significant plasticity, that is to say a faculty of being able to conform as precisely as possible to the face of the patient wearing this mask.
  • Another object of the present invention is to provide a nasal mask having great comfort in use, even during a repeated and prolonged application of this mask.
  • the nasal mask according to the invention must be able to be used daily for several consecutive hours so as to transmit a pressure and / or a flow of gas to the upper airways of the patient, in accordance with medical prescriptions.
  • the nasal mask must not generate any leaks other than those planned and calibrated inside this device.
  • the invention also intends to solve the problem of the correct and effective adaptation and positioning of the mask on the patient's face, regardless of the morphology of said patient.
  • the present invention therefore relates to a respiratory mask comprising a shell defining a nasal chamber, internal and hollow, shaped to cover at least part of the nasal region of a user.
  • said shell comprises at least two lateral expansions or wings capable of coming to bear on at least part of the user's face, preferably on the regions of the face close to the nose, when said mask is in position on said nasal region of said user, said shell comprises at least one gas supply orifice and connection means, arranged at said gas supply orifice, the connection means comprising at least one connector comprising at least one ring, said ring comprising attachment means comprising attachment holes capable of cooperating with holding means, the attachment holes being in several fixing positions, so as to allow positioning and effective holding of the mask on the face of the user depending on the morphology of the face of said user and thus ensuring an effective seal.
  • the mask according to the invention can comprise one or more of the following characteristics: said shell and said at least two lateral expansions are made of a polymer material, preferably silicone; said shell and said at least two lateral expansions form a single piece capable of having been manufactured by molding; - Said at least two lateral expansions are arranged symmetrically with respect to each other;
  • At least two lateral expansions have a dimension of between 1 and 5 cm;
  • the gas supply orifice crosses the wall of the shell so as to be able to supply the interior of the nasal chamber with a gas under pressure conveyed by one or more gas pipes;
  • connection means allowing at least the connection of the mask to a source of pressurized gas via one or more gas pipes, preferably a flexible and / or flexible gas pipe;
  • connection means comprise at least one connector comprising at least one ring;
  • the connector comprises an elbow connector making it possible to connect at least one gas pipe to said mask, said connector being able to be movable or not in rotation relative to the axis of the gas supply orifice;
  • Said ring includes attachment means, in particular attachment holes capable of cooperating with holding means, in particular straps or straps;
  • the holding means are straps, straps or a fixing harness, preferably a fixing harness with hooks;
  • the fixing harness comprising three adjustable straps each provided with a fixing hook;
  • the ring comprising hooking means comprising two symmetrical lateral hooking orifices each comprising three different fixing positions to allow the fixing site of the hook harness to be modified;
  • the harness consists of several straps and or straps, elastic or not, provided at their ends with fixing hooks capable of coming to cooperate with the symmetrical lateral hooking orifices arranged in the ring.
  • FIG. 1 represents a general view and seen slightly in profile, of a respiratory nasal mask according to the invention, which is positioned on the nasal region of a user 8.
  • the nasal mask 1 comprises a shell 2 defining a nasal chamber 3, which nasal chamber 3 is shaped to cover at least part of the nasal region of the user 8, that is to say to cover at least the nose of one user.
  • the shell 2 comprises two lateral extensions 4, symmetrical and intended to come to bear on a part of the face of the user 8 when said mask 1 is in position on the nasal region of the user 8, so as to ensure and improve and on the one hand, the seal, and on the other hand, the maintenance in position of the mask 1 on the face.
  • the shell 2 and the lateral extensions 4 are produced in a single molded part, that is to say in a single piece made of a polymer material, such as silicone or the like.
  • connection means 5 and 6 enabling the mask to be connected to a gas source under pressure, such as a ventilator or other breathing assistance device delivering breathing gas at one or more pressure levels.
  • connection means comprise a connector 6 provided with a connection ring 5, which carries hooking means, in particular hooking orifices 11 and a securing orifice 13 capable of cooperating with a harness. 14 with hooks and / or straps and / or similar fixing means.
  • the ring 5 of the connector 6 forms a shoulder, that is to say that it has, here, a shape of a truncated ring from its lower part.
  • the ring 5 comprises, in this case, two symmetrical lateral orifices 11 each comprising three different attachment points 11a to 11e to allow the attachment site of the harness 14 to be modified, in particular via the hook 7, as a function of the morphology of the user 8, so as to allow positioning and effective maintenance of the mask on the face of said user 8.
  • the securing orifice 13 is arranged in the upper part of the ring 5 and equidistant from the two lateral orifices symmetrical 11.
