FR2824739A1 - Nasal and oral/nasal mask, for non-invasive artificial respiration, is molded from a synthetic material by heat and pressure, using numerical photographic data to shape the mold according to the patient's features - Google Patents

Abstract

The nasal and oral/nasal mask (1) is shaped from photography of the raised and recessed zone of the patient's facial features by numerical photography. The numerical photographic data are used to generate a program to shape the interior of a mold, step-by-step, in the required mask structure. The mold shapes a sheet of synthetic material by heat and pressure, together with inserts of blocks of resin or metal alloy.. A cushion (16) is formed to lie against the skin

Description

dehydroepiandrosterone is mixed before compression with mineral salts.

  TAILOR-MADE NASAL AND BUCCO-NASAL MASKS

,

  AND METHOD FOR PRODUCING SUCH MASKS

  The present invention relates to nasal masks and

  custom bucco-nasals, as well as the process for making such masks.

  They are intended for non-invasive mechanical ventilation of the respiratory tract by gas generator with single-branch or double-branch patient circuit with or without respiratory valve, of the ventilator type, continuous positive pressure generator, pressure relaxer, volume relaxer or flow restrictor, for the treatment of respiratory pathologies in hospitals, at home and all

  another place where non-invasive mechanical ventilation is practiced.

  Non-invasive ventilation masks are most often used in the homes of patients treated for various respiratory pathologies such as sleep apnea syndrome, ventilation of chopulmonary-chronic-obstructive bronchial tubes (COPD) or pulmonary pathologies

  restrictive for adults and newborns.

  Non-invasive ventilation (NIV) is opposed to invasive ventilation.

  The latter requires surgery that allows ventilation of the patient's lungs by tracheostomy. Many medical practices in invasive artificial ventilation are now giving way to NIV, which is clearly less traumatic for the patient and much less costly while reducing the risks associated

to any surgical intervention.

  The gas generator is adjusted by the doctor or a medical technician (nurse, physiotherapist) to generate the volume, flow and pressure

  required by the patient depending on the pathologies to be treated.

  A pipe (2, Figure 1) leaves the generator to reach the mask (1) and conduct the gases to the patient's lungs. It is the mask, applied to the patient's face, which delivers gas through the nostrils or / and through the mouth. This same mask authorizes on expiration, on the one hand the expiration of the exhaled gases and, on the other hand, the "rinsing" of the CO2 contained in the exhaled gases which is carried out by a calibrated hole provided in the mask. The air exhaust thus formed -2 can cause physical discomfort and significant stress for the

sick and his immediate entourage.

  The existing non-invasive ventilation masks (1, Figure 1) most often consist of a plastic shell and parts in contact with the skin formed from a material which does not cause skin allergy. For this purpose,

  silicone beads are generally provided.

  These masks are generally made from a single mold, or from a few molds of different sizes. As a result, they do not perfectly match the morphology of each patient. Consequently, more or less significant leaks exist and require permanent and proportional automatic compensation of the generator. The size of the mask and the free space it frees between the human face and the shell are all dead spaces which

  may affect the efficiency of mechanical ventilation.

  To limit leaks, patients tend to tighten the harnesses (3, Figure 1) which hold the mask on the face (4), which can tend to limit

  comfort of use and cause skin irritations.

  The "rinsing" of the CO2 contained in the exhaled gases is carried out through a calibrated hole provided in the mask. The air exhaust thus formed can cause physical discomfort and significant stress for the patient and his

immediate entourage.

  The accessories are diverse and allow adaptability to the morphology of each user. Many components are taken into account and constitute a relatively cumbersome and costly management, both for the

  manufacturer only for the patient and the various intermediaries of the prescription.

  The device according to the present invention aims to remedy these drawbacks. It makes it possible, compared to known embodiments, to significantly improve the comfort of patients and to limit the drawbacks of those around them, while facilitating the work of therapists as well as simplicity

  installation, silent operation and CO2 flushing efficiency.

  It also has a series of advantages such as a limited size of the masks, their maintenance by a simple strip with two anchoring points on the body of the mask, a possibility among others for the user to choose a location on the left. or to the right of the air supply and rinsing -3 CO2, the absence of special and additional fittings for the connection of the gas connection pipe to the mask, and a method of digital management of the data of each mask ensuring significant reduction in costs related to

  production, distribution, inventory management and use of the product.

  s This device consists of a ventilation mask made to measure by photographing the shapes, reliefs and hollows of the patient's face using a digital camera, then modeling the digital file obtained using design software. computer-assisted to produce, by means of a numerically controlled machining system step by step, a mold representing the internal imprint of the mask and making it possible to form it

  thermoforming of a sheet of synthetic material.

  The mold of each mask (and accessories) is produced by

  chip removal from resin blocks or metal alloys.

  In the appended schematic drawings, given by way of nonlimiting examples of embodiments of the subject of the invention: FIG. 1, already cited, shows an existing non-invasive ventilation mask seen from three quarters before, FIG. 2 shows one of the possibilities of ventilation masks according to the invention, seen from the side and FIGS. 3 and 4 show, respectively from the front and in view

  overhanging, two variants of the same mask.

  The device, Figures 2 to 4, consists of a shell 11 made to measure, including only the final rounding of the nose 15 and the nostrils, and held on the face by means of a band 13 of adjustable length provided two anchor points to the mask. He therefore authorizes the wearing of glasses and the practice of various activities by the patient, even when he is ventilated. The shell 11, made of thermoformed hard plastic, can be used for many years and can be cleaned

very simply.

