FR2775905A1 - Nasal ventilation mask for post operative ventilation of children - Google Patents

Abstract

The nasal ventilation mask has a rigid concave shell (12) defining a domed section (18) to cover the nose and with an opening (14) for connection to a ventilator. The shell has a front wing (28) and two side wings (30) to contact the upper jaw area.

Description

The present invention relates to a nasal ventilation mask of the

  type comprising a concave rigid shell defining a curved curvature

  vertex of the nasal pyramid provided with an orifice for connection to a device

  reil of ventilation, in which the bending delimits an imprint of the py-

  ramide nasal and forms a peri-nasal bearing surface, The invention further relates to a method of manufacturing a mask

nasal ventilation.

  The indications for wearing such a mask mainly concern-

  ment children to be ventilated for the long term either for hypoventi-

  lations of central origin (Ondine syndrome), or for respiratory failure in the context of a neuromuscular disease. Such a ventilation mask is also intended for children suffering from a syndrome

  severe obstructive upper airway corresponding to a pa-

  congenital bone theology (picnodysostosis, achondroplasia) or syn-

  Pierre Robin's drome of ili form or of a glossoptosis in encephalopathic children. An additional indication is immediate postoperative ventilation to limit the time of intubation in days

following the intervention.

  In order to fight against certain respiratory deficiencies, it is necessary

  be sure to provide children with a breathing aid device during sleep. Such a device includes a nasal ventilation mask worn by

  the child during the night and a ventilation device to which is connected, by the

  through a flexible air supply duct, the ventilation mask

nasal.

  A nasal ventilation mask only covers the nose, mouth

  remaining free. Such a mask is described for example in the patent application.

vet FR-A-2,658,725.

  In this application, the mask comprises a concave rigid shell covering the nasal pyramid provided with a connection orifice to the ventilation device. The shell being molded according to the shape of the patient's face, this defines an imprint of the nasal pyramid and forms a

peri-nasal bearing surface.

  The hull is provided, at its periphery, with a seal.

  The outline of the mask shell applies to the immediate periphery

  nose date. In order to guarantee satisfactory sealing of the mask, it

  apply this firmly to the patient's nose through

  diary of a traction applied by a strap surrounding the head. We note that the stresses exerted by the mask on the face

  at the level of the nose cause skin lesions ranging from simple erosion

  at the level of support points, ulcers, or even pressure sores. In addition, the support of the mask on the nose hinders the facial growth of the child, when the mask is worn for long periods, which is the case.

  in case of respiratory assistance during sleep.

  The invention aims to provide a nasal ventilation mask

  avoiding skin lesions on the face, while ensuring a watertight seal

  satisfying and respect for facial growth.

  To this end, the invention relates to a nasal ventilation mask of the

  aforementioned type, characterized in that the hull comprises a front wing of ap-

  then on the middle part of the forehead and two lateral support wings on the

  upper maxilla, each lateral wing extending at least up to the

hard malar bone.

  According to particular embodiments, the ventilation mask

  one or more of the following characteristics:

  - the perinasal bearing surface, the front wing and the two lateral wings

  define them as a single continuous contact surface on the face; - The front wing has lateral support extensions on the forehead above the browbones;

  - the hull has temporal support flanks connecting the extensions -

  lateral frontal elements with lateral wings defining a closed support contour around each orbital cavity; - the shell defines an imprint of the face in the areas of support of the shell on the face; - It comprises a cranial harness for holding said shell pressed against the face, and the harness is adapted to exert a substantially zero force on the shell in the absence of ventilation;

  - the connection orifice comprises two cannulas which open sensi-

  in the extension of the nostrils; and

  - the connection orifice comprises an external integral tubing-

  The concave rigid shell extending along the bending and opening out

  song in the vicinity of the front wing. The invention further relates to a method of manufacturing such a mask, characterized in that it comprises the following successive steps: a) the patient is stretched out in the sleeping position; b) the muscles of the patient's face are relaxed; c) an impression is made of the relaxed face of the patient in the sleeping position at least in the area of application of the mask shell; d) a model of the patient's face is produced by molding, from the impression at least in the area of application of the mask shell; and

  e) the shell of the mask is shaped on the model of the face

  read. According to another mode of implementation, it is applied to the face

  hull support a covering film compatible with the skin of the

wise.

  The invention will be better understood on reading the description which follows.

  vre, given only by way of example, and made with reference to the drawings in which: - Figure 1 is a perspective view of three quarters of a child's face wearing a nasal ventilation mask according to the invention; - Figure 2 is a view similar to that of Figure 1 of an alternative embodiment of the mask of Figure 1; and

  - Figure 3 is a view similar to those of Figures 1 and 2 of an au-

  be a nasal ventilation mask according to the invention.