  • FIG. 2 represents a detailed schematic view of a lateral expansion 4 of the shell 2, where it can be seen that, to allow effective maintenance of the mask 1 on the face of the user 8 while distributing the pressure effort and therefore the comfort for the user, a dimension D of between 1 and 5 centimeters and a width L of between 1 and 4 centimeters for each of the two lateral extensions 4 is chosen.
  • the nasal mask according to 1 • invention can be directly connected, via connector 6, to a gas circuit conveying a respiratory flow coming from a source of respiratory gas, such as a respiratory assistance device, up to the airways of a patient.
  • the connector 6 comprises a bent polycarbonate connection and the fixing harness 14 comprises three adjustable straps each provided with a fixing hook 7.
  • the mask according to the present invention can be used for the systematic treatment of respiratory sleep disorders, in particular sleep apnea or snoring.
  • the respiratory mask according to the invention can be either of the nasal type or of the nasal-oral type.

Abstract

The invention concerns a respirator (1) comprising a shell (2) defining a nasal chamber (3). The shell (2) comprises two lateral extensions (4) urged to be supported on the user's face (8) when the respirator (1) is positioned on his nasal region, so as to enhance tightness. The respirator comprises a connector (6) with a ring (5) provided with catching orifices (11) co-operating with a fixing harness (14) consisting of hooked straps (7). The catching orifices (11) have several fixing positions (11a, 11b, 11c), to enable the respirator to be properly positioned and efficiently maintained, whatever be said user's (8) face morphology. The respirator is useful for treating respiratory disorders, in particular sleep apnea.

Description

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La présente invention concerne un masque respiratoire nasal susceptible d'être utilisé pour soigner ou prévenir les troubles respiratoires chez un utilisateur, telle l'apnée du sommeil.The present invention relates to a nasal respiratory mask capable of being used to treat or prevent respiratory disorders in a user, such as sleep apnea.
Actuellement, les masques respiratoires sont communément utilisés à des fins diverses et variées, notamment pour administrer de 1 ' oxygène ou des mélanges d'air enrichi en oxygène aux personnes souffrant de problèmes pulmonaires, pour administrer des gaz anesthésiques pendant la phase préopératoire, pour administrer de l'air sous pression aux personnes souffrant de troubles respiratoires, par exemple l'apnée du sommeil, dans le cadre d'un traitement du type CPAP (pour Continous Positive Airway Pressure) ou d'un traitement mettant en oeuvre deux niveaux de pression.At present, respiratory masks are commonly used for various and varied purposes, in particular for administering oxygen or mixtures of oxygen-enriched air to persons suffering from pulmonary problems, for administering anesthetic gases during the preoperative phase, for administering pressurized air for people suffering from respiratory disorders, for example sleep apnea, as part of a CPAP (Continous Positive Airway Pressure) type of treatment or a treatment using two pressure levels .
Les masques respiratoires permettent donc de faire l'interface entre les appareils médicaux de ventilation barométriques et/ou volumétriques et les patients devant être alimentés en gaz d'assistance respiratoire.Breathing masks therefore make it possible to interface between barometric and / or volumetric medical ventilation devices and patients to be supplied with respiratory assistance gas.
Habituellement, les masques respiratoires sont fabriqués par moulage de matériaux plastiques et conformés pour s'adapter aux contours de la région nasale de l'utilisateur. En fait, il existe deux types principaux de masques respiratoires nasaux, à savoir : - ceux recouvrant la région nasale, etUsually, respiratory masks are made by molding plastic materials and shaped to fit the contours of the user's nasal region. In fact, there are two main types of nasal breathing masks, namely: - those covering the nasal region, and
- ceux comportant des embouts qui s'appliquent au contact des narines à la manière de canules.- those with tips that apply to the nostrils like cannulas.
En fait, ces deux types de masques diffèrent principalement par la manière dont est réalisée 1 "étanchéité.In fact, these two types of masks differ mainly by the way in which 1 "sealing is carried out.
Ainsi, dans le premier cas, l'étanchéité est réalisée autour du nez, ainsi que décrit par les documents DE-A-8813445 ou FR-A-2749176. A l'inverse, dans le second cas, l'étanchéité est réalisée au niveau de chaque narine.Thus, in the first case, the seal is produced around the nose, as described in documents DE-A-8813445 or FR-A-2749176. Conversely, in the second case, the seal is made at each nostril.
Les masques à embouts nasaux présentent 1 ' avantage d'éviter tout contact avec l'arête du nez du patient, laquelle arête du nez est une zone habituellement très sensible à l'appui des masques industriels.Masks with nasal tips have the advantage of avoiding contact with the bridge of the patient's nose, which bridge of the nose is an area usually very sensitive to the support of industrial masks.
