FR3139469A1 - Flexible interface made up of two detachable parts for respiratory mask - Google Patents

Abstract

Title of the invention Flexible interface formed of two detachable parts for respiratory mask The invention relates to a flexible interface (1) for respiratory mask (30) formed of two parts. It comprises an interface body (10) with a connection rim (13-1) for being connected to a mask body (31) of a respiratory mask (30), a central opening (22) or two openings ( 22) carried by two nasal cannulas (22A). The central opening (22) or the two nasal cannulas (22A) carrying the two openings (22) are carried by a detachable part (20) of the flexible interface (1), tightly coupled to said interface body ( 10). Respiratory mask (30) equipped with such a flexible interface (1). Abstract figure: Fig. 1

Description

Flexible interface made up of two detachable parts for respiratory mask

The invention relates to a flexible interface or cushion for a respiratory mask, which is formed of two parts coupled to each other, and a respiratory mask comprising such an interface.

In the medical field, certain patients suffering from respiratory disorders or pathologies, such as obstructive sleep apnea (OSA) or others, must be ventilated by administering gas under pressure, such as air or an air/oxygen mixture. This gas administration is conventionally done using a respiratory mask covering the nose and/or mouth of the patient and used to administer the gas under pressure.

In general, such a respiratory mask comprises a mask body to which is fluidly connected, via a suitable connector, one (or more) flexible pipes used to convey the gas from a gas source, such as a respiratory assistance device or ventilator medical, and a support harness used to hold the mask in position on the patient's face during treatment, for example during the night in the case of OSA.

In order to ensure good gas tightness and comfort of use for the patient, a flexible interface, also called a cushion or flexible pad, for example made of silicone, is generally attached to the mask body.

The flexible interface of the respiratory mask, depending on whether it is a nasal, facial or nostril interface, comprises a single opening or two openings or orifices carried by nasal cannulas ensuring gas exchanges with between the interface of the mask and the nostrils of the respiratory mask. the user.

A flexible nasal or facial respiratory mask interface comprises a contact zone coming into contact with the patient's face, when he wears the mask, by matching the contours of his face against which it presses. It must adapt to the facial morphology of the patient to ensure gas tightness and comfort of use, and therefore effective treatment of the user, i.e. patient.

In this case, the flexible interface can be presented in several more or less simple forms ranging from a simple “sausage” or flexible ring to more advanced forms, as taught by EP-A-3622994, EP-A-3470101 or EP-A-3246065. It is usually formed from a single piece, for example in silicone or elastomer, manufactured by injection molding for example.

Given the facial morphological differences existing from one patient to another, it would be necessary to create tailor-made mask interfaces or cushions specific to the patient's morphology. Indeed, personalized interfaces make it possible to minimize gas leaks, reduce the apnea-hypopnea index, increase comfort as well as the time of use of the continuous positive pressure ventilation device.

However, this is difficult to achieve on an industrial level due to the costs involved since this would require manufacturing a specific mold for each new interface model and therefore for each patient or group of patients.

We also know FR-A-2749176 which proposes to deposit a paste based on silicone and hardener directly on the face of a patient, that is to say to take an imprint of the patient's face, then to fix the paste once hardened constituting the cushion on a rigid mask shell.

A disadvantage of this method lies in having to make the silicone-based paste impression directly on the patient's face, therefore having to travel to where the patient is, which is a major constraint during pandemic periods. , like that of Covid-19 for example, and generates high costs since each mask is specific to a given patient. Such a method can therefore only be used on a very small number of patients.

Similar problems exist with nasal interfaces which must also be able to be adapted to different nostril shapes and/or morphologies, in order to ensure a good gas seal during use, as well as comfort of use, and therefore effective treatment of the user, i.e. the patient.

Generally speaking, it is desirable to use masks equipped with different interfaces (i.e. shapes, dimensions, weight, etc.) to be able to effectively treat different types of patients, so as to be able to take into account different facial morphologies or existing nostrils among patients, given that there is no standard interface suitable for all patient populations, i.e. all facial morphologies.

Therefore, a mask interface for children or adolescents must necessarily be different from that for adults or newborns. Analogously, a mask interface for a “Caucasian” type patient is also different from an interface for an “Asian” or other type patient. Specific interfaces could be developed for groups of patients belonging to different populations.

Production constraints therefore limit the number of different interfaces available for a given respiratory mask and do not ensure effective treatment of categories of patients for whom a specific interface does not exist, due to the inability to easily produce specific masks. , quickly and at a reasonable cost.

A The problem is therefore to propose a flexible interface (i.e. cushion), in particular nasal, facial or nostril, for a respiratory mask that can be manufactured at a reasonable cost and can be suitable for patients with different facial or, as the case may be, nostril morphologies. , so as to ensure, during its use, a good gas tightness, comfort of use and effective treatment, and a respiratory mask equipped with such a flexible interface.

A solution of the invention relates to a flexible interface, also called flexible cushion or soft cushion, for a respiratory mask comprising:

- an interface body comprising at least one connection rim configured to be connected to a mask body of a respiratory mask, and

- a central opening or two openings carried by two nasal cannulas,

characterized in that the central opening or the two nasal cannulas carrying the two openings are carried by a detachable part of the flexible interface, said detachable part being coupled in a sealed manner to said interface body, preferably in a sealed and removable manner .