  The nasal ventilation mask shown in FIG. 1 is intended to be connected to a ventilation device of the VC type, that is to say an appliance

conventional ventilation.

  The mask essentially comprises a concave rigid shell 12 provided with a double orifice 14 for connection to the ventilation device and

a retaining harness 16.

  The shell 12 has an interior surface defining exactly the imprint of the surface of the face covered by the mask. In its central part, the shell 12 defines a bending 18 internally defining the imprint of the nasal pyramid. The interior surface of the bending defines

a perinasal support surface.

  The double orifice 14 comprises two cannulas 20A, 20B opening at the base of the bending 18 substantially in the extension of the nostrils of the patient. The cannulas 20A, 20B are extended by two flexible pipes 22 converging towards the same main supply pipe 24 to which they are

  connected via a connector 26.

  According to the invention, the mask comprises a front wing 28 which fits

  puie on the middle part of the patient's forehead and two lateral wings 30A, B on the upper jaw of the patient. Each side wing

  extends at least to the edge of the malar bone.

  The two lateral wings 30A, 30B and the front wing 28 came integrally with the bending 18, so that these define a single

  continuous support surface on the face.

  The front wing 28 has lateral extensions on either side.

  rals 32A, 32B defining bearing surfaces on the patient's forehead,

above the eyebrows.

  The internal surface of the shell 12 is covered with a thin film compared

tible with the surface of the face.

  The two front extensions 30A, 30B and the two lateral wings A, 30B have at their ends external hooks intended for

docking the harness 16.

  This comprises four flexible links 34A, 34B, 36A, 36B intended for

  be moored at the ends of the front extensions and side wings

  the. These links are connected, at their other end, to a flexible main arch 38 overlapping the patient's head from one ear to the other, passing through the

top of the skull.

  The arch 38 has, in its upper middle part, a loop for holding the supply pipe 24. In addition, the harness 16 includes a strap 42 encircling the back of the skull in the extension of the links

  34A, 34B fixed to the ends of the lateral wings 30A, 30B.

  The harness 16, and in particular the links 34A, 34B, 36A, 36B, are dimensioned so that, in the absence of induced ventilation transmitted via the double orifice 14, the harness 16 does not exert substantially

  no effort on the rigid shell and ensures that it is maintained.

  When wearing the mask, as shown in Figure 1, the links

  34A, 34B, 36A, 36B follow the shape of the face. They apply in particular

  lie on the anterior parts of the cheeks and forehead.

  We understand that the force applied to the mask shell being qua-

  simulate zero, and the surface of contact with the face being very large

  since, in addition to most of the surface of the nasal pyramid, it pre-

  feels a large support surface on the forehead and cheeks, the low

  local strain applied in each area of the face is of no consequence.

  Each mask is specific to a patient and is made special-

  lying for him, it requires taking a facial print of the child.

  To do this, the child is lying at rest in a correct position.

  laying in the sleeping position. In order to relax the facial muscles, the operation is performed in a calm and restful atmosphere. To avoid

  any unnecessary tension, the child may have been premedicated beforehand.

  While the child is fully rested and in a relaxed position

  chée, we perform a molding of the upper two-thirds of the face, that is

  say from the area extending from the top of the mouth to the top of the forehead. In particular, the nose and eyes are covered with material intended to

taking the imprint.

  This molding is carried out by application to the face of a succession

  of materials. First apply an alginate. This is then rigi-

  dified with "Zelgan 2000" brand plaster bands which form a

  rigid shell allowing demoulding without deformation.

  After a sufficient drying period, around a quarter

  hour, the imprint thus formed is released from the child's face.

  The stiffened impression thus obtained is filled with plaster in order to obtain a conforming model of the upper part of the child's face. We obtain

  thus, after hardening of the plaster, the positive model of the child's face no-

  especially areas on which the mask shell will rest.

  In order to produce the mask shell, a sheet of a self-curing resin in the open air, for example a dental resin, is used. The resin of the company BAYER distributed in France by the company DENTAL under the name

  "Pekatray" is ideal for making masks.

  In its plastic state, the sheet is applied to the molding of the

  previously performed face. The outline of the mask shell is de-

  cut and the hooks are placed at the four ends. While the mask shell is strictly resting on the model of the face, the sheet is polymerized. Also, when removing the shell, it retains its shape and its inner surface exactly delimits the profile of the face of

The child in the sleep phase.

  The inner surface of the shell is then covered with a coating

  compatible with facial skin, in particular an "al-" type coating

  goplaque H.P "marketed by the company URGO.

  The harness 16 is then made to measure by a seamstress so that it exactly matches the dimensions of the child's head. Thus, the harness ensures unconstrained support of the mask shell on the face. In Figure 2, there is shown an alternative embodiment of the mask of Figure 1. In this figure, elements similar to those of Figure 1

  are designated by the same reference numbers.