Cependant, les masques de ce type sont difficiles à maintenir en bonne position du fait de la faible surface de contact avec le visage, laquelle est limitée à une partie de la région interne des narines. II s'ensuit que les masques recouvrant au moins le nez sont les plus utilisés.However, masks of this type are difficult to maintain in a good position because of the small contact surface with the face, which is limited to a part of the internal region of the nostrils. It follows that the masks covering at least the nose are the most used.
Ceux-ci sont, en général, réalisés en un matériau polymère, tel un chlorure de vinyle ou du silicone, étant donné que ces matières permettent d'éviter ou de minimiser les effets irritant du masque pour la peau du patient.These are, in general, made of a polymeric material, such as vinyl chloride or silicone, since these materials make it possible to avoid or minimize the irritating effects of the mask for the patient's skin.
Selon le masque, la disposition de l'arrivée de gaz peut varier mais la majorité d'entre eux comporte un orifice central d'alimentation en gaz dont le raccordement au circuit d'alimentation en gaz de l'appareil d'assistance respiratoire ou de la source de gaz sous pression est réalisé à l'aide d'un connecteur ou d'un dispositif analogue.Depending on the mask, the layout of the gas supply may vary, but the majority of them have a central gas supply orifice, the connection of which to the gas supply circuit of the breathing assistance device or the source of pressurized gas is produced using a connector or similar device.
A ce titre, on peut citer les documents US-A- 4,655,213, US-A-3 , 580 , 051 et US-A-5 , 117 , 819.As such, we can cite the documents US-A-4,655,213, US-A-3, 580, 051 and US-A-5, 117, 819.
Parfois, le masque peut comprendre plusieurs orifices d'alimentation en gaz, ainsi que décrit dans le document US-A-4,944, 310.Sometimes the mask may include several gas supply ports, as described in document US-A-4,944,310.
En outre, pour obtenir une meilleure étanchéité du masque, lorsque celui-ci est en position sur le visage de l'utilisateur, le document EP-A-462701 propose un masque nasal comprenant une coquille conformée pour recouvrir la région nasale de l'utilisateur, sur laquelle coquille est montée une membrane en un matériau élastomère capable de se distendre pour définir une chambre ayant une région terminale extérieurement convexe à parois mince pouvant se gonfler vers l'extérieur lorsque le masque est en service, c'est-à-dire lorsqu'il est placé en position sur le nez de l'utilisateur.In addition, to obtain a better seal of the mask, when it is in position on the face of the user, the document EP-A-462701 proposes a nasal mask comprising a shell shaped to cover the nasal region of the user. , on which the shell is mounted a membrane of an elastomeric material capable of distending to define a chamber having an externally convex end region with thin walls which can swell outwards when the mask is in use, that is to say when placed in position on the user's nose.
Une alternative à ce type de masque est proposé par les documents O-A-97/09090 qui décrit un masque comportant une coquille destinée à recevoir la région nasale de l'utilisateur, l'étanchéité entre ladite coquille et le visage de l'utilisateur étant obtenue grâce à la présence, sur le contour de la coquille en contact avec le visage du patient, d'une chambre périphérique remplie d'un gel.An alternative to this type of mask is proposed by documents OA-97/09090 which describes a mask comprising a shell intended to receive the nasal region of the user, the seal between said shell and the face of the user being obtained. thanks to the presence, on the contour of the shell in contact with the patient's face, of a peripheral chamber filled with a gel.
Cependant, on a remarqué que de tels masques, qui comportent une membrane souple ou une chambre périphérique remplie de gel, présentent l'inconvénient de devoir remplacer assez fréquemment cette partie relativement fragile qui est en contact constant avec le visage de l'utilisateur.However, it has been noted that such masks, which comprise a flexible membrane or a peripheral chamber filled with gel, have the disadvantage of having to replace this relatively fragile part which is in constant contact with the face of the user quite frequently.
