Nasal conformer for postoperative rhinoplasty treatment

Abstract

The invention relates to a nasal conformer (20) comprising: two nasal cannulas (40) respectively configured for insertion into the patient's nostrils, and a facial flange (30) comprising: two openings (31) junctioning the facial flange (30) and the two nasal cannulas (40) extending behind the facial flange (30), a midsection (32) configured to cover the patient's columella, the midsection (32) being disposed between the two openings (31). According to the invention, each nasal cannula (40) has a boss (44) configured to bear against the soft triangle of the patient's nostril. [Figure for the abstract: Fig. 7]

Description

Title of the invention: Nasal conformer for postoperative rhinoplasty treatment. Technical field

[0001] The invention relates to a nasal conformer for the post-operative treatment of patients who have undergone surgery of the tip and wings of the nose, or rhinoplasty, and more particularly, a primary cheilorhinoplasty.

[0002] Generally speaking, rhinoplasty is a surgical procedure aimed at modifying the structure of the nose for aesthetic or functional reasons. It often involves manipulating cartilage, bone, and soft tissues to achieve the result desired by the patient and / or the surgeon. Postoperative rhinoplasty treatment is also important, including managing inflammation, reducing pain, preventing infection, and facilitating a rapid recovery. In addition, in some cases, to achieve the desired results, postoperative nasal shaping plays an almost equally important role as the procedure 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 significant when rhinoplasty is performed on a child or even a newborn. This is especially true in cheilorhinoplasty, which is 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. Previous technique

[0004] To improve healing and nasal conformation following rhinoplasty, and particularly cheilorhinoplasty, nasal conformers are available. Following cheilorhinoplasty, doctors recommend wearing the nasal conformer for several months to allow the nose to heal in 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 limit dead spaces to prevent the formation of hematomas or fibrous scars in the surgical dissection areas, especially after the alar cartilages have been detached and released. The nasal conformer also helps to facilitate the positioning of the various endonasal mucosal flaps.

[0005] Conformers already exist on the market but, according to practitioners, have certain characteristics that could be improved. According to a survey of surgeons performing primary cheilorhinoplasties in France and 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 to patients 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 difficulties encountered when using nasal conformers currently available on the market. The lack of stability and retention of conformers causes discomfort for patients, as it then becomes necessary to readjust them several times during 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, it is sometimes difficult to reposition the conformer. This is a problem because, without a conformer, the surgical outcome is less satisfactory from both a morphological and functional standpoint, with a flapping of the nasal ala, or of the nasal alae in the case of bilateral clefts. This deformity causes not only aesthetic but also functional impairment, resulting in poor nasal ventilation. A poor aesthetic and functional outcome can sometimes lead to a second surgical procedure, then called secondary cheilorhinoplasty or revision cheilorhinoplasty, before adulthood, particularly to improve nasal ventilation. This lack of retention of nasal conformers known to date has led the inventors to conclude that their shape is poorly adapted to the anatomy of the nose and nasal cavities of 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 comprising two nasal tubes coupled by a bridge intended to be placed in contact with the patient's columella. The nasal tubes have at least two ridges that are configured to be positioned under the nasal turbinate in order to hold the conformer in place. These ridges are designed To ensure the retaining power of the nasal conformer, however, they are designed to be in contact with the inferior nasal turbinate, which is an anatomical area relatively far from the area targeted by the conformer, namely the nostrils 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 an element on which the slightest contact could lead to the conformer being removed, whether intentionally or unintentionally.

[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 face shield which includes: • two openings joining the collar and the two nasal cannulas which extend, to a free end, behind the facial collar, each nasal cannula having a through cavity between an opening and the free end of the nasal cannula, • a middle portion which is configured to cover the patient's columella, the middle portion is positioned between the two openings, each nasal cannula having a boss configured to bear against the soft triangle of the patient's nostril, the boss being positioned on an upper part of the nasal cannula near the junction between the facial collar and the nasal cannula.

[0013] The inventors discovered that the soft triangle located in the cranial part of the nasal vestibule constituted an interesting support point for improving the retentiveness 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, thus enhancing patient comfort. The boss of the device, positioned just behind the soft triangle, contributes to the shaping while preventing the conformer from being easily expelled from the nose. Furthermore, the improved retention of the nasal conformer allows for enhanced tissue healing as targeted by the clinician. A nasal conformer conforming to an embodiment of the invention can therefore be used in the postoperative treatment protocol for surgery of the tip and alae of the nose, such as certain rhinoplasties or cheilorhinoplasties.