  The mask in Figure 2 differs in that the shell, denoted 52, comprises

  carries temporal support flanks 54A, 54B connecting the lateral extensions

  rails 32A, 32B with side wings 30A, 30B. Thus, the supporting flanks tempo-

  ral, the lateral front extensions and the lateral wings define a closed contour around each orbital cavity. The material used in this

  case is "Sansplint" from the company SMITH-NEPHEW.

  In this embodiment, the lateral wings in their area of

  connection with the temporal support flanks extend over the malar bones.

  The hooks connecting the shell to the retaining harness are worn

  ted by the temporal support flanks 54A, 54B.

  Such a shell is particularly suitable for children whose face has a relatively flat surface, for example very young children. In addition, this type of shell is particularly recommended for children with fragile skin. Indeed, the bearing surface of the

  shell is increased compared to that of the mask shown in Figure 1.

  FIG. 3 shows another embodiment of the mask according to the invention.

  vention. This mask is intended to be associated with ventilation equipment.

  PPC type, that is to say a posi-pressure ventilation device

tive continues.

  This mask comprises a shell having a continuous bearing surface substantially similar to that of the mask of FIG. 1. However, the two cannulas 20 for connecting the supply pipes are replaced by a single nozzle 60 provided in the vicinity of the wing front 28. The nozzle 60 is oriented upwards to receive a single flexible supply pipe

  62. The nozzle 60 is extended by a tube 64 integrated into the shaped shell.

  mant a conduit connecting the cannula 60 to the nostrils 64 of the patient. The tubing

  64 extends along the nasal bulge 18.

  In the example of FIG. 3, the upper links 36A, 36B of the har-

  nais connected to the front wing 28 came integrally with the arch 38. Likewise, the strap 42 surrounding the head of the child also came integrally with the arch. This strap extends the top links and extends

above the child's ears.

  If the child must, during the sleep phases, wear a cor-

  dental erection, it can be connected mechanically by any means

  adapted, in particular rigid arms to the mask shell. The device applied

  that thus a constraint taken up by the harness on the child's jaws

  thus ensuring the establishment of extra oral orthopedic force.

Claims (10)

  1.- Nasal ventilation mask of the type comprising a ri- shell   concave gide (12) defining a bending (18) to cover the pyra-   nasal mide provided with an opening (14) for connection to a ventilation device   tion, in which the bending (18) delimits an imprint (18) of the nasal pyramid and forms a peri-nasal bearing surface, characterized in that the shell (12) has a front wing (28, 32A, 32B) bearing on the middle part of the forehead and two lateral wings (30A, 30B) bearing on the upper jaw, each lateral wing (30A, 30B) extending at least up to the border of the malar bone.   2. Mask according to claim 1, characterized in that the peri-nasal bearing surface (18), the front wing (28) and the two lateral wings (30A,   B) define a single continuous contact surface on the face.   3.- Mask according to claim 1 or 2, characterized in that the front wing (28) has lateral extensions (32A, 32B) bearing on the   forehead above the browbones.   4. Mask according to claim 3, characterized in that the shell   (12) has flanks (54A, 54B) of temporal support connecting the extensions   lateral frontal elements (32A, 32B) to the lateral wings (30A, 30B) defining   a closed contour of support around each orbital cavity.   5. Mask according to any one of the preceding claims,   characterized in that the shell (12) defines an imprint of the face in   the hull support areas on the face.   6. Mask according to any one of the preceding claims,   characterized in that it comprises a cranial harness (16) for maintaining the   said shell (12) pressed against the face, and in that the harness (16) is   adapted to exert a substantially zero force on the shell (12) in the ab- sence of ventilation.   7. Mask according to any one of the preceding claims,   characterized in that the connection orifice (14) has two cannulas   (20) opening substantially in the extension of the nostrils.   8.- Mask according to any one of claims 1 to 6, character-   risé in that the connection orifice (14) comprises a tubing (64) so-   externally of the concave rigid shell (12) extending along the   bending (18) and opening in the vicinity of the front wing (28).   9.- Method of manufacturing a nasal ventilation mask according to   any one of claims 1 to 8, characterized in that it comprises   the following successive steps: a) the patient is stretched out in the sleeping position b) the muscles of the patient's face are relaxed; c) an impression is made of the relaxed face of the patient in the sleeping position at least in the area of application of the mask shell; d) a model of the patient's face is produced by molding, from the imprint at least in the area of application of the mask shell, and   e) the shell of the mask is shaped on the model of the face read.   10.- Method according to claim 9, characterized in that one app-   apply a covering film compatible with the shell facial skin.