Par ailleurs, le document WO-A-96/28207 décrit un masque de ventilation facial muni d'une coque rigide concave avec un orifice de raccordement à un appareil de ventilation, laquelle coque a une forme particulière englobant non seulement l'intégralité du nez et de la bouche, mais aussi une bonne partie du visage, à savoir la totalité de la partie adjacente du visage définie extérieurement par l'os malaire, l'écaillé de l'os temporal et le maxillaire inférieur. Cette forme très étendue de masque est destinée à améliorer l'étanchéité du masque, c'est-à-dire minimiser les fuites de gaz, grâce à un appui continu de la surface interne du masque sur les régions du visage susmentionnées. Toutefois, on comprend aisément que, de par ses dimensions importantes, ce masque présente de nombreux inconvénients, en particulier en termes d'encombrement et de gêne pour le patient, en particulier lorsque celui-ci doit porter le masque durant son sommeil pour lutter contre des troubles respiratoires du sommeil, telle l'apnée du sommeil.Furthermore, document WO-A-96/28207 describes a facial ventilation mask provided with a concave rigid shell with an orifice for connection to a ventilation device, which shell has a particular shape encompassing not only the entire nose and of the mouth, but also a good part of the face, namely the whole of the adjacent part of the face defined externally by the malar bone, the scale of the temporal bone and the lower maxilla. This very form mask extension is intended to improve the sealing of the mask, that is to say to minimize gas leaks, by means of a continuous pressing of the internal surface of the mask on the aforementioned regions of the face. However, it is easily understood that, by its large dimensions, this mask has many drawbacks, in particular in terms of space and discomfort for the patient, in particular when the latter must wear the mask during his sleep to fight against sleep-disordered breathing, such as sleep apnea.
Un premier but de la présente invention est alors de proposer un masque nasal ne présentant pas les inconvénients des masques existants. Un autre but de la présente invention est également de proposer un masque respiratoire nasal dont le poids soit compatible avec une utilisation nocturne et qui présente une plasticité importante, c'est-à-dire une faculté de pouvoir se conformer aussi précisément que possible au visage du patient portant ce masque.A first object of the present invention is therefore to propose a nasal mask which does not have the drawbacks of existing masks. Another object of the present invention is also to provide a nasal respiratory mask whose weight is compatible with night use and which has significant plasticity, that is to say a faculty of being able to conform as precisely as possible to the face of the patient wearing this mask.
Un autre but de la présente invention est de proposer un masque nasal présentant un grand confort d'utilisation, même lors d'une application répétée et prolongée de ce masque. En effet, le masque nasal selon l'invention doit pouvoir être utilisé de façon quotidienne pendant plusieurs heures consécutives de manière à transmettre une pression et/ou un débit de gaz aux voies aériennes supérieures du patient, conformes aux prescriptions médicales.Another object of the present invention is to provide a nasal mask having great comfort in use, even during a repeated and prolonged application of this mask. Indeed, the nasal mask according to the invention must be able to be used daily for several consecutive hours so as to transmit a pressure and / or a flow of gas to the upper airways of the patient, in accordance with medical prescriptions.
En d'autres termes, étant donné de l'efficacité du traitement dépend de la bonne étanchéité du dispositif d'administration de gaz, le masque nasal ne doit pas générer d'autres fuites que celles prévues et calibrées à l'intérieur de ce dispositif.In other words, given the effectiveness of the treatment depends on the good sealing of the gas delivery device, the nasal mask must not generate any leaks other than those planned and calibrated inside this device. .
Pour y parvenir, il convient donc d'ajuster aussi précisément que possible le masque nasal du patient, c'est-à-dire d'éviter ou de minimiser les fuites au niveau de la région nasale du patient qui représente un réel inconfort pour celui-ci et qui ne peuvent pas être évités uniquement par le biais d'un serrage plus étroit du masque sur le visage du patient, d'autant que le positionnement correct et efficace du masque sur le nez du patient dépend étroitement de la morphologie de celui- ci. De là, l'invention entend aussi résoudre le problème de l'adaptation et du positionnement correct et efficace du masque sur le visage du patient et ce, quelle que soit la morphologie dudit patient.To achieve this, it is therefore necessary to adjust also precisely as possible the patient's nasal mask, that is to say to avoid or minimize leaks in the patient's nasal region which represents real discomfort for the patient and which cannot be avoided solely by the bias of a closer tightening of the mask on the patient's face, especially since the correct and effective positioning of the mask on the patient's nose depends closely on the morphology of the latter. From there, the invention also intends to solve the problem of the correct and effective adaptation and positioning of the mask on the patient's face, regardless of the morphology of said patient.
La présente invention concerne alors un masque respiratoire comprenant une coquille définissant une chambre nasale, interne et creuse, conformée pour recouvrir au moins une partie de la région nasale d'un utilisateur.The present invention therefore relates to a respiratory mask comprising a shell defining a nasal chamber, internal and hollow, shaped to cover at least part of the nasal region of a user.