[0014] In particular, each nasal cannula extends behind the facial collar in an anteroposterior direction relative to the facial collar.

[0015] 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.

[0016] In some embodiments, the boss is made in an extra thickness in a wall of the nasal cannula.

[0017] 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 it to conform 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.

[0018] In 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°.

[0019] In 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 of between 130° and 160° with the longitudinal axis of the proximal section. The offset nature 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.

[0020] In embodiments, the distal section may include a coronal section whose dimensions decrease between the proximal section and the free end of the nasal cannula.

[0021] 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.

[0022] In some embodiments, each nasal cannula may have an outer wall whose external profile of the coronal section is convex. The convexity of the external profile allows it to conform to the anatomical shape of the nasal alae within the nasal cavity. The external profile of the outer wall is opposite to the internal profile of that same outer wall.

[0023] 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 may be curved inwards to conform to the shape of the nasal septum.

[0024] 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).

[0025] In embodiments, the facial collar can be configured to at least partially cover the patient's nose, the facial collar having a peripheral contour that is configured to at least partially or totally cover the nostrils and the tip of the patient's nose, the middle part and the peripheral contour forming a concave conformation set with respect to at least one frontal plane Y, Z in an orthonormal coordinate system X, Y, Z, the concave conformation allowing the facial collar to cover the external surface of the nose.

[0026] This collar helps stabilize the nasal conformer on the patient's nose. This stabilizing effect can reinforce the role of the boss on each nasal cannula, which rests on the soft triangle of the patient's nostril. Retentivity is improved by the degree to which the peripheral contour of the facial collar covers the contours of the nose. The facial collar can also be sutured to the nose and serves as a visible marker for 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. The facial collar is therefore particularly useful in the postoperative management of primary cheilorhinoplasty.

[0027] In some embodiments, the peripheral contour may include a lower rim extending below the two openings and the median portion of the collar. The 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 latter or to any scar that may be present following surgery.

[0029] In embodiments, the peripheral contour may include two wing extensions opposite each other and configured to cover respectively 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 delimits the collar at the top, the superior extension having 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, 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 preserving the properties of the collar. This limits the overlap of the nose by the collar, which can prove particularly useful for postoperative nasal conformation in adults. Indeed, adult noses have much more variable shapes and contours than infants' 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 collar, and the opening plane PO is set back from the facial collar 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 embodiments, the opening plane PO can be inclined at an angle [3] between 20 and 40° with respect to said front plane Y, Z.

[0036] In 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 nostrils and the tip of the nose, the collar comprising: • 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, • a central portion which is configured to cover the patient's columella; the central portion is positioned between the two openings, • a peripheral contour that is configured to cover the nostrils and the tip of the patient's nose, the median part and the peripheral contour form a concave conformation set with respect to at least one frontal plane Y, Z in an orthonormal coordinate system X, Y, Z, the concave conformation 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, in particular, by the more or less significant overlap of the nasal contours by the peripheral contour of the collar. facial. It also improves the conforming power of the device by applying stress to the external surface of the nose. Brief description of the drawings

[0039] Other features and advantages of the invention will become apparent from the following description. This description is purely illustrative and should be read in conjunction with the accompanying drawings, in which:

[0040] [Fig.1] is a schematic representation, in front view, of a conforming nasal conformer of an embodiment of the invention.

[0041] [Fig.2] is a schematic representation, top view, of the nasal conformer of [Fig.1].

[0042] [Fig.3] is a schematic representation, viewed from below, of the nasal conformer of [Fig.1].

[0043] [Fig.4] is a schematic representation, in rear view, of the nasal conformer of [Fig.1],

[0044] [Fig.5] is a schematic representation of a cross-section of a conforming nasal conformer of an embodiment of the invention.

[0045] [Fig.6] is a schematic representation of a sagittal section of a conforming nasal conformer of an embodiment of the invention.

[0046] [Fig.7] is a schematic three-quarter rear view representation of a conforming nasal conformer of an embodiment of the invention.

