Unilateral implant for spreading one nostril

Abstract

An implant (40) for spreading a nostril, which, in the implanted state, lies fully against an inner surface of a nostril and is constructed from a blank made of thin sheet metal and provided with a plurality of continuous perforations, wherein the initially flat blank is bent into a spatial shape curved out of the sheet plane, which follows the natural curvature of the inner side of the soft nasal lateral wall; wherein the implant, in the implanted state, lies fully against only one inner surface of a single one of the two nostrils and has a triangular base body (41), in which, starting from a triangular vertex (S), two catheti edges (42', 43') are arranged at a triangular angle to one another, each leading away from the triangular vertex and extending on both sides in the direction of a hypotenuse edge (44') opposite the triangular vertex, is characterized in thatThe base tips of the triangular body, where each cathetial edge meets the hypotenuse edge opposite the triangle apex, are shortened or truncated, so that the end of the respective cathetial edge facing away from the triangle apex is connected to one end of the hypotenuse edge via another edge line (42x'). This device enables a permanently secure fit of the implant because its shape allows it to be fitted particularly well and optimally across the entire surface of the inner side of the nostril.

Description

The invention relates to a rhinological implant for spreading at least one nose lobe, which implant can be fastened in the human nose, bears over its entire surface on at least one inner surface of a nose lobe in the implanted state and is constructed from a blank of thin sheet metal provided with a multiplicity of through-perforations, wherein the initially flat blank is bent before the implantation into a three-dimensional shape which is curved out of the sheet metal plane and follows the natural bending of the inner side of the soft nose side wall; wherein the implant bears over its entire surface on only one inner surface of a single one of the two nose lobes in the implanted state; and wherein the implant has a triangular base body, in which two catheter edges are arranged at a triangular angle φ relative to one another starting from a triangle tip, each lead away from the triangle tip and each run on both sides in the direction of a hypotenuse edge opposite the triangle tip.Such a rhinological implant for spreading nasal wings is disclosed in the generic prior art DE 20 2008 010 203 U1 (=reference [0])A similar implant is described in U.S. Pat. No. 2021 / 0 077 292 A1 (=reference

[00] ), but without explicit mentioning that the initially flat blank is bent up into a three-dimensional shape curved out of the sheet metal plane before the implantation.BACKGROUND OF THE INVENTIONIn general, implants for spreading the nasal wings and handling them are described in great detail, for example, on the following Internet pages (reviewed on 30.01.2024):Reference [3a] (Prof. Dr. a Wengen) https: / / breathhe implant.com / de / .Reference [3b] (the Applicant Company Kunz) https: / / www.kunzmed.com / de / produkt / rhinology / breathe-implantawenqen.htmlReference [3c] (Bess) https: / / bess.eu / rhinology / breathe-implant-awengenThe implantation of an implant, i.e. a generally non-body tissue piece or substance, into the human body is a long-known method in medical technology, which is carried out in many variations for eliminating functional disorders of various body parts and / or psychic disorders.A spreading of the nasal wings can be indicated, for example, in the event of a constriction of the nasal flap or in the event of a collapse of the soft parts of the nasal wings.In the following, the essential differences between an engagement for spreading the nasal wings and the known Columella-Strut technique will first be explained:The spreading of the nose wings aims exclusively to permanently enlarge the interior of the nose and thus to optimize the air supply via the nose. This is therefore purely functional surgery. There are a number of surgical techniques for achieving the goal via sutures and grafts. Different methods, which are essentially dependent on the experience and skill of the operator, are possible for this purpose. Disarticulation techniques up to targeted cartilage incisions can play more or less a role.In contrast, the Columella-Strut technique aims to increase the nose tip for cosmetic reasons. A web is then pushed between the two ends of the two wing cartilages in order to increase the tip of the nose. The graft / implant is placed in a pocket between the medial legs of the wing cartilage anteriorly via the spines nasalis and secured between the medial legs with sutures passing through.This is described, for example, in US 2012 / 0078367 A1 (=reference [4]). Here, an implant is referred to which is biologically degraded and is therefore not intended for long-term retention. The target region is the lower third of the nose, mainly the region around the nose tip. Although this also refers to a connection of the implant to the septum, not for straightening it, but for lengthening if the septum is shortened by external action or from a cosmetic point of view. The curved parts of the implant described are at most about 20 mm long in their longitudinal extension, i.e. they extend, when they are placed on the basis of the spine nasalis and the two limbs of the wing cartilage are received, just to the end of the septum.Even the seat of this implant in the implanted state would be completely unsuitable for a wing-of-the-nose spread.The implant according to reference [4] is therefore