Manufacturing process for a custom-made respiratory mask

Abstract

Title of the invention Method for manufacturing a custom-made respiratory mask The invention relates to a method for manufacturing a custom-made respiratory mask adapted to the facial morphology of a patient suffering from a respiratory disorder or pathology, such as obstructive sleep apnea (OSA). Abstract figure: Fig. 1

Description

Title of the invention: Method for manufacturing a custom-made respiratory mask

[0001] The present invention relates to a method for manufacturing a custom-made respiratory mask adapted to the facial morphology of a patient suffering from a respiratory disorder or pathology, such as obstructive sleep apnea (OSA).

[0002] 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 pressurized gas, such as air or an air / oxygen mixture.

[0003] This administration of gas is conventionally carried out using a respiratory mask covering the patient's nose and / or mouth and used to administer the gas under pressure.

[0004] In general, such a respiratory mask comprises a mask body to which is fluidically connected, via a suitable connector, one (or more) flexible hoses used to convey the gas from a gas source, such as a respiratory assistance device or medical ventilator, 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.

[0005] In order to ensure good gas tightness and comfort of use for the patient, a flexible pad, for example made of silicone, is generally fixed around the edges of the mask body.

[0006] This pad constitutes a waterproof, flexible and comfortable facial interface which comes into contact with the patient's face when wearing the mask.

[0007] The mask pad, i.e. facial interface, can take 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

[0008] Given the facial morphological differences that exist from one patient to another, it has been proposed to produce custom-made mask cushions, which conform to each particular morphology, minimizing gas leaks and improving comfort of use for patients.

[0009] This is far from easy, particularly when the patient has an unusual and / or complicated facial morphology resulting for example from a facial malformation, deterioration following an accident, surgery or other intervention.

[0010] To produce a pad and a mask incorporating it, FR-A-2749176 proposes depositing a paste based on silicone and hardener directly onto a patient's face, i.e. taking an impression of the patient's face, then fixing the paste once hardened, forming the pad on a rigid mask shell. The disadvantage of this method lies in the fact that the silicone-based paste impression must be made directly on the patient's face, which is a major constraint during pandemic periods, such as that of Covid-19 for example.

[0011] Another method consists of manufacturing the mask pad from a flexible material by additive manufacturing from photos or a video based on a patient's face. The disadvantages of this method lie in the high cost involved, the difficulty of producing a pad directly from photos of the face and the limits of adapting the pad to the face and the mask body used.

[0012] In this context, the problem is to be able to produce a respiratory mask and more particularly a mask pad that faithfully conforms to the particular facial morphology of a patient, including when this morphology is complicated and / or unusual, and this, including remotely, that is to say without having physical access to this patient, in particular in the event of a pandemic and / or confinement.

[0013] The solution of the invention relates to a method for manufacturing a respiratory mask, preferably custom-made, comprising the steps of: a. taking at least one shot of the shape of a person's face using a digital camera comprising shooting means for taking said at least one shot and computer processing means with a processor for processing said at least one shot and delivering a 3D digital model of said person's face, b. manufacturing a 3D face mold from the 3D digital model of the face obtained in step a), using a 3D printing device, c. depositing on the 3D face mold a flexible paste comprising silicone and at least one hardener so as to form an annular structure which fits the contours of the 3D mold in regions of the face located around the nose and / or the mouth, d. inserting into the annular structure made of soft paste, a mask body comprising a rear opening bordered by a peripheral rim so that said annular structure covers the entire peripheral rim all around the rear opening, and e. solidifying the annular structure into a soft paste so as to obtain a soft pad forming a seal along the peripheral edge of the rear opening of the mask body.

[0014] Depending on the embodiment considered, the method of the invention may comprise one or more of the following characteristics: - the digital camera is a multifunction phone or a digital tablet.