Selon ce masque, ladite coquille comporte au moins deux expansions latérales ou ailes susceptibles de venir prendre appui sur au moins une partie du visage de l'utilisateur, de préférence sur les régions du visage proches du nez, lorsque ledit masque est en position sur ladite région nasale dudit utilisateur, ladite coquille comporte au moins un orifice d'alimentation en gaz et des moyens de connexion, agencés au niveau dudit orifice d'alimentation en gaz, les moyens de connexion comprenant au moins un connecteur comportant au moins une bague, ladite bague comportant des moyens d'accrochage comprenant des orifices d'accrochage susceptibles de coopérer avec des moyens de maintien, les orifices d'accrochage étant à plusieurs positions de fixation, de manière à permettre un positionnement et un maintien efficace du masque sur le visage de l'utilisateur en fonction de la morphologie du visage dudit utilisateur et assurer ainsi une étanchéité efficace. Selon le cas, le masque selon l'invention peut comprendre l'une ou plusieurs des caractéristiques suivantes : ladite coquille et lesdites au moins deux expansions latérales sont réalisées en un matériau polymère, de préférence en silicone ; ladite coquille et lesdites au moins deux expansions latérales forment une pièce unique susceptible d'avoir été fabriquée par moulage ; - lesdites au moins deux expansions latérales sont agencées symétriquement l'une par rapport à l'autre;According to this mask, said shell comprises at least two lateral expansions or wings capable of coming to bear on at least part of the user's face, preferably on the regions of the face close to the nose, when said mask is in position on said nasal region of said user, said shell comprises at least one gas supply orifice and connection means, arranged at said gas supply orifice, the connection means comprising at least one connector comprising at least one ring, said ring comprising attachment means comprising attachment holes capable of cooperating with holding means, the attachment holes being in several fixing positions, so as to allow positioning and effective holding of the mask on the face of the user depending on the morphology of the face of said user and thus ensuring an effective seal. Depending on the case, the mask according to the invention can comprise one or more of the following characteristics: said shell and said at least two lateral expansions are made of a polymer material, preferably silicone; said shell and said at least two lateral expansions form a single piece capable of having been manufactured by molding; - Said at least two lateral expansions are arranged symmetrically with respect to each other;
- lesdites au moins deux expansions latérales ont une dimension comprise entre 1 et 5 cm ;- Said at least two lateral expansions have a dimension of between 1 and 5 cm;
- l'orifice d'alimentation en gaz traverse la paroi de la coquille de manière à pouvoir alimenter l'intérieur de la chambre nasale avec un gaz sous pression véhiculé par une ou plusieurs canalisations de gaz ;- The gas supply orifice crosses the wall of the shell so as to be able to supply the interior of the nasal chamber with a gas under pressure conveyed by one or more gas pipes;
- les moyens de connexion permettant au moins le raccordement du masque à une source de gaz sous pression par l'intermédiaire d'une ou plusieurs canalisations de gaz, de préférence une canalisation de gaz flexible et/ou souple ;- The connection means allowing at least the connection of the mask to a source of pressurized gas via one or more gas pipes, preferably a flexible and / or flexible gas pipe;
- les moyens de connexion comprennent au moins un connecteur comportant au moins une bague ; - le connecteur comporte un raccord coudé permettant de raccorder au moins une canalisation de gaz audit masque, ledit raccord pouvant être mobile ou non en rotation par rapport à l'axe de l'orifice d'alimentation en gaz ; - ladite bague comporte des moyens d'accrochage, notamment des orifices d'accrochage susceptibles de coopérer avec des moyens de maintien, notamment des lanières ou des sangles;- The connection means comprise at least one connector comprising at least one ring; - The connector comprises an elbow connector making it possible to connect at least one gas pipe to said mask, said connector being able to be movable or not in rotation relative to the axis of the gas supply orifice; - Said ring includes attachment means, in particular attachment holes capable of cooperating with holding means, in particular straps or straps;
- ladite bague comporte orifices d'accrochage à plusieurs positions fixation. - les moyens de maintien sont des lanières, des sangles ou un harnais de fixation, de préférence un harnais de fixation à crochets ;- Said ring has attachment holes with several fixing positions. - The holding means are straps, straps or a fixing harness, preferably a fixing harness with hooks;
- le harnais de fixation comprenant trois sangles réglables munies chacune d'un crochet de fixation ; la bague comportant des moyens d ' accrochage comprenant deux orifices d'accrochage latéraux symétriques comportant chacun trois positions de fixation différents pour permettre de modifier le site de fixation du harnais à crochets ;- the fixing harness comprising three adjustable straps each provided with a fixing hook; the ring comprising hooking means comprising two symmetrical lateral hooking orifices each comprising three different fixing positions to allow the fixing site of the hook harness to be modified;
- le harnais est constitué de plusieurs lanières et ou sangles, élastiques ou non, munies à leurs extrémités de crochets de fixation susceptibles de venir coopérer avec les orifices d'accrochage latéraux symétriques aménagés dans la bague.- The harness consists of several straps and or straps, elastic or not, provided at their ends with fixing hooks capable of coming to cooperate with the symmetrical lateral hooking orifices arranged in the ring.