not provided at all for spreading the nasal wings and is also not attachable on both sides of the septum of the human nose on the respective outer surface of the septum in the left or right side of the nasal cavity. Rather, the implant according to reference [4] is a "Columella Strut", but not a device according to the present invention for spreading the nasal wings. An expedient for such spreading is the subject and does not mention reference [4] at all.Also in WO 2008 / 153263 A1 (=reference [5]) only techniques are described which aim to raise the nose tip. Thus, the septum is mentioned there. For example, the technique is described that the implant must be attached to the upper boundary of the septum cartilage. However, this again takes place only for stabilizing the nose tip implant.The known implantation systems according to reference [4] and according to reference [5] thus attempt to use the end of the septum for stabilization or for extension. However, neither system aims at or would be capable of permanently spreading one or both nasal wings away from the septum.CN 21 538 4901 U (=reference [6]) discloses a nasal correction support for plastic surgery comprising a columella nasi support portion, a nasal septum extension portion, leaflets of the columella nasi support portion, leaflets of the nasal septum extension portion, a nasal spike and a columella nasi having a clamping groove at the support end, a clamping groove at the head end of the nasal septum extension and a U-shaped groove.U.S. Pat. No. 11 241 306 B2 (=reference [7]) describes nasal implants having a planar profile which has partially open spaces. Such a nasal implant may be compressible along one or more dimensions, such as the width or length of the planar profile. In any case, such an implant is not suitable for spreading the nasal wings and therefore serves a completely different, independent supply field.A simple and frequently used method for spreading the nasal wings is to use a nasal support plaster which also employs, in particular, high-performance sportsrs for improving nasal respiration. However, this procedure is unsuitable for permanent use. With regular use of the nasal patches, skin problems can arise due to the adhesive. In addition, a nasal patch affects the external appearance of a human.Therefore, surgical methods are also known for the permanent spreading of the nasal wings, in which cartilage is used for stabilizing the lateral nasal switch parts. However, the results are not always satisfactory optically and functionally. Moreover, this procedure entails still other disadvantages. Since cartilage of the body is preferably used for stabilization, the removal of the cartilage, preferably from the ear or from the nasal septum of the patient, must proceed to this step, which means a time outlay and an additional risk for the patient. Often, the inserted part has too little residual stress to maintain the caudal airway of the nose open in a satisfactory manner. The method may even prove counterproductive because the inserted parts press the soft parts inward and may lead to a further constriction of the nose.Metallic implants are also used for spreading the nasal wings. For this purpose, an opening is surgically introduced in the region of the wing edge of the nose, through which opening the implant is inserted and fastened to the triangular cartilage. Metallic implants are substantially stronger and more elastic than cartilage and have sufficient residual stress to maintain the nasal airway open in a durable and satisfactory manner.The triangular cartilage of the human nose is known to have a relatively flat plateau region or at most a plateau region which is very slightly curved. A disadvantage of many known implants is that they are each curved so strongly around the nasal bridge that in the implanted state, in the region of this plateau of the triangular cartilage, a cavity is formed between the triangular cartilage and the implant, which can lead to an unfavorable healing behavior after the implantation and possibly to uncontrolled growing tissue accumulations. Furthermore, many known implants are geometrically designed such that they do not optimally abut the flanks of the triangular cartilage in the region of the nasal wings.A further roof-shaped implant for spreading the nasal wings, which in the implanted state, as well as the implants according to DE 10 2006 023 058 B3≈ EP 1 857 078 B1 (=reference [1]) or from DE 203 07 058 U1≈ DE 20 2004 021 075 U1≈ EP 1 475 056 B1 (=reference [2]), extends over the back of the septum, is described in U.S. Pat. No. 6,322,590 B1 (=reference [8]). This implant is also made of a straight flat metal strip. The metal strip has perforations in the form of round holes at its two ends and is bent out of the plane into a spatially V-shaped roof shape, but with a "round tip" of the spatially V.Implants according to reference [1], in which the planar strip is likewise bent out of the plane into a spatially V-shaped roof shape, but already has an angular or trapezoidal contour in the plane, make possible geometrically more favorable implantation arrangements in the nose and represent an improvement over the rhinological implant according to reference [8]:Reference [1] proposes that a back section of the implant above the nasal bridge is angled flat or only very slightly against the plateau region of the triangular cartilage at a spreading angle ω>160° or curved in barrel shape with a radius of curvature r>4 cm, preferably r>10 cm, around the plateau region of the triangular cartilage, and that two side sections of the implant on both sides of the nasal wings run essentially parallel to