NARINA CONFORMER

Description

[0001] The invention relates to a nasal conformer, intended to shape the nostrils, particularly after rhinoplasty treatment.

[0002] Nasal conformers, such as the one described in patent RU 2,477,088, are already known and used after rhinoplasty, particularly in reconstructive surgery for cleft lip and palate in children. These conformers function relatively well. It is also known that any scar can have an unsightly appearance due to ridges or depressions that form during healing. This is particularly problematic for a facial scar located in the area between the lip and the nose, i.e., in the philtrum. However, the nasal conformer described in patent RU 2,477,088 does not produce a satisfactory aesthetically pleasing scar for all patients.

[0003] Also known from US patent 5,665,104 A is an article inserted into each nostril of a human's nose to increase breathing space. The article comprises two substantially cylindrical pieces attached to each other by a connecting band at their respective bases.

[0004] The invention aims in particular to provide a nasal conformer to improve healing after rhinoplasty, while ensuring the restoration of nasal breathing and combating the creation of edema.

[0005] To this end, the invention relates to a nasal conformer configured to be inserted into the nose of a subject and comprising two tubes suitable for insertion into one nostril of the nose, connected at their lower ends by a connecting bridge and a plate attached to the connecting bridge and extending opposite the connecting bridge relative to the tubes, the plate being configured to exert pressure on the subject's philtrum when the tubes are inserted into one nostril of the nose.

[0006] Thus, a nasal conformer is proposed, comprising a plate designed to press against the philtrum after the conformer has been inserted into the nostrils. Thanks to this pressure exerted on the philtrum, the plate not only protects any scar located there, but can also apply sufficient pressure to the scar to prevent it from becoming raised or depressed. The action of this plate therefore follows the principle of compression therapy, the benefits of which on surgical scars are well-established.

[0007] It should be noted that the conformer is particularly interesting because of this aspect of pressure on the scar: it not only protects the scar, but also applies pressure that helps control the healing process. It is therefore understandable that the proposed plate is designed to be in surface contact with the philtrum.

[0008] The term "lower end" of the tubes refers to the end that is located at the lower end of the nostrils when the conformer is in place.

[0009] The nasal conformer may also include the following characteristics, taken alone or in combination: The plate is attached to the connecting bridge by being deformable between: a rest position, in which the plate extends towards the rear of the nasal conformer, opposite the tubes before the conformer is put in place, and a use position, when the nasal conformer is introduced into the nose, in which the plate extends towards the front of the nasal conformer.

[0010] This configuration of the movable plate between two positions is particularly advantageous for exerting pressure on the philtrum. The nasal conformer includes stiffening means, such as an insert, that return the plate to its resting position. These stiffening means may be integral to the plate or attached to it. They may also be made of the same material as the plate or a different material. Such stiffening means further improve the pressure exerted by the plate on the philtrum by increasing the plate's return to its resting position. Each tube includes, in its upper anterior portion, at least one protrusion for positioning the tube within the nostril. The protrusion(s) are thus positioned in the upper anterior end of the nostril, which allows for better retention of the conformer. Each tube includes, in its posterior portion, at least one protrusion for securing the tube within the subject's nasal cavities, and preferably two protrusions for securing the tube within the subject's nasal cavities.This embodiment is particularly advantageous. Indeed, when the conformer is in place in the nostrils, the protrusion is positioned under the turbinate, allowing for optimal positioning and retention of the conformer. It has been observed that with existing conformers, particularly the one proposed in publication RU2477088, which have a rear portion lacking such a protrusion, the conformer does not stay securely in place in the nostrils because it tends to slip downwards, often requiring suturing in the patient's nose, especially in children. The protrusion is understood to be a convex portion projecting from the rear surface of the tube. When the tube has two protrusions, it actually comprises two convex portions separated by a concave portion.The lower end of each tube has a notch to create a space between the lower end of the tube and the bottom of the nostril. Preferably, this notch has the general shape of a step, with chamfers to soften the angles, connecting the rear and lower part of the tube. This creates a shape without any sharp angles, thus preventing friction on the sutures placed at the entrance of the nostrils, which can be painful and / or damage the stitches. The nasal conformer also includes external tabs for securing the conformer to the nose, extending upwards from the lower end of the tubes. Preferably, there are two lateral tabs designed to rest on the wings of the nose and / or one anterior tab designed to rest on the tip of the nose.The presence of these tabs improves the nasal conformer's hold in the nose and can advantageously allow pressure to be applied to the different tissue layers of the nasal alae, which may be detached during surgery. This improves healing and helps maintain the shape desired by the surgeon during the operation. These tabs can also be used to hold sutures placed through the alae, further improving contact between the different tissue layers of the nasal alae. The nasal conformer is made of silicone, and preferably is. The plate and / or stiffening elements are made of a material more rigid than the tubing. The nasal conformer is available in different colors.Thus, it is possible to manufacture the conformer in colors that best match the patient's skin tone, and decorations can also be added to the conformer. The nasal conformer has a variable length connecting bridge, or columellar bridge. This variable length allows the nasal conformer to adapt to anatomical differences, such as ethnicity, in humans.