  The part in contact with the skin, made for example of a silicone cushion 16 playing the role of joint, does not overflow on the cheeks or on the mouth. The patient can eat, drink and chat during ventilation sessions. In -4 night ventilation session, he undergoes fewer physical constraints and can consider moving in bed. The gas can be supplied to the mask by means of an air inlet 17 on the left or right side, a front inlet, etc.

  below the nostrils, by a flexible tube 12.

  The purge of the expired CO2 at each respiratory cycle (feeding by single-circuit) is protected by an adjustable fan which directs the exhaled air in a direction left to the choice of the patient. The bleed hole 18, adjustable in three

  positions, makes the mask compatible with all generators on the market.

  For the production of a mask, the shapes, reliefs and hollows of the patient's face are photographed by means of a type camera.

  digital, by simple click "double capture".

  The patient's image is thus acquired in the form of a digital file stored in the memory medium of the camera. The photo file is transferred to the memory of a standard home computer or

  laptop with graphics card and modem.

  The digital files of the faces are transmitted via the internet, or another telematic network, to a site for using the files for making the masks. These files are modeled using computer-aided design software (CAD) (for example: "Amapi Meta Stream"). The CAD software models each mask automatically taking into account the morphology specific to each human facial shape. The physical constraints of the respiratory mask are also defined in the CAD software: distances, contact points, nose-mask dead space, position and shape of the mask accessories, attachment and connection. A numerical control system step by step (for example: Microsteps 4 axes) and its software allow the calculation of three-dimensional paths

from CAD files.

  The mold for a mask (and accessories) is produced by removing shavings from resin blocks or liq ual metal bindings. The mold represents the interior imprint of the mask which contains all of the human and physical constraints of the mask. It is ready to accommodate a plate of

  transparent plastic material such as PTEG poyester for thermoforming.

  The quality of the mold resin combined with that of polyester allows rapid and precise shaping by vacuum forming at a temperature below 100 C. The product obtained has excellent transparency, a beautiful surface gloss and compliant food accounting to European regulations on health facilities and those instructed by Food

  Drug Administration (FDA) of the United States.

  The release is instantaneous after the thermoforming operation.

  Cutting and trimming are simply done with a sharp object following the contours defined during modeling. The holes for the mask are made

using a milling machine.

  The m ise in p lace of the supply ends receiving the flexible hose 12 is carried out by simple pressure, for example on one or two articulated ball joints mounted on the air inlet 17, and a silicone cushion 16, or Another type

  interface, playing the role of joint is assembled by clipping or gluing.

  The mask, with its accessories, can be cleaned with soapy water.

  It can be washed in a dishwasher without disassembly and sterilized using

  cold solutions. The strip can be washed in the washing machine.

  Digital data, which can be stored on any IT medium with the patient's identity or code, allows immediate realization

new masks and accessories.

  The positioning of the various constituent elements gives the object of the invention a maximum of useful effects which had not, to date, been obtained by

similar devices.

-6

Claims (8)

  1. Method of making custom nasal and bucco-nasal masks, intended for non-invasive mechanical ventilation of the respiratory tract by gas generator with single-branch or double-branch patient circuit with or without respiratory valve, of the ventilator type, pressure generator continuous positive, pressure relaxer, volume relaxer or flow relaxer, for the treatment of respiratory pathologies in hospitals, at home and any other place where non-invasive mechanical ventilation is practiced, characterized in that the masks are produced by photographing the shapes, reliefs and hollows of the patient's face by means of a digital photographic device, then by modeling the digital file obtained by means of computer-aided design software to produce by means of a machining system using digital control step by step a mold representing the inner imprint of the mask and allowing it to be formed by ther moforming of a sheet of synthetic material.   2. Method according to claim 1, characterized in that the digital photographic file is transferred to the memory of a standard or portable home computer equipped with a graphics card and a modem, then transmitted via the Internet or another network. telematics, to an operating site for   files for making masks.   3. Method according to any one of the preceding claims,   characterized by the fact that computer-aided design software is arranged to automatically take into account the specific morphology of each human facial form.   4. Method according to any one of the preceding claims,   characterized by the fact that the physical constraints of respiratory masks, such as distances, contact points, nose mask dead space, position and shape A 2824 739   -7 mask accessories, fixing and connection, are defined in the software   computer-aided design.    . Method according to any one of the preceding claims,   characterized by the fact that the numerically controlled machining system produces the molds for the masks by removing chips from a block of resin or of metallic alloy.   6. Method according to any one of the preceding claims,   characterized by the fact that the plastic sheet used for thermofor-   sea masks is made of transparent PTEG polyester.   7. Tailor-made nasal masks produced using the process according to   one of the preceding claims, characterized in that they consist of a   shell (11) made to measure, including only the final rounding of the nose (15) and the nostrils, and held on the face by means of a band (13) of adjustable length provided   two anchor points to said mask.   8. Nasal masks according to claim 7, characterized in that the part in contact with the skin is made of a silicone cushion (16) or other type of interface playing the role of joint and assembled by clipping or gluing, not overflowing neither on the cheeks nor on the mouth so that the patient can   eat, drink and chat during ventilation sessions.   9. Nasal masks according to any of claims 7   and 8, characterized in that the gas supply takes place by means of an air inlet (17) on the left or right or front side, below the nostrils, by a flexible pipe (12) connected to a nozzle set up by simply pressing   an articulated ball joint mounted on said lateral inlet.    . Nasal masks according to any of claims 7   at 9, characterized by the fact that they are supplied by a single-branch circuit and that the purge orifice (18) of the CO2 exhaled at each respiratory cycle is protected by -8 an adjustable fan adjustable in three positions making it possible to direct the air expired dens