the respective nasal wing at an angle φ of in each case more than 50° and angled downward against the flat back section. Thus, without a greater manufacturing effort, a particularly good geometric adaptation of the implant to the (normal) configuration of the human triangular cartilage is achieved. In particular, no hollow spaces arise after the operation between the implant and the triangular cartilage, neither in the region of the plateau of the triangular cartilage nor at the flanks thereof. Rather, the implant rests closely against the triangular cartilage over its entire surface facing the triangular cartilage, which also brings about a particularly good mechanical hold of the implant on the triangular cartilage.Object of the InventionIn contrast, the object of the present invention is to modify a rhinological implant of the generic type with the features defined at the beginning with uncomplicated technical means to the effect that the device does not have to be placed over the nasal bridge-side part of the septum and attached to both sides of the nasal septum, but rather one-sided application is made possible. In addition, the manufacturing effort is to be substantially reduced and a considerable proportion of material and weight is to be saved. In the implanted state of the device, the most permanently secure possible fit of the implant is to be achieved. Finally, the shape of the implant is intended to allow it to fit particularly well and optimally over the entire surface onto the inner side of the nasal lobe.BRIEF DESCRIPTION OF THE INVENTIONThis relatively complex object is achieved in a surprisingly simple and cost-effective manner in that at least one, preferably both, base tips of the triangular base body, where in each case one catheter edge meets the hypotenuse edge opposite the triangle tip, are of shortened or chopped design, so that the end of the respective catheter edge facing away from the triangle tip is connected to an end of the hypotenuse edge via a further edge line.This produces a kind of compact "boomerang" shape which can be fitted onto the inside of the nose lobe in a particularly good and optimum manner over the entire surface.As is the case with the generic rhinological implants, the implant according to the invention serves in particular for stabilizing, supporting and expanding the soft side wall of the nose in the region between the lower end of the triangular cartilage of the human nose, the bony nose entry "Aperturea piriformis", the nasal bridge and the nose entry on one side (or even on both sides in the case of multiple applications of the implant). The implant according to the invention thus contributes to reducing or eliminating the suction of the nose side wall and thereby to facilitate and thus improve the nose breathing.The novel basic idea of the invention is to present an implant which can be inserted only on one side and which is applied to the inner wall of the corresponding nose lobe only on one side of the septum. This substantially simplifies the implantation surgical procedure, because it is only necessary to operate on an inner surface of a nasal lobe on one side of the septum in order to insert the implant. In particular, for this purpose, the nasal mucosa no longer has to be lifted off the cartilage of the septum. Rather, the slightly curved, substantially rigid implant of the invention is immediately inserted into its desired position on the inner wall of a nasal wing.Although theoretically two implants can also be used on both sides of the septum on the inner sides of both nasal wings, in order to achieve a particularly high mechanical stability or in order to be able to more sensitive and better correct asymmetric deformations of the nasal septum. However, even in such cases, the absence of a nose bridge section on the implant according to the invention makes the operation much less costly and thus less burdensome for the patient.The special geometric structure according to the invention of the implant with an essentially triangular base body creates a relatively large contact surface on the inside of the nose lobe, which can guarantee a secure, stable fit of the implant even during long-term use and during the then expected numerous mechanical movements of the patient's nose (for example during chewing).The saving in material during the production of the implant according to the invention compared to the generic prior art discussed above is likewise considerable: due to the omission of the previously always obligatory nasal bridge section and of the opposite further side part, 60-70% smaller amounts of material are required, which naturally also leads to a great saving in weight in the implant according to the invention.Finally, the manufacturing process is also substantially simplified:The implant is bent up after punching out the original flat, unbent blank into a space shape which is only very slightly curved and follows the natural bending of the inner side of the soft nose side wall. The implant according to the invention can thus be better introduced into the existing structure of the patient's nose. A very strong bending (as is absolutely necessary in the case of the generic implants according to reference [1] or [2], for example, already because of the shaping of the nasal bridge part which is always present there relative to the two side portions which are likewise always present there into a roof shape) is now completely dispensed with, which in turn contributes to a significant saving in labor during production, but subsequently also during the insertion of the implant according to the invention during implantation.In this way, despite