In other words, unlike the interfaces of masks of the prior art which are formed in a single piece, the interface of the invention is formed of two parts, i.e. sub-elements, fixed to each other including a first part forming most of the body of the interface, that is to say the main body of the interface, called interface body, and a second part forming the rear part of the interface, called detachable part , which forms a sort of “cover” which is removably connected to the interface body or main body.

Thanks to such an architecture, the interface body forming the front part of the mask interface can be manufactured in a conventional manner, by injection molding for example or any other suitable technique. For example, we can manufacture only 2 or 3 interface bodies of different dimensions, typically dedicated to one or more of the possible patient categories, namely adult, child/adolescent or newborn/baby.

Furthermore, the rear structure or detachable part is advantageously manufactured by additive manufacturing so as to be able to adapt it easily and quickly to the different facial morphologies and the different categories of patients to be treated.

Such an interface according to the invention makes it possible to resolve the aforementioned problems given that it is no longer necessary to manufacture the entire interface to adapt it to patients of different categories and/or having different facial morphologies since It is enough to change the rear part of the interface, namely the detachable part to make it specific while the major part of the interface, namely the main interface body, remains unchanged.

This saves a significant amount of material and, above all, it is no longer necessary to use specific molds to manufacture all of the different interfaces. Only the detachable part, that is to say the rear part of the interface, requires adaptation but given that it is of simple structure, it can therefore be manufactured by other processes which do not require mold, advantageously an additive manufacturing process.

We therefore understand that, according to the invention, several detachable parts of different shapes, that is to say dedicated to patients of different morphologies, can be coupled to the same interface body, namely a “standard” main body, so as to allow the mask interface to play its role despite different facial morphologies of patients.

• la partie détachable présente une première dureté (D1) inférieure à une seconde dureté (D2) du corps principal, i.e. D1<D2.
• la partie détachable présente une première dureté (D1) comprise entre Shore 20A et Shore 40A, par exemple de l’ordre de shore 30A.
• le corps d’interface présente une seconde dureté (D2) comprise entre Shore 40A et Shore 80A, par exemple de l’ordre de shore 60A.
• la partie détachable et le corps principal sont formés d’au moins un matériau(x) silicone.
• la partie détachable est formée d’un premier matériau silicone et le corps d’interface est formé d’un second matériau silicone, lesdits premier et second matériaux silicone sont différents l’un de l’autre.
• les matériau silicone sont par exemple des caoutchoucs silicones liquides ou LSR (pour Liquid Silicone Rubber).
• le corps d’interface comprend une ouverture arrière bordée par au moins un premier rebord périphérique.
• le corps d’interface comprend un volume interne pour recevoir du gaz.
• l’ouverture arrière du corps d’interface est en communication fluidique avec le volume interne du corps d’interface.
• la partie détachable comprend une ouverture avant bordée par au moins un second rebord périphérique.
• le (au moins un) premier rebord périphérique et le (au moins un) second rebord périphérique sont conformés pour venir coopérer l’un avec l’autre afin d’assurer un raccordement mécanique étanche de partie détachable au corps d’interface et une communication fluidique entre l’ouverture arrière du corps d’interface et l’ouverture avant de la partie détachable.
• le (au moins un) premier rebord périphérique et le (au moins un) second rebord périphérique forment ou constituent un système de couplage mâle/femelle.
• le système de couplage mâle/femelle comprend au moins une gorge annulaire et au moins un bourrelet annulaire, i.e. ceux-ci coopèrent pour assurer le couplage.
• ledit au moins un bourrelet annulaire est conformé pour venir se loger et être retenu dans ladite au moins une gorge annulaire, de préférence de manière étanche.
• le corps d’interface comprend en outre une ouverture d’entrée bordée par le rebord de raccordement servant au raccordement du corps d’interface à une structure de masque respiratoire, en particulier à un corps de masque.
• le (ou les) rebord de raccordement vient se coupler au corps de masque de préférence via un raccordement de type mâle/femelle. Avantageusement, le (ou les) rebord de raccordement du corps d’interface vient coopérer avec une structure de couplage complémentaire portée par le corps de masque.
• le corps d’interface comprend un volume interne formant tout ou partie d’une compartiment ou d’une chambre interne par lequel transite le gaz, c'est-à-dire du gaz respiratoire, tel de l’air ou un mélange air/oxygène.
• la partie détachable forme une structure de joint souple comprenant une région périphérique externe entourant l’ouverture centrale configurée pour venir au contact de zones du visage de l’utilisateur, pendant l’utilisation de l’interface, de manière à y assurer une étanchéité gazeuse.
• la région périphérique externe entourant l’ouverture centrale de la partie détachable constitue une jupe souple autour de l’ouverture centrale, c'est-à-dire une membrane étanche.
• la partie détachable constitue un « couvercle » venant fermer le corps d’interface.
• une première épaisseur (E1) de la paroi de la partie détachable, dans la région périphérique externe entourant l’ouverture centrale, est inférieure à une deuxième épaisseur (E2) de la paroi de la partie détachable, dans la région de l’ouverture avant bordée par le second rebord périphérique, c'est-à-dire que E1<E2.
• la première épaisseur (E1) de la paroi de la partie détachable est inférieure ou égale à 1 mm environ, de préférence inférieure ou égale à 0,5 mm environ.
• la deuxième épaisseur (E2) de la paroi de la partie détachable est supérieure à 0.5 mm, de préférence supérieure ou égale à 1 mm environ, par exemple d’au moins 1.1 mm.