[0047] [Fig.8] is a schematic representation, according to a first frontal section, of a conforming nasal conformer of an embodiment of the invention.

[0048] [Fig.9] is a schematic representation, according to a second frontal section, of a conforming nasal conformer of an embodiment of the invention.

[0049] [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.

[0050] [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.

[0051] [Fig. 12] is a schematic representation of an adult or adolescent patient wearing the nasal conformer of [Fig.11].

[0052] [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. Description of the implementation methods

[0053] 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 cheilorhinoplasty and secondary cheilorhinoplasty. Primary cheilorhinoplasty is performed, as described above, on patients aged 1 to 6 months, to close the cleft lip and correct the nasal deformity at the same time.Secondary cheilorhinoplasty is performed at a later stage on older children, adolescents, or adults who have already undergone primary cheilorhinoplasty, and who present with nasal breathing difficulties due to a deviated septum, nasal stenosis, or nasal wing obstruction, or an aesthetic result that could be improved due to a residual deformity or an unsightly scar.

[0054] 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 of 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 related to a pressure point, for example, induced by prolonged enteral nutrition via a nasogastric tube in neonatology.

[0055] In figures 1 to 12, the nasal conformer 20 is represented in an orthonormal X, Y, Z coordinate system. The different axes and planes which are used in this document to define the nasal conformer refer to this orthonormal coordinate system.

[0056] As illustrated in particular in [Fig. 1], the nasal conformer 20 comprises a facial collar 30 and two nasal cannulas 40 which are attached to the facial collar 30. The facial collar 30 is configured to cover the external surface of the patient's nose. The two nasal cannulas 40 are respectively configured to be inserted into the patient's nostrils as illustrated in Figures 10 and 12.

[0057] 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.

[0058] 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 cannulas The nasal 40s 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 which is in contact with the patient's nose when the nasal conformer 20 is positioned on the patient's nose.

[0059] 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 [Fig. 5], each nasal cannula 40 can extend over a distance Csl that extends from the junction between the nasal cannula 40 and the facial flange 30 to the free end 41. The distance Csl can be between 10 mm and 50 mm. When the distance Csl is less than 30 mm, the nasal conformer 20 is a priori intended for smaller patients rather than children. Conversely, when the Csl distance is greater than 30 mm, the 20 nasal conformer is a priori intended for larger patients such as adults.The nasal cannula 40 includes a cavity 42 extending from the opening 31 to its tip 4L. The cavity 42 ensures the passage of air and allows the patient to breathe while wearing the nasal conformer 20.

[0060] As illustrated in Figures 1, 3, and 8, each opening 31 has an oval coronal section. In particular, 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 [Fig. 8] correspond to a portion of the facial collar 30.

[0061] In the example illustrated in Figures 1 and 2, the collar 30 has a central portion 32 which is 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.

[0062] According to an embodiment illustrated in [Fig. 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 The nasal conformer 20 is fixed to the nose with transfixing sutures if the surgeon wishes it 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 reference point for the correct positioning of the nasal conformer 20 on the patient's nose.

[0063] According to an embodiment illustrated in particular in [Fig. 1], the peripheral contour comprises 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 shown in [Fig. 1] by a dashed line. The lower rim 34 delimits the nasal conformer 20 below. As illustrated in [Fig. 10], the lower rim 34 is shaped to conform to the edge of the upper lip without applying pressure to it or to the cleft lip closure scar which extends onto the philtrum.

[0064] To this end, according to 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 [Fig. 4], in which a fictitious transverse plane X, Z is materialized and passes through the descending portions 341 of the lower rim 34 that extend furthest down. The concavity of the concave cutout 340 is highlighted by an arrow extending from the transverse plane X, Z towards the peripheral edge 33 of the concave cutout 340.

[0065] According to another embodiment illustrated in [Fig. 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, which is shown in [Fig. 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.

[0066] 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.

[0067] According to an embodiment illustrated in particular in [Fig. 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 [Fig. 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 edge peripheral 33 which delimits the alar extensions 35 is curved so as to follow the contour of the patient's nasal wing.