the significantly lower manufacturing complexity compared to the prior art, a particularly good geometric adaptation of the implant to the current, possibly also strongly deformed, nasal situation of the respective patient and a particularly good contact of the implant on one of the inner surfaces of the nasal wings are achieved. In particular, no cavities can arise between the implant and the septum after the surgery (as is entirely possible and in some cases even unavoidable in the prior art). Rather, the substantially flat implant according to the invention, which is only very slightly curved, rests closely against the nose wing over its entire surface facing the nose wing after surgery, which also brings about a particularly good fit and mechanical hold of the implant in the nose.By prefabricated implants according to the invention, the intervention can be carried out in a particularly well reproducible, standardized and planable manner. If a certain number of different sizes and also different shapes of the implant according to the invention are provided, the operator can be optimally based in a particularly accurate and sensitive manner on the individual geometric conditions in the respective patient nose. A primary objective in this case is always to stabilize the soft side wall of the nose permanently.Preferred Embodiments of the InventionIn practice, embodiments of the rhinological implant according to the invention are used in which at least one of the two catheter edges and / or the hypotenuse edge opposite the triangle tip does not run linearly in a straight line, but rather following a curved curve.In this way, it is possible to realize particularly "soft" outer contours of the implant and to bring about an optimum adaptation to the actual geometric conditions on the inner side of the nose lobe.In one class of advantageous embodiments, the implant according to the invention is characterized in that the triangular base body is extended at the two catheter edges by two side sections each projecting away from the triangle tip beyond the hypotenuse edge, wherein the outer edges of the two side sections each run in alignment with their respective catheter edge.The blank for such implants is not significantly more complicated to produce and the protruding side sections increase the contact surface and improve the fit in the implanted state.Embodiments of the implant according to the invention are very particularly preferred, which are characterized in that the triangle tip and preferably also all further, at least the outer, corner structures of the implant are rounded.This on the one hand makes it possible to reliably prevent sticking or even splashing during the implantation, and on the other hand, this also prevents or at least minimizes a risk of injury in the implanted state in the event of possible post-surgical movements of the implant relative to its environment. The ingrowth of the implant into the human tissue is also facilitated thereby and the coverage by the soft parts of the nasal side wall is improved.In a class of particularly preferred embodiments, the implant is constructed symmetrically with respect to an (imaginary) height axis running from the triangle tip at right angles to the hypotenuse edge, which divides the implant laterally into two mirror-image halves.This symmetrical shape can be realized particularly easily and precisely from a manufacturing standpoint.Alternatively, a further class of embodiments of the invention is characterized in that the implant is constructed asymmetrically, wherein a first catheter edge has a greater longitudinal extent away from the triangle tip of the triangular base body than the second catheter edge.In this way, in an assortment with different shapes and sizes, individual peculiarities and unusual deformations of the respective patient's nose, which could not be optimally treated with a symmetrical shape of the implant, can be taken into account.Advantageous variants of the implant according to the invention are therefore also distinguished in that one or more spikes are incorporated into the triangular base body.The latter become entangled in the nasal lobe during implantation and thus ensure excellent and extremely durable retention of the implant. This type of attachment can, of course, also be combined with other types of attachment described above in order to guarantee a particularly secure fit of the implant on the nasal lobe.As already described above, the implant according to the invention has a multiplicity of perforations. On the one hand, the mass of the implant is thus reduced and therefore its weight is reduced, and on the other hand, the proportion of non-body material introduced into the human body through the implant is minimized as far as possible. In addition, the perforations promote the ingrowth of the implant with the tissue. In particular, the perforations are important to ensure the supply of soft tissue on both sides of the implant, to allow tissue ingrowth and thus secure and durable fixation of the implant in the tissue, to allow the implant to be sutured to the bone of the aperture a piriformis and fixed to the outermost part of the wing cartilage.The perforations are preferably present both on the triangular base body and on the two side sections of the implant and can be formed, for example, as circular holes, as elongated holes or else as differently shaped openings.Furthermore, these perforations also serve for secure fixation by suturing the implant by means of an surgical suture. This also ensures that the tissue concerned is supplied with nutrients sufficiently.However, the production of a durable attachment