[0011] The invention also relates to a nasal conformer comprising two tubes suitable for being introduced each into a nostril of the nose, connected to each other at their lower ends by a connecting bridge, each tube comprising in its rear part at least one protuberance for securing the tube in the nasal cavities of the subject, preferably two protuberances for securing the tube in the nasal cavities of the subject.

[0012] As previously explained, such a nasal conformer addresses the problem of ensuring better retention of the conformer within the nostril, since the protrusion(s) eliminate the need to suture the conformer inside the nostril to secure it. This nasal conformer may incorporate one or more of the features of the previously described model, either individually or in combination. Specifically, the nasal conformer may or may not include the plate attached to the connecting bridge.

[0013] Another object of the invention is a method for manufacturing a nasal conformer as described above, comprising an injection molding step, and the mold preferably being made by additive manufacturing.

[0014] Additive manufacturing offers the advantage of creating a custom mold, and therefore a custom nasal conformer, which is particularly useful for ensuring a good fit and pressure on the philtrum. Brief description of the figures

[0015] The invention will be better understood upon reading the following description, given solely by way of example and made with reference to the accompanying drawings in which: there [ Fig. 1 ] is an isometric perspective view of a nasal conformer according to a first embodiment of the invention, the [ Fig. 2 ] is a lateral view of the nasal conformer of the [ Fig. 1 ], there [ Fig. 3 ] is a bottom view of the nasal conformer of the [ Fig. 1 ], there [ Fig. 4 ] is a front view of a nasal conformer according to a second embodiment of the invention, the [ Fig. 5 ] is a perspective view of the nasal conformer of the [ Fig. 2], there [ Fig. 6 ] is a lateral view of the nasal conformer of the [ Fig. 2 ], there [ Fig. 7 ] is a perspective view of a mold for manufacturing a nasal conformer similar to that of the [ Fig. 1 ]. Detailed description

[0016] We have represented on the figures 1 to 3 a nasal conformer according to a first embodiment of the invention, designated by general reference 1.

[0017] Such nasal conformers are generally used after rhinoplasty. The most frequent use of a nasal conformer is following reconstructive surgery for a cleft lip and palate in a child. Following this type of surgery, the nasal conformer aims to shape the patient's nostrils according to a form predetermined by the surgeon, while allowing them to breathe and, especially in infants, to feed easily. Furthermore, as explained in detail below, and based on the principle of compression therapy, this nasal conformer has the advantage of producing a scar with a better appearance than those obtained with state-of-the-art conformers.

[0018] The nasal conformer 1 shown on the figures 1 to 3comprises two tubes 10 intended to be inserted into the nostrils of a subject. The tubes 10 are connected to each other by a connecting bridge 50. When the tubes 10 are in place in the nostrils of the subject, the connecting bridge 50 generally comes into approximate contact with the base of the subject's nose.

[0019] In the embodiment illustrated by the figures 1 to 3 The nasal conformer 1 also includes a plate 20 which is attached to the connecting bridge 50. The plate 20 is configured so that, when the nasal conformer 1 is in place in the subject's nose—that is, when the tubes 10 are each inserted into one of the subject's nostrils—the plate 20 lies flat on the subject's philtrum and exerts pressure on it. This pressure helps to create a scar on the philtrum with a satisfactory aesthetic appearance.