L'invention va maintenant être décrite plus en détail à l'aide de figures annexées, données à titre illustratif mais non limitatif.The invention will now be described in more detail using the appended figures, given by way of illustration but not limitation.
La figure 1 représente une vue générale et vue légèrement de profil, d'un masque nasal respiratoire selon l'invention, lequel est positionné sur la région nasale d'un utilisateur 8.FIG. 1 represents a general view and seen slightly in profile, of a respiratory nasal mask according to the invention, which is positioned on the nasal region of a user 8.
Plus précisément et ainsi que détaillé sur les figures 1, 2 et 3, le masque 1 nasal selon l'invention comporte une coquille 2 définissant une chambre nasale 3, laquelle chambre nasale 3 est conformé pour recouvrir au moins une partie de la région nasale de l'utilisateur 8, c'est-à-dire pour recouvrir au moins le nez de 1 'utilisateur. La coquille 2 comporte deux extensions latérales 4, symétriques et destinées à venir prendre appuis sur une partie du visage de l'utilisateur 8 lorsque ledit masque 1 est en position sur la région nasale de l'utilisateur 8, de manière à assurer et à améliorer et d'une part, l'étanchéité, et d'autre part, le maintien en position du masque 1 sur le visage. De préférence, la coquille 2 et les extensions 4 latérales sont réalisées en une pièce unique moulée, c'est-à-dire en une pièce monobloc en un matériau polymère, tel du silicone ou analogue. En outre, la coquille 2 du masque 1 est dotée d'un orifice 9 d'alimentation en gaz respiratoire au niveau duquel orifice 9 d'alimentation sont agencés des moyens de connexion 5 et 6 permettant de raccorder le masque à une source de gaz sous pression, tel un ventilateur ou tout autre appareil d'assistance respiratoire délivrant un gaz respiratoire à un ou plusieurs niveau de pression. Dans le cas présent, les moyens de connexion comprennent un connecteur 6 muni d'une bague 5 de connexion, laquelle porte des moyens d'accrochage, notamment des orifices d'accrochage 11 et un orifice d'arrimage 13 susceptibles de coopérer avec un harnais 14 à crochets et/ou des lanières et/ou des moyens analogues de fixation.More precisely and as detailed in FIGS. 1, 2 and 3, the nasal mask 1 according to the invention comprises a shell 2 defining a nasal chamber 3, which nasal chamber 3 is shaped to cover at least part of the nasal region of the user 8, that is to say to cover at least the nose of one user. The shell 2 comprises two lateral extensions 4, symmetrical and intended to come to bear on a part of the face of the user 8 when said mask 1 is in position on the nasal region of the user 8, so as to ensure and improve and on the one hand, the seal, and on the other hand, the maintenance in position of the mask 1 on the face. Preferably, the shell 2 and the lateral extensions 4 are produced in a single molded part, that is to say in a single piece made of a polymer material, such as silicone or the like. In addition, the shell 2 of the mask 1 is provided with an orifice 9 for supplying respiratory gas at the level of which orifice 9 for supplying are arranged connection means 5 and 6 enabling the mask to be connected to a gas source under pressure, such as a ventilator or other breathing assistance device delivering breathing gas at one or more pressure levels. In the present case, the connection means comprise a connector 6 provided with a connection ring 5, which carries hooking means, in particular hooking orifices 11 and a securing orifice 13 capable of cooperating with a harness. 14 with hooks and / or straps and / or similar fixing means.
Comme on le voit sur la figure 4, la bague 5 du connecteur 6 forme un épaulement, c'est-à-dire qu'elle a, ici, une forme d'anneau tronqué de sa partie inférieure.As seen in Figure 4, the ring 5 of the connector 6 forms a shoulder, that is to say that it has, here, a shape of a truncated ring from its lower part.
La bague 5 comporte, dans ce cas, deux orifices latéraux symétriques 11 comportant chacun trois points de fixation différents lia à lie pour permettre de modifier le site de fixation du harnais 14, notamment via le crochet 7, en fonction de la morphologie de l'utilisateur 8, de manière à permettre un positionnement et un maintien efficace du masque sur le visage dudit utilisateur 8. En outre, l'orifice d'arrimage 13 est aménagé dans la partie supérieure de la bague 5 et à égale distance des deux orifices latéraux symétriques 11.The ring 5 comprises, in this case, two symmetrical lateral orifices 11 each comprising three different attachment points 11a to 11e to allow the attachment site of the harness 14 to be modified, in particular via the hook 7, as a function of the morphology of the user 8, so as to allow positioning and effective maintenance of the mask on the face of said user 8. In addition, the securing orifice 13 is arranged in the upper part of the ring 5 and equidistant from the two lateral orifices symmetrical 11.