of the implant by sewing on is generally time-consuming and sometimes also somewhat complicated due to the spatial conditions.In further advantageous embodiments of the invention, the perforations of the implant together can have a greater surface area than the solid partial sections of the implant, which sections are in particular formed in the shape of webs and surround the perforations.The mass and thus the weight of the implant according to the invention can thus be significantly minimized while still having high mechanical stability. This also ensures adequate supply of nutrients to the tissue.Preferably, in variants of the invention, at least some of the perforations may be polyhedron-shaped or honeycomb-shaped.This enables a high stability even with a low use of material.At least some of the perforations can, however, also be formed slot-shaped, preferably by elongated slots running parallel to one another.This facilitates suture guidance for the implanting surgeon, among other things.Embodiments of the implant according to the invention are particularly preferred in which all edges of the implant, at least all outer edges, are rounded.This minimizes a possible risk of injury, substantially facilitates ingrowth into the human tissue, and significantly improves the covering by the soft parts of, for example, a cartilage skin and the nasal mucosa.In practice, embodiments of the invention are contemplated wherein the thickness of the flat blank for the implant is between 0.2 mm and 1.2 mm, preferably about 0.8 mm.The implant according to the invention can assume up to the maximum the extent of the entire inner surface of a human nose lobe and has a greatest longitudinal extent in the plane of the blank of between 2 mm and 7 mm, preferably approximately 5 mm.Embodiments are suitable for the most conceivable application cases of the implant according to the invention in which the triangle angle φ at the triangle tip of the triangular base body is between 60° and 160°, preferably between 100° and 120°.This shape serves to reinforce the implant and thus reduces the occurrence of bending by external forces in the sense of a gusset plate.For some applications it may be advantageous if the implant is made wholly or partly of metal. Metals and their alloys are predestined as material for surgical and orthopedic implants which are intended to remain permanently in the body, because they have high durability and elasticity in addition to very good biocompatibility. Despite a relatively low density, implants made of such materials as pure titanium or titanium compounds have excellent mechanical properties with a long life. Likewise, non-magnetizable metals or alloys are well suited for the aforementioned purposes, with which MRI safety aspects can also be taken into account.Embodiments are preferred in which the implant is constructed from a material with memory effect and / or superelastic properties, preferably from nitinol, so that optimal spring properties relative to the septum can be introduced, for example, by suitable thermal treatment of the implant.For other applications, it may be advantageous if the implant is made entirely or partially of plastic sheet metal, in particular of polymer material, preferably of a material which has a similar flexibility to the human nasal wings, but has sufficient stiffnesses to guarantee a permanent spreading of the corresponding nasal wing away from the septum.In addition to the good biocompatibility of the material used itself, the implant can also have a special biocompatible and / or germ-repellent coating.To achieve a finely coordinated shape of the implant, the implant can expediently be produced by 3D printing technology and / or by laser technology.According to the individual requirements, the implant according to the invention can also be produced in machining technology, in particular by means of milling technology and / or by means of grinding technology, preferably sliding grinding, magnetic sliding grinding or satellite sliding grinding, and / or by means of polishing technology, preferably electrohydraulic polishing, or in etching technology.Finally, in further advantageous embodiments of the invention, the implant is produced by injection molding according to the micro-injection molding (=MIM) method, which is known per se from WO 00 / 06327 A2 (=reference [9]), for example. Thus, an extremely cost-effective production of even very large quantities with constant quality can be achieved, while the conventional implants, as a rule such as, for example, ornaments, are hand-produced and are therefore, on the one hand, relatively expensive to produce and, on the other hand, can vary individually in terms of dimensional accuracy.Further features and advantages of the invention are evident from the following detailed description of exemplary embodiments of the invention with reference to the figures of the drawing, which shows details essential to the invention, and from the claims.DETAILED DESCRIPTION OF THE INVENTION With reference to the DrawingsExemplary embodiments of the invention are illustrated in the schematic drawing, which are explained in more detail in the following description.The following are shown: FIG. 1 shows a schematic plan view in a greatly enlarged illustration perpendicularly from above onto the blank plane of a symmetrical embodiment of the implant according to the invention with lateral sections of large L size formed exactly mirror-symmetrically with respect to one another; FIG. 2 shows a plan view of the blank for an embodiment of the implant according to the invention with symmetrically extending side sections; FIG. 3 shows an embodiment