Depending on the embodiment considered, the mask interface of the invention may comprise one or more of the following characteristics:

• the detachable part has a first hardness (D1) lower than a second hardness (D2) of the main body, ie D1<D2.
• the detachable part has a first hardness (D1) between Shore 20A and Shore 40A, for example of the order of shore 30A.
• the interface body has a second hardness (D2) between Shore 40A and Shore 80A, for example of the order of shore 60A.
• the detachable part and the main body are formed of at least one silicone material(s).
• the detachable part is formed of a first silicone material and the interface body is formed of a second silicone material, said first and second silicone materials are different from each other.
• silicone materials are for example liquid silicone rubbers or LSR (for Liquid Silicone Rubber).
• the interface body comprises a rear opening bordered by at least a first peripheral rim.
• the interface body includes an internal volume for receiving gas.
• the rear opening of the interface body is in fluid communication with the internal volume of the interface body.
• the detachable part comprises a front opening bordered by at least one second peripheral rim.
• the (at least one) first peripheral rim and the (at least one) second peripheral rim are shaped to cooperate with one another in order to ensure a sealed mechanical connection of the detachable part to the interface body and communication fluidic between the rear opening of the interface body and the front opening of the detachable part.
• the (at least one) first peripheral rim and the (at least one) second peripheral rim form or constitute a male/female coupling system.
• the male/female coupling system comprises at least one annular groove and at least one annular bead, ie these cooperate to ensure coupling.
• said at least one annular bead is shaped to be housed and retained in said at least one annular groove, preferably in a watertight manner.
• the interface body further comprises an inlet opening bordered by the connection rim for connecting the interface body to a respiratory mask structure, in particular to a mask body.
• the connecting rim(s) are coupled to the mask body preferably via a male/female type connection. Advantageously, the connecting rim(s) of the interface body cooperates with a complementary coupling structure carried by the mask body.
• the interface body comprises an internal volume forming all or part of a compartment or an internal chamber through which the gas passes, that is to say respiratory gas, such as air or an air/air mixture. oxygen.
• the detachable portion forms a flexible seal structure including an outer peripheral region surrounding the central opening configured to contact areas of the user's face, during use of the interface, so as to provide a gastight seal thereto .
• the external peripheral region surrounding the central opening of the detachable part constitutes a flexible skirt around the central opening, that is to say a waterproof membrane.
• the detachable part constitutes a “cover” which closes the interface body.
• a first thickness (E1) of the wall of the detachable part, in the outer peripheral region surrounding the central opening, is less than a second thickness (E2) of the wall of the detachable part, in the region of the front opening bordered by the second peripheral edge, that is to say that E1<E2.
• the first thickness (E1) of the wall of the detachable part is less than or equal to approximately 1 mm, preferably less than or equal to approximately 0.5 mm.
• the second thickness (E2) of the wall of the detachable part is greater than 0.5 mm, preferably greater than or equal to approximately 1 mm, for example at least 1.1 mm.

• une interface nasale, i.e. classique ou à contact minimum, comprend une ouverture centrale unique qui vient se positionner dans les régions nasales de l’utilisateur en englobant les deux narines de l’utilisateur. Lorsque l’interface est du type « classique » (cf. par exemple), l’ouverture centrale reçoit tout ou partie du nez, c'est-à-dire qu’elle englobe la pointe du nez qui fait lors saillie à l’intérieur de l’interface, et tout ou partie les zones situées de part et d’autre et au-dessus de la pointe du nez, à savoir les régions des ailes du nez et de tout ou partie du cartilage nasal et peut s’étendre jusqu’à la zone de jonction entre le cartilage nasal et l’os nasal, voire même au-delà, c'est-à-dire inclure toute ou partie de la zone osseuse située au-dessus de cette jonction. Par contre, lorsque l’interface est type « à contact minimum » (cf. par exemple), l’ouverture centrale vient se positionner uniquement en regard des sorties des narines mais sans englober le nez lui-même, c'est-à-dire que le pourtour de l’ouverture centrale ou la région périphérique externe entourant l’ouverture centrale vient prendre appui sur les zones faciales situées immédiatement autour des orifices des narines du patient, c'est-à-dire les zones péri-nasales situées à proximité immédiate, par exemple des deux côtés ou ailes du nez et/ou en dessous du nez, i.e. entre le nez et la bouche.
• une interface faciale, c'est-à-dire naso-buccale ou bucco-nasale, comprend aussi une ouverture centrale unique mais celle-ci vient se positionner de sorte de recourir à la fois les régions nasales et buccales de l’utilisateur de manière à englober tout ou partie du nez et toute la bouche de l’utilisateur. Dans ce cas, le nez et la bouche de l’utilisateur, ainsi qu’éventuellement des zones faciales situées immédiatement autour, comme par exemple la zone située sous la bouche et allant jusqu’au menton, sont entourés par l’ouverture centrale, de sorte que le nez et la bouche se projettent ou fassent saillie vers l’intérieur de l’interface, au travers de ladite ouverture centrale unique.
• une interface narinaire (cf. par exemple) comprend quant à elle deux canules nasales portant chacune une ouverture assurant les échanges gazeux avec le patient, notamment l’alimentation du patient en gaz respiratoire et préférentiellement aussi le passage des gaz expirés riches en CO₂. Elles sont conformées pour venir s’insérer dans les narines de l’utilisateur en y assurant de préférence une étanchéité gazeuse.