La figure 2 représente une vue schématique détaillée d'une expansion latérale 4 de la coquille 2, où l'on voit que, pour permettre un maintien efficace du masque 1 sur le visage de l'utilisateur 8 tout en répartissant l'effort de pression et donc le confort pour l'utilisateur, on choisit une dimension D comprise entre 1 et 5 centimètres et une largeur L comprise entre 1 et 4 centimètres pour chacune des deux extensions latérales 4. Le masque nasal selon 1 • invention peut être directement relié, via le connecteur 6, à un circuit de gaz acheminant un flux respiratoire issu d'une source de gaz respiratoire, tel un dispositif d'assistance respiratoire, jusqu'aux voies aériennes d'un patient. De préférence, le connecteur 6 comporte un raccord coudé en polycarbonate et le harnais 14 de fixation comprend trois sangles réglables munies chacune d'un crochet 7 de fixation.FIG. 2 represents a detailed schematic view of a lateral expansion 4 of the shell 2, where it can be seen that, to allow effective maintenance of the mask 1 on the face of the user 8 while distributing the pressure effort and therefore the comfort for the user, a dimension D of between 1 and 5 centimeters and a width L of between 1 and 4 centimeters for each of the two lateral extensions 4 is chosen. The nasal mask according to 1 • invention can be directly connected, via connector 6, to a gas circuit conveying a respiratory flow coming from a source of respiratory gas, such as a respiratory assistance device, up to the airways of a patient. Preferably, the connector 6 comprises a bent polycarbonate connection and the fixing harness 14 comprises three adjustable straps each provided with a fixing hook 7.
Le masque selon la présente invention peut être utilisé pour le traitement systématique de troubles respiratoires du sommeil, notamment de l'apnée du sommeil ou du ronflement.The mask according to the present invention can be used for the systematic treatment of respiratory sleep disorders, in particular sleep apnea or snoring.
En selon le cas, le masque respiratoire selon l'invention peut être soit de type nasal, soit de type naso-buccal. Depending on the case, the respiratory mask according to the invention can be either of the nasal type or of the nasal-oral type.

Claims

PEVENnTCΑTTON.q PEVENnTCΑTTON.q
1. Masque respiratoire (1) comprenant une coquille (2) définissant une chambre nasale (3) conformée pour recouvrir au moins une partie de la région nasale d'un utilisateur (8) , ladite coquille (2) comportant : au moins deux expansions latérales (4) susceptibles de venir prendre appui sur au moins une partie du visage de l'utilisateur (8) lorsque ledit masque (1) est en position sur ladite région nasale dudit utilisateur (8) , et1. Respiratory mask (1) comprising a shell (2) defining a nasal chamber (3) shaped to cover at least part of the nasal region of a user (8), said shell (2) comprising: at least two expansions lateral (4) capable of coming to bear on at least part of the user's face (8) when said mask (1) is in position on said nasal region of said user (8), and
- au moins un orifice (9) d'alimentation en gaz et des moyens de connexion (5, 6) , agencés au niveau dudit orifice (9) d'alimentation en gaz, les moyens de connexion (5, 6) comprenant au moins un connecteur (6) comportant au moins une bague (5) , ladite bague (5) comportant des moyens d ' accrochage comprenant des orifices d'accrochage (11) susceptibles de coopérer avec des moyens de maintien (7, 14), les orifices d'accrochage (11) étant à plusieurs positions de fixation (lia, 11b, lie) , de manière à permettre un positionnement et un maintien efficace du masque sur le visage de l'utilisateur (8) en fonction de la morphologie du visage dudit utilisateur (8) .- At least one orifice (9) for gas supply and connection means (5, 6), arranged at said orifice (9) for gas supply, the connection means (5, 6) comprising at least a connector (6) comprising at least one ring (5), said ring (5) comprising hooking means comprising hooking orifices (11) capable of cooperating with holding means (7, 14), the orifices attachment (11) being at several fixing positions (11a, 11b, lie), so as to allow positioning and effective maintenance of the mask on the face of the user (8) according to the morphology of the face of said user (8).
2. Masque selon la revendication 1, caractérisé en ce que ladite coquille (2) et lesdites au moins deux expansions latérales (4) sont réalisées en un matériau polymère, de préférence en silicone.2. Mask according to claim 1, characterized in that said shell (2) and said at least two lateral expansions (4) are made of a polymer material, preferably silicone.
3. Masque selon l'une des revendications 1 ou 2, caractérisé en ce que ladite coquille (2) et lesdites au moins deux expansions latérales (4) forment une pièce unique susceptible d'avoir été fabriquée par moulage.3. Mask according to one of claims 1 or 2, characterized in that said shell (2) and said at least two lateral expansions (4) form a single piece capable of having been manufactured by molding.
