Nostril shaper for post-operative treatment after rhinoplasty

Abstract

The invention relates to a nostril shaper (20) which comprises: - two nasal cannulas (40) each configured to be inserted into a patient's nostrils, and - a facial collar (30) which comprises: - two openings (31) forming the join between the facial collar (30) and the two nasal cannulas (40) that extend behind said facial collar (30), - a middle portion (32) which is configured to cover the patient's columella, said middle portion (32) being arranged between the two openings (31). According to the invention, each nasal cannula (40) comprises a bump (44) configured to press against the soft triangle of the patient's nostril.

Description

Description Title of the invention: Nasal conformer for postoperative rhinoplasty treatment [Technical field]

[0001] The invention relates to a nasal conformer for the postoperative treatment of patients who have undergone surgery on the tip and wings of the nose, or rhinoplasty, and more particularly, primary cheilorhinoplasty. The conformer according to the invention can also be used to improve airflow during breathing. The nasal conformer can thus reduce snoring or be used in situations of hyperventilation, particularly during high-intensity sports.

[0002] Generally speaking, rhinoplasty is a surgical procedure designed to modify the structure of the nose for aesthetic or functional reasons. It often involves manipulating cartilage, bone, and soft tissue to achieve the desired result for the patient and / or surgeon. Postoperative care following rhinoplasty is also important, including managing inflammation, reducing pain, preventing infection, and facilitating a rapid recovery. Furthermore, in some cases, postoperative nasal shaping plays an almost equally important role as the surgery itself, allowing the soft tissues to be shaped and / or maintained in the desired form during the postoperative healing period.

[0003] The issue of postoperative nasal conformation is particularly acute when rhinoplasty is performed on a child or even a newborn. This is especially true in cheilorhinoplasty, a surgical procedure to repair the lip and nose of a patient with a cleft lip or cleft palate. This malformation is currently the most common congenital facial malformation. Primary cheilorhinoplasty is generally performed on patients aged 1 to 6 months, depending on the specific surgical protocol. [Prior art]

[0004] To improve healing and nasal shape following rhinoplasty, and particularly cheilorhinoplasty, nasal conformers are available. After cheilorhinoplasty, doctors recommend wearing the nasal conformer for several months to allow the nose to heal into the desired shape after the operation. Indeed, the nasal conformer helps to give and maintain a normal, symmetrical, and harmonious shape to the baby's nose. during the healing period. Furthermore, the conformer aims to maintain nasal ventilation and minimize dead space to prevent hematomas or fibrous scarring in the surgical dissection spaces, particularly after the alar cartilages have been detached and released. The nasal conformer also helps facilitate the positioning of the various endonasal mucosal flaps.

[0005] Conformers already exist on the market, but according to practitioners, they have certain characteristics that could be improved. According to a survey of surgeons performing primary cheilorhinoplasties in France, published in the scientific article Poulet V, et al. "Use of nasal retainers in the primary management of cleft lip: Current practices in France" J Stomatol Oral Maxillofac Surg. 2024 Mar 8:101812. doi: 10.1016 / j.jormas.2024.101812, 94% of them use nasal conformers postoperatively and prescribe them for 3 to 6 months after the operation. However, the majority of surgeons surveyed are not entirely satisfied with the nasal conformers currently available on the market. Some surgeons even note that adherence to the prescription is poor or average in almost half of the cases.

[0006] The retention and patient / child tolerance of the device represent the greatest challenges encountered when using currently available nasal conformers. The lack of stability and retention of conformers causes discomfort for patients, as they require repeated repositioning throughout the day. In the remainder of this document, retention refers to the device's ability to remain in the initial position set by the clinician.

[0007] For some parents, repositioning the conformer can be difficult. This is problematic because, without a conformer, the surgical outcome is less satisfactory both morphologically and functionally, with the nasal ala (or alae) becoming floppy in cases of bilateral cleft palates. This deformity results in not only aesthetic but also functional impairment, causing poor nasal ventilation. A poor aesthetic and functional outcome can sometimes necessitate a second surgical procedure, known as secondary cheilorhinoplasty or revision cheilorhinoplasty, before adulthood, primarily to improve nasal ventilation. This lack of retention in currently available nasal conformers has led inventors to conclude that their shape is poorly suited to the anatomy of the nose and nasal cavities in patients.

[0008] Document EP 3 860 532 describes, in particular, a nasal conformer intended for postoperative treatment following cheilorhinoplasty. This document describes A nasal conformer comprises two nasal tubes coupled by a bridge designed to be placed in contact with the patient's columella. The nasal tubes have at least two ridges configured to be positioned under the nasal turbinate to hold the conformer in place. These ridges are designed to allow for the conformer's retention; however, they are intended to come into contact with the inferior nasal turbinate, an anatomical area relatively distant from the area targeted by the conformer, namely the alae and tip of the nose, the nasal vestibule. Pressure or friction on this area can produce a sensation of discomfort that may lead the patient to remove the conformer.

[0009] Furthermore, the conformer described in this document also includes a plate extending downwards from the bridge, designed to apply pressure to the philtrum. The purpose of this plate is to perform compression therapy on the labial scar to improve healing. This extension, in the immediate postoperative period, is likely to produce undesirable pressure during the first few postoperative days; moreover, it is a component that can be easily and unintentionally removed from the conformer.

[0010] The invention aims to overcome all or part of these drawbacks. [Description of the invention]

[0011] The invention aims to improve the retentiveness of nasal conformers.

[0012] In this context, a first aspect of the invention relates to a nasal conformer comprising: - two nasal cannulas respectively configured to be inserted into the patient's nostrils, each nasal cannula having a profiled coronal section designed to fit the nasal vestibule and the entrance to the nasal cavities, - a facial collar configured to at least partially cover the patient's nose, the facial collar comprising: o two openings joining the collar to the two nasal cannulas extending, to a free end, behind the facial collar, each nasal cannula having a through-hole between an opening and the free end of the nasal cannula, o a mid-section configured to cover the patient's columella, the mid-section being positioned between the two openings, o a peripheral contour configured to at least partially cover the alae of the nose and the tip of the nose, the mid-section and the peripheral contour forming a concave conformation with respect to at least one frontal plane Y, Z in an orthonormal coordinate system X, Y, Z, the concave shape allowing the facial collar to cover the external surface of the nose.

[0013] This collar helps stabilize the nasal conformer on the patient's nose. Specifically, its retention is improved by the degree to which the peripheral contour of the facial collar covers the nasal contours. The facial collar can also be sutured to the nose and serves as a visible marker for the correct positioning of the nasal conformer. Such a facial collar can be particularly useful after surgery on the tip and alae of the nose in children, especially newborns. Therefore, the facial collar is particularly helpful in the postoperative management of primary cheilorhinoplasty.