In the context of the invention, according to the embodiment considered, the interface can be nasal, facial or nostril, where:

• a nasal interface, ie classic or minimum contact, comprises a single central opening which is positioned in the nasal regions of the user by encompassing the two nostrils of the user. When the interface is of the “classic” type (cf. for example), the central opening receives all or part of the nose, that is to say it includes the tip of the nose which then projects inside the interface, and all or part of the areas located on either side and above the tip of the nose, namely the regions of the wings of the nose and all or part of the nasal cartilage and can extend to the junction area between the nasal cartilage and the nasal bone, or even beyond, that is to say include all or part of the bony area located above this junction. On the other hand, when the interface is “minimum contact” type (cf. for example), the central opening is positioned only opposite the outlets of the nostrils but without encompassing the nose itself, that is to say that the perimeter of the central opening or the external peripheral region surrounding the central opening rests on the facial areas located immediately around the orifices of the patient's nostrils, that is to say the perinasal areas located in the immediate vicinity, for example on both sides or wings of the nose and/or below of the nose, ie between the nose and the mouth.
• a facial interface, that is to say naso-oral or bucco-nasal, also includes a single central opening but this is positioned so as to use both the nasal and oral regions of the user in a manner to encompass all or part of the nose and the entire mouth of the user. In this case, the nose and mouth of the user, as well as possibly facial areas located immediately around it, such as for example the area located under the mouth and going up to the chin, are surrounded by the central opening, so that the nose and mouth project or protrude towards the interior of the interface, through said single central opening.
• a nasal interface (cf. for example) comprises two nasal cannulas each carrying an opening ensuring gas exchanges with the patient, in particular the supply of respiratory gas to the patient and preferably also the passage of exhaled gases rich in CO ₂ . They are shaped to fit into the user's nostrils, preferably ensuring a gas-tight seal.

A nasal, facial or nostril interface, respectively, according to the invention is intended to equip a nasal, facial or nostril mask, respectively. The invention therefore also relates to a respiratory mask comprising a mask body and an interface according to the invention fixed to said mask body.

• il est un masque nasal, narinaire ou facial.
• il comprend un corps de masque.
• le corps de masque est traversé par un passage central configuré pour recevoir un raccord tubulaire, tel un raccord tubulaire coudé.
• le corps de masque comprend deux bras latéraux, à savoir un bras droit et un bras gauche, se projetant latéralement à droite et à gauche du corps de masque.
• le corps de masque comprend bras frontal se projetant vers le haut, c'est-à-dire sensiblement au-dessus du corps de masque.
• les bras comprennent des structures de connexion mécanique, par exemple des fentes, des crochets, des boucles ou analogues, pour la fixation d’un harnais de tête.
• un harnais de tête est raccordé aux structures de connexion mécanique des bras.
• les bras sont préférentiellement flexibles
• le corps de masque et les bras sont préférentiellement en polymère, par exemple en polyamide, polyéthylène ou autre.
• l’interface flexible est fixée mécaniquement à la face arrière du corps de masque.

Depending on the embodiment considered, the respiratory mask of the invention may comprise one or more of the following characteristics:

• it is a nasal, nostril or facial mask.
• it includes a mask body.
• the mask body is crossed by a central passage configured to receive a tubular connector, such as an elbow tubular connector.
• the mask body includes two side arms, namely a right arm and a left arm, projecting laterally to the right and left of the mask body.
• the mask body comprises frontal arm projecting upwards, that is to say substantially above the mask body.
• the arms include mechanical connection structures, e.g. slots, hooks, loops or the like, for attaching a head harness.
• a head harness is connected to the mechanical connection structures of the arms.
• the arms are preferably flexible
• the mask body and the arms are preferably made of polymer, for example polyamide, polyethylene or other.
• the flexible interface is mechanically attached to the rear face of the mask body.

The invention will now be better understood thanks to the following detailed description, given by way of illustration but not limitation, with reference to the appended figures among which:

schematizes an embodiment of an interface for a respiratory mask according to the invention, namely here a nasal mask, represented with the detachable part decoupled from the interface body,

is analogous to , but shows the detachable part coupled to the interface body,

is a sectional view of ,

schematizes an embodiment of the system for coupling the detachable part to the interface body of ,

schematizes another embodiment of the system for coupling the detachable part to the interface body of ,

represents an embodiment of a nasal respiratory mask equipped with a flexible nasal interface according to the prior art,

schematizes an embodiment of an additive manufacturing process that can be used to produce the detachable part of the interface of has ,

schematizes another embodiment of an additive manufacturing process that can be used to produce the detachable part of the interface of has ,

schematizes an embodiment of a minimum contact nasal interface according to the invention, and

schematizes an embodiment of a nasal interface with nasal cannulas according to the invention.

represents an embodiment of a respiratory mask assembly 30 according to the prior art, namely here a nasal mask, equipped with a flexible interface or cushion 1. This respiratory mask 30 comprises a mask body 31, which is here of tubular shape, crossed by a central passage 32 into which an elbowed tubular connector 40 is inserted, on the front or exterior side of the mask body 31.