[0015]

[0016]

[0017]

[0018]

[0019] - the digital camera is of the multi-lens type. - step b), the 3D face mold is made of polymer, preferably ABS. - the peripheral rim bordering the rear opening of the mask body includes hanging structures. - the peripheral rim bordering the rear opening of the mask body has an annular shape. - the wall forming the peripheral rim bordering the rear opening of the mask body is shaped to present said attachment structures. - the mask body is made of rigid or semi-rigid polymer, for example polycarbonate (PC), polypropylene (PP) or polyamide (PA), such as Nylon® or any other suitable polymer. - the mask body includes a front connection port to receive a connector for a flexible hose connected to a gas source, such as a medical ventilator. - the mask body defines an internal volume, that is to say a chamber or compartment to receive gas. - the mask body includes harness securing structures, such as loops, hooks or the like, for attaching a harness to it to hold the mask on the face of a person, i.e. a user of the mask, such as a patient. - the lashing structures are designed to attach the straps of a harness. - the front connection port is in fluid communication with the internal volume of the mask body. The invention also relates to a respiratory mask comprising a mask body, preferably rigid or semi-rigid, with a rear opening bordered by a peripheral rim, and an annular structure made of flexible paste partially solidified into a flexible pad forming a seal along the peripheral rim of the rear opening of the mask body, directly obtained by the manufacturing method according to the invention. The invention will now be better understood thanks to the following detailed description, given for illustrative but non-limiting purposes, with reference to the appended figures among which: [Fig.l] illustrates the mask manufacturing process according to the invention, [Fig.2] is a schematic ¾ front view of a mask body used in the method of the invention, and [Fig.3] is a rear schematic view of the mask body of [Fig.2].

[0020] [Fig.l] illustrates the method of manufacturing a respiratory mask 10 according to the invention making it possible to obtain a sufficiently precise representation of the face V of a patient P, without having physical access to this patient, i.e. remotely, to make it possible to produce a pad or an interface of the mask perfectly adapted to the face V of the patient P, i.e. faithfully conforming to the particular facial morphology of the patient P, even when this morphology is complicated and / or unusual.

[0021] Firstly, one (or more) shots of the shape of the face V of a person, i.e. of a patient P, are taken using a digital camera 20 comprising shooting means for taking this (or these) shots and computer processing means with a processor, in particular an electronic card carrying one or more microprocessors implementing algorithms, for processing this (or these) shots and delivering a 3D digital model 21 of the face V of the patient in question.

[0022] Preferably, the shooting is carried out remotely, that is to say without the presence of healthcare personnel and by the patient himself for example.

[0023] The digital device 30 is preferably a multifunction telephone (smartphone) or a digital tablet equipped with several shooting lenses, preferably at least 3 lenses.

[0024] The digital device 30 is chosen to enable a precise capture of the shape of the face V of the patient P and then to be able to deliver a faithful 3D digital model of the patient's face. The resolutions available today on modern smartphones, in particular those equipped with multi-focus cameras, i.e. with several shooting lenses, make it possible, thanks to a software application, i.e. a computer program or suitable processing algorithm, to produce the 3D digital model of good resolution.

[0025] After processing the shot(s), i.e. the image(s) obtained, the computer processing means of the digital device 30 provide a 3D digital model 21 of the face obtained to a 3D printing device 22, such as a 3D printer, which is configured to perform a 3D printing of a 3D face mold 23 from the 3D digital model 21 of the face provided to it. The 3D face mold 23 can be made of ABS.

[0026] The printing can also be carried out remotely, that is to say at a location different from that where the patient P is located.

[0027] Once the face mold 23 has been manufactured, a flexible paste comprising silicone, preferably medical silicone, and at least one hardener is deposited on this mold, so as to form an annular structure 24, for example a sort of annular sausage, which fits the contours of the 3D mold 23 in regions of the face. located around the nose and / or mouth, depending on the type of mask desired, namely a nasal or facial mask, i.e. oronasal.

[0028] The annular structure 24 remains flexible, that is to say malleable, even once deposited on the face mold 23.

[0029] A rigid or semi-rigid mask body 1 is then inserted therein comprising a rear opening 2 bordered by a peripheral rim 3, that is to say an edge surrounding the rear opening 2, so that the annular structure 24 made of flexible paste covers the whole of this peripheral rim 2, that is to say the paste borders the whole of the rear opening 2.

[0030] This makes it possible to guarantee a functional and durable integration of the annular structure 24 intended to constitute the custom interface, that is to say the pad 7 obtained after solidification of the annular structure 24 in flexible paste, with the mask body 1 to be used.

[0031] As illustrated in [Fig.2] and [Fig.3], such a mask body 1 may be formed from a polymer shell, rigid or semi-rigid, for example polycarbonate (PC), polypropylene (PP) or polyamide, such as Nylon®.

[0032] It has a front orifice 4 for the fluid connection of a connector of a flexible hose connected to a gas source, such as a medical ventilator, so as to enable the mask, and therefore the patient P, to be supplied with gas from the gas source.