[0020] Advantageously, the plate 20 is movable between a rest position and a working position. In its rest position, the plate 20 extends towards the rear of the nasal conformer 1, opposite the tubes 10. This rest position of the plate 20 is generally the position of the plate 20 obtained at the end of the manufacturing process of the nasal conformer. The angle α formed by the plane of the plate and the plane passing through the lower part of the connecting bridge 50, and visible on the figure 2 is between 0° and 90°.

[0021] In the position of use of the plate 20, corresponding to the position in which the nasal conformer 1 is in place in the subject's nose, the plate 20 extends forward of the nasal conformer 1, opposite the tubes 10 relative to the connecting bridge 50. The plate 20 is configured such that when the nasal conformer 1 is in place on the subject's nose the plate exerts a pressure considered sufficient to improve healing.

[0022] Advantageously, as illustrated in the figure 3The nasal conformer 1 includes stiffening means 60 that increase the return of the plate 20 from its working position to its resting position. These stiffening means 60 may be inserts placed in the lower part of the plate 20 and the connecting bridge 50, or may be formed from the rest of the plate 20. These stiffening means 60 may constitute, at least in part, the attachment elements of the plate 20 to the connecting bridge 50. The presence of these stiffening means 60 improves the action of the plate 20 by increasing the pressure it exerts on the subject's philtrum.

[0023] In one embodiment, the tubes 10 of the nasal conformer 1 include a protrusion 16, visible on the figure 2, located in the front and upper part of tube 10 and intended to be placed in the front and upper part of a nostril, which has the advantage of improving the retention of the nasal conformer 1 in the subject's nose.

[0024] In another embodiment, each of the tubes 10 is provided with at least one shim protrusion 12, 14 such as are shown in particular on the figures 1 and 2 These shims are located in the rear part of the tube. They are positioned in the subject's nasal cavities when the nasal conformer is in place, specifically under the turbinate. The presence of these shims (12, 14) allows for optimal positioning and retention of the nasal conformer. This can, in particular, eliminate the need to suture the nasal conformer into the subject's nose, which was a frequent and significant drawback of existing conformers.

[0025] In yet another embodiment, each tube 10 has at its lower front end a notch 18, visible on the figure 2 such that a space is left between the lower end of tube 10 and the bottom of the nostril. Advantageously, this recess has the general shape of a step, with fillets to soften the angles. In other words, the recess has a cross-section substantially shaped like an "S" whose ends are tangent to tube 10 and connecting bridge 50, respectively.

[0026] In another embodiment illustrated by the figures 4 to 6The nasal conformer 1 further includes external retaining tabs 30, 40, designed to hold the nasal conformer 1 in place in the subject's nose. These tabs 30, 40 extend upwards from the lower end of the tubes 10. These tabs may be two lateral external tabs 30 designed to rest on the nostrils, one on each side. Alternatively, there may be a front tab 40, designed to rest on the tip of the nose. These lateral tabs 30 and front tabs 40 may be used alone or in combination.

[0027] In addition to improving the retention of the nasal conformer 1 in the patient's nose, these tabs allow pressure to be applied to the different tissue layers of the nasal alae, which are typically detached during surgery. This promotes healing and helps maintain the shape of the nostrils created by the surgeon during the procedure. Finally, these tabs can support sutures placed through the alae, further enhancing contact between the different tissue layers of the nasal alae.

[0028] Following labio-palatine reconstruction procedures, the surgeon advantageously uses, in the first few days after the procedure, a nasal conformer 1 not including the 30, 40 tabs, then for the following few weeks, a nasal conformer 1 with the lateral external tabs 30 and / or the anterior external tab 40. This allows for better healing of the nostrils, and for shaping the nostrils well according to the desired form.

[0029] In another embodiment, the length of the connecting bridge 50 is variable, and can be adapted to the anatomy of each subject.

[0030] Preferably, the tubes 10 are made of a flexible material so that they can be inserted into the nostril more easily and with less discomfort. Silicone is a particularly suitable material for the tubes 10. It has good flexibility, is biologically inert, and well-tolerated by the body. Similarly, the connecting bridge 50 is preferably flexible, and silicone is particularly well-suited for this. Advantageously, the connecting bridge 50 is supplied as part of the same material as the tubes 10.