The connector 40 is located at one end of a flexible gas pipe (not shown) for supplying pressurized gas, such as air, from a pressurized gas source, such as a medical ventilator or other respiratory assistance apparatus or device. The connector 40 allows the flexible pipe to be fluidly connected to the mask body 31.

The mask body 31 comprises two lateral arms 33, namely a right arm and a left arm, projecting laterally to the right and left of the mask body 31 and, moreover, a frontal arm 34 projecting upwards, c that is to say substantially above the mask body 31, during its use, that is to say when it is worn by a user, i.e. a patient. Conventionally, the arms 33, 34 comprise, at their free ends, mechanical connection structures 35, for example slots, hooks, loops or the like, for fixing a head harness (not shown) serving to maintain the mask 30 in position on the user's face, during its use, typically in the context of the implementation of a treatment by gas administration. The arms 33, 34 are preferably flexible so as to be able to bend slightly towards the user's face, when they are put under tension by tightening the head harness, so as to ensure good retention in position of the mask 30.

In order to make the mask 30 light and resistant, the mask body 31 and the arms 33, 34 are preferably made of polymer, for example polyamide, polyethylene or other.

On the rear or interior side, the mask body 31 comprises a flexible interface 1, also called a cushion, for example made of silicone or elastomer, which is mechanically attached to the rear face of the mask body 31. Conventionally, the interface 1 is formed entirely in one piece, for example injection molded or the like.

More precisely, such a flexible interface 1 usually comprises a hollow interface body 10 delimiting an internal volume 11, also called a gas chamber or compartment. It further comprises an inlet opening 13 surrounded by at least one connection rim 13-1 configured to allow connection of the interface 1 to the rear face of the mask body 31, for example by interlocking or any other connection system. male/female type coupling or the like.

In the embodiment illustrated in , the inlet opening 13 is surrounded by two coaxial directory connection edges spaced from one another by an annular connection groove 13-2, intended to cooperate with a complementary coupling structure carried by the body of mask 31 so as to form a coupling for example by male/female type interlocking. The complementary coupling structure may for example also comprise one or more walls and/or annular grooves.

The inlet opening 13 is in fluidic communication with the internal volume 11 so that, when the flexible interface 1 is mechanically and fluidically connected to the mask body 31, fluidic communication takes place between the interior or lumen of the mask. connection 40 and the internal volume 11 of the flexible interface 1, through the mask body 31, in order to allow the gas coming from the gas source to reach the internal volume 11 of the flexible interface 1 where the user can inhale it.

To do this, a central opening 22 (visible in ) is located on the other side of the hollow main body 10, that is to say opposite the inlet opening 13 with respect to the internal volume 11. The central opening 22 is configured and dimensioned for receive at least part of the user's nasal and/or oral regions.

The gas seal between the interface 1 and the user's face is ensured, during use of the mask, by the external peripheral region 23 surrounding the central opening 22 which comes into contact with the user's face during the mask. use of the mask 30. This external peripheral region 23 is flexible, for example formed of a thin and flexible membrane, that is to say flexible.

When the mask 30 is a nasal mask, as illustrated in , the interface 1 or flexible cushion of the mask 30 is positioned only on the nasal regions, that is to say all or part of the user's nose so that their nostrils are found in the internal volume 11 of the interface 1 to breathe the gas found there, while when it is facial, interface 1 encompasses both the nasal and oral regions, that is to say the nose and mouth of the 'user. Such an arrangement of mask 30, including the interface 1 formed from a single part, is classic and known.

However, as explained above, the fact that the entire interface 1 is formed in a single piece can be a serious problem when interfaces 1 intended for different morphologies and/or face sizes must be used to ensure effective treatment of morphologically different patients, such as adults, children/adolescents or babies/neonates, and/or patients from different populations, for example with Caucasian, Asian, African or other facial morphology.

• une première partie constituant l’essentiel du corps d’interface, appelée corps d’interface 10 ou corps principal, et
• une seconde partie constituant la partie arrière de l’interface 1, appelée partie détachable 20 ou partie arrière, laquelle forme une sorte de couvercle venant se raccorder au corps d’interface 10 et le fermer, à la manière d’un couvercle ou similaire.

To try to remedy this, according to the present invention, it is proposed to make the flexible interface 1 of the mask 30 in two parts which are connected in a watertight and detachable manner, one to the other, as illustrated in has and detailed below, namely:

• a first part constituting the bulk of the interface body, called interface body 10 or main body, and
• a second part constituting the rear part of the interface 1, called detachable part 20 or rear part, which forms a sort of cover which connects to the interface body 10 and closes it, in the manner of a cover or the like.

Unlike a flexible interface of the prior art formed in a single piece, that of the invention is formed of two elements which couple to one another in a watertight and detachable manner.

More precisely, the flexible interface 1 of the invention is formed of an interface body 10 delimiting, in the embodiment of the has , an internal volume or compartment 11 which receives the gas, such as air, and a detachable part 20, that is to say removable, forming in here a flexible joint structure comprising the central opening 22 which is shaped to receive the nasal and/or oral regions of the user, during use of the mask 30, in the case of a nasal or facial interface for a nasal or facial mask, respectively.

