FR2749176A1 - Silicone respirator mask manufacturing procedure - Google Patents

Silicone respirator mask manufacturing procedure Download PDF

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Publication number
FR2749176A1
FR2749176A1 FR9606952A FR9606952A FR2749176A1 FR 2749176 A1 FR2749176 A1 FR 2749176A1 FR 9606952 A FR9606952 A FR 9606952A FR 9606952 A FR9606952 A FR 9606952A FR 2749176 A1 FR2749176 A1 FR 2749176A1
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France
Prior art keywords
silicone
shell
resin
nostrils
fittings
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Granted
Application number
FR9606952A
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French (fr)
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FR2749176B1 (en
Inventor
Charles Norbert Bouhadana
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MIDI OXYGENE
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MIDI OXYGENE
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Priority to FR9606952A priority Critical patent/FR2749176B1/en
Publication of FR2749176A1 publication Critical patent/FR2749176A1/en
Application granted granted Critical
Publication of FR2749176B1 publication Critical patent/FR2749176B1/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • A61M16/0666—Nasal cannulas or tubing
    • 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
    • A61M16/0688—Holding devices therefor by means of an adhesive
    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B9/00—Component parts for respiratory or breathing apparatus
    • A62B9/06—Mouthpieces; Nose-clips
    • 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
    • A61M2016/0661—Respiratory or anaesthetic masks with customised shape
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0618—Nose

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

Abstract

A nose mask manufacturing procedure, e.g. for treating apnoea, consists of moulding a semi-fluid silicone shell (3) directly on the patient's nose and incorporating two ring joints in line with the nostrils at this stage. After catalysing of the shell the ring joints are pierced, the shell is covered with a layer of a photo-polymerisable material, and attachments (6) for holding straps (5) and fitted. Following photo-polymerisation, connectors (1) are attached to the nostril holes with the aid of photo-polymerisable resin joints (4), and the resin shell and silicone mould are joined together with a silicone adhesive. The silicone material used for the procedure can be, for example, a bicomponent silicone produced under the name 'Biopor' (RTM).

Description

La présente invention concerne un procédé de fabrication d'un masque respiratoire. The present invention relates to a method of manufacturing a respiratory mask.

II existe de nombreuses utilisations pour ce genre de masque et, en particulier, I'utilisation d'un respirateur barométrique ou volumétrique dans le cas d'une prescription de ventilation par masque nasal ou d'une PPC (Pression
Positive Continue) prescrites dans le cas de syndrome d'apnée du sommeil. Ces appareils sont communément appelés CPAP et BPAP.There are many uses for this kind of mask and, in particular, the use of a barometric or volumetric respirator in the case of a prescription for ventilation by nasal mask or CPAP (Pressure
Positive Continue) prescribed for sleep apnea syndrome. These devices are commonly called CPAP and BPAP.

Pour mettre en oeuvre ces techniques, des coffrets renfermant les produits nécessaires à la fabrication de ces masques, ont déjà été proposés. To implement these techniques, boxes containing the products necessary for the manufacture of these masks have already been proposed.

Selon une de ces méthodes, on emploie un mélange de pâte à base de silicone et de durcisseur. Dans un premier temps, on applique ce mélange sur le nez du patient et on réalise le moulage du nez. Lorsque la pâte a durci, on l'enlève du visage du patient et on perce des orifices correspondant aux empreintes laissées par les narines. Dans un second temps on place sur le moulage de silicone une plaquette de plastique thermoformable et on la conforme grossiérement à ce moulage pour obtenir une coque rigide. Des tubulures, ainsi que des attaches élastiques sont alors fixées à la coque. According to one of these methods, a mixture of silicone-based paste and hardener is used. Firstly, this mixture is applied to the patient's nose and the nose is molded. When the paste has hardened, it is removed from the patient's face and holes are drilled corresponding to the imprints left by the nostrils. In a second step, a thermoformable plastic plate is placed on the silicone molding and roughly conforms to this molding to obtain a rigid shell. Tubing, as well as elastic fasteners are then fixed to the hull.