[0068] According to an embodiment more particularly illustrated in Figures 4 and 5, each alar extension 35 has an alar 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 represented in [Fig. 4], passes here through the peripheral edges 33 of the alar extensions 35. The alar concavity 350 is represented by a curved dashed line which extends, within the rear face of the facial collar 30, between the peripheral edge 33 and the junction 43 between the facial collar 30 and a nasal cannula 40. The alar concavity 350 gives the peripheral edge 33, which delimits the alar extension 35, a curved shape with respect to the frontal plane Y, Z, as can be seen in [Fig. 5]. The alar concavity 350 of the alar extension 35 allows the patient's nasal wing to be covered as illustrated in [Fig. 10].Each 35 alar extension thus includes a hollow extension which allows it to wrap around the patient's nasal ala.

[0069] According to one embodiment, the peripheral contour includes a superior extension 36 which delimits the facial collar 30 superiorly. As illustrated in [Fig.1], the superior extension 36 extends longitudinally between each wing extension 35. The superior extension 36 has a concavity with respect to a frontal plane Y, Z of the orthonormal frame X, Y, Z as illustrated in [Fig.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 Y, Z plane 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 transverse median axis 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 conform to the curved shape of the tip of the nose.

[0070] As can be seen in [Fig.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.

[0071] According to a particular embodiment, the angle of inclination a is between 20° and 40°, preferably between 25° and 35°. According to this embodiment, the angle of inclination a 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 extension upper 36 according to the angle of inclination a is represented for the front face of the collar 30.

[0072] The upper extension 36 thus defines a supra-nasal portion, that is, a portion extending above the nostril openings 31. The upper supra-nasal extension 36 is extended on each side by the two wing extensions 35. This is illustrated more particularly in [Fig. 2], on which a dashed line is shown curving around the openings 31 and the median part of the facial collar 30.

[0073] As is particularly evident in Figures 1 to 3, the facial collar 30 has a protrusion 37 which is positioned along the median axis of the collar between the median portion 32 and the upper 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 [Fig. 9]. The protrusion 37 is also the most prominent part of the nasal conformer 20 in front of the collar 30. [Fig. 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.

[0074] According to an embodiment illustrated in [Fig. 6], the openings 31 are positioned recessed 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 which intersects a frontal plane Y, Z which 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 [3] between 20° and 40° with respect to said frontal plane Y, Z. Preferably, the angle [3] is between 25° and 35°.

[0075] 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.

[0076] The thin walls of the facial collar 30, on the order of 1 mm, allow practitioners to suture the alar extensions 35 to the alae of a newborn patient's nose to fix the nasal conformer 20 at the end of the surgical procedure. The nasal conformer 20 can thus be fixed in the immediate postoperative context, that is, in the first few days following the surgical procedure.

[0077] For example, in the context of follow-up after cheilorhinoplasty, several sizes of nasal conformer 20 may be provided to accommodate the size of each child and / or allow a child to wear a conformer for several months while accompanying their growth.

[0078] 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 an 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, this additional thickness is denoted S and can be between 1 mm and 3 mm. Preferably, the additional thickness is between 1.5 mm and 2.5 mm. The boss 44 is also visible in the frontal section of Figure 8.

[0079] 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°.

[0080] 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 [Fig. 7] by an imaginary dashed line which encircles the nasal cannula 40.

[0081] According to an embodiment illustrated in [Fig. 6], the distal section 46 is offset relative to the proximal section 45. In particular, the distal section 46 comprises a longitudinal axis TD that forms an angle co between 130° and 160° with the longitudinal axis TP of the proximal section 45. The longitudinal axis TD is, in particular, oriented downwards in a direction opposite to that of the proximal section 45. As illustrated in [Fig. 13], the floor C of the nasal cavities D is offset relative to 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 F (see [Fig. 13]).

[0082] 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 the dimensions of the opening 31. This reduction in caliber follows the anatomy of the nasal cavities, the width of which decreases from front to back at the level of the head of the inferior turbinate, due to the presence of the latter. 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 promote the retentiveness of the nasal conformer 20.

[0083] 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 [Fig. 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 towards the center. This coronal section helps to maintain the normal anatomy of the nasal cavity and, unlike existing nasal conformers, avoids uncomfortable pressure points.

[0084] 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 in the lower part 460 of the nasal cannula 40 and a tapered portion in the upper part 461 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 distinctive character tapered. The wavy shape of the internal profile 462 allows it to conform to the anatomical specificities of the nasal septum.