The detachable part 20, i.e. the flexible seal structure, further comprises an outer peripheral region 23 surrounding the central opening 22, which is configured to come into contact with the user's face during use of the interface 1 so as to ensure a gas seal, that is to say that the external peripheral region 23 surrounding the central opening 22 is configured and dimensioned to fit the facial regions of the user on which it takes support by avoiding or minimizing gas leaks around the perimeter of the external peripheral region 23.

Preferably, the detachable part 20 comprises a thinner and very flexible region, typically formed of a thin and flexible membrane, forming a skirt 24 bordering the immediate periphery of the central opening 22, that is to say arranged all the way around. around the central opening 22, as illustrated in And , in order to improve waterproofing and comfort of use. This thinner region has for example a first thickness E1 less than or equal to 1 mm, typically less than or equal to approximately 0.5 mm.

This thin and flexible skirt 24 bordering the immediate periphery of the central opening 22 has a first thickness E1 thinner than the rest of the external peripheral region 23, as visible in , that is to say that the external peripheral region 23 preferably has a thickness gradually increasing in distance from the central opening 22, preferably until reaching the second thickness E2 mentioned below.

According to the invention, the detachable part 20, which forms a sort of flexible “lip” in the embodiment of the has , is mechanically coupled, in a sealed manner, to the interface body 10, as illustrated in And .

In other words, the flexible interface 1 is formed of the two aforementioned sub-parts coupled to each other, namely the detachable part 20 here forming a flexible joint structure and the interface body 10, and not 'a unique piece as in the prior art.

The detachable part 20 is positioned and fixed to the rear of the interface body 10, in the manner of a cover closing the rear opening 12 of the interface body 10, as shown schematically in .

More precisely, the interface body 10 comprises a rear opening 12 in fluid communication with the internal volume 11, that is to say the internal compartment of the interface 1, which is bordered by a first peripheral rim 12-1 which extends over the entire perimeter of the wall defining this rear opening 12.

Furthermore, the flexible detachable part 20 comprises a front opening 21 bordered by a second peripheral rim 21-1 which extends over the entire periphery of the wall defining this front opening 21.

The region of the front opening 21 preferably has a second wall thickness E2 greater than that of the first thickness E1 of the skirt 24, typically a second thickness E2 of at least 0.5 mm, preferably of at least approximately 1 mm. , for example of the order of 1.2 mm.

These rear opening 12 and front opening 21 have substantially the same shape and the same dimension, typically the same diameter, the same section or the like, as illustrated in has , so that the first peripheral rim 12-1 and the second peripheral rim 21-1 are complementary to each other, that is to say that they can be mechanically coupled and secured together. 'to each other, as explained below.

Indeed, according to the invention, the first peripheral rim 12-1 and the second peripheral rim 21-1 are shaped to cooperate with one another in order to constitute a male/female type connection, making it possible to ensure a sealed mechanical connection of the flexible joint structure 20 to the main body 10, for example by interlocking or the like, in order to form the entirety of the flexible interface 1, that is to say the flexible cushion of the mask.

Once coupled to each other, fluidic communication is obtained between the rear opening 12 of the interface body 10 and the front opening 21 of the flexible detachable part 20 ensuring the circulation of gas in the internal volume of interface 1, namely respiratory gas, such as air, towards the nostrils of the patient when he inhales the gas during his inspiratory phases and, conversely, gas exhaled by the patient which is rich in CO ₂ , that is to say coming out of the patient's nostrils when he exhales the gas during his expiratory phases. The gas rich in CO ₂ exhaled by the patient is evacuated through one or more gas evacuation orifices (not shown) which can be arranged in the mask body 31 or in the tubular connection 40.

As already said, the detachable part 20 is therefore positioned and fixed to the rear of the interface body 10, like a cover closing the rear opening 12 of the interface body 10.

In order to ensure good sealing and comfort of use, the detachable part 20 and the interface body 10 preferably have different flexibilities or hardnesses. Advantageously, the detachable part 20 has a first hardness D1 lower than a second hardness D2 of the main body 10, i.e. D1 < D2, so that the detachable part 20 is significantly more flexible and flexible than the interface body 10.

Typically, the hardness (D1) of the flexible detachable part 20 is chosen between Shore 20A and Shore 40A, while that (D2) of the interface body 10 is chosen between Shore 40A and Shore 80A, so that the detachable part 20 presents a flexibility or flexibility greater than that of the interface body 10 of the interface 1.

Preferably, the flexible detachable part 20 and the interface body 10 are formed of different silicone materials, for example one or more siloxanes catalyzed by a metal, for example a transition metal such as Pt, in order to obtain the desired hardnesses.

As already said, the detachable part 20 is advantageously manufactured by additive manufacturing, as detailed below, so as to be able to adapt it easily and quickly to the different facial morphologies and the different categories of patients to be treated, without having to resort to to a mold or the like.

Furthermore, the interface body 10 forming the front part of the interface 1 can be manufactured in a conventional manner, for example by injection molding or any other suitable technique, which makes it possible to limit costs. However, it could also be produced by additive manufacturing.