Cette méthode présente de sérieux inconvénients. Le premier découle du fait que le manipulateur est obligé d'exercer une pression sur le nez du patient pour faire adhérer le silicone. Les parois du nez étant relativement souple, celles-ci se déforment. Par conséquent, le moulage réalisé, qui a pour but l'étanchéité du masque, ne remplit pas correctement son rôle : les fuites occasionnées peuvent être à l'origine de conjonctivites. This method has serious drawbacks. The first arises from the fact that the manipulator is forced to exert pressure on the patient's nose to adhere the silicone. The walls of the nose being relatively flexible, these deform. Consequently, the molding carried out, which aims at sealing the mask, does not correctly fulfill its role: the leaks caused can be the cause of conjunctivitis.

Autre inconvénient, le poids du masque dû à l'épaisseur de pâte utilisée.  Another drawback is the weight of the mask due to the thickness of paste used.

La présente invention a pour but de remédier à ces inconvénients. The object of the present invention is to remedy these drawbacks.

Pour ce faire, elle propose un procédé de fabrication facile à mettre en oeuvre. Le masque obtenu est étanche, léger, et ne met le patient à contribution que pour une courte durée (5 minutes environ). To do this, it offers a manufacturing process that is easy to implement. The mask obtained is waterproof, light, and only involves the patient for a short time (approximately 5 minutes).

Ce masque est réalisé directement sur le patient grâce à un injecteur muni d'un bec mixeur mélangeant le produit au fur et à mesure de la réalisation. This mask is produced directly on the patient thanks to an injector provided with a mixer nozzle mixing the product as it is produced.

La réalisation du masque s'effectue comme suit en deux temps
Voir figures N"1 Dépose du silicone sur le nez
N"2 . Vue frontale d'ensemble du masque
N"3 Coupe A '1 B' du masque
N"4: Coupe C / D du masque
N"5 : Vue de profil du masque complet sur le visage.The mask is made as follows in two stages
See figures N "1 Deposit of the silicone on the nose
No. 2. General front view of the mask
N "3 Section A '1 B' of the mask
# 4: Mask C / D cut
N "5: Profile view of the full face mask.

1 - réalisation et modelage du silicone:
On délimite le tracé du masque en effectuant un dépôt de silicone sur le nez du patient, puis on rempli l'intérieur en effectuant plusieurs passages concentriques de l'extérieur (A) vers l'intérieur (B), jusqu'à obtenir le recouvrement complet du nez et des narines (figure 1). Pour ce faire on peut utiliser un silicone bi-composants de marque "B1OPOR" de chez "DREVE"
On positionne alors les 2 embouts cannelés (1) en regard des narines dont le pourtour est noyé dans le silicone.La catalysation s'effectue au bout de 4 à 5 minutes.1 - realization and modeling of the silicone:
We delimit the outline of the mask by making a silicone deposit on the patient's nose, then we fill the inside by making several concentric passages from the outside (A) to the inside (B), until obtaining the covering. full of nose and nostrils (Figure 1). To do this we can use a two-component silicone brand "B1OPOR" from "DREVE"
The 2 fluted tips (1) are then positioned opposite the nostrils, the periphery of which is embedded in the silicone. Catalysting takes place after 4 to 5 minutes.

2 - Réalisation de la coque de maintien en résine photopolymérisable (2) que l'on met en forme sur le silicone (3). 2 - Creation of the retaining shell in photopolymerizable resin (2) which is shaped on the silicone (3).

On peut donc faire les découpes nécessaires, les rajouts utiles et solidariser enfin les raccords annelés grace à un joint (4) constitué.We can therefore make the necessary cuts, useful additions and finally secure the corrugated fittings with a seal (4) formed.

Il faut prévoir toutes les découpes et les passages de sangles de fixation(5) (6)avant passage en photopolymérisation d'éventuels rajouts sont possibles avec une exposition supplémentaire. aux U.V. It is necessary to plan all the cutouts and the passages of fixing straps (5) (6) before passage in photopolymerization of possible additions are possible with an additional exposure. in the U.V.