[0085] Unlike newborns, in whom there is little variability regarding the shape of the nasal tip, the adult population exhibits a wide variety of nasal morphologies. In addition to the size of the nasal conformer 20, there is also the issue of covering the nostrils and the tip of the nose with a standard nasal conformer 20 that conforms to the invention. These issues can 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 the nasal conformer to be adapted to the patient's anatomy while retaining all or part of the properties of the facial collar 30.The cutting guides can be made up of pre-cuts made in the facial collar 30.

[0086] 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 with respect to a transverse plane X, Z that passes through the apexes of the supra-nasal 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 [Fig. 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.

[0087] As illustrated in [Fig. 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 are, on the other hand, retained as described above.

[0088] As previously mentioned, several sizes of nasal conformer 20 can be produced, for example, to adapt to the morphology of the patient, whether a baby, child, adolescent, or adult. This also allows for To offer a newborn patient who has undergone, in particular, cheilorhinoplasty, the option of replacing the nasal conformer 20 during postoperative treatment as the baby grows. As illustrated in [Fig. 1], the length Lri of the lower rim 34 can be between 20 mm and 40 mm, the length Lbs of the upper extension 36 can be between 15 mm and 35 mm, while the height Hba of the alar extension 35 can be between 6 mm and 20 mm.

[0089] Depending on the patient's pathology 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 the context of bilateral cheilorhinoplasty.

[0090] 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.

[0091] 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 the production of a nasal conformer 20 whose dimensions are adapted to the patient's morphology. The shape of the collar 30, and in particular its concavity or the shape of the extensions, can also be adjusted to the patient's anatomy.

Claims

Demands

1. Nasal conformer (20) comprising: - two nasal cannulas (40) respectively configured for insertion into the patient's nostrils, each nasal cannula (40) having a coronal section contoured to fit the nasal vestibule and the entrance to the nasal cavities, - a face flange (30) comprising: • two openings (31) junctioning the face flange (30) and the two nasal cannulas (40) extending respectively, to a free end (41), behind the face flange (30), each nasal cannula (40) having a through-hole (42) between an opening (31) and the free end (41) of the nasal cannula (40), • a mid-portion (32) configured to cover the patient's columella, the mid-portion (32) being disposed between the two openings (31), each cannula nasal (40) comprising 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).

2. Nasal conformer (20) according to claim 1, wherein the boss (44) is made in excess thickness in a wall of the nasal cannula (40).

3. Nasal conformer (20) according to any one of claims 1 and 2, wherein each nasal cannula (40) comprises a proximal section (45) of the opening (31), the proximal section (45) being curved in order 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 transverse plane X, Z of an orthonormal frame X, Y, Z, the transverse plane X, Z passing through a lower edge of the facial collar (30), preferably, the proximal section (45) comprises 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 facial collar (30) is configured to at least partially cover the patient's nose, the facial collar (30) having a peripheral contour which is configured to at least partially cover the nostrils and the tip of the nose, the middle portion (32) and the peripheral contour forming a concave conformation assembly with respect to at least one frontal plane Y, Z in an orthonormal coordinate system X, Y, Z, the concave conformation enabling the facial collar (30) to cover the external surface of the nose.

11. Nasal conformer (20) according to claim 10, wherein the peripheral contour comprises a lower rim (34) extending under the two openings (31) and under the middle portion (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 coordinate system X, Y, Z.

12. Nasal conformer (20) according to claim 11, 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.

13. Nasal conformer (20) according to any one of claims 10 to 12, wherein the peripheral contour comprises two alar extensions (35) opposed to each other and configured to respectively cover a nasal wing.

14. Nasal conformer (20) according to claim 13, 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.

15. Nasal conformer (20) according to any one of claims 10 to 14, wherein the peripheral contour comprises a superior extension (36) which superiorly delimits the facial collar (30), the superior 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 superior extension (36).

16. Nasal conformer (20) according to any one of claims 10 to 15, wherein the peripheral contour has cutting lines or guides to allow adaptation of the nasal conformer to the patient's anatomy while retaining the properties of the collar.

17. Nasal conformer (20) according to any one of claims 1 to 16, 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 in recess from the facial collar (30) and inclined downwards in front of the facial collar (30).