The interface 1 according to the invention makes it possible to resolve the aforementioned problems since it is no longer necessary to manufacture the entire interface 1 each time to adapt it to patients of different categories and/or having different facial morphologies since it suffices to change the rear part of the interface 1, namely the detachable part 20 here forming a flexible joint structure or "lip", to make it specific, while the majority of the The interface 1, namely the main interface body 10, remains unchanged.

Thus, it is possible, for example, to manufacture only 2 or 3 interface bodies 10 of different dimensions/sizes dedicated to categories of patients of different morphologies, i.e. adults, children/adolescents and newborns/babies, in order to have an interface 1 in three (or more) corresponding sizes, namely an adult size, a child/teen size and a newborn/baby size. This saves a significant amount of material and, above all, it is no longer necessary to use specific molds to manufacture all of the different interfaces.

Only the detachable part 20, that is to say the rear part of the interface 1, requires adaptation but given that it is of simple structure, it can therefore be manufactured easily and quickly by a process additive manufacturing that does not require a mold. It is then simply the detachable parts 20 which must be adapted to the particular morphologies of the patient(s) to be treated.

In other words, according to the invention, several different and specific detachable parts 20 can be coupled to the same main interface body 10 so as to allow the interface 1 of the mask to play its role despite different facial morphologies of patients.

And schematize two embodiments of the additive manufacturing process usable to produce the flexible joint structure 20 of the interface 1 of has

On , we see that non-crosslinked silicone 45 is continuously supplied to an additive manufacturing system 40 comprising a movable injection nozzle 41 allowing the progressive deposition of the two-component silicone to gradually form the detachable part 20 of the desired interface on a plate 43 adapted and movable vertically 44.

The crosslinking of the layers thus deposited can be aided by the addition of heat or UV irradiation in order to be able to reposition it relative to the nozzle 41 as the layers of silicone are added, gradually forming the flexible joint structure 20.

According to an alternative embodiment (not shown), the non-crosslinked silicone 10 can also be deposited by the nozzle 41 in the form of silicone droplets in liquid form.

In all cases, the nozzle 41 is movable at least in a horizontal plane 42, that is to say along two axes (X, Y), to allow the silicone material to be deposited according to the desired geometries. In , we can see a hiring of a detachable part structure 20 in progress, that is to say a start of manufacturing of the detachable part structure 20.

Control means (not shown) such as a programmable controller or the like ensure the control of the installation or additive manufacturing system 40, in particular the movements of the plate 43 and/or those of the nozzle 41. In addition, the control means control the additive manufacturing system 40 based for example on a memorized model of detachable part 20 whose dimensions and shapes are known, for example stored within a computer memory grouping together different models of detachable parts 20 which can be produced in depending on the morphologies of the patients to be treated.

Preferably, the silicone material 45 provided in liquid form is non-crosslinked whereas after deposition to form the detachable part 20, the silicone material becomes crosslinked, for example a siloxane type material. Additional heating for example to 200°C in an oven (not shown) can be applied to the flexible joint structure 20 after formation to improve or perfect the crosslinking of the silicone material.

schematizes another embodiment of the additive manufacturing process similar to that of , with the exception that, in this case, the silicone material 45 is also in liquid form and contained in a tank 46 or the like and the detachable part 20 is manufactured by crosslinking the silicone material by light rays emitted by a source light 47, for example an ultraviolet (UV) radiation lamp, within said tank 46. In this case, it is the light source 47 which is movable in a horizontal plane, that is to say in two axes (X, Y) as previously, to allow the silicone material to be deposited according to the desired geometry(s).

Whatever the additive manufacturing process implemented, according to the invention, a detachable part 20 is obtained for a flexible interface 1 of a respiratory mask 30, also called a nasal cushion, having shapes, weight and dimensions perfectly suited to the facial morphologies of the patients to be treated, for example nasal and perinasal morphologies for a detachable part 20 forming a flexible joint structure of nasal cushion 1, as illustrated in .

schematizes an embodiment of the male/female coupling system of the detachable part 20 to the interface body 10 of the interface 1 of .

As can be seen, the detachable part 20 comprises, along the second peripheral rim 21-1 bordering the front opening 21, an annular bead 21-2 having a section greater than the wall 21-3 of the detachable part 20 to which it is attached. This annular bead 21-2 here has a (quasi)circular section.

This bead 21-2 is intended to be housed and retained in an annular groove 12-3 arranged along the first peripheral rim 12-1 of the interface body 10. This groove 12-3 is arranged in a region of end 12-2 wider than the wall of the interface body 10 to which it is attached. The groove 12-3 here has a (quasi)circular section substantially equal to that of the bead 21-2, that is to say that the bead 21-2 and the groove 12-3 are complementary to each other. other.

In order to facilitate the insertion of the bead 21-2 into the groove 12-3, a cutout 12-4 is provided, for example substantially V-shaped, the opposite side walls of which form an angle A between them, typically between 25 and 50 °, for example of the order of 35°.

Thanks to these configurations, the bead 21-2 can be inserted by force into the groove 12-3 and then be held there to secure the detachable part 20 to the interface body 10 of the interface 1 to obtain a mask interface 1 as illustrated in .

schematizes another embodiment of the system for coupling the detachable part 20 to the interface body 10 of the interface 1 of .