[0014] Furthermore, improved retention allows for enhanced tissue healing targeted by the clinician. A conforming nasal conformer of an embodiment of the invention can thus be used in the postoperative treatment protocol for surgery of the tip and wings of the nose, such as certain rhinoplasties or cheilorhinoplasties. In addition, the collar can have a surfactant effect on the skin and improve healing, particularly when the collar contains silicone.

[0015] In some embodiments, each nasal cannula may include a boss configured to bear against the soft triangle of the patient's nostril, the boss being located on the upper part of the nasal cannula near the junction between the facial collar and the nasal cannula. The inventors discovered that the soft triangle located in the cranial part of the nasal vestibule constituted a useful point of support for improving the retention of the nasal conformer. Indeed, the soft triangle is a less sensitive area than the turbinate mucosa. Therefore, the inventors chose to add a boss to each nasal cannula near the collar to cooperate with the soft triangle and improve the retention of the nasal conformer and enhance patient comfort. This stabilizing function can reinforce the stabilizing effect of the facial collar.The device's bulge, by positioning itself just behind the soft triangle, contributes to the shaping while preventing the conformer from being easily expelled from the nose.

[0016] In particular, each nasal cannula extends behind the facial collar in an anteroposterior direction relative to the facial collar.

[0017] In some embodiments, the nasal conformer can be made of a biocompatible elastomer material such as silicone or polyurethane. Therefore, if necessary, the nasal conformer can be sterilized.

[0018] In some embodiments, the boss is made in an extra thickness in a wall of the nasal cannula.

[0019] In some embodiments, each nasal cannula may include a proximal section of the opening to which the nasal cannula is connected, the proximal section being curved to cooperate with the nasal vestibule. The curved shape of the proximal section allows for conformity to the anatomy of the nasal vestibule as described below. It should be noted that the boss is located on the upper wall of the proximal section of the nasal cannula.

[0020] In some embodiments, the curvature of the proximal section may be inclined upwards with respect to a transverse plane X, Z of an orthonormal coordinate system X, Y, Z, the transverse plane X, Z then passing through a lower edge of the collar; preferably, the proximal section may have a longitudinal axis inclined with respect to the transverse plane X, Z at an angle θ between 10° and 40°. Preferably, the angle θ may be between 20° and 30°.

[0021] In some embodiments, each nasal cannula may include a distal section extending between the proximal section and the free end of the nasal cannula. The distal section comprises a longitudinal axis that is offset from the longitudinal axis of the proximal section. Preferably, the longitudinal axis of the distal section is oriented downwards and forms an angle θ of between 130° and 180° with the longitudinal axis of the proximal section. The offset of the distal section allows the nasal cannula to follow the floor of the nasal cavity without coming into contact with anatomical structures located in the cranial part of the nasal cavity. For example, an angle θ of between 130° and 150° may be more suitable for a child or young adult patient, while an angle of between 160° and 180° may be more suitable for an adult patient.

[0022] In some embodiments, the distal section may include a coronal section whose dimensions decrease between the proximal section and the free end of the nasal cannula.

[0023] In some embodiments, each nasal cannula may have an outer wall with a corrugated inner profile in its coronal section. The corrugated nature of the inner profile allows it to conform to the anatomical features of the nasal septum.

[0024] In some embodiments, each nasal cannula may have an outer wall with a convex coronal profile. The convexity of this outer profile allows it to conform to the anatomical shape of the nasal alae within the nasal cavity. The outer profile of this wall is opposite to its inner profile.

[0025] In some embodiments, the coronal section of the nasal cannula wall may have, at the distal end, a rounded portion in the lower part of the nasal cannula and a tapered portion in the upper part of the nasal cannula. In particular, the tapered portion can be curved inwards to fit the shape of the nasal septum.

[0026] In some embodiments, at the free end of the nasal cannula, the coronal section of the nasal cannula may have dimensions smaller than the dimensions of the opening. This allows the nasal cannula to adapt to the physiological narrowing of the nasal cavity and to limit uncomfortable pressure against adjacent structures (turbinates).

[0027] In some embodiments, the peripheral contour may include a lower rim extending below the two openings and the medial portion of the collar. This lower rim has a concave cutout with respect to, in particular, a first transverse plane X, Z of the orthonormal coordinate system X, Y, Z. Furthermore, the lower rim delimits the facial collar and the nasal conformer below. Its concave shape provides minimal lip coverage to limit pressure on the scar.

[0028] In some embodiments, the lower rim may have a concavity with respect to, in particular, a frontal plane Y, Z of the orthonormal coordinate system X, Y, Z; this concavity gives the lower rim a forward-curved shape. This concavity allows it to conform to the shape of the philtrum without applying pressure to the philtrum or to any surgical scars present there.

[0029] In some embodiments, the peripheral contour may include two opposing wing extensions configured to respectively cover a nasal wing.

[0030] In some embodiments, each alar extension may have a concavity with respect to a frontal plane Y, Z of the orthonormal coordinate system X, Y, Z, said frontal plane passing through peripheral edges of the two alar extensions, this concavity allowing it to cover the nasal ala. In particular, the alar extensions are curved so as to conform to the contour of the patient's nasal ala.

[0031] In some embodiments, the peripheral contour may include a superior extension that defines the upper edge of the collar. This superior extension has a concavity with respect to a frontal plane Y, Z along the orthonormal coordinate system X, Y, Z, said frontal plane passing through the lateral extremities of the superior extension. The concavity of the superior extension allows it to conform to the profile of the nose and the curved nature of the junction between the tip and the nasal dorsum. It should be noted that the superior extension extends longitudinally between the two alar extensions, with the lateral extremities of the superior extension forming a junction with each alar extension.

[0032] In embodiments, the upper extension can extend substantially at an angle of inclination a with respect to a frontal plane Y, Z, the angle of inclination a being between 20° and 40°, preferably the angle of inclination a is between 25° and 35°.

[0033] In some embodiments, the peripheral contour may include cutting lines or guides to allow the nasal conformer to be adapted to the patient's anatomy while maintaining the properties of the collar. This helps to limit the collar's coverage of the nose, which can be particularly useful for postoperative nasal shaping in adults. Indeed, adult noses have much more variable shapes and contours than infant noses.

[0034] In some embodiments, each opening can extend along an opening plane PO that intersects a frontal plane Y, Z in the X, Y, Z coordinate system. The frontal plane is substantially tangent to the facial rim, and the opening plane PO is set back from the facial rim and inclined downwards in front of it. This orientation of the opening plane of the nasal openings of the nasal conformer allows it to follow the anatomy of the nasal vestibule.