with asymmetrical side sections; FIG. 4 shows an asymmetrical embodiment with an extending side section on one side and a chopped base tip on the other side; FIG. 5a is a schematic top view perpendicular from above onto the plane of the blank of an asymmetric embodiment of the implant according to the invention with base tips cut off on both sides and with a curved catheter edge and a curved hypotenuse edge; FIG. 5 bshows the embodiment of FIG. 5 ain a curved spatial representation; FIG. 6a shows a similar embodiment of the implant according to the invention as in FIG. 5a as a three-dimensional plan view of the blank which has already been slightly curved; FIG. 6 bshows the embodiment of FIG. 6 a, viewed in the plane of the curved blank; FIG. 6 cshows the embodiment of FIG. 6 ain a three-dimensional illustration obliquely from the side; FIG. 7 a shows a schematic top view perpendicular from above onto the blank plane of an asymmetric embodiment similar to FIGS. 5 and 6 with dimensions; and FIG. 7 bshows the embodiment of FIG. 7 a, viewed in the plane of the curved blank with dimension.The rhinological implant 10; 20; 30; 40; 50; 60 for spreading at least one nasal wing, which implant is illustrated in all the figures of the drawing, can be fastened in the human nose. In the implanted state, it rests over the entire surface on at least one inner surface of a nose flap and is constructed from a blank of thin sheet metal provided with a plurality of through-going perforations 15.The perforations 15 can be polyhedron-shaped or honeycomb-shaped as shown in the figures of the drawing, but in embodiments not specifically shown can also be circular holes or also elongated holes. They help to reduce the weight of the implant on the one hand and to reduce the proportion of non-body material in the body of a patient as much as possible on the other hand. In addition, the perforations 15 promote the ingrowth of the implant 10; 20; 30; 40; 50; 60 with the surrounding tissue.In the embodiments of the invention illustrated in FIGS. 1 to 4 and 6, the perforations 15 have a greater total surface area than the fixed partial sections 15' of the implant 10; 20; 30; 40; 60 which surround the perforations 15 and are embodied in the form of webs. However, other shapes are also possible, such as elongated or circular holes.The implant 10; 20; 30; 40; 50; 60 is operatively inserted into the human nose and secured by suture. In this case, a plurality of individual seams are placed and fixed through the perforations 15.According to the invention, the implant 10; 20; 30; 40; 50; 60 is characterized, among other things, in that the initially flat blank is bent up before the implantation into a three-dimensional shape which is curved out of the sheet metal plane and follows the natural bending of the inner side of the soft nose side wall.In contrast to the two-sided implants known hitherto, which engage over the septum, the implant 10; 20; 30; 40; 50; 60 according to the invention bears over its entire surface on only an inner surface of a single one of the two nasal wings in the implanted state.In applications not specifically shown in the drawing, however, implants according to the invention can also be applied to both nasal wings. In these cases, the two implants used will generally be mirror images of one another. Of course, use cases are also conceivable where, due to an individual asymmetry or other deviations in the geometry of the two nose wings of a patient, implants according to the invention of different sizes can also be used in the two nose halves. Compared to the known implants on both sides, the implant which can always be attached only in one nose half according to the invention at least offers the treating otologist a substantially higher flexibility in order to optimally address the peculiarities of the respective individual case.The implant 10; 20; 30; 40; 50; 60 according to the invention has an approximately triangular basic body 11; 21; 31; 41; 51; 61 in which, starting from a triangle apex S, two catheter edges 12', 13'; 22', 23'; 32', 33'; 42', 43'; 52', 53'; 62', 63' are arranged with respect to one another at a triangle angle φ, each lead away from the triangle apex S and each run on both sides in the direction of a hypotenuse edge 14'; 24'; 34'; 44'; 54'; 64'.In all the embodiments of the invention shown in the drawing, the triangle tip S and also all further, at least the outer, corners of the implant 10; 20; 30; 40; 50; 60 are rounded.The sheet thickness of the flat blank for the implant 10; 20; 30; 40; 50; 60 according to the invention is generally between 0.2 mm and 1.2 mm, preferably about 0.8 mm, and the maximum longitudinal extent is between 2 mm and 7 mm, preferably about 5 mm.The triangle angle φ at the triangle tip S of the triangular base body 11; 21; 31; 41; 51; 61 can be between 60° and 160°, preferably between 100° and 120°. In the embodiments shown, it is about 100°.The implant 10; 20; 30; 40; 50; 60 according to the invention can be manufactured completely or partially from metal, in particular from titanium, preferably from pure titanium or a titanium alloy, or from stainless steel and / or from a material with memory effect and / or superelastic properties, preferably from nitinol. Preferably, it will have a biocompatible antibacterial coating.However, the implant 10; 20; 30; 40; 50; 60 can also be made entirely or partially of plastic sheet metal, in particular of polymer material, preferably of a material which has a similar flexibility to the human nasal wings, but has sufficient stiffnesses to effect a permanent and stable spreading of a nasal wing from the septum.The implant 10; 20; 30; 