[0033] The mask body 1 defines an internal volume 5, i.e. a chamber or compartment for receiving the gas and then supplying it to the airways of the patient P via the rear opening 2, which is sufficiently wide to allow the patient P to insert his nose and / or his mouth, through the pad 7 obtained after solidification of the annular structure 24 made of soft paste.

[0034] In other words, by solidifying, the annular structure 24 made of flexible paste becomes less flexible but retains a certain flexibility so as to constitute a flexible pad 7, that is to say capable of slightly deforming, forming a seal along the peripheral edge 3 of the rear opening 2 of the mask body 1.

[0035] The solidification of the annular structure 24 into a flexible and malleable paste is done for example by photo-polymerization or other means.

[0036] The flexible pad 7 thus obtained constitutes a flexible, waterproof and comfortable interface, perfectly adapted to the shape of the face, that is to say to the facial morphology of the patient P, thanks to the application of said malleable paste on the mold 23 of the face V of the patient P.

[0037] In order to improve the fixing and maintenance of the annular structure 24 made of malleable paste on the mask body 1, attachment structures are preferably provided in the wall forming the peripheral rim 3 bordering the rear opening. 2 of the mask body 1, that is to say that the wall forming the peripheral rim 3 is shaped to have recesses, small walls or the like, serving to better anchor the annular structure 24 in flexible paste intended to constitute a seal.

[0038] The seal formed by the flexible pad 7 makes it possible to improve the effectiveness of the treatment and the comfort of use by preventing or limiting gas leaks around the edge of the mask 10, that is to say in the contact zone between the user's face and the flexible pad 7.

[0039] Conventionally, the mask body 2 also comprises harness securing structures 6, such as loops, hooks or the like, allowing a harness (not shown) to be attached thereto, in particular the harness straps, in order to hold the mask 1 in position on the face of the user of the mask 1, i.e. the patient P for whom the mask 1 is intended.

[0040] The mask 10 thus obtained is suitable for use in the treatment of a respiratory disorder or pathology, for example obstructive sleep apnea (OSA) or any other respiratory pathology requiring administration of a gas by means of such a mask 10, in a person, that is to say a patient, whether an adult, an adolescent, a child or a newborn.

Claims

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4. Claims Method for manufacturing a respiratory mask (10) comprising the steps of: a. taking at least one shot of the shape of the face (V) of a person (P) by means of a digital camera (20) comprising shooting means for taking said at least one shot and computer processing means with a processor for processing said at least one shot and delivering a 3D digital model (21) of the face (V) of said person (P), b. manufacturing a 3D face mold (23) from the 3D digital model (21) of the face obtained in step a), using a 3D printing device (22), c. depositing on the 3D face mold (23) a flexible paste comprising silicone and at least one hardener so as to form an annular structure (24) which fits the contours of the 3D mold (23) in regions of the face located around the nose and / or the mouth, d. inserting into the annular structure (24) made of soft paste, a mask body (1) comprising a rear opening (2) bordered by a peripheral rim (3) so that said annular structure (24) covers the entire peripheral rim (3) all around the rear opening (2), and e. solidifying the annular structure (24) into a soft paste so as to obtain a soft pad (7) forming a seal along the peripheral edge (3) of the rear opening (2) of the mask body (1). Method according to claim 1, characterized in that the digital camera (20) is a multifunction telephone or a digital tablet, preferably with several lenses. Method according to claim 1, characterized in that in step b), the 3D face mold (23) is made of polymer, preferably ABS. Method according to claim 1, characterized in that the peripheral rim (3) bordering the rear opening (2) of the mask body (1) comprises hooking structures (7).

5. Method according to one of claims 1 or 4, characterized in that the mask body (1) is made of rigid or semi-rigid polymer, in particular polycarbonate (PC), polypropylene (PP) or polyamide (PA).

6. Method according to one of claims 1, 4 or 5, characterized in that the mask body (1) defines an internal volume (5) and comprises a front connection orifice (4) in fluid communication with the internal volume (5).

7. Method according to one of claims 1 or 4 to 6, characterized in that the mask body (1) comprises harness securing structures (6).

8. Method according to one of the preceding claims, characterized in that the respiratory mask (10) is obtained comprising the mask body (1) with the rear opening (2) bordered by the peripheral rim (3), and the annular structure (24) made of partially solidified soft paste in the soft pad (7) forming the seal along the peripheral rim (3) of the rear opening (2) of the mask body (1).

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