On solidarise le silicone et la coque par un collage avec une colle spécifique (colle silicone).The silicone and the shell are joined together by bonding with a specific adhesive (silicone adhesive).

En conclusion, les avantages majeurs de ce type de masque sont:
- moulage parfait étant donné la viscosité du silicone avant catalysation
- l'étanchéité afin d'éviter les fuites (risques de conjonctivite) sans pour autant avoir à serrer les sangles et donc risquer de blesser le patient.In conclusion, the major advantages of this type of mask are:
- perfect molding given the viscosity of the silicone before catalyzing
- tightness to avoid leaks (risk of conjunctivitis) without having to tighten the straps and therefore risk injuring the patient.

- la durée de travail non limitée tant que la résine n'est pas photopolymérisée
- suppression du chauffage du plastique thermoformable, et donc des risques de brûlure du patient.- unlimited working time as long as the resin is not light-cured
- elimination of heating of thermoformable plastic, and therefore of the patient's risk of burns.

- les narines ne risquent plus de collapsus comme pour les autres masques. - the nostrils no longer risk collapse as for other masks.

- le masque terminé, il peut être passé à l'autoclave sans risque de déformation (chose impossible avec un matériau thermoformable). - the mask finished, it can be autoclaved without risk of deformation (something impossible with a thermoformable material).

- le montage et le démontage des sondes est aisé du fait de l'absence de collage, II s'agit simplement d'un emboîtage des sondes sur les raccords annelés.  - The assembly and disassembly of the probes is easy due to the absence of bonding, it is simply a fitting of the probes on the corrugated fittings.

Claims (2)

REVENDICATIONS 1 - Procédé de fabrication d'un masque respiratoire caractérisé en ce qui comprend les étapes suivantes, consistant à  1 - Process for manufacturing a respiratory mask characterized in which comprises the following steps, consisting in a) Réaliser une coquile en silicone (3) semi fluide directement sur le patient en y incluant lors de cette phase deux raccords annelés (1) en regard des narines, a) Make a semi-fluid silicone shell (3) directly on the patient by including during this phase two ringed fittings (1) facing the nostrils, b) Après catalysation, percer en regard des raccords annelés, dans le silicone, les ouvertures permettant le passage de l'air par les narines b) After catalyzing, pierce the openings allowing the passage of air through the nostrils, opposite the ringed fittings, in the silicone c) Confection d'une coque en matière photopolymérisable (2) en modelant sur le silicone une plaque de la dite matière, c) Making a shell of photopolymerizable material (2) by modeling a plate of said material on the silicone, d) Effectuer le perçage correspondant aux raccords annelés et celui (6) des attaches de sangles de maintien (5), d) Carry out the drilling corresponding to the corrugated fittings and that (6) of the retaining strap attachments (5), e) Effectuer la photopolymérisation, e) Carry out the photopolymerization, f) Solidariser les raccords avec la coque de résine à l'aide d'un joint en résine photopolymérisable (4), f) Secure the connections with the resin shell using a light-curing resin seal (4), g) Insoler une dernière fois pour parfaire la polymérisation, g) Insolate one last time to perfect the polymerization, h) Collage de la coque en résine et du moulage silicone à l'aide d'un colle silicone. h) Bonding of the resin shell and the silicone molding using a silicone adhesive. 2 - Procédé de fabrication selon la revendication 1 caractérisé en ce qu'il utilise 2 - Manufacturing method according to claim 1 characterized in that it uses - à l'étape a) un silicone bi-composants avec un système d'injection /mixage. - in step a) a two-component silicone with an injection / mixing system. - à l'étape b) la fabrication d'une coque en résine photopolymérisable et l'ajout des embouts dans la même matière.  - in step b) the manufacture of a photopolymerizable resin shell and the addition of end caps in the same material.
FR9606952A 1996-05-31 1996-05-31 RESPIRATORY MASK IN TWO-COMPONENT SILICONE AND PHOTOPOLYMERIZABLE RESIN Expired - Fee Related FR2749176B1 (en)

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US9895505B2 (en) 2004-04-09 2018-02-20 Resmed Limited Nasal assembly
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