40; 50; 60 can be produced by 3D printing technology and / or by laser technology. It is also possible to produce and process the implant 10; 20; 30; 40; 50; 60 using machining technology, in particular using milling technology and / or using grinding technology, preferably sliding grinding, magnetic sliding grinding or satellite centrifugal force grinding, and / or using polishing technology, preferably electrohydraulic polishing, or using etching technology. In addition, the implant 10; 20; 30; 40; 50; 60 can also be manufactured, for example, by injection molding using the micro injection molding (=MIM) method.FIG. 1 shows a geometrically particularly simple embodiment of the implant 10 according to the invention, in which the entire implant consists solely of the triangular base body 11.In other embodiments of the invention, however, parts of the base body can also be shortened or extended:Thus, FIGS. 2 to 4 show embodiments of the implant 20; 30; 40 according to the invention, in which the triangular base body 21; 31; 41 is extended at one or both catheter edges 22', 23'; 32', 33'; 43' by two side sections 22a, 23a; 32a, 33a; 43a, which respectively extend away from the triangle tip S beyond the hypotenuse edge 24'; 34'; 44', wherein the outer edges 22a', 23a'; 32a', 33a'; 43a" of the two side sections 22a, 23a; 32a, 33a; 43a respectively extend in alignment with their respective catheter edge 22', 23'; 32', 33'; 43'.In the embodiments of the invention illustrated in FIGS. 1 and 2, the implant 10; 20 is constructed symmetrically with respect to an (imaginary) height axis running from the triangle tip S at right angles to the hypotenuse edge 14'; 24', which divides the implant 10; 20 laterally into two mirror-image halves.Exemplary embodiments of an asymmetric construction of the implant 30; 40; 50; 60 according to the invention are shown in FIGS. 3 to 6 c. There, the first catheter edge 32'; 42'; 52'; 62' has a greater longitudinal extension away from the triangle tip S of the triangular base body 31; 41; 51; 61 than the second catheter edge 33'; 43'; 53'; 63'.As can be seen from the embodiments of FIGS. 4 to 6c, at least one, optionally also both, of the base tips of the triangular base body 41; 51; 61, where in each case one catheter edge 42'; 52', 53'; 62', 63' meets the hypotenuse edge 44'; 54'; 64' lying opposite the triangle tip S, can be of shortened or chopped design, so that the end of the respective catheter edge 42'; 52', 53'; 62', 63' facing away from the triangle tip S is connected via a further edge line 42x'; 52x', 53x'; 62x', 63x' to one end of the hypotenuse edge 44'; 54'; 64'.Furthermore, the edge lines of the implant according to the invention do not necessarily have to run linearly:FIGS. 5a to 6c show embodiments of the invention in which at least one of the two catheter edges 53'; 63' and / or the hypotenuse edge 54'; 64' opposite the triangle tip S does not run linearly in a straight line, but rather following a curved curve.As can be seen, for example, in the embodiment spatially represented in FIG. 6c, in the implant 10; 20; 30; 40; 50; 60 according to the invention, some or all edges 12',13',14'; 22',23',24'22a', 23a'; 32',33',34',32a',33a'; 42',43',44',42x',43a'; 52',53',54'52x', 53x'; 62',63',64',62x',63x'in particular at least all outer edges, can also be rounded off in the sheet metal plane of the blank.Embodiments of the invention are not specifically shown in the drawing, in which one or more spikes are incorporated into the triangular base body 11; 21; 31; 41; 51; 61 and optionally also into the side sections 22 a, 23 a; 32 a, 33 a; 43 a.Typical blank sizing designs for the boomerang embodiments of the implant 50; 60 of the present invention are shown in Figures 7a and 7b. In particular, FIG. 7 ashows the respective radii of curvature of the non-linearly extending hypotenuse and catheter edge and FIG. 7 bshows the radius of the slight curvature from the blank plane.The main purpose of the implant according to the invention is a permanent spreading of a nasal lobe from the nasal septum. Indications may be, for example, deviations due to trauma, conjunctival deviation, etc., or simply breathing disorders of the patient due to a nasal lobe located too close to the septum and the flow constriction of the breathing air flow caused thereby.List of reference numbers:10; 20; 30; 40; 50; 60 A rheological implant 11; 21; 31; 41; 51; 61 of triangular basic body 12', 13'; 22', 23'; 32', 33'; 42', 43'; 52', 53'; 62', 63' catheter edges 14'; 24'; 34'; 44'; 54'; 64' hypotenuse edge 22a, 23a; 32a, 33a; 43a protruding lateral sections 22a', 23a'; 32a', 33a'; 43a' outer edges of the lateral sections 42x'; 52x', 53x'; 62x', 63x' further edge line 15 perforations 15' fixed partial sections S triangle apex φ triangle angleReference list:Publications considered for the evaluation of patentability:[0] DE 20 2008 010 203 U1

[00] US 2021 / 0 077 292 A1[1] DE 10 2006 023 058 B3≈ EP 1 857 078 B1[2] DE 203 07 058 U1≈ DE 20 2004 021 075 U1≈ EP 1 475 056 B1[3a] Internet site of Prof. Dr. a Wengen, 30.01.2024, https: / / breathhe implant.com / de / .[3b] Internet page of the company Kurz of 30.01.2024 https: / / www.kurmed.com / de / produkt / rhinology / breatheplant-awengen. html[3c] Web page from Bess of 30.01.2024 https: / / bess.eu / rhinology / breathe-implant-awenagen[4] US 2012 / 0078367 A1[5] WO 2008 / 153263 A1[6] CN 21 538 4901 U[7] U.S. Pat. No. 11 241 306 B2[8] U.S. Pat. No. 6,322,590 B1[9] WO 00 / 06327 A2

Claims