As previously, a bead 21-2 is provided on the flexible joint structure 20 which is inserted into a groove 12-3 of the interface body 10 of the interface 1, however here these are arranged laterally on the internal walls 20-1 and external 10-1, respectively, of the detachable part 20 and the interface body 10.

In addition, there is also provided an annular shoulder 20-4 projecting from the internal wall 20-1 of the detachable part 20 and extending over its entire internal periphery, cooperating with an annular housing 12-5 of substantially complementary shape carried by the internal wall 10-1 of the interface body 10 and extending over its entire external periphery. The shoulder 20-4 abuts in the housing 12-5 to prevent untimely removal, i.e. decoupling, of the detachable part 20 when it is coupled to the interface body 10.

Of course, other embodiments of the male/female coupling system are possible.

schematizes an embodiment of a nasal interface 1 of the minimum contact type according to the invention, shown not coupled to a mask body. This has a structure similar to interface 1 of has , with the exception of the fact that, in this case, in use, that is to say when the mask equipped with the interface 1 is worn by a user, such as a patient, the central opening 22 is located facing only the areas located around the outlets of the user's nostrils, that is to say the user's nose is not inserted through the central opening 22 protruding into the internal volume 11. In this case, the peripheral edges 23 forming the flexible skirt 24 surrounding the central opening 22 come to bear on the areas located immediately around the orifices of the nostrils and/or the perinasal areas located in the immediate vicinity of the orifices of the nostrils , for example on both sides or wings of the nose and/or below the nose, such as the areas located under the nose, ie between the nose and the mouth, but without including the tip of the nose and the regions above.

In this case, nasal interface 1 is also formed of two parts detachable from one another, namely the interface body 10 comprising one (or more) connecting rim 13-1 configured to be connected to a body of mask 31 and the detachable part 20 carrying the central opening 22 which fits or the like, in a sealed manner, to said interface body 10.

We can see that here, the central opening 22 is divided by a junction element 22-1 making it possible in particular to avoid sagging of the flexible skirt over time.

schematizes an embodiment of a nasal interface 1 with nasal cannulas 22A according to the invention shown coupled to a body 31 of nasal mask 30.

Analogously, the nasal interface 1 is formed of two parts detachable from one another, namely the interface body 10 comprising one (or more) connecting rims 13-1 configured to be connected to the body 31 nasal mask 30 and the detachable part 20 carrying the two nasal cannulas 22A arranged in parallel to one another and each carrying an opening 22 used for gas exchange with the user's nostrils. The detachable part 20 fits or the like, in a sealed manner, to the interface body 10, as explained above.

In this case, the two nasal cannulas 22A are terminated by enlarged portions forming “heads” 22B carrying the openings 22. These heads 22B being made of flexible material, i.e. silicone, they can deform under the effect of gas pressure exerted in the internal canal or lumen of each of the nasal cannulas 22A, and thus come into contact with the internal walls of the patient's nostrils to ensure a gas seal during the distribution of the respiratory gas.

Generally speaking, a respiratory mask 30 equipped with an interface 1 according to the invention can be used to treat a person, that is to say a patient suffering from a respiratory pathology requiring administration of gas under pressure , such as sleep apnea or any other pathology.

Claims (9)

Flexible interface (1) for respiratory mask (30) comprising:
- an interface body (10) comprising at least one connection rim (13-1) configured to be connected to a mask body (31) of a respiratory mask (30), and
- a central opening (22) or two openings (22) carried by two nasal cannulas (22A),
characterized in that the central opening (22) or the two nasal cannulas (22A) carrying the two openings (22) are carried by a detachable part (20) of the flexible interface (1), coupled in a sealed manner to said body interface (10). Interface according to claim 1, characterized in that the detachable part (20) has a first hardness (D1) lower than a second hardness (D2) of the interface body (10), i.e. D1<D2. Interface according to claim 2, characterized in that:

• the flexible detachable part (20) has a first hardness (D1) between Shore 20A and Shore 40A and
• the interface body (10) has a second hardness (D2) between Shore 40A and Shore 80 A.

Interface according to one of the preceding claims, characterized in that the detachable part (20) and the interface body (10) are formed of at least one silicone material. Interface according to one of the preceding claims, characterized in that:

• the interface body (10) comprises a rear opening (12) bordered by at least a first peripheral rim (12-1) and
• the detachable part (20) comprises a front opening (21) bordered by at least one second peripheral rim (21-1),
• and in which the first peripheral rim (12-1) and the second peripheral rim (21-1) are shaped to cooperate with one another in order to ensure:
  • a sealed mechanical connection of the detachable part (20) to the main body (10) and
  • fluid communication between the rear opening (12) of the main body (10) and the front opening (21) of the flexible detachable part (20).

Interface according to claim 5, characterized in that the first peripheral rim (12-1) and the second peripheral rim (21-1) form a male/female coupling system. Interface according to one of the preceding claims, characterized in that the detachable part (20) forms a flexible joint structure (20) comprising an external peripheral region (23) surrounding the central opening (22) configured to come into contact with areas of the user's face, during use of the interface (1), so as to ensure a gas seal. Respiratory mask (30) comprising a mask body (31) and an interface (1) according to one of the preceding claims, fixed to said mask body (31). Mask according to claim 8, characterized in that it is a nasal, nostril or facial mask provided with a nasal, nostril or facial interface (1).