4. Masque selon l'une des revendications 1 à 3, caractérisé en ce que lesdites au moins deux expansions latérales (4) sont agencées symétriquement l'une par rapport à l'autre.4. Mask according to one of claims 1 to 3, characterized in that said at least two lateral expansions (4) are arranged symmetrically with respect to each other.
5. Masque selon l'une des revendications 1 à 4, caractérisé en ce que lesdites au moins deux expansions latérales (4) ont une dimension (D) comprise entre 1 cm et 5 cm et/ou une largeur (L) comprise entre 1 cm et 4 cm.5. Mask according to one of claims 1 to 4, characterized in that said at least two lateral expansions (4) have a dimension (D) between 1 cm and 5 cm and / or a width (L) between 1 cm and 4 cm.
6. Masque selon l'une des revendications 1 à 5, caractérisé en ce que les moyens de connexion permettent au moins le raccordement du masque (1) à une source de gaz sous pression, de préférence par l'intermédiaire d'une canalisation de gaz souple et flexible.6. Mask according to one of claims 1 to 5, characterized in that the connection means allow at least the connection of the mask (1) to a source of pressurized gas, preferably via a line of soft and flexible gas.
7. Masque selon l'une des revendications 1 à 6, caractérisé en ce que le connecteur (6) est coudé ou comporte un raccord coudé.7. Mask according to one of claims 1 to 6, characterized in that the connector (6) is bent or has a bent connector.
8. Masque l'une des revendications 1 à 7, caractérisé en ce que les moyens de maintien sont des lanières, des sangles ou un harnais (14) de fixation, de préférence un harnais (14) de fixation muni de crochets (7) .8. Mask one of claims 1 to 7, characterized in that the holding means are straps, straps or a harness (14) for fixing, preferably a harness (14) for fixing provided with hooks (7) .
9. Masque selon l'une des revendications 1 à 8, caractérisé en ce que le harnais (14) de fixation comprend trois sangles réglables munies chacune d'un crochet (7) de fixation.9. Mask according to one of claims 1 to 8, characterized in that the harness (14) for fixing comprises three adjustable straps each provided with a hook (7) for fixing.
10. Masque l'une des revendications 1 à 9, caractérisé en ce que la bague (5) comporte des moyens d'accrochage comprenant deux orifices d'accrochage (11) latéraux symétriques comportant chacun trois positions de fixation (lia, 11b, lie) différents pour permettre de modifier le site de fixation du harnais (14) à crochets (7).10. Mask one of claims 1 to 9, characterized in that the ring (5) has hooking means comprising two symmetrical hooking holes (11) each having three fixing positions (11a, 11b, lie ) different to allow modify the attachment site of the hook harness (14) (7).
11. Masque l'une des revendications 1 à 10, caractérisé en ce que la bague (5) comporte au moins un orifice d'arrimage (13), de préférence ledit orifice d'arrimage (13) est aménagé dans la partie supérieure de la bague (5) et à égale distance des deux orifices latéraux symétriques (11) .11. Mask one of claims 1 to 10, characterized in that the ring (5) comprises at least one securing orifice (13), preferably said securing orifice (13) is arranged in the upper part of the ring (5) and equidistant from the two symmetrical lateral orifices (11).
12. Masque l'une des revendications 1 à 11, caractérisé en ce que la bague (5) du connecteur (6) a une forme d'anneau tronqué. 12. Mask one of claims 1 to 11, characterized in that the ring (5) of the connector (6) has the shape of a truncated ring.
PCT/FR1999/002447 1998-10-13 1999-10-12 Nasal respirator for treating respiratory disorders, in particular sleep apnea WO2000021600A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP99947541A EP1121172A1 (en) 1998-10-13 1999-10-12 Nasal respirator for treating respiratory disorders, in particular sleep apnea
AU60950/99A AU6095099A (en) 1998-10-13 1999-10-12 Nasal respirator for treating respiratory disorders, in particular sleep apnea
JP2000575572A JP2002527155A (en) 1998-10-13 1999-10-12 Nasal respiratory mask for treating breathing disorders, especially sleep apnea

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR98/12801 1998-10-13
FR9812801A FR2784298B1 (en) 1998-10-13 1998-10-13 NASAL RESPIRATORY MASK FOR THE TREATMENT OF RESPIRATORY DISORDERS, ESPECIALLY SLEEP APNEA

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WO2000021600A1 true WO2000021600A1 (en) 2000-04-20

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JP2002527155A (en) 2002-08-27
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FR2784298B1 (en) 2001-01-19
AU6095099A (en) 2000-05-01

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