Implant (10; 20; 30; 40; 50; 60) for spreading at least one nasal leaflet, which can be fastened in the human nose, bears over the whole area on at least one inner surface of a nasal leaflet in the implanted state and is constructed from a blank of thin sheet metal provided with a plurality of through-perforations (15); wherein the initially flat blank is bent, before the implantation, into a three-dimensional shape which is curved out of the sheet metal plane and follows the natural bending of the inner side of the soft nasal side wall; wherein the implant (10; 20; 30; 40; 50; 60) bears over the whole area on only one inner surface of a single one of the two nasal leaflets; and wherein the implant (10; 20; 30; 40; 50; 60) bears over the whole area on only one inner surface of a single one of the two nasal leaflets; and wherein the implant (10; 21; 31; 41; 51; is a triangular basic body (11; 21; 31; 41; 51; 61 ), in which two catheter edges (12', 13'; 22', 23'; 32', 33'; 42', 43'; 52', 53'; 62', 63') are arranged relative to one another at a triangle angle (φ) starting from a triangle tip (S), each lead away from the triangle tip (S) and each run on both sides in the direction of a hypotenuse edge (14'; 24'; 34'; 44'; 54'; 64'), opposite the triangle tip (S), characterized in that at least one, preferably both, base tips of the triangular base body (41; 51; 61), where a catheter edge (42'; 52', 53'; each case runs in the direction of a hypotenuse edge (14'; 24'; 34'; 44'; 54'; 64'), characterized in that at least one, preferably both, base tips of the triangular base body (41; 51; 61) are each a catheter edge (42'; 52', 53'; 62', 63') on which the hypotenuse edge (44'; 54'; 64') opposite the triangle tip (S) meets, are of shortened or chopped design, so that the end of the respective catheter edge (42'; 52', 53'; 62', 63') facing away from the triangle tip (S) is connected to an end of the hypotenuse edge (44'; 54'; 64') via a further edge line (42x'; 52x', 53x'; 62x', 63x').Implant according to claim 1, characterised in that at least one of the two catheter edges (53'; 63') and / or the hypotenuse edge (54'; 64') opposite the triangle tip (S) does not run linearly in a straight line, but rather following a curved curve.Implant according to claim 1 or 2, characterised in that the triangular base body (21; 31; 41) is extended at one or both catheter edges (22', 23'; 32', 33'; 43') by two side sections (22a, 23a; 32a, 33a; 43a) which each extend away from the triangle tip (S) beyond the hypotenuse edge (24'; 34'; 44'), wherein the outer edges (22a',23a'; 32a', 33a'; 43a') of the two side sections (22a, 23a; 32a, 33a; 43a) each extend in alignment with their respective catheter edge (22', 23'; 32', 33'; 43').Implant according to one of the preceding claims, characterized in that the triangle tip (S) and preferably also all further, at least the outer, corners of the implant (10; 20; 30; 40; 50; 60) are rounded.Implant according to one of claims 1 to 4, characterised in that the implant (10; 20) is constructed symmetrically with respect to a height axis running from the triangle tip (S) at right angles to the hypotenuse edge (14'; 24'), which divides the implant (10; 20) laterally into two mirror-image halves.Implant according to one of claims 1 to 4, characterised in that the implant (30; 40; 50; 60) is constructed asymmetrically, wherein a first catheter edge (32'; 42'; 52'; 62') has a greater longitudinal extent away from the triangle tip (S) of the triangular base body (31; 41; 51; 61) than the second catheter edge (33'; 43'; 53'; 63').Implant according to one of the preceding claims, characterized in that one or more spikes are incorporated into the triangular base body (11; 21; 31; 41; 51; 61).Implant according to one of the preceding claims, characterized in that the perforations (15) together have a greater surface area than the solid partial sections (15') of the implant (10; 20; 30; 40; 50; 60), which sections surround the perforations (15) and are in particular formed in the shape of webs, and in that preferably at least some of the perforations (15) are formed in the shape of polyhedrons or honeycombs.Implant according to one of the preceding claims, characterized in that all edges (12',13',14'; 22',23',24'; 22a', 23a'; 32',33',34',32a',33a'; 42',43',44',42x',43a'; 52',53',54'; 52x', 53x'; 62',63',64',62x',63x') of the implant (10; 20; 30; 40; 50; 60), at least all outer edges, are rounded off in the sheet metal plane of the blank.Implant according to any one of the preceding claims, characterized in that the sheet thickness of the flat blank for the implant (10; 20; 30; 40; 50; 60) is between 0.2 mm and 1.2 mm, preferably about 0.8 mm, and the maximum longitudinal extent is between 2 mm and 7 mm, preferably about 5 mm.Implant according to one of the preceding claims, characterized in that the triangle angle (φ) at the triangle tip (S) of the triangular base body (11; 21; 31; 41; 51; 61) is between 60° and 160°, preferably between 100° and 120°.Implant according to one of the preceding claims, characterized in that the implant (10; 20; 30; 40; 50; 60) has a body-compatible coating.Implant according to one of claims 1 to 12, characterised in that the implant (10; 20; 30; 40; 50; 60) is made of sheet metal, in particular of pure titanium or a titanium alloy, or of a material with memory effect and / or superelastic properties, preferably of nitinol.Implant according to one of claims 1 to 12, characterised in that the implant (10; 20; 30; 40; 50; 60) is made entirely or partially from sheet plastic, in particular from polymer material, preferably from a material which has a similar flexibility to the human nasal wings but has sufficient rigidity to effect a permanent and stable spreading of a nasal wing from the septum.

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