[0035] In some embodiments, the opening plane PO can be inclined at an angle p between 20 and 40° with respect to said front plane Y, Z.

[0036] In some embodiments, the peripheral contour may be delimited by rounded peripheral edges to ensure patient comfort.

[0037] According to a second aspect of the invention, the characteristics of which may define the invention independently or in combination with the first aspect, the nasal conformer may comprise: - two nasal cannulas respectively configured to be inserted into the patient's nostrils, each nasal cannula having a profiled coronal section designed to fit the nasal vestibule and the entrance to the nasal cavities, - a facial collar configured to cover the external surface of the nose: the columella of the nose, the alae of the nostrils and the tip of the nose, the collar comprising: o two openings joining the collar and the two nasal cannulas which extend, to a free end, behind the collar in an anteroposterior direction relative to the facial collar, o a median part which is configured to cover the columella of the patient, the median part being arranged between the two openings, o a peripheral contour which is configured to cover the alae of the nostrils and the tip of the nose of the patient, the median part and the peripheral contour forming a concave conformation with respect to at least one frontal plane Y, Z in an orthonormal coordinate system X, Y, Z, the concave shape allowing the facial collar to cover the external surface of the nose.

[0038] As mentioned previously, the collar improves the retention of the nasal conformer on the patient's nose, notably through the varying degrees of overlap of the nasal contours by the peripheral contour of the facial collar. It also enhances the device's conforming power by applying pressure to the external surface of the nose.

[0039] Another aspect of the invention relates to a nasal conformer comprising a single nasal cannula. The single nasal cannula of this conformer may have all the characteristics of the nasal cannulas in embodiments of the two-cannula nasal conformer. Thus, as described previously, the nasal cannula may extend behind the flange to a free end. The nasal cannula may also have a proximal and a distal section, notably offset from each other. The nasal cannula may include a boss to improve the retentiveness of the nasal conformer. Furthermore, the characteristics related to the coronal section may be identical to those previously described in embodiments of the two-cannula nasal conformer.

[0040] In some embodiments, the nasal conformer may include a flange with an opening communicating with the through-hole of the nasal cannula. The nasal cannula may then extend behind the flange. The flange may be advantageously configured to extend over the contour of the nostril: the nasal sill, the columella, or the ala. The flange thus improves the retentiveness of the nasal conformer.

[0041] In some embodiments, the collar can be configured to cover either the left or right nostril, depending on its shape. The nasal conformer is then chiral and adapted to be positioned on either the right or left nostril, depending on its shape. A pair of chiral nasal conformers is therefore required to equip both nostrils of a patient.

[0042] In particular, the collar can be asymmetrical to cover and / or contain, on one side, the alar rim of the nostril, and on the other side, the inner edge of the columella. To achieve this, the collar may have a concavity that extends radially around the collar opening. This concavity can contain the alar wing and the inner wall of the columella. The collar may also include a convex portion that conforms to the shape of the nasal sill. According to this configuration, the concave portion of the collar extends radially around the opening from one side of the convex portion to the other. The concavity may be asymmetrical with respect to an axis. medial sagittal MS of the collar. In case of asymmetry, the collar also takes on a chiral character. The collar can thus be configured to cover the left or right nostril depending on its conformation.

[0043] In some embodiments, the nasal cannula boss can be offset from the sagittal median axis MS. The nasal cannula then also has a chiral character and can be adapted to be inserted into the right or left nostril.

[0044] In some embodiments, the collar may include a first portion configured to extend over the patient's nasal sill. This first portion extends radially from the collar opening to a peripheral edge. The peripheral edge may be curved, so that the first portion substantially corresponds to a radial portion of a disc. Furthermore, the first portion may be slightly convex, particularly on the posterior surface of the collar. This convexity allows the collar to conform to the slightly concave morphology of the nasal sill. The first portion may extend anterior to a plane PO of the collar opening. This plane PO may correspond to a frontal plane Y, Z in the three-dimensional coordinate system X, Y, Z.

[0045] In some embodiments, the collar may also include a second and a third portion configured to extend up the contours of the nostril. The second and third portions are opposite each other. In particular, the second portion may be configured to extend up the lateral part of the ala. The second portion may at least partially cover the lateral part of the ala. However, the second portion preferentially contains the lateral part of the ala. To achieve this, it may have a concavity, particularly on the rear face of the collar. The rear face of the collar is preferably in contact with the patient's skin. This concavity allows it to contain the lateral part of the ala, and in particular the outer wall of the lateral part of the ala. This concavity may be arranged at a flared extension of the second portion.Conversely, the junction area with the first portion may have a convexity so that the collar rises, following the anatomy of the nostril, from the nasal threshold on the lateral part of the nasal wing.

[0046] It should be noted that the third portion may also have a convexity at its junction with the first portion, in order to extend up the inner wall of the columella. The third portion may therefore also include a concavity, particularly on its posterior surface, to conform to the inner rim of the columella. However, the peripheral rim of the third portion, although curved, does not flare out like the second portion. This asymmetry between the second and third portions may give nasal conformers a chiral character. A first One nasal conformer can be adapted to the left nostril, while the second conformer can be adapted to the right nostril. Alternatively, the second portion can be symmetrical to the third portion and therefore not include the flared extension. The collar will then be adjustable to both of the patient's nostrils.

[0047] In other embodiments, the collar may include a fourth portion configured to extend over the upper part of the alar wing. To this end, the fourth portion may include a concavity, particularly on its posterior surface. The concavity of the second portion may be extended into the fourth portion like a groove. Conversely, the depth of the concavity may be reduced as it passes into the third portion compared to the depth of the concavity of the fourth portion. This can be explained by the lesser overlap of the collar on the columella, which is a thinner anatomical structure than the alar wing.

[0048] Alternatively, the nasal conformer can be adjusted to fit both nostrils of a patient. In this case, the flange is symmetrical about the median sagittal axis of the nasal conformer, and the nasal cannula also extends along this axis. The same conformer can then be used for both nostrils. [Description of the drawings]

[0049] Other features and advantages of the invention will become apparent upon reading the following description. This description is purely illustrative and should be read in conjunction with the accompanying drawings, in which:

[0050] [Fig. 1] is a schematic representation, in front view, of a conforming nasal conformer of an embodiment of the invention.

[0051] [Fig. 2] is a schematic representation, top view, of the nasal conformer of figure 1.

[0052] [Fig. 3] is a schematic representation, viewed from below, of the nasal conformer of Figure 1.

[0053] [Fig.4] is a schematic representation, in rear view, of the nasal conformer of figure 1.