[0031] Preferably, plate 20 also includes silicone. Furthermore, plate 20 is configured to allow sufficient and substantially uniform pressure to be applied to the philtrum, and more specifically to the area of ​​the philtrum where the scar is located, and for this purpose it has an appropriate, i.e., relatively high, rigidity.

[0032] Thus, advantageously, plate 20 is more rigid than tubes 10 and connecting bridge 50. Indeed, to increase ease of use and comfort, it is useful for tubes 10 to be very flexible. Conversely, for satisfactory operation, plate 20 needs to be rigid.

[0033] The stiffening means 60 advantageously also include silicone, or are even made of silicone. Because they must contribute to increasing the spring force exerted on the plate 20, they generally have a relatively high rigidity, for example, the same rigidity as the plate 20. In one embodiment, the stiffening means 60 are formed from the material of the plate 20 and are attached to the connecting bridge 50. In another embodiment, the stiffening means 60 are inserts placed in the lower part of the plate 20 and connected to the connecting bridge 50.

[0034] Another object of the invention is a method for manufacturing the nasal conformer 1. Preferably, the nasal conformer 1 is manufactured by injection molding. Advantageously, the material used is silicone.

[0035] In a particularly advantageous embodiment, the mold used for injection molding is itself manufactured by additive manufacturing. This manufacturing method potentially allows for the production of custom-made molds.

[0036] An example of a mold used for manufacturing nasal conformer 1 is illustrated in the figure 7The mold 100 comprises two external parts 110 and 120 and an internal part 130. Part 110 is the upper part and includes an opening 112 for injecting silicone (or other suitable material). Part 120 is the lower part of the mold. The mold 100 also includes an internal part 130, specifically comprising two tabs 132 around which the tubes 10 of the nasal conformer 1 will be molded. [Table 1]. 1 Nasal conformer 10 Tube intended to be inserted into a nostril 12 Rear protrusion of tube 10 intended to be received by a nasal turbinate of a subject 14 Rear protrusion of tube 10 intended to be received by a nasal turbinate of a subject 16 Front protrusion of tube 10 intended to be received by the upper front part of a subject's nose 18 Step at the lower end of tube 10, with a rounded angle 20 Philtrum support plate 30 External side tab 40 External front tongue 50 Bridge connecting the tubes 10 60 Method of stiffening 100 Mold for manufacturing nasal conformer 1 110 Upper part of the mold 112 Injection port 120 Lower part of the mold 130 Part of the mold intended to form the tubes 10 132 Paws

[0037] The invention is not limited to the embodiments shown and other embodiments will be obvious to a person skilled in the art.

[0038] In particular, it is possible to consider that the nasal conformer 1 does not have a plate 20. In this case, the mere fact that the tubes are provided with one or two shims 12, 14 makes it possible to provide a nasal conformer ensuring better retention in the nose, in particular that does not require suturing of the conformer in the nose.

[0039] In other words, the nasal conformer 1 is configured to be inserted into a subject's nose and includes: two tubes 10 suitable for being introduced each into a nostril of the nose, connected to each other at their lower ends by a connecting bridge 50 and, in which each tube 10 includes in its rear part at least one protuberance 12, 14 for securing the tube 10 in the nasal cavities of the subject, preferably two protuberances 12, 14 for securing in the nasal cavities of the subject.

[0040] A nasal conformer of this type is useful, for example, in rhinoplasties where no sutures are placed on the philtrum. When the conformer is in place in the nostrils, the protrusion is positioned under the turbinate, allowing for optimal positioning and retention of the conformer. Indeed, it has been observed that existing conformers, particularly the one described in publication RU2477088, which lack these protrusions, do not stay securely in place in the nostrils because they tend to slip downwards, often requiring suturing inside the nose.

[0041] In another embodiment, the nasal conformer 1 does not include a plate 20, but instead has external tabs for holding the conformer on the subject's nose. In such an embodiment, the nasal conformer 1 is configured to be inserted into a subject's nose and includes: two tubes 10 suitable for being inserted each into a nostril of the nose, connected to each other at their lower ends by a connecting bridge 50 and external tabs 30,40 for holding the conformer on the nose, extending upwards from the lower end of the tubes, preferably two lateral tabs 30 intended to press against the wings of the nose and / or a front tab 40 intended to press against the tip of the nose.