[0054] [Fig. 5] is a schematic representation of a cross-section of a conforming nasal conformer of an embodiment of the invention.

[0055] [Fig. 6] is a schematic representation of a sagittal section of a conforming nasal conformer of an embodiment of the invention.

[0056] [Fig. 7] is a schematic three-quarter rear view representation of a conforming nasal conformer of an embodiment of the invention.

[0057] [Fig. 8] is a schematic representation, according to a first frontal section, of a conforming nasal conformer of an embodiment of the invention.

[0058] [Fig. 9] is a schematic representation, according to a second frontal section, of a conforming nasal conformer of an embodiment of the invention.

[0059] [Fig. 10] is a schematic representation of a newborn patient who has undergone rhinoplasty, in particular cheilorhinoplasty, the patient wearing a conforming nasal conformer of the invention.

[0060] [Fig. 11] is a schematic representation of a conforming nasal conformer of an embodiment of the invention, the nasal conformer being here adapted for adults or adolescents.

[0061] [Fig. 12] is a schematic representation of an adult or adolescent patient wearing the nasal conformer of Figure 11.

[0062] [Fig. 13] is a schematic representation of a sagittal section of a patient's airways showing the anatomical structure of the nasal vestibule and nasal cavities.

[0063] [Fig. 14] is a schematic representation of two nasal conformers comprising respectively a single nasal cannula in accordance with another aspect of the invention.

[0064] [Fig. 15] is a schematic representation according to a sagittal section of a nasal conformer from figure 14.

[0065] [Fig. 16] is a representation of a patient wearing in each nostril a nasal cannula conforming to figure 14. [Description of the embodiments]

[0066] With reference to Figures 1 to 13, the invention relates to a nasal conformer 20 intended to be worn for a period of 3 to 6 months following nasal surgery, in particular following cheilorhinoplasty. There are two types of cheilorhinoplasty: primary and secondary. Primary cheilorhinoplasty is performed, as described above, on patients aged 1 to 6 months to close the cleft lip and correct the nasal deformity simultaneously. Secondary cheilorhinoplasty, on the other hand, is performed later on older children, adolescents, or adults who have already undergone primary cheilorhinoplasty and who present, in particular, with nasal breathing difficulties due to to a deviation of the nasal septum, a stenosis of the nasal orifice or a cladding of the nostrils, or an aesthetic result that could be improved in connection with a sequelae deformity or an unsightly scar.

[0067] The nasal conformer can also be used in the postoperative treatment of other types of surgical procedures involving the tip or alae of the nose, such as septorhinoplasty. The nasal conformer can also be used as part of the postoperative treatment of other types of surgery, such as full-thickness nasal reconstruction involving the alae and / or tip of the nose, which can be performed in children or adults; the management of penetrating or extensive nasal wounds in children or adults; the management of nasal deformities related to lesions, for example, tumors; or nasal deformities due to trauma from a pressure point, for example, induced by prolonged enteral feeding via a nasogastric tube in neonatology.

[0068] In figures 1 to 12, the nasal conformer 20 is represented in an orthonormal X, Y, Z coordinate system. The different axes and planes used in this document to define the nasal conformer refer to this orthonormal coordinate system.

[0069] As illustrated in Figure 1, the nasal conformer 20 comprises a facial flange 30 and two nasal cannulas 40 attached to the facial flange 30. The facial flange 30 is configured to cover the external surface of the patient's nose. The two nasal cannulas 40 are configured to be inserted into the patient's nostrils, as illustrated in Figures 10 and 12.

[0070] Thus, as illustrated in Figures 10 and 12, once the nasal conformer 20 is positioned on the patient's nose, while the nasal cannulas 40 are inserted into the patient's nostrils, the facial collar 30 covers the columella of the nose, the alae of the nose and the tip of the nose.

[0071] The collar 30 includes two openings 31 to allow the passage of air between the collar 30 and the nasal cannulas 40. As can be seen, the two nasal cannulas 40 are respectively connected at the openings 31 to the rear face of the collar 30. The rear face of the collar 30 is the face that is in contact with the patient's nose when the nasal conformer 20 is positioned on the patient's nose.

[0072] As illustrated in Figures 3 to 5, each nasal cannula 40 extends behind the flange 30 to a free end 41. In this example, each nasal cannula 40 extends in an anteroposterior direction relative to the facial flange 30. The anteroposterior direction follows an axis that is parallel to the X-axis of the orthonormal X, Y, Z coordinate system. In particular, as illustrated in Figure 5, each nasal cannula 40 can extend over a distance Cs / that extends from the junction between the The nasal cannula 40 and the facial flange 30 extend to the free end 41. The Csl distance can range from 10 mm to 50 mm. When the Csl distance is less than 30 mm, the nasal conformer 20 is generally intended for smaller patients, such as children. Conversely, when the Csl distance is greater than 30 mm, the nasal conformer 20 is generally intended for larger patients, such as adults. The nasal cannula 40 includes a through cavity 42 extending from the opening 31 to its end 41. The cavity 42 allows air to pass through and enables the patient to breathe while wearing the nasal conformer 20.

[0073] As illustrated in Figures 1, 3, and 8, each opening 31 has an oval coronal section. Specifically, the coronal section of each opening 31 is oval with its major axis oriented upwards along the Y-axis and its midpoint along the Z-axis. The coronal section of the opening 31 is mirrored by the coronal section of the nasal cannulas 40. The coronal section of the nasal cannulas 40 is defined along a frontal plane Y, Z of the orthonormal coordinate system X, Y, Z. Each nasal cannula 40 can thus be shaped to fit the nasal vestibule and the entrance to the patient's nasal cavities. Note that the brackets visible in Figure 8 correspond to a portion of the facial collar 30.

[0074] In the example illustrated in Figures 1 and 2, the collar 30 has a central portion 32 positioned between the two openings 31. The central portion 32 is configured to cover the patient's columella. The central portion 32 also serves to secure the two nasal cannulas 40 to the collar 30.

[0075] According to an embodiment illustrated in Figure 10, the collar 30 also includes a peripheral contour configured to cover the nostrils and the tip of the nose. The peripheral contour is delimited by rounded peripheral edges 33 to ensure patient comfort. In this embodiment, the median portion 32 and the peripheral contour form a concave conformation with respect to at least one frontal plane Y, Z in an orthonormal coordinate system X, Y, Z, see in particular Figures 4 and 5. This concave conformation allows the facial collar 30 to cover the external surface of the nose. The concavity of the collar 30 stabilizes the nasal conformer 20.In particular, the facial collar 30 can be sutured to the nose with transfixing sutures if the surgeon wishes the conformer 20 to be fixed rather than removable, which is common in the immediate postoperative period, i.e., the few days following surgery. Furthermore, the facial collar 30 provides the practitioner with a visible marker for the correct positioning of the nasal conformer 20 on the patient's nose.

[0076] According to an embodiment illustrated in particular in Figure 1, the peripheral contour includes a lower rim 34 which extends under the two openings 31 but also under the median part 32 of the facial collar 30. The lower rim 34 is materialized on Figure 1 is represented by a fictitious dotted line. The lower rim 34 delimits the nasal conformer 20 inferiorly. As illustrated in Figure 10, the lower rim 34 is shaped to fit the limit of the upper lip without applying pressure to it or to the closure scar of the cleft lip which extends onto the philtrum.

[0077] In one embodiment, the lower rim 34 has a concave cutout 340 with respect to a first transverse plane X, Z of the orthonormal coordinate system X, Y, Z. This is illustrated in Figure 4, in which a fictitious transverse plane X, Z is shown and passes through the descending portions 341 of the lower rim 34 that extend furthest down. The concavity of the concave cutout 340 is indicated by an arrow extending from the transverse plane X, Z to the peripheral edge 33 of the concave cutout 340.

[0078] According to another embodiment illustrated in Figure 3, the lower rim 34 has a concavity 342 with respect to a frontal plane Y, Z of the orthonormal coordinate system X, Y, Z. The frontal plane Y, Z, shown in Figure 3, passes through the alar extensions 35 of the peripheral contour. The concavity is represented by a dashed arrow 342 extending from a frontal plane Y, Z to the rear face of the collar 30. In particular, this concavity 342 extends under the median part 32 of the facial collar 30 so as to accommodate, among other things, the curvature of the patient's columella. This concavity 342 gives the lower rim 34 a forward-curved shape that allows the nasal conformer 20 to conform to the anatomy of the patient's nose.

[0079] According to a preferred embodiment, the lower rim 34 comprises a double concavity, the concavity 342 along a frontal plane and the concave cutout 340.

[0080] According to an embodiment illustrated in particular in Figure 1, the peripheral contour comprises two opposing alar extensions 35, configured to respectively cover a nasal ala of the patient's nose, as illustrated in Figure 10. Each alar extension 35 extends from the lower edge 34 to the upper extension 36 of the peripheral contour. Each alar extension 35 thus contours around the opening 31 to which it is proximal. The alar extensions 35 are identified by an oval shape shown in dashed lines in Figures 1 and 2. Here, the peripheral edge 33, which delimits the alar extensions 35, is curved to follow the contour of the patient's nasal ala.

[0081] According to an embodiment more particularly illustrated in Figures 4 and 5, each wing extension 35 has a wing concavity 350 with respect to a frontal plane Y, Z of the orthonormal coordinate system X, Y, Z. The frontal plane Y, Z, which is shown in Figure 4, passes here through the peripheral edges 33 of the wing extensions 35. The wing concavity 350 is represented by a curved dashed line extending, within the rear face of the facial collar 30, between the peripheral edge 33 and the junction 43 of the collar. facial 30 and a nasal cannula 40. The alar concavity 350 gives the peripheral edge 33 which delimits the alar extension 35 which has a curved shape relative to the frontal plane Y, Z as can be seen in figure 5. The alar concavity 350 of the alar extension 35 allows it to cover the patient's nasal ala as illustrated in figure 10. Each alar extension 35 thus includes a hollow extension which allows it to envelop the patient's nasal ala.

[0082] According to one embodiment, the peripheral contour includes an upper extension 36 that delimits the facial collar 30 at its upper end. As illustrated in Figure 1, the upper extension 36 extends longitudinally between each wing extension 35. The upper extension 36 has a concavity with respect to a frontal plane Y, Z of the orthonormal coordinate system X, Y, Z, as illustrated in Figure 2. Here, the frontal plane Y, Z passes through the junction between each wing extension 35 and the upper extension 36. The concavity is represented by an arrow 360 extending between the plane Y, Z and the median axis of the upper extension 36. In this embodiment, the median axis of the upper extension 36 includes the most pronounced concavity of the upper extension 36. It should be noted that the median axis is parallel to the Y-axis of the orthonormal coordinate system and also constitutes the median axis. transverse of the facial collar 30.In the example of figures 1 to 5, the nasal conformer is symmetrical with respect to the transverse median axis of the facial collar 30. The concavity of the upper extension 36 allows it to follow the curved character of the tip of the nose.

[0083] As can be seen in Figure 6, the upper extension 36 extends, along the Y axis, substantially at an angle of inclination a with respect to a frontal plane Y, Z. The term substantially means that the angle of inclination a defines a general orientation followed by the upper extension 36, the latter having, however, a slightly curved shape along the Y axis of the orthonormal frame.

[0084] According to a particular embodiment, the angle of inclination α is between 20° and 40°, preferably between 25° and 35°. According to this embodiment, the angle of inclination α can be structurally linked to the concavity 360 of the upper extension 36. Figure 6 illustrates this, with the concavity 360 shown on the rear face of the collar 30, while the orientation of the upper extension 36 according to the angle of inclination α is shown for the front face of the collar 30.

[0085] The upper extension 36 thus defines a supranasal portion, that is, a portion extending above the nostril openings 31. The upper supranasal extension 36 is extended on each side by the two alar extensions 35. This is more particularly illustrated in Figure 2, on which a dashed line is shown, outlining the openings 31 and the median part of the facial collar 30.

[0086] As is particularly evident in Figures 1 to 3, the facial collar 30 includes a protrusion 37, which is positioned along the median axis of the collar between the median portion 32 and the superior extension 36. The protrusion 37 is schematically delimited by a dashed oval shape. The protrusion 37 corresponds to the portion of the facial collar 30 that covers the junction between the tip of the nose and the columella of the patient, as illustrated in Figure 9. The protrusion 37 is also the most prominent part of the nasal conformer 20 anterior to the collar 30. Figure 6 illustrates the protrusion of the protrusion 37, with the Y, Z plane drawn substantially tangent to the most prominent area of ​​the protrusion 37.

[0087] According to an embodiment illustrated in Figure 6, the openings 31 are set back from the protrusion 37 and also from the upper extension 36. The openings 31 are also oriented downwards. In particular, each opening 31 extends along an opening plane PO that intersects a frontal plane Y, Z that is substantially tangent to the protrusion 37 of the facial collar 30. In this embodiment, the opening plane PO is inclined downwards in front of the collar at an angle p between 20° and 40° with respect to said frontal plane Y, Z. Preferably, the angle p is between 25° and 35°.