[0042] A nasal conformer of this type is useful, for example, in rhinoplasties where no sutures are placed on the philtrum. The presence of tabs 30 and 40 improves the conformer's hold and also allows pressure to be applied to the different tissue layers of the nasal alae, in cases where they are detached during surgery. This improves healing and helps maintain the shape given by the surgeon during the procedure. These tabs 30 and 40 can also be used to hold sutures placed through the alae, further improving contact between the different tissue layers of the nasal alae.

[0043] It is also possible to combine the two embodiments above, an object of the invention then being a nasal conformer 1 comprising: two tubes 10, each suitable for insertion into a nostril of the nose, connected to each other at their lower ends by a connecting bridge 50, and wherein each tube 10 comprises in its rear part at least one protuberance 12, 14 for securing the tube 10 in the nasal cavities of the subject, preferably two protuberances 12, 14 for securing the tube 10 in the nasal cavities of the subject; external tabs 30, 40 for holding the conformer on the nose, extending upwards from the lower end of the tubes, preferably two lateral tabs 30 intended to rest on the wings of the nose and / or one front tab 40 intended to rest on the tip of the nose.

[0044] Other combinations or deletions of features from the different embodiments can be considered.

Claims

1. Nasal shaper (1) configured to be introduced into the nose of a subject, characterised in that it comprises: - two tubes (10) suitable for each being introduced into a nostril of the nose, connected together at their lower ends by a connecting bridge (50) and - a plate (20) attached to the connecting bridge (50) and extending opposite the connecting bridge (50) relative to the tubes (10), the plate (20) being configured to exert a pressure on the philtrum of the subject when the tubes (10) are each introduced into a nostril of the nose.

2. Nasal shaper (1) according to the preceding claim, wherein the plate (20) is attached to the connecting bridge (50), being deformable between: - a rest position, in which the plate (20) extends towards the rear of the nasal shaper (1), opposite the tubes (10) before positioning the shaper, and - a use position, when the nasal shaper (1) is introduced into the nose, in which the plate extends towards the front of the nasal shaper (1).

3. Nasal shaper (1) according to the preceding claim, comprising stiffening means (60), exerting a force to return the plate (20) to its rest position, for example an insert.

4. Nasal shaper (1) according to any one of the preceding claims, wherein each tube (10) comprises in its upper front part at least one protuberance (16) to position the tube (10) in the nostril.

5. Nasal shaper (1) according to any one of the preceding claims, wherein each tube (10) comprises in its rear part at least one blocking protuberance (12, 14) to block the tube (10) in the nasal cavities of the subject, preferably two blocking protuberances (12, 14) in the nasal cavities of the subject.

6. Nasal shaper (1) according to any one of the preceding claims, wherein the lower end of each tube (10) has a recess so as to leave a space between the lower end of the tube (10) and the bottom of the nostril, preferably, this recess has the general shape of a step, provided with fillets to soften the corners, connecting the rear and the lower part of the tube (10).

7. Nasal shaper (1) according to any one of the preceding claims, further comprising external tabs (30, 40) to hold the shaper on the nose, extending upwards from the lower ends of the tubes, preferably two lateral tabs (30) intended to press against the wings of the nose and / or one front tab (40) intended to press against the tip of the nose.

8. Nasal shaper (1) according to any one of the preceding claims, comprising silicone, preferably made of silicone.

9. Nasal shaper (1) according to one of the preceding claims, wherein the plate (20) is made of a material which is stiffer than the material of the tubes (10).

10. Nasal shaper (1) according to one of claims 3 to 9, wherein the stiffening elements (60) are made of a material which is stiffer than the material of the tubes (10).

11. Nasal shaper (1) according to any one of the preceding claims, comprising materials of different colours.

12. Nasal shaper (1) according to any one of the preceding claims, having a connecting bridge of variable length.

13. Method for manufacturing a nasal shaper (1) according to one of the preceding claims, wherein the nasal shaper (1) is manufactured by injection moulding, the mould preferably being manufactured by additive manufacturing.