[0088] According to one embodiment of the invention, the facial collar 30 has a constant thickness, the value of which can be between 1 mm and 3 mm. For example, the thickness of the collar can be 1 mm for a nasal conformer 20 intended for a newborn and, conversely, 3 mm for a conformer 20 intended for an adult.

[0089] The thin walls of the facial collar 30, approximately 1 mm thick, allow surgeons to suture the alar extensions 35 to the nostrils of a newborn patient to secure the nasal conformer 20 at the end of the surgical procedure. The nasal conformer 20 can thus be fixed in the immediate postoperative period, that is, within the first few days following surgery.

[0090] For example, in the context of follow-up after cheilorhinoplasty, several sizes of nasal conformer 20 may be provided to fit the size of each child and / or allow a child to wear a conformer for several months while accompanying their growth.

[0091] According to an embodiment illustrated in particular in Figures 4, 5, and 11, each nasal cannula 40 has a boss 44 configured to bear against the soft triangle of the patient's nostril. In this example, the boss 44 is located on the upper wall of the nasal cannula 40 near the junction 43 between the flange 30 and the nasal cannula 40. Figure 6 shows an embodiment in which the boss 44 is formed as an additional thickness on the wall of the nasal cannula 40. Depending on the dimensions of the nasal conformer 20, the extra thickness is denoted S and can be between 1 mm and 3 mm. Preferably, the extra thickness is between 1.5 mm and 2.5 mm. The boss 44 is also visible in the frontal section of Figure 8.

[0092] According to the embodiment illustrated in Figures 4, 6 and 7, the boss 44 is disposed on a section 45 of the nasal cannula 40, which is proximal to the facial collar 30. As illustrated in Figures 6 and 7, the proximal section 45 connects the nasal cannula 40 to the nostril opening 31 via the junction 43. The proximal section 45 is configured to be inserted at the level of the nasal vestibule A, see Figures 10 and 13. Therefore, the proximal section 45 is curved. The curvature of the proximal section 45 is inclined upwards with respect to a transverse plane X, Z passing through the lower rim 34 of the facial collar 30. Thus, as illustrated in figures 10 and 13, the curvature of the proximal section 45 is adapted to penetrate the nasal vestibule A while following, on the one hand, the curvature of the subdomal region of the wall B, and on the other hand, the floor C of the nasal fossa D.As can be seen in 6, the longitudinal axis TP of the proximal section 45 is inclined at an angle 0 with respect to the transverse plane X, Y. The angle 0 can be between 10° and 40°, preferably the angle 0 can be between 20° and 30°.

[0093] According to an embodiment illustrated in Figures 6 and 7, each nasal cannula 40 comprises a distal section 46 which extends between the proximal section 45 and the free end 41 of the nasal cannula 40. The distal section 46 is configured to extend into the nasal cavity D, see Figures 10 and 13. The demarcation between the proximal section 45 and the distal section 46 is schematically represented in Figure 7 by an imaginary dashed line which encircles the nasal cannula 40.

[0094] According to an embodiment illustrated in Figure 6, the distal section 46 is offset relative to the proximal section 45. In particular, the distal section 46 includes a longitudinal axis TD that forms an angle œ between 130° and 180° with the longitudinal axis TP of the proximal section 45. For example, an angle œ between 130° and 150° may be more suitable for a child or young adult patient, while an angle between 160° and 180° may be more suitable for an adult patient. The longitudinal axis TD is oriented downwards in a direction opposite to that of the proximal section 45. As illustrated in Figure 13, the floor C of the nasal cavities D is offset relative to the nasal vestibule B. Consequently, the inventors chose to offset the distal section 46 relative to the proximal section 45 so that the distal section follows the floor C of the nasal cavity D.This allows the nasal airflow to follow a physiological direction (ventilation is provided by the lower portion of the nasal cavities), while limiting unnecessary and uncomfortable contact with more cranial structures such as the middle turbinate (see figure 13).

[0095] According to an embodiment illustrated in particular in Figures 5 and 7, the distal section 46 has a coronal cross-section whose dimensions decrease between the proximal section 45 and the free end 41. Consequently, the coronal cross-section of the free end 41 of the nasal cannula 40 has dimensions smaller than those of the opening 31. This reduction in caliber follows the anatomy of the nasal cavities, whose width decreases from front to back at the level of the head of the inferior turbinate, due to its presence. This is also one of the reasons why existing conformers are sometimes poorly tolerated by patients: since this cross-section remains identical in shape and size between the nasal vestibule and the most posterior part of the nasal conformer, the stresses applied to the anatomical structures surrounding the conformer are greater, thus making wearing the conformer more uncomfortable.The larger dimensions of the coronal section of the proximal segment 45 promote ventilation through a greater airflow. At the distal segment 46, the dimensions of the coronal section are reduced to enhance the retention of the nasal conformer 20.

[0096] According to an embodiment illustrated in Figures 4, 7, and 9, in addition to the difference in dimensions, the coronal section of the distal segment 46 has a geometric shape that differs from that of the opening 31. The coronal section of the distal segment 46 has an irregular lenticular shape. According to an embodiment illustrated in Figure 9, which shows a frontal section of the nasal cannulas 40 at the level of the distal segment 46, the coronal section of the cavity 42 is oval with its long axis oriented upwards and mid-point. This coronal section helps to maintain the normal anatomy of the nasal cavity and, unlike existing nasal conformers, avoids uncomfortable pressure points.

[0097] According to an embodiment illustrated in Figures 4 and 7, the coronal section of the walls of the distal segment 46 has a rounded portion 460 in the lower part of the nasal cannula 40 and a tapered portion 461 in the upper part of the nasal cannula 40. As can be seen in Figures 4 and 7, the outer wall has an internal profile 462 that is undulating, convex in the lower part 460 and concave in the upper part 461. The external profile 463 is convex along its entire length, which, in particular, gives the upper part of the outer wall a tapered shape. The undulating nature of the internal profile 462 allows it to conform to the anatomical features of the nasal septum.

[0098] Unlike newborns, who exhibit little variability in the shape of the nasal tip, the adult population displays a wide variety of nose morphologies. In addition to the size of the nasal conformer 20, there is also the issue of the coverage of the alae and the nasal tip by a The nasal conformer 20 is a standard device conforming to the invention. These questions may arise, particularly for adults, from an aesthetic point of view, during the wearing of the nasal conformer 20, but also from the point of view of adapting it to the patient's specific morphology. To this end, according to one embodiment, the peripheral contour of the collar 30 may include cutting lines or guides to allow adaptation of the nasal conformer to the patient's anatomy while retaining all or part of the properties of the facial collar 30. The cutting guides may consist of pre-cuts made in the facial collar 30.

[0099] This limits the coverage of the nose by the facial collar 30, which is particularly useful for postoperative rhinoplasty treatment in adults. An example of this cut is shown in Figures 11 and 12. In this example, the peripheral contour has been cut to maintain good retentiveness while avoiding covering certain areas of the nose, such as the tip and nostrils. As shown in Figures 10 and 11, the upper extension has been extensively cut, but a reduced peripheral edge 33 remains, featuring a concave cut 361 relative to a transverse plane X, Z that passes through the apexes of the supranasal lobes 362, which overhang the openings 31. The concave cut 361 allows the tip of the nose to be bypassed without being covered, as illustrated in Figure 11.These supra-nasal lobes 362 belong to the peripheral contour which is now reduced in the same way as the wing extensions 35, the latter although reduced are still present.

[0100] As illustrated in Figure 12, the alar extensions 35 conform to the interior of the alar rims of the nose. The lower rim 34 is also reduced but retains its double concavity and a subnasal extension 343 of reduced dimensions. The subnasal extension 343 connects the alar extensions 35 to the median portion 32, which is also retained. It should be noted that the shapes of the openings 31 and the nasal cannulas 40, on the other hand, are retained as described previously.

[0101] As previously mentioned, several sizes of nasal conformer 20 can be produced, for example, to adapt to the morphology of the patient, whether infant, child, adolescent, or adult. This also allows for the option of replacing the nasal conformer 20 during postoperative treatment, particularly for newborn patients who have undergone cheilorhinoplasty, as the baby grows. As illustrated in Figure 1, the length Lr / of the lower rim 34 can range from 20 mm to 40 mm, the length Lbs of the upper extension 36 can range from 15 mm to 35 mm, while the height Hba of the alar extension 35 can range from 6 mm to 20 mm.

[0102] Depending on the patient's condition and / or the rhinoplasty they undergo, the distance Do between the two openings 31 can also differ between 6 mm and 15 mm. For example, compared to a nasal conformer 20 used following unilateral cheilorhinoplasty, the spacing defined by the distance Do between the two openings 31 must be 20% greater for a nasal conformer 20 used in bilateral cheilorhinoplasty.

[0103] According to one embodiment, the nasal conformer 20 can be made of biocompatible elastomer material. Several types of biocompatible elastomer material can be used, for example, silicone, polyurethane, or more broadly, biocompatible thermoplastic elastomers.

[0104] According to one embodiment of the invention, the nasal conformer 20 can be manufactured by plastic injection molding or by 3D printing, provided that the printing resin conforms to the standards defining biocompatible materials and to the elasticity criteria required for the present invention. 3D printing can advantageously allow for the production of a nasal conformer 20 with dimensions adapted to the patient's morphology. The shape of the collar 30, and in particular its concavity or the shape of its extensions, can also be adjusted to the patient's anatomy.

[0105] Another aspect of the invention is illustrated in Figures 14 to 16; it is a nasal conformer 50, 51 comprising a single nasal cannula 40. The nasal cannula 40 of this conformer 50, 51 may advantageously incorporate all the characteristics of the nasal cannulas 40 of the embodiments of the nasal conformer 20 with two cannulas 40, which is illustrated in Figures 1 to 12. The nasal conformers 50, 51 are illustrated while positioned in the nostrils of a patient in Figure 16.

[0106] Figure 14 shows a pair of nasal conformers 50, 51. Each nasal conformer comprises a flange 60 and a nasal cannula 40. The nasal cannula 40 extends behind a flange 60. The flange 60 includes an opening 61 that communicates with the through-hole 42 of the nasal cannula 40. As illustrated in Figure 15, the cannula 40 extends behind the flange 60 to a free end 41. The nasal cannula 40 has a proximal section 45 and a distal section 46 offset from each other. A boss 44 is also observed, and the features related to the coronal section can be identical to those of the embodiment of the nasal conformer with two cannulas 40, and in particular to Figure 9.

[0107] As illustrated in Figure 14, the collar 60 is configured to extend over the contour of the nostril: the nasal sill, the columella, and the ala. However, the collar 60 does not cover the philtrum or the most distal part of the nasal tip. To this end, the collar 60 includes a first portion 62 that is configured to extend over the patient's nasal sill. Specifically, the first portion 62 extends radially from the opening 61 to a peripheral edge 620. The peripheral edge 620 is curved, so that the first portion 62 corresponds approximately to a radial portion of a disc. As illustrated in Figure 15, the first portion 62 can be slightly convex, particularly at the rear face 600 of the collar 60, see Figure 15. This convexity allows the collar to be adjusted to the morphology of the nasal threshold, which is slightly concave.Furthermore, as illustrated in Figure 15, the first portion 62 extends in front of the opening plane PO of the opening 61 of the collar 60. As can be seen in Figure 14, the plane PO can correspond to a frontal plane Y, Z according to the three-dimensional coordinate system X, Y, Z.

[0108] The collar 60 may also include a second portion 63 and a third portion 64 configured to extend up the contours of the nostril, as shown in Figure 16. The second portion 63 and the third portion 64 are opposite each other. In the example in Figure 14, the second portion 63 is configured to extend up the lateral part of the nostril wing. The lateral part of the nostril wing extends from the nasal sill to the upper part of the alar wing, thus circumventing the nostril opening. The upper part of the alar wing, in turn, joins the tip of the nose. The second portion 63 may at least partially cover, and preferably includes, the lateral part of the alar wing. The second portion 63 may, for this purpose, include a concavity in particular of the rear face 600 of the collar 60.The rear face 600 of the collar 60 is preferentially in contact with the patient's skin. This concavity allows it to contain the lateral part of the nostril, and in particular its outer wall. This concavity can be arranged at the level of a flared extension 630 of the second portion 63. Conversely, the junction zone with the first portion 62 has a convexity so that the collar 60 ascends, following the anatomy of the nostril, from the nasal sill onto the nostril.

[0109] The third portion 64 also has a convexity at the junction with the first portion 62. The third portion 64 extends up the inner wall of the columella of the nostril, as can be seen in Figure 16. The third portion 64 may therefore also include a concavity, particularly on the posterior face 600, to to conform to the inner edge of the columella. However, the peripheral edge 640 of the third portion 64, although curved, does not flare out like the second portion 63. This asymmetry between the second portion 63 and the third portion 64 may give a chiral character to the nasal conformers 50, 51. A first nasal conformer 50 can be adapted to the left nostril while the second conformer 51 can be adapted to the right nostril. Alternatively, the second portion 63 may be symmetrical to the third portion 64 and therefore not include the flared extension 630. In this case, the same conformer 50, 51 can be used for both nostrils.

[0110] As illustrated in Figure 16, the collar 60 has a fourth portion 65 configured to extend over the upper part of the nostril. To this end, the fourth portion 65 includes a concavity, specifically on the rear face 600. Figure 15 shows the concavity of the fourth portion 65 facing the boss 44 of the nasal cannula 40. The demarcations between the different portions 62, 63, 64, and 65 of the collar 60 are approximately represented by dashed lines in Figure 14. The concavity of the second portion 63 can be extended into the fourth portion 65, forming a groove. Conversely, the depth of the concavity is reduced in the third portion 64 compared to the depth of the concavity of the fourth portion 65. This can be explained by the less significant overlap of the collar 60 on the columella as illustrated in figure 16.

[0111] Collar 60 thus has a concavity that extends radially around opening 61. As illustrated in Figure 16, this concavity contains the nasal wing and the inner wall of the columella. Collar 60 also includes a convex portion that conforms to the shape of the nasal sill. The concave portion of collar 60 therefore extends radially around opening 61 from one side of the convex portion of collar 60 to the other side of the convex portion of collar 60. The concavity may be asymmetrical with respect to a medial sagittal axis (MS) of collar 60, as illustrated in Figure 14. In the case of asymmetry, collar 60 has a chiral character. Collar 60 is thus configured, depending on its shape, to cover either the left or right nostril. As can be seen in Figure 14, boss 44 can be offset from the MS median sagittal axis.Nasal cannula 40 also has a chiral character and can be adapted for insertion into either the right or left nostril. Nasal conformer 50, 51 can thus be adapted for positioning in either the right or left nostril.

Claims

Demands

1. Nasal conformer (20) comprising: - two nasal cannulas (40) respectively configured to be inserted into the patient's nostrils, each nasal cannula (40) having a profiled coronal section to fit the nasal vestibule and the entrance to the nasal cavities, - a facial collar (30) configured to at least partially cover the patient's nose, the facial collar (30) comprising: o two openings (31) joining the facial collar (30) and the two nasal cannulas (40) extending respectively, to a free end (41), behind the facial collar (30), each nasal cannula (40) having a through cavity (42) between an opening (31) and the free end (41) of the nasal cannula (40), o a mid-section (32) configured to cover the patient's columella, the mid-section (32) being disposed between the two openings (31), o a peripheral contour configured to at least partially cover the alae of the nose and the tip of the nose, the mid-section (32) and the peripheral contour forming a concave conformation with respect to at least one frontal plane Y, Z in a orthonormal coordinate system X, Y, Z,the concave shape allowing the facial collar (30) to cover the external surface of the nose.

2. Nasal conformer (20) according to claim 1, wherein each nasal cannula (40) has a boss (44) configured to bear against the soft triangle of the patient's nostril, the boss (44) being disposed on an upper part of the nasal cannula (40) near the junction (43) between the facial collar (30) and the nasal cannula (40), preferably the boss (44) is made in excess thickness in a wall of the nasal cannula (40).

3. Nasal conformer (20) according to claim 2, wherein each nasal cannula (40) comprises a proximal section (45) of the opening (31), the proximal section (45) being curved to cooperate with the nasal vestibule.

4. Nasal conformer (20) according to claim 3, wherein the curvature of the proximal section (45) is inclined upwards with respect to a plane transverse X, Z of an orthonormal coordinate system X, Y, Z, the transverse plane X, Z passing through a lower edge of the facial collar (30), preferably, the proximal section (45) has a longitudinal axis inclined with respect to the transverse plane X, Z at an angle 0 between 10° and 40°.

5. Nasal conformer (20) according to any one of claims 3 and 4, wherein each nasal cannula (40) comprises a distal section (46) extending between the proximal section (45) and the free end (41) of the nasal cannula (40), the distal section (46) comprising a longitudinal axis which is offset from the longitudinal axis of the proximal section (45), preferably the longitudinal axis of the distal section (46) is oriented downwards and forms an angle between 130 and 160° with the longitudinal axis of the proximal section (45).

6. Nasal conformer (20) according to claim 5, wherein the distal section (46) has a coronal section whose dimensions decrease between the proximal section (45) and the free end (41) of the nasal cannula (40).

7. Nasal conformer (20) according to any one of claims 1 to 6, wherein each nasal cannula (40) has an outer wall whose internal profile (462) of the coronal section is corrugated.

8. Nasal conformer (20) according to any one of claims 1 to 7, wherein each nasal cannula (40) has an outer wall whose external profile (462) of the coronal section is convex.

9. Nasal conformer (20) according to any one of claims 1 to 8, wherein, at the free end (41) of the nasal cannula (40), the coronal section of the nasal cannula (40) has dimensions smaller than the dimensions of the opening (31).

10. Nasal conformer (20) according to any one of claims 1 to 9, wherein the peripheral contour comprises a lower rim (34) which extends under the two openings (31) and under the middle part (32) of the facial collar (30), the lower rim (34) comprising a concave cut (361) with respect in particular to a first transverse plane X, Z of the orthonormal frame X, Y, Z.

11. Nasal conformer (20) according to claim 10, wherein the lower rim (34) has a concavity (342) with respect, in particular, to a frontal plane Y, Z, of the orthonormal frame X, Y, Z, this concavity gives the lower rim (34) a forward-curved character.

12. Nasal conformer (20) according to any one of claims 1 to 11, wherein the peripheral contour comprises two alar extensions (35) opposed to each other and configured to respectively cover a nasal wing.

13. Nasal conformer (20) according to claim 12, wherein each wing extension (35) has a wing concavity (350) with respect to a frontal plane Y, Z of the orthonormal frame X, Y, Z, said frontal plane passing through peripheral edges of the two wing extensions (35), this wing concavity (350) allowing the nasal wing to be covered.

14. Nasal conformer (20) according to any one of claims 1 to 13, wherein the peripheral contour comprises an upper extension (36) which superiorly delimits the facial collar (30), the upper extension (36) comprising a concavity (360) with respect to a frontal plane Y, Z of the orthonormal frame X, Y, Z, said frontal plane passing through lateral extremities of the upper extension (36).

15. Nasal conformer (20) according to any one of claims 1 to 14, wherein the peripheral contour includes cutting lines or guides to allow adaptation of the nasal conformer to the patient's anatomy while retaining the properties of the collar.

16. Nasal conformer (20) according to any one of claims 1 to 15, wherein each opening (31) extends along an opening plane PO which is secant to a frontal plane Y, Z in the X, Y, Z frame, the frontal plane being substantially tangent to the facial collar (30), the opening plane PO is also disposed recessed relative to the facial collar (30) and inclined